Bachour Candi C, Bachmann Gloria A, Foster David C, Wan Jim Y, Rawlinson Leslie A, Brown Candace S
1 Department of Clinical Pharmacy, The University of Tennessee Health Science Center, Memphis, TN, USA.
2 Department of Obstetrics, Gynecology and Reproductive Sciences, UMDNJ-Robert Wood Johnson Medical Center, New Brunswick, NJ, USA.
Clin Trials. 2017 Feb;14(1):103-108. doi: 10.1177/1740774516663461. Epub 2016 Aug 11.
Successful recruitment in clinical trials for chronic pain conditions is challenging, especially in women with provoked vulvodynia due to reluctance in discussing pain associated with sexual intercourse. The most successful recruitment methods and the characteristics of women reached with these methods are unknown.
To compare the effectiveness and efficiency of four recruitment methods and to determine socioeconomic predictors for successful enrollment in a National Institutes of Health-sponsored multicenter clinical trial evaluating a gabapentin intervention in women with provoked vulvodynia.
Recruitment methods utilized mass mailing, media, clinician referrals and community outreach. Effectiveness (number of participants enrolled) and efficiency (proportion screened who enrolled) were determined. Socioeconomic variables including race, educational level, annual household income, relationship status, age, menopausal status and employment status were also evaluated regarding which recruitment strategies were best at targeting specific cohorts.
Of 868 potential study participants, 219 were enrolled. The most effective recruitment method in enrolling participants was mass mailing ( p < 0.001). There were no statistically significant differences in efficiency between recruitment methods ( p = 0.11). Relative to clinician referral, black women were 13 times as likely to be enrolled through mass mailing (adjusted odds ratio 12.5, 95% confidence interval, 3.6-43.1) as white women. There were no differences in enrollment according to educational level, annual income, relationship status, age, menopausal status, or employment status and recruitment method.
In this clinical trial, mass mailing was the most effective recruitment method. Race of participants enrolled in a provoked vulvodynia trial was related to the recruitment method.
慢性疼痛疾病临床试验的成功招募具有挑战性，尤其是对于患有激发性外阴痛的女性，因为她们不愿讨论与性交相关的疼痛。最成功的招募方法以及通过这些方法招募到的女性的特征尚不清楚。
比较四种招募方法的有效性和效率，并确定在一项由美国国立卫生研究院资助的多中心临床试验中成功入组的社会经济预测因素，该试验评估加巴喷丁对患有激发性外阴痛的女性的干预效果。
招募方法包括大规模邮寄、媒体宣传、临床医生推荐和社区宣传。确定有效性（入组参与者数量）和效率（筛选后入组的比例）。还评估了社会经济变量，包括种族、教育水平、家庭年收入、婚姻状况、年龄、绝经状态和就业状况，以确定哪种招募策略最适合针对特定人群。
在868名潜在研究参与者中，219人入组。招募参与者最有效的方法是大规模邮寄（p < 0.001）。招募方法之间的效率没有统计学上的显著差异（p = 0.11）。相对于临床医生推荐，黑人女性通过大规模邮寄入组的可能性是白人女性的13倍（调整后的优势比为12.5，95%置信区间为3.6 - 43.1）。根据教育水平、年收入、婚姻状况、年龄、绝经状态或就业状况以及招募方法，入组情况没有差异。
在这项临床试验中，大规模邮寄是最有效的招募方法。参与激发性外阴痛试验的参与者的种族与招募方法有关。
