Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), Cooperative Studies Coordinating Center, VA Boston Healthcare System, Jamaica Plain, Massachusetts 02130, USA.
J Am Med Inform Assoc. 2012 Jun;19(e1):e170-6. doi: 10.1136/amiajnl-2011-000623. Epub 2012 Feb 24.
The Massachusetts Veterans Epidemiology Research and Information Center in collaboration with the Stanford Center for Innovative Study Design set out to test the feasibility of a new method of evidence generation. The first pilot of a point-of-care clinical trial (POCCT), adding randomization and other study processes to an electronic medical record (EMR) system, was launched to compare the effectiveness of two insulin regimens.
Existing functionalities of the Veterans Affairs (VA) computerized patient record system (CPRS)/veterans health information systems and technology architecture (VISTA) were modified to support the activities of a randomized controlled trial including enrolment, randomization, and longitudinal data collection.
The VA's CPRS/VISTA was successfully adapted to support the processes of a clinical trial and longitudinal study data are being collected from the medical record automatically. As of 30 June 2011, 55 of the 67 eligible patients approached received a randomized intervention.
The design of CPRS/VISTA made integration of study workflows and data collection possible. Institutions and investigators considering similar designs must carefully map clinical workflows and clinical trial workflows to EMR capabilities. POCCT study teams are necessarily interdisciplinary and interdepartmental. As a result, executive sponsorship is critical.
POCCT represent a promising new method for conducting clinical science. Much work is needed to understand better the optimal uses and designs for this new approach. Next steps include focus groups to measure patient and clinician perceptions, multisite deployment of the current pilot, and implementation of additional studies.
马萨诸塞州退伍军人流行病学研究和信息中心与斯坦福创新研究设计中心合作，旨在测试一种新的证据生成方法的可行性。首个即时护理临床试验（POCCT）试点启动，该试验在电子病历（EMR）系统中加入随机化和其他研究流程，以比较两种胰岛素方案的有效性。
对退伍军人事务部（VA）计算机化患者记录系统（CPRS）/退伍军人健康信息系统和技术架构（VISTA）的现有功能进行了修改，以支持随机对照试验的活动，包括入组、随机化和纵向数据收集。
VA 的 CPRS/VISTA 成功适应了支持临床试验流程的要求，并且正在从病历中自动收集纵向研究数据。截至 2011 年 6 月 30 日，已向 67 名符合条件的患者中的 55 名提供了随机干预措施。
CPRS/VISTA 的设计使得研究工作流程和数据收集的整合成为可能。考虑类似设计的机构和研究人员必须仔细映射临床工作流程和临床试验工作流程与 EMR 功能。POCCT 研究团队必然是跨学科和跨部门的。因此，行政支持至关重要。
POCCT 代表了进行临床科学的一种很有前途的新方法。需要做更多的工作来更好地了解这种新方法的最佳用途和设计。下一步包括测量患者和临床医生认知的焦点小组、当前试点的多站点部署，以及实施其他研究。
