MedicalResearch.com Interview with: Alejandro Hoberman, M.D. Vice Chair of Clinical Research, Division Director, General Academic Pediatrics, and Professor of Pediatrics and Clinical and Translational Science Jack L. Paradise, MD Endowed Professor of Pediatric Research, UPMC Children's Hospital of PittsburghPresident, UPMC Children's Community Pediatrics MedicalResearch.com: What is the background for this study? Response: Acute otitis media (AOM) is the most frequently diagnosed illness in children in the United States for which antibiotics are prescribed. Recurrent AOM is the principal indication for tympanostomy-tube placement, the most frequently performed operation in children after the newborn period. Supporting the performance of tympanostomy-tube placement for recurrent acute otitis media has been the commonplace observation, after surgery, of acute otitis media–free periods of varying duration. Counterbalancing this view have been the cost of tympanostomy-tube placement; risks and possible late sequelae of anesthesia in young children; the possible occurrence of refractory tube otorrhea, tube blockage, premature extrusion, or dislocation of the tube into the middle-ear cavity; various structural tympanic membrane sequelae; and the possible development of mild conductive hearing loss. Tempering support for surgery is the progressive reduction in the incidence of acute otitis media that usually accompanies a child’s increasing age. Previous trials of tympanostomy-tube placement for recurrent acute otitis media, all conducted before the introduction of pneumococcal conjugate vaccine, have given mixed results and were limited, variously, by small sample size, uncertain validity of diagnoses of acute otitis media determining trial eligibility, short periods of follow-up, and substantial attrition of participants. Official recommendations regarding tympanostomy-tube placement for children with recurrent acute otitis media differ — an otolaryngologic guideline recommends the procedure for children with recurrent acute otitis media, provided that middle-ear effusion is present in at least one ear; a contemporaneous pediatric guideline discusses tympanostomy-tube placement as an “option [that] clinicians may offer.” Given these uncertainties, we undertook the present trial involving children 6 to 35 months of age who had a history of recurrent acute otitis media to determine whether tympanostomy-tube placement, as compared with medical management (comprising episodic antimicrobial treatment, with the option of tympanostomy-tube placement in the event of treatment failure), would result in a greater reduction in the children’s rate of recurrence of acute otitis media during the ensuing 2-year period. (more…)