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eSource for clinical trials : implementation and evaluation of a standards-based approach in a real world trial

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Ethier, Jean-Francois, Curcin, Vasa, McGilchrist, Mark, Lim Choi Keung, Sarah Niukyun, Zhao, Lei, Andreasson, Anna, Bródka, Piotr, Michalski, Radoslaw, Arvanitis, Theodoros N., Mastellos, Nikolaos, Burgun, Anita and Delaney, Brendan C. (2017) eSource for clinical trials : implementation and evaluation of a standards-based approach in a real world trial. International Journal of Medical Informatics, 106 . pp. 17-24. doi:10.1016/j.ijmedinf.2017.06.006 ISSN 1386-5056.

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Official URL: https://doi.org/10.1016/j.ijmedinf.2017.06.006

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Abstract

Objective

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.

Materials and Methods

The EU FP7 TRANSFoRm project’s approach is based on dual modeling, 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.

Results

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.

Discussion

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.

Conclusion

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.

Item Type: Journal Article
Subjects: Q Science > QA Mathematics > QA76 Electronic computers. Computer science. Computer software
R Medicine > R Medicine (General)
Divisions: Faculty of Science, Engineering and Medicine > Engineering > WMG (Formerly the Warwick Manufacturing Group)
Library of Congress Subject Headings (LCSH): Clinical trials -- Software -- Testing, Medical records -- Data processing
Journal or Publication Title: International Journal of Medical Informatics
Publisher: Elsevier
ISSN: 1386-5056
Official Date: October 2017
Dates:
DateEvent
October 2017Published
29 June 2017Available
24 June 2017Accepted
Volume: 106
Page Range: pp. 17-24
DOI: 10.1016/j.ijmedinf.2017.06.006
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Restricted or Subscription Access
Date of first compliant deposit: 3 July 2017
Date of first compliant Open Access: 4 July 2017
Funder: Seventh Framework Programme (European Commission) (FP7), Marie Skłodowska-Curie actions
Grant number: DG INFSO FP7 247787, Grant Agreement Number 316097, ENGINE (FP7), Grant agreement No. 691152 (Marie Skłodowska-Curie actions)
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