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Rosenfeld RM, Schwartz SR, Cannon CR, et al. Clinical practice guideline: acute otitis externa. Otolaryngol Head Neck Surg. 2014 Feb;150(1 Suppl):S1-S24.
[Free full-text American Academy of Otolaryngology-Head and Neck Surgery Foundation Clinical Practice Guideline PDF | PubMed® abstract |National Guideline Clearinghouse version online]

[EXCERPTS]

Major Recommendations.

Statement 1. Differential Diagnosis

Clinicians should distinguish diffuse acute otitis externa (AOE) from other causes of otalgia, otorrhea, and inflammation of the external ear canal.

Recommendation based on observational studies with a preponderance of benefit over risk.

Action Statement Profile

• Aggregate evidence quality: Grade C, observational studies, and Grade D, reasoning from first principles
• Level of confidence in evidence: High
• Benefit: Improved diagnostic accuracy
• Risks, harms, costs: None in following the recommended action
• Benefits-harm assessment: Preponderance of benefit over harm
• Value judgments: Importance of accurate diagnosis

Statement 2. Modifying Factors

Clinicians should assess the patient with diffuse AOE for factors that modify management (nonintact tympanic membrane, tympanostomy tube, diabetes, immunocompromised state, prior radiotherapy).

Recommendation based on observational studies with a preponderance of benefit over risk.

Action Statement Profile

• Aggregate evidence quality: Grade C, observational studies
• Level of confidence in evidence: High
• Benefit: Optimizing treatment of AOE through appropriate diagnosis and recognition of factors or comorbid conditions that might alter management
• Risks, harms, costs: None from following the recommendation; additional expense of diagnostic tests or imaging studies to identify modifying factors
• Benefits-harm assessment: Preponderance of benefits over harm
• Value judgments: Avoiding complications that could potentially be prevented by modifying the management approach based on the specific factors identified

Statement 3. Pain Management

The clinician should assess patients with AOE for pain and recommend analgesic treatment based on the severity of pain.

Strong recommendation based on well-designed randomized trials with a preponderance of benefit over harm.

Action Statement Profile

• Aggregate evidence quality: Grade B, 1 randomized controlled trial limited to AOE; consistent, well-designed randomized trials of analgesics for pain relief in general
• Level of confidence in evidence: High
• Benefit: Increase patient satisfaction, allow faster return to normal activities
• Risks, harms, costs: Adverse effects of analgesics; direct cost of medication
• Benefits-harms assessment: Preponderance of benefit over harm
• Value judgments: Consensus among guideline development group that the severity of pain associated with AOE is under-recognized; preeminent role of pain relief as an outcome when managing AOE

Statement 4. Systemic Antimicrobials

Clinicians should not prescribe systemic antimicrobials as initial therapy for diffuse, uncomplicated AOE unless there is extension outside the ear canal or the presence of specific host factors that would indicate a need for systemic therapy.

Strong recommendation based on randomized controlled trials with minor limitations and a preponderance of benefit over harm.

Action Statement Profile

• Aggregate evidence quality: Grade B, randomized controlled trials with minor limitations; no direct comparisons of topical versus systemic therapy
• Level of confidence in evidence: High
• Benefit: Avoid side effects from ineffective therapy, reduce antibiotic resistance by avoiding systemic antibiotics
• Risks, harms, costs: None
• Benefits-harms assessment: Preponderance of benefit over harm
• Value judgments: Desire to decrease the use of ineffective treatments, societal benefit from avoiding the development of antibiotic resistance

Statement 5. Topical Therapy

Clinicians should prescribe topical preparations for initial therapy of diffuse, uncomplicated AOE.

Recommendation based on randomized trials with some heterogeneity and a preponderance of benefit over harm.

Action Statement Profile

• Aggregate evidence quality: Grade B, meta-analyses of randomized controlled trials with significant limitations and heterogeneity
• Level of confidence in evidence: High for the efficacy of topical therapy as initial management, but low regarding comparative benefits of different classes of drugs or combinations of ototopical drugs
• Benefit: Effective therapy, low incidence of adverse events
• Risks, harms, costs: Direct cost of medication (varies greatly depending on drug class and selection), risk of secondary fungal infection (otomycosis) with prolonged use of topical antibiotics
• Benefits-harms assessment: Preponderance of benefit over harm
• Value judgments: randomized controlled trial results from largely specialty settings may not be generalizable to patients seen in primary care settings, where the ability to perform effective aural toilet may be limited

Statement 6. Drug Delivery

The clinician should enhance the delivery of topical drops by informing the patient how to administer topical drops and by performing aural toilet, placing a wick, or both, when the ear canal is obstructed.

Recommendation based on observational studies with a preponderance of benefit over harm.

Action Statement Profile

• Aggregate evidence quality: Grade C, observational studies and D, first principles
• Level of confidence in evidence: High
• Benefit: Improved adherence to therapy and drug delivery
• Risks, harms, costs: Pain and local trauma caused by inappropriate aural toilet or wick insertion; direct cost of wick (inexpensive)
• Benefits-harms assessment: Preponderance of benefit over harm
• Value judgments: Despite an absence of randomized controlled trials demonstrating a benefit of aural toilet, the guideline development group agreed that cleaning was appropriate, when necessary, to improve penetration of the drops into the ear canal

Statement 7. Nonintact Tympanic Membrane

When the patient has a known or suspected perforation of the tympanic membrane, including a tympanostomy tube, the clinician should prescribe a non-ototoxic topical preparation.

Recommendation based on reasoning from first principles and on exceptional circumstances in which validating studies cannot be performed and there is a preponderance of benefit over harm.

Action Statement Profile

• Aggregate evidence quality: Grade D, reasoning from first principles, and Grade X, exceptional situations in which validating studies cannot be performed
• Level of confidence in evidence: Moderate, because of extrapolation of data from animal studies and little direct evidence in patients with AOE
• Benefit: Reduce the possibility of hearing loss and balance disturbance
• Risk, harm, cost: Eardrops without ototoxicity may be more costly
• Benefits-harms assessment: Preponderance of benefit over harm
• Value judgments: Importance of avoiding iatrogenic hearing loss from a potentially ototoxic topical preparation when non-ototoxic alternatives are available; placing safety above direct cost

Statement 8. Outcome Assessment

The clinician should reassess the patient who fails to respond to the initial therapeutic option within 48 to 72 hours to confirm the diagnosis of diffuse AOE and to exclude other causes of illness.

Recommendation based on observational studies and a preponderance of benefit over harm.

Action Statement Profile

• Aggregate evidence quality: Grade C, outcomes from individual treatment arms of randomized controlled trials of efficacy of topical therapy for AOE
• Level of confidence in evidence: Medium, because most randomized trials have been conducted in specialist settings and the generalizability to primary care settings is unknown
• Benefit: Identify misdiagnosis and potential complications from delayed management; reduce pain
• Risks, harms, costs: Cost of reevaluation by clinician
• Benefits-harms assessment: Preponderance of benefit over harm
• Value judgments: None

[Definitions of Levels of Evidence - available online]

[Link to free full-text guideline: American Academy of Otolaryngology-Head and Neck Surgery Foundation Clinical Practice Guideline PDF | National Guideline Clearinghouse version online]

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