Standardized approaches for clinical sampling and endpoint ascertainment in tuberculous meningitis studies
File(s)
Author(s)
Type
Working Paper
Abstract
Tuberculous meningitis (TBM), the most severe manifestation of tuberculosis, has poorly understood immunopathology and high mortality and morbidity despite antituberculous therapy. This calls for accelerated clinical and basic science research in this field. As TBM disproportionally affects poorer communities, studies are often performed in resource-limited environments, creating challenges for data collection and harmonisation. Comparison of TBM studies has been hampered by variation in sampling strategies, study design and choice of study endpoints. Based on literature review and expert consensus, this paper provides firstly, practical recommendations to enable thorough diagnostic, pathophysiological and pharmacokinetic studies using clinical samples, and facilitates better data aggregation and comparisons across populations and settings. Secondly, we discuss clinically relevant study endpoints, including neuroimaging, functional outcome, and cause of death, with suggestions of how these could be applied in different designs for future TBM studies.
Date Issued
2019-12-16
Citation
2019
Publisher
Wellcome Open Research
Copyright Statement
© 2019 Rohlwink UK et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Identifier
https://wellcomeopenresearch.org/articles/4-204/v1
Subjects
Tuberculous Meningitis International Research Consortium
Publication Status
Published