TY - JOUR
T1 - Pulmonary exacerbation in adults with bronchiectasis
T2 - A consensus definition for clinical research
AU - for the EMBARC/BRR definitions working group
AU - Hill, Adam T.
AU - Haworth, Charles S.
AU - Aliberti, Stefano
AU - Barker, Alan
AU - Blasi, Francesco
AU - Boersma, Wim
AU - Chalmers, James D.
AU - de Soyza, Anthony
AU - Dimakou, Katerina
AU - Elborn, J. Stuart
AU - Feldman, Charles
AU - Flume, Patrick
AU - Goeminne, Pieter C.
AU - Loebinger, Michael R.
AU - Menendez, Rosario
AU - Morgan, Lucy
AU - Murris, Marlene
AU - Polverino, Eva
AU - Quittner, Alexandra
AU - Ringshausen, Felix C.
AU - Tino, Gregory
AU - Torres, Antoni
AU - Vendrell, Montserrat
AU - Welte, Tobias
AU - Wilson, Rob
AU - Wong, Conroy
AU - O'Donnell, Anne
AU - Aksamit, Timothy
N1 - Funding Information:
Support statement: This project was funded by EMBARC, a European Respiratory Society Clinical Research Collaboration. Funding information for this article has been deposited with the Crossref Funder Registry.
Publisher Copyright:
Copyright © ERS 2017
PY - 2017/6/1
Y1 - 2017/6/1
N2 - There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research. A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa. The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required. The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis.
AB - There is a need for a clear definition of exacerbations used in clinical trials in patients with bronchiectasis. An expert conference was convened to develop a consensus definition of an exacerbation for use in clinical research. A systematic review of exacerbation definitions used in clinical trials from January 2000 until December 2015 and involving adults with bronchiectasis was conducted. A Delphi process followed by a round-table meeting involving bronchiectasis experts was organised to reach a consensus definition. These experts came from Europe (representing the European Multicentre Bronchiectasis Research Collaboration), North America (representing the US Bronchiectasis Research Registry/COPD Foundation), Australasia and South Africa. The definition was unanimously approved by the working group as: a person with bronchiectasis with a deterioration in three or more of the following key symptoms for at least 48 h: cough; sputum volume and/or consistency; sputum purulence; breathlessness and/or exercise tolerance; fatigue and/or malaise; haemoptysis AND a clinician determines that a change in bronchiectasis treatment is required. The working group proposes the use of this consensus-based definition for bronchiectasis exacerbation in future clinical research involving adults with bronchiectasis.
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U2 - 10.1183/13993003.00051-2017
DO - 10.1183/13993003.00051-2017
M3 - Article
C2 - 28596426
AN - SCOPUS:85030033042
VL - 49
JO - European Respiratory Journal
JF - European Respiratory Journal
SN - 0903-1936
IS - 6
M1 - 1700051
ER -