Abstract
BackgroundSemantic interoperability is essential for improving data quality and sharing. The ISO/IEC 11179 Metadata Registry (MDR) standard has been highlighted as a solution for standardizing and registering clinical data elements (DEs). However, the standard model has both structural and semantic limitations, and the number of DEs continues to increase due to poor term reusability. Semantic types and constraints are lacking for comprehensively describing and evaluating DEs on real-world clinical documents.MethodsWe addressed these limitations by defining three new types of semantic relationship (dependency, composite, and variable) in our previous studies. The present study created new and further extended existing semantic types (hybrid atomic and repeated and dictionary composite common data elements [CDEs]) with four constraints: ordered, operated, required, and dependent. For evaluation, we extracted all atomic and composite CDEs from five major clinical documents from five teaching hospitals in Korea, 14 Fast Healthcare Interoperability Resources (FHIR) resources from FHIR bulk sample data, and MIMIC-III (Medical Information Mart for Intensive Care) demo dataset. Metadata reusability and semantic interoperability in real clinical settings were comprehensively evaluated by applying the CDEs with our extended semantic types and constraints.ResultsAll of the CDEs (n = 1142) extracted from the 25 clinical documents were successfully integrated with a very high CDE reuse ratio (46.9%) into 586 CDEs (259 atomic and 20 unique composite CDEs), and all of CDEs (n = 238) extracted from the 14 FHIR resources of FHIR bulk sample data were successfully integrated with high CDE reuse ration (59.7%) into 96 CDEs (21 atomic and 28 unique composite CDEs), which improved the semantic integrity and interoperability without any semantic loss. Moreover, the most complex data structures from two CDE projects were successfully encoded with rich semantics and semantic integrity.ConclusionMDR-based extended semantic types and constraints can facilitate comprehensive representation of clinical documents with rich semantics, and improved semantic interoperability without semantic loss.
Highlights
IntroductionThe ISO/IEC 11179 Metadata Registry (MDR) standard has been highlighted as a solution for standardizing and registering clinical data elements (DEs)
Semantic interoperability is essential for improving data quality and sharing
The present study further proposes extended semantic types (hybrid atomic CED and repeated and dictionary composite common data element (CDE)) and four semantic constraints for correctly representing even more complex but essential semantic relationships between CDEs that are found in real-world clinical documents (Fig. 1)
Summary
The ISO/IEC 11179 Metadata Registry (MDR) standard has been highlighted as a solution for standardizing and registering clinical data elements (DEs). Data harmonization and interoperability are essential for advancing biomedical research These features can be achieved by representing clinical data in a standard format, and they are crucial for facilitating understanding and sharing data across diverse translational studies [1, 2]. The ISO/IEC 11179 Metadata Registry (MDR) standard describes a method of standardizing and registering DEs to make them understandable and shareable between studies and institutions. MDR-based DE provide data uniformly and interoperability between clinical studies and institutions since they are specified based on a standard metadata model that consists of a sets of attributes, which are delineating the definition, identification, representation, classification, and permissible values [3,4,5]. We used the term DE to describe the concept of metadata, but for all other cases we used the term CDE
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