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The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study

机译：使用电子健康记录在临床试验中招募：混合方法分析和谐结果电子健康记录辅助研究

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The electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information on site-level facilitators of and barriers to optimal use of EHR systems with respect to trial recruitment. We conducted qualitative focus groups and quantitative surveys as part of the EHR Ancillary Study, which is being conducted alongside the multicenter, global, Harmony Outcomes Trial comparing albiglutide to standard care for the prevention of cardiovascular events in type 2 diabetes. Subject matter experts used findings from focus groups to draft a 20-question survey examining the use of the EHR for participant identification, common site recruitment strategies, and variation in perceived barriers to optimal use of the EHR. The final survey was fielded with 446 site investigators actively enrolling participants in the main trial. Nearly two-thirds of respondents were study coordinators (63.2%), 23.1% were principal investigators, and 13.7% held other research roles. Approximately half of the respondents reported using the EHR to find potential trial participants. Of these, 79.4% reported using EHR searches in conjunction with other recruitment methods, including reviewing of upcoming clinic schedules (75.3%) and contacting past trial participants (71.2%). Important barriers to optimal use of the EHR included the lack of availability of certain research-focused EHR modules and limitations on the ability to contact patients cared for by other providers. Of survey respondents who did not use the EHR to find potential participants, one-quarter reported that the EHR was not accessible in their country; this finding varied from 2.6% of respondents in North America to 50% of respondents in the Asia Pacific. While EHR screening was commonly used for recruitment in a cardiovascular outcomes trial, important technical, governance, and regulatory barriers persist. Multifaceted, scalable, and customizable strategies are needed to support the optimal use of the EHR for trial participant identification.
机译：电子健康记录（EHR）含有丰富的临床数据，可用于简化潜在的临床试验参与者的识别。但是，关于现场级别促进者的实证信息很少，以最佳地利用EHR系统在审判招聘中的最佳利用。我们将定性焦点小组和定量调查作为EHR辅助研究的一部分，该研究与多中心，全球和谐结果试验相比，将苯化石蛋白质与标准护理进行标准治疗2型糖尿病中的心血管事件。主题专家专家使用焦点小组的调查结果来起草20题的调查，审查使用EHR进行参与者身份证明，共同的网站招聘策略以及感知障碍的变化，以最佳使用EHR。最后的调查有446个现场调查人员，积极注册主要审判的参与者。近三分之二的受访者是学习协调员（63.2％），23.1％是主要调查人员，13.7％持有其他研究作用。大约有一半的受访者使用EHR找到潜在的试验参与者。其中79.4％，使用EHR搜索与其他招聘方法一起进行，包括审查即将到来的临床时间表（75.3％）并联系过去的试验参与者（71.2％）。最佳利用EHR的重要障碍包括缺乏某些研究的EHR模块的可用性和有关联系其他提供者所关心的患者的能力的限制。一季度没有使用EHR寻找潜在参与者的调查受访者报告，他们的国家无法访问EHR;这一发现从北美的2.6％的受访者差不多到亚太地区受访者的50％。虽然EHR筛选常用于心血管成果试验，重要的技术，治理和监管障碍持续存在。需要多方面，可扩展和可定制的策略来支持EHR进行试用参与者识别的最佳使用。

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