Accuracy and Precision of Desktop Spirometers in General Practices
Accuracy and Precision of Desktop Spirometers in General Practices
directly from the manufacturers. Investigating such ‘off- air pressure 1,016 mb (SD 11.9), range 989–1,054 mb; humidity
the-shelf’ equipment may give a biased view on the per- 50.3% (SD 8.9), range 33–64%]. The waveform generator system
formance of devices that have routinely been used in was maintained in accordance with the manufacturers’ operat-
ing manual. The 8 waveforms were selected from the full set of
general practices for a period of time, especially while 24 ATS waveforms because together they represent a wide range
maintenance and calibration of spirometers in general of FEV1 and FVC values. A selection of the complete set of 24
practices is often well below laboratory standards [5, 11, waveforms has previously been used to evaluate lung function
12]. Lack of maintenance and calibration and wear of the equipment [29].
equipment over time are likely to negatively impact the Each waveform was applied 3 consecutive times to each spi-
rometer. Spirometer performance was expressed in terms of ac-
level of spirometer performance [14], which may have curacy and precision. To determine accuracy, we calculated the
consequences for the interpretations that are based on the mean of the 3 readings for the FEV1, FVC and forced mid-expi-
results of a spirometry test and the subsequent manage- ratory flow (FEF25–75) for each waveform, and compared these
ment of patients. with the gold standard reference values for these indices pro-
Several previous studies have looked at performance duced by the waveform generator. For FEV1 and FVC, we consid-
ered a spirometer to be inaccurate for a particular waveform in
markers of particular spirometry devices when used in case of a 6100 ml or 63.5% deviation (either positive or nega-
research or secondary care settings [15–27], but as far as tive) from the waveform generator reference value [28]. For
we are aware there are no published reports on the per- FEF25–75, we considered a 6250 ml/s or 65.5% deviation as inac-
formance of spirometers that are being used in general curate [28]. Precision of the spirometers was determined by cal-
practices as part of routine patient care. In this study, we culating the difference between the highest and the lowest of the
3 FEV1, FVC and FEF25–75 readings for each of the 8 waveforms.
evaluated a random sample of spirometers from Dutch In order to determine whether or not a spirometer was imprecise
general practices with regard to their accuracy and preci- for a particular waveform, the same cutoff points as for accuracy
sion. We applied recommendations from the American were used [28].
Thoracic Society (ATS) [28] to determine spirometer per-
formance. Analysis
We used SPSS (Statistical Package for Social Sciences), version
17.0, for all analyses (volumes and flows are expressed in ml and
ml/s, respectively). Mean values and 95% confidence intervals (CI)
were calculated for accuracy and precision estimates for the 8 sep-
Materials and Methods arate waveforms as well as for all waveforms combined. After cal-
culating accuracy and precision estimates for FEV1, FVC and
Study Design FEF25–75 for each of the spirometers tested, we plotted the differ-
We first took a random sample of 700 general practices from ences between the respective waveform generator reference values
all 4,533 practices registered in the national database of the Neth- and the spirometer readings against the mean of these values in
erlands Institute for Health Services Research (www.nivel.nl) in Bland-Altman plots [30]. The upper and lower limits of agreement
Accuracy = Mean of the 3 spirometer readings for the FEV1 and FVC with the gold standard reference values for these indices as
produced by the waveform generator; precision = difference between the highest and the lowest of the 3 FEV1 and FVC readings for
the applied waveform.
around the mean difference were set on 8100 ml for FEV1 and spirometry [5]. In total, 154 practices (62%) reported
FVC, and 8250 ml for FEF25–75, respectively [28]. Based on the age owning 61 spirometers. Of these 154 practices, 63 (41%)
distribution in the sample, we divided the subset of turbine spi- agreed to submit their spirometer for testing and to com-
rometers (the predominant type of sensor in our sample as well as
in Dutch general practices nationally [5]) into three categories: plete the questionnaire about its details and use. Eventu-
1–2; 3–5, and 66 years old. We used analysis of variance (ANOVA) ally 50 (32%) spirometers were submitted for testing on
to analyze associations between spirometer type and age and FEV1 the waveform generator. The main reasons for practices
and FVC accuracy and precision estimates. To correct for multiple not to submit their spirometer after all were that they
comparisons in these analyses, statistical significance was defined ‘could not miss their spirometer’ (35%) or ‘were too busy
as p ! 0.0031 (Bonferroni correction: ␣ = 0.05/2⫻8 waveforms).
to arrange shipment of the spirometer to the testing site’
(21%).
One spirometer was sent to the testing site but could
Results not be tested because the software necessary to operate
the spirometer was not available. Fourteen of the tested
Spirometers in the Study spirometers could not measure FEF25–75. Of the 49 spi-
Of the random sample of 300 general practices, 269 rometers tested, 38 (78%) had been manufactured by Mi-
(90%) practices could be contacted by telephone and 250 croMedical (now known as CareFusion), 6 (12%) by Vi-
(83%) were willing to provide information about their talograph, 3 (6%) by Clement Clarke International, and 1
Crockett /Poels
Table 2. Summary of accuracy (a) and precision (b) performance oldest 18 years. Mean and median age for the subset of
criteria for FEV1 and FVC for the sample of 49 spirometers from turbine spirometers were 3.7 (SD 2.9) and 3.0 (interquar-
general practices
tile range: 4.0) years, respectively, with a minimum age of
a Accuracy 4 months and a maximum age of 12 years.
Online supplementary appendix 1 provides further
Number of waveforms Number of waveforms not meeting accuracy
not meeting accuracy1 criteria1 for FVC details for each of the tested spirometers in the sample
criteria for FEV1 (for all online supplementary material, see www.
0 1 2 3 4 5 6 7 8
karger.com/doi/10.1159/000334320).
0 21 10 4 1 1 1
1 1 1 Accuracy and Precision of the Spirometers
2 1 The total average deviation from the waveform gen-
3 erator reference values for the 8 applied waveforms (i.e.
4 1 accuracy) was 25 ml (95% CI 12–39 ml) for FEV1, 27 ml
5 1 (10–45 ml) for FVC, and –24 ml/s (–48 to 1 ml/s) for
6 1 FEF25–75, respectively. For precision, the respective mean
7 1 1 ranges were 14 (11–17) and 35 (24–47) ml and 45 (23–67)
8 1 1 1 ml/s. Table 1 shows the accuracy and precision results per
waveform (in ml as well as in %).
b Precision Figure 1 shows the difference against mean (Bland-
Altman) plots for FEV1 and FVC accuracy in milliliter by
Number of waveforms Number of waveforms not meeting precision
not meeting precision1 criteria1 for FVC
type of spirometer. The plot for FEV1 (fig. 1a) shows non-
criteria for FEV1 0 1 2 3 4 5 6 7 8
linearity of accuracy: the deviations between the genera-
tor reference values and the spirometer readings became
0 38 4 2 1 1 larger as the FEV1 value of the waveform increased. The
1 2 1 vast majority of the out-of-range FEV1 readings were at-
2 tributable to 5 of the 8 pneumotachographs in the sample
3 (for the deviations above the upper limit of agreement)
4 and to the single volume displacement spirometer (for the
5 deviations below the lower limit). Non-linearity was also
6 observed for the deviations in FVC readings (fig. 1b), with
7 deviations up to +590 and –490 ml. The deviations above
8 the upper limit of agreement were attributable to 19 tur-
bine spirometers, 7 pneumotachographs, and the volume
Numbers in the cells indicate numbers of spirometers.
1 ≥100 ml or ≥3.5% deviation (either positive or negative) from displacement spirometer. Online supplementary figure
the waveform generator reference value. 1c shows the Bland-Altman plot for FEF25–75 accuracy for
the subset of 35 spirometers that could measure this in-
dex.
With regard to accuracy, ANOVA testing showed that
FEV1 deviations were statistically significantly larger in
(2%) by Mijnhardt. Information about the brand and type the pneumotachographs than in the turbine spirometers
of the sensor was missing for 1 spirometer. Thirty-nine for all waveforms; FVC deviations did not differ between
spirometers (80% of all) had turbine flow sensors, 8 (16%) the two types of spirometers for any of the waveforms.
were pneumotachographs, and 1 (2%) was a volume dis- With regard to precision, the ranges in FEV1 readings
placement spirometer. Six spirometers (12%) had been re- were statistically significantly larger in the pneumo-
paired after having been purchased by the practice, and tachographs than in the turbine spirometers for 5 wave-
1 practice reported that the transducer of their spirome- forms (Nos. 1, 4, 11, 17, and 19). For the ranges in FVC
ter had once been replaced. readings, this was true for 3 waveforms (Nos. 1, 4, and 19).
Mean and median age for the total sample of spirom- Table 2 provides a summary of the combined accu-
eters were 4.3 (SD 3.7) and 3 (interquartile range: 4.5) racy and precision performance criteria for FEV1 and
years. The ‘youngest’ spirometer was 4 months old, the FVC for the total spirometer sample. With regard to ac-
300
Mean deviation
0
–200
–300
Turbine (n = 39)
Pneumotachograph (n = 8)
–400 Volume displacement (n = 1
WF 24 WF 11 WF 21 WF 15
600 WF 17 WF 1
WF 4 WF 19
500
400
FVC spirometer – FVC WF generator (ml)
300
200
100
–100
–200
–300
–400
Fig. 1. Difference against mean plots for –500 Turbine (n = 39)
accuracy of FEV1 (a) and FVC (b) for all 49 Pneumotachograph (n = 8)
–600 Volume displacement (n = 1)
spirometers in the study sample. Each
symbol represents the result for 1 of the 8
1,000 2,000 3,000 4,000 5,000 6,000 7,000
applied waveforms (WF) (mean of 3 read-
b Mean of FVC spirometer and FVC WF generator (ml)
ings for WF 1, 4, 11, 15, 17, 19, 21, and 24
[28]) for 1 spirometer.
curacy, 21 (42%) devices fulfilled the FEV1 and FVC per- es fulfilled the FEV1 and FVC performance criteria for
formance criteria for all 8 waveforms, 11 (22%) devices all 8 waveforms or failed to meet the criteria for only 1
failed to meet the criteria for only 1 waveform, and the waveform. If the precision performance criteria were not
remaining 17 (36%) devices failed to meet the criteria for met, this was mostly due to FVC values being imprecise
61 waveform. With regard to precision, 42 (86%) devic- (table 2b).
Crockett /Poels
Influence of Age on Turbine Spirometer Performance
Figure 2 shows the difference against mean plots for 1–2 years old (n = 14)
400
FEV1 and FVC accuracy by age category for the subset of 3–5 years old (n = 15)
turbine spirometers. Only 4 devices (all aged 12 years) 300
≥6 years old (n = 8)
Discussion
gard to accuracy, for FEV1 as well as FVC the overall av- 100
erage deviation from the waveform generator reference 0
values was approximately +25 ml. With regard to preci- –100
sion, the average difference between the highest and the
–200
lowest of the three readings was 14 ml for FEV1 and 35 ml
for FVC. The single (18-year-old) volume displacement –300
Crockett /Poels
likely at higher values for these indices. In general, accu- Acknowledgments
racy seemed to be more of an issue than precision was.
This study was sponsored by the Radboud University Nijme-
The vast majority of the sample consisted of turbine spi- gen Medical Centre. The authors appreciate the work put in the
rometers, but lack of accuracy was mainly attributable to project by Jorn de Vreede, who conscientiously tested the spirom-
the small number of pneumotachographs, especially with eters on the waveform generator. We also appreciate the time and
regard to FEV1. The subset of turbine spirometers showed effort it took the general practice staffs to submit their spirome-
a wide age range, from only a few months up to 12 years, ters for testing.
but we did not observe an association between the age of
the devices and their actual performance, despite the lim-
ited attention towards calibration and maintenance in Disclosure Statement
many of the practices that owned them. General prac-
None of authors has any conflict of interest to declare.
tices should pay more attention to the calibration of their
spirometer, either by using a calibration syringe or a bio-
logical control. When obtaining a spirometer, they should
take the robustness of the different types of sensors and
the frequency of maintenance and calibration they re-
quire into consideration.
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