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Tuberculous meningitis (TBM) remains a major cause of death and disability in tuberculosis-endemic areas, especially in young children and immunocompromised adults. Research aimed at improving outcomes is hampered by poor standardization, which limits study comparison and the generalizability of results. We propose standardized methods for the conduct of TBM clinical research that were drafted at an international tuberculous meningitis research meeting organized by the Oxford University Clinical Research Unit in Vietnam. We propose a core dataset including demographic and clinical information to be collected at study enrollment, important aspects related to patient management and monitoring, and standardized reporting of patient outcomes. The criteria proposed for the conduct of observational and intervention TBM studies should improve the quality of future research outputs, can facilitate multicenter studies and meta-analyses of pooled data, and could provide the foundation for a global TBM data repository.

Original publication

DOI

10.1093/cid/ciw757

Type

Journal article

Journal

Clin Infect Dis

Publication Date

15/02/2017

Volume

64

Pages

501 - 509

Keywords

tuberculous meningitis, research methods, clinical research, core dataset, Antitubercular Agents, Biomedical Research, Clinical Studies as Topic, Data Collection, Disease Management, Humans, Mycobacterium tuberculosis, Outcome Assessment (Health Care), Quality of Health Care, Tuberculosis, Meningeal