Technical and Functional Assessment of 10 Office Spirometers: Results

Technical and Functional Assessment of 10 Office Spirometers: ResultsA total of 399 different subjects (age range, 25 to 87 years; mean ± SD, 61.2 ± 14.6 years; 128 women) were studied in the three centers. The distribution of the 300 COPD patients according to the GOLD classification was as follows: stage 1, 10.3%; stage 2, 20.4%; stage 3, 59.0%; and stage 4, 6.3%. The nine ETs (three women) all had normal spirometric data (FVC, 4.68 ± 1.04 L; FEV1, 3.80 ± 0.90 L). paxil 40 mg
Table 2 presents the precision of the standard diagnostic spirometers and each model of office spirometer. The precision was measured in ETs from the three centers (n = 9). The precision of FEV1 was comparable between the standard and office spirometers, except for one device (Simplicity; Puritan Bennett; Pleasanton, CA), in which the limits of precision were > 200 mL. Three models—OneFlow (Clement Clarke International; Harlow, Essex, UK), EasyOne (NDD; Zurich, Switzerland), and Simplicity—showed precision limits > 200 mL for FVC.
Tables 3, 4 show the bias and the limits of agreement of each office spirometer for FVC, FEV1, and FEV1/FVC (n = 48). One spirometer presented a significant bias for FVC, four spirometers presented a significant bias for FEV1, and five spirometers presented a significant bias for FEV1/FVC. The biases remained within acceptable limits for FVC and FEV1 (< 100 mL). The limits of agreement were different between the office spirometers according to the variable studied. Only three devices had acceptable limits of agreement for FVC (MicroLoop; Micro Medical; Chatham, Kent, UK; Pneu-motrac; Vitalograph; Maids Moreton, Buckingham, UK; and Spiropro; SensorMedics; Yorba Linda, CA), and four devices had acceptable limits of agreement for FEV1 (Datospir models 70 and 120, MicroLoop, and Pneumotrac). The Bland and Altman graphs of FVC, FEV1, and FEV1/FVC are submitted as on-line supplementary material.

Table 2—The 95% Limits of Precision (1.96 X Sw) Obtained in Nine ETs With the Office and Standard Spirometers

Devices FVC FEV1
Standard 0.15 0.14
Datospir 120 0.18 0.14
Datospir 70 0.15 0.12
EasyOne 0.25 0.19
Microloop 0.18 0.18
OneFlow 0.43 0.15
Pneumotrac 0.18 0.13
Simplicity 0.34 0.29
Spirobank 0.15 0.15
SpiroPro 0.17 0.16
SpiroStar 0.19 0.17

Table 3—Parameters From the Bland and Altman Analysis of the Office Spirometers

Variables Bias (95%CI), L Limits of Agreement r p Value
FVC
Datospir 120 – 0.06 (-0.13 to 0.01) – 0.52 to 0.40 – 0.19 NS
Datospir 70 – 0.07 (- 0.16 to 0.02) – 0.67 to 0.53 0.05 NS
EasyOne 0.07 (0.00 to 0.15) – 0.43 to 0.57 – 0.15 NS
Microloop – 0.03 (- 0.09 to 0.04) – 0.47 to 0.42 0.08 NS
OneFlow 0.03 (- 0.12 to 0.19) – 1.00 to 1.07 – 0.21 NS
Pneumotrac – 0.03 (- 0.09 to 0.04) – 0.46 to 0.40 0.36 < 0.05
Simplicity 0.03 (- 0.06 to 0.11) – 0.57 to 0.62 – 0.24 NS
Spirobank – 0.04 (- 0.12 to 0.04) – 0.56 to 0.49 – 0.12 NS
SpiroPro – 0.06 (- 0.12 to 0.00) – 0.47 to 0.35 0.06 NS
SpiroStar 0.10 (0.02 to 0.19)* – 0.49 to 0.70 – 0.27 NS
FEV1
Datospir 120 0.00 (- 0.04 to 0.05) – 0.29 to 0.30 – 0.06 NS
Datospir 70 0.02 (- 0.02 to 0.05) – 0.24 to 0.27 0.07 NS
EasyOne 0.08 (0.04 to 0.13)t – 0.21 to 0.38 – 0.40 < 0.01
Microloop 0.06 (0.02 to 0.09)t – 0.16 to 0.28 – 0.09 NS
OneFlow 0.07(0.01 to 0.14)t – 0.37 to 0.52 – 0.21 NS
Pneumotrac 0.08 (0.05 to 0.12)t – 0.13 to 0.30 0.35 < 0.05
Simplicity 0.00 (- 0.09 to 0.08) – 0.55 to 0.55 – 0.38 < 0.01
Spirobank – 0.06 (- 0.11 to 0.00) – 0.45 to 0.33 – 0.07 NS
SpiroPro – 0.03 (- 0.08 to 0.02) – 0.37 to 0.31 – 0.31 < 0.05
SpiroStar – 0.08 (- 0.16 to 0.00) – 0.63 to 0.47 – 0.10 NS

Table 4—Parameters From the Bland and Altman Analysis of the Office Spirometers for FEVj/FVC

Variables Bias (95%CI), % Limits of Agreement r p Value
Datospir 120 0.1 (0.2 to 1.8)t – 4.3 to 6.3 – 0.01 NS
Datospir 70 1.1 (0.0 to 2.3) – 6.7 to 9.0 – 0.51 < 0.001
EasyOne 1.8 (0.6 to 3.0)t – 6.4 to 10.0 – 0.26 NS
Microloop 2.3 (1.3 to 3.2)t – 4.3 to 8.8 – 0.25 NS
OneFlow 2.0 (- 0.7 to 4.8) – 16.2 to 20.3 – 0.07 NS
Pneumotrac 2.8 (1.8 to 3.7)t – 3.8 to 9.4 – 0.24 NS
Simplicity 0.5 (- 1.1 to 2.0) – 9.9 to 10.8 – 0.22 NS
Spirobank – 0.9 (- 2.2 to 0.5) – 9.7 to 7.9 0.10 NS
SpiroPro 0.4 (- 0.5 to 1.4) – 5.9 to 6.7 – 0.43 < 0.01
SpiroStar – 4.9 (- 6.1 to – 3.6)t – 13.1 to 3.4 0.08 NS
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