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Use of metered-dose inhaler electronic monitoring in a real-world asthma randomized controlled trial

Patel, Mitesh; Pilcher, Janine; Travers, Justin; Perrin, Kyle; Shaw, Dominick; Black, Peter; Weatherall, Mark; Beasley, Richard

Authors

Mitesh Patel

Janine Pilcher

Justin Travers

Kyle Perrin

Dominick Shaw

Peter Black

Mark Weatherall

Richard Beasley



Abstract

Background

Electronic monitoring of inhaled asthma medications is one method to measure medication adherence and patterns of use. Information on the performance of monitors in a randomized controlled trial allows researchers and clinicians to understand their utility and limitations. The Smartinhaler Tracker is an electronic monitor for metered-dose inhalers (MDIs) that records the date, time, and number of actuations.
Objective

To determine the performance of the Smartinhaler monitors used in a 24-week randomized controlled trial of 303 patients with asthma in a real-world setting.
Methods

Prestudy use checks involved 2 actuations of the MDI, with a further 2 performed 2 hours later. Within-study monitor checks, performed before dispensing at clinic visits 2 to 4, included a computerized check of monitor clock function, actuation accuracy, and battery life. Within-study data checks involved computerized checks of monitor clock function before data upload.
Results

Two thousand six hundred seventy-eight of 2728 monitors (98.2%) passed prestudy use checks. Seventy-six of 2642 monitors (2.9%) dispensed to participants failed within-study monitor checks. Fifty-one of 2642 monitors (1.9%) malfunctioned before data upload, mostly as a result of fluid immersion. Ninety-three of 2642 monitors (3.5%) were lost or thrown away by participants. Complete data was available from 2498 of 2642 dispensed monitors (94.5%) and 2498 of 2549 returned monitors (98.0%).
Conclusions

The Smartinhaler Tracker is a reliable monitor for measuring MDI use in a real-world setting. Use of extensive monitor and data-checking protocols reduces data loss. In a research or clinical setting, the use of a validated and reliable electronic monitor represents the reference standard for assessing patterns of medication use.

Journal Article Type Article
Publication Date Jan 1, 2013
Journal Journal of Allergy and Clinical Immunology: In Practice
Electronic ISSN 2213-2201
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 1
Issue 1
APA6 Citation Patel, M., Pilcher, J., Travers, J., Perrin, K., Shaw, D., Black, P., …Beasley, R. (2013). Use of metered-dose inhaler electronic monitoring in a real-world asthma randomized controlled trial. Journal of Allergy and Clinical Immunology: In Practice, 1(1), doi:10.1016/j.jaip.2012.08.004
DOI https://doi.org/10.1016/j.jaip.2012.08.004
Keywords Adherence; Asthma; Electronic; Metered-dose inhaler; Monitoring; Patterns of use; Smartinhaler; Validation
Publisher URL http://www.sciencedirect.com/science/article/pii/S2213219812000074
Copyright Statement Copyright information regarding this work can be found at the following address: http://eprints.nottingh.../end_user_agreement.pdf
Additional Information

Composition Type:
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