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.

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.
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TBDBT:一个结核病数据库模板,用于收集RedCap协调的结核病临床研究数据,促进研究间比较和荟萃分析的数据标准化。

DOI:
10.1371/journal.pone.0249165
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发表时间:
2021
期刊:
影响因子:
3.7
通讯作者:
Tiffin N
Tiffin N
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Allie T;Jackson A;Ambler J;Johnston K;Du Bruyn E;Schultz C;Boloko L;Wasserman S;Davis A;Meintjes G;Wilkinson RJ;Tiffin N

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临床结核病研究,无论是在研究小组内还是在研究生态系统中,往往是孤立地使用定制的数据收集平台和应用不同的数据惯例进行的。这种未能协调临床表型数据或应用标准化数据收集和存储标准的做法反过来限制了利用同一研究领域多个研究项目产生的数据进行荟萃分析的机会。我们已经开发了结核病数据库模板(TBDBT),这是一个为得到良好支持的、免费的和普遍部署的临床数据库平台RedCap的模板。该模板可用于建立具有一套内置标准化数据约定的新结核病研究数据库,以确保跨研究项目和计划的标准化数据捕获。模块化设计使研究人员能够只实现数据库模板中适合其特定研究的模块。该模板包括知情同意数据、参与者人口统计、临床症状和陈述、诊断成像和实验室测试的核心模块。可选模块已设计用于访问计划和日历功能、临床试验随机化、研究后勤和操作以及药代动力学数据。可以根据需要添加其他字段。该Redcapp模板可促进为结核病研究收集高质量数据,提供一种工具来确保更好的数据协调、分析和荟萃分析。
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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