Fenland study - application for participant tracking & mortality data MR1420

The objective of the current data request is to obtain current address, GP information and mortality data (and is thus identifiable data) for participants of the Fenland study to enable the University of Cambridge to appropriately invite the participants 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 information 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 is the sole data controller and processor and the MRC Epidemiology Unit refers to the specific unit of the University of Cambridge where the Fenland Study work is based. Funders have no role in the purpose/processing of this data.

The Fenland Study is an existing population-based cohort study of the interaction between genetic and environmental factors in determining risk of diabetes, obesity and related health conditions. The University of Cambridge recruited 12,435 participants (male and female, born between 1950-1975) from general practices across Cambridgeshire to phase 1 of the study (patients suffering from psychotic illness, pregnant and lactating females, people who are unable to walk unaided, individuals with diagnosed diabetes or a prognosis of less than 1 year were excluded). 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 has re-approached the same cohort of participants to invite them to re-attend for screening with the same battery of tests. NHS Digital data will only be used for purposes of contacting participants, ensuring to date address information is provided and that the participant has not passed away (so that distress to family members is not caused). Phase 2 of the study 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.

This study is part of the University of Cambridge and as such the legal basis to hold and use personal data is covered under the General Data Protection Regulation “Article 6(1) (e) processing is necessary for the performance of a task carried out in the public interest”. To hold special categories of personal data our lawful basis is for pursuing scientific research under “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 research is in the public interest because it 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.

A file containing the identifiers (forename, surname, NHS number, date of birth, full postal address and gender) of participants will be sent securely to NHS Digital using encryption software as instructed by NHS Digital. Address update and mortality 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 an Information Security Policy 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 (i.e. those approved to work on the Fenland Study as well as the in-house data management team managing that access) accessing the data are substantive employees of the University of Cambridge.

The up to date addresses provided by NHS Digital will only 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. No automated profiling will be used in this 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 nor will it be linked with any other datasets; it will only be used for locating participants and their GPs to ask them to take part in follow-up.

The fact of death field will be used to cross reference with the University of Cambridge's mailing list to exclude participants who are deceased from further contact to ensure no distress is caused to family members.

Where NHS Digital are unable to find a positive data match to records from the cohort, these participants shall be removed from the study and they will therefore not be re-contacted or invited to take part in the second phase of the study.

NHS Digital reminds all organisations party to this agreement of the need to 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)

The primary output from 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. As a result, the study is now able to follow up more of the cohort thereby necessitating the extension of the study into 2020.

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.

Completion of phase 2 is expected by late Spring/early Summer 2020. 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.

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.

The primary benefits of using NHS Digital's List Cleaning service are that it has enabled the Fenland Study team to send out invitations to more participants thanks to having up to date contact details and has significantly increased the number of participants that have been able to take part. As a result of having more participants take part in Phase 2 (with help from the List Clean Service), researchers will now have more data with which to conduct their research therefore increasing the power of their respective studies and leading to a more comprehensive representation of the original cohort to further elucidate the longitudinal effects of diet and physical activity choices within a cohort, with particular attention paid to metabolic traits, including insulin-resistant and diabetic persons.

Furthermore, knowing which participants are deceased has enabled the study team to avoid attempting contact and potentially causing distress to living relatives. As previously stated, completion of phase 2 is expected by late Spring/early Summer 2020.

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.

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.

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

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.

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 authorities: http://pathways.nice.org.uk/pathways/diet