Steroids and Antibiotics for OME Quality Improvement Opportunities Rosenfeld RM, Bellmunt AM, and Shin JJ SUNY Downstate Medical Center, Brooklyn, NY, USA Universitat Autònoma de Barcelona, Barcelona, Spain Harvard Medical School, Boston, MA, USA

Rosenfeld RM and Post JC. Otolaryngol Head Neck Surg 1992; 106:378-86 Antibiotic therapy has a clinically and statistically significant impact on resolution of otitis media with effusion (absolute RD, 22%)

Neither guideline discussed topical intranasal steroids Considered oral antibiotics and systemic steroids a reasonable option for managing OME Rosenfeld et al. Pediatrics & Otolaryngol HNS, 2004 Neither guideline discussed topical intranasal steroids Recommended against “routine” use of antibiotics and steroids, but considered oral antibiotics an option prior to ear tube insertion Stool et al. Publication 94-0622 Rockville: 1994

Lannon et al, Pediatrics 2011 Quality Measures for the Care of Children with Otitis Media with Effusion Lannon et al, Pediatrics 2011 Compliance with AMA performance measures for OME was assessed for children aged 2m-12y in 23 practices in 2 primary care networks Nineteen practices submitted data for 378 encounters 71% did not get audiogram if OME >3m or if speech, language, or learning problems 67% did not use pneumatic otoscopy or tympanometry for diagnosis 13% inappropriately prescribed oral antibiotics 3% inappropriately prescribed steroids Reliability and accuracy of records-based data extraction judged suboptimal by investigators Pediatrics 2011; 127:e1490-7

Rosenfeld RM, et al. Otolaryngol Head Neck Surg 2016: February (Supplement)

Antibiotics for OME STATEMENT 8b. Clinicians should recommend against using systemic antibiotics for treating otitis media with effusion (OME). Strong recommendation based on systematic review of randomized, controlled trials and preponderance of harm over benefit.

Antibiotics for OME in Children Venekamp et al, Cochrane Database 2016 Cochrane systematic review of 23 RCTs that compared antibiotics with placebo, no treatment, or ineffective therapy for treatment of OME Antibiotics increased OME resolution at 2-3m, RR=2.0, 95% CI 1.6-2.5 (6 trials, NNT benefit =5) Antibiotics increased diarrhea, vomiting, or skin rash, RR=2.2, 95% CI 1.3-3.6 (5 trials, NNT harm = 20) Conflicting results on hearing levels at 2-4w (2 trials) No change in rate of tube insertion or TM sequelae Conclude that adverse events of oral antibiotics exceed questionable benefits for OME Cochrane Database Syst Rev 2016; 12:CD009163

Steroids for OME STATEMENT 8a. Clinicians should recommend against using intranasal steroids or systemic steroids for treating OME. Strong recommendation based on systematic review of randomized, controlled trials and preponderance of harm over benefit.

Efficacy of Intranasal Corticosteroids for Persistent Bilateral OME in Primary Care Williamson et al, Health Technol Asses 2009 Double-blind trial of 217 British children aged 4-11y with OM in past year and bilateral OME (B/B or B/C2) randomized to mometasone QD vs. placebo for 3m No change when adjusted for age, season, atopy or severity 7-22% of treatment group had nasal stinging, cough, epistaxis, and/or dry throat 80% of caregivers in both groups thought they had received active treatment P=NS P=NS P=NS Health Technology Assessment 2009; 13 (www.hta.ac.uk)

Steroids and Antibiotics for OME Study Rationale Steroids and Antibiotics for OME Despite national guidelines to the contrary, many clinicians in the US are still prescribing antibiotics or steroids for OME, especially topical intranasal steroids The specific usage rates of medical therapy for OME are largely unknown, but gaps in care are likely highly prevalent Even small gaps in care could have a large clinical impact because of the high prevalence of OME in children Findings in this study would help inform development of quality measures for a national otolaryngology data registry

The National Ambulatory Medical Care Survey (NAMCS) is based on a sample of visits to non-federally employed office-based physicians who are primarily engaged in direct patient care and, starting in 2006, a separate sample of visits to community health centers. The National Hospital Ambulatory Medical Care Survey (NHAMCS) is based on a national sample of visits to emergency departments, outpatient departments, and ambulatory surgery locations of noninstitutional general and short-stay hospitals.

Oral Antibiotic Use for Otitis Media with Effusion: Ongoing QI Opportunities Roditi et al, Otolaryngol HNS 2016 Cross-sectional analysis of US National and Hospital Ambulatory Medical Care Surveys 2005-2010 for 1.4 million visits of OME without AOM 32% of OME visits had oral antibiotics prescribed versus 13% of non-OME visits (adjusted odds ratio 4.31) Emergency department visits were 41% more likely to result in antibiotics (OR 1.41, 95% CI 1.29-1.54) Otolaryngology visits were 59% less likely to result in antibiotics (OR 0.41, 95% CI 0.29-0.57) Otolaryngol Head Neck Surg 2016; 154:797-803

Oral Steroid Use for Otitis Media with Effusion & Eustachian Tube Dysfunction Bellmunt et al, Otolaryngol HNS 2016 Cross-sectional analysis of US National and Hospital Ambulatory Medical Care Surveys 2005-2010 for 7.1 million OME or ETD visits 3.2% of OME/ETD visits had oral steroids prescribed versus 1.7% of other visits (P=.002) Adults, but not children, were more likely to get steroids for OME/ETD (odds ratio 3.50, P<.001) Patients seen by an otolaryngologist or in the emergency room were less likely to receive steroids than other settings Otolaryngol Head Neck Surg 2016; 155:139-46

Wang et al, Otolaryngol HNS 2017 Intranasal Steroid Use for Otitis Media with Effusion: Ongoing QI Opportunities Wang et al, Otolaryngol HNS 2017 Cross-sectional analysis of nearly 2 million OME visits in the US National and Hospital Ambulatory Medical Care Surveys 2005-2012 10.9% of OME visits had intranasal steroids (prescription and non-prescription) versus 3.5% of other visits (P<.001) Adjusted OR (age, sex, race/ethnicity, rhinitis, sinusitis) for intranasal steroids of 3.6 (95% CI, 1.6 to 8.0) Steroids used more in physician offices vs. hospital or ED (risk difference 6.6%) Significant QI opportunities exist Otolaryngol Head Neck Surg, May 2017; ePub.

http://otojournal.org (May 2017, ePub ahead of print)

Antibiotics (32%) Nasal Steroids (11%) Oral Steroids (3%) Antireflux Drugs (?) Antihistamines (?) Decongestants (?)

Inventor, Author, and Diplomat, 1706-1790 Benjamin Franklin Inventor, Author, and Diplomat, 1706-1790 He’s the best physician that knows the worthlessness of the most medicines Rosenfeld’s addendum: especially for OME