Standardized approaches for clinical sampling and endpoint ascertainment in tuberculous meningitis studies.

Ursula K Rohlwink ORCID logo; Felicia C Chow ORCID logo; Sean Wasserman ORCID logo; Sofiati Dian ORCID logo; Rachel Pj Lai; Lidya Chaidir ORCID logo; Raph L Hamers ORCID logo; Robert J Wilkinson ORCID logo; David R Boulware ORCID logo; Fiona V Cresswell ORCID logo; +2 more... Arjan van Laarhoven ORCID logo; Tuberculous Meningitis International Research Consortium; (2020) Standardized approaches for clinical sampling and endpoint ascertainment in tuberculous meningitis studies. Wellcome Open Research, 4. 204-. ISSN 2398-502X DOI: 10.12688/wellcomeopenres.15497.2
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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.


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