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 Valeska Elli Brown, Ramzi Ajjan, Jan Rasmus Boehnke, Timothy Doran, Ian Kellar, David Shiers, Judy Wright, Najma Siddiqi

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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.

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.

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.

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.

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 languageEnglish
Article numbere15288
Number of pages10
JournalDiabetic Medicine
Early online date18 Jan 2024
Publication statusE-pub ahead of print - 18 Jan 2024

Bibliographical note

© 2024 The Authors.


  • Type 2 diabetes mellitus
  • severe mental illness
  • core outcome set

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