Abstract
BackgroundPeople with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone. There is increasing interest in interventions that target diabetes in SMI in order to help to improve physical health and reduce the associated health inequalities. However, there is a lack of consensus about which outcomes are important for this comorbid population, with trials differing in their focus on physical and mental health. A core outcome set, which includes outcomes across both conditions that are relevant to patients and other key stakeholders, is needed.MethodsThis study protocol describes methods to develop a core outcome set for use in effectiveness trials of self-management interventions for adults with comorbid type-2 diabetes and SMI. We will use a modified Delphi method to identify, rank, and agree core outcomes. This will comprise a two-round online survey and multistakeholder workshops involving patients and carers, health and social care professionals, health care commissioners, and other experts (e.g. academic researchers and third sector organisations). We will also select appropriate measurement tools for each outcome in the proposed core set and identify gaps in measures, where these exist.DiscussionThe proposed core outcome set will provide clear guidance about what outcomes should be measured, as a minimum, in trials of interventions for people with coexisting type-2 diabetes and SMI, and improve future synthesis of trial evidence in this area. We will also explore the challenges of using online Delphi methods for this hard-to-reach population, and examine differences in opinion about which outcomes matter to diverse stakeholder groups.Trial registrationCOMET registration: http://www.comet-initiative.org/studies/details/911. Registered on 1 July 2016
Highlights
People with diabetes and comorbid severe mental illness (SMI) form a growing population at risk of increased mortality and morbidity compared to those with diabetes or SMI alone
In England, it is estimated that approximately 50,000 people with SMI have diabetes [7], a figure that is expected to grow in line with the growing numbers of people with both diabetes and mental illness; recent evidence suggests that prevalence of diabetes is increasing at a faster rate in people with SMI than in people without [1]
To ensure that evidence about what works for particular populations can inform policy and practice and improve the quality and effectiveness of health care, evaluation research must measure what matters to people living with the condition and those who support them and commission health services, as well as to researchers
Summary
Overview Using a modified Delphi method, this study will employ a three-stage process to (1) Identify, (2) Rank, and (3) Agree core outcomes. Findings from the review of existing evidence will be presented, followed by further small group work to identify duplicate and overlapping outcomes, and to develop a final ‘long-list’ of potential outcomes to include in a core outcome set. Text data provided by participants in the free text fields will be reviewed by the research team to identify new outcomes to include in round 2 of the Delphi study survey and delete or merge duplicate or overlapping concepts. Delphi consensus workshop The detailed results from the survey will be presented at a Delphi workshop to be attended by people with SMI and type-2 diabetes, carers, health and social care professionals, health care commissioners, and other relevant stakeholders as well as the research group (n = 20). The measurement and psychometric properties of all potentially matching tools will be assessed using the COSMIN Checklist [47] before selecting which tools to include for outcomes in the core outcome set Outcomes for which no matching validated measurement tool is identified will be highlighted in the review to inform future research priorities
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