TY - JOUR
T1 - Task Force report
T2 - European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials
AU - Chang, Anne B.
AU - Zacharasiewicz, Angela
AU - Goyal, Vikas
AU - Boyd, Jeanette
AU - Alexopoulou, Efthymia
AU - Aliberti, Stefano
AU - Bell, Leanne
AU - Bush, Andrew
AU - Claydon, Alison
AU - Constant, Carolina
AU - Fortescue, Rebecca
AU - Hill, Adam T.
AU - Karadag, Bulent
AU - Powell, Zena
AU - Wilson, Christine
AU - Grimwood, Keith
AU - Kantar, Ahmad
AU - Chalmers, James
AU - Collaro, Andrew
AU - Douros, Kostas
AU - Griese, Matthias
AU - Grigg, Jonathan
AU - Hector, Andreas
AU - Mazulov, Oleksandr
AU - Midulla, Fabio
AU - Möller, Alexander
AU - Proesmans, Marijke
AU - Yerkovich, Stephanie
N1 - Funding Information:
Drs Alexopoulou, Bush, Constant, Fortescue, Grimwood, Karadag, Hill, Kantar, Goyal, Zacharasiewicz have nothing to disclose. Ms Boyd, Claydon, Powell and Wilson also have nothing to disclose. 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. Dr. Grimwood reports grants from Australian National Health and Medical Research Council, and Medical Research Futures Fund, during the conduct of the study. Dr Aliberti reports grants and personal fees from AstraZeneca, grants and personal fees from Insmed, Fisher & Paykel, and Chiesi, and personal fees from GlaxoSmithKline, Gilead Sciences, Novartis, MENARINI, Fondazione Charta, Grifols, Boehringer Ingelheim, Zambon, outside the submitted work.
Publisher Copyright:
Copyright © The authors 2022.
PY - 2022/11/1
Y1 - 2022/11/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85141594395&partnerID=8YFLogxK
U2 - 10.1183/13993003.00300-2022
DO - 10.1183/13993003.00300-2022
M3 - Article
C2 - 35728974
SN - 0903-1936
VL - 60
SP - 1
EP - 39
JO - European Respiratory Journal
JF - European Respiratory Journal
IS - 5
M1 - 2200300
ER -