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. 2005 May;90(5):480–485. doi: 10.1136/adc.2004.059444

Grommets in otitis media with effusion: an individual patient data meta-analysis

M Rovers 1, N Black 1, G Browning 1, R Maw 1, G Zielhuis 1, M Haggard 1
PMCID: PMC1720375  PMID: 15851429

Abstract

Aims: To identify subgroups of children with otitis media with effusion (OME) that might benefit more than others from treatment with ventilation tubes.

Methods: An individual patient data (IPD) meta-analysis on seven randomised controlled trials (n = 1234 children in all), focusing on interactions between treatment and baseline characteristics—hearing level (HL), history of acute otitis media, common colds, attending day-care, gender, age, socioeconomic status, siblings, season, passive smoking, and history of breast feeding. Outcome measures that could be studied were mean time spent with effusion (n = 557), mean hearing levels (n = 557 in studies that randomised children, and n = 180 in studies that randomised ears), and language development (n = 381).

Results: In the trials that treated both ears the only significant interaction was between day-care and surgery, occurring where mean hearing level was the outcome measure. None of the other baseline variables showed an interaction effect with treatment that would justify subgrouping. In the trials that treated only one ear, the baseline hearing level showed a significant but not pervasive interaction with treatment—that is, only with a cut-off of 25 dB HL.

Conclusions: The effects of conventional ventilation tubes in children studied so far are small and limited in duration. Observation (watchful waiting) therefore seems to be an adequate management strategy for most children with OME. Ventilation tubes might be used in young children that grow up in an environment with a high infection load (for example, children attending day-care), or in older children with a hearing level of 25 dB HL or greater in both ears persisting for at least 12 weeks.

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Figure 1.

Figure 1

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 QUOROM flow chart.

Figure 2.

Figure 2

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 (A) Stratified results regarding the interaction between day-care and treatment (k = 4 trials) after 6 months follow up. p = 0.02 for interaction. Number of cases in each subgroup: VT and day-care, n = 123; WW + day-care, n = 118; VT without day-care, n = 67; WW without day-care, n = 63. (B) Stratified results regarding the interaction between day-care and treatment (k = 4 trials) after 12 months follow up. p = 0.61 for interaction. Number of cases in each subgroup: VT and day-care, n = 127; WW + day-care, n = 112; VT without day-care, n = 68; WW without day-care, n = 61.

Figure 3.

Figure 3

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 (A) Stratified results regarding the interaction between baseline hearing level and treatment in the trials that randomised ears (k = 3) after 6 months follow up. p = 0.05 for interaction. Number of cases in each subgroup: VT and ⩽25 dB HL, n = 60; WW and ⩽25 dB HL, n = 57; VT and >25 dB HL, n = 20; WW and >25 dB HL, n = 23. (B) Stratified results regarding the interaction between baseline hearing level and treatment in the trials that randomised ears (k = 3) after 12 months follow up. p = 0.28 for interaction. Number of cases in each subgroup: VT and ⩽25 dB HL, n = 58; WW and ⩽25 dB HL, n = 55; VT and >25 dB HL, n = 20; WW and >25 dB HL, n = 23.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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