Table A.1Scope of the Report and Definitions

Disease EntityUncomplicated AOM, including recurrent and persistent AOM1
Patient PopulationAge 4 weeks to 18 years
Exclude: patients with immunodeficiencies and craniofacial deficiencies including cleft palate
SettingsAll types of providers and practice settings
Interventions2“Wait and see” approach/placebo
Antibiotic treatment (all classes, schedule, dosage, length, and mode)
Delayed antibiotic
Analgesics/other non-antibiotic medical therapies/surgery (including PE tubes)
Influencing factorsAge
Otorrhea or perforation
AOM severity
Signs and physical symptoms (ear pulling, otorrhea, irritability, fever, tympanic membrane (TM) inflammation, retracted TM, middle ear effusion [MEE])
Comorbidities (e.g., asthma)
Day care attendance
Environmental factors
Recurrent OM/otitis prone
Persistent/relapse OM (continued on next page)
Diagnostic mode (otoscopy; tympanocentesis; pneumatic otoscopy/tympanometry; acoustic reflectometry
Outcome measuresTreatment failure
Duration of symptoms or illness
Presence of MEE by otoscopic findings (Bulging, cloudy, erythematous TM; air fluid level behind TM; Loss of landmarks; otorrhea)
Presence of MEE by Pneumatic otoscopy/tympanometry (Limited or absent mobility of TM)
Presence of MEE by acoustic reflectometry (presence of MEF)
Presence of MEE by tympanocentesis
Signs and symptoms of middle ear inflammation (MEI) by symptoms (otalgia, ear fullness)
Signs or symptoms of MEI by otoscopy (distinct TM erythema)
Other symptoms (decreased hearing, fever)
Invasive infections
Bacteriological cure/failure
Disease recurrence
Adverse effects of treatment (e.g., diarrhea, vomiting, bacterial resistance) and method of assessment
Quality of life or functional outcome
Parental satisfaction
Cost of outcomes, e.g., Days school/daycare missed
Bacteriologic outcomes by nasopharyngeal cultures
Otologic complications- i.e., cholestetoma
PE tube placement
Health care utilization
Microbial epidemiology and antibiotic resistance3
Time Period1998–20094
Literature SourcesMedline
Web of Science
Cochrane Database of Systematic Reviews
Proceedings of International Society of Otolaryngology
LanguagesNo restriction
Study DesignRandomized controlled trials, blinded and unblinded
Non-randomized controlled trials, blinded and unblinded
Prospective and retrospective observational studies5
Case-control studies6

Definition of AOM: A diagnosis of AOM requires 1) a history of acute onset of signs and symptoms, 2) the presence of middle ear effusion (MEE), and 3) signs and symptoms of middle-ear inflammation.

Elements of the definition of AOM are all of the following:

  1. Recent, usually abrupt, onset of signs and symptoms of middle-ear inflammation and MEE
  2. The presence of MEE that is indicated by any of the following:
    1. Bulging of the tympanic membrane
    2. Limited or absent mobility of the tympanic membrane
    3. Air-fluid level behind the tympanic membrane
    4. Otorrhea
  3. Signs or symptoms of middle-ear inflammation as indicated by either
    1. Distinct erythema of the tympanic membrane or
    2. Distinct otalgia (discomfort clearly referable to the ear[s] that results in interference with or precludes normal activity or sleep)

Definition of Recurrent AOM (RAOM): A diagnosis of RAOM requires three or more episodes of acute otitis media within 6 months or four episodes within 12 months, including at least 1 episode during the preceding 6 months.

Definition of Persistent Otitis Media: Persistent otitis media is manifested by persistence during antimicrobial therapy of symptoms and signs of middle ear infection (treatment failure) and/or relapse of acute otitis media within 1 month of completion of antibiotic therapy. When two episodes of otitis media occur within 1 month, it may be difficult to distinguish recurrence of acute otitis media (i.e. a new episode) from persistent otitis media (i.e. relapse).


Antibiotics and other treatment modalities are considered individually for questions 3–6 on treatment outcomes;


These outcomes are considered only for question 2 on PNC7 vaccine.


Search for articles on recurrent and persistent AOM spanned 1966–2009


Where RCTs unavailable to answer a particular question

From: Appendix A, Scope, Definitions and Search Strategies

Cover of Management of Acute Otitis Media: Update
Management of Acute Otitis Media: Update.
Evidence Reports/Technology Assessments, No. 198.
Shekelle PG, Takata G, Newberry SJ, et al.

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