The ISO/IEC 11179 norm for metadata registries: Does it cover healthcare standards in empirical research?

Abstract

In order to support empirical medical research concerning reuse and improvement of the expressiveness of study data and hence promote syntactic as well as semantic interoperability, services are required for the maintenance of data element collections. As part of the project for the implementation of a German metadata repository for empirical research we assessed the ability of ISO/IEC 11179 "Information technology - Metadata registries (MDR)" part 3 edition 3 Final Committee Draft "Registry metamodel and basic attributes" to represent healthcare standards. First step of the evaluation was a reformulation of ISO's metamodel with the terms and structures of the different healthcare standards. In a second step, we imported instances of the healthcare standards into a prototypical database implementation representing ISO's metamodel. Whereas the flat structure of disease registries as well as some controlled vocabularies could be easily mapped to the ISO's metamodel, complex structures as used in reference models of electronic health records or classifications could be not exhaustively represented. A logical reconstruction of an application will be needed in order to represent them adequately. Moreover, the correct linkage between elements from ISO/IEC 11179 edition 3 and concepts of classifications remains unclear. We also observed some restrictions of ISO/IEC 11179 edition 3 concerning the representation of items of the Operational Data Model from the Clinical Data Interchange Standards Consortium, which might be outside the scope of a MDR. Thus, despite the obvious strength of the ISO/IEC 11179 edition 3 for metadata registries, some issues should be considered in its further development.

Current applications and future directions for the CDISC Operational Data Model standard: A methodological review

“…The ODM literature on planning activities covers a broad range of topics [2, 11, 13, 20–23, 45, 47–68]. The SDM-XML study design ODM extension, covering a portion of the protocol requirements, is currently available for use [16].…”

“…Dugas and Briel [64] use ODM for a large EHR and clinical research data model repository consisting of 3,320 medical forms with 102,677 data elements [23, 62, 64]. ODM has also been shown to align with the ISO 11179 metadata registry standard, with the exception of a standard representation for ISO 11179’s Data Element Concept (DEC) [13]. …”

“…Instead, ODM provides a hierarchical container for defining clinical data items according to the needs of a given study [65], as shown in Figure 3. The lack of a source definition for a clinical data item was highlighted when the ISO 11179 DECs were found missing from the ODM model [13]. Studies that use CDASH CRFs achieve semantic alignment through a shared data standard, rather than through specific semantics [66].…”

“…Data interchange, a key process in the data collection phase, is an original ODM use case, was the focus of ODM v1.0, and has been covered broadly in the literature [2, 13, 26, 35, 43, 45, 46, 52, 53, 57, 58, 60, 62–64, 73–85]. ODM’s basic hierarchical structure is particularly well suited for data capture [84].…”

“…In response to increasing demands for interoperability, ODM has been extended over the years to cover a broad range of data and metadata needs [13]. This versatility has yielded research literature that reflects a diverse array of topic areas.…”