Joseph Christine Lm, Ownby Dennis R, Zoratti Edward, Johnson Dayna, Considine Shannon, Bourgeois Renee, Melkonian Christina, Miree Cheryl, Johnson Christine Cole, Lu Mei
Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.
Department of Pediatrics, Georgia Regents University, Augusta, GA, USA.
Clin Res Regul Aff. 2016;33(2-4):25-32. doi: 10.1080/10601333.2016.1182693. Epub 2016 Jun 1.
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.
We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma.
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.
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.
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. .
多中心随机对照试验（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）进行多中心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务实试验，即在“现实生活”环境中进行的试验。
我们描述一项RCT的招募经验，该试验旨在评估针对城市哮喘青少年的基于诊所的干预措施。
利用就诊和处方数据库，将一份潜在合格患者名单与Epic预约系统相链接。患者在预定就诊期间入组，然后通过电子方式随机分配到量身定制的在线干预组或通用在线干预组。
共识别出5家诊所的580名合格患者的1146次预约，其中45.9%（266/580）被随机分组以达到目标入组人数（n = 250）。远程数据采集促进了多中心入组。通过在就诊时实时录入所开具的哮喘药物，干预内容得到了进一步个性化。电子病历监测有助于解决招募过程中的问题。系统性挑战包括全系统的电子病历转换和全系统的诊所人员重组。
现代化的随机对照试验可以加速研究结果的转化。电子化举措促进了该随机对照试验的实施；然而，对招募策略的调整导致了一个更具“解释性”的框架。
