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ODM2CDA and CDA2ODM: tools to convert documentation forms between EDC and EHR systems.

Dugas M - BMC Med Inform Decis Mak (2015)

Bottom Line: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format.There are limitations of this conversion method due to different scope and design of ODM and CDA.Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

View Article: PubMed Central - PubMed

Affiliation: Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, A11, D-48149, Münster, Germany. dugas@uni-muenster.de.

ABSTRACT

Background: Clinical trials apply standards approved by regulatory agencies for Electronic Data Capture (EDC). Operational Data Model (ODM) from Clinical Data Interchange Standards Consortium (CDISC) is commonly used. Electronic Health Record (EHR) systems for patient care predominantly apply HL7 standards, specifically Clinical Document Architecture (CDA). In recent years more and more patient data is processed in electronic form.

Results: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format. There are limitations of this conversion method due to different scope and design of ODM and CDA. Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

Conclusions: Automated transformation of ODM files to CDA and vice versa is technically feasible in principle.

No MeSH data available.


Related in: MedlinePlus

Example for an entry element of a CDA file. It corresponds to an ODM item named “Date of Birth”. C0421451 is the UMLS code for Date of Birth
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Fig3: Example for an entry element of a CDA file. It corresponds to an ODM item named “Date of Birth”. C0421451 is the UMLS code for Date of Birth

Mentions: XML elements in the CDA standard were reviewed to identify suitable data structures for CRF items. A CDA document consists of several sections, including a generic assessment section. Because a CRF can be considered a patient assessment, it was decided to map each CRF in ODM format into an assessment section of a CDA document. Each data item from a CRF was mapped to an entry element within this CDA assessment section (see Fig. 3). CDA entry elements can contain semantic annotations like Unified Medical Language System (UMLS) codes [11].Fig. 3


ODM2CDA and CDA2ODM: tools to convert documentation forms between EDC and EHR systems.

Dugas M - BMC Med Inform Decis Mak (2015)

Example for an entry element of a CDA file. It corresponds to an ODM item named “Date of Birth”. C0421451 is the UMLS code for Date of Birth
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4494189&req=5

Fig3: Example for an entry element of a CDA file. It corresponds to an ODM item named “Date of Birth”. C0421451 is the UMLS code for Date of Birth
Mentions: XML elements in the CDA standard were reviewed to identify suitable data structures for CRF items. A CDA document consists of several sections, including a generic assessment section. Because a CRF can be considered a patient assessment, it was decided to map each CRF in ODM format into an assessment section of a CDA document. Each data item from a CRF was mapped to an entry element within this CDA assessment section (see Fig. 3). CDA entry elements can contain semantic annotations like Unified Medical Language System (UMLS) codes [11].Fig. 3

Bottom Line: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format.There are limitations of this conversion method due to different scope and design of ODM and CDA.Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

View Article: PubMed Central - PubMed

Affiliation: Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, A11, D-48149, Münster, Germany. dugas@uni-muenster.de.

ABSTRACT

Background: Clinical trials apply standards approved by regulatory agencies for Electronic Data Capture (EDC). Operational Data Model (ODM) from Clinical Data Interchange Standards Consortium (CDISC) is commonly used. Electronic Health Record (EHR) systems for patient care predominantly apply HL7 standards, specifically Clinical Document Architecture (CDA). In recent years more and more patient data is processed in electronic form.

Results: An open source reference implementation was designed and implemented to convert forms between ODM and CDA format. There are limitations of this conversion method due to different scope and design of ODM and CDA. Specifically, CDA has a multi-level hierarchical structure and CDA nodes can contain both XML values and XML attributes.

Conclusions: Automated transformation of ODM files to CDA and vice versa is technically feasible in principle.

No MeSH data available.


Related in: MedlinePlus