The University of Southampton
University of Southampton Institutional Repository

A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes

A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes
A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes
Background: people with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI, and it is not known whether diabetes self-management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co-existing SMI and diabetes.

Aims: to develop a core outcome set (COS) for use in effectiveness trials of diabetes self-management interventions in adults with both type 2 diabetes and SMI.

Methods: the COS was developed in three stages: i) identification of outcomes from systematic literature review of intervention studies, followed by multi-stakeholder and service user workshops; ii) rating of outcomes in a two-round online Delphi survey; iii) agreement of final ‘core’ outcomes through a stakeholder consensus workshop.

Results: seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health-related quality of life, diabetes self-management, diabetes-related distress, and medication adherence.

Conclusions: this COS is recommended for future trials of effectiveness of diabetes self-management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy.
0742-3071
Carswell, Claire
d3b55879-0f24-42c4-8426-2fe9ce42d7ef
Taylor, Jo
f48a60e0-f7bd-4a6a-bfb7-866c6e1a2334
Holt, Richard I.G.
d54202e1-fcf6-4a17-a320-9f32d7024393
Brown, Jennifer V.E.
e09a355f-8491-401a-a691-ffed902bbbf3
Ajjan, Ramzi
72cbdc5a-4173-4f07-b64c-5eae4eb9fc39
Böhnke, Jan R.
43d58599-4e7a-4b04-9edf-416c840f64af
Doran, Tim
0da91d8a-268f-41b0-af38-280ac454137a
Kellar, Ian
770eca5c-d39b-4dc0-bbb0-d37be3d68e08
Shiers, David
39865c9f-6ea7-4c59-b317-2e0ab656bbba
Wright, Judy
ab292eaa-0b97-422c-9b49-4902b1a0c5ab
Siddiqi, Najma
4bff7b9b-91c0-4b72-96f5-ede207e7f361
Carswell, Claire
d3b55879-0f24-42c4-8426-2fe9ce42d7ef
Taylor, Jo
f48a60e0-f7bd-4a6a-bfb7-866c6e1a2334
Holt, Richard I.G.
d54202e1-fcf6-4a17-a320-9f32d7024393
Brown, Jennifer V.E.
e09a355f-8491-401a-a691-ffed902bbbf3
Ajjan, Ramzi
72cbdc5a-4173-4f07-b64c-5eae4eb9fc39
Böhnke, Jan R.
43d58599-4e7a-4b04-9edf-416c840f64af
Doran, Tim
0da91d8a-268f-41b0-af38-280ac454137a
Kellar, Ian
770eca5c-d39b-4dc0-bbb0-d37be3d68e08
Shiers, David
39865c9f-6ea7-4c59-b317-2e0ab656bbba
Wright, Judy
ab292eaa-0b97-422c-9b49-4902b1a0c5ab
Siddiqi, Najma
4bff7b9b-91c0-4b72-96f5-ede207e7f361

Carswell, Claire, Taylor, Jo, Holt, Richard I.G., Brown, Jennifer V.E., Ajjan, Ramzi, Böhnke, Jan R., Doran, Tim, Kellar, Ian, Shiers, David, Wright, Judy and Siddiqi, Najma (2024) A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes. Diabetic Medicine. (In Press)

Record type: Article

Abstract

Background: people with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI, and it is not known whether diabetes self-management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co-existing SMI and diabetes.

Aims: to develop a core outcome set (COS) for use in effectiveness trials of diabetes self-management interventions in adults with both type 2 diabetes and SMI.

Methods: the COS was developed in three stages: i) identification of outcomes from systematic literature review of intervention studies, followed by multi-stakeholder and service user workshops; ii) rating of outcomes in a two-round online Delphi survey; iii) agreement of final ‘core’ outcomes through a stakeholder consensus workshop.

Results: seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health-related quality of life, diabetes self-management, diabetes-related distress, and medication adherence.

Conclusions: this COS is recommended for future trials of effectiveness of diabetes self-management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy.

Text
CoreOutcomeSet_v5_20231211_Revision2_clean - Accepted Manuscript
Restricted to Repository staff only until 9 January 2025.
Request a copy
Text
Supplementary materials 1_List of outcomes identified from Step 1 - Accepted Manuscript
Restricted to Repository staff only until 9 January 2025.
Request a copy
Text
Supplementary materials 2_ Round 1 and 2 Results Summary Ranked_Consensus summary - Accepted Manuscript
Restricted to Repository staff only until 9 January 2025.
Request a copy

More information

Accepted/In Press date: 9 January 2024

Identifiers

Local EPrints ID: 486150
URI: http://eprints.soton.ac.uk/id/eprint/486150
ISSN: 0742-3071
PURE UUID: d5152a53-d724-4c43-8aae-1c86e679ade8
ORCID for Richard I.G. Holt: ORCID iD orcid.org/0000-0001-8911-6744

Catalogue record

Date deposited: 11 Jan 2024 17:30
Last modified: 17 Aug 2024 01:37

Export record

Contributors

Author: Claire Carswell
Author: Jo Taylor
Author: Jennifer V.E. Brown
Author: Ramzi Ajjan
Author: Jan R. Böhnke
Author: Tim Doran
Author: Ian Kellar
Author: David Shiers
Author: Judy Wright
Author: Najma Siddiqi

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×