Department of Orthopaedic Surgery, Cleveland Clinic Foundation, Cleveland, OH, 44195, USA.
Center for Hip Preservation Orthopaedic and Rheumatologic Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue Mail code A41, Cleveland, OH, 44195, USA.
Arch Orthop Trauma Surg. 2024 May;144(5):1977-1987. doi: 10.1007/s00402-024-05285-7. Epub 2024 Mar 30.
Prior studies investigating the racial and ethnic representation of orthopedic trial participants have found low rates of reporting, but these studies are dated due to the passing of the National Institutes of Health Final Rule in 2017 requiring the reporting of racial and ethnic data among clinical trials. Therefore, we evaluated the representativeness of orthopedic clinical trials before and after the Final Rule.
A cross-sectional survey of orthopaedic clinical trials registered at ClinicalTrials.gov between October 1, 2007 and May 20, 2023 was conducted. After identifying and screening 23,752 clinical trials, 1564 trials were included in the analysis. Trials started before the implementation of the Final Rule on January 18, 2017 were grouped and compared to trials that began after. Odds ratios (OR) were utilized to identify trial characteristics associated with reporting race/ethnicity data. One-proportion z tests compared the representation of each racial and ethnic category to the 2020 United States Census.
In total, 34% (544 of 1564) of orthopedic clinical trials evaluated reported the race of participants, while 28% (438 of 1564) reported ethnicity. Trials registered after the Final Rule were more likely to report racial (OR: 5.15, 95%CI: 3.72-7.13, p < 0.001) and ethnic (OR: 3.23, 95%CI: 2.41-4.33, p < 0.001) representation of participants. Compared with the distribution of race and ethnicity reported by the United States 2020 Census, orthopedic trials had 16.6% more White participants (95% CI 16.4%, 16.8%; p < 0.001), 3.2% fewer Black participants (95%CI 3.1%, 3.3%; p < 0.001), and 5.7% fewer Hispanic/Latino participants (95%CI 5.2%, 6.2%; p < 0.001). Trials with enrollment sizes over 100 participants were also more likely to report race and ethnicity, with odds increasing with increased sample size.
The Final Rule marginally improved the reporting of race and ethnicity in orthopedic clinical trials, and underrepresentation of Black or African American, Multiracial, and Hispanic populations persists.
III.
先前研究调查了骨科试验参与者的种族和民族代表性，发现报告率较低，但由于 2017 年美国国立卫生研究院最终规定的通过，这些研究已经过时，该规定要求在临床试验中报告种族和民族数据。因此，我们评估了最终规定实施前后骨科临床试验的代表性。
对 2007 年 10 月 1 日至 2023 年 5 月 20 日在 ClinicalTrials.gov 注册的骨科临床试验进行了横断面调查。在确定并筛选了 23752 项临床试验后，有 1564 项试验被纳入分析。将在 2017 年 1 月 18 日最终规定实施之前开始的试验分组并与之后开始的试验进行比较。比值比（OR）用于确定与报告种族/民族数据相关的试验特征。单比例 z 检验比较了每个种族和族裔类别与 2020 年美国人口普查的代表性。
共有 34%（544/1564）的骨科临床试验评估报告了参与者的种族，而 28%（438/1564）报告了种族。在最终规定实施后注册的试验更有可能报告参与者的种族（OR：5.15，95%CI：3.72-7.13，p<0.001）和民族（OR：3.23，95%CI：2.41-4.33，p<0.001）代表性。与 2020 年美国人口普查报告的种族和民族分布相比，骨科试验的白人参与者多 16.6%（95%CI 16.4%，16.8%；p<0.001），黑人参与者少 3.2%（95%CI 3.1%，3.3%；p<0.001），西班牙裔/拉丁裔参与者少 5.7%（95%CI 5.2%，6.2%；p<0.001）。纳入人数超过 100 人的试验也更有可能报告种族和民族，随着样本量的增加，可能性增加。
最终规定略微提高了骨科临床试验中种族和民族的报告率，但黑人和非洲裔美国人、多种族和西班牙裔人口的代表性仍然不足。
III。
