Home Spirometry
DESCRIPTION
Home spirometry devices allow for the monitoring of pulmonary function in the home. Battery-operated spirometers permit regular daily measurement of pulmonary function, typically forced expiratory volume in 1 second (FEV-1) and forced vital capacity (FVC). Home spirometry may also be referred to as ambulatory spirometry.
The primary proposed use is to aid in the early diagnosis of infection and rejection in lung transplant recipients. These devices have also been suggested for use in monitoring pulmonary function in chronic obstructive pulmonary disease (COPD), Cystic Fibrosis and asthma.
POLICY
Home monitoring of pulmonary function is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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ADDITIONAL INFORMATION
There remains a lack of high-quality evidence to determine if home monitoring of pulmonary function results in improved health outcomes.
SOURCES
Anand, R., McLeese, R., Busby,J., Stewart, J., Clarke, M., Man, W. D-C., et al. (2023). Unsupervised home spirometry versus supervised clinic spirometry for respiratory disease: a systematic methodology review and meta-analysis. European Respiratory Review, 32 (169), 220248. Doi: 10.1183/16000617.0248-2022. (Level 1 evidence)
Finkelstein, S., Lindgren, B., Robiner, W., Lindquist, R., Hertz, M., Carlin, B., et al. (2013). A randomized controlled trial comparing health and quality of life of lung transplant recipients following nurse and computer-based triage utilizing home spirometry monitoring. Telemedicine and e-Health, 19 (12), 897-903. (Level 2 evidence)
International Society for Heart & Lung Transplantation, American Thoracic Society, European Respiratory Society. (2014). Clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Retrieved June 2, 2016 from http://erj.ersjournals.com.
Maher, T.M., Schiffman, C., Kreuter, M., Moor, C.C., Nathan, S.D., Axmann, J., et al. (2022). A review of the challenges, learnings and future directions of home handheld spirometry in interstitial lung disease. Respiratory Research, 23 (1), 307. (Level 4 evidence)
National Institute for Health and Care Excellence. (2017, November; last update search March 2021). Asthma: diagnosis monitoring and chronic asthma management. Retrieved November 9, 2023 from https://www.nice.org.uk/guidance.
National Institute for Health and Care Excellence. (2018, December; last update search July 2019). Chronic obstructive pulmonary disease in over 16s: diagnosis and management. Retrieved November 25, 2019 from https://www.nice.org.uk/guidance.
Noth, I., Cottin, V., Chaudhuri, N., Corte, J.T., Johannson, KA., Wijsenbeek, M., & et al. (2021). Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial. European Respiratory Journal, 58 (1), 2001518. (Level 4 evidence)
Robson, K. & West, A. (2014). Improving survival outcomes in lung transplant recipients through early detection of bronchiolitis obliterans: daily home spirometry versus standard pulmonary function testing. Canadian Journal of Respiratory Therapy, 50 (1), 17-22. (Level 2 evidence)
Russell, A., Adamali, H., Molyneaux, P., Lukey, P., Marshall, R., Renzoni, E., et al. (2016). Daily home spirometry: an effective tool for detecting progression in idiopathic pulmonary fibrosis. American Journal of Respiratory Critical Care Medicine, 194 (8), 989-997. (Level 3 evidence)
Shakkottai, A., Kaciroti, N., Kasmikha, L., & Nasr, S.Z. (2018). Impact of home spirometry on medication adherence among adolescents with cystic fibrosis. Pediatric Pulmonology, 53 (4), 431-436. Abstract retrieved March 2, 2018 from PubMed database.
Turner, J., He, Q., Baker, K., Chung, L., Lazarevic-Fogelquist, A., Bethune, D., et al. (2021). Home spirometry telemonitoring for early detection of bronchiolitis obliterans syndrome in patients with chronic graft-versus-host disease. Transplantation and Cellular Therapy, 27 (7), 616.e1–616.e6, doi.10.1016/j.jtct.2021.03.024. (Level 4 evidence)
U. S. Food and Drug Administration. (2011, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K031643 (SpiroPD®) Retrieved June 2, 2016 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2012, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K120635 (EasyOne®). Retrieved November 4, 2013 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 12/13/2008
MOST RECENT REVIEW DATE: 12/14/2023
ID_BT
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