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. 2023 Nov 15;11(11):CD015215.
doi: 10.1002/14651858.CD015215.pub2.

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

Samuel MacKeith  1 , Caroline A Mulvaney  2 , Kevin Galbraith  2 , Katie E Webster  2 , Rachel Connolly  3 , Aye Paing  3 , Tal Marom  4 , Mat Daniel  5 , Roderick P Venekamp  6 , Maroeska M Rovers  7 , Anne Gm Schilder  8   9
Affiliations

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

Samuel MacKeith et al. Cochrane Database Syst Rev. .

Abstract

Background: Otitis media with effusion (OME) is an accumulation of fluid in the middle ear cavity, common amongst young children. It may cause hearing loss which, when persistent, may lead to developmental delay, social difficulty and poor quality of life. Management includes watchful waiting, autoinflation, medical and surgical treatment. Insertion of ventilation tubes has often been used as the preferred treatment.

Objectives: To evaluate the effects (benefits and harms) of ventilation tubes (grommets) for OME in children.

Search methods: We searched the Cochrane ENT Register, CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science, ClinicalTrials.gov, ICTRP and additional sources for published and unpublished trials on 20 January 2023.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs in children (6 months to 12 years) with OME for ≥ 3 months. We included studies that compared ventilation tube (VT) insertion with five comparators: no treatment, watchful waiting (ventilation tubes inserted later, if required), myringotomy, hearing aids and other non-surgical treatments.

Data collection and analysis: We used standard Cochrane methods. Our primary outcomes were determined following a multi-stakeholder prioritisation exercise and were: 1) hearing; 2) OME-specific quality of life; 3) persistent tympanic membrane perforation (as a severe adverse effect of the surgery). Secondary outcomes were: 1) persistence of OME; 2) other adverse effects (including tympanosclerosis, VT blockage and pain); 3) receptive language skills; 4) speech development; 5) cognitive development; 6) psychosocial skills; 7) listening skills; 8) generic health-related quality of life; 9) parental stress; 10) vestibular function; 11) episodes of acute otitis media. We used GRADE to assess the certainty of evidence for key outcomes. Although we included all measures of hearing assessment, the proportion of children who returned to normal hearing was our preferred method, due to challenges in interpreting the results of mean hearing thresholds.

Main results: We included 19 RCTs (2888 children). We considered most of the evidence to be very uncertain, due to wide confidence intervals for the effect estimates, few participants, and a risk of performance and detection bias. Here we report our key outcomes at the longest reported follow-up. There were some limitations to the evidence. No studies investigated the comparison of ventilation tubes versus hearing aids. We did not identify any data on disease-specific quality of life; however, many studies were conducted before the development of specific tools to assess this in otitis media. Short-acting ventilation tubes were used in most studies and thus specific data on the use of long-acting VTs is limited. Finally, we did not identify specific data on the effects of VTs in children at increased risk of OME (e.g. with craniofacial syndromes). Ventilation tubes versus no treatment (four studies) The odds ratio (OR) for a return to normal hearing after 12 months was 1.13 with VTs (95% confidence interval (CI) 0.46 to 2.74; 54% versus 51%; 1 study, 72 participants; very low-certainty evidence). At six months, VTs may lead to a large reduction in persistent OME (risk ratio (RR) 0.30, 95% CI 0.14 to 0.65; 20.4% versus 68.0%; 1 study, 54 participants; low-certainty evidence). The evidence is very uncertain about the chance of persistent tympanic membrane perforation with VTs at 12 months (OR 0.85, 95% CI 0.38 to 1.91; 8.3% versus 9.7%; 1 RCT, 144 participants). Early ventilation tubes versus watchful waiting (six studies) There was little to no difference in the proportion of children whose hearing returned to normal after 8 to 10 years (i.e. by the age of 9 to 13 years) (RR for VTs 0.98, 95% CI 0.94 to 1.03; 93% versus 95%; 1 study, 391 participants; very low-certainty evidence). VTs may also result in little to no difference in the risk of persistent OME after 18 months to 6 years (RR 1.21, 95% CI 0.84 to 1.74; 15% versus 12%; 3 studies, 584 participants; very low-certainty evidence). We were unable to pool data on persistent perforation. One study showed that VTs may increase the risk of perforation after a follow-up duration of 3.75 years (RR 3.65, 95% CI 0.41 to 32.38; 1 study, 391 participants; very low-certainty evidence) but the actual number of children who develop persistent perforation may be low, as demonstrated by another study (1.26%; 1 study, 635 ears; very low-certainty evidence). Ventilation tubes versus non-surgical treatment (one study) One study compared VTs to six months of antibiotics (sulphisoxazole). No data were available on return to normal hearing, but final hearing thresholds were reported. At four months, the mean difference was -5.98 dB HL lower (better) for those receiving VTs, but the evidence is very uncertain (95% CI -9.21 to -2.75; 1 study, 125 participants; very low-certainty evidence). No evidence was identified regarding persistent OME. VTs may result in a low risk of persistent perforation at 18 months of follow-up (no events reported; narrative synthesis of 1 study, 60 participants; low-certainty evidence). Ventilation tubes versus myringotomy (nine studies) We are uncertain whether VTs may slightly increase the likelihood of returning to normal hearing at 6 to 12 months, since the confidence intervals were wide and included the possibility of no effect (RR 1.22, 95% CI 0.59 to 2.53; 74% versus 64%; 2 studies, 132 participants; very low-certainty evidence). After six months, persistent OME may be reduced for those who receive VTs compared to laser myringotomy, but the evidence is very uncertain (OR 0.27, 95% CI 0.19 to 0.38; 1 study, 272 participants; very low-certainty evidence). At six months, the risk of persistent perforation is probably similar with the use of VTs or laser myringotomy (narrative synthesis of 6 studies, 581 participants; moderate-certainty evidence).

Authors' conclusions: There may be small short- and medium-term improvements in hearing and persistence of OME with VTs, but it is unclear whether these persist after longer follow-up. The RCTs included do not allow us to say when (or how much) VTs improve hearing in any specific child. However, interpretation of the evidence is difficult: many children in the control groups recover spontaneously or receive VTs during follow-up, VTs may block or extrude, and OME may recur. The limited evidence in this review also affects the generalisability/applicability of our findings to situations involving children with underlying conditions (e.g. craniofacial syndromes) or the use of long-acting tubes. Consequently, RCTs may not be the best way to determine whether an intervention is likely to be effective in any individual child. Instead, we must better understand the different OME phenotypes to target interventions to children who will benefit most, and avoid over-treating when spontaneous resolution is likely.

Trial registration: ClinicalTrials.gov NCT00365092 NCT02490332.

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Conflict of interest statement

Samuel MacKeith: ENT private practice (employment); sees patients with general ENT problems in NHS and private practice; Assistant Co‐ordinating Editor of Cochrane ENT 2020‐2023, but had no role in the editorial process for this review.

Caroline A Mulvaney: none known.

Kevin Galbraith: none known.

Katie Webster: none known.

Rachel Connolly: National Institute for Health and Care Excellence (employment: systematic reviewer on the upcoming NICE guideline on otitis media with effusion in under 12s).

Aye Paing: none known.

Tal Marom: no relevant interests; Attending Otolaryngologist.

Mat Daniel: Aventa Med (stock; consultant); Nottingham University Hospitals NHS Trust (employment: ENT consultant); published research papers relevant to the interventions in the work; co‐author of the TARGET trial.

Roderick P Venekamp: no relevant interests; work as a GP; editorial board member of Cochrane ARI and ENT, but had no role in the editorial process for this review.

Maroeska M Rovers: no relevant interests; involved in the KNOOP‐3 study on the effectiveness of ventilation tubes performed in the Netherlands (sponsored by ZonMw).

Anne GM Schilder: joint Co‐ordinating Editor of Cochrane ENT until April 2020, but had no role in the editorial process for this review.; treats patients with OME in her NHS practice. Her evidENT team at the UCL Ear Institute is supported by the National Institute of Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC), with research projects being supported by the NIHR, Wellcome Trust, RNiD, ENT UK and industry; National Specialty Lead for the NIHR Clinical Research Network ENT and Surgical Specialty Lead for ENT for the Royal College of Surgeons of England's Clinical Research Initiative; in her role as director of the NIHR UCLH BRC Deafness and Hearing Problems Theme, she advises CRO, biotech and pharma companies in the hearing field on clinical trial design and delivery.

Figures

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The Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool
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4
4
1.1
1.1. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 1: Return to normal hearing, randomised by ear (medium‐term)
1.2
1.2. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 2: Mean final hearing threshold, randomised by ear (medium‐term)
1.3
1.3. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 3: Change in hearing threshold from baseline, randomised by ear (medium‐term)
1.4
1.4. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 4: Adverse event: perforation/retraction, randomised by ear (medium‐term)
1.5
1.5. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 5: Persistence of OME: randomised by child (very short‐term)
1.6
1.6. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 6: Persistence of OME: randomised by child (medium‐term)
1.7
1.7. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 7: Persistence of OME: randomised by ear (medium‐term)
1.8
1.8. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 8: Mean improvement in comprehensive language, randomised by child (medium‐term)
1.9
1.9. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 9: Mean improvement in expressive language, randomised by child (medium‐term)
1.10
1.10. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 10: Adverse event: tympanosclerosis, randomised by ear (medium‐term)
2.1
2.1. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 1: Return to normal hearing, randomised by child (long‐term)
2.2
2.2. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 2: Mean final hearing threshold, randomised by child (short‐term)
2.3
2.3. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 3: Mean final hearing threshold (air conduction), randomised by child (medium‐term)
2.4
2.4. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 4: Mean final hearing threshold (air‐bone gap), randomised by child, analysed by ear (medium‐term)
2.5
2.5. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 5: Mean final hearing threshold, randomised by child (long‐term)
2.6
2.6. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 6: Hearing in noise test, randomised by child (long‐term)
2.7
2.7. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 7: Change in hearing threshold from baseline, randomised by child (medium‐term)
2.8
2.8. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 8: Adjusted mean difference in hearing improvement, randomised by child (medium term)
2.9
2.9. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 9: Adverse event: persistent perforation, randomised by child (medium‐term)
2.10
2.10. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 10: Adverse event: persistent perforation, randomised by child (long‐term)
2.11
2.11. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 11: Presence/persistence of OME, randomised by child, measured by otoscopy (medium‐term)
2.12
2.12. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 12: Presence/persistence of OME, randomised by child, measured by tympanometry (medium‐term)
2.13
2.13. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 13: Presence/persistence of OME, mean percentage of days, randomised by child (medium‐term)
2.14
2.14. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 14: Presence/persistence of OME, randomised by child (long‐term)
2.15
2.15. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 15: Presence/persistence of OME, adjusted OR, randomised by child (long‐term)
2.16
2.16. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 16: Adverse event: tympanosclerosis (long‐term)
2.17
2.17. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 17: Adverse event: fibrosis (long‐term)
2.18
2.18. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 18: Adverse event: segmental atrophy (long‐term)
2.19
2.19. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 19: Adverse event: retraction pocket with other abnormality (long‐term)
2.20
2.20. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 20: Receptive language development, Reynell test, randomised by child (medium‐term)
2.21
2.21. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 21: Receptive language development, Reynell test, adjusted MD (medium‐term)
2.22
2.22. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 22: Receptive language, Reynell test, randomised by child (long‐term)
2.23
2.23. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 23: Receptive language: Reynell test, long‐term, adjusted MD
2.24
2.24. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 24: Receptive language: WOLD adjusted OR (long‐term)
2.25
2.25. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 25: Receptive language, mean difference (months) in improvement in Reynell test score (equivalent age‐real age): medium‐term
2.26
2.26. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 26: Receptive language, adjusted mean difference (months) in improvement in Reynell test score (equivalent age ‐ real age): medium‐term
2.27
2.27. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 27: Expressive language development: Reynell test (medium‐term)
2.28
2.28. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 28: Expressive language development: Reynell test, medium‐term, adjusted MD
2.29
2.29. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 29: Expressive language development: Reynell test (long‐term)
2.30
2.30. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 30: Expressive language development: Reynell test, long‐term, adjusted MD
2.31
2.31. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 31: Expressive language: WOLD adjusted OR (long‐term)
2.32
2.32. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 32: Expressive language, MD (months) in improvement in Schlichting test score (equivalent age‐real age): medium‐term
2.33
2.33. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 33: Expressive language, adjusted mean difference (months) in improvement in Schlichting test score (equivalent age‐real age): medium‐term
2.34
2.34. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 34: Non‐word repetition total score, adjusted OR (long‐term)
2.35
2.35. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 35: Reading, WORD test, adjusted OR (long‐term)
2.36
2.36. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 36: Spelling, ALSPAC test, adjusted OR (long‐term)
2.37
2.37. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 37: Phoneme deletion, adjusted OR (long‐term)
2.38
2.38. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 38: Cognitive development: Griffiths practical reasoning (medium‐term)
2.39
2.39. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 39: Cognitive development: IQ (WISC‐III UK short form) adjusted OR (long‐term)
2.40
2.40. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 40: Behaviour, Richman score (medium‐term)
2.41
2.41. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 41: Behaviour, Richman score, dichotomised (medium‐term)
2.42
2.42. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 42: Behaviour, Richman score, adjusted OR (medium‐term)
2.43
2.43. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 43: Behaviour, Richman score (long‐term)
2.44
2.44. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 44: Behaviour, Richman score, dichotomised (long‐term)
2.45
2.45. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 45: Behaviour: SDQ teacher report, total, adjusted OR (long‐term)
2.46
2.46. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 46: Parent‐child interaction: Erickson child scale (medium‐term)
2.47
2.47. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 47: Parent‐child interaction: Erickson parent scale (medium‐term)
2.48
2.48. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 48: Generic health‐related quality of life: TAIQOL (medium‐term)
2.49
2.49. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 49: Parental stress, Parental Stress Index, short form (long‐term)
2.50
2.50. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 50: Literacy (long‐term)
2.51
2.51. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 51: Phonological awareness (long‐term)
2.52
2.52. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 52: Attention, impulsivity and psychosocial function, long‐term (1): disruptive behaviour disorders, child behaviour and impairment rating
2.53
2.53. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 53: Attention, impulsivity and psychosocial function, long‐term (2): social skills
2.54
2.54. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 54: Attention, impulsivity and psychosocial function, long‐term: Visual and auditory continuous performance
2.55
2.55. Analysis
Comparison 2: Early ventilation tubes versus watchful waiting (treatment later if required) , Outcome 55: Intelligence and academic achievement (long‐term)
3.1
3.1. Analysis
Comparison 3: Ventilation tubes versus non‐surgical treatment, Outcome 1: Mean final hearing threshold (short‐term)
3.2
3.2. Analysis
Comparison 3: Ventilation tubes versus non‐surgical treatment, Outcome 2: Mean final hearing threshold (medium‐term)
3.3
3.3. Analysis
Comparison 3: Ventilation tubes versus non‐surgical treatment, Outcome 3: Adverse event: myringosclerosis (long‐term)
3.4
3.4. Analysis
Comparison 3: Ventilation tubes versus non‐surgical treatment, Outcome 4: Number of doctor‐diagnosed AOM episodes (medium‐term)
3.5
3.5. Analysis
Comparison 3: Ventilation tubes versus non‐surgical treatment, Outcome 5: Number of doctor‐diagnosed episodes of AOM (long‐term)
4.1
4.1. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 1: Hearing returned to normal: VT versus laser myringotomy (medium‐term)
4.2
4.2. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 2: Mean final hearing threshold, randomised by child (short‐term). Adjusted for non‐independence of within‐individual measurements; assumed ICC of 0.5
4.3
4.3. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 3: Mean final hearing threshold, randomised by ear (short‐term)
4.4
4.4. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 4: Mean final hearing threshold (medium‐term)
4.5
4.5. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 5: Adverse event: persistent perforation (medium‐term)
4.6
4.6. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 6: Adverse event: persistent perforation cold‐steel myringotomy (medium‐term)
4.7
4.7. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 7: Persistence of OME: VT versus laser myringotomy (short‐term)
4.8
4.8. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 8: Persistence of OME: VT versus thermal myringotomy, randomised by ear (short‐term)
4.9
4.9. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 9: Persistence of OME: VT versus cold‐steel myringotomy (medium‐term)
4.10
4.10. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 10: Persistence of OME: VT versus laser myringotomy (medium‐term)
4.11
4.11. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 11: Persistence of OME: VT versus laser myringotomy, randomised by ear (medium‐term)
4.12
4.12. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 12: Persistence of OME: mean days to first recurrence
4.13
4.13. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 13: Persistence of OME (long‐term)
4.14
4.14. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 14: Adverse events: otorrhoea (long‐term)
4.15
4.15. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 15: Zero, one or two episodes of AOM in 12 months
4.16
4.16. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 16: Three or more episodes of AOM in 12 months
4.17
4.17. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 17: Adverse event: retraction of TM: VT versus laser myringotomy (medium‐term)
4.18
4.18. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 18: Adverse event: hypertrophic scar of TM: VT versus laser myringotomy (medium‐term)
4.19
4.19. Analysis
Comparison 4: Ventilation tubes versus myringotomy, Outcome 19: Adverse event: otorrhoea: VT versus laser myringotomy (medium‐term)
5.1
5.1. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 1: Sensitivity analysis: Return to normal hearing, randomised by ear (medium‐term); CC = 0.3
5.2
5.2. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 2: Sensitivity analysis: Return to normal hearing, randomised by ear (medium‐term); CC = 0.7
5.3
5.3. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 3: Sensitivity analysis: Return to normal hearing, randomised by ear (medium‐term). Normal defined as < 25 dB; CC = 0.5
5.4
5.4. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 4: Sensitivity analysis: Mean final hearing threshold, randomised by ear (medium‐term); CC = 0.3
5.5
5.5. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 5: Sensitivity analysis: Mean final hearing threshold, randomised by ear (medium‐term); CC = 0.7
5.6
5.6. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 6: Sensitivity analysis: Change in hearing threshold from baseline, randomised by ear (medium‐term); CC = 0.3
5.7
5.7. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 7: Sensitivity analysis: Change in hearing threshold from baseline, randomised by ear (medium‐term); CC = 0.7
5.8
5.8. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 8: Sensitivity analysis: Adverse event: perforation/retraction, randomised by ear (medium‐term); CC = 0.3
5.9
5.9. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 9: Sensitivity analysis: Adverse event: perforation/retraction, randomised by ear (medium‐term); CC = 0.7
5.10
5.10. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 10: Sensitivity analysis: Persistence of OME: randomised by child (medium‐term); ICC = 1.0
5.11
5.11. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 11: Sensitivity analysis: Persistence of OME: randomised by child (medium‐term); ICC = zero
5.12
5.12. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 12: Sensitivity analysis: Persistence of OME: randomised by ear (medium‐term); CC = 0.3
5.13
5.13. Analysis
Comparison 5: Sensitivity analyses: Ventilation tubes versus no treatment, Outcome 13: Sensitivity analysis: Persistence of OME: randomised by ear (medium‐term); CC = 0.7
6.1
6.1. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 1: Sensitivity analysis: Mean final hearing threshold (air‐bone gap), randomised by child, analysed by ear (medium‐term); ICC = 1.0
6.2
6.2. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 2: Sensitivity analysis: Mean final hearing threshold (air‐bone gap), randomised by child, analysed by ear (medium‐term); ICC = zero
6.3
6.3. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 3: Sensitivity analysis: Mean final hearing threshold, randomised by child (long‐term); CC for Paradise 2007 of 0.3
6.4
6.4. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 4: Sensitivity analysis: Mean final hearing threshold, randomised by child (long‐term); CC for Paradise 2007 of 0.7
6.5
6.5. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 5: Sensitivity analysis: Persistent perforation, randomised by child (long‐term); ICC = 1.0
6.6
6.6. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 6: Sensitivity analysis: Persistent perforation, randomised by child (long‐term); ICC = zero
6.7
6.7. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 7: Sensitivity analysis: Persistence of OME, randomised by child, measured by otoscopy (medium‐term); ICC = 1.0
6.8
6.8. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 8: Sensitivity analysis: Persistence of OME, randomised by child, measured by otoscopy (medium‐term); ICC = zero
6.9
6.9. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 9: Sensitivity analysis: Tympanosclerosis (long‐term); ICC = 1.0
6.10
6.10. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 10: Sensitivity analysis: Tympanosclerosis (long‐term); ICC = zero
6.11
6.11. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 11: Sensitivity analysis: Adverse event: fibrosis (long‐term); ICC = 1.0
6.12
6.12. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 12: Sensitivity analysis: Adverse event: fibrosis (long‐term); ICC = zero
6.13
6.13. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 13: Sensitivity analysis: Segmental atrophy (long‐term); ICC = 1.0
6.14
6.14. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 14: Sensitivity analysis: Segmental atrophy (long‐term); ICC = zero
6.15
6.15. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 15: Sensitivity analysis: Retraction pocket with other abnormality (long‐term); ICC = 1.0
6.16
6.16. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 16: Sensitivity analysis: Retraction pocket with other abnormality (long‐term); ICC = zero
6.17
6.17. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 17: Sensitivity analysis: Parent‐child interaction: Erickson child scale (medium‐term); CC = 0.3
6.18
6.18. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 18: Sensitivity analysis: Parent‐child interaction: Erickson child scale (medium‐term); CC = 0.7
6.19
6.19. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 19: Sensitivity analysis: Parent‐child interaction: Erickson parent scale (medium‐term); CC = 0.3
6.20
6.20. Analysis
Comparison 6: Sensitivity analyses: Early ventilation tubes versus watchful waiting, Outcome 20: Sensitivity analysis: Parent‐child interaction: Erickson parent scale (medium‐term); CC = 0.7
7.1
7.1. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 1: Sensitivity analysis: Hearing returned to normal: VT versus laser myringotomy (medium‐term); ICC = 1.0
7.2
7.2. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 2: Sensitivity analysis: Hearing returned to normal: VT versus laser myringotomy (medium‐term); ICC = zero
7.3
7.3. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 3: Sensitivity analysis: Mean final hearing threshold, randomised by child (short‐term); ICC = 1.0
7.4
7.4. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 4: Sensitivity analysis: Mean final hearing threshold, randomised by child (short‐term); ICC = zero
7.5
7.5. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 5: Sensitivity analysis: Mean final hearing threshold (medium‐term); ICC = 1.0
7.6
7.6. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 6: Sensitivity analysis: Mean final hearing threshold (medium‐term); ICC = zero
7.7
7.7. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 7: Sensitivity analysis: Persistent perforation (medium‐term); ICC = 1.0
7.8
7.8. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 8: Sensitivity analysis: Persistent perforation (medium‐term); ICC = zero
7.9
7.9. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 9: Sensitivity analysis: Persistence of OME: VT versus laser myringotomy (short‐term); ICC = 1.0
7.10
7.10. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 10: Sensitivity analysis: Persistence of OME: VT versus laser myringotomy (short‐term); ICC = zero
7.11
7.11. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 11: Sensitivity analysis: Persistence of OME: VT versus laser myringotomy (medium‐term); ICC = 1.0
7.12
7.12. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 12: Sensitivity analysis: Persistence of OME: VT versus laser myringotomy (medium‐term); ICC = zero
7.13
7.13. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 13: Sensitivity analysis: Persistence of OME: VT versus laser myringotomy, randomised by ear (medium‐term); CC = 0.3
7.14
7.14. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 14: Sensitivity analysis: Persistence of OME: VT versus laser myringotomy, randomised by ear (medium‐term); CC = 0.7
7.15
7.15. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 15: Sensitivity analysis: Retraction of TM: VT versus laser myringotomy (medium‐term); ICC = 1.0
7.16
7.16. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 16: Sensitivity analysis: Retraction of TM: VT versus laser myringotomy (medium‐term); ICC = zero
7.17
7.17. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 17: Sensitivity analysis: Otorrhoea: VT versus laser myringotomy (medium‐term); ICC = 1.0
7.18
7.18. Analysis
Comparison 7: Sensitivity analyses: Ventilation tubes versus myringotomy, Outcome 18: Sensitivity analysis: Otorrhoea: VT versus laser myringotomy (medium‐term); ICC = zero
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References

References to studies included in this review

Bernard 1991 {published data only}
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Paradise 2007 {published data only}
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Popova 2010 {published data only}
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Rach 1991 {published data only}
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Rovers 2000 {published data only}
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Ruckley 1988 {published data only}
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Sujatha 2015 {published data only}
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Tao 2020 {published data only}
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To 1984 {published data only}
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References to studies excluded from this review

Ah‐Tye 2001 {published data only}
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Black 1990 {published data only}
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El Begermy 2022 {published data only}
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Gebhart 1981 {published data only}
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Gibson 1996 {published data only}
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Hammaren‐Malmi 2005 {published data only}
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Hao 2019 {published data only}
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Hassmann 2004 {published data only}
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Iino 1989 {published data only}
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Jabeen 2019 {published data only}
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Kremer 1979 {published data only}
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Kujala 2012 {published data only}
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Li 2020 {published data only}
    1. Li H, Zhou Y, Huang J, Zhang L, Lou Z. Treatment of secretory otitis media with balloon dilation and tympanostomy tube insertion: a randomized controlled trial. Basic & Clinical Pharmacology & Toxicology 2020;127(Suppl 1):292-3. [CENTRAL: CN-02230226] [EMBASE: 633830686]
Lildholdt 1983 {published data only}
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Liu 2004 {published data only}
    1. Liu L, Sun YG, Ma L, Zhao W, Wu R. Effect of ventilation tube insertion on otitis media with effusion in cleft palate children. Zhonghua Er Bi Yan Hou Ke za Zhi 2004;39(4):216-8. [CENTRAL: CN-00549233] [EMBASE: 39714817] - PubMed
Mandel 1989 {published data only}
    1. Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Archives of Otolaryngology--Head & Neck Surgery 1989;115(10):1217-24. [CENTRAL: CN-00062654] [PMID: ] - PubMed
Mandel 1992 {published data only}
    1. Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Pediatric Infectious Disease Journal 1992;11(4):270-7. [CENTRAL: CN-00338034] [PMID: ] - PubMed
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NCT05545345 {published data only}
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Nguyen 2004 {published data only}
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Paradise 1990 {published data only}
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Paradise 1997 {published data only}
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Stenstrom 2005 {published data only}
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Tao 2004 {published data only}
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Uvarova 2001 {published data only}
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Xu 2016 {published data only}
    1. Xu WM, Ye YH. Effect of tympanostomy tube insertion with adenoidectomy for children with recurrent otitis media with effusion. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke za Zhi [Journal of Clinical Otorhinolaryngology, Head, and Neck Surgery] 2016;30(23):1873-5. [CENTRAL: CN-01614396] [EMBASE: 622451696] [PMID: ] - PubMed
Yousaf 2014 {published data only}
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References to studies awaiting assessment

Diacova 2016 {published data only}
    1. Diacova S, McDonald TJ, Ababii I. Clinical, functional, and surgical findings in chronic bilateral otitis media with effusion in childhood. Ear, Nose, & Throat Journal 2016;95(8):E31-7. [CENTRAL: CN-01339417] [EMBASE: 614412861] [PMID: ] - PubMed
Marshak 1980 {published data only}
    1. Marshak G, Neriah ZB. Adenoidectomy versus tympanostomy in chronic secretory otitis media. Annals of Otology, Rhinology, and Laryngology. Supplement 1980;89(3 Part 2):316-8. - PubMed
Maw 1986 {published data only}
    1. Maw AR. Adenoidectomy and adenotonsillectomy for otitis media with effusion in children: a prospective randomized controlled study (Masters thesis). Bristol, UK: University of Bristol, 1986. [CENTRAL: CN-00849155]
Tawfik 2002 {published data only}
    1. Tawfik S, Belal A, Sorour W. A comparative study of the different treatment modalities of otitis media with effusion in children. In: 8th International Congress of Paediatric Otorhinolaryngology (ESPO). Oxford, UK, 11-14 September, 2002. 2002:151. [ABSTRACT NUMBER: P2.26] [CENTRAL: CN-00508402]

References to ongoing studies

ACTRN12611001073998 {unpublished data only}
    1. ACTRN12611001073998. Surgery for otitis media in Indigenous Australian children [A 12 month, multi-centred, randomized trial to compare the outcomes of two surgical and one medical intervention on chronic Otitis Media in Indigenous children living in remote communities of Australia. Medicine V surgery sub-study]. www.anzctr.org.au/ACTRN12611001073998.aspx (first received 17 October 2011). [CENTRAL: CN-01012938]
NCT02546518 {published data only}
    1. NCT02546518. A comparison of surgical and a new non-surgical treatment methods for secretory otitis media in children- hearing and socioeconomic aspects. clinicaltrials.gov/show/nct02546518 (first received 11 September 2015). [CENTRAL: CN-01102072]
NCT04584073 {published data only}
    1. NCT04584073. Secretory otitis media in adenoids hypertrophy patients [Comparison between the fate of secretory otitis media in patients with adenoids hypertrophy undergoing adenoidectomy alone or with myringotomy or with myringotomy and tympanostomy tube application]. clinicaltrials.gov/show/NCT04584073 (first received 12 October 2020). [CENTRAL: CN-02181953]

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References to other published versions of this review

MacKeith 2022
    1. MacKeith S, Mulvaney CA, Galbraith K, Marom T, Daniel M, Venekamp RP, et al. Ventilation tubes (grommets) for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2022, Issue 3. Art. No: CD015215. [DOI: 10.1002/14651858.CD015215] - DOI - PMC - PubMed

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