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

Claire Carswell; Jo Taylor; Richard I. G. Holt; Jennifer V. E. Brown; Ramzi Ajjan; Jan R. Böhnke; Tim Doran; Ian Kellar; David Shiers; Judy Wright; Najma Siddiqi

doi:10.1111/dme.15288

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

Claire Carswell (Lead / Corresponding author)
, Jo Taylor
, Richard I. G. Holt
, Jennifer V. E. Brown
, Ramzi Ajjan
, Jan R. Böhnke
, Tim Doran
, Ian Kellar
, David Shiers
, Judy Wright
, Najma Siddiqi

Health Sciences

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	e15288
Number of pages	10
Journal	Diabetic Medicine
Volume	41
Issue number	4
Early online date	18 Jan 2024
DOIs	https://doi.org/10.1111/dme.15288
Publication status	Published - Apr 2024

Keywords

core outcome set
self-management
severe mental illness
type 2 diabetes

ASJC Scopus subject areas

Endocrinology
Internal Medicine
Endocrinology, Diabetes and Metabolism

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1111/dme.15288Licence: CC BY

Final published versionFinal published version, 279 KBLicence: CC BY

2 Article

DIAMONDS-a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial
O'Carroll, G. C., Brown, J. V. E. (Lead / Corresponding author), Carswell, C., Peck, C., Russell, G., Ajjan, R. A., Boehnke, J. R., Coventry, P. A., Hadjiconstantinou, M., Hewitt, C., Holt, R. I. G., Johnson, V., Kellar, I., Li, J., Mandefield, L., Osborn, D., Parrott, S., Sheehan, L., Shiers, D. & Watson, J. & 2 others, Siddiqi, N. & DIAMONDS Research Team, Mar 2025, In: BMJ Open. 15, 3, 11 p., e090295.
Research output: Contribution to journal › Article › peer-review

Open Access
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Time is now to consider how we evaluate person-centred care—the role of patient-reported outcomes
Rutherford, C. (Lead / Corresponding author), Boehnke, J., Greenhalgh, J., Tyagi, V., McCance, T. & McCormack, B., 13 Jun 2025, In: Frontiers in Health Services. 5, 9 p., 1578037.
Research output: Contribution to journal › Article › peer-review

Open Access
File
2 Citations (Scopus)

40 Downloads (Pure)

1 Invited talk
1 Oral presentation

Quality assurance, quantitative, and qualitative evaluation methods for psychotherapeutic interventions including assessment instruments (annually)
Boehnke, J. (Speaker)
Jul 2025
Activity: Talk or presentation types › Invited talk
Panel: Measuring what matters: How do we know that we do?
Boehnke, J. (Chair), Brown, G. (Speaker), Hertz, N. (Speaker), Gugel, J. (Speaker) & Barkham, M. (Speaker)
28 Jun 2025
Activity: Talk or presentation types › Oral presentation

Cite this

Carswell, C., Taylor, J., Holt, R. I. G., Brown, J. V. E., Ajjan, R., Böhnke, J. R., Doran, T., Kellar, I., Shiers, D., Wright, J., & Siddiqi, N. (2024). A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes. Diabetic Medicine, 41(4), Article e15288. https://doi.org/10.1111/dme.15288

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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.",

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author = "Claire Carswell and Jo Taylor and Holt, \{Richard I. G.\} and Brown, \{Jennifer V. E.\} and Ramzi Ajjan and B{\"o}hnke, \{Jan R.\} and Tim Doran and Ian Kellar and David Shiers and Judy Wright and Najma Siddiqi",

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AU - Brown, Jennifer V. E.

AU - Ajjan, Ramzi

AU - Böhnke, Jan R.

AU - Doran, Tim

AU - Kellar, Ian

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AU - Wright, Judy

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N2 - 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.

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Fingerprint

Research output

DIAMONDS-a diabetes self-management intervention for people with severe mental illness: protocol for an individually randomised controlled multicentre trial

Time is now to consider how we evaluate person-centred care—the role of patient-reported outcomes

Activities

Quality assurance, quantitative, and qualitative evaluation methods for psychotherapeutic interventions including assessment instruments (annually)

Panel: Measuring what matters: How do we know that we do?

Cite this