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Publication year
2009Source
Chest, 136, 3, (2009), pp. 918-23ISSN
Publication type
Article / Letter to editor

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Organization
Health Evidence
Former Organization
Epidemiology, Biostatistics & HTA
Journal title
Chest
Volume
vol. 136
Issue
iss. 3
Page start
p. 918
Page end
p. 23
Subject
NCEBP 2: Evaluation of complex medical interventions; ONCOL 2: Age-related aspects of cancer; ONCOL 5: Aetiology, screening and detectionAbstract
Many definitions of COPD exacerbations are reported. The choice for a definition determines the number of exacerbations observed. However, the effect of different definitions on the effect sizes of randomized controlled trials is unclear. This article provides an overview of the large variation of definitions of COPD exacerbations from the literature. Furthermore, the effect of using different definitions on effect sizes (relative risk and hazard ratio) was investigated in a randomized controlled discontinuation trial of inhaled corticosteroids. The following definitions were applied: (1) unscheduled medical attention, (2) a course of oral corticosteroids/antibiotics, (3) deterioration in two major or one major and one minor symptom according to Anthonisen (referenced later), (4) a change in one or more symptoms, (5) a change in two or more symptoms, and (6) a combination of numbers 2 and 4. Relative risks for the exacerbation rate ranged from 1.19 to 1.49, and hazard ratios for time to first exacerbation ranged from 1.36 to 1.84 for the various definitions, varying from nonsignificant to significant. Because the definition of a COPD exacerbation has an impact on the effect size of interventions, there is an urgent need for concerted attempts to reach agreement on a definition of an exacerbation. Also, the exact definition to be used in a study should be specified in the protocol.
This item appears in the following Collection(s)
- Academic publications [227437]
- Electronic publications [107154]
- Faculty of Medical Sciences [86157]
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