Performances of a Solution to Semi-Automatically Fill eCRF with Data from the Electronic Health Record: Protocol for a Prospective Individual Participant Data Meta-Analysis. - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Studies in Health Technology and Informatics Année : 2020

Performances of a Solution to Semi-Automatically Fill eCRF with Data from the Electronic Health Record: Protocol for a Prospective Individual Participant Data Meta-Analysis.

Helena Pereira
Juliette Djadi-Prat
María Teresa García
  • Fonction : Auteur
Sara Testoni
  • Fonction : Auteur
Manon Cariou
  • Fonction : Auteur
Aurèle N'Dja
  • Fonction : Auteur
Grégory Navarro
  • Fonction : Auteur
Nicola Gentili
  • Fonction : Auteur
Oriana Nanni
  • Fonction : Auteur
Massimo Raineri
  • Fonction : Auteur
Gilles Chatellier
Agustín Gómez de La Camara
  • Fonction : Auteur
Martine Lewi
  • Fonction : Auteur
Mats Sundgren
  • Fonction : Auteur
Almenia Garvey
  • Fonction : Auteur
Marija Todorovic
  • Fonction : Auteur
Nadir Ammour
  • Fonction : Auteur

Résumé

Clinical trial data collection still relies on a manual entry from information available in the medical record. This process introduces delay and error risk. Automating data transfer from Electronic Health Record (EHR) to Electronic Data Capture (EDC) system, under investigators' supervision, would gracefully solve these issues. The present paper describes the design of the evaluation of a technology allowing EHR to act as eSource for clinical trials. As part of the EHR2EDC project, for 6 ongoing clinical trials, running at 3 hospitals, a parallel semi-automated data collection using such technology will be conducted focusing on a limited scope of data (demographic data, local laboratory results, concomitant medication and vital signs). The evaluation protocol consists in an individual participant data prospective meta-analysis comparing regular clinical trial data collection to the semi-automated one. The main outcome is the proportion of data correctly entered. Data quality and associated workload for hospital staff will be compared as secondary outcomes. Results should be available in 2020.
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Dates et versions

hal-03560320 , version 1 (07-02-2022)

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Citer

Nicolas Griffon, Helena Pereira, Juliette Djadi-Prat, María Teresa García, Sara Testoni, et al.. Performances of a Solution to Semi-Automatically Fill eCRF with Data from the Electronic Health Record: Protocol for a Prospective Individual Participant Data Meta-Analysis.. Studies in Health Technology and Informatics, 2020, 270, pp.367-371. ⟨10.3233/SHTI200184⟩. ⟨hal-03560320⟩
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