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Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1–2 years
  1. M M Roversa,
  2. P F M Krabbeb,
  3. H Straatmanc,
  4. K Ingelsa,
  5. G-J van der Wiltb,
  6. G A Zielhuisc
  1. aDepartment of Otorhinolaryngology, University Medical Centre Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands, bDepartment of Medical Technology Assessment, University Medical Centre Nijmegen, cDepartment of Epidemiology, University Medical Centre Nijmegen
  1. Dr RoversM.Rovers{at}mie.kun.nl

Abstract

AIMS To study the effect of treatment with ventilation tubes on quality of life in children aged 1–2 years with persistent otitis media with effusion (OME), as compared to watchful waiting.

METHODS Multicentre randomised controlled trial (n = 187) with two treatment arms: ventilation tubes and watchful waiting. Children were detected by auditory screening at the age of 9–12 months, and were subsequently diagnosed as having persistent (4–6 months) bilateral OME. Quality of life (TAIQOL and Erickson scales) was measured at 0, 6, and 12 months follow up.

RESULTS There was improvement in quality of life, but the ventilation tube group did not improve significantly more than the watchful waiting group. Although an attempt has been made to identify possible subgroups that benefit more, we were not able to find such subgroups, which might be a result of lack of power in this study.

CONCLUSION Ventilation tubes do not have a substantial incremental effect on the quality of life of infants aged 1–2 years with uncomplicated persistent bilateral OME.

  • otitis media with effusion
  • ventilation tubes
  • randomised controlled trial
  • quality of life

https://doi.org/10.1136/adc.84.1.45

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    • Rapid responses
      Rapid responses
      BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health
      Archives of Disease in Childhood 2001; 84 310-310 Published Online First: 01 Apr 2001. doi: 10.1136/adc.84.4.310