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

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Title: eSource for clinical trials: implementation and evaluation of a standards-based approach in a real world trial
Authors: Ethier, J-F
Curcin, V
McGilchrist, M
Kueng, SN
Zhao, L
Andreasson, A
Brodka, P
Michalski, R
Arvanitis, TN
Burgun, A
Delaney, BC
Item Type: Journal Article
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 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. 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.
Issue Date: 29-Jun-2017
Date of Acceptance: 24-Jun-2017
ISSN: 1872-8243
Publisher: Elsevier
Start Page: 17
End Page: 24
Journal / Book Title: International Journal of Medical Informatics
Volume: 106
Copyright Statement: © 2017 Elsevier B.V. All rights reserved. This manuscript is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International
Sponsor/Funder: Medical Research Council (MRC)
Funder's Grant Number: MKQBABR
Keywords: cs.CY
08 Information And Computing Sciences
09 Engineering
11 Medical And Health Sciences
Medical Informatics
Publication Status: Published
Appears in Collections:Division of Surgery
Faculty of Medicine
Epidemiology, Public Health and Primary Care

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