Table 1.
Selected Demographic and Clinical Characteristics of the Children, According to Treatment Group.*
| Characteristic | 10-Day Group (N = 257) | 5-Day Group (N = 258) | All Children (N = 515) |
|---|---|---|---|
| Age at entry — no. (%) | |||
| 6–11 mo | 129 (50) | 132 (51) | 261 (51) |
| 12–17 mo | 80 (31) | 77 (30) | 157 (30) |
| 18–23 mo | 48 (19) | 49 (19) | 97 (19) |
| Sex — no. (%) | |||
| Female | 115 (45) | 123 (48) | 238 (46) |
| Male | 142 (55) | 135 (52) | 277 (54) |
| Exposure to other children — no. (%)† | |||
| No | 109 (42) | 105 (41) | 214 (42) |
| Yes | 148 (58) | 153 (59) | 301 (58) |
| AOM-SOS score at entry‡ | |||
| Mean score | 8.6±3 | 8.2±3 | 8.4±3 |
| Distribution — no. (%) | |||
| 3–5 | 43 (17) | 59 (23) | 102 (20) |
| 6–8 | 75 (29) | 70 (27) | 145 (28) |
| 9–11 | 98 (38) | 95 (37) | 193 (37) |
| 12–14 | 41 (16) | 34 (13) | 75 (15) |
| Estimated severity of illness on the basis of pain and fever history only — no. (%)§ | |||
| Probably nonsevere | 111 (43) | 121 (47) | 232 (45) |
| Probably severe | 146 (57) | 137 (53) | 283 (55) |
| No. of ears affected by acute otitis media — no. (%) | |||
| One ear | 136 (53) | 126 (49) | 262 (51) |
| Two ears | 121 (47) | 132 (51) | 253 (49) |
| Degree of tympanic-membrane bulging in worse ear — no. (%) | |||
| Slight | 35 (14) | 45 (17) | 80 (16) |
| Moderate | 137 (53) | 135 (52) | 272 (53) |
| Marked | 85 (33) | 78 (30) | 163 (32) |
Plus–minus values are means ±SD. There were no significant between-group differences at baseline in the characteristics listed here. Percentages may not total 100 because of rounding.
Exposure to other children was defined as exposure to three or more children for 10 or more hours per week.
The Acute Otitis Media–Severity of Symptoms (AOM-SOS) scale consists of seven discrete items — tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. Parents are asked to rate these symptoms, as compared with the child’s usual state, as “none,” “a little,” or “a lot,” with corresponding scores of 0, 1, and 2. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms.
The current American Academy of Pediatrics clinical practice guideline concerning the management of acute otitis media refers to children with “severe signs or symptoms” as those with “moderate or severe otalgia or otalgia for at least 48 hours or temperature 39°C (102.2°F) or higher.”3 In an effort to simulate that definition with the use of scores on only two of the AOM-SOS items, we categorized the episode of acute otitis media as “probably severe” if the parent described the child as having had “a lot” of ear tugging or “a lot” of fever during the preceding 24 hours.