The University of Alabama, Birmingham, AL, USA.
The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA.
Clin Trials. 2023 Oct;20(5):546-558. doi: 10.1177/17407745231175919. Epub 2023 Jun 17.
BACKGROUND/AIMS: We present and describe recruitment strategies implemented from 2013 to 2017 across 45 clinical sites in the United States, participating in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study, an unmasked, randomized controlled trial evaluating four glucose-lowering medications added to metformin in individuals with type 2 diabetes mellitus (duration of diabetes <10 years). We examined the yield of participants recruited through Electronic Health Records systems compared to traditional recruitment methods to leverage access to type 2 diabetes patients in primary care.
Site selection criteria included availability of the study population, geographic representation, the ability to recruit and retain a diverse pool of participants including traditionally underrepresented groups, and prior site research experience in diabetes clinical trials. Recruitment initiatives were employed to support and monitor recruitment, such as creation of a Recruitment and Retention Committee, development of criteria for Electronic Health Record systems queries, conduct of remote site visits, development of a public screening website, and other central and local initiatives. Notably, the study supported a dedicated recruitment coordinator at each site to manage local recruitment and facilitate screening of potential participants identified by Electronic Health Record systems.
The study achieved the enrollment goal of 5000 participants, meeting its target with Black/African American (20%), Hispanic/Latino (18%), and age ≧60 years (42%) subgroups but not with women (36%). Recruitment required 1 year more than the 3 years originally planned. Sites included academic hospitals, integrated health systems, and Veterans Affairs Medical Centers. Participants were enrolled through Electronic Health Record queries (68%), physician referral (13%), traditional mail outreach (7%), TV, radio, flyers, and Internet (7%), and other strategies (5%). Early implementation of targeted Electronic Health Record queries yielded a greater number of eligible participants compared to other recruitment methods. Efforts over time increasingly emphasized engagement with primary care networks.
Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness successfully recruited a diverse study population with relatively new onset of type 2 diabetes mellitus, relying to a large extent on the use of Electronic Health Record to screen potential participants. A comprehensive approach to recruitment with frequent monitoring was critical to meet the recruitment goal.
背景/目的：我们展示并描述了 2013 年至 2017 年期间在美国 45 个临床站点实施的招募策略，这些站点参与了“糖尿病血糖降低方法：一项比较有效性研究”，这是一项未设盲、随机对照试验，评估了在糖尿病持续时间<10 年的 2 型糖尿病患者中添加四种降血糖药物对二甲双胍的疗效。我们检查了通过电子健康记录系统招募的参与者与传统招募方法的收益，以利用初级保健中 2 型糖尿病患者的资源。
站点选择标准包括研究人群的可用性、地域代表性、招募和保留包括传统代表性不足群体在内的多样化参与者群体的能力，以及在糖尿病临床试验方面的前期站点研究经验。采用了招募计划来支持和监测招募，例如成立了招募和保留委员会、制定电子健康记录系统查询标准、进行远程站点访问、开发公共筛选网站以及其他中央和地方计划。值得注意的是，该研究在每个站点都支持一名专门的招募协调员，以管理本地招募并促进电子健康记录系统识别的潜在参与者的筛选。
该研究实现了 5000 名参与者的入组目标，满足了黑/非裔美国人（20%）、西班牙裔/拉丁裔（18%）和年龄≧60 岁（42%）亚组的目标，但未满足女性（36%）的目标。招募需要比原计划多 1 年的时间。参与的站点包括学术医院、综合医疗系统和退伍军人事务医疗中心。参与者通过电子健康记录查询（68%）、医生推荐（13%）、传统邮件推广（7%）、电视、广播、传单和互联网（7%）和其他策略（5%）入组。早期实施有针对性的电子健康记录查询比其他招募方法产生了更多的合格参与者。随着时间的推移，努力越来越强调与初级保健网络的合作。
“糖尿病血糖降低方法：一项比较有效性研究”成功招募了一组相对较新确诊 2 型糖尿病的多样化研究人群，在很大程度上依赖于使用电子健康记录筛选潜在参与者。全面的招募方法和频繁的监测对于实现招募目标至关重要。
