Table 4.
Secondary outcomes
| Intervention (N= 94), mean (95% CI) | Usual care (N= 129), mean (95% CI) | Effect estimate, rate ratio (95% CI) | ||||
|---|---|---|---|---|---|---|
|
| ||||||
| Characteristic | n | n | ||||
| Days with complaints | ||||||
| Ear pain | 90 | 7.58 (6.59 to 8.56) | 121 | 6.76 (5.96 to 7.56) | crude | 1.12 (0.94 to 1.34) |
| adjusteda | 1.13 (0.96 to 1.31) | |||||
| Fever | 85 | 2.98 (2.39 to 3.57) | 116 | 3.37 (2.83 to 3.91) | crude | 0.88 (0.68 to 1.14) |
| adjusteda | 0.99 (0.78 to 1.25) | |||||
|
| ||||||
| Oral antibiotic prescriptions | ||||||
| At index consultation | 94 | 0.23 (0.15 to 0.31) | 129 | 0.39 (0.30 to 0.48) | crude | 0.60 (0.40 to 0.91) |
| adjustedb | 0.66 (0.43 to 1.03) | |||||
| After index consultation | 94 | 0.19 (0.11 to 0.28) | 129 | 0.09 (0.04 to 0.13) | crude | 2.25 (1.09 to 4.62) |
| adjustedb | 2.27 (1.05 to 4.92) | |||||
| Total | 94 | 0.43 (0.31 to 0.54) | 129 | 0.47 (0.37 to 0.58) | crude | 0.90 (0.64 to 1.27) |
| adjustedb | 0.97 (0.68 to 1.38) | |||||
|
| ||||||
| AOM-related GP consultations during 28-day follow-up | ||||||
| GP visits only | 94 | 0.63 (0.45 to 0.81) | 129 | 0.36 (0.25 to 0.48) | crude | 1.72 (1.12 to 2.65) |
| adjusteda | 1.75 (1.13 to 2.71) | |||||
| Total (telephone and visits) | 94 | 0.70 (0.51 to 0.89) | 129 | 0.41 (0.29 to 0.54) | crude | 1.71 (1.14 to 2.57) |
| adjusteda | 1.73 (1.14 to 2.62) | |||||
|
| ||||||
| Working days lost | ||||||
| Father | 71 | 0.17 (0.05 to 0.29) | 96 | 0.29 (0.12 to 0.46) | crude | 0.58 (0.22 to 1.53) |
| adjusteda | 0.60 (0.23 to 1.55) | |||||
| Mother | 78 | 0.37 (0.12 to 0.62) | 100 | 0.49 (0.28 to 0.70) | crude | 0.78 (0.36 to 1.62) |
| adjusteda | 0.70 (0.42 to 1.17) | |||||
|
| ||||||
| Daycare or school hours lost | 76 | 7.2 (4.9 to 9.5) | 100 | 9.1 (6.8 to 11.4) | crude | 0.79 (0.52 to 1.19) |
| adjusteda | 0.88 (0.60 to 1.29) | |||||
|
| ||||||
| Odds ratio (95% CI) | ||||||
|
| ||||||
| Proportion of children with ear pain, n (%) | ||||||
| After 24 hours | 87 | 83 (95.4) | 118 | 100 (84.7) | crude | 3.74 (1.22 to 11.47) |
| adjusteda | 3.12 (0.91 to 10.65) | |||||
| After 72 hours | 86 | 63 (73.3) | 116 | 74 (63.8) | crude | 1.56 (0.85 to 2.86) |
| adjusteda | 1.37 (0.70 to 2.70) | |||||
| After 7 days | 77 | 16 (20.8) | 97 | 16 (16.5) | crude | 1.33 (0.62 to 2.86) |
| adjusteda | 1.39 (0.57 to 3.41) | |||||
|
| ||||||
| Mean difference (95% CI) | ||||||
|
| ||||||
| OM-6 questionnairec at end of follow-up, mean ± SD | ||||||
| OM-6 score | 80 | 2.20 ± 1.07 | 102 | 1.97 ± 1.25 | crude | −0.23 (−0.57 to 0.12) |
| adjustedd | −0.18 (−0.51 to 0.15) | |||||
|
| ||||||
| EQ-5D VAS scoree after 14 days, mean ± SD | ||||||
| Father | 66 | 81 ± 17 | 95 | 86 ± 13 | crude | 4.71 (0.05 to 9.37) |
| adjustedd | 3.90 (−0.08 to 7.88) | |||||
| Mother | 70 | 83 ± 11 | 97 | 83 ± 15 | crude | 0.19 (−3.91 to 4.29) |
| adjustedd | −1.38 (−5.14 to 2.38) | |||||
a
Adjusted for: sex; age; unilateral versus bilateral acute otitis media; ill appearance; number of days ear pain prior to consultation; ear pain; fever and otorrhea at inclusion; history of recurrent otitis media; oral antibiotic prescriptions (immediate).
b
Adjusted for all factors previously given in prior footnote excluding oral antibiotic prescriptions (immediate).
c
Score on 6-item questionnaire, scale 6–42.
d
Additionally adjusted for baseline score.
e
Score on a VAS scale ranging from 0–100. AOM = acute otitis media. EQ-5D VAS = EuroQol 5 dimensions visual analogue scale. OM-6 = otitis media-6. SD = standard deviation.