临床试验活动计划规范使用快速医疗互操作性资源定义资源:混合方法研究研究
Andrew Richardson1, Patrick Genyn2
1fhir4pharma, Hungerford, Berkshire, United Kingdom.
JMIR medical informatics
|September 16, 2025
概括
本研究引入了基于图形的方法,以使用快速医疗互操作性资源 (FHIR) 来表示复杂的临床研究活动计划 (SoA). 该方法准确地捕捉了复杂的研究设计,提高了数字健康记录的数据质量和互操作性.
科学领域:
- 临床信息学是一种临床信息学.
- 生物医学数据标准 生物医学数据标准
- 计算生物学是一种计算生物学.
背景情况:
- 活动计划 (SoA) 对于临床研究至关重要,但传统的表格格式与复杂的设计扎.
- 现有的快速医疗互操作资源 (FHIR) 对SOA的方法是有限的,特别是对于有条件逻辑或重复周期的瘤学研究.
- 需要数字SoA表示来捕捉复杂的研究设计,而不仅仅是简单的线性时间表.
研究的目的:
- 开发方法来表示复杂的SOA,包括多个路径和条件逻辑,在一个统一的模型.
- 为研究规范创建人类可读的语法,并将其映射到FHIR资源.
- 为了实现基于图形的SoA模型和FHIR表示之间的双向转换,以实现互操作性.
主要方法:
- 使用指向图,以活动为节点,过渡为边缘,并包含时间和条件的属性来建模SoA.
- 图形模型被翻译成FHIR PlanDefinitions和相关资源,并为特定图形数据提供自定义扩展 (soaTimePoint, soaTransition).
- 使用Python,NetworkX,pandas,FHIR简体和FHIR服务器实现和验证了概念验证模型.
主要成果:
- 基于图形的方法成功建模了复杂的SoA,包括多个路径,非计划事件和条件规则.
- FHIR PlanDefinition扩展使SoA图表的全面数字表示成为可能,超越了表格限制.
- 图形模型和FHIR资源之间的双向转换证实了数据的准确性,该方法还确定了协议不一致性.
结论:
- 使用FHIR PlanDefinition扩展的基于图形的建模提供了一个准确和全面的方法来表示复杂的临床SoA.
- 这种方法提高了互操作性,减少了手动翻译,并支持与电子健康记录的自动化集成.
- 这些方法为数字协议的实施提供了精确和可扩展的解决方案,尽管需要进一步的工具来实现全面的运营部署.
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