Evidence map›Paper›PMID 34806987›Full record

ArticleJMIR medical informatics2021

An Open-Source, Standard-Compliant, and Mobile Electronic Data Capture System for Medical Research (OpenEDC): Design and Evaluation Study.

Leonard Greulich, Stefan Hegselmann, Martin Dugas

Open access · goldAbstract read
In one paragraph

Article in JMIR medical informatics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 13 citations in OpenAlex.

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  5. Translation, cross-cultural adaptation into Brazilian Portuguese and electronic migration of the WERF EPHect endometriosis patient questionnaire.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Leonard GreulichInstitute of Medical Informatics, University of Münster, Münster, Germany.ORCID https://orcid.org/0000-0003-3148-2105
Stefan HegselmannInstitute of Medical Informatics, University of Münster, Münster, Germany.ORCID https://orcid.org/0000-0002-2145-3258
Martin DugasInstitute of Medical Informatics, Heidelberg University Hospital, Heidelberg, Germany.ORCID https://orcid.org/0000-0001-9740-0788
University of Münster · DEHeidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMedical research and machine learning for health care depend on high-quality data. Electronic data capture (EDC) systems have been 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, the configuration and financial requirements of typical EDC systems frequently prevent small-scale studies from benefiting from their inherent advantages.

objectiveThe aim of this study is to develop and publish an open-source EDC system that addresses these issues. We aim to plan a system that is applicable to a wide range of research projects.

methodsWe conducted a literature-based requirements analysis to identify the academic and regulatory demands for digital data collection. After designing and implementing OpenEDC, we performed a usability evaluation to obtain feedback from users.

resultsWe identified 20 frequently stated requirements for EDC. According to the International Organization for Standardization/International Electrotechnical Commission (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 (CDISC ODM) standard. Mobile device support enables the collection of patient-reported outcomes. OpenEDC is publicly available and released under the MIT open-source license.

conclusionsAdopting an established standard without modifications supports metadata reuse and clinical data exchange, but it limits item layouts. OpenEDC is a stand-alone web app that can be used without a setup or configuration. This should foster compatibility between medical research and open science. OpenEDC is targeted at observational and translational research studies by clinicians.

Indexed as

data interoperabilitydata standardelectronic data capturemetadata reusemobile healthmobile phoneopen science

Identifiers

PMID34806987
PMCPMC8663450
OpenAlexW3203357538

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.