Summary of findings 1. Autoinflation compared to no treatment for otitis media with effusion (OME) in children.
| Autoinflation compared to no treatment for otitis media with effusion (OME) in children | ||||||
| Patient or population: otitis media with effusion (OME) in children aged 6 months to 12 years Setting: outpatient Intervention: autoinflation Comparison: no treatment | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | What happens | ||
| Without autoinflation | With autoinflation | Difference | ||||
| Proportion of children whose hearing is normal Follow‐up: up to 3 months № of participants: 94 (1 RCT) |
RR 2.67 (1.73 to 4.12) | 31.9% | 85.2% (55.2 to 100) | 53.3% more (23.3 more to 68.1more) | ⊕⊝⊝⊝ Very low1,2,3 | The evidence is very uncertain about the effect of autoinflation on return to normal hearing at 3 months. |
| Disease‐specific quality of life Mean difference in standardised OMQ‐14 scores (lower score is favourable) Follow‐up: 3 months (short‐term) № of participants: 247 (1 RCT) |
— | — | — | MD 0.42 lower (0.62 lower to 0.22 lower) | ⊕⊕⊝⊝ Low1,4 | The evidence suggests that autoinflation may improve disease‐specific quality of life at 3 months. The study authors reported a change of 0.3 as clinically meaningful. |
| Pain and distress related to the procedure: otalgia Follow‐up: 3 months (short‐term) № of participants: 320 (1 RCT) |
RR 3.50 (0.74 to 16.59) | 1.3% | 4.4% (1 to 22.6) |
3.1% more (0.3% fewer to 19.5% more) | ⊕⊝⊝⊝ Very low1,5 | Autoinflation may slightly increase the risk of ear pain (otalgia), but the evidence is very uncertain. |
| Persistence of OME Follow‐up: 3 months (short‐term) № of participants: 483 (4 RCTs) |
RR 0.88 (0.80 to 0.97) | 74.1% | 65.2% (59.3 to 71.9) | 8.9% fewer (14.8 fewer to 2.2 fewer) | ⊕⊕⊝⊝ Low1,6 | The evidence suggests that autoinflation may slightly reduce persistence of OME at 3 months. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OME: otitis media with effusion; OMQ‐14: Otitis Media Questionnaire‐14; RCT: randomised controlled trial; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
1Downgraded by one level for a risk of performance bias.
2Downgraded by one level for indirectness, as no description of 'normal hearing' was provided.
3Downgraded by one level for imprecision, as the optimal information size (OIS) was not reached (< 300 events).
4Downgraded by one level for imprecision, as the OIS was not reached (< 400 participants).
5Downgraded by two levels for imprecision, as the OIS was not reached (< 300 events) and the confidence interval crosses two decision thresholds (RR 0.8 and 1.25).
6Downgraded by one level for a risk of detection bias.