Hassani Sara, Bou Dargham Tarek, Cantrell Sarah, Ikramuddin Salman, Feng Wuwei
Department of Neurology, Duke University School of Medicine, Durham, NC, USA.
Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.
Top Stroke Rehabil. 2025 Mar;32(2):208-212. doi: 10.1080/10749357.2024.2384324. Epub 2024 Jul 29.
Inclusion of diverse patient populations in stroke rehabilitation clinical trials is key for generalizability and detecting differences in subgroups. The aim of this study was to assess the reporting and inclusion of race, ethnicity, and sex in publications in post-stroke motor recovery clinical trials over the past 5 years.
We conducted a systematic review of stroke motor recovery trials conducted only within the United States with at least one control group and published between 2019 and 2023. The percent of racial minorities, ethnicities, and women enrolled in the trials was extracted and calculated for those trials using available data found in the manuscript or on clinicaltrials.gov.
Sixty-eight trials (total of 2,801 participants) met the inclusion criteria and were included in the analysis. 100%, 35%, and 21% of the trials included reported enrollment by sex, race, and ethnicity in the manuscript. All publications reported sex and 38% of the subjects were female. Among the trials reporting race, 59% of the participants were White, followed by 34% Black, 0.4% Native American, 4% Asian, and 3% Other. Among the trials that reported ethnicity, Hispanic or Latino participants were represented as 13% of the total participants.
In the past 5 years, while all stroke rehab trial publications reported data on sex, they underrepresented women. Most publications did not report race or ethnicity. Improvement in reporting of race/ethnicity in stroke motor recovery trials is needed for understanding of progress with inclusion, and improvement in inclusion of women is needed for better generalizability.
将不同患者群体纳入中风康复临床试验是实现研究结果可推广性以及发现亚组差异的关键。本研究的目的是评估过去5年中风后运动恢复临床试验出版物中种族、民族和性别的报告情况及纳入情况。
我们对仅在美国境内开展的、设有至少一个对照组且于2019年至2023年期间发表的中风运动恢复试验进行了系统综述。利用稿件或clinicaltrials.gov上的可用数据，提取并计算这些试验中纳入的少数族裔、不同民族和女性的百分比。
68项试验（共2801名参与者）符合纳入标准并被纳入分析。100%、35%和21%的试验在稿件中报告了按性别、种族和民族的入组情况。所有出版物均报告了性别，38%的受试者为女性。在报告种族的试验中，59%的参与者为白人，其次是34%为黑人，0.4%为美洲原住民，4%为亚洲人，3%为其他种族。在报告民族的试验中，西班牙裔或拉丁裔参与者占总参与者的13%。
在过去5年中，虽然所有中风康复试验出版物都报告了性别数据，但女性代表性不足。大多数出版物未报告种族或民族。为了解纳入情况的进展，需要改进中风运动恢复试验中种族/民族的报告；为提高可推广性，需要增加女性的纳入。
