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
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Authors
Juul, Sophie
Faltermeier, Pascal
Petersen, Johanne Juul
Siddiqui, Faiza
Kamp, Caroline Barkholt
Thabane, Lehana
Samaan, Zainab
Mbuagbaw, Lawrence
Horowitz, Mark
Moncrieff, Joanna
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Issue Date
09/06/2025
Type
Journal article
Language
Keywords
Mental Health
Alternative Title
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.
Description
Citation
BMJ Open 2025;15:e093958. doi: 10.1136/bmjopen-2024-093958
Publisher
License
Journal
BMJ Open
Volume
15
Issue
6