Abstract
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.
Highlights
We propose standardized methods for the conduct of Tuberculous meningitis (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
Because treatment outcomes and diagnostic test performance may vary according to the severity of disease, age, immune status, and patient management, the study population must be well characterized in terms of setting, inclusion criteria, demographics, human immunodeficiency virus (HIV) infection and immune status, disease classification, and treatment received
Summary
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 essential data points are intended to define minimum criteria for the conduct of both observational and intervention studies, and to identify a core dataset for universal use in future clinical research. Essential data points include information required by the previously published uniform TBM research case definition (Table 2) [2], which should be applied to ensure adequate diagnostic workup and to characterize the study cohort in a standardized fashion.
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