实用随机对照试验的招募经验:利用 EMR 计划,最大限度地减少研究基础设施。

Christine Lm Joseph, Dennis R Ownby, Edward Zoratti, Dayna Johnson, Shannon Considine, Renee Bourgeois, Christina Melkonian, Cheryl Miree, Christine Cole Johnson, Mei Lu
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引用次数: 0

摘要

背景:多地点随机对照试验(RCT)的现代化方法包括使用电子病历(EMR)进行招募,使用远程数据采集(RDC)进行多地点数据收集,以及减少对研究基础设施需求的策略。这些特点有助于开展实用性试验或在 "真实生活 "环境中进行的试验:我们描述了一项 RCT 的招募经验,该 RCT 评估了一项针对城市哮喘青少年的诊所干预措施:利用就诊和处方数据库,将可能符合条件的患者名单与 Epic 预约排期系统连接起来。结果与讨论:确定了 580 名符合条件的患者在 5 家诊所就诊的 1146 次预约,其中 45.9%(266/580)的患者被随机分配,达到目标注册人数(n=250)。RDC 促进了多站点注册。通过实时输入就诊时开具的哮喘药物处方,进一步个性化了干预内容。EMR 监控有助于解决招募过程中的问题。系统性挑战包括全系统的 EMR 过渡和全系统的诊所人员重组:现代化的 RCT 可以加速研究成果的转化。电子化措施促进了该 RCT 的实施;然而,对招募策略的调整导致了一个更具 "解释性 "的框架。.
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure.

Context: Modernized approaches to multisite randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in "real life" settings.

Objective: We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma.

Materials and methods: Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored versus generic online intervention.

Results and discussion: 1146 appointments for 580 eligible patients visiting 5 clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n=250). RDC facilitated multisite enrollment. Intervention content was further personalized through real- time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing.

Conclusions: Modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more "explanatory" framework. .

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