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.

Objective Biomedical research increasingly relies on the integration of information from multiple heterogeneous data sources. Despite the fact that s

The Learning Health System (LHS) requires integration of research into routine practice. 'eSource' or embedding clinical trial functionalities into routine electronic health record (EHR) systems has long been put forward as a solution to the rising costs of research. We aimed to create and validate an eSource solution that would be readily extensible as part of a LHS. The EU FP7 TRANSFoRm project's approach is based on dual modelling, using the Clinical Research Information Model (CRIM) and the Clinical Data Integration Model of meaning (CDIM) to bridge the gap between clinical and research data structures, using the CDISC Operational Data Model (ODM) standard. Validation against GCP requirements was conducted in a clinical site, and a cluster randomised evaluation by site nested into a live clinical trial. Using the form definition element of ODM, we linked precisely modelled data queries to data elements, constrained against CDIM concepts, to enable automated patient identification for specific protocols and pre-population of electronic case report forms (e-CRF). Both control and eSource sites recruited better than expected with no significant difference. Completeness of clinical forms was significantly improved by eSource, but Patient Related Outcome Measures (PROMs) were less well completed on smartphones than paper in this population. The TRANSFoRm approach provides an ontologically-based approach to eSource in a low-resource, heterogeneous, highly distributed environment, that allows precise prospective mapping of data elements in the EHR. Further studies using this approach to CDISC should optimise the delivery of PROMS, whilst building a sustainable infrastructure for eSource with research networks, trials units and EHR vendors.

Background: Secondary use of health data has reached unequaled potential to improve health systems governance, knowledge, and clinical care. Transparency regarding this secondary use is frequently cited as necessary to address deficits in trust and conditional support and to increase patient awareness. Objective: We aimed to review the current published literature to identify different stakeholders’ perspectives and recommendations on what information patients and members of the public want to learn about the secondary use of health data for research purposes and how and in which situations. Methods: Using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines, we conducted a scoping review using Medline, CINAHL, PsycINFO, Scopus, Cochrane Library, and PubMed databases to locate a broad range of studies published in English or French until November 2022. We included articles reporting a stakeholder’s perspective or recommendations of what information patients and members of the public want to learn about the secondary use of health data for research purposes and how or in which situations. Data were collected and analyzed with an iterative thematic approach using NVivo. Results: Overall, 178 articles were included in this scoping review. The type of information can be divided into generic and specific content. Generic content includes information on governance and regulatory frameworks, technical aspects, and scientific aims. Specific content includes updates on the use of one’s data, return of results from individual tests, information on global results, information on data sharing, and how to access one’s data. Recommendations on how to communicate the information focused on frequency, use of various supports, formats, and wording. Methods for communication generally favored broad approaches such as nationwide publicity campaigns, mainstream and social media for generic content, and mixed approaches for specific content including websites, patient portals, and face-to-face encounters. Content should be tailored to the individual as much as possible with regard to length, avoidance of technical terms, cultural competence, and level of detail. Finally, the review outlined 4 major situations where communication was deemed necessary: before a new use of data, when new test results became available, when global research results were released, and in the advent of a breach in confidentiality. Conclusions: This review highlights how different types of information and approaches to communication efforts may serve as the basis for achieving greater transparency. Governing bodies could use the results: to elaborate or evaluate strategies to educate on the potential benefits; to provide some knowledge and control over data use as a form of reciprocity; and as a condition to engage citizens and build and maintain trust. Future work is needed to assess which strategies achieve the greatest outreach while striking a balance between meeting information needs and use of resources.

To synthesize concepts and approaches related to the analysis of patterns or processes of care and patient's outcomes into a comprehensive model of care trajectories, focusing on hospital readmissions for patients with chronic ambulatory care sensitive conditions (ACSCs). Narrative literature review. Published studies between January 2000 and November 2017, using the concepts of 'continuity', 'pathway', 'episode', and 'trajectory', and focused on readmissions and chronic ACSCs, were collected in electronic databases. Qualitative content analysis was performed with emphasis on key constituents to build a comprehensive model. Specific common constituents are shared by the concepts reviewed: they focus on the patient, aim to measure and improve outcomes, follow specific periods of time and consider other factors related to care providers, care units, care settings, and treatments. Using these common denominators, the comprehensive '6W' multidimensional model of care trajectories was created. Considering patients' attributes and their chronic ACSCs illness course ('who' and 'why' dimensions), this model reflects their patterns of health care use across care providers ('which'), care units ('where'), and treatments ('what'), at specific periods of time ('when'). The '6W' model of care trajectories could provide valuable information on 'missed opportunities' to reduce readmission rates and improve quality of both ambulatory and inpatient care.