Literature
Clinical Pearls & Morning Reports
Published May 12, 2021
How did tympanostomy-tube placement compare with medical management in the trial by Hoberman et al.?
Next to the common cold, acute otitis media is the most frequently diagnosed illness in children in the United States. Hoberman et al. compared tympanostomy-tube placement with medical management (episodic antimicrobial treatment) in children 6 to 35 months of age who had recurrent acute otitis media. Read the NEJM Original Article here.
Clinical Pearls
Q: What is the definition of recurrent acute otitis media?
A: Recurrent acute otitis media — conventionally defined as at least three episodes in 6 months, or at least four episodes in 12 months with at least one episode within the preceding 6 months — is the principal indication for tympanostomy-tube placement, the most frequently performed operation in children after the newborn period. Previous trials of tympanostomy-tube placement for recurrent acute otitis media, most 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 differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.
Q: What are the potential advantages and disadvantages of tympanostomy-tube placement?
A: 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 into the middle-ear cavity; various structural tympanic-membrane sequelae; and the possible development of mild conductive hearing loss. Finally, tempering support for surgery is the progressive reduction in the incidence of acute otitis media that usually accompanies a child’s increasing age.
Morning Report Questions
Q: How did tympanostomy-tube placement compare with medical management in the trial by Hoberman et al.?
A: The authors found no significant difference between the tympanostomy-tube group and the medical-management group in the rate of episodes of acute otitis media during the 2-year follow-up period (primary outcome measure). With respect to most secondary outcomes, the authors found no significant between-group differences. In particular, despite their greater use of antimicrobial treatment, they found no evidence of increased antimicrobial resistance among the many isolates obtained from the children in the medical-management group. Differences that were found favoring children in the tympanostomy-tube group included the time to a first episode of acute otitis media and the percentage of children meeting specified criteria for treatment failure; however, children in the medical-management group had fewer cumulative days with otorrhea.
Q: What strengths and limitations do Hoberman et al. identify regarding their trial?
A: The trial has certain strengths: a diverse participant population in the age group most prone to recurrences of acute otitis media, otoscopic diagnoses by validated otoscopists, pretrial confirmation in each child of at least one episode of acute otitis media, a standardized protocol for treating episodes, validated scales for rating the severity of symptoms and functional outcomes, monitoring for antimicrobial resistance, follow-up of children for 2 full years, and modest attrition. A trial limitation stems from receipt of tympanostomy tubes, for differing reasons and at differing times, by certain children in the medical-management group, thereby complicating the task of analysis.