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Automated Generation of CONSORT Diagrams Using Relational Database Software.
Teresa O'Leary1,2, June Weiss1,2, Benjamin Toll3
1Department of Emergency Medicine, Yale School of Medicine, New Haven, Connecticut.
Applied Clinical Informatics
|January 24, 2019
Summary
Automating the generation of Consolidated Standards of Reporting Trials (CONSORT) diagrams using commercial software simplifies patient flow tracking. This technique enhances data collection, project management, and reporting for clinical trials.
Area of Science:
- Clinical Trials Methodology
- Health Informatics
Background:
- Prospective clinical trials require patient flow reporting via the Consolidated Standards of Reporting Trials (CONSORT) statement.
- Manual CONSORT diagram generation can be laborious and time-intensive.
- Electronic data entry in trials presents an opportunity for automated CONSORT diagram creation.
Purpose of the Study:
- To develop an automated technique for generating CONSORT diagrams.
- To utilize off-the-shelf software for CONSORT diagram automation.
Main Methods:
- Patient-level data were entered into FileMaker Pro during a prospective clinical trial.
- Data coding was implemented to automatically generate CONSORT diagrams.
- Diagrams were generated weekly for study team meetings.
Main Results:
- 1,044 participants were enrolled between August 2012 and July 2014.
- CONSORT diagrams tracked follow-up rates at 1, 6, and 12 months (92%, 90%, and 88% respectively).
- Reasons for loss to follow-up were systematically captured.
Conclusions:
- Standard software can automate CONSORT diagram generation for any clinical trial.
- Automated CONSORT diagrams facilitate data collection, project management, and reporting.
- This approach streamlines adherence to CONSORT reporting guidelines.
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