Evidence-Based Medicine for Student Health Services Robert J. Flaherty, MD Swingle Student Health Service Montana State University Bozeman, MT 59717  

Otitis Media 
  

Etiology	Monitoring
Epidemiology	Prognosis
Diagnosis	Prevention
Treatment	Patient Education

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Etiology   The following environmental factors may increase potential risks of getting acute otitis media or otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection):   - Bottle-feeding rather than breast-feeding infants   - Passive smoking   - Group child-care facility attendance  Caveats Age group targeted: 1 through 3 years Type/sample size: Meta-analysis (158 studies) Population characteristics: Patients with otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection), otherwise healthy with  no craniofacial or neurologic abnormalities or sensory deficits  Outcome measures: Discomfort and behavior changes, effect of hearing loss on speech and language development Citations Managing Otitis Media with Effusion in Young Children - From AHCPR Clinical Practice Guidelines       Epidemiology   No evidence is cited.       Diagnosis   Clinical Diagnosis  The symptom with the strongest association with acute otitis media was earache but sore throat, night restlessness and fever also had significant associations. Logistic regression analysis  showed 71% of the cases to be correctly diagnosed on the basis of the symptoms of earache and night restlessness. The  parents were able to predict the presence of acute otitis media with a sensitivity and specificity of 71 and 80%, respectively  (positive predictive value, 51%; negative predictive value, 90%).  Caveats Age group studied: Mean age 3.7y Type/size: Population study of 837 Population characteristics: Outpatient children Outcome measures: Otitis media on otoscopy Citations Kontiokari T et al, Symptoms of acute otitis media, Pediatr Infect Dis J 1998 Aug;17(8):676-9 - From PubMed  Pneumatic otoscopy is recommended for assessment of the middle ear because it combines visualization of the tympanic membrane (otoscopy) with a test of membrane mobility (pneumatic otoscopy). When pneumatic otoscopy is performed by an experienced examiner, the accuracy for diagnosis of otitis media with effusion  (fluid in the middle ear without signs or symptoms of ear infection) may be between 70 and 79 percent.  Half of ears with abnormal tympanograms may have otitis media with effusion. Because the strengths of tympanometry (it provides a quantitative measure of tympanic membrane mobility) and pneumatic otoscopy (many abnormalities of the eardrum and ear canal that can skew the results of tympanometry are visualized) offset the weaknesses of each, using the two tests together improves the accuracy of diagnosis.   Caveats Age group targeted: 1 through 3 years Type/sample size: Meta-analysis (158 studies) Population characteristics: Patients with otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection), otherwise healthy with  no craniofacial or neurologic abnormalities or sensory deficits  Outcome measures: Discomfort and behavior changes, effect of hearing loss on speech and language development Citations Managing Otitis Media with Effusion in Young Children - From AHCPR Clinical Practice Guidelines   Laboratory/X-ray Diagnosis  No evidence is cited.        Treatment    Antibiotics  Antibiotics provide no reduction in pain at 24 hours, but a small reduction in pain at 2-7 days. There was no effect of antibiotics on complication rates, as measured by subsequent tympanometry or recurrence.  Caveats Age group studied: Children Type/sample size: Meta-analysis (8 trials) Population characteristics: Unknown Outcome measure: Symptom relief and subsequent complications Citations Antibiotic versus placebo for acute otitis media in children - Reviewed by  Cochrane  Similarly: Froom J et al, Antimicrobials for acute otitis media? A review from the international primary care network, BMJ 1997;315:98-102 (12 July) - From the British Medical Journal  Early treatment of AOM with antibiotics can reduce the severity of pain, but the majority of children will feel better in 24 hours with or without antibiotics. Due to the poor quality of the available evidence, additional benefits or harm of treatment remain uncertain. Withholding antibiotic treatment while following closely with adequate analgesia is acceptable for children aged 2 years or older without a high fever or severe pain.  Caveats Age group studied: 7 mo to 15 y Type/sample size: Meta-analysis (6 studies) Population characteristics:  Outcome measures: Pain at 24 hours, pain at 2 to 7 days, tympanic membrane (TM) perforation, side effects of medication including vomiting, diarrhea and rash, middle ear effusion at 1 and 3 months (deafness), contralateral AOM, recurrent AOM Selection bias favoring no treatment may have been significant Few good quality studies Citations Antibiotics for acute otitis media: Review of Del Mar C et al, Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis. BMJ 1997;314:1526-29 - Reviewed by POEMS/JFP   No statistically significant difference was found between antibiotic-treated children and controls under two years of age with acute otitis media, judged on the basis of clinical improvement within seven days.  Caveats Age group studied: <2 years Type/size: Systematic review (5 studies) Population characteristics: Young children with AOM Outcome measures: "Clinical improvement" Citations Damoiseaux RA et al, Antibiotic treatment of acute otitis media in children under two years of age: evidence based? Br J Gen Pract 1998 Dec;48(437):1861-4 - From PubMed  Antimicrobial drugs have a modest but significant impact on the primary control of acute otitis media (AOM). Six of every seven children with AOM either do not need antibiotics for primary control or will not respond to antibiotic therapy. All seven children have to be treated  because we cannot predict which one of the seven is both at risk for failure and responsive to antibiotics. Treatment with extended spectrum antibiotics does not increase resolution of acute symptoms or middle ear effusion when compared to penicillin and ampicillin/amoxicillin. Initial therapy should be guided by considerations of safety, tolerability, and affordability, and not by the theoretical advantage of an extended antibacterial spectrum.  Caveats Age group studied: 4wks-18y Type/sample size: Meta-analysis (33 RCTs = 5400 patients) Population characteristics: Patients with acute otitis media and with no underlying disorders which might influence susceptibility to infection Outcome measures: Absence (or otherwise) of all presenting signs and symptoms of acute otitis media at the evaluation point closest to 7 to 14 days after therapy was started, improvement in the appearance of the tympanic membrane. Presence or absence of middle ear effusion in both ears at the evaluation point closest to 30 days after therapy was started Citations Antibiotics for Acute Otitis Media - Reviewed by Bandolier  Also: Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from  thirty-three randomized trials - Reviewed by DARE  Trials of short-acting antibiotics (penicillin V potassium, amoxicillin [-clavulanate], cefaclor, cefixime, cefuroxime, cefpodoxime proxetil, cefprozil) were compared to trials of intramuscular ceftriaxone and oral azithromycin. 5 days of short-acting antibiotic use is effective treatment for uncomplicated acute otitis media in children.  Caveats Age group studied: 4 wks to 18 y Type/sample size: Meta-analysis (30 trials) Population characteristics: Clinical diagnosis of acute otitis media, no antimicrobial therapy at time of diagnosis Outcome measures: Number of treatment failures, relapses, reinfections Citations Kozyrskyj AL et al, Treatment of acute otitis media with a shortened course of antibiotics: a meta-analysis, JAMA 1998 Jun 3;279(21):1736-1742 - From PubMed  Cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and ceftibuten were compared to conventional antibiotic therapies (usually amoxicillin/clavulanate, cefaclor or cephalexin) for community acquired infections. Infections included acute otitis media, pharyngitis, sinusitis, bronchitis, pneumonia, urinary tract infection and skin and skin-structure infections. The newer agents appear to be as clinically effective as conventional therapies (but not more effective) for the treatment of common community-acquired infections. They may also have the potential to improve compliance due to their once/twice daily mode of  administration.   Caveats Age group studied: Unknown Type/sample size: Analytical review of studies: acute otitis media: 19 studies, pharyngitis: 13 studies, sinusitis: 4 studies, bronchitis: 10 studies, pneumonia: 7 studies, urinary tract infection: 11 studies, skin and skin-structure infections: 4 studies. Most studies consisted of 30-50 patients in each arm Population: Unknown Outcome measure: Clinical response to therapy For some of these infections other studies show that there is no evidence that any antibiotic therapy is beneficial Citations Comparison of cefprozil, cefpodoxime proxetil, loracarbef, cefixime, and ceftibuten - Reviewed by DARE  Observation OR antibiotic therapy are treatment options for children with otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection) that has been present less than 4 to 6 months and at any time in children without a 20-decibel hearing threshold level or worse in the better-hearing ear. For the child who has had bilateral effusion for a total of 3 months and who has a bilateral hearing deficiency (defined as a 20-decibel hearing threshold level or worse in the better-hearing ear), bilateral myringotomy with tube insertion becomes an additional treatment option. Placement of tympanostomy tubes is recommended after a total of 4 to 6 months of bilateral effusion with a bilateral hearing deficit.   Caveats Age group targeted: 1 through 3 years Type/sample size: Meta-analysis (158 studies) Population characteristics: Patients with otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection), otherwise healthy with  no craniofacial or neurologic abnormalities or sensory deficits  Outcome measures: Discomfort and behavior changes, effect of hearing loss on speech and language development Citations Managing Otitis Media with Effusion in Young Children - From AHCPR Clinical Practice Guidelines   Receiving a prescription for an antibiotic for a URI was not associated with increased patient satisfaction. Better to spend time explaining the nature of a particular illness and the physician's choice of treatment.  Caveats Age group: Adults Type/size: RCT of 113 Outcome measure: Patient satisfaction Diagnostic criteria unclear Citations Antibiotic use and patient satisfaction: Review of Hamm RM et al, Antibiotics and respiratory infections: Are patients more satisfied when expectations are met? J Fam Pract 1996;43:56-62 - Reviewed by POEMS/JFP   Similarly: Mangione-Smith R et al, The relationship between perceived parental expectations and pediatrician antimicrobial prescribing behavior, Pediatrics 1999 Apr;103(4 Pt 1):711-8 - From PubMed  Similarly: Himmel W et al, Are patients more satisfied when they receive a prescription? The effect of patient expectations in general practice. Scand J Prim Health Care 1997 Sep;15(3):118-22 - From PubMed     Other Treatments     A number of treatments are not recommended for treatment of otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection) in the otherwise healthy child age 1 through 3 years.   - Steroid medications  - Antihistamines and/or decongestants  -  Adenoidectomy in the absence of adenoid pathology  - Allergy management  - Chiropractic, holistic, naturopathic, homeopathic,       traditional/indigenous, or other treatments Caveats Age group targeted: 1 through 3 years Type/sample size: Meta-analysis (158 studies) Population characteristics: Patients with otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection), otherwise healthy with  no craniofacial or neurologic abnormalities or sensory deficits  Outcome measures: Discomfort and behavior changes, effect of hearing loss on speech and language development Citations Managing Otitis Media with Effusion in Young Children - From AHCPR Clinical Practice Guidelines         Monitoring  Although hearing evaluation may be difficult to perform in young children, evaluation is recommended after otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection) has been present bilaterally for 3 months, because of the strong belief that surgery is not indicated unless otitis media with effusion is causing hearing impairment (defined as equal to or worse than 20 decibels hearing threshold level the better hearing ear).   Caveats Age group targeted: 1 through 3 years Type/sample size: Meta-analysis (158 studies) Population characteristics: Patients with otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection), otherwise healthy with  no craniofacial or neurologic abnormalities or sensory deficits  Outcome measures: Discomfort and behavior changes, effect of hearing loss on speech and language development Citations Managing Otitis Media with Effusion in Young Children - From AHCPR Clinical Practice Guidelines      Prognosis    There is no rigorous, methodologically sound research to support the theory that untreated otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection) results in speech or language delays or deficits.    Caveats Age group targeted: 1 through 3 years Type/sample size: Meta-analysis (158 studies) Population characteristics: Patients with otitis media with effusion (fluid in the middle ear without signs or symptoms of ear infection), otherwise healthy with  no craniofacial or neurologic abnormalities or sensory deficits  Outcome measures: Discomfort and behavior changes, effect of hearing loss on speech and language development Citations Managing Otitis Media with Effusion in Young Children - From AHCPR Clinical Practice Guidelines       Prevention   No evidence is cited.       Patient Education  The following patient education materials are consistent with the available evidence.  Otitis Media with Effusion - From the AAFP Ear Problems Self-Care Flowchart - From the AAFP Middle Ear Fluid in Young Children - From AHCPR Earache and Otitis Media - From the American Academy of Otolaryngology You, Your Family and Antibiotics: The Untold Story - From the AAFP Rev. 8/28/99

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