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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
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 | ||||||||
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| Subjects: | Q Science > QA Mathematics > QA76 Electronic computers. Computer science. Computer software R Medicine > R Medicine (General) |
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| 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: |
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| 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) | ||||||||
| Open Access Version: |
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