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Demographic Comparisons

Sex. There were no statistical sex differences between the treatment groups. Table 2 presents the demographics of each treatment group.

Age. There were no statistical differences in age between the two treatment groups. The overall (pooled) mean age for all of the AOMT patients was 2.72 years (with a standard deviation [SD] of 2.47). The mean age of the Cdex treatment group was 2.77 years (SD, 2.53), with a 95% confidence interval (CI) of 2.43 to 3.10 years. In contrast, the mean age of the Oflx group was 2.68 years (SD, 2.42), with a 95% CI of 2.35 to 3.00 years.

Duration of Otorrhea

Otic drainage stopped approximately 1.5 days sooner in the Cdex children than in those treated with Oflx (Table 3). The median time to cure was 2.5 days for the Cdex patients (CI, 95% in 2-3 days) compared with 4 days (CI, 95% in 3.5^.5 days) for the Oflx patients. The 25th and 75th percentile time-to-cure figures are also consistent. The 25th percentile column is the treatment, it is again the caregiver who assesses the effectiveness of therapy. Our caregiver satisfaction survey showed that using Cdex for a child with AOMT rather than Oflx resulted in higher overall caregiver satisfaction. Our results agree with those of Shikiar et al., who found that satisfaction with a drug was highly correlated with relief of symptoms. Compared with Oflx, better caregiver satisfaction results were obtained with Cdex for most of the questionnaire items, including satisfaction with the time needed to stop ear drainage, control of ear pain, and the number of days for which the patient had to take the antibiotic.

Table 2 A Comparison of Gender Demographics Between Two Pediatric AOMT Treatment Groups

Some researchers may dispute the use of linear regression on a satisfaction scale with an ordinal nature. To address this issue, we also analyzed the satisfaction-duration of otorrhea relationship using two different logistic regression approaches.

Figure 1 Cessation of otorrhea in children with AOMT

First, we analyzed the relationship between the raw “overall satisfaction with ear drops” ordinal scores in relation to the duration of otorrhea. Second, we transformed the raw satisfaction scores into the nominal categories (“satisfied” or “unsatisfied”) and analyzed the relationship of the transformed scores relative to the duration of otorrhea. In both instances, the logistic models and according to the caregivers, 25% of Cdex patients were otor-rhea-free after 1.5 days, whereas 2.5 days were required for 25% of the Oflx patients to achieve an otorrhea-free state. The time to cure was even more pronounced at the 75th percentile. Only 4.5 days were required for drainage to cease in 75% of the Cdex-treated patients, compared with seven days for the Oflx-treated patients. There was a statistical difference (P < .001) in the cure rates between the Cdex and Oflx treatment groups. The mean time to cessation of otorrhea for the Cdex group of patients was 3.65 days (standard error [SE], 0.19) and 4.88 days (SE, 0.19) for the Oflx patients.
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Table 3 Cure Rate for Children with AOMT

In Figure 1, the Kaplan-Meier survival curves depict the contrasting cure rates for the Cdex and Oflx groups. Cessation of otorrhea was faster with Cdex, and the proportion of otorrhea-free patients over time was significantly greater in the Cdex group. The area between the curves in Figure 1 represents the differences between the two cure rates. Stated another way, this region signifies the proportion of patients who experienced the added benefit of treatment with Cdex rather than with Oflx. The difference in cure rates represents the alleviation of suffering resulting from the more rapid curing action of Cdex.

Figure 2 Relationship between otorrhea duration in children

Satisfaction of Caregivers with Treatment

Table 4 compares caregiver satisfaction scores between the Cdex and Oflx treatment groups and provides the resultant statistical significance levels. Cdex caregivers were significantly more satisfied than Oflx caregivers on 13 of the 19 satisfaction items. There were no statistically significant differences on the remaining six satisfaction items.
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Table 4 Caregiver Satisfaction with AOMT Treatment

Relationship Between Duration of Otorrhea and Caregiver Satisfaction

The relationship between the duration of otorrhea and care-givers’ overall satisfaction with the ear drops was statistically significant (P < .001). Caregivers’ satisfaction for both Cdex and Oflx was inversely related to the duration of otorrhea (Figure 2). The longer the otorrhea lasted, the less satisfied caregivers were with treatment. All 19 caregiver satisfaction items, except the questions concerning the “appetite of the patient” and the “effect on patient attending school or day care,” demonstrated a statistically significant correlation with the duration of otorrhea.