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

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Standard

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 tidsskriftTidsskriftartikelForskningfagfællebedømt

Harvard

Mathioudakis, AG, Abroug, F, Agusti, A, Ananth, S, Bakke, P, Bartziokas, K, Beghe, B, Bikov, A, Bradbury, T, Brusselle, G, Cadus, C, Coleman, C, Contoli, M, Corlateanu, A, Corlateanu, O, Criner, GJ, Csoma, B, Emelyanov, A, Faner, R, Romero, GF, Hammouda, Z, Horváth, P, Garcia, AH, Jacobs, M, Jenkins, C, Joos, G, Kharevich, O, Kostikas, K, Lapteva, E, Lazar, Z, Leuppi, JD, Liddle, C, Linnell, J, López-Giraldo, A, McDonald, VM, Nielsen, R, Papi, A, Saraiva, I, Sergeeva, G, Sioutkou, A, Sivapalan, P, Stovold, E, Wang, H, Wen, F, Yorke, J, Williamson, PR, Vestbo, J, Jensen, JU & DECODE-NET 2022, 'ERS statement: A core outcome set for clinical trials evaluating the management of COPD exacerbations', European Respiratory Journal, bind 59, nr. 5, 2102006. https://doi.org/10.1183/13993003.02006-2021

APA

Mathioudakis, A. G., Abroug, F., Agusti, A., Ananth, S., Bakke, P., Bartziokas, K., Beghe, B., Bikov, A., Bradbury, T., Brusselle, G., Cadus, C., Coleman, C., Contoli, M., Corlateanu, A., Corlateanu, O., Criner, G. J., Csoma, B., Emelyanov, A., Faner, R., ... DECODE-NET (2022). ERS statement: A core outcome set for clinical trials evaluating the management of COPD exacerbations. European Respiratory Journal, 59(5), [2102006]. https://doi.org/10.1183/13993003.02006-2021

Vancouver

Mathioudakis AG, Abroug F, Agusti A, Ananth S, Bakke P, Bartziokas K o.a. ERS statement: A core outcome set for clinical trials evaluating the management of COPD exacerbations. European Respiratory Journal. 2022;59(5). 2102006. https://doi.org/10.1183/13993003.02006-2021

Author

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. / ERS statement : A core outcome set for clinical trials evaluating the management of COPD exacerbations. I: European Respiratory Journal. 2022 ; Bind 59, Nr. 5.

Bibtex

@article{6b06853bad534b50bf3af90cce33a5d3,
title = "ERS statement: A core outcome set for clinical trials evaluating the management of COPD exacerbations",
abstract = "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.",
author = "Mathioudakis, {Alexander G.} and Fekri Abroug and Alvar Agusti and Sachin Ananth and Per Bakke and Konstantinos Bartziokas and Bianca Beghe and Andras Bikov and Thomas Bradbury and Guy Brusselle and Cordula Cadus and Courtney Coleman and Marco Contoli and Alexandru Corlateanu and Olga Corlateanu and Criner, {Gerard J.} and Balazs Csoma and Alexander Emelyanov and Rosa Faner and Romero, {Gustavo Fernandez} and Zeineb Hammouda and Peter Horv{\'a}th and Garcia, {Arturo Huerta} and Michael Jacobs and Christine Jenkins and Guy Joos and Olga Kharevich and Konstantinos Kostikas and Elena Lapteva and Zsofia Lazar and Leuppi, {Joerg D.} and Carol Liddle and John Linnell and Alejandra L{\'o}pez-Giraldo and McDonald, {Vanessa M.} and Rune Nielsen and Alberto Papi and Isabel Saraiva and Galina Sergeeva and Agni Sioutkou and Pradeesh Sivapalan and Elizabeth Stovold and Hao Wang and Fuqiang Wen and Janelle Yorke and Williamson, {Paula R.} and J{\o}rgen Vestbo and Jensen, {Jens Ulrik} and DECODE-NET",
note = "Publisher Copyright: {\textcopyright} 2022 European Respiratory Society. All rights reserved.",
year = "2022",
doi = "10.1183/13993003.02006-2021",
language = "English",
volume = "59",
journal = "The European respiratory journal",
issn = "0903-1936",
publisher = "European Respiratory Society",
number = "5",

}

RIS

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