African American Screening and Enrollment in (Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage III) CLEAR III.

Clinical researcher (Alexandria, Va.) Pub Date : 2018-08-01 Epub Date: 2018-08-14
Karen Lane, Maningbe Keita, Radhika Avadhani, Rachel Dlugash, Steven Mayo, Richard E Thompson, Issam Awad, Nichol McBee, Wendy Ziai, Daniel F Hanley
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Abstract

Background: Under-enrolling minority patients in clinical trials reduces generalizability. CLEAR III, a randomized controlled trial, presented an opportunity to assess African American (AA) participation.

Methods: AA enrollment was compared to U.S. population and NINDS trial data then stratified by region; census data for 42 recruitment cities were compared to screening and randomization percentages, using simple linear regression.

Results: AAs were 25% of screens and 45.1% of enrollments (n=370), more than twice the 19.8% participation rate reported by the 2011 NINDS Advisory Panel on Health Disparities Research and triple the projected 13.9% 2014 U.S. population. Conversion rates were (AA vs. non-AA): overall (8.7% vs. 3.4%, p<0.001); Northeast (7.7% vs. 2.9%, p<0.001); South (8.2% vs. 4.0%, p<0.001); Midwest (10.3% vs. 3.6%, p<0.01); and West (8.9% vs. 3.8%, p=0.02). AA enrollments ranged from 0% to 100% (mean: 40.4%). AA screening ranged from 0% to 63.7% (mean: 23.2%). AA city census ranged from 1.3% to 82.7% (mean: 28.0%); higher census was associated with higher screening (p<0.0001) and enrollment (p=0.004).

Conclusions: AAs were willing to enroll in an acute stroke trial. AA city census rates should be considered when selecting enrollment centers and setting recruitment goals. Factors leading to successful AA recruitment should be further investigated, as population-based participation is a goal in all trials.

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非裔美国人的筛选和登记(血块溶解:评估脑室内出血的加速解决III)
背景:在临床试验中未充分纳入少数民族患者降低了普遍性。CLEAR III是一项随机对照试验,提供了评估非裔美国人(AA)参与情况的机会。方法:AA入组比较美国人口和NINDS试验数据,然后按地区分层;采用简单线性回归对42个招工城市的普查数据进行筛选和随机化百分比的比较。结果:AAs占筛查的25%,占登记人数的45.1% (n=370),是2011年NINDS健康差异研究咨询小组报告的19.8%的参与率的两倍多,是2014年美国人口预计13.9%的三倍。转换率为(AA vs.非AA):总体(8.7% vs. 3.4%)。结论:AA患者愿意参加急性卒中试验。在选择招生中心和制定招生目标时应考虑AA城市人口普查率。应进一步调查导致AA成功招募的因素,因为基于人群的参与是所有试验的目标。
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