优化务实临床试验中的多样性、公平性和包容性:疼痛管理合作组织的研究结果。

IF 4 2区 医学 Q1 CLINICAL NEUROLOGY
Travis I Lovejoy, Amanda M Midboe, Diana M Higgins, Joseph Ali, Robert D Kerns, Alicia A Heapy, Ethel Kirabo Nalule, Natassja Pal
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引用次数: 0

摘要

美国国立卫生研究院、美国国防部和美国退伍军人事务部于 2017 年成立了疼痛管理合作组织(PMC),旨在通过开展务实的临床试验,在军队和退伍军人医疗保健系统中实施和评估非药物方法来管理疼痛和并发症。本研究的目的是详细介绍并批判性地检查 PMC 大规模多地点实用临床试验的招募和保留程序,同时关注试验人员为实现研究样本多样化所做的努力。来自 11 项务实临床试验的团队成员完成了半结构化访谈,访谈的重点是试验团队在计划样本组成时多元化的意义、招募和保留多元化患者样本的方法以及考虑到多元化患者亚群的计划分析。各项试验共招募了近 18,000 名患者,其中 22% 的患者出生时性别为女性,34% 的患者属于边缘化种族或民族。受访者强调,研究地点的选择、与患者团体建立合作关系以及利用数据信息学等策略有助于招募出生性别、种族和民族不同的患者。值得注意的是,试验人员采用了狭义的多样性定义,没有考虑到试验参与者的多重交叉身份。根据 PMC 的经验,我们就如何使临床疼痛研究中的患者样本多样化提出了 14 条建议。观点:本文描述了疼痛实用临床试验设计所面临的挑战和提供的机遇,强调了优化纳入社会身份群体的方法,这些群体在疼痛研究中的代表性历来不足。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Optimizing Diversity, Equity and Inclusion in Pragmatic Clinical Trials: Findings from the Pain Management Collaboratory.

The National Institutes of Health, U.S. Department of Defense, and U.S. Department of Veterans Affairs established a Pain Management Collaboratory (PMC) in 2017, with the purpose of implementing and evaluating nonpharmacological approaches for management of pain and co-occurring conditions in military and veteran healthcare systems through the execution of pragmatic clinical trials. The purpose of the current study is to detail and critically examine recruitment and retention procedures across the PMC's large-scale multi-site pragmatic clinical trials, with attention to efforts made by trialists to diversify their study samples. Team members from 11 pragmatic clinical trials completed semi-structured interviews that focused on the meaning of diversity to the trial teams when planning the composition of their samples, methods used to recruit and retain diverse samples of patients, and planned analyses that take into consideration diverse subgroups of patients. Nearly 18,000 patients have been enrolled across trials, 22% of whom were assigned female sex at birth and 34% of whom identify with a marginalized race or ethnicity. Respondents highlighted study site selection, formation of partnerships with patient groups, and leveraging of data informatics as strategies that aided in the recruitment of patients diverse in terms of birth sex, race, and ethnicity. Notably, trialists adopted a narrow definition of diversity that did not take into consideration multiple intersecting identities of trial participants. Based on experiences of the PMC, we provide 14 recommendations on ways to diversify patient samples in clinical pain research. PERSPECTIVE: This article describes challenges posed, and opportunities provided, with pain pragmatic clinical trial designs, emphasizing approaches that optimize the inclusion of social identity groups that have historically been under-represented in pain research.

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来源期刊
Journal of Pain
Journal of Pain 医学-临床神经学
CiteScore
6.30
自引率
7.50%
发文量
441
审稿时长
42 days
期刊介绍: The Journal of Pain publishes original articles related to all aspects of pain, including clinical and basic research, patient care, education, and health policy. Articles selected for publication in the Journal are most commonly reports of original clinical research or reports of original basic research. In addition, invited critical reviews, including meta analyses of drugs for pain management, invited commentaries on reviews, and exceptional case studies are published in the Journal. The mission of the Journal is to improve the care of patients in pain by providing a forum for clinical researchers, basic scientists, clinicians, and other health professionals to publish original research.
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