在丹麦,挪威和瑞典进行药物流行病学研究的EpiCore-A共同数据模型
Peter Bjødstrup Jensen1, Jacob H Andersen1, Martin Thomsen Ernst1
1Clinical Pharmacology, Pharmacy, and Environmental Medicine, Department of Public Health, University of Southern Denmark, Odense, Denmark.
Pharmacoepidemiology and drug safety
|November 4, 2025
概括
我们介绍了EpiCore共同数据模型 (CDM),这是一个为斯堪的纳维亚制药流行病学研究设计的简化框架. 这种可访问的工具增强了研究人员的数据标准化和协作.
科学领域:
- 医疗信息学 医疗信息学
- 药学流行病学 药学流行病学
- 数据管理数据管理
背景情况:
- 在研究中越来越多地使用共同数据模型 (CDM).
- 现有CDM的复杂性构成了采用障碍.
- 需要更简单的CDM用于特定的用例,如本地和协作研究.
研究的目的:
- 提出EpiCore CDM,这是斯堪的纳维亚制药流行病学研究的简单框架.
- 解决现有的CDM框架的复杂性障碍.
- 促进数据协调和合作在药物流行病学.
主要方法:
- 基于可访问性和可用性的指导原则开发.
- 优先考虑结构和语法协调,推迟临床概念映射.
- 设计用于协作和单站设置,并支持质量控制.
- 与R包 (EpiCoreAssistant) 集成,用于合规测试.
主要成果:
- 该EpiCore CDM包括强制性管理表 (人,观察) 和可选事件/查找表.
- 一个规范模板和一个R包 (EpiCoreAssistant) 便于实现和质量控制.
- 通过模板和测试程序来支持CDM的定制.
- 展示了基于CDM的药物流行病学研究的逐步过程.
结论:
- 介绍了EpiCore CDM,一个简单的框架,有一个规范模板和R包.
- 为斯堪的纳维亚制药流行病学研究提供了改进的工作流程,标准化和协作.
- 适用于广泛的基于登记的医疗保健研究人员.
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