下一代研究数据库需要FAIR,EHR集成和可扩展的电子数据采集,用于医疗文档和决策支持.
Martin Dugas1, Max Blumenstock1, Tobias Dittrich1,2
1Institute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.
NPJ digital medicine
|January 12, 2024
概括
下一代研究数据库集成电子健康记录和电子病例报告表格在技术上是可行的临床研究. 这项概念验证研究证明了在德国一家医院的成功实施,为增强数据管理铺平了道路.
科学领域:
- 临床信息学 临床信息学
- 健康数据管理 管理健康数据
- 医学研究 技术 技术
背景情况:
- 结构化患者数据对于临床研究至关重要,通常存储在研究数据库中.
- 现有的系统往往缺乏整合性和可扩展性,阻碍了有效的数据利用.
- 对于像FAIR数据访问和电子健康记录 (EHR) 集成等高级功能的需求正在增长.
研究的目的:
- 定义下一代研究数据库的特征.
- 评估在临床研究环境中实施此类数据库的可行性.
- 确定改善医疗文档和患者数据管理的关键特征.
主要方法:
- 在德国一所大学医院进行了一项概念验证研究.
- 确定了关键特征,包括FAIR数据访问,符合监管的电子数据捕获 (EDC),EHR集成和可扩展性.
- 实施了下一代研究数据库,将19个EDC系统连接到i.s.h.med (Oracle Cerner) 和OpenEDC.
主要成果:
- 实施成功集成了19个电子数据捕获 (EDC) 系统,用于2217名患者.
- 分析了来自11个临床部门的功能和功能请求,以定义所需的数据库.
- 该研究证实了拟议的下一代研究数据库的技术和临床可行性.
结论:
- 结合先进功能的下一代研究数据库在技术和临床上是可行的.
- 实施的系统证明了将各种EDC系统与EHR集成的可行方法.
- 建议进一步进行多中心验证,以评估更广泛的适用性.
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