OBJECTIVE: To determine the long-term effects of ventilation tube insertion on hearing thresholds and tympanic membrane pathologic abnormalities in children with otitis media with effusion. DESIGN: Prospective cohort study. SETTING:Tertiary care children's hospital, otorhinolaryngology and audiology service. PARTICIPANTS: Patients aged 8 to 16 years who participated in a randomized controlled trial of medical vs surgical (ventilation tube [VT]) treatment for recurrent otitis media with effusion at ages 2.5 to 7 years. MAIN OUTCOME MEASURES: Hearing thresholds and tympanic membrane sequelae. METHODS:One hundred thirteen of 125 children who had participated in the trial underwent blinded audiometric, tympanometric, otomicroscopic, and parental questionnaire evaluation 6 to 10 years following the trial. Thirty of 57 [corrected] medical subjects received ventilation tubes and 18 of 56 [corrected] VT subjects received more than 1 set of tubes. To evaluate sequelae risk associated with ventilation tubes independent of disease severity, we compared 27 medical subjects who never received ventilation tubes and 38 subjects randomized to VT who only received 1 set of tubes. RESULTS:Tympanic membrane pathologic abnormalities were present in 81% of VT subjects and 19% of medical subjects (relative risk, 4.4; 95% confidence interval, 2.2-9.9). Hearing thresholds were 2.1 to 8.1 dB higher in subjects treated with tubes (P = .005). CONCLUSIONS: In children who were candidates for ventilation tube insertion randomly assigned toreceive medical or VT treatment for otitis media with effusion, elevated hearing thresholds and tympanic membrane pathologic abnormalities were more common in VT subjects 6 to 10 years after insertion.
RCT Entities:
OBJECTIVE: To determine the long-term effects of ventilation tube insertion on hearing thresholds and tympanic membrane pathologic abnormalities in children with otitis media with effusion. DESIGN: Prospective cohort study. SETTING: Tertiary care children's hospital, otorhinolaryngology and audiology service. PARTICIPANTS: Patients aged 8 to 16 years who participated in a randomized controlled trial of medical vs surgical (ventilation tube [VT]) treatment for recurrent otitis media with effusion at ages 2.5 to 7 years. MAIN OUTCOME MEASURES: Hearing thresholds and tympanic membrane sequelae. METHODS: One hundred thirteen of 125 children who had participated in the trial underwent blinded audiometric, tympanometric, otomicroscopic, and parental questionnaire evaluation 6 to 10 years following the trial. Thirty of 57 [corrected] medical subjects received ventilation tubes and 18 of 56 [corrected] VT subjects received more than 1 set of tubes. To evaluate sequelae risk associated with ventilation tubes independent of disease severity, we compared 27 medical subjects who never received ventilation tubes and 38 subjects randomized to VT who only received 1 set of tubes. RESULTS: Tympanic membrane pathologic abnormalities were present in 81% of VT subjects and 19% of medical subjects (relative risk, 4.4; 95% confidence interval, 2.2-9.9). Hearing thresholds were 2.1 to 8.1 dB higher in subjects treated with tubes (P = .005). CONCLUSIONS: In children who were candidates for ventilation tube insertion randomly assigned to receive medical or VT treatment for otitis media with effusion, elevated hearing thresholds and tympanic membrane pathologic abnormalities were more common in VT subjects 6 to 10 years after insertion.
Authors: Peter Torre; Bret Zeldow; Howard J Hoffman; Ashley Buchanan; George K Siberry; Mabel Rice; Patricia A Sirois; Paige L Williams Journal: Pediatr Infect Dis J Date: 2012-08 Impact factor: 2.129
Authors: Christine E McLaren; Sharon Fujikawa-Brooks; Wen-Pin Chen; Daniel L Gillen; Daniel Pelot; Eugene W Gerner; Frank L Meyskens Journal: Cancer Prev Res (Phila) Date: 2008-12