Automated Generation of CONSORT Diagrams Using Relational Database Software.
Journal
Applied clinical informatics
ISSN: 1869-0327
Titre abrégé: Appl Clin Inform
Pays: Germany
ID NLM: 101537732
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
entrez:
24
1
2019
pubmed:
24
1
2019
medline:
31
3
2020
Statut:
ppublish
Résumé
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. Our objective was to use an off-the-shelf software to develop a technique to generate CONSORT diagrams automatically. 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. 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. CONSORT diagrams can be generated using a standard software for any trial and can facilitate data collection, project management, and reporting.
Sections du résumé
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.
Identifiants
pubmed: 30674042
doi: 10.1055/s-0038-1677043
pmc: PMC6344335
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
60-65Subventions
Organisme : NHLBI NIH HHS
ID : R18 HL108788
Pays : United States
Informations de copyright
Georg Thieme Verlag KG Stuttgart · New York.
Déclaration de conflit d'intérêts
None declared.
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