Pulmonary exacerbations in patients with primary ciliary dyskinesia: an expert consensus definition for use in clinical trials
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Published version
Author(s)
Type
Journal Article
Abstract
Pulmonary exacerbations are a cause of significant morbidity in patients with primary ciliary dyskinesia (PCD) and are frequently used as an outcome measure in clinical research into chronic lung diseases. So far, there has been no consensus on the definition of pulmonary exacerbations in PCD. 30 multidisciplinary experts and patients developed a consensus definition for children and adults with PCD. Following a systematic review, the panel used a modified Delphi process with a combination of face-to-face meetings and e-surveys to develop a definition that can be used in research settings for children and adults with PCD. A pulmonary exacerbation was defined by the presence of three or more of the following seven items: 1) increased cough, 2) change in sputum volume and/or colour, 3) increased shortness of breath perceived by the patient or parent, 4) decision to start or change antibiotic treatment because of perceived pulmonary symptoms, 5) malaise, tiredness, fatigue or lethargy, 6) new or increased haemoptysis, and 7) temperature >38°C. The consensus panel proposed that the definition should be used for future clinical trials. The definition should be validated and the usability assessed during these studies.
Date Issued
2019-02-01
Date Acceptance
2018-12-05
Citation
ERJ Open Research, 2019, 5 (1)
ISSN
2312-0541
Publisher
European Respiratory Society
Journal / Book Title
ERJ Open Research
Volume
5
Issue
1
Copyright Statement
©ERS 2019. This article is open access and distributed under the terms of the Creative Commons AttributionNon-Commercial Licence 4.0 (https://creativecommons.org/licenses/by-nc/4.0/)
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/30723730
PII: 00147-2018
Publication Status
Published
Coverage Spatial
England