The evidence grades (A-D) and evidence-based statements (Strong Recommendation, Recommendation, Option, and No Recommendation) are repeated at the end of the "Major Recommendations" field.
1A. Pneumatic Otoscopy: Clinicians should use pneumatic otoscopy as the primary diagnostic method for otitis media with effusion (OME), and OME should be distinguished from acute otitis media (AOM).
(This is a strong recommendation based on systematic review of cohort studies and the preponderance of benefit over harm).
Aggregate evidence quality: A, diagnostic studies in relevant populations
Policy level: strong recommendation
1B. Tympanometry: Tympanometry can be used to confirm the diagnosis of OME.
(This option is based on cohort studies and a balance of benefit and harm.)
Aggregate evidence quality: B, diagnostic studies with minor limitations
Policy level: option
1C. Screening: Population-based screening programs for OME are not recommended in healthy, asymptomatic children.
(This recommendation is based on randomized, controlled trials and cohort studies, with a preponderance of harm over benefit.)
Aggregate evidence quality: B, randomized, controlled trials with minor limitations and consistent evidence from observational studies
Policy level: recommendation against
- Documentation
: Clinicians should document the laterality, duration of effusion, and presence and severity of associated symptoms at each assessment of the child with OME.
(This recommendation is based on observational studies and strong preponderance of benefit over harm.)
Aggregate evidence quality: C, observational studies
Policy level: recommendation
- Child at Risk
: Clinicians should distinguish the child with OME who is at risk for speech, language, or learning problems from other children with OME and should evaluate hearing, speech, language, and need for intervention more promptly.
(This recommendation is based on case series, the preponderance of benefit over harm, and ethical limitations in studying children with OME who are at risk.)
Aggregate evidence quality: C, observational studies of children at risk; D, expert opinion on the ability of prompt assessment and management to alter outcomes
Policy level: recommendation
- Watchful Waiting
: Clinicians should manage the child with OME who is not at risk with watchful waiting for 3 months from the date of effusion onset (if known) or diagnosis (if onset is unknown).
(This recommendation is based on systematic review of cohort studies and the preponderance of benefit over harm.)
Aggregate evidence quality: B, systematic review of cohort studies
Policy level: recommendation
- Medication
: Antihistamines and decongestants are ineffective for OME and are not recommended for treatment; antimicrobials and corticosteroids do not have long-term efficacy and are not recommended for routine management.
(This recommendation is based on systematic review of randomized, controlled trials and the preponderance of harm over benefit.)
Aggregate evidence quality: A, systematic review of well-designed, randomized, controlled trials
Policy level: recommendation against
- Hearing and Language
: Hearing testing is recommended when OME persists for 3 months or longer or at any time that language delay, learning problems, or a significant hearing loss is suspected in a child with OME; language testing should be conducted for children with hearing loss.
(This recommendation is based on cohort studies and the preponderance of benefit over risk.)
Aggregate evidence quality: B, diagnostic studies with minor limitations; C, observational studies
Policy level: recommendation
- Surveillance
: Children with persistent OME who are not at risk should be reexamined at 3- to 6-month intervals until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected.
(This recommendation is based on randomized, controlled trials and observational studies with a preponderance of benefit over harm.)
Aggregate evidence quality: C, observational studies and some randomized trials
Policy level: recommendation
- Referral
: When children with OME are referred by the primary care clinician for evaluation by an otolaryngologist, audiologist, or speech-language pathologist, the referring clinician should document the effusion duration and specific reason for referral (evaluation, surgery) and provide additional relevant information such as history of acute otitis media (AOM) and developmental status of the child.
(This option is based on panel consensus and a preponderance of benefit over harm.)
Aggregate evidence quality: C, observational studies
Policy level: option
- Surgery
: When a child becomes a surgical candidate, tympanostomy tube insertion is the preferred initial procedure; adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis). Repeat surgery consists of adenoidectomy plus myringotomy, with or without tube insertion. Tonsillectomy alone or myringotomy alone should not be used to treat OME.
(This recommendation is based on randomized, controlled trials with a preponderance of benefit over harm.)
Aggregate evidence quality: B, randomized, controlled trials with minor limitations
Policy level: recommendation
- Complementary and Alternative Medicine (CAM)
: No recommendation is made regarding complementary and alternative medicine (CAM) as a treatment for OME.
(There is no recommendation based on lack of scientific evidence documenting efficacy and an uncertain balance of harm and benefit.)
Aggregate evidence quality: D, case series without controls
Policy level: no recommendation
- Allergy Management
: No recommendation is made regarding allergy management as a treatment for OME.
(There is no recommendation based on insufficient evidence of therapeutic efficacy or a causal relationship between allergy and OME.)
Aggregate evidence quality: D, case series without controls
Policy level: no recommendation
Definitions:
Evidence-Based Statements
Strong Recommendation: A strong recommendation means that the subcommittee believes that the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits in the case of a strong negative recommendation) and that the quality of the supporting evidence is excellent (grade A or B)*. In some clearly identified circumstances, strong
recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. Implication: Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.
Recommendation: A recommendation means that the subcommittee believes that the benefits exceed the harms (or that the harms exceed the benefits in the case of a negative recommendation), but the quality of evidence is not as strong (grade B or C)*. In some clearly identified circumstances, recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. Implication: Clinicians also should generally follow a recommendation but should remain alert to new information and sensitive to patient preferences.
Option: An option means that either the quality of evidence that exists is suspect (grade D)* or that well-done studies (grade A, B, or C)* show little clear advantage to one approach versus another. Implication: Clinicians should be flexible in their decision-making
regarding appropriate practice, although they may set boundaries on alternatives; patient preference should have a substantial influencing role.
No Recommendation: No recommendation means that there is both a lack of pertinent evidence (grade D)* and an unclear balance between benefits and harms. Implication: Clinicians should feel little constraint in their decision-making and be alert to new published evidence that
clarifies the balance of benefit versus harm; patient preference should have a substantial influencing role.
* Refer to "Rating Scheme for the Strength of the Evidence" field above for the definitions of evidence grades.
Evidence Quality for Grades of Evidence
Grade A: Well-designed, randomized, controlled trials or diagnostic studies performed on a population similar to the guideline’s target population
Grade B: Randomized, controlled trials or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies
Grade C: Observational studies (case-control and cohort design)
Grade D: Expert opinion, case reports, or reasoning from first principles (bench research or animal studies)