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临床试验少数侵袭性妇科手术中的种族和民族差异

Katherine Moran Sweterlitsch¹, Raanan Meyer², Aviran Ohayon³

¹Department of Obstetrics and Gynecology, Cedars-Sinai Medical Center (Drs. Sweterlitsch, Meyer, Hamilton, Truong, Wright, and Siedhoff), Los Angeles, California.

Journal of minimally invasive gynecology

|February 7, 2024

概括

在最小侵入性妇科手术 (MIGS) 随机对照试验 (RCT) 中存在种族和种族差异. 白人和黑人参与者占比过高,而西班牙裔和亚裔参与者占比不足,这凸显了需要改进招聘和报告的需要.

科学领域:

生殖医学和外科手术
临床试验方法论临床试验方法论
健康公平研究健康公平研究

背景情况:

随机对照试验 (RCT) 对于推进微创妇科手术 (MIGS) 至关重要.
了解MIGS RCT参与者的种族和民族多样性对于确保概括性和公平性至关重要.

研究的目的:

在MIGS RCT中调查参与者代表性的种族和民族差异.
为了比较不同种族和种族群体在MIGS RCT中的入学比例与美国人口普查数据.

主要方法:

一项横截面研究,涉及到在2012年至2023年期间在高影响力妇产科杂志上发表的MIGSRCT的在线审查.
在PubMed和ClinicalTrials.gov上搜索了MIGS程序的相关术语.
使用美国人口普查局数据计算实际与预期参与者的入学比例 (ER),用于美国的试验,并提供种族和种族信息.

主要成果:

在352个已识别的MIGSRCT中,只有65个 (18.5%) 报告了种族和/或种族数据.
在46项美国试验中 (4645名参与者),白人 (70.8%) 和黑人或非裔美国人 (15.4%) 与预期的比例相比,参与者的比例过高.
西班牙裔 (6.7%),亚裔 (1.7%),夏威夷原住民或太平洋岛民 (0.1%),美洲印第安人或阿拉斯加原住民 (0.2%) 参与者显著代表性不足.

结论:

在招募美国MIGSRCT的参与者方面存在显著的种族和民族差异.
在分析的试验中,报告的种族数据不到五分之一.
未来的MIGS RCT需要改进公平的种族和民族招聘策略,以及全面的数据报告.

关键词:

临床试验临床试验是指临床试验的临床试验.不平等的差异差异的差异民族身份民族身份最少侵入性的妇科手术.种族种族种族种族

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