Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
Clin Trials. 2010 Dec;7(6):744-8. doi: 10.1177/1740774510383886. Epub 2010 Sep 10.
To evaluate two recruitment strategies used during the full-scale randomized, placebo-controlled Selenium and Vitamin E Cancer Prevention Trial (SELECT) at one clinical center.
Recruitment of participants to cancer prevention trials is challenging and costly and more efficient methods are needed.
SELECT participants were males ≥60 years old who were solicited with two recruitment strategies. In the control strategy, potential participants, identified through purchased mailing lists, were sent a SELECT invitation letter. In the 'spouse' strategy, letters were sent to married postmenopausal women already participating in the Women's Health Initiative (WHI) at our clinical center asking them to provide an enclosed SELECT invitation letter (identical to the one in the control strategy) to the 'man in her life'. Our hypothesis was that SELECT recruitment of men would be enhanced by this indirect mailing to their spouses already participating in a similar program.
In the control strategy, 183,315 invitation letters were mailed to 60,000 men; cumulative response was 2.16%; 600 men ultimately enrolled in SELECT (15.1% of respondents) for a mailing recruitment cost of $259 per participant. In the spouse strategy, 800 women participating in WHI clinical studies had husbands; of the 2214 invitation letters mailed to this group of women, cumulative response was 2.75%; 34 men ultimately enrolled in SELECT (55.7% of respondents) for a mailing recruitment cost of $59 per participant.
Process information on how invitation letters were handled in the spouse strategy was not collected.
A direct mail recruitment strategy was successful in recruiting men to a cancer prevention trial. A recruitment strategy involving indirect mailing to married women participating in a similar research program in the same center did not increase initial response substantially, but a higher proportion of respondents ultimately entered the prevention trial.
评估在一个临床中心进行的全规模随机、安慰剂对照硒和维生素 E 癌症预防试验（SELECT）中使用的两种招募策略。
招募癌症预防试验的参与者具有挑战性且成本高昂，因此需要更有效的方法。
SELECT 参与者是年龄≥60 岁的男性，他们通过两种招募策略被招募。在对照策略中，通过购买的邮寄名单确定潜在参与者，向他们发送 SELECT 邀请信。在“配偶”策略中，向已经参加我们临床中心的妇女健康倡议（WHI）的已婚绝经后妇女发送信件，要求她们将一份包含 SELECT 邀请信（与对照策略中的相同）寄给“她生命中的男人”。我们的假设是，通过这种间接邮寄给已经参加类似计划的配偶，SELECT 对男性的招募会得到加强。
在对照策略中，向 60000 名男性邮寄了 183315 份邀请信；累计响应率为 2.16%；最终有 600 名男性入选 SELECT（占受访者的 15.1%），每位参与者的邮寄招募成本为 259 美元。在配偶策略中，参加 WHI 临床研究的 800 名女性有丈夫；向该组女性邮寄了 2214 份邀请信，累计响应率为 2.75%；最终有 34 名男性入选 SELECT（占受访者的 55.7%），每位参与者的邮寄招募成本为 59 美元。
未收集配偶策略中邀请信处理的过程信息。
直接邮件招募策略成功招募了男性参加癌症预防试验。一种涉及向在同一中心参加类似研究计划的已婚女性间接邮寄的招募策略并没有显著增加初始响应，但最终有更高比例的受访者参加了预防试验。
