A Review of Patient Demographics and Patient-Reported Outcome Measures in Trials Used to Inform a Clinical Practice...

Clinical practice guidelines (CPGs) are vital for ensuring high-quality standardized care, yet patient demographics and outcome measures used to formulate CPGs may not be representative of the diversity of the general population. Sociocultural factors have been shown to markedly influence musculoskeletal outcomes, making it essential to assess: (1) the linguistic, racial, and ethnic representation of participants in trials informing a CPG for hip osteoarthritis (OA); and (2) the use of culturally and linguistically adapted patient-reported outcome measures (PROMs) in those trials.

Randomized controlled trials cited in the 2023 American Academy of Orthopaedic Surgeons CPG for hip OA and related clinical trial registrations were reviewed. Extracted data included trial inclusion and exclusion criteria, study location, patient language proficiency, racial and ethnic demographics, and the use of translated or culturally adapted PROMs. Descriptive statistics are summarized in the findings.

Among 74 studies from 23 countries, only 13 studies (17.6%) reported patient preferred language, increasing to 14 (19%) when including registration data. Race and ethnicity were reported in just four studies (5%), rising to five (7%) with registration details. Overall, 54 studies (73%) failed to report any language or racial/ethnic data. Of the 61 (82%) studies utilizing PROMs, 14 (23%) included translated versions and only nine (15%) employed culturally adapted PROMs.

This analysis reveals critical gaps in the reporting of linguistic, racial, and ethnic demographics in trials informing a hip OA CPG. These factors are vital, as sociocultural differences can have a major effect on outcomes and PROM validity. The limited use of translated and culturally adapted PROMs is particularly concerning, given the potential for cultural differences to impact scores. With studies spanning 23 countries, these findings emphasize the need for more inclusive practices in trials to enhance the representation of recommendations in CPGs to drive equitable care.