Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials
Strategies for Successful Recruitment of Pregnant Patients Into Clinical Trials
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DOI：
10.1097/aog.0000000000001900
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发表时间：
2017-03-01
影响因子：
7.2
通讯作者：
Redman, Leanne M.
中科院分区：
文献类型：
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作者：
Sutton, Elizabeth F.;Cain, Loren E.;Redman, Leanne M.
在怀孕人群中进行的临床研究可以为产科提供高质量的循证护理。然而，近年来，产科领域在招募孕妇进入临床试验方面面临着严峻的挑战，其他几个医学学科也面临着这一挑战。我们坦率地描述了我们未能招募一个健康的超重和肥胖的孕妇在他们的头三个月。然后，我们能够收集不成功和成功的招聘方法，并通过对失败策略的尸检来改善我们的招聘工作，并通过传播调查来指导我们了解社区对怀孕期间参与研究的感受。这些“经验教训”告诉我们，在这一人群中积极招募是必要的;也就是说，直接（在产科预约面对面的讨论）与间接（传单和一般电子邮件）模式相比，产前护理提供者对拟议研究的支持对患者参与的意愿至关重要。通过实施“经验教训”，我们描述了我们如何成功地招募了一个类似的怀孕人口1年后。与我们文章相关的临床试验如下：1）预期成功：NCT 01610752，https：//clinicaltrials.gov/ct2/show/NCT01610752; 2）MomEE：NCT 01954342，https：//clinicaltrials.gov/ct2/show/NCT01954342;和3）妊娠期间参与调查：NCT 02699632，https://clinicaltrials.gov/ct2/show/NCT02699632。
Clinical research in the pregnant population allows for delivery of quality, evidence-based care in obstetrics. However, in recent years, the field of obstetrics has faced severe challenges in the recruitment of the pregnant population into clinical trials, a struggle also shared by several other medical disciplines. We candidly describe our failure to recruit a healthy population of overweight and obese pregnant women in their first trimester. We were then able to glean unsuccessful and successful recruitment approaches and improve our recruitment effort by autopsy of failed strategies and with guidance from a survey disseminated to improve our understanding of community feelings about participating in research while pregnant. These "lessons learned" taught us that active recruitment within this population is a necessity; that is, direct (face-to-face discussions at obstetric appointments) compared with indirect (flyers and general emails) modalities and that prenatal care provider support of the proposed research study is vital to a patient's willingness to participate. By implementation of "lessons learned," we describe how we successfully recruited a similar pregnant population 1 year later. The Clinical Trials related to our article are as follows: 1) Expecting Success: NCT01610752, https://clinicaltrials.gov/ct2/show/NCT01610752; 2) MomEE: NCT01954342, https://clinicaltrials.gov/ct2/show/NCT01954342; and 3) Participate While Pregnant Survey: NCT02699632, https://clinicaltrials.gov/ct2/show/NCT02699632.