A Core Outcome Set for Comorbid Diabetes and Severe Mental Illness
Research type
Research Study
Full title
Developing a Core Outcome Set for evaluating non-pharmacological interventions in people with comorbid diabetes and severe mental illness
IRAS ID
199333
Contact name
Jo Taylor
Contact email
Sponsor organisation
Bradford District Care NHS Foundation Trust
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Background: People living with severe mental illness (e.g. schizophrenia and bipolar disorder) are more than twice as likely to have diabetes compared to the general population. They also have poorer diabetic control and more complications from their diabetes. To address this, new health services and interventions are currently being developed for patients living with both these conditions. However, there is a no agreement about which outcomes (e.g. blood sugar, depression) should be measured to test how effective these interventions are. Studies vary in their focus on physical or mental health, and this makes it difficult to combine results to work out how interventions might benefit people with these conditions. A core outcome set, which is a standardised set of outcomes that should be measured in all studies that evaluate interventions in a particular population, is therefore needed.
Aim: This study will develop a core outcome set to use in trials (which test how effective interventions are) of adults living with both type 2 diabetes and severe mental illness.
Methods: A three-stage process will 1) Identify, 2) Rank and 3) Agree which outcomes to include in the core outcome set. This will involve a Delphi survey (where participants rate how important potential outcomes are) and a consensus workshop. Participants will include service users and carers, healthcare staff and commissioners, and other experts (e.g. academic researchers). In a fourth stage, the study will 4) Select appropriate measurement tools for each outcome so that future trials can easily measure outcomes in the core set.
Potential benefits: This study aims to provide clear guidance about what outcomes should be measured in trials of people with coexisting SMI and type 2 diabetes. It is hoped that this will help to build good evidence about how to improve health and wellbeing for this patient group.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0149
Date of REC Opinion
16 May 2016
REC opinion
Further Information Favourable Opinion