Accepted for/Published in: JMIR Medical Informatics
Date Submitted: Mar 29, 2021
Open Peer Review Period: Mar 29, 2021 - May 24, 2021
Date Accepted: Sep 28, 2021
Date Submitted to PubMed: Nov 22, 2021
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
OpenEDC: an open-source, standard-compliant, and mobile electronic data capture system for medical research
ABSTRACT
Background:
Medical research and machine learning for healthcare depend on high-quality data. Electronic data capture (EDC) systems are widely adopted for metadata-driven digital data collection. However, many systems use proprietary and incompatible formats that inhibit clinical data exchange and metadata reuse. In addition, configuration and financial requirements of typical EDC systems frequently prevent small-scale studies to profit from their eminent benefits.
Objective:
The goal was to develop and publish an open-source EDC system that addresses the aforementioned issues. We planned applicability of the system in a wide range of research projects.
Methods:
We conducted a literature-based requirements analysis to identify academic and regulatory demands towards digital data collection. After designing and implementing OpenEDC, we performed a usability evaluation to obtain feedback from users.
Results:
We identified 20 frequently stated requirements towards EDC. According to the ISO/IEC 25010 norm, we categorized the requirements into functional suitability, availability, compatibility, usability, and security. We developed OpenEDC based on the regulatory-compliant Clinical Data Interchange Standards Consortium Operational Data Model standard. Mobile device support enables the collection of patient-reported outcomes. OpenEDC is publicly available and released under the MIT open-source license.
Conclusions:
Adopting an established standard without modifications supports metadata reuse and clinical data exchange but it limits item layouts. OpenEDC is a standalone web application that can be used without setup or configuration. This should foster compatibility of medical research and open science. OpenEDC is targeted at observational and translational research studies by clinician scientists.
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.