MD Anderson Cancer Center, University of Texas, Houston, TX 77230-1439, USA.
Clin Trials. 2010 Feb;7(1):90-9. doi: 10.1177/1740774509357227.
African American accrual to prevention trials at rates representative of the disease burden experienced by this population requires additional resources and focused efforts.
To describe the rationale, context, and criteria for selection of sites that received Minority Recruitment Enhancement Grants (MREGs) to increase African American recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). To determine if African American accrual was higher among the 15 MREG sites when compared with similar nonawarded sites.
Changes in African American accrual at sites that received MREGs are compared with changes in a group of 15, frequency-matched, nonawarded sites using a quasi-experimental, post hoc analysis. Successful and unsuccessful recruitment strategies reported by the MREG sites are described.
The increased number of African American participants accrued per month at MREG sites post-funding was higher than the change at comparison sites by a factor of 3.38 (p = 0.004, 95% CI: 1.51-7.57). An estimated 602 additional African American participants were recruited at MREG sites due to MREG funding, contributing to the overall 14.9% African American recruitment. Successful recruitment strategies most reported by MREG sites included increasing staff, transportation resources, recruiting through the media, mailings, and prostate cancer screening clinics during off-hours.
Comparison sites were chosen retrospectively, not by randomization. Although comparison sites were selected to be similar to MREG sites with regard to potential confounding factors, it is possible that unknown factors could have biased results. Cost-effective analyses were not conducted.
MREG sites increased African American accrual in the post-funding period more than comparison sites, indicating MREG funding enhanced the sites' abilities to accrue African American participants. Targeted grants early in the accrual period may be a useful multi-site intervention to increase African American accrual for a prevention study where adequate African American representation is essential.
非裔美国人参与预防试验的比例应与该人群所经历的疾病负担相匹配,这需要额外的资源和有针对性的努力。
描述获得少数族裔招募增强拨款(MREG)的站点的选择依据、背景和标准,这些站点旨在增加非裔美国人参与硒和维生素 E 癌症预防试验(SELECT)。确定与类似的非拨款站点相比,15 个 MREG 站点的非裔美国人入组率是否更高。
使用准实验后分析方法,比较获得 MREG 的站点与 15 个频率匹配的非拨款站点的非裔美国人入组率变化。描述 MREG 站点报告的成功和不成功的招募策略。
获得 MREG 资金后,MREG 站点每月增加的非裔美国参与者人数是比较站点的 3.38 倍(p = 0.004,95%CI:1.51-7.57)。由于 MREG 资金,MREG 站点共招募了 602 名额外的非裔美国人,使非裔美国人总体入组率增加了 14.9%。MREG 站点报告的成功招募策略包括增加员工、交通资源、通过媒体、邮件和非工作时间的前列腺癌筛查诊所进行招募。
比较站点是回顾性选择的,而不是随机选择的。尽管选择比较站点是为了与 MREG 站点在潜在混杂因素方面相似,但仍有可能存在未知因素会影响结果。没有进行成本效益分析。
在获得资金后的时期,MREG 站点的非裔美国人入组率增加幅度超过了比较站点,表明 MREG 资金增强了这些站点招募非裔美国参与者的能力。在入组期早期,针对特定人群的拨款可能是一种增加预防研究中非裔美国人入组率的有效多站点干预措施,因为该研究需要充分代表非裔美国人。