NHS Digital Data Release Register - reformatted
University Of East Anglia projects
- ARRISA-UK study request for secondary care data for asthma patients at participating GP practices in England and Wales
- Falls in Care Homes (FinCH) study: Data Access Request
- Request for data including addresses and ages to contact healthy controls for participation in STEC case-control study
- Project 4
44 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
ARRISA-UK study request for secondary care data for asthma patients at participating GP practices in England and Wales — DARS-NIC-79526-V8F2X
Opt outs honoured: Anonymised - ICO Code Compliant, Identifiable, Yes (Section 251 NHS Act 2006)
Legal basis: Health and Social Care Act 2012 s261(1) and s261(2)(b)(ii); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 s261(2)(b)(ii); 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'.
Purposes: No (Academic)
Sensitive: Sensitive, and Non-Sensitive
When:DSA runs 2020-07-01 — 2021-10-31 2022.01 — 2022.05.
Access method: One-Off
Data-controller type: UNIVERSITY OF EAST ANGLIA
Sublicensing allowed: No
- Civil Registration (Deaths) - Secondary Care Cut
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Admitted Patient Care
- Hospital Episode Statistics Critical Care
- Hospital Episode Statistics Outpatients
- Civil Registrations of Death - Secondary Care Cut
- Hospital Episode Statistics Accident and Emergency (HES A and E)
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Hospital Episode Statistics Critical Care (HES Critical Care)
- Hospital Episode Statistics Outpatients (HES OP)
The purpose of this application is to request pseudonymised secondary care data (hospital admissions, Accident and Emergency (A&E), outpatient and critical care data, and mortality data) for a selected cohort of previously identified patients for the At-Risk Registers Integrated into primary care to Stop Asthma crises in the UK (ARRISA-UK) study.
Approximately 74,000 people with asthma are admitted to hospital and 1,150 die unnecessarily in the UK every year. Excellent drugs are available for asthma and clear advice on prescribing them that should allow asthma to be controlled in most patients. It is known that certain asthma patients are at greater risk of being admitted or dying than others and that targeting intensive support and care to these patients improves their health.
Development of the ARRISA approach began with a single-practice pilot study in 2002, which was followed by a regional, cluster-randomised trial in 30 GP practices in Norfolk (2006-2009) funded by Asthma UK (Project no. 06/047). The current ARRISA-UK cluster-randomised trial of 275 practices in England, Scotland and Wales will be a definitive study which, if it has a positive outcome, it would be expected to change UK primary care policy and practice.
In the regional study, at-risk patients were identified within GP practices and computer-based systems were used to create pop-up alerts when these patients contacted the practice. Practice staff were trained on what to do when they see the alert. This didnt reduce the total number of attacks but reduced the hospital admissions as more patients appeared to receive appropriate treatment for their asthma (J. R. Smith et al, Thorax, 2012, 12, 1052). Based on these promising findings the study is now undertaking a nationwide study to confirm that it is possible to improve the care of these patients in a way that is cost-effective and doesnt affect the care of other asthma patients within GP practices. (https://www.uea.ac.uk/arrisa-uk/about).
The ARRISA-UK study is sponsored and led by the data controller University of East Anglia (UEA), with analysis to be completed at UEA who is also acting as data processor. The purpose of the study is to determine whether flagging the electronic health records of people identified as being at risk of asthma attacks and training staff on the action to take when seeing the flag reduces asthma related crisis events (defined as hospital admissions, A&E attendances and deaths) over a 12 month period. The primary outcome is the difference in the proportion of at-risk patients (as identified by a prior database search) who have an asthma-related crisis event in the 12 months from the date that alert flags go live on the computer system in the intervention practices compared to the control group practices. This is a clinically meaningful, patient centred outcome that represents the severest form of asthma attacks that are the most costly to patients and society.
The study will also find out how many people have well controlled asthma, what medications are prescribed for asthma, how often patients attend appointments and if they stop smoking. The study will calculate how much this costs and whether it improves (or interferes with) the care of other patients with asthma in the practice.
So far, the study has collected pseudonymised primary care data from participating GP practices in England, Scotland and Wales. However, this data lacks sufficient detail to answer the primary outcome (asthma-related crisis event) as this requires secondary care data. The data requested here will build a more precise picture of asthma patient outcomes during the study.
Public and patient involvement has been fundamental to all aspects of the study and follows on from PPI involvement in the previous study, a smaller regional study of 30 GP practices in Norfolk. This includes review of the end of study report. PPI contributors - including a local representative who was involved in the previous study and a National PPI representative supported by the Asthma UK Centre for Applied Research - were co-applicants on the grant submission and have helped with the study design and the patient-facing documents in particular. They are also members of the Trial Management Group and will have a crucial role in the dissemination of findings.
The plans and processes for extracting data from GP practices and linking it with secondary care data from NHS Digital have been reviewed by the Asthma UK Centre for Applied Research (AUKCAR) including their public and patient group, lay members of the Trial Management Group and Independent Trial Steering Committee, and members of a patient discussion forum around the proposed use of patient data without consent. Feedback from PPI representatives was used to improve fair processing materials (poster and leaflet) produced by the research team.
2) Legal Basis
The ARRISA-UK study is publicly funded research being undertaken in the public interest to inform knowledge on how best to improve care for patients with asthma who are at high risk of exacerbations of their disease. The study is funded by the National Institute for Health Research's Health Technology Assessment Programme (NIHR HTA) under the Department of Health UK and has undergone rigorous peer review. The data requested is to be used in the primary analysis of the ARRISA-UK study and will be reported as aggregated results in the NIHR journal monograph series and presented in peer-reviewed publications. The results of the research may inform public guidance and decisions about funding, resources and technologies available in GP practices, and as such may help improve care for asthma patients in the future.
Processing is therefore lawful under Article 6 1(e) of the General Data Protection Regulation (GPDR) (processing is necessary for the performance of a task carried out in the public interest) and article 9(2)(j) (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes ).
The data will not be used for commercial purposes, will not be provided in record level to any third party, and will not be used for direct marketing. All analysis will be conducted at the University of East Anglia, Norwich, UK.
Data from GP practice records is captured remotely in a manner that is completely non-identifiable to the researchers, so individual patients are not asked to give informed consent. Instead, the NHS Research Ethics Committee agreed that the Caldicott Guardian or Information Governance lead for each GP practice (who is responsible for the use of their patients records) could approve the conduct of the study at their practice as they had been made aware of the purpose of the study and how their patients data would be used. There is no anticipated harm to the public by the dissemination of the data requested. Patients with have opted-out for use of their data in research are excluded from both the primary and secondary care data requests.
With around 160,000 asthma patients across 222 participating GP practices in England, it would have been too great a burden on research and GP practice staff, and impossible in a reasonable timescale, to individually consent patients to provide this information. Instead, this study has section 251 approval in place which allows the study to collect secondary care data from NHS Digital. This is coupled with data available routinely from the GP practices and organisations.
Patient identifiers (NHS number, date of birth and sex) will be provided to NHS Digital for matching, but the data to be disseminated by NHS Digital will be pseudonymised. Disseminated data is required to be patient level rather than aggregated, as it will then be linked by UEA to pseudonymised primary care data via the Study ID, before being fully anonymised for analysis. Analysis of the primary and secondary outcome measures requires a patient level dataset, as the effectiveness of the ARRISA approach cannot be obtained from practice or region-level aggregated data. It is unfeasible to undertake a study with sufficient statistical power to understand the effectiveness of our intervention which is based on practice level data in the UK.
It is essential for the purposes of this study to collect primary/secondary and mortality data for the population included in the study. While the intervention is randomised at practice level, the flagging is at patient level, and study analysis will need to distinguish the outcome of patients who have been identified as at-risk vs those not at-risk. NHS Digital requires patient identifiers to match records at a patient level. It is not possible to use an alternative study design to answer our question as there will not be sufficient statistical power and it is not possible to obtain written informed consent from patients. There are no alternative ways of collecting this data which are less intrusive. The study team have collected pseudonymised data from GP practice records, but secondary care service use is not adequately recorded in GP practice records to enable the primary outcome to be answered. By using the linkage service provided by NHS Digital, with the data flows proposed in this application, no identifiable data needs to be shared with the research team.
3) The ARRISA Cohort
The study closed recruitment in April 2018 with 275 participating GP practices in total across England, Wales and Scotland; 35 of those are in Wales and 18 in Scotland. Each GP practice was randomised to either the intervention or control arm of the study. The study will receive GP practice record data for all asthma patients at both intervention and control practices, and the request for secondary care data covers this same group. Therefore, this data request to NHS Digital covers approximately 160,000 patients with a current diagnosis of asthma from 228 participating GP practices from England and border Wales.
At this stage it is not possible to give an exact cohort size, as some GP practices may choose not to take part in the secondary care data collection activity. They will be approached with a variation of the site agreement if IGARD approval is granted.
The geographical spread of the data requested reflects the locations of the GP practices in the trial. There are participating practices in 14 of the 15 Clinical Research Network regions of England, and the request also covers six practices in Welsh local health boards near the border with England. Separate requests for secondary care data for Scotland and Wales have been made to the relevant data custodians (eData Research and Innovation Service and NHS Wales Informatics Service). This request is for secondary care data in England, and includes all of the GP practices in England participating in the study. However, participating GP practices have advised that patients registered at Welsh practices near the border with England may attend hospital in England. Therefore, this request includes six GP practices in Wales. In Scotland, GP practices participating in ARRISA-UK are not close to the border with England, and all asthma patients of interest are therefore expected to routinely be using secondary care services in Scotland only.
All patients in the study will have had asthma, according to our study definition based on primary care data, at some point in the study. Automated electronic searches will be used to identify patients with asthma: those with asthma-related codes in their electronic medical record. Some may not have had the diagnosis at the start of the study period, but may qualify for the diagnosis and inclusion in the study during the observation period. Thus the data request includes both people with current asthma at the beginning of recruitment, as well as those diagnosed with asthma throughout the recruitment period. Patients in the cohort may include those who died or left the practice during the follow-up period.
In earlier work, an algorithm was developed and validated for aiding GP practice staff in recognising those patients most at risk of being admitted to hospital or dying from an asthma exacerbation. This is based on known risk factors such as previous exacerbation history, coding for anxiety or depression, smoking history and prescribing data and laboratory results all of which are associated with more severe asthma and asthma excerbations. This candidate at-risk list is generated by each GP practice and reviewed by their clinical asthma lead. The practices respiratory clinical lead can add new at-risk patients who join the practice to their register or remove patients for whom a flag on their health record would not be appropriate (e.g. if they are receiving palliative care). To meet the intended study outcomes, including the impact of the ARRISA intervention on all asthma patients at a GP practice, data from NHS Digital is being requested for all patients with asthma, not just those deemed to be at higher risk.
Because asthma is a variable condition, the date of initial presentation with the condition, or the date(s) of presentation within any specified study dates is not relevant for the diagnosis in our study protocol. Their inclusion in the population with active asthma does depend on having a prescription issue within a year period, but no single date or date range for an asthma diagnosis or event is critical across the whole study population.
4) Data Requested
The data required from NHS Digital is individual level data on patient outcomes for ARRISA patients of interest (asthma patients in participating GP practices). The study require data on admitted patient care, A&E attendance, outpatient visits, critical care, and mortality for the primary and secondary outcome measures of the study. The primary outcome is the difference in the proportion of at-risk asthma patients who have an asthma-related crisis event (A&E attendance, hospitalisation or death) in the 12 months from the date the pop-up alerts go live on the computer system in the intervention practices compared to the control group practices.
The secondary outcomes include time to first crisis event, asthma control, asthma medications, attendance at appointments, medication adherence, smoking status, all cause admission and death, health care costs in all and at-risk asthma patients. Data contained in the Hospital Episode Statistics and mortality datasets listed above, linked with data collected in primary care, will provide the information needed for the analysis of these outcome measures.
Obtaining the requested data from NHS Digital is vital to the study analysis, as primary care data alone does not contain the level of detail on hospital visits and deaths needed to give an accurate picture of the effectiveness of the intervention.
By requesting data regarding all deaths and hospital episodes for the cohort, rather than just those recorded as due to asthma, the data regarding secondary care resource utilisation will be as complete as possible, and additional resources used due to poorly controlled asthma as a co-morbidity will be included. The intention is to assess all episodes for any asthma-related elements as part of the study analysis at Norwich CTU.
By including data from HES Critical Care and Outpatients, in addition to HES APC and A&E, the data regarding secondary care resource utilisation will be as complete as possible, benefiting the assessment of the effectiveness of the ARRISA study intervention. In addition, out-patient attendance data will be used to measure a key secondary outcome as part of a health economics (cost-effectiveness) analysis.
5) Data Minimisation
Data is requested only for the participants in the study (asthma patients at GP practices participating in ARRISA-UK). Data from all patients with asthma in a research practice is required to determine if there are any consequences of our intervention by diverting care towards an at-risk group.
Data is requested only for the relevant time period (April 2015 September 2019). This period facilitates three years of data for all patients of interest at GP practices recruited into the study, within which the recruitment period ran from April 2016 April 2018; practices started study activities at different times. The overall time period of the data request includes, for all practices:
- A baseline year before the practice was randomised to the intervention or control arm of the study
- A variable time period of less than one year for staff training, at-risk register creation etc
- A one year follow-up period of flags live for intervention practices or normal care for control practices.
Each data item requested has been carefully assessed and is considered to be essential for the completion of the study objectives. The study are requesting the minimum amount of data that will answer our research questions: does our intervention reduce asthma crisis events, does it improve other aspects of patient care, is it cost effective and does it adversely affect the care of asthma patients who are NOT at a high risk of an attack?
The datasets and fields requested will allow the research team to assess whether a hospital event or death is asthma-related. For example, hospital admission and A&E data includes the diagnosis and procedure data, as well as dates of admission and discharge and Healthcare Resource Group (HRG)/administrative data. These data items will facilitate analysis of the reasons for admission and procedures carried out and the frequency and lengths of admissions, as well as the health economics data to support the study objectives. The reason for hospitalisation and A&E attendance is not reliably available from primary care electronic health records. Mortality data includes the month and year of death, as well as the cause of death, which will facilitate analysis of the study endpoint of death.
6) Organisational structure of ARRISA-UK
The day-to-day running of the study is managed by Norwich Clinical Trials Unit at UEA, and all statistical and health economic analysis of all primary and secondary care clinical and mortality data (including all of the data to be provided by NHSD) will be controlled and carried out at UEA by the researchers at UEA. The sole data controller for the request is therefore UEA, and only UEA will be processing the data provided by this request. UEA will receive pseudonymised data from both NHS Digital and Optimum Patient Care, containing the Study ID, and the secondary/mortality and primary care data respectively.
The study is supported by a group of collaborators from around the UK including University of Southampton, University of Exeter, University of Manchester, University of Oxford, Queen Mary University of London, University of Aberdeen, and University of Edinburgh. The initiative is carried out with the support of the Asthma UK Centre for Applied Research, and Asthma UK. The roles and responsibilities of the collaborating research institutions are laid out in the Collaboration Agreement; full control over analysis and data processing remains with UEA.
Only aggregate data is shared with the research collaborators, or any other third party. Additionally, small numbers are suppressed (i.e. values of five or fewer people per outcome variable are not made available).
Other organisations involved in the wider project but not processing data requested in this application:
Name: Optimum Patient Care Ltd
1) To facilitate extraction of pseudonymised primary care data from participating GP practices.
2) To obtain pseudonymised secondary care data for GP practices in Scotland and Wales only.
3) To provide the research team at UEA with the ARRISA pseudonymised primary care dataset for England, and the linked pseudonymised primary/secondary care dataset for Scotland and Wales.
Study data held: Pseudonymised patient-level data from participating GP practices in England. Pseudonymised patient-level linked primary/secondary care data for participating GP practices in Scotland and Wales. Optimum Patient Care Ltd will not have access to or process any HES data for this study.
Name: Wellbeing Software Group Ltd (Apollo)
Role: Sub-contractor of Optimum Patient Care Ltd. Facilitating extraction of primary care data from approx. 70% of participating GP practices.
Study data held: None
Name: Harvey Walsh Ltd
Role: Sub-contractor of Optimum Patient Care Ltd. To host a secure online portal to which participating GP practices upload asthma patient study ID and key identifiers (NHS number, date of birth and gender), for the purpose of transferring this data to NHS Digital for matching with secondary care/mortality data.
Study data held: Patient Study ID and key identifiers (NHS number, date of birth, and gender only) of asthma patients at ARRISA GP practices, hosted on a secure server, for the sole purpose of transferring this data to NHS Digital for matching. No clinical data will be obtained or held.
The National Institute for Health Research Health Technology Assessment (NIHR HTA) programme funded the research but play no further role.
The results of the trial will be reported first to the Trial Management Group (i.e. University of East Anglia, co-applicants from the collaborating universities and Asthma UK, and patient representatives). The main report will be drafted by members of the trial team for submission in draft form two weeks after the end of study, and the final version will be agreed by the Trial Steering Committee before anticipated submission for publication on the 15th of May 2021. This will be presented in the HTA monograph series published on NIHR journals. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Further publications may be submitted from May 2021 onwards, after the main report, where they explore specific aspects of the work in more detail.
Findings from the study analysis will be reported and disseminated through peer reviewed scientific journals, internal reports, conference presentations, published on the study website, and through the infrastructure of the Asthma UK Centre for Applied Research to support innovative approaches to dissemination (e.g. via social media, Science Festivals, etc). PPI contributors will be involved in the dissemination planning to ensure that the results are widely available and accessible. The result of the trial will be disseminated regardless of the direction of effect. The results will also be made available to the wider community via the websites of Asthma UK, HTA and academic, patient care, and research organisations such as the Asthma UK Centre for Applied Research and the Primary Care Respiratory Society. The participating GP practices will be given and encouraged to display links to the research. Press releases and website links to summaries of the research will be publicised on the websites of prominent campaigning and charitable organisations such as Asthma-UK.
Summary results will be publicised via social media such as the Twitter accounts of the ARRISA study (@arrisauk), Norwich Clinical Trials Unit (@norwichctu), Asthma UK (@asthmauk) and Asthma UK Centre for Applied Research (@aukcar).
This will be a definitive study and therefore it is expected that, if the study has a positive outcome, then guideline writers and commissioners throughout the world will incorporate similar methods of identifying and managing patients with at-risk asthma in management algorithms within primary care or family practice. British asthma guidelines are updated annually and would expect a definitive study to lead to new recommendations within a year of publication. The study has a strong representation within the BTS/SIGN guideline committee and within the Primary Care Respiratory Society UK. Thus the study could change UK practice within a year of publication.
The data tables and statistics included in all outputs will contain only aggregate data. No patient level data will be included, and small numbers, if they arise will be suppressed in line with the HES Analysis Guide (i.e. values of five or fewer people per outcome variable are not made available). All research outputs are prepared and reviewed for consistency with UEA Guidelines on Good Practice in Research, specifically the UEA Research Data Management Policy and UEA Research Data Management Procedures and Guidance v1.3.
Overview of processing activities:
General practices participating in the ARRISA-UK study in England (and six Welsh practices near the border with England) are currently providing pseudonymised GP electronic health record (EHR) data for all asthma patients to Optimum Patient Care Ltd (OPC), and will separately provide patient identifiers for the same cohort to NHS Digital. NHS Digital will use the identifiers to link and provide Hospital Episode Statistics (HES) and mortality data for the requested cohort to UEA.
The researchers at UEA will receive a pseudonymised linked cohort file of HES/mortality data from NHS Digital, and pseudonymised primary care or GP EHR data from OPC. The two datasets contain a common, randomly generated link value (Study ID), which will be used to link the two datasets to form the ARRISA-UK linked GP-HES Dataset for England and border Wales practices.
The specific data flows are described in detail in the following paragraphs.
Flow of Data into NHS Digital:
Each GP practice participating in ARRISA-UK holds a single Patient Identifiable Data (PID) file which is created during the extraction of primary care EHR data for the study. It is information in this file which will be transferred to NHS Digital. Note that no patient identifiable data (name, address etc) leaves the GP practice during the process of primary care data extraction. OPC are not able to re-identify patients from any extracted data themselves only the GP practice can re-identify its own patient data.
Details of the PID file contents and creation are as follows. First, the data extraction software (either Apollo or MIQUEST) is installed on the GP practice IT system. This software automatically queries the clinical data to look for asthma patients (excluding those who have dissented from data sharing, as recorded in their electronic health record), and the specific data fields required by the study.
To pseudonymise the GP EHR data before it leaves the practice, the software takes the 10 digit NHS number of each asthma patient and adds a value known as a salt and then applies a secure one-way (irreversible) hash algorithm (SHA-256). The SHA-256 hash algorithm converts the NHS number and salt to a 256-bit hash ID (i.e. practice level pseudonym). The salt value is held within the GP practice only, and is not accessible to any of the organisations involved in ARRISA-UK, or other third parties. Using a salt in the hash prevents re-identification of the original NHS number from using a pre-computed look-up table to find the original value. In this case, a look-up table containing 16^64 possible values would need to be built in order to obtain the original NHS numbers, which exceeds routinely available computing power.
The hash ID will not be provided or used for HES data linkage. A randomly generated Study ID is then assigned to each patient record, and this Study ID is unrelated to the hash ID generated at each practice. Only OPC has the ability to match the hashed ID with the corresponding Study ID. To guarantee no possibility whatsoever of patient re-identification from any data provided to UEA by OPC, any matching table between hashed ID and Study ID will be destroyed by OPC following completion of the ARRISA-UK study and receipt of instruction from UEA.
The Study IDs will be provided to NHS Digital as the unique reference for each data subject, along with the PID information (i.e. NHS number, Date of Birth, Sex) required for data linkage. The PID file to be transferred to NHS Digital for data linkage will contain the following fields only for every asthma patient of interest to the study:
Field / Description
Study ID / Unique reference
NHS Number / Valid 10 digit NHS number
Date of birth / DD/MM/YYYY
Gender (sex) / Female (Ff) or Male (Mm)
Each GP practice will upload their PID file to a secure online portal hosted by Harvey Walsh Ltd (HW). This data transfer occurs over the HSCN (N3) network, which is used to transfer patient data securely within the NHS. The legal basis for this flow of data into NHS Digital is that it is considered to be in the public interest under Section 251 of the National Health Service Act 2006. This has been approved by the NHS Health Research Authority Confidentiality Advisory Group (ref. 18CAG1085).
Once each GP practice involved in the ARRISA-UK study has uploaded their PID file, the HW portal will run an automated process which will combine the PID files received from multiple GP practices to create a single ARRISA-UK PID file extract, which will be transferred to NHS Digital.
Processing at NHS Digital:
The trusted third party linkage service provided by NHS Digital will match the patient identifiers received from the HW portal with data held in the HES and mortality datasets specified in Section 5a. Matching will be done using NHS number in combination with other partial identifiers (date of birth and sex) to reduce the incidence of missed and/or false matches.
Flow of Data out of NHS Digital:
NHS Digital will generate a patient-level pseudonymised linked dataset which includes the Study ID, and requested fields from HES and mortality data, as specified in Section 5a. This dataset will be transferred to UEA.
There will be no further flows of data between UEA and NHS Digital.
Processing at UEA:
UEA will receive a patient-level pseudonymised linked dataset (Study ID and HES/mortality data) from NHS Digital. UEA will receive a pseudonymised primary care dataset (Study ID and GP EHR data) from OPC. UEA will link the two datasets using the Study ID, to form the ARRISA-UK linked GP-HES Dataset for England and border Wales practices.
Data received from NHS Digital will be uploaded onto the study database stored on the servers at UEA. Access to the study database is granted via unique username and password combinations, with database permissions restricted according to the users role. It is only accessible to members of the ARRISA-UK trial team at Norwich Clinical Trials Unit (NCTU) and external regulators. Access and operations are recorded in the database audit trail. The servers are in a secure room, which is protected by CCTV, where access is restricted to members of the UEA Information Systems team by security door access. The study database will be built using Microsoft SQL Server tools and all internet traffic will be encrypted using the standard SSL (Secure Sockets Layer) methodology. The study database is designed to comply with the principles of ICH Good Clinical Practice (GCP), within the Standard Operating Procedures for Data Management in NCTU and also where appropriate with UEA IT procedures.
Data processing will be carried out by substantive employees of UEA within the NCTU, all of whom are required by policy and contract to undertake annual, assessed data security and protection training.
No other data is held by UEA using the Study ID, and UEA will have no ability to re-identify any data subject whatsoever for this data. UEA shall instruct OPC to destroy any matching table between the hashed ID with the corresponding Study ID at the end of the study, to guarantee no possibility whatsoever of patient re-identification from any data provided to UEA.
OPC will not be holding or processing GP practice data beyond the purposes of the ARRISA-UK study for participating practices (such data will be destroyed following completion of the study). The only scenario where OPC will continue to hold and process a practices data is where: the practice has opted-in to contribute their practice data to OPC's Research Database (excluding the ARRISA-specific Study ID), or has a separate agreement (legal basis) with OPC for such data to be held and processed for the purposes of receiving the OPC quality improvement programme and/or research support for another study the practice is participating in and supported by OPC. Thus any additional processing is subject to agreement between OPC and the GP practice, and UEA has no involvement.
Note that UEA will also hold data separately collected with consent from a subset of the patient cohort, who have agreed to participate in further qualitative research regarding the impact of the intervention at primary care level. This data does not include any patient identifiers. The research team have no means of linking this data to the data obtained as part of this application to NHS Digital. The research team undertake to make no efforts to attempt to link these datasets.
Any data shared by UEA with third parties will be anonymous, in aggregate form and small numbers will be suppressed in accordance with NHS Digitals HES Analysis Guide.
Falls in Care Homes (FinCH) study: Data Access Request — DARS-NIC-195235-Q0B5T
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(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 - 'Other dissemination of information', Health and Social Care Act 2012 s261(2)(b)(ii)
Purposes: No (Academic)
Sensitive: Non Sensitive, and Non-Sensitive
When:DSA runs 2019-05-30 — 2020-05-29 2019.09 — 2019.09.
Access method: One-Off
Data-controller type: UNIVERSITY OF EAST ANGLIA, UNIVERSITY OF NOTTINGHAM
Sublicensing allowed: No
- Hospital Episode Statistics Admitted Patient Care
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Outpatients
- Hospital Episode Statistics Accident and Emergency (HES A and E)
- Hospital Episode Statistics Admitted Patient Care (HES APC)
- Hospital Episode Statistics Outpatients (HES OP)
1) Purpose of the data request:
The specific purpose of this data request is to monitor number of hospital admissions, A&E visits, outpatient visits, and ambulance call outs for participants recruited to the Falls in Care Homes (FinCH) randomised controlled trial. The FinCH trial is sponsored by University of Nottingham and the Principle Investigator is based at the University of Nottingham, with analysis completed at University of East Anglia. It is the largest randomised controlled trial (RCT) conducted in UK care homes to date, and having access to detailed health service use for 1,661 residents will be a valuable resource to better understand this population. It covers England only. Unit costs will be allocated for each participant, for inclusion in a cost-effectiveness analysis of the falls prevention intervention compared to usual care. Cost per participant will be presented in aggregated form (comparing the two treatment arms) as opposed to at individual or record level.
Where possible, the study has collected resource use data from care home records, however information care homes document about secondary care lacks sufficient detail to allow accurate costing. The data requested here will build a more precise picture of the participants resource use during the trial follow-up period of 12 months.
2) Legal basis:
Processing shall be lawful as both Article 6 1(e) and 9 2(j) of the General Data Protection Legislation apply. Article 6 1(e) applies, 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 NIHR HTA FinCH trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The results of the research may inform public guidance and decisions about funding for care home fall prevention programmes and as such may help improve the health and well-being of care home residents in future. Processing shall be lawful as article 9(2)(j) applies - ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes…’ of Regulations (EU) 2016/679, April 27th 2016. The trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The data will not be used for commercial purposes, will not be provided in record level to any third party, and will not be not used for direct marketing. All analysis will be conducted at University of East Anglia, Norwich, UK.
The FinCH trial also has the consent of participants and consultees in order to meet common law, that is the individual has given clear consent for the research team to process their personal data for a specific purpose. This is evidenced in the patient consent form where individual participants or their consultee initial to show agreement to “I agree to hospital and social care information about me being requested from National Data providers such as the Health and Social Care Information Centre.” The individual or their consultee will have had chance to read about this in more detail in the patient information sheet prior to the consent process taking place. Participants are informed of their right to withdraw at any time from the study without this affecting their legal or medical rights. This is again detailed in both the consent form and participant information sheet. The PIS and consent forms were designed to meet the requirements for this vulnerable population. Feedback from PPI was to ensure that the documents were simple to read and understand, and contained the essential information to enable them to decide whether to participate or not. Although a proportion of care home residents have capacity, PPI, including family member of a care home resident and a Care Home Manager, as well as clinicians, recommended that the information provided to the resident was kept as simple as possible to cover the relevant areas of consent while avoiding confusion.
Where the consultee has consented on behalf of the participant, the research is being undertaken under the Mental Capacity Act 2005. This Act provides a framework for decision making on behalf of adults aged over 16 who lack capacity to make decisions themselves, including decisions to take part in research, such as health research. Sections 30-33 of the Act provide lawful authority for research to be carried out involving people without capacity provided that the research has been approved by an appropriate body. An appropriate body is a Research Ethics Committee (RECs) recognised by the Secretary of State or Welsh Ministers, and some RECs have particular expertise and training in considering such applications. This research is approved by the Yorkshire & The Humber – Bradford Leeds Research Ethics Committee which, as noted on the Health Research Authority (HRA) website, has this expertise – committee flag “Research Involving Adults Lacking Capacity” (https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/yorkshire-and-humber-bradford-leeds/).
Institutional consent was also sought to permit the study to be conducted within the care home, and as such the care home managers who are responsible for the use of their residents records were made aware of the purpose of the study including how their residents’ data would be used and consented to the study.
3) Background to the research/trial:
The data requested will enable the research team to estimate the secondary care costs over the trial period for all participants in the study such that we can report a mean cost per participant that includes all types of NHS care not just those based in the community. This will enable a more accurate estimate of the cost effectiveness of the falls prevention intervention compared to usual care. This information will in turn help inform the evidence base used to decide which fall prevention interventions should be funded in the care home setting.
The Falls in Care Homes (FinCH) study; A multi-centre cluster randomised controlled trial to evaluate the Guide to Action Care Home (GtACH) fall prevention programme in old age UK care homes was funded by a grant from the NIHR Health Technology Assessment Programme (HTA 13/115/29) for £1.8 million in 2014.
The data requested is to be used in the economic evaluation which is nested within the FinCH clinical trial and will be reported alongside aggregated results in the NHIR journal monograph series and presented in peer-reviewed publications.
The study recruited adult care homes and their residents from a broad geographical area in the UK, to capture a range of health and social contexts. The sample size of the study was 1308 residents (654 to intervention group and 654 to control group). Updated calculations were made to allow for a variation in cluster size and a smaller number of participants per care home. The updated calculation gives a recruitment target of 78 care homes and 1482 individuals. In total 87 homes and 1698 residents were consented.
To have been eligible for inclusion in the trial long term care home residents must have provided informed consent or those without capacity to have informed consent from a relative/consultee who will provide advice on their behalf. Residents were excluded if they were in receipt of end of life care or in the home for short term care, respite care or for rehabilitation.
Randomisation to intervention or control (usual care) was at the care home level. The intervention arm received the GtACH Intervention. The intervention involved care home staff completing the GtACH Tool with residents in a private area of the care home. The results were discussed with family, friends and other care home staff. Completed GtACH documentation was placed in the resident’s care records. The actions might have required changes within the care home, changes to residents’ personal care, referral to other services, or purchase of equipment. The actions were written in the GtACH documentation. The GtACH was completed ideally within four weeks of randomisation (and within two weeks of staff training being completed in the care home) for all trial participants in the care home. Actions were started immediately after the identification of risk. As part of GtACH training, re-assessment was undertaken if the participant developed a new medical or cognitive condition, if they fell, or every three- six months if there are no other changes.
Those in the control group received the comparator of usual care, i.e. the care that was in place prior to the trial.
More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf
The aim of the FinCH trial is to determine the clinical and cost effectiveness of the GtACH for fall prevention in care homes compared to usual care. This is important as 415,000 people live in UK care homes. These facilities provide care either with or without registered nursing input and are referred to as care homes with or without nursing respectively. The majority of residents are aged over 80, have cognitive impairment, mobility problems and multiple medical conditions. Health and social care interventions may require modifications in order to work in the care home setting, either because of the configuration of disability and dependency amongst residents, or to work within the organisational setting of care homes. One area where interventions might require to be designed with care homes specifically in mind is in the field of falls prevention. Community falls prevention interventions reduce falls and risk of falls by 30%, but literature to date has found no conclusive reduction in falls in care homes. Care home specific research is scarce and the existing research is inconclusive. Current fall interventions rely on patient engagement and adherence to advice. These present difficulties in care homes, where 75% of residents are cognitively impaired and non-targeted interventions with cognitively impaired older adults have not been successful.
At a rate of 2.5 falls per person, per year there are 160,000 falls per year in care home residents. In care homes, nearly one in ten people who fall sustain a fracture, one in five are admitted to hospital and one in five will die within a year due to a fall related injury. One third of the UK’s hip fractures occur in care home residents, which is devastating to residents and their carers, and costly to the NHS. Even when falls do not result in fractures, they frequently result in other forms of injury. They cause fear of falling which contributes to a cycle of functional decline and increasing dependency with associated care costs. The Guide to Action for Falls Prevention - Care Homes (GtACH) intervention aims to reduce fall rates by supporting care home staff to identify risk factors for falling pertinent for an individual and take action to reduce those risks. It was co-produced by a group of care home staff, clinicians, researchers, public, voluntary and social care organisations and includes care home staff training, support and documentation. With training, the GtACH takes on average 20 minutes to complete for each resident. Initial proof of concept work and a subsequent feasibility randomised controlled trial (RCT) have shown that GtACH is implementable and changes staff behaviour in line with gold standard practice. This study will determine whether the use of GtACH has an impact on clinical outcomes for care home residents that are at risk of falling.
More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf
4) Data requirements:
The data required is individual level data on the resource use of participants in the FinCH trial from the Hospital Episode Statistics (HES) Outpatients (OP), the Hospital Episode Statistics Admitted Patient Care (APC) and the Hospital Episode Statistics Accident and Emergency (A&E) in order to be able to cost their secondary care use over the trial period in order to see if mean cost in the intervention arm was different to that in the control arm. Identifiers will be provided to NHS Digital for linkage, but the data to be disseminated by NHS Digital will be pseudonymised. Data is requested for three periods (2016/17, 2017/18, and latest available(18/19)). The date range required is 1st August 2016 – 28th February 2019 to reflect the date’s recruitment into the trial and when 12 month follow-up completed. The geographical spread of the data requested reflects the locations of the care homes in the trial.
There are no alternative ways of collecting this data which is less intrusive. The study team have collected resource use data pertaining to primary and community care from care home maintained records but secondary care is not adequately recorded in care home records to enable recourse use to be costed.
The data is minimised in that it relates to the trial cohort only. In addition, the study team have taken on board the advice of data managers from NHS digital with respect to fields requested, and this is reflected in this agreement.
There are two joint data controllers, reflecting the fact that the grant for the research was awarded to and managed by Nottingham University and that the University of East Anglia manage the day to day running of the trial via their Clinical trials unit and lead the health economic aspect of the grant. Some other organisations are involved in an advisory capacity only - Nottingham City Care NHS and participating care homes. University Hospitals of Leicester and University of Leicester no longer have any involvement in the trial. The NIHR HTA programme funded the research but play no further role.
The data will not be used for commercial purposes or direct marketing. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide. All analysis will be conducted at University of East Anglia, Norwich, UK.
This research is important as 415,000 people live in UK care homes. The majority of residents are aged over 80, have cognitive impairment, mobility problems and multiple medical conditions. Community falls prevention interventions reduce falls and risk of falls by 30%, but literature to date has found no conclusive reduction in falls in care homes. Care home specific research is scarce and the existing research is inconclusive. Current fall interventions rely on patient engagement and adherence to advice. These present difficulties in care homes, where 75% of residents are cognitively impaired and non-targeted interventions with cognitively impaired older adults have not been successful.
At a rate of 2.5 falls per person, per year there are 160,000 falls per year in care home residents. In care homes, nearly one in ten people who fall sustain a fracture, one in five are admitted to hospital and one in five will die within a year due to a fall related injury. One third of the UK's hip fractures occur in care home residents, which is devastating to residents and their carers, and costly to the NHS. Even when falls do not result in fractures, they frequently result in other forms of injury. They cause fear of falling which contributes to a cycle of functional decline and increasing dependency with associated care costs.
The Guide to Action for Falls Prevention - Care Homes (GtACH) intervention aims to reduce fall rates by supporting care home staff to identify risk factors for falling pertinent for an individual and take action to reduce those risks. It was co-produced by a group of care home staff, clinicians, researchers, public, voluntary and social care organisations and includes care home staff training, support and documentation. With training, the GtACH takes on average 20 minutes to complete for each resident. Initial proof of concept work and a subsequent feasibility randomised controlled trial (RCT) have shown that GtACH is implementable and changes staff behaviour in line with gold standard practice. This study will determine whether the use of GtACH has an impact on clinical outcomes for care home residents that are at risk of falling and whether implementing the GTACH is likely to be cost effective. Any benefits of the intervention will be realised by residents, care homes staff, the NHS, and tax payers.
Without HES data the research team will not know the true cost differential with and without the GTACH falls prevention programme and as such the true value for money of this intervention will be unknown meaning tax payers may not get value for money if the wrong decision is made with respect to funding this intervention.
Therefore, the expected output from the trial will include an evidence based patient treatment programme for older people living in care homes who are at risk of falls. The programme will be supported by a comprehensive treatment
manual and training programme. These will aid care home staff to build capacity in falls prevention and will benefit residents. The manual will have Intellectual Property rights but will be distributed freely to all NHS/social care/care home staff who are working in care homes. As such the manual will be written to identify the core skills needed to provide a falls prevention process in a care home and it will provide an evidence based risk assessment and action plan with practical activities that care home staff can implement.
Publication of the results will enable decision makers to access the evidence to inform their decisions and ultimately benefit patients by reducing falls in a care home setting.
The clinical trial will demonstrate whether the intervention results in less falls, less injuries and a reduced fear of falling in care home residents. Reducing falls will have a positive impact on care home staff, families and the NHS. By not falling residents will remain more active having an impact on mood and behaviour. These are areas that care home staff and family find very distressing and difficult to address.
The impact on the NHS will be the formation of an evidence based training programme which will give falls experts the materials to train care home staff in small groups to use a systematic falls prevention process. There is an anticipated impact of lower fracture rates, admissions to hospital, calls to emergency ambulance, calls to GPs and community services. The costs for an admission with a fracture has been estimated. The 'Guide to Action to prevent falls in Care Homes' (GtACH) has been costed resident which for most residents would be a one off cost.
The impact to research in care homes will be the relationships built between researchers and care home staff in 87 homes. This could lead to care homes joining the EnRICH network and taking part in future studies. The research team experienced this in our feasibility study: All six care homes have now joined the AHSN Falls Network. Care home residents will benefit from having a research project taking place in their homes as it has been recognised that environments where research takes place are more positive than those who do not.
The specific benefit of the economic evaluation attached to FinCH is anticipated to be that the results of the trial help inform future resource allocation decisions about investment in falls prevention programmes in UK care homes.
Organisations such as NICE may use the evidence to inform appraisals about falls prevention interventions.
The results of the economic evaluation conducted alongside FinCH will be presented in the HTA monograph published on NIHR journals, submitted for publication to peer reviewed journals and presented at academic conferences. The HTA monograph needs to be submitted by the end of August 2019 alongside the submission of peer reviewed publications. Though publications may be submitted after this date where they explore specific aspects of the work in more detail.
The results of the trial will be reported first to all trial collaborators (i.e. University of East Anglia, University of Nottingham, Nottingham City Care NHS and patient/nursing home representatives). The main report will be drafted by members of the Trial Management Group, and the final version will be agreed by the Trial Steering Committee before submission for publication, on behalf of the collaboration. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All publications will be subject to the forthcoming FinCH publications protocol, which will explicitly stipulate the requirements for authorship of publications. Findings will be disseminated to academic audiences through publication in open access academic journals and presentations at academic conferences. Dissemination of findings will be prioritised to study participants (residents/care home staff) who will receive quarterly newsletter updates. At the end of active involvement participants will receive thank you letters. Oral/poster presentations and workshops at sponsor hosted events, community meetings and professional/stake holder/user conferences will be targeted. The study will be submitted by the end of August 2019 for publication in the NIHR Journals in due course.
The study team will seek to disseminate in a way to support best practice. They will liaise with ProFouND (The Prevention of Falls Network for Dissemination) and EnRICH to identify potential research users, other researchers, policy makers, commissioners, clinicians, care home managers and staff, care home residents and relatives. One member of the research team is the lead for the programmes related to older people in Collaboration for Leadership in Applied Health Research and Care East Midlands and the East Midlands Academic Health Sciences Network which will enable dissemination through these regional and national networks and to prepare for subsequent adoption at pace and scale. Dissemination outputs will be tailored towards each group including peer reviewed journal articles, evidence summaries, briefing papers, video clips and a DVD. Media coverage will be sought in the form of local newspapers, television and radio outlets. This will be enabled further via connecting with the university’s specialist experts in information technology and communication departments. Requests will be sent to relevant agencies to feature the research project in their newsletters and websites. A study web page will feature on the University of Nottingham Rehabilitation and Ageing divisional website.
The data will not be used for commercial or direct marketing purposes. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.
There are four stages to the data flow: 1) data extraction, 2) data aggregation, 3) data matching and 4) data linkage.
1) data extraction:
The ten participating sites in the trial are responsible for providing the identifiers to Norwich Clinical Trial Unit (CTU) at the University of East Anglia (UEA) via a secure password protected database. The CTU will undertake data extraction and transfer Patient Identifiable data (PID) data consisting of FinCH trial ID, NHS number, name, date of birth and gender to NHS Digital's secure N3 portal so that the FinCH study ID can be matched to NHS HES APC, A&E and outpatient data by NHS Digital (no other organisations are involved in processing of the data) for the requested years.
2) data aggregation:
3rd party secure N3 portal at the CTU receives and aggregates PID files from the ten sites (FinCH care homes) including study ID (Data Aggregation).
3) data matching:
NHS Digital receive PID for FinCH participants from 3rd party secure N3 portal, match PID with HES data and send pseudonymised HES data for FinCH patients to UEA for analysis (data matching stage). NHS Digital will then send the pseudonymised HES data for FinCH participants to UEA via the secure N3 portal for analysis. The data sent back to UEA need only have the FinCH ID attached. No other organisations are involved in processing of the data. To access the pseudonymised data individuals will have to have system access to the REDCap database, which is provided only after the individual signs a delegation log, countersigned by a PI and then a copy provided to the study team.
4) data linkage:
Once NHS digital have linked the data and created the new datasets these will be returned to UEA via the same secure N3 portal. UEA will then merge the HES data from NHS Digital with FinCH trial data to create a final dataset for analysis. This will be done using the study ID and creating a pseudonymised dataset only.
Once the data has flowed from UEA to NHS Digital and back again there will be no further flows of data between UEA and NHS digital.
The FinCH trial store the trial data (which includes a study ID for each record) onto an electronic database using a secure web application called REDCap. Names and contact details for participants are kept separately on paper at each of the 10 research sites to ensure re-identification by a third party is not possible.
No further linkage of the data is permitted, other than that already stated in this agreement. UEA will hold the identifiers and pseudonymised data separately, and permissions are set so that the statisticians analysing the pseudonymised data cannot access the identifiers. Re-identification is not permitted under this agreement.
Under this agreement, data processing will only be carried out by substantive employees of the University of East Anglia, who have all undertaken training in data security and GDPR. 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).
All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.
Request for data including addresses and ages to contact healthy controls for participation in STEC case-control study — DARS-NIC-171083-Q8R4B
Opt outs honoured: Yes - patient objections upheld, Identifiable (Section 251, Section 251 NHS Act 2006)
Legal basis: Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 s261(7)
Purposes: No (Academic)
Sensitive: Sensitive, and Non-Sensitive
When:DSA runs 2019-09-07 — 2020-03-31 2018.10 — 2018.12.
Access method: One-Off
Data-controller type: PUBLIC HEALTH ENGLAND (PHE), UNIVERSITY OF EAST ANGLIA
Sublicensing allowed: No
- MRIS - Bespoke
The food poisoning bacteria Shiga-toxin E. coli (STEC) are a public health concern because of the severity of the infections caused. Evidence from outbreaks suggests that the transmission routes for STEC infection are evolving; for example, more outbreaks are now attributed to leafy vegetables as opposed to undercooked meat. Since a majority of infections in England are sporadic, case-control studies are the preferred method to determine risk factors for infections. However, the last case-control study on Shiga-toxin E. coli infections was performed in the late 90s; an update is urgently needed to reflect current causes of infection in England so better prevention strategies can be developed.
The University of East Anglia (UEA) is leading a STEC case-control study, working with Public Health England. This study has been funded by the NIHR Health Protection Research Unit in Gastrointestinal Infections (HPRU GI) project grant. The overall aim of this award is to bring Universities together with Public Health England (PHE) to assist in protecting public health, with the HPRU GI branch exploring the causes and distribution of diarrheal disease in the population. This Unit also funds studies led by other universities. Therefore, UEA also have access, should they need it, to specialise advice from the other universities funded by the Unit. The other universities have no control over decisions regarding this study, and no access to data provided by NHS Digital. As UEA does not have a Patient and Public Involvement Group (PPI), the University of Liverpool does allow UEA to use their PPI Group.
This agreement relates to the first part of this study only, which is led by PHE. For this purpose, PHE requires a list of 50,0001 randomly selected (by age bracket) individuals registered with a GP in England, along with their addresses and ages. This information provided by NHS Digital will serve as a database of potential healthy control participants for a case-control study investigating Shiga-toxin E. coli transmission pathways. PHE will send invitation letters and study information to those individuals provided by NHS Digital to seek their consent in participating in the study. For this purpose, only substantive employees of PHE will have access to the personally identifiable data provided by NHS Digital as they have the data security systems in place to deal with such data. No other organisation will have access to the personally identifiable data provided by NHS Digital.
As part of routine surveillance, PHE collects questionnaires on potential transmission routes from all confirmed cases of STEC in England and Wales. PHE will be providing a pseudonymised dataset of all STEC cases during the study period, ending March 31st 2019, to UEA. In order to determine which potential transmission routes are associated with acquiring STEC infections, then the questionnaires of cases need to be compared to questionnaires completed by healthy control participants. The database provided by NHS Digital to PHE will be used to recruit these control participants.
Recruitment began in February 2019. PHE have recruited over 250 controls for the study.
The benefit of receiving the database is that PHE will be able to recruit participants and successfully undertake the case-control study so that the research team can identify the most common sources for STEC infections and use this information to try and reduce the number of infections that occur per year in England.
The output from receiving the database, and therefore for this agreement, will be PHE contacting potential control participants to invite them to participate in the case-control study.
For the analysis of the completed study (which goes beyond the remit of this agreement) all results will be reported at an aggregate level, with no reference to any individual data, as odds ratios for different risk factors associated with STEC infection.
Once analysis is completed, a summary of results for the general public will be produced. This will be sent to any control participants that indicated in their consent form that they would like to be informed of any results and it will also be published on the NIHR Health Protection Research Unit in Gastrointestinal Infections website (hprugi.nihr.ac.uk). A peer reviewed research article on the study will also be produced for publishing in an Epidemiology journal. The results will also be presented at conferences, such as the HPRU GI annual conference, Public Health England’s Applied Epidemiology conference and at the International symposium for Shiga-toxin E. coli infections. PHE hope to have a draft of the research article prepared within one year of completion of the study, so by March 2020.
NHS Digital will provide the lead researcher at Public Health England with a database containing the names, ages, and addresses of 50,001 individuals, aged 0-70 years, that are resident in England and registered with a GP. This will be stored on password protected PHE computers and will only be accessed by the research team at PHE authorised to work on the case-control study. They will access the database to print out addresses on envelopes and include names on information packets to invite people to participate as controls in our study. PHE would then post out the questionnaires.
UEA will only process data provided by the individuals who have directly responded. They will not process any data provided by NHS Digital.
This agreement relates to the above part of the study only. However, in order to make clear the broader context for this, details of the study processing as a whole are described below.
If someone from the database decides to participate, they will sign a consent form for University of East Anglia (UEA) to hold their data as provided by the questionnaire. The invitation letter will ask them to ensure they can be considered a “healthy” participant by the design of the study. The questionnaire will also ask them to provide their age and post code again, so that no personal information is being passed from PHE to UEA. The completed questionnaires will be returned to UEA for entry into a database of control subjects for the eventual analysis of the study.
The case-control study will run for a period of a year, potentially collecting up to 1,000 cases if current trends for STEC infections are maintained. The study proposes to recruit 2 controls for every case, meaning PHE will need up to 2,000 controls. Recently, a similar case-control study was performed by the University of Liverpool investigating Campylobacter infections. Based on their response rate of 4% for control participants, PHE will need to be provided 50,001 names and addresses to ensure that UAE are able to recruit the 2,000 controls. PHE are age-frequency matching controls to cases, and the following numbers have been determined using data from STEC infections for the past 10 years.
RANGES # to request
This is a mass mail out approach to 50,001 individuals asking them to consent to take part in the study. PHE will need the name, age, and address of all individuals provided so that they can invite those that are within the range of cases and write to them with the invitation packet at their address. The case-control study is for all of England, so there is no way to geographically restrict data in this manner. Furthermore, they will attempt to recruit up until the end of the study, on March 31st for 2019, and the data will be retained until March 2020. During the study, however, data will be deleted when this is requested by responders, and the information of non-responders will be deleted if they have not responded after the second contact attempt. Furthermore, the data of individuals that respond after 2,000 questionnaires have been received will be deleted from the database.
Project 4 — DARS-NIC-148298-N5HDR
Opt outs honoured: N ()
Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC
Sensitive: Sensitive, and Non Sensitive
When:2016.04 — 2016.11.
Access method: Ongoing
- MRIS - Cause of Death Report
- MRIS - Cohort Event Notification Report
The primary research question is whether a community based screening program for osteoporosis reduces, and is cost-effective in reducing, the incidence of fractures in older women.
Questions to be addressed in the feasibility study
1) Can sufficient GPs be recruited to the study to allow access to the number of women required for a successful main study?
2) What is the rate of uptake amongst those women invited to take part in the study?
3) What are the characteristics of those accepting the invitation to join the study and what percentage are excluded (based on stated exclusion criteria) ?
4) What are the completion rates for the baseline questionnaires?
5) What proportion of women in the intervention group will be assigned to different categories of risk (i.e. low risk, intermediate risk, high risk)?
6) What proportion of intermediate risk cases will attend for a BMD scan?
7) What proportion of the control group will commence therapy after enrolment ?
8) What proportion of the intervention group will follow the suggested management pathway?
9) What proportion of the intervention group will adhere to the suggested management pathway and be compliant with therapy at 6 months?