TY - JOUR
T1 - Criteria and definitions for the radiological and clinical diagnosis of bronchiectasis in adults for use in clinical trials
T2 - international consensus recommendations
AU - Aliberti, Stefano
AU - Goeminne, Pieter C.
AU - O'Donnell, Anne E.
AU - Aksamit, Timothy R.
AU - Al-Jahdali, Hamdan
AU - Barker, Alan F.
AU - Blasi, Francesco
AU - Boersma, Wim G.
AU - Crichton, Megan L.
AU - De Soyza, Anthony
AU - Dimakou, Katerina E.
AU - Elborn, Stuart J.
AU - Feldman, Charles
AU - Tiddens, Harm
AU - Haworth, Charles S.
AU - Hill, Adam T.
AU - Loebinger, Michael R.
AU - Martinez-Garcia, Miguel Angel
AU - Meerburg, Jennifer J.
AU - Menendez, Rosario
AU - Morgan, Lucy C.
AU - Murris, Marlene S.
AU - Polverino, Eva
AU - Ringshausen, Felix C.
AU - Shteinberg, Michal
AU - Sverzellati, Nicola
AU - Tino, Gregory
AU - Torres, Antoni
AU - Vandendriessche, Thomas
AU - Vendrell, Montserrat
AU - Welte, Tobias
AU - Wilson, Robert
AU - Wong, Conroy A.
AU - Chalmers, James D.
N1 - Funding Information:
This project was an initiative of the European Multicentre Bronchiectasis Audit and Research Collaboration and the US Bronchiectasis and non-tuberculous mycobacteria Research Registry (BRR). The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no. 115721, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies' in kind contribution (grant no 115721), the European Respiratory Society through the EMBARC2 consortium, and the US BRR (funded by the COPD Foundation). EMBARC2 is supported by project partners AstraZeneca, Chiesi, Grifols, Insmed, Janssen, Novartis, and Zambon. JDC receives funding as a GlaxoSmithKline–British Lung Foundation Chair of Respiratory Research. SJE has received grants from the European Commission. TW has received grants from the German Ministry of Research and Education. The funding sources had no involvement in the project.
Funding Information:
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.
Publisher Copyright:
© 2022 Elsevier Ltd
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
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U2 - 10.1016/S2213-2600(21)00277-0
DO - 10.1016/S2213-2600(21)00277-0
M3 - Review article
C2 - 34570994
AN - SCOPUS:85125469615
VL - 10
SP - 298
EP - 306
JO - The Lancet Respiratory Medicine
JF - The Lancet Respiratory Medicine
SN - 2213-2600
IS - 3
ER -