克罗恩病生物制剂和小分子药物试验中的种族和民族代表性:系统回顾与元分析》。

IF 8.3 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Journal of Crohns & Colitis Pub Date : 2024-02-26 DOI:10.1093/ecco-jcc/jjad138
Matt Pelton, Paddy Ssentongo, Ashley Sun, Destin Groff, Shannon Dalessio, Kofi Clarke
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引用次数: 0

摘要

背景和目的:历史上,随机对照试验对边缘化种族和民族人群的代表性不足。随着这些群体中克罗恩病发病率和患病率的上升,将他们纳入一线和二线药物的随机对照试验非常重要:按照 PRISMA 指南,我们在 PubMed 上系统检索了生物制剂和小分子抑制剂 [SMI] 药物的随机对照试验,试验的主要结果与疗效有关。我们使用描述性统计来总结人口统计学变量,并使用元回归分析来估计种族纳入的时间趋势:结果:一半以上的试验未报告任何种族/族裔人口统计数据[53.7%],一些试验仅报告了一个种族的人口统计数据[20.9%]。在报告种族数据时,白人占参与者的 90.2%。在 3901、3742、828 和 4027 个样本中,黑人、亚裔、美国原住民/太平洋岛民和被视为 "其他 "的参与者的平均比例分别为 2.9%、11.6%、0.5% 和 1.6%。随着时间的推移,白人参与者的比例有所下降[p 结论:在已发表的克罗恩病随机对照试验中,有一半不包含种族或族裔人口统计,其余的试验通常只有限地纳入了黑人、美国原住民/太平洋岛民和西班牙裔患者。进一步的工作应确定观察性和前瞻性试验中的代表性特征。研究人员应努力1] 增加种族和民族人口统计数据的报告;以及 2] 改善边缘化人群的招募和保留。
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Race and Ethnic Representation in Crohn's Disease Trials of Biologic and Small Molecule Medications: A Systematic Review and Meta-analysis.

Background and aims: Randomised controlled trials historically under-represent marginalised racial and ethnic populations. As incidence and prevalence of Crohn's disease in these groups rise, it is important to characterise their inclusion in randomised controlled trials on first-line and pipe-line medications.

Methods: PubMed was searched systematically for randomised controlled trials of biologic and small molecule inhibitor [SMI] medications, with a primary outcome related to efficacy following PRISMA guidelines. We used descriptive statistics to summarise demographic variables and meta-regression analyses to estimate temporal trends in racial inclusion.

Results: More than a half of trials did not report any racial/ethnic demographics [53.7%] and several reported racial demographics for only one race [20.9%]. When racial data were reported, Whites made up 90.2% of participants. Percentages of Black, Asian, Native American/Pacific Islander, and participants considered 'Other' averaged 2.9%, 11.6%, 0.5%, and 1.6% out of the total sample sizes of 3901, 3742, 828 and 4027, respectively. Proportional representation of White participants decreased over time [p <0.01] and proportional representation of Asian participants increased over time [p = 0.047]. In ordinal logistic regression, mean year of trial enrolment significantly increased the number of racial groups reported [p <0.001].

Conclusions: Half of published randomised controlled trials in Crohn's disease contain no racial or ethnic demographics, and the remaining often only have limited inclusion of Black, Native American/Pacific Islander, and Hispanic patients. Further work should characterise representation in observational and prospective trials. Researchers should work to: 1] increase reporting of racial and ethnic demographics; and 2] improve recruitment and retention of marginalised populations.

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来源期刊
Journal of Crohns & Colitis
Journal of Crohns & Colitis 医学-胃肠肝病学
CiteScore
15.50
自引率
7.50%
发文量
1048
审稿时长
1 months
期刊介绍: Journal of Crohns and Colitis is concerned with the dissemination of knowledge on clinical, basic science and innovative methods related to inflammatory bowel diseases. The journal publishes original articles, review papers, editorials, leading articles, viewpoints, case reports, innovative methods and letters to the editor.
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