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Published on: April 8, 2022
Assessment of a low-cost home monitoring spirometer for children
Yvonne Bastian-Lee1, Richard Chavasse, Hazel Richter
1Rockinghorse Research Centre, Royal Alexandra Hospital for Sick Children, Brighton, UK. rah@mistral.co.uk
Insights
This study validated the VM Plus spirometer for home use in children with respiratory conditions. While accurate and reproducible for lung function, its peak expiratory flow readings are higher than standard devices.
Area of Science:
- Respiratory Medicine
- Medical Device Validation
- Pediatric Pulmonology
Background:
- Home-based spirometry devices offer potential for monitoring lung function.
- Validation in target patient populations is crucial before clinical adoption.
- Existing devices require assessment for accuracy and reproducibility.
Purpose of the Study:
- To validate the VM Plus, a low-cost portable spirometer, against a laboratory standard (Jaeger spirometer).
- To assess the VM Plus's accuracy and reproducibility for peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV(1)) in children.
- To determine the suitability of the VM Plus for home monitoring in pediatric respiratory diseases.
Main Methods:
- Seventy children with stable asthma or cystic fibrosis performed spirometry using both VM Plus and Jaeger spirometers.
- Measurements were compared using separate and series methods.
- Reproducibility of VM Plus measurements was evaluated.
Main Results:
- Close correlations were observed between VM Plus and Jaeger spirometer measurements (R values up to 0.99).
- VM Plus showed substantially higher peak expiratory flow readings compared to the Jaeger spirometer.
- VM Plus measurements demonstrated acceptable reproducibility for both PEF and FEV(1).
Conclusions:
- The VM Plus spirometer provides reasonably accurate and reproducible lung function measurements (PEF and FEV(1)) in children.
- An intrinsic bias, particularly in PEF, exists and must be considered when using the VM Plus.
- The VM Plus holds potential for longitudinal lung function monitoring in pediatric respiratory patients at home.
Abstract:
Electronic devices are now available to measure and store lung function parameters in the home. Before adopting a device for clinical or research use, it is important to validate it in the target patient group. The aim of this study was to assess a low-cost, portable, logging spirometer, the VM Plus (VM), against a standard laboratory Jaeger spirometer (JS) for use in children with respiratory disease. Seventy children with stable asthma or cystic fibrosis performed spirometry on the two devices, and results for peak expiratory flow (PEF) and forced expiratory volume in 1 sec (FEV(1)) were compared. Comparison was made both using the two devices separately (separate method) and with the devices connected in series (series method). Reproducibility of the VM measurements was also assessed. Correlation between measurements was close (R values: separate, PEF, 0.91; FEV(1), 0.94; series, PEF, 0.97, FEV(1), 0.99), but PEF readings on the VM Plus were substantially higher than with the JS (mean difference: separate, 54.8 L/min; series, 28.2 L/min). This reflects well-reported differences in PEF measurements between the Mini-Wright PEF meter, on which the VM Plus spirometer is based, and conventional spirometers. Limits of agreement (series method) were: PEF, -13.2 to +69.6 L/min; FEV(1), -0.03 to +0.19 L. Reproducibility of VM Plus measurements was acceptable: coefficient of variation for PEF was 4%; for FEV(1), 4.3%; coefficient of reproducibility for PEF, 39 L/min; for FEV(1), 0.26 L. The VM Plus provides reasonably accurate, reproducible measurements of PEF and FEV(1), but intrinsic bias, particularly in PEF measurement, needs to be taken into account. Its potential to document longitudinal changes in lung function in children with respiratory disease at home merits further study.
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