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Grommets in otitis media with effusion: an individual patient data meta-analysis
  1. M M Rovers1,
  2. N Black2,
  3. G G Browning3,
  4. R Maw4,
  5. G A Zielhuis5,
  6. M P Haggard6
  1. 1Julius Center for Health Sciences and Primary Care and Department of Pediatrics, University Medical Center Utrecht, Netherlands
  2. 2Department of Public Health & Policy, London School of Hygiene & Tropical Medicine, London, UK
  3. 3MRC Institute of Hearing Research (Scottish Section), Glasgow Royal Infirmary University NHS Trust, Glasgow, UK
  4. 4Department of Otolaryngology, St Michaels Hospital, University of Bristol, Bristol, UK
  5. 5Department of Epidemiology and Biostatistics, University Medical Centre Nijmegen, Netherlands
  6. 6MRC ESS Team in Children’s Middle Ear Disease, Addenbrooke’s Hospital, Cambridge, UK
  1. Correspondence to:
    Dr M M Rovers
    University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care, Stratenum 6.139, PO Box 85060, 3508 AB Utrecht, Netherlands; mroversumcutrecht.nl

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.

  • HL, hearing level
  • IPD, individual patient data
  • OME, otitis media with effusion
  • RCT, randomised controlled trial
  • VT, ventilation tube
  • WW, watchful waiting
  • IPD meta-analysis
  • otitis media with effusion
  • ventilation tubes
  • hearing
  • language
  • grommets

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Footnotes

  • * A standardised and validated test measuring the comprehensive language development.

  • Funding: this study was funded by a grant from the Dutch Health Care Insurance Board (VAZ01121)

  • Competing interests: none declared

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