MRC National Survey of Health and Development (NSHD) - tracing

University College London (UCL) requires access to NHS England Data for the purpose of the following research project:

“Medical Research Council (MRC) National Survey of Health and Development (NSHD) - also known as the 1946 British Birth Cohort”

The following is a summary of the aims of the research project provided UCL:

The MRC NSHD is the oldest and longest running of the British birth cohort studies. From an initial maternity survey of 13,687 (82%) of all births recorded in England, Scotland and Wales during one week of March, 1946, a socially stratified sample of 5,362 singleton babies born to married parents was selected for follow-up.

Over the years, the NSHD’s findings have made an important contribution to society by influencing government policy. Some highlights are given below The study’s first direct policy impact was a private member’s bill (the ‘Analgesia in Childbirth bill) which was introduced in the House of Commons in 1949. This increased training for midwives to give gas and air analgesia to all mothers during childbirth. It was in response to the maternity survey’s finding that, as only one in five midwives was qualified to administer gas and air, and just 20 per cent of mothers in the survey had received any kind of pain relief during labour. Other policy investigations that directly used study findings included: The Platt Committee (The welfare of children in hospital, 1959) The Plowden Committee (Children and their primary schools, 1967) The Finer Committee (Report of the committee on one parent families, 1974) The Acheson Committee (Independent inquiry into inequalities in health, 1998) The Marmot Review (Fair society, healthy lives, 2010) The study’s findings have also had an indirect impact on policy by influencing popular thinking. Evidence for this is described in Expected Measurable Benefits to Health and/or Social Care.

The NSHD study team has collected unique lifetime data on body size and maturation, cognitive and physical function, socioeconomic status and diet; and has repeat adult data on diet, smoking, physical activity, blood pressure and lung function. The most intensive data collection to the whole cohort in 2006-2010, when study members were aged 60-64 years, included measurement of cardiac structure and function, body composition and bone density.

The most recent data collection (2022-24) to the whole sample included postal questionnaires, a home visit by a trained research nurse for interview and assessment in 2022 and/or a London clinic visit in 2022/23. At this follow-up, all eligible UK study members were contacted: 2,162 study members gave information, of which 1,918 study members completed a postal questionnaire, 1,812 study members completed a cost of living questionnaire and 1,095 study members completed a home visit.

Each year the Lifelong Health and Ageing (LHA) at University College London (UCL) sends an annual postal mailing to all NSHD participants. NSHD asks that participants complete a reply slip which is returned to LHA which allows participants to provide LHA with any change in their details e.g., a new email address, phone number. LHA also ask them to return the reply slip even if none of their details have changed, and in doing so, seek a positive confirmation that that is the address LHA hold for them. As a result LHA, can maintain the cohorts' latest details on the NSHD database. In the event of the annual mailing not reaching the participant it is returned to LHA as a 'return to sender'. LHA will attempt to trace all these returns but if LHA cannot locate the participants then they are flagged on the database as a 'lost'.

NHS England may potentially hold a more recent address and provide LHA with an opportunity to invite cohort members who have been lost to follow-up to re-join the study. The LHA at UCL would therefore like to access to NHS England Data to provide address details in order to re-contact study members who have been lost to follow up. This will avoid potential bias to the results, due to loss of participants to follow-up. Obtaining address details will enable UCL, where possible, to re-contact the study members who had not previously refused and who had been lost to follow-up, to invite them to continue participating in the study, as well as inviting them to consent to future participation.

The following NHS England Data will be accessed:

Demographics – necessary because the study would like to maintain contact with as large a number of study participants as possible.

The level of the Data will be:

Identifiable – necessary so UCL can maintain contact with as large a number of study members as possible. LHA at UCL require updated addresses for study members.

The Data will be minimised as follows:

- Limited to the NSHD study cohort identified by UCL of those who have been lost to follow-up (approx. 200-350 of the study cohort). UCL will exclude individuals whose deaths have been reported or who have withdrawn from the study.

University College London (UCL) is the research sponsor and controller as the organisation ensuring the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under UK GDPR is Article 9(2)(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing 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.

The funding is provided by the MRC. The funding is specifically for the NSHD, 1946 Birth Cohort. Funding is in place until 31st March 2029. The funder will have no ability to suppress or otherwise limit the publication of findings.

Amazon Web Services provides cloud hosting services to UCL and will store the Data as contracted by UCL.

VIRTUS Data Centre provides offsite back-up services but does not process the data.

Formara Limited provides a mail out service and will process the Data as contracted by UCL.

All those accessing the data supplied by NHS England are substantive employees of University College London or authorised employees of Formara Limited carrying out work on behalf of UCL.

A Public involvement, engagement and participation (PPIE) group was formed in 2021, where they have provided feedback and shaped documentation on how we explain how data are used. Further work is on-going with NSHD participants to enable co-creation of questionnaires and other areas of interest.

UCL is contracting Formara Limited to send mailing to NSHD participants.

UCL will share the cohort members' personal information with Formara Limited (name, address) these may contain some of the addresses provided by NHS England to UCL. UCL will use the Data Safe Have Secure mail function to provide Formara Limited with an encrypted file. Only Data Safe Haven account holders with Outbound rights are able to use the Secure Mail feature.   The Secure Mail feature allows UCL to send messages and files as secure "packages". Packages are secured using a system-generated password which UCL should communicate to the recipient in a method other than email. Recipients will get an email with a unique link to each package, allowing them to download the message and files through a secure connection. Formara Limited will delete all information after the activity has been completed.

UCL will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Full Name and Study ID) for the cohort to be linked with NHS England Data.

The file supplied will only contain study members who have consented to be part of the NSHD and have been lost to follow-up. It will not include study members known to have died or to have withdrawn from the study.

NHS England will provide the relevant records from the Demographics dataset to UCL. The Data will contain directly identifying data items including NHS number, name, address, postcode and study ID which are required to update the NSHD database with the correct address and facilitate contact with participants.

The 'Reason for removal date' is used to compare the address confirmation data UCL holds on their database. If UCL hold an address which has been confirmed more recently than the ‘reason for removal date’ they receive from NHS England, they will retain the address in their database but if the ‘reason for removal date’ from NHS England is later than the address confirmation date they hold then they will update their records. On receipt of Data from NHS England, UCL will remove details of deceased cohort members before providing information to the Formara Limited.

UCL require identifiers in the circumstance that any discrepancies arise. This is because there are instances where UCL receive identifying details that do not accurately match the cohort member. Using the identifying details UCL will be able to assess whether the details they hold correctly associate with the participant.

The data will be stored on servers at UCL and Formara Limited.

UCL uses offsite back-up services provided by VIRTUS Data Centres.

UCL stores data on the Cloud provided by Amazon Web Services.

The data file supplied by NHS England will be processed within LHA at UCL and entered into LHAs secure confidential address database.

Access is restricted to employees of UCL and Formara Limited.

Formara Limited will use the Data to send mailing to participants on behalf of UCL.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

Data will be accessed by authorised personnel via remote access.

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.

For remote access:

- 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;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- 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.

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).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Personnel are prohibited from downloading or copying data to local devices.

UCL staff using the DSH complete annual training and regularly review data access arrangements ensuring data are only limited to those authorised to access it.

The data will not be linked with any other data.

The addresses supplied by NHS England under this agreement will help ensure the NSHD have contact details for the cohort which is lost to follow-up, and can re-contact them to determine whether they would like to continue to take part in the study – which would not otherwise have been possible. This will reduce the potential impact of bias attributed to loss to follow-up and will ensure the study sample is maintained and the study remains representative of the studied population.

The output will be continued participation in the NSHD, for those participants who would not otherwise have participated due to loss to follow-up.

NSHD will continue to produce a range of research outputs. This research has already generated multiple publications in peer review journals and findings are further disseminated via conference presentations.

A full list of publications produced to date are published on the MRC LHA website at: http://www.nshd.mrc.ac.uk/.

Publications and conference attendances target an audience of researchers and scientists. Typical conferences attended annually by UCL researchers include Alzheimer’s Association International Conference (AAIC), CLOSER (various dates throughout the year) Society for Social Medicine & Population Health (SSM).

UCL also participate in the annual MRC Festival of Medical Research to disseminate at a lay/population level. Members of the team regularly engage with policy makers and health professionals to influence policy- a recent example is of senior members of the team acting as advisors to the House of Lords Science and Technology Select Committee inquiry into Ageing, Science, Technology and Healthy Living.

The NSHD study website is currently being updated to incorporate a section summarising research findings and their implications for participants and researchers and will also incorporate a current study news section for both participants and researchers (with ongoing updates). High quality research outputs are always needed to inform health and social care policy.

A full list of publications can be found at http://www.nshd.mrc.ac.uk/findings/

Results of the NSHD will also be disseminated to the study members through their annual birthday/newsletter and the NSHD website (www.nshd.mrc.ac.uk).

Outputs are planned on a rolling basis.

The outputs will not contain NHS England Data provided under this Data Sharing Agreement.

The NSHD has informed UK health care, education and social policy for 70 years and is the oldest and longest running of the British birth cohort studies. Today, with study members in their early seventies, the NSHD offers a unique opportunity to explore the long-term biological and social processes of ageing and how ageing is affected by factors acting across the whole of life.

The information provided by study members provides valuable evidence for the research and policy community about the cohort's transitions from birth to older age.

A specific benefit of the data dissemination under this agreement is being able to trace study members, using this data ensures the study sample is maintained and the study remains representative of the studied population.

Below are some examples of existing publications using the NSHD data benefiting public health:

• The NSHD finding that more rapid rises in systolic blood pressure during midlife (even if not crossing into hypertension) were related to poorer cardiac structure (published in the European Heart Journal in 2014) has implications for treatment guidelines as it suggests that identification and treatment of people with rapidly increasing SBP, even if they are not reaching the criteria for hypertension, may be beneficial in preventing subsequent cardiovascular disease.

• The NSHD findings suggesting that those who lost weight at any age during adulthood, even if weight was regained later, had better cardiovascular risk profiles than those who remained overweight or obese supports public health strategies that help individuals to lose weight at all ages.

• The NSHD finding that better performance in tests of physical capability (i.e. grip strength, chair rising and standing balance) in midlife was linked to higher survival rates over 13 years of follow up was published in the British Medical Journal. This highlighted the value of these simple objective physical tests in helping to identify those people who from at least as early as midlife onwards may require more support than others to achieve a long and healthy life.

Due to their age and pace of implementing intervention, the NSHD study participants are unlikely to directly benefit from this research, but through UCL's dissemination strategy, it is hoped that the research will be used in policy and used to benefit successive generations. Through UCL's annual newsletter, study participants receive information on how their data is used, which can encourage continued participation in the study.

Yielded Benefits is not a requirement for new applications.