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Accuracy and reliability of personal home spirometers: a multicentre laboratory quality-control study in children and
Jamie McBride1, Michael Doumit2, Jody Bell3
1Sydney Children's Hospital, Department of Respiratory Medicine, Randwick, Australia; School of Women's and Children's Health, University of NSW, Sydney, Australia.
Background:
Personal home spirometry enables remote monitoring of chronic lung disease, however, evidence regarding the agreement with laboratory spirometers, device performance over extended use and quality control remains limited. This study evaluated supervised personal home spirometry in children and adults by assessing agreement with laboratory spirometry and device accuracy during extended use.
Methods:
Multi-centre prospective study (April 2023-May 2025) including patients with a chronic lung disease who owned a personal home spirometer. They were assessed on both personal home spirometer via virtual telehealth and in-lab face to face conventional laboratory spirometer under respiratory scientist supervision in random order. Concordance was assessed using Pearson correlation, Bland-Altman plots, and regression. Verification of device accuracy was conducted using a certified 3L calibration syringe. Patient-reported usability and perceived accuracy were recorded.
Results:
158 participants (age 6-66 years) with a chronic respiratory condition were included in this study. Correlations were very strong between personal home spirometers and conventional laboratory spirometers for FEV1 and FVC (Pearson's r = 0.99, p < 0.001). Bland-Altman analysis showed small mean biases but wide limits of agreement (LoA), exceeding ATS/ERS repeatability criteria (>150 mL) in 35% of cases. Initial verification testing identified inaccuracies in 73% of Spirohome devices due to adaptor design; after modification, ≥96% met ATS/ERS accuracy standards. Participant satisfaction was high, with 89% perceiving accuracy and 99% reporting ease of use.
Conclusions:
Supervised personal home spirometry correlates well with laboratory spirometry in children and adults with chronic lung disease but is not interchangeable due to the wide limits of agreement. Regular verification checks are recommended to ensure accuracy and reliability.
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