Standardized Methods for Enhanced Quality and Comparability of Tuberculous Meningitis Studies.
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.
Marie Bashir Institute for Infectious Diseases and Biosecurity and the Children's Hospital at Westmead, University of Sydney, Australia.
Ben J
BJ
Marais
Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.|Nuffield Department of Medicine, University of Oxford, United Kingdom.
Anna D
AD
Heemskerk
Clinical Infectious Diseases Research Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Observatory, 7925, Cape Town, South Africa.|Department of Neurology, Inkosi Albert Luthuli Central Hospital, Durban, South Africa.
Suzaan S
SS
Marais
Department of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Reinout
R
van Crevel
Division of Neurosurgery, University of Cape Town, South Africa.
Ursula
U
Rohlwink
Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
Maxine
M
Caws
Clinical Infectious Diseases Research Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Observatory, 7925, Cape Town, South Africa.
Graeme
G
Meintjes
Sanjay Ghandi Postgraduate Institute of Medical Sciences, Lucknow, India.
Usha K
UK
Misra
Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.
Nguyen T H
NTH
Mai
Universitas Padjadjaran, Bandung, Indonesia.
Rovina
R
Ruslami
Department of Medicine, Imperial College London, United Kingdom.
James A
JA
Seddon
Tygerberg Children's Hospital and the Department of Paediatrics and Child Health, University of Stellenbosch, Tygerberg, South Africa.
Regan
R
Solomons
Tygerberg Children's Hospital and the Department of Paediatrics and Child Health, University of Stellenbosch, Tygerberg, South Africa.
Ronald
R
van Toorn
Division of Neurosurgery, University of Cape Town, South Africa.
Anthony
A
Figaji
Clinical Infectious Diseases Research Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Observatory, 7925, Cape Town, South Africa.
Helen
H
McIlleron
Department of Medicine and Radboud Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Robert
R
Aarnoutse
Tygerberg Children's Hospital and the Department of Paediatrics and Child Health, University of Stellenbosch, Tygerberg, South Africa.
Johan F
JF
Schoeman
Clinical Infectious Diseases Research Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Observatory, 7925, Cape Town, South Africa.|Department of Medicine, Imperial College London, United Kingdom.|Francis Crick Institute Mill Hill Laboratory, London, United Kingdom.
Robert J
RJ
Wilkinson
Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.|Nuffield Department of Medicine, University of Oxford, United Kingdom.
Guy E
GE
Thwaites
D000995:Antitubercular Agents / Q000494:pharmacology / Q000627:therapeutic use; D035843:Biomedical Research / Q000379:methods / Q000592:standards; D000068456:Clinical Studies as Topic / Q000379:methods / Q000592:standards; D003625:Data Collection; D019468:Disease Management; D006801:Humans; D009169:Mycobacterium tuberculosis; D017063:Outcome Assessment, Health Care; D011787:Quality of Health Care; D014390:Tuberculosis, Meningeal / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*
D000995:Antitubercular Agents
tuberculous meningitis; research methods; clinical research; core dataset