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桥接研究、准确信息和对话(BRAID)临床试验研究方案:一项基于社区的干预措施改善临床试验中信任和多样化参与的混合方法研究。

Research protocol for bridging research, accurate information and dialogue (BRAID)-clinical trials: a mixed-methods study of a community-based intervention to improve trust and diversify participation in clinical trials.

机构信息

Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, United States.

Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, NY, United States.

出版信息

Front Public Health. 2024 Sep 16;12:1407726. doi: 10.3389/fpubh.2024.1407726. eCollection 2024.

Abstract

Cultural beliefs, personal experiences, and historic abuses within the healthcare system-rooted in structural racism-all contribute to community distrust in science and medicine. This lack of trust, particularly within underserved communities, contributes to decreased participation in clinical trials and a lack of representation in the data. Open dialogue about community concerns and experiences related to research participation and medical care processes can help build trust and change attitudes and behaviors that affect community health. This protocol outlines an approach to increase trust in science and clinical trials among communities in the Bronx, New York that are typically underrepresented in research data. Bridging Research, Accurate Information and Dialogue (BRAID) is a two-phased, evidence-based community engagement model that creates safe spaces for bilateral dialogues between trusted community messengers, and clinicians and scientists. The team will conduct a series of BRAID Conversation Circles on the topic of clinical trials with local trusted community messengers. Participants will be members of the community who are perceived as "trusted messengers" and can represent the community's voice because they have insight into "what matters" locally. Conversation Circles will be audiotaped, transcribed, and analyzed to identify emergent challenges and opportunities surrounding clinical trial participation. These key themes will subsequently inform the codesign and co-creation of tailored messages and outreach efforts that community participants can disseminate downstream to their social networks. Surveys will be administered to all participants before and after each Conversation Circle to understand participants experience and evaluate changes in knowledge and attitudes about clinical trials, including protections for research participants the advantages of having diverse representation. Changes in motivation and readiness to share accurate clinical trial information downstream will also be assessed. Lastly, we will measure participants dissemination of codesigned science messages through their social networks by tracking participant specific resource URLs of materials and videos posted on a BRAID website. This protocol will assess the effectiveness and adoptability of an innovative CBPR model that can be applied to a wide range of public health issues and has the potential to navigate the ever-changing needs of the communities that surround health systems.

摘要

文化信仰、个人经历以及医疗保健系统中的历史虐待——这些都源于结构性种族主义——导致社区对科学和医学的不信任。这种不信任,特别是在服务不足的社区中,导致参与临床试验的人数减少,数据中代表性不足。就参与研究和医疗护理过程相关的社区关注和经验进行公开对话,可以帮助建立信任,并改变影响社区健康的态度和行为。本方案概述了一种在纽约布朗克斯社区中增加对科学和临床试验的信任的方法,这些社区在研究数据中通常代表性不足。“建立研究、准确信息和对话(BRAID)”是一个两阶段、基于证据的社区参与模型,为受信任的社区传讯者与临床医生和科学家之间的双边对话创造了安全空间。该团队将与当地受信任的社区传讯者就临床试验主题开展一系列 BRAID 对话圈。参与者将是被视为“受信任的传讯者”的社区成员,因为他们了解当地“重要事项”,所以可以代表社区的声音。对话圈将进行录音、转录和分析,以确定围绕临床试验参与的新出现的挑战和机遇。这些关键主题随后将为量身定制的信息和外展工作提供信息,以便社区参与者可以将其传播到自己的社交网络中。在每次对话圈之前和之后,将向所有参与者发放调查问卷,以了解参与者的经验,并评估他们对临床试验的知识和态度的变化,包括研究参与者的保护措施、多样化代表性的优势。还将评估参与者在下游传播准确临床试验信息的动机和准备情况的变化。最后,我们将通过跟踪参与者在 BRAID 网站上发布的材料和视频的特定资源 URL 来衡量参与者通过其社交网络传播代码设计的科学信息的情况。本方案将评估一种创新的 CBPR 模型的有效性和可采用性,该模型可应用于广泛的公共卫生问题,并有可能满足围绕卫生系统的社区不断变化的需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ccf5/11439785/785137b1e09e/fpubh-12-1407726-g001.jpg

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