Technical and Functional Assessment of 10 Office Spirometers: Recommendation

We did not compare the quality and the cost of the mouthpieces, nor the facility of disinfecting the parts in contact with the exhaled air. We do not have any information on the long-term solidity of the devices, nor on their resistance to shocks during transportation, and to changes in humidity and temperature. We did not make any price/quality assessment. Last but not least, we have no feedback about the aftersales service of the different spirometer representatives. This could be of major importance in real-world circumstances.
Other limitations of the study should also be considered. Of course, all the office spirometers available on the market could not be tested during this study. However, we included office spirometers coming from Europe and the United States, showing different technical characteristics, and our sample was sufficiently diversified. It is noticeable that some of these devices (both hardware and software) are frequently upgraded or changed, so that the same brands sold now may differ from the devices tested. The devices tested were those available in Belgium in 2002. comments
Another issue is our assumption that standard diagnostic spirometers are accurate and precise. Indeed, if one standard diagnostic spirometer presents a proportional error, it will make the office spirometer look like it has a proportional error, even if this latter is accurate. In a multicentric study like the present one, the risk that all the reference spirometers are inaccurate is relatively low. Moreover, the office spirometers were compared to two types of laboratory spirometers: volumetric and hot wire. If only one reference spirometer presented a proportional error, the relation between the average and the difference of FEV1 would not be significant. The clinically acceptable limits for the bias, the precision, and the limits of agreement of FEV1 and FVC were fixed by analogy with the quality criteria of the ATS for diagnostic spirometers and with the coefficients of repeatability observed in COPD patients, because these limits are not available in the literature.

This entry was posted in Spirometers and tagged comparative study, COPD detection, pulmonary function tests, spirometer, spirometry.