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
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
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).
Keywords: psychosis, severe mental illness, schizophrenia, bipolar disorder, diabetes, self-management, core outcome set, co-morbidity, complex interventions
1-26
Taylor, J.
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Bohnke, J.R.
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Wright, J.
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Kellar, I.
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Alderson, S.
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Hughes, T.
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Holt, R.I.G.
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Siddiqi, N.
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Taylor, J.
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Bohnke, J.R.
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Wright, J.
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Kellar, I.
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Alderson, S.
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Hughes, T.
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Holt, R.I.G.
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Siddiqi, N.
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Taylor, J., Bohnke, J.R., Wright, J., Kellar, I., Alderson, S., Hughes, T., Holt, R.I.G. and Siddiqi, N.
(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, .
(In Press)
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).
Keywords: psychosis, severe mental illness, schizophrenia, bipolar disorder, diabetes, self-management, core outcome set, co-morbidity, complex interventions
Text
__userfiles.soton.ac.uk_Users_nl2_mydesktop_Deposits_One off_Taylor COS study protocol manuscript v3 141016 CLEAN.docx
- Accepted Manuscript
More information
Accepted/In Press date: 14 January 2017
Organisations:
Faculty of Medicine
Identifiers
Local EPrints ID: 404947
URI: http://eprints.soton.ac.uk/id/eprint/404947
ISSN: 1745-6215
PURE UUID: 8bdc5e37-6411-4963-b46e-865f56a003f0
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Date deposited: 25 Jan 2017 11:12
Last modified: 16 Mar 2024 03:19
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Contributors
Author:
J. Taylor
Author:
J.R. Bohnke
Author:
J. Wright
Author:
I. Kellar
Author:
S. Alderson
Author:
T. Hughes
Author:
N. Siddiqi
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