Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research
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...
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creator | Hill, Adam T Haworth, Charles S Aliberti, Stefano Barker, Alan Blasi, Francesco Boersma, Wim Chalmers, James D De Soyza, Anthony Dimakou, Katerina Elborn, J Stuart Feldman, Charles Flume, Patrick Goeminne, Pieter C Loebinger, Michael R Menendez, Rosario Morgan, Lucy Murris, Marlene Polverino, Eva Quittner, Alexandra Ringshausen, Felix C Tino, Gregory Torres, Antoni Vendrell, Montserrat Welte, Tobias Wilson, Rob Wong, Conroy O'Donnell, Anne Aksamit, Timothy |
description | 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. |
doi_str_mv | 10.1183/13993003.00051-2017 |
format | Article |
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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.</description><identifier>ISSN: 0903-1936</identifier><identifier>EISSN: 1399-3003</identifier><identifier>DOI: 10.1183/13993003.00051-2017</identifier><identifier>PMID: 28596426</identifier><language>eng</language><publisher>England: European Respiratory Society Journals Ltd</publisher><subject>Asia ; Australia ; Bronchiectasis ; Bronchiectasis - diagnosis ; Bronchiectasis - therapy ; Chronic obstructive pulmonary disease ; Clinical trials ; Clinical Trials as Topic ; Consensus ; Cough ; Cough - drug therapy ; Delphi Technique ; Disease Progression ; Dyspnea ; Europe ; Fatigue ; Humans ; Lung - physiopathology ; North America ; Pulmonary Medicine ; South Africa ; Sputum ; Working groups</subject><ispartof>The European respiratory journal, 2017-06, Vol.49 (6), p.1700051-1700051</ispartof><rights>Copyright ©ERS 2017.</rights><rights>Copyright European Respiratory Society Journals Ltd. Jun 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c411t-169ff33532c5ce0f696e824136bf5cb24f13dd32fc6327e67d2733dcc309f3273</citedby><cites>FETCH-LOGICAL-c411t-169ff33532c5ce0f696e824136bf5cb24f13dd32fc6327e67d2733dcc309f3273</cites><orcidid>0000-0002-0090-4531</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28596426$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hill, Adam T</creatorcontrib><creatorcontrib>Haworth, Charles S</creatorcontrib><creatorcontrib>Aliberti, Stefano</creatorcontrib><creatorcontrib>Barker, Alan</creatorcontrib><creatorcontrib>Blasi, Francesco</creatorcontrib><creatorcontrib>Boersma, Wim</creatorcontrib><creatorcontrib>Chalmers, James D</creatorcontrib><creatorcontrib>De Soyza, Anthony</creatorcontrib><creatorcontrib>Dimakou, Katerina</creatorcontrib><creatorcontrib>Elborn, J Stuart</creatorcontrib><creatorcontrib>Feldman, Charles</creatorcontrib><creatorcontrib>Flume, Patrick</creatorcontrib><creatorcontrib>Goeminne, Pieter C</creatorcontrib><creatorcontrib>Loebinger, Michael R</creatorcontrib><creatorcontrib>Menendez, Rosario</creatorcontrib><creatorcontrib>Morgan, Lucy</creatorcontrib><creatorcontrib>Murris, Marlene</creatorcontrib><creatorcontrib>Polverino, Eva</creatorcontrib><creatorcontrib>Quittner, Alexandra</creatorcontrib><creatorcontrib>Ringshausen, Felix C</creatorcontrib><creatorcontrib>Tino, Gregory</creatorcontrib><creatorcontrib>Torres, Antoni</creatorcontrib><creatorcontrib>Vendrell, Montserrat</creatorcontrib><creatorcontrib>Welte, Tobias</creatorcontrib><creatorcontrib>Wilson, Rob</creatorcontrib><creatorcontrib>Wong, Conroy</creatorcontrib><creatorcontrib>O'Donnell, Anne</creatorcontrib><creatorcontrib>Aksamit, Timothy</creatorcontrib><creatorcontrib>EMBARC/BRR definitions working group</creatorcontrib><title>Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research</title><title>The European respiratory journal</title><addtitle>Eur Respir J</addtitle><description>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.</description><subject>Asia</subject><subject>Australia</subject><subject>Bronchiectasis</subject><subject>Bronchiectasis - diagnosis</subject><subject>Bronchiectasis - therapy</subject><subject>Chronic obstructive pulmonary disease</subject><subject>Clinical trials</subject><subject>Clinical Trials as Topic</subject><subject>Consensus</subject><subject>Cough</subject><subject>Cough - drug therapy</subject><subject>Delphi Technique</subject><subject>Disease Progression</subject><subject>Dyspnea</subject><subject>Europe</subject><subject>Fatigue</subject><subject>Humans</subject><subject>Lung - physiopathology</subject><subject>North America</subject><subject>Pulmonary Medicine</subject><subject>South Africa</subject><subject>Sputum</subject><subject>Working groups</subject><issn>0903-1936</issn><issn>1399-3003</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU1LxDAQhoMouq7-AkECXrxUM5k2bbzJ4hcIetBzSdOEjXQTTVrUf2_Wr4MnT2Fenncg8xByAOwEoMFTQCmRMTxhjFVQcAb1Bpmt02Idb5IZkwwLkCh2yG5KT4yBKBG2yQ5vKilKLmaku5-GVfAqvlPzprSJnRpd8NR5qvppGBN9deOSdjF4vXRGjyq5dEYV1cEn49OUaG-s8-6zZUOkesiTVgONJhkV9XKPbFk1JLP__c7J4-XFw-K6uL27ulmc3xa6BBgLENJaxAq5rrRhVkhhGl4Cis5WuuOlBex75FYL5LURdc9rxF5rZNLmBOfk-Gvvcwwvk0lju3JJm2FQ3oQptSBByorXvPkHypoSeb5rRo_-oE9hij5_JFMNSi5FwzKFX5SOIaVobPsc3SpftQXWrm21P7baT1vt2lZuHX7vnrqV6X87P3rwA4xMjw8</recordid><startdate>20170601</startdate><enddate>20170601</enddate><creator>Hill, Adam T</creator><creator>Haworth, Charles S</creator><creator>Aliberti, Stefano</creator><creator>Barker, Alan</creator><creator>Blasi, Francesco</creator><creator>Boersma, Wim</creator><creator>Chalmers, James D</creator><creator>De Soyza, Anthony</creator><creator>Dimakou, Katerina</creator><creator>Elborn, J Stuart</creator><creator>Feldman, Charles</creator><creator>Flume, Patrick</creator><creator>Goeminne, Pieter C</creator><creator>Loebinger, Michael R</creator><creator>Menendez, Rosario</creator><creator>Morgan, Lucy</creator><creator>Murris, Marlene</creator><creator>Polverino, Eva</creator><creator>Quittner, Alexandra</creator><creator>Ringshausen, Felix C</creator><creator>Tino, Gregory</creator><creator>Torres, Antoni</creator><creator>Vendrell, Montserrat</creator><creator>Welte, Tobias</creator><creator>Wilson, Rob</creator><creator>Wong, Conroy</creator><creator>O'Donnell, Anne</creator><creator>Aksamit, Timothy</creator><general>European Respiratory Society Journals Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0090-4531</orcidid></search><sort><creationdate>20170601</creationdate><title>Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research</title><author>Hill, Adam T ; Haworth, Charles S ; Aliberti, Stefano ; Barker, Alan ; Blasi, Francesco ; Boersma, Wim ; Chalmers, James D ; De Soyza, Anthony ; Dimakou, Katerina ; Elborn, J Stuart ; Feldman, Charles ; Flume, Patrick ; Goeminne, Pieter C ; Loebinger, Michael R ; Menendez, Rosario ; Morgan, Lucy ; Murris, Marlene ; Polverino, Eva ; Quittner, Alexandra ; Ringshausen, Felix C ; Tino, Gregory ; Torres, Antoni ; Vendrell, Montserrat ; Welte, Tobias ; Wilson, Rob ; Wong, Conroy ; O'Donnell, Anne ; Aksamit, Timothy</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c411t-169ff33532c5ce0f696e824136bf5cb24f13dd32fc6327e67d2733dcc309f3273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Asia</topic><topic>Australia</topic><topic>Bronchiectasis</topic><topic>Bronchiectasis - diagnosis</topic><topic>Bronchiectasis - therapy</topic><topic>Chronic obstructive pulmonary disease</topic><topic>Clinical trials</topic><topic>Clinical Trials as Topic</topic><topic>Consensus</topic><topic>Cough</topic><topic>Cough - drug therapy</topic><topic>Delphi Technique</topic><topic>Disease Progression</topic><topic>Dyspnea</topic><topic>Europe</topic><topic>Fatigue</topic><topic>Humans</topic><topic>Lung - physiopathology</topic><topic>North America</topic><topic>Pulmonary Medicine</topic><topic>South Africa</topic><topic>Sputum</topic><topic>Working groups</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hill, Adam T</creatorcontrib><creatorcontrib>Haworth, Charles S</creatorcontrib><creatorcontrib>Aliberti, Stefano</creatorcontrib><creatorcontrib>Barker, Alan</creatorcontrib><creatorcontrib>Blasi, Francesco</creatorcontrib><creatorcontrib>Boersma, Wim</creatorcontrib><creatorcontrib>Chalmers, James D</creatorcontrib><creatorcontrib>De Soyza, Anthony</creatorcontrib><creatorcontrib>Dimakou, Katerina</creatorcontrib><creatorcontrib>Elborn, J Stuart</creatorcontrib><creatorcontrib>Feldman, Charles</creatorcontrib><creatorcontrib>Flume, Patrick</creatorcontrib><creatorcontrib>Goeminne, Pieter C</creatorcontrib><creatorcontrib>Loebinger, Michael R</creatorcontrib><creatorcontrib>Menendez, Rosario</creatorcontrib><creatorcontrib>Morgan, Lucy</creatorcontrib><creatorcontrib>Murris, Marlene</creatorcontrib><creatorcontrib>Polverino, Eva</creatorcontrib><creatorcontrib>Quittner, Alexandra</creatorcontrib><creatorcontrib>Ringshausen, Felix C</creatorcontrib><creatorcontrib>Tino, Gregory</creatorcontrib><creatorcontrib>Torres, Antoni</creatorcontrib><creatorcontrib>Vendrell, Montserrat</creatorcontrib><creatorcontrib>Welte, Tobias</creatorcontrib><creatorcontrib>Wilson, Rob</creatorcontrib><creatorcontrib>Wong, Conroy</creatorcontrib><creatorcontrib>O'Donnell, Anne</creatorcontrib><creatorcontrib>Aksamit, Timothy</creatorcontrib><creatorcontrib>EMBARC/BRR definitions working group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>The European respiratory journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hill, Adam T</au><au>Haworth, Charles S</au><au>Aliberti, Stefano</au><au>Barker, Alan</au><au>Blasi, Francesco</au><au>Boersma, Wim</au><au>Chalmers, James D</au><au>De Soyza, Anthony</au><au>Dimakou, Katerina</au><au>Elborn, J Stuart</au><au>Feldman, Charles</au><au>Flume, Patrick</au><au>Goeminne, Pieter C</au><au>Loebinger, Michael R</au><au>Menendez, Rosario</au><au>Morgan, Lucy</au><au>Murris, Marlene</au><au>Polverino, Eva</au><au>Quittner, Alexandra</au><au>Ringshausen, Felix C</au><au>Tino, Gregory</au><au>Torres, Antoni</au><au>Vendrell, Montserrat</au><au>Welte, Tobias</au><au>Wilson, Rob</au><au>Wong, Conroy</au><au>O'Donnell, Anne</au><au>Aksamit, Timothy</au><aucorp>EMBARC/BRR definitions working group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research</atitle><jtitle>The European respiratory journal</jtitle><addtitle>Eur Respir J</addtitle><date>2017-06-01</date><risdate>2017</risdate><volume>49</volume><issue>6</issue><spage>1700051</spage><epage>1700051</epage><pages>1700051-1700051</pages><issn>0903-1936</issn><eissn>1399-3003</eissn><abstract>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. 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subjects | Asia Australia Bronchiectasis Bronchiectasis - diagnosis Bronchiectasis - therapy Chronic obstructive pulmonary disease Clinical trials Clinical Trials as Topic Consensus Cough Cough - drug therapy Delphi Technique Disease Progression Dyspnea Europe Fatigue Humans Lung - physiopathology North America Pulmonary Medicine South Africa Sputum Working groups |
title | Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research |
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