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. METHODS 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. RESULTS 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. CONCLUSION 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.

中文翻译：

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在糖尿病降血糖方法中使用综合招募策略：一项比较有效性研究（GRADE）多中心临床试验。

背景/目标 我们介绍并描述了 2013 年至 2017 年在美国 45 个临床中心实施的招募策略，参与糖尿病的血糖降低方法：比较有效性研究，这是一项评估添加的四种降糖药物的公开、随机对照试验2 型糖尿病患者（糖尿病病程 <10 年）患者使用二甲双胍。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相比的收益率，以利用初级保健中 2 型糖尿病患者的机会。方法 地点选择标准包括研究人群的可用性、地理代表性、招募和保留不同参与者（包括传统上代表性不足的群体）的能力以及先前在糖尿病临床试验中的地点研究经验。采用招聘举措来支持和监督招聘，例如成立招聘和保留委员会、制定电子健康记录系统查询标准、进行远程现场访问、开发公共筛查网站以及其他中央和地方举措。值得注意的是，该研究支持在每个地点设立专门的招聘协调员来管理当地招聘并促进对电子健康记录系统识别的潜在参与者的筛选。结果 该研究实现了 5000 名参与者的入组目标，黑人/非裔美国人 (20%)、西班牙裔/拉丁裔 (18%) 和年龄 ≥ 60 岁 (42%) 亚组达到了目标，但女性 (36%) 未达到目标。招聘比原计划的3年多了1年。地点包括学术医院、综合卫生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%）、传统邮件外展（7%）、电视、广播、传单和互联网（7%）以及其他策略（5%）进行登记。与其他招募方法相比，早期实施有针对性的电子健康记录查询产生了更多的合格参与者。随着时间的推移，人们越来越强调与初级保健网络的接触。结论 糖尿病的降血糖方法：比较有效性成功招募了新发 2 型糖尿病的不同研究人群，很大程度上依赖于使用电子健康记录来筛选潜在参与者。具有频繁监控的综合招聘方法对于实现招聘目标至关重要。