European Respiratory Society statement for defining respiratory exacerbations in children and adolescents with bronchiectasis for clinical trials.

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 2021 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, parent survey, and a Delphi approach 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 3.6-7.2%). The panel unanimously endorsed the four consensus definitions for 1a) non-severe exacerbation and 1b) severe exacerbation as an outcome measure, 2) non-severe exacerbation for studies initiating treatment, and 3) 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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Déclaration de conflit d'intérêts

Conflict of Interest: E. Alexopoulou, L. Bell, A. Bush, C. Constant, R. Fortescue, B. Karadag, A.T. Hill, A. Kantar, V. Goyal, A. Zacharasiewicz, J. Boyd, A. Claydon, Z. Powell and C. Wilson have nothing to disclose. A.B. Chang reports grants from National Health and Medical Research Council, Australia, during the conduct of the study; is IDMC member for an unlicensed vaccine (GSK), is advisory member of study design for an unlicensed molecule for chronic cough (Merck), and is IDMC member for an unlicensed monoclonal antibody (AstraZeneca); and has received personal fees from being an author of two UpToDate chapters, outside the submitted work. K. Grimwood reports grants from Australian National Health and Medical Research Council, and Medical Research Futures Fund, during the conduct of the study. S. Aliberti reports grants and personal fees from AstraZeneca, Insmed, Fisher & Paykel and Chiesi, and personal fees from GlaxoSmithKline, Gilead Sciences, Novartis, MENARINI, Fondazione Charta, Grifols, Boehringer Ingelheim and Zambon, outside the submitted work.