Are Orthopaedic Clinical Trials Linguistically and Culturally Diverse?

Abstract

Background: Underrepresentation and misrepresentation of historically underrepresented populations in randomized controlled trials (RCTs) may have implications for the validity of research results and their application to diverse populations. The purpose of this study was to evaluate the representation of historically linguistically, racially, and ethnically underrepresented participants in orthopaedic RCTs and to assess the use of translated and culturally adapted patient-reported outcome measures (PROMs). Methods: Separate and comprehensive literature searches of PubMed, Web of Science, and Embase databases were performed to identify RCTs using PROMs between 2012 and 2022 among the top 5 highest 5-year impact factor orthopaedic journals according to the 2021 Journal Citation Reports database. The primary outcomes of interest included reporting of linguistic, racial, and ethnic demographic characteristics of trial participants and the utilization of translated PROMs. The methodological quality of each clinical trial was assessed using the Jadad Criteria. Results: A total of 230 RCTs met inclusion criteria. The language of participants was reported in 14% of trials and in 17% of trials when searching both the published text and clinical trial registration information. In addition, race and/or ethnicity was reported in 11% of trials, and the use of translated PROMs was reported in 7% of trials. Among the 6 multinational studies, none reported the language of the study population, nor the use of translated PROMs. Notably, 4 studies (2%) reported using culturally adapted PROMs. The average Jadad score was 3.07. Conclusion: Participant language, race, and ethnicity are infrequently reported in orthopaedic clinical trials, potentially limiting the application and interpretation of study results. Similarly, the linguistic and cultural adaptation of PROMs used is often not reported, which also limits interpretations of the validity and generalizability of orthopedic study results. Researchers and journals should promote standard reporting of demographic data and methods of PROM adaptation to ensure that results are generalizable to diverse patient populations. Level of Evidence: Level III. See Instructions for Authors for a complete description of levels of evidence.