临床试验中慢性疼痛参与者的年龄、种族、民族和性别。
Age, Race, Ethnicity, and Sex of Participants in Clinical Trials Focused on Chronic Pain.
机构信息
Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Medicine, Harvard Medical School, Boston, Massachusetts.
Division of Gastroenterology, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.
出版信息
J Pain. 2024 Aug;25(8):104511. doi: 10.1016/j.jpain.2024.03.007. Epub 2024 Mar 16.
There is limited data on equitable inclusion in chronic pain trials. We aimed to 1) identify the frequency of reporting age, race, ethnicity, and sex in clinical trials targeting chronic pain, and 2) compare sociodemographic representation to the United States (US) population. We examined US-based intervention trials for chronic pain initiated between 2007 and 2021 and registered on ClinicalTrials.gov. We 1) assessed the frequency of reporting each demographic variable, 2) compared representation with US population estimates, and 3) explored change in reporting over time. Of 501 clinical trials, the frequency of reporting was as follows: 36.9% reported older adults, 54.3% reported race, 37.4% reported ethnicity, and 100% reported sex. Rates of race and ethnicity reporting increased, but older adult age reporting decreased over time (ps < .00001). Compared to 2020 US population estimates, there was an equitable representation of older adults, under-representation of individuals identifying as American Indian or Alaska Native (.8% vs .6%), Asian (5.6% vs 2.9%), Black or African American (12.6% vs 12.2%), with more than one race (2.9% vs 1.2%), and Hispanic/Latino (16.9% vs 14.1%). There was an over-representation of individuals identifying as Native Hawaiian or Pacific Islander (.2% vs .5%) or White (70.4% vs 72.9%), and of females (50.8% vs 68.4%). Some representation rates varied by chronic pain condition. Reporting of older adult age, race, and ethnicity was low in chronic pain trials in ClinicalTrials.gov, reinforcing the need for adhering to reporting guidelines. Representation varied across trials compared with US population data, particularly among those identifying as Hispanic/Latino and certain minority racial groups. PERSPECTIVE: Despite initiatives to increase the reporting of demographic information, doing so in clinical pain trials is far from ubiquitous. Moreover, efforts to improve diversity in these trials continue to be insufficient. Indeed, Black, Indigenous, and People of Color (BIPOC) remain under-represented in clinical pain trials.
关于慢性疼痛试验中的公平纳入,数据有限。我们的目的是:1)确定针对慢性疼痛的临床试验报告年龄、种族、族裔和性别的频率;2)将社会人口统计学代表性与美国(US)人口进行比较。我们检查了 2007 年至 2021 年期间在美国启动并在 ClinicalTrials.gov 上注册的基于干预的慢性疼痛临床试验。我们:1)评估报告每个人口变量的频率;2)将代表性与美国人口估计值进行比较;3)探索随时间的报告变化。在 501 项临床试验中,报告的频率如下:36.9%报告了老年人,54.3%报告了种族,37.4%报告了族裔,100%报告了性别。种族和族裔报告的比例增加,但老年人年龄报告的比例随着时间的推移而下降(p<0.00001)。与 2020 年美国人口估计值相比,老年人的代表性是公平的,美洲印第安人或阿拉斯加原住民的代表性不足(0.8%比 0.6%),亚洲人(5.6%比 2.9%),黑人或非裔美国人(12.6%比 12.2%),有多种族(2.9%比 1.2%),西班牙裔或拉丁裔(16.9%比 14.1%)。代表性过高的是夏威夷原住民或太平洋岛民(0.2%比 0.5%)或白人(70.4%比 72.9%)和女性(50.8%比 68.4%)。一些代表性率因慢性疼痛状况而异。ClinicalTrials.gov 中的慢性疼痛试验中报告老年人年龄、种族和族裔的比例较低,这表明需要遵守报告指南。与美国人口数据相比,代表权在试验之间存在差异,特别是在那些自认为是西班牙裔或拉丁裔和某些少数族裔群体的人中。观点:尽管有增加报告人口信息的举措,但在临床疼痛试验中这样做远非普遍。此外,改善这些试验中多样性的努力仍然不足。事实上,黑人和有色人种(BIPOC)在临床疼痛试验中仍然代表性不足。