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BMC Primary Care
Published in: BMC Primary Care 1/2016

Open Access 01-12-2016 | Research article

Diagnostic accuracy of a pocket screening spirometer in diagnosing chronic obstructive pulmonary disease in general practice: a cross sectional validation study using tertiary care as a reference

Authors: Marina Labor, Žarko Vrbica, Ivan Gudelj, Slavica Labor, Davor Plavec

Published in: BMC Primary Care | Issue 1/2016

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Abstract

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/ex-smokers 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 readily available to the patient/physician taken into account that the traditional FEV1/FEV6 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
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Metadata
Title
Diagnostic accuracy of a pocket screening spirometer in diagnosing chronic obstructive pulmonary disease in general practice: a cross sectional validation study using tertiary care as a reference
Authors
Marina Labor
Žarko Vrbica
Ivan Gudelj
Slavica Labor
Davor Plavec
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2016
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/s12875-016-0518-8

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