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评估HL7 FHIR标准的站点级实施情况以支持临床研究中的电子源数据交换。

Evaluating Site-Level Implementations of the HL7 FHIR Standard to Support eSource Data Exchange in Clinical Research.

作者信息

Garza Maryam Y, Rutherford Michael W, Adagarla Bhargav, Eisenstein Eric, Kumar Karan R, Zimmerman Kanecia O, Topaloglu Umit, Zozus Meredith

机构信息

University of Arkansas for Medical Sciences, Little Rock, Arkansas.

Duke Clinical Research Institute, Duke University, Durham, North Carolina.

出版信息

Stud Health Technol Inform. 2021 May 27;281:397-401. doi: 10.3233/SHTI210188.

DOI:10.3233/SHTI210188
PMID:34042773
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9137245/
Abstract

Direct extraction and use of electronic health record (EHR) data is a long-term and multifaceted endeavor that includes design, development, implementation and evaluation of methods and tools for semi-automating tasks in the research data collection process, including, but not limited to, medical record abstraction (MRA). A systematic mapping of study data elements was used to measure the coverage of the Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard for a federally sponsored, pragmatic cardiovascular randomized controlled trial (RCT) targeting adults. We evaluated site-level implementations of the HL7® FHIR® standard to investigate study- and site-level differences that could affect coverage and offer insight into the feasibility of a FHIR-based eSource solution for multicenter clinical research.

摘要

直接提取和使用电子健康记录(EHR)数据是一项长期且多方面的工作,包括设计、开发、实施和评估用于在研究数据收集过程中实现任务半自动执行的方法和工具,包括但不限于病历摘要(MRA)。对于一项针对成年人的联邦资助的实用心血管随机对照试验(RCT),我们使用了研究数据元素的系统映射来衡量健康级别七(HL7®)快速医疗保健互操作性资源(FHIR®)标准的覆盖范围。我们评估了HL7® FHIR®标准在各站点的实施情况,以调查可能影响覆盖范围的研究层面和站点层面差异,并深入了解基于FHIR的电子源解决方案用于多中心临床研究的可行性。

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本文引用的文献

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Evaluating the Coverage of the HL7 FHIR Standard to Support eSource Data Exchange Implementations for use in Multi-Site Clinical Research Studies.评估 HL7 FHIR 标准的覆盖范围,以支持用于多站点临床研究的电子源数据交换实施。
AMIA Annu Symp Proc. 2021 Jan 25;2020:472-481. eCollection 2020.
2
Evaluative Outcomes in Direct Extraction and Use of EHR Data in Clinical Trials.临床试验中电子健康记录(EHR)数据的直接提取与使用中的评估结果。
Stud Health Technol Inform. 2019;257:333-340.
3
eSource for Standardized Health Information Exchange in Clinical Research: A Systematic Review.临床研究中标准化健康信息交换的电子源:一项系统综述。
Stud Health Technol Inform. 2019;257:115-124.
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New Benchmarks Characterizing Growth in Protocol Design Complexity.用于描述协议设计复杂性增长的新基准。
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PLoS One. 2015 Oct 20;10(10):e0138649. doi: 10.1371/journal.pone.0138649. eCollection 2015.
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