Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials
- Anne B Chang1,2,3⇑,
- Angela Zacharasiewicz4,
- Vikas Goyal1,2,
- Jeanette Boyd5,
- Efthymia Alexopoulou6,
- Stefano Aliberti7,
- Leanne Bell8,
- Andrew Bush9,
- Alison Claydon10,
- Carolina Constant11,
- Rebecca Fortescue12,
- Adam T Hill13,
- Bulent Karadag14,
- Zena Powell8,
- Christine Wilson15,
- Keith Grimwood3,16,17,20,
- Ahmad Kantar18,20,
- other members of Child-BEAR-Net19
- 1Australian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Australia
- 2Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, Australia
- 3NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Child Health Division, Menzies School of Health Research, Charles Darwin University, Australia
- 4Department of Pediatrics, and Adolescent Medicine, Teaching Hospital of the University of Vienna, Wilhelminen Hospital, Klinikum Ottakring Vienna, Austria
- 5European Lung Foundation, Sheffield, United Kingdom
- 62nd Radiology Department, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece
- 7Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy
- 8European Lung Foundation bronchiectasis paediatric patient advisory group
- 9Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, and National Heart and Lung Institute, Imperial School of Medicine, London, United Kingdom
- 10Centre for PCD Diagnosis and Research, Department of Respiratory Sciences, University of Leicester, Leicester, United Kingdom
- 11Department of Pediatrics, Hospital de Santa Maria and Faculty of Medicine, University of Lisbon, Lisbon, Portugal
- 12Population Health Research Institute, St George's University of London, London, United Kingdom
- 13Dept of Respiratory Medicine, Royal Infirmary and University of Edinburgh, Edinburgh, United Kingdom
- 14Division of Pediatric Pulmonology, Marmara University Faculty of Medicine, Istanbul, Turkey
- 15Department of Physiotherapy, Queensland Children's Hospital, Brisbane, Australia
- 16Departments of Infectious Disease and Paediatrics, Gold Coast Health, Southport, Australia
- 17School of Medicine and Dentistry, Menzies Health Institute Queensland, Griffith University, Gold Coast campus, Southport, Australia
- 18Pediatric Asthma and Cough Centre, Istituti Ospedalieri Bergamaschi, University and Research Hospitals, Bergamo, Italy
- 19Other Child-BEAR-Net committee members: James Chalmers, Andrew Collaro, Kostas Douros, Matthias Griese, Jonathan Grigg, Andreas Hector, Oleksandr Mazulov, Fabio Midulla, Alexander Möller, Marijke Proesmans and Stephanie Yerkovich.
- 20equal senior co-authors
- Corresponding author: Anne Chang (Anne.Chang{at}menzies.edu.au)
Abstract
Bronchiectasis is being diagnosed increasingly in children and adolescents. Recurrent respiratory exacerbations are common in children and adolescents with this chronic pulmonary disorder. Respiratory exacerbations are associated with an impaired quality-of-life, poorer long-term clinical outcomes and substantial costs to the family and health systems. The European Respiratory Society (ERS) clinical practice guideline for the management of children and adolescents with bronchiectasis provided a definition of acute respiratory exacerbations for clinical use but to date there is no comparable universal definition for clinical research. Given the importance of exacerbations in the field, this ERS task force sought to obtain robust definitions of respiratory exacerbations for clinical research. The panel was a multidisciplinary team of specialists in paediatric and adult respiratory medicine, infectious disease, physiotherapy, primary care, nursing, radiology, methodology, patient advocacy and parents of children and adolescents with bronchiectasis. We used a standardised process that included a systematic literature review, parents’ survey and a Delphi involving 299 physicians (54 countries) caring for children and adolescents with bronchiectasis. Consensus was obtained for all four statements drafted by the panel as the disagreement rate was very low (range 3.6% to 6.4%). The panel unanimously endorsed the four consensus definitions for: non-severe and severe exacerbations as an outcome measure; non-severe exacerbation for studies initiating treatment and; resolution of a non-severe exacerbation; for clinical trials involving children and adolescents with bronchiectasis. This ERS task force proposes using these internationally derived, consensus-based definitions of respiratory exacerbations for future clinical paediatric bronchiectasis research.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of Interest: Dr. Chang reports grants from National Health and Medical Research Council , Australia, during the conduct of the study; other from IDMC Member of an unlicensed vaccine (GSK) , other from Advisory member of study design for unlicensed molecule for chronic cough (Merck), other from IDMC Member of an unlicensed monoclonal antibody (AstraZeneca), personal fees from being an author of two UpToDate chapters, outside the submitted work.
Conflict of Interest: Angela Zacharasiewicz has nothing to disclose.
Conflict of Interest: Dr. Goyal has nothing to disclose.
Conflict of Interest: Ms. Boyd has nothing to disclose.
Conflict of Interest: Dr E. Alexopoulou has nothing to disclose
Conflict of Interest: Dr. Aliberti reports grants and personal fees from INSMED Incorporated, grants and personal fees from CHIESI, grants from Fisher & Paykel, personal fees from McGRAW HILL, personal fees from INSMED Italy, personal fees from INSMED Ireland Ltd, personal fees from ZAMBON, personal fees from AstraZeneca UK Limited, personal fees from CSL Behring GmbH, personal fees from Grifols, personal fees from Fondazione Charta, personal fees from Boehringer Ingelheim, personal fees from ZCUBE Srl, personal fees from MENARINI, personal fees from GlaxoSmithKline Spa, outside the submitted work; .
Conflict of Interest: Mrs Bell has nothing to disclose.
Conflict of Interest: Dr. Bush has nothing to disclose.
Conflict of Interest: Dr. Claydon has nothing to disclose.
Conflict of Interest: Dr. Constant has nothing to disclose.
Conflict of Interest: Dr. Fortescue has nothing to disclose.
Conflict of Interest: Prof. Hill has nothing to disclose.
Conflict of Interest: Dr. KARADAG has nothing to disclose.
Conflict of Interest: Mrs Powell has nothing to disclose.
Conflict of Interest: Dr. Wilson has nothing to disclose.
Conflict of Interest: Dr. Grimwood reports grants from Australian National Health and Medical Research Council, and Medical Research Futures Fund, during the conduct of the study;
Conflict of Interest: Dr. Kantar has nothing to disclose.
This is a PDF-only article. Please click on the PDF link above to read it.
- Received February 9, 2022.
- Accepted April 4, 2022.
- Copyright ©The authors 2022. For reproduction rights and permissions contact permissions{at}ersnet.org