PDF(Pubmed)
Abstract：
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: III.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: III.
摘要：
■在随机对照试验（RCT）中，历史上代表性不足的人群的代表性不足和虚假陈述可能会影响研究结果的有效性及其在不同人群中的应用。为了评估历史语言的代表性，种族方面,和骨科随机对照试验（RCT）中种族代表性不足的参与者，并评估翻译和文化适应的患者报告结局指标（PROM）的使用。
■PubMed的单独和全面的文献检索，WebofScience,根据2021年期刊引文报告数据库，在2012年至2022年的前五名最高5年影响因素骨科期刊中，使用了Embase数据库来识别RCT。感兴趣的主要结果包括语言报告，试验参与者的种族和民族人口统计学特征以及翻译的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.
■230项RCT符合纳入标准。在搜索已发表的文本和临床试验注册信息时，14％的试验和17％的试验报告了参与者的语言。此外,11%的试验报告了种族和/或族裔，7%的试验报告了翻译的PROM的使用。在六项跨国研究中，没有人报告研究人群的语言，也没有使用翻译的PROM。值得注意的是，4项研究（2%）报告使用文化适应的PROM，平均Jadad评分为3.07。
■参与者语言，种族,在骨科临床试验中很少报道种族，潜在地限制了研究结果的应用和解释。同样，使用的PROM的语言和文化适应通常没有报告，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数据和PROM适应方法的标准报告，以确保结果可推广到不同的患者人群。
■III.
■PubMed的单独和全面的文献检索，WebofScience,根据2021年期刊引文报告数据库，在2012年至2022年的前五名最高5年影响因素骨科期刊中，使用了Embase数据库来识别RCT。感兴趣的主要结果包括语言报告，试验参与者的种族和民族人口统计学特征以及翻译的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.
■230项RCT符合纳入标准。在搜索已发表的文本和临床试验注册信息时，14％的试验和17％的试验报告了参与者的语言。此外,11%的试验报告了种族和/或族裔，7%的试验报告了翻译的PROM的使用。在六项跨国研究中，没有人报告研究人群的语言，也没有使用翻译的PROM。值得注意的是，4项研究（2%）报告使用文化适应的PROM，平均Jadad评分为3.07。
■参与者语言，种族,在骨科临床试验中很少报道种族，潜在地限制了研究结果的应用和解释。同样，使用的PROM的语言和文化适应通常没有报告，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数据和PROM适应方法的标准报告，以确保结果可推广到不同的患者人群。
■III.
