From the Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, Massachusetts (JKS); Spaulding Rehabilitation Hospital, Charlestown, Massachusetts (JKS); Massachusetts General Hospital, Boston, Massachusetts (JKS); Brigham and Women's Hospital, Boston, Massachusetts (JKS); College of Allied Health Professions, University of Nebraska Medical Center, Omaha, Nebraska (LEF); Universidad Central del Caribe, Bayamón, Puerto Rico (AMG); Department of Physical Medicine, Rehabilitation and Sports Medicine, University of Puerto Rico School of Medicine, San Juan, Puerto Rico (WRF); and Department of Physiology, University of Puerto Rico School of Medicine, San Juan, Puerto Rico (WRF).
Am J Phys Med Rehabil. 2021 Jun 1;100(6):546-554. doi: 10.1097/PHM.0000000000001750.
Our objective was to investigate whether women, people 65 yrs and older, or individuals who identify with racial and/or ethnic minority groups, were underrepresented among participants in rehabilitation clinical trials.
This is a cross-sectional study of completed rehabilitation clinical trials investigating the number and percentage of women, older adults, and racial and/or ethnic minorities enrolled in rehabilitation clinical trials between January 1, 2011, and January 1, 2020. Secondary outcome measures were inclusion by diagnostic group, as well as International Classification of Functioning, Disability and Health category, and intervention by diagnostic group.
Of the 108 studies meeting inclusion criteria, a majority (69%) were based in the United States. Stroke was the most frequent diagnostic group, followed by musculoskeletal conditions. Ninety-six percent of the United States-based trials included at least one female participant in their study, but among specific diagnostic groups, this ranged from 5% to 73%. Age information was reported inconsistently; however, of the trials reporting age, 100% of cardiac trials included older adults, whereas no spinal cord injury (SCI) trials included them. Among trials based in the United States reporting race, 70% of participants were White, followed by 20% Black or African American and 1% Asian. Among trials based in the United States reporting ethnicity, Hispanic or Latino participants were underrepresented overall and among each diagnostic group.
In this study, we found that among participants of rehabilitation clinical trials women, older individuals, and racial/ethnic minorities were generally underrepresented. In contrast, Black or African American participants were overrepresented with the exception of cardiac trials. An important finding was that many trials did not report age and/or race/ethnicity. Investigators should aim to include underrepresented populations and improve reporting.
我们的目的是调查女性、65 岁及以上人群或属于少数族裔的人群在康复临床试验参与者中是否代表性不足。
这是一项对已完成的康复临床试验进行的横断面研究，调查了 2011 年 1 月 1 日至 2020 年 1 月 1 日期间在康复临床试验中登记的女性、老年人以及少数族裔的人数和百分比。次要结局指标包括按诊断组和国际功能、残疾和健康分类纳入的人数，以及按诊断组进行的干预措施。
在符合纳入标准的 108 项研究中，大多数（69%）来自美国。最常见的诊断组是脑卒中，其次是肌肉骨骼疾病。96%的基于美国的试验至少有一名女性参与者，但在特定的诊断组中，这一比例从 5%到 73%不等。年龄信息的报告不一致；然而，在报告年龄的试验中，100%的心脏试验纳入了老年人，而没有脊髓损伤（SCI）试验纳入他们。在美国基于报告种族的试验中，70%的参与者是白人，其次是 20%的黑人或非裔美国人，1%的亚洲人。在美国基于报告族裔的试验中，西班牙裔或拉丁裔参与者总体上和每个诊断组中都代表性不足。
在这项研究中，我们发现康复临床试验参与者中女性、老年人和少数族裔通常代表性不足。相比之下，黑人或非裔美国人参与者除了心脏试验外，其他试验中都存在代表性过多的情况。一个重要的发现是，许多试验没有报告年龄和/或种族/族裔。研究人员应致力于纳入代表性不足的人群，并改善报告。
