How real-world evidence can really deliver: a case study of data source development and use.
How real-world evidence can really deliver: a case study of data source development and use.
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DOI：
10.1136/bmjsit-2019-000024
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
Resnic F
中科院分区：
文献类型：
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作者：
Drozda J;Zeringue A;Dummitt B;Yount B;Resnic F
电子健康记录 (EHR) 数据对于评估护理质量和效率具有广阔的前景。要实现 EHR 的潜力，需要在不干扰临床工作流程且不需要将数据手动输入数据库的情况下捕获数据。迄今为止，提取 EHR 数据的工作在很大程度上依赖于自然语言处理，并且尚未扩展到超出其开发环境的范围。 1-42012 年，美国食品和药物管理局 (FDA) 资助了 Mercy Health (Mercy) 进行的一项演示，将唯一设备标识符 (UDI) 纳入 Mercy 的电子信息系统中，从而能够使用 EHR 数据评估心血管设备性能。 5 演示的目标和设计已在前面描述过。 6-8 总之，2012 年 5 月至 12 月期间，5 个 Mercy 心导管实验室（Cath Labs）安装了条形码扫描系统，用于采集所有消耗品（包括冠状动脉支架）的数据。冠状动脉支架条形码用作原型 UDI，并在患者层面与来自血流动力学系统（Merge Hemo，Merge，芝加哥，伊利诺伊州，美国）和 Mercy 的 EHR（EpicCare，Epic，维罗纳，威斯康星州，美国）的临床数据相关联。建立了一个名为 UDI 研究数据库 (UDIR) 的数据库，其中包含 EHR 提取的数据、UDI 相关的冠状动脉支架属性以及来自其他来源的数据，例如社会保障死亡主文件。 UDIR 每周更新一次 EHR 数据，以便能够出于设备评估（包括安全监测）的目的进行纵向随访。 UDIR 内容和结构的详细信息已于之前发布 8 和初始版本
Electronic health record (EHR) data hold great promise for evaluating the quality and efficiency of care. Realization of the potential for EHRs requires that data be captured without interfering with clinical workflow and without requiring manual data entry into databases. Efforts to extract EHR data to date have largely depended on natural language processing and have not scaled beyond the settings in which they were developed. 1–4In 2012, the US Food and Drug Administration (FDA) funded a demonstration performed by Mercy Health (Mercy) whereby unique device identifiers (UDIs) were incorporated into Mercy’s electronic information systems, enabling assessments of cardiovascular device performance using EHR data. 5 The goals and design of the demonstration have been previously described. 6–8 In summary, between May and December 2012, a barcode scanning system was installed in 5 Mercy cardiac catheterization laboratories (Cath Labs) for capturing data on all consumable supplies, including coronary stents. Coronary stent barcodes were used as prototype UDIs and were linked at the patient level with clinical data from the hemodynamic system (Merge Hemo, Merge, Chicago, Illinois, USA) and Mercy’s EHR (EpicCare, Epic, Verona, Wisconsin, USA). A database termed the UDI research database (UDIR) was built that contains EHR-extracted data, UDI-associated coronary stent attributes, and data from other sources, for example, the Social Security Death Master File. The UDIR is updated weekly with EHR data enabling longitudinal follow-up for purposes of device evaluation, including safety surveillance. Details of UDIR content and structure have been published previously 8 and initial