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Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol
Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
European Respiratory Society
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487360/ https://www.ncbi.nlm.nih.gov/pubmed/32964006 http://dx.doi.org/10.1183/23120541.00193-2020 |
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author | Mathioudakis, Alexander G. Abroug, Fekri Agusti, Alvar Bakke, Per Bartziokas, Konstantinos Beghe, Bianca Bikov, Andras Bradbury, Thomas Brusselle, Guy Cadus, Cordula Coleman, Courtney Contoli, Marco Corlateanu, Alexandru Corlateanu, Olga Criner, Gerard Csoma, Balazs Emelyanov, Alexander Faner, Rosa Romero, Gustavo Fernandez Hammouda, Zeineb Horváth, Peter Huerta, Arturo Garcia Jacobs, Michael Jenkins, Christine Joos, Guy Kharevich, Olga Kostikas, Konstantinos Lapteva, Elena Lazar, Zsofia Leuppi, Joerg D. Liddle, Carol 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 |
author_facet | Mathioudakis, Alexander G. Abroug, Fekri Agusti, Alvar Bakke, Per Bartziokas, Konstantinos Beghe, Bianca Bikov, Andras Bradbury, Thomas Brusselle, Guy Cadus, Cordula Coleman, Courtney Contoli, Marco Corlateanu, Alexandru Corlateanu, Olga Criner, Gerard Csoma, Balazs Emelyanov, Alexander Faner, Rosa Romero, Gustavo Fernandez Hammouda, Zeineb Horváth, Peter Huerta, Arturo Garcia Jacobs, Michael Jenkins, Christine Joos, Guy Kharevich, Olga Kostikas, Konstantinos Lapteva, Elena Lazar, Zsofia Leuppi, Joerg D. Liddle, Carol 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 |
author_sort | Mathioudakis, Alexander G. |
collection | PubMed |
description | Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations. For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus. Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS. |
format | Online Article Text |
id | pubmed-7487360 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-74873602020-09-21 Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol Mathioudakis, Alexander G. Abroug, Fekri Agusti, Alvar Bakke, Per Bartziokas, Konstantinos Beghe, Bianca Bikov, Andras Bradbury, Thomas Brusselle, Guy Cadus, Cordula Coleman, Courtney Contoli, Marco Corlateanu, Alexandru Corlateanu, Olga Criner, Gerard Csoma, Balazs Emelyanov, Alexander Faner, Rosa Romero, Gustavo Fernandez Hammouda, Zeineb Horváth, Peter Huerta, Arturo Garcia Jacobs, Michael Jenkins, Christine Joos, Guy Kharevich, Olga Kostikas, Konstantinos Lapteva, Elena Lazar, Zsofia Leuppi, Joerg D. Liddle, Carol 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 ERJ Open Res Study Protocol Randomised controlled trials (RCTs) on the management of COPD exacerbations evaluate heterogeneous outcomes, often omitting those that are clinically important and patient relevant. This limits their usability and comparability. A core outcome set (COS) is a consensus-based minimum set of clinically important outcomes that should be evaluated in all RCTs in specific areas of health care. We present the study protocol of the COS-AECOPD ERS Task Force, aiming to develop a COS for COPD exacerbation management, that could remedy these limitations. For the development of this COS we follow standard methodology recommended by the COMET initiative. A comprehensive list of outcomes is assembled through a methodological systematic review of the outcomes reported in relevant RCTs. Qualitative research with patients with COPD will also be conducted, aiming to identify additional outcomes that may be important to patients, but are not currently addressed in clinical research studies. Prioritisation of the core outcomes will be facilitated through an extensive, multi-stakeholder Delphi survey with a global reach. Selection will be finalised in an international, multi-stakeholder meeting. For every core outcome, we will recommend a specific measurement instrument and standardised time points for evaluation. Selection of instruments will be based on evidence-informed consensus. Our work will improve the quality, usability and comparability of future RCTs on the management of COPD exacerbations and, ultimately, the care of patients with COPD. Multi-stakeholder engagement and societal support by the European Respiratory Society will raise awareness and promote implementation of the COS. European Respiratory Society 2020-09-14 /pmc/articles/PMC7487360/ /pubmed/32964006 http://dx.doi.org/10.1183/23120541.00193-2020 Text en Copyright ©ERS 2020 http://creativecommons.org/licenses/by-nc/4.0/This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. |
spellingShingle | Study Protocol Mathioudakis, Alexander G. Abroug, Fekri Agusti, Alvar Bakke, Per Bartziokas, Konstantinos Beghe, Bianca Bikov, Andras Bradbury, Thomas Brusselle, Guy Cadus, Cordula Coleman, Courtney Contoli, Marco Corlateanu, Alexandru Corlateanu, Olga Criner, Gerard Csoma, Balazs Emelyanov, Alexander Faner, Rosa Romero, Gustavo Fernandez Hammouda, Zeineb Horváth, Peter Huerta, Arturo Garcia Jacobs, Michael Jenkins, Christine Joos, Guy Kharevich, Olga Kostikas, Konstantinos Lapteva, Elena Lazar, Zsofia Leuppi, Joerg D. Liddle, Carol 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 Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol |
title | Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol |
title_full | Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol |
title_fullStr | Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol |
title_full_unstemmed | Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol |
title_short | Core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the COS-AECOPD ERS Task Force study protocol |
title_sort | core outcome set for the management of acute exacerbations of chronic obstructive pulmonary disease: the cos-aecopd ers task force study protocol |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487360/ https://www.ncbi.nlm.nih.gov/pubmed/32964006 http://dx.doi.org/10.1183/23120541.00193-2020 |
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