Patient-Reported Outcome Measures in Mental Health Clinical Research: a Descriptive Review in Comparison with Clinician-Rated Outcome Measures

PURPOSE: To review how patient-reported outcome (PRO) measures in mental health clinical research complement traditional clinician-rated outcome (CRO) measures.

DATA SOURCES: Medline, Embase, PsycInfo and Scopus.

STUDY SELECTION: Latest update of the literature search was conducted in August 2019, using a specified set of search terms to identify controlled and uncontrolled studies (published since 1996) of pharmacological or non-pharmacological interventions in adults (≥18 years) in hospital-based mental health care.

DATA EXTRACTION: Two authors extracted data independently using a pre-designed extraction form.

RESULTS OF DATA SYNTHESIS: Among the 2962 publications identified, 257 were assessed by full text reading. A total of 24 studies reported in 26 publications were included in this descriptive review. We identified subjective and objective outcome measures, classified these according to the pharmacopsychometric triangle and compared them qualitatively in terms of incremental information added to the clinical study question. The data reviewed here from primarily depression and schizophrenia intervention studies show that results from PRO measures and CRO measures generally point in the same direction. There was a relative lack of PRO measures on functioning and medication side effects compared with PRO measures on symptom burden and health-related quality of life.

CONCLUSION: PROs and CROs supplement each other and at most times support identical study conclusions. Future studies would benefit from a more systematic approach toward use of PROs and a clearer rationale of how to weigh and report the results in comparison with CROs.