Objective: To determine the costs and effectiveness of treatment with ventilation tubes as compared with watchful waiting in children with persistent otitis media with effusion.
Design: Randomized controlled trial.
Setting: Institutional practice.
Patients: A total of 187 young children (19 months old) with persistent bilateral otitis media with effusion.
Interventions: Treatment with ventilation tubes or watchful waiting.
Main outcome measures: The time without effusion, language development, and the costs from a societal perspective during 1-year follow-up.
Results: The mean duration of effusion was 9.2 months in the watchful waiting group and 4.7 months in the ventilation tube group. The language development was comparable in both groups (0.7 month of improvement difference [95% confidence interval, -0.3 to 1.7 months] after correction for confounding variables). Because no statistically significant differences were found in the language development between the treatment groups, we performed a cost minimization analysis. The mean costs per child during 1 year of follow-up were 454 US dollars in the ventilation tube group and 120 US dollars in the watchful waiting group. On average, an additional investment of 334 US dollars per patient was needed for ventilation tube treatment.
Conclusion: In the absence of differences in language development and in view of higher costs, treatment with ventilation tubes is not recommended as standard treatment in all young children with persistent otitis media with effusion traced by a population-based screening program.