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. There is increasing interest in interventions that target diabetes in this population to help improve physical health and reduce the associated health inequalities. However, there is a no agreement about which outcomes (e.g. blood sugar, depression) should be measured to test how effective these interventions are, with trials differing in their focus on physical and mental health.
Aim: This study will develop a core outcome set to use in trials of adults living with both type 2 diabetes and severe mental illness.
Potential benefits: The study aims to provide clear guidance about what outcomes should be measured in trials of people with coexisting severe mental illness and type 2 diabetes. It is hoped that this will help to build good evidence about how to improve health and well-being for this patient group.
Protocol: https://www.ncbi.nlm.nih.gov/pubmed/28196512?dopt=Abstract&utm_content=bufferf8908&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
Dr Najma Siddiqi (principal investigator), University of York and Bradford District Care NHS Foundation Trust
Dr Jo Taylor (study manager), University of York, UK
Dr Jan Böhnke, University of York, UK
Dr Judy Wright, University of Leeds, UK
Dr Ian Kellar, University of Leeds, UK
Dr Sarah Alderson, University of Leeds, UK
Dr Tom Hughes, Leeds and York Partnership NHS Foundation Trust, UK
Professor Richard Holt, University of Southampton, UK
This study is also supported by the DIAMONDS research group (http://www.diamonds.nihr.ac.uk/Meet-The-Team), who are conducting a programme of research which aims to improve diabetes services and outcomes for people with severe mental illness.
Disease Category: Endocrine & metabolic, Mental health
Disease Name: Severe mental illness , Bipolar disorder , Depression, Diabetes mellitus , Schizophrenia & psychosis
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Educational/self-management
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Methodologists
- Patient/ support group representatives
- Researchers
- Service commissioners
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion
- Systematic review
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 literature review and multi-stakeholder workshop to identify potential outcomes followed by a two-round online Delphi survey to identify which outcomes are the most important to different stakeholder groups. A final consensus workshop will review findings of the Delphi survey and agree which outcomes to include in the core outcome set. Participants will include service users and carers, healthcare staff and commissioners, and other experts (e.g. academic researchers, charities).
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. This will involve identifying commonly used tools that are well-validated through discussion during the consensus workshop and a systematic review of available measurement instruments for each remaining outcome.