TBDBT: A TB DataBase Template for collection of harmonized TB clinical research data in REDCap, facilitating data standardisation for inter-study comparison and meta-analyses
File(s)journal.pone.0249165.pdf (1.18 MB)
Published version
Author(s)
Type
Journal Article
Abstract
Clinical tuberculosis research, both within research groups and across research ecosystems, is often undertaken in isolation using bespoke data collection platforms and applying differing data conventions. This failure to harmonise clinical phenotype data or apply standardised data collection and storage standards in turn limits the opportunity to undertake meta-analyses using data generated across multiple research projects for the same research domain. We have developed the Tuberculosis DataBase Template (TBDBT), a template for the well-supported, free and commonly deployed clinical databasing platform, REDCap. This template can be used to set up a new tuberculosis research database with a built-in set of standardised data conventions, to ensure standardised data capture across research projects and programs. A modular design enables researchers to implement only the modules of the database template that are appropriate for their particular study. The template includes core modules for informed consent data, participant demographics, clinical symptoms and presentation, diagnostic imaging and laboratory tests. Optional modules have been designed for visit scheduling and calendar functionality, clinical trial randomisation, study logistics and operations, and pharmacokinetic data. Additional fields can be added as needed. This REDCap template can facilitate collection of high-quality data for tuberculosis research, providing a tool to ensure better data harmonisation, analysis and meta-analysis.
Date Issued
2021-03-26
Date Acceptance
2021-03-13
Citation
PLoS One, 2021, 16 (3)
ISSN
1932-6203
Publisher
Public Library of Science (PLoS)
Journal / Book Title
PLoS One
Volume
16
Issue
3
Copyright Statement
© 2021 Allie et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
License URL
Sponsor
Wellcome Trust
European and Developing Countries Clinical Trial Partnership
European and Developing Countries Clinical Trials Partnership
Wellcome Trust
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/33770143
PII: PONE-D-20-38446
Grant Number
104803/Z/14/Z
SRIA2015-1065
SRIA2015-1065
WDAI_P83556
Subjects
General Science & Technology
Publication Status
Published
Coverage Spatial
United States
Article Number
ARTN e0249165