缩小差距:美国国立卫生研究院(NIH)试验招募的文化应对策略。

IF 3.2 3区 医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Journal of Racial and Ethnic Health Disparities Pub Date : 2024-10-29 DOI:10.1007/s40615-024-02166-y
Lindsey Ross, Samuel Eberlein, Carine Khalil, So Yung Choi, Karma McKelvey, Brennan M R Spiegel
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引用次数: 0

摘要

目标:提高非西班牙裔黑人(NHB)和西班牙裔成年患者在美国国立卫生研究院资助的一项新兴医疗技术临床试验中的招募率和参与率:在一项由美国国立卫生研究院(NIH)资助的研究新兴医疗技术的临床试验中,提高非西班牙裔黑人(NHB)和西班牙裔成年患者的招募率和参与率:本研究包括 2020 年 11 月至 2023 年 11 月在加利福尼亚州洛杉矶市收集的原始数据:为了提高 NHB 和西班牙裔患者在美国国立卫生研究院(NIH)资助(NCT04409353)的慢性下背痛(cLBP)虚拟现实试验中的代表性,我们采用混合方法开展了一项多阶段研究。首先,我们对 18 岁及以上的非华裔和西班牙裔人群进行了焦点小组讨论;根据反馈意见,我们对招募材料和研究报告进行了文化调整。此外,我们还使用了队列构建器来过滤电子病历,以分离出患有 cLBP 的非西班牙裔黑人 (NHB) 和西班牙裔患者,进行微目标招募。当美国国立卫生研究院的母研究招募到 385 个最终样本中的 222 个(57.7%)时,这些变化被整合在一起,形成了一个前后比较时间点(2022 年 5 月 17 日)。通过比较干预前后招募和随机分配的 NHB 和西班牙裔患者人数,进行定量分析以评估修改后招募策略的效果:与新罕布什尔州和西班牙裔患者及社区成员(18 岁及以上)进行了半结构化焦点小组讨论。焦点小组在线进行,并在征得参与者同意后进行了录音;录音誊本进行了归纳式主题分析。新出现的主题指导了研究材料的修改,包括修改语言和图像、有针对性的外联以及纳入主治医生,这些都在研究的后半期实施。在父母研究完成后,通过比较新招募方法实施后(2022 年 5 月 17 日)与之前加入筛选数据库的记录,进行了定量分析:对焦点小组的专题分析确定了四个关键主题:不信任、缺乏兴趣、文化和沟通。对招募方法的修改使整个研究人群的随机化前成功率和随机化后成功率都有了统计学意义上的显著提高(p 结论:本研究引入了几种文化因素,包括:"文化"、"文化 "和 "沟通":本研究介绍了在设计招募材料时应考虑的几个文化敏感因素和可能的方法,解决了不信任、缺乏兴趣、文化和沟通等问题,适用于 NHB 和西班牙裔人群。同样,所述的微目标技术利用了队列构建的技术进步,提高了对代表性不足群体的覆盖率和随机化率,从而增强了临床试验的多样性。
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Bridging the Gap: Culturally Responsive Strategies for NIH Trial Recruitment.

Objective: To enhance recruitment and participation rates of non-Hispanic Black (NHB) and Hispanic adult patients in a NIH-funded clinical trial studying an emerging health technology.

Data sources and study setting: This study includes primary data collected in Los Angeles, California from November 2020 through November 2023.

Study design: To improve the representation of NHB and Hispanic patients in a NIH-funded (NCT04409353) trial on virtual reality for chronic lower back pain (cLBP), we conducted a multi-phase study utilizing a mixed-method approach. First, we conducted focus groups with NHB and Hispanic cohorts aged 18 and older; based on the feedback, we culturally adapted recruitment materials and study correspondences concordantly. Additionally, a cohort builder was used to filter the electronic medical record to isolate non-Hispanic Black (NHB) and Hispanic patients with cLBP for micro-targeted recruitment. These changes were collectively integrated when the parent NIH study had recruited 222 of its 385 final samples (57.7%), creating a pre-post comparison timepoint (May 17, 2022). Quantitative analysis was performed to assess the efficacy of the modified recruitment strategies by comparing the number of recruited and randomized NHB and Hispanic patients pre- and post-intervention.

Data collection/extraction methods: Semi-structured focus groups were conducted with NHB and Hispanic patients and community members (age 18 and older). The focus groups were conducted online and recorded with participant consent; transcripts of the recording underwent inductive thematic analysis. Emergent themes directed the modification of study materials, including revised language and imagery, targeted outreach, and incorporation of treating physicians, were implemented in the second half of the study. Quantitative analyses were conducted following parent study completion by comparing records added to the screening database following the implementation of new recruiting methods (5/17/2022) to those added before.

Principal findings: Thematic analysis of focus groups identified four key themes: mistrust, lack of interest, culture, and communication. Modifications to recruitment methodology resulted in statistically significant increases in the pre- to post-randomization success rate for the overall study population (p < 0.001), the NHB population (p = 0.011), and the Hispanic population (p < 0.015). When looking at each cohort at different points in the recruitment process before and after the intervention, in the Hispanic population, we saw significant increases in the number approached (p < 0.001) and number randomized (p < 0.001) and statistically insignificant increases in the NHB population approached (p = 0.067) and randomized (p = 0.295). Similarly, we saw that the changes in the recruitment letter led to a statistically significant increase in Hispanic recruitment (7.0 to 39.1%, p < 0.001) but not the NHB cohort (19.6 to 35.8%, p < 0.065).

Conclusion: This study introduces several culturally sensitive considerations and possible approaches for the design of recruitment materials, addressing mistrust, lack of interest, culture, and communication for use in NHB and Hispanic populations. Similarly, the described microtargeting techniques leverage the technological advancements in cohort building to improve the reach and efficiency of the randomization rate of underrepresented groups thereby enhancing clinical trial diversity.

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来源期刊
Journal of Racial and Ethnic Health Disparities
Journal of Racial and Ethnic Health Disparities PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-
CiteScore
7.30
自引率
5.10%
发文量
263
期刊介绍: Journal of Racial and Ethnic Health Disparities reports on the scholarly progress of work to understand, address, and ultimately eliminate health disparities based on race and ethnicity. Efforts to explore underlying causes of health disparities and to describe interventions that have been undertaken to address racial and ethnic health disparities are featured. Promising studies that are ongoing or studies that have longer term data are welcome, as are studies that serve as lessons for best practices in eliminating health disparities. Original research, systematic reviews, and commentaries presenting the state-of-the-art thinking on problems centered on health disparities will be considered for publication. We particularly encourage review articles that generate innovative and testable ideas, and constructive discussions and/or critiques of health disparities.Because the Journal of Racial and Ethnic Health Disparities receives a large number of submissions, about 30% of submissions to the Journal are sent out for full peer review.
期刊最新文献
Disparities in Patient Portal Activation and Usage at a Large Pediatric Academic Institution. Intersecting Epidemics: Examining the Impact of Internalized Homophobia and Depression Symptoms on HIV Testing Through a Suicide Syndemic Among Young Black Men Who Have Sex with Men. Socioeconomic Status, Social Support, and Quality of Life Among Black Adults. Bridging the Gap: Culturally Responsive Strategies for NIH Trial Recruitment. A Review of the Public Health Literature Examining the Roles of Socioeconomic Status and Race/Ethnicity on Health Outcomes in the United States.
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