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

Jean Francois Ethier, Vasa Curcin, Mark M. McGilchrist, Sarah N.Lim Choi Keung, Lei Zhao, Anna Andreasson, Piotr Bródka, Radoslaw Michalski, Theodoros N. Arvanitis, Nikolaos Mastellos, Anita Burgun, Brendan C. Delaney (Lead / Corresponding author)

    Research output: Contribution to journalArticle

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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 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.

    Original languageEnglish
    Pages (from-to)17-24
    Number of pages8
    JournalInternational Journal of Medical Informatics
    Volume106
    Early online date29 Jun 2017
    DOIs
    Publication statusPublished - 1 Oct 2017

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    Clinical Trials
    Electronic Health Records
    Research
    Learning
    Systems Integration
    Health
    Population
    Outcome Assessment (Health Care)
    Costs and Cost Analysis

    Keywords

    • Clinical trial
    • Electronic health records
    • Interoperability
    • Learning health system
    • Operational data model

    Cite this

    Ethier, Jean Francois ; Curcin, Vasa ; McGilchrist, Mark M. ; Choi Keung, Sarah N.Lim ; Zhao, Lei ; Andreasson, Anna ; Bródka, Piotr ; Michalski, Radoslaw ; Arvanitis, Theodoros N. ; Mastellos, Nikolaos ; Burgun, Anita ; Delaney, Brendan C. / eSource for clinical trials : Implementation and evaluation of a standards-based approach in a real world trial. In: International Journal of Medical Informatics. 2017 ; Vol. 106. pp. 17-24.
    @article{59a320ac54344cf2a90260b62072a660,
    title = "eSource for clinical trials: Implementation and evaluation of a standards-based approach in a real world trial",
    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.",
    keywords = "Clinical trial, Electronic health records, Interoperability, Learning health system, Operational data model",
    author = "Ethier, {Jean Francois} and Vasa Curcin and McGilchrist, {Mark M.} and {Choi Keung}, {Sarah N.Lim} and Lei Zhao and Anna Andreasson and Piotr Br{\'o}dka and Radoslaw Michalski and Arvanitis, {Theodoros N.} and Nikolaos Mastellos and Anita Burgun and Delaney, {Brendan C.}",
    note = "This work was supported in part by the European Commission—DG INFSO (FP7 247787) and partially supported by the European Commission under the 7th Framework Programme, Coordination and Support Action, Grant Agreement Number 316097, ENGINE - European research centre of Network intelliGence for INnovation Enhancement (http://engine.pwr.edu.pl/). The RENOIR project - Reverse EngiNeering of sOcial Information pRocessing - leading to this publication has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 691152.",
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    Ethier, JF, Curcin, V, McGilchrist, MM, Choi Keung, SNL, Zhao, L, Andreasson, A, Bródka, P, Michalski, R, Arvanitis, TN, Mastellos, N, Burgun, A & Delaney, BC 2017, 'eSource for clinical trials: Implementation and evaluation of a standards-based approach in a real world trial', International Journal of Medical Informatics, vol. 106, pp. 17-24. https://doi.org/10.1016/j.ijmedinf.2017.06.006

    eSource for clinical trials : Implementation and evaluation of a standards-based approach in a real world trial. / Ethier, Jean Francois; Curcin, Vasa; McGilchrist, Mark M.; Choi Keung, Sarah N.Lim; Zhao, Lei; Andreasson, Anna; Bródka, Piotr; Michalski, Radoslaw; Arvanitis, Theodoros N.; Mastellos, Nikolaos; Burgun, Anita; Delaney, Brendan C. (Lead / Corresponding author).

    In: International Journal of Medical Informatics, Vol. 106, 01.10.2017, p. 17-24.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - eSource for clinical trials

    T2 - Implementation and evaluation of a standards-based approach in a real world trial

    AU - Ethier, Jean Francois

    AU - Curcin, Vasa

    AU - McGilchrist, Mark M.

    AU - Choi Keung, Sarah N.Lim

    AU - Zhao, Lei

    AU - Andreasson, Anna

    AU - Bródka, Piotr

    AU - Michalski, Radoslaw

    AU - Arvanitis, Theodoros N.

    AU - Mastellos, Nikolaos

    AU - Burgun, Anita

    AU - Delaney, Brendan C.

    N1 - This work was supported in part by the European Commission—DG INFSO (FP7 247787) and partially supported by the European Commission under the 7th Framework Programme, Coordination and Support Action, Grant Agreement Number 316097, ENGINE - European research centre of Network intelliGence for INnovation Enhancement (http://engine.pwr.edu.pl/). The RENOIR project - Reverse EngiNeering of sOcial Information pRocessing - leading to this publication has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 691152.

    PY - 2017/10/1

    Y1 - 2017/10/1

    N2 - 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.

    AB - 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.

    KW - Clinical trial

    KW - Electronic health records

    KW - Interoperability

    KW - Learning health system

    KW - Operational data model

    U2 - 10.1016/j.ijmedinf.2017.06.006

    DO - 10.1016/j.ijmedinf.2017.06.006

    M3 - Article

    C2 - 28870379

    AN - SCOPUS:85024473685

    VL - 106

    SP - 17

    EP - 24

    JO - International Journal of Medical Informatics

    JF - International Journal of Medical Informatics

    SN - 1386-5056

    ER -