NYMC Faculty Publications
Clinical Outcome Assessment Instruments in Schizophrenia: A Scoping Literature Review With a Focus on the Potential of Patient-Reported Outcomes
Author Type(s)
Faculty
Journal Title
Innovations in Clinical Neuroscience
First Page
14
Last Page
33
Document Type
Article
Publication Date
1-2023
Department
Psychiatry and Behavioral Sciences
Abstract
OBJECTIVE: The complexity inherent in the treatment of schizophrenia results in a multitude of outcome assessments being employed when conducting clinical trials. Subjective outcome assessments and minimal clinically important differences (MCIDs) to evaluate clinical meaningfulness have gained traction; however, the extent of application in evaluation of treatments for schizophrenia is unknown. A scoping review was conducted to assess the availability of published psychometric evaluations, including MCIDs, for clinical outcome assessments used to evaluate treatments for schizophrenia.
METHOD OF RESEARCH: Key databases (PubMed®, Embase®, APA PsycINFO®, International Society for Pharmacoeconomics and Outcomes Research) were searched for studies on schizophrenia published from 2010 to 2020. Secondary sources (ClinicalTrials.gov, PROLABELS™, FDA.gov) were also reviewed. Clinical outcome assessments were organized by type (patient-reported outcomes [PROs], clinician-reported outcomes [ClinROs], observer-reported outcomes [ObsROs]) and further classified by intended use (generic, mental health, schizophrenia). Reliability and internal consistency were evaluated using Cronbach's α. External validity was evaluated by intraclass correlation coefficient (ICC).
RESULTS: Across 140 studies, 66 clinical outcome assessments were identified. MCIDs were reported for eight of the 66 studies. Of these, two were PROs (generic) and six were ClinROs/ObsROs (three mental health-specific, three schizophrenia-specific). Reliability was good across generic, mental health-specific, and schizophrenia-specific categories, whereas external validity was strong mainly for schizophrenia-specific PROs. Overall, ClinROs/ObsROs that focused on mental health had good reliability and strong external validity.
CONCLUSION: This review provides a comprehensive overview of the clinical outcome assessments used in schizophrenia research during the past ten years. Results highlight the heterogeneity of existing outcomes and a growing interest in PROs for schizophrenia.
Recommended Citation
Citrome, L., Mychaskiw, M., Cortez, A., Opler, M., Sopina, L., & Kotak, S. (2023). Clinical Outcome Assessment Instruments in Schizophrenia: A Scoping Literature Review With a Focus on the Potential of Patient-Reported Outcomes. Innovations in Clinical Neuroscience, 20 (4-6), 14-33. Retrieved from https://touroscholar.touro.edu/nymc_fac_pubs/5062