Nordo Amy Harris, Levaux Hugh P, Becnel Lauren B, Galvez Jose, Rao Prasanna, Stem Komathi, Prakash Era, Kush Rebecca Daniels
Duke Center for Health Informatics Durham North Carolina.
Protocol First, Inc., Headquarters Salt Lake City Utah.
Learn Health Syst. 2019 Jan 16;3(1):e10076. doi: 10.1002/lrh2.10076. eCollection 2019 Jan.
The benefits of reusing EHR data for clinical research studies are numerous. They portend the opportunity to bring new therapies to patients sooner, potentially at a lower cost, and to accelerate learning health cycles-through faster data acquisition in clinical research studies. Metrics have proven that time can be saved, workflow and processes streamlined, and data quality increased significantly. Pilot projects and now actual investigational trials used for regulatory submissions have shown that these benefits support the transformation of clinical research by leveraging EHRs for research. Panelists at a recent collaborative focused on bridging clinical research and clinical care offered varying perspectives on how the latest standards and technologies could be leveraged to facilitate data transfer from EHR systems into clinical research databases, as well as the associated improvements in data quality. Panelists also discussed other avenues to leverage EHR in clinical research. Improvements and exciting possibilities notwithstanding, much work remains. Data ownership and access, attention to metadata and structured data for data sharing, and broader adoption of global standards are key areas for collaboration. With the steady increase in adoption of EHRs around the world, this is an excellent time for all stakeholders to work together and create an environment such that EHRs can be used more readily for research. The capacity for research can thus be increased to provide more high-quality information that will contribute to rapid continuous learning health systems from which all patients can benefit.
将电子健康记录(EHR)数据重新用于临床研究的益处众多。它们预示着有机会更快地为患者带来新疗法,可能降低成本,并通过在临床研究中更快地获取数据来加速学习型健康循环。指标已证明,这样做可以节省时间、简化工作流程和程序,并显著提高数据质量。试点项目以及现在用于监管申报的实际研究性试验表明,这些益处支持通过利用电子健康记录进行研究来实现临床研究的转型。最近一次聚焦于弥合临床研究与临床护理差距的合作会议上,专家小组成员就如何利用最新标准和技术促进数据从电子健康记录系统传输到临床研究数据库,以及数据质量的相关改善提出了不同观点。专家小组成员还讨论了在临床研究中利用电子健康记录的其他途径。尽管有改进和令人兴奋的可能性,但仍有许多工作要做。数据所有权和访问权、对用于数据共享的元数据和结构化数据的关注,以及全球标准的更广泛采用是合作的关键领域。随着全球电子健康记录采用率的稳步上升,现在是所有利益相关者共同努力创造一个环境的绝佳时机,以便电子健康记录能更方便地用于研究。这样就能提高研究能力,提供更多高质量信息,为快速持续的学习型健康系统做出贡献,所有患者都能从中受益。