Fouad Mona N, Corbie-Smith Giselle, Curb David, Howard Barbara V, Mouton Charles, Simon Michael, Talavera Greg, Thompson Joanice, Wang Ching-Yun, White Cornelia, Young Rosalie
Division of Preventive Medicine, University of Alabama at Birmingham, 1530 3rd Avenue South, MT 618, Birmingham, AL 35294-4410, USA.
Control Clin Trials. 2004 Aug;25(4):335-52. doi: 10.1016/j.cct.2004.03.005.
The Women's Health Initiative (WHI) is a study designed to examine the major causes of death and disability in women. This multi-arm, randomized, controlled trial of over 160,000 post-menopausal women of varying ethnic and socioeconomic backgrounds and a goal of 20% of the study participants from minority populations is perhaps one of the most challenging recruitment efforts ever undertaken. Of the two main study arms, the Clinical Trial (CT) and the Observational Study (OS), the CT arm recruitment goal was to randomize 64,500 postmenopausal women 50-79 years of age. Women enrolled in the study will be followed for a period of 8-12 years. Ten clinical centers, out of a total of 40 throughout the United States, were selected as minority recruitment centers on the basis of their history of interaction with and access to large numbers of women from certain population subgroups. WHI enrollment began in September 1993 and ended in December 1998, resulting in the randomization and enrollment of a total of 161,856 (17.5% minority) women participants (68,135 (18.5% minority) in the CT and 93,721 (16.7%) in the OS). Within the CT arm, WHI achieved 101.7% of the goal of 48,000 participants in the Dietary Modification (DM) component, and 99.4% of the goal of 27,500 in the hormone-replacement component (HRT), with 11.8% overlap between DM and HRT. Of those who expressed initial interest in WHI, African Americans had the highest randomization yields in the DM component and Hispanics had the highest in the HRT component (15.2% and 10.2%, respectively). Overall, mass mailing was the greatest source of randomized participants. In addition, minority clinics found community outreach, personal referrals, and culturally appropriate recruitment materials particularly effective recruitment tools. For minority recruitment, our findings suggest that the key to high yield is reaching the target population through appropriate recruitment strategies and study information that get their attention. Also, once minority subjects are reached, they tend to participate.
妇女健康倡议（WHI）是一项旨在研究女性死亡和残疾主要原因的研究。这项针对超过160,000名不同种族和社会经济背景的绝经后女性的多组、随机、对照试验，目标是让20%的研究参与者来自少数族裔群体，这可能是有史以来最具挑战性的招募工作之一。在两个主要研究组，即临床试验（CT）组和观察性研究（OS）组中，CT组的招募目标是将64,500名50至79岁的绝经后女性随机分组。参与该研究的女性将被跟踪8至12年。在美国总共40个临床中心中，有10个被选为少数族裔招募中心，依据是它们与特定人群亚组的大量女性互动的历史以及接触这些女性的机会。WHI的招募工作于1993年9月开始，1998年12月结束，共随机分组并招募了161,856名女性参与者（17.5%为少数族裔）（CT组68,135名（18.5%为少数族裔），OS组93,721名（16.7%））。在CT组内，WHI在饮食调整（DM）部分实现了48,000名参与者目标的101.7%，在激素替代部分（HRT）实现了27,500名目标的99.4%，DM和HRT之间有11.8%的重叠。在那些最初对WHI表示感兴趣的人中，非裔美国人在DM部分的随机分组成功率最高，西班牙裔在HRT部分的随机分组成功率最高（分别为15.2%和10.2%）。总体而言，大规模邮寄是随机分组参与者的最大来源。此外，少数族裔诊所发现社区宣传、个人推荐以及符合文化特点的招募材料是特别有效的招募工具。对于少数族裔招募，我们的研究结果表明，高成功率的关键在于通过合适的招募策略和能引起他们注意的研究信息来接触目标人群。而且，一旦接触到少数族裔受试者，他们往往会参与。
