About the PIO-Psych Initiative
The Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative: Developing a transdiagnostic core outcome set for adult mental health disorders
Mental health disorders are among the leading causes of disability and economic burden worldwide. Despite a growing number of clinical trials evaluating interventions for mental health, outcome reporting remains highly heterogeneous. This heterogeneity limits evidence synthesis and hinders the translation of research into meaningful clinical practice.
The PIO-Psych Initiative is an international effort that aims to address this heterogeneity by developing an overarching, transdiagnostic core outcomes set (COS) for adult mental health disorders. The project is led by Assistant Professor Sophie Juul at the Copenhagen Trial Unit, Centre for Clinical Intervention Research, at Copenhagen University Hospital, Rigshospitalet.
Unlike previous diagnosis-specific COS projects in mental health, the PIO-Psych Initiative takes a broader, patient-centered approach. We believe there is a need for a common set of outcomes that are important to patients, regardless of their diagnosis, as these outcomes are often under-represented in current research.
Project design
The PIO-Psych Initiative is structured in three key phases (also illustrated in the figure below)
1. Systematic Scoping Review: A review of recent randomized clinical trials to identify existing transdiagnostic outcomes used in mental health research.
2. Delphi Survey: Key stakeholders (e.g., people with lived experience, clinicians, researchers, policy makers etc.) will rate the importance of each outcome and recommend the most important time-points for measurements. This evaluation will be carried out through a structured, international Delphi process consisting of three online rounds.
3. Hybrid Meeting: A final hybrid (online and in-person) meeting will be held in Copenhagen, Denmark, to discuss and vote on the final set of core outcomes and time-points.
The result will be a scientifically robust and patient-centered COS, which can be used in future clinical trials, clinical practice, and observational studies. It is designed to complement, rather than replace, diagnosis-specific outcomes and offers a flexible, yet standardized, framework to guide outcome selection in psychiatric research.
The Delphi Survey
Do you have lived experience with mental health challenges, or are you a relative, clinician, or researcher working in the field of mental health?
You are invited to take part in our international Delphi survey study, a key step in developing a core outcome set for adult mental health research.
Learn more
The full methodology behind the PIO-Psych Initiative is described in our protocol.
The initiative is also registered on the COMET Initiative website, where further details can be found.
The PIO-Psych Initiative is funded by the Independent Research Fund Denmark and runs from 2024 to 2027.
Steering Group
An international team of researchers with expertise in psychiatric research and/or research methodology, guiding the development of the PIO-Psych Intiative
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark, Copenhagen, Denmark
Department of Psychology, University of Copenhagen, Copenhagen, Denmark
-
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
St Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada
Faculty of Health Sciences, University of Johannesburg, Johannesburg, South Africa
-
Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Ontario, Canada
-
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada
St Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada
-
Research and Development Department, North East London NHS Foundation Trust (NELFT), London, United Kingdom
Institute of Pharmaceutical Sciences, King's College London, London, United Kingdom
-
Division of Psychiatry, University College London, London, United Kingdom
Research and Development Department, North East London NHS Foundation Trust (NELFT), London, United Kingdom
-
Department of Applied Psychology, Kalaidos University of Applied Sciences, Zürich, Switzerland
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Department of Neuroanaesthesiology, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
-
Department of Intensive Care, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Capital Region of Denmark, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
-
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark