Executive Summary

The TRANSFoRm project aims to radically advance the understanding of ICT system interoperability relevant to healthcare and clinical research and to develop an EU-wide system capable of integrating Primary Care electronic health records systems and research systems. To develop and validate the software and services two representative research use cases (a genomic-phenotype study and an RCT) are being developed.

This deliverable reports on the development of these research use cases. The report contains four major parts. After the introduction (Ch1) the two clinical use cases are presented in separate chapters.

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Chapter two concerns an epidemiological study on genotype-phenotype associations in diabetes type 2. Chapter three involves an RCT and 10-year follow-up study of patients with GORD (gastro esophageal reflux disease). In a fourth chapter an overview of the use cases involved are provided, discussion points are summarized and links to other work packages within TRANSFoRm are indicated.

Both clinical use cases report on 4 main pillars: the study outline, examples of eligible databases for the study, archetypes and the modeling process (describing actors and interactions).

The archetypes, elaborated based on information from the Open EHR foundation, and the use case structures are worked out according to a common structure.
Iteratively developed between researchers from medical and informatical world, following functionalities of the TRANSFoRm system are assumed to be essential to work out both use cases:

TRANSFoRm key functionalities

  1. Present system options to the researcher (could include: Preview available research information e.g.counts/characteristics)
  2. Authorize (including present conditions and need for informed consent) data extraction (and linkage)
  3. Select patients (study population) in different databases and/or eHR
  4. Extract information for the selected population/patients – a. Information to be able to determine cases and controls or to determine risk factors for a cohort design; b. Covariates
  5. Reintegrate this data in a new temporary TRANSFoRm-database - a. link at the level of individual persons; b. put information from different databases, eHR and countries in one database
  6. Present the extracted data so that it is ready for further analyses

A general storyboard describes the consecutive steps that guide the TRANSFoRm user, the clinical researcher, automated, from research question to received study data.

All the actors, involved in this TRANSFoRm process, are described with their roles and responsibilities.

Report Details

Authors: P. Leysen, H. Bastiaens, P. Van Royen – University of Antwerp; L. Agreus, A.N. Andreasson – Karolinska Institutet

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