Julian Kaitlyn R, Mulakaluri Ashley, Truong Nicole M, Fernandez Alicia, Kamal Robin N, Shapiro Lauren M
Department of Orthopaedic Surgery, University of California - San Francisco, 1500 Owens St., San Francisco, CA 94158.
Department of Medicine, University of California - San Francisco, 1001 Potrero Ave #107, San Francisco, CA 94110.
JBJS Rev. 2024 May;12(5). doi: 10.2106/JBJS.RVW.24.00012. Epub 2024 May 3.
PURPOSE: Underrepresentation and misrepresentation of historically underrepresented populations in randomized controlled trials (RCTs) may have implications for the validity of research results and their application for diverse populations. To evaluate the representation of historically linguistically, racially, and ethnically underrepresented participants in orthopaedic randomized controlled trials (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 utilizing PROMs between the years 2012 - 2022 among the top five 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: 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 six multinational studies, none reported the language of the study population nor the use of translated PROMs. Notably, four studies (2%) reported utilizing 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 utilized are 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 results are generalizable to diverse patient populations. LEVEL OF EVIDENCE: III.
目的：历史上代表性不足的人群在随机对照试验（RCT）中的代表性不足和错误呈现可能会影响研究结果的有效性及其在不同人群中的应用。评估历史上在语言、种族和民族方面代表性不足的参与者在骨科随机对照试验（RCT）中的代表性，并评估翻译和文化适应性患者报告结局测量（PROMs）的使用情况。 方法：根据2021年期刊引证报告数据库，对PubMed、科学网和Embase数据库进行单独且全面的文献检索，以识别2012年至2022年期间在前五大5年影响因子最高的骨科期刊中使用PROMs的随机对照试验。感兴趣的主要结局包括试验参与者语言、种族和民族人口统计学特征的报告以及翻译后的PROMs的使用情况。使用Jadad标准评估每个临床试验的方法学质量。 结果：230项随机对照试验符合纳入标准。在14%的试验中报告了参与者的语言，在同时搜索已发表文本和临床试验注册信息时，这一比例为17%。此外，11%的试验报告了种族和/或民族，7%的试验报告了使用翻译后的PROMs。在六项跨国研究中，没有一项报告研究人群的语言或翻译后的PROMs的使用情况。值得注意的是，四项研究（2%）报告使用了文化适应性PROMs。平均Jadad评分为3.07。 结论：骨科临床试验中很少报告参与者的语言、种族和民族，这可能会限制研究结果的应用和解释。同样，所使用的PROMs的语言和文化适应性通常也未报告，这也限制了对骨科研究结果的有效性和普遍性的解释。研究人员和期刊应促进人口统计学数据和PROMs适应性方法的标准报告，以确保结果能够推广到不同的患者群体。 证据水平：III级。
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