Summary of findings 4. Ventilation tubes compared to myringotomy for OME in children.
| Ventilation tubes compared to myringotomy for OME in children | ||||||
| Patient or population: children aged 6 months to 12 years with OME Setting: outpatient Intervention: ventilation tubes Comparison: myringotomy | ||||||
| Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Certainty of the evidence (GRADE) | Comments | ||
| With myringotomy | With ventilation tubes | Difference | ||||
|
Hearing ‐ return to normal *Ventilation tubes versus laser myringotomy (6 to 12 months ‐ medium‐term) Adjusted for non‐independence of within‐individual measurements Assumed ICC of 0.5 № of participants: 132 (2 RCTs) |
RR 1.22 (0.59 to 2.53) | 63.6% | 77.6% (37.5 to 100) | 14.0% more (26.1 fewer to 97.4 more) | ⊕⊝⊝⊝ Very low1 | The evidence is very uncertain about the effect of ventilation tubes on the likelihood of a return to normal hearing at 6 to 12 months, when compared to laser myringotomy. |
| Disease‐specific quality of life | No evidence was identified for this outcome. | |||||
|
Presence/persistence of OME *Ventilation tubes versus laser myringotomy, randomised by ear (6 months ‐ medium‐term) Assumed CC of 0.5 № of participants: 272 (1 RCT) |
OR 0.27 (0.19 to 0.38) | 61% | 29.7% (22.9 to 37.3) |
31.3% fewer (38.1 fewer to 23.7 fewer) |
⊕⊝⊝⊝ Very low2 | The evidence is very uncertain about the effect of ventilation tubes on persistent OME at 6 months, when compared with laser myringotomy. |
|
Adverse event: persistent perforation Range of follow‐up: 3 months to 2 years № of participants: 581 (6 RCTs) |
The number of persistent perforations following insertion of ventilation tubes ranged from 1 ear to 4 ears, and from 1 to 3 children (D'Eredita 2006; Gates 1989; Sujatha 2015; To 1984). One study yielded a RR for persistent perforation (ventilation tubes versus laser myringotomy) of 1.00 (95% CI 0.06 to 15.56) at 6 months (Yousaf 2016). | ⊕⊕⊕⊝ Moderate3 | Ventilation tubes likely increase the risk of persistent perforation. When compared with laser myringotomy, there is likely to be little to no difference in risk at 6 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). CC: correlation coefficient; CI: confidence interval; ICC: intraclass correlation coefficient; OME: otitis media with effusion; OR: odds ratio; 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 two levels for risk of bias (performance and reporting bias). Downgraded by one level for serious inconsistency, as the I2 was 95%, with minimal overlap of confidence intervals. Downgraded by two levels for very serious imprecision as the optimal information size (OIS) was not reached (< 300 events) and two decision thresholds were crossed by the CI (RR 0.80 and 1.25).
2Downgraded by two levels for very serious risk of bias (performance, detection, reporting and attrition bias). Downgraded by one level for serious imprecision as the optimal information size (OIS) was not reached (< 300 events).
3Not downgraded for risk of bias, as this outcome was felt to be sufficiently objective that it would not be impacted by performance or detection bias. Downgraded by one level for serious imprecision, as this was a narrative synthesis only.