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纳入代表性不足的种族和族裔群体进行心血管临床试验。

Inclusion of Under-Represented Racial and Ethnic Groups in Cardiovascular Clinical Trials.

机构信息

Nassau University Medical Center, East Meadow, NY, USA.

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, Hempstead, NY, USA.

出版信息

Heart Lung Circ. 2022 Sep;31(9):1263-1268. doi: 10.1016/j.hlc.2022.06.668. Epub 2022 Jul 16.

DOI:10.1016/j.hlc.2022.06.668
PMID:35850910
Abstract

INTRODUCTION

Non-White racial and ethnic groups have been traditionally under-represented for decades in the field of cardiology, specifically in cardiovascular research studies. This underrepresentation has occurred despite the fact that these racial and ethnic groups have been shown to be at increased risk of cardiovascular disease (CVD).

METHODS

To assess the trend of representation in mainstream landmark cardiovascular trials, we performed a review of major cardiovascular trials published between 1986 and 2019. Mainstream landmark trials were selected as classified by established cardiology standards. The reported numbers of racial and ethnic participants were assessed within these categorised cardiovascular trials over a continuous time period.

RESULTS

A total of 1,138,683 patients were assessed from 153 randomised clinical trials. Of these trials, only 56% (n=86) reported information about race. Of note, 99% (n=152) of these trials reported gender. About three-quarters of the trials (77%) were undertaken at least partly in the United States (US). Our results show that the percentage of non-White participants in clinical trials was not significantly different over time (p=0.85), suggesting no significant improvement in non-White racial/ethnic representation. Further analysis of only the US inclusive trials (n=20) also showed no significant improvement in representation (p=0.38).

CONCLUSION

Only about half of all major cardiovascular landmark trials reported any racial or ethnic information, despite more recent calls over the last 5-10 years for diversity and representation in cardiovascular research studies. Additionally, no significant improvement in inclusion of traditionally under-represented racial and ethnic groups (UREGs) in these trials has occurred over time. Our analysis shows that there is still major work to be done to foster better representation and evaluation of the UREG population in cardiovascular trials.

摘要

简介

几十年来,非白种人种族和族裔群体在心脏病学领域,特别是在心血管研究中一直代表性不足。尽管这些种族和族裔群体已被证明患心血管疾病(CVD)的风险增加,但仍存在这种代表性不足的情况。

方法

为了评估主流标志性心血管试验中的代表性趋势,我们对 1986 年至 2019 年期间发表的主要心血管试验进行了回顾。主流标志性试验被选为已建立的心脏病学标准分类。在这段连续的时间内,在这些分类的心血管试验中评估了报告的种族和族裔参与者人数。

结果

从 153 项随机临床试验中评估了 1138683 名患者。在这些试验中,只有 56%(n=86)报告了种族信息。值得注意的是,99%(n=152)的试验报告了性别。大约四分之三的试验(77%)至少部分在美国(US)进行。我们的结果表明,临床试验中非白种参与者的比例在时间上没有显著差异(p=0.85),这表明在非白种人种族/族裔代表性方面没有显著改善。对仅包括美国的试验(n=20)的进一步分析也表明代表性没有显著改善(p=0.38)。

结论

尽管在过去 5-10 年中,人们多次呼吁在心血管研究中实现多样性和代表性,但只有大约一半的主要心血管标志性试验报告了任何种族或族裔信息。此外,随着时间的推移,这些试验中传统代表性不足的种族和族裔群体(UREG)的纳入情况并没有显著改善。我们的分析表明,在促进心血管试验中 UREG 人群的更好代表性和评估方面仍有大量工作要做。

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