Standardized Methods for Enhanced Quality and Comparability of Tuberculous Meningitis Studies.
Marais BJ., Heemskerk AD., Marais SS., van Crevel R., Rohlwink U., Caws M., Meintjes G., Misra UK., Mai NTH., Ruslami R., Seddon JA., Solomons R., van Toorn R., Figaji A., McIlleron H., Aarnoutse R., Schoeman JF., Wilkinson RJ., Thwaites GE., Tuberculous Meningitis International Research Consortium None.
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.