Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel
Journal of Infectious Diseases
Centre for International Child Health, University of Melbourne, Department of Paediatrics and Murdoch Childrens, Flemington Rd, Parkville, VIC 3052, Australia; International Union Against Tuberculosis and Lung Disease, Paris, France; International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh; Indus Hospital, Karachi, Pakistan; Henry Jackson Foundation-Maternal Adolescent Pediatric Research Branch, National Institute of Allergyand Infectious Diseases, National Institutes of Health, Bethesda, United States; Aeras, Rockville, MD, United States; Medecins Sans Frontières, Geneva, Switzerland; School of Tropical Medicine, University of Liverpool, United Kingdom; Medecins Sans Frontières, Sydney, Australia; Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa; Stop TB Partnership, World Health Organization, Geneva, Switzerland; Maternal Adolescent Pediatric Research Branch, National Institute of Allergy And, Infectious Diseases, National Institutes of Health, Bethesda, MD, United States; South African Tuberculosis Vaccine Initiative, School of Child and Adolescent Health, University of Cape Town, South Africa; Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Stellenbosch University, Cape Town, South Africa; Department of Paediatrics, Imperial College, London, United Kingdom; Medical Research Council Laboratories, Gambia; All India Institute of Medical Sciences, New Delhi, India; New York University School of Medicine, New York, NY, United States; National Institute for Communicable Diseases, National Health Laboratory Services, Johannesburg, South Africa; Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States; Children's Hospital Westmead, University of Sydney, Australia; Medical Service Corporation International, Arlington, VA, United States; International Research and Programs Branch, National Center for HIV/AIDS, Viral Hepatitis, STD, and Tuberculosis Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States; University of Miami, Miller School of Medicine, Miami, FL, United States; Maternal and Child Health Branch, Division of Global HIV/AIDS, Centers for Disease Control and Prevention, Atlanta, GA, United States; Adolescent and Maternal AIDS Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Rockville, MD, United States; Makerere University, Johns Hopkins University Research Collaboration, Kampala, Uganda; State University of New York School of Medicine, Stony Brook, United States; Division of Infectious Disease, Office of Health, Infectious Disease, and Nutrition Bureau for Global Health, US Agency for International Development, Washington, DC, United States; GHESKIO Centers, Port au Prince, Haiti; Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States; National Institute for Research in Tuberculosis, Tuberculosis Research Centre, Chennai, India; Treatment Action Group, New York, NY, United States
There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis. © 2012 The Author.
antibiotic agent; antimalarial agent; tuberculostatic agent; age distribution; article; clinical feature; community acquired pneumonia; comorbidity; consensus; coughing; diagnostic test; disease classification; fever; health care management; human; image analysis; image display; intrathoracic tuberculosis; lethargy; medical decision making; morbidity; mortality; Mycobacterium tuberculosis; outcome assessment; priority journal; thorax radiography; tuberculosis; Adolescent; Age Factors; Antitubercular Agents; Bacteriological Techniques; Child; Child, Preschool; Humans; Infant; Tuberculosis, Pulmonary