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The Capital Region of Denmark - a part of Copenhagen University Hospital
E-pub ahead of print

ERS Statement: A core outcome set for clinical trials evaluating the management of chronic obstructive pulmonary disease (COPD) exacerbations

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  • Alexander G Mathioudakis (Member of study group)
  • Fekri Abroug (Member of study group)
  • Alvar Agusti (Member of study group)
  • Sachin Ananth (Member of study group)
  • Per Bakke (Member of study group)
  • Konstantinos Bartziokas (Member of study group)
  • Bianca Beghe (Member of study group)
  • Andras Bikov (Member of study group)
  • Thomas Bradbury (Member of study group)
  • Guy Brusselle (Member of study group)
  • Cordula Cadus (Member of study group)
  • Courtney Coleman (Member of study group)
  • Marco Contoli (Member of study group)
  • Alexandru Corlateanu (Member of study group)
  • Olga Corlateanu (Member of study group)
  • Gerard J Criner (Member of study group)
  • Balazs Csoma (Member of study group)
  • Alexander Emelyanov (Member of study group)
  • Rosa Faner (Member of study group)
  • Gustavo Fernandez Romero (Member of study group)
  • Zeineb Hammouda (Member of study group)
  • Peter Horváth (Member of study group)
  • Arturo Huerta Garcia (Member of study group)
  • Michael Jacobs (Member of study group)
  • Christine Jenkins (Member of study group)
  • Guy Joos (Member of study group)
  • Olga Kharevich (Member of study group)
  • Konstantinos Kostikas (Member of study group)
  • Elena Lapteva (Member of study group)
  • Zsofia Lazar (Member of study group)
  • Joerg D Leuppi (Member of study group)
  • Carol Liddle (Member of study group)
  • John Linnell (Member of study group)
  • Alejandra López-Giraldo (Member of study group)
  • Vanessa M McDonald (Member of study group)
  • Rune Nielsen (Member of study group)
  • Alberto Papi (Member of study group)
  • Isabel Saraiva (Member of study group)
  • Galina Sergeeva (Member of study group)
  • Agni Sioutkou (Member of study group)
  • Pradeesh Sivapalan (Member of study group)
  • Elizabeth Stovold (Member of study group)
  • Hao Wang (Member of study group)
  • Fuqiang Wen (Member of study group)
  • Janelle Yorke (Member of study group)
  • Paula R Williamson (Member of study group)
  • Jørgen Vestbo (Member of study group)
  • Jens-Ulrik Jensen (Member of study group)
  • DECODE-NET
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Clinical trials evaluating the management of acute exacerbations of COPD assess heterogeneous outcomes, often omitting those that are clinically relevant or more important to patients. We have developed a core outcome set, a consensus-based minimum set of important outcomes that we recommend are evaluated in all future clinical trials on exacerbations management, to improve their quality and comparability. COPD exacerbations outcomes were identified through methodological systematic reviews and qualitative interviews with 86 patients from 11 countries globally. The most critical outcomes were prioritized for inclusion in the core outcome set through a two-round Delphi survey that was completed by 1,063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in 5 continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to (i) finalize the core outcome set and (ii) prioritize a single measurement instrument to be used for evaluating each of the prioritized outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for in all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, need for higher level of care, arterial blood gases, disease progression, future exacerbations and hospital admissions, treatment safety and adherence were all included in the core outcome set. Focused methodological research was recommended to further validate and optimize some of the selected measurement instruments. The panel did not consider the prioritized set of outcomes and associated measurement instruments burdensome for patients and health professionals to use.

Original languageEnglish
JournalThe European respiratory journal
ISSN0903-1936
DOIs
Publication statusE-pub ahead of print - 14 Oct 2021

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