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成功招募少数族裔参与临床试验:斯沃普的“踢走它”项目。

Successful recruitment of minorities into clinical trials: The Kick It at Swope project.

作者信息

Harris Kari Jo, Ahluwalia Jasjit S, Catley Delwyn, Okuyemi Kolawole S, Mayo Matthew S, Resnicow Ken

机构信息

University of Kansas School of Medicine, Department of Preventive Medicine, Kansas City, KS 66160, USA.

出版信息

Nicotine Tob Res. 2003 Aug;5(4):575-84. doi: 10.1080/1462220031000118540.

DOI:10.1080/1462220031000118540
PMID:12959796
Abstract

Ethnic minorities are often underrepresented in clinical trials, and their recruitment can challenge researchers. Developing and communicating effective and efficient recruitment strategies may help researchers enroll more minorities into research studies. Kick It at Swope was a double-blind, randomized trial that evaluated bupropion for smoking cessation among 600 adult African Americans who smoked 10 or more cigarettes a day. Proactive recruitment strategies (in-person appeals by study staff and health care providers) and reactive recruitment strategies (disseminating information that asked people to call a study hotline) were implemented sequentially in an additive fashion over 16 months. Resulting patterns of recruitment are described and the two phases are compared based on their relative effectiveness, efficiency, and cost. More enrollees were recruited in the reactive phase (n=534) than in the proactive phase (n=66). Those recruited in the reactive phase were more likely to be eligible (OR=4.8) and more likely to be enrolled (OR=4.2) than those recruited in the proactive phase. Participants recruited in the reactive phase reported significantly higher levels of education and income, better health, and significantly lower indicators of depression and life hassles, compared with those recruited in the proactive phase. The reactive recruitment phase was less expensive than the proactive recruitment phase (22 US Dollars/enrollee vs. 159 US Dollars/enrollee). Reactive recruitment strategies added to multiple proactive clinic-based recruitment strategies were more effective, more efficient, and less costly than proactive recruitment alone. Close monitoring combined with the use of multiple recruitment methods and flexible recruitment plans can lead to successful, efficient, and low-cost recruitment of minorities into clinical trials.

摘要

少数族裔在临床试验中的代表性往往不足,招募他们可能会给研究人员带来挑战。制定并传达有效且高效的招募策略或许有助于研究人员让更多少数族裔参与到研究中来。“在斯沃普戒烟”是一项双盲随机试验,评估安非他酮对600名每天吸烟10支或更多的成年非裔美国人戒烟的效果。主动招募策略(研究人员和医疗服务提供者亲自呼吁)和被动招募策略(传播信息,要求人们拨打研究热线)在16个月内以累加方式依次实施。描述了由此产生的招募模式,并根据其相对有效性、效率和成本对两个阶段进行了比较。被动阶段招募的参与者(n = 534)比主动阶段(n = 66)更多。与主动阶段招募的参与者相比,被动阶段招募的参与者更有可能符合条件(比值比=4.8),也更有可能被招募(比值比=4.2)。与主动阶段招募的参与者相比,被动阶段招募的参与者报告的教育水平和收入水平显著更高,健康状况更好,抑郁和生活困扰指标显著更低。被动招募阶段比主动招募阶段成本更低(每位参与者22美元 vs. 159美元)。与单独的主动招募相比,在多种基于诊所的主动招募策略基础上增加被动招募策略更有效、更高效且成本更低。密切监测结合使用多种招募方法和灵活的招募计划可以成功、高效且低成本地将少数族裔招募到临床试验中。

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