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Margriet Hartman, MSc; Maroeska M. Rovers, PhD; Koen Ingels, PhD; Gerhard A. Zielhuis, PhD; Johan L. Severens, PhD; Gert Jan van der Wilt, PhD

Arch Otolaryngol Head Neck Surg. 2001;127:1471-1476.

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 US $454 in the ventilation tube group and US $120 in the watchful waiting group. On average, an additional investment of US $334 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.

From the Departments of Medical Technology Assessment (Ms Hartman and Drs Severens and van der Wilt), Otorhinolaryngology (Dr Ingels), and Epidemiology and Biostatistics (Drs Rovers and Zielhuis), University Medical Centre, Nijmegen, the Netherlands. Dr Severens is now with the Department of Health Organization, Policy, and Economics, University Maastricht, Maastricht, the Netherlands.