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.

Toward an Information Infrastructure for Global Health Improvement

“…Specifically, in the European Community, the TRANSFoRm project has addressed some of the challenges of achieving a robust infrastructure for LHSs [39,40]. The European Institute for Innovation through Health Data seeks "to tackle areas of challenge in the successful scaling up of innovations that critically rely on high-quality and interoperable health data" [41].…”

“…Systems such as Deliberative Dialogue can support the work of learning communities [65]. The European Community's TRANSFoRm project [39] provides scalable infrastructure that supports both D2K and K2P. Further maturation of these existing services, development of infrastructure components supporting other needed services, and their integration into a coherent workflow are the fundamental challenges of an LHS, comprising some of the most interesting and important challenges faced by informatics in the coming decade.…”

Real world big data for clinical research and drug development

“…At the opposite end of the RWD spectrum, individual care organizations such as hospitals and general practitioners (GPs) have long used their locally held data for quality and safety monitoring (e.g., via audit), and many have established clinical data warehouses for internal research use. The incorporation of electronic health record (EHR) data for research at a care site level is now well recognized and supported [1,2]. Claims databases are widely available on a large scale and are used for population health research, but have recognized selection and up-coding bias that questions the scientific validity of real world evidence (RWE) derived from them [3,4].…”

An instrument to identify computerised primary care research networks, genetic and disease registries prepared to conduct linked research: TRANSFoRm International Research Readiness (TIRRE) survey

“…The Translational Research and Patient Safety in Europe (TRANSFoRm) project aims to reduce barriers to conducting research using routine healthcare data across Europe 8 – 10. The European eHealth Action Plan prioritises interoperability between health records so that internationally comparable data can be collected on the quality of care and for research 11.…”