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解锁心血管临床研究多样性:少数民族人群心脏淀粉样变性核素影像学筛查研究的经验教训。

Unlocking Diversity in Cardiovascular Clinical Research: Lessons from the Screening for Cardiac Amyloidosis With Nuclear Imaging in a Minority Populations Study.

机构信息

Department of Cardiology, Cardiac Amyloidosis Program, Columbia University Irving Medical, New York City, NY.

Feinstein Institute for Medical Research/Northwell Health, Manhasset, NY.

出版信息

J Card Fail. 2024 Nov;30(11):1507-1511. doi: 10.1016/j.cardfail.2024.04.019. Epub 2024 May 11.

Abstract

BACKGROUND

The Screening for Cardiac Amyloidosis with Nuclear Imaging in Minority Populations study seeks to determine the prevalence of transthyretin cardiac amyloidosis (ATTR-CA) among older Black or Caribbean Hispanic individuals with heart failure and an increased wall thickness. We noticed varied recruitment percentages across the recruiting sites and sought to determine the factors associated with greater percentage enrollment of eligible participants.

METHODS

The percentage of enrolled to eligible participants was calculated across study sites. Baseline demographic and clinical characteristics, health literacy, trust in providers, perceived discrimination, area deprivation index (ADI) and English proficiency were compared by site using Kruskal-Wallis's test or one-way ANOVA for continuous variables and the Chi-Square test or Fisher's exact test for categorical variables. Wilcoxon rank sum and Chi-Square tests, with multiple comparisons correction using the false discovery rate (FDR) method, were used as post-hoc analysis when results were statistically significant.

RESULTS

Among the four recruiting sites, Boston Medical Center, Columbia University Irving Medical Center, Harlem Hospital and Yale University, which employed different recruitment approaches, the percentage of participants enrolled among eligible participants differed, with the highest rate at Harlem Hospital (n=149 of 310, 48%), followed by Yale University (n=27 of 67, 40%), Boston University (n=247 of 655, 38%), and Columbia University (n=137of 442, 32%), p <0.01. Direct recruitment by the primary cardiovascular care team providing clinical care was associated with higher percent enrolled across sites as were higher education levels and English proficiency. Enrollment differences across sites were not associated with the number of chronic diseases, physician trust, perceived discrimination, or health literacy.

CONCLUSIONS

Recruitment of eligible under-represented minorities (URMs) in SCAN-MP was associated with approaches employed in recruitment, including direct initial contact by the primary cardiovascular care team providing the potential participant's clinical care. Such data may help improve approaches to more successful recruitment of URMs in clinical research.

摘要

背景

少数民族人群心脏淀粉样变核成像筛查研究(Screening for Cardiac Amyloidosis with Nuclear Imaging in Minority Populations study)旨在确定在心力衰竭且壁增厚的老年黑人和加勒比裔西班牙人群中,转甲状腺素蛋白心脏淀粉样变(transthyretin cardiac amyloidosis,ATTR-CA)的患病率。我们注意到各研究地点的入组率存在差异,因此希望确定与更多合格参与者入组百分比相关的因素。

方法

我们计算了各研究点合格参与者的入组百分比。使用 Kruskal-Wallis 检验或单因素方差分析比较了各研究点的基线人口统计学和临床特征、健康素养、对提供者的信任、感知歧视、区域剥夺指数(area deprivation index,ADI)和英语水平。使用 Chi-Square 检验或 Fisher 确切检验比较了分类变量。当结果具有统计学意义时,使用 Wilcoxon 秩和检验和 Chi-Square 检验,采用错误发现率(false discovery rate,FDR)方法进行多重比较校正,作为事后分析。

结果

在采用不同招募方法的四个招募地点中,波士顿医疗中心(Boston Medical Center)、哥伦比亚大学欧文医学中心(Columbia University Irving Medical Center)、哈莱姆医院(Harlem Hospital)和耶鲁大学(Yale University),合格参与者的入组率不同,哈莱姆医院的入组率最高(n=149/310,48%),其次是耶鲁大学(n=27/67,40%)、波士顿大学(n=247/655,38%)和哥伦比亚大学(n=137/442,32%),p<0.01。在各研究点,为提供潜在参与者临床护理的主要心血管护理团队直接招募与更高的入组百分比相关,较高的教育水平和英语水平也与更高的入组百分比相关。各研究点的入组率差异与慢性病数量、医生信任、感知歧视或健康素养无关。

结论

SCAN-MP 中合格的代表性不足少数群体(under-represented minorities,URM)的招募与招募中采用的方法有关,包括为潜在参与者提供临床护理的主要心血管护理团队的直接初步接触。此类数据可能有助于改善更成功招募临床研究中 URMs 的方法。

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