Study Sample
The results of this paper are drawn from a larger study, reflecting a nationally representative sample of U.S. allergy sufferers (n = 10,023) conducted online during the month of December, 2002. Data were weighted to reflect demographics of the U.S. adult population which suffers from seasonal or perennial allergies. Weighting targets were based on the results of the December, 2002 Harris Poll®, a telephone poll that randomly surveyed over 1,000 U.S. adults. All U.S. resident allergy sufferers over the age of 18 were included in the weighting. They were weighted by educational attainment, age by sex, race/ethnicity, region, and household income to be representative of the population of adult allergy sufferers in the U.S. This larger study design included over 18 patient segments, reflecting specific treatment practices, disease states, current medications, and medication switching behavior.
From this larger study, two patient segments were identified for analysis within this paper: patients who were dissatisfied with loratadine and converted to desloratadine (Clarinex; n = 61), and patients who were dissatisfied with loratadine and converted to fexofenadine (Allegra; n = 211). Qualification was determined in the screener section of the survey. In order to qualify for these segments, patients had to meet certain criteria. They had to have been on each medication (previous and current) for at least one week, with no more than one year elapsed between product usages, and the patient reported that the reason for switching products was dissatisfaction with loratadine. Patients who reported combination prescription product use did not qualify for these segments (e.g., prescription antihistamine use and prescription nasal steroid use). However, patients who reported concomitant OTC use were allowed in these segments. Once identified for qualification, patients completed survey questions which examined disease state and medication behavior, reasons for switching products, and satisfaction with previous and current medications.
Study Measures
The two segments were compared along a series of measures that the literature suggests are related to treatment satisfaction [
5‐
7]. We asked patients to assess their product satisfaction across three categories: side effects associated with the medication, satisfaction with symptom relief, and overall satisfaction. For side effects, patients identified instances of adverse events or side effects associated with each medication experience. The list of side effects included the following: difficulty falling asleep, trouble sleeping through the night, trouble waking up, early wakening, daytime drowsiness, nervousness, mood swings, poor concentration, reduced ability to be productive at work/school, headache, nausea, fatigue, dry mouth, and other. For each respondent, we summed the recorded instances of medication-related side effects or adverse events and created a composite measure, reported as "sum of adverse events." All analyses examined mean differences in this measure between the two patient segments.
For satisfaction related to symptom relief, we asked respondents to assess their medication in five ways. Respondents were asked to indicate how effective their medication was in covering their symptoms through to the next dose, a measure we report as "coverage period." This measure is based on a seven point Likert scale, where 1 equals not effectively at all and 7 equals extremely effectively. Additionally, respondents were asked to indicate how quickly their medication begins to relieve their symptoms after they dose, a measure we report as "onset of relief." This measure is based on a seven point Likert scale, where 1 equals not quickly at all and 7 equals extremely quickly. Respondents were also asked to indicate how frequently their allergy symptoms prevented them from sleeping through the night, a measure we report as "end of dose failure – nighttime awakenings." This measure is based on a seven point Likert scale, where 1 equals not frequently at all and 7 equals extremely frequently. Respondents were further asked to indicate how troubled they were by their allergy symptoms when they get out of bed in the morning, a measure we report as "end of dose failure – morning symptoms." This measure is based on a seven point Likert scale, where 1 equals not troubled at all and 7 equals extremely troubled. And finally, respondents were asked to indicate their overall level of symptom relief they attained while taking their prescription medication, a measure we report as "overall symptom relief." This measure is based on a seven point Likert scale, where 1 equals no relief and 7 equals complete relief.
For overall prescription medication satisfaction, we asked respondents to indicate product satisfaction in four ways. Respondents were asked to indicate how likely they were to recommend their current prescription medication to a friend or family member, a measure we report as "likelihood to recommend." This measure is based on a seven point Likert scale, where 1 equals not likely at all and 7 equals extremely likely. Additionally, respondents were asked to indicate how likely they were to continue their current prescription medication, a measure we report as "continuation intentions." This measure is based on a seven point Likert scale, where 1 equals not likely at all and 7 equals extremely likely. Respondents were also asked to indicate their overall satisfaction with their current prescription medication, a measure we report as "overall satisfaction with current Rx." This measure is based on a seven point Likert scale, where 1 equals extremely unsatisfied and 7 equals extremely satisfied. And finally, respondents were asked to indicate their overall satisfaction with the change in prescription products, a measure we report as "satisfaction with Rx switch." This measure is based on a seven point Likert scale, where 1 equals extremely unsatisfied and 7 equals extremely satisfied. For a summary of the satisfaction Likert scales used in this analysis, see table
1.
Symptom Relief | | |
EOD Failure – Nighttime Awakening | Not Frequently at All | Extremely Frequently |
EOD Failure – Morning Symptoms | Not Troubled at All | Extremely Troubled |
Onset of Relief | Not Quickly at All | Extremely Quickly |
Coverage Period | Not Effectively at All | Extremely Effectively |
Overall Symptom Relief | No Relief | Complete Relief |
Overall Satisfaction | | |
Continuation Intentions | Extremely Unlikely | Extremely Likely |
Likelihood to Recommend | Extremely Unlikely | Extremely Likely |
Overall Satisfaction with Current Rx | Extremely Unsatisfied | Extremely Satisfied |
Satisfaction with Rx Change | Extremely Unsatisfied | Extremely Satisfied |
The two patient segments were compared along the above listed satisfaction measures as complete segments and separately as severe sufferers within the two segments. Severity of disease was assessed on a self-reporting basis of how troubled the patient was by his or her allergies. Severe sufferers were identified by responses of quite a bit troubled, very troubled, or extremely troubled on a seven point Likert scale (top three box). For the severity sub-group analyses, the weighted segments sizes were 88 for loratadine-fexofenadine and 35 for loratadine-desloratadine.
To test for mean differences in the ten separate study measures, difference in means tests were conducted using the t-distribution. All significance testing was performed at the 95% confidence level, two-tailed.
Although respondents were asked to assess their prescription medication across categories related to perceived efficacy and side effects, an important caveat to highlight is the fact that patient perceptions regarding medication use captured through survey research cannot establish differences in the clinical properties related to efficacy or safety. The survey research reported here was designed to assess dimensions of satisfaction, across patient self-reported categories of side effects, efficacy, and overall product satisfaction. Only through head-to-head controlled clinical trials can differences in efficacy and safety be established.