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Open Access Clinical standards for drug-susceptible pulmonary TB

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BACKGROUND: The aim of these clinical standards is to provide guidance on ‘best practice´ for diagnosis, treatment and management of drug-susceptible pulmonary TB (PTB).

METHODS: A panel of 54 global experts in the field of TB care, public health, microbiology, and pharmacology were identified; 46 participated in a Delphi process. A 5-point Likert scale was used to score draft standards. The final document represents the broad consensus and was approved by all 46 participants.

RESULTS: Seven clinical standards were defined: Standard 1, all patients (adult or child) who have symptoms and signs compatible with PTB should undergo investigations to reach a diagnosis; Standard 2, adequate bacteriological tests should be conducted to exclude drug-resistant TB; Standard 3, an appropriate regimen recommended by WHO and national guidelines for the treatment of PTB should be identified; Standard 4, health education and counselling should be provided for each patient starting treatment; Standard 5, treatment monitoring should be conducted to assess adherence, follow patient progress, identify and manage adverse events, and detect development of resistance; Standard 6, a recommended series of patient examinations should be performed at the end of treatment; Standard 7, necessary public health actions should be conducted for each patient. We also identified priorities for future research into PTB.

CONCLUSION: These consensus-based clinical standards will help to improve patient care by guiding clinicians and programme managers in planning and implementation of locally appropriate measures for optimal person-centred treatment for PTB.

Keywords: clinical standards; diagnosis; education; management; pulmonary TB; rehabilitation; treatment

Document Type: Research Article

Affiliations: 1: TB Center Beatrixoord, University Medical Center Groningen, University of Groningen, Haren, the Netherlands, Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands 2: Centro Hospitalar de Vila Nova de Gaia/Espinho; Instituto de Ciencias Biomédicas de Abel Saalazar, Universidade do Porto, Instituto de Saúde Publica da Universidade do Porto, Unidade de Investigação Clínica, ARS Norte, Porto, Portugal 3: Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Division of Infection, Royal London Hospital, Barts Health NHS Trust, London, UK 4: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa 5: Division of Clinical Infectious Diseases, Research Center Borstel, Borstel, Germany, German Center for Infection Research (DZIF) Clinical Tuberculosis Unit, Borstel, Germany, Respiratory Medicine & International Health, University of Lübeck, Lübeck, Germany, The Global Tuberculosis Program, Texas Children´s Hospital, Immigrant and Global Health, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA 6: Sydney Institute for Infectious Diseases, The University of Sydney, Sydney, NSW, Australia, School of Pharmacy, The University of Sydney Faculty of Medicine and Health, Sydney, NSW, Australia, Westmead Hospital, Sydney, NSW, Australia 7: Victorian Tuberculosis Program, Melbourne Health, Department of Infectious diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia 8: Laboratório de Inovações em Terapias, Ensino e Bioprodutos, Instituto Oswaldo Cruz, Fundação Oswaldo Cruz (FIOCRUZ), Rio de Janeiro, RJ, Brazil 9: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands 10: Moscow Research and Clinical Center for Tuberculosis Control, Moscow, Russia 11: Division of Infectious Diseases, Department of Medicine, Karolinska Institutet, Solna, Stockholm, Sweden, Department of Infectious Disease, Karolinska University Hospital, Stockholm, Sweden 12: Emerging Bacterial Pathogens Unit, Division of Immunology, Transplantation and Infectious Diseases, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele Scientific Institute, Milan, Italy 13: Department of Pneumology, University General Hospital of Gran Canaria “Dr Negrin”, Las Palmas, Spain, ALOSA (Active Learning over Sanitary Aspects) TB Academy, Spain 14: Pediatric Department, Vila Nova de Gaia Outpatient Tuberculosis Centre, Vila Nova de Gaia Hospital Centre, Vila Nova de Gaia, Portugal 15: Department of Medicine, Therapeutics and Dermatology, Kenyatta University, Nairobi, Kenya, Department of Clinical Sciences. Liverpool School of Tropical Medicine, Liverpool, UK 16: Servizio di Epidemiologia Clinica delle Malattie Respiratorie, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy 17: Reference Center Helio Fraga, FIOCRUZ, Brazil 18: Public Health Consulting Group, Lugano, Switzerland 19: Department of Infectious Diseases, Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK 20: Centre for Lung Infection and Immunity Unit, Department of Medicine, Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa, South African Medical Research Council Centre for the Study of Antimicrobial Resistance, University of Cape Town, Cape Town, South Africa, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK 21: Center for Tuberculosis Research, Johns Hopkins, Baltimore, MD 22: Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA 23: Tuberculosis Research Programme SEPAR, E-08029 Barcelona, Spain 24: Department of Pulmonary Diseases and Tuberculosis, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands, Municipal Public Health Service Groningen, Groningen, The Netherlands 25: Mycobacteriology Unit, Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium 26: UBT-Higher Education Institution Prishtina, Kosovo 27: Antimicrobial Pharmacodynamics and Therapeutics, Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK 28: Kilimanjaro Christian Medical University College, Moshi, United Republic of Tanzani, Kibong´oto Infectious Diseases Hospital, Sanya Juu, Siha, Kilimanjaro, United Republic of Tanzania 29: Clínica de Tuberculosis, Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas, México City, Mexico 30: Department of Pulmonology of Central Hospital of Maputo, Maputo, Mozambique, Faculty of Medicine of Eduardo Mondlane University, Maputo, Mozambique 31: Infectious Disease Translational Research Programme, Department of Medicine, National University of Singapore, Yong Loo Lin School of Medicine, Singapore, National University of Singapore Institute for Health Innovation & Technology (iHealthtech), Singapore, Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore 32: Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil 33: Department of Biomedical Science, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia, Research Center for Care and Control of Infectious Disease (RC3iD), Universitas Padjadjaran, Bandung, Indonesia 34: Department of Internal Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia, Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia 35: Research, Innovation and Data Science Division, Rwanda Biomedical Center, Kigali, Rwanda 36: Instituto Vaccarezza, Hospital Muñiz, Buenos Aires, Argentina 37: National Institute of Tuberculosis & Respiratory Diseases, New Delhi, India 38: National Institute of Tuberculosis, Lung Diseases and Thoracic Surgery, Faculty of Health, Catholic University, Ružomberok, Vyšné Hágy, Slovakia 39: Department of Pulmonary Immunology, University of Texas Health Science Centre at Tyler, Tyler, TX, USA 40: Department of Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre Rotterdam, Rotterdam, the Netherlands 41: Institute of Epidemiology and Healthcare, University College London, London, UK, Find and Treat, University College Hospitals NHS Foundation Trust, London, UK 42: Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy 43: P. D. Hinduja National Hospital and Medical Research Centre, Mumbai, India 44: Department of Pediatrics, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands 45: TB Competence Center, Swiss Lung Association, Berne, Switzerland

Publication date: July 1, 2022

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