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. 2024 Nov 19;24(1):821.
doi: 10.1186/s12888-024-06294-x.

Development of a core outcome set for psychological therapy trials on acute psychiatric inpatient wards

Pamela Jacobsen  1 , Katherine Berry  2   3 , Lucy Clarkson  4 , Rebecca Hiscocks  4 , India Hopkins  4 , Ceri Morgan  4 , Dhaarna Tandon  4 , Ashley-Louise Teale  4 , Natasha Tyler  5 , Lisa Wood  6   7
Affiliations

Development of a core outcome set for psychological therapy trials on acute psychiatric inpatient wards

Pamela Jacobsen et al. BMC Psychiatry. .

Abstract

Background: Consensus on what outcomes should be included in trials of psychological therapies on acute psychiatric inpatient wards is currently lacking. Inclusion of different viewpoints, including service user perspectives, is crucial in ensuring that future trials measure outcomes which are meaningful and important. Development of a Core Outcome Set (COS), a minimum standardised set of outcomes to be measured and reported, would help improve synthesis and interpretation of clinical trial data in this area.

Methods: Stage 1 of the COS development involved compiling a comprehensive long-list of outcomes from key sources including i) a systematic review of outcomes from published trials, ii) online survey of key stakeholders (service users, carers, healthcare professionals, researchers, and end users of research), iii) qualitative interviews with service users and carers. Stage 2 involved stakeholder groups short-listing the outcomes using consensus methods (e-Delphi survey). The final outcome set was derived from the short-list at a consensus meeting of stakeholders, facilitated by an Independent Chair.

Results: A long-list of 68 outcomes was compiled from the systematic review (n = 30 trials), online stakeholder survey (n = 100 participants) and qualitative interviews (n = 15 participants). Fifty stakeholders took part in the e-Delphi study, where the long-list was cut down to a short-list of 12 outcomes over 2 rounds. Nine stakeholders took part in the final consensus meeting, and after some outcomes were removed and/or amalgamated, a final set of 6 outcomes was recommended for inclusion in the COS. These were Ability to Cope, Hopefulness, Quality of Life, Psychosis Symptoms, Mood, and Self-Harm Behaviours.

Conclusions: Widespread future adoption of the COS will reduce research waste by ensuring that outcomes are more easily comparable across trials, and that the full range of stakeholder priorities are represented in trial outcomes. This makes it more likely that effective therapies will be identified in a timely fashion and successfully implemented in routine clinical practice. The final 6-outcome COS should be feasible to implement given the need keep participant burden to a minimum in inpatient trials. Further work is needed to make recommendations for the best outcome measurement instruments to use, including the use of patient-reported outcomes alongside clinician-rated measures.

Trial registration: Not applicable.

Keywords: Clinical Trial; Consensus; Inpatients; Measures.

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Conflict of interest statement

Declarations Ethics approval and consent to participate Ethical approval for the study was given by the University of Bath Psychology Research Ethics Committee (REC reference number: 22–107). All participants gave written informed consent. Consent for publication Not applicable. Competing interests The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Summary of COS development
Fig. 2
Fig. 2
Final Core Outcome Set
See this image and copyright information in PMC

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