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. 2025 Jun 9;15(6):e093958.
doi: 10.1136/bmjopen-2024-093958.

Protocol for the development of a transdiagnostic core outcome set for mental health disorders in adults: the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative

Sophie Juul  1   2   3 , Pascal Faltermeier  4   5 , Johanne Juul Petersen  4 , Faiza Siddiqui  4 , Caroline Barkholt Kamp  4 , Lehana Thabane  6   7   8 , Zainab Samaan  9 , Lawrence Mbuagbaw  6   7 , Mark Horowitz  10 , Joanna Moncrieff  10   11 , Michael P Hengartner  12 , Markus Harboe Olsen  4   13 , Rikke Hermann  4 , Morten Hylander Møller  14   15 , Christian Gluud  4   5 , Janus C Jakobsen  4   5
Affiliations

Protocol for the development of a transdiagnostic core outcome set for mental health disorders in adults: the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative

Sophie Juul et al. BMJ Open. .

Abstract

Introduction: Mental health problems are important causes of disability and economic costs worldwide. Randomised clinical trials examining the treatment of mental health disorders measure heterogeneous outcomes, causing difficulties in data synthesis, interpretation and translation into clinical practice. The aim of the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative is to develop an overarching, transdiagnostic research-based and consensus-based core outcome set for adult mental health disorders.

Methods and analysis: The development of the PIO-Psych transdiagnostic core outcome set will include three phases: (1) a systematic scoping review of the literature to develop the initial list of outcomes for the Delphi study; (2) a Delphi study in three rounds including people with lived experience of mental health disorders and their relatives, clinicians, researchers and others (administrators, mental healthcare policymakers, philosophers); (3) a hybrid consensus meeting to agree on the final overarching, transdiagnostic core outcome set and corresponding time points of assessment of each outcome.

Ethics and dissemination: Ethical approval is not applicable to this study according to the Research Ethics Committee of the Capital Region of Denmark, as it is not an interventional study. All data will be reported anonymously, and it will not be possible to identify study participants. Results will be disseminated via stakeholder and research networks and peer-reviewed publications.

Trial registration details: The PIO-Psych Initiative was pre-registered with COMET (Core Outcome Measures for Effectiveness Trials) on 17 May 2024 (https://www.comet-initiative.org/Studies/Details/3125).

Keywords: Methods; PSYCHIATRY; Randomized Controlled Trial; Research Design.

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Conflict of interest statement

Competing interests: JM and MH are collaborating investigators on the NHMRC-funder and MRFF-funded RELEASE and RELEASE+ trials in Australia investigating hyperbolic tapering of antidepressants. MH is a co-founder of Outro Health, a digital clinic which aims to help people who wish to stop no longer needed antidepressant medication in North America. MH has received honoraria for lectures on deprescribing from NHS Trusts, Washington University and the University of Arizona. JM is a co-investigator on a National Institute of Health Research (NIHR) funded study exploring methods of antidepressant discontinuation (REDUCE) and the Chief Investigator on the RADAR trial of antipsychotic reduction and discontinuation funded by the NIHR. She collects royalties from three books on psychiatric drugs. ZS is a board member of the Canadian mood and anxiety disorders treatment guidelines. LM receives consulting fees from AstraZeneca, Bayer and WHO. LT is on the Editorial Advisory Board for BMJ Open. All other authors declare that they have no competing interests.

Figures

Figure 1
Figure 1. The three phases of the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative.
Figure 2
Figure 2. Flowchart of the Delphi process.
See this image and copyright information in PMC

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