The Oxford Vascular Study (consent cohort)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Cancer Registration Data; + Emergency Care Data Set (ECDS); + 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)

Objective for processing

The following provides background information on the purpose of the original study: University of Oxford requires access to NHS England data for the purpose of the following research project: The Oxford Vascular Study(OxVasc) (consent cohort) The following is a summary of the aims of the research project provided by University of Oxford: [1 paragraph unchanged] ACS is the leading cause of death in the developed world, causing [50 words unchanged] have never been measured in the same population at the same time. Comparison of OCSP (Oxford Community Stroke Project) and OXMIS (Oxford Myocardial Infarction Study) which took place in the early 1980s suggests that mortality due to stroke is lower than that due to ACS, but overall incidence is similar, and the total clinical instance of stroke may be greater. There are no data from the UK on recent time trends in [58 words unchanged] clinical services and limited governmental funding for medical research could be made. [1 paragraph unchanged] The GDPR legal bases for processing the data held under this Agreement are Article 6(1)(e) (processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller) and Article 9(2)(j) (processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes). This research into the health outcomes for people who have suffered from stroke or other vascular events is a task in the public interest under General Data Protection Regulation (GDPR) as it aims to improve care for all patients considering undergoing this type of process – informing clinicians and commissioners of variation and outcomes and complications to support work to improve and standardise treatment selection choices. The protocol has had appropriate ethics committee approval and CAG support (all documentary evidence is included in this application. The following NHS England Data will be accessed: Since 2008, mortality and demographic data were supplied to the University of Oxford by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of this research study. The overall aims of the study have not changed since 2002 and the benefits of a cohort study of this length and detail will continue to improve the public’s health through disease prevention, earlier disease diagnosis and better disease management. The study to date has had significant impacts (as described in the benefits section) and it is expected that further measurable benefits will be outputs that underpin NICE and other Department of Health strategies for detection, management and treatment of vascular disease. • Civil Registration Mortality data – necessary for survival after vascular event to evaluate treatment interventions, natural history of disease, to establish underlying and contributing factors to death and to stop further contact for follow up visits. The minimal information is requested under this agreement to meet the aims of the study and ensure integrity of study outputs, specifically: • Demographics – necessary for health economic analyses of recovery and use of assisted living/institutional care. Date of death-survival after vascular event to evaluate treatment interventions, natural history of disease and to stop further contact for follow up visits. • Cancer registrations - necessary to identify the interaction of the commonly prescribed treatments given as secondary prevention of vascular disease on the development and outcome of previously known and new cancers. This includes aspirin and Place of normal residence and place of death-health economic analyses of recovery and use of assisted living/institutional care. some of the newly introduced antihypertensive agents. Cause of death (including ICD10 codes and free text) to establish underlying and contributing factors to death. • Hospital Episode Statistics - Admitted Patient Care (back from 1997), Emergency Care Data Set (ECDS)( 2018 - present), Critical Care(from 2008 - present) and Outpatients(from 2003 - present) - necessary to evaluate the full cost of acute vascular events and the cost savings with the introduction of new treatments i.e. thrombolysis, mechanical thrombectomy The University of Oxford previously flowed identifying information to NHS Digital for the purpose of list cleaning. The University of Oxford used the list cleaning service to provide a newsletter to participants. Upon receipt of the Demographics data, University of Oxford will destroy this data and provide a data destruction certificate to NHS Digital as it will no longer be required. The level of the Data will be: No attempt is made to contact families after the death of a participant notified to the study team through this process. • Identifiable The analyses are determined by the Principal Investigator (PI) and the study statistician and performed by the University of Oxford research team to support the aims and objectives of the study. Ethical approval and grant funding from the Wellcome Trust and the NIHR Oxford Biomedical Research Centre have been granted for the study, for the same purposes as described in this Agreement. The Data will be minimised as follows: The progress is evaluated annually and new analyses are added or completed based on findings to date and the length of time required to collect outcomes (cause of death) to determine the prognosis of different presentations of vascular disease and/or achieve statistical power to answer the research question. For example, mortality data is required to determine the outcome (disability or death) and time course of bleeding requiring medical attention in patients taking long-term antiplatelet treatment after acute vascular events. This is then used to estimate the age-specific numbers needed to treat to prevent upper gastrointestinal bleeding with routine proton-pump inhibitor co-prescription. • Limited to a study cohort of 1441 participants. These participants are under the consent subset of the cohort Not all of the work of the Oxford Vascular Study involve use of data on mortality obtained from NHS Digital but use of the data will be important in some analyses in order to determine firstly the impact of any treatment on survival and secondly the health economic value of any intervention e.g. prevention of recurrent stroke and subsequent health resource use. • Limited to the following geographic areas - eight GP practices in Oxfordshire The data subjects are patients registered in one of eight GP practices in Oxfordshire who have had a stroke, transient ischaemic attack (TIA), Acute Coronary Syndrome (ACS) or acute peripheral vascular events. These are the same practices (and associated demographic characteristics of the previous studies-OCSP/OXMIS) allowing valid comparisons over time. Since 2002, participants have been recruited from hospital, outpatients’ clinics or home following referral from a collaborating GP and interviewed by a researcher following written consent. Clinical information is gathered from participants about their health, medical history, family history and current treatment. The study team extract information about their vascular event and related conditions from health records for the duration of the study in order to follow up on participants health status. Regular face-to-face or telephone contact is maintained with participants and their GPs over the first two years and they are contacted again at five and ten years after entering the study. However, over this period participants may move out of Oxfordshire or register with a different GP. In order to achieve the study aims, accurate information on the date and cause of death of participants in the cohort to evaluate long term morbidity and mortality for the study population is required. For this reason, national data is required. Data will need to be shared at a record level as agreed between the University of Oxford and NHS Digital to flag and receive date and cause of death for each individual cohort member and in order to produce accurate matching. There is no alternative way to obtain all cause mortality data sufficiently robust to achieve the aims of the study. All results will be presented as aggregated data. • Limited to data between 1997 and latest available The earliest participants were recruited while the study was in a pilot phase and they were all asked to re-consent to participate in the full study when version 2 of the consent form (dated 28/12/2006) came into use. Under this Agreement, the University of Oxford is permitted to share with NHS Digital details of participants who have given consent using version 2 of the consent form or any subsequent version. The current Agreement does not permit the processing of data relating to any participant who was recruited using an earlier version - which did not include a declaration of consent for "information held by the NHS and records maintained by the General Register Office" to be used to maintain contact and follow up their health status - and did not re-consent using version 2 or a subsequent version. The data for these participants is to be obtained using section 251 support from the Confidential Advisory Group (CAG) under a separate Agreement, DARS-NIC-148369-8PPWK. University of Oxford is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. The University of Oxford is the sole data controller who also process the data supplied by NHS Digital under this Agreement. No other organisation determines the purpose for data processing or has any access to the data. Funding for OxVasc is provided by the Wellcome Trust and the NIHR Oxford Biomedical Research Centre. Past funding has been provided by the Stroke Association which is still acknowledged on some of the study outputs. The funders expect the Nuffield Department of Clinical Neurosciences to undertake research such as this but the funding body can not access data nor has a role in analysis or interpretation. The lawful basis for processing personal data under the UK GDPR is: Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. This processing in the public interest because it adheres to the UK Policy Framework and Social Care Reearch, as it aims to improve care for all patients considering undergoing this type of process – informing clinicians and commissioners of variation and outcomes and complications to support work to improve and standardise treatment selection choices. The funding is provided by National Institute for Health and Care Research (NIHR). The funding is specifically for the OxVasc study described. The earliest participants were recruited while the study was in a pilot phase and they were all asked to re-consent to participate in the full study when version 2 of the consent form (dated 28/12/2006) came into use. Under this Agreement, the University of Oxford is permitted to share with NHS England details of participants who have given consent using version 2 of the consent form or any subsequent version. The current Agreement does not permit the processing of data relating to any participant who was recruited using an earlier version - which did not include a declaration of consent for "information held by the NHS and records maintained by the General Register Office" to be used to maintain contact and follow up their health status - and did not re-consent using version 2 or a subsequent version. The data for these participants is to be obtained using section 251 support from the Confidential Advisory Group (CAG) under a separate Agreement, DARS-NIC-148369-8PPWK.

Processing activities

The following provides background on the processing activities undertaken for the original study: University of Oxford will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Surname, First name, and a unique person ID) for the cohort to be linked with NHS England data. The study data, including data provided by NHS Digital under previous versions of this Agreement, are held by the University of Oxford. The data are stored electronically on University of Oxford central servers which are connected to the main University of Oxford’s network. At no time will sole employees of John Radcliffe Hospital have access to the data held on the server for University of Oxford. NHS England will provide the relevant records from the Civil Registration Mortality Data, Demographics, HES data, Cancer Registrations datasets to University of Oxford. The Data will contain directly identifying data items including date of birth and NHS number to link the Data at record level with data already held by the recipient Identifying details of participants have previously been supplied to ONS and subsequently NHS Digital so that their patient records could be flagged and mortality data could be reported to the study. The University of Oxford will flow identifiers (Surname, First name, NHS number, date of birth, study ID) to NHS Digital to update the cohort to flag participants recruited after 2018. The Data will not be transferred to any other location. The Data will be stored in an access-controlled server room within the University of Oxford Medical Sciences Division, situated on the Old Road Campus and connected to the main University network, located behind a firewall. The Data will be accessed onsite at the premises of University of Oxford only. Physical access is limited to Computer Services Department staff. Access is restricted to individuals within the Oxford Vascular study team of University of Oxford who have authorisation from the Principal Investigator. All such individuals are substantive employees of University of Oxford. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. Analyst from the University of Oxford will analyse the Data for the purposes described above. [1 paragraph unchanged] The following datasets are processed by the study: i. Civil Registration Mortality data – details of participants’ deaths including date and cause; ii. Demographics – details of embarkations or lost to follow up Data received from NHS Digital will be linked to unique study ID using date of birth and NHS number to ensure a perfect match to each participant’s date of vascular event to calculate outcomes (Kaplan-Meier survival analyses). All data supplied by NHS Digital will be used only for the approved Medical Research Project MR1086-The Oxford Vascular Study. No data will be shared with any individuals or agencies outside of the study team and all study staff are substantive employees of the University of Oxford. The data is held in an access-controlled server room within the University of Oxford Medical Sciences Division, situated on the Old Road Campus and connected to the main University network, located behind a firewall. Physical access is limited to Computer Services Department staff. Data will be encrypted using industry standard techniques meeting the Information Governance Toolkit standard (RBQ).

Expected output

The study overall has produced over 250 300 peer reviewed publications on incidence of disease, risk factor management, prognosis and [82 words unchanged] and secondary prevention of vascular disease over a long period of time. Research aims and findings from the Oxford Vascular Study are summarised on the study website (www.ndcn.ox.ac.uk/research/oxvasc) and presented at open days organised by the NIHR Oxford Biomedical Research Centre (BRC), Nuffield Department of Clinical Neurosciences and public involvement and engagement groups. Talks on OxVasc and related topics (e.g., high blood pressure, vascular dementia) are also available on YouTube (https://oxfordbrc.nihr.ac.uk/research-themes-overview/stroke-and-vascular-dementia/videos-stroke-and-vascular-dementia). Selected results of the study have been reported in the local, national and international press. The outputs (presentations, posters, peer reviewed publications and oral presentations at conferences) will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. The outputs will be communicated to relevant recipients through the following dissemination channels: > The study website (www.ndcn.ox.ac.uk/research/oxvasc) > Public Events - Presented at open days organised by the NIHR Oxford Biomedical Research Centre (BRC), Nuffield Department of Clinical Neurosciences and public involvement and engagement groups. > Social Media - Talks on OxVasc and related topics (e.g., high blood pressure, vascular dementia) are also available on YouTube (https://oxfordbrc.nihr.ac.uk/research-themes-overview/stroke-and-vascular-dementia/videos-stroke-and-vascular-dementia). > Selected results of the study have been reported in the local, national and international press. [2 paragraphs unchanged] All outputs (presentations, posters, peer reviewed publications and oral presentations at conferences) report numbers at an aggregated level, with small numbers suppressed.

Expected measurable benefits

[5 paragraphs unchanged] Mortality data from NHS Digital England also potentially reduces distress to participant’s relatives by attempting to contact them for follow up/information about circumstances of death. [1 paragraph unchanged]

Unchanged: Benefits reported.