Cochrane · systematic review · CD015215

Ventilation tubes (grommets) for otitis media with effusion (OME) in children

MacKeith, S, Mulvaney, CA, Galbraith, K, et al. · Cochrane Database of Systematic Reviews · 2023 · Cochrane Library

ENTAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
16
current version
GRADE rated
11
No studies
5
Included studies
NR
No studies 5 · 31.3%Ungraded 0 · 0%Very low 8 · 50%Low 2 · 12.5%Moderate 1 · 6.3%High 0 · 0%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Ventilation tubes compared to no treatment for OME in children

Population: children aged 6 months to 12 years with OME
4 questions
OutcomeEffectEvidenceStatus / GRADE
Hearing ‐ return to normal hearing Randomised by ear: normal defined as < 15 dB Assumed CC = 0.5
Ventilation tubes vs no treatment
OR 1.13 [0.46, 2.74]NRVery low
Downgraded: risk of bias, inconsistency
Disease‐specific quality of life
Ventilation tubes vs no treatment
no estimate extractedNRNo studies
Presence/persistence of OME Randomised by child Adjusted for non‐independence of within‐individual measurements, assumed ICC = 0.5
Ventilation tubes vs no treatment
RR 0.3 [0.14, 0.65]NRLow
Downgraded: imprecision, indirectness
Adverse event: persistent perforation Randomised by ear, assumed CC = 0.5
Ventilation tubes vs no treatment
OR 0.85 [0.38, 1.91]NRVery low
Downgraded: risk of bias, imprecision, inconsistency, indirectness

Early ventilation tubes compared to watchful waiting (treatment later if required) for OME in children

Population: children aged 6 months to 12 years with OME
4 questions
OutcomeEffectEvidenceStatus / GRADE
Hearing ‐ return to normal hearing Randomised by child
Early ventilation tubes vs watchful waiting (treatment later if required)
RR 0.98 [0.94, 1.03]NRVery low
Downgraded: risk of bias, imprecision, indirectness
Disease‐specific quality of life
Early ventilation tubes vs watchful waiting (treatment later if required)
no estimate extractedNRNo studies
Presence/persistence of OME Randomised by child
Early ventilation tubes vs watchful waiting (treatment later if required)
RR 1.21 [0.84, 1.74]NRVery low
Downgraded: risk of bias, imprecision, indirectness
Adverse event: persistent perforation
Early ventilation tubes vs watchful waiting (treatment later if required)
no estimate extractedNRVery low
Downgraded: risk of bias, imprecision, indirectness

Ventilation tubes compared to non‐surgical treatment for OME in children

Population: children aged 6 months to 12 years with OME
4 questions
OutcomeEffectEvidenceStatus / GRADE
Hearing ‐ mean final hearing threshold (4 months ‐ medium‐term) № of participants: 125 (1 RCT)
Ventilation tubes vs non‐surgical treatment
no estimate extractedNRVery low
Downgraded: risk of bias, imprecision, indirectness
Disease‐specific quality of life
Ventilation tubes vs non‐surgical treatment
no estimate extractedNRNo studies
Presence/persistence of OME
Ventilation tubes vs non‐surgical treatment
no estimate extractedNRNo studies
Adverse event: persistent perforation (18 months ‐ long‐term) № of participants: 60 (1 RCT)
Ventilation tubes vs non‐surgical treatment
no estimate extractedNRLow
Downgraded: risk of bias, imprecision, indirectness

Ventilation tubes compared to myringotomy for OME in children

Population: children aged 6 months to 12 years with OME
4 questions
OutcomeEffectEvidenceStatus / GRADE
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)
Ventilation tubes vs myringotomy
RR 1.22 [0.59, 2.53]NRVery low
Downgraded: risk of bias, inconsistency
Disease‐specific quality of life
Ventilation tubes vs myringotomy
no estimate extractedNRNo studies
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)
Ventilation tubes vs myringotomy
OR 0.27 [0.19, 0.38]NRVery low
Downgraded: imprecision
Adverse event: persistent perforation Range of
Ventilation tubes vs myringotomy
no estimate extractedNRModerate
Downgraded: risk of bias, imprecision, inconsistency