Use of metered-dose inhaler electronic monitoring in a real-world asthma randomized controlled trial.
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.
Medical Research Institute of New Zealand, Wellington, New Zealand; Capital & Coast District Health Board, Wellington, New Zealand; Division of Respiratory Medicine, School of Clinical Sciences, University of Nottingham, Nottingham, United Kingdom. Electronic address: mitesh.patel@mrinz.ac.nz.
Mitesh
M
Patel
Janine
J
Pilcher
Justin
J
Travers
Kyle
K
Perrin
Dominick
D
Shaw
Peter
P
Black
Mark
M
Weatherall
Richard
R
Beasley
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents; D001249:Asthma / Q000188:drug therapy*; D001315:Australia; D001993:Bronchodilator Agents; D005260:Female; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers / Q000592:standards*; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data; D009520:New Zealand; D011446:Prospective Studies; D055815:Young Adult; D016903:Drug Monitoring
D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents
Adherence; Asthma; Electronic; Fixed-dose combination inhaler as maintenance therapy with short-acting beta agonist as reliever; MDI; Metered-dose inhaler; Monitoring; Patterns of use; RCT; Randomized controlled trial; SMART; STANDARD; Single combination inhaler as Maintenance And Reliever Therapy; Smartinhaler; Validation