A FHIR Specification to Formalize Cohort Definitions.

Britta Berens, Joscha Grüger, Carolin Poschen, Konstantin Knorr
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Abstract

Retrospective studies play an important role in advancing medical research, yet especially cohort definitions are often provided in unstructured text form or in a non-standardized format. This lack of formalization hinders reproducibility, consistency, and automated reuse. Therefore, we present a framework for the structured and standardized specification of cohort definitions within FHIR resources. Drawing from a systematic review of retrospective studies, we derived six modelling categories for cohort definitions (1) patient demographics, (2) standardized medical terminology, (3) clinical results definition, (4) temporal data representation, (5) temporal relationships and dependencies, and (6) logical combination of criteria. Each category is implemented using native or minimally extended FHIR properties, establishing a one-to-one correspondence between cohort definitions and the original clinical data. This enables both human readability and automated processing, supporting use cases such as feasibility searches and transparent cohort documentation in study publications.

一个FHIR规范来形式化队列定义。
回顾性研究在推进医学研究方面发挥着重要作用,但特别是队列定义往往以非结构化文本形式或非标准化格式提供。这种形式化的缺乏阻碍了再现性、一致性和自动重用。因此,我们提出了一个框架,用于FHIR资源中队列定义的结构化和标准化规范。从回顾性研究的系统回顾中,我们得出了队列定义的六个建模类别(1)患者人口统计学,(2)标准化医学术语,(3)临床结果定义,(4)时间数据表示,(5)时间关系和依赖关系,以及(6)标准的逻辑组合。每个类别都使用原生或最小限度扩展的FHIR属性实现,在队列定义和原始临床数据之间建立一对一的对应关系。这使得人类的可读性和自动处理成为可能,支持可行性搜索和研究出版物中的透明队列文档等用例。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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