Abstract
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.
Keywords
clinical research - data management - relational database
