Multilingual Medical Data Models in ODM Format: A Novel Form-based Approach to Semantic Interoperability between Routine Healthcare and Clinical Research.

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 (https://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.