Background: Investigators conducting prospective clinical trials must report patient flow using the Consolidated Standards of Reporting Trials (CONSORT) statement. Depending on how data are collected, this can be a laborious, time-intensive process. However, because many trials enter data electronically, CONSORT diagrams may be generated in an automated fashion.
Objective: Our objective was to use an off-the-shelf software to develop a technique to generate CONSORT diagrams automatically.
Methods: During a recent trial, data were entered into FileMaker Pro, a commercially available software, at enrollment and three waves of follow-up. Patient-level data were coded to automatically generate CONSORT diagrams for use by the study team.
Results: From August 2012 to July 2014, 1,044 participants were enrolled. CONSORT diagrams were generated weekly for study team meetings to track follow-ups at 1, 6, and 12 months, for 960 (92%), 921 (90%), and 871 (88%) participants who were contacted or deceased, respectively. Reasons for loss to follow-up were captured at each follow-up.
Conclusion: CONSORT diagrams can be generated using a standard software for any trial and can facilitate data collection, project management, and reporting.
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| http://dx.doi.org/10.1055/s-0038-1677043 | DOI Listing |
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