Multilingual Medical Data Models in ODM FormatA Novel Form-based Approachto Semantic Interoperability between Routine Health care and Clinical Research
29 March 2012
accepted: 24 June 2012
16 December 2017 (online)
Background: Semantic interoperability between routine healthcare and clinical research is an unsolved issue, as information systems in the healthcare domain still use proprietary and site-specific data models. However, information exchange and data harmonization are essential for physicians and scientists if they want to collect and analyze data from different hospitals in order to build up registries and perform multicenter clinical trials. Consequently, there is a need for a standardized metadata exchange based on common data models. Currently this is mainly done by informatics experts instead of medical experts.
Objectives: We propose to enable physicians to exchange, rate, comment and discuss their own medical data models in a collaborative web-based repository of medical forms in a standardized format.
Methods: Based on a comprehensive requirement analysis, a web-based portal for medical data models was specified. In this context, a data model is the technical specification (attributes, data types, value lists) of a medical form without any layout information. The CDISC Operational Data Model (ODM) was chosen as the appropriate format for the standardized representation of data models. The system was implemented with Ruby on Rails and applies web 2.0 technologies to provide a community based solution. Forms from different source systems – both routine care and clinical research – were converted into ODM format and uploaded into the portal.
Results: A portal for medical data models based on ODM-files was implemented (http://www.medical-data-models.org). Physicians are able to upload, comment, rate and download medical data models. More than 250 forms with approximately 8000 items are provided in different views (overview and detailed presentation) and in multiple languages. For instance, the portal contains forms from clinical and research information systems.
Conclusion: The portal provides a system-independent repository for multilingual data models in ODM format which can be used by physicians. It serves as a platform for discussion and enables the exchange of multilingual medical data models in a standardized way.
- 1 Dugas M, Roeder N. Entlastung des medizinischen Personalsbei derDokumentationsarbeit im Krankenhaus. Das Krankenhaus 2011; 103 (01) 35-2. Health LevelSeven (HL7)[Internet], [cited 2012 Mar22]. Available from: http://www.hl7.org.
- 3 Clinical Data Interchange Consortium (CDISC) [Internet],[cited 2012 Mar22]. Available from: http://www.cdisc.org
- 4 Kuchinke W, Wiegelmann S, Verplancke P, Ohmann C. Extendedcooperation in clinical studies through exchange of CDISC metadatabetween differentstudy softwaresolutions. Methods InfMed 2006; 45 (04) 441-446.
- 5 Reisinger SJ, Ryan PB, O’Hara DJ, Powell GE, Painter JL, Pattishall EN. et al. Developmentand evaluation of acommondatamodel enabling active drug safety surveillanceusing disparate health cared at abases. J Am Med Inform Assoc 2010; 17 (Suppl. 06) 652-662.
- 6 Eurorec [Internet], [cited 2012 Mar22]. Available from: http://www.eurorec.org
- 7 Oemig F, Blobel B. Semantic interoperabilityadheres to proper models and code systems. Adetailed exam-inationofdifferent approaches forscore systems. Methods InfMed 2010; 49 (02) 148-155.
- 8 Prokosch HU, Ganslandt T. Perspectivesfor medical informatics. Reusing the electronic medical record for clinical research. Methods InfMed 2009; 48 (01) 38-44.
- 9 Kush R, Alschuler L, Ruggeri R, Cassells S. et al. Implementing Single Source: the STARBRITE proof-of concept study. J Am MedInform Assoc 2007; 14 (05) 662-673.
- 10 Breil B, Semjonow A, Müller-Tidow C, Fritz F, Dugas M. HIS-based Kaplan-Meierplots–a single source approachfor documenting and reusing routine survival information. BMCMed Inform Decis Mak 2011; 11: 11.
- 11 El Fadly A, Lucas N, Rance B, Verplancke P, Lastic PY, Daniel C. The REUSE project: EHRassingle data-source for biomedical research. Stud Health Technol Inform 2010; 160 Pt2 1324-1328.
- 12 Murphy EC, Ferris 3rd, FL, O’Donnell WR. Anelectronic medical recordssystemfor clinical research and the EMREDC interface. Invest OphthalmolVis Sci 2007; 48 (10) 4383-4389.
- 13 Fritz F, Ständer S, Breil B, Riek M, Dugas M. CIS-based registration of qualityoflife in asingle source approach. BMC Med Inform Decis Mak 2011; 11: 26.
- 14 Dziuballe P, Forster C, Breil B, Thiemann V. et al. The single source architecture x4Ttoconnect medical documentation and clinical research. StudHealthTechnol Inform 2011; 169: 902-906.
- 15 Stausberg J, Löbe M, Verplancke P, Drepper J. et al. Foundationsofa metadatarepositoryfor databasesof registersand trials. Stud Health Technol Inform 2009; 150: 409-413.
- 16 Jiang G, Solbrig HR, Iberson-Hurst D, Kush RD, Chute CG. Acollaborativeframework forrepresentation and harmonizationofclinical studydataelementsusing semantic MediaWiki. AMIASummits TranslSci Proc 2010; 2010: 11-15.
- 17 Kohl CD, Garde S, Knaup P. Facilitating secondary useofmedical data by using openEHR archetypes. Stud Health Technol Inform 2010; 160 Pt2 1117-1121.
- 18 Martínez-Costa C, Menárguez-Tortosa M, Fernández-Breis JT. Anapproach forthe semantic interoperabilityofISO EN 13606and OpenEHR archetypes. J Biomed Inform 2010; 43 (05) 736-746.
- 19 Jenders RA, Sujansky W, Broverman CA, Chadwick M. Towards improved knowledgesharing: assessment of the HL7 ReferenceInformationModel to supportmedical logicmodulequeries. ProcAMIA Annu Fall Symp 1997: 308-312.
- 20 Smith B, Ceusters W. HL7 RIM: an incoherentstandard. Stud Health Technol Inform 2006; 124: 133-138.
- 21 CDA[Internet], [cited 2012 Mar22]. Available from: http://www.cdisc.org/odm
- 22 ODM[Internet], [cited 2012 Mar22]. Available from: http://www.cdisc.org/odm
- 23 Dolin RH, Alschuler L, Boyer S, Beebe C. et al. HL7 Clinical Document Architecture, Release 2. J Am Med Inform Assoc 2006; 13 (Suppl. 01) 30-39.
- 24 El Fadly A, Rance B, Lucas N. et al. Integrating clinical research with the HealthcareEnterprise: from the RE-USE projecttothe EHR4CR platform. JBiomedInform 2011; 44 (Suppl. 01) S94-S102.
- 25 Medidata Rave [Internet],[cited 2012 Mar22]. Available from: http://www.mdsol.com/products rave_overview.htm
- 26 OpenClinica [Internet],[cited 2012 Mar22]. Available from: https://community.openclinica.com
- 27 Xclinical [Internet],[cited 2012 Mar22]. Available from: www.xclinical.com
- 28 XML4 Pharma [Internet],[cited 2012 Mar22]. Available from: http://www.xml4pharma.com/ODMi nEDC/Samples.html
- 29 Kuchinke W, Aerts J, Semler SC, Ohmann C. CDISC standard-basedelectronic archiving of clinical trials. Methods InfMed 2009; 48 (05) 408-413.
- 30 SNOMED CT [Internet],[cited 2012 Mar22]. Available from: http://www.ihtsdo.org
- 31 UMLS [Internet],[cited 2012 Mar22]. Available from: http://www.nlm.nih.gov/research/umls
- 32 LOINC[Internet], [cited 2012 Mar22]. Available from: http://loinc.org
- 33 DIMDI[Internet], [cited 2012 Mar22]. Available from: http://www.dimdi.de
- 34 WHO Classifications [Internet],[cited 2012 Mar22]. Available from: http://www.who.int/classifications
- 35 MedDRA [Internet],[cited 2012 Mar22]. Available from: http://meddraso.com
- 36 CDASH [Internet],[cited 2012 Mar22]. Available from: http://www.cdisc.org/cdash
- 37 SDTM [Internet],[cited 2012 Mar22]. Available from: http://www.cdisc.org/sdtm
- 38 BRIDG [Internet],[cited 2012 Mar22]. Available from: http://www.bridgmodel.org
- 39 BRIDG [Internet],[cited 2012 May 15]. Available from: http://www.cdisc.org/bridg
- 40 El Fadly A, Daniel C, Bousquet C, Dart T, etal. Electronic heal thcarerecordand clinical research in cardiovascular radiology. HL7 CDAand CDISC ODMinteroperability. AMI A Annu Symp Proc 2007; Oct11: 216-220.
- 41 Ruby on Rails[Internet], [cited 2012 Mar22]. Available from: http://rubyonrails.org
- 42 INTERNATIONAL ISOSTANDARD9241–11, [Internet],[cited 2012 Mar22]. Available from: http://www.it.uu.se/edu/course/homepage/acsd/vt09/ISO9241part11.pdf
- 43 OpenVista[Internet], [cited 2012 Mar22]. Available from: http://sourceforge.net/projects/openvista
- 44 Bruland P, Breil B, Fritz F, Dugas M. Interoperabilityinclinical research: Frommet adataregistries to semantically annotated CDISC ODM. Accepted for oral presentation at “MIE 2012”.
- 45 Clinical Trials[Internet], [cited 2012 Mar22]. Available from: http://www.clinicaltrials.gov
- 46 Pathak J, Wang J, Kashyap S, Basford M. et al. Mapping clinical phenotypedataelementstostandardized metadatarepositories and controlled terminologies:the eMERGE Networkexperience. J Am Med Inform Assoc 2011; 18 (Suppl. 04) 376-386.
- 47 Gardner D, Knuth KH, Abato M, Erde SM. et al. Commondatamodel forneurosciencedataand data modelexchange. J Am Med Inform Assoc 2001; 8 (Suppl. 01) 17-33.
- 48 Carlson D, Farkash A, Timm JT. A model-driven approachfor biomedical data integration. Stud Health Technol Inform 2010; 160 Pt2 1164-1168.
- 49 Kunz I, Lin MC, Frey L. Metadata mapping and reuseincaBIG. BMC Bioinformatics 2009; 10 (Suppl. 02) S4.
- 50 LexEVSServerand API. National Cancer Institute [Internet],[cited 2012 Mar24]. Available from: https://cabig.nci.nih.gov/community/tools/LexEVS_Server
- 51 Musen MA, Noy NF, Shah NH, Whetzel PL. et al. The National Centerfor Biomedical Ontology. J Am Med Inform Assoc 2012; 19 (Suppl. 02) 190-195.
- 52 NCBOBioportal.[Internet], [cited 2012 Mar24]. Available from: http://bioportal.bioontology.org