title: Translational Medicine and Patient Safety in Europe: TRANSFoRm--Architecture for the Learning Health System in Europe.
abstract: 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.
authors.affiliation: King's College London, London SE1 3QD, UK.
authors.forename: Brendan C
authors.initials: BC
authors.lastname: Delaney
authors.affiliation: King's College London, London SE1 3QD, UK.
authors.forename: Vasa
authors.initials: V
authors.lastname: Curcin
authors.affiliation: Karolinska Institutet, 14183 Stockholm, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Andreasson
authors.affiliation: University of Warwick, Coventry CV4 7AL, UK.
authors.forename: Theodoros N
authors.initials: TN
authors.lastname: Arvanitis
authors.affiliation: University of Antwerp, 2610 Antwerp, Belgium.
authors.forename: Hilde
authors.initials: H
authors.lastname: Bastiaens
authors.affiliation: Royal College of Surgeons of Ireland, Dublin 2, Ireland.
authors.forename: Derek
authors.initials: D
authors.lastname: Corrigan
authors.affiliation: INSERM, 6 Paris, France.
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Ethier
authors.affiliation: King's College London, London SE1 3QD, UK.
authors.forename: Olga
authors.initials: O
authors.lastname: Kostopoulou
authors.affiliation: University of Düsseldorf, 40225 Düsseldorf, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kuchinke
authors.affiliation: University of Dundee, Dundee DD2 4BF, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: McGilchrist
authors.affiliation: University of Antwerp, 2610 Antwerp, Belgium.
authors.forename: Paul
authors.initials: P
authors.lastname: van Royen
authors.affiliation: Quintiles GmbH, 63263 Neu-isenberg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Wagner
mesh_terms: D020000:Decision Support Systems, Clinical; D057286:Electronic Health Records; D005060:Europe; D006801:Humans; D008962:Models, Theoretical; D061214:Patient Safety / Q000592:standards*; D057170:Translational Research, Biomedical