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

Abstract

BackgroundCOPD-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.MethodsConsecutive 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.ResultsCOPD 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).ConclusionsOur 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 registrationClinicalTrials.gov Identifier NCT01550679 Registered 28 September 2014, retrospectively registered

A COPD Case-Finding Program in a Large Cohort of HIV-Infected Persons

“…Our results are therefore comparable to other studies conducted in HIV-infected individuals. These tests performed more poorly in our research compared to previous studies conducted in the general population 11,22 ; as a consequence the most appropriate screening tool in HIV-infected subjects remains unclear. Age, education, socioeconomic status, and comorbidities could be confounding factors, altering screening performance.…”

“…These findings are in line with others in the literature, confirming the high rate of under-diagnosed COPD and other obstructive lung diseases both in the general population and in HIV-infected individuals. 9,10,[17][18][19] Portable spirometry and formal laboratory-based spirometry have demonstrated an acceptable correlation in subjects with 20 and without 21,22 obstructive lung disease.…”

Public Spirometry Campaign in Chronic Obstructive Pulmonary Disease Screening–Hope or Hype?

“…Different patient characteristics and different model of screening can be responsible for significant variability in the response rate found in public campaigns and in screening programs conducted in health care centers. For example, approximately 70% of potentially eligible participants were recruited by general practitioners in one recent Croatian study aimed at the evaluation of the diagnostic accuracy of active screening for COPD [14], while the respective percentage in our public project conducted by medical students was much lower and did not exceed 20%. Acceptable response rates vary depending on the method of recruitment applied.…”

“…Portable spirometers can be conveniently used during screening programs and spirometry testing do not necessarily need to be performed indoors [22]. The results of previous studies pointed out that active case finding in a population at risk for COPD should be instituted, even using a pocket screening spirometer/peak flowmeter [14,23]. High correlations between the results of pulmonary function measured with Spirobank hand-held spirometer and Jaeger MasterScope in a laboratory environment were demonstrated [24].…”

Early detection of COPD patients in GOLD 0 population: an observational non-interventional cohort study - MARKO study

“…Numerous studies have been focused on testing simple screening tools (questionnaires and/or simplified flow measurement devices) for already developed COPD, in order to surpass the limitations of spirometry obtaining a specificity of up to 84.4%, with inadequate blinding between an index test and spirometry being a major source of bias in these studies [ 26 ]. We have managed to surpass this major bias using the subsample from Phase I of the MARKO study and showing that lung function testing with COPD-6™ can substitute spirometry testing in cases where it is not readily available to the patient/physician, but bearing in mind that the traditional cutoff value of <0.7 for FEV 1 /FEV 6 ratio, cannot be the only criterion for COPD diagnosis and/or further referral [ 27 ]. Early diagnosis and early intervention (based on data from pathophysiological studies) is highly advocated and studies already starting chronic bronchodilator treatment in early stages of COPD (in GOLD stages 1 and 2) have been initiated [ 7 , 28 – 30 ].…”