STEADFAST: Education outcomes in young people with diabetes: innovative involvement and governance to support public trust.

Diabetes is a common long-term health condition affecting 40,000 children and young people in the UK, requiring daily management. The four UK home nations have legal commitments to support young people with medical conditions in their education. However, there are significant challenges in providing evidence to support interventions.

Wide public understanding and strong support are critical for the use of sensitive data in research, such as health and education data. Young people are particularly challenging to engage in such conversations. Researchers at Cardiff University, charity Diabetes UK and partners previously developed a data access framework and set up a Young People with Diabetes Panel to support research into education outcomes for young people with diabetes.

The STEADFAST project will build on this work. We will explore the best ways to inform, engage and involve young people, their families and the wider public in important issues around the use of their sensitive data for research. 50% of participants will come from under-represented groups. The perspectives of young people living with diabetes informed this application and our project will be co-produced with them. We will develop our findings into a toolkit for use across other health conditions and social impacts. This will inform the DARE programme and have broader impact, for example enabling research to support children with asthma at school or young people with epilepsy in employment.

Background: Approximately 40,000 children and young people live with diabetes in the UK (primarily type 1 diabetes) with prevalence increasing in young people. Poor long-term management leads to serious complications, which can significantly impact quality of life and NHS costs. The four UK home nations each have a statutory commitment to support young people with medical conditions in their education, yet the evidence base to develop and evaluate interventions remains weak.
Research between health and characteristics beyond health (e.g. education outcomes for young people with diabetes) requires large-scale linkage of sensitive data without consent. Strong information governance (‘IG’) and meaningful public and patient involvement and engagement (‘PPIE’) are essential to gain public trust and support for such research. However, this presents particular challenges. One must find a legal basis to process data, gain agreement from data providers, repositories, and secure regulatory approvals. PPIE must be meaningful and there should be no surprises for the wider public around how their data are used. PPIE for young people and under-represented groups is particularly challenging. These issues are not fully addressed by current frameworks developed by the ICO and NIHR. Our STEADFAST project aims to address this gap.
Aims: STEADFAST builds on previous pioneering research between Cardiff University, Diabetes UK and consortium partners, to develop leading-edge IG and PPIE frameworks in support of large-scale cross-sector data-driven research for public benefit. Focusing on education outcomes in diabetes as an exemplar, we aim to improve engagement and involvement of young people living with diabetes. We will target 50% participation from under-represented groups. We will develop a toolkit to further develop, test and evaluate the IG framework we have developed so this can be applied to other health conditions and linkages beyond health.
Methods: We will set up a PPIE Advisory Group to guide the project. We will co-produce 6 focus groups with young people living with diabetes and community organisations to ensure our outreach and communications are accessible and meaningful. The focus groups will explore critical issues identified in our previous research: (i) IG framework issues (legal basis for processing; Section 251 approvals; anonymisation; Digital Economy Act); (ii) types of data (e.g. continuous glucose monitoring device data controlled by private companies; sensitive non-health data e.g. employment records); challenging data use (research with a profit-making motive, expectations of how data might be used versus what would not be expected, linkage to non-health data), future use of data (e.g. COPI notices, machine learning, scope for opting-out); (iii) public benefit and trust (legitimate pathways for claiming real-world benefit from research). We will develop an IG and PPIE toolkit based on our experience, which we will test, develop and evaluate with stakeholders. We will facilitate dialogue between young people and our partners.
Impact: Our project will inform DARE Programme requirements for the design of cross-council digital research environments, with education outcomes for young people living with diabetes as a real-world use-case, with broader impact across health/biomedical and social science research. Our findings will be widely disseminated, communicated and evaluated so that others can learn from our experience.