NHS Digital Data Release Register - reformatted

London School Of Hygiene And Tropical Medicine projects

745 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 London School Of Hygiene And Tropical Medicine was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. London School Of Hygiene And Tropical Medicine may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

Delivering integrated care systems and patient choice for specialist cancer treatments in the NHS: impact on access, equity and outcomes of care — DARS-NIC-656815-R5X0N

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2025-06-28 — 2027-06-27

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Cancer Waiting Times (CWT) Data Set
  2. NDRS Cancer Registrations
  3. NDRS Linked HES AE
  4. NDRS Linked HES APC
  5. NDRS Linked HES Outpatient
  6. Radiotherapy Data Set
  7. Systemic Anti-Cancer Therapy Data Set

Objectives:

London School of Hygiene and Tropical Medicine (LSHTM) requires access to NHS England data for the purpose of the following research project:
Delivering integrated care systems and patient choice for specialist cancer treatments in the NHS: impact on access, equity and outcomes of care

The following is a summary of the aims of the research project provided by the London School of Hygiene and Tropical Medicine:

The NHS is centralising cancer services to fewer centres, either by closing smaller specialist cancer units or limiting the types of treatments they offer to improve patient outcomes and use limited resources more effectively. It is expected that networking between referring hospitals and specialist cancer centres will guarantee access to all evidence-based treatments. However, these models of care delivery have been associated with difficulties in access to treatment for cancer patients, which has had a worsening effect on their health outcomes. In addition, variation in the quality of treatment persists across specialist NHS cancer centres. The NHS also continues to support patients to have a choice of treating hospital. Through their choices, it is expected that patients will shape the service to improve their experience and reduce waiting lists. This is important given the findings from previous research which demonstrated that up to one in three prostate cancer patients travel beyond their nearest surgical or radiotherapy centre for treatment, especially younger, healthier and more affluent patients. This movement of patients had unintended consequences on the number of cancer centres performing surgery and the use of high-cost technologies, with no evidence this has improved the quality of care.

The main aim of this project is to work out how specialist cancer treatment services can be integrated or centralised in a way that reduces the burden of travel for the sickest, elderly and most socially deprived patient groups but at the same time improves the quality and effectiveness of service delivery given workforce constraints (such as access to limited numbers highly specialised surgeons or the availability of new treatments like Proton Beam Therapy, a type of radiotherapy).

Service design also needs to make sure patients have an appropriate choice of treating hospital and are allowed to shape the service to improve their overall experience, without impacting on the equity (fairness) and efficiency of the health service through their mobility. This is a complex issue and needs to start by understanding the factors influencing differences in access, type of treatment, and outcomes of specialist cancer care.

LSHTM will use this data to look at the following:

· investigate the patient and hospital factors that influence where patients with different cancer types receive their treatment (patient mobility). This includes the use of specialist services (such as robotic surgery, stereotactic radiotherapy) and measures of hospital and treatment quality (such as waiting times, short and long term toxicity, recurrence rates, readmission rates, survival, and patient experience)
· understand what patient mobility means for patterns of hospital service use and patient-level outcomes
· look at the impact of the organisation of cancer services in England on access to specialist cancer treatments, type of treatment and outcomes and the factors related to this
· model what impact different configurations (closures or reallocation) of specialist cancer treatment services would have on travel burden, equity in access to services and patient outcomes to inform service design
· consider changes in the delivery of cancer care services, particularly patient mobility and consolidation of specialist cancer treatment services during the COVID-19 pandemic

The project will be comprised of four work packages to address the following objectives:

1. To investigate whether patients with different cancers bypass their nearest specialist treatment services, and to understand the patient and service characteristics associated with this mobility.
2. To understand what patient mobility means for patterns of hospital service utilisation.
3. To investigate the impact of hub-and-spoke centralisation of cancer services in England on access to specialist cancer treatments and outcomes.
4. To model what impact different configurations (closures or reallocation) of specialist cancer treatment services would have on travel burden, equity in access to services and patient outcomes to inform service design.

The following NHS England Data will be accessed:
> NDRS Linked Hospital Episode Statistics (HES) Admitted Patient Care (APC), Outpatients (OP) and Accident & Emergency (A&E) - necessary because they provide information on treatments and provider characteristics to enable comparison.
> NDRS Cancer Registration – necessary because to identify the cohort of patients to which this dataset pertains, fields included in this dataset capture mortality data this data is necessary because it provides information on patient outcomes necessary for the mobility and outcome work.
> Cancer Waiting Times (CWT) - necessary to map treatment pathways including treatments after a cancer diagnosis. CWT data will be used a performance measure.
> The National Cancer Patient Experience Survey (CPES) - necessary because it provides information on experience of care at individual hospitals and services and with it the potential reasons why patients select particular hospitals for treatment.
> Radiotherapy Data Set (RTDS) and Systemic Anti-Cancer Therapy (SACT) data set to identify patients receiving these modalities, and to categorise them according to type, intent and duration of regimen.

The level of the Data will be:
> Pseudonymised

The Data will be minimised as follows:
> Limited to a study cohort identified by NHS England as meeting the following criteria: all breast, bowel, prostate and oesophageal cancer patients, newly diagnosed between 2013 to 2022 in England (approximately 1.2 million patients). These cancers have been chosen as they present different challenges in defining how best to organise services as they vary in their presentation and treatments. 40 men and women treated for these cancers in the English NHS will be interviewed as part of the study.
> HES data is minimised to all episodes of care 12 months before to 36 months after diagnosis in the initial cohort defined above. HES data is requested 12 months before diagnosis to calculate comorbidity scores and understand history of investigations and interventions prior to diagnosis.
> RTDS/SACT data is minimised to all episodes of care within 30 days before to 36 months after diagnosis in the initial cohort defined above.

LSHTM is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because the routinely collected data is to be used to support improvements in the quality and equality of access of NHS cancer services.

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the project described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

Public and Patient Involvement (PPI) has informed the scope, objectives and design of the study. Patients expressed concerns around the continued lack of transparent information on why NHS cancer services are continually changing; expecting some patients to travel further for care with no clear evidence of quality improvement. Following their recommendations, four cancer types will be investigated, and interviews undertaken with patients diagnosed with these cancers. The written proposal has been reviewed by four PPI groups and feedback regarding the lay summary, methods and dissemination strategy incorporated. A six-person PPI Advisory Panel will feed into the work packages, guide the dissemination strategy, and co-design planned engagement activity.

Yielded Benefits:

Through this NIHR funded project, LSHTM have: 1. Developed centralisation models for organising NHS cancer services which are being adopted by NHS England and have been presented at the WHO and the IAEA and have informed cancer control policy. 2. Modelling work has provided analysis to support management of the cancer backlog in the NHS by identifying spare capacity. 3. Modelling work has identified at risk regions and populations where worse access to treatment (measured by travel times) is observed and where direct recommendations for building NHS capacity is recommended. 4. Analysis has identified how different models of service design of treatment services directly impacts on patient outcomes. 5. The outputs have directly involved patients in the co-development of the question, analysis and writing.

Expected Benefits:

This study is expected to provide high quality evidence to inform how the NHS can improve the delivery of specialist cancer treatment services (particularly surgery and radiotherapy). From the patients’ perspectives, understanding how different patient groups respond to the current service and treatments on offer will inform service re-design to reduce inequalities and improve outcomes.

From the hospitals’ perspective, this study will provide an understanding of how current networked models of cancer care delivery between referring and specialist centres impact on access to specialist treatments and outcomes. It will support health care planners to investigate the service and audit the impact of potential changes in the configuration of cancer (or non-cancer) specialist services on access and patient outcomes.

From the health policy makers’ perspective, it is important that further integration or centralisation of services is based on evidence that alternative centres provide either better care or improved access, particularly for vulnerable groups. This research will inform commissioners, Clinical Commissioning Groups and cancer alliance boards of the current use of cancer services and identify gaps in access. By advising policymakers how to reconfigure cancer services for breast, bowel, prostate and oesophageal cancer types, this research is expected to have a significant impact for individuals with these cancers.

The use of the data could:
> help the system to better understand the health and care needs of populations.
> lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
> advance understanding of regional and national trends in health and social care needs.
> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

Research publications and policy briefings to hospitals and NHS Cancer Alliances will be used to disseminate the research findings. Engagement with NHS policymakers, clinicians, charitable and academic communities will take place through the Steering Committee and planned policy workshops. A debate will be organised to engage with the public regarding the implications of NHS hospital closures, guided by my findings.

Outputs:

The expected outputs of the processing will be:
> Clinical and health policy related peer reviewed journals
> Presenting at cancer specific, health services research and policy focused conferences

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
> Journals
> Policy briefings
> National and international clinical/health policy related conferences

Outputs are expected to be produced throughout late 2024 – mid 2026.

Processing:

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the HES, Cancer Registry, SACT, CWT, CPES, RTDS to LSHTM. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at LSHTM.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;
- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England. The data will not leave England at any time.

Access is restricted to employees or agents of LSHTM who have authorisation from the Principal Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The data will not be linked with any other data than that requested.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Researchers from LSHTM will analyse the Data for the purposes described above.

Management of patients with chronic liver disease admitted to hospital as an emergency - ICNARC — DARS-NIC-708052-S1L9J

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 - s261(5)(d)

Purposes: No (Research)

Sensitive: Non-Sensitive

When:DSA runs 2023-08-14 — 2024-08-13

Access method: One-Off

Data-controller type: KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Demographics

Objectives:

London School of Hygiene and Tropical Medicine (LSHTM) and Kings College Hospital NHS Foundation Trust (KCH) require access to NHS England data for the purpose of the following research project: Management of patients with chronic liver disease admitted to hospital as an emergency

The following is a summary of the aims of the research project provided by LSHTM and KCH:
“The overall aim is to identify which characteristics of treatments and services for acutely ill people with chronic liver disease (CLD) impact on care processes and outcomes, in order to improve the national organisation and delivery of care for all people acutely ill with CLD.

Specific objectives include:
• Describe critical care use and clinical outcomes after a first emergency admission in patients with CLD.
• Explore the impact of regional clinical networks on referral patterns, by creating “super-spells” for each patient and identifying within this super-spell the hospital of the admission and the hospital trust where most of the care was provided. The configuration and characteristics of these networks will be compared, as will regional and organisation changes in referral patterns as a result of the Covid-19 pandemic.
• Explore the impact of regional, hospital and patient characteristics, and the impact of the Covid-19 pandemic at a hospital and regional level, on critical care use of chronic liver disease patients who had a first emergency admission.
• Explore the regional variation in the use of liver transplantation in the first year after an emergency admission”

The following NHS England data will be accessed:
• Demographics – necessary to provide cohort identifiable information to the Intensive Care National Audit & Research Centre (ICNARC) for the purpose of retrieving additional relevant intensive care clinical data, which will be sent on to LSHTM in a pseudonymised form.

The data will be minimised as follows:
• Limited to a study cohort identified by NHS England under DARS-NIC-667506-N6Q9G as meeting the following criteria: all patients older than 18 years (or with missing age) with chronic liver disease (CLD) who were admitted with an emergency hospital admission between 1 April 2007 and 31 March 2022. It is anticipated that this will cover ~210,000 patients.

KCH as the research sponsor, and LSHTM as the main collaborator, are joint controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by National Institute for Health Research (NIHR). The funding is for the programme of work and is not specifically limited to the study described. Funding is in place until October 2024.

ICNARC is a processor acting under the instructions of KCH and LSHTM. ICNARC’s role is limited to retrieving additional relevant intensive care clinical data from their databases for the study cohort described above, and sending this on to LSHTM in a pseudonymised form.

Exponential-E provide IT storage/ back-up to ICNARC and will store the data as contracted by ICNARC.

Babble Cloud (SUI) Limited provide external desktop and network managed services to ICNARC. Babble Cloud (SUI) Limited will not access the data held under this agreement.

The British Liver Trust is involved in the wider project in an advisory capacity for the patient engagement and dissemination stages, and will have no access to the data or involvement in data analysis.

University of Exeter and King’s College London are involved in social science work packages of the wider project, and will have no access to the data or involvement in data analysis.

Consultation with people with liver disease was undertaken at the very earliest initial planning stages of this project. Informal discussion was first held with people hospitalised with CLD at King’s College Hospital, and with their next of kin, and following an encouraging response an initial research plan was developed.

Through research partners (the British Liver Trust), an online survey of 57 people with CLD from across the UK was conducted to understand their attitudes to the goals and basic research methods under consideration. This sample was representative of the patients with CLD who would be in the proposed study cohort in respect of age, sex and cause of liver disease. More than 80% had required hospitalisation as a consequence of CLD. More than 90% felt it “extremely important” to understand regional variations in outcome of CLD. More than 90% supported the research and felt it to be addressing an important subject, endorsing the approaches proposed to be utilised, including the use of de-identified linked electronic health records. Thirty-three of the respondents volunteered to join an online patient consultation group for the research project.

A face-to face focus group was then conducted with 19 people who had liver transplant for CLD, many of whom had experienced emergency admission at an early stage of their illness. This group also confirmed support for the proposed research and its methodology.

A patient representative with lived experience of CLD, emergency admission and liver transplant is now a grant co-applicant and member of the research team, as is a representative of a patient organisation, the British Liver Trust (BLT). As members of the research team they will be involved in all stages of the research cycle including prioritising research questions, advising upon and managing the research process and routes to data opt-out, analysing and interpreting the results of research, with a prominent role in dissemination of findings.

A Patient Advisory Group (PAG) is to be recruited that will include people with liver disease and lived experience of drug and alcohol services and homelessness. The PAG will be convened at 6 monthly intervals to consider and advise on research questions, conduct and the actions that should follow its findings, feeding back to the research team.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of chronic liver disease (CLD) patients.
The research is expected to provide a better understanding of three interacting complexities: the complexity of CLD and its treatment options, the complexity of the life situation of many CLD patients, and the complexity of the healthcare system. The study’s findings are expected to lead to recommendations about how the services for patients with CLD can be made safer and more effective.

The use of the data could :
· help the system to better understand the health and care needs of populations.
· lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
· advance understanding of regional and national trends in health and social care needs.
· inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
· inform decisions on how to effectively allocate and evaluate funding according to health needs.
· provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
· support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Patient representatives with lived experience of CLD are members of the research team and will be involved in analysing and interpreting the results of the study, with a prominent role in dissemination of findings.

Recognising patients and the public as key stakeholders in the research, the dissemination plan includes webinars, presentations and reports for patients and patient organisations. Patient representatives will be involved to ensure that all relevant organisations are engaged and that the style and format of publications is accessible to these audiences.

Outputs:

The expected outputs of the processing will be:

• Reports and papers:
The research team will contribute to a final research report for the funder (NIHR) detailing research methods, findings and conclusions, including recommendations for practice and an extensive summary for patients and the wider public.

The research team will prepare manuscripts to submit for publication in peer-reviewed academic journals, in line with the research objectives outlined above.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• The research team intend to organise an end-of-project workshop to formulate recommendation for practice. Participants of this workshop are expected to include NHS England’s Specialised Commissioning Team (or its relevant successor), the British Association for the Study of the Liver (BASL), the British Society for Gastroenterology (BSG) and the Intensive Care Society (ICS). This workshop is planned to produce messages that fit the research team’s audiences (e.g., patient and public, commissioners, clinicians, regulators and policy makers). The recommendations are intended to be summarised in a report that will be disseminated across all the research team’s stakeholders.

The research team expect to produce policy advice targeting NHS England at national level to the Specialised Commissioners, and at a regional level by engagement with regional medical directors through formal meetings to discuss the findings and inform change at the local commissioning level. In addition to formal commissioning, the research team plan to engage lead hepatologists in NHS Trusts via the BASL and BSG liver networks and ensure they are aware of the findings and the value of introducing change to their organisations.

The research team intend to feed back to The National Institute for Health and Care Excellence (NICE) on findings relating to NICE Pathways on the management of acutely ill patients in hospital, and NICE guidelines on gastrointestinal bleeding, acute kidney injury, complications of cirrhosis, and recognising and responding to deterioration. The research team plan to prepare a training package and associated resources aimed at relevant professional bodies, including the BSG, BASL, ICS, and NHS Blood and Transplant, and which can be used by clinicians and drug and alcohol services to give information, address stigma and improve patient engagement.

The target dates for production and dissemination of the outputs are Q4 2023- Q3 2024.

Processing:

No data will flow to NHS England for the purposes of this Agreement.

NHS England will provide the relevant records for the cohort identified under DARS-NIC-667506-N6Q9G to the Intensive Care National Audit & Research Centre (ICNARC). The data will contain directly identifying data items including NHS number, sex, date of birth, postcode and a unique person ID which are required to link with ICNARC data.

ICNARC will store the NHS England data on private Cloud servers hosted by Exponential-E.

The NHS England data will be accessed onsite at the premises of ICNARC, or by authorised personnel via remote access. The data will remain on the servers at Exponential-E at all times. Babble Cloud (SUI) Limited have the ability to access NHS England data for logistical reasons but will not access the data held under this agreement. The NHS England data will not be transferred to any other location.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to employees of ICNARC who have authorisation from the Head Statistician.

Employees or agents of LSHTM and KCH will not have access to identifiable NHS England data.

Exponential-E and Babble Cloud (SUI) Limited are not permitted to access the data.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will be linked at a person record level with datasets obtained from ICNARC. ICNARC will destroy the NHS England data once the pseudonymised intensive care records for those individuals have been provided to LSHTM and successfully linked back to the pseudonymised HES and mortality data provided to LSHTM under DARS-NIC-667506-N6Q9G.

Data managers will process the data for the purposes described above.

Updating trends in the cancer survival index for England and Wales ( ODR1920_179 ) — DARS-NIC-656861-S5H3R

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Does not include the flow of confidential data)

Legal basis: National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive

When:DSA runs 2023-05-22 — 2023-12-31

Access method: One-Off

Data-controller type: CANCER RESEARCH UK, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations

Objectives:

The aim of this project is to assess progress in an index of cancer survival up to 10 years after diagnosis for patients diagnosed with a cancer in England or Wales.

The index is a simple, one-number summary of survival for all cancers combined.

The index was last published for patients who had been diagnosed in England and Wales up to 2010, as part of CRUK's research strategy launch in 2014. The work is funded and commissioned by CRUK.

In this project, The LSHTM will update the cancer survival index with the most up-to-date available data.

Noting CRUK commission this work to LSHTM, CRUK have been added as joint data controller under this iteration of the agreement.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

Yielded Benefits:

None so far - we expect to be able to produce a report for Cancer Research UK within the next six weeks, and to submit an article for peer-reviewed publication by the end of 2023.

Expected Benefits:

The Cancer Survival Index (CSI) is a one number summary of survival for all cancers combined. It represents a weighted average of survival for each of the many types of cancer. Survival for the various types of cancer differs very widely, for example less than 10% at five years for pancreatic cancer, and almost 100% for testicular cancer. The weights that are used are designed to ensure that the CSI only changes over time if survival for a particular cancer changes, whether in men or women, or at a particular age. The CSI is therefore a useful simple measure that enables comparison within England and Wales over a very long period of time. The CSI can be estimated at one, five, seven or even 10 years after diagnosis.

The CSI is readily understood by the public and by politicians. Cancer Research UK has used previous iterations of the CSI extensively in its campaigns aimed to raise resources from the general public for research into improving cancer survival.

Outputs:

The aim of this project is to assess progress in an index of cancer survival for all cancers combined up to 10 years after diagnosis for patients diagnosed with a cancer during the period 1971-2018 in England or Wales and followed up to the end of 2019. The index is a simple, one-number summary of survival for all cancers combined.

The index was last published for patients who had been diagnosed in England and Wales between 1971 and 2010, as part of CRUK's research strategy launch in 2014. We expect that the cancer survival index at 10 years after diagnosis will have increased since 2014.

Processing:

Data for England was obtained from the National Cancer Registry, maintained since 2013 by Public Health England and NHS England from 2021. The Office for National Statistics (ONS) and predecessor bodies had previously collated data from regional cancer registries covering the entire population of England since the 1960s. Individual cancer registrations are routinely updated with information on each patient’s vital status (alive, emigrated, dead or not traced). Data will be extracted for patients diagnosed during 1971-2018. As of 1 January 2021, the vital status at 31 December 2018 or 2019 is expected to be known for at least 99% of these patients.

Equivalent data for Wales will be obtained from the Welsh Cancer Intelligence & Surveillance Unit.

Data will be requested for all adults (15-99 years) who were diagnosed with a first, primary, invasive malignancy, but patients diagnosed with a malignancy of the skin other than melanoma will not be included.

Extensive, standardised quality control procedures will be performed on all the data sets.

Population-based survival estimates must take account of the wide variations in background mortality by age, sex and region, and over time. Background mortality will be taken from life tables that we have created for England and Wales, comprising all-cause mortality rates per 100,000 by single year of age and sex for each calendar year 1971-2018.

Analyses for the cancer survival index will combine the data for England and Wales.

Separate analyses for England and for Wales may be produced later.
The study team will first produce estimates of net survival for each combination of cancer (or group of cancers), age at diagnosis (5 groups), sex and period of diagnosis. The study team will then construct the survival index as a weighted sum of the net survival estimates for every combination of these groupings, using the proportion of cancer patients diagnosed in England and Wales during 1996-99 in each age group, sex and type of cancer as the standard weights.

The LSHTM will use statistical models to estimate the excess hazard of death in each calendar period since 1971 among cancer patients in each stratum defined by age group, sex and type of cancer, over and above the corresponding risk of death in the same calendar period in the general population (obtained from the life tables). The study team will use flexible, parametric excess hazard regression models. The study team will include age and year at diagnosis as main effects, modelled on a continuous scale with regression cubic splines, in order to account for potential non-linearity of excess hazards with time since diagnosis. This will enable the study to make a reasonable prediction of survival up to 10 years after diagnosis for patients who were diagnosed as recently as 2018.

The standard weights to be used in all analyses will be the proportionate distribution by age, sex and type of cancer of patients who were diagnosed in England and Wales during 1996-1999, the same weights as used for previous analyses.

Models will be fitted with the STATA command stpm2. Model selection procedures will be automated to choose the best-fitting model among candidate models, by choosing the model with the smallest Akaike Information Criterion. The STATA post-estimation command predictnl will be used to predict a cancer survival estimate from the cumulative excess hazard estimated by the model. Net survival estimates for each type of cancer, sex and year of diagnosis will be obtained by averaging the individual net survival curves, predicted by the model, over all the ages within each age group.

The LSHTM will present the number of cancer patients included in the analyses by type of cancer and period of diagnosis.

The LSHTM will provide estimates of the net survival index at 5 and 10 years after diagnosis, for each calendar period, for all adults (adjusted for age, sex and cancer), and separately by sex (adjusted only for age and cancer)

Inequalities in Cancer Survival (ODR_1516_050) — DARS-NIC-656757-J8V9D

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Non-Sensitive

When:DSA runs 2023-07-10 — 2024-07-09

Access method: One-Off, Ongoing

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations
  2. NDRS Linked Cancer Waiting Times (Treatments only)
  3. NDRS Linked DIDs
  4. NDRS Linked HES AE
  5. NDRS Linked HES APC
  6. NDRS Linked HES Outpatient
  7. NDRS Lung Cancer Data Audit (LUCADA)
  8. NDRS National Cancer Diagnosis Audit (NCDA)
  9. NDRS National Cancer Patient Experience Survey (CPES)
  10. NDRS National Radiotherapy Dataset (RTDS)
  11. NDRS Quality of Life of Cancer Survivors in England
  12. NDRS Quality of Life of Colorectal Cancer Survivors in England
  13. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)
  14. NDRS Cancer Pathway
  15. NDRS National Lung Cancer Audit (NLCA)

Objectives:

The London School of Hygiene and Tropical Medicine (LSHTM) requires continued access to NHS England National Disease Registration Service (NDRS) data for the purpose of the following research project:
Inequalities in cancer care and cancer outcomes: the role of patient, tumour, clinical and healthcare system factors in primary and secondary care sectors.

Access to the required data was previously provided by the Public Health England (PHE) Office for Data Release (ODR) under the reference ODR1516_050. Following the dissolution of PHE in October 2021, the function of governing access to NDRS data transferred to NHS Digital, NHS Digital has since merged into NHS England.

The following is a summary of the aims of the research:
The study aims to study why and how inequalities in cancer survival (e.g. between geographies, age groups, or socioeconomic levels) arise and persist in England, by studying how survival is affected by characteristics of the patient (including awareness, co-morbidity), the tumour (including the stage at diagnosis), the management and care of the patients (including the primary and secondary care pathways) and the healthcare system factors (including the characteristics of the hospital or surgeons).

To explain these observed inequalities and the mechanisms leading to these inequalities, the study needs to disentangle the respective roles of the patient, tumour, clinical and healthcare system factors along the journey experienced by the patients from their first symptoms to their diagnosis, treatment and eventually death (from any cause).

Research questions the study has planned to investigate include (but are not limited to):
•Does late diagnosis lead to differential management and a higher risk of emergency presentation?
•Are the prevalence and severity of comorbid conditions associated with the quality of cancer care?
•Do the referral pathway and other factors impact the diagnostic investigation, the decision to treat and the type of treatment received?
•Do healthcare system factors affect cancer outcomes?
•What are the barriers and factors that patients and healthcare professionals consider fundamental for making clinical decisions?
•What factors affect patient-reported outcomes and which characteristics of their experience affect cancer outcomes?
•Can differential long-term survival be due to late recurrence or late adverse effects?

While the above list is not an exhaustive list of all research questions the study plans to address, all research questions are limited to lines of enquiry that will allow the study to better understand how and why inequalities in cancer survival arise and persist.

The following NHS England NDRS datasets have already been received and will continue to be accessed:
•NDRS Cancer Registry
•NDRS Linked Cancer Waiting Times (treatments only)
•NDRS Linked Diagnostic Imaging Dataset (DIDS)
•NDRS Linked Hospital Episode Statistics (HES) Accident and Emergency (A&E)
•NDRS Linked HES Admitted Patient Care (APC)
•NDRS Linked HES Outpatient (OP)
•NDRS National Lung Cancer Data Audit (NLCA)
•NDRS National Cancer Diagnosis Audit (NCDA)
•NDRS National Cancer Patient Experience Survey (CPES)
•NDRS National Radiotherapy Dataset (RTDS)
•NDRS Quality of Life of Cancer Survivors
•NDRS Quality of Life of Colorectal Cancer Survivors
•NDRS Systemic Anti-Cancer Therapy (SACT) Datasets


The level of data is pseudonymised, and the data has been minimised as follows:
•Limited to individuals with invasive malignant cancers.
•Limited to data between 1995-2018, the minimum amount required to achieve the aims outlined within this Agreement
•Limited to the following geographic areas: England
•Limited to the least granular data possible (i.e. full dates are not held)

LSHTM is the controller who determines the purpose and means of processing, and the organisation responsible for ensuring that the data will only be processed for the purposes described above. LSHTM is the only processor, and will only process data as outlined above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The funding for this project comes from multiple sources, including but not limited to:

The funding comes from multiple sources. Current funders include:
•Cancer Research UK (CRUK)
•Medical Research Council (MRC)
•National Institute for Health and Care Research (NIHR)
•Pancreatic Cancer Research Fund (PCRF)
Funding for the work is ongoing and will continue for the foreseeable future.

The study undertakes various Public and Patient Involvement and Engagement (PPIE) activities. The project team works with patients whose lives have been affected by cancer, these individuals may serve as co-investigators, collaborators or lay members of project advisory groups. The project team have a long association with the National Cancer Research Institute (NCRI) Consumer Forum, which runs ‘Dragon’s Den’ Sessions where patients can provide input and feedback on research proposals.

Yielded Benefits:

The project has continued to benefit the provision of health and social care since it began. Due to the wide-ranging nature of the project, there are many yielded benefits, a selection of examples is provided on the project's webpages.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practices to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

Specific benefits may include, but are not limited to:
• Informing the development of strategies and solutions for tackling inequalities in cancer care and cancer outcomes
• Better and more informed management of cancer patients and their treatment
• Improved access to optimised care.

It is hoped that through the publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

The project team has regular engagement with key stakeholders, patient representatives, clinicians and cancer alliances to ensure that findings are widely advertised. In addition, regular engagement with CRUK and the All Party Parliamentary Group for Cancer aids the project in disseminating findings and ensuring that appropriate strategies are implemented to address inequalities.

Outputs:

The expected outputs of the processing will be:
•Submissions to peer-reviewed journals, submissions will be regular and ongoing due to the broad scope of the project. The project will submit to reputable journals including the British Journal of Cancer, the Lancet and Oncology.
•Presentations at wide variety of conferences, including the World Cancer Congress, World Congress of Epidemiological and other relevant events relating to cancer, epidemiology and health statistics.
•Tools containing aggregated data.

The outputs will not contain NHS England data. They will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
•Journals
•Social media- Twitter (@icon_lshtm)
•Co-hosted events with the likes of the NIHR- next event scheduled for July 2023
•Public events with patients and stakeholders
•Press/media engagement
•Public promotion of the research on the project's web pages and other relevant blogs. Infographics are regularly produced to ensure research findings are accessible to all audiences.
•Reports aimed at patients

Outputs will continue to be produced on a regular and ongoing basis.

Processing:

No data will flow into or out of NHS England for the purposes of this Agreement, this permits the retention and processing of data already held only.

The data will not be transferred to any other location once at LSHTM. The data will be stored on servers based at LSHTM, all back-ups are onsite and at LSHTM.

The data will be accessed by authorised personnel via remote access. The data will remain on servers at LSHTM at all times, and personnel are prohibited from downloading or copying data to local devices.

The data will be processed and accessed within England and Wales only. This DSA strictly prohibits access of data outside of England and Wales.

Access is restricted to employees, students or agents of LSHTM who have authorisation from the Project Lead.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will not be linked with any other data.

There will be no requirement or attempt to re-identify individuals when using the data.

Analysts from LSTHM will process the data for the purposes described above.

(MR1355) The MANCHESTER and (MR1016) ARTISTIC COHORTS (HPV and Cervical Cancer) — DARS-NIC-58603-S6Z1B

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N, Yes - patient objections upheld, Anonymised - ICO Code Compliant, Identifiable, Yes (Section 251 NHS Act 2006)

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii); Other-Section 251, Health and Social Care Act 2012 – s261(7); Other-Section 251, Health and Social Care Act 2012 – s261(2)(b)(ii); Other-Section 251, Health and Social Care Act 2012 – s261(2)(a); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2018-09-01 — 2021-08-31 2017.12 — 2024.08.

Access method: Ongoing, One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. Civil Registration - Deaths
  5. Cancer Registration Data
  6. Demographics
  7. MRIS - Bespoke
  8. Civil Registrations of Death

Objectives:

The objective for the Manchester Cohort is to study the long term risk of cervical cancer and cervical pre-cancer following Human papilloma virus (HPV) infection.

The aims are to obtain the data required to evaluate the long-term benefits and costs of alternative screening strategies using primary HPV testing and to investigate;

1. The long-term protection of a negative HPV test and hence the safe screening interval at different ages

2. Optimal ages at start and stopping screening

3. The role of HPV typing and test sensitivity

4. Triage of HPV positive women, particularly the interval to retesting for HPV positive women

The team will follow-up this unique cohort in order to determine long-term risks associated with HPV infection. HPV is the most common sexually transmitted disease but unfortunately most people do not know they are infected with the virus since the initial symptoms can be minor.

The cohort was recruited between 1987-1993 in collaboration with over 100 general practitioners and screening clinics in the Greater Manchester area who used the Christie Hospital cytology laboratory (now the Manchester Cytology Centre sited at Manchester Royal Infirmary). 78,062 cervical cell samples were collected from 61,564 women attending for routine screening. There was no age restriction. Participating practices and clinics covered a wide area in and around the city of Manchester, and offered screening either in the context of well-woman clinics or in association with family planning services.

The study was approved by the local ethics committee. Verbal informed consent obtained when the smear was taken was deemed appropriate at the time, as the clinical significance of HPV infection was not then known. However, verbal consent is not being presented as the legal basis for this application and is merely for background information. HPV assays were performed after recruitment had ended, and no HPV results were reported either to the cytology laboratory or to the women.

Samples taken before Jan 1989 were centrifuged and only the pellet was stored. This procedure (in the pre-PCR era) entailed some loss of DNA and the possibility of contamination. The proposed study will therefore be restricted to the 49,549 women recruited 1989-93.

The Manchester Study was an observational study and now LSHTM wish to 'flag' the cohort for cancer incidence and mortality and relate these outcomes back to their previous HPV results.

At the time the Manchester Cohort was set up, HPV testing was not routine or cheap and so the study team tested only a minority of samples. The untested samples were stored until such a time as funding could cover the testing costs. Once the Manchester cohort is flagged the study team will be able to see who has developed cervical cancer or cervical pre-cancer from the cancer registration data. LSTHM will then test the stored samples from these women and also a randomly selected control group to compare them.

In summary, the routine screening records collected on these women and the additional linked data will help inform policy makers about how best HPV testing should be done. Questions this research aims to influence are:

(1) Is it safe to leave a longer interval between screening tests when a woman has a negative HPV test?

(2) What follow-up tests should be done in women who test positive for HPV? We can evaluate cytology, genotyping (identifying the strain of HPV) or new testing methods.

(3) What age is it safe to stop screening? Can a woman stop screening if she has tested negative for HPV when aged 50 years?

Yielded Benefits:

A report describing the 15 year follow-up of the ARTISTIC trial is currently in press (HTA journal). Additional papers centred on triage strategies and screening intervals are currently being prepared. The LSHTM is currently analysing data from the Manchester Study. The following publications and resources have been created to date regarding data from these cohorts: Long-term follow-up of ARTISTIC cervical screening trial cohort Gilham C, Sargent A, Kitchener H, Peto J 2018 Health Technol Assess Longer screening intervals are recommended following a negative HPV test in primary cervical screening Peto J, Gilham C 2017 Evid Based Med. Jul 22; 22(5) The PapilloCheck® Assay for the Detection of High Grade Cervical Intraepithelial Neoplasia Crosbie EJ, Bailey A, Sargent A, Gilham C, Peto J, Kitchener HC 2015 J Clin Microbiol. Nov;53(11):3553-9 The clinical effectiveness and cost-effectiveness of primary human papillomavirus cervical screening in England: extended follow-up of the ARTISTIC randomised trial cohort through three screening rounds Kitchener H, Canfell K, Gilham C, Sargent A, Roberts C, Desai M, Peto J 2014 Health Technol Assess. Apr;18(23):1-196 Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials Ronco G, Dillner J, Elfström KM, Tunesi S, Snijders PJ, Arbyn M, Kitchener H, Segnan N, Gilham C, Giorgi-Rossi P, Berkhof J, Peto J, Meijer CJ; the International HPV screening working group 2014 Lancet. Feb 8;383(9916):524-32 A comparison of HPV DNA testing and liquid based cytology over three rounds of primary cervical screening: Extended follow up in the ARTISTIC trial Kitchener HC;Gilham C;Sargent A;Bailey A;Albrow R;Roberts C;Desai M;Mather J;Turner A;Moss S;Peto J 2011 Eur J Cancer. 2011. 47(6 ):864-871 Sexual Behavior and HPV Infection in British Women, by Postal Questionnaires and Telephone Interviews Almonte M;dos Santos Silva I;Asare A;Gilham C;Sargent A;Bailey A;Turner A;Desai M;Kitchener HC;Peto J 2011 J Med Virol. 83(7 ):1238-1246 Optimal threshold for a positive hybrid capture 2 test for detection of human papillomavirus: data from the ARTISTIC trial Sargent A, Bailey A, Turner A, Almonte M, Gilham C, Baysson H, Peto J, Roberts C, Thomson C, Desai M, Mather J, Kitchener H 2010 J Clin Microbiol. Feb;48(2):554-8 ARTISTIC: a randomised trial of human papillomavirus (HPV) testing in primary cervical screening Kitchener HC, Almonte M, Gilham C, Dowie R, Stoykova B, Sargent A, Roberts C, Desai M, Peto J; ARTISTIC Trial Study Group 2009 Health Technol Assess. Nov;13(51):1-150, iii-iv HPV testing in combination with liquid-based cytology in primary cervical screening (ARTISTIC): a randomised controlled trial Kitchener HC, Almonte M, Thomson C, Wheeler P, Sargent A, Stoykova B, Gilham C, Baysson H, Roberts C, Dowie R, Desai M, Mather J, Bailey A, Turner A, Moss S, Peto J 2009 Lancet Oncol. Jul;10(7):672-82 Prevalence of type-specific HPV infection by age and grade of cervical cytology: data from the ARTISTIC trial Sargent A, Bailey A, Almonte M, Turner A, Thomson C, Peto J, Desai M, Mather J, Moss S, Roberts C, Kitchener HC; ARTISTIC Study Group 2008 Br J Cancer. May 20;98(10):1704-9 HPV testing in routine cervical screening: cross sectional data from the ARTISTIC trial H C Kitchener, M Almonte, P Wheeler, M Desai, C Gilham, A Bailey, A Sargent, J Peto 2006 Br J Cancer Jul 3; 95(1): 56-61 Cervical HPV infection and neoplasia in a large population-based cohort: the Manchester study Peto J, Gilham C, Deacon J, Taylor C, Evans C, Binns W, Haywood M, Elanko N, Coleman D, Yule R, Desai M 2004 Br J Cancer Aug 31; 91(5): 942-53 Sexual behaviour and smoking as determinants of cervical HPV infection and of CIN3 among those infected: a case-control study nested within the Manchester cohort Deacon JM, Evans CD, Yule R, Desai M, Binns W, Taylor C, Peto J 2000 Br J Cancer 2000 Dec;83(11):1565-72 The National Screening Committee (NSC) makes recommendations for policy changes to the NHS Cervical Screening Programme (NHSCSP) based on published epidemiological and trial data. ARTISTIC is particularly informative to the NSC as it is the only cohort of women in the UK with long follow-up. The aims of the screening programme are to identify and treat women at greatest risk of cancer and pre-cancer, but also minimise anxiety and over-treatment in women who have transient infections, which are likely to disappear on their own without treatment. Policy changes informed by the research are made to improve the efficiency of the programme in these respects. The greatest change to the NHSCSP is currently happening this year with the introduction of primary HPV screening. The decision that led to this change was based on a pooled analysis of the 4 major European clinical trials, one of which was ARTISTIC. Despite rollout of the new programme, due to be complete by December 2019, there are still decisions to be made regarding the screening protocol. For this reason, the results from current work on the ARTISTIC and the MANCHESTER cohort will continue to influence policy and yield patient benefit.

Expected Benefits:

The demonstration that a high proportion of women who subsequently developed cervical cancer had detectable HPV by age 40, and often earlier, would be of major importance and may show for example, that a single HPV test in middle age may be the most effective practicable form of screening.

The London School of Hygiene and Tropical Medicine and the lead researcher in this area have been proactive in ensuring the health system and patients benefit from the results of this research. Indeed they have already influenced policy changes in this area, with the results from a similar study (ARTISTIC TRIAL). The results have influence the piloting of primary HPV screening. The LSHTM expect evidence from this cohort to influence further screening policy changes regarding screening interval and triage strategies.

This research will be disseminated officially in peer-reviewed papers. These will be used by the National Screening Committee to decide whether changes should be made to the screening programme. The lead in this research is also the chair of an advisory group specifically put together to advise the National Screening Committee on the scientific evidence that exists regarding cervical cancer and HPV screening and therefore this research could directly influence screening policy.

The London School of Hygiene and Tropical Medicine findings will add to the body of evidence to allow policy-makers to improve the cervical screening programme in the UK (and around the world)

Outputs:

Human papillomavirus (HPV) infection is known to cause cervical cancer, but it is a relatively common infection, especially in young women, which usually clears without any symptoms or long-lasting effects. There are different strains (known as genotypes) of HPV, and some are more likely to cause pre-cancer or cancer than others. Until recently, cervical cancer screening has been done using a smear test (known as cytology), but the latest scientific evidence points towards screening first for HPV infection (known as “HPV primary screening”). This method is currently being tested in six areas in England, and in January 2016, the UK National Screening Committee announced that primary HPV testing should be introduced countrywide. It is not sensible or cost-effective to refer a large number of women for treatment when their infection is likely to clear on its own, so women who are positive for HPV will be only referred if they also have some abnormal cells (from their cytology test). Cytology is not always the most efficient second test and screening studies such as the Manchester Cohort study can help policy makers decide what the best options are to save women being referred unnecessarily and to save money.

The long-term cervical cancer risk following HPV infection will be estimated from the following:

1. Long-term follow-up of women in The Manchester Study for whom HPV status was known at baseline,

2. a case-control analysis comparing baseline HPV status in those developing cervical cancer during follow-up in The Manchester Study.

The results (target 2017) will be presented at international HPV conferences including the International Papillomavirus Conference and the Eurogin conference on HPV held every 18 months respectively. The results will also be published in peer-reviewed journals such as the European Journal of Cancer and the British Journal of Cancer.

All outputs will be aggregate with small numbers supressed in line with HES analysis Guidance.

Processing:

The request is for notification of and date of cancer incidence, mortality and current status (i.e. NHS, cancelled, emigration, armed forces etc.). In order to conduct a valid statistical analysis, it is essential to know the number of individuals at risk from developing the disease of interest at any point in time. This includes being aware of which members of the cohort are being actively followed at any point in time. Once an individual leaves the notification system, due to being cancelled or emigration for example, they must be excluded from the analysis. For example, any woman who emigrated would leave the study at this point and would not be able to re-enter the study because cervical cancer may occur while a women is living abroad.

LSHTM will send NHS Digital the following identifiers - NHS Number where known, Names (including former), DOB, Address, Postcode. This data will be from when the cohort was recruited.

NHS Digital will provide latest demographic data (NHS number and DOB only) , cancer, NHS exits/status and cause of death data. LSHTM will quality check and merged it with the current data held on the cohort. Before merging, fields containing names and addresses will be removed.

LSHTM data files being returned will not contain names or addresses, but will contain dates of birth and NHS numbers for linkage purposes to onward screening. LSHTM also hold cervical screening histories which include dates and results of cervical smears and associated histology results, and HPV results. LSHTM then analyse the data in terms of estimating risks of cervical cancer and CIN3 (cervical cancer-in-situ) associated with previous HPV results.

In addition to these “cohort analyses”, the team would like to retrieve stored, yet untested, samples from the Manchester Study from women who have subsequently developed cervical cancer or CIN3. A set of controls will be analysed as a nested case-control study within the cohort. The team can directly compare the screening histories and HPV results among those women who do and do not develop cervical cancer or CIN3.

Processing will include the following steps:
1. The Manchester cohort will be matched PDS (MIDAS)
2. NHS Digital will provide LSHTM with Cause of death and cancer registration data, NHS Number,DOB and NHS Exits.

The data will be processed at the LSHTM and will not be shared with any third parties. All outputs will be aggregate with small numbers supressed in line with HES analysis Guidance.

Management of patients with chronic liver disease admitted to hospital as an emergency — DARS-NIC-667506-N6Q9G

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-08-14 — 2026-08-13 2024.07 — 2024.07.

Access method: One-Off

Data-controller type: KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death - Secondary Care Cut
  2. Emergency Care Data Set (ECDS)
  3. Hospital Episode Statistics Accident and Emergency (HES A and E)
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)
  5. Hospital Episode Statistics Critical Care (HES Critical Care)
  6. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

London School of Hygiene and Tropical Medicine (LSHTM) and Kings College Hospital NHS Foundation Trust (KCH) require access to NHS England data for the purpose of the following research project: Management of patients with chronic liver disease admitted to hospital as an emergency

The following is a summary of the aims of the research project provided by LSHTM and KCH:
“The overall aim is to identify which characteristics of treatments and services for acutely ill people with chronic liver disease (CLD) impact on care processes and outcomes, in order to improve the national organisation and delivery of care for all people acutely ill with CLD.

Specific objectives include:
• Describe critical care use and clinical outcomes after a first emergency admission in patients with CLD.
• Explore the impact of regional clinical networks on referral patterns, by creating “super-spells” for each patient and identifying within this super-spell the hospital of the admission and the hospital trust where most of the care was provided. The configuration and characteristics of these networks will be compared, as will regional and organisation changes in referral patterns as a result of the Covid-19 pandemic.
• Explore the impact of regional, hospital and patient characteristics, and the impact of the Covid-19 pandemic at a hospital and regional level, on critical care use of chronic liver disease patients who had a first emergency admission.
• Explore the regional variation in the use of liver transplantation in the first year after an emergency admission”

The following NHS England data will be accessed:
Hospital Episode Statistics:
• Admitted Patient Care/ Critical Care – necessary to describe time trends in acute secondary care for patients with chronic liver disease and its outcomes, including admission to critical care and its duration, clinical condition at critical care admission, proportion of cases for whom critical care was withdrawn, total length of hospital stay, readmission rate, and total time spent in hospital within the first year.
• Outpatients – necessary to describe the impact of coordinated specialist outpatient review after discharge on readmissions, referral for transplantation, and mortality, by comparing the outcomes of patients who are discharged from hospitals that offer coordinated specialist outpatient review with patients from hospitals where this type of outpatient review is not available.
• Accident & Emergency/ the Emergency Care Data Set – necessary to examine short-term outcomes including readmissions and total time spent in hospital.

• Civil Registrations of Death – necessary to describe in-hospital and 1-year mortality.

The level of the data will be pseudonymised.

The data will be minimised as follows:
· Limited to a study cohort identified by NHS Blood & Transplant (NHSBT) – patients undergoing liver transplant in England between 1 April 2008 and 31 March 2022, and
· Limited to a study cohort identified by NHS England as meeting the following criteria: all patients older than 18 years (or with missing age) with CLD who were admitted with an emergency hospital admission between 1 April 2007 and 31 March 2022.
· Limited to data between 1 April 2007 and 31 March 2022.

LSHTM will further minimise the data by identifying when each individual had their first emergency admission for CLD, and excluding anyone who had their first CLD admission prior to 1st April 2009, or a first CLD admission not as an emergency.

KCH as the research sponsor, and LSHTM as the main collaborator, are joint controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by National Institute for Health Research (NIHR). The funding is for the programme of work and is not specifically limited to the study described. Funding is in place until October 2024.

The British Liver Trust is involved in the wider project in an advisory capacity only for the patient engagement and dissemination stages, and will have no access to the data or involvement in data analysis.

University of Exeter and King’s College London are involved in social science work packages of the wider project, and will have no access to the NHS England data or involvement in data analysis.

Data will be accessed by:
· Substantive employees of LSHTM
· Up to three PhD students registered at LSHTM. Any student working with the data held under this Agreement must have completed relevant data protection and confidentiality training and are subject to LSHTM’s policies on data protection and confidentiality. Any students accessing the data will do so under the supervision of a substantive employee of LSHTM. LSHTM would be responsible and liable for any work carried out by students. These students would only work on the data for the purposes described in this Agreement.

Consultation with people with liver disease was undertaken at the very earliest initial planning stages of this project. Informal discussion was first held with people hospitalised with CLD at KCH, and with their next of kin, and following an encouraging response an initial research plan was developed.

Through research partners (the British Liver Trust), an online survey of 57 people with CLD from across the UK was conducted to understand their attitudes to the goals and basic research methods under consideration. This sample was representative of the patients with CLD who would be in the proposed study cohort in respect of age, sex and cause of liver disease. More than 80% had required hospitalisation as a consequence of CLD. More than 90% felt it “extremely important” to understand regional variations in outcome of CLD. More than 90% supported the research and felt it to be addressing an important subject, endorsing the approaches proposed to be utilised, including the use of de-identified linked electronic health records. Thirty-three of the respondents volunteered to join an online patient consultation group for the research project.

A face-to face focus group was then conducted with 19 people who had liver transplant for CLD, many of whom had experienced emergency admission at an early stage of their illness. This group also confirmed support for the proposed research and its methodology.

A patient representative with lived experience of CLD, emergency admission and liver transplant is now a grant co-applicant and member of the research team, as is a representative of a patient organisation, the British Liver Trust (BLT). As members of the research team they will be involved in all stages of the research cycle including prioritising research questions, advising upon and managing the research process and routes to data opt-out, analysing and interpreting the results of research, with a prominent role in dissemination of findings.

A Patient Advisory Group (PAG) is to be recruited that will include people with liver disease and lived experience of drug and alcohol services and homelessness. The PAG will be convened at 6 monthly intervals to consider and advise on research questions, conduct and the actions that should follow its findings, feeding back to the research team.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of chronic liver disease (CLD) patients.
The research is expected to provide a better understanding of three interacting complexities: the complexity of CLD and its treatment options, the complexity of the life situation of many CLD patients, and the complexity of the healthcare system. The study’s findings are expected to lead to recommendations about how the services for patients with CLD can be made safer and more effective.

The use of the data could :
· help the system to better understand the health and care needs of populations.
· lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
· advance understanding of regional and national trends in health and social care needs.
· inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
· inform decisions on how to effectively allocate and evaluate funding according to health needs.
· provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.
· support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Patient representatives with lived experience of CLD are members of the research team and will be involved in analysing and interpreting the results of the study, with a prominent role in dissemination of findings.

Recognising patients and the public as key stakeholders in the research, the dissemination plan includes webinars, presentations and reports for patients and patient organisations. Patient representatives will be involved to ensure that all relevant organisations are engaged and that the style and format of publications is accessible to these audiences.

Outputs:

The expected outputs of the processing will be:

• Reports and papers:
The research team will contribute to a final research report for the funder (NIHR) detailing research methods, findings and conclusions, including recommendations for practice and an extensive summary for patients and the wider public.

The research team will prepare manuscripts to submit for publication in peer-reviewed academic journals, in line with the research objectives outlined above.

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• The research team intend to organise an end-of-project workshop to formulate recommendation for practice. Participants of this workshop are expected to include NHS England’s Specialised Commissioning Team (or its relevant successor), the British Association for the Study of the Liver (BASL), the British Society for Gastroenterology (BSG) and the Intensive Care Society (ICS). This workshop is planned to produce messages that fit the research team’s audiences (e.g., patient and public, commissioners, clinicians, regulators and policy makers). The recommendations are intended to be summarised in a report that will be disseminated across all the research team’s stakeholders.

The research team expect to produce policy advice targeting NHS England at national level to the Specialised Commissioners, and at a regional level by engagement with regional medical directors through formal meetings to discuss the findings and inform change at the local commissioning level. In addition to formal commissioning, the research team plan to engage lead hepatologists in NHS Trusts via the BASL and BSG liver networks and ensure they are aware of the findings and the value of introducing change to their organisations.

The research team intend to feed back to The National Institute for Health and Care Excellence (NICE) on findings relating to NICE Pathways on the management of acutely ill patients in hospital, and NICE guidelines on gastrointestinal bleeding, acute kidney injury, complications of cirrhosis, and recognising and responding to deterioration. The research team plan to prepare a training package and associated resources aimed at relevant professional bodies, including the BSG, BASL, ICS, and NHS Blood and Transplant, and which can be used by clinicians and drug and alcohol services to give information, address stigma and improve patient engagement.

The target dates for production and dissemination of the outputs are Q4 2023- Q3 2024.

Processing:

NHS Blood & Transplant (NHSBT) will transfer data to NHS England. The data will contain identifying details (specifically NHS number, sex, date of birth, and postcode plus pseudonymised unique Liver Transplant ID) for the cohort to be linked with NHS England data.

NHS England will also generate a study cohort of patients older than 18 years, or with age missing from the dataset at the time of first admission, with chronic liver disease (CLD), who were admitted with an emergency hospital admission between 1 April 2007 and 31 March 2022.

For both cohorts, NHS England will provide the relevant records from the Hospital Episode Statistics (HES) Admitted Patient Care (APC), Critical Care (CC), Outpatient (OP) and Accident & Emergency (A&E) datasets, alongside the Emergency Care Data Set (ECDS) and Civil Registrations of Death dataset to the London School of Hygiene & Tropical Medicine (LSHTM).

The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data already held by the recipient (see below). Individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The data will not be transferred to any other location.

The data will be stored on a secure server at LSHTM.

The data will be accessed onsite at the premises of LSHTM, or by authorised personnel via remote access. The data will remain on the servers at LSHTM at all times.

Personnel are prohibited from downloading or copying data to local devices.

The data will not leave England at any time.

Access is restricted to employees or PhD students of LSHTM who have authorisation from the principal investigator (PI) or co-PI.

King’s College Hospital NHS Foundation Trust (KCH) are only permitted to access anonymised data including information derived from NHS England data. Such datasets will adhere to the relevant small number suppression rules to minimise the risk of individuals being identified.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The data will be linked at a person record level with datasets obtained from NHSBT and the Intensive Care National Audit & Research Centre (ICNARC).

The NHSBT data will be clinical data on liver transplantation.

The ICNARC data will be intensive care clinical data.

Under DARS-NIC-708052-S1L9J, for the NHS England-derived cohort described above, NHS England will supply the following identifiers to ICNARC for linkage with ICNARC data: NHS number, sex, date of birth, postcode and a unique person ID.

ICNARC will link this cohort to ICNARC data, then pseudonymise the ICNARC dataset before supplying the clinical data to LSHTM.

Researchers from LSHTM will analyse the data for the purposes described above.

CONCORD Programme (ODR1617_033) — DARS-NIC-659283-N1S1H

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Yes (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Research)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2022-11-24 — 2023-11-23 2024.07 — 2024.07.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer registration (pre-1995)
  2. NDRS Cancer Registrations
  3. NDRS Cancer Pathway
  4. NDRS Somatic Molecular Dataset
  5. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England.

This is a request from the London School of Hygiene and Tropical Medicine (LSHTM) to extend an Agreement (ODR1516_330) that was previously managed by Public Health England (PHE) before its dissolution in October 2021.

This request relates to the CONCORD Programme. CONCORD is a worldwide cancer surveillance programme, run and managed by LSHTM, that looks specifically at trends in cancer survival. CONCORD began in 2000, and since that time the study has gradually expanded its scope in response to international policies and guidance.

At the United Nations General Assembly High-Level Meeting in New York in September 2011, the governments of 113 countries set new strategic objectives for worldwide control of non-communicable diseases (such as cancer). The UN declaration emphasised the need for broader research and better policy for preventing and controlling all non-communicable diseases, including cancer, because of their rapidly growing impact on public health, especially in developing countries.

Following the World Health Assembly in 2012, the governments of 119 countries agreed on a set of 25 indicators and a voluntary global target to reduce premature deaths (defined as deaths in people aged 30-69 years) from all non-communicable diseases by 25% by 2025. Achieving this target for cancer will require more effective prevention to reduce the incidence of cancer, and more effective health systems to improve survival.

The CONCORD programme provides the information required to assess the effectiveness of healthcare systems around the world in managing cancer patients and allows the assessment of how individual countries compare on the 25 indicators and global targets set by the World Health Assembly.

The CONCORD programme aims to inform national and global policy for cancer control:
• To provide quantitative and directly comparable estimates of cancer survival in many countries worldwide, for 15 malignancies that are common in adults, and leukaemia, lymphoma, and brain tumours in children using individual data from population-based cancer registries.
• To maintain systematic global surveillance of cancer survival, by documenting worldwide trends and inequalities in cancer survival.
• To enable examination of the underlying causes of survival differences.
• To derive measures such as the population “cure” fraction and the number of avoidable premature deaths.

To support them in achieving their aims LSHTM has previously requested identifiable Cancer Registration data from the National Disease Registration Service (NDRS) for both the CONCORD-2 and CONCORD-3 cohorts, the two cohorts that collectively constitute the CONCORD Programme.

For the CONCORD-2 cohort, this data was inclusive of all English residents aged between 15- and 99, who also received a diagnosis of malignant, invasive or primary neoplasm of the breast, colon, rectum, lung, ovary, prostate, stomach, liver or cervix; or leukaemia between 01/01/1990-31/12/2013.

For the CONCORD-3 cohort, this data was inclusive of all adults residing in England who received a diagnosis of one or more of the following neoplasms: Oesophagus, Stomach, Colon, Rectum, Liver, Pancreas, Lung, Melanoma, Breast, Cervix Uteri, Ovary, Prostate, Brain, Lymphomas and Leukaemias between 01/01/2000-31/12/2014. Children aged between 0-14 who had received a diagnosis of one or more of the following neoplasms during the same time were also included in the cohort: Brain, Lymphomas and Leukaemias.

In line with the UK General Data Protection Regulation (GDPR), this request is limited to the minimum amount of data necessary to achieve the purposes outlined within this Data Sharing Agreement (DSA). At the time of the initial request, the study team liaised closely with the NDRS analyst to ensure that the data fields being requested were adequate, relevant and limited to what is necessary.

National data is required for this project to ensure that the analyses are representative of the entire population. Data covering 1990-2014 has been deemed necessary for this project to ensure that the study can appropriately capture the effects of changing practices and policies across the study period.

LSHTM is now requesting to continue to retain and process this data to support the completion of the remaining analyses and publications.

It has been determined that there is no alternative, less intrusive ways of achieving the purposes set out within this DSA. The study has taken the appropriate steps to obtain a favourable opinion from an NHS Research Ethics Committee (REC).

LSHTM is the sole data controller who processes the data for the purposes described within this Agreement. The CONCORD programme has both a Working Group and a Steering Group, these groups consist of scientists, representatives from national and international cancer registries, and members of the public. These groups serve in an advisory capacity only, and no individual or organisation represented in these groups plays a role in determining the purpose and means of the processing of the data covered under this Agreement. Further to this, LSHTM does not share data with individuals or organisations involved in these groups, or any other third parties.

LSTHM’s lawful basis for processing personal data under the UK GDPR is Article 6(1)(e): the processing is necessary for the performance of a task carried out in the public interest, and that task has a basis in law. The specific task takes the form of research and has been deemed to be in the public interest as it has the potential to benefit the provision of health and social care in England. The basis in law is the School’s Royal Charter, which empowers the School to perform certain functions in operating as a higher education institution. These functions include “promoting … research… and education in public health and tropical medicine and such other academic subjects as [the School] may consider appropriate”.

LSHTM’s lawful basis for processing special category data under the UK GDPR is GDPR Article 9(2)(j): the processing is necessary for scientific research purposes or statistical purposes, by Article 89(1) and with a basis in law. The basis in law is the School’s Royal Charter.

Yielded Benefits:

The findings of CONCORD, and their implications, have been incorporated into national and international policy and guidance, the implementation of these has in turn impacted the provision of health and social care around the world, including in England. CONCORD results have been used by the Organisation for Economic Co-operation and Development in its global, continental and online publications ‘Health at a Glance’ since 2017; by the World Health Organisation to evaluate the pricing of medicines for cancer prevention and treatment in 2018, and in a Lancet Oncology Commission on the benefits of delivering sustainable care for children with cancer in 2020. CONCORD results have also been used in the European Union’s new Country Health Profiles as part of the State of Health in the EU initiative, by the World Health Organisation to examine the impact of the pricing of medicines for cancer prevention and treatment, and in a Lancet Oncology Commission on the long-term economic benefit of delivering sustainable care for children with cancer around the world.

Expected Benefits:

Information on the survival of all cancer patients in a population has the potential to enable comparison of the effectiveness of health systems. Long-term surveillance will contribute to the evidence base for global policy on cancer control.

CONCORD will monitor progress towards the overarching goal of “major reductions in premature deaths from cancer, and improvements in quality of life and cancer survival”. This could significantly improve prospects for global cancer control and therefore has the potential to benefit the provision of health and social care in England.

This programme of work has the potential to impact international and national policy, and to provide benefits to health services around the world and their patients. The CONCORD programme will continually monitor the impact of these findings.

Outputs:

The study already has, and aims to continue to publish its findings in reputable peer-reviewed journals. An extensive list of publications can be found on the studies' web pages: https://researchonline.lshtm.ac.uk/view/research_centre/XCSG/. Any data contained within any publications will be aggregated with small numbers suppressed in line with the appropriate suppression rules.

The study regularly updates its web pages to ensure that the scientific community and the public are kept up to date with the study's findings (https://csg.lshtm.ac.uk/research/themes/concord-programme/). LSHTM also publish a blog entitled “Surviving cancer: how big data is helping patients live longer, healthier lives.” (https://www.lshtm.ac.uk/research/research-action/features/surviving-cancer-how-big-data-helping-patients-live-longer), which highlights some of the key findings and the benefits of the CONCORD project.

The study regularly posts lay-person accessible updates on social media to encourage engagement from the public. The social media impact score of 1,416 for CONCORD-3 is in the top 0.02% of 19 million scientific articles evaluated to date. CONCORD-3 was one of the 10 most widely cited articles published during 2018-2019 in The Lancet, a leading medical journal.

The programme takes demonstrable action to ensure that they engage with members of the public, cancer patients have been members of the CONCORD Steering Committee since the study began in 2000. In 2017, Cancer Research UK awarded the Cancer Survival Group special recognition “for [our] sector-leading working involving people affected by cancer in the design and delivery of cancer research”.

Processing:

There was no flow of patient identifiers into Public Health England (PHE) to support this request.

Under ODR1516_330 (which has now been superseded by this Agreement) PHE provided LSHTM with identifiable Cancer Registration for all individuals who met the studies inclusion criteria (except where either the national data opt-out or the NDRS opt-out is at play).

Following the receipt of the data by LSHTM, there have been no further flows of data. LSHTM does not share any personal data with other bodies. This Data Sharing Agreement expressly prohibits such transfers. LSHTM does not use external agencies to do any data processing on their behalf.

Once in receipt of the data LSHTM analysed the data to obtain the following:
• An estimation of survival by age and sex
• Standardisations for age with the appropriate set of weights for each cancer from the International Cancer Survival Standard (ICSS) weights
• Obtain statistics to compare survival and the excess hazard of death between populations over time, while adjusting for age, sex and race

In addition, LSHTM will carry out the following secondary analyses based on the survival estimates:
• Modelling of the population cure fraction
• Estimation of prevalence
• Estimation of the number of avoidable premature deaths
The data disseminated under this Agreement will not be linked to other datasets to achieve the analyses stated above.

The processing necessary for the above-listed analyses will be carried out by members of the Cancer Survival Group, all of whom have undergone appropriate training and have signed a binding declaration to maintain the security and confidentiality of the data. All members of the Cancer Survival Group are substantive employees of LSHTM.

LSHTM operate comprehensive physical, managerial and electronic procedures to reduce the risk of data loss to the absolute minimum. Computers used for processing and storage are in a digitally locked room to which only Cancer Survival Group personnel have access. The computers are not connected to the internet by cable, wireless or any other means.

CRASH-4 Trial - Intramuscular tranexamic acid for the treatment of symptomatic mild traumatic brain injury in older adults: a randomised, double-blind, placebo-controlled trial — DARS-NIC-398405-S0M4K

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-12-14 — 2026-12-13 2024.03 — 2024.03.

Access method: Ongoing

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death - Secondary Care Cut
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

London School of Hygiene and Tropical Medicine (LSHTM) requires access to NHS England Data for the purpose of the following research project:

CRASH-4 Trial - Intramuscular tranexamic acid for the treatment of symptomatic mild traumatic brain injury in older adults.

The CRASH-4 Trial is a randomised, double-blind, placebo-controlled clinical trial (ClinicalTrials.gov Identifier: NCT04521881, EudraCT Number: 2020-003391-40) which aims to assess the effects of early intramuscular tranexamic acid (TXA) on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild traumatic brain injury (TBI). To assess safety and effectiveness, CRASH-4 need to monitor deaths due to intracranial bleeding and other causes, and the risk of key outcomes associated with having at TBI at 1 year. Key outcomes include dementia, mood disorders, blood clots and other bleeds around the brain, epilepsy and convulsions.

The following NHS England Data will be accessed:

- Civil Registrations of Death – necessary to understand which participants have died within 1 year of randomisation into the trial, and of what cause
- Hospital Episode Statistics (HES) Admitted Patient Care (APC) - necessary as the most suitable and complete dataset for capturing the dementia diagnoses, which are commonly given clinically during hospital admission. Other key outcomes listed above may also be captured during inpatient hospital admissions.

The level of the Data will be identifiable because LSHTM retains the identifying details of the study participants beyond the time at which NHS England Data is disseminated to LSHTM. However, the data that will be disseminated under this Agreement will contain no identifying details.

The Data will be minimised as follows:

• Limited to a study cohort of ~5000 participants identified by NHS research site staff, Ambulance Services and Acute Care Trusts located in the United Kingdom as meeting the CRASH-4 Trial inclusion criteria, and not fitting any of the exclusion criteria. All participants are consented directly or via a legal representative. As of 22/10/2023, 6% of all participants recruited to date had been via a legal representative.
• Limited to Data between April 2021 and February 2026. For each individual patient, NHS England Data will only be provided for a period of 12 months from their date of randomisation into the trial.
• Limited to HES APC Data relating to diagnoses of all cause dementia, mood disorders, blood clots and other bleeds around the brain, epilepsy and convulsions, identified by specific ICD-10 codes

LSHTM is the research sponsor and the Controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

LSHTM's lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e): - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the Controller

The lawful basis for processing special category personal data under the UK GDPR is:

Article 9(2)(j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because aims to produce reliable evidence to inform future decisions over the care of thousands of patients with mild traumatic brain injury each year.

The funding comes from multiple sources. Funders include:
• The JP Moulton Charitable Foundation – This funding is for the pilot phase of the trial and ended on 31/08/2023
• The National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme – Funding is in place until 31/01/2027

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

Rackspace Technology is a Processor acting under the instructions of LSHTM. Rackspace Technology’s role is limited to storing CRASH-4 trial Data only.

A Patient and Public Involvement (PPI) advisory group has been established for the trial and contributed significantly to the design of the trial, outcomes of importance to patients and their families, the consent process and the data to be collected. This group includes a representative from RoadPeace, a national charity who represent road crash victims; a representative who is highly experienced in advising on the public perspective on emergency ambulance care; and a representative who has suffered a traumatic brain injury (TBI) and experienced being included in a TBI trial.

The PPI advisory group aided the development and finalisation of the content of the informed consent documents. They also agreed the need for 1-year follow-up and the personal data to be collected. They considered these as essential for the trial. The CRASH-4 trial has also received written recommendation from the Caldicott Guardian at LSHTM for this Data Sharing Agreement.

Outputs:

The expected outputs of the processing will be:

• Submissions to peer reviewed journals
• Presentations at appropriate conferences
• Creation of, for example, videos, cartoons, comic strips and/ or films

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Trials websites
• Social Media
• Direct bilateral engagement with trial participants, governments, patient organisations, donors, stakeholder organisations, manufacturers, NGOs, hospital directors and clinicians
• Press/ media engagement
• Links to publications in applicable trial registries

The estimated production of outputs: ~6 months post study completion, anticipated August 2026.

Processing:

LSHTM will transfer data to NHS England. The data will consist of identifying details (specifically Surname, Forename, Date of Birth, Postcode, NHS Number, and a unique person ID) for the cohort to be linked with NHS England Data. LSHTM will also supply dates of randomisation into the trial and 12 months post-randomisation, for each individual participant in the trial.

NHS England will provide the relevant records from the HES APC and Civil Registrations (Deaths) datasets to LSHTM.

The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The Data will be stored on servers at RackSpace Technology.

The Data will be accessed onsite at the premises of LSHTM only.

The Data will not leave England at any time.

Access is restricted to employees of LSHTM who have authorisation from the Chief Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with de-identified health outcomes data collected through Case Report Forms as part of the CRASH-4 Trial.

There will be no requirement and no attempt to reidentify individuals when using the Data. The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the LSHTM CTU will analyse the Data for the purposes described in Objective for Processing.

Small-area analysis of morbidity risks associated to environmental stressors — DARS-NIC-329869-Q9Z2Z

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 - s261(5)(d), Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Non-Sensitive

When:DSA runs 2022-11-07 — 2025-11-06 2023.01 — 2024.01.

Access method: Ongoing

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

The London School of Hygiene & Tropical Medicine (LSHTM) is requesting Hospital Episodes Statistics (HES) data to perform epidemiological analyses on the impact of environmental stressors on human health. In these analyses, LSHTM will act as the sole Data Controller who also processes the data.

Several environmental exposures, such as air pollutants, heat and cold temperature, and pollens are established risk factors for human health. However, several questions about their association with health conditions still exist. First, epidemiological studies on environmental stressors have mainly focused on mortality risks, while milder health outcomes such as hospital admissions have received less attention. Second, analyses have used data aggregated over large areas and within limited study periods, preventing the analysis of the substantial geographical and temporal variation in risks. Third, and more importantly, little is known about vulnerability factors responsible for differential risks within and between populations.

This project aims to address these limitations by characterising the morbidity risk associated with environmental stressors at small-area level across England. It will offer a detailed picture of current and future health risks associated to environmental stressors in England, extending the knowledge of underlying mechanisms and providing critical information for the definition and implementation of integrated public health and climate change policies. This project follows up similar analysis performed by this research team at LSHTM on mortality risks in the UK using data from the Office of National Statistics (ONS), that has provided accurate maps of risks from temperature (https://doi.org/10.1016/s2542-5196(22)00138-3) and air pollution (ongoing project).

For the realisation of this project, the study team aim to construct a resource of hospital admission data for England. This resource will then be used by LSHTM researchers in the necessary epidemiological analyses for the pursuit of this project. Such environmental risks are small, although they are associated with a large health impact due to widespread exposure. It is therefore necessary to construct a broad and extensive dataset allowing for enough admission cases to accurately estimate the risks and their impacts. Specifically, a low number of fields for all records of the HES Admitted Patient Care (APC) dataset from 1997 to the latest available (around 20 million records per year) are being requested. The request for data spanning a relatively long study period is motivated by the small individual-level risks usually associated with environmental exposures, and the need to assess potential temporal variations in health impacts often linked to public health policies, for instance related to the general decrease in air pollution levels or the implementation of heat warning systems.

Only the fields that are necessary to the analyses are being requested. Date and method of admission are necessary to construct daily hospital admission time series, and to separate elective from emergency admissions. Augmented care period outcome indicator, date of discharge, and pseudonymised person identifier are necessary to non-lethal hospital admissions and deaths from specific causes, as well as to account for multiple hospital episodes. All diagnoses codes are central to create time series of specific causes such as cardiopulmonary. Lower-layer Super Output Area (LSOA) of residence and site code of treatment are requested to link admissions to environmental stressors at a fine enough scale without allowing any patient identification. Finally, age of admission, sex of patient, and all indices of multiple deprivation will be used to stratify the analyses between groups with various vulnerability to the environment.

For data minimisation, the only geographical information requested is the LSOA of residence instead of postcode or output area. LSOAs are small census-based administrative areas and each includes on average about 1,700 residents. This allows enough granularity for accurate epidemiological analysis while minimising risks of subject re-identification through the project results. In addition, data from 1997 onwards is requested to provide a long time series, which is necessary to accurately estimate environmental risks on rarer disease categories. Requesting the full record list is necessary to the project as it will need to create area-specific morbidity time series for a range of disease categories (e.g., cardiopulmonary, asthma-related) across the whole of England, using LSOA as an aggregation level. Requesting data for the whole of England is necessary to exhaustively map the risks across the country, effectively assessing the differences between regions, rural and urban areas, as well as different vulnerability profiles linked with features such as socio-economic, climatological, infrastructural, and topographical factors. As the project also includes the analysis of potentially less common disease categories, it is also necessary to request individual records for ad-hoc aggregations. Requesting all age data is fundamental to evaluate the differential vulnerabilities across age-groups.

The requested data will only be used for the project outlined above. No directly identifiable information is requested, as analysis will only be performed at an area level, although very small. However, requesting already aggregated data is not possible as the research outputs will include constructing different times series for age groups, locations, and specific diseases. Dissemination of the results will only consist of risks and standardised impacts aggregated through time and location and will not contain any identifiable information. The chosen LSOA granularity, the sole dissemination of aggregated risk measures, and the fact that no additional individual/record level data is linked to HES records make re-identification of individuals extremely unlikely. Furthermore, the project has received approval from the Harrow Research Ethics Committee (IRAS 273928) and the Research Ethics Committee of the London School of Hygiene & Tropical Medicine (Ref: 27353).

The lawful basis for processing data is Article 6 (1)(e) (processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller). Processing in this project is necessary to better understand environmental risks to human health and to develop appropriate policies to protect citizens. Additionally, the processing is lawful under Article 9 (2)(j) (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject). The data requested are required for scientific research in the public interest, i.e., how environmental factors impact health, hence meeting the conditions in the Data Protection Act 2018 Schedule 1 Part 1(4) – which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data.

Expected Benefits:

This project is expected to benefit the population in the long term by providing crucial information to policymakers in order to protect the most vulnerable populations from environmental risks. The project could offer a detailed picture at small-area scale of current and future risks associated with environmental stressors in England. It is hoped that the results of the project could be disseminated broadly, including risk maps at fine geographical level and detailed information on variation in risk across areas or sub-groups of population. These findings could be pivotal to identify high-risk regions and locations and developing action plans targeting the sub-groups of population more at risk. By showing the full impact of environmental stressors, it is hoped the results contribute in strategies to reduce population exposure to air pollution or climate change mitigation.

Furthermore, the project has the potential to inform public health decisions, both at the UK and European level, by helping devise efficient strategies to reduce exposure during extreme events. This could include providing air-conditioned areas to elderly people during heat waves, or creating more accurate early warning systems to air pollution targeting small areas.

It is also hoped that this project can bring a positive impact on the scientific community by providing crucial information on the geographical patterns of risks This information can then be used to identify the specific factors that determine heightened or attenuated health risks to environmental stressors. Targeted scientific communities include environmental epidemiologists to study effect modification of the risk associated to temperature, and atmospheric scientists to identify the most adverse sources or chemical components of air pollution, among others.

Given the scale of the project, it is hoped that the benefits affect the whole of England and potentially the rest of the UK, as well as other countries. It is expected that the results of this project help in the long term to reduce the burden of environmental stressors with lowered risks and attributable impacts. Reduction of the air pollution burden have already been observed in Great Britain, as well as reduced risks to extreme heat in most of high-income countries. However, given the complexity of environmental impact on health and the associated policies, achievement of further benefits following this project is not expected to be measurable before years or even decades.

Outputs:

Research outcomes are expected during the year 2025 and will be mainly disseminated through specialised technical reports, peer-reviewed articles published in high-impact journals such as The Lancet Planetary Health or Environmental Health Perspectives, and presentations at international conferences such as the Annual Conference of the International Society of Environmental Epidemiology. The journals will be selected with the aim of reaching researchers working in different areas and widening the potential audience, with a preference for open access options. Specifically, substantive findings and health impact projections will be published in epidemiological, medical, environmental, and public health journals.

The research will also be presented at conferences such as the Annual Conference of the International Society of Environmental Epidemiology. The selection will include a variety of research areas, with the aim to disseminate substantive research findings to an audience of epidemiologists and public health researchers. Project outputs, in terms of risks and large-scale impacts will also be disseminated through the collaborative network of the investigators, both at international and national levels. Examples of research networks are the Multi-Country Multi-City (MCC) Collaborative Research Network (https://mccstudy.lshtm.ac.uk/) and the EU-funded project Exhaustion (https://www.exhaustion.eu/). No data from NHS Digital will be shared with collaborators or be disseminated.

Maps of morbidity risks and impacts may also be published on the LSHTM study team’s website to facilitate dissemination to wider audiences, in particular public health authorities that may have an interest in these results. This website will store the whole set of data on exposure levels and related health risks and impacts and provide easy-to-use web tools to retrieve the information and to summarise/display results. The output will be represented only by epidemiological risk summaries, and not actual figures of morbidity counts if not aggregated over large geographical areas and periods. Particular care will be taken that no sensitive information will be released. Only aggregated data with small numbers suppressed are being shared, and the web tools do not permit anyone to retrieve the record level or aggregated with small numbers not suppressed data. These web resources will be disseminated to the scientific community through peer-review articles and congress dissemination, and to the general public through workshops and webinars, press releases and social media. LSHTM has an established expertise in this setting, with a recent example being represented by the Vaccine Tracker (https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/) and other repositories and apps (https://cmmid.github.io/topics/covid19/) on the COVID-19 pandemic.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Individual (pseudonymised) HES APC records will be sent by NHS digital to LSHTM and stored on a secure server accessible only to the team members, all of whom are LSHTM staff, using a unique network password within the data processor secure system. No additional flow of data into or out of NHS Digital is required. The linkage with environmental data will make use of either from public repositories or from databases produced internally. Examples of databases are the 1x1km HadUK-Grid dataset of daily temperatures made publicly available by the Met Office (https://catalogue.ceda.ac.uk/uuid/4dc8450d889a491ebb20e724debe2dfb), and a similar 1x1km gridded dataset of fine particulate matter (PM2.5) levels created by the LSHTM team (http://dx.doi.org/10.3390/rs12223803). The linkage will be performed only by employees of LSHTM, the data controller. Upon recruitment, all employees are requested to attend a series of courses on data protection essentials, including the GDPR. In addition, all employees processing the data are accredited researchers by ONS allowing them to access secure data.

At the start of each subproject analysis, individual/record level HES APC records will be aggregated into daily time series of morbidity counts by specific outcomes, age groups, gender and LSOA. Only these aggregated time series will then be linked to additional data, namely time series of exposure (temperature, air pollution, pollen) by LSOA, and variables such as the index of multiple deprivation and urban/rural classification will be extracted and linked to morbidity time series.

The created time series will then be used in state-of-the-art statistical techniques to derive LSOA-level morbidity risks and impacts associated to the environmental stressors. Although these risks can be further aggregated, for instance by district or by urban area, our objective is to produce comprehensive maps of risks across England with the highest possible resolution. See for instance a recent publication using mortality data from ONS (https://doi.org/10.1016/s2542-5196(22)00138-3).

Individual (pseudonymised) information will only be used at the first step to create LSOA-level morbidity time series for various causes and subgroup, depending on the environmental stressor under study, and not moved from the secure server. Only these aggregated time series will be subsequently linked to environmental time series and socio-economic characteristics. Only risks and attributable impacts at the LSOA level will then be published and shared outside LSHTM. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. Therefore, no re-identification will either be performed, nor will it be possible using the processed and shared information. While analysis will be performed at aggregated level, individual data is necessary to aggregate daily series for various causes and other factors.

All the data processing will be performed by substantive employees of LSHTM using internally developed computer code and no external help will be needed to perform analyses. All LSHTM employees are appropriately trained in data protection and confidentiality upon hiring with regular refreshers. All data processing and analysis will be performed on LSHTM owned and secured computers.

Homeless Health Peer Advocacy Evaluation: Primary analyses of Hospital Episodes Statistics — DARS-NIC-686058-N9C5V

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Research)

Sensitive: Non-Sensitive

When:DSA runs 2023-02-24 — 2026-02-23 2023.03 — 2023.06.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Emergency Care Data Set (ECDS)
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)
  3. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The London School of Hygiene and Tropical Medicine (LSHTM) require access to NHS England data for the purpose of the following research project: Homeless Health Peer Advocacy Evaluation: Primary analyses of Hospital Episodes Statistics

The following is a summary of the aims of the research project provided by LSHTM:
“People experiencing homelessness suffer extreme health inequalities. The average age of death is 45 years for men who are homeless and even younger for women (43 years). They are between 5-7 times more likely to die prematurely than the general population. Owing to limited access to health care and harsh living conditions, people experiencing homelessness are more vulnerable to tuberculosis, hepatitis C, HIV, injury, chronic conditions. Access to health care is hindered by organizational challenges, fear of stigma, and difficulties prioritizing care over the daily demands of being homeless.

As a result, presentation at health care is delayed until it is urgent, leading to frequent use of accident and emergency services. These delays represent potentially not only avoidable ill-health and distress, but also per capita health system costs which are estimated to be eight times higher than the general population. To mitigate health inequities, Groundswell have pioneered the homeless health peer advocacy (HHPA) program among homeless populations in London.

The aim of the HHPA evaluation is to compare the frequency of hospital use (i.e. accident & emergency visits, outpatient appointments, inpatient admissions) between homeless adults who had contact with a peer advocate and homeless adults who did not have contact with peer advocate. Peer advocates are people with lived experience of homelessness who were trained and supported by Groundswell, a homeless service non-governmental organisation which has been commissioned across several London boroughs to improve access to health care.

This research will evaluate how and to what extent the intervention changes the way homeless populations use outpatient and emergency services and how it shapes other health and social outcomes.

The primary outcome for the main quantitative study using NHS England data is the relative probability of attending a scheduled outpatient appointment for HHPA clients compared to comparison participants. Each participant will have a number of outpatient appointments scheduled, of which some proportion would be attended.”

The following NHS England data will be accessed:
• Hospital Episode Statistics Admitted Patient Care – necessary to track the number of inpatient hospital admissions
• Hospital Episode Statistics Outpatients – necessary to assess the number of scheduled and attended outpatient appointments
• Emergency Care Data Set (ECDS) – necessary to track the number of visits to accident and emergency services (without inpatient admission)
All three data sets will be used to measure and account for imbalances between the two comparison groups, and characterise the nature of the hospital visits including gender, age, ethnicity, previous non-attendance at an outpatient appointment.

The level of the data will be identifiable because LSHTM holds the identifying details. However, the data that will be disseminated under this Agreement will contain no identifying details.

The data will be minimised as follows:
• Limited to data for a study cohort identified by LSHTM who have consented to their data being accessed
• Limited to data between May 2020 and December 2022. For each individual patient, data will only be provided from 12 months prior to date of study enrolment and until 12 months after date of study enrolment.

LSHTM is the sole data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because there is limited evidence showing the impact of peer advocates on health service utilisation and other health and social outcomes, nor the mechanisms through which the intervention works. Further evidence is expected to facilitate development and scale-up of the intervention among homeless and other vulnerable populations in London and elsewhere. This evidence can support the overarching aim of reducing inequalities in health.

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the project described. Funding is in place until 31/07/2023. Funding to continue the work described will be sought on an ongoing basis.

King’s College London are leading a qualitative study relating to the overall HHPA evaluation. The qualitative study does not involve the data under this Agreement.

Groundswell is a charity that works across London and seeks to empower people who are currently homeless to overcome barriers to accessing health care through the provision of peer advocates, all of whom have experience of homelessness themselves. It is Groundswell’s HHPA programme that is the subject of this broader evaluation, and it is their clients who were recruited to be participants in the quantitative evaluation to which this Data Sharing Agreement relates.

The study steering committee includes members from Heriot-Watt University, the University of Manchester, the University of Exeter, Pathway (a homeless healthcare charity), Tower Hamlets Council, Greater London Authority and St Mungo’s homeless charity.

The research team is committed to participatory methods. People with experience of homelessness are employed as peer researchers or invited to become members of the study steering group. Peer researchers provide advice and input in relation to study processes and associated documents such as the participant information sheets.

The viability of consenting participants for this study and data linkage was informed by a workshop with 13 people with experience of homelessness who were asked whether they would be happy for health, criminal records and hostel information to be linked together for research purposes.

Workshops throughout the study, for participants and for the wider community of people experiencing homelessness, will provide additional opportunities to engage the community in the study’s findings and consult with them over future directions for analysis.

Expected Benefits:

The research team anticipate the following benefits to health and social care:

1. Commissioning
The research is expected to provide vital UK-specific evidence on how a peer advocacy intervention improves health care utilisation among people who are homeless. By collaborating with Groundswell and people with current or past experience of homelessness and consulting widely with other community stakeholders through the study steering group, the research team aim to ensure that findings are directly relevant to people who are homeless, to service providers, activities and policy makers. Study findings are intended to be used to inform the nature and scope of peer advocacy in the future. Commissioners in the 10 boroughs which fund HHPA services from Groundswell are, in particular, anticipating the findings of this study.

2. Implementation
The findings from this research are also hoped to inform peer advocacy implementation for policies and practices that protect the health and rights of people who are experiencing homelessness. The data provided under this Agreement and the consequent analysis has the potential to provide invaluable lessons to be learned by HHPA services. The study aims to bring benefits to Groundswell in terms of providing important data to inform the implementation of the intervention as well as potentially demonstrating effectiveness and cost-effectiveness.

3. Addressing inequalities in health
Inequalities in health experienced by people who are homeless reflect multiple experiences of exclusion as well as limited access to health care: just 66% of people sleeping rough are registered with a GP. Primary care access is further limited by structural challenges including stigma and difficulties in reconciling the daily demands of being homeless with prioritising care. As a result, people experiencing homelessness have high rates of accident and emergency use (35% in the past year) and hospital admission (26%). Such figures represent potentially avoidable ill-health and distress, but also significant health system costs: the health care costs of homeless people are estimated to be 8 times higher than the general population.

The National Inclusion Health Board which aimed to improve the health of the UK's most marginalised, identified people experiencing homeless as one of four priority groups. By evaluating the effectiveness of the peer advocacy intervention, this research aims to inform the development of a non-NHS intervention that specifically seeks to improve access to services and health of this population. It is hoped to support an emerging evidence base for peer advocacy as a response to homelessness in the UK, and through doing this support the on-going development of Groundswell's HHPA intervention and other interventions using peer advocates.

The use of the data could:
• help the system to better understand the health and care needs of populations.
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.
• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.
• inform decisions on how to effectively allocate and evaluate funding according to health needs.

It is hoped that the research will help support services for people who are homeless.

The workshops for people experiencing homelessness are intended to incorporate their feedback and give space to reflect on the interpretation of the findings and implications for practice. The workshops with policy makers, service providers and specialist services are intended as a means to integrate study findings into practice in order to reach a wider audience. The project is overseen by a steering group consisting of academics in the field, non-governmental organisations and health and social care sector. LSHTM will consult with the steering group about further promotion of results.

Outputs:

The expected outputs of the processing are expected to be:
• A report of findings to NIHR’s Public Health Research Programme at the end of the project
• A minimum of 2 submissions to open-access peer-reviewed journals at the end of the project
• Presentation to Groundswell and other collaborating organisations
• Presentations at Health Security Agency/Inclusion Health Conferences

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs are intended to be communicated to relevant recipients through the following dissemination channels:
• Journals
• Workshops involving people experiencing homelessness to report on preliminary and end of-project findings
• Workshops with policy-makers, clinical and social service providers working with homeless people
• Workshops with specialist services working with peer advocates (Find and Treat, Pathway, Groundswell and other similar organisations seeking to develop such approaches)
• The project specific website (https://www.lshtm.ac.uk/research/centres-projects-groups/hhpa)
• Social media
• Policy briefs

It is anticipated that these outputs will be produced by the end of December 2023.

Processing:

The London School of Hygiene and Tropical Medicine (LSHTM) collect identifiable information and questionnaire data directly from the study participants, and assign a unique person ID.

LSHTM will transfer a cohort linkage dataset to NHS England. The linkage dataset will consist of a unique person ID, with identifying details (specifically forename, surname, Date of Birth, Gender, alongside NHS number, alias and postcode where possible) for the cohort to be linked with NHS England data. An enrolment date to the study, with the unique person ID, will also be provided in a separate spreadsheet.

NHS England will provide the relevant records from HES Admitted Patient Care, HES Outpatients and the Emergency Services Data Set to LSHTM. The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data already held by the recipient.

Where participants have given additional permissions, LSHTM will also transfer the identifying details to the Combined Homelessness and Information Network (CHAIN) database. CHAIN will return de-identified records containing a unique person ID back to LSHTM. CHAIN is a database recording information on characteristics and service use of people sleeping rough and the wider street population in London in order to assess service need, including information such as accommodation status, alcohol, drugs or mental health support needs.

LSHTM will link the HES, CHAIN and cohort questionnaire data using the unique person ID, and thus create a de-identified dataset for analysis. Questionnaire data includes characteristics such as education, ethnicity, homeless category, access of social services, and health status.

The data will be stored on servers at LSHTM.

The data will remain on the servers at LSHTM at all times.

Personnel are not technically capable of downloading or copying data to local devices.

The data will not be transferred to any other location.

The data will not leave England/Wales at any time.

Access is restricted to employees or agents of LSHTM who have authorisation from the Principal Investigator or lead of the quantitative analysis workstream.
Employees or agents of Groundswell, KCL and the study steering committee are only permitted to access anonymised data including information derived from NHS England data. Such datasets will adhere to the relevant suppression rules.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the LSHTM will analyse the data to compare attendance at outpatient appointments, use of A&E and inpatient stays among people who are homeless using peer advocates and those who do not. This will provide evidence to inform the provision of services for people who are homeless.

Identifying Cancer Recurrence within Patient Care Pathways across Linked National Clinical Datasets — DARS-NIC-671672-G6R6W

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Non-Sensitive

When:DSA runs 2023-02-23 — 2025-02-22 2023.06 — 2023.06.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Pathway
  2. NDRS Cancer Registrations
  3. NDRS Linked Cancer Waiting Times (Treatments only)
  4. NDRS Linked DIDs
  5. NDRS Linked HES AE
  6. NDRS Linked HES APC
  7. NDRS Linked HES Outpatient
  8. NDRS National Cancer Patient Experience Survey (CPES)
  9. NDRS National Radiotherapy Dataset (RTDS)
  10. NDRS Rapid Cancer Registrations
  11. NDRS Somatic Molecular Dataset
  12. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

The London School of Hygiene and Tropical Medicine (LSHTM) requires access to National Disease Registration Service (NDRS) data for the purposes of the following research project:
Identifying Cancer Recurrence within Patient Care Pathways across Linked National Clinical Datasets

The following is a summary of the key aims of the research project being undertaken:
The aim of this research study is to develop and validate methods to phenotype cancer recurrence after curative treatment for bowel cancer in linked national clinical datasets and to assess how well the methods extend to other cancer sites.

Key objectives include:
1. Construct care and outcomes pathways of cancer patients across datasets, from diagnosis and treatment to
subsequent investigations and treatments for recurrence (Workpackages 1 & 2)
2. Develop four indicators of the presence and timing of bowel cancer recurrence, one using clinical rule-based
methods, one using statistical modelling and two using machine learning (ML). (Workpackage 3)
3. Validate the four indicators, including using clinical adjudication for a subset of patients (Workpackage 4)
4. Demonstrate the clinical use of the optimal indicator (Workpackage 5)
5. Assess how well the optimal indicator extends to other cancers (Workpackage)

In support of these aims, LSHTM requests access to the following NDRS Datasets:
• NDRS National Radiotherapy Dataset (RTDS)
• NDRS Systemic Anti-cancer Dataset (SACT)
• NDRS Linked Hospital Episode Statistics (HES)- Admitted Patient Care, Outpatient and Accident and Emergency Subsets
• NDRS Cancer Waiting Times
• NDRS Linked Diagnostic Imaging Dataset (DIDS)
• NDRS National Cancer Patient Experience Survey (CPES)
• NDRS Cancer Pathways
• NDRS Somatic Molecular Testing Data
• NDRS Cancer Registrations- including fields relating to deaths.
• NDRS Rapid Cancer Registration Data (RCRD)
The above-listed datasets are required because the research relies on being able to identify in the data the details of all types of healthcare activity in order to distinguish activity for cancer recurrence from activity for diagnoses, treatment and surveillance.

The level of data accessed will be pseudonymised.

Data is required for all of England to ensure that methods are developed in a fully representative cohort of patients and that the recurrence indicator is not sensitive to any idiosyncrasies of coding practices between healthcare providers.

LSHTM is the sole data controller who also processes the data for the purposes described within this Agreement. LSHTM is responsible for ensuring that the data will only be processed for the purposes described above.

Alongside substantive employees of LSHTM, data will be accessed by no more than four PhD students affiliated with LSHTM. Data will only be accessed by students where the processing is in support of the purposes outlined within this Agreement. In line with University’s policies, students who access data are required to undertake training in data protection and information security. Students processing the data will be under the supervision of a substantive employee of LSHTM.

Individuals employed by the Christie NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust may provide advice to the study team. However, they will play no role in determining the purposes and means of processing. These individuals will not process any data disseminated under this Agreement.

LSHTM rely on Article 6 (1) (e) of the UK GDPR as the lawful basis of processing - "processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller". This is justified and falls under the official functions outlined within the University’s Royal Charter.

LSHTM rely on Article 9 (2) (j) as the legal basis for processing under the UK GDPR – “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject”. The basis in law is the University’s Royal Charter.

The National Institute of Health and Care Research (NIHR) funds this project, funding is in place until April 2025.

A PPI-focused Study Steering Committee (SSC) has been integral to the design and development from the outset. The SSC will meet twice per year to guide the design and delivery of the project, representing key NHS, data provider and clinician stakeholders and including a PPI and a charity representative for each cancer site. Additionally, the committee will be key in overseeing the planning and delivery of the outputs of the project. There are three confirmed PPI representatives in addition to the PPI co-applicant, representatives from Bowel Cancer UK, Breast Cancer Now, Prostate Cancer UK and NHS England.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for policymakers, local decision-makers (i.e. doctors), as well as patients, to inform best practices to improve the care, treatment and experience of healthcare users relevant to the subject matter of the study.

The methods the study aims to develop have the potential to allow cancer recurrence to be routinely identified
in cancer registries and national cancer audits by the end of the research project (March 2025). Knowledge of the date of recurrence will open up a large number of research opportunities (which in turn may provide a benefit to the provision of health and social care in England). Examples include:

• It may enable research into patterns of initial care which may be associated with recurrence, allowing studies with shorter follow-up than those using mortality as their key outcome.
• Making cancer recurrence indicators routinely available could allow better monitoring of healthcare providers, leading to improved care.
• It may permit further research into the care and outcomes of patients whose cancer has recurred.
• Recurrence information from routine health data could become available as an outcome in cancer clinical trials, decreasing the need for patient follow-up, making clinical trials more feasible and reducing costs.

The results of this research have the potential to enable these benefits, initially for bowel cancer before extending across other cancer sites including breast, prostate, oesophago-gastric, lung and head and neck cancers. Together these cancers make up 40% of cancer diagnoses, amounting to over 120,000 new diagnoses per year in England alone.

The research has the potential to benefit a huge number of research studies and audit outputs in the future as this study has the potential to allow cancer recurrence to become measurable in routine data. The resulting algorithms could give more representative estimates of cancer recurrence or recurrence-free survival for patients according to disease stage and physical fitness and other specific patient characteristics, treatments, and characteristics of providers of cancer services. An important contribution is that it has the potential to enhance clinical trials that typically have limited applicability in ‘real-world’ settings due to the limited ability to have long-term follow-up.

The study team also expect NHS England and regional commissioners of cancer services to be aided in various ways through the availability of better information on cancer recurrence facilitated by the study’s algorithms. In particular, cancer recurrence is a key element in models evaluating the cost-effectiveness of cancer treatments. More accurate national and regional information on the number of cancer patients who experience a recurrence will guide resource planning. The cancer recurrence indicators can be used to compare outcomes between treatments and providers, with subsequent implications for performance management and quality improvement.

Outputs:

The expected outputs of the processing will be:
- Publication of methods and validation work in peer-reviewed articles. The study team are aiming to publish papers covering the development and validation of recurrence indicators in 2023, articles on the clinical use of indicators for bowel cancer in December 2023- June 2024 and articles on recurrence indicators in other cancers in July-November 2024.
- The PPI lead is closely linked to Bowel Cancer UK, Prostate Cancer UK and Breast Cancer Now, and aims to use these connections to publicise the projects' findings. These publications will be patient summaries of any peer-reviewed publications.
- The study team expect to be able to publish any algorithm in peer-reviewed articles and on the Health Data Research UK (HDRUK) Innovation Gateway.
- The study team will provide a research report to the study funder, NIHR, on the findings and conclusions of all work packages. Any such information will be inclusive of any recommendations for practice and will include a lay-accessible summary of the work undertaken.
-The study team aim to present the findings of the work at methodological conferences (such as the International Society for Clinical Biostatistics, Health Data Research UK Conference) and clinical conferences (such as the European Society of Surgical Oncology, American Society of Clinical Oncology, and annual meetings of the relevant professional bodies).

The outputs will not contain NDRS data, and will only contain aggregated information with small numbers suppressed in line with relevant suppression rules.

Processing:

No data will flow to the NDRS in support of this request.

The NDRS will provide the relevant records from the following datasets:
• NDRS National Radiotherapy Dataset (RTDS)
• NDRS Systemic Anti-cancer Dataset (SACT)
• NDRS Linked Hospital Episode Statistics (HES)- Admitted Patient Care, Outpatient and Accident and Emergency Subsets
• NDRS Cancer Waiting Times
• NDRS Linked Diagnostic Imaging Dataset (DIDS)
• NDRS National Cancer Patient Experience Survey (CPES)
• NDRS Cancer Pathways
• NDRS Somatic Molecular Testing Data
• NDRS Cancer Registrations- including fields relating to deaths.
• NDRS Rapid Cancer Registration Data (RCRD)

In line with the UK General Data Protection Regulation (GDPR) principle of Data Minimisation, the data will be minimised as follows:

• Data will be restricted to the pertaining C codes for; Oesophago-gastric cancers, Colorectal Cancer, Lung Cancers, Female Breast Cancers, Prostate Cancer, Head and Neck Cancers, Secondary cancers other.
• Data will be limited to patients who were 18 or older upon a diagnosis occurring between 2013 to the latest available data.
• For Cancer Registrations and NDRS Linked HES APC data will be further minimised to two years before diagnosis to the latest available.

Data disseminated under this Agreement will not be linked to any other data already held by the controller.

The data will contain no direct identifying items but will include a unique person ID which can be used to identify the same individual across the datasets requested. There will be no requirement or attempt to re-identify individuals from the pseudonymised data.

Following the receipt of the data, the data will not be transferred to any other location. The data will not leave England & Wales at any time, and will not be accessed outside this area.

The data will be stored on servers at LSHTM. All backups will be located onsite at LSHTM.

Data will be accessed onsite at the premises of LSHTM, or by authorised personnel via remote access. The data will remain on the servers at LSHTM at all times. The data will remain on the servers at LSHTM at all times and personnel are prohibited from copying/ downloading data to local devices. The study uses role-based access to the data, which means that only staff involved in the study work can be granted access to the strictly necessary information.

Access is restricted to substantive employees of LSHTM and PhD students affiliated with LSHTM. In line with University’s policies, all staff and students accessing data must complete mandatory data protection and information security training. These individuals will process the data for the purposes described above.

Evaluation of community-based health and social care multi-disciplinary teams (MDTs) - data linkage and comparison patients — DARS-NIC-332870-B6Z4R

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2022-06-13 — 2025-06-12 2022.09 — 2023.04.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Civil Registration (Deaths) - Secondary Care Cut
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Critical Care
  4. Civil Registrations of Death - Secondary Care Cut
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)
  6. Hospital Episode Statistics Critical Care (HES Critical Care)

Objectives:

The Policy Innovation & Evaluation Research Unit (PIRU), based at the London School of Hygiene & Tropical Medicine (LSHTM), is carrying out a long-term programme of research on the Integrated Care & Support Pioneers (Pioneers) in order to identify factors that enable or inhibit progress towards the joining up (integration) of health and social care services and to assess whether such integrated services lead to better outcomes for patients in a more patient-centred and cost-effective way. Since the current project began in 2015, there has been an increasing number of initiatives in England designed to better integrate the health and care systems, most recently the development of Integrated Care Systems (ICSs) in all parts of England which will be placed on a statutory basis from June 2022. Thus the need for solid evidence on how best to deliver integrated systems and integrated care is more urgent than ever, particularly in light of the White Paper (“Integration and Innovation: working together to improve health and care for all”) released by the Government in February 2021 and the further health and social care integration White Paper published in February 2022 (https://www.gov.uk/government/publications/health-and-social-care-integration-joining-up-care-for-people-places-and-populations) setting out legislative proposals for integrating health and social care services, the financial austerity of recent years, and the likely impacts of the Covid-19 pandemic on health and care professionals, patients, informal carers, service delivery and coordination between NHS and social care providers. This is the precise focus of the current evaluation. It is unique in being able to examine integration activities in specific areas over a timeframe of over six years, with most previous studies having much shorter timescales; thus, this project is able to look at the extent to which barriers can be surmounted over time, the extent to which integration initiatives can be sustained, as well as any unanticipated side-effects of these initiatives.

The PIRU evaluation is funded by the Department of Health and Social Care (DHSC)/National Institute for Health Research (NIHR) Policy Research Programme (PRP) and covers all of the 25 Pioneers in England. The Pioneer Programme (2013-2018) was a national scheme covering 25 geographically and socio-demographically different areas of the country chosen by DHSC to develop and test new ways of joining up health and social care services https://www.england.nhs.uk/new-care-models/integrated-care-pioneers/#:~:text=Integrated%20Care%20Pioneers%20were%20local,to%20efficiently%20deliver%20integrated%20care). The Pioneer Programme was, in many respects, the precursor to the current policy to establish ICSs throughout England. Further details are available on the evaluation’s website: https://piru.ac.uk/projects/current-projects/integrated-care-pioneers-evaluation.html.

The current research programme, which is due to be completed in autumn 2022, follows on from an earlier evaluation of the Pioneers which was undertaken by the same research team (2014-15), and involves three work packages.
• Work package 1: Implementation and progress – Pioneer level process evaluation and (limited) impact evaluation in all 25 Pioneers via interviews, web based panel surveys and analysis of performance indicators relevant to integrated health and social care;
• Work package 2: Impacts, costs and patient outcomes – impact and economic evaluations of selected Pioneer initiatives using mixed methods, and designed to follow patients, carers and staff over the longer-term;
• Work package 3: Lessons learned – Working with Pioneers, national policy makers and partners, patient/user organisations and experts to derive and spread learning on improving integrated care.

The second work package comprises a quasi-experimental impact and economic evaluation, comparing costs and outcomes for patients on the caseload of community-based health and social care multi-disciplinary teams (MDTs) in two of the former Pioneer areas and a comparison group of patients not receiving MDT care. Such MDTs are the most widely reported integration initiative undertaken by the Pioneers and are common to many health and social care integration initiatives elsewhere in the country. For the current study, MDTs had to: 1) include both primary and social care, as well as allied healthcare professionals, and in some instances, the community and voluntary sector (CVS); 2) bring these professionals together in a shared process of care coordination; and 3) have a target caseload that included people aged 55 and over with multiple long-term conditions, i.e. those who often need complex care coordination and high levels of health and social care support. As well as focusing on service use-related outcomes, this prospective, mixed methods evaluation also involves surveys and qualitative interviews with MDT staff, MDT patients, and their nominated informal carers, as well as observation of MDT meetings.

Specific research questions include:
• Is the health, well-being and life expectancy of patients improved by a community-based MDT approach when compared with similar patients not managed by a community-based MDT?
• Does a community-based MDT approach reduce health and social care service use and costs?
• Do these improvements justify the cost of developing and implementing community-based MDTs?
• How much are the cost and quality of providing health and social care services to patients through a community-based MDT affected by the design of teams (e.g., its service functions, target patient population, team composition and competencies, enabling structure and resources and other contextual factors at the local and national level)?

PIRU is requesting NHS Digital Hospital Episode Statistics (HES) and Mortality data to examine whether patients treated by community-based MDTs are admitted to hospital less frequently than a matched comparison group of non-MDT patients and whether there are any survival advantages of being managed by MDTs. Another aim is to look at any differences in health care costs between these two groups. For the MDT patient group, HES and mortality data will be linked to survey data which have already been collected from patients. For the comparison group, HES data will be used both to match comparison patients with MDT patients, and to examine the outcomes of the comparison patient group.

This application for HES and mortality data has three purposes:
1. To obtain a group of matched comparison patients. Comparison patients will be obtained by using HES data to find matches with the MDT patients. Matches will be established on the basis of selected demographic variables (sex, age, etc) along with hospital use over the past 5 years. The matched comparison patients will be taken from geographic areas not covered by the Pioneer programme or by other national integrated care initiatives such as the NHS New Care Models (Vanguards).
2. To compare the MDT and matched comparison group on key outcomes (emergency admissions, inpatient admissions, mortality, etc);
3. To compare these outcomes between patients on the caseloads of different models of community-based MDTs. The HES data will also allow for the calculation of the comparative service use costs of MDT and non-MDT patients by applying national reference costs to hospital activity.

The COVID-19 pandemic provides an unanticipated opportunity to examine how the pandemic may have affected patient care and outcomes, and whether these differ between MDT and comparison patients. With the policy support of the Department of Health and Social Care, the study has been amended to collect additional primary data for MDT patients through surveys and interviews which, in combination with HES data, will allow an exploration of possible COVID-19-related outcomes after March 2020. The pandemic also highlights the importance of this study, as collaboration between the NHS and social care providers increased in both scale and pace as a result of the pandemic, and has been a significant contributor to current proposals to introduce legislation on integrating these services, as set out in the Government White Paper “Integration and Innovation: working together to improve health and social care for all” (February 2021).

The study is concerned with the experience and outcomes of patients managed through health and social care integrated, community-based MDTs, in two Pioneer areas (Islington and Vale of York) in England. MDT patients who meet the study inclusion criteria are aged 55 years and over, have multiple chronic conditions, live at a private residential address, and were added to the caseload during the recruitment period. MDT patients were sent an invitation to participate in the study together with a baseline postal questionnaire by MDT administrative staff and asked to return it to the LSHTM research team in a freepost envelope, starting in October 2018. Patients returning the questionnaire and agreeing to be followed-up were sent a second questionnaire about 9 months later. At baseline, MDT patients were asked to provide written consent to link their survey data with their hospital data.

To meet the study aims, data is requested for two specific purposes:
Firstly, data covering a period of up to 5 years preceding the start of the study in order to have sufficient information to enable the identification of suitable matches as comparison patients.

Secondly, data that will enable comparisons between the MDT and the comparison patient groups, as well as between patients from different MDTs, on outcomes such as hospital admissions, emergency admissions, re-admissions, mortality, etc. over the approximately 9-month follow-up period. The MDT patient recruitment period ran from December 2018 to September 2019, and data is requested covering the period from January 2014 (ideally) to the end of March 2021.

The GDPR Article 6(1)(e)and Article 9(2)(j) provide the legal basis for the processing of the data:
- Article 6(1)(e): The LSHTM is a public authority as described under Schedule 1 of the FOI Act 2000 and has a basis in law for lawfulness of processing as they have a Royal Charter, and public interest provides justification for data to be released in a pseudonymized format.
- Article 9(2)(j): The data are required for research purposes in the public interest meeting the conditions in the DPA 2018 Schedule 1 Part 1(4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data, demonstrated in the Objectives

The data requested have been minimized by requesting only those variables that meet the criteria for the analysis from patients aged 55 years or older. The request is for access to mortality data, and HES datasets (inpatient, emergency, and critical care), starting 5 years before the study period, up to the most recent data available . These datasets will provide the key outcome measures to compare MDT and matched comparison patients. The use of HES data is the only means of identifying a suitable matched comparison group; this will be accomplished by examining data 5 years previous to the study recruitment period. Likewise, HES and mortality data are the only means available to examine the key outcome measures and to estimate health care costs for both MDT and comparison groups.

Individual record level data is required as this is the only means by which HES data can be linked to the MDT patient survey data collected by the present study and to identify matched comparison patients. Data for the comparison patients will be pseudonymised to the research team. For MDT patients, consent was obtained for data linkage, but the dataset will be pseudonymised and linked only by a unique study number. There will be no attempts to re-identify these individuals.

LSHTM is the only organisation involved in the process of obtaining the HES and mortality data. LSHTM will provide NHS Digital with unique study number, full name, and date of birth for MDT patients who have consented to data linkage. LSHTM will be the sole data controller who also processes the data, and will hold the linked HES, mortality and survey data for MDT patients, and all the pseudonymised HES and mortality data for the comparison group patients. LSHTM have made all decisions on the way that data would be processed. All data analysis will be carried out by LSHTM staff. Only substantive employees of LSHTM will have access to the pseudonymised data requested and supplied by NHS Digital. Additionally, while the DHSC is commissioning this evaluation, they do not carry out data controllership activities.

Expected Benefits:

The specific component of the wider evaluation which this application supports focuses on the most common local integration intervention in England, i.e., the implementation of community-based MDTs, of which there are different models. By having a matched comparison group of non-MDT patients, and using HES and mortality data, it should be possible to examine whether MDT patients have better outcomes than the comparison patients. Also, by looking at a number of different models of MDTs within our evaluation, it should also be possible to look at whether some models lead to better outcomes than others, and which models are most cost-effective. By combining the quantitative analysis with the extensive qualitative data collected within the MDT sites, it should enable a better understanding of the mechanisms generating any different outcomes within the different models of MDTs. The qualitative data generated during the evaluation should provide a unique combination of perspectives from patients, informal carers, and strategic and frontline staff on the receipt, planning and delivery of care respectively, including since the start of the Covid-19 pandemic, which could contribute to the future development of MDTs, as a key intervention designed to provide integrated care. In turn, better designed MDTs involving health and social services staff coordinating care could benefit patients living in the community who have multiple long-term conditions that require the skills and services of a range of health and local authority staff.

The ultimate aim of the wider evaluation, of which the analysis of patient outcomes using the HES and mortality data is a part, is to provide policymakers with better evidence on how best to integrate health and social care services in a cost-effective way. Given limited resources within both NHS and local authority social care budgets, these results should be of clear public benefit to the extent they can contribute to improved patient outcomes, and more efficient use of resources.

The research team at LSHTM is part of a Policy Research Unit (PIRU), funded by the NIHR Policy Research Programme. Its goal is to improve evidence-based policymaking and implementation across DHSC, NHS England and other arm’s-length bodies, and it has a wealth of experience working with policymakers in government.

Outputs:

The planned outputs include briefings and presentations to policy and management staff at DHSC and other national policy agencies such as NHS England and Improvement (NHSE/I) as well as published papers in high-profile, peer-reviewed scientific journals (previous articles on this evaluation have been published in BMC Health Services Research and the Journal of Public Health) and presentations at national/international academic, policymaker and practitioner seminars/ conferences/workshops (e.g., briefings with DHSC and NHSE/I, possibly joint events with the Nuffield Trust and the Health Foundation). These will form part of a package of outputs covering the wider long-term evaluation of the Pioneer programme, and all journal articles will be brought together within an over-arching ‘portfolio’ report highlighting the policy implications of the various strands of the evaluation and which will be made available to policymakers within the DHSC, NHS England, local authorities, Clinical Commissioning Groups (CCGs) and other relevant stakeholders. The research team has regular contacts with DHSC staff and other researchers involved in integrated care research and provides an annual report to DHSC covering progress and key findings of the research programme. Presentations will also be offered to the NHS and local authority social services organisations in the two localities involved in this particular component of the wider Pioneer Programme evaluation.

To facilitate dissemination among a wider audience, lay summaries of key outputs will be provided and the research team will write blogs and articles for newsletters (e.g., Health Service Journal) and newspapers, as well as engage with the mainstream media (e.g., press releases, interviews). LSHTM has an active press office, with good connections to both specialist and mainstream media outlets, and the project team will work closely with the press office to promote the project among both key stakeholders and the wider public. Moreover, all outputs will be available on the project’s website (https://piru.ac.uk/projects/current-projects/integrated-care-pioneers-evaluation.html).

All publications derived from record level data will contain only aggregate level data without patient identifiers and with suppression of small numbers in line with the HES analysis guide.

The wider Pioneer evaluation already has a number of publications and other outputs. Outputs based on patient HES and mortality data will start to be produced in the Second Quarter of 2022 and are likely to be published later in 2022. One paper on the MDTs was submitted in late 2021 and is currently in revision with a journal and others will be submitted during 2022.

Processing:

In order to obtain HES and mortality data for MDT patients within the two Clinical Commissioning Group (CCG) areas included in the study, LSHTM will provide NHS Digital with unique study number, name, and date of birth for those 441 MDT patients who consented to data linkage of their survey data with HES and mortality data. The patient consent form said that this information would be passed to the NHS Commissioning Support Unit (i.e., NEL CSU), which was the intention at the start of the study. However, by the time the study ended, this route for obtaining data linkage was no longer an option, and it was decided that these details should be passed by LSHTM directly to NHS Digital, without the intervention of NEL CSU. Following advice from IGARD, the research team carried out a consultation to determine whether patients had any objections to their details being passed by LSHTM directly to NHS Digital, and all contacted patients agreed with this proposed change.

NHS Digital will use name, date of birth, and CCG to trace NHS numbers for consenting MDT patients and then use NHS numbers to link to these consenting patients' HES and mortality data. After removing NHS number, name, date of birth and CCG, NHS Digital will provide the HES and mortality data directly to LSHTM, who will link this data with the survey data for individual MDT patients using the unique study number.

For the comparison patients, NHS Digital is asked to provide the data items requested for all patients born before 1st October 1964 (and who were still alive on 1st October 2018 when the study started data collection). For the comparison patients, the request does not include any identifiers or potential identifiers, so the data provided by NHS Digital will be pseudonymised. The data will be provided directly to LSHTM. Only variables needed for the research have been requested, and only for patients relevant for the research, i.e., those aged 55 and over at baseline. The comparison (control) group comprises patients aged 55 years or older living at a private residential address located in an area not covered by the Pioneer programme and by other national integrated care initiative. The years requested cover the time period needed to identify a suitable comparison sample and to allow follow-up (i.e., 5 years before baseline to latest available).

To identify the matched comparison group, common matching algorithms (e.g., nearest neighbour matching) will be applied to a pool of patients aged 55 years or older living at a private residential address located in an area not covered by the Pioneer programme and by other national integrated care initiative. The use of this matching approach will ensure that the requested key observable socio-demographic variables are balanced between the comparison groups and that individuals in the matched comparison group are not subject to the influence of similar interventions. The balance on the requested key observable variables (e.g., age, sex, ethnicity, deprivation) is a necessary condition for the unbiased identification of the MDT’s treatment effects. Data from patients younger than 55 years old and not living at a private residential address have been excluded from this request as they were not the target population of MDTs and there is no expected effect of the intervention in this population. The years requested cover the time period needed to identify a suitable comparison sample and to allow follow-up.

Only pseudonymised data will flow to LSHTM and there will be no attempts to re-identify these individuals. The pseudonymised dataset used for analysis will not include identifiers and will be stored on the secure server at LSHTM. (The paper consent forms are kept securely in a locked office at LSHTM.)

The dataset which includes HES and mortality data will be saved on LSHTM’s secure server, which has been certified as meeting NHS Digital’s security standards. The dataset will only be accessible by authorised members of the LSHTM project research team. All LSHTM staff accessing these data have undergone training in GDPR and data protection regulations.

Prioritising patients for Emergency Surgery Or Not: the impact of COVID-19 (ESORT-C19) — DARS-NIC-583534-X7S2N

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (Research)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2022-03-18 — 2025-03-17 2022.04 — 2022.11.

Access method: Frequent Adhoc Flow

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Civil Registration (Deaths) - Secondary Care Cut
  2. HES:Civil Registration (Deaths) bridge
  3. Hospital Episode Statistics Admitted Patient Care
  4. Hospital Episode Statistics Critical Care
  5. Civil Registrations of Death - Secondary Care Cut
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)
  7. Hospital Episode Statistics Critical Care (HES Critical Care)

Objectives:

BACKGROUND
Patients with acute conditions who present as emergency hospital admissions may receive emergency surgery (operative) or non-operative care. Within the emergency general surgery specialty, some patients with acute conditions have improved health following emergency surgery and others from non-operative care. However, for many patients the relative benefits, risks and costs of emergency surgery versus non-operative care are unknown.

The Getting it Right First Time (GIRFT) report for emergency general surgery (https://gettingitrightfirsttime.co.uk/wp-content/uploads/2018/08/GIRFT-GeneralSurgery-Aug17-O1.pdf), found wide variation across NHS trusts in care quality and outcomes after emergency surgery, which reflect local logistical and resource constraints, but also clinical uncertainty. For common acute conditions, such as diverticular disease, there are well-developed non-operative strategies and little evidence that emergency surgery leads to better outcomes.

THIS STUDY
The Prioritising Patients for Emergency Surgery Or Not: the impact of COVID-19 (ESORT-C19) study aims to estimate the effectiveness and cost-effectiveness of emergency surgery (ES) versus non-emergency surgery (NES) to inform which patients should be prioritised for ES during the COVID-19 recovery period. The study will consider emergency hospital admissions for five acute conditions where there is great clinical uncertainty about which patients should have ES. The five conditions are: acute appendicitis, cholelithiasis, diverticulitis, abdominal wall hernia, and intestinal bowel obstruction. ESORT-C19 will consider access to ES versus NES according to patient subgroups (e.g. age >=70 or not; ethnic origin, deprivation, co-morbidities). Access to ES versus NES will be contrasted across different time periods to reflect the different ‘stages’ of the COVID-19 pandemic. The final decision as to the number and timing of the different stages will be made following initial descriptive analysis of the data, but it is planned that there will be five time periods defined as: ‘pre’ COVID-19 pandemic (February 1 2015 - 31 January 2020); ‘first peak’ (February 1 2020 to June 30 2020), ‘first recovery phase’ (July 1, 2020- September 30, 2020), ‘second peak’ (October 1, 2020 to February 28, 2021), and ‘second recovery phase’ (March 1, 2021 to August 31, 2021).

ESORT-C19 will also aim to build on the ongoing Emergency Surgery OR noT (ESORT) (https://www.lshtm.ac.uk/research/centres-projects-groups/esort) study funded by the National Institute for Health Research (NIHR) with data provided under an existing data sharing agreement (DARS-NIC-185179-V0B0T). Data provided under NIC-185179 have been used to supplement the analysis used in the final report for the ESORT study (currently under review) and three papers (one published, one accepted, one provisionally accepted). Key findings from ESORT are differences in the effectiveness and cost-effectiveness of ES for specific subgroups – in particular, level of frailty. Two patient and public involvement workshops were held in September 2021 and resulted in the dissemination of study findings aimed at patients and the public. Further dissemination and subsequent yielded benefits will follow publication of the main effectiveness and cost-effectiveness results.

Health Research Authority Research Ethics Committee approval for the ESORT-C19 study is not required as this data application does not include the flow of confidential data. Local institutional ethics approval is however adequate and in place and evidence provided to NHS Digital.

The ESORT-C19 study (https://www.lshtm.ac.uk/research/centres-projects-groups/esort#esort-c19), funded by the Health Foundation (COVID-19 Research Programme) hopes to examine the impact of COVID-19 on the effectiveness and cost-effectiveness of ES. The Health Foundation have no role in decisions made over the processing or analysis of NHS Digital data. The Health Foundation are funders only.

The data requested for ESORT-C19 are identical in scope with the data provided for ESORT with the exception of the time-period covered and will be provided under this new data sharing agreement to ensure full separation between the two studies. Cause of death is required so that the number and proportion of deaths attributed to COVID-19 can be reported and sensitivity analyses conducted to examine the impact of both COVID-19 diagnoses and deaths on study results. Duplication of data flowing under NIC-583534-X7S2N and NIC-185179-V0B0T is required as the core objective of the respective studies are the same (with the exception of the COVID-19 purpose to NIC-583534-X7S2N) - to estimate the relative effectiveness and cost-effectiveness of ES versus non-operative care for common acute conditions. The same five conditions will be assessed across both studies, with identical ICD-10 codes supplied to NHS Digital. The same variables will also be assessed across the two studies – eg. patient characteristics, surgical volume for each acute condition.

The ESORT-19 study requires a separate Data Sharing Agreement and cannot be covered by the data supplied under NIC-185179 for a number of reasons. This includes having separate ethical approval, a different funder (Health Foundation for ESORT-19 rather than National Institute for Health Research for ESORT), a different Data Sharing Agreement end date, and a different purpose for processing NHS Digital data (the effectiveness and cost-effectiveness of ES versus NES is related specifically to the COVID-19 pandemic).

London School of Hygiene & Tropical Medicine (LSHTM) is the sole data controller who will process data. Only LSHTM will determine the purpose for and the manner in which the data in ESORT-C19 are processed. Only LSHTM will have access to the pseudonymised data requested and supplied by NHS Digital. Data will not flow to other partners (listed on the ESORT website homepage – https://www.lshtm.ac.uk/research/centres-projects-groups/esort) who will only act in an advisory capacity. Clinical co-applicants comprise representatives of University of Nottingham, Royal Alexander Hospital, University of Bristol, University College London and Royal Devon and Exeter NHS Foundation Trust. These clinical co-applicants provide specialist guidance to the study only and do not carry any responsibility for the purpose and manner in which data provided under this Agreement are processed. This responsibility lies solely with LSHTM. Clinical co-applicant and research partner responsibilities include attending investigators' meetings, providing input on relevant clinical and policy matters, responding to clinical queries from LSHTM staff processing the data, and providing a clinical interpretation of the outputs of data analyses.

A patient and public involvement (PPI) group has informed the design of the study through the involvement of the co-investigator. The group are involved in this study in an advisory capacity only. Two virtual PPI panels were held on the 6th and 9th July 2020. These panels sought the views of members of the public and individuals who had experience of the conditions being studied in ESORT and ESORT-19. Panelists discussed outcomes of treatment, as well as quality of life issues. Topics of discussion included pain-management and the psychological impact of treatment, as well as the potential impact of COVID-19 on decisions about care. Further panels were held in September 2021 where a Plain English Summary of the study was shared with participants.

OBJECTIVES
The aim of the ESORT-C19 study is to estimate the effectiveness and cost-effectiveness of ES versus NES strategies to inform which patients should be prioritised for ES during the COVID-19 recovery period. Its specific objectives are:
1 - To estimate the effects of the ‘peak’ and ‘recovery’ periods versus ‘pre’ COVID-19 period, on access to ES according to patient- level characteristics, for common acute conditions presenting as emergency admissions.

2 - To estimate the effectiveness and cost-effectiveness of ES versus NES for common acute conditions presenting as emergency admissions during the ‘peak’ and ‘recovery’ versus ‘pre’ periods, according to patient-level characteristics.

3 - To recommend which patients to prioritise for ES for common acute conditions presenting as emergency admissions during the COVID-19 recovery period.

The study objectives were written in 2020 before the second COVID-19 wave in the UK and assumed an on-going recovery period following the first wave of COVID-19 that peaked in March-May 2020. It was anticipated that the recovery period would see a return to normal services for emergency surgery and other parts of the health system. Subsequent COVID-19 waves require the study to consider multiple ‘peak’ periods coinciding with high COVID hospital admissions that are interspersed with ‘non-peak’ periods rather than the anticipated single ‘recovery’ period.

DATA MINIMISATION:
1) All patients with an emergency admission which includes a diagnosis (via International Classification of Diseases version 10 (ICD-10) code) of one of 5 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2013 and latest available.

2) All episodes of all admissions (emergency and elective) which include a diagnosis (via International Classification of Diseases version 10 (ICD-10) code) of one of the above 5 acute conditions, with an admission date between 1 April 2013 and latest available.

Data are required from 2013/2014 – latest available to provide an analysis cohort split into pre-pandemic (5 years from 2014/15) and peak/recovery periods during the pandemic for analysis. The additional year of the cohort (from 2013/14) is required to calculate the instrumental variable, the tendency to operate, for all patients in the analysis cohort. These data are required to describe and control for longer-term trends in the receipt of ES and outcomes both prior to and during the COVID-19 era, and to investigate changes in the instrumental variable, the tendency to operate, during this period. An instrumental variable is a variable that allows causal relationships to be estimated without the need for a randomised controlled trial.

Overall justification for the data requested:
Hospital Episode Statistics, Admitted Patient Care (HES APC) data are required to determine the exposure (emergency surgery or non-operative care), to identify patient characteristics (age, sex, ethnicity, index of multiple deprivation) and comorbidities, to identify subsequent admissions (emergency or elective), to derive the surgical volume (a measure of quality) for each acute condition, and to derive and the proportion of emergency admissions for each acute condition where ES is undertaken (the tendency to operate, subsequently used as an instrumental variable). HES APC and HES Critical Care (CC) data are required for estimating resource use and costs associated with ES and non-operative care. National data are required to ensure sufficient events for analysis and provide nationally representative findings.

The HES APC data being requested relate to:
i) a specific cohort of adult patients (18 years+) relating to the above 5 acute conditions only, and
ii) a broader extract of adult patients (18 years+) relating to the above 5 acute conditions only which will allow the LSHTM to assess the quality of care experienced by the patients in the cohort.

i) Cohort
The cohort of patients is defined as all adult patients with an emergency admission which includes a diagnosis (via ICD-10 code) of one of 5 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2013 and latest available. This is the index admission. LSHTM are also requesting data relating to this cohort of patients for all episodes of all admissions (emergency and elective) from 1 year prior to their index admission to 1 year after their index admission (i.e. covering the period 1 April 2012 to latest available). Data at the index admission will be used to determine the exposure (ES or non-operative care); data from 1 year prior to the index admission up to and including the index admission will be used to identify patient characteristics (age, sex, ethnicity, index of multiple deprivation) and comorbidities, and for applying exclusion criteria such as prior surgery; data from the 1 year following the index admission will be used to identify subsequent admissions (emergency or elective).

The size of this data request has been minimised by requesting only data relating to the cohort patients (i.e. for the above acute conditions only); the number of years of data requested has been minimised by requesting only data relating to the period within 1 year of the index admission for each cohort patient; the number of variables requested has been minimised by only requesting those which are necessary for the proposed analysis.

Exclusion criteria for defining the index admission will include: age less than 18, a previous emergency admission for the condition within the year prior to the index admission, and referrals from tertiary referral centres.

The rationale for each of these exclusions is as follows.
a) For patients aged under 18 years old, the string consensus amongst the clinical co-applicants is that there is no clinical equipoise for the decision whether to provide ES or alternative strategies. It was therefore judged inappropriate to include this population in the study and hence in the data request;
b) Patients who had had a previous emergency admission within the preceding 12 months are more likely to have a chronic condition rather than acute presentation, and were also judged to represent a different target population;
c) Patients referred from a tertiary referral centre were also judged to be quite different in their prognosis and more likely to be triaged for ES. Hence, the inclusion of this subgroup of patients would likely lead to biased estimates of the relative effectiveness and cost-effectiveness of ES, and hence provide less useful results for NHS decision-making.

The study will include clear justification for these exclusions in the outputs from the research. LSHTM will offer clear guidance as to how the groups excluded could be considered in future studies that had different objectives, in particular with respect to the comparator strategies or service decision-makers of interest. For example, a future research programme targeted at patients under 18, may focus on those acute hospitals that provide specialist children’s services.

Health Inequalities Impact Assessment

The ESORT-19 project will provide direct evidence on the effect that the COVID-19 period has had on inequalities in the provision of ES. Specifically, in addressing objective 1, LSHTM will provide the NHS with direct evidence on the proportion of patients, and the delay to receiving ES, for these common acute conditions according to socioeconomic characteristics, such as the patients’ age, ethnicity, and index of multiple deprivation. In addressing objective 2, LSHTM will present effectiveness and cost-effectiveness results according to these same socioeconomic characteristics, in order to identify those subgroups for whom ES may be under- (or over-) provided following the outbreak of COVID-19. Under objective 3, LSHTM will provide clear recommendations on how the future provision of acute surgical services should be targeted to particular subgroups to improve efficiency, but also equity, in service provision. In making these recommendations, LSHTM will draw from their Public and Patient Involvement (PPI) findings to help ensure that recommendations, especially with respect to health inequalities, reflect the concerns of a representative group of ex-patients and public contributors.

ii) Broader extract
LSHTM are also requesting data on a very limited number of variables relating to all episodes of all admissions (emergency and elective) which include a diagnosis (via ICD-10 code) of one of 5 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2013 and latest available (i.e. not just the cohort patients). These data will be used to derive the surgical volume (a measure of quality) for each acute condition for inclusion in the instrumental variable analysis.

The size of this data request has been minimised by requesting only data relating to the diagnoses of interest; the number of years of data requested has been minimised by requesting only data corresponding to the cohort (2013/14 to latest available); the number of variables requested has been minimised by only requesting those which are necessary for the proposed analysis.

Civil Registration (Deaths)
Date of death is required for two reasons:
(i) deriving a primary outcome, and
(ii) allocation to the emergency surgery or conservative management arm.
The ESORT study's patient and public involvement (PPI) meetings discussed potential outcomes and highlighted 'days alive and out of hospital' as an important outcome. Accurate measurement of this outcome requires date of death. The second reason for requiring date of death is to enable an allowance to be made in the analysis for any bias that might arise if death occurs before surgery can occur. This relates to the use of a time window within which surgery must occur (e.g. 7 days) to be defined as 'emergency surgery' and the possibility that a patient may die without having surgery during this window. Date of death will allow the study to identify these patients for each day in the window.

The General Data Protection Regulation (GDPR) Article 6 (1) (e) and Article 9 (2) (j) are the legal basis for the processing of the data. Article 6(1)(e) - task in the public interest: LSHTM is a public authority as described under Schedule 1 of the Freedom of Information Act 2000. LSHTM has a basis in law for the lawfulness of processing as LSHTM holds a Royal Charter. The Royal Charter states “there shall be one Body Corporate and Politic under the name of the London School of Hygiene and Tropical Medicine (“London School”) for the purpose of and with the objects of promoting original research, consultancy and the study of and education in public health and tropical medicine”. It is, based upon evidence this research will generate, in the public interest to provide and prioritise effective and cost-effective health care.
Article 9(2)(j) Archiving in the public interest/scientific or historical research/statistical purposes: The data are required for the purposes of a study analysing the impact that COVID-19 has had on the effectiveness and cost-effectiveness of ES. The outcomes of this study are in the public interest as it will allow health care services to better plan and prioritise care for patients. To this end, the study meets the conditions detailed in Data Protection Act 2018 Schedule 1 Part 1 (4). The GDPR Recital 52(2) determines that this is an appropriate derogation from the prohibition on processing special categories of personal data, as demonstrated in the Purpose section of this application.

Expected Benefits:

The main results from the ESORT-19 study are expected to be delivered within 12 months of receipt of data with initial results within three months.

Benefits to patients:
The five emergency general surgery conditions included in ESORT-19 are typically responsible for a total of around 2,000 hospital admissions per week in England. The provision of data may allow the effectiveness and cost-effectiveness of ES to be compared with alternatives such as medical management or later planned surgery during different stages of the COVID pandemic. The study design, in particular the study populations included, has been carefully specified, drawing on clinical expertise, to generate reliable evidence for those populations where the choice of ES versus alternatives is most important during the COVID-19 periods.

This information hopes to allow NHSE and its hospitals and staff to better plan the provision and prioritisation of care given the uncertainties with the future direct and indirect impact of COVID-19. For example, alternatives to ES may be more effective in some circumstances but ES more effective in others depending on the condition, the diagnosis or other characteristics such as patient frailty, leading to greater effectiveness and better outcomes overall.

Key findings from the study hope to be promptly disseminated to NHSE, e.g. via webinar.

Inclusion of key senior NHSE staff as co-investigators or advisory group members hopes to ensure findings are presented appropriately and reach relevant decision-makers.

Outputs:

The aim is to complete the study by September 2022 with all the below outputs scheduled between approximately April 2022 and December 2023. The request for the data sharing agreement to run for three years to 2025 is to allow for potential delays in the peer review process and post-publication queries that may require further analysis of the data.

The clinical co-applicants, who are listed as collaborating partners on the ESORT study website, hope to ensure the study recommendations can quickly feed into NHS guidelines, and shape practice. The research questions tackle priorities designated by policy-makers at NHS England, the Getting it Right First Time (GIRFT) initiative, clinical opinion leaders, service commissioners, leaders of surgical networks and Patient and Public representatives. These views have shaped the study objectives and strategy for impact. The dissemination plan has the following key components:

a) Workshops and discussions at NHS England (NHSE)
One co-applicant, a National Clinical Director at NHSE hope to lead communication of results to national policy-makers and inform imminent policy decisions, for example about Best Practice Tariffs (e.g. for emergency laparotomy) and Commissioning for Quality and Innovation. An advisory group member, a Medical Director at NHSE, fully supports the proposed study, and has agreed to chair webinars at NHSE to raise awareness of the study’s early results.

b) Future updates to GIRFT initiative
Another advisory group member, former lead of the highly influential GIRFT initiative, hopes to ensure that future updates of the GIRFT report for emergency general surgery, draw on this study’s recommendations about emergency general surgery provision in the COVID-19 recovery phases.

c) Presentation to networks of clinical decision-makers
The incoming President of the Association of Surgeons of Great Britain and Ireland (ASGBI) requested that the main results of ESORT-C19 are presented during a COVID-19 symposium at the ASGBI annual conference. The incoming president of the Association of Coloproctology of Great Britain and Ireland (ACPGBI) would like results of the ESORT-19 study to be presented at the societies’ annual meeting in 2022. The study team hope to give informal webinars to these groups to ensure the study’s early results are widely available.

d) Presentation to networks of health service managers and researchers
The study team hope to present findings to national (Health Services Research Network) and international (e.g. Academy Health) health services research conferences in 2022.

e) Wider clinical, policy and public audiences
The study's clinical and PPI panels hope to help ensure the widespread presentation and interpretation of the study findings, and that the implications for clinical guidelines are clear for clinicians, patients and carers. The study team will write blogs discussing the issues raised by emergency general surgery provision following COVID-19 for the Department of Health and Social Care support unit, Policy-Innovation Research Unit (PIRU), https://piru.ac.uk/ and for the RCS COVID-19 website, https://www.rcseng.ac.uk/coronavirus/blog-views-from-the-nhs-frontline/.

Outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide.

Processing:

The process will involve:

1. NHS Digital provide the LSHTM with bespoke data extracts of HES APC linked to mortality data, and HES CC episodes including Master Person Service (MPS) ID.

2. Extract will be received by the LSHTM by file transfer and stored on the LSHTM secure server.

3. Eligible index episodes/admissions and derived variables such as comorbidities, surgical volume and tendency to operate will be identified from the HES APC cohort data and 1-year prior data.

4. Subsequent HES episodes will be used to identify patient outcomes in addition to those provided via linkage to Civil Registration (Deaths) data.

5. A single patient-level dataset for each condition will be created including the above derived variables. The main analysis will be on these patient-level datasets.

LSHTM will store the data on a secure server in London (at LSHTM's Keppel Street building with back-ups at LSHTM's 15-17 Tavistock Place building) which can only be accessed at LSHTM.

No organisations other than LSHTM are involved in the planned data analysis. All those involved in the processing of the data are substantive employees of LSHTM or students/honorary staff of LSHTM with contracts meeting NHS Digital’s requirements. LSHTM staff and students are only granted access to the secure server if they have undergone Information Security and Awareness training. This is a requirement of LSHTM's Data Security and Protection Toolkit.

There will be no requirement nor attempt to re-identify individuals from the data.

No elements of the work will take place outside the England and Wales.

Impact of Community Perinatal Mental Health Teams on mental health and birth outcomes (The ESMI-II study). — DARS-NIC-376141-W5D3L

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (Research)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2021-12-02 — 2024-12-01 2022.01 — 2022.02.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Bridge file: Hospital Episode Statistics to Mental Health Minimum Data Set
  2. Civil Registration (Deaths) - Secondary Care Cut
  3. HES:Civil Registration (Deaths) bridge
  4. Hospital Episode Statistics Admitted Patient Care
  5. Improving Access to Psychological Therapies Data Set_v1.5
  6. Mental Health and Learning Disabilities Data Set
  7. Mental Health Minimum Data Set
  8. Mental Health Services Data Set
  9. Civil Registrations of Death - Secondary Care Cut
  10. Hospital Episode Statistics Admitted Patient Care (HES APC)
  11. Improving Access to Psychological Therapies (IAPT) v1.5
  12. Mental Health and Learning Disabilities Data Set (MHLDDS)
  13. Mental Health Minimum Data Set (MHMDS)
  14. Mental Health Services Data Set (MHSDS)

Expected Benefits:

Although there will be no direct benefit to the women or babies included in the cohort for this study, the aim of this study is to evaluate the impact of CPMHTs on psychiatric inpatient admissions during the perinatal period and the health of mothers and babies it is hoped this will help future patients.

It is hoped the findings will inform best practice, the commissioning of perinatal mental health services, the components to commission, future updated NICE and NHSE guidance, and best practice leading to greater staff satisfaction and potential efficiency savings.

Findings could also inform criteria for maternity tariffs for standard, intermediate and high-risk care (currently the high-risk tariff is based on postpartum psychosis history only).

The research should lead to improvement of services; as a result women and their families should benefit through fewer barriers to accessing care, better tailored care across the care pathway, better mental health, functioning and quality of life and better family outcomes.

Outputs:

It is hoped that LSHTM will disseminate the findings through stakeholder events for staff at CPMHTs, maternity mental health leads and policy makers, including places prioritised for sub national site collaborators, regional perinatal network managers and clinical leads. These events will be held in different parts of England each year to facilitate attendance by sub national clinicians and maintain interest and research participation.

The results of this research will also be discussed with NHS England towards the end of the research. LSHTM will also disseminate through other relevant organisational meetings. LSHTM will also disseminate the findings through academic papers and conference presentations.

Expected academic papers will include:
- Maternity outcomes in women with pre-existing mental health conditions.
- Results of the clinical analysis, presenting the estimated impact of CPMHTs maternal and maternity outcomes (June 2022)
- Results of the economic analysis (June 2022)
- Methodological development, describing a classification system for mental health conditions for the purpose of perinatal mental health research.

It is hoped the findings of this study will inform commissioning of perinatal mental health services in England, elsewhere in the United Kingdom and abroad. They will also support the further development of NICE guidance and NHS England policy with respect to the commissioning of perinatal mental health services.

Depending on the results, the study may lead to improvement of services to women with mental health conditions before and during pregnancy and in the first year after birth.

Using medical-detection dogs to identify people with SARS-CoV-2. Phase I-III studies. Application for participant results details. — DARS-NIC-426830-M1C1K

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c)

Purposes: Yes (Research)

Sensitive: Sensitive

When:DSA runs 2021-03-04 — 2022-03-02 2021.04 — 2021.06.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Covid-19 UK Non-hospital Antigen Testing Results (pillar 2)
  2. COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2)

Objectives:

ARCTEC, the commercial arm of The London School of Hygiene and Tropical Medicine (LSHTM) is requesting details of study participants’ COVID test results obtained at Pillar 2 sites and NHS hospitals. The data request is being made to support an HRA-approved study “Using Medical Detection Dogs to identify people with SARS-CoV-2. Phase 1, Proof-of-concept studies”. This study, initiated in 2020, will assess the sensitivity and specificity of medical detection dogs in identifying SARS-CoV-2 infection. The success of this study would aid in preventing future outbreaks of the virus, as the medical detection dogs could provide a high-throughput screening tool in key public risk areas such as airports.

ARCTEC is a wholly owned subsidiary of the LSHTM, all staff are employed on LSHTM contracts, housed in LSHTM building and supported by the same infrastructure [IT and Data Protection Office]). ARCTEC staff have acted as the Trial Coordinating Centre for this study, leading study activities, and recruiting all volunteers for the current data application.

Following the changing path of the epidemic in the UK, the Department of Health and Social Care (DHSC) has made a request for evidence that:
~ The medical detection dogs can detect COVID-19 in people with new viral strains.
~ The dogs can detect COVID-19 in people with low viral loads, and asymptomatic individuals.

The aim of this data request is to identify key subsets within the existing samples (people with variant of concern, low viral load), and test these samples to assess whether dogs’ screening accuracy remains consistent under these variations.

The SARS-CoV-2 ‘Kent’ viral strain (SARS-CoV-2, variant of concern 202012/01) shows S-gene target failure in commonly used Polymerase Chain Reaction (PCR) assays (a method of amplifying tiny amounts of genetic material e.g. DNA, from a sample so it can be detected more easily. It runs in cycles with a higher amount of genetic material present after each cycle is complete). The data requests will give details of assay outcomes, which can be used to infer which participants may have been infected with the ‘Kent’ strain.

Recruitment to the study was conducted between August 2020 and January 2021. As the ‘Kent’ strain became common in the UK in December 2020, it is highly likely that the study contains a mix of samples representing different viral strains.

London School of Hygiene and Tropical Medicine requires further data from the COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2) Dataset to understand which strain of SARS-CoV-2 participants were infected with when the individual tested positive and the onset of symptoms for approximately 900 study participants.

Test outcomes, symptom start dates and PCR cycle thresholds (Ct thresholds) will be used to assess claims around screening success in people with no symptoms/ low viral load.

Release of data will be needed for modelling studies assessing the detection dogs’ utility in different screening scenarios (low/ high infection prevalence, and at ports of entry with novel viral strains present). Release of data will impact the study team’s ability to obtain funding for phase 2. The scope of this data request is to provide data useful to the current study phase (phase 1, proof of principle), next phase (phase 2, in-person training with healthy volunteers) and input into the accessory modelling study.

The LSHTM is the sole Data Controller and Processor. Medical Detection Dogs (MDD), University of Durham and DHSC will not process the NHS Digital pseudonymised data. They will however be given access to sections of aggregated data (in line with the HES analysis guide) in order to assess and report on study outcomes (chiefly the dogs’ sensitivity and specificity in screening key subset groups). The aggregated data provided to MDD will contain group information (viral load, strain type), sent via encrypted file transfer.

The Trial Steering Committee have an advisory role, they do not have any control over how NHS Digital data is used or access to these data (except in the form of aggregated (with small numbers suppressed) trial results produced for or presented at these meetings). They provide advice, guidance, and support to the trial. The Trial Steering Committee meet virtually, and are chaired by an LSHTM staff member.

The research is funded by the Department of Health and Social Care (DHSC). DHSC does not have access to data, except for aggregated reports (with small numbers suppressed) on study outcomes, which do not contain identifiable information.

The data is being processed under the following legal basis:
GDPR 6 (1) (e): Public Task; The study is performing research on a disease of high public health importance, and the data request is required to as part reporting requirements put in place by government stakeholders and GDPR 9(2)(j): Public health research; This research is on a screening tool for COVID-19, a disease of public health importance.
All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data). There will be no requirement nor attempt to re-identify individuals from the data. The data from NHS Digital will not be used for any other purpose other than that outlined in this agreement.

Expected Benefits:

The expected benefits of the study are the testing and validation of a medical detection dogs as a screening tool for identification of COVID-19. If found to be an accurate screening tool, medical detection dogs could be deployed at key ports of entry, and high risk public gatherings to quickly and accurately identify people with COVID-19.

Preliminary results from phase I of the study have been promising in indicating that the Medical Detection Dogs are able to detect samples from positive participants.

Medical Detection Dogs are able to screen up to 250 individuals per hour, and are suitable tools for a number of settings, including but not limited to border points, public events, and screening of groups for whom nasal swabs are unfeasible or distressing.

The application of dogs could provide a key tool in preventing further outbreaks of the SARS-CoV-2. If dogs are established as screening tools in such locations, this could have a noticeable impact on future considerations to alleviate lockdown measures.

The data from NHS Digital will be crucial ensuring that the dogs are trained not just to detect the virus, but also picking up variation in virus strain, viral loads, and asymptomatic infected individuals. The knowledge of these details in individuals can enable targeted strategies for treating them and preventing spread.

Outputs:

It is expected that there will be a number of different outputs with the results of the study data:

PUBLICATIONS
A scientific report on phase 1 findings is already in draft for submission to peer-reviewed scientific journals (open access publication) and data provided by NHS Digital will feed in to results and discussion of this paper. Publications will only contain data aggregated with small numbers suppressed in line with the HES analysis guide. Target date for publication: June 2021.

GENERAL PUBLIC
Research findings will also be disseminated to the public through various routes including the study websites, newsletters and through the active public engagement programmes. The LSHTM will work with its media department and its lay representatives to ensure the findings are accessible to the broader public. Target date: periodic updates to be provided throughout course of study.

PARTICIPANTS
Participants will be appraised of study findings through a newsletter, to be sent out at study close, July/ August 2021.

ENGAGEMENT WITH POLICY MAKERS
LSHTM will rapidly disseminate evidence on medical detection dogs as a disease-screening tool to key stakeholders (policy-makers, Border Force) through regular meetings and provision of interim reports. Government stakeholders sit on the Trial Steering Committee, and are therefore appraised of trial progress twice monthly in committee meetings.

In addition to engagement with policy-makers, the study will provide reports on key outcomes to stakeholders with a role in translation of the tool to operational deployment (Innovation Leads).

HANDBOOK
At the conclusion of phase 3 of the study, a handbook on dog training for COVID-19 detection will be produced, offering guidance to other teams both in the UK and internationally, on rolling out this strategy, thereby maximising impact of the study. Target data for completion: July 2021.

STUDY DATA SHARING
The research conducted in this study may provide valuable evidence on the use of dogs as a screening tool for other viral infections and health conditions. To enhance future research in the area, anonymised study data may be published in a data repository (only aggregated data with small numbers suppressed in line with the HES analyses guide will be published). This will be beneficial in generating high quality research evidence related to viruses and outbreaks similar to the COVID-19 pandemic in the future. Thus, the potential benefits of this study may be substantial. Target date: To be published alongside publication, June 2021.

No identifiable personal data will ever be published.

Processing:

LSHTM will supply a file of approximately 900 trial participants containing participant identifiers (Study ID, Name, Gender, Date of Birth and Test date) to NHS Digital. Data will be transferred to NHS Digital twice, once when the agreement is signed off, and once 2 weeks after the newsletter has been distributed to cohort members to give them sufficient time to withdraw from the study.

Data subjects are trial participants, who have provided informed consent to participate in the trial. Participants are adults aged 16+, who sought a COVID test for reasons of symptoms or probable disease exposure (via household or occupational risk). Participants provided odour samples to the trial, and were subsequently given follow-up for adverse events (up to 30 days after first participation). At 30 days after participation, participants’ involvement in the study ends.

The participant identifiers provided by LSHTM will be linkable to COVID-19 PCR results data in the COVID-19 UK Non-hospital Antigen Testing Results (Pillar 2) Dataset.

The detailed sample results will be returned to LSHTM where the data will be pseudonymised using Participant ID numbers such that it cannot be linked to individual participants without use of a participant ID log.

The dataset will be immediately stored on an LSHTM secure server. Data will only be accessible to named individuals, who are substantively employed by LSHTM. Access must be approved by the Data Manager.

This data will be securely encrypted on the Secure Encrypted Server at LSHTM to form a list of participants IDs, infection status, Date of Birth, Gender, Ethnicity, Enrolment Site, Medical History (if relevant). This fully anonymised encrypted dataset will be shared with Medical Detection Dogs. The fully anonymised decrypted dataset, including participant IDs, will be shared with statisticians.

All data requested is essential to address study aims, and has been minimised to contain only relevant outcomes. The subjects involved have been minimised- no data will be requested on participants who have been withdrawn from the study, or whose samples have been classified unusable (e.g. due to improper packaging, or excessive time lag between day of test, and day of sample collection).

Emergency Surgery Or noT (the ESORT study) — DARS-NIC-185179-V0B0T

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), , Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2018-09-07 — 2021-09-06 2018.10 — 2020.12.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Critical Care
  3. Civil Registration (Deaths) - Secondary Care Cut
  4. HES:Civil Registration (Deaths) bridge
  5. Civil Registrations of Death - Secondary Care Cut
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)
  7. Hospital Episode Statistics Critical Care (HES Critical Care)

Objectives:

Patients with acute conditions who present as emergency hospital admissions may receive emergency surgery (operative) or non-operative care. Within the emergency general surgery specialty, some patients with acute conditions have improved health following emergency surgery and others from non-operative care. However, for many patients the relative benefits, risks and costs of emergency surgery versus non-operative care are unknown.

The Getting it Right First Time (GIRFT) report for emergency general surgery, found wide variation across NHS trusts in care quality and outcomes after emergency surgery, which reflect local logistical and resource constraints, but also clinical uncertainty. For common acute conditions, such as diverticular disease, there are well-developed non-operative strategies and little evidence that emergency surgery leads to better outcomes.

This observational study will provide a rigorous evaluation of the relative effectiveness and costs of emergency surgery versus non-operative care for common acute conditions, and inform change to emergency general surgery provision across the NHS.

London School of Hygiene & Tropical Medicine (LSHTM) requires HES and Civil Registration (Deaths) data for use in the “Emergency Surgery Or noT (ESORT)” study activities.

The LSHTM instigated the work in order to estimate the effectiveness and cost-effectiveness of emergency surgery versus non-operative care for patients with common acute conditions presenting as emergency admissions to NHS trust hospitals. No other organisations are involved. Only LSHTM will have access to the pseudonymised data requested and supplied by NHS Digital.

The LSHTM has applied for and secured funding from the NIHR to undertake this work.

The aim of this work is to estimate the effectiveness and cost-effectiveness of emergency surgery versus non-operative care for patients with common acute conditions presenting as emergency admissions to NHS trust hospitals. The acute conditions being considered are appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction, acute intestinal ischaemia, and peptic ulcer’. This observational study will provide a rigorous evaluation of the relative effectiveness and costs of emergency surgery versus non-operative care for common acute conditions, and inform change to emergency general surgery provision across the NHS. The specific objectives are to evaluate using HES and Civil Registration (Deaths) data:

1. The effectiveness of emergency surgery versus non-operative care for common acute conditions presenting as emergency admissions across broad ICD-10 categories.

2. The relative cost-effectiveness of emergency surgery versus non-operative care across broad ICD-10 categories.

3. The clinical and cost-effectiveness of operative versus non-operative care for specific patient subgroups, including diagnostic subcategories and patient characteristics.

HES Admitted Patient Care (APC) and Civil Registration (Deaths) data are required from NHS Digital in order to undertake this study. Overall justification of the data requested:

HES APC data are required to determine the exposure (emergency surgery or non-operative care), to identify patient characteristics (age, sex, ethnicity, index of multiple deprivation) and comorbidities, to identify subsequent admissions (emergency or elective), to derive the surgical volume (a measure of quality) for each acute condition, and to derive and the proportion of emergency admissions for each acute condition where emergency surgery is undertaken (the tendency to operate, subsequently used as an instrumental variable). Civil Registration (Deaths) data are required so that 30-day, 90-day and 1-year mortality can be considered as outcomes.

The number of years of data requested (2009-2016) will provide sufficient events for analysis without being an unduly long period.

National data are required to ensure sufficient events for analysis and provide nationally representative findings.

The HES APC data being requested relate to: i) a specific cohort of patients (relating to the above 7 acute conditions only) and ii) a broader extract (relating to the above 7 acute conditions only) which will allow the LSHTM to assess the quality of care experienced by the patients in the cohort.

i) Cohort
The cohort of patients is defined as all patients with an emergency admission which includes a diagnosis (via ICD-10 code) of one of 7 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction, acute intestinal ischaemia, peptic ulcer) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2009 and 31 March 2016. This is the index admission. LSHTM are requesting data relating to their cohort of patients for all episodes of all admissions (emergency and elective) from 1 year prior to their index admission to 1 year after their index admission (i.e. covering the period 1 April 2008 – 31 March 2017 overall). Data at the index admission will be used to determine the exposure (emergency surgery or non-operative care); data from 1 year prior to the index admission up to and including the index admission will be used to identify patient characteristics (age, sex, ethnicity, index of multiple deprivation) and comorbidities; data from the 1 year following the index admission will be used to identify subsequent admissions (emergency or elective).

The sample size of this data request has been minimised by requesting only data relating to the cohort patients (i.e. for the above acute conditions only); the number of years of data requested has been minimised by requesting only data relating to the period within 1 year of the index admission for each cohort patient; the number of variables requested has been minimised by only requesting those which are necessary for the proposed analysis.

ii) Broader extract
LSHTM are also requesting data on a very limited number of variables relating to all episodes of all admissions (emergency and elective) which include a diagnosis (via ICD-10 code) of one of 7 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction, acute intestinal ischaemia, peptic ulcer) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2008 and 31 March 2016 (i.e. not just the cohort patients). These data will be used to derive the surgical volume (a measure of quality) for each acute condition and the proportion of emergency admissions for each acute condition where emergency surgery is undertaken (the tendency to operate, subsequently used as an instrumental variable).

The sample size of this data request has been minimised by requesting only data relating to the diagnoses of interest; the number of years of data requested has been minimised by requesting only data relating to the period of interest (1 year prior to their first index admission until their final index admission); the number of variables requested has been minimised by only requesting those which are necessary for the proposed analysis.

Civil Registration (Deaths)
Rather than applying to access death dates from the Civil Registration (Deaths) dataset, LSHTM are requesting derived variables indicating, for each patient in their cohort, whether or not they had died by 30-days, 90-days and 1-year after their index admission. This removes the need for them to directly access this sensitive data from the Civil Registration (Deaths) dataset.

Yielded Benefits:

There are no Yielded Benefits to date. The initial data provided by NHS Digital have been used to develop and refine definitions of the cohorts and intervention (emergency surgery). This work will be included in a section of the final report to the funders (Autumn 2021) and will form the basis of a planned protocol paper to be drafted in Summer 2020 and submitted for publication.

Expected Benefits:

The aim is to complete the study by April 2021, with all the below measurable benefits scheduled between April 2019 and April 2021 (exact dates TBC).

To help ensure that evidence will be generated that can improve emergency general surgery provision, the study design has been informed by service providers, commissioners and patient representatives. As well as a health economist, statisticians and an econometrician, the wider project team includes clinicians (senior perioperative researcher; consultant vascular surgeon; medical director) and a senior member of the Clinical Effectiveness Unit, Royal College of Surgeons, who will bring a national surgical perspective.

The study will inform service change via a translation workshop which will draw on the views of patient representatives, surgeons, national policy makers (e.g. NICE, NHS England), commissioners and managers of surgical services and those setting future research priorities.

The actual expected benefits of the project are increased effectiveness and cost-effectiveness of emergency general surgery within the NHS. Increased effectiveness will lead to improved quality of care, survival rates and quality of life. Increased cost-effectiveness will enable commissioners/care providers to reallocate funding to other areas of care, benefitting care users.

It is not possible to state the expected magnitude of the impact since this will depend on the findings of the project. However, if the project identifies commonly used surgical services where disinvestment is warranted and/or potentially commonly used surgical services where additional investment is required then the impact in terms of both effectiveness and cost-effectiveness could be substantial.

Outputs:

The aim is to complete the study by April 2021, with all the below outputs scheduled between April 2019 and April 2021 (exact dates TBC).

Findings will be presented at national and international conferences including clinical (surgical, perioperative) and academic (Health Services and Health Economist) meetings. A translation workshop will draw on the views of patient representatives, surgeons, national policy makers (e.g. NICE, NHS England), commissioners and managers of surgical services and those setting future research priorities, to ensure the study can inform service change.

Direct communication of knowledge to key clinical organisations and, if appropriate, input into clinical guideline development will be ensured by team members. This will include contributing to future Royal College of Surgeons initiatives, and working with NHS Rightcare to modify decision aids aimed at supporting shared decision making.

The LSHTM will work with its media department and its lay representatives to ensure the findings are accessible to the broader public. A full and complete account of the research will be made available by open access as a publication in the NIHR Health Services and Delivery Research Journal. Research papers will be published in peer-reviewed journals.

The research will provide recommendations to commissioners and providers of surgical services on those services where disinvestment is warranted, those where additional investment is required, and those where additional evidence, for example from new randomised controlled trials, would be of greatest value.

Outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide.

Processing:

The process will involve:

1. NHS Digital provide the LSHTM a bespoke data extract of HES Admitted Patient Care episodes and mortality data including the Unique Study ID and no other identifiers.

2. Extract will be received by the LSHTM by file transfer and stored on the LSHTM secure server.

3. The historic HES records of patients will be used to calculate surgical volume (by financial year and surgeon, hospital and Trust), tendency to operate (by financial year and surgeon, hospital and Trust), and patient comorbidities.

4. Subsequent HES episodes will be used to identify patient outcomes in addition to those provided via linkage to Civil Registration (Deaths) data.

5. A single patient-level dataset will be created including the above derived variables. The main analysis will be on this patient-level dataset. No other data will be used or linked to the data provided by NHS Digital.

LSHTM will store the data on a secure server in London which can be only be accessed at LSHTM.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

The data will not be linked with any record level data.

There will be no requirement nor attempt to reidentify individuals from the data.

The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Only specific conditions will be considered. Data relating to other conditions are not being requested.

No identifiers are requested.

MR1471 (MR865 & MR850) - HEALTH OF CIVIL SERVANTS — DARS-NIC-148044-RGS7W

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Identifiable, Yes (Section 251 NHS Act 2006)

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Academic)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2018-10-01 — 2020-09-30 2016.04 — 2020.07.

Access method: Ongoing, One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE, UNIVERSITY COLLEGE LONDON (UCL), UNIVERSITY OF OXFORD

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Bespoke
  4. Civil Registration - Deaths
  5. Demographics
  6. Cancer Registration Data
  7. MRIS - Flagging Current Status Report
  8. Civil Registrations of Death

Objectives:

The objectives of the Whitehall resurvey are to quantify reliably the relevance of blood lipids, markers of inflammation and nutrition and genetic markers, for cardiovascular and non-cardiovascular mortality in older people. This resurvey in 1997 of over 5500 older men (mean age 77 years) with questionnaires and blood samples who participated in the 1970 Whitehall study, involves over 3300 deaths over a 14-15 year follow-up period in the subset with complete data. The study has already contributed reports on vascular and non-vascular mortality in relation to blood lipids, biomarkers of inflammation, phospholipid fatty acids and cystatin C. Work is ongoing on reports mortality in relation to 25-hydroxy-vitamin D, smoking and alcohol consumption.

Yielded Benefits:

The study already made a major contribution to the identification of cardiovascular risk factors in middle aged men in the UK. The study confirmed the importance of smoking, elevated blood cholesterol, elevated blood pressure and diabetes for heart disease death rates in lower compared with upper employment grades which were not fully explained by established risk factors. The access to lifestyle and medical information in both middle and old age allowed assessment of prolonged differences in such risk factors for life expectancy and causes of death in old age. The study has provided unique data on causes of death in old age in relation to very prolonged differences in cardiovascular risk factors and socioeconomic circumstances in middle and old age. These reports will guide public health policy on the provision of health services to reduce the risks of death and disability in older people in the UK and elsewhere. The study will highlight the importance of modifiable risk factors for avoidable disability in old age using information collected in both middle and old age. Influence on guidelines for the management of hypertension and blood lipids: The 2002 report of the Prospective Studies Collaboration report on blood pressure and stroke and heart disease (Lewington et al, Lancet 2002), included the Whitehall data and was also based on the methodology to correct for regression dilution bias developed in the Whitehall and Framingham studies (Clarke et al, Am J Epidemiol 1999). Likewise, the 2007 report of the Prospective Studies Collaboration report on blood cholesterol and stroke and heart disease (Lewington et al, Lancet 2007), included the Whitehall data and was also based on the methodology to correct for regression dilution bias developed in the Whitehall and Framingham studies. These reports influenced JNC7 Guidelines on the Detection and Treatment of Hypertension in the USA and NICE guidelines for the management of hypertension and blood lipids in the UK in addition to the European Society of Cardiology reports on prevention of heart disease (Piepolo 2016) and detection and management of blood lipids (Capetano, 2016) and American Heart Association reports for prevention of heart disease over the last 15 years. References for benefits of study Lewington S, Clarke R, Quizilbash N, Peto R, Collins R for the Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: One million adults in 61 prospective studies. Lancet. 2002;360:1903-1913. Lewington S, Whitlock G, Clarke R, Sherliker P, Emberson J, Halsey J, Qizilbash N, Peto R, Collins R on behalf of the Prospective Studies Collaboration. Blood cholesterol and vascular mortality by age, sex and blood pressure: a meta-analysis of individual participant data from 61 prospective studies with 55,000 vascular deaths. Lancet. 2007;370:1829-1839. Piepolo MF, Hoes AW, Agewal S, Albus C, Brotons C, Catapano AL, Cooney MT. 2016 guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J 2016; 37 (29): 2315-81. Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Ž, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J 2016;37: 2999-3058.

Expected Benefits:

The study will conduct medical research into the causes of death in this sample of the UK population. It is anticipated that the results of the planned analysis will be published in peer review medical journals. The results from this study have helped to inform UK response to the epidemic of deaths from heart disease and stroke in 1970’s and 1980’s and the extent to which mortality from both of these diseases have declined thereafter.

Anonymised data from this study were incorporated in the Prospective Studies Collaboration meta-analysis which guided public health policy on detection and treatment of elevated blood pressure and of elevated cholesterol levels in the UK and worldwide. Data from the resurvey on blood lipids and CHD mortality have helped to clarify the relevance of lipids for prediction of death from vascular disease in old age.

Lastly, data on blood levels of vitamin D (25(OH)D) in this study have guided policy on the relevance of vitamin D and specifically for testing for vitamin D for prediction of vascular and non-vascular causes of death in the UK. The study will generate a series of scientific publications on the causes of mortality, particularly focusing on determinants of cardiovascular disease in old age in relation to cardiovascular risk factors measured in middle and old age. It will also generate reports on cardiovascular and non-vascular causes of death in relation to socioeconomic circumstances measured in both middle and old age.

As well as peer-reviewed scientific publications, the University of Oxford will also communicate with NHS and other organisations (Food Standards Agency) or Public Health England where outputs from the study will provide information needed for health strategies using up-to-date evidence on effects of cardiovascular risk factors on risk of death. This will improve provision of health care delivery and health services in response to demands on health and social care in the present and the future.

Outputs:

The chief aim of the study is to assess mortality risks in old age in relation to cardiovascular risk factors measured in middle and old age, and assess life expectancy and lifetime risks of cardiovascular risk factors measured in middle and old age.

All outputs and publications contain only aggregated data with small numbers suppressed in line with HES Analysis Guide.

The results of analyses of the Whitehall study have been presented at national and international meetings, including the Society of Social Medicine and the European Society of Cardiology and American Heart Association annual scientific sessions. The results of planned analyses will be submitted for publication and some may also be presented at national and international meetings. Likewise, results of some analyses will be posted on the Nuffield Department of Population Health (a department within the University of Oxford) website. The target time frame for publication of the results of the planned analyses is during 2018-2020.

Examples of publications are:
Underestimation of risk associations due to regression dilution in long-term follow-up of prospective studies.
Clarke R, Shipley M, Collins R, Marmot M, Peto R.
Am J Epidemiol. 1999;150:341-353.

Re-survey of the Whitehall study of London civil servants: changes in risk factors for cardiovascular disease during 29 years of follow-up.
Clarke R, Breeze E, Youngman L, Sherliker P, Bell P, Shah S, Shipley M, Collins R, Leon D, Marmot M, Fletcher A.
J Cardiovasc Risk. 2000;7:251-257.

Socioeconomic disadvantage persists into old age: self-reported morbidity in a 29 year follow-up of the Whitehall Study.
Breeze E, Fletcher AE, Leon DA, Marmot MG, Clarke R, Shipley MJ.
Am J Publ Health. 2001;91:277-283.

Cause-specific mortality in relation to body mass index in middle age in old age.
Breeze E, Clarke R, Shipley MJ, Marmot MG, Fletcher AE.
Int J Epidemiol. 2006;35:169-178.

Cholesterol fractions and apolipoproteins as risk factors for heart disease mortality in older men.
Clarke R, Emberson J, Armitage J, Shipley M, Clark S, Linksted P , Fletcher A, Collins R.
Arch Intern Med. 2007;167:1373-1378.

Survival in relation to angina symptoms and diagnosis among men aged 70-90 years: the Whitehall Study.
Clarke R, Shipley M, Breeze E, Collins R, Marmot M, Halsey J, Fletcher A, Hemingway H.
Eur J Cardiovasc Prev Rehabil. 2007;14:280-286.

Life expectancy in relation to cardiovascular risk factors: 38 year follow-up of 19000 men in the Whitehall Study.
Clarke R, Emberson J, Fletcher A, Breeze E, Marmot M, Shipley M J.
BMJ. 2009;339:b3513. doi: 104136/bmj.63513

Risk factors for pancreatic cancer mortality: extended follow-up of the original Whitehall Study.
Batty GB, Kivimaki M, Morrison D, Huxley R, Smith GD, Clarke R, Marmot M, Shipley MJ.
Cancer Epidemiol Biomarkers Prev. 2009;18:673-675.

Plasma phospholipid fatty acids and CHD in older men: Whitehall study of London civil servants.
Clarke R, Shipley M, Armitage J, Collins R, Harris W.
Br J Nutr. 2009; 102:279-284.

Whitehall Study Authors’ reply.
Clarke R, Shipley MJ.
BMJ. 2009;339:b5097.

Height loss and future coronary heart disease in London: the Whitehall II study.
Batty GD, Shipley MJ, Gunnell D, Smith GD, Ferrie JE, Clarke R, Marmot MG, Kivimaki M.
J Epidemiol Comm Health. 2011;65:461-464.

Modifiable risk factors for prostate cancer mortality in London: forty years of follow-up in the Whitehall study.
Batty GD, Kivimäki M, Clarke R, Davey Smith G, Shipley MJ.
Cancer Causes Control. 2011;22:311-318.

Vitamin D and risk of death from vascular and non-vascular causes in the Whitehall study and meta-analyses of 12,000 deaths.
Tomson J, Emberson J, Hill M, Gordon A, Armitage J, Shipley M, Collins R, Clarke R.
Eur Heart J. 2013;34:1365-74

Processing:

The cohorts were flagged by NHS Digital under an earlier data sharing agreement (DARS-NIC-148044-RGS7W-v0.0). NHS Digital will provide updates on participant events, including removals and re-entries to NHS Registration, cancer registrations and deaths including cause of death details. Participants in the Whitehall study were flagged for mortality and cancer registration at the Office for National Statistics (England), which provided the date (mm/yyyy) and cause (including International Classification of Disease (ICD) codes) of all deaths. Cause-specific mortality is coded using ICD-9 up to August 2002 and ICD-10 subsequently. In the past, mortality data and cancer registration data were provided electronically at 3-monthly intervals to the London School of Hygiene and Tropical Medicine. The data were sent to University of Oxford by encrypted email. The University of Oxford incorporated these data into the Whitehall database but in summer 2018 the data provided by NHS Digital was securely destroyed.

The participants in this study have agreed to prolonged follow-up via central registries via patient consent, with the patient information sheet and consent form making reference to the fact that information about health and lifestyle and causes of death could be collected for medical research purposes. Due to the age of the consent involved, Section 251 support was also obtained to cover the continued use of identifiable data. All data on the study will be stored in secure electronic files at University of Oxford. Pseudonymised copies of the linked study data will be sent at periodic intervals by secure email using password encrypted files to named researchers at LSHTM and UCL to maintain the 3-way collaboration for supervision of the study.

The Whitehall study database held by the University of Oxford contains identifiable data for the study participants, including date of birth and name if this was provided by participants in response to questionnaires. The data disseminated by NHS Digital will be in a pseudonymised format using a Study ID, but once received by the University of Oxford the data will be combined with the identifiable study data already held. For the purposes of this agreement the data disseminated by NHS Digital is therefore considered to be identifiable. A senior statistician at the Clinical Trial Service Unit (CTSU) links the data, using study ID, with the study participants questionnaire records. All subsequent analyses use only subsets of the pseudonymised data. All such subsets are customised for specific analyses intended for specific purposes.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract, i.e. employees, agents and contractors of the Data Recipient who may have access to that data). The study will not share any data supplied by NHS Digital with any other institution or individual outside the study of the University of Oxford, London School of Hygiene, or UCL.

Long-term follow-up and further analyses of the National Chronic Kidney Disease Audit — DARS-NIC-170564-P9F0D

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes, Identifiable (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 - s261(5)(d)

Purposes: No (Research)

Sensitive: Sensitive, and Non Sensitive, and Non-Sensitive

When:DSA runs 2019-07-10 — 2022-07-09 2019.11 — 2019.11.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE, UNIVERSITY COLLEGE LONDON (UCL)

Sublicensing allowed: No

Datasets:

  1. Civil Registration - Deaths
  2. HES:Civil Registration (Deaths) bridge
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Critical Care
  5. Hospital Episode Statistics Admitted Patient Care
  6. Civil Registration (Deaths) - Secondary Care Cut
  7. Civil Registrations of Death - Secondary Care Cut
  8. Hospital Episode Statistics Admitted Patient Care (HES APC)
  9. Hospital Episode Statistics Critical Care (HES Critical Care)
  10. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

Chronic kidney disease (CKD) is estimated to affect 1 in 10 people of the adult population in the UK. Although it is known that the bulk of patients with CKD are managed by primary care, it is not known who has progressive kidney disease, whether better management could improve outcomes other than developing kidney failure and how care (including the interphase between primary and secondary specialist care) could be improved further.

London School of Hygiene and Tropical Medicine (LSHTM) and University College London (UCL) seeks to link data from the National CKD Audit to Hospital Episodes Statistics and Mortality data from the Civil Registrations dataset to create the National CKD Audit Research database. For both organisations, the legal basis for processing the NHS Digital data under GDPR is Article 6 (1)(e) - "processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller" and Article 9 (2)(j) - "processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes".

History of the National CKD Audit giving rise to the current research data application to NHS Digital:
The National Chronic Kidney Disease Audit (NCKDA) took place in England and Wales in 2014-2016. It was tendered by the Health Quality Improvement Partnership (HQIP) to a commercial provider (Informatica systems). Informatica systems extracted the primary care data from consenting GP practices and provided pseudonymised data to LSHTM for analysis.

The NCKDA aimed to provide a comprehensive picture of management and outcomes for people with chronic kidney disease (CKD) stages 3-5 managed in primary care in the region.
The following key questions were addressed based on the NICE CKD guidance:
1. Are patients with risk factors tested for CKD?
2. Are people who have repeated abnormal kidney function values appropriately coded?
3. Measure the number of patients assessed for cardiovascular risk and the numbers receiving cholesterol lowering treatment
4. What percentage of people with CKD received other NICE-recommended key aspects of CKD management applicable in primary care?
5. For people with CKD, what are the rates of acute complications (hospitalisation with acute kidney injury, hospitalisation with cardiovascular events/interventions, and death)?

Audit data were collected from primary care up to June 2016, and subsequently linked to HES/PEDW/ONS data in September 2016 for audit reporting purposes. Data analyses using the linked Audit data were carried out at LSHTM. The most recent Audit report (published in Dec 2017) reported on short term outcomes. This showed that people who have CKD based on their biochemical data but who have no corresponding diagnosis in their GP record die more often than those who are coded for their disease, and very high burden of hospitalisations in this this population, again more often if they were not formally identified by a diagnostic GP code in the health record. However, there is a substantive proportion of patients who were only diagnosed with CKD in 2016 for whom there are no meaningful data on outcomes (i.e. in whom audit question 5 in particular was not addressed, this includes hospitalisation with acute kidney injury, [short term outcomes] hospitalisation with cardiovascular events/interventions, and death [long term outcomes] ). Therefore, there are a number of patients for whom there is not sufficient follow-up time to assess their outcomes, and some outcomes, such as cardiovascular outcomes, kidney failure and death require longer periods of follow-up to assess impact of care. In addition, understanding interfaces between primary and secondary care, i.e. supply/care pathways requires further data validation by linkage to the data held at the UK Renal Registry. Such validation is necessary for understanding features of renal service delivery; originally this was planned for years 4 and 5 of the audit, but NHS England had decided in 2016 to not continue funding the Audit. The linked Audit outcome (hospitalisation and death) data for which HQIP was not the data controller were deleted at the contract end in December 2017. After securing HRA approval for the establishment of this NCKDA research database, and section 251 approval for linking NCKDA data for research purposes without consent, prior to the end of the Audit in December 2017, HQIP signed a data-sharing agreement with UCL and LSHTM, for UCL and LSHTM to retain a copy of the historical Audit data for future research, and for set up of the National CKD Audit research database.

This new agreement with NHS Digital is led by LSHTM, who was the data processor for the Audit database, in collaboration with UCL, and wishes to address the short falls of the terminated Audit that were listed above by establishing the National CKD Audit Research database. The team at UCL agreed to house the identifiers required for future data linkage, whilst LSHTM holds the pseudonymised clinical data. The audit website contains information on how to opt out from the audit, and there has been no individual contact to the study team asking for individual opt out from the study. After the data sharing agreement with HQIP was signed, a copy of the identifiable data held at Informatica systems (NHS number, study pseudo-identifier) was moved to the secure server at UCL and the original data at Informatica systems were deleted.

In brief, the plan is to establish a research database by retaining the existing NCKDA data (the entire database derived from primary care records), and to augment these data by carrying out linkages with other databases (HES, Civil Registrations (deaths) data, PEDW, UK Renal Registry, and datasets held at NICOR) under the research approvals that were obtained.

Research questions that the research data base will address are as follows:

1. What are the long-term outcomes of patients at risk of and with CKD and which aspects of primary care management influences outcomes?

This study question relates to the original question posed by the audit data collection which HQIP could not answer with the previous Audit-linkage as at the time of the first linkage there was too short follow-up at the time for a considerable subset of study participants. Outcomes include hospitalisations, cause-specific hospitalisations (e.g. angina, stroke, heart failure, infection, acute kidney injury etc), progressive renal disease, requirement of acute and chronic dialysis (both planned and unplanned), and deaths. All of these outcomes (apart from acute kidney injury) are long-term outcomes of care. As outlined above, the preliminary audit analyses are suggestive that death rates may be higher in those people with kidney disease (based on their kidney function test results) who are not formally recognised to have kidney disease based on the coded disease list in the GP health record. Similar observations were made for hospitalisation rates, though there may be competing risk by mortality. In order to better understand how GP care of people with kidney disease impacts on their health outcomes, the research team therefore require information on mortality to deal with competing risk of death, and also cause-specific mortality to capture renal and cardiovascular deaths. It is here that data from cardiac registries held at NICOR will be very useful as some of these outcomes are only partially captured by HES.

2. How and where are patients with CKD managed? - Investigating the patient journey from primary care to dialysis.

This question is crucial to address as currently there is little knowledge on where the best (i.e. most complete) clinical data on patients with more advanced kidney disease are held as these patients are often seen by specialists in secondary care, thus primary care data may be incomplete. To understand which out-patient specialist sees the patient, HES outpatient records are required for those with kidney disease. The ethics permissions for this particular study question do not cover those at risk of kidney disease and hence outpatient data are only requested for the subset of people with known kidney problems.

3. What is the burden of progressive kidney disease and what are its consequences?

The audit has shown that testing of kidney disease varies by underlying risk profile, therefore to date there is no official estimate on the numbers affected by progressive kidney disease. The audit database can be used to derive an estimate of the burden of progressive kidney disease, and if linked to long-term outcome data (cardiovascular hospitalisations, death, dialysis) would inform on cardiac and renal outcomes of patients with progressive kidney disease, and also mortality (most patients with CKD die before they ever reach dialysis)

4. To which extent does acute kidney injury contribute to progressive kidney disease and incidence of acute and chronic dialysis?

This question cannot be simply addressed with linking hospital admission data to the UK Renal Registry as there is significant concern that the awareness for acute kidney injury (AKI) amongst hospital doctors may depend on the patient's underlying CKD status, thus introducing differential misclassification. The data from the AKI Think Kidneys programme (held at the UK Renal Registry) may address this question with gold standard data. In addition, mortality data are needed as patients with severe AKI may have died before having been identified as a chronic dialysis patient.

5. What are the disability adjusted life years, years of life lost, healthy life expectancy and cost associated with CKD, AKI and progressive renal disease?

There are no precise UK estimates for any of these important figures. The data from the above research studies can contribute to a more precise estimation of the impact of CKD on health, and when combined with estimates from existing relevant randomised trials simulations could be run to investigate which known evidence based interventions would be most cost-effective to reduce the impact on patients' lives due to CKD, as well as costs to the community. Mortality data are needed to calculate life expectancies.

6. Data validation to enable analyses of single existing datasets (e.g. primary care, or HES data) so that these do not require future linkages

Questions include: How good are primary care codes of transplantation and dialysis?, How well is dialysis/transplantation captured in HES compared to the UK renal registry?, Can data from HES inform on acute dialysis?, Is there differential misclassification of AKI coding in hospital records by CKD status (see above)? The referral date held in the UK Renal Registry database could be used to validate primary care referral entries. How much extra information on renal disease progression is held in renal clinics for those with CKD stages 4 & 5? For this type of analysis HES outpatient data are needed, as well as data on admitted care and mortality data (as other data sources may only collect reliable information on survivors and this bias is important to detect)

In summary, hospital data from NHS digital are key to addressing the questions listed above, informing on specialist and critical care and outcomes of people at risk of and with CKD in primary care. In addition there is the need of accurate death data to understand what people with CKD die of, whether there is a difference due to coding of kidney disease, and the role of competing mortality, duration of follow-up and causes of death.

The data will not be used for commercial purposes and not used for direct marketing. Any data access for people wanting to use the research database is reviewed by the steering committee.

Any research outside of the currently 6 specified research questions listed above will have to undergo new ethics and new data-sharing approvals by all data controllers who provided original data.

Funding source:
The current linkage has been funded by HQIP/National CKD Audit. Additional funding has been secured for pilot analyses of these linked data when these become available from Kidney Research UK. However, none of these organisations will have any influence on the research findings, and they play no role in defining the means or purpose for which the data will be used.

Expected Benefits:

The early stages of CKD are usually asymptomatic. Hence it is important that those who are at risk are tested at appropriate intervals so that CKD is identified early, with the opportunity to institute appropriate management to prevent kidney disease progression and cardiovascular disease (CVD) complications. Most patients with CKD will be identified and managed by their GP and there a number of Read codes used by practice computer systems which identify these patients and enable a practice register to support regular monitoring and treatment decisions.

The specific benefit that relates to Question 1 of the Research Questions; "What are the long-term outcomes of patients at risk of and with CKD and which aspects of primary care management influences outcomes?" is as follows: Currently it is unknown how primary care activities affect long-term outcomes of people at risk of or living with kidney disease. For example, the December 2017 Audit report of the NCKDA data showed that those who have chronic kidney disease (CKD) stages 3-5 based on biochemical test results but who do not have a corresponding read code in their primary care record have worse outcomes than those who do (i.e. they die faster, have more hospital admissions). This raises the question what the outcomes are of patients at risk of CKD or with CKD in practices who are less good in identifying those with CKD have worse outcomes than those who do. The answer to this question has considerable implications for continued incentivisation of testing for and identification of CKD, including whether earlier stages of CKD (1-2) should be identified to improve cardiovascular outcomes and prevent premature deaths. The mortality data will be important to better understand the distribution of cause of deaths. Note that most patients with CKD die before they require dialysis.

The specific benefit that relates to Question 3 of the Research Questions; "What is the burden of progressive kidney disease and what are its consequences?" is as follows: The statistician who carried out the NCKDA analyses has obtained a MRC PhD fellowship to investigate within the next 3 years the burden of progressive kidney disease and its consequences (Question 3). The answer to this question is currently unknown and of clear importance to the planning of health care delivery.

The specific benefit that relates to Question 2 of the Research Questions; "How and where are patients with CKD managed? - Investigating the patient journey from primary care to dialysis" is as follows: HES and Mortality data will be used to examine the association between variation in coding/ management of CKD with outcomes to better understand if and how these are related. Linked data from outpatient records will identify those CKD patients who were not just managed in primary care and provide a more holistic picture of the burden of health needs of the CKD population. This will also contribute to answering Question 1.

In summary: Patient information will be used to improve patient care by improving the diagnosis of chronic kidney disease (CKD) in primary care and to improve diagnosis and care using electronic patient systems.

Patient information will be used to serve the wider public interest by identifying gaps or shortfalls in commissioning services and providing a more comprehensive picture of care and outcomes of people with CKD within primary care in England and Wales. The research data base will for the first time give a comprehensive picture of renal and cardiovascular care in those at risk of and with CKD. This is also contributing to answering Question 2 of the research questions.

The linked data will for the first time be able to address the question whether short-term outcomes of CKD management such as acute kidney injury (AKI) contribute to later outcomes such as progressive kidney disease, and dialysis start (Question 4: To which extent does acute kidney injury contribute to progressive kidney disease and incidence of acute and chronic dialysis?)

Overall, these linked data will be incredibly useful for health economic analyses which to date have only focused on subsets of patients with CKD (Question 5. What are the disability adjusted life years, years of life lost, healthy life expectancy and cost associated with CKD, AKI and progressive renal disease?)

The multiple linkages will be extremely useful to understand key data items that are available in other datasets for kidney patients (Question 6. Data validation to enable analyses of single existing datasets (e.g. primary care, or HES data) so that these do not require future linkages.

The National Institute for Clinical Excellence (NICE) issued guidance on the early identification and management of CKD in adults in primary and secondary care in 2008 (National Institute for Health and Care Excellence, 2008) with a recent update in 2014 (National Institute for Health and Care Excellence, 2014). These guidelines are currently reviewed.

Findings from the research database will reflect how adherence to these guidelines at the time was associated with outcomes and address open research questions as listed in the respective guidelines. Engagement with all stakeholders and dissemination of findings (see section 5c) will enable further quality improvement efforts and more joint up care, and updates to any relevant further guidelines.

Currently LSHTM are working on obtaining additional funding from the Wellcome trust, BHF, NIHR and Kidney Research UK for analyses of the database, and LSHTM would anticipate that within the next 3-5 years, LSHTM have analysed and published the data with regards to the 6 broad research questions covered by the audit research ethics approval.

Outputs:

What will be produced as a result of the data processing?

LSHTM will process the data and proceed with analyses as outlined above for the research questions. Analyses will take place between 2019-2021. As each result becomes available, there will be submissions to peer reviewed journals (BMJ, JASN, AJKD, PLOS, BMC, JAMA, Heart, etc), presentations and conference contributions (UK Kidney week, European Renal Association, American Society of Nephrology, British cardiovascular Society, British Society for Heart Failure).
Currently, ethics approvals are only until 2022, with the plan to make the most of the data until then.

What level of data will be contained in the output?

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Dissemination and communication approach

The findings of the research will be shared within the renal and cardiovascular community. Preliminary findings from the National CKD Audit are currently informing discussions with regards to the NICE CKD guideline update. Researchers at LSHTM and UCL are presenting Audit findings to relevant national conferences and training days both for academics as well as clinical practitioners. Researchers from LSHTM have engaged with the public at the Pint of Science event in 2018. The planned analyses will be discussed with patients attending the Patient Council at the UK Renal Registry. There is an Audit website which informs about the audit and its findings to date. UCL plan to continue with this dissemination as more data accrue after linkage of records. The Audit steering group anticipate engaging with the renal, cardiovascular, diabetes and hypertension societies as well as the RCGP to publicise the findings of research and to inform future quality improvement projects.

Exploitation of results

Findings from the research will inform on the need of future linkages in cardiovascular and renal research. This information will be shared in research papers and algorithms used within the HDR UK for linked primary and secondary care data. This information will be made publicly available.


Processing:

The audit was tendered by HQIP and the commercial Audit supplier was at the time Informatica systems. Data were extracted by Informatica systems for the Audit purposes and any patients having a Read code for opt out were removed from the database at extraction. The last extraction took place in 2016. After securing ethics permissions for holding identifiable data elsewhere, and signing the relevant data sharing agreements, Informatica has now transferred NHS numbers and a corresponding pseudo-identifier code to UCL, and deleted any information related to the audit on their systems.

An explanation of the role of each organisation involved in the set-up of the NCKDA is as follows:

1. UCL provides list of NHS numbers with NCKDA pseudo-id (study ID) to NHS Digital. These are the only identifiers that will flow to NHS Digital.
2. NHS digital links data for HES & Civil Registration Mortality data, and returns clinical and mortality data to LSHTM with NCKDA pseudo-id (study ID), with the NHS numbers removed.
3. UCL provides list of NHS numbers with NCKDA pseudo-id to NWIS
4. NWIS links data for PEDW and returns clinical data to LSHTM with NCKDA pseudo-id, with the NHS numbers removed
5. UCL provides list of NHS numbers with NCKDA pseudo-id to NICOR
6. UK Renal Registry provides list of NHS numbers with Renal registry pseudo-id to NICOR
7. NICOR generate Master-patient index of NHS number matches with NICOR, the UK Renal Registry, and the NCKDA.
8. NICOR return Renal registry pseudo-id and NCKDA pseudo-id to the UK renal registry
9. UK Renal Registry sends clinical data with NCKDA pseudo-id to LSHTM.
10. NICOR sends clinical data with NCKDA pseudo-id to LSHTM

- University College London (UCL) - UCL is seeking to link data from the National Chronic Kidney Disease (CKD) Audit to Hospital Episodes Statistics and Mortality data to create the National CKD Audit Research database. They are working with the London School of Hygiene and Tropical Medicine to determine the nature and processing of the NHS Digital data, and will process the data. They will also provide to NHS Digital a list of NHS numbers to enable linkage with third parties (The National Institute for Cardiovascular Outcomes Research/NICOR and the UK Renal Registry). They are, therefore, a data controller who will process data.
In relation to the identifiers, (NHS numbers, NCKDA pseudo-id) have already flowed from Informatica systems to UCL secure data haven

- London School of Hygiene and Tropical Medicine (LSHTM) - the LSHTM is the other organisation working with UCL to link data from the National Chronic Kidney Disease (CKD) Audit to Hospital Episodes Statistics and Mortality data to create the National CKD Audit Research database. They are working with UCL to determining the nature and processing of the NHS Digital data, and will process the data. They are, therefore, a data controller who will process data.
- Healthcare Quality Improvement Partnership (HQIP): HQIP were the data controller for the original primary care data extraction of the NCKDA, and tendered the Audit on behalf of NHS England and Wales. They have given permission for the data to be used by UCL and LSHTM (see SD11, SD11.1), but play no role in defining the means or purpose for which the data will be used, and therefore play no role in this application.
- NICOR - the NCKDA research database will also contain data from NICOR, allowing the individual validation of key data items in HES for the population in the Audit (which will require linkage to the HES data). This is one of the stated aims of the establishment of the data base. However, NICOR play no role in determining the nature of the research or processing, and will not have access to the NHS Digital data.
- UK Renal Registry (UKRR)- the NCKDA research database will eventually contain data from the UKRR, allowing the individual validation of key data items in HES for the population in the Audit (which will require linkage to the HES data). This is one of the stated aims of the establishment of the data base. However, NICOR play no role in determining the nature of the research or processing, and will not have access to the NHS Digital data.
- Informatica Systems: they were original Audit provider for the NCKDA under the tender agreement with HQIP. Prior to the termination of the Audit, they transferred a copy of the identifiable data to UCL and subsequently deleted all Audit data on their systems. Since then they have had no further involvement, and have no role in defining the means or purpose for which the data will be used for this application.
- Queen Mary, University of London (QMUL) - researchers at QMUL previously contributed to the writing of two national Audit reports from the NCKDA, but have had no further involvement, and have no role in defining the means or purpose for which the data will be used in this application.

Data flows for this current agreement for linkages carried out by NHS digital:
All data flows have been reviewed by ethics and CAG and have section 251 approval for linkage without individual consent.
1. Any identifiable data flows only involve transfer of the NHS number and a pseudo-identifier (study ID) to allow data linkage.
2. Data flows to LSHTM involve pseudonymised linked data.

1. The Patient Identifiable data:
Data flows to NHS Digital include the identifiable data held at UCL (NHS number) with the pseudo-id for the clinical data held at LSHTM. UCL will supply data from the entire Audit dataset irrespective of GP location in order to track patients who have moved across national boundaries. Cohort details will be transferred as a password-protected and encrypted CSV file to NHS digital. Details of patients who have chosen to opt out during 2014-16 will not be sent to NHS digital as these were never extracted. Data extraction stopped in 2016, and no new data were extracted since then. There has been no contact asking for individual opt outs from 2014 up to now.

NHS digital will check whether there are any national opt-outs that UCL were not made aware of and quantify the total number for the study. LSHTM anticipate that this number will be very small, as all research opt-outs were removed from the outset prior to Audit data extraction.

Data requested from NHS digital include hospitalisation, outpatient and critical care and death data. In order to supplement the data from primary care in terms of comorbidities (allowing the control for confounding for the objectives outlined above) LSHTM require data on past hospital admissions and care received in the patient population. LSHTM require data from Audit participants who are located either in England or Wales, as some patients from Wales may have had acute care in England (and vice versa).

2. The Pseudonymised data:
NHS digital will supply HES in and outpatient records, critical care records (for England) and mortality data from the Civil Registration dataset (for England and Wales) for the cohort provided for the agreed period to LSHTM with the pseudo-id to be incorporated in the existing database held at LSHTM which only uses pseudonymised data. NHS digital will not supply records for those who have opted out from research.

Further linkages:
A similar process will take place to obtain hospitalisation and outpatient data for people seen by health services in Wales, with identifiable data flowing from UCL to NWIS, and NWIS supplying pseudonymised hospital outpatient and admission data to LSHTM. Therefore, the NCKDA research database will have hospital data and death data for England and Wales.

Data will also be linked to data held at the UK Renal Registry and data held at the National Institute for Cardiovascular Outcomes Research (NICOR) to gather further information on kidney and cardiovascular outcomes. The data for NICOR and the UK Renal Registry will be using NICOR as trusted third party for linkage, and therefore are not shown on this simplified diagram. The full data flow diagram can be found in the data management protocol. In brief, audit identifiable data (NHS number) and pseudo-identifier will be sent to NICOR. NICOR will then send linked pseudonymised data to LSHTM for analysis. A similar process applies to UK renal registry data where NICOR will act as trusted third party.

Legal/ethical basis:
The entire set-up of the NCKDA research database has been ethically approved for research purposes as outlined above, and with approval by CAG for linking data without individual consent. The NCKDA was originally set up and funded by NHS England and Wales to audit care and to determine how care impacts on long-term health outcomes, and so there is in addition a need to capture these data for historical research/statistical purposes.

Identifiable primary care data will only be handled by UCL as outlined above for linkage purposes. Data will only be accessed by individuals within UCL who have authorisation as per the data-sharing agreement with HQIP and ethics/CAG to process the data for the purposes described above, all of whom are substantive employees of UCL.

The core clinical pseudonymised data will only be accessed by 2 individuals within LSHTM who have authorisation as per the data-sharing agreements with HQIP and ethics/CAG to process the data to produce subsets of the data that will be accessed by researchers using the data. These subsets of data will only be extracted after the project has been reviewed and approved by the NCKDA steering group. The NCKDA steering group consists of former representatives of the Audit steering group when the Audit was live (before 2017), representatives from UCL, LSHTM, NICOR, Wales, and the UK Renal Registry.

Research project-specific data would be analysed on a project by project basis. Analysts who used the project specific data are trained in analysing routine electronic health record data under appropriate supervision by LSHTM and UCL at LSHTM and UCL (other locations are not suitable based on the existing data sharing agreements). Results from analyses of the pseudonymised clinical data will be published in peer reviewed clinical and epidemiological journals. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by "Personnel" (as defined within the Data Sharing Framework Contract i.e.: employees, agents, and contractors of the Data Recipient who may have access to that data).

There will be no data linkage undertaken with NHS Digital data provided under this agreement other than that which is already stated.

Data will only be accessed and processed by substantive employees of UCL, or LSHTM and will not be accessed or processed by any other third parties not mentioned in this agreement.

Liver transplantation as treatment for patients with hepatocellular carcinoma; a study using existing electronic data. — DARS-NIC-72064-V5V2X

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (Research)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2019-06-19 — 2020-09-30 2017.12 — 2019.11.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE, THE ROYAL COLLEGE OF SURGEONS OF ENGLAND, LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Outpatients
  2. Hospital Episode Statistics Accident and Emergency
  3. Hospital Episode Statistics Critical Care
  4. Hospital Episode Statistics Admitted Patient Care
  5. Office for National Statistics Mortality Data
  6. Civil Registration - Deaths
  7. Civil Registration (Deaths) - Secondary Care Cut
  8. HES:Civil Registration (Deaths) bridge
  9. Civil Registrations of Death - Secondary Care Cut
  10. Hospital Episode Statistics Accident and Emergency (HES A and E)
  11. Hospital Episode Statistics Admitted Patient Care (HES APC)
  12. Hospital Episode Statistics Critical Care (HES Critical Care)
  13. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The Clinical Effectiveness Unit (CEU) based at The Royal College of Surgeons (RCS) requires linked data from four large national databases containing information on all patients in the last two decades who have had liver cancer (Hepatocellular Carcinoma (HCC) being the most common liver cancer) and of those patients who have subsequently received a liver transplantation. The CEU is a collaborative research unit formed from both the RCS and London School of Hygiene & Tropical Medicine (LSHTM) and therefore both RCS and LSHTM are joint data controllers.

The linked data requested is minimised to two cohorts of liver cancer patients and liver transplantation patients.

The project is funded by the NIHR as part of a Doctoral Research Fellowship (DRF) grant.

The databases include the National Cancer Registration and Analysis Service (NCRAS) to identify all patients with liver cancer in England, the Hospital Episode Statistics (HES) database and Office for National Statistics (ONS) Mortality database to determine comorbidities, treatments and outcomes, and the UK Liver Transplant Audit (UKLTA) database to evaluate the outcome of transplantation.

The National Cancer Registration and Analysis Service (NCRAS) is run by Public Health England and is responsible for cancer registration. UK Liver Transplant Audit (UKLTA) is run by NHS Blood and Transplant (NHSBT) who manage blood and platelet donation, and organ, stem cell and tissue donation and transplantation.

The datasets to be linked from each national database are as follows: -

Liver cancer specific dataset: - records of patients diagnosed with liver cancer between 1996 and 2016, including date of diagnosis, TNM stage, cancer morphology, and treatment indicators will be used, including already linked: Chemotherapy (SACT), Radiotherapy (RTDS) and Radiology Datasets (DID) supplied from NCRAS;

UK Liver Transplant Audit (UKLTA): - records of all patients who received a liver transplant since 1994 and all patients on the liver transplant waiting list, including 'standard liver dataset' and 'waiting list data', supplied from NHSBT

Hospital Episode Statistics (HES) datasets (Admitted Patient Care (APC), Outpatients (OP), Critical Care (CC), Accident and Emergency (A&E) supplied from NHS Digital and ONS Mortality Data supplied by the Office for National Statistics via NHS Digital.

Project aim:
To maximise the benefit of liver transplantation as a treatment option for patients with liver cancer.

Work packages:
Detailed below are five separate work packages, each with specific objectives, that have been constructed in order address the project aim.

Work package 1: Identifying the rising incidence and mortality of HCC in England and worldwide
Identifying the main risk factors causing the rise in HCC will encourage NHS services to better identify HCC earlier in patients and thus increase their treatment options. It will also help to educate the public in avoiding the high-risk behaviours that can lead to the development of liver disease and subsequent risk of HCC.

Work package 2: Assessing the validity of the linked national databases as a data source for HCC research
Large linked health databases will provide the data to answer our research questions. Prior to conducting any analysis, the validity of the national databases will be evaluated by checking the consistency of the recorded liver disease and treatment information.

Work package 3: Assessing the impact of sociodemographic and clinical factors on treatment selection and survival of patients with HCC
Evaluating treatment options for patients with HCC will help us identify the best treatment available for patients based on their individual disease and medical conditions. This will promote the use of effective alternative treatments for HCC whilst potentially easing the pressure on our liver transplant services.

Work package 4: Analysing outcomes of liver transplantation in patients with HCC
Identifying individual patient characteristics that are associated with the best and worst outcomes following liver transplantation will help us better identify HCC patients suitable for transplantation. This could lead to an improvement in post-operative survival and increase the number of patients with HCC considered suitable for liver transplantation.

Work package 5: Analysing outcomes of liver transplantation in patients with HCC who receive a cardiac death donor liver?
Exploring the transplantation of livers from cardiac death donors as compared with brainstem death donor livers could potentially increase the number of livers suitable for donation. This could lead to the earlier transplantation of patients with HCC and reduce the number of patients falling of the waiting list due to spread of their cancer.

Background:
Hepatocellular carcinoma (HCC) is the most common liver cancer. Each year, more than 4,000 patients are being diagnosed with HCC in the UK. The incidence of HCC has increased four-fold in the last 30 years. Liver diseases such as obesity and hepatitis C lead to liver cirrhosis and eventually cancer. There is often a lag time of two decades between the acquisition of liver disease and the development of HCC.

Overall survival of patients diagnosed with HCC is poor. Despite small improvements in outcome, less than 30% of the patients are alive at one year after diagnosis. The available treatment options depend on the size and spread of the cancer at the time of diagnosis. Patients who are eligible to receive a liver transplantation have the best prognosis with about 75% being alive at five years.

Liver transplantation is increasingly being used as a treatment for patients with HCC. As a result, HCC is now the most common indication for liver transplantation. This development has increased the gap between the number of patients waiting for liver transplantation and the availability of suitable livers.

In response, the transplant centres have started to use more and more livers from donors who have sustained a cardiac death. They accept that transplant outcomes with livers from these donors might be worse than with livers from the normal donors who have sustained brainstem death. However, transplant surgeons have little choice as they need to find a donor for patients with HCC before their disease spreads to the bloodstream and they become unfit for potentially curative transplantation.

Yielded Benefits:

The overarching theme of the results is that livers donated following circulatory death (DCD) – previously thought to be sub-optimal – produce equivocal results as livers donated after brain stem death (DBD) traditionally thought to be of higher quality. The results will therefore encourage clinicians and patients alike to increase the utilisation of DCD livers and thus increase the number of patients who are receiving a potentially life-saving liver transplantation and decrease the number patients waiting to receive a liver transplantation. To date outputs for the project include: Poster Presentations 1. British Transplant Society (BTS) Annual Congress, Harrogate, March 2017 2. British Association for study of the liver (BASL) Annual Congress, Warwick, September 2017. Oral Presentations 1. BASL Annual HCC-UK Research Meeting, Newcastle, April 2017 2. British Transplant Society (BTS) Annual Congress, Brighton, March 2018 (x2 presentations) 3. BASL Annual HCC-UK Research Meeting, London, April 2018 4. European Society of Transplantation Annual Conference: July 2018

Expected Benefits:

The incidence of HCC in the UK is increasing. Given the observed time trends in etiological and contributing factors and the considerable lag time between first onset of liver disease and the development of HCC, this increase is likely to continue over the next decade. It is imperative that we are equipped with the necessary information to combat this devastating disease and to determine the role of liver transplantation. This thesis aims to make a significant contribution in this area.

CEU expect this research can make three fundamental contributions. First, it is now recognised that using linked national health based datasets will expand the scope of clinical questions that can be addressed (10). CEU will demonstrate how linked data can be used to study an entire disease pathway from recognising the first presence of aetiological agents and contributing factors to the development of cirrhosis and HCC. A better understanding of the entire disease pathway will guide NHS services in developing a comprehensive response to the increasing burden of HCC that may include developing measures to prevent viral hepatitis and cirrhosis, screening patients at risk of developing HCC, and improving the capacity of liver transplantation as a potentially curative treatment option for HCC.

Second, evaluating liver transplantation as a curative treatment and exposing the liver diseases and treatments options associated with the best and worst outcome has an immediate benefit as it will help to improve the information that is available for the selection of potential recipients of a liver transplant and the allocation of donor organs. The potential of liver transplantation as a treatment option for HCC is determined by the limited availability of suitable donor organs. Using our linked dataset, we hope to determine whether transplanting organs from DCD donor’s produces improved survival outcomes. Furthermore, identifying risk factors of post-transplant survival in HCC patients, including the use of organs from DCD and other marginal donors, can improve patient selection and organ allocation policy which will further improve the potential of liver transplantation as a treatment option for HCC patients.

Third, the work using the linked national databases will also demonstrate how this resource can contribute to the investigation of potential inequity of access and variation in treatment and outcomes across NHS providers. A better understanding of the determinants of treatment and outcomes has the potential to inform how HCC services, including liver transplantation, can be further improved, ultimately leading to an overall improvement of the quality of care for patients with HCC.

Outputs:

Publications:
During the project, CEU would look to publish a minimum of four to five high quality research papers in high impact transplant and cancer specific journals (Target:- January 2018-2020). Selected journals include; Transplantation; Liver Transplantation; American Journal of Transplantation and The British Journal of Cancer. Significant research findings will also be put forward to the external relations departments at the London School of Hygiene and Tropical Medicine and The Royal College of Surgeons, London for further distribution. It will be mandatory to recognise all contributory organisations in all publications.

Presentations:
Research outputs will be presented at national and international meetings. CEU aim for yearly presentations at the British Transplant Society (BTS) Conference with international presentations focused on conferences hosted by the European Society of Transplantation (ESOT). CEU will also aim for an oral presentation at the two-yearly World Transplant Conference (WTC). Cancer specific workshops hosted by the National Cancer Intelligence Network (NCIN) will provide the platform for oral presentations on the main determinants of HCC.

These meetings will provide the opportunity for CEU's results to positively affect the wider public through influencing policy on prevention strategies of the risk factors identified as causing the greatest burden to the hepatocellular carcinoma (HCC) epidemic.

Intended Presentation Dates and Venue
British Transplant Society Annual Conference: March, 2018, 2019
European Society of Transplantation Annual Conference: July 2018
World Transplant Conference: 2018 – venue to de determined

Patient Groups:
An update of progress will be made to local patient groups. This will be part of the process of informing NHS patients of CEU's findings and allowing them to help further influence their research by working with the HCC advisory group to formulate the best platforms to disseminate the research findings to the public.

Local NHS Trust Feedback:
CEU will use select local meetings within the Institute of Liver Sciences at Kings College Hospital to feedback the results of this thesis. In attendance, will be consultant hepatobiliary and transplant surgeons, hepatologists, junior doctors, clinical nurse specialists, transplant coordinators and NHS service managers.

This forum presents an efficient way of translating the output of this research into active clinical practice. It is therefore imperative that these meetings, are conducted on a regular basis throughout the duration of the thesis. The major theme of the project is identifying the extent to which we can increase the capacity of liver transplantation to meet the increasing demand driven by HCC. It is hoped that highlighting this information will help regulate and in turn drive improvements in treatment selection and outcomes for individual HCC patients.

NHSBT:
The research outputs indicating the influence of the HCC epidemic and its impact on liver transplantation will be discussed with NHSBT’s Liver Selection and Allocation Working Party and Liver Advisory Group. Results from this thesis can be potentially used by these national committees to determine allocation policy by contributing to the construction of further complex statistical models that NHSBT can use to determine the allocation policy of donor organs. This will result in rapid improvements in patient outcome through maximising the survival benefit of deceased donor livers in HCC patients.

All outputs will be aggregated with small numbers supressed in line with the HES analysis guide.

Processing:

PHE (NCRAS) will submit the following identifiers for a cohort of liver cancer patients to NHS Digital: NHS number, gender, date of birth, and postcode plus unique Liver Cancer ID.

NHSBT will also submit the following identifiers for a cohort of liver transplant patients to NHS Digital: NHS number, gender, date of birth, and postcode plus unique Liver Transplant ID.

PHE (NCRAS) and NHSBT will send additional data about these individuals from their respective databases to CEU. These datasets will contain no identifiers other than unique Liver Cancer ID and Liver Transplant ID respectively.

NHS Digital will then add both cohorts together to make one cohort and will link the combined cohort to HES and ONS mortality data. The data will be pseudonymised containing no identifiers other than encrypted HESID, Liver Cancer or Liver Transplant person ID and, where applicable, Date of Death. The encrypted HESID will be the common identifier across all datasets.

NHS Digital will supply the linked HES and ONS mortality data for each matched patient within the cohort of liver cancer and liver transplant patients to a secure data handling facility at the Clinical Effectiveness Unit (CEU) based at The Royal College of Surgeons of England (RCS). The CEU is a collaborative research unit formed from both the RCS and London School of Hygiene & Tropical Medicine (LSHTM).

NHS Digital will also supply to the CEU the unique Liver Cancer ID or Liver Transplant ID for any patients from the respective cohorts whose data could not be matched to HES and/or ONS data. In any deterministic linkage of data, there will be a small percentage of patients whose records did not match (i.e. none of the identifiers such as NHS number, D.O.B, postcode correlated). The Liver Cancer and Liver Transplant IDs of unmatched patients will be used by CEU to link back to additional data supplied by NHSBT and NCRAS. These will be used to compare the characteristics of patients who were not matched to HES with those that were in order to assess potential bias arising from the exclusion of their HES and/or ONS data from the analyses. Bias is dangerous to any epidemiological study as it affects the strength of causality that any analysis may display it then also affects the interpretation of the results and credibility of the research.

In order to test (and hopefully disprove bias) in this study CEU need to make sure the patient characteristics are not different between matched and unmatched patients.

CEU will compare patients with HCC who underwent liver transplant against patients with HCC who received other forms of treatment (i.e. liver resection, radiotherapy, chemotherapy etc). In addition, CEU also need to compare patients who had a liver transplant for HCC against patients who had a liver transplant for other indications (i.e. alcohol, hepatitis etc).

The CEU requires the HES and mortality data for all matched patients whether they were included in the PHE (NCRAS) cohort, the NHSBT cohort or both. There will be quite a few patients who are in one cohort but not the other as only a small proportion of patients unfortunately receive a liver transplant. CEU require all the records to compare the outcomes for patients who do receive a liver transplant against those who do not receive a liver transplant. CEU need the records to identify the characteristics (age, sex, sociodemographic status, co-morbidities) that influence patients with HCC who receive a liver transplant against those who do not.

Additionally, the CEU requires all HES records of patients with an ICD10 code of ‘C22’ (liver cancer) and / or an OPCS4 code of ‘J01’ (liver transplantation) who are not linked to either the NHSBT or NCRAS data set. This will provide an even better opportunity to explore if there is a case ascertainment issue (i.e. that NHSBT or NCRAS have not identified 100% of instances of liver transplantation or liver cancer). The characteristics of omitted individuals’ hospital episodes will be considered to explore the possible bias that this will produce.

Data supplied by NHS Digital will only be accessed by the clinical researcher and statistical supervisor who are substantive employees of LSHTM and the data manager who is a substantive employee of RCS. No data will be shared with a third party in any form. All outputs will be aggregated with small numbers supressed in line with the HES analysis guide. All data will be processed and accessed at the CEU.

Justification of years requested in each dataset:
Much of CEU's intended analysis is determining trends over time in the incidence and outcomes of patients with HCC hence the request of historical data across all 5 datasets.

Important in identifying any potential improvements (or even decline) in outcomes is assessing the changing patient characteristics of patients with HCC in addition to identifying any significant changes in the services (and or treatment options) that these patients receive i.e. better post-op critical care, reduced post-op emergency department attendances, increase outpatient surveillance etc.

Fundamentally important to the initial analysis (work package 1) is also mapping the pathway to the development of HCC. CEU know the development of HCC is often part of a 20-year process from the development of a primary liver disease to cirrhosis and then to cancer. Hence, in order to identify what clinical and sociodemographic factors (in addition to cirrhosis) are important in the development of HCC, CEU need the historical data. This is especially relevant of the inpatient (APC) dataset which contain the diagnosis and procedural codes necessary to perform this analysis.

The linked dataset will be validated by checking the consistency of cancer diagnoses and treatment across all three databases. The level of agreement will be detailed using statistics.

CEU will perform statistical analysis on their linked dataset to address five work packages (research questions).

Processing of data will be done so in accordance with ONS terms and conditions.

There will be no linkage with other record level data, nor will there be any attempt to re-identify an individual through the use of the data.

Infectious disease triggers of chronic disease exacerbations — DARS-NIC-145260-G4Y0G

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (Research)

Sensitive: Non Sensitive, and Non-Sensitive

When:DSA runs 2018-12-21 — 2021-12-20 2019.02 — 2019.02.

Access method: One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

Plain language summary:

Respiratory viruses (like colds and flu) trigger asthma attacks, chronic obstructive pulmonary disease (COPD) exacerbations, and heart attacks. Other factors like air pollution can trigger these attacks too. Virus surveillance data on its own is not good enough to work out what proportion of these attacks are from viral infections or are caused by other factors. The research team at the London School of Hygiene and Tropical Medicine (LSHTM) need to know which factor is most important so that they can try to do something to prevent these attacks.

The pattern of viral circulation in populations is affected by how people mix together and pass viruses to each other. Children have a lot of contacts each day and pass a lot of viruses to each other, to their parents, and to other people they meet. School holidays are especially important, because children pass viruses less when they are not in school, because they meet fewer people. By combining what is known about how viruses transmit and how people mix together, it is possible to better understand the circulation of viruses.

This can then be used with the viral surveillance data (which is not good enough on its own) to understand the effect of each factor on the number of attacks of asthma, COPD, and heart disease each day. This kind of analysis is scientifically really hard to do, because it depends on the small differences in school holidays from place-to-place, and different amounts of pollution in one place compared to another. These small differences in lots of places over many years add up, and so scientists can calculate the effect of each factor. This is the benefit of “big data”, which lets scientists do studies that would not work otherwise, and is how NHS data can be used to help other patients.

It should be noted that the entire population is of interest for this study, not just children.

Further details:

This study examines the timing of hospitalisations for three major chronic diseases to detect associations between known viral and environmental triggers for these conditions.

The health impacts of asthma, chronic obstructive pulmonary disease (COPD), and coronary heart disease (CHD) are greatly increased by acute episodes of worsening symptoms (exacerbations). Exacerbations are triggered by environmental factors e.g. poor air quality and temperature, and by acute respiratory infections. The large (and growing costs) of exacerbations provide considerable motivation to improve understanding the triggers of exacerbations.

Current methods do not include the dynamic risk of exacerbation caused by respiratory virus transmission, which means that estimates of risk from other variables may be unreliable. This project will begin to tackle the need to understand how viral triggers affect population-level timing of exacerbations. The project will use interdisciplinary methods to develop a novel quantitative framework to assess the population-level drivers of chronic disease exacerbations.

The outcome under study is the daily timing of inpatient chronic disease exacerbations for three chronic diseases under study. Therefore, this study is requesting these data from NHS digital for this analysis. The study is also requesting information from NHS digital on infectious respiratory inpatient hospitalisations to aid in the analysis of the chronic disease exacerbations.

Specific information:

The London School of Hygiene & Tropical Medicine (LSHTM) requires Hospital Episodes Statistics data for use in project: “Novel methods in data science to quantify viral and environmental triggers of chronic disease exacerbations”.

There are two organisations involved in this work: the London School of Hygiene & Tropical Medicine, and Public Health England (PHE). LSHTM is the lead for the study, and instigated it as part of the research project being carried out by the Principal Investigator of this project, who is substantially employed by the LSHTM. Members of staff at PHE are also involved in an advisory capacity to the Principal Investigator, due to their expertise in respiratory infections and respiratory virus surveillance. They have no further role in the study, and will not have access to the data provided by NHS Digital. The LSHTM is, therefore, the sole data controller who will also process data.

The raw data will only be viewed, accessed and analysed by direct substantive employees of the London School of Hygiene & Tropical Medicine (LSHTM). PhD students may use aggregated time series containing small numbers but will not access the record-level data. This must be aggregated with small numbers suppressed in line with the HES Analysis Guide. Only substantive employees at LSHTM will have access to the record-level data requested from NHS Digital.

LSHTM established the Electronic Health Records Research Group to undertake health research using electronic health records. This project was proposed as part of a request for projects using UK health data, funded by Health Data Research UK (HDR-UK). LSHTM responded to a call for research in this area, and the project proposed by the lead researcher for the project was successful.

LSHTM/lead researcher applied for and secured funding from Health Data Research UK (HDR-UK) to undertake this work. HDR UK is a joint investment led by the Medical Research Council, together with the National Institute for Health Research (England), the Chief Scientist Office (Scotland), Health and Care Research Wales, Health and Social Care Research and Development Division (Public Health Agency, Northern Ireland), the Engineering and Physical Sciences Research Council, the Economic and Social Research Council, the British Heart Foundation and Wellcome. It supports world-leading research to develop cutting-edge analytical tools and methodologies to address the most pressing health research challenges.

This work is a study on inpatient hospitalisations resulting from exacerbations of 3 chronic diseases. Inpatient hospitalisation from respiratory infections will be an input to the study. Inpatient data are requested from NHS digital.

The aim is to better understand the triggers of chronic disease exacerbations, and to do this LSHTM need to link the circulation of respiratory viruses to the patterns of exacerbations. Inpatient hospitalisation data are needed to achieve this aim and deliver the study results and benefits.

This study will develop new methods that allow estimation of both the parameters of dynamic transmission models for viruses, and the contribution of environmental factors, at the same time.

This is a new study, and no data have been supplied for this study before.

Expected Benefits:

Decreasing the cost of chronic disease exacerbations is a public health priority, because those costs are rising in the UK and worldwide. To do this, LSHTM need better scientific understanding of the factors that can trigger exacerbations.

There is a lot of research from studies of individuals with chronic conditions that viral infections can trigger exacerbations of their conditions. However, public health policy is made at the level of populations, not individuals. There is a real need to determine if the effects we see in individuals are true at the population level.

Previous research has shown that environmental variables affect the population-level patterns of exacerbations, but no study has included both environmental triggers and infectious triggers in the UK. The benefits of this study will therefore be in bringing scientific understanding to the interactions between environmental and infectious triggers.

The study is generating new knowledge that will not only benefit researchers but will benefit the wider community and society as a whole. Analyses of the patterns of these serious conditions will help to better understand the risks and causes of ill health, especially in these populations that already have serious chronic conditions. Rigorous epidemiology like this study will allow design of better preventive strategies, to help patients and populations decrease the burden of chronic disease exacerbations.

Studies of long time series of cases from around England and Wales will allow understanding of whether the exacerbations from one factor, for example, air pollution, have gotten more or less likely over time. It also allows estimation of whether the baseline rate of exacerbations has improved or gotten worse. Short studies cannot detect these kind of changes. Studies of long time periods allow evaluation of interventions that have been made, such as vaccination programs, but to properly estimate their impact, the analysis must have enough data before the intervention before estimating the impact of the new intervention.

Results will be shared in open-access scientific articles, in reports, and in talks, and promoted as widely as possible. They will be shared with scientists, and through links with PHE, with public health officials. The results will also be shared publicly and written so that non-specialists can understand and interpret the results. Findings on environmental triggers, especially air quality, will feed into evidence of the role of air pollution on health.

These benefits are achieved through the full use of hospital data on exacerbations, public air quality sources, and surveillance data on the viruses involved. These can then be used in population modelling and quantifying public health outcomes

Outputs:

A final report of results will be submitted to HDR-UK in February 2021. This will cover key findings of the study including: methodological developments, scientific findings, policy implications.

Academic paper(s) will be published in open-access, peer-reviewed journals, and on the organisation’s website on the following topics:
• impact of air quality, viral circulation and other covariates on daily exacerbation rate for each condition;
• methodology in using “big data”;
• cost and effectiveness of potential vaccination strategies.
Target dates for submission will be minimum 2 per year, starting mid 2019.

Where possible, the project will target general public health and/or epidemiology journals with a broad audience (e.g. Lancet Respiratory Medicine, Lancet Global Health, Lancet Public Health. PLOS Medicine, PLOS Computational Biology. BMJ, BMJ Open. International Journal of Epidemiology, American Journal of Epidemiology, Epidemiology.). Because analyses are likely to be of interest not just in public health but in methodological advance, the project will also consider specialist journals in statistical methods for large datasets. Dissemination at national and international conferences will adopt a similar strategy of aiming for as broad as possible a reach. They will include disease-focused meetings such as Chest, COPD, and Asthma, and modelling meetings such as Epidemics. The project will also seek presentations at specialty conferences where results have relevance to those audiences, as well as meetings where public health decisionmakers are likely to be represented.

For each paper published, a presentation will be developed to summarise the findings for a range of stakeholders, e.g. scientists, patient groups, public engagement events, outreach, policymakers. Findings will be presented at appropriate events.

A simplified version of the findings will be generated for sharing with charities/patient groups of interest, and publishing on the organisation’s website.
Findings from the study like this will also be shared in posters, presentations, and online. They will be promoted through Twitter and the University website. Where appropriate they will be included in the public engagement work the PI already does (e.g. New Scientist Live, TEDx talks, other events).

The LSHTM website provides links to LSHTM open access papers. All publications and conference presentations are promoted on twitter, via the @ehr_lshtm account (Electronic Health Records Research Group, >200 followers), @cmmid_lshtm account (Centre for Mathematical Modelling of Infectious disease, >600 followers) and sometimes the @LSHTM account (main University account, >19,000 followers). They may be promoted through the @HDR_UK account (the funder, >1300 followers), or my personal account (>200 followers).

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Processing information:

There will be no flows of data to NHS Digital.

There will be a flow of requested data from NHS Digital to LSHTM.
The pseudonymised HES data will be transferred from NHS Digital using the secure data transfer portal. This data will be stored on the secure server at LSHTM which can be accessed only by the LSHTM study team using a unique network password. No-one else outside of the LSHTM study team will have access to any of the NHS Digital data from this application.

There are no subsequent flows of data.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

The data will not be linked with any record level data.

There will be no requirement nor attempt to reidentify individuals from the data.

The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Data requested:

This project requests Hospital Episode Statistics Admitted Patient Care data. The project minimises data requested by limiting to specific health conditions and diagnosis codes. This is a large study, and needs to be, because the differences from city-to-city in viral circulation and pollution are expected to be quite small. Therefore “big data” are needed to give the statistical power to estimate these effects.

The project requests 13 years of data. This number of years is needed for 4 major reasons:

1) School holidays affect transmission of viruses and hence risk of exacerbations. There are small changes to school calendars each year, and so as many years as are possible are needed to be able to detect the effect of these small changes in holiday timing.
2) Over long time periods we expect demographic change in the populations (e.g. increase or decrease in number of children, or fraction of older adults). These changes can alter viral circulation, i.e. a higher proportion of children in the population increases the circulation of respiratory viruses, because children have higher contact rates. This is a slow process, and therefore a fairly long time period is needed over which to estimate these effects. If the time period is too short, the estimation procedures will not have the power to detect the effect of demographic changes on viral circulation. Therefore the public health benefit may not be met.
3) The fraction of older adults with chronic conditions has been increasing through time in the UK. These changes are quite slow and therefore a fairly long time period is needed over which to estimate these effects. If the time period is too short, the estimation procedures will not have the power to detect the effect of demographic changes on number of individuals at risk. Therefore the public health benefit might not be met.
4) Affecting all 4 previous reasons, the study period contains two major events in influenza circulation: the 2009 pandemic, and the phased introduction of the paediatric influenza vaccination program (2013 onwards). Influenza is known to be a trigger for chronic disease exacerbations, so data from before and after these events is needed in order to properly assess the baseline and the effect of these events on viral circulation. Without this, the effect of viral circulation may be confounded by these events/changes and the study will not achieve the aims and therefore the public health benefit.

Data is requested nationally because there is variation in school calendar timing and air quality in different regions, and this is what is being studied. Using national-level data will maximise the number of hospitalisation events in each school calendar year which will increase power to detect the effect of each factor on exacerbation risk.

Data are minimised by filtering to limited specific conditions of relevance. There are 4 categories: 1) Asthma and similar, 2) COPD and similar, 3) CHD and similar, 4) respiratory infections and similar. Categories 1, 2 & 3 are the target conditions, and Category 4 is an input to the model to understand the exacerbations of 1, 2 & 3.


Daily resolution is required to detect effects of air quality on exacerbation risk, because air quality changes every day. Age of patients (month-year) is required for assigning to correct year of school. Location is required for assigning to geographic areas covered by particular school calendars, but only first part of postcode is needed.

MR1451 Vitamin D and Longevity (VIDAL) Trial: randomised feasibility study — DARS-NIC-123200-J0L4T

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable (Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c), Informed Patient consent to permit the receipt, processing and release of data by NHS Digital, Health and Social Care Act 2012 – s261(2)(c); Informed Patient consent to permit the receipt, processing and release of data by NHS Digital

Purposes: No (Research)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2018-12-15 — 2020-04-30 2018.03 — 2018.12.

Access method: Ongoing, One-Off

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Critical Care
  3. MRIS - Flagging Current Status Report
  4. MRIS - Cause of Death Report
  5. MRIS - Cohort Event Notification Report
  6. Hospital Episode Statistics Admitted Patient Care (HES APC)
  7. Hospital Episode Statistics Critical Care (HES Critical Care)

Objectives:

The Chief Investigator for this feasibility study is from the London School of Hygiene & Tropical Medicine, and instigated this with support from interested collaborators in Queen Mary University of London and University College London. This is a feasibility study for a larger trial. The question the main trial will address is whether vitamin D supplementation reduces morbidity and increases lifespan in men and women aged 65 to 84 in response to a growing literature base suggesting that such trials are required. The International Agency for Research on Cancer (IARC) Working Group on vitamin D and cancer, of which the chief investigator was a member, reviewed the epidemiological evidence on vitamin D and cancer and concluded that the evidence was strong for colorectal cancer but inconclusive for other individual cancers (IARC Working Group on Vitamin D, 2008). Their report concluded: “The only way to further address the cause-effect issue is to organise new randomized trials to evaluate the impact of vitamin D on all-cause mortality and on the incidence and mortality from common conditions including cancer. These trials should make sure that key parameters of vitamin D status (e.g., serum 25-hydroxyvitamin D levels before and in trial) can be assessed.”

Many people in the UK do not receive enough sun exposure to achieve a satisfactory vitamin D blood level. Epidemiological evidence suggests that people with low vitamin D levels are at increased risk for several diseases, including heart disease, various infections and some types of cancer. However, similar epidemiological evidence of benefit for various other vitamins was disproved when randomized trials were conducted. LSHTM is therefore planning a large (n=20,000) trial to evaluate the effect of vitamin D supplementation on mortality and morbidity among older members of the general population. For the primary endpoint of overall mortality in the main trial the necessity of placebo control is not clear. This feasibility study, which is funded by the Government’s Health Technology Assessment agency, will compare a placebo controlled trial in 10 GP practices against an open randomised trial in 10 practices, randomising 800 people aged 65-84 double blind to monthly placebo versus monthly vitamin D for 2 years, and 800 to no treatment versus 2 years of monthly vitamin D.

One of the research objectives is to establish the feasibility of flagging for lifelong follow-up through national registers for death and cancer registration, and tracing through the Hospital Episodes Statistics database (HES) for hospital admissions and diagnoses. Comparing hospital admissions, cancer registrations and deaths between participants who have and have not taken vitamin D will answer the question of whether high-dose vitamin D supplementation might help to prolong life and reduce various diseases.

The other primary objectives of the trial are to determine the recruitment rate and the compliance rate (the proportion adhering to allocated treatment over 2 years) in practices with placebo control, and in practices with open control. The institution shall also determine contamination rates in those allocated to placebo and those allocated to open control (ie self-administration of >400 IU vitamin D per day or equivalent). IMP adherence and use of additional vitamin D supplements were studied both by self-report and from blood levels of 25(OH) vitamin D at entry and at 2 years.

The outcomes of this feasability study will assist with a decision as to the study design of the main trial by providing unbiased data on adverse events in each treatment arm. This will be compared to the (potentially) biased real-time collection of adverse events during the trial to see whether an open allocation trial (where people know which treatment they’ve been allocated to) is more biased in this regard than a blinded design (where patients either receive treatment or placebo). This in turn will help us to present a reasoned argument for the study design that should be adopted in the main trial.

Yielded Benefits:

Due to the unavailability of cancer registration data from April 2017, LSHTM have not received cancer data over the course of the original version of the agreement. As a result, LSHTM confirmed they have been restricted in producing outputs outlined above. LSHTM projects that supplementing the omitted cancer data for use within the trial will enable the expected outputs to be produced and the appropriate reports be directed back to stakeholders assessing the feasibility of the main trial. Once this process is complete, LSHTM will be in a position to identify benefits realised as a result of the processing of NHS Digital data and the wider project.

Expected Benefits:

There is a growing consensus that most people in the UK do not receive enough sun exposure to achieve a satisfactory vitamin D blood level, and that current recommendations on the optimal daily dose of vitamin D should be increased. Eighty percent of men and 87% of women aged over 65 years living independently in the UK have blood levels of 25hydroxyvitamin D (25(OH)D the measure of vitamin D status) below the recommended concentration for optimal health (75 nmol/l or 30 ng/ml). Epidemiological evidence suggests that people with low blood levels may be at increased risk for several diseases, including heart disease, various infections and some cancers. However, similar epidemiological evidence of overall benefit for various other vitamins was disproved when randomized trials were conducted, and no adequately powered trial has tested vitamin D in doses that are high enough to achieve blood 25 (OH)D concentration > 75 nmol/l. Although the majority of observational studies report associations between vitamin D deficiency and susceptibility to a range of pathologies, some studies are null, and a few report opposite associations. A large randomized trial is therefore required to assess whether vitamin D supplementation can decrease the risk of various diseases and increase longevity. The importance of a clinical trial of oral supplementation of vitamin D is emphasized by the finding that in practice it is difficult for the majority of UK residents to obtain optimal vitamin D from sunlight or diet. If self administered vitamin D supplementation were shown to confer substantial health benefits it would be routinely recommended and widely adopted. This would also provide a rationale for a national policy of vitamin D supplementation for the general population, a review of the relative risks and benefits of sun exposure, and a revision of existing policy on vitamin D fortification of foods. If no benefit or unforeseen disadvantages are shown this will also be a valuable contribution to knowledge. The target audience for such findings would be the Department of Health and National Institute for Health Research.

An important public health priority is therefore to demonstrate the feasibility of a large randomized trial of prolonged vitamin D supplementation in older people, and to show that this will increase serum 25(OH)D to >=75 nmol/l in the majority of subjects. The main trial for which this is the feasibility study will be a randomized trial with 20,000 participants followed for 10 years. A trial of that size is needed to detect the 7% reduction that vitamin D supplementation might plausibly achieve in total mortality in healthy adults aged over 65. As well as demonstrating an expected increase in circulating 25hydroxyvitamin D levels, the feasibility study will provide estimates of cost and establish the study design and procedures required for the main trial.

Feedback from patients and GP practice nurses was encouraging for the feasibility study. A number of sites reported that there was a strong interest among the study population and indeed, overall trial response rates were nearly double the protocol target. The final number of patients randomised was 1615 (vs protocol target of 1600) and the overall response rate was 17.2% (9,406 invited, 1615 randomised) compared with the protocol target of 9%. The final study analyses are currently underway, but interim estimates of participant compliance demonstrated excellent compliance at 3, 6 and 9 months, with 97.3%, 96.7% and 95.9% respectively taking all 3 monthly doses of trial medication. The draft report containing all study results is scheduled for Spring 2018.

Outputs:

The results of this feasibility study will be reported in peer reviewed scientific journals with accompanying conference presentations and submissions to regulatory authorities. The first NIHR draft report was submitted in Autumn 2017 to the peer-reviewed Health Technology Assessment journal. It will be several months before this draft version of the NIHR report is finalised, pending referees' comments. During this period, the institution will also target the scientific medical community by submitting a report to the peer-reviewed British Medical Journal.

In addition, further funding will be sought for a larger “main” trial (for which this is a feasibility study), involving up to 20,000 participants across 200+ GP practices in the United Kingdom. NIHR have indicated that they would like to see the results of several similar large scale international vitamin D trials, due in the next few years, before they will consider funding a similar large scale study in the UK.

Processing:

Data from all 1615 patients randomised to the trial will be included for the statistical analysis. LSHTM will supply each participant's unique Study ID, NHS number, date of birth and post code to NHS Digital for the purpose of following each participant's health status (mortality, cancer registration data and hospital admissions) on the basis of informed patient consent to permit the receipt, processing and release of data by NHS Digital. The participant's Study ID, NHS number, date of birth and postcode will be linked to medical records held by NHS Digital on cancer registrations (provided by NHS Digital on behalf of Public Health England), deaths (sourced from civil registration data and provided by NHS Digital on behalf of the Office for National Statistics) and the Hospital Episodes Statistics database on hospital admissions. This linked data will then flow to LSHTM, and the trial statistician will analyse the mortality, cancer registration and hospital admissions data by treatment allocation & baseline blood serum vitamin D level to assess how vitamin D deficiency and treatment with vitamin D might affect these outcomes.

The main analyses will be the matched pair comparison of recruitment and overall compliance rates between placebo control and open control designs. Details of additional vitamin D supplement use will be recorded at entry, and retrospectively at the 2 year final visit. Failure to report taking at least 19 doses of allocated IMP or to attend the 2 year final visit are included in the definition of noncompliance, so there will be no missing data for the main analyses. Change in blood level of 25(OH) vitamin D from entry to exit will be analysed in relation to self reported compliance. The effect of treatment on serum 25(OH)D both overall by allocated treatment, and in compliant participants, will also be analysed in relation to the pre treatment 25(OH)D level. Other principal outcome data from this trial will include deaths, cancer cases and hospital admissions from major causes during and after the trial. This is the reason for requesting the mortality, cancer registration and HES data from NHS Digital. The data from a year preceding the beginning of the trial are required to provide baseline rates for deaths, cancer cases and hospital admissions. Deaths, cancer registration rates and hospital admission rates for major disease categories will be estimated by treatment allocation group (vitamin D versus no treatment) and baseline serum vitamin D level (blood samples were taken at entry to the trial).

The data will be used to assist the LSHTM making a decision as to the study design of the main trial by providing unbiased data on adverse events in each treatment arm. This can then be compared to the (potentially) biased real-time collection of adverse events during the trial to see whether an open allocation trial (where people know which treatment they’ve been allocated to) is more biased in this regard than a blinded design (where patients either receive treatment or placebo). This in turn will help the LSHTM to present a reasoned argument for the study design that should be adopted in the main trial.

Data containing personal identifiers will be transferred to and from NHS Digital using the secure data transfer portal. This data will be stored on the secure server at LSHTM which can be accessed only by the LSHTM study team using a unique network password. No-one else outside of the LSHTM study team will have access to any of the NHS Digital data from this application.

The data will only be viewed, accessed and analysed by direct substantive employees of the London School of Hygiene & Tropical Medicine (LSHTM). There are two collaborators in this study – University College London and Queen Mary University of London, they do not have access to the data.

All processing of ONS data will be in line with ONS standard conditions. The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide apart from the date of death which is converted from age at death down to the granularity of weeks to ensure sufficient anonymisation as described.

Project 22 — DARS-NIC-104802-G2J0P

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y

Legal basis: Section 251 approval is in place for the flow of identifiable data

Purposes: ()

Sensitive: Non Sensitive

When:2017.09 — 2017.11.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Flagging Current Status Report

Objectives:

The need to research for potential genetic damage amongst British nuclear test veterans and the possibility of transmitted genetic alterations in their children has been a cornerstone requirement identified by members of the nuclear community for many years. A recent award from the Aged Veteran Fund (AVF) is now enabling such investigations to take place in a study led by Brunel University London in collaboration with the London School of Hygiene & Tropical Medicine. The project is part of a larger portfolio coordinated by the Nuclear Community Charity Fund (NCCF) on behalf of British Nuclear Test Veteran Association. This project will carry out chromosomal analysis of cells from nuclear test veterans and their children. The study will recruit 50 veteran family trios (father, mother, child) to provide samples for fluorescence in situ hybridisation (FISH)-based analyses to ask if there is any evidence of altered frequencies of chromosomal aberrations in veterans and/or their children when compared to 50 control family groups.

Participants will be selected from a defined group of veterans known to have been present at nuclear tests and inclusion will not be related to ill-health (case veterans). The control group of veterans will be matched on age, service, rank and will have served at the same time in tropical regions but will be verified as not being present at test sites. All veterans will be interviewed for their medical and service history. Knowledge gained from this project will make significant in-roads into clarifying ongoing uncertainties about the possible impact on health by providing cytogenetic evidence to address identified issues and/or to dispel unfounded concerns. Outputs from this work will benefit the broader nuclear community by providing a scientific rationale that will improve understanding and, if genetic effects are observed, to inform health and social care providers to better support this community’s needs.

The applicant has received approval for a “Consent for Consent” application from the Confidentiality Advisory Group (CAG) for the London School of Hygiene & Tropical Medicine (LSHTM) to receive NHS number, date of birth (for validation) and GP details of armed services veterans identified from Public Health England’s (PHE’s) nuclear test veteran’s cohort study via NHS Digital. LSHTM has gained Section 251 Approval to cover NHS Digital receiving and processing NHS Number and date of birth from PHE, and the receipt from NHS Digital of NHS number, date of birth and GP name and address code for the purpose of patient identification and recruitment via the GP practice. The applicant is applying to NHS Digital with S251 support for the contact data.

PHE will supply NHS number and date of birth for selected cases (those who have been exposed to nuclear testing) and control veterans (those who have not been exposed) to NHS Digital for linkage to GP practice details. NHS Digital will remove deceased veterans and those with a diagnosis of cancer (other than non-melanoma skin cancer) from the list prior to sending on NHS number, date of birth, GP practice details and case/control status to the London School of Hygiene & Tropical Medicine for the purpose of patient identification and recruitment via GP practices.

At this stage, only the above linkage (NHS number, date of birth, GP details and case/control status) from NHS Digital for the purpose of patient identification and recruitment via GP practices is being requested. However, the Section 251 application includes approval for all participants to be flagged for lifelong followup through national registers for death and cancer registration and hospital admissions via HES, subject to further funding for this aspect of the study. It is therefore anticipated that a subsequent amendment to NHS Digital for this additional work will be made in the future.

Expected Benefits:

The benefit of this application is patient identification and recruitment via GP practices to gain consent from individuals to participate in the study and not contacting deceased patients and causing distress to their families.

Outcomes from this project will bring benefit to families in the nuclear community by providing them with the first ever comprehensive cytogenetic exploration to examine for possible genetic differences between members of their community and control family groups.

The findings will underpin evidence-based information and education that will seek to reduce the reported confusion, anxiety and uncertainties voiced by members of the nuclear community. The findings, which will be translated for the benefit of the nuclear community, may also lead to further research with the aim of informing care & wellbeing programmes. Participating families will also benefit from a sense of contributing and being part of a research study, designed in partnership with the BNTVA that has the sole aim of seeking answers to outstanding questions within their community.

Outputs:

There will be no outputs produced directly from the data requested under this application.

The wider project, which will be subject to a further application for data will produce a number of outputs and on completion of the study report, the main findings will be summarised and sent in a letter to those who participated in the study. The study results will also be published in peer-reviewed scientific journals and presented at conferences. Examples of conferences that this work may be presented at include the International Congress of Radiation Research 2019 in Manchester (the largest Congress for radiation research, held every 4 years); the Association for Radiation Research; the European Association for Radiation Research; the Radiation Protection Week (large EU supported conference); the Annual General Meetings of British Nuclear Test Veterans Association).

The study is being conducted on behalf of the Nuclear Community Charity Fund, so there will also be presentations at nuclear community events and articles pertaining to the study results will be published in nuclear community publications.

All outputs and publications contain only aggregated data with small numbers suppressed in line with the HES Analysis Guide.

Processing:

PHE will provide to LSHTM a completely pseudonymised data set containing the exposure data held on the Nuclear Test Veterans in the cohort. This will not include any NHS Digital data. These data will be used to select the most heavily exposed test veterans (using stratified random sampling based on number and location of tests attended, measured or estimated exposures, job role at test site) including personnel who flew through the dust cloud after each test. Unexposed controls will be matched on age, rank, service (RAF, Royal Navy, Army) and period of service in tropical regions.

PHE will submit lists of identified patients to NHS Digital who hold the flagging data on these individuals. Participants who have died or have cancer registrations (other than non-melanoma skin cancer) will be excluded by NHS Digital. NHS Digital will also match the list against the national register to exclude the most recently deceased or cancer registered participants prior to linking with GP data and sending the finalised list [containing NHS number (for identification), DOB (for validation) and GP name and address] to LSHTM. This is the minimum identifiable data required in order to seek consent. Access to the data will only be by substantive employees of LSHTM.

The LSHTM study team, who are substantive employees of LSHTM, will invite potential subjects to participate in the study via their GP practice. The LSHTM study team will write to each potential participant's GP, supplying the subject's NHS number and date of birth for identification, and explaining the purpose of the study. If the GP does not feel it is inappropriate for any reason, the GP practice is requested to pass on a letter, patient information sheet & consent form and reply slip with pre-paid addressed envelopes outlining the study and asking the couple to let the LSHTM study team know whether or not they might be willing to take part. Those replying and supplying a contact telephone number will be telephoned by the LSHTM study team to discuss the study, answering any questions the respondents may have. Fully informed written consent to participate in the study will then be obtained from willing eligible participants.

Identifiable data is required in order to identify, contact, and gain consent from individuals to participate in the study (via their GP practice). This by definition would not be possible with anonymised or pseudonymised data. Sampling from the PHE nuclear test veteran’s cohort is a non-biased method of identifying potential participants. This is also an unbiased source of exposure data which will be used to identify those veterans who are likely to be at the highest risk of radiation exposure. The cohort also contains an unexposed set of veterans from which controls for this study will be selected. If the applicant were not able to utilise this cohort as the sampling frame, the study would have to rely on a biased set of volunteers.

The response rate for veteran trios recruited is anticipated to be quite low due to the multi-step nature of the recruitment process. Initially, case veterans will be anonymously selected from the PHE cohort based on exposure history, with control veterans being selected to match on various variables (age, rank, service type and period of service). Once veterans are selected, NHS Digital will remove members who are deceased or registered with cancer (other than non-melanoma skin cancer) prior to sending to the study team. GP practices will then be contacted to confirm eligibility, at which point ineligible veterans will be excluded. Subsequently, eligible veterans and their wives or partners will both have to agree to take part in the study and they need to have had a biological child together, who is still alive and resident in the UK. Thus potentially eligible veterans will be lost at this stage of the recruitment process. Eligible and willing veteran couples will then forward a letter on behalf of the study team to their child, who must also be confirmed as eligible (via their GP) and agree to take part in the study before the veteran trio can be counted as one unit towards the overall response rate. Further to this, control veterans must be frequency matched on four different variables to case veterans (age, rank, service type and period of service), without knowing a priori which case veterans will respond and take part in the study. This will require four times as many controls to be selected a priori. Previous studies in this age-range have achieved a response rate of approximately 10% for individual respondents. It may therefore be prudent to assume that approximately 3-4% of case veterans will eventually participate as a complete veteran trio in this study, with approximately 1% of control veterans participating as a family trio once matching has been done. To avoid time-consuming and costly multiple applications to NHS Digital for recruitment purposes, the applicant is therefore seeking to receive NHS number, date of birth and GP practice details from 1500 case veterans (to allow for an eventual response rate of 3-4% for case trios), plus 6000 controls (to allow for a priori frequency matching on four variables).

Appropriate controls will be in place to ensure that access to confidential research information is restricted only to those who need it. The study data will be electronically stored inside a secure network at LSHTM, apart from the percentage which are paper copies of study materials (reply slips, consent forms and telephone interview data). These will be stored in locked filing cabinets at LSHTM, accessible only to the direct study team. Data containing personal identifiers will be transferred to and from NHS Digital using their secure data transfer portal. This data will be stored on the secure server at LSHTM which can be accessed only by the LSHTM study team using their unique network password. Brunel University London staff will not have access to any NHS Digital (or otherwise) patient identifiable data as part of this application. Once consent has been gained and that data collected, the two organisations will liaise over patients using study ID (though again Brunel will not be accessing any NHS Digital data).

Project 23 — DARS-NIC-63345-L7D3D

Type of data: information not disclosed for TRE projects

Opt outs honoured: N

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Purposes: ()

Sensitive: Non Sensitive

When:2017.06 — 2017.11.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - List Cleaning Report

Objectives:

The objective of the request is to receive information about fact of death and current postcode for members of the cohort prior to writing out therefore preventing the writing out to any people in the cohort who may have passed away and not writing to people who have moved address. The output is to create a 'live' consented database and the benefit is not to cause distress

PhD Research Study on the Use of PROMs in Emergency Admissions, a feasibility study conducted to explore the use of Patient reported outcome measures in emergency admissions patient cohorts. The aim of the work is to assess the feasibility of retrospective PROMs in emergency admissions and follow-up PROMs to determine change in Health Related Quality of Life (HRQL) of patients following emergency hospital care. This is the last phase of a three year study and links directly with the National Emergency Laparotomy Audit (NELA), who if the study proves to be a success, will be looking at the feasibility of including PROMs in National Clinical Audit.

In England, emergency admissions accounted for nearly 38% of all hospital admissions in 2012-13, with an increase of 47% over the last 15 years. Two thirds of hospital beds are occupied by people admitted as emergencies and the cost is approximately £12.5 billion. Of these, emergency general surgery represents approximately half of the general surgical workload and accounts for over 600,000 hospital admissions at a cost of £88 million a year. Furthermore, emergency admissions is an area whereby variation in clinical outcome is greater than for elective care, and an area where there is no information on patient-reported outcomes.

Capturing PROMs for unexpected emergency admissions is primarily to measure the quality of health services. The aim of healthcare is to restore patients’ health to their full potential and health related quality of life (HRQL). Patients’ recovery can be compared with their pre-event baseline quality of life to determine the effectiveness of the health service. This, however, is impossible to obtain prior to an acute event and therefore collection of a retrospective PROM by patient recall to replace the baseline HRQL is an option.

Patient Reported Outcomes Measures (PROMs) have the potential to transform healthcare delivery through enhancing patient-centred care, assessing relative clinical quality, comparing providers’ performance and evaluating the effectiveness of treatments. The development of routinely collected PROMs data in four elective surgical procedures in England has been heralded as one of the missing components of quality in the jigsaw in the evaluation of our health service. (DoH Guide to PROMs Methodology 2009, Black 2013).
With growing acceptance of the importance of patients' views of their outcome, as well as clinicians' measures such as mortality and impairment, when evaluating interventions and assessing the quality of services, it is necessary to devise ways in which accurate PROMs can be obtained, since these provide information on the effectiveness of treatment, an important component in determining the quality of healthcare. Development to widen use of PROMs helps to focus the health service towards patient-centred care (Greenhalgh and Long 2004).
There is sustained clinical and political interest in the systematic development of PROMS (Morris et al 2007, DoH NHS Outcomes Framework 2015-16, DoH The Mandate to the NHS 2015-16).

This is a new study, a new phase as part of a 3 year doctoral programme of research on the topic of Patient Reported Outcomes Measures. This study applied for HRA approval in Nov 2016, and received approval in Dec 2016. Planned data collection to begin in March 2017. Study participant's (patient) death status (fact of death) from MRIS/ PDS is required to ensure that the researchers do not send follow-up PROMs questionnaires to patients who have passed away prior to follow-up.

Emergency conditions account for 40% of NHS hospital admissions and have been an area of increasing resource use and political importance (DoH NHS Outcomes Framework 2015-16). There is mounting interest to extend the use of PROMs to emergency admissions.

Participating trusts, national clinical audit group (NELA) will be informed of the research findings through dissemination through partnering providers and Collaborations for Leadership in Applied Health Research and Care (CLARHC) research network, at conferences and workshops- HSR symposium 2018, National PROMS conference 2018 and also though reports to national clinical audit collaborators as well as traditional forms of research dissemination pathways including academic conferences, publications in peer reviewed journals- e.g. BMJ journal for quality and safety, and a PhD thesis.

Expected Benefits:

Request of data for FACT OF DEATH requirement only. The purpose is to enable the researcher not to cause distress. So the objective is not to write to any dead people, the output is to create a 'live' consented database and the benefit is not to cause distress.

Study findings will be disseminated to participating providers and National Emergency Laparotomy Audit and at conferences such as HSR symposium 2018, National PROMS conference 2018 involving provider trusts and clinicians, reports to National clinical audit collaborators .They will be able to use patient reported outcomes for service improvement decisions and on-going benchmarking of services.

There is prior engagement with the National Clinical Audit groups who are interested in adopting the use of Patient Reported Outcomes to clinical audit. There is significant interest from policy makers in extending the use of PROMs in emergency admissions.

PROMs helps providers, commissioners to measure effectiveness and quality of care, extending the use of PROMs in emergency admissions allows for increased patient-centred care. Benefiting care users through understanding quality of care and quality of life post-treatment/care from the patients' perspective.

Emergency Admissions make up nearly 40% of all hospital admissions in England and is increasing each year.

Outputs:

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The following outputs will be produced :

The main findings will be included in PhD thesis due in May 2018.

The final report of results will be submitted to NELA in Dec 2017. This will cover all findings of the study including: factors influencing planning and implementation and key findings. Once finalised, this will be submitted for publication in the open access, peer-reviewed journals with an estimated submission date of January 2018.

Further academic paper(s) will be published in open-access and peer-reviewed journal such as BMJ quality and safety on [methodology; cost and effectiveness of the feasilibty of using PROMs in emergency admissions]; impact on policy and clinical care. A simplified version of the findings will be disseminated to patient groups of interest (e.g. CLAHRC network, participating hospitals patient forums).

Findings will be presented at conferences and events with CLARHC patient groups.

Processing:

London School of Hygiene and Tropical Medicine (LSHTM) will securely transfer patient identifiers (NHS number, DOB, postcode) and unique study ID to NHS digital from consented patients of the study (patient recruitment is over 3 months from hospitals), the information will be requested monthly over 3 months before follow-up questionnaires are sent directly to patients. NHS Digital data for patients who do not respond to follow-up questionnaire will be deleted.
NHS Digital will send any known fact of death with Unique study ID (and no other identifiers) from study participants to LSHTM. LSTHM stores the data on a secure server in LSHTM which can be only accessed by applicant and the study team at LSHTM.
Data will only be accessed by individuals within the study team who have authorisation from the applicant (chief investigator of the study) to access the data for the purpose(s) described.
Economic and Social Research Council PhD funding awards are provided through doctoral training centres for which LSHTM belong to the Bloomsbury Doctoral Training Centre partnerships which is managed by the University College London Institute Of Education, therefore the grant for the study is managed by Bloomsbury doctoral training Centre partnerships and this organisation also issues the funding letter. The PhD student conducting this study is a full time PhD student at the LSHTM and this study solely belongs to LSHTM's clinical governance; this includes the sponsorship and indemnity, quality and responsibility of the overall study. University College London Institute Of Education have no further involvement in this study.
Knowledge of the fact of death of any study participants within this cohort study allows researchers to minimize any potential distress caused by sending a follow-up questionnaire to a participant who have passed away. Due to the nature of emergency admissions, there could be a 2-5% mortality within the first 2-3 months of hospital discharge in the study patient cohort.

MR104a - Regional Heart Study (Female Cohort) — DARS-NIC-148101-R7RSL

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, Identifiable, Anonymised - ICO Code Compliant (Consent (Reasonable Expectation))

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7); Informed Patient consent to permit the receipt, processing and release of data by NHS Digital, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2018-06-22 — 2020-03-31 2016.09 — 2017.02.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY COLLEGE LONDON (UCL)

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Flagging Current Status Report
  5. MRIS - List Cleaning Report
  6. MRIS - Members and Postings Report
  7. Cancer Registration Data
  8. Civil Registrations of Death
  9. Demographics

Objectives:

The data supplied by the NHS IC to London School of Hygiene & Tropical Medicine will be used only for the approved Medical Research Project MR104A.

Yielded Benefits:

The BWHHS has 218 publications within peer reviewed journals to date addressing the aims outlined previously in this application. Many of the journals for BWHHS manuscripts are considered high ranking journals. This “ranking” of journals is measured by something called the ‘impact factor’ which reflects the frequency with which the average article in a journal has been cited within the year. 31% of the publishing journals for BWHHS manuscripts have been published in journals with a high-impact factor (>8). This means that the output is published in journals that are widely read by doctors, scientist and public health practitioners, ensuring a greater impact of the work. The BWHHS has also had measurable benefit directly as fourteen of the 218 publications have contributed to the following fifteen clinical care and public health guidelines: 1. National Clinical Guideline Centre NICE clinical guideline CG181 Lipid modification (2014) 2. Diabetes, Pre-Diabetes and Cardiovascular Diseases developed with the EASD ESC Clinical Practice Guidelines (2013) 3. Dyslipidaemias 2016 (Management of) ESC Clinical Practice Guidelines (2011) 4. Dyslipidaemias 2016 (Management of) ESC Clinical Practice Guidelines (2016) 5. Arterial Hypertension (Management of) ESC Clinical Practice Guidelines (2013) 6. CVD Prevention in Clinical Practice (European Guidelines on) (2016) 7. Factors Influencing the Decline in Stroke Mortality: A Statement from the American Heart Association/American Stroke Association (2013) 8. Genetics and Genomics for the Prevention and Treatment of Cardiovascular Disease: Update A Scientific Statement From the American Heart Association (2013) 9. Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association (2014) 10. Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes Mellitus in Light of Recent Evidence: A Scientific Statement From the American Heart Association and the American Diabetes Association 11. Social Determinants of Risk and Outcomes for Cardiovascular Disease: A Scientific Statement From the American Heart Association 12. Future Translational Applications From the Contemporary Genomics Era: A Scientific Statement From the American Heart Association 13. Basic Concepts and Potential Applications of Genetics and Genomics for Cardiovascular and Stroke Clinicians: A Scientific Statement From the American Heart Association 14. Salt Sensitivity of Blood Pressure: A Scientific Statement From the American Heart Association 15. Preventing and Experiencing Ischemic Heart Disease as a Woman: State of the Science. A Scientific Statement from the American Heart Association

Expected Benefits:

To be completed by the customer on re-submission

Outputs:

To be completed by the customer on re-submission

Processing:

To be completed by the customer on re-submission

Project 25 — DARS-NIC-382718-N1T4C

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y, N

Legal basis: Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , Health and Social Care Act 2012

Purposes: ()

Sensitive: Non Sensitive, and Sensitive

When:2016.04 — 2017.02.

Access method: One-Off

Data-controller type:

Sublicensing allowed:

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Office for National Statistics Mortality Data
  3. Office for National Statistics Mortality Data (linkable to HES)

Objectives:

To support a research study that aims to determine the association between different services aimed at identification and management of patients at risk of deterioration and ward-based cardiac arrest rates and outcomes.

The London School of Hygiene & Tropical Medicine (LSHTM) will carry out a survey to map interventions across all hospitals participating in the National Cardiac Arrest Audit (NCAA) (managed by the Intensive Care National Audit and Research Centre (ICNARC)) and using a cross-sectional approach, will determine which combinations of services are associated with the lowest cardiac arrest rates and best outcomes derived from the NCAA database. The LSHTM will also look at how arrest rates and outcomes have changed over time in hospitals as new services have been. NCAA data will be linked to other ICNARC datasets: the Case Mix Programme (CMP) to determine patient's condition on admission to ICU.

Linking this ICNARC dataset to Hospital Episode Statistics (HES) will provide data on co-morbidity and hospital treatments enabling case mix adjustment at Trust level and assessment of dates when interventions were received by patients (the pattern of interventions before cardiac arrest will support the cross sectional and time series analyses). Linkage to ONS death data will provide 30 day and 90 day mortality for those patients in the NCAA who were discharged from hospital alive. HES and ONS data will be requested for all patients who have been admitted to hospitals taking part in the NCAA audit since it began in 2010 and will only be used for the purposes specified above.

Expected Benefits:

By December 2016, the LSHTM aims to have identified key intervention features that improve outcomes, and will be able to disseminate the findings and recommendations across the NHS to enable hospital managers, clinicians and policy makers to raise standards of care for all patients at risk of deterioration and reduce avoidable mortality.

As well as the review of the evidence associated with different interventions, the LSHTM will also be able to provide a map of the range of interventions targeting acutely ill patients in place across the NHS which will support health service managers in determining the design of their own service improvements.

In addition, this study will provide preliminary information on the feasibility of using in hospital cardiac arrest rates as a routine measure of quality of care within the NHS.

Outputs:

1. A literature review and qualitative paper published describing the evidence base behind current interventions and how they are being implemented in practice (by Dec 14-Feb 16) and publication of a paper on the findings from the survey of Trusts taking part in the NCAA Trust Survey (by May 2016)
2. Publication of a paper and final report for NIHR describing the findings from analysis of the association between different intervention types and IHCA incidence and outcomes (by November 2016).
3. To inform NHS acute Trusts, NHS England and DH of intervention features associated with the lowest IHCA incidence and best outcomes and the feasibility of using in-hospital cardiac arrests as an indicator of hospital quality and safety through published reports and presentations by December 2016.

This study will provide key information to guide service redesign for clinicians, hospital managers and policy makers. Evidence-based standardisation of practice across the NHS will not only result in reducing avoidable mortality and better quality care for all patients at risk of deterioration but also result in more efficient investment of NHS funds. A summary of the evidence about the effectiveness of interventions for identifying and responding to the deteriorating patient and how these were originally implemented will be produced as a guide. The service evaluation (based on in-depth work in 20 hospitals and the descriptive survey) will provide information on the variety of current service provision enabling identification of where improvements might need to be targeted. The survey will provide information on the types of interventions and will be linked with HES/ONS/ICNARC data by trust/hospital. Findings from the quantitative analyses will provide an evidence base as to which interventions should be implemented and how. It will also identify further research priorities for exploration in future studies. In addition, the LSHTM will be able to assess the feasibility of using in-hospital cardiac arrest (IHCA) rates and outcomes as indicators of hospital quality of care for acutely ill patients which will feed into the NHS Outcomes Framework Technical Advisory Group (one member of the team is a member).

In addition findings will be disseminated via the following routes:
• The research will produce a detailed report for NIHR Health Services & Delivery Research (HS&DR) programme detailing research methods, findings and conclusions. In addition, short summaries of the research will be produced. Summaries of the methodological approach will be made available. (By October 2016)
• For national policy through links with the NHS Commissioning Board and the Care Quality Commission (and its Chief Inspector of Hospitals).
• Regionally through north London, Essex and Hertfordshire via the UCL Partners Academic Health Science Network (including 15 associated NHS hospital Trusts), the Clinical Senates and the Collaboration for Leadership in Applied Healthcare Research and Care (CLAHRC)
• Presentations will be made at national meetings of professional organisations including ICNARC, Resuscitation Council and Royal Colleges with study investigators drawing on their extensive contacts to ensure the widest audience possible.
• Presentations to relevant patient and voluntary groups, e.g., through UCL Partners.
• Production of papers for peer reviewed academic journals (such as British Medical Journal, BMJ Quality and Safety, Resuscitation, Heart, or Journal of Health Services Research and Policy) and conference presentations (International Forum on Quality and Safety, Patient Safety Congress etc.).

Processing:

The LSHTM will request HSCIC to undertake a bespoke data linkage between HES/ONS data sets and the ICNARC NCAA/CMP datasets. The primary identifier would be the NHS Number, but it may improve linkage to also include other available identifiers, i.e. date of birth and post code (ICNARC does not hold the name or full address of patients in the NCAA audit), so permission is also requested to include these (in line with the s251 support). Once linkage has been achieved, the LSHTM will request HSCIC to provide the pseudonymised linked ONS/HES data set.

The process will involve:
1. ICNARC uploading a dataset of identifiers to HSCIC
2. HSCIC perform 'bespoke data linkage' to HES/ONS
3. HSCIC returns a list of matched Study_IDs to ICNARC
4. HSCIC provides pseudonymised HES/ONS data with Study_IDs to LSHTM
5. ICNARC provides pseudonymised CMP+NCAA data with Study_IDs to LSHTM
6. LSHTM link the datasets (CMP+NCAA data and HES/ONS using Study_ID).

A description of the ICNARC databases is as follows:
The National Cardiac Arrest Audit (NCAA) is the national clinical audit of in-hospital cardiac arrests. Data are collected on all individuals (excluding neonates) receiving chest compression(s) and/or defibrillation and attended by the hospital-based resuscitation team (or equivalent) in response to a 2222 call (2222 is the standardised number for a crash/cardiac arrest call). The dataset includes patient demographics (NHS number, date of birth, sex and ethnicity, but not full name or address), information regarding the hospital admission (date, reason), details of the arrest (time of call, status at team arrival, location, presenting rhythm) and outcomes (return of spontaneous circulation and survival to hospital discharge).

The Case Mix Programme (CMP) is the national clinical audit of adult critical care units. Data are collected on all patients admitted to a participating critical care unit. The dataset includes patient demographics (NHS number, date of birth, sex, ethnicity and post code, but not full name or address), severe conditions in the past medical history, information regarding the hospital and critical care unit admission (dates/times, prior location), physiological data from the first 24 hours following admission, organ support received in the critical care unit and outcomes up to ultimate discharge from acute hospital.

CMP data will only be included for patients experiencing an in-hospital cardiac arrest (identified from the NCAA dataset).


No identifiers will be received, stored, or processed by LSHTM (other than the identifiable ONS Mortality fields, used for calculating 30 and 90-day mortality).

Only the following HES/ONS data items will be retained at LSHTM:

From HES:
Patient Information:Age in years, Sex, Ethnicity, Index of Multiple Deprivation (IMD by decile),rural urban indicator

Episode information: From one year before to one year after the index admission: Diagnosis and operative codes, Date of admission, Source of admissions, Method of admission, Date of interventions, Date of discharge, Start and end date of spells, Destination after discharge

Organisation: SUS system codes, Hospital and Trust code, Purchaser (CCG)

From ONS:
Date of death, Primary and additional causes of death. Please note that the date of death will only be retained for a maximum of 3 months to carry out checks/data cleansing, in line with the s251 support.

The data analysis will be completed at LSHTM by a statistician from ICNARC at LSHTM and under the supervision of co-applicants employed by LSHTM and ICRNARC on this NIHR-funded study. These are the only people who will have access to the data, and are all employed substantively by either LSHTM or ICNARC.

After undertaking statistical analysis, outputs will be in the form of tables containing aggregated data with small numbers suppressed in line with the HES Analysis Guide.

MR1162: British Breast Cancer Study - NCRN cohort — DARS-NIC-372684-X6Q3M

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Yes

Legal basis: , Informed Patient consent to permit the receipt, processing and release of data by NHS Digital

Purposes: No (Research)

Sensitive: Sensitive

When:DSA runs 2010-05-10 — 2025-05-09 2016.12 — 2016.12.

Access method: Ongoing

Data-controller type: LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report
  5. MRIS - Personal Demographics Service
  6. MRIS - Scottish NHS / Registration

Objectives:

A national population based study of treatment effect and endocrine, genetic and cellular risk factors for contralateral primary cancer in women in Britain.  Short title; British Breast Cancer study - (NCRN cohort)One of the aims of the genetic component of this study is the identification of low penetrate breast cancer susceptibility alleles.  TO this end, several (lab-based) studies are already underway.  Epidemiological studies, published data from association studies and our own, unpublished, results suggest that some alleles confer risks for a broad spectrum of cancers.  We have now a large population-based cohort of about 25,000 breast cancer cases, both bilateral and unilateral cases.  This cohort contains the largest collection of bilateral breast cancer cases in the world.  It is thus ideal for carrying out association studies to identify breast cancer susceptibility genes and assess their value in risk prediction.  For this, it is vital to ascertain cancer diagnoses and status.