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Open Access Clinical standards for the diagnosis, treatment and prevention of TB infection

BACKGROUND: Tuberculosis (TB) preventive therapy (TPT) decreases the risk of developing TB disease and its associated morbidity and mortality. The aim of these clinical standards is to guide the assessment, management of TB infection (TBI) and implementation of TPT.

METHODS: A panel of global experts in the field of TB care was identified; 41 participated in a Delphi process. A 5-point Likert scale was used to score the initial standards. After rounds of revision, the document was approved with 100% agreement.

RESULTS: Eight clinical standards were defined: Standard 1, all individuals belonging to at-risk groups for TB should undergo testing for TBI; Standard 2, all individual candidates for TPT (including caregivers of children) should undergo a counselling/health education session; Standard 3, testing for TBI: timing and test of choice should be optimised; Standard 4, TB disease should be excluded prior to initiation of TPT; Standard 5, all candidates for TPT should undergo a set of baseline examinations; Standard 6, all individuals initiating TPT should receive one of the recommended regimens; Standard 7, all individuals who have started TPT should be monitored; Standard 8, a TBI screening and testing register should be kept to inform the cascade of care.

CONCLUSION: This is the first consensus-based set of Clinical Standards for TBI. This document guides clinicians, programme managers and public health officers in planning and implementing adequate measures to assess and manage TBI.

Keywords: TB infection tests; TB preventive therapy; clinical standards; tuberculosis

Document Type: Research Article

Affiliations: 1: Respiratory Diseases Clinical Epidemiology Unit, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy 2: Division of Infectious Diseases, Department of Medicine, National University Hospital, National University Health System, Singapore City 3: Division of Infectious and Tropical Diseases, Spedali Civili University Hospital, Brescia, Italy, WHO Collaborating Centre for TB/HIV Collaborative Activities and for TB Elimination Strategy, University of Brescia, Brescia, Italy 4: Centre for Global Public Health, Institute for Population Health Sciences, Queen Mary University, London, UK 5: Translational Research Unit, National Institute for Infectious Diseases “Lazzaro Spallanzani”, IRCCS, Rome, Italy 6: USAID, Bureau for Global Health, TB Division, Washington, DC, USA 7: Directorate General for Disease Surveillance and Control, Ministry of Health, Muscat, Oman 8: Division of Infectious Diseases, Department of Medicine, National University Hospital, National University Health System, Singapore City, Infectious Disease Translational Research Programme, Department of Medicine, National University of Singapore, Yong Loo Lin School of Medicine, Singapore City 9: Department of Infectious Diseases, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile 10: Centro de Investigação em Saúde de Manhiça (CISM), Maputo, Mozambique, ISGlobal, Barcelona Centre for International Health Research, Hospital Clínic - Universitat de Barcelona, Barcelona, Spain 11: IAME UMR1137, INSERM, University of Paris, F-75018 Paris; AP-HP-Bichat Hospital, Associate laboratory of National Reference Center for Mycobacteria and Antimycobacterial Resistance, Paris, France 12: Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA 13: Tuberculosis Control Unit, Tan Tock Seng Hospital, Singapore, Singapore 14: Helio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Rio de Janeiro, Brazil 15: Victorian Tuberculosis Program, Melbourne Health, Melbourne, VIC, Australia, Department of Infectious Diseases, Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Australia 16: KNCV Tuberculosis Foundation, The Hague, The Netherlands 17: Paediatric Clinic, Pietro Barilla Children´s Hospital, University of Parma, Parma, Italy 18: Mycobacteriology Research Center (MRC), National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran 19: Institute for Infection and Immunity, St George´s, University of London, London, UK 20: Department of Paediatrics, Center for International Child Health, University of Melbourne, Melbourne, VIC, Australia, Murdoch Children´s Research Institute, Royal Children´s Hospital, Melbourne, Australia 21: Institute for Global Health, University College London, London, UK 22: International Union Against Tuberculosis and Lung Disease, Paris, France, Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK 23: The Global Tuberculosis Program, Texas Children´s Hospital, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA 24: Academic Tuberculosis Program Center, Faculty of Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil 25: Operational Center, Medecins Sans Frontieres (MSF), Paris, France 26: Department of Infectious Diseases and Microbiology, The Children´s Hospital at Westmead, Westmead, NSW, Australia, The University of Sydney Institute for Infectious Diseases, Sydney, NSW, Australia 27: Montréal Chest Institute, Montréal, QC, Canada, Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, Montréal, QC, Canada, McGill International Tuberculosis Centre, Montréal, QC, Canada 28: Infectious Diseases, National Centre for Infectious Diseases, Singapore 29: Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, University Hospital of Monterrey UANL (Universidad Autonoma de Nuevo Leon), Monterrey, Mexico 30: Faculdade de Medicina, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil 31: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa 32: Republican Research and Practical Center for Pulmonology and Tuberculosis, Minsk, Belarus 33: Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy 34: Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK 35: Department of Infection, Royal London Hospital, Barts Health NHS Trust, London, UK, Blizard Institute, Queen Mary University of London, London, UK 36: National Center for Tuberculosis and Lung Diseases, Tbilisi, Georgia 37: TB Competence Center, Swiss Lung Association, Berne, Switzerland 38: Public Health Consulting Group, Lugano, Switzerland 39: Division of Infectious Diseases, Department of Medicine, National University Hospital, National University Health System, Singapore City, Infectious Disease Translational Research Programme, Department of Medicine, National University of Singapore, Yong Loo Lin School of Medicine, Singapore City, National University of Singapore Institute for Health Innovation & Technology (iHealthtech), Singapore, Singapore

Publication date: March 1, 2022

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