NHS Digital Data Release Register - reformatted

University Of Cambridge

Project 1 — DARS-NIC-147034-XH3H2

Opt outs honoured: N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2018/05.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Flagging Current Status Report

Benefits:

The CFAS has been and will continue to be beneficial to health care in the following ways: Findings on dementia prevalence and incidence are extremely beneficial to the NHS. Services are planned based on estimates of prevalence and incidence but the CFAS study is providing evidence that reductions in numbers are possible through proactive interventions. Such information encourages such interventions and helps care providers to more accurately plan services ensuring patients’ needs are catered for while reducing risk of wasting resources. The benefits are achieved through use of the full data the CFAS studies collect from various sources. Mortality data comprises a small but important proportion of that data making it possible to ascertain the survival of individuals based on different conditions which can then be used in population modelling and public health outcomes. Specifically for example, the date of death will enable estimates of life expectancy for those who develop cognitive impairment between different waves of interviewing. Information is also required in relation to those leaving the NHS through emigration etc. in order to allow more accurate estimates of survival rates. Dramatic global increases in future numbers of people with dementia have been predicted. No multi-centre population based study powered to detect changes over time had previously reported dementia incidence. Dependency: Little is known about how the proportions of dependency states have changed between generational cohorts of older people. The CFAS study aimed to estimate years lived in different dependency states at age 65 years in 1991 and 2011(4) and provided new projections of future demand for care. These recent findings will have considerable implications for families of older people, who provide the majority of unpaid care, but the findings also provide valuable new information for governments and care providers planning the resources and funding required for the care of their future ageing populations. CFAS Wales – The initial outputs using longitudinal data are expected to be published in 2018 (initial outputs using cross-sectional data from the wave 1 interviews have been published in 2015) In Wales, the approach to targets differs, but policy will be influenced by findings on the concordance of dementia registers and ascertained dementia in the community. Public Health Wales issues guidance on lifestyle changes to reduce the risk of developing dementia (5). The studies will contribute to revisions of this advice. The study will inform the Welsh government regarding aspects of social exclusion and the relationship between social exclusion and mortality (6,7,8) will be a key part of these findings. Service planning will benefit from more accurate estimates of morbidity and disability, and will allow resources to be targeted where they can be most effective.

Outputs:

The CFAS study (which comprises the original CFAS study (CFAS I) plus CFAS II and CFAS Wales) has produced over 250 peer reviewed papers in high profile publications including The Lancet, BMJ, New England Journal of Medicine, Age and Ageing and Mental Health. All study papers can be accessed via the study website: www.cfas.ac.uk. The study covers multiple areas including: population projections of risk, mortality, dementia prevalence and incidence, policy, healthy active life expectancy, social implications, pharmacology, mild cognitive impairment (MCI) and neuropathology. In the past four years the study has led to the publication of 33 academic papers and there are currently 14 papers in draft, awaiting submission or awaiting acceptance by publications. CFAS disseminates its findings widely in both the UK and abroad, recent activity includes: • Presentation to Participant Panel of European Prospective Investigation of Cancer (EPIC Norfolk), April 2017, Norwich. • Presentations at the Alzheimer’s Society annual conference, June 2017 in London. • Symposium at the Alzheimer’s Association International Conference (AAIC), July 2017 London. • Presentations at International Association of Gerontology and Geriatrics (IAGG) World Congress in San Francisco, July 2017 • Presentation at the British Society of Gerontology conference, July 2017 Swansea. The study is one of the core cohorts of the Dementias Platform UK (DPUK). CFAS data (non- identifiable) is available to researchers through the DPUK data application processes. Though the mortality data supplied by NHS Digital is not made available, it is used to calculate binary mortality outcomes (i.e. living or deceased) which are made available through the DPUK. Current CFAS work with the Newcastle DELIRIUM study is helping to prospectively elucidate the size of the effect of delirium upon cognitive decline and incident dementia. The results will be used to inform future dementia prevention trials that focus on delirium intervention. The study is expected to report in 2018. In the coming three years CFAS will be conducting a Dementia risk reduction pilot study funded by Alzheimer’s Research UK (ARUK) with CFAS II participants in Cambridgeshire, Newcastle and Nottingham to test feasibility, acceptability and adherence of the proposed intervention. The results will be available in 2020.

Processing:

The University of Cambridge is the administrative centre for all the CFAS studies. The University of Cambridge maintains an administrative database containing participants’ identifying details and a separate pseudonymised database containing self-reporting information and data from tests (e.g. hearing tests) and from analysing samples (e.g. saliva, blood, etc.). The University of Cambridge has previously supplied lists of identifiers for CFAS II participants to NHS Digital. This contained the name, date of birth, NHS number, postcode and a unique study identifier for each participant. NHS Digital linked that data and routinely reports details of participants’ deaths (date and cause) to the University of Cambridge. In addition, the University of Cambridge will securely transfer to NHS Digital a file of identifiers for each CFAS Wales participant. These will be added to the existing cohort held by NHS Digital. NHS Digital will continue to provide routine reports of participants’ deaths and/or exits from the NHS for the existing cohort plus the additional participants. The data supplied by NHS Digital is held as identifiable data within the Secure Data Hosting Service (SDHS) at the School of Clinical Medicine, University of Cambridge. Only the core CFAS team (4 persons) has access to the identifiable data held on the secure server. All are substantive employees of the University of Cambridge. Access to the SDHS is via a 15 character password and 2 factor authentication token. There is no internet access inside the SDHS. All data imported or exported to/from the SDHS is made via the secure transfer server. All transfers are audited. No identifiable data is ever released to collaborating researchers. No data set with mortality information from NHS Digital will be transferred, with all analyses on mortality information undertaken solely within the core study team at the University of Cambridge. All outputs produced will be aggregated and anonymised with small numbers suppressed, in line with HES governance guidelines. Mortality data is converted into binary indicators (i.e. deceased; not deceased) and those derivations are made more widely available along with other data collected by the CFAS II and CFAS Wales studies. The data from NHS Digital will be used to model life expectancy, differentials between different diseases and causes of death. The use of exact dates of death will ascertain the survival of individuals based on different conditions and then be used in population modelling and public health policy outcomes. The mortality data are linked with other data collected on the CFAS II and CFAS Wales cohorts and analyses of that data may be compared with equivalent analyses from the original CFAS study to assess changes in prevalence and incidence within the same geographical areas or variations across different areas.

Objectives:

MRC Cognitive Function and Ageing Study - CFAS II This study builds on the design and infrastructure of the MRC Cognitive Function and Ageing Study collaborative (CFAS). New cohorts in Cambridgeshire, Newcastle and Nottingham (N=7,500) are now to be included and will provide important base−line information on older people aged 65−84 in 2007−2008 who will reach the age of greatest frailty during the 2020's. The integration of a new cohort will provide the opportunity to address government policy of whether gains in active life expectancy have occurred between generations. By studying a recent cohort it will be possible to estimate the effect that changing mortality and incidence rates of specific diseases have had on active life expectancy The data from MRIS will be used to model life expectancy, differentials between different diseases and causes of death. The use of exact dates of death will ascertain the survival of individuals based on different conditions and then be used in population modelling and public health policy outcomes.


Project 2 — DARS-NIC-147829-5K4QP

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2018/05.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data, Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Objectives:

The data supplied will be used only for the approved medical research project MR480 - MRC Study of Cognitive Function and Ageing


Project 3 — DARS-NIC-147874-HVBFB

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2017/11.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Objectives:

Are to estimate the incidence and mortality of Psychiatric and Mental Illnesses i.e Dementia, Neurosis,Alzheimer's Disease and Depression and to assess their relationships with various external factors.


Project 4 — DARS-NIC-148129-FK1JJ

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/09 — 2017/05.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Objectives:

The data supplied to the University of Cambridge will be used for the approved Medical Research Project identified above.


Project 5 — DARS-NIC-156334-711SX

Opt outs honoured: Y, N

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2017/11.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Objectives:

This randomised study aims to determine: 1. What is the optimum interval between donations that maximises blood supply, maintains well-being, and avoids unacceptably increasing risk of iron deficiency/anaemia and its potential complications, for men and women? 2. If it is appropriate to tailor blood donation intervals to donors by their demographic, haematological, genetic and lifestyle factors? The benefits of this study are twofold. Firstly, identification of donors that are likely to become anaemic following blood donation would enable NHS Blood and Transplant to allow such donors a longer period to recover their iron stores post-donation. Currently, such donors often fail their anaemia screening test at their next donation appointment and are temporarily prevented (or deferred) from donating blood; this often results in donors withdrawing completely from donating. Secondly, the ability to decrease donation intervals would enable NHSBT to collect more blood from the same number of donors.


Project 6 — DARS-NIC-24422-R3W3S

Opt outs honoured: N

Sensitive: Non Sensitive, and Sensitive

When: 2017/09 — 2018/05.

Repeats: Ongoing, One-Off

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Admitted Patient Care
  • MRIS - Flagging Current Status Report
  • MRIS - Cause of Death Report

Benefits:

Supplementation with colecalciferol at high and infrequent doses in patients with renal failure on dialysis provides an effective, safe approach to addressing vitamin D deficiency. It is also cheaper than active vitamin D compounds which are in wide clinical use and have not been assessed in interventional trials. Current treatment guidelines recommend cholecalciferol or ergocalciferol in patients on dialysis, even when they are receiving treatment with VDRAs. The Kidney Disease Improving Global Outcomes (KDIGO) guideline group identified “native” vitamin D supplementation in dialysis as a key research priority, but nevertheless argues for its use on the basis that the intervention is safe and inexpensive. Caution is necessary, however, as epidemiological data similarly supported the use of anti-oxidant vitamins including vitamins C and E, which were found to be of no benefit or even harmful in adequately powered interventional trials. Widespread supplementation with cholecalciferol should therefore be rigorously tested in an adequately powered randomised trial. Further, most clinicians continue to preferentially prescribe 1-hydroxyated compounds on the basis of epidemiological data suggesting a survival benefit compared to no vitamin D; Despite guidleines to supplement “native” vitamin D being in force since 2007, clinical practice has not changed. It is therefore imperative to generate data from an adequately powered randomised comparison of colecalciferol versus standard care. The findings of the trial will be provided to NICE. Study findings will have the potential to influence the NICE guidelines and other guidelines regarding clinical practice in this areas.

Outputs:

The University of Cambridge will test the hypothesis that supplementation with high dose colecalciferol (inactive vitamin D) in patients receiving dialysis will reduce mortality and improve quality of life. The trial results will be published in peer-reviewed journals and presented at national and international conferences. These outputs are dependent upon the primary endpoint being achieved. With an average median survival of 5.5 years for patients on dialysis, the trial is likely to end in 2023, with the final study report being available in 2024. Prior to the final publication, the trial will have an interim analysis as described in the protocol. A feasibility assessment will be carried out between months 12 and 15 of the trial. Feasibility will be predicated on recruitment rate (target 887 patients recruited after 12 months), and separation between arms by plasma vitamin D concentration after 4 months of treatment of 20nmol/l. Publications will follow in 2025 although this target date is difficult to accurately predict at this early stage. The trial protocol will be submitted for publication in “Trials” (target date February 2017), and will include a section on data capture and handing. During the conduct of the trial, reports will be submitted to the NIHR as required. Findings from the trial will be presented at the British Renal Society annual UK Kidney Week (June 2025), the European Renal Association (May 2025) and the American Society of Nephrology annual meeting November 2025). The primary report from the trial will be submitted for publication in the New England Journal of Medicine or The Lancet during the course of 2025. The results will also be published on the EU Clinical Studies Register website, a central registry for all clinical trials conducted within the EU. Participating patients will be informed of the results and can request a copy of published papers. The final study report will be provided to NICE

Processing:

The University of Cambridge aim to harness the information routinely collected by NHS Digital (including HES and ONS Mortality data) for use as follow-up for those patients participating in their clinical trial. The University of Cambridge will also be collecting data from the UK Renal Registry and UKIACR for the same purposes. All datasets will be linked. The University of Cambridge will submit the following patient identifiers to NHS Digital on a quarterly basis: - NHS number, date of birth and initials. Using these minimal patient identifiers NHS Digital will correctly identify the clinical trial patients of their cohort and track their cohort, providing quarterly updates of cancer registrations, cause of death (ONS Mortality) and linked HES APC, A&E and CC. Data will be uploaded by NHS Digital to the secure DES (cancer registrations and cause of death) and SEFT (HES) accounts; available to download by the study team at the University of Cambridge. The study team will download the data onto a secure hosting environment and anonymised datasets generated . The team is made up of both University of Cambridge and Cambridge University Hospital NHS Trust employees. Data will be stored, processed and linked in a secure university data hosting server, which can be accessed on a permission basis via NHS computers. Only the database programmer, coordinator and data manager have access to data in the Secure Data Hosting Server (SDHS) provided by the university. Access to the SDHS may be done via NHS hardware however access will only ever be permitted subject to permissions which are controlled by the university of Cambridge. These permissions are also required where a university computer is used. Access to SDHS is only ever permitted via a secure encrypted remote desktop connection via the University network and the data will remain at all times within the SDHS. Access to the SDHS is protected by three factor authentication (username, password, PIN + Signify key fob code). All processing activities will take place in Cambridge University Hospitals (CUH). The data set will be kept and stored at the secure data hosting server at patient level. All reports/outputs will be aggregated with small numbers suppressed in line with the HES analysis guide. The only exception to this is safety events, which may be listed at an individual patient level as is standard practice for clinical trials study reports. In these circumstances data will be anonymised and un-linkable. An internal participant trial number will be used to keep the data anonymised at the stages of analysis, reporting and eventually publishing. The anonymised safety reports will initially be shared only by the DMEC committee members and CCTU Pharmacovigilance team. The anonymised datasets, in aggregated format with small numbers suppressed in line with the HES analysis guide will be used for statistical analysis and incorporated into the study report. Trial results will be submitted for publishing in peer-reviewed medical journals, presented at conferences and published on EU Clinical Studies Register Website. All processing and storage will take place at the University of Cambridge. All data collected will be stored on highly secure encrypted servers held within the University of Cambridge secure data hosting area, and will be accessible only to the team of researchers directly involved with the study. All individuals with access to the data are substantive employees of the University of Cambridge or Cambridge University Hospitals NHS Foundation Trust. The secure data hosting area for this study is subject to an existing data governance agreement between the University of Cambridge and the Cambridge University Hospitals NHS Foundation Trust. The use of personal identifiers is to correctly identify clinical trial subjects only. Anonymised datasets for analysis will be generated within the secure data hosting environment and transferred securely to the trial statistician within the Cambridge Trials Unit. These anonymised datasets will be used to determine the primary and secondary endpoints of the clinical trial, namely patient survival, quality of life, and secondary clinical outcomes including cardiovascular events, infections requiring admission, cancer incidence, and fractures requiring admission.

Objectives:

The randomised controlled trial aims to assess the effect of colecalciferol (vitamin D) supplementation versus standard care on health outcomes in patients with kidney failure receiving dialysis and will involve approximately 4,200 patients over a 7-8 year period. This novel approach of capturing follow up will remove the need for additional study visits and will lessen the burden and cost of participating in research for both patients and sites. Vitamin D deficiency is highly prevalent in patients with kidney failure and is associated with increased mortality. Kidney failure patients are treated with “active” vitamin D compounds (VDRAs) based on the now disproven belief that activation can only occur in the kidneys. VDRAs induce hypercalcaemia, result in tissue deficiency of calcitriol, and may promote vascular calcification. Contemporary treatment guidelines now recommend administration of “native” vitamin D (colecalciferol). This guidance is not currently implemented given the lack of evidence from randomised trials. Colecalciferol has been used to treat vitamin D deficiency for more than 80 years. It is cheap and safe, even at high doses. In contrast, VDRAs are expensive and despite their wide use, their efficacy and safety have never been tested in interventional trials. There is an urgent unmet need for a trial to determine which approach is preferable. In this trial, the University of Cambridge will test the hypothesis that population-wide supplementation with high-dose colecalciferol (inactive vitamin D) in patients receiving dialysis will reduce mortality and improve quality of life.


Project 7 — DARS-NIC-28744-S4F8H

Opt outs honoured: N

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - List Cleaning Report

Benefits:

The primary benefits of using the HSCIC’s List Cleaning service are that it enables ADDITION-Cambridge to continue to collect information about its participants fairly and transparently giving participants the option to withdraw should they wish and mitigates the risk of attempting to contact deceased participants and potentially causing distress to living relatives. The benefits of collecting information about the participants are achieved through the wider study. It is estimated that 1 in 16 UK adults has (diagnosed or undiagnosed) type 2 diabetes, and this creates a substantial burden of suffering and health service use. Treatment of type 2 diabetes and related complications (cardiovascular disease, amputation, blindness, kidney failure) accounts for 10% of the NHS budget. This is expected to rise as the number of people in the UK who have type 2 diabetes is estimated to rise to 6.25 million by 2035. Type 2 diabetes is frequently asymptomatic, with the true onset occurring several years before diagnosis. While detection of the condition may be improving, around 30-50% of people with diabetes remain undiagnosed, and when patients are diagnosed, around 20-30% have evidence of diabetic complications. Long-term follow-up of the ADDITION-Europe trial will inform the management of newly diagnosed patients and to establish the size and nature of the benefits of detecting and treating diabetes earlier. Participation in the trial has facilitated earlier diagnosis and treatment of diabetes. The ADDITION trial has shown that this is not associated with adverse consequences in terms of anxiety and depression. Data from one year follow-up show that overall trial participants had lower levels of risk factors at one year than at the time of diagnosis. Furthermore, one year data suggest that, compared with routine care, intensive treatment is associated with reduced CVD risk, reduced anxiety, increased functional status and treatment satisfaction, with no detriment to quality of life. The intervention promoting target driven, intensive management of patients with screen-detected type 2 diabetes in ADDITION-Cambridge was associated with a non-significant relative reduction (17%) in the incidence of cardiovascular events and a reduction in all-cause mortality at 5 years. The lower than expected event rate during the trial suggests five years of follow up may have been insufficient to detect a potentially important difference. Furthermore, the apparent divergence of event rates from four years indicates that further follow up of this cohort is justified to establish whether early intensive multifactorial treatment reduces long term cardiovascular risk. Modelling work suggests that there might be a difference in cardiovascular risk over the long term. Significant reductions in myocardial infarction and all-cause mortality associated with glucose lowering were only observed after ten years of follow up in the UKPDS trial. Whether such a legacy effect might be seen in ADDITION Europe is unclear. Resolving this uncertainty is important in assessing the costs and benefits of screening for diabetes. No other trials of screening for diabetes or intensive treatment of screen detected cases have been reported and no others are underway in Europe. First line treatment for diabetes has changed following results from the UKPDS. While newly diagnosed individuals were previously offered lifestyle advice for six months and then prescribed metformin, metformin is increasingly being prescribed from diagnosis. Long term follow up of the ADDITION-Europe trial will allow examination of the potential legacy effect of a health service intervention that targeted practices and patients, and whether differences in the intensity of the intervention of the routine care and intensive treatment practices remain. Results will add evidence to decisions about treatment from diagnosis and the balance between treatment and disease burden. ADDITION-Cambridge has existing responsibility for organisation and delivery of diabetes care both locally and nationally (e.g. guideline development, managed care networks, expert review group for diabetes QOF indicators, National Screening Committee Advisory Group, UK Department of Health Vascular screening programme) and therefore have established mechanisms for influencing policy and practice in these and related fields. Results from this study will help inform care early in the course of the disease and will provide information on whether people in middle-age should be offered screening for diabetes in the UK and worldwide.

Outputs:

As described above, the outputs to be achieved from use of the List Cleaning service are: (1) Informing living participants of the 10-year follow-up process; reminding them of their right to withdraw from the study; providing them with an up to date study Participant Information Sheet, and inviting them to fill in study questionnaires; (2) Requests to participants’ GPs asking them to provide data from consenting participants’ medical notes; (3) Medical notes passed to the ADDITION Study Research Assistant who will review the notes to look for CVD endpoints and clinical measures (during surgery visits or remotely, with remote electronic access approved by the surgery). Knowing which participants are deceased will enable the study team to avoid attempting contact and potentially causing distress to living relatives. The aim of contacting participants is to enable the study to continue collecting information to be used in the ADDITION-Europe study. The ADDITION–Europe study has so far led to the publication of 76 papers in peer-reviewed scientific journals, with a further 4 under review or in press. Data from ADDITION has also contributed to 12 PhD theses and 52 oral presentations or posters at international conferences. The primary analysis of 5 year outcomes was published in the Lancet (Griffin et al. (2011). Lancet, 378 (9786), 156–167). The results of the 10 year analysis will be submitted to this or a similar leading medical journal by December 2016 (subject to the completion of the processing activities described above). Findings will also be presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2016. Throughout 2017 and 2018, secondary analyses including cost-utility analysis and mechanistic analyses will be published in leading medical or disease-specific peer-reviewed journals such as the Lancet, BMJ, Diabetalogia, Diabetes Care, and International Journal of Obesity. All publications will be open access, in line with the University of Cambridge open-access policy, and can be accessed by clinicians, academics, policy makers and interested members of the public. Outputs presented and/or reported will contain aggregate level data with small numbers supressed in line with the HES analysis guide. No personal identifiable data will be released or published.

Processing:

The University of Cambridge will submit a file containing the identifiers of the 867 participants recruited in Cambridge to the HSCIC using its secure electronic file transfer system. The HSCIC will link the identifiers to its copy of Patient Demographic Service (PDS) data and produce an output file containing the latest name, NHS number, GP practice code, address and postcode, date of birth and, where applicable, date of death for each participant. The data will be downloaded at the University of Cambridge’s MRC Epidemiology Unit and transferred immediately to an independent, physically-separated network that is isolated from public network systems and can only be accessed locally, with a managed access system including both password and procedural controls. Access to this network must be approved by both local senior management and the ADDITION study CI. The address and GP data will be used to re-contact participants who were lost to follow up, and to contact their registered GP surgery to enable to collection of recent endpoint and clinical measures. Where HSCIC data identifies changed contact details for participants, the data will leave the MRC Epidemiology Unit in one of two ways: (1) Individual letters addressed to participants informing them of the 10-year follow-up process, reminding them of their right to withdraw from the study, providing them with an up to date study Participant Information Sheet, and inviting them to fill in study questionnaires. (2) Individual letters to GPs asking them to provide data from consenting participants' medical notes. The supplied address and GP data will never be released for analysis; it will only be used for locating participants and their GPs to enable them to be asked if they wish to take part in the 10-year follow-up.

Objectives:

ADDITION-Europe is a 4 centre (Cambridge, Leicester, Denmark and the Netherlands) trial of assessing the effectiveness & cost effectiveness of intensive treatment of multiple risk factors among people with screen-detected type 2 diabetes. It has been supported by grants from the MRC, NIHR and the Wellcome Trust. This study aims to collect 10 year follow up information on cardiovascular events and risk factors, treatment and mortality for the cohort of 1,212 participants of the ADDITION study who enrolled in the UK. This will allow an assessment of the long term effects of the differences in intensity of treatment achieved during the first five years after diagnosis. The researchers plan to contact all ADDITION participants in the UK with a self-report questionnaire to assess health behaviour and patient-reported outcomes. Prior to sending any questionnaires, the participant list will be cross-checked with available records to minimise the risk of sending questionnaires to participants who are deceased. Section 251 support has been granted to permit the study to obtain up to date address details for all participants in order to inform them of the 10 year follow up (and if they wish, speak to the study team about the study); invite them to fill in questionnaires, and to update the study team of their current GP practice in order to complete the follow up. The University of Cambridge requires a List Cleaning service for a subset of the 867 participants recruited in Cambridge between 2001 & 2007. A separate application in respect of the participants recruited in Leicester will be made in the future. Personal identifiable data will only be accessed and used by those who have permission within the research team. Personal identifiable data cannot be used or given to any other third party. Results from this trial are needed in order to inform the management of newly diagnosed patients and to establish the size and nature of the benefits of detecting and treating diabetes earlier. Ten year follow-up of the trial participants will add to the existing research base concerning early treatment of type 2 diabetes and inform NHS policy decisions concerning whether population-based diabetes screening programmes should be established in Europe and worldwide.


Project 8 — DARS-NIC-302473-K6R0Z

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2016/11.

Repeats: Ongoing

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Objectives:

Purpose The data supplied by the NHS IC to University of Cambridge will be used only for the approved Medical Research Project identified above.


Project 9 — DARS-NIC-321968-S4Q6L

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/09 — 2017/11.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Benefits:

The University of Cambridge has already contributed substantially to clinical and health policy guidelines as detailed above. The University of Cambridge anticipates adding to the knowledge to improvements in preventing chronic disease and maintaining good health in later life in the next 5 years. This is a long term study involving a huge amount of data and EPIC has a well-characterised cohort that has been shown to be comparable to the general UK population. EPIC hopes to continue to add to this rich database and further characterise the longitudinal trajectory of the population as it ages and examine determinants of healthy ageing as well as chronic disease. Prevention depends on understanding of causes. We need a much better understanding of the biological mechanisms underlying disease and health; how these are influenced by the environment and what the potential population impact might be. There is increasing evidence for common pathophysiological pathways including glucose metabolism, inflammation, hormonal profile (thyroid and sex hormones) for ageing related conditions. In addition to chronic disease, we need to have a much better understanding of outcomes relevant to older populations such as functional health and quality of life. EPIC-Norfolk is a large long term prospective study that allows this approach. Previous results from the EPIC study have informed Department of Health public health initiatives (2010 ‘Small Change, Big Difference’ campaign), NICE and other clinical and public health policies and guidelines. Findings are also shared through extensive public engagement activities including regular Science Festival events and lectures to general public and charitable groups.

Outputs:

There have been over 1300 peer reviewed scientific publications from this study, with a number of findings making it into news. There are too many publications to list, but can be found at the website at http://www.srl.cam.ac.uk/epic/publications.shtml with news articles found at http://www.srl.cam.ac.uk/epic/news.shtml. Results from this study have informed Department of Health public health initiatives (2010 ‘Small Change, Big Difference’ campaign), NICE and other clinical and public health policies and guidelines. The University of Cambridge also shares results from this study via extensive public engagement activities including regular Science Festival events and lectures to general public and charitable groups. As well as continuing to analyse the data collected so far and publish on the health outcomes covered to date, the University of Cambridge have more recently collected objective data on cognition and hope to gather data on Dementia outcomes. Over 600,000 people in the UK suffer from dementia, costing over £17 billion a year. Dementia is such an important health issue, that the Prime Minister, David Cameron launched a challenge on Dementia on 26 March 2012 in order to speed up the progress in prevention and treatment. The MRC Dementias Platform UK (DPUK), a multi-million pound initiative that was developed and led by the Medical Research Council as part of the activity to meet this challenge. The EPIC-Norfolk study is a partner of DPUK and with the data collected to date and in the follow up planned for 2015-2018, will make EPIC-Norfolk a hugely powerful study of Dementia. The University of Cambridge also plans to use the linkage data to investigate the healthier individuals in the cohort to be able to inform policies on healthy and successful ageing. EPIC-Norfolk is an ongoing longitudinal study. The University of Cambridge received last HES update in 2015. The study continues to use outcome measures from HES data in publications and it is essential for the study to have up to date events for a number of reasons; • Firstly, the statistical power of the analyses depend on the number of known events. Less common outcomes can only be studied with sufficiently long follow-up and event numbers. • Secondly, EPIC-Norfolk has made multiple approaches to the cohort. Each approach is a new baseline and is necessary to have non-fatal events • Thirdly, journals are unwilling to accept publications where the outcomes presented are too old since the missing information may effect the results and their interpretation. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide. The University of Cambridge communicate research findings to members of the scientific community through publication in a broad range (both specialist and more general, scientific and medical based) national and international peer-reviewed journals and at national and international conferences. Please find below selected conferences and a list of some the journals that EPIC-Norfolk (plus the international EPIC study or consortia using EPIC-Norfolk data) have published in. Equally important is the dissemination of results outside the research community. The University of Cambridge communicate the results to the research participants via an annual newsletter. A list of recent newsletters can be found on our website at http://www.srl.cam.ac.uk/epic/newsletter_archive.shtml. The EPIC-Norfolk research team also recognises the value and importance of public engagement and have made this an integral part of its research agenda. The primary objective is to inform the general public (all age ranges) on high quality research data collected by the EPIC-Norfolk researchers team relating to diet, lifestyle choices, ageing and health and also to promote awareness of healthy living. The secondary objective is to make science more accessible and better understood in society. A list of public events including activities designed for younger individuals presented at the Cambridge Science Festival for the past few years can be found at http://www.srl.cam.ac.uk/epic/publicevents.shtml. In 2015, the EPIC-Norfolk researchers developed (and continue to manage) a web based system where other researchers taking part in the Cambridge festival could contribute their activities to be catalogued that could then be borrowed by schools and local community group setting. Information on this ‘library’ can be found at http://www.sciencefestival.cam.ac.uk/resources The University of Cambridge also actively promote participant involvement in this research. The University of Cambridge set up an advisory panel in 2010 to act as a consultation group to advise us on the research. The EPIC-Norfolk Participant Advisory Panel (EPAP) has been involved in all aspects of the research project from designing health questionnaires, writing of lay summaries, participant information, dissemination of results and providing a lay perspective on potential projects being considered for the future. The panel met three times in 2015, details of the meetings can be found at http://www.srl.cam.ac.uk/epic/participant_panel_archive_2015.html. Further information on EPAP can be found at http://www.srl.cam.ac.uk/epic/participant_panel.html The University of Cambridge held a public meeting to celebrate 20 years of EPIC-Norfolk research in 2013 . Details of this meeting and the posters presentations can be found at http://www.srl.cam.ac.uk/epic/20yr_meeting.shtml Recent Selected Conferences where EPIC data has been presented 7-9 December 2015 nutrition society winter conference. Oral presentation: "Total (food and supplement) n-3 PUFA intake is associated with lower Coronary Heart Disease mortality, independently of fish intake". March 2015 American Heart Association Scientific sessions Lifestyle and Epidemiology Science Festival Cambridge Institute of Child Health London GP Forum Norfolk May 2015 International society for Atherosclerosis Scientific symposium August 2015 European Society of Cardiology September 2015 European Association for the Study of Diabetes Nordic Epidemiology Conference October 2015 Singapore/Cambridge Scientific symposium November 2015 Netherlands Symposium on dietary saturated fats Cambridge Denmark Symposium 2015 American Heart Association Scientific Sessions on Epidemiology and Lifestyle March 2015 Baltimore USA Plenary invited Lecture on Optimizing Cardiovascular Health: examples from the EPIC-Norfolk study 17th International Symposium on Atherosclerosis May 2015 Amsterdam Invited lectures on • Epidemiology and prevention of Cardiovascular disease • Cardiovascular disease risk prediction Both presenting EPIC-Norfolk data International Society of Cardiovascular Disease Epidemiology and Prevention, seminar Fiji June 2015 Cardiovascular disease Epidemiology and Prevention examples from EPIC-Norfolk Cancer Research UK Researchers Scientific sessions Leeds July 2015 Population Research on Cancer aetiology and prevention: examples from the EPIC Norfolk study Cambridge Science Festival March 12 2015 Cambridge Vitamin D and health –findings from EPIC-Norfolk University College London Institute of child Health March 2015 London Ageing and lifecourse - data from EPIC-Norfolk Poster presentation at the Nutrition Society's Summer Meeting in July 2015 2014 Oslo University Department of Medicine Obesity and genetics – EPIC Norfolk findings Karolinska Institute Stockholm April 2014 Is Ageing modifiable: findings from EPIC-Norfolk CambridgeScience and Policy June 2014 Work shop on ageing – data from EPIC-Norfolk ARVO – Association of Research into Vision and Ophthalmology (also presented 2011, 2012, 2013) American association of Ophthalmologists (also presented in 2012, and 2013) Nutrition Society meetings (also presented in 2007, 2011, 2013,) Cardiovascular Research Trust (2014) 2013 and before Royal College of Ophthalmologists 2013 Faculty of Public Health annual conference 2012 Vision 2020 UK in 2012 Oral presentation at ICDAM 2006 in Copenhagen International Conference of Dietary and Activity Methods (2012 and 2006) Hundreds of manuscripts on EPIC data have been published in journals. The most common journals in which manuscripts have been published are (number indicates number of manuscripts per journal): 109 Int J Cancer 80 Cancer Epidemiol Biomarkers Prev 72 Am J Clin Nutr 61 Eur J Clin Nutr 50 Public Health Nutr 36 Int J Epidemiol 36 Br J Nutr 36 Am J Epidemiol 30 PLoS One 29 Nat Genet 26 Diabetologia 24 Cancer Causes Control 23 Br J Cancer 21 Hum Mol Genet 21 Eur J Epidemiol 20 Carcinogenesis 19 J Natl Cancer Inst There have been many more publications in many other journals.

Processing:

With the permission of the GPs, all patients on their registers born between 01/01/1918 and 31/12/1957 were invited to join EPIC. Those who consented were asked to provide information via questionnaires and undertake health checks. All participants attending the baseline health examination provided signed informed consent at inception of the study agreeing to provide lifestyle and health data and biological samples for this study and access to medical records. Participants provided signed informed consent again for subsequent attendance at follow up examinations in 1997-2005, in 2006-2011 and 2012-present. At each point the University of Cambridge have updated the consent process to be in line with the current guidelines. This included permission for access to medical records. The study has also received approval from the Norfolk and Norwich Ethics committee of each phase as well as clarification of previous permissions to be in line with current standards. EPIC-Norfolk is a flagging study and data form HSCIC (and previously ONS) is restricted to the EPIC-Norfolk participants. All participants in the study have to date been followed up through routine data linkage for mortality with death certification by cause, and cancer incidence through cancer registration and linkage with hospital records, GP records and other disease registers. This has allowed for the follow up for a large range of health outcomes that are relevant to an ageing population. The data has been subjected to ongoing analysis to determine links between dietary and lifestyle factors and health outcomes. All participants in the study have to date been followed up through routine data linkage for mortality with death certification by cause, and cancer incidence through cancer registration and linkage with hospital records, GP records and other disease registers. This has allowed for the follow up for a large range of health outcomes that are relevant to an ageing population. The data has been subjected to ongoing analysis to determine links between dietary and lifestyle factors and health outcomes. Linkage strengthens the study by allowing the follow up of participants who drop out of the study due to health reasons or death. It also allows the validation of self-reported conditions such as Parkinson's disease, dementia or stroke. Access to death data provides information on mortality but is also used for administrative purposes to prevent inappropriately mailing to participants who have died. Events identified through record linkage will be documented and linked with data collected from individuals on lifestyle so that the University of Cambridge can assess associations between lifestyle and subsequent health outcomes. The University of Cambridge combines mortality data and Hospital Episode Statistics data to define outcomes for fatal and non-fatal incident diseases. For example, the University of Cambridge can define an outcome of heart disease using the same range of ICD 10 codes applied to both fatal events from death certificates and non-fatal events from hospital admissions. Data from HSCIC is processed by a EPIC-Norfolk team within the Department of Public Health and Primary Care University of Cambridge School of Clinical Medicine, Cambridge. Data is not accessed outside the UK. On-going updates of data are necessary for the accurate follow up of participants.

Objectives:

The European Prospective Investigation into Cancer (EPIC) was established to examine the relationship between lifestyle, in particular, diet and physical activity, biological factors and health outcomes. Though EPIC is an international ten country collaboration, co-ordinated by the International Agency for Research into Cancer in Lyon, which is part of World Health Organisation, such that collaborating partners agreed a core protocol for the collection and standardisation of data throughout EPIC, each individual cohort is able to develop specialist areas for investigation. As part of this collaboration, data may be shared with the nine other centres but strictly in anonymised aggregated format. Anonymised data is also shared with other collaborators from recognised academic and research institutions. No identifiable data from HSCIC is processed or stored at any other site or location other than at the Department of Public Health and Primary Care University of Cambridge School of Clinical Medicine, Cambridge. This application relates to the Norfolk component of EPIC (EPIC-Norfolk) and the follow-up on approximately 25,000 men and women aged 40-79 resident in Norfolk at the time of recruitment. The scientific and public health strength of the population cohort is that through routine record linkage, the University of Cambridge are able to follow up the whole cohort who originally participated for health outcomes. Access to data only for the subset that, more than 20 years later are able to provide new signed informed consent will bias the follow up hugely, and make subsequent follow up and results impossible to interpret. The substantial investment of effort by participants over two decades in contributing to this research and increasingly valuable information from long term follow up of the whole population will be lost. Non-fatal disease is an important area of the research and access to linked HES data is essential to analyse this. Many diseases cannot be studied using mortality data alone as the diseases do not cause a death and may only occasionally appear on death certificates. These would include diabetes, eye diseases such as glaucoma, bone diseases such as osteoporosis, frailty and sarcopenia, inflammatory bowel diseases and dementia. Hospital usage is another important area for future research.


Project 10 — DARS-NIC-38314-C3P0Z

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2018/03 — 2018/05.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Flagging Current Status Report

Benefits:

The outcomes of this study are expected to directly benefit patients by improving the understanding of this poorly-understood disease to enable earlier detection and determination of the likely severity and rates of progression so that more appropriately personalised medicines and treatment plans can be prescribed. This will also improve awareness for patients so they can better understand their pathway so that their own expectations and those of their families can be appropriately managed. The current knowledge base for this cancer type is particularly small and patients’ outcomes not often analysed on an aggregate level. This study will perform one of the first analyses of prognosis and mortality on a cohort of this size. The release of mortality data will enhance the existing efforts to fully categorise Oesophageal cancer and understand the different prognosis and pathway of patients with particular clinical and genomic characteristics. One aim and potential benefit if successful is to understand how an individual’s genetic profile determines whether they will be respond to particular treatment or which sub-category of cancer type (and prognosis) they fall in to. The analysis and publication of the findings are expected to pave the way for more effective strategies including earlier detection of cancer or more targeted, personalised treatment approaches providing benefits to individuals, health care services and society in general. In future, alternative cancer treatments and diagnostics will benefit from the increased knowledge base that the research team expect to develop through the ONS dataset to allow further research teams to develop new treatment trials. One such treatment trial already linked in to OCCAMS is Neo-AEGIS, led by Plymouth which is trialling different approaches to chemotherapy in treatment. The findings of this study and associated clinical trials, which will include information on differentiating more aggressive cancers from less aggressive cancers as well as biomarkers for earlier detection will be widely disseminated on an international scale to maximise the impact and benefits to patients and patient care. The aim is also to feed into NICE guidelines via publications, recommendations from key advisory bodies, and stakeholder consultations. OCCAMS additionally convey information to current patients in follow up, meeting up with patients regularly at clinics and giving feedback about study progress and recruitment. This keeps the patients motivated and also lets them know how valuable their contribution is. New patients are also very keen to know details of how current samples and data are progressing the study towards improving knowledge and treatment options and developing new trials. At no point in this process would specific information about another patient be given to anyone else, and no information from NHS Digital be shared with anyone else. NHS Digital data will not be shared with associated clinical trials or any other third party, except in aggregate form with small numbers suppressed.

Outputs:

The OCCAMS research team regularly publish findings relating to their studies about oesophageal cancer in high profile journals such as ‘Nature Genetics’ and the ‘British Medical Journal’. The most recent publication was a paper on ‘Mutational signatures in oesophageal adenocarcinoma define etiologically distinct subgroups with therapeutic relevance’ published in ‘Nature Genetics’ in September 2016. This paper proposed a framework to classify types of oesophageal cancer by genomic profile. To date, 5 papers have been published as a direct result of the study and over 20 from closely-linked research projects. Findings from the analyses of the ONS data will supplement existing data areas as well as allowing the team to test further certain correlations between what is affecting prognosis and length of time that a participant is living with the disease and clinical and genomic characteristics of the individual. A mortality-related paper will be submitted to journals such as ‘Nature Genetics’ and the ‘British Medical Journal’. This is expected by December 2021. This is beyond the end date of the OCCAMS research project as there is necessarily some time needed between the last patient enrolled and the final processing being finished. Please note that OCCAMS clinical trial is a single research project that will solely have access to data provided by NHS Digital. It is one of the largest cohort studies of its kind, and is invaluable for increasing/improving the knowledge base for oesophageal cancer. This project is not done in a vacuum, however: the OCCAMS research team have additional projects that will look at the end results of this work, but no data provided by NHS Digital will be shared with other studies. Any outputs from the OCCAMS trial will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. The OCCAMS dataset is being continually expanded as hospitals continue to enrol patients and submit findings. As more information is amassed, it enables re-examination of previous findings but also new depths of analysis. For example, increasing evidence makes it possible to identify groups of patients with common characteristics that can be studied. As a consequence, the exact subjects of future studies and publications is unknown from the outset. However, it is expected that papers will continue to be written and published and the study disseminates findings regularly through conferences presentations in the UK and internationally where experts in the field will meet to discuss the latest developments in classification of cancer through genomics and treatment/diagnosis innovations. The Principal Investigator is actively working to use evidence from the study to make recommendations on how treatments are planned and delivered based on specific indicators. Specifically: - Developing algorithms to reduce diagnostic delay - Developing trials to evaluate precision treatment based on the molecular make-up of the tumour matched with treatment response and outcome - Developing standardised reporting tools in oesophageal cancer for endoscopy, surgery and pathology through evaluation of geographical variation in data collected in this UK wide study The outcomes of the OCCAMS clinical trial will be used in corroborating findings and showing evidence of the benefits of new treatment pathways and early detection to evidence best practice; this will be shared directly with NICE. (No patient-level data will be shared with any other party, solely research result and generic findings.) The ultimate aim is to influence the NICE guidelines which determine best practice for GPs and doctors via publications, recommendations from key advisory bodies, and stakeholder consultations. Recruitment and data collection is expected to continue until 2020 and numerous outputs, in line with those described above, are expected over the course of the study. Findings will be fed back directly to collaborating hospitals. As is common in research, depending on findings, there may be appropriate media attention to this work. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

Processing:

Data supplied by participating trusts The NHS hospital trusts identify and recruit eligible participants and provide details of the participants (including biological samples and person identifiable data) to the Cambridge University Hospitals NHS Foundation Trust. The samples are labelled with a unique patient ID, and Cambridge University performs laboratory tests on the anonymised samples. NHS Digital data Access and storage The Cambridge University Hospitals NHS Foundation Trust will provide to NHS Digital a list of participants’ identifiers (specifically name, sex, date of birth and NHS number plus unique OCCAMS ID). NHS Digital will provide quarterly cohort event notification and Cause of Death reports (including date of death) for all deceased participants. This data will only be stored at the Cambridge University Hospitals NHS Foundation Trust. The date and cause of death data will only be accessed by individuals within the Upper GI trials office at the Cambridge University Hospitals NHS Foundation Trust who have authorisation from the Clinical Study Coordinator to access the data for the purpose(s) described, all of whom are substantive employees of the Cambridge University Hospitals NHS Foundation Trust or Cambridge University. Processing Mortality data will be linked and analysed in conjunction with data acquired from the participating trusts and derived from analysing the samples. The mortality data will provide additional intelligence to analyses already being undertaken. This data provides the outcome and indicates effectiveness of treatment each patient received. Analysts at the Cambridge University Hospitals NHS Foundation Trust will have access to the minimum amount of personal data necessary to perform their analyses including full date of birth and date of death, as well as cause of death. OCCAMS is an independent clinical trial , although it is expected that findings from OCCAMS trial will pave the way for future research in this area. The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Objectives:

Cancer of the stomach or oesophagus (gullet) or at the junction between the oesophagus and the stomach (Oesophageal and junctional adenocarcinomas (OAC)) have a poor prognosis and survival rate and in contrast to other cancers, knowledge of the molecular pathogenesis of the disease has not yet been used to determine prognosis and therapy. Cambridge University and the Cambridge University Hospitals NHS Foundation Trust require ONS mortality data for use in the Oesophageal cancer clinical and molecular stratification (OCCAMS) research study. The study is funded by Cancer Research UK and has been running since 2010. It was instigated by Cambridge University in collaboration with Cambridge University Hospitals NHS Foundation Trust. OCCAMS is a large multisite observational study involving over 15 NHS hospital trusts in the UK and it has been adopted on the National Institute for Health Research’s portfolio of high-quality research studies. Recruitment to the study and data collection will be complete in 2020. The main focus of the OCCAMS study is to develop a model that can be used to better assess therapeutic options for future patients with this specific condition. A key aim is identifying markers that indicate the likely pathway and rate of progression of the condition in individuals so that care plans can be appropriately tailored. The aims of the OCCAMS study are to: Better characterise the clinico-demographic risk factors; Characterise the molecular genetic landscape (DNA, RNA, epigenome); Determine disease sub-types and develop new clinically relevant classification systems; Develop and validate improved clinical staging and prognostic algorithms; Ascertain new therapeutic targets for future research Mortality data is required in order to complete the clinical research records collected from the participating NHS hospital trusts. It gives a vital end point. Understanding how long a participant has lived with the disease and the particular nature of their condition will allow the research team to better understand the progression of the disease. With a poor prognosis, the patient group is likely to move into palliative pathway and die in the community including in hospices and at home. As such, the recording of death is less likely to be part of the original hospital record supplied by the participating hospital trusts. Full date of death is required as these patients' prognosis is measured in months. If only the month and year of death were provided, it would make survival data inaccurate (+/- 4 weeks is a very long period for these patients), rendering this dataset less valuable and rich for research purposes. This study aims to maximise specificity in order to achieve clear and robust outcomes. Where deaths are recorded in the hospital record, the study will have access to full date of death supplied by the NHS hospital trusts so receiving equivalent data from NHS Digital will enable consistency in analyses.


Project 11 — DARS-NIC-43771-N0W3Q

Opt outs honoured: Y

Sensitive: Sensitive

When: 2017/09 — 2018/05.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data

Categories: Identifiable

Datasets:

  • MRIS - List Cleaning Report

Benefits:

The Fenland study has a number of outputs that have significantly impacted on health policy and have provided important evidence for NHS commissioners in the priority area of type 2 diabetes. In March 2015 a Fenland study professor delivered an expert testimony on the impact of physical activity and diet on health at the House of Commons Select Committee inquiry looking at the most effective way of conveying healthy eating and drinking to the public in order to achieve a more healthy weight, and evidence of the impact of physical activity on health, including its impact independent of weight. A summary of the written evidence submitted, which used data from the Fenland study is available here: http://www.cedar.iph.cam.ac.uk/wp-content/uploads/2014/04/HoC-Health-Diet-and-PA-Dec14-PHYSICAL-ACTIVITY-from-MRC-Epid-CEDAR.pdf The Fenland cohort was also used to examine the association between density of takeaway food outlets at home, at work, as well as along commuting routes from home to work. We found that takeaway exposure was associated with increased takeaway consumption and was strongly associated with a greater Body Mass Index (BMI). This research has influenced the NICE diet recommendations, which has recommendations for strategy, policy and commissioning for local authorites: http://pathways.nice.org.uk/pathways/diet Continued longitudinal follow up of the Fenland study will provide information on the change in quantitative metabolic risk factors over time, an important aspect not covered by the single snapshot we have of participants at the moment. The Fenland team is committed to continue to influence health policy and have a significant benefit to public health.

Outputs:

The primary output form this application will be an updated cohort contact database, which will allow the Fenland study to invite participants appropriately to phase 2 of the study. This follow-up study will enable important aetiological investigations into the causes of common metabolic disease, including the interplay between genetic and environmental risk factors. By studying the determinants of lifestyle behaviour change in mid-life, it will also contribute to the translation of that aetiological understanding into preventive action. The University of Cambridge are also keen to ensure participants are updated of their findings and have recently run a second series of opening evenings in a number of local areas. In summer 2016 the University of Cambridge held a series of public meetings for Fenland Study volunteers, to provide an opportunity to hear about progress so far, key scientific findings and plans for future. More than 550 people attended the three meetings, which comprised of a short presentation from Fenland Chief Investigator, followed by a longer panel discussion with Fenland researchers, who answered questions from the audience about the study, its’ findings, and their implications for public health policy and practice. These panel discussions were very lively, with many excellent questions from audience members. Feedback from the meetings was collected on paper forms with free-text space available for attendees to add comments. Participant responses have been overwhelmingly positive, with most keen to return for a second visit as they benefit from a free comprehensive ‘health check’ of sorts and see the research we are producing is relevant and high impact. Completion of phase 2 is expected by 2019. Fenland data has already led to a number of publications in leading peer reviewed journals, as listed on the University of Cambridge webpage: http://www.mrc-epid.cam.ac.uk/research/studies/fenland/fenland-publications/ The MRC Epidemiology Unit is committed to building clinical and public health pathways for the application of their work. Examples of their outputs include: · Research regularly receives national and international press coverage. Many of our news stories have direct relevance to practice and policy: www.mrc-epid.cam.ac.uk/news · The majority of scientific publications are Open Access: www.mrc-epid.cam.ac.uk/research/research-papers. CEDAR publications can also be searched at www.cedar.iph.cam.ac.uk/publications/ · Evidence Briefs and data visualisations (http://www.cedar.iph.cam.ac.uk/resources/evidence/-) . Succinct summaries of research findings for policymakers and practitioners, developed in collaboration with our partners. · Evidence submissions (http://www.cedar.iph.cam.ac.uk/resources/evidence-submissions/ )to policy bodies and guidance producing organisations. The Fenland study cohort is a unique in the scale and depth of phenotyping and constitutes a significant resource to researchers investigating questions important to the management and prevention of diabetes. Follow up of this cohort (completion of phase 2) will collect longitudinal data on key risk factors and continuous metabolic traits, in order to define the temporal and dynamic relationships between these exposures and changes in metabolism, which are currently limited by the cross-sectional nature of Fenland 1.

Processing:

Data will be sent securely to NHS Digital using encryption software as instructed by NHS Digital. Data received from NHS Digital will be downloaded at the MRC Epidemiology Unit and transferred immediately to an independent, physically-separated network that is isolated from public network systems and can only be accessed locally, with a managed access system including both password and procedural controls. Access to this network must be approved by both local senior management and the Fenland study CI. MRC Epidemiology data security processes are compliant with the MRC Information Security Policy and are also aligned with ISO 27001. The Unit has a System Level Security Policy (SLSP) which applies to all studies and has been approved by the National Information Governance Board (NIGB, prior to its replacement). The standard that the Unit works to is also recognised as being equivalent to the University of Cambridge Clinical School Information Security Policy. All persons accessing the data are substantive employees of the University of Cambridge. NHS Digital address will be used to contact participants who were lost to follow up. Where NHS Digital data identifies changed contact details for participants, NHS Digital data will leave the MRC Epidemiology Unit through individual letters addressed to participants inviting them to participate in phase 2 of the Fenland study. GP practice code is required as participants were originally recruited through their GP practices and the University of Cambridge therefore keep GPs informed of their patient’s involvement in the study and feedback clinical results (such as blood pressure, blood test results) where participants have consented to this. The University of Cambridge also highlight abnormal results (for example a blood result indicating diabetes) with the participant’s GPs so it is important to have current information on where they are registered for their continued care. NHS Digital address and GP data will never be released for analysis; it will only be used for locating participants and their GPs to ask them to take part in follow-up. Fact of death will be used to cross reference with the University of Cambridge's mailing list to exclude participants who are deceased from further contact. Where NHS Digital are unable to find a positive data match to records from the cohort the study will remove these participants from the study and they will therefore not be re-contacted or invited to take part in the second phase of the study.

Objectives:

The objective of the current data request is to obtain current address, GP information and mortality data for participants of the Fenland study to enable the University of Cambridge to invite appropriately to phase 2 of the study. Without up-to-date contact information from NHS Digital a significant proportion of participants will not be notified of the opportunity to take part in phase 2. Maintaining a high retention rate to the study will ensure the continued quality of the University of Cambridge research outputs in terms of completeness of follow up and ability to generalise to the wider population. Mortality data will enable the University of Cambridge to avoid attempting contact with deceased participants and therefore prevent unnecessary distress for relatives. The Fenland study began in 2005 and is funded by the Medical Research Council through its block grant to the University of Cambridge to support the MRC Epidemiology Unit. The study aims to investigate the interaction between genetic and lifestyle factors in determining obesity, diabetes and related metabolic disorders which present a considerable public health concern. The University of Cambridge recruited 12,435 participants from general practices across Cambridgeshire to phase 1 of the study. All attended a baseline visit and provided information on their health-related behaviours, past and current medical conditions and family history. They also participated in objective assessment of body composition, cardio-respiratory fitness and physical activity. They provided blood samples to determine blood glucose and blood fat (such as cholesterol) levels, and for further research aimed at understanding the cause of diabetes and related disorders. In phase 2 of the study the University of Cambridge will re-approach the same cohort of participants to invite them to re-attend for screening with the same battery of tests. This will provide information on the change in quantitative metabolic-related behaviours and health status over time and allow longitudinal investigation of the determinants of change. Finally, the assembly of information at the individual and collective level will permit investigations into the relative importance of different factors that drive key lifestyle behaviours.