Standardized methods for enhanced quality and comparability of tuberculous meningitis studies

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Title: Standardized methods for enhanced quality and comparability of tuberculous meningitis studies
Authors: 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
Item Type: Journal Article
Abstract: Tuberculous meningitis 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 tuberculous meningitis 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 enrolment, important aspects related to patient management and monitoring, and standardized reporting of patient outcomes. The criteria proposed for the conduct of observational and intervention tuberculous meningitis studies should improve the quality of future research outputs, facilitate multi-centre studies and meta-analyses of pooled data, and could provide the foundation for a global tuberculous meningitis data repository.
Issue Date: 15-Nov-2016
Date of Acceptance: 1-Nov-2016
ISSN: 1058-4838
Publisher: Oxford University Press
Start Page: 501
End Page: 509
Journal / Book Title: Clinical Infectious Diseases
Volume: 64
Issue: 4
Copyright Statement: © 2016 The Authors. Published by Oxford University Press for the Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Sponsor/Funder: Wellcome Trust
Funder's Grant Number: 104803/Z/14/ZR
Keywords: tuberculous meningitis
research methods
clinical research
core dataset
06 Biological Sciences
11 Medical And Health Sciences
Publication Status: Published
Appears in Collections:Department of Medicine
Faculty of Medicine

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