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Two new studies this week from pediatric infectious disease specialists suggest possible changes in the way that one of the most frequently diagnosed infections in US children—acute otitis media (AOM), or middle ear infections—can be managed, and the role that antibiotics play in treatment.
Ear tubes vs medical management
In a randomized clinical trial published yesterday in the New England Journal of Medicine, a team led by researchers with the University of Pittsburgh School of Medicine and UPMC Children’s Hospital report that the surgical insertion of ear tubes in infants with recurrent AOM was no better than medical management with antibiotics at reducing recurrent infections.
The trial enrolled children ages 6 to 35 months of age who had had at least three episodes of AOM within 6 months, or four episodes within 12 months with at least one episode within the preceding 6 months, at three different hospitals from December 2015 to March 2020. The children were randomly assigned to undergo tympanostomy-tube placement or receive nonsurgical medical management, which included treatment with amoxicillin-clavulanate (or, if the response appeared inadequate, ceftriaxone).
After randomization, the children were assessed at 8-week intervals by trial clinicians. The primary outcome was the mean number of episodes of AOM per child-year during a 2-year period. Secondary outcomes included the percentage of children who had treatment failure, the median time to a first occurrence of AOM, and antimicrobial resistance in nasopharyngeal and throat isolates.
A total of 250 children were enrolled in the trial, with 129 in the tympanostomy-tube group and 121 in the medical management group. In the main, intention-to-treat analysis, the rate of acute otitis media episodes over 2 years was 1.48 in the tympanostomy-tube group and 1.56 in the medical management group (risk ratio [RR], 0.97; 95% confidence interval [CI], 0.84 to 1.12).
In the per-protocol analysis, conducted because 10% of the children in the tympanostomy-tube group did not undergo surgery and 16% of the children in the medical management groups had tubes inserted on parental request, the corresponding rates were 1.47 and 1.72, respectively (RR, 0.82; 95% CI, 0.69 to 0.97).
In each treatment group, the rate of occurrence of AOM during the first year of follow-up was roughly twice the rate during the second year, and the rate among children ages 6 to 11 months was 2.63 times the rate among children ages 24 to 35 months.
Analysis of secondary outcomes found that the median time to a first occurrence of acute otitis media was longer in children who received tympanostomy tubes than in those who received medical management (4.34 months vs 2.33 months). In addition, fewer children in the tympanostomy-tube group met criteria for treatment failure (45% vs 62%). But children who received tympanostomy tube had more days of tube otorrhea (ear drainage) (7.96 days vs 2.83 days).
Notably, there was no difference between the two groups in the percentage of children colonized with any penicillin-resistant pathogen at follow-up.
Tympanostomy-tube placement is the most frequently performed operation performed in US children after the newborn period, according to the authors. But lead study author Alejandro Hoberman, MD, of UPMC Children’s Hospital and the University of Pittsburgh School of Medicine, said the findings suggest the risks of subjecting young children to anesthesia and surgery, and the possible development of structural changes in the tympanic membrane, don’t outweigh the benefits.
“We used to often recommend tubes to reduce the rate of ear infections, but in our study, episodic antibiotic treatment worked just as well for most children,” Hoberman said in a university press release. “Another theoretical reason to resort to tubes is to use topical ear drops rather than systemic oral antibiotics in subsequent infections in the hope of preventing the development of bacterial resistance, but in this trial, we did not find increased resistance with oral antibiotic use. So, for most children with recurrent ear infections, why undergo the risks, cost and nuisance of surgery?”
Delayed antibiotic prescribing for AOM
In the other study, published yesterday in Pediatrics, a team that included researchers from Denver Medical Health Center, the Colorado Department of Public Health, the American Academy of Pediatrics (AAP), and the Centers for Disease Control and Prevention sought to answer a different question about treatment for pediatric ear infections: How often are clinicians writing delayed antibiotic prescriptions for AOM?
Ear infections result in 8.7 million antibiotic prescriptions annually, but as the study authors note, an estimated 85% of those infections self-resolve and do not benefit from antibiotic treatment. To reduce unnecessary antibiotic use, the AAP recommends the use of delayed antibiotic prescriptions for cases of mild to moderate AOM, which caregivers can have filled if symptoms don’t improve after 48 to 72 hours. But little is known about how often clinicians use delayed prescriptions for mild-to-moderate cases.
In the study, the researchers set out to evaluate the rate of delayed antibiotic prescriptions for AOM at eight outpatient pediatric practices in Colorado. They also invited the practices to participate in an antibiotic stewardship quality improvement initiative that addressed antibiotic prescribing for ear infections and pharyngitis.
One aim of the intervention, which included education, audit and feedback, online resources, and content expertise, was to improve delayed prescribing for AOM in children 6 months of age and older. All practices were provided templates for delayed prescribing-focused patient education material. A total of eight practice teams from urban, suburban, and rural clinics, including 69 clinicians, participated in the 6-month intervention and reported data on a monthly basis.
All practices increased delayed antibiotic prescribing during the intervention period, with the percentage of delayed antibiotic prescriptions for AOM increasing from 2% at baseline (the 2 months prior to the intervention) to 21% at intervention end (relative risk ratio [RRR], 8.96; 95% CI, 4.68 to 17.17). Among the five practices that submitted post-intervention data, the rate of delayed prescribing at 3 months (RRR, 8.46; 95% CI, 4.18 to 17.11) and 6 months (RRR, 6.69; 95% CI, 3.53 to 12.65) post-intervention remained significantly higher than baseline.
“An economical intervention that included educational webinars, access to a system for providers to enter data for audit and feedback, access to an online community, and monthly data review resulted in a significant improvement in delayed antibiotic prescribing rates,” the study authors wrote.
The authors say the approach is likely replicable at other practices, including those in resource-limited settings.