Tympanostomy tube outcomes in children at-risk and not at-risk for developmental delays Richard M. Rosenfeld a, *, David W. Jang b , Konstantin Tarashansky c a Department of Otolaryngology, State University of New York Downstate Medical Center and the Long Island College Hospital, 339 Hicks Street, Brooklyn, NY, United States b Department of Otolaryngology, Mount Sinai Medical Center, New York, NY, United States c Long Island ENT Associates, Plainview, NY, United States 1. Introduction Tympanostomy tube insertion is one of the most common surgical procedures in children, with more than 10,000 cases performed weekly in the United States [1]. The efficacy of tubes for reducing ear infections, hearing loss, and middle-ear effusion is well-documented [2–8], but the impact on child development and quality of life is less clear. Published studies are limited by short- term follow-up [9], loss to follow-up [10], and limited generaliz- ability because of restricted cohorts that include mainly healthy, asymptomatic children with middle-ear effusion identified by screening [11] or intense surveillance [12]. Although current guidelines for otitis media with effusion (OME) emphasize prompt intervention in children at-risk for developmental delays [13], there are very limited data on outcomes of tympanostomy tube insertion in this sub-population. The paucity of data stems from ethical concerns about including children with delays in speech, language, learning, or development in randomized trials [14]. Nonetheless about 17% of children under age 17 years in the United States have developmental disorders, which include transient delays in attaining milestones (e.g., speech, motor, social-adaptive) and persistent disabilities such as autism, cerebral palsy, mental retardation, speech disorders, and learning disabilities later in childhood [15]. Accordingly, evaluat- ing the benefit from tube insertion in this large group of candidates is an important goal of current otitis media research [16]. Our study is the first to compare tympanostomy tube outcomes in children at-risk and not at-risk for developmental delays using the national tri-academy criteria proposed by the American Academies of Pediatrics, Family Physicians, and Otolaryngology – Head and Neck Surgery [13]. The results suggest that caregivers of children with developmental delays perceive more favorable outcomes, when adjusted for child age, gender, and baseline hearing status. Although limited by observational design, theses International Journal of Pediatric Otorhinolaryngology 75 (2011) 190–195 ARTICLE INFO Article history: Received 3 April 2010 Received in revised form 27 October 2010 Accepted 27 October 2010 Available online 23 November 2010 Keywords: Otitis media Tympanostomy tubes Developmental delays Quality of life Outcomes research ABSTRACT Objectives: To assess outcomes after tympanostomy tubes in children at-risk or not-at-risk for developmental delays based on criteria from the American Academies of Pediatrics, Family Physicians, and Otolaryngology – Head and Neck Surgeons. Methods: Historical cohort study in a pediatric otolaryngology practice at an urban, not-for-profit hospital. All children had baseline audiometry followed by bilateral tube insertion with a Likert-type outcome questionnaire administered to the caregiver by telephone (86%) or mail (14%). Results: We identified 229 eligible children aged .5–13 years, of which caregivers of 168 children (73%) were available for follow-up at a median time of 2.0 years (range .7–3.1 years). Most children (55%) had at least one condition placing them at-risk for developmental delays. The mean pure-tone average at baseline for the better-hearing ear was 32 dB HL (10.4 SD). After tube insertion most caregivers (89%) stated that their child’s life ‘‘much better,’’ and that expectations were met (60%) or exceeded (38%). Speech and language was ‘‘much better’’ for 55%, more often in at-risk children (odds ratio 4.6, 95% CI 2.4–8.8). Similarly, learning or school performance was ‘‘much better’’ after tubes for 55%, more often in at-risk children (odds ratio 3.1, 95% CI 1.6–5.9). Improved hearing was reported by 84% with no relationship to at-risk status. Conclusions: Caregivers reported favorable outcomes regardless of their child’s at-risk status, but children at-risk for delays had better reported outcomes for speech, language, learning, and school performance. Results are limited by lack of a control group and reliance on caregiver-report, but add to the very limited data currently available about predictors of benefit from tubes. ß 2010 Elsevier Ireland Ltd. All rights reserved. * Corresponding author. Tel.: +1 718 780 1282; fax: +1 718 780 2819. E-mail address: richrosenfeld@msn.com (R.M. Rosenfeld). Contents lists available at ScienceDirect International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl 0165-5876/$ – see front matter ß 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijporl.2010.10.032