British Regional Heart Study - follow-up of the BRHS cohort

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Processing activities

[25 paragraphs unchanged] UCL will manipulate the Data to generate a dataset: the following datasets: [2 paragraphs unchanged] 3. The resultant data ("the UKDS Mortality dataset") will contain a study id plus the outputs of 1) and [8 words unchanged] England data held by UCL. This linkage will not re-identify the dataset. The UKDS dataset will be deposited in the UKDS and a copy retained by UCL and University of Newcastle. 1. UCL will create a new cancer diagnosis variable by recoding each original NHS England ICD-10 4-digit code into aggregated 3-digit ICD-9 categories. 2. UCL will create a perturbed date of cancer diagnosis registration by using a statistical programme to generate a random number between 1 and 14, which will be added to the original NHS England-supplied date to create a new variable with a perturbed date. UCL will not retain a record of the random number generated or used 3. The resultant data ("the UKDS Cancer dataset") will contain a study id plus the outputs of 1) and 2) above and will be linked to non-NHS England data held by UCL. This linkage will not re-identify individuals. 4. The original NHS England cancer data will be destroyed. The "UKDS Mortality dataset" and "the UKDS Cancer dataset" will be deposited in the UKDS and a copy retained by UCL and University of Newcastle. [1 paragraph unchanged] NHS England has considered the above processing, and is content that the UKDS dataset datasets described above qualifies as derived under the definition of this DSA so long as the processing is undertaken solely as stated within this DSA, and no reidentification occurs.

Unchanged: Objective for processing, Expected output, Expected measurable benefits, Benefits reported.

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

Objective for processing

On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England. University College London (UCL) requires access to NHS England data for the purpose of the following research project: British Regional Heart Study. The lawful basis for processing personal data (Article 6.1) e: Public task: the processing is necessary for the data controller to perform a task in the public interest or for their official functions, and the task or function has a clear basis in law. and GDPR article 10 and Part 1 of the DPA 2018 for sensitive/special category personal data. The following is a summary of the aims of the research programme provided by UCL: Legal basis for processing special category data: (Article 9.2) j: Processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The British Regional Heart Study (BRHS), which began in 1978, aims to become a national research data resource. To support this a fully de-identified version of the study database with the UK Data Service (UKDS) will be deposited. Research data are valuable public assets. By enabling responsible data sharing and wider access, the team aim to support scientific discovery, replication, and long-term public benefit. The Data Protection Act 2018 s7(1)(a) defines ‘public bodies’ for the purpose of the GDPR as “a public authority as defined by the Freedom of Information Act 2000”. The FOI Act 2000 Part 1, section 3 (1)(a)(i) specifies that a public authority means anybody which is listed in Schedule 1. Schedule 1 of the FOI Act 2000 lists “Maintained schools and further and higher education institutions” as public authorities. The Data is used to enhance the BRHS cohort study by obtaining more robust detailed data on disease outcomes to research ways to prevent Cardiovascular disease (CVD), types of heart failure, dementia and disability in older ages. University College London’s Royal Charter includes the following statement “The objects of the College shall be to provide education and courses of study in the fields of Arts, Laws, Pure Sciences, Medicine and Medical Sciences, Social Sciences and Applied Sciences and in such other fields of learning as may from time to time be decided upon by the College and to encourage research in the said branches of knowledge and learning and to organise, encourage and stimulate postgraduate study in such branches.” The following NHS England Data will be accessed: The British Regional Heart Study (BRHS) is an established, long-term cohort study of cardiovascular disease and other common chronic diseases - this request relates to ~8000 older men, currently aged 82-102 years, who originally joined the study in 1978. • Cancer Registration Data The BRHS study team has collected data on smoking, physical activity, blood pressure and lung function, cardiac structure and function, body composition, oral health, cognitive and physical function, frailty, socioeconomic status, diet and a number of biomarkers. The BRHS currently receives pseudonymised Hospital Episode Statistics (HES), Mental Health Minimum Dataset (MHMDS) and the Diagnostic Imaging Dataset (DIDS) under DARS-NIC-28591-H5Q3X , this data is used for the same purpose described in this Agreement. Under the present Agreement the study obtains Identifiable Mortality, Cancer Registration and Demographics data. • Civil Registration of Death The data received under DARS-NIC-28591-H5Q3XS and the identifiable data received under this Agreement are linked and integrated into the study database. All identifiable data received under DARS-NIC-148411-Q64H is kept separately to the study database and is only used for the purpose of maintaining contact with study members. The linked data will be processed in a way that allows the study to address its key aims. • Demographics Data The British Regional Heart Study (BRHS) is a cohort of men recruited from 1978-80. DARS-NIC-148411-Q64H8 relies on S251 support under this agreement UCL receive mortality, cancer notifications and demographic data to trace participants for the entire cohort. DARS-NIC-28591-H5Q3X- is a subset of the overall BRHS cohort of men who have provided written consent, under this agreement the subset is linked to NHS HES, MMHDS and DIDS data sets. The level of the Data will be Identifiable – necessary to enable linkage of the data with data collected from other sources. Using these data UCL will examine trends in cardiovascular disease (CVD) mortality, CVD of morbidity and burden of disability, frailty and functional and cognitive decline in older adults. This rich scientific study resource will facilitate research on the development of novel CVD preventive strategies and for improving the cardiovascular health of older adults. The Data will be minimised as follows: The BRHS study team is housed within the Institute of Public Health and Epidemiology at University College London (UCL). The Institute produces internationally recognised quality research on the determinants of health and health behaviour across the life-course, develops and evaluates cross-sectoral policies and strategies to improve health, and optimise healthcare delivery and practice. University College London and Newcastle University are joint data controllers, who also process the data for the purpose outlined within this Agreement. The British Heart Foundation (BHF) fund the BRHS cohort study, as well as the data linkage which forms the basis of this DSA. • Limited to a study cohort identified by UCL of approximately 8,000 individuals aged 82-102 years, who originally joined the study in 1978. The BRHS study team has a 5-year British Heart Foundation core funded program of research to study the causes, pathways and prevention of cardiovascular disease and disability among older British men. Core funding has been in place since 1985 and is renewed every five years after scientific review. UCL is the research sponsor. UCL and University of Newcastle are joint controller's the organisations responsible for ensuring that the Data will only be processed for the purpose described above. Morbidity rates in this study population are exceptionally high, with many study participants developing cardiovascular disease (CVD) and other physical illnesses; fractures and dementia are also major health problems. In order to obtain an accurate assessment of chronic disease outcomes, the researchers are seeking, under a renewal of this current agreement; to continue with the ongoing supply of cancer registration, demographics and mortality data. The lawful basis for processing personal data under the UK GDPR is: The data from NHS Digital will be used to inform the investigation into the cause, mechanisms and prevention of these age-related conditions in older men and allow the researchers to test new hypotheses in cardiovascular ageing. 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 overarching objectives/purpose of this data request is to enhance the BRHS cohort study by obtaining more robust detailed data on disease outcomes to research ways to prevent CVD, types of heart failure, dementia and disability in older ages. The researchers will link the NHS Digital data to pseudonymised data in the BRHS cohort study, which has been obtained (from the cohort) over the last 40 years - this includes mortality, cancer, postal questionnaire data completed by the participants, questionnaire data collected from General Practice and data collected during the physical assessments in 1978-1980, 1998-2000 and 2010-2012. The lawful basis for processing special category data under the UK GDPR is: The key aims of the study, which will use all data provided by NHS Digital, include: 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. 1. Prediction of CVD risk in older people - To investigate the use of non-invasive arterial markers and novel blood markers reflecting a range of biological pathways in improving CVD risk prediction in older men. This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. 2. Lifestyle determinants of CVD in older age - To assess patterns of key health behaviour (physical activity, obesity, diet) in influencing CVD morbidity and mortality in both men with and without established CVD. The funding is provided by British Heart Foundation and is specifically for the British Regional Heart Study. The funder(s) will have no ability to suppress or otherwise limit the publication of findings. 3. Modifiable risk factors and dementia - To investigate lifestyle factors measured in mid-life and older age (obesity, smoking, physical activity) as well as diet quality and nutritional markers in older age and risk of developing dementia. Amazon Web Services (AWS) is a processor acting under the instructions of UCL. AWS’ role is limited to secure back-up of data stored in UCL’s Data Safe Haven. 4. Socioeconomic determinants of cardiovascular aging - To investigate the impact of socioeconomic factors that are important in preventing CVD and dementia in older people. Data will be accessed substantive employees of UCL and University of Newcastle, or by honorary contract holders with UCL and University of Newcastle. 5. Dementia and CVD – To investigate shared risk factors and mechanistic pathways underlying CVD and dementia and improving early identification of CVD and dementia. This research will help develop strategies to prevent dementia and CVD. Individuals holding an honorary contract under the supervision of a substantive employee of UCL for the purposes described in this DSA only. UCL must maintain records in a single location that cover the following details of each individual given access under an honorary contract: 6. Determinants of Heart failure – (i) To investigate pathways to prevention of heart failure distinguishing between different types of heart failure; (ii) to develop prediction risk scores for use in clinical practice to identify older adults at high risk of developing any type of heart failure. o Their substantive employer; 7. Later life determinants of stroke – To differentiate subtypes of strokes and distinguish risk factors for ischaemic and haemorrhagic strokes. o Their role in respect of the purpose for the processing specified in the DSA; 8. Physical disability and frailty – To identify social, lifestyle and biological factors that affect physical functioning and frailty and identify common pathways underlying CVD and frailty which can inform efforts to prevent the development of disability in older people with CVD. o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract; 9. Type 2 Diabetes, CVD and dementia - To examine the influence of duration of diabetes on CVD risk and dementia and identify metabolic pathways linking diabetes with dementia. o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA; 10. Improving clinical outcome – To identify and inform ways of evaluating and improving clinical outcomes in patients with CVD and/or dementia such as reducing hospitalisations and mortality. o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder. 11. Enhancing BRHS data- To develop a new source of data in an established population-based cardiovascular cohort study to facilitate the development of ways to improve strategies for preventions of CVD, heart failure, dementia and disability. The Data will also be accessed by students under supervision of a substantive employee of UCL or University of Newcastle. The data requested has been minimised to a cohort of approximately 8,000 individuals who originally joined the study in 1978. Undergraduate, Masters or PhD students enrolled with UCL and University Newcastle Upon Tyne. Any student working with the Data held under this DSA must have completed relevant data protection and confidentiality training and are subject to UCL and University Newcastle Upon Tyne policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of UCL and University Newcastle. UCL and University Newcastle would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this DSA. The data has been further minimised in version 3 of the Agreement to remove several identifiable data fields that were no longer deemed necessary for the purpose of this research. Pulsant provide a backup data storage facility, this is a storage location for the Newcastle University servers and no Pulsant employees can access the data. Pulsant is therefore not considered to be acting as a data processor.

Processing activities

The BRHS currently receives data from three sources: UCL will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth and Gender and a unique person ID) for the cohort to be linked with NHS England data. 1. Study participants- Physical Examinations - 1978-80, 1998-2000, 2010-2012 and regular postal NHS England will provide the relevant records from the following datasets to UCL: questionnaires • Cancer Registration Data 2. GP record review - Morbidity data collected annually directly from participants GP • Civil Registration of Death 3. NHS Digital – Identifiable Mortality data quarterly, Demographics and Cancer registration data on an annual basis via this existing data-sharing agreement. • Demographics Data 4. NHS Digital- Pseudonymised HES, MHMDS and DIDs data is received under DARS-NIC-28591-H5Q3X. To facilitate the flagging of the cohort UCL securely transferred identifiers to NHS Digital (Study ID, NHS Number, Date of Birth, Sex). The Data will contain directly identifying data to link the Data at record level with data already held by the recipient. The Data Safe Haven has been certified to the ISO27001 information security standard and conforms to NHS Digital's Data Security and Protection Toolkit. UCL will extract a subset of the Data containing pseudonymised mortality dataset without any direct identifiers containing only date and cause of death and securely transfer this to the University of Newcastle. GP Record review more information- The data will be stored on the UCL Data Safe Haven on servers at UCL and stored on servers at University of Newcastle. UCL uses offsite back-up services provided by VIRTUS Data Centres. UCL stores data on the Cloud provided by Amazon Web Services as contracted by UCL. Pulsant provides a backup data storage facility, this is a storage location for the University of Newcastle servers and no Pulsant employees can access the data. Pulsant is therefore not considered to be acting as a data processor. GP data is collected through the BRHS record review – this is a bespoke collection of data from GP records of BRHS cohort participants. The BRHS record Review has been a central part of the BRHS morbidity data collection. Since 1978, at regular intervals, the BRHS research team send a survey form to the study participants GP, information on specific health events is ascertained The Data will be accessed onsite at the premises of UCL and University of Newcastle . Processing of data for the linkage requested: The Data will also be accessed by authorised personnel via remote access. Data received under DARS-NIC-28591-H5Q3X and DARS-NIC-148411-Q64H8 are linked to form a pseudonymised database. The Data manager from UCL will link the NHS Digital pseudonymised dataset to the BRHS cohort data base. This is done by matching the Study ID to the BRHS cohort data. The NHS Digital data will not be linked back to any personal identifiers. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. Prior to linkage all identifiers are removed and stored on a separate database, the pseudonymised information received under both Agreements is then linked on a pseudo-ID. The identifiers are obtained for the purpose of maintaining contact with study members. For remote access: Identifiable data received under DARS-NIC-148411-Q64H is kept separately from the study database and is only used for the purpose of maintaining contact with study members. No attempt will be made to re-identify cohort members from the pseudonymised dataset. The linked data will be processed in a way that allows the study to address its key aims. - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; The pseudonymised linked dataset, containing the NHS Digital data and the BRHS cohort data, will be stored on UCL’s Sync & Share network drives. The dataset created is robustly pseudonymised, and it was previously agreed by the NHSD Security team that the data could be stored on UCL’s Sync and share drive which are only accessible with a UCL user ID and password.. To prevent any re-identification the identifiable information received under DARS-NIC-148411-Q64H8 is stored separately to the linked dataset, with access to the identifiers restricted to one named individual. - Access controls granting users the minimum level of access required are in place; Data is downloaded securely from NHS Digital SEFT and provides data security during transmission appropriate encryption into UCL Data Safe Haven via the DSH Data Ingress Desktop. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; The BRHS team at UCL are responsible for the downloading, processing and storing of data. Pseudonymised BRHS data will be transferred securely to the BRHS team based at Newcastle University via their encrypted secure file drop. This data will be used only for analytical and analysis purposes. - Multifactor authentication (MFA) is required for remote access; The pseudonymised data, containing the NHS Digital data and the BRHS cohort data, will then be made available to the research team of Medical Statisticians, Epidemiologists and Public Health clinicians, to carry out their research analysis. All the researchers working on the data are substantive employees of UCL / Newcastle University or hold honorary contracts with UCL. The terms ‘students’ include MSc Students, PhD Students, Clinical Academic Teaching Fellows (Medical Doctors in academic training). ‘Students’ are closely supervised by the study directors. All researchers are substantive employees of UCL or Newcastle University, their work is supervised by the study directors and students are registered with UCL or Newcastle University. - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; Student access -The number of students involved will vary each year, approximately five students and two medical academic fellows will require access to the data. All researchers will hold formal UCL contracts or honorary UCL contracts with the addendum contract for NHSD data. Students will be working within the agreed scope of the previously approved protocol and no students have accessed the data under this DSA previously. ‘Students’ include MSc Students, PhD Students, Clinical Academic Teaching Fellows (Medical Doctors in academic training). 'Students’ are closely supervised by the study directors. - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. All researchers must undergo annual Information Governance training. Researchers are able to access the data via remote access by logging onto UCL’s VPN. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). All outputs will be restricted to aggregated data with small numbers suppressed in line with the HES analysis guide. No publications/outputs from the BRHS have ever presented or will present data which allow the identification of individuals. All data presented is based on groups of subjects (generally >50 subjects, often considerably larger numbers). The Data will not leave England/Wales at any time. The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. Access is restricted to employees of UCL and University of Newcastle who have authorisation from the Principal Investigator. 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). All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will be linked at person record level with the BRHS cohort database from UCL. The identifying details will be stored in a separate database at UCL to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. The database storing the identifying details will be destroyed by Feb 2026. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. Researchers from the UCL and University of Newcastle analyse the Data for the purposes described above. UCL will manipulate the Data to generate a dataset: 1. UCL will create a new “cause of death” variable by recoding each original NHS England ICD-10 4-digit code into 3-digit ICD-9 categories. The transformation from ICD-10 to ICD-9, and from a 4-digit to aggregated 3-digit code. 2. UCL will create a perturbed “Date of death” by using a statistical programme to generate a random number between 1 and 14 which will be added to the original NHS England supplied “Date of death” to create a new variable with a perturbed date. UCL will not keep a record of the random number generated and used. 3. The resultant data ("the UKDS dataset") will contain a study id plus the outputs of 1) and 2) above and will be linked to non-NHS England data held by UCL. This linkage will not re-identify the dataset. The UKDS dataset will be deposited in the UKDS and a copy retained by UCL and University of Newcastle. NHS England Data will be retained for a minimum period at UCL in compliance with this DSA. This will remain the case until the UKDS dataset is created and deposited in the UKDS, and undergoes the required quality assurance to allow UKDS and UCL to be content that NHS England supplied mortality and demographics Data will be destroyed before the end of 2025. Only the derived UKDS mortality dataset will be retained. NHS England has considered the above processing, and is content that the UKDS dataset qualifies as derived under the definition of this DSA so long as the processing is undertaken solely as stated within this DSA, and no reidentification occurs.

Expected output

More than 600 peer-reviewed reports have already been published based on the study which uses mortality data from NHS Digital. It is hoped that research from using the data requested under this Agreement will be published and utilised in the same way. The expected outputs of the processing will be: Research from the BRHS has already been used to shape and change many policies on cardiovascular disease prevention, both nationally and internationally, for example, in developing initiatives for primary prevention of CVD and dementia in South East London. Peer reviewed publications from the research in specialty journals in cardiovascular disease, heart failure, diabetes, stroke, public health and geriatric medicine. It may also provide research directly to funding bodies and policy makers (Department of Health, British Heart Foundation, National Institute of Health Research, Medical Research Council, UK Health Forum), clinicians, public health specialists and other health researchers who then use the evidence to develop preventive strategies Researchers have drawn on their expertise, established through working with BRHS data to develop independent initiatives for primary prevention of cardiovascular disease (CVD) and dementia in South East London. This was part of work undertaken in 2010. It was through evidence in the form of published peer-reviewed papers from the BRHS which were included as part of evidence for making a case for primary prevention of CVD in the work of the local Primary Care Trust The BRHS may provide outputs in the form of peer reviewed publications from the research in specialty journals in cardiovascular disease, heart failure, diabetes, stroke, public health and geriatric medicine. It may also provide research directly to funding bodies and policy makers (Department of Health, British Heart Foundation, National Institute of Health Research, Medical Research Council, UK Health Forum), clinicians, public health specialists and other health researchers who then use the evidence to develop preventive strategies. The study plans for future findings to be disseminated via national conference presentations including The Society for Social Medicine, the Nutrition Society, the British Geriatric Society, and Public Health England and via international conference presentations including the AHA Epidemiology and Prevention | Lifestyle and Cardiometabolic Health and The International Society of Behavioural Nutrition and Physical Activity meetings. [5 paragraphs unchanged] The Study findings may also be cited in reports by a range of influential national and international public sector bodies including the UK House of Commons Health Select Committee, the UK Department of Health, the U.S. Surgeon General (whose reports inform health policies both in USA and other countries around the world) and the World Health Organisation (e.g. their Guidelines for assessment and management of cardiovascular risk). The UKDS dataset will be a significant output and will be utilised as a resource for health research. All outputs will be restricted to aggregate data with small numbers suppressed in line with the HES Analysis Guide. No publications/ outputs from the British Regional Heart Study have ever presented or will present data which allow the identification of individuals. All data presentation is based on groups of subjects (generally > 50 subjects, often considerably larger numbers). The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. Findings from the study have helped influence the following Guidelines and policies: Outputs are expected within1-5 years of the DSA commencing. Outputs are expected to continue beyond 5 years. Cardiovascular and Stroke Prevention - 2000 UK Parliament Select committee on Health, Memorandum by the Stroke Association (TB 17). - 2003 European Society of Cardiology clinical practice guidelines - European Heart Risk Score. -2003 Estimation of ten-year risk of fatal cardiovascular disease in Europe: the score project. European Heart Journal. - 2005 Joint British Societies. Guidelines on Prevention of Cardiovascular Disease in Clinical Practice. - 2004 NICE - Public health guidance on the prevention of cardiovascular disease (CVD) at population level. - 2007 Management of stable angina. SIGN guidance 96. - 2007 Risk estimation and the prevention of cardiovascular disease. SIGN guidance 97. - 2007 WHO Prevention of Cardiovascular Disease Guidelines for assessment and management of cardiovascular risk. - 2008 Management of patients with stroke or TIA: assessment, investigation, immediate management and secondary prevention A national clinical guideline. SIGN National guideline 108. - 2008 European Guidelines for management of ischaemic stroke and transient ischaemic attack. - 2010 Cardiovascular disease prevention Public health guideline [PH25] NICE Guidance. - 2011 European Guidelines for management of ischaemic stroke and transient ischaemic attack. - 2011 AHA / ASA Guidelines for the Primary Prevention of Stroke - 2014 AHA / ASA Guidelines for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack. - 2014 AHA / ASA Guidelines for the Primary Prevention of Stroke. - 2014 Joint British Societiesconsensus recommendations for the prevention of cardiovascular disease (JBS3). - 2016 European guidelines on cardiovascular disease prevention in clinical practice. This guideline is cited to update The New 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease in the US. Smoking & Passive smoking - 2016 Stopping Smoking: What health professionals should know and how to encourage smokers to quit: British Thoracic Society Tobacco Specialist Advisory Group March 2016. - 2012 Papers examining the health effects of passive smoking using an objective measure of smoke exposure rather than a self-report, were published in 2009-10 and received news media coverage. The findings informed the UK 2012 government campaign about the dangers of passive smoking. The BRHS papers are cited in the evidence about passive smoking and risk of CHD, stroke in the updated Surgeon General report in USA. - 2014: The Health Consequences of Smoking - 50 Years of Progress: A Report of the Surgeon General Editors National Centre for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. Atlanta (GA): Centres for Disease Control and Prevention (US); 2014. Alcohol - 2010 Dietary guidelines for Americans: Alcohol. - 2012 House of Commons Science and Technology Committee Alcohol guidelines Eleventh Report of Session 2010- 12: Volume II Additional written evidence Ordered by the House of Commons to be published 12 and 19 October 2011. Diabetes - 2008 An Endocrine Society Clinical Practice Guideline. Primary Prevention of Cardiovascular Disease and Type 2 Diabetes in Patients at Metabolic Risk. - 2010 Management of diabetes. SIGN National clinical guideline 116. - 2012 Endocrine Society clinical practice guidelines for Hypertriglyceridemia. - 2014 Lipid modification NICE clinical guideline CG181. - 2015 AHA/ ADA. Update on Prevention of Cardiovascular Disease in Adults with Type 2 Diabetes - 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/ SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients with Extracranial Carotid and Vertebral Artery Disease. - 2012 UK National Screening Committee. The Handbook for Vascular Risk Assessment, Risk Reduction and Risk Management. - 2015 Endocrine Society clinical practice guidelines for the pharmacological management of obesity. - 2015 NICE Clinical Guideline CG 43 Obesity Prevention. Social Determinants - 2015 AHA Scientific Statement Social Determinants of Risk and Outcomes for Cardiovascular Disease. Physical activity (Not a guideline but a resource) - ACSM's Resource Manual for Guidelines for Exercise Testing and Prescription. edited by David P. Swain, ACSM, Clinton A. Brawner. - 2013 IACR Cardiac Rehabilitation Guidelines.

Expected measurable benefits

[2 paragraphs unchanged] Linking the existing BRHS databases to NHS Digital England data will permit the researcher to study a wider range of public [37 words unchanged] achieve healthier ageing and improve the quality of life in older people. Cardiovascular disease prevention is a major public health priority in the UK. Heart and circulatory disease accounts for more than a quarter of all deaths in the UK, with over 80% of those deaths occurring in people aged >65 years. CVD deaths are mainly attributable to coronary heart disease (CHD), heart failure (HF) and stroke. As a consequence, the prevalence and incidence of CVD morbidity has continued to increase in the last ten years with population ageing and improved event survival. In the UK, there is an admission to hospital from a heart attack every 5 minutes (100,00 each year). Around 650000 people in the UK are on the GP’s heart failure register. Incidence of CVD in particular stroke and HF are exceptionally high at older ages and imposes a huge burden of morbidity and also physical disability, cognitive and functional decline and impaired quality of life in older individuals. [2 paragraphs unchanged] Research from the BRHS has already been used to shape and change many policies on cardiovascular disease prevention, both nationally and internationally, for example, in developing initiatives for primary prevention of CVD and dementia in South East London. Researchers have drawn on their expertise, established through working with BRHS data to develop independent initiatives for primary prevention of cardiovascular disease (CVD) and dementia in South East London. This was part of work undertaken in 2010. It was through evidence in the form of published peer-reviewed papers from the BRHS which were included as part of evidence for making a case for primary prevention of CVD in the work of the local Primary Care Trust. The study plans for future findings to be disseminated via national conference presentations including The Society for Social Medicine, the Nutrition Society, the British Geriatric Society, and Public Health England and via international conference presentations including the AHA Epidemiology and Prevention | Lifestyle and Cardiometabolic Health and The International Society of Behavioural Nutrition and Physical Activity meetings. The Study findings may also be cited in reports by a range of influential national and international public sector bodies including the UK House of Commons Health Select Committee, the UK Department of Health, the U.S. Surgeon General (whose reports inform health policies both in USA and other countries around the world) and the World Health Organisation (e.g. their Guidelines for assessment and management of cardiovascular risk).

Benefits reported

To date, the The study has published over 600 peer reviewed research papers, providing high quality evidence about the epidemiology of these conditions, CVD and diabetes and improving understanding on how to manage, treat and prevent them. Importantly, [45 words unchanged] diabetes which together cause substantial burdens of ill health in UK and globally and will continue to contribute with findings from the new data requested. globally. The study contributes to the global efforts to improve risk assessment and prediction of CVD in older adults and to developing novel CVD preventive strategies to improving the health of older adults. Through these efforts, the BRHS has the potential to contribute to reducing the burden of CVD and related morbidity and improve social care and to refinement of clinical guidelines for improved management of CVD in later life. Improved detection and management of cardiovascular disease would yield substantial cost savings and health benefit. CVD and cancer are among the leading causes of morbidity and mortality globally, and is recognised to have a bidirectional relationship, with shared mechanisms and risk factors that predispose individuals to both disease states. With extended cancer follow-up data to 2024 which has now been linked to the BRHS data assessment in middle-age and at age 60-79, 70-89 and 78+ the study is well place to investigate the role of modifiable risk factors particularly in older adults, novel vascular biomarkers and early atherosclerosis and social determinants in the development of cancer in later life. To date there are over 3700 cancer registrations in the 7735 men; almost 50% of the men have developed cancer. The BRHS will contribute to the aetiology and prevention of cancer morbidity and mortality in an ageing population. Understanding the risk factors and mechanisms shared between CVD and cancer will enable the prediction, prevention and treatment of both diseases and improve the understanding of how to prevent and manage cancer in an ageing population where incident CVD and cancer are particularly high. In addition to investigating CVD outcomes we have also investigated all-cause mortality outcomes. This includes: Our recent research on CVD together with the cancer data linkage will enable us to investigate many important topics in cancer which will have potential implications in clinical practice including: - 1) Oral health and mortality (Publications since 2023 and future research) Oral health problems, including tooth loss, periodontal disease, and dry mouth, accumulate throughout adult life and worsen with increasing age. We examined associations of oral health problems with all-cause, cardiovascular disease (CVD), and respiratory mortality in older people. Oral health comprised tooth loss, periodontal disease, dry mouth, and self-rated oral health. The findings published in Sci Report 2021 suggest that poor oral health is associated with mortality and highlight the importance of improving oral health to lengthen survival in older age. 1.Healthy lifestyle and survival free of cardiometabolic diseases, heart failure and cancer 2) Trajectories of physical activity from midlife to old age and associations with subsequent cardiovascular disease and all-cause mortality Life’s Simple 7 (LS7) recommended by the American Heart Association (AHA) are 7 risk factors (smoking, physical activity, obesity, blood pressure, blood cholesterol, blood glucose and diet) It is well established that physical activity (PA) protects against mortality and morbidity, but how long-term patterns of PA are associated with mortality and cardiovascular disease (CVD) remains unclear. A dose-response relationship was observed, with higher levels of PA from midlife to old age associated with additional benefits. However, even fairly modest and sustained PA was protective and may be more achievable for the most inactive. The findings published in the J Epidemiol Community Health 2020 has important implications for promoting physical activity. Promoting a light sustained level of PA across adulthood may be a feasible intervention target for the most inactive. that people can manage through lifestyle changes to improve health. The study team have estimated that life expectancy free of cardiometabolic disease was up to 4.5 years longer in men engaging in a healthier lifestyle compared to those who had a poor healthy lifestyle score. The findings have been published in Commun Med (Lond). 2024. The study team have also shown that a consistently healthy lifestyle, as reflected in a better CVD score (life’s simple 7) maintained over an adult lifetime, is associated with lower HF risk in older men. Results of the study have been published in the Eur J Preventive cardiology 2025 with an accompanying editorial. These available findings show that the application of life’s simple 7 score can significantly contribute to understanding the development of HF and cardiometabolic health in the population and, through this insight, help the healthcare system to implement preventive measures for the benefit of the individual and the society. 3) Accelerometer-measured physical activity and sedentary time with all-cause mortality. Given that CVD and cancers are increasingly recognized to share common modifiable risk factors the team are now investigating whether life’s simple 7 and current CVD risk scores could predict overall cancer risk and certain common cancer types in middle-aged and older men. Addressing the shared modifiable risk factors for cardiovascular disease (CVD) and cancer provides an opportunity to improve screening and prevention of both diseases We found that high amounts of sedentary time (>10.7 hours per day) was associated with higher risk of mortality, especially in those with low or very low levels of moderate-to-vigorous intensity physical activity. About 30-40 min of moderate-to-vigorous intensity physical activity per day attenuate the association between sedentary time and risk of death, which is lower than previous estimates from self-reported data. Individuals who currently must spend large amounts of time sedentary due to work and transportation should aim to achieve the upper recommended level of 150–300min of moderate-to-vigorous-intensity physical activity per week. Our work published in Br J Sports Med 2019 may inform the development of future recommendations for physical activity and sedentary time by WHO and other public health authorities 2. Subclinical vascular disease and incident CVD and cancer 4. Vitamin D deficiency impaired lung function and mortality Carotid intima-media thickness (CIMT) and carotid distensibility are markers of arterial change and indicators of subclinical vascular disease and are known to predict coronary heart disease and stroke. Less has been studied on the role of these vascular markers and the development of heart failure (HF) in older adults in whom incident HF risk is high. The study has investigated these association with incident HF and showed that lower carotid distensibility (least flexible carotid arteries) and higher carotid intima thickness (thicker carotid artery walls) were associated with an increased risk of incident HF. The carotid ultrasound is a safe, cheap and painless investigation, and the findings published in the Journal of the American Heart Associations 2025, suggest it may be able to provide an early warning sign for heart failure. These findings may be particularly important in cancer survivors who are at high risk of heart failure. The team are now able to investigate whether detection of subclinical vascular disease may prevent cancers in older community dwelling adults and whether they predict heart failure in cancer survivors. Chronic obstructive lung disease (COPD) is a common chronic inflammatory disease in the elderly and is a major cause of morbidity and mortality.1 Much attention has focused on identifying factors which may influence prognosis and mortality in these patients. Vitamin D deficiency is recognised as an important health problem particularly in the elderly. Although vitamin D deficiency is traditionally known for its role in bone health, there is growing interest in the role of vitamin D in the pathogenesis and severity of COPD. We have shown that men with COPD were more likely to be vitamin D deficient than those with normal lung function. Vitamin D deficiency was associated with increased total mortality and mortality from respiratory and COPD causes in older men, and this was seen in those without lung impairment and in those with earlier stages of lung impairment. The finding published in BMJ open (2021) has potential clinical implications. Intervention trials in older people with mild or moderate impaired lung function are needed to confirm whether increasing vitamin D levels through supplements in those with vitamin D deficiency will reduce both risk of COPD deaths and overall mortality. 3. The Mediterranean diet and cardiometabolic multimorbidity and cancer 5.Healthy lifestyle and survival free of cardiometabolic diseases This study investigated the prospective relationships between diet quality, dietary components, and risk of cardiometabolic multimorbidity (CMM) (having at least two of CHD, stroke or diabetes) in older British men. There were no significant association between baseline adherence to the Mediterranean-adapted diet quality score (EDI) and the risk of CMM., fish /seafood consumption, a dietary component of the mediterranean diet was found to be significantly inversely related to the risk of CMM. These results are in keeping with the AHA and traditional Mediterranean diet recommendations of consuming nonfried fish/seafood 1–2 days/week, and further the potential health benefits towards reducing the risk of CMM. The findings are published in the European J Clinical Nutrition 2023. The importance of nutrition in the prevention of cancer will be investigated together with detailed measurements of serum metabolites to understand the role of diet in the prevention of cancer. Cardiometabolic diseases (MI, stroke and diabetes) are major contributors to morbidity, mortality and disability. Life’s Simple 7 (LS7) recommended by the American Heart Association (AHA) are 7 risk factors (smoking, physical activity, obesity, blood pressure, blood cholesterol, blood glucose and diet) that people can manage through lifestyle changes to improve health. We are currently investigating the impact of adopting the AHA’s life simple 7 on cardiometabolic disease free life expectancy for older British men. We have estimated that life expectancy free of cardiometabolic disease was up to 4.5 years longer in men engaging in a healthier lifestyle compared to those who had a poor healthy lifestyle score (work in progress). Results of the study can be used as key messages to educate the public and inform policymakers. 4. Socioeconomic deprivation, individual social class and diabetes and cancer. Some particular examples of evidence generated of relevance to the wider health and social care system are – the importance of oral health and its influence on improving health outcomes in later life; persistent protective effects of physical activity in later life and potential protective effects of vitamin D in reducing the risk of mortality from respiratory disease This study investigates the prospective associations of neighborhood-level deprivation and individual socioeconomic position (SEP) with T2DM incidence in older age. Inequalities in T2DM risk persist in later life, both in relation to neighborhood-level and individual-level socioeconomic factors largely due to obesity and family history of diabetes. The findings are published in BMJ Open Diabetes Res Care. 2023. Underlying modifiable risk factors continue to need to be addressed in deprived older age populations to reduce disease burden. Previous studies have reported lower cancer survival probabilities for socioeconomically deprived patients. With linked data to cancer morbidity and mortality the study are well placed to investigate inequalities in cancer survival and understand mechanisms of social inequalities and work towards reducing the social burden of cancers. 5. Social engagement and loneliness and health outcomes. Loneliness is recognized as a significant public health concern, affecting quality of life and a wide range of health outcomes, including CVD, cancer-related outcomes and frailty. The study has shown that a higher level of loneliness at baseline and an increase in loneliness raised the risk of developing frailty. For reversal of frailty, higher social engagement at baseline and an increase in social engagement were beneficial. Social connections may be potentially important and modifiable factors in both preventing and reversing progression of frailty in older adults. These findings have been published in the American Journal of Epidemiology 2024. This study provides evidence that social inactivity and loneliness are potentially important factors that increase the risk of developing frailty as well as hinder its reversal. Increasing social engagement and reducing loneliness among older adults could be beneficial in reducing the burden of frailty. There is also empirical evidence of cancer specific mortality among those experiencing loneliness and social isolation. The proposed pathways in which loneliness and social isolation affect cancer outcomes specifically and health outcomes more broadly are not well understood. The study will continue to contribute to understanding the importance of loneliness and social engagement as a crucial and modifiable factor in interventions to promote healthy ageing and survival free of CVD and cancer in the elderly. Some particular examples of evidence generated of relevance to the wider health and social care system are the importance of maintaining a healthy lifestyle in improving life expectancy free of cardiometabolic diseases and HF risk and that it is never too late to adopt a healthy lifestyle for health benefits. Underlying modifiable risk factors continue to need to be addressed intensively in deprived older age populations to reduce diabetes and disease burden. Future work will focus on cancer outcomes and the interplay between CVD and cancer. Addressing the shared modifiable risk factors for CVD and cancer provides an opportunity to improve screening and prevention of both diseases. Research into the shared mechanisms underlying CVD and cancer will help identify effective strategies needed to improve the health of the growing population of patients with CVD and cancer. The retention of the Cancer data will allow the study to continue to contribute to the global efforts to improve risk assessment and prediction of CVD and other major chronic diseases including cancer in older adults and to developing preventive strategies to improving the health of older adults. Through these efforts, the BRHS has the potential to contribute to reducing the burden of CVD, cancers and related morbidity and improve social care and to refinement of clinical guidelines for improved management of CVD and cancers in later life. Improved detection and management of CVD and cancer would yield substantial cost savings and health benefit.

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

Data controllers: + UNIVERSITY OF NEWCASTLE UPON TYNE

Objective for processing

The legal basis for processing outlined in this Agreement is covered by article 6(1)(e) of the GDPR, ‘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) of the GDPR, ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.’ University College London is a public authority. On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England. The lawful basis for processing personal data (Article 6.1) e: Public task: the processing is necessary for the data controller to perform a task in the public interest or for their official functions, and the task or function has a clear basis in law. and GDPR article 10 and Part 1 of the DPA 2018 for sensitive/special category personal data. Legal basis for processing special category data: (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. [4 paragraphs unchanged] The data received under DARS-NIC-28591-H5Q3XS and the identifiable data received under this [23 words unchanged] is only used for the purpose of maintaining contact with study members. There will be no attempt to re-identify cohort members from the pseudonymised dataset. The linked data will be processed in a way that allows the study to address its key aims. The BRHS study team is housed within the Institute of Public Health and Epidemiology at University College London (UCL). The Institute produces internationally recognised quality research on the determinants of health and health behaviour across the life-course, develops and evaluates cross-sectoral policies and strategies to improve health, and optimise healthcare delivery and practice. University College London are the sole data controller, who also process the data for the purpose outlined within this Agreement. The British Regional Heart Study (BRHS) is a cohort of men recruited from 1978-80. DARS-NIC-148411-Q64H8 relies on S251 support under this agreement UCL receive mortality, cancer notifications and demographic data to trace participants for the entire cohort. DARS-NIC-28591-H5Q3X- is a subset of the overall BRHS cohort of men who have provided written consent, under this agreement the subset is linked to NHS HES, MMHDS and DIDS data sets. Using these data UCL will examine trends in cardiovascular disease (CVD) mortality, CVD of morbidity and burden of disability, frailty and functional and cognitive decline in older adults. This rich scientific study resource will facilitate research on the development of novel CVD preventive strategies and for improving the cardiovascular health of older adults. The BRHS study team is housed within the Institute of Public Health and Epidemiology at University College London (UCL). The Institute produces internationally recognised quality research on the determinants of health and health behaviour across the life-course, develops and evaluates cross-sectoral policies and strategies to improve health, and optimise healthcare delivery and practice. University College London and Newcastle University are joint data controllers, who also process the data for the purpose outlined within this Agreement. The British Heart Foundation (BHF) fund the BRHS cohort study, as well as the data linkage which forms the basis of this DSA. [3 paragraphs unchanged] The overarching objectives/purpose of this data request is to enhance the BRHS [5 words unchanged] robust detailed data on disease outcomes to research ways to prevent CVD, types of heart failure, dementia and disability in older ages. The researchers will link [42 words unchanged] and data collected during the physical assessments in 1978-1980, 1998-2000 and 2010-2012. [6 paragraphs unchanged] 6. Determinants of Heart failure – (i) To investigate pathways to prevention of heart failure distinguishing between reduced ejection different types of heart failure and preserved ejection heart failure which is more common in older adults; failure; (ii) to develop prediction risk scores for use in clinical practice to identify older adults at high risk of developing any type of heart failure. [4 paragraphs unchanged] 11. Enhancing BRHS data- To develop a new source of data in an established population based population-based cardiovascular cohort study to facilitate the development of ways to improve strategies for preventions of CVD, heart failure, dementia and disability. [2 paragraphs unchanged] Pulsant provide a backup data storage facility, this is a storage location for the Newcastle University servers and no Pulsant employees can access the data. Pulsant is therefore not considered to be acting as a data processor.

Processing activities

[4 paragraphs unchanged] 3. NHS Digital – Identifiable Mortality , data quarterly, Demographics and Cancer registration data on an annual basis via this existing data sharing data-sharing agreement. 4. NHS Digital- Pseudonymised HES, MHMDS and DIDs data is received under DARS-NIC-28591-H5Q3X. To facilitate the flagging of the cohort UCL securely transferred identifiers to NHS Digital (Study ID, NHS Number, Date of Birth, Sex). To facilitate the flagging of the cohort UCL securely transferred identifiers to NHS Digital (Study ID, NHS Number, Date of Birth, Sex). The Data Safe Haven has been certified to the ISO27001 information security standard and conforms to NHS Digital's Data Security and Protection Toolkit. The personal identifiers are held in the Data Safe Haven and access to this is strictly limited to a single named individuals, all substantive employees of University College London (UCL). The Data Safe Haven has been certified to the ISO27001 information security standard and conforms to NHS Digital's Data Security and Protection Toolkit. Built using a walled garden approach, where the data is stored, processed and managed within the security of the system, avoiding the complexity of assured end point encryption. GP Record review more information- Processing of data for the linkage requested: Linkage has already been established. GP data is collected through the BRHS record review – this is a bespoke collection of data from GP records of BRHS cohort participants. The BRHS record Review has been a central part of the BRHS morbidity data collection. Since 1978, at regular intervals, the BRHS research team send a survey form to the study participants GP, information on specific health events is ascertained The Data manager will then link this NHS Digital pseudonymised dataset provided under DARS-NIC-28591-H5Q3X and a pseudonymised version of the data provided under DARS-NIC-148411-Q64H8, this is done by matching the Study ID to the BRHS cohort data. The NHS Digital data will not be linked back to any personal identifiers. Processing of data for the linkage requested: The pseudonymised linked dataset will be stored on UCL’s Sync & Share network drives. The dataset created is robustly pseudonymised, and it was previously agreed the data could be store on UCL’s Sync and share drive which are only accessible with a UCL user ID and password. There is no need to re-identify the patients from the pseudonymised dataset. To prevent any re-identification the identifiable information Data received under DARS-NIC-28591-H5Q3X and DARS-NIC-148411-Q64H8 is stored separately are linked to form a pseudonymised database. The Data manager from UCL will link the NHS Digital pseudonymised dataset to the linked dataset, with access BRHS cohort data base. This is done by matching the Study ID to the identifiers restricted BRHS cohort data. The NHS Digital data will not be linked back to one named individual. any personal identifiers. The pseudonymised data will then be made available to the BRHS research team of Medical Statisticians, Epidemiologists and Public Health clinicians, to carry out their research analysis Prior to linkage all identifiers are removed and stored on a separate database, the pseudonymised information received under both Agreements is then linked on a pseudo-ID. The identifiers are obtained for the purpose of maintaining contact with study members. All the researchers working on the data are substantive employees of UCL, or of its Data Processors. All researchers must undergo annual Information Governance training. Due to the ongoing pandemic researchers currently access the data via remote access and logging onto a VPN. Identifiable data received under DARS-NIC-148411-Q64H is kept separately from the study database and is only used for the purpose of maintaining contact with study members. No attempt will be made to re-identify cohort members from the pseudonymised dataset. The linked data will be processed in a way that allows the study to address its key aims. The pseudonymised linked dataset, containing the NHS Digital data and the BRHS cohort data, will be stored on UCL’s Sync & Share network drives. The dataset created is robustly pseudonymised, and it was previously agreed by the NHSD Security team that the data could be stored on UCL’s Sync and share drive which are only accessible with a UCL user ID and password.. To prevent any re-identification the identifiable information received under DARS-NIC-148411-Q64H8 is stored separately to the linked dataset, with access to the identifiers restricted to one named individual. Data is downloaded securely from NHS Digital SEFT and provides data security during transmission appropriate encryption into UCL Data Safe Haven via the DSH Data Ingress Desktop. The BRHS team at UCL are responsible for the downloading, processing and storing of data. Pseudonymised BRHS data will be transferred securely to the BRHS team based at Newcastle University via their encrypted secure file drop. This data will be used only for analytical and analysis purposes. The pseudonymised data, containing the NHS Digital data and the BRHS cohort data, will then be made available to the research team of Medical Statisticians, Epidemiologists and Public Health clinicians, to carry out their research analysis. All the researchers working on the data are substantive employees of UCL / Newcastle University or hold honorary contracts with UCL. The terms ‘students’ include MSc Students, PhD Students, Clinical Academic Teaching Fellows (Medical Doctors in academic training). ‘Students’ are closely supervised by the study directors. All researchers are substantive employees of UCL or Newcastle University, their work is supervised by the study directors and students are registered with UCL or Newcastle University. Student access -The number of students involved will vary each year, approximately five students and two medical academic fellows will require access to the data. All researchers will hold formal UCL contracts or honorary UCL contracts with the addendum contract for NHSD data. Students will be working within the agreed scope of the previously approved protocol and no students have accessed the data under this DSA previously. ‘Students’ include MSc Students, PhD Students, Clinical Academic Teaching Fellows (Medical Doctors in academic training). 'Students’ are closely supervised by the study directors. All researchers must undergo annual Information Governance training. Researchers are able to access the data via remote access by logging onto UCL’s VPN. All outputs will be restricted to aggregated data with small numbers suppressed in line with the HES analysis guide. No publications/outputs from the BRHS have ever presented or will present data which allow the identification of individuals. All data presented is based on groups of subjects (generally >50 subjects, often considerably larger numbers). The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. [1 paragraph unchanged] All outputs will be restricted to aggregated data with small numbers suppressed in line with the HES analysis guide. No publications/outputs from the BRHS have ever presented or will present data which allow the identification of individuals. All data presentation is based on groups of subjects (generally >50 subjects, often considerably larger numbers). The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement.

Expected output

More than 500 600 peer-reviewed reports have already been published based on the study which uses [15 words unchanged] under this Agreement will be published and utilised in the same way. [1 paragraph unchanged] Researchers have drawn on their expertise, established through working with BRHS data to develop independent initiatives for primary prevention of cardiovascular disease (CVD) and dementia in South East London. This was part of work undertaken in 2010. It was through evidence in the form of published peer-reviewed papers from the BRHS which were included as part of evidence for making a case for primary prevention of CVD in the work of the local Primary Care Trust [2 paragraphs unchanged] Abstracts recently submitted for presentation include: (i) Associations between CVD health and types of heart failure in older British men: findings from the BRHS study has been submitted to presented at the next Society of Social Medicine to take place in September 2021. (September 2021). (ii) Prospective associations of NT-proBNP and troponin T with stroke events in older men free of CVD has been submitted to presented at the European Society of Cardiology meeting to take place in September 2021. (September 2021). Further abstract on current projects are expected to be submitted for conferences in 2022. (iii) “Associations between diet quality, dietary components, and risk of cardiometabolic multimorbidity in older British men has been accepted for presentation for the Society Social Medicine meeting in September 2022. (iv) Abstract on associations between oral health and incident diabetes has been accepted for presentation for the Society Social Medicine meeting in September 2022. [2 paragraphs unchanged] Findings from the study have helped influence the following Guidelines and policie: policies: [47 paragraphs unchanged]

Expected measurable benefits

[1 paragraph unchanged] The It is hoped the specific benefits from the use of the data will be to generate [8 words unchanged] diseases and to improve the health of older populations and management of people with multiple health conditions. As the population ages, an increasing proportion are living with multiple health conditions and frailty. The management of these patients conditions is complex. To meet this challenge, new ways of supporting clinical decision making need to be developed. [3 paragraphs unchanged] Moreover, CVD and cancers are two leading causes of morbidity and mortality in the developed world. Advances in cancer therapeutics and diagnostics have led to improved survival of cancer patients. As survival from cancer increases, CVD in survivors has become increasingly prevalent. Although commonly thought of as 2 separate disease entities. the emerging field of cardio-oncology suggests common pathophysiological linkages owing to shared modifiable risk factors and overlapping molecular mechanisms. As a result, interest has increased in understanding the fundamental biological mechanism that are central to the relationship between CVD and cancer. With the continued collection of CVD and cancer events, the study is thus uniquely placed to study the modifiable risk factors and biological mechanisms common to CVD and cancer. It is hoped these findings will lay the foundation for developing prevention strategies and provide opportunities to improve the care of the growing cancer survivors.

Benefits reported

To date, the study has published over 500 600 peer reviewed research papers, providing high quality evidence about the epidemiology of [72 words unchanged] and will continue to contribute with findings from the new data requested. [1 paragraph unchanged] In addition to investigating CVD outcomes we have also investigated all-cause mortality outcomes. This includes: 1) Oral health and mortality Oral health problems, including tooth loss, periodontal disease, and dry mouth, accumulate throughout adult life and worsen with increasing age. We examined associations of oral health problems with all-cause, cardiovascular disease (CVD), and respiratory mortality in older people. Oral health comprised tooth loss, periodontal disease, dry mouth, and self-rated oral health. The findings published in Sci Report 2021 suggest that poor oral health is associated with mortality and highlight the importance of improving oral health to lengthen survival in older age. 2) Trajectories of physical activity from midlife to old age and associations with subsequent cardiovascular disease and all-cause mortality It is well established that physical activity (PA) protects against mortality and morbidity, but how long-term patterns of PA are associated with mortality and cardiovascular disease (CVD) remains unclear. A dose-response relationship was observed, with higher levels of PA from midlife to old age associated with additional benefits. However, even fairly modest and sustained PA was protective and may be more achievable for the most inactive. The findings published in the J Epidemiol Community Health 2020 has important implications for promoting physical activity. Promoting a light sustained level of PA across adulthood may be a feasible intervention target for the most inactive. 3) Accelerometer-measured physical activity and sedentary time with all-cause mortality. We found that high amounts of sedentary time (>10.7 hours per day) was associated with higher risk of mortality, especially in those with low or very low levels of moderate-to-vigorous intensity physical activity. About 30-40 min of moderate-to-vigorous intensity physical activity per day attenuate the association between sedentary time and risk of death, which is lower than previous estimates from self-reported data. Individuals who currently must spend large amounts of time sedentary due to work and transportation should aim to achieve the upper recommended level of 150–300min of moderate-to-vigorous-intensity physical activity per week. Our work published in Br J Sports Med 2019 may inform the development of future recommendations for physical activity and sedentary time by WHO and other public health authorities 4. Vitamin D deficiency impaired lung function and mortality Chronic obstructive lung disease (COPD) is a common chronic inflammatory disease in the elderly and is a major cause of morbidity and mortality.1 Much attention has focused on identifying factors which may influence prognosis and mortality in these patients. Vitamin D deficiency is recognised as an important health problem particularly in the elderly. Although vitamin D deficiency is traditionally known for its role in bone health, there is growing interest in the role of vitamin D in the pathogenesis and severity of COPD. We have shown that men with COPD were more likely to be vitamin D deficient than those with normal lung function. Vitamin D deficiency was associated with increased total mortality and mortality from respiratory and COPD causes in older men, and this was seen in those without lung impairment and in those with earlier stages of lung impairment. The finding published in BMJ open (2021) has potential clinical implications. Intervention trials in older people with mild or moderate impaired lung function are needed to confirm whether increasing vitamin D levels through supplements in those with vitamin D deficiency will reduce both risk of COPD deaths and overall mortality. 5.Healthy lifestyle and survival free of cardiometabolic diseases Cardiometabolic diseases (MI, stroke and diabetes) are major contributors to morbidity, mortality and disability. Life’s Simple 7 (LS7) recommended by the American Heart Association (AHA) are 7 risk factors (smoking, physical activity, obesity, blood pressure, blood cholesterol, blood glucose and diet) that people can manage through lifestyle changes to improve health. We are currently investigating the impact of adopting the AHA’s life simple 7 on cardiometabolic disease free life expectancy for older British men. We have estimated that life expectancy free of cardiometabolic disease was up to 4.5 years longer in men engaging in a healthier lifestyle compared to those who had a poor healthy lifestyle score (work in progress). Results of the study can be used as key messages to educate the public and inform policymakers. Some particular examples of evidence generated of relevance to the wider health and social care system are – the importance of oral health and its influence on improving health outcomes in later life; persistent protective effects of physical activity in later life and potential protective effects of vitamin D in reducing the risk of mortality from respiratory disease

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

Objective for processing

The British Regional Heart Study (BRHS) is an established, long-term cohort study of cardiovascular disease and other common chronic diseases - the study comprises older men, currently aged 75-94 years, who originally joined the study in 1978. The BRHS currently obtain HES, MHMDS and DIDs data under NIC-28591-H5Q3X-v0.18, the data held under NIC-28591-H5Q3X-v0.18 will not be linked to the cancer registration and mortality data being disseminated under this Agreement, NIC-148411-Q64H8-v1.4. The legal basis for processing outlined in this Agreement is covered by article 6(1)(e) of the GDPR, ‘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) of the GDPR, ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.’ University College London is a public authority. Morbidity rates in this study population are exceptionally high, with many study participants developing cardiovascular disease (CVD) and other physical illnesses; fractures and dementia are also major health problems. In order to obtain an accurate assessment of chronic disease outcomes, the researchers are seeking, under a renewal of this current agreement; to continue with the ongoing supply of cancer registration and mortality data. The Data Protection Act 2018 s7(1)(a) defines ‘public bodies’ for the purpose of the GDPR as “a public authority as defined by the Freedom of Information Act 2000”. The FOI Act 2000 Part 1, section 3 (1)(a)(i) specifies that a public authority means anybody which is listed in Schedule 1. Schedule 1 of the FOI Act 2000 lists “Maintained schools and further and higher education institutions” as public authorities. University College London’s Royal Charter includes the following statement “The objects of the College shall be to provide education and courses of study in the fields of Arts, Laws, Pure Sciences, Medicine and Medical Sciences, Social Sciences and Applied Sciences and in such other fields of learning as may from time to time be decided upon by the College and to encourage research in the said branches of knowledge and learning and to organise, encourage and stimulate postgraduate study in such branches.” The British Regional Heart Study (BRHS) is an established, long-term cohort study of cardiovascular disease and other common chronic diseases - this request relates to ~8000 older men, currently aged 82-102 years, who originally joined the study in 1978. The BRHS study team has collected data on smoking, physical activity, blood pressure and lung function, cardiac structure and function, body composition, oral health, cognitive and physical function, frailty, socioeconomic status, diet and a number of biomarkers. The BRHS currently receives pseudonymised Hospital Episode Statistics (HES), Mental Health Minimum Dataset (MHMDS) and the Diagnostic Imaging Dataset (DIDS) under DARS-NIC-28591-H5Q3X , this data is used for the same purpose described in this Agreement. Under the present Agreement the study obtains Identifiable Mortality, Cancer Registration and Demographics data. The data received under DARS-NIC-28591-H5Q3XS and the identifiable data received under this Agreement are linked and integrated into the study database. All identifiable data received under DARS-NIC-148411-Q64H is kept separately to the study database and is only used for the purpose of maintaining contact with study members. There will be no attempt to re-identify cohort members from the pseudonymised dataset. The linked data will be processed in a way that allows the study to address its key aims. The BRHS study team is housed within the Institute of Public Health and Epidemiology at University College London (UCL). The Institute produces internationally recognised quality research on the determinants of health and health behaviour across the life-course, develops and evaluates cross-sectoral policies and strategies to improve health, and optimise healthcare delivery and practice. University College London are the sole data controller, who also process the data for the purpose outlined within this Agreement. The BRHS study team has a 5-year British Heart Foundation core funded program of research to study the causes, pathways and prevention of cardiovascular disease and disability among older British men. Core funding has been in place since 1985 and is renewed every five years after scientific review. Morbidity rates in this study population are exceptionally high, with many study participants developing cardiovascular disease (CVD) and other physical illnesses; fractures and dementia are also major health problems. In order to obtain an accurate assessment of chronic disease outcomes, the researchers are seeking, under a renewal of this current agreement; to continue with the ongoing supply of cancer registration, demographics and mortality data. [3 paragraphs unchanged] 1. Enhancing BRHS data - To develop a new source of data in an established population- 1. Prediction of CVD risk in older people - To investigate the use of non-invasive arterial markers and novel blood markers reflecting a range of biological pathways in improving CVD risk prediction in older men. based cardiovascular cohort study to facilitate the development of ways to improve 2. Lifestyle determinants of CVD in older age - To assess patterns of key health behaviour (physical activity, obesity, diet) in influencing CVD morbidity and mortality in both men with and without established CVD. strategies for prevention of CVD, heart failure, dementia and disability. 3. Modifiable risk factors and dementia - To investigate lifestyle factors measured in mid-life and older age (obesity, smoking, physical activity) as well as diet quality and nutritional markers in older age and risk of developing dementia. 2. Prediction 4. Socioeconomic determinants of CVD risk in older people cardiovascular aging - To investigate the use impact of non-invasive arterial socioeconomic factors that are important in preventing CVD and dementia in older people. markers and novel blood markers reflecting a range of biological pathways in improving 5. Dementia and CVD – To investigate shared risk factors and mechanistic pathways underlying CVD and dementia and improving early identification of CVD and dementia. This research will help develop strategies to prevent dementia and CVD. CVD risk prediction in older men. 6. Determinants of Heart failure – (i) To investigate pathways to prevention of heart failure distinguishing between reduced ejection heart failure and preserved ejection heart failure which is more common in older adults; (ii) to develop prediction risk scores for use in clinical practice to identify older adults at high risk of developing heart failure. 3. Lifestyle determinants of CVD in older age - To assess patterns of key health behaviour 7. Later life determinants of stroke – To differentiate subtypes of strokes and distinguish risk factors for ischaemic and haemorrhagic strokes. (physical activity, obesity, diet) in influencing CVD morbidity and mortality in both men 8. Physical disability and frailty – To identify social, lifestyle and biological factors that affect physical functioning and frailty and identify common pathways underlying CVD and frailty which can inform efforts to prevent the development of disability in older people with CVD. with and without established CVD. 9. Type 2 Diabetes, CVD and dementia - To examine the influence of duration of diabetes on CVD risk and dementia and identify metabolic pathways linking diabetes with dementia. 4. Modifiable risk factors and dementia - To investigate lifestyle factors measured in mid-life 10. Improving clinical outcome – To identify and inform ways of evaluating and improving clinical outcomes in patients with CVD and/or dementia such as reducing hospitalisations and mortality. and older age (obesity, smoking, physical activity) as well as diet quality and nutritional 11. Enhancing BRHS data- To develop a new source of data in an established population based cardiovascular cohort study to facilitate the development of ways to improve strategies for preventions of CVD, heart failure, dementia and disability. markers in older age and risk of developing dementia. The data requested has been minimised to a cohort of approximately 8,000 individuals who originally joined the study in 1978. 5. Socioeconomic determinants of cardiovascular ageing - To investigate the impact of The data has been further minimised in version 3 of the Agreement to remove several identifiable data fields that were no longer deemed necessary for the purpose of this research. socioeconomic factors in older people operating at neighbourhood as well as individual levels and life-course socioeconomic position on CVD and dementia. 6. Dementia and CVD – To investigate shared risk factors and mechanistic pathways underlying CVD and dementia and improving early identification of CVD and dementia. This research will help develop strategies to prevent dementia and CVD. 7. Determinants of Heart failure – (i) To investigate pathways to prevention of heart failure distinguishing between reduced ejection heart failure and preserved ejection heart failure which is more common in older adults; ) ii) to develop prediction risk scores for use in clinical practice to identify older adults at high risk of developing heart failure. 8. Later life determinants of stroke – To differentiate sub-types of strokes and distinguish risk factors for ischaemic and hemorrhagic strokes. 9. Physical disability and frailty – To identify social, lifestyle and biological factors that affect physical functioning and frailty and identify common pathways underlying CVD and frailty which can inform efforts to prevent the development of disability in older people with CVD. 10. Type 2 Diabetes, CVD and dementia - To examine the influence of duration of diabetes on CVD risk and dementia and identify metabolic pathways linking diabetes with dementia. 11. Improving clinical outcome – To identify and inform ways of evaluating and improving clinical outcomes in patients with CVD and/or dementia such as reducing hospitalisations and mortality. The cohort has been followed-up for morbidity (BRHS researchers directly contact the participants GP on an annual basis) and mortality outcomes since 1978-80, therefore, the researchers are requesting NHS Digital data to be linked back for as far back as possible for this cohort (i.e. all the available years of data). Data on mortality in the British Regional Heart Study is used for research focusing on understanding ways to prevent mortality from diseases such as cardiovascular disease. The Study aims are to investigate patterns in mortality of chronic diseases over time as well as to identify factors that predispose to greater risk of mortality in later life. Detailed follow-up of information on mortality is essential for these research aims. For example, previous research has demonstrated a decline in mortality from heart disease in Britain. The goal of this research is to inform change in policy and clinical practice to prevent deaths from chronic diseases. **************** The researcher already holds data from the following reports: ~ MRIS - Cause of Death ~ MRIS - Cohort Event Notification ~ MRIS - Flagging Current Status ~ MRIS - Members and Postings UCL are requesting the additional data under this application (MRIS - Cause of Death and MRIS - Cohort Event Notification (monthly dissemination) and (MRIS - Flagging Current Status and MRIS - Members and Postings (one-off dissemination)) to supplement the cohort data (mortality, cancer, postal questionnaire data and data collected during physical assessments) and develop a larger programme of research on the prevention of cardiovascular disease, heart failure and related ageing conditions to help achieve the BRHS aim of determining the factors responsible for the considerable variation in coronary heart disease, hypertension and stroke in Great Britain. It also seeks to determine the causes of these conditions in order to provide a rational basis for recommendations towards their prevention. **********

Processing activities

UCL have requested continuation of the monthly updates to the cohort regarding cancer registration, date, fact and cause of death. The BRHS currently receives data from three sources: The BRHS currently receives data from three sources; [3 paragraphs unchanged] 3. NHS Digital - Participants flagged in 1978-80 and the study receives Mortality notification & 3. NHS Digital – Identifiable Mortality , Demographics and Cancer registration data on an annual basis via this existing data sharing agreement. Cancer registration on a monthly basis via this existing data sharing agreement. HES, MHMDS and DIDs data under NIC-28591-H5Q3X-v0.18 4. NHS Digital- Pseudonymised HES, MHMDS and DIDs data is received under DARS-NIC-28591-H5Q3X. The personal identifiers are held in the data safe haven and access to this is strictly limited to a few named individuals, all substantive employees of University College London (UCL). UCL will provide NHS Digital with the following cohort identifiers for linkage to the datasets: To facilitate the flagging of the cohort UCL securely transferred identifiers to NHS Digital (Study ID, NHS Number, Date of Birth, Sex). 1) Study ID The personal identifiers are held in the Data Safe Haven and access to this is strictly limited to a single named individuals, all substantive employees of University College London (UCL). The Data Safe Haven has been certified to the ISO27001 information security standard and conforms to NHS Digital's Data Security and Protection Toolkit. Built using a walled garden approach, where the data is stored, processed and managed within the security of the system, avoiding the complexity of assured end point encryption. 2) NHS Number Processing of data for the linkage requested: Linkage has already been established. 3) Date of Birth The Data manager will then link this NHS Digital pseudonymised dataset provided under DARS-NIC-28591-H5Q3X and a pseudonymised version of the data provided under DARS-NIC-148411-Q64H8, this is done by matching the Study ID to the BRHS cohort data. The NHS Digital data will not be linked back to any personal identifiers. 4) Sex The pseudonymised linked dataset will be stored on UCL’s Sync & Share network drives. The dataset created is robustly pseudonymised, and it was previously agreed the data could be store on UCL’s Sync and share drive which are only accessible with a UCL user ID and password. There is no need to re-identify the patients from the pseudonymised dataset. To prevent any re-identification the identifiable information received under DARS-NIC-148411-Q64H8 is stored separately to the linked dataset, with access to the identifiers restricted to one named individual. 5) Last known postcode. The pseudonymised data will then be made available to the BRHS research team of Medical Statisticians, Epidemiologists and Public Health clinicians, to carry out their research analysis NHS Digital will return a pseudonymised dataset to the applicant containing Study ID and match rank code. UCL's Data manager will then link this NHS Digital pseudonymised dataset to the BRHS cohort data Study ID for analysis. All the researchers working on the data are substantive employees of UCL, or of its Data Processors. All researchers must undergo annual Information Governance training. Due to the ongoing pandemic researchers currently access the data via remote access and logging onto a VPN. ***** 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). Only study ids are used to link the NHS Digital data to the BRHS cohort data. No Personal identifiers are contained within this dataset. ****** All outputs will be restricted to aggregated data with small numbers suppressed in line with the HES analysis guide. No publications/outputs from the BRHS have ever presented or will present data which allow the identification of individuals. All data presentation is based on groups of subjects (generally >50 subjects, often considerably larger numbers). The data will then be made available to the research team of Medical Statisticians, Epidemiologists and Public Health clinicians, to carry out their research analysis. All the researchers working on the data are substantive employees of UCL. The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. No publications/outputs from the British Regional Heart Study have ever presented or will present data which allow the identification of individuals. All data presentation is based on groups of subjects (generally >50 subjects, often considerably larger numbers). Therefore all outputs will be restricted to aggregate data with small numbers suppressed in line with the HES Analysis Guide. The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. Data will not be linked with any other sources, other than those specified 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data). There will be no requirement nor attempt to re-identify individuals from the data. All processing of ONS data will be in line with ONS standard conditions. The data from NHS Digital will not be used for any other purpose other than that outlined in this agreement.

Expected output

[1 paragraph unchanged] Research from the BRHS has already been used to shape and change many policies on cardiovascular disease prevention, [8 words unchanged] initiatives for primary prevention of CVD and dementia in South East London. The BRHS provide outputs in the form of peer reviewed publications from the research in speciality journals in cardiovascular disease, heart failure, diabetes, stroke and geriatric medicine. It also provides research directly to funding bodies and policy makers (Department of Health, British Heart Foundation, National Institute of Health Research, Medical Research Council, UK Health Forum), clinicians, public health specialists and other health researchers who then use the evidence to develop preventive strategies. Findings will be further disseminated via national conference presentations including The Society for Social Medicine, the Nutrition Society, the British Geriatric Society, and Public Health England and via international conference presentations including the AHA Epidemiology and Prevention | Lifestyle and Cardiometabolic Health and The International Society of Behavioral Nutrition and Physical Activity meetings. The BRHS may provide outputs in the form of peer reviewed publications from the research in specialty journals in cardiovascular disease, heart failure, diabetes, stroke, public health and geriatric medicine. It may also provide research directly to funding bodies and policy makers (Department of Health, British Heart Foundation, National Institute of Health Research, Medical Research Council, UK Health Forum), clinicians, public health specialists and other health researchers who then use the evidence to develop preventive strategies. The Study findings will also be cited in reports by a range of influential national and international public sector bodies including the UK House of Commons Health Select Committee, the UK Department of Health, the U.S. Surgeon General (whose reports inform health policies both in USA and other countries around the world) and the World Health Organisation (e.g. their Guidelines for assessment and management of cardiovascular risk). The study plans for future findings to be disseminated via national conference presentations including The Society for Social Medicine, the Nutrition Society, the British Geriatric Society, and Public Health England and via international conference presentations including the AHA Epidemiology and Prevention | Lifestyle and Cardiometabolic Health and The International Society of Behavioural Nutrition and Physical Activity meetings. All outputs will be restricted to aggregate data with small numbers suppressed in line with the HES Analysis Guide. No publications/ outputs from the British Regional Heart Study have ever presented or will present data which allow the identification of individuals. All data presentation is based on groups of subjects (generally > 50 subjects, often considerably larger numbers). The data from NHS Digital will not be used for any other purpose other than that outlined in this Agreement. Abstracts recently submitted for presentation include: (i) Associations between CVD health and heart failure in older British men: findings from the BRHS study has been submitted to the next Society of Social Medicine to take place in September 2021. (ii) Prospective associations of NT-proBNP and troponin T with stroke events in older men free of CVD has been submitted to the European Society of Cardiology meeting to take place in September 2021. Further abstract on current projects are expected to be submitted for conferences in 2022. The Study findings may also be cited in reports by a range of influential national and international public sector bodies including the UK House of Commons Health Select Committee, the UK Department of Health, the U.S. Surgeon General (whose reports inform health policies both in USA and other countries around the world) and the World Health Organisation (e.g. their Guidelines for assessment and management of cardiovascular risk). All outputs will be restricted to aggregate data with small numbers suppressed in line with the HES Analysis Guide. No publications/ outputs from the British Regional Heart Study have ever presented or will present data which allow the identification of individuals. All data presentation is based on groups of subjects (generally > 50 subjects, often considerably larger numbers). Findings from the study have helped influence the following Guidelines and policie: Cardiovascular and Stroke Prevention - 2000 UK Parliament Select committee on Health, Memorandum by the Stroke Association (TB 17). - 2003 European Society of Cardiology clinical practice guidelines - European Heart Risk Score. -2003 Estimation of ten-year risk of fatal cardiovascular disease in Europe: the score project. European Heart Journal. - 2005 Joint British Societies. Guidelines on Prevention of Cardiovascular Disease in Clinical Practice. - 2004 NICE - Public health guidance on the prevention of cardiovascular disease (CVD) at population level. - 2007 Management of stable angina. SIGN guidance 96. - 2007 Risk estimation and the prevention of cardiovascular disease. SIGN guidance 97. - 2007 WHO Prevention of Cardiovascular Disease Guidelines for assessment and management of cardiovascular risk. - 2008 Management of patients with stroke or TIA: assessment, investigation, immediate management and secondary prevention A national clinical guideline. SIGN National guideline 108. - 2008 European Guidelines for management of ischaemic stroke and transient ischaemic attack. - 2010 Cardiovascular disease prevention Public health guideline [PH25] NICE Guidance. - 2011 European Guidelines for management of ischaemic stroke and transient ischaemic attack. - 2011 AHA / ASA Guidelines for the Primary Prevention of Stroke - 2014 AHA / ASA Guidelines for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack. - 2014 AHA / ASA Guidelines for the Primary Prevention of Stroke. - 2014 Joint British Societiesconsensus recommendations for the prevention of cardiovascular disease (JBS3). - 2016 European guidelines on cardiovascular disease prevention in clinical practice. This guideline is cited to update The New 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease in the US. Smoking & Passive smoking - 2016 Stopping Smoking: What health professionals should know and how to encourage smokers to quit: British Thoracic Society Tobacco Specialist Advisory Group March 2016. - 2012 Papers examining the health effects of passive smoking using an objective measure of smoke exposure rather than a self-report, were published in 2009-10 and received news media coverage. The findings informed the UK 2012 government campaign about the dangers of passive smoking. The BRHS papers are cited in the evidence about passive smoking and risk of CHD, stroke in the updated Surgeon General report in USA. - 2014: The Health Consequences of Smoking - 50 Years of Progress: A Report of the Surgeon General Editors National Centre for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. Atlanta (GA): Centres for Disease Control and Prevention (US); 2014. Alcohol - 2010 Dietary guidelines for Americans: Alcohol. - 2012 House of Commons Science and Technology Committee Alcohol guidelines Eleventh Report of Session 2010- 12: Volume II Additional written evidence Ordered by the House of Commons to be published 12 and 19 October 2011. Diabetes - 2008 An Endocrine Society Clinical Practice Guideline. Primary Prevention of Cardiovascular Disease and Type 2 Diabetes in Patients at Metabolic Risk. - 2010 Management of diabetes. SIGN National clinical guideline 116. - 2012 Endocrine Society clinical practice guidelines for Hypertriglyceridemia. - 2014 Lipid modification NICE clinical guideline CG181. - 2015 AHA/ ADA. Update on Prevention of Cardiovascular Disease in Adults with Type 2 Diabetes - 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/ SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients with Extracranial Carotid and Vertebral Artery Disease. - 2012 UK National Screening Committee. The Handbook for Vascular Risk Assessment, Risk Reduction and Risk Management. - 2015 Endocrine Society clinical practice guidelines for the pharmacological management of obesity. - 2015 NICE Clinical Guideline CG 43 Obesity Prevention. Social Determinants - 2015 AHA Scientific Statement Social Determinants of Risk and Outcomes for Cardiovascular Disease. Physical activity (Not a guideline but a resource) - ACSM's Resource Manual for Guidelines for Exercise Testing and Prescription. edited by David P. Swain, ACSM, Clinton A. Brawner. - 2013 IACR Cardiac Rehabilitation Guidelines.

Expected measurable benefits

[1 paragraph unchanged] To date the study has published over 500 peer reviewed research papers, providing high quality evidence about the epidemiology of these conditions and improving understanding on how to manage, treat and prevent them. The specific benefits from the use of the data will be to generate further high-quality research evidence about prevention of chronic diseases and to improve the health of older populations and management of people with multiple health conditions. As the population ages, an increasing proportion are living with multiple health conditions and frailty. The management of these patients is complex. To meet this challenge, new ways of supporting clinical decision making need to be developed. Importantly, these papers have informed evidence based strategies to reduce the health and social care burden in older populations, as outlined in detail in section “Specific output” above. The researchers have contributed to a range of influential UK and international clinical guidelines for management and treatment of important chronic conditions including CHD, stroke, angina, arrhythmias, and diabetes which together cause substantial burdens of ill health in UK and globally, and will continue to contribute with findings from the new data requested. Linking the existing BRHS databases to NHS Digital data will permit the researcher to study a wider range of public health relevant topics including multimorbidity which is an increasing concern for healthcare systems globally. The potential benefits for prevention of cardiovascular disease, diabetes, dementia, other age-related chronic diseases, multimorbidity and disability in later life are substantial to achieve healthier ageing and improve the quality of life in older people. The specific benefits from the use of the data will be to generate further high quality research evidence about prevention of chronic diseases and to improve the health of older populations. Linking the existing BRHS databases to NHS Digital data will permit the researcher to study a wider range of public health relevant topics. The potential benefits for prevention of cardiovascular disease, diabetes, dementia, other chronic diseases and disability in later life are substantial. Target dates will run from the time of acquiring the data until 2019 with plans to further extend funding for our study. Cardiovascular disease prevention is a major public health priority in the UK. Heart and circulatory disease accounts for more than a quarter of all deaths in the UK, with over 80% of those deaths occurring in people aged >65 years. CVD deaths are mainly attributable to coronary heart disease (CHD), heart failure (HF) and stroke. As a consequence, the prevalence and incidence of CVD morbidity has continued to increase in the last ten years with population ageing and improved event survival. In the UK, there is an admission to hospital from a heart attack every 5 minutes (100,00 each year). Around 650000 people in the UK are on the GP’s heart failure register. Incidence of CVD in particular stroke and HF are exceptionally high at older ages and imposes a huge burden of morbidity and also physical disability, cognitive and functional decline and impaired quality of life in older individuals. Healthcare costs relating to heart and circulatory diseases are estimated at £9 billion each year. It is estimated that the CVD’s cost to the UK economy (including premature death, disability and other costs) is estimated to be £19billion each year. Given the rapidly growing proportion of older people in the UK population, the health burden attributable to people living longer with CVD will continue to rise. There is a clear need to foster successful cardiovascular aging and to increase healthy life expectancy through improvements in CVD assessment, prevention, management and care at advanced age.

Benefits reported

Research from the BRHS has been used to shape and change many policies on cardiovascular disease prevention, both nationally and internationally- a selection of these are listed below. Previous research is also cited in guidelines produced by professional organisations for treatment of specific chronic conditions, e.g. NICE guidelines, American Heart Association guidelines for prevention of stroke and transient ischemic attack, for management of cardiovascular disease, and management of patients with ventricular arrhythmias, Australian guidelines for management of cardiovascular disease risk, Joint British Societies management of cardiovascular disease guidelines, Endocrine Society guidelines on hypertriglyceridemia and obesity. To date, the study has published over 500 peer reviewed research papers, providing high quality evidence about the epidemiology of these conditions, and improving understanding on how to manage, treat and prevent them. Importantly, these papers have informed evidence-based strategies to reduce the health and social care burden in older populations. The researchers have contributed to a range of influential UK and international clinical guidelines for management and treatment of important chronic conditions including CHD, stroke, angina, arrhythmias, and diabetes which together cause substantial burdens of ill health in UK and globally and will continue to contribute with findings from the new data requested. Evidence generated from the research has also been used to support local public health programmes, for example, in developing initiatives for primary prevention of CVD and dementia in South East London. The research findings have been published in open access peer-reviewed scientific journals related to public health. The study contributes to the global efforts to improve risk assessment and prediction of CVD in older adults and to developing novel CVD preventive strategies to improving the health of older adults. Through these efforts, the BRHS has the potential to contribute to reducing the burden of CVD and related morbidity and improve social care and to refinement of clinical guidelines for improved management of CVD in later life. Improved detection and management of cardiovascular disease would yield substantial cost savings and health benefit. Cardiovascular and Stroke Prevention - 2000 UK Parliament Select committee on Health, Memorandum by the Stroke Association (TB 17). - 2003 European Society of Cardiology clinical practice guidelines - European Heart Risk Score. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the score project . European Heart Journal (2003) - 2005 Joint British SocietiesGuidelines on Prevention of Cardiovascular Disease in Clinical Practice. - 2004 NICE - Public health guidance on the prevention of cardiovascular disease (CVD) at population level. - 2007 Management of stable angina. SIGN guidance 96. - 2007 Risk estimation and the prevention of cardiovascular disease. SIGN guidance 97. - 2007 WHO Prevention of Cardiovascular Disease Guidelines for assessment and management of cardiovascular risk. - 2008 Management of patients with stroke or TIA: assessment, investigation, immediate management and secondary prevention A national clinical guideline. SIGN National guideline 108. - 2008 European Guidelines for management of ischaemic stroke and transient ischaemic attack. - 2010 Cardiovascular disease prevention Public health guideline [PH25] NICE Guidance. - 2011 European Guidelines for management of ischaemic stroke and transient ischaemic attack. - 2011 AHA / ASA Guidelines for the Primary Prevention of Stroke - 2014 AHA / ASA Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack. - 2014 AHA / ASA Guidelines for the Primary Prevention of Stroke. - 2014 Joint British Societiesconsensus recommendations for the prevention of cardiovascular disease (JBS3). - 2016 European guidelines on cardiovascular disease prevention in clinical practice. Smoking & Passive smoking - 2016 Stopping Smoking: What health professionals should know and how to encourage smokers to quit: British Thoracic Society Tobacco Specialist Advisory Group March 2016. - 2012 Papers examining the health effects of passive smoking using an objective measure of smoke exposure rather than a self report, were published in 2009-10 and received news media coverage. The findings informed the UK 2012 government campaign about the dangers of passive smoking. The BRHS papers are cited in the evidence about passive smoking and risk of CHD, stroke in the updated Surgeon General report in USA. - 2014: The Health Consequences of Smoking - 50 Years of Progress: A Report of the Surgeon General Editors National Center for Chronic Disease Prevention and Health Promotion (US) Office on Smoking and Health. Atlanta (GA): Centers for Disease Control and Prevention (US); 2014. Alcohol - 2010 Dietary guidelines for Americans: Alcohol. - 2012 House of Commons Science and Technology Committee Alcohol guidelines Eleventh Report of Session 2010-12: Volume II Additional written evidence Ordered by the House of Commons to be published 12 and 19 October 2011. Diabetes - 2008 An Endocrine Society Clinical Practice Guideline. Primary Prevention of Cardiovascular Disease and Type 2 Diabetes in Patients at Metabolic Risk. - 2010 Management of diabetes. SIGN National clinical guideline 116. - 2012 Endocrine Society clinical practice guidelines for Hypertriglyceridemia. - 2014 Lipid modification NICE clinical guideline CG181. - 2015 AHA/ ADA. Update on Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes - 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/ SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease. - 2012 UK National Screening Committee. The Handbook for Vascular Risk Assessment, Risk Reduction and Risk Management. - 2015 Endocrine Society clinical practice guidelines for the pharmacological management of obesity. - 2015 NICE Clinical Guideline CG 43 Obesity Prevention. Social Determinants - 2015 AHA Scientific Statement Social Determinants of Risk and Outcomes for Cardiovascular Disease . Physical activity (Not a guideline but a resource) - ACSM's Resource Manual for Guidelines for Exercise Testing and Prescription. edited by David P. Swain, ACSM, Clinton A. Brawner. - 2013 IACR Cardiac Rehabilitation Guidelines.

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

Datasets: + Cancer Registration Data; + Civil Registrations of Death; + Demographics

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.