چکیده (انگلیسی):

Background:COPD-6™is a lung function testing device for a rapid pre-spirometry testing to screen-out at-risk
individuals not having COPD and indicating those at risk. The aim of this study was to validate COPD-6™lung function
testing (index test) in general practice in discriminating patients with COPD out of the population at risk - smokers/exsmokers with no previous diagnosis of COPD, using measurements at tertiary care as reference standard.
Methods:Consecutive 227 subjects (115 women, 185 smokers/42 ex-smokers,≥20 pack-years) with no previous
diagnosis of COPD, aged 52.5 (SD 6.8) years from 26 general practitioners (GPs) were recruited, lung function tested
with COPD-6™, referred to the tertiary institution for repeated COPD-6™testing followed by spirometry with a
bronchodilator (salbutamol), examination, and pulmonologist consultation for the diagnosis and severity of COPD.
Results:COPD was diagnosed in 43 subjects (18.9 %), with an AUC of 0.827 (95 % CI 0.769-0.875,P< 0.001) for the
diagnosis of COPD when lung function was measured using COPD-6™in GP’s office with a specificity of 100 % (95 % CI,
97.95–100 %) but a very low sensitivity of 32.56 % (95 % CI, 20.49–47.48 %). Significant agreement for forced expiratory
volume in 1 s measured at GP’s office and at lung function lab was found (mean difference 0.01 L,p= 0.667) but not for
other measured parameters (p< 0.001 for all).
Conclusions:Our study results point out that active case finding in a population at risk for COPD should be instituted
(almost 20 % of undiagnosed COPD). Based on our results lung function testing with COPD-6™can substitute spirometry
testing in cases where it is not readilyavailable to the patient/physician taken into account that the traditional FEV1/FEV
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cutoff value of <0.7 is not the only criterion for diagnosis and/or further referral.
Trial registration:ClinicalTrials.gov Identifier NCT01550679 Registered 28 September 2014, retrospectively registered