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Lancet Respir Med. 2021 Sep 24; doi: 10.1016/S2213-2600(21)00277-0. Epub 2021 Sep 24.

Criteria and definitions for the radiological and clinical diagnosis of bronchiectasis in adults for use in clinical trials: international consensus recommendations.

The Lancet. Respiratory medicine

Stefano Aliberti, Pieter C Goeminne, Anne E O'Donnell, Timothy R Aksamit, Hamdan Al-Jahdali, Alan F Barker, Francesco Blasi, Wim G Boersma, Megan L Crichton, Anthony De Soyza, Katerina E Dimakou, Stuart J Elborn, Charles Feldman, Harm Tiddens, Charles S Haworth, Adam T Hill, Michael R Loebinger, Miguel Angel Martinez-Garcia, Jennifer J Meerburg, Rosario Menendez, Lucy C Morgan, Marlene S Murris, Eva Polverino, Felix C Ringshausen, Michal Shteinberg, Nicola Sverzellati, Gregory Tino, Antoni Torres, Thomas Vandendriessche, Montserrat Vendrell, Tobias Welte, Robert Wilson, Conroy A Wong, James D Chalmers

Affiliations

  1. Department of Biomedical Sciences, Humanitas University, Milan, Italy; IRCCS Humanitas Research Hospital, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. Electronic address: [email protected].
  2. Department of Respiratory Disease, AZ Nikolaas, Sint-Niklaas, Belgium.
  3. Division of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Medical Center, Washington, DC, USA.
  4. Mayo Clinic Pulmonary Disease and Critical Care Medicine, Rochester, MN, USA.
  5. King Saud University for health sciences, Riyadh, Saudi Arabia.
  6. Pulmonary and Critical Care, Oregon Health and Science University, Portland, OR, USA.
  7. Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy; University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy.
  8. Northwest Clinics Alkmaar, Alkmaar, Netherlands.
  9. Scottish Centre for Respiratory Research, University of Dundee, Dundee, UK.
  10. Population and Health Science Institute, Newcastle University, National Institute for Health Research Biomedical Research Centre for Ageing and Freeman Hospital, Newcastle, UK.
  11. Fifth Respiratory Department, Sotiria Hospital for Chest Diseases, Athens, Greece.
  12. Faculty of Medicine, Health and Life Sciences at Queen's University Belfast, Belfast, UK.
  13. Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  14. Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands.
  15. Cambridge Centre for Lung Infection, Royal Papworth Hospital and University of Cambridge, Cambridge, UK.
  16. University of Edinburgh, Edinburgh, UK.
  17. Host Defence Unit, Royal Brompton Hospital and Imperial College London, London, UK.
  18. Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
  19. Concord Clinical School, Sydney Medical School, The University of Sydney, NSW, Australia.
  20. Department of Pulmonology, Transplantation, and Cystic Fibrosis Centre, Larrey Hospital, Toulouse, France.
  21. Adult Cystic Fibrosis and Bronchiectasis Unit, Respiratory Disease Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca, Barcelona, Spain.
  22. Hannover Medical School, Department of Respiratory Medicine, Member of the German Centre for Lung Research, Hannover, Germany.
  23. Pulmonology Institute and Cystic Fibrosis Centre, Carmel Medical Centre and the Technion-Israel Institute of Technology, Haifa, Israel.
  24. Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, Università di Parma, Parma, Italy.
  25. Penn Presbyterian Medical Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
  26. Pulmonology Department, Hospital Clinic, Universitat of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Ciber de Enfermedades Respiratorias, ICREA Academia, Barcelona, Spain.
  27. KU Leuven Libraries, 2Bergen, Learning Centre Désiré Collen, Leuven, Belgium.
  28. Department of Pneumology Dr Josep Trueta Hospital, Biomedical Research Institute of Girona, Universitat de Girona, Girona, Spain.
  29. Department of Respiratory Medicine, Middlemore Hospital, Counties Manukau District Health Board and University of Auckland, Auckland, New Zealand.

PMID: 34570994 DOI: 10.1016/S2213-2600(21)00277-0

Abstract

Bronchiectasis refers to both a clinical disease and a radiological appearance that has multiple causes and can be associated with a range of conditions. Disease heterogeneity and the absence of standardised definitions have hampered clinical trials of treatments for bronchiectasis and are important challenges in clinical practice. In view of the need for new therapies for non-cystic fibrosis bronchiectasis to reduce the disease burden, we established an international taskforce of experts to develop recommendations and definitions for clinically significant bronchiectasis in adults to facilitate the standardisation of terminology for clinical trials. Systematic reviews were used to inform discussions, and Delphi processes were used to achieve expert consensus. We prioritised criteria for the radiological diagnosis of bronchiectasis and suggest recommendations on the use and central reading of chest CT scans to confirm the presence of bronchiectasis for clinical trials. Furthermore, we developed a set of consensus statements concerning the definitions of clinical bronchiectasis and its specific signs and symptoms, as well as definitions for chronic bacterial infection and sustained culture conversion. The diagnosis of clinically significant bronchiectasis requires both clinical and radiological criteria, and these expert recommendations and proposals should help to optimise patient recruitment into clinical trials and allow reliable comparisons of treatment effects among different interventions for bronchiectasis. Our consensus proposals should also provide a framework for future research to further refine definitions and establish definitive guidance on the diagnosis of bronchiectasis.

Copyright © 2021 Elsevier Ltd. All rights reserved.

Conflict of interest statement

Declaration of interests SA reports personal fees from AstraZeneca, Bayer Healthcare, Chiesi, GlaxoSmithKline, Grifols, Insmed, Menarini, Zambon, and ZetaCube; and grants from Chiesi, Fisher & Paykel,

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