Implementing patient-reported outcome measures: A scoping review of existing guidance across clinical trials, practice and registries

Le résumé fourni par la source

OBJECTIVES: To identify existing guiding documents such as guidelines, frameworks, checklists and recommendations on implementing patient-reported outcome measures (PROMs) in clinical trials, clinical practice and clinical registries. STUDY DESIGN: Scoping Review. METHODS: A literature search of five scientific databases was conducted from database inception to June 2024. Google Scholar and grey literature sites were searched to identify relevant guiding documents. Existing documentation, including guidelines, frameworks, checklists, and recommendations for implementing PROMs in clinical trials, practice, and clinical registries, was included. A narrative synthesis of selected publications was conducted. RESULTS: In total, 4905 records were identified and assessed for eligibility, and 177 publications underwent full-text screening, resulting in 38 guiding documents in this review. Of the 38, 18 (47 %) were guiding documents for PROMs use in clinical trials, 12 (32 %) in clinical practice, and eight (21 %) in clinical registries. Most guidelines and recommendations were on PROMs implementation in clinical trials and clinical practice, with only a few recommendations published for clinical registries. CONCLUSIONS: This review mostly identified guiding documents for implementing PROMs in clinical trials and practice. There is a gap in the literature regarding guidelines for implementing PROMs in clinical registries. Given the growing recognition of clinical registries and PROMs data for healthcare quality improvement and patient-centred care, an evidence-based standard guideline to implement PROMs in clinical registries efficiently will be beneficial.

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