학술논문
Criteria and definitions for the radiological and clinical diagnosis of bronchiectasis in adults for use in clinical trials: international consensus recommendations.
Document Type
Academic Journal
Author
Aliberti S; 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: stefano.aliberti@hunimed.eu.; Goeminne PC; Department of Respiratory Disease, AZ Nikolaas, Sint-Niklaas, Belgium.; O'Donnell AE; Division of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Medical Center, Washington, DC, USA.; Aksamit TR; Mayo Clinic Pulmonary Disease and Critical Care Medicine, Rochester, MN, USA.; Al-Jahdali H; King Saud University for health sciences, Riyadh, Saudi Arabia.; Barker AF; Pulmonary and Critical Care, Oregon Health and Science University, Portland, OR, USA.; Blasi F; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy; University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy.; Boersma WG; Northwest Clinics Alkmaar, Alkmaar, Netherlands.; Crichton ML; Scottish Centre for Respiratory Research, University of Dundee, Dundee, UK.; De Soyza A; Population and Health Science Institute, Newcastle University, National Institute for Health Research Biomedical Research Centre for Ageing and Freeman Hospital, Newcastle, UK.; Dimakou KE; Fifth Respiratory Department, Sotiria Hospital for Chest Diseases, Athens, Greece.; Elborn SJ; Faculty of Medicine, Health and Life Sciences at Queen's University Belfast, Belfast, UK.; Feldman C; Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.; Tiddens H; Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands.; Haworth CS; Cambridge Centre for Lung Infection, Royal Papworth Hospital and University of Cambridge, Cambridge, UK.; Hill AT; University of Edinburgh, Edinburgh, UK.; Loebinger MR; Host Defence Unit, Royal Brompton Hospital and Imperial College London, London, UK.; Martinez-Garcia MA; Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.; Meerburg JJ; Erasmus MC Sophia Children's Hospital, Rotterdam, Netherlands.; Menendez R; Pneumology Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.; Morgan LC; Concord Clinical School, Sydney Medical School, The University of Sydney, NSW, Australia.; Murris MS; Department of Pulmonology, Transplantation, and Cystic Fibrosis Centre, Larrey Hospital, Toulouse, France.; Polverino E; Adult Cystic Fibrosis and Bronchiectasis Unit, Respiratory Disease Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca, Barcelona, Spain.; Ringshausen FC; Hannover Medical School, Department of Respiratory Medicine, Member of the German Centre for Lung Research, Hannover, Germany.; Shteinberg M; Pulmonology Institute and Cystic Fibrosis Centre, Carmel Medical Centre and the Technion-Israel Institute of Technology, Haifa, Israel.; Sverzellati N; Scienze Radiologiche, Dipartimento di Medicina e Chirurgia, Università di Parma, Parma, Italy.; Tino G; Penn Presbyterian Medical Center, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.; Torres A; 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.; Vandendriessche T; KU Leuven Libraries, 2Bergen, Learning Centre Désiré Collen, Leuven, Belgium.; Vendrell M; Department of Pneumology Dr Josep Trueta Hospital, Biomedical Research Institute of Girona, Universitat de Girona, Girona, Spain.; Welte T; Hannover Medical School, Department of Respiratory Medicine, Member of the German Centre for Lung Research, Hannover, Germany.; Wilson R; Host Defence Unit, Royal Brompton Hospital and Imperial College London, London, UK.; Wong CA; Department of Respiratory Medicine, Middlemore Hospital, Counties Manukau District Health Board and University of Auckland, Auckland, New Zealand.; Chalmers JD; Scottish Centre for Respiratory Research, University of Dundee, Dundee, UK.
Source
Publisher: Elsevier Country of Publication: England NLM ID: 101605555 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-2619 (Electronic) Linking ISSN: 22132600 NLM ISO Abbreviation: Lancet Respir Med Subsets: MEDLINE
Subject
Language
English
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.
Competing Interests: 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, and Insmed, outside of the submitted work. AFB reports personal fees from Wolters Kluwer and UpToDate, during the conduct of the study. FB reports personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Grifols, Guidotti, Insmed, Menarini, Novartis, Pfizer, Vertex, and Zambon; and grants from AstraZeneca, Bayer, Chiesi, GlaxoSmithKline, Menarini, and Pfizer, outside of the submitted work. JDC reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Insmed, Janssen, Novartis, and Zambon; and grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Gilead Science, Insmed, and Novartis, outside of the submitted work. MLC reports personal fees from AstraZeneca, outside of the submitted work. ADS reports grants and personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Chiesi, Forest Labs, GlaxoSmithKline, Grifols, Insmed, Teva, and Zambon, outside of the submitted work. PCG reports personal fees from AstraZeneca and GlaxoSmithKline; and grants and non-financial support from Chiesi, outside of the submitted work. CSH reports personal fees from Aradigm, CSL Behring, GlaxoSmithKline, Grifols, Insmed, International Biophysics, Janssen, Meiji, Mylan, Novartis, Teva, and Zambon; and grants from Insmed, International Biophysics, and Teva, outside of the submitted work. MSM reports non-financial support from Boehringer Ingelheim, Insmed, and Zambon; and personal fees from Zambon, outside of the submitted work. MRL reports personal fees from AstraZeneca, Grifols, and Insmed, outside of the submitted work. AEO'D reports personal fees from Electromed, Insmed, and Zambon; and grants from AstraZeneca, Insmed, Janssen, and Zambon, outside of the submitted work. EP reports grants from Chiesi and Grifols; and personal fees from CSL Behring, Chiesi, Shionogi, Insmed, Shire, Teva, and Zambon, during the conduct of the study. FCR reports personal fees from AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, Celtaxsys, Chiesi, Corbus, Grifols, InfectoPharm, Insmed, Novartis, PARI, Parion, Polyphor, Vertex, and Zambon; grants from Bayer Healthcare, Grifols, InfectoPharm, Insmed, Novartis, and PARI; and non-financial support from PARI, outside of the submitted work. MS reports personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Kamada, Novartis, Teva, Vertex, and Zambon; grants from GlaxoSmithKline and Novartis; and non-financial support from Actelion, GlaxoSmithKline, and Rafa, outside of the submitted work. HT reports personal fees from Insmed, Novartis, Thirona, and Vertex; and grants from the Cystic Fibrosis Foundation, Insmed, and Novartis, outside of the submitted work. In addition, HT's institution, Erasmus MC, receives license fees for the chest CT image analysis PRAGMA-CF software developed by Thirona (Nijmegen, Netherlands) and by Resonance Health (Perth, Australia) and for the chest CT image analysis AA-method software co-developed by Erasmus MC and Thirona (Nijmegen, Netherlands). HT contributed to the development and validation of this software. GT reports grants from the US Bronchiectasis and non-tuberculous mycobacteria Research Registry (which is funded by the COPD Foundation); and personal fees from AstraZeneca and Cipla, outside of the submitted work. MV reports non-financial support from Chiesi, GlaxoSmithKline, Novartis, and Zambon; and personal fees from Insmed, outside of the submitted work. All other authors declare no competing interests.
(Copyright © 2022 Elsevier Ltd. All rights reserved.)
Competing Interests: 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, and Insmed, outside of the submitted work. AFB reports personal fees from Wolters Kluwer and UpToDate, during the conduct of the study. FB reports personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, Grifols, Guidotti, Insmed, Menarini, Novartis, Pfizer, Vertex, and Zambon; and grants from AstraZeneca, Bayer, Chiesi, GlaxoSmithKline, Menarini, and Pfizer, outside of the submitted work. JDC reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Insmed, Janssen, Novartis, and Zambon; and grants from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Gilead Science, Insmed, and Novartis, outside of the submitted work. MLC reports personal fees from AstraZeneca, outside of the submitted work. ADS reports grants and personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Chiesi, Forest Labs, GlaxoSmithKline, Grifols, Insmed, Teva, and Zambon, outside of the submitted work. PCG reports personal fees from AstraZeneca and GlaxoSmithKline; and grants and non-financial support from Chiesi, outside of the submitted work. CSH reports personal fees from Aradigm, CSL Behring, GlaxoSmithKline, Grifols, Insmed, International Biophysics, Janssen, Meiji, Mylan, Novartis, Teva, and Zambon; and grants from Insmed, International Biophysics, and Teva, outside of the submitted work. MSM reports non-financial support from Boehringer Ingelheim, Insmed, and Zambon; and personal fees from Zambon, outside of the submitted work. MRL reports personal fees from AstraZeneca, Grifols, and Insmed, outside of the submitted work. AEO'D reports personal fees from Electromed, Insmed, and Zambon; and grants from AstraZeneca, Insmed, Janssen, and Zambon, outside of the submitted work. EP reports grants from Chiesi and Grifols; and personal fees from CSL Behring, Chiesi, Shionogi, Insmed, Shire, Teva, and Zambon, during the conduct of the study. FCR reports personal fees from AstraZeneca, Bayer Healthcare, Boehringer Ingelheim, Celtaxsys, Chiesi, Corbus, Grifols, InfectoPharm, Insmed, Novartis, PARI, Parion, Polyphor, Vertex, and Zambon; grants from Bayer Healthcare, Grifols, InfectoPharm, Insmed, Novartis, and PARI; and non-financial support from PARI, outside of the submitted work. MS reports personal fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Kamada, Novartis, Teva, Vertex, and Zambon; grants from GlaxoSmithKline and Novartis; and non-financial support from Actelion, GlaxoSmithKline, and Rafa, outside of the submitted work. HT reports personal fees from Insmed, Novartis, Thirona, and Vertex; and grants from the Cystic Fibrosis Foundation, Insmed, and Novartis, outside of the submitted work. In addition, HT's institution, Erasmus MC, receives license fees for the chest CT image analysis PRAGMA-CF software developed by Thirona (Nijmegen, Netherlands) and by Resonance Health (Perth, Australia) and for the chest CT image analysis AA-method software co-developed by Erasmus MC and Thirona (Nijmegen, Netherlands). HT contributed to the development and validation of this software. GT reports grants from the US Bronchiectasis and non-tuberculous mycobacteria Research Registry (which is funded by the COPD Foundation); and personal fees from AstraZeneca and Cipla, outside of the submitted work. MV reports non-financial support from Chiesi, GlaxoSmithKline, Novartis, and Zambon; and personal fees from Insmed, outside of the submitted work. All other authors declare no competing interests.
(Copyright © 2022 Elsevier Ltd. All rights reserved.)