Reproducibility and Validity of a Handheld Spirometer

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Abstract:

BACKGROUND: Handheld spirometers have several advantages over desktop spirometers, but worries persist regarding reproducibility and validity of data from handheld spirometers. We undertook an independent examination of the EasyOne handheld spirometer. METHODS: The laboratory testing included reproducibility and validity testing with a waveform generator. We used standard American Thoracic Society waveforms for in-line testing, calibration adaptor testing, and testing during compression of the mouthpiece. The clinical testing involved repeated tests with 24 spirometry-naïve volunteers and comparison to spirometry results from laboratory (volume-sensing dry rolling seal) spirometer. RESULTS: The EasyOne exceeded standard thresholds for acceptability with the American Thoracic Society waveforms. In-line testing yielded valid results from the EasyOne. Between the EasyOne and the reference spirometer readings the mean ± SD difference was 0.03 ± 0.23 L for forced vital capacity (FVC) and −0.06 ± 0.09 L for forced expiratory volume in the first second (FEV1). The calibration adaptor showed no appreciable problems. Extreme compression of the mouthpiece reduced the measured values. In clinical testing the coefficients of variation and limits of agreement were, respectively, 3.3% and 0.24 L for FVC, 2.6% and 0.18 L for FEV1, and 1.9% and 0.05 for the FEV1/FVC ratio. The EasyOne readings were lower than those from the reference spirometer; the differences were: −0.12 L for FVC, −0.17 L for FEV1, and −0.02 for FEV1/FVC. The limits of agreement were within criteria for FVC but not for the FEV1, possibly due to a training effect. CONCLUSION: The EasyOne spirometer yielded generally reproducible results that were generally valid, compared to the values from the laboratory spirometer. The use of the EasyOne in clinical, occupational, and research settings seems justified.

Keywords: FEV1; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; FVC; SPIROMETER; SPIROMETRY

Document Type: Research Article

Affiliations: 1: Department of Medicine, Columbia University Medical Center, New York, New York; Department of Epidemiology, Columbia University Medical Center, New York, New York 2: National Institute for Occupational Safety and Health, Atlanta, Georgia; National Institute of Allergy and Infectious Diseases, Bethesda, Maryland 3: Department of Medicine, Columbia University Medical Center, New York, New York 4: National Institute for Occupational Safety and Health, Atlanta, Georgia 5: School of Public Health, Harvard University, Cambridge, Massachusetts

Publication date: April 1, 2008

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