Usadi Rebecca S, Diamond Michael P, Legro Richard S, Schlaff William D, Hansen Karl R, Casson Peter, Christman Gregory, Wright Bates G, Baker Valerie, Seungdamrong Aimee, Rosen Mitchell P, Lucidi Scott, Thomas Tracey, Huang Hao, Santoro Nanette, Eisenberg Esther, Zhang Heping, Alvero Ruben
Carolinas Healthcare System Reproductive Medicine and Infertility, 1025 Morehead Medical Dr., Charlotte, NC 28232, United States.
Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, GA 30912, United States.
Contemp Clin Trials. 2015 Nov;45(Pt B):196-200. doi: 10.1016/j.cct.2015.09.010. Epub 2015 Sep 18.
Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited.
We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials.
3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was the use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials.
Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment.
招募个体参与临床试验是完成研究的关键步骤。关于不同招募策略有效性的报告，尤其是针对不孕夫妇的报告有限。
我们调查了两项由美国国立卫生研究院资助的试验中所使用的招募方法，即多囊卵巢综合征妊娠试验（PPCOS II）和卵巢刺激多胎妊娠评估试验（AMIGOS），并研究了哪种策略能使完成试验的参与者数量最多。
3683对夫妇符合筛查条件。1650名参与者被随机分组，1339人完成了试验。在PPCOS II试验中，750名女性被随机分组；完成试验的参与者中有212人是由医生推荐的。在PPCOS II试验中，通过广播广告招募的参与者（84/750）和通过互联网招募的参与者（81/750）的试验完成率相似。在AMIGOS试验中，900名参与者被随机分组。完成试验的440名参与者是由医生推荐参加该研究的。在AMIGOS试验中，其次最成功的方法是使用互联网，有78名参与者完成试验。对于年收入低于5万美元的参与者来说，广播广告在两项试验中都是最成功的策略。广播广告在PPCOS II试验中招募白人患者最为成功，在AMIGOS试验中招募黑人患者最为成功。七个辅助临床研究科学家培训（CREST）站点招募了324名完成试验的参与者。
医生推荐是最成功的招募策略。广播广告和互联网是其次最成功的策略，尤其是对于收入有限的女性。辅助临床站点对总体招募很重要。
