Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials

Anne B. Chang; Angela Zacharasiewicz; Vikas Goyal; Jeanette Boyd; Efthymia Alexopoulou; Stefano Aliberti; Leanne Bell; Andrew Bush; Alison Claydon; Carolina Constant; Rebecca Fortescue; Adam T. Hill; Bulent Karadag; Zena Powell; Christine Wilson; Keith Grimwood; Ahmad Kantar; James Chalmers; Andrew Collaro; Kostas Douros; Matthias Griese; Jonathan Grigg; Andreas Hector; Oleksandr Mazulov; Fabio Midulla; Alexander Möller; Marijke Proesmans; Stephanie Yerkovich

doi:10.1183/13993003.00300-2022

Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials

Anne B. Chang, Angela Zacharasiewicz, Vikas Goyal, Jeanette Boyd, Efthymia Alexopoulou, Stefano Aliberti, Leanne Bell, Andrew Bush, Alison Claydon, Carolina Constant, Rebecca Fortescue, Adam T. Hill, Bulent Karadag, Zena Powell, Christine Wilson, Keith Grimwood, Ahmad Kantar, James Chalmers, Andrew Collaro, Kostas DourosMatthias Griese, Jonathan Grigg, Andreas Hector, Oleksandr Mazulov, Fabio Midulla, Alexander Möller, Marijke Proesmans, Stephanie Yerkovich

Child and Maternal Health

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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.

Original language	English
Article number	2200300
Pages (from-to)	1-39
Number of pages	39
Journal	European Respiratory Journal
Volume	60
Issue number	5
DOIs	https://doi.org/10.1183/13993003.00300-2022
Publication status	Published - 1 Nov 2022

Bibliographical note

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.

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Chang, A. B., Zacharasiewicz, A., Goyal, V., Boyd, J., Alexopoulou, E., Aliberti, S., Bell, L., Bush, A., Claydon, A., Constant, C., Fortescue, R., Hill, A. T., Karadag, B., Powell, Z., Wilson, C., Grimwood, K., Kantar, A., Chalmers, J., Collaro, A., ... Yerkovich, S. (2022). Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials. European Respiratory Journal, 60(5), 1-39. Article 2200300. https://doi.org/10.1183/13993003.00300-2022

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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.",

author = "Chang, {Anne B.} and Angela Zacharasiewicz and Vikas Goyal and Jeanette Boyd and Efthymia Alexopoulou and Stefano Aliberti and Leanne Bell and Andrew Bush and Alison Claydon and Carolina Constant and Rebecca Fortescue and Hill, {Adam T.} and Bulent Karadag and Zena Powell and Christine Wilson and Keith Grimwood and Ahmad Kantar and James Chalmers and Andrew Collaro and Kostas Douros and Matthias Griese and Jonathan Grigg and Andreas Hector and Oleksandr Mazulov and Fabio Midulla and Alexander M{\"o}ller and Marijke Proesmans and Stephanie Yerkovich",

note = "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 {\textcopyright} The authors 2022.",

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doi = "10.1183/13993003.00300-2022",

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Chang, AB, Zacharasiewicz, A, Goyal, V, Boyd, J, Alexopoulou, E, Aliberti, S, Bell, L, Bush, A, Claydon, A, Constant, C, Fortescue, R, Hill, AT, Karadag, B, Powell, Z, Wilson, C, Grimwood, K, Kantar, A, Chalmers, J, Collaro, A, Douros, K, Griese, M, Grigg, J, Hector, A, Mazulov, O, Midulla, F, Möller, A, Proesmans, M & Yerkovich, S 2022, 'Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials', European Respiratory Journal, vol. 60, no. 5, 2200300, pp. 1-39. https://doi.org/10.1183/13993003.00300-2022

Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials. / Chang, Anne B.; Zacharasiewicz, Angela; Goyal, Vikas et al.
In: European Respiratory Journal, Vol. 60, No. 5, 2200300, 01.11.2022, p. 1-39.

Research output: Contribution to journal › Article › peer-review

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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.

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ER -

Task Force report: European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials

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