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- and consensus-based core outcome set for adult mental health disorders.
We believe that there is a need for a minimum list of overarching, transdiagnostic (regardless of mental disorder) core outcomes to be used across randomised clinical trials of all common adult mental health disorders. No transdiagnostic core outcome set recommendations are available for common mental health disorders.
Previous core outcome sets for adult mental health disorders have primarily recommended symptom rating scales. It is evident that assessing mental health symptoms is highly relevant in mental health trials but it is unclear if symptom reduction results in increased functioning or improved quality of life or decreased risks of adverse events. The objective of the PIO-Psych Initiative is to develop an overarching core outcome set for adult mental health disorders. The overarching core outcome set will contain only the most critical and minimal domains (i.e. what to measure) and the final core outcome set may be used for all adult mental health disorders. The core outcome set can be used concurrently with disorder-specific core outcome sets and/or other assessments. The core outcome set will provide feasible and generalisable recommendations for a minimum list of patient important outcomes to be used in clinical trials, clinical practice, and clinical studies within each adult mental health disorder.
Principal investigator:
Sophie Juul, assistant professor, PhD
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Disease Category: Mental health
Disease Name: Mental health
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (patients)
- Families
- Methodologists
- Researchers
- Consumers (caregivers)
- Epidemiologists
- Patient/ support group representatives
- Policy makers
- Service providers
- Service users
- Statisticians
- Other
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
- Literature review
- Semi structured discussion
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 health care policy makers, 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.