Automated Generation of CONSORT Diagrams Using Relational Database Software

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.

Searching of Clinical Trials Made Easier in cBioPortal Using Patients' Genetic and Clinical Profiles

“…Fegeler et al 33 are currently developing a solution focusing on the administrative part including communication methods for performing virtual tumor boards. Studies in the field of recruitment support often tackle different aspects than searching fitting trials for a specific patients, for example, optimize eligibility criteria 34 or assess trial population representativeness, 35 supporting data collection 36 or helping to find patients for screening. 37,38 A key factor in enrollment of MTB patients in clinical trials are matching genomic alterations of the patient's tumor and the study's inclusion criteria, yet these alterations are not specified in a well-structured matter and often only found study's descriptive text.…”

“…Fegeler et al 33 are currently developing a solution focusing on the administrative part including communication methods for performing virtual tumor boards. Studies in the field of recruitment support often tackle different aspects than searching fitting trials for a specific patients, for example, optimize eligibility criteria 34 or assess trial population representativeness, 35 supporting data collection 36 or helping to find patients for screening. 37 38 …”

Gain efficiency with streamlined and automated data processing: Examples from high-throughput monoclonal antibody production

“…Since the database engine can be accessed through a GUI, querying the data is straightforward and queries are easily modifiable. Although FM may require some initial effort to become proficient, it remains an intuitive and user-friendly tool for biologists without prior experience in database design (27)(28)(29).…”