Table 3.
Primary outcome of acceptable hearing at 5 weeks by treatment group
| Placebo group | Oral steroid group | Treatment effect | p value | ||
|---|---|---|---|---|---|
| Intention-to-treat population | |||||
| Acceptable hearing | |||||
| No | 121/180 (67%) | 110/183 (60%) | Ref | .. | |
| Yes | 59/180 (33%) | 73/183 (40%) | aOR 1·36 (0·88 to 2·11)*; RR 1·21 (0·92 to 1·60) | 0·16; 0·17 | |
| Per-protocol population† | |||||
| Acceptable hearing | |||||
| No | 76/116 (66%) | 75/127 (59%) | Ref | .. | |
| Yes | 40/116 (34%) | 52/127 (41%) | aOR 1·27 (0·75 to 2·17) | 0·38 | |
| Complier averaged causal effects | |||||
| Primary analysis | .. | .. | 0·07† (−0·02 to 0·16) | 0·11 | |
| Full adherence to oral steroid (vs none or some)‡ | .. | .. | 0·08† (−0·03 to 0·20) | 0·10 | |
| Ear-level analysis, mean dB HL§ | |||||
| Baseline | 37·81 (7·91) | 36·20 (8·79) | .. | .. | |
| 5 weeks | 31·01 (11·82) | 29·38 (11·54) | −0·78¶ (−2·79 to 1·23) | .. | |
| Change (5 weeks to baseline) | −6·80 (11·79) | −6·82 (10·98) | .. | .. | |
Data are n (%) or mean (SD), unless otherwise stated. aOR=adjusted odds ratio. RR=relative risk. dB=decibels. HL=hearing level.
*
Adjusted for site, child's age group at recruitment (2–5 years vs 6–8 years) and time since recruitment to 5-week assessment (days).
†
Adjusted difference in proportions (95% CI).
‡
Full adherence is all oral steroids taken for 7 days versus some or none taken for less than 7 days.
§
n=361 in placebo group, n=364 in oral steroid group.
¶
Adjusted difference in means (95% CI) adjusted for baseline hearing, age at recruitment, time since recruitment to 5-week assessment (days), site, and child.