Patterns: a simple but expressive data modelling formalism

Austin, Tony; Sun, Shanghua; Lea, Nathan; Lim, Yin Su; Tapuria, Archana; Nguyen, David H.; Kalra, D

doi:10.1504/ijkedm.2016.082078

Cited by 1 publication

(1 citation statement)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The EN13606 editor called Object Dictionary Client (ODC) was used, which was developed in-house by University College London (UCL), the latest version of which is recently published, and the information models built with it are open source for use. 35 …”

Section: Methodsmentioning

confidence: 99%

Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data

et al. 2018

Self Cite

View full text Add to dashboard Cite

ObjectivesIntegrating Electronic Health Record (EHR) systems into the field of clinical trials still contains several challenges and obstacles. Heterogeneous standards and specifications are used to represent healthcare and clinical trial information. Therefore, this work investigates the mapping and data interoperability between healthcare and research standards: EN13606 used for the EHRs and the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) used for clinical research.MethodsBased on the specifications of CDISC ODM 1.3.2 and EN13606, a mapping between the structure and components of both standards has been performed. Archetype Definition Language (ADL) forms built with the EN13606 editor were transformed to ODM XML and reviewed. As a proof of concept, clinical sample data has been transformed into ODM and imported into an electronic data capture system. Reverse transformation from ODM to ADL has also been performed and finally reviewed concerning map-ability.ResultsThe mapping between EN13606 and CDISC ODM shows the similarities and differences between the components and overall record structure of the two standards. An EN13606 archetype corresponds with a group of items within CDISC ODM. Transformations of element names, descriptions, different languages, datatypes, cardinality, optionality, units, value range and terminology codes are possible from EN13606 to CDISC ODM and vice versa.ConclusionIt is feasible to map data elements between EN13606 and CDISC ODM and transformation of forms between ADL and ODM XML format is possible with only minor limitations. EN13606 can accommodate clinical information in a more structured manner with more constraints, whereas CDISC ODM is more suitable and specific for clinical trials and studies. It is feasible to transform EHR data in the EN13606 form to ODM to transfer it into research database. The attempt to use EN13606 to build a study protocol (that was already built with CDISC ODM) also suggests the possibility of using EN13606 standard in place of CDISC ODM if needed to avoid transformations.

show abstract

Section: Methodsmentioning

confidence: 99%