Table 3.

Symptomatic Response in Index Episode of Acute Otitis Media as Measured by AOM-SOS Score.^*

Measure of Symptomatic Response	10-Day Group (N = 242)	5-Day Group (N = 238)	All Children (N = 480)	P Value
AOM-SOS score over period from day 6 to 14†
All children
No. of children	232	228	460
Mean score	1.34 ±1.76	1.61±1.96	1.47±1.86	0.07‡
Children with clinical success§
No. of children	193	145	338
Mean score	1.32 ±1.81	1.34±1.69	1.33±1.76	0.02¶
Children with clinical failure
No. of children	33	73	106
Mean score	1.63±1.53	1.99±2.20	1.88±2.02
AOM-SOS score at the day-12-to-14 assessment
All children
No. of children	233	227	460
Mean score	1.20±2.06	1.89±2.73	1.54±2.44	0.001‡
Children with clinical success§
No. of children	199	151	350
Mean score	1.04±2.02	1.27±2.02	1.14±2.02	<0.001¶
Children with clinical failure
No. of children	34	76	110
Mean score	2.15±2.06	3.13±3.45	2.83±3.11
Decrease of >50% in AOM-SOS score from base-line to the day-12-to-14 assessment — no./total no. (%)||
All children	211/233 (91)	181/227 (80)	392/460 (85)	0.003‡
Children with clinical success§	182/199 (91)	133/151 (88)	315/350 (90)	<0.001¶
Children with clinical failure	29/34 (85)	48/76 (63)	77/110 (70)

^*Data were missing for some children for some analyses. Analyses included adjustments for study site, age group, exposure or nonexposure to three or more other children for 10 or more hours per week, AOM-SOS score at entry, day of diary notation, and treatment, singly or in combination as appropriate.

^†Day 6 marked the beginning of placebo use in place of amoxicillin–clavulanate in the 5-day group. Over the period from day 1 to day 5, during which treatment in the 10-day group and the 5-day group was uniform, the mean AOM-SOS scores in the 10-day group and the 5-day group, with adjustment for scores at entry, did not differ significantly. In children with clinical failure, the period that was considered for this analysis was from day 6 to the day preceding the day on which clinical failure was determined.

^‡The P value is for the comparison between the 10-day group and the 5-day group.

^§There was no significant interaction between treatment and AOM-SOS scores in relation to clinical outcome (clinical success vs. clinical failure).

^¶The P value is for the comparison, in the study groups combined, between children who had clinical success and those who had clinical failure.

^||The cutoff of 50% or less versus more than 50% was based on data from a study of minimal clinically important difference in AOM-SOS scores.¹²