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Background: Electronic monitoring of medication use has proved valuable in both clinical and research settings. The Doser, a new and inexpensive commercially available device for monitoring metered-dose inhaler (MDI) use, displays 3 measures of daily use of an attached MDI: (1) the daily total of actuations, (2) the number of doses remaining in the MDI, and (3) the number of actuations on each of the preceding 30 days for later recall., Objective: We sought to validate the accuracy of the Doser with several commonly prescribed MDIs., Methods: In the laboratory, clinic personnel actuated an MDI with an attached Doser several times in succession on 3 consecutive days and recorded each of the 3 measures of MDI use (study 1). In study 2 clinic personnel carried an MDI and attached Doser with them for 4 weeks, actuating the MDI according to a prescribed protocol each morning and evening and again recording each of the 3 measures of daily use. In addition, during 2 weeks of study 2, a thermistor-based Nebulizer Chronolog was attached to the MDI to electronically record the date and time of each actuation. In study 3 clinic patients had both a Doser and Nebulizer Chronolog attached to their routinely used inhalers for 2 weeks and a Doser alone during a separate 2-week period., Results: In study 1 agreement was 99% to 100% among the 3 Doser measures, and each measure agreed with actual use by self-report 97% of the time. In study 2 agreement among the 3 Doser measures of use ranged from 98% to 99%. Agreement between each of the 3 Doser measures and the Nebulizer Chronolog ranged from 90% to 93%. Agreement between each of the 3 Doser measures and actual use ranged from 96% to 97%, and the Nebulizer Chronolog agreed with actual use 93% of the time. In study 3 Doser and Nebulizer Chronolog agreement with patient self-report were 85% and 80%, respectively. Agreement between the Doser and Nebulizer Chronolog was 76%. Several failures of the thermistor-based Nebulizer Chronolog occurred, and occasional mechanical problems occurred with the Doser, primarily on particular types of MDI canisters., Conclusion: The Doser provides an accurate measure of MDI use with most commonly prescribed medications and may be useful for monitoring MDI use by investigators, clinicians, and patients.

Study Objective: To assess objectively measured, long-term trends in compliance with physician-prescribed metered-dose inhaler (MDI) use during a clinical trial., Design: A prospective study., Setting: The Lung Health Study, a 5-year clinical trial to determine the effect of special intervention with an intensive smoking cessation program and bronchodilator therapy in cigarette smokers 35 to 60 years of age with minimal to moderate airflow limitation due to COPD., Participants: Two hundred thirty-one participants who were issued an MDI with an attached Nebulizer Chronolog (NC) (Forefront Technologies Inc; Lakewood, Colo) which electronically records the date and time of each MDI actuation. One hundred two participants were not informed of the recording capabilities of the attached NC, while 129 participants were aware of the NC's monitoring function., Intervention: Following an initial 12-week period of counseling, participants returned to the clinic every 4 months., Measurements and Results: Analysis of the data from the NC collected over a period of 2 years indicates that compliance with the prescribed medication regimen was best immediately following each follow-up visit and gradually declined during the interval between follow-up visits. The level of compliance after each visit was lower for each successive follow-up. These trends could not be observed from self-report or weighting the medication canisters at follow-up visits. The participants who were informed of the NC's function and who were provided with detailed feedback about their inhaler use generally showed better compliance.

Poor adherence to medication regimens is a well-documented phenomenon in clinical practice and an ever-present concern in clinical trials. Little is known about adherence to inhaled medication regimens over extended periods. The present paper describes the 2-yr results of the Lung Health Study (LHS) program, which was developed to maintain long-term adherence to an inhaled medication regimen in 3,923 special intervention participants (as measured by self-report and medication canister weight). The LHS is a double-blind, multicenter, randomized controlled clinical trial of smoking intervention and bronchodilator therapy (ipratropium bromide or placebo) for early intervention in chronic obstructive pulmonary disease (COPD). At the first 4-mo follow-up visit, nearly 70% of participants reported satisfactory or better adherence. Over the next 18 mo, self-reported satisfactory or better adherence declined to about 60%. Canister weight classified adherence as satisfactory or better in 72% of participants returning all canisters at 1 yr, and in 70% of the participants returning all canisters at the 2-yr follow-up. Self-reporting confirmed by canister weight classified 48% of participants at 1 yr as showing satisfactory or better adherence. Overusers were 50% more likely than others to misrepresent their true smoking status, suggesting that canister weights indicating overuse may be deceptive. Results of multiple logistic regression analysis indicate that the best compliance was found in participants who were married, older, white, had more severe airways obstruction, less shortness of breath, and fewer hospitalizations, and who had not been confined to bed for respiratory illnesses.(ABSTRACT TRUNCATED AT 250 WORDS)

This study examined whether utilizing an electronic medication monitor (Nebulizer Chronolog) to provide participants with detailed feedback on their metered-dose inhaler (ipratropium bromide or placebo) usage patterns would result in closer adherence to the prescribed regimen of two inhalations three times daily compared to a control group not receiving feedback. Adherence was also measured by canister weighing and self-report. Two-hundred fifty-one consecutive special intervention participants from the University of California, Los Angeles, and Johns Hopkins University centers of a National Heart, Lung, and Blood Institute-sponsored clinical trial were enrolled in this ancillary study. Compared to controls, feedback participants at the 4-month follow-up adhered more closely to the prescribed three sets per day (mean 1.95 vs 1.65) and used the prescribed two actuations in a greater percentage of sets (80 percent vs 60.3 percent). These results indicate that electronic monitoring of metered-dose inhaler use with a Nebulizer Chronolog in a clinical trial not only provides a more accurate assessment of adherence to prescribed inhaler use, but also enhances adherence when participants are given feedback of the monitoring results.

The Lung Health Study is a 10-center 5-year clinical trial sponsored by the National Heart, Lung, and Blood Institute to evaluate the effectiveness of early intervention in chronic obstructive pulmonary disease (COPD). The specific objectives of the trial are to determine whether the accelerated decline in lung function characteristic of COPD and morbidity due to COPD can be reduced by special intervention at a relatively early stage in the evolution of the disease. Special intervention consists of a smoking-cessation program and the use of an inhaled bronchodilator to suppress airway hyperreactivity. The use of the inhaler canister is monitored every 4 months by canister weighing and, at two of the 10 centers, by an electronic recording device, the Nebulizer Chronolog. Among trial participants assigned the latter device, results from the first 4 months of the study indicate that only 52% of trial participants who were uninformed as to the nature of the chronolog used their inhaler at least twice daily as measured by the chronolog, compared with 87% as determined by self-report. Satisfactory or good compliance was achieved by 52% of these subjects as measured by the chronolog compared with 85% as assessed by canister weighing. Eighteen percent of uninformed participants "dumped" their inhalers within a 3-hour time period, contributing to the inaccuracy of canister weights as an indicator of compliance. Feedback of information to the participants from the chronolog improved the level of compliance and eliminated the "dumping" phenomenon. We conclude that, when accurate determinations of compliance are important, as in a drug trial, objective medication monitors should be considered. Electronic monitoring of inhaler use can provide valuable feedback, which encourages improved compliance.