Harmonization of Detailed Clinical Models with Clinical Study Data Standards
Harmonization of Detailed Clinical Models with Clinical Study Data Standards
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DOI：
10.3414/me13-02-0019
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发表时间：
2015-01-01
影响因子：
1.7
通讯作者：
Chute, C. G.
中科院分区：
文献类型：
--
作者：
Jiang, G.;Evans, J.;Chute, C. G.
简介：这篇文章是医学信息方法的焦点主题“管理卫生系统的互操作性和复杂性”的一部分。背景：临床研究数据管理系统和电子健康记录系统之间的数据共享和集成仍然是一个具有挑战性的问题。为了解决这个问题，在各种背景下利用详细临床模型（DCM）方法的兴趣正在兴起。Intermountain Healthcare Clinical Element Models（CEMs）已被国家协调员办公室采用，该办公室授予战略健康IT高级研究项目标准化（SHARPn）项目，用于标准化电子健康记录（EHR）中的患者数据。目的：本研究的目的是描述我们为协调SHARPn CEMs与CDISC所做的初步努力（临床数据交换标准协会）临床研究数据标准。方法：我们集中在三个通用领域：人口统计学，实验室测试和药物。我们对从CDISC模板和SHARPn CEMs中提取的每个数据元素进行了小组审查。结果：我们确定了一组数据元素，这些数据元素在临床研究和广泛的EHR数据二次使用中是共同的，并讨论了突出的协调问题。结论：我们认为，这些结果将有助于为DCM建模社区定义新的需求，并最终促进语义用于临床研究和广泛的二次使用领域的系统之间的互操作性。
Introduction: This article is part of the Focus Theme of Methods of Information in Medicine on "Managing Interoperability and Complexity in Health Systems".Background: Data sharing and integration between the clinical research data management system and the electronic health record system remains a challenging issue. To approach the issue, there is emerging interest in utilizing the Detailed Clinical Model (DCM) approach across a variety of contexts. The Intermountain Healthcare Clinical Element Models (CEMs) have been adopted by the Office of the National Coordinator awarded Strategic Health IT Advanced Research Projects for normalization (SHARPn) project for normalizing patient data from the electronic health records (EHR).Objective: The objective of the present study is to describe our preliminary efforts toward harmonization of the SHARPn CEMs with CDISC (Clinical Data Interchange Standards Consortium) clinical study data standards.Methods: We were focused on three generic domains: demographics, lab tests, and medications. We performed a panel review on each data element extracted from the CDISC templates and SHARPn CEMs.Results: We have identified a set of data elements that are common to the context of both clinical study and broad secondary use of EHR data and discussed outstanding harmonization issues.Conclusions: We consider that the outcomes would be useful for defining new requirements for the DCM modeling community and ultimately facilitating the semantic interoperability between systems for both clinical study and broad secondary use domains.