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A Review of Patient-Reported Outcome Measures and Patient Demographics in Randomized Controlled Trials Used to
Luca M Valdivia1, Christopher J Farid2, Alexander X Nguyen3
1Department of Orthopaedic Surgery, Icahn School of Medicine at Mount Sinai, New York, New York.
Background:
Clinical practice guidelines (CPGs) are vital to uphold quality orthopaedic care in various populations. The outcome measures and patient demographics in studies used to synthesize the CPGs may not be fully representative of the general population, even though many studies have demonstrated the impact of sociocultural elements with musculoskeletal outcomes. Assessing the linguistic, racial, and ethnic representation of participants and the linguistic and cultural adaptation of patient-reported outcome measures (PROMs) used in trials informing CPGs for hip fractures in older adults is essential.
Methods:
The 2021 American Academy of Orthopaedic Surgeons CPGs for the management of hip fractures in older adults and related clinical trial registrations were screened for full-text randomized controlled trials. Included studies were reviewed, and the location of the trial, inclusion/exclusion criteria, patient language proficiency, ethnic and racial demographics, PROM usage, and the use of translated and culturally adapted PROMs were extracted. Descriptive statistics were used to summarize findings. Of the 160 included studies from 31 different countries, seven studies (4.4%) reported the patient population's preferred language.
Results:
All seven studies utilized language proficiency to select study participants. There were nine studies (5.6%) that reported race and ethnicity of the participants. In total, 145 studies (90.6%) did not report any language, race, or ethnicity data. The PROMs were reported in 125 studies (78.9%), eight (6.4%) of which utilized a translated version and four (3.2%) employed culturally adapted PROMs.
Conclusions:
Trials that inform CPGs for hip fracture adults demonstrate low reporting of patient language, race, and ethnicity. When language was recorded, it functioned exclusively as an inclusion or exclusion criterion rather than as a demographic characteristic, raising further concerns for selection bias and underrepresentation of patients who have limited English proficiency. Although PROMs were widely used, translated and culturally adapted versions were rarely reported.
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