NHS Digital Data Release Register - reformatted
University of Edinburgh
Project 1 — DARS-NIC-149576-G6M4B
Opt outs honoured: No - consent provided by participants of research study (Consent (Reasonable Expectation))
Sensitive: Non Sensitive, and Sensitive
When: 2019/06 — 2019/06.
Legal basis: Health and Social Care Act 2012 – s261(2)(c)
- Hospital Episode Statistics Admitted Patient Care
- Civil Registration - Deaths
- HES:Civil Registration (Deaths) bridge
The University of Edinburgh will use the data for the REstart or STop Antithrombotics Randomised Trial. RESTART is studying the potentially beneficial effects of starting antiplatelet drugs (one or more of aspirin, clopidogrel or dipyridamole, chosen by the patients physician), on the risks of a heart attack, stroke and other clotting problems as well as their effect on the risk of a brain haemorrhage happening again, for adults surviving a stroke due to bleeding in the brain and who were taking a prescribed antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of illnesses such as angina, heart attack or stroke before their bleed. A magnetic resonance imaging (MRI) sub-study will also study whether the presence of brain microbleeds modify the effects of antiplatelet drugs. 537 consented participants were recruited from 103 recruiting sites in NHS hospitals throughout the UK and randomly allocated to take an antiplatelet or avoid taking antiplatelets. All participants are followed up for at least 6 months after randomisation either by postal or telephone questionnaire to check for the occurrence of any relevant events or outcomes and their medications. In addition, participants GPs, and the hospital which recruited them, provide information on any relevant adverse events which occur during the follow up period including hospital admissions and deaths. These events will be compared in those taking an antiplatelet and those avoiding it to compare the event rate. Recruitment commenced on the 22nd May 2013 and closed at midday on the 31st May 2018 with 537 participants (97 from Scotland). Follow-up will be completed for events that occur by the end of November 2018. This proposal for NHS Digital data along with the data from NHS Scotland will enable RESTART to more accurately determine the number of outcome events which occur after the date of a patient’s randomisation, until the time of this data extract or the last period of data available. It is already known that the primary source of ascertainment of these outcome events (annual postal questionnaires to participants’ general practitioners) misses some events that participants have reported. Therefore, RESTART seeks secondary data to improve the accuracy of its data on the occurrence of the trial’s major outcomes, which will improve the scientific validity of the trial’s findings. The primary objective of the trial is to estimate, when all participants have completed at least 6 months of follow-up, the relative and absolute effects of antiplatelet drugs on the risk of brain haemorrhage happening again associated with a policy of starting antiplatelet drugs after the acute phase of brain haemorrhage. Ultimately, RESTART intends to determine whether antiplatelet drugs are beneficial for patients after brain haemorrhage because the gains from prevention of clotting problems outweigh the risks of bleeding at any site. A brain MRI sub-study is incorporated into the trial protocol to determine whether patients with tiny deposits of blood in the brain called 'microbleeds' on an MRI brain scan have an increased risk of having a recurrent brain haemorrhage if prescribed antiplatelet drugs following a brain haemorrhage. This specific proposal will allow RESTART to identify any missing primary and secondary outcome events in the trial which were not reported using the primary sources of follow-up (patient and GP follow-up, ad hoc reports from patients or research staff at participating sites) and determine the long-term survival of participants. This will enable RESTART to determine whether antiplatelet drugs are a safe and effective treatment.
More than one third of the adults with a stroke due to bleeding into the brain – known as brain haemorrhage – are taking drugs to prevent clotting when they have a brain haemorrhage. These patients had previously suffered illnesses like angina, heart attack, or stroke due to blood vessel blockage, which is why they are treated with drugs to prevent further clots occurring. These drugs are usually stopped when the brain haemorrhage occurs. But when patients recover from brain haemorrhage, they and their doctors are often uncertain about whether to restart these drugs to prevent further clots occurring, or whether to avoid them in case they increase the risk of brain haemorrhage happening again. RESTART will study the potentially beneficial effects of antiplatelet drugs such as aspirin on the risks of heart attack, stroke and other clotting problems as well as their effect on the risk of a brain haemorrhage happening again. If RESTART can reliably demonstrate this it will help patients make better decisions about their treatment and inform clinicians and patients about potential preventative treatment pathways.
All outputs will consist of aggregate data only with small numbers suppressed in line with the HES analysis guide. After database lock in the second week of January 2019, the final trial results will be submitted to The Lancet in February/March 2019 after approval by the Steering Committee. If the data is not received from NHS Digital by the second week then the results will be used in a subsequent publication later in the year. The results will be presented at the European Stroke Organisation Conference in May 2019, hopefully alongside simultaneous publication in The Lancet (or other prominent peer-reviewed medical journal, if not accepted by The Lancet). The trial report will be published open access, to enable professional and lay audiences to access it. The results will be shared with participants/carers (who have expressed a wish for this to be done) in June 2019. This report will be prepared with reference to the HRA guidelines, and with input from the Chief Investigator's patient reference group. Presentations will be made to non-medical audiences after publication of the trial report, although the dates and venues have not yet been determined. A final report will be prepared for the trial funder, based on aggregate data and the final results, and submitted to the British Heart Foundation in May 2019. When processing has been completed, the following will have been created: 1. A trial database which will be kept securely in the University of Edinburgh Safe Haven - patient level data identifiable. 2. A completely pseudonymised version of the patient-level data used for the primary analysis will be made available, behind access controls that require approval by the Trial Steering Committee, for use by the wider research community upon reasonable request. These outputs are primarily for health professionals to guide their patient care and for those developing evidence based guidelines. This output does not include record level data provided by NHS Digital, the processing of which has been detailed in the processing activities section of the application. 3. Pseudonymised data which is for use solely for the RESTART trial by the University of Edinburgh (and includes NHS Digital data). 4. Presentations for healthcare staff and lay audiences - aggregated data only 5. Open access papers in peer reviewed journals - aggregated data only.
The processing of NHS Digital data will be carried out within the University of Edinburgh Safe Haven. A similar application is being made to the Public Benefit and Privacy Panel for Health and Social Care for data relating to patients recruited in Scotland. RESTART will supply NHS Digital with patients’ identifiers (forename, surname, date of birth, NHS No., postcode, and RESTART study id [i.e. pseudonymous identifier]) to facilitate the linkage and the participant’s date of randomisation to limit the data extraction from this date to the end of the available follow up period. RESTART will not request data on any patient who has withdrawn consent following recruitment. The data received back from NHS Digital will include the RESTART trial ID (as provided) and any dates of admission to NHS hospitals and the primary diagnosis leading to these admissions from HES Admitted Patient Care, as well as Mortality data (including Date of Death and Cause of Death). The data will be securely transferred to the University of Edinburgh Safe Haven. A copy of the RESTART trial dataset will be transferred to the Safe Haven. The Data manager will link these dataset with the data provided by NHS Digital, using the RESTART study number. The two datasets will then be compared in order to find the Outcome Events (Intracranial events, Extracranial Cardiovascular events, and Death of any cause which are present in the NHS data but not in the RESTART trial dataset. If the record-level data provided by NHS Digital indicate that any of these outcomes might have occurred, University of Edinburgh will obtain source data from participating sites to verify or refute the occurrence of these outcomes. For any outcomes that are verified, two fields will be manually populated in the trial database for relevant participants after characterising the outcome (outcome event type and date); this will not involve importing record-level data provided by NHS Digital. This will be the only linkage with the NHS Digital data. RESTART has a study-specific database that is password protected and held securely on University Datastore. Access is routinely reviewed and revoked when any team member leaves RESTART. Data will only be accessed and processed by substantive employees of the University of Edinburgh and will not be accessed or processed by any other third parties not mentioned in this agreement. 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).
Project 2 — DARS-NIC-08472-V9S6K
Opt outs honoured: No - consent provided by participants of research study, No - data flow is not identifiable (Consent (Reasonable Expectation))
Sensitive: Sensitive, and Non Sensitive
When: 2016/04 (or before) — 2020/05.
Repeats: Ongoing, One-Off
Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012, Health and Social Care Act 2012 – s261(2)(c), Informed Patient consent to permit the receipt, processing and release of data by NHS Digital
Categories: Identifiable, Anonymised - ICO code compliant
- MRIS - Cause of Death Report
- Hospital Episode Statistics Admitted Patient Care
- Diagnostic Imaging Dataset
- MRIS - Scottish NHS / Registration
- MRIS - Cohort Event Notification Report
- Mental Health and Learning Disabilities Data Set
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Outpatients
- MRIS - List Cleaning Report
- MRIS - Members and Postings Report
- Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
- Hospital Episode Statistics Critical Care
- Mental Health Services Data Set
- National Diabetes Audit
- Emergency Care Data Set (ECDS)
UK Biobank, a registered charity, is one of the world’s largest medical research resources http://www.ukbiobank.ac.uk/. It was established in 2003. It is funded by the Wellcome Trust, the Department of Health and the Medical Research Council. The recruitment of its 500,000 participants, aged between 45 and 69, took place between 2007 and 2010, whose health is now being followed long term. Access to the resource opened in 2012, since which time there have been over 330 applications and almost 2,000 researchers have registered to use the resource. The overall purpose of the research is to create a prospective epidemiological resource of 500,000 people aged 45 -69 from around the UK. The methods to be used for the identification, invitation and assessment of participants have been developed following extensive consultation with leading research groups in the UK and internationally, and with research participants and representatives of the general population. All participants in the UK Biobank study have given fully informed consent for access to and long-term storage of information from their medical and other health-related records, and use of this and other information for health-related research purposes; long-term storage and use of their blood and urine samples for health-related research purpose; and recontact by UK Biobank to invite them (but without any obligation) to answer further questions or take part in further assessments. A copy of the consent form is available in the DAAG pack. UK Biobank is a unique resource, because of the combination of its very large size and the range and detail of data that it contains on its participants, including extensive phenotype and genotype information on each of them. Further, rather than recruiting participants with specific diseases or risk factors, UK Biobank is a prospective population-based resource established to support research into the causes of a wide range of diseases affecting people in middle and older age. Thus, the ability to link to participant’s health records, so that specific outcomes occurring during long-term follow-up of the participants can be identified and appropriate disease-based research carried out, is critical. UK Biobank’s priority is to combine extensive and precise measurement of exposures, along with the detailed and rigorous follow-up for a wide range of health related outcomes, and to promote innovative science by maximising secure access to deidentified data. Participants are now being followed through fully approved linkages to death and cancer registries. Flagging of the cohort with these data sources in England Wales and Scotland has been performed with the data provision ongoing. UK Biobank obtained at baseline and holds identifiable information on its participants (with an appropriately high level of security and monitored restricted access to a few, named and approved individuals). It is very important for UK Biobank to be able to maintain as accurate information as possible about participants contact details (including postal address) and registered GP practice (which were up to date for the whole cohort at the time of recruitment but there will be undoubtedly have been changes since then. There are several reasons for this requirement: - Ongoing approved linkages to primary care data require accurate information about registered GP practice (as practice as well as PCT level) to ensure that data about a particular participant are requested from the correct practice. - Direct contact with GPs may be required to seek further details about particular health related outcomes identified through linkages to coded primary care data. - To enable GPs to be confident in their assessing primary care data about participants registered in their practices, Biobank will need to be able to provide GP practices with up to date listings of UK Biobank participants in their practices, and – where requested – evidence of their consent. - Follow-up in a cohort study needs to be as complete as possible. This is to avoid both unnecessary reduction in size of the cohort (which reduces statistical power of data analyses), and loss-to-follow-up bias (which can cause misleading research results). Part of UK Biobank’s follow-up strategy relies on intermittent re-contact with Biobank’s participants to invite them to complete brief questionnaires about health related exposures or outcomes. It is important that Biobank have correct and up-to-date participant contact details for this. Although Biobank encourage participants to inform Biobank when they move, this is not a failsafe method of ensuring the most accurate information. - Biobank are committed to ensuring participants continue to be kept aware of progress and developments in UK Biobank, to obtaining their opinions on proposed enhancements to the study, and to providing them with information on how to contact Biobank should they have any questions. Biobank do this in part through Biobank’s annual newsletter, sent via e-mail and/or regular mail. Clearly, Biobank need up to date contact details (especially postal address) to do this. Biobank wish to avoid contacting participants at the wrong address, as this may cause confusion or even occasional distress. - Important potential research questions about the effects of environmental exposures on health require information about current and previous postal address since this allows these exposures to be estimated (from postcodes). These include, for example, valuable studies of the health effects of living close to power cables, aspects of the local environment such as nearby local public amenities and green space, and exposure to background radiation.
UK Biobank has approved over 850 applications since it first opened to researches in 2012. List of the approved applications can be found here: http://www.ukbiobank.ac.uk/approved-research/ In addition in 2017 alone there have been over 70 publications from researchers using the UK Biobank resources on a wide variety of topics including genetics, diet, exercise, mental health, respiratory disease and many more topics. You can see the full list of publications based on the resource here: http://www.ukbiobank.ac.uk/published-papers/
UK Biobank is a major national health resource, and a registered charity in its own right, with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the country to take part in this project. They have undergone measures, provided blood, urine and saliva samples for future analysis, detailed information about themselves and agreed to have their health followed. This is an increasingly powerful resource that is helping – and will continue over many years to help - scientists discover why some people develop particular diseases and others do not. UK Biobank has joined other world leaders in research at the launch of the Dementias Platform UK, a powerful new tool for studying dementia. The ground-breaking collaboration between industry and academia has been established by the Medical Research Council (MRC) and bolstered by government funding. UK Biobank will be one of the key resources used to help scientists: • Get a better understanding of who is at risk of developing dementia and why the progression of the disease varies from person to person; • Explore the anatomy of the disease to help develop new medicines and enable more accurate diagnosis • Look into how existing drugs which are used to treat other conditions might help to treat the progression of dementia and improve symptoms. All research projects that have already been completed using UK Biobank are required to be displayed at http://www.ukbiobank.ac.uk/approved-research/ . This shows the many projects achieved using Biobank. Compliance with HSCIC requirements under The 2014 Care Act • As a research resource, the benefits that will be generated from researchers using UK Biobank are potentially very considerable to the population of the United Kingdom and the National Health Service. UK Biobank’s public service remit, which in due course will benefit the UK population and the health care system, is set out unambiguously on the introductory page of its 2007 Ethics and Governance Framework: “UK Biobank aims to build a major resource that can support a diverse range of research intended to improve the prevention, diagnosis, and treatment of illness and the promotion of health throughout society. Lifestyle and environmental information, medical history, physical measurements, and biological samples are to be collected from about 500,000 people aged 40 to 69 at presentation and then, with consent, their health will be followed for many years through medical and other health related records. The biological samples will be stored so that they can be used for a wide range of biochemical and genetic analyses in the future. Scientists have known for many years that our risks of developing different diseases are due to the complex combination of different factors: our lifestyle and environment; our personal susceptibility (genes); and the play of chance (luck). Because UK Biobank will involve thousands of people who develop any particular disease, it will be able to show more reliably than ever before why some people develop that disease while others do not. This should help to find new ways to prevent death and disability from many different conditions. “ • This remit is re-iterated in UK Biobank’s 2012 Access Procedures, which state: “UK Biobank’s purpose is to build a major resource that can support a diverse range of research intended to improve the prevention, diagnosis and treatment of illness and the promotion of health throughout society”. This intent is paraphrased in the Consent Form (www.ukbiobank.ac.uk/consent) and related information materials as being “health-related” and in the “public interest”. Researchers who apply to use the Resource will be required to explain explicitly how their research project supports this stated purpose.” • In the intervening period between 2007 and 2015, the resource has been built, enhanced and has been open to researchers for just over 3 years. There is simply no other resource currently available, which enables researchers to study such a wide range of diseases with such rich and extensive data. What UK Biobank does is to enable researchers to conduct research in a highly cost-effective manner, rather than duplicate spending and effort on sample and case collection.
Access to the resource UK Biobank’s access policy is set out in the Ethics and Governance Framework. Its Access Procedures were prepared during 2010 to 2011 and were the subject of extensive discussion and dialogue with its funders, the REC and the EGC. The Access Procedures were also put out to public consultation, including consultation with UK Biobank participants. In summary: - Every researcher has to register and apply to UK Biobank. If successful, they have to execute UK Biobank's Material Transfer Agreement (MTA) (http://www.ukbiobank.ac.uk/wp-content/uploads/2012/09/Material- Transfer-Agreement.pdf ( for information presented to DAAG as document B2). The application process is the same irrespective of the nature of the applicant and the applicant's location. The MTA governs the legal relationship between UK Biobank and each researcher and, inter alia, ensures that the researcher complies with all the applicable data protection requirements relating to all participant data that they receive. In addition to audit provisions (i.e. UK Biobank is entitled to audit any applicant if it transpires that a transgression has or may have taken place) the MTA contains explicit provisions stating that UK Biobank will bar a transgressing institution from any further use of the resource as well as publicly informing its governing bodies, funders et al ; - The criteria are that the applicant must be a bona fide researcher conducting health-related research in the public interest. Note that the researcher may be based internationally, but that the terms under which that international researcher may access the data is set out within the MTA and are the same as those for a UK researcher. The adjudication of each application is made by UK Biobank’s Access and Scientific teams, with independent ethical advice (from the University of Oxford’s multidisciplinary bioethics research centre, Ethox: http://www.ndph.ox.ac.uk/research/ethox-centre) as well as input from UK Biobank’s independent Ethics and Governance Council, and the whole process is overseen by UK Biobank’s Access Sub Committee (http://www.ukbiobank.ac.uk/access-to-the-resource/), which contains both scientific and legal / ethical expertise; - Any data released to researchers is pseudonymised and encrypted. The researcher is only permitted to use the data for a particular (approved) research project for a particular (approved) time frame after which the researcher must securely destroy the data. The results of the research have to come back to UK Biobank – where they are then accessible by other researchers – and the researcher is obliged to publish their work; - In other words, any data supplied by UK Biobank to a researcher can only be used for the research project in question and for a limited time through UK Biobank’s access procedures (http://www.ukbiobank.ac.uk/wp-content/uploads/2012/09/Access-Procedures-2011.pdf, provided for convenience as document B3). Further, any such data cannot be sub-licensed or made available by researchers to any other party under any circumstances. This is all covered in UK Biobank’s MTA, which is non-negotiable.
UK Biobank’s IT infrastructure ensures that the most up-to-date security technology is used to maintain confidentiality of participant data, with regularly up-dated firewalls, antivirus software and other data encryption protocols to ensure on-going compliance with the Data Protection Act and other regulatory requirements. Periodic penetrance testing, as part of a regular security audits, is carried out by an independent third party to ensure that no data can be accessed by unauthorised individuals. Importantly, the main administrative database, which includes identifiable information on participants (allowing for linkage to health-related records, re-contact for further data collection and keeping participants informed of study progress) is located and maintained separately from the research database (which contains all the data of potential interest for researchers but no data from which any participant could be identified). Access to the administrative database is closely monitored and is strictly limited to a very small number of named staff. Data once processed may be provided to researchers according to the UK Biobank access policy and procedures, which were developed through extensive consultation, including public consultation and consultation with UK Biobank participants. Further detail is given within the Outputs section. Any proposed research project, whether led from an academic institution, a company, a charity, or a collaborative combination of any of these, is only approved for access to data held by UK Biobank (which data can only be used for the purposes of approved research project) following a clear demonstration that the primary aim of the project is to generate results that are for the benefit of the public’s health and for the promotion of health throughout society. Since the UK Biobank resource is based on 500,000 UK-based participants (90% of whom were recruited in England and registered with the English NHS), the public health and health promotion benefits arising from the results of approved research based on the UK Biobank resource will be apply most directly to recipients of health services and social care in England, although many of the benefits will also have broader applicability to populations beyond those of England and the UK.