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Table 1 compares the feedback and control groups with respect to demographic variables, respiratory illness, lung function, and smoking status at 4 months. The two groups were similar with regard to most of these characteristics with the following exceptions. Significantly more feedback participants than control participants were nonsmokers at 4 months (p = 0.04). Baseline lung function was marginally worse in the control group (p = 0.05). In addition, a substantially larger proportion of control subjects demonstrated a significant acute respojnse at baseline to bronchodilator therapy (isoproterenol) as indicated by 10 percent or more improvement in FEVi within 10 min after inhalation of the bronchodilator (p<0.0001).
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The first two actuations within the first three sets of the day were defined as prescribed actuations while all other actuations were considered nonprescribed actuations. Percentage of prescribed actuations was calculated as the ratio of prescribed actuations to total actuations. A measure of percent-adherent days was derived by dividing the sum of the number of days participants used their inhaler in a clinically acceptable manner by the number of days the NC was available for use. An adherent day was defined as a day that contained two, three, or four sets with at least two of the sets containing two or three actuations. If any set contained five or more actuations, the day was considered nonadherent.
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In a preliminary study, the weight of each MDI actuation was found to be 0.0676 g. Therefore, the average number of actuations per day was calculated by dividing the mean daily usage in grams by 0.0676. Mean canister weight sets per day was calculated by dividing the average number of actuations by two, on the assumption that each set contained the prescribed two actuations.
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Feedback Condition: At the time they initially received their inhalers, participants in the feedback group were instructed in the ability of the NC to record the time and date of each actuation. Participants received printed copies of their NC record of inhaler use at the end of weeks 1 and 7 of the 12-week smoking cessation program. At these feedback sessions, the health educator and participant jointly reviewed the pattern of inhaler use during the previous period for appropriateness and adherence to prescribed use. Praise was given for the areas in which usage was satisfactory, and individual behavioral strategies, such as “anchoring” inhaler use to daily routines (eg, before tooth brushing in the morning or evening), were collaboratively developed to address problem areas. These brief (5-min) feedback sessions continued at each 4-month follow-up visit.
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The time measurement has a 4-min resolution, and at least 6 months of data can be stored in volatile solid-state memory before the battery requires changing. The dates and times of approximately 4,000 actuations can be stored in memory, which exceeds the number of inhalations needed to empty all four of the dispensed canisters. The NC data are easily downloaded through an external interface into an IBM-compatible computer where they are stored as a database file and can be printed at any time.
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At each 4-month visit, participants were interviewed about their smoking status and inhaler adherence. The inhaler canisters were collected and weighed, and four replacement canisters were issued. Self-report and canister weighing, discussed later on, were the two measures of inhaler compliance at all sites of this ten-center study.
The prescribed medication protocol consisted of two inhalations, three times per day, of the assigned MDI (either ipratropium bromide or placebo) every day for the duration of the the trial. Canisters were initially dispensed to the participants at the second session of the group smoking cessation program. A health educator provided detailed instructions on proper use of the MDI and observed and corrected the inhaler technique of each participant individually. Strategies for linking inhaler use to daily activities, such as tooth brushing or meal schedules, were discussed in an effort to insure maximum adherence. Inhaler technique was rechecked on at least two occasions during the initial 12 sessions and at each follow-up visit.
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Methods
The Lung Health Study
The Lung Health Study is an ongoing five-year, ten-center National Heart, Lung, and Blood Institute-sponsored randomized clinical trial testing the hypothesis that smoking cessation and the regular use of an inhaled bronchodilator, ipratropium bromide, will slow the decline in lung function in smokers with early COPD. Eligible participants included men and women between the ages of 35 and 60 years at randomization who were active cigarette smokers and had spirometric evidence of mild to moderate airflow obstruction, as indicated by a ratio of FEV, to forced vital capacity of 70 percent or less and an FEV^ of 55 to 90 percent of predicted. Prior to randomization, participants were excluded if they had serious health problems which might limit study participation or life expectancy, or if they were regularly using a bronchodilator or beta-adrenergic blocking agent.
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Nonadherence to prescribed medication regimens is a major concern in clinical trials, as well as in clinical practice. Nonadherence rates are estimated to range from 20 to 80 percent depending on a variety of factors, including the complexity of the regimen, the severity of symptoms, side effects, and the health beliefs of the patient. Inadequate adherence, particularly when undetected, can result in potentially effective medications being deemed ineffective.
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