Taylor, J, Böhnke, JR, Wright, J orcid.org/0000-0002-5239-0173 et al. (5 more authors) (2017) A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review. Trials, 18. 70. ISSN 1745-6215
Abstract
Background: 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. There is increasing interest in interventions that target diabetes in SMI in order to help 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. Methods: This 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 multi-stakeholder workshops involving patients and carers, health and social care professionals, healthcare 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. Discussion: The 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. COMET registration: http://www.comet-initiative.org/studies/details/911 (registered 01 July 2016).
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
Keywords: | psychosis; severe mental illness; schizophrenia; bipolar disorder; diabetes; self-management; core outcome set; co-morbidity; complex interventions |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Health Economics (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Primary Care (Leeds) The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Psychology (Leeds) |
Funding Information: | Funder Grant number National Inst for Health Research (NIHR) RP-DG-1214-10002 |
Depositing User: | Symplectic Publications |
Date Deposited: | 17 Jan 2017 12:40 |
Last Modified: | 05 Oct 2017 16:21 |
Status: | Published |
Publisher: | BioMed Central |
Identification Number: | 10.1186/s13063-017-1805-y |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:110649 |