Recruitment of Black Adults into Cardiovascular Disease Trials.
Recruitment of Black Adults into Cardiovascular Disease Trials.
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DOI：
10.1161/jaha.121.021108
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发表时间：
2021-09-07
影响因子：
5.4
通讯作者：
Juraschek SP
中科院分区：
文献类型：
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作者：
Prasanna A;Miller HN;Wu Y;Peeler A;Ogungbe O;Plante TB;Juraschek SP
虽然不成比例地受到心血管疾病的影响，但黑人成年人在临床试验中的代表性仍然不足。美国国立卫生研究院建议，研究确定招聘代表性不足的人口的目标。然而，心血管试验在其方案中纳入循证招募策略的程度尚未得到充分研究。我们系统地回顾了2000年至2019年期间在ClinicalTrials.gov上注册的美国国立卫生研究院资助的心血管临床试验。基于公开可用或要求的协议，我们专注于黑人成年人的招募以及以下招募策略：基于社区，基于电子病历和基于提供者的招募。共有100项专注于心血管疾病的临床试验被纳入我们的分析，其中62%已发表协议，46%的试验招募了黑人<25%的人群。在我们对现有试验方案的分析中，21%的试验为代表性不足的群体定义了招募目标;然而，只有一项研究报告达到了招募目标。虽然13%的试验方案参考了基于社区的招募策略，但5%明确提到在试验设计过程中让社区成员参与。定义招募目标与黑人参与者的高入学率相关。黑人成年人在美国国立卫生研究院资助的心血管试验中的代表性不足，这些试验中的大多数没有指定黑人招募目标，没有达到目标，并且在很大程度上没有报告招募黑人成年人参加研究的具体计划。未来的干预措施应针对研究开始前的试验设计和计划阶段，以解决这些入组差异。
Although disproportionately affected by cardiovascular disease, Black adults remain underrepresented in clinical trials. The National Institutes of Health recommends that studies define goals for recruitment of underrepresented populations. However, the extent to which cardiovascular trials incorporate evidence‐based recruitment strategies in their protocols is understudied. We systematically reviewed National Institutes of Health‐funded cardiovascular clinical trials registered in ClinicalTrials.gov between 2000 and 2019. Based on publicly available or requested protocols, we focused on enrollment of Black adults as well as the following recruitment strategies: community‐based, electronic medical record‐based, and provider‐based recruitment. A total of 100 clinical trials focused on cardiovascular disease were included in our analysis, of which 62% had published protocols, and 46% of trials had enrolled populations that were <25% Black. In our analysis of available trial protocols, 21% of trials defined a recruitment target for underrepresented groups; however, only one study reported achieving its enrollment goal. While 13% of trial protocols referenced community‐based recruitment strategies, 5% explicitly mentioned involving community members in the trial design process. Defining recruitment targets was associated with higher enrollment of Black participants. Black adults are underrepresented in National Institutes of Health‐funded cardiovascular trials, and the majority of these trials did not specify a Black enrollment target, did not meet targets, and largely did not report specific plans to enroll Black adults in their studies. Future interventions should target trial design and planning phases before study initiation to address these enrollment disparities.