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

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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 languageEnglish
    Article number2200300
    Pages (from-to)1-39
    Number of pages39
    JournalEuropean Respiratory Journal
    Volume60
    Issue number5
    DOIs
    Publication statusPublished - 1 Nov 2022

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