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.
Highlights
Clinical research in tuberculosis (TB) is a rich and diverse field, and many research projects overlap, collecting and analysing the same types of information in different ways, with research groups or research collaboratives generally working on their own data collection platforms using niche or bespoke methods
Whilst curated online data resources may contain harmonised, cleaned and standardised data for specialised types of clinical TB data [1, 2], clinical TB research projects are usually initiated by clinician researchers, with data clerks, managers and analysts to capture and store new data collected on case report forms (CRFs) in the field or laboratory
In recognition of the different types of data that may be collected for different studies, we have used a modular approach so that a researcher wishing to build their own TB clinical research database using this template will be able to select only the modules that are relevant to their specific study
Summary
Clinical research in tuberculosis (TB) is a rich and diverse field, and many research projects overlap, collecting and analysing the same types of information in different ways, with research groups or research collaboratives generally working on their own data collection platforms using niche or bespoke methods. Whilst curated online data resources may contain harmonised, cleaned and standardised data for specialised types of clinical TB data [1, 2], clinical TB research projects are usually initiated by clinician researchers, with data clerks, managers and analysts to capture and store new data collected on case report forms (CRFs) in the field or laboratory The aim of this project is to provide a generic TB databasing tool that will assist researchers to build a TB clinical research database for a variety of types of data, with inbuilt data standards and data compatibility with other study data that have been captured in databases built using the same template. We have identified, characterised and standardised essential TB research elements, and developed a standardized harmonized database template as a base on which to develop data collection, storage and analysis
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