MR1475: WRAP-Up: 5 and 10 year follow up of the WRAP trial - access to MRIS data

The University of Cambridge, MRC Epidemiology Unit (MRCEU) wishes to request access to data held by NHS Digital for the WRAP trial cohort. This is the first application relating to this cohort. In this submission the MRCEU would like to apply for current address details for the WRAP trial cohort, via MRIS - List Cleaning Report, with section 251 support from the Confidentiality Advisory Group.

The List Clean Report data is being requested for the Weight Loss Referrals for Adults in Primary Care (WRAP) trial. This trial ran from 09/12 to 03/16, and assessed the effect of referral to a community based open-group programme (12 weeks or 52 weeks) vs standard care, on weight and glycaemia, at 12 and 24 months. Cost-effectiveness was demonstrated at 12 and 24 months for adults who are overweight or obese. The impact of the three programmes was modelled over the next 25 years and cost-effectiveness was demonstrated; 5-year follow-up of the cohort will help establish whether medium-term assumptions of weight loss were correct.

WRAP participants are currently being invited to participate in a 5-year follow-up visit as part of the WRAP-Up study. WRAP-Up is the 5- and 10-year follow up of the WRAP trial. WRAP-Up will provide objective evidence of 5-year and 10-year outcomes for body weight, glycaemia, and incidence of diabetes and cardiovascular disease. These data will also allow the MRCEU to improve its modelling of longer-term outcomes. Approvals have been received for 5-year follow-up, a new application will be sought for 10-year follow-up. The MRIS List Cleaning Report will provide current address details for the cohort; a subsequent amendment to this application will request HES data, supported by the appropriate legal basis.

The 5-year follow-up of the trial participants has been funded by the National Institute of Health Research to provide the NHS with vital evidence about the long-term impact of commonly commissioned weight management services on health and health resource use. It will be used to inform policy makers about which weight management services offer best value for money and will support commissioning decisions. The study team aims to complete 5- and 10-year follow-up of the WRAP participants with as high a follow-up rate as possible, in order to reduce uncertainties and provide a more precise estimate of longer-term impact of referral to community based open-group behavioural weight loss programmes on incidence of diabetes and other obesity-related conditions and associated resource use.

Of the original WRAP cohort size of 1267, 225 participants did not complete the study visits and 2 declined access to medical records, and the remaining 1040 participants are recorded as maintaining their consent to remain in the cohort. The 1040 participants have provided consent to be contacted for further follow-up.

Purpose:

List Cleaning (MRIS) service is being requested now that Section 251 support has been granted from the Confidentiality Advisory Group for this purpose. Access to up-to-date address information is required to cross-reference our existing contacts database with details in the list clean provided by NHS Digital to ensure our participant records are up to date, to allow follow-up of participants who have moved since the last trial contact and to prevent the MRCEU from attempting to contact participants who have passed away since their previous contact with the MRCEU. The list clean data will not be linked to study questionnaires, HES, MINAP or SSNAP data. The WRAP contacts database with personal identifiable information is held separately to any outcome data and linked only by ID numbers.

List clean data will be used to cross reference the MRCEU's existing contacts database with details in the list clean provided by NHS Digital to ensure participant address records are up to date, to allow follow-up of participants who have moved since the last trial contact and to prevent the MRCEU from attempting to contact participants have passed away since our previous contact. The list clean data will not be linked to study questionnaires, HES, MINAP or SSNAP data. The WRAP contacts database with personal identifiable information is held separately to any outcome data and linked only by ID numbers.

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 a password and procedural controls. This ‘other network’ is still on the Unit premises but is known as the ‘private network’ where all of the Unit's patient data is stored. It is not connected to the internet and can only be accessed by being at the Unit.

Access to this network must be approved by both local senior management and the Chief Investigator for the WRAP-Up study. All study team members accessing the data have a contract with the Unit.

The Unit’s data policies and governance are available at:

http://epi-meta.medschl.cam.ac.uk/data_sharing_policy.html

The direct outputs from this application will be an up-to-date list of participant address records, to support initial contact to commence the WRAP-Up study.

The initial 5-year WRAP Up results are planned to be published at the end of 2019. They will also be included in a grant report to the NIHR which is due in April 2022. The 10 year WRAP Up results are planned to be published at the end of 2024.

Previous outputs of the WRAP trial include two papers in peer-reviewed scientific journals, including the Lancet (Lancet, v.389(10085), p2214–2225). Results from WRAP have also been presented at conferences and NHS Primary care meetings. Data has also contributed to MSc and PhD theses.

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 sup[ressed in line with the HES analysis guide. No personal identifiable data will be released or published.

Findings will also be used to advise policy makers on the cost-effectiveness of referral to behavioural weight management programmes and the impact on incidence of diabetes and other risk factors for cardiovascular diseases.

When the study is completed, meta-data will be added to the data dictionary on the meta-data access portal http://epi-meta.medschl.cam.ac.uk/. The trial team will also send all WRAP-Up participants a summary of the results in the form of a newsletter.

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 ie: employees, agents and contractors of the Data Recipient who may have access to that data)

WRAP-Up is the 5 and 10 year follow up of the WRAP trial, which was one of the largest trials of publicly available based open-group weight management programmes for people with overweight and obesity. Overweight and obesity are a major risk factor for diabetes type 2.

WRAP results demonstrated that referring people with overweight and obesity to publicly available open-group weight management programmes (such as Weight Watchers or Slimming World) can help people to lose weight and reduce glycaemia over 2 years. Modelled data suggests it is likely to be cost-effective in the long term because it reduces disease incidence and associated health care costs. The 5 and 10 year follow up of the WRAP trial (WRAP Up) will provide important data about weight regain, disease incidence, and health resource use. The objective data on 5-year and 10-year outcomes will enable more realistic estimations of long-term impacts on disease incidence and associated resource use.

The overall results of this research will provide policy makers and commissioners with robust evidence regarding the effectiveness and value for money of scalable behavioural weight management programmes for the prevention and treatment of type 2 diabetes. This will help them to decide which programmes to fund.

Yielded Benefits is not a requirement for new applications.