应用质量改进概念、策略和工具,提高拉丁裔家庭对临床试验的参与度。

IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Journal of Clinical and Translational Science Pub Date : 2024-10-10 eCollection Date: 2024-01-01 DOI:10.1017/cts.2024.557
Keanaan Malke, Jennifer R Hemler, Daniel Lima, Pablo Colon, Caroline Mendoza, Naomy Azcona, Katie A Devine, Thomas I Mackie, Usha Ramachandran, Darlene Forbes, Michael Lucas, Shawna V Hudson, Manuel E Jimenez
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引用次数: 0

摘要

来自少数种族和族裔群体的人员在临床试验中的代表性不足,威胁着临床和转化科学的外部有效性,降低了创新成果在实践中的吸收率,并限制了人们获得参与试验的潜在益处。尽管我们努力提高临床试验的多样性,但拉丁裔背景的儿童和成人参与临床试验的比例仍然偏低。质量改进概念、策略和工具在提高临床试验的招募和入组方面展现了前景。为了证明这一前景,我们借鉴了我们团队开展随机临床试验的经验,该试验测试了三种行为干预措施,旨在促进来自资源匮乏社区的拉丁裔父母-婴儿二人组在语言和社会情感技能习得方面的公平性。招募活动是在 COVID-19 大流行期间进行的,因此更加需要采取应对策略和程序。我们采用了 "改进模式 "来实现招募目标。在各个研究阶段,我们采用了以下策略:(1)有意识地组建团队;(2)采用参与式方法设定目标、监督成果、选择变革策略;(3)进行小型迭代测试,为后续工作提供依据。这些策略帮助我们的团队克服了一些障碍。这些策略可以帮助其他研究人员应用质量改进工具,提高少数群体参与临床和转化研究的程度。
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The application of quality improvement concepts, strategies, and tools to enhance participation in clinical trials among Latino families.

Underrepresentation of people from racial and ethnic minoritized groups in clinical trials threatens external validity of clinical and translational science, diminishes uptake of innovations into practice, and restricts access to the potential benefits of participation. Despite efforts to increase diversity in clinical trials, children and adults from Latino backgrounds remain underrepresented. Quality improvement concepts, strategies, and tools demonstrate promise in enhancing recruitment and enrollment in clinical trials. To demonstrate this promise, we draw upon our team's experience conducting a randomized clinical trial that tests three behavioral interventions designed to promote equity in language and social-emotional skill acquisition among Latino parent-infant dyads from under-resourced communities. The recruitment activities took place during the COVID-19 pandemic, which intensified the need for responsive strategies and procedures. We used the Model for Improvement to achieve our recruitment goals. Across study stages, we engaged strategies such as (1) intentional team formation, (2) participatory approaches to setting goals, monitoring achievement, selecting change strategies, and (3) small iterative tests that informed additional efforts. These strategies helped our team overcome several barriers. These strategies may help other researchers apply quality improvement tools to increase participation in clinical and translational research among people from minoritized groups.

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来源期刊
Journal of Clinical and Translational Science
Journal of Clinical and Translational Science MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
2.80
自引率
26.90%
发文量
437
审稿时长
18 weeks
期刊最新文献
Overview of ACTIV trial-specific lessons learned. Preparing better: Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) therapeutics trials lessons learned: A call to the future. The future is now: Using the lessons learned from the ACTIV COVID-19 therapeutics trials to create an inclusive and efficient clinical trials enterprise. ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic. Lessons learned from COVID-19 to overcome challenges in conducting outpatient clinical trials to find safe and effective therapeutics for the next infectious pandemic.
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