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. 2021 Mar 26;16(3):e0249165.
doi: 10.1371/journal.pone.0249165. eCollection 2021.

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

Taryn Allie  1 , Amanda Jackson  1 , Jon Ambler  1   2 , Katherine Johnston  2 , Elsa Du Bruyn  1   3 , Charlotte Schultz  1   3 , Linda Boloko  1   3 , Sean Wasserman  1   3 , Angharad Davis  1 , Graeme Meintjes  1   3 , Robert J Wilkinson  1   3   4   5 , Nicki Tiffin  1   2   6
Affiliations

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

Taryn Allie et al. PLoS One. .

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.

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Conflict of interest statement

No authors have competing interests.

Figures

Fig 1
Fig 1. Auto archiver & eConsent framework ENABLED in survey setting, to capture all responses in a pdf, and maintain versioning of consent documents.
Fig 2
Fig 2. Encapsulation of data collection arm & clinical visits arm.
Fig 3
Fig 3. A. Example of repeating instruments for capturing medication data. B. Example of structured report for medication log, showing dummy data.
See this image and copyright information in PMC

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