Standardized approaches for clinical sampling and endpoint ascertainment in tuberculous meningitis studies

Wellcome Open Research

article

Ursula K Rohlwink¹  Felicia C Chow²  Sean Wasserman³  Sofiati Dian⁵  Rachel PJ Lai⁷  Lidya Chaidir⁵  Raph L Hamers^1,10  Robert J Wilkinson⁴  David R Boulware^1,13  Fiona V Cresswell^1,14  Arjan van Laarhoven^1,17 

[1] Division of Neurosurgery, Department of Surgery, Neuroscience Institute, University of Cape Town;Weill Institute for Neurosciences and Departments of Neurology and Medicine ,(Infectious Diseases), University of California;Division of Infectious Diseases and HIV Medicine, Department of Medicine, University of Cape Town;Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town;Infectious Disease Research Center, Faculty of Medicine, Universitas Padjadjaran;Department of Neurology, Faculty of Medicine, Universitas Padjadjaran/Hasan Sadikin Hospital;The Francis Crick Institute;Department of Infectious Diseases, Imperial College London;Department of Biomedical Sciences, Faculty of Medicine, Universitas Padjadjaran;Eijkman-Oxford Clinical Research Unit;Faculty of Medicine, University of Indonesia;Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford;University of Minnesota;Clinical Research Department, London School of Hygiene and Tropical Medicine;Infectious Disease Institute, Mulago College of Health Sciences;MRC-UVRI LSHTM Uganda Research Unit;Department of Internal Medicine and Radboud Center of Infectious Diseases ,(RCI), Radboud University Medical Center

关键词: tuberculous meningitis;    sampling;    immunology;    metabolomics;    proteomics;    microbiology;    imaging;    outcome;    endpoints;   

DOI  :  10.12688/wellcomeopenres.15497.2

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Tuberculous meningitis (TBM), the most severe manifestation of tuberculosis, has poorly understood immunopathology and high mortality and morbidity despite antituberculous therapy. This calls for accelerated clinical and basic science research in this field. As TBM disproportionally affects poorer communities, studies are often performed in resource-limited environments, creating challenges for data collection and harmonisation. Comparison of TBM studies has been hampered by variation in sampling strategies, study design and choice of study endpoints.  Based on literature review and expert consensus, this paper provides firstly, practical recommendations to enable thorough diagnostic, pathophysiological and pharmacokinetic studies using clinical samples, and facilitates better data aggregation and comparisons across populations and settings. Secondly, we discuss clinically relevant study endpoints, including neuroimaging, functional outcome, and cause of death, with suggestions of how these could be applied in different designs for future TBM studies.

【 授权许可】

CC BY