临床试验中的电子源数据的数据流构建和质量评估:基于中国医院电子医疗记录的试点研究
Yannan Yuan1, Yun Mei2, Shuhua Zhao1
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), National Drug Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing, China.
JMIR medical informatics
|July 8, 2024
概括
电子源 (eSource) 数据通过直接从电子健康记录 (EHR) 中提取患者信息到电子数据捕获 (EDC) 系统,简化了临床试验. 虽然实现了100%的准确性,但数据的可用性和完整性需要进一步改进,以实现最佳的eSource数据流.
科学领域:
- 临床研究信息学 临床研究信息学
- 健康数据管理 管理健康数据
- 生物医学数据科学是生物医学数据科学.
背景情况:
- 传统的临床试验数据收集依赖于授权人员手动审查电子病历.
- 电子源 (eSource) 数据可以从电子健康记录 (EHR) 直接提取到电子数据捕获 (EDC) 系统.
- eSource 技术提高了数据质量和及时性,同时降低了临床试验成本.
研究的目的:
- 探索从医院EHR系统中提取临床试验数据的方法.
- 将EHR数据转换和传输到与EDC系统兼容的格式.
- 为了验证eSource数据流的可用性,完整性和准确性.
主要方法:
- 使用了前性临床试验,从结构化EHR数据中提取数据模块 (人口统计,生命体征,实验室数据,药物).
- 数据在转移到赞助商的环境之前经历了映射,转换和非识别.
- 验证重点是数据的可用性,完整性和准确性.
主要成果:
- 临床试验数据成功地从EHR转移到赞助商的环境中,转录准确率为100%.
- 安全传输证明了eSource数据流的可行性.
- 数据的可用性和完整性被确定为需要改进的领域.
结论:
- 数据的低可用性源于电子健康记录中缺少的字段和非结构化/纸质数据.
- 建立强大的eSource技术和医院电子数据标准至关重要.
- 这些基本要素将促进未来的端到端电子数据流从EHR到EDC系统.
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