ERS statement: A core outcome set for clinical trials evaluating the management of COPD exacerbations
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ERS statement : A core outcome set for clinical trials evaluating the management of COPD exacerbations. / Mathioudakis, Alexander G.; Abroug, Fekri; Agusti, Alvar; Ananth, Sachin; Bakke, Per; Bartziokas, Konstantinos; Beghe, Bianca; Bikov, Andras; Bradbury, Thomas; Brusselle, Guy; Cadus, Cordula; Coleman, Courtney; Contoli, Marco; Corlateanu, Alexandru; Corlateanu, Olga; Criner, Gerard J.; Csoma, Balazs; Emelyanov, Alexander; Faner, Rosa; Romero, Gustavo Fernandez; Hammouda, Zeineb; Horváth, Peter; Garcia, Arturo Huerta; Jacobs, Michael; Jenkins, Christine; Joos, Guy; Kharevich, Olga; Kostikas, Konstantinos; Lapteva, Elena; Lazar, Zsofia; Leuppi, Joerg D.; Liddle, Carol; Linnell, John; López-Giraldo, Alejandra; McDonald, Vanessa M.; Nielsen, Rune; Papi, Alberto; Saraiva, Isabel; Sergeeva, Galina; Sioutkou, Agni; Sivapalan, Pradeesh; Stovold, Elizabeth; Wang, Hao; Wen, Fuqiang; Yorke, Janelle; Williamson, Paula R.; Vestbo, Jørgen; Jensen, Jens Ulrik; DECODE-NET.
I: European Respiratory Journal, Bind 59, Nr. 5, 2102006, 2022.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - ERS statement
T2 - A core outcome set for clinical trials evaluating the management of COPD exacerbations
AU - Mathioudakis, Alexander G.
AU - Abroug, Fekri
AU - Agusti, Alvar
AU - Ananth, Sachin
AU - Bakke, Per
AU - Bartziokas, Konstantinos
AU - Beghe, Bianca
AU - Bikov, Andras
AU - Bradbury, Thomas
AU - Brusselle, Guy
AU - Cadus, Cordula
AU - Coleman, Courtney
AU - Contoli, Marco
AU - Corlateanu, Alexandru
AU - Corlateanu, Olga
AU - Criner, Gerard J.
AU - Csoma, Balazs
AU - Emelyanov, Alexander
AU - Faner, Rosa
AU - Romero, Gustavo Fernandez
AU - Hammouda, Zeineb
AU - Horváth, Peter
AU - Garcia, Arturo Huerta
AU - Jacobs, Michael
AU - Jenkins, Christine
AU - Joos, Guy
AU - Kharevich, Olga
AU - Kostikas, Konstantinos
AU - Lapteva, Elena
AU - Lazar, Zsofia
AU - Leuppi, Joerg D.
AU - Liddle, Carol
AU - Linnell, John
AU - López-Giraldo, Alejandra
AU - McDonald, Vanessa M.
AU - Nielsen, Rune
AU - Papi, Alberto
AU - Saraiva, Isabel
AU - Sergeeva, Galina
AU - Sioutkou, Agni
AU - Sivapalan, Pradeesh
AU - Stovold, Elizabeth
AU - Wang, Hao
AU - Wen, Fuqiang
AU - Yorke, Janelle
AU - Williamson, Paula R.
AU - Vestbo, Jørgen
AU - Jensen, Jens Ulrik
AU - DECODE-NET
N1 - Publisher Copyright: © 2022 European Respiratory Society. All rights reserved.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
U2 - 10.1183/13993003.02006-2021
DO - 10.1183/13993003.02006-2021
M3 - Journal article
C2 - 34649975
AN - SCOPUS:85129973551
VL - 59
JO - The European respiratory journal
JF - The European respiratory journal
SN - 0903-1936
IS - 5
M1 - 2102006
ER -
ID: 308364491