Richesson Rachel L, Green Beverly B, Laws Reesa, Puro Jon, Kahn Michael G, Bauck Alan, Smerek Michelle, Van Eaton Erik G, Zozus Meredith, Hammond W Ed, Stephens Kari A, Simon Greg E
Division of Clinical Systems and Analytics, Duke University School of Nursing, Durham, NC, USA.
Duke Center for Health Informatics, Durham, NC, USA.
J Am Med Inform Assoc. 2017 Sep 1;24(5):996-1001. doi: 10.1093/jamia/ocx016.
Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. The Health Care Systems Research Collaboratory, initiated by the National Institutes of Health Common Fund in 2010, is a pioneering cooperative aimed at identifying and overcoming operational challenges to pragmatic research. Drawing from our experience, we present 4 broad categories of informatics-related challenges: (1) using clinical data for research, (2) integrating data from heterogeneous systems, (3) using electronic health records to support intervention delivery or health system change, and (4) assessing and improving data capture to define study populations and outcomes. These challenges impact the validity, reliability, and integrity of PCTs. Achieving the full potential of PCTs and a learning health system will require meaningful partnerships between health system leadership and operations, and federally driven standards and policies to ensure that future electronic health record systems have the flexibility to support research.
实用性临床试验（PCTs）是嵌入医疗保健环境中的研究调查，旨在提高研究效率及其与临床实践的相关性。由美国国立卫生研究院共同基金于2010年发起的医疗保健系统研究协作实验室，是一个开创性的合作项目，旨在识别并克服实用性研究的操作挑战。根据我们的经验，我们提出了4大类与信息学相关的挑战：（1）将临床数据用于研究，（2）整合来自异构系统的数据，（3）使用电子健康记录来支持干预措施的实施或卫生系统变革，以及（4）评估并改进数据采集以定义研究人群和结果。这些挑战影响着实用性临床试验的有效性、可靠性和完整性。要充分发挥实用性临床试验和学习型健康系统的潜力，将需要卫生系统领导与运营部门之间建立有意义的伙伴关系，以及联邦推动的标准和政策，以确保未来的电子健康记录系统具有支持研究的灵活性。
