Translational Medicine and Patient Safety in Europe: TRANSFoRm - Architecture for the Learning Health System in Europe

Brendan C. Delaney (Lead / Corresponding author), Vasa Curcin, Anna Andreasson, Theodoros N. Arvanitis, Hilde Bastiaens, Derek Corrigan, Jean Francois Ethier, Olga Kostopoulou, Wolfgang Kuchinke, Mark McGilchrist, Paul Van Royen, Peter Wagner

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    The Learning Health System (LHS) describes linking routine healthcare systems directly with both research translation and knowledge translation as an extension of the evidence-based medicine paradigm, taking advantage of the ubiquitous use of electronic health record (EHR) systems. TRANSFoRm is an EU FP7 project that seeks to develop an infrastructure for the LHS in European primary care. Methods. The project is based on three clinical use cases, a genotype-phenotype study in diabetes, a randomised controlled trial with gastroesophageal reflux disease, and a diagnostic decision support system for chest pain, abdominal pain, and shortness of breath. Results. Four models were developed (clinical research, clinical data, provenance, and diagnosis) that form the basis of the projects approach to interoperability. These models are maintained as ontologies with binding of terms to define precise data elements. CDISC ODM and SDM standards are extended using an archetype approach to enable a two-level model of individual data elements, representing both research content and clinical content. Separate configurations of the TRANSFoRm tools serve each use case. Conclusions. The project has been successful in using ontologies and archetypes to develop a highly flexible solution to the problem of heterogeneity of data sources presented by the LHS.

    Original languageEnglish
    Article number961526
    Number of pages8
    JournalBioMed Research International
    Publication statusPublished - 2015

    ASJC Scopus subject areas

    • General Biochemistry,Genetics and Molecular Biology
    • General Immunology and Microbiology


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