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加强特殊人群的代表性:将女性退伍军人纳入退伍军人事务部临床试验的一种方法。

Enhancing representation of special populations: An approach to the inclusion of women veterans in VA clinical trials.

作者信息

Goldstein Karen M, Yano Elizabeth M, Schnurr Paula P, Bastian Lori A, Alton Dailey Susan, Pomernacki Alyssa, Carney Diane, Gierisch Jennifer M, Hamilton Alison B, Nevedal Andrea, Vogt Dawne, Frayne Susan M

机构信息

VA Health Systems Research (HSR) Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA; Department of Medicine, Division of General Internal Medicine, Duke University, Durham, NC, USA.

VA Health Systems Research (HSR) Center for the Study of Healthcare Innovation, Implementation, and Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Medicine, UCLA Geffen School of Medicine, Los Angeles, CA, USA; Department of Health Policy & Management, UCLA Fielding School of Public Health, Los Angeles, California, USA.

出版信息

Contemp Clin Trials. 2025 Feb;149:107812. doi: 10.1016/j.cct.2025.107812. Epub 2025 Jan 11.

Abstract

The under-recruitment of historically marginalized populations into clinical trials thwarts equitable inclusion of individuals who could benefit from healthcare innovations and limits the generalizability of results. For decades, the Veterans Health Administration (VA) has conducted large clinical trials that impact clinical guidelines for veterans and civilians alike. Within the VA, women are a numeric minority, and recruitment of this population into trials is challenged by gender-specific care structures, distinct demographic characteristics, and mistreatment such as higher rates of military sexual trauma and harassment on VA grounds. We describe our approach to enhancing the inclusion of women veterans in clinical trials through the VA Women's Enhanced Recruitment Program (WERP) as developed for the VA Cooperative Studies Program. This information is relevant to clinical trial teams seeking to include women veterans in their trials. Our findings also have implications for other researchers seeking equitably increase participation of marginalized populations so that findings are generalizable to broader populations.

摘要

历史上被边缘化的人群参与临床试验的招募不足,阻碍了那些可能从医疗创新中受益的个体得到公平纳入,并限制了研究结果的可推广性。几十年来,退伍军人健康管理局(VA)开展了大型临床试验,这些试验影响着退伍军人和平民的临床指南。在VA内部,女性在数量上占少数,将这一人群纳入试验面临着特定性别的护理结构、独特的人口特征以及诸如军事性创伤发生率较高和在VA场所遭受骚扰等虐待问题的挑战。我们描述了我们通过为VA合作研究项目制定的VA女性强化招募计划(WERP)来提高女性退伍军人参与临床试验的方法。这些信息对于试图将女性退伍军人纳入其试验的临床试验团队具有参考价值。我们的研究结果对于其他寻求公平增加边缘化人群参与度以使研究结果能够推广到更广泛人群的研究人员也具有启示意义。

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