ERS statement: A core outcome set for clinical trials evaluating the management of COPD exacerbations

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Dokumenter

  • Fulltext

    Accepteret manuskript, 3,04 MB, PDF-dokument

  • Alexander G. Mathioudakis
  • Fekri Abroug
  • Alvar Agusti
  • Sachin Ananth
  • Per Bakke
  • Konstantinos Bartziokas
  • Bianca Beghe
  • Andras Bikov
  • Thomas Bradbury
  • Guy Brusselle
  • Cordula Cadus
  • Courtney Coleman
  • Marco Contoli
  • Alexandru Corlateanu
  • Olga Corlateanu
  • Gerard J. Criner
  • Balazs Csoma
  • Alexander Emelyanov
  • Rosa Faner
  • Gustavo Fernandez Romero
  • Zeineb Hammouda
  • Peter Horváth
  • Arturo Huerta Garcia
  • Michael Jacobs
  • Christine Jenkins
  • Guy Joos
  • Olga Kharevich
  • Konstantinos Kostikas
  • Elena Lapteva
  • Zsofia Lazar
  • Joerg D. Leuppi
  • Carol Liddle
  • John Linnell
  • Alejandra López-Giraldo
  • Vanessa M. McDonald
  • Rune Nielsen
  • Alberto Papi
  • Isabel Saraiva
  • Galina Sergeeva
  • Agni Sioutkou
  • Pradeesh Sivapalan
  • Elizabeth Stovold
  • Hao Wang
  • Fuqiang Wen
  • Janelle Yorke
  • Paula R. Williamson
  • Jørgen Vestbo
  • Jensen, Jens Ulrik Stæhr
  • DECODE-NET

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 prioritised for inclusion in the core outcome set through a two-round Delphi survey completed by 1063 participants (256 patients, 488 health professionals and 319 clinical academics) from 88 countries in five continents. Two global, multi-stakeholder, virtual consensus meetings were conducted to 1) finalise the core outcome set and 2) prioritise a single measurement instrument to be used for evaluating each of the prioritised outcomes. Consensus was informed by rigorous methodological systematic reviews. The views of patients with COPD were accounted for at all stages of the project. Survival, treatment success, breathlessness, quality of life, activities of daily living, the need for a 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 optimise some of the selected measurement instruments. The panel did not consider the prioritised set of outcomes and associated measurement instruments to be burdensome for patients and health professionals to use.

OriginalsprogEngelsk
Artikelnummer2102006
TidsskriftEuropean Respiratory Journal
Vol/bind59
Udgave nummer5
ISSN0903-1936
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
Conflict of interest: A.G. Mathioudakis reports grants from Boehringer Ingelheim, outside the submitted work. F. Abroug has nothing to disclose. A. Agusti reports grants and personal fees for advisory board work and lectures from GSK, Menarini, Chiesi and AZ, outside the submitted work. S. Ananth has nothing to disclose. P. Bakke reports personal fees for lectures from AstraZeneca, Novartis and GlaxoSmithKline, outside the submitted work. K. Bartziokas has nothing to disclose. B. Beghe has nothing to disclose. A. Bikov has nothing to disclose. T. Bradbury reports receiving an academic scholarship funded by GlaxoSmithKline outside the submitted work. G. Brusselle reports personal fees for advisory board work and lectures from Astra Zeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Sanofi and Teva, outside the submitted work. C. Cadus reports personal fees from Mundipharma and AstraZeneca outside the submitted work. C. Coleman is an employee of the European Lung Foundation. M. Contoli reports board membership, payment for lectures, grants for research and travel expenses reimbursement from Chiesi, AstraZeneca and GlaxoSmithKline, board membership, consultancy, payment for lectures, grants for research and travel expenses reimbursement from Boehringer Ingelheim, board membership, consultancy and travel expenses reimbursement from Alk-Abello, board membership, payment for lectures, travel expenses reimbursement from Novartis and Zambon, grants from University of Ferrara, Italy, outside the submitted work. A. Corlateanu has nothing to disclose. O. Corlateanu has nothing to disclose. G.J. Criner reports grants and personal fees from GlaxoSmithKline, Boehringer Ingelheim, Chiesi, Mereo, AstraZeneca, Pulmonx, Pneumrx, Olympus, Broncus, Lungpacer, Nuvaira, ResMed, Respironics and Patara, personal fees from Verona, BTG, EOLO and NGM, grants from Alung, Fisher Paykel and Galapagos, outside the submitted work. B. Csoma has nothing to disclose. A. Emelyanov has nothing to disclose. R. Faner reports grants and other (advisory board) from GSK, grants from Menarini and AstraZeneca, other (lecture fee) from Chiesi, outside the submitted work. G. Fernandez Romero has nothing to disclose. Z. Hammouda has nothing to disclose. P. Horváth has nothing to disclose. A. Huerta Garcia has nothing to disclose. M. Jacobs has nothing to disclose. C. Jenkins reports personal fees for advisory board work and educational content from AstraZeneca and Boehringer Ingelheim, grants and personal fees for advisory board work and educational content from GlaxoSmithKline, personal fees for consultancy, advisory board work and educational content from Novartis, outside the submitted work. G. Joos reports grants, personal fees for lectures and advisory board work, and non-financial support from AstraZeneca and GlaxoSmithKline, grants from Chiesi, personal fees for lectures from Novartis and Lapharcon, outside the submitted work; all fees were paid to his department. O. Kharevich has nothing to disclose. K. Kostikas was an employee and shareholder of Novartis Pharma AG until 2018; he has received honoraria for presentations and consultancy fees from AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, ELPEN, GSK, Menarini, Novartis, Sanofi Genzyme and WebMD; his department has received funding and grants from AstraZeneca, Boehringer Ingelheim, Chiesi, Innovis, ELPEN, GSK, Menarini, Novartis and NuvoAir; and he is a member of the GOLD Assembly. E. Lapteva has nothing to disclose. Z. Lazar has nothing to disclose. J.D. Leuppi is supported by grants from the Swiss National Science Foundation (SNF 160072 and 185592) as well as by Swiss Personalised Health Network (SPHN 2018DR108); and has also received unrestricted grants from AstraZeneca AG Switzerland, Boehringer Ingelheim GmbH Switzerland, GSK AG Switzerland, and Novartis AG Switzerland. C. Liddle has nothing to disclose. J. Linnell has nothing to disclose. A. López-Giraldo has nothing to disclose. V.M. McDonald reports grants and personal fees from GSK and AZ, personal fees from Novartis, outside the submitted work. R. Nielsen reports grants from GlaxoSmithKline Norway and Boehringer Ingelheim, grants and personal fees from AstraZeneca, outside the submitted work. A. Papi report grants, personal fees, non-financial support, and other interests at AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma and Teva; personal fees and non-financial support from Menarini, Novartis and Zambon; and grants from Sanofi. I. Saraiva has nothing to disclose. G. Sergeeva has nothing to disclose. A. Sioutkou has nothing to disclose. P. Sivapalan reports personal fees for lectures from Boehringer Ingelheim, AstraZeneca and GSK, outside the submitted work. E. Stovold has nothing to disclose. H. Wang has nothing to disclose. F. Wen has nothing to disclose. J. Yorke has nothing to disclose. P.R. Williamson reports personal fees from European Respiratory Society, during the conduct of the study. J. Vestbo reports personal fees for consultancy and lectures from AstraZeneca, Chiesi and Novartis, grants and personal fees for consultancy and lectures from Boehringer Ingelheim, personal fees for consultancy from GSK, outside the submitted work; and the author’s son works for Chiesi. J-U. Jensen has nothing to disclose.

Funding Information:
Support statement: This study is funded by the European Respiratory Society (ERS TF-2019-12). A.G. Mathioudakis, A. Bikov and J. Vestbo are supported by the NIHR Manchester Biomedical Research Centre (BRC). P.R. Williamson is supported by the Medical Research Council (MRC) Trials Methodology Research Partnership (grant reference MR/ S014357/1). The research salary for P. Sivapalan was provided by Herlev-Gentofte University Hospital. Funding information for this article has been deposited with the Crossref Funder Registry.

Publisher Copyright:
© 2022 European Respiratory Society. All rights reserved.

ID: 308364491