Hoberman reports owning stock in Kaizen Bioscience, holding a patent on a method and apparatus for aiding diagnosis of otitis media by classifying tympanic-membrane images, and holding a patent on a pediatric oral-suspension formulation of amoxicillin–clavulanate potassium and the method for use, licensed to Kaizen Bioscience. Wald reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Tympanostomy tubes were not superior to medical management in reducing the rate of episodes of acute otitis media over a 2-year period in infants and toddlers, according to a study published in The New England Journal of Medicine.
Alejandro Hoberman, MD, vice chair of clinical research in the department of pediatrics at the University of Pittsburgh School of Medicine, and colleagues randomly assigned 250 children aged between 6 and 35 months to undergo tympanostomy tube placement or receive medical management, which involved antimicrobial treatment.
They selected participants based on whether they had at least three episodes of acute otitis media within a 6-month period, or four episodes in a 12-month period. The trial was conducted between December 2015 and March 2020 at UPMC Children’s Hospital of Pittsburgh and affiliated practices, Children’s National Medical Center in Washington, D.C., and Kentucky Pediatric and Adult Research in Bardstown, Kentucky.
Children were stratified by age — 6 to 11 months, 12 to 23 months and 24 to 35 months — and randomly assigned in groups of four at each site to receive either tympanostomy tube placement or medical management. Following randomization, the researchers assessed the children every 8 weeks.
“We asked parents to bring children for evaluation if the children had any respiratory symptoms for at least 5 days and to bring children within 48 hours if they had any symptom suggestive of acute otitis media or had received a diagnosis of acute otitis media at a nontrial site,” the authors wrote.
Of the 250 children selected for the trial, 229 completed 1-year of follow-up, and 208 completed 2 years. There were 129 participants assigned to the tympanostomy tube group, but 13 children did not undergo tube placement. Of the 121 participants selected for the medical management group, 54 eventually underwent tube placement.
“In each treatment group, the rate of occurrence of acute otitis media during the first follow-up year was approximately twice the rate during the second year,” the authors wrote.
In the intention to treat analysis, the rate of episodes of acute otitis media per child was 1.48 + 0.08 in the tympanostomy tube group, and 1.56 + 0.08 in the medical management group (RR = 0.97; 95% CI, 0.84-1.12).
The rate of occurrence of acute otitis media among children aged 6 to 11 months was 2.63 (95% CI, 1.79-3.88) times the rate among those aged 24 to 35 months at enrollment. The rate of occurrences for those aged 12 to 23 months at enrollment was 1.8 (95% CI, 1.22-2.63) times the rate of older children.
In the per-protocol analysis, the rate of episodes in the tympanostomy tube group was 1.47 + 0.08, and 1.72 + 0.11 in the medical management group (RR = 0.82; 95% CI, 0.69 to 0.97).
“In this trial, we found that tympanostomy tube placement was not superior to medical management in reducing the rate of episodes of acute otitis media during the ensuing 2-year period,” the authors wrote.
In a related editorial, Ellen R. Wald, MD, chair of the department of pediatrics at the University of Wisconsin, said the study was performed “as meticulously as possible.”
However, Wald noted that the authors may not have anticipated the parental decision to opt for tympanostomy tube placement, which led to “‘treatment failure’ by definition without meeting specified criteria for failure,” she said.
“The 19 children in the medical-management group whose parents opted for tympanostomy tube placement plus the 35 who met the specified criteria for treatment failure constitute nearly 45% of the 121 children originally assigned to receive medical management,” Wald wrote. “Therefore, when outcomes are compared between the two groups with the use of intention-to-treat analysis, only 55% of the children in the medical-management group were actually treated medically throughout the trial.”
Wald said the results of the trial are still “very useful” for shared decision-making with caregivers.