Otitis Media with Effusion

- Committee

Chair of the Panel:

Usama Abdel Naseer

Scientific Group Members:

Abdalla Anayet, Abdelrahman Eltahaan, Ahmed Mostafa, Alaa Gaafar, Amr Taha, Ashraf Lotfy, Athar Reda Ibrahim, Bahaa Eltoukhy, Haytham Elfarargy, Hazem Dewidar, Ihab Sifin, Loay Elsharkawy, Mai Mohammed Salama, Mina Esmat, Rania Abdou, Reda Sharkawy, Saad Elzayat, Samir Halim

Abbreviations

AOM: Acute otitis media

OME: Otitis media with effusion

Glossary

Acute otitis media (AOM) The rapid onset of signs and symptoms of inflammation of the middle ear.

Chronic OME OME persisting for 3 months from the date of onset (if known) or from the date of diagnosis (if onset is unknown).

Conductive hearing loss: Hearing loss from the abnormal or impaired sound transmission to the inner ear, which is often associated with effusion in the middle ear but can be caused by other middle ear abnormalities, such as tympanic membrane perforation, or ossicle abnormalities

Hearing assessment A means of gathering information about a child’s hearing status, which may include a caregiver report, audiological assessment by an audiologist, or hearing testing by a physician or allied health professional using screening or standard equipment, which may be automated or manual. Does not include the use of noisemakers or other nonstandardized methods.

Middle ear effusion Fluid in the middle ear from any cause. Middle ear effusion is present with both OME and AOM and may persist for weeks or months after the signs and symptoms of AOM resolve.

Otitis media with effusion (OME) The presence of fluid in the middle ear without signs or symptoms of acute ear infection.

Pneumatic otoscopy A method of examining the middle ear by using an otoscope with an attached rubber bulb to change the pressure in the ear canal and see how the eardrum reacts. A normal eardrum moves briskly with applied pressure, but when there is fluid in the middle ear, the movement is minimal or sluggish.

Sensorineural hearing loss Hearing loss that results from abnormal transmission of sound from the sensory cells of the inner ear to the brain.

- Executive Summary

This Guideline is concerned with diagnosis and treatment decision of otitis media with effusion. This is targeting a child aged 2 months through 12 years with OME, with or without developmental disabilities or underlying conditions that predispose to OME and its sequelae. This patient characteristics correspond with inclusion criteria in many OME studies. This guideline, however, does not apply to patients <2 months or >12 years of age.

· The clinician should document the presence of middle ear effusion with pneumatic otoscopy when diagnosing OME in a child.

· The clinician should perform pneumatic otoscopy to assess for OME in a child with otalgia, hearing loss, or both.

· The clinician should obtain tympanometry in children with suspected OME for whom the diagnosis is uncertain after performing (or attempting) pneumatic otoscopy.

· The clinician 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 3 months from the date of diagnosis (if onset is unknown).

· The clinician may recommend Autoinflation using a balloon more than 3 times a day as a treatment option.

· The clinician should recommend against (catheterization) as it can result in TM perforation and affect the surrounding organs (epistaxis, emphysema, etc.).

· The clinician should recommend against using intranasal or systemic steroids for treating OME.

· The clinician should recommend against using systemic antibiotics for treating OME, and should recommend against using antihistamines, decongestants, or both for treating OME.

· The clinician should document in the medical record counseling of parents of infants with OME who fail a newborn screening regarding the importance of follow-up to ensure that hearing is normal when OME resolves and to exclude an underlying sensorineural hearing loss.

· The clinician should determine if a child with OME is at increased risk for speech, language, or learning problems from middle ear effusion because of baseline sensory, physical, cognitive, or behavioral factors.

· The clinician should evaluate at-risk children for OME at the time of diagnosis of an at-risk condition and at 12 to 18 months of age (if diagnosed as being at risk prior to this time).

· The clinician should not routinely screen children for OME who are not at risk and do not have symptoms that may be attributable to OME, such as hearing difficulties, balance (vestibular) problems, poor school performance, behavioral problems, or ear discomfort.

· The clinician should educate children with OME and their families regarding the natural history of OME, need for follow-up, and the possible sequelae.

· The clinician should obtain an age-appropriate hearing test if OME persists for 3 months or longer OR for OME of any duration in an at-risk child.

· The clinician should counsel families of children with bilateral OME and documented hearing loss about the potential impact on speech and language development.

· The clinician should reevaluate, at 3- to 6-month intervals, children with chronic OME until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected.

· The clinician should recommend tympanostomy tubes when surgery is performed for OME in a child <4 years old; adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis).

· The clinician should recommend tympanostomy tubes, adenoidectomy, or both when surgery is performed for OME in a child ³4 years old.

· The clinician should not place long-term tubes as initial surgery for children who meet the criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube.

· The clinician should not routinely prescribe postoperative antibiotic ear drops after tympanostomy tube placement.

· The clinician should prescribe topical antibiotic ear drops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea.

· The clinician should not encourage routine, prophylactic water precautions (use of earplugs or headbands, avoidance of swimming or water sports) for children with tympanostomy tubes.

· The clinician should document resolution of OME, improved hearing, or improved quality of life when managing a child with OME.

- Introduction

OME is defined as the presence of fluid in the middle ear without signs or symptoms of acute ear infection.The condition is common enough to be called an ‘‘occupational hazard of early childhood’’ because about 90% of children have OME before school age 5, and they develop, on average, 4 episodes of OME every year. Synonyms for OME include ear fluid and serous, secretory, or nonsuppurative otitis media. OME may occur during an upper respiratory infection, spontaneously because of poor eustachian tube function, or as an inflammatory response following AOM, most often between the ages of 6 months and 4 years. In the first year of life, .50% of children will experience OME, increasing to .60% by age 2 years. When children aged 5 to 6 years in primary school are screened for OME, about 1 in 8 are found to have fluid in one or both ears. The prevalence of OME in children with Down syndrome or cleft palate, however, is much higher, ranging from 60% to 85%.

Most episodes of OME resolve spontaneously within 3 months, but about 30% to 40% of children have repeated OME episodes, and 5% to 10% of episodes last year.⁶ Persistent middle ear fluid from OME results in decreased mobility of the tympanic membrane and serves as a barrier to sound conduction. At least 25% of OME episodes persist for  3 months and may be associated with hearing loss, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, recurrent AOM, or reduced QOL. Less often, OME may cause structural damage to the tympanic membrane that requires surgical intervention.

The high prevalence of OME—along with many issues, including difficulties in diagnosis and assessing its duration, associated conductive hearing loss, the potential impact on child development, and significant practice variations in management makes OME an important condition for up-to-date clinical practice guidelines.

- Purpose

The purpose of this multidisciplinary guideline is to identify quality improvement opportunities in managing OME and to create explicit and actionable recommendations to implement these opportunities in clinical practice.

Specifically, the goals are to improve diagnostic accuracy, identify children who are most susceptible to developmental sequelae from OME , and educate clinicians and patients regarding the favorable natural history of most OME and the lack of clinical benefits for medical therapy (eg, steroids, antihistamines, decongestants). Additional goals relate to OME surveillance, hearing and language evaluation, and management of OME detected by newborn screening.

The target audience

The guideline is intended for all clinicians who are likely to diagnose and manage children with OME, and it applies to any setting in which OME would be identified, monitored, or managed..

- Methods

A comprehensive search for guidelines was undertaken to identify the most relevant guidelines to consider for adaptation.

inclusion/exclusion criteria followed in the search and retrieval of guidelines to be adapted: 

· Selecting only evidence-based guidelines (guideline must include a report on systematic literature searches and explicit links between individual recommendations and their supporting evidence) 

· Selecting only national and/or international guidelines 

· Specific range of dates for publication (using Guidelines published or updated 2015 and later)

· Selecting peer reviewed publications only 

· Selecting guidelines written in English  language 

· Excluding guidelines written by a single author not on behalf of an organization in order to be valid and comprehensive, a guideline ideally requires multidisciplinary input

· Excluding guidelines published without references as the panel needs to know whether a thorough literature review was conducted and whether current evidence was used in the preparation of the recommendations 

The following characteristics of the retrieved guidelines were summarized in a table:

• Developing organisation/authors

• Date of publication, posting, and release

• Country/language of publication

• Date of posting and/or release

• Dates of the search used by the source guideline developers

All retrieved Guidelines were screened and appraised using AGREE II instrument (www.agreetrust.org) by at least two members. the panel decided a cut-off point or rank the guidelines  (any guideline scoring above 50% on the rigour dimension was retained)

- Evidence assessment

According to WHO handbook for Guidelines we used the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to assess the quality of a body of evidence, develop and report recommendations. GRADE methods are used by WHO because these represent internationally agreed standards for making transparent recommendations. Detailed information on GRADE is available on the following sites:

■ GRADE working group: http://www.gradeworkingroup.org

■ GRADE online training modules: http://cebgrade.mcmaster.ca/

■ GRADE profile software: http://ims.cochrane.org/revman/gradepro

Table 1 Quality of evidence in GRADE

Table 2 Significance of the four levels of evidence

Table 3 Factors that determine How to upgrade or downgrade the quality of evidence

- The strength of the recommendation

The strength of a recommendation communicates the importance of adherence to the recommendation.

Strong recommendations

With strong recommendations, the guideline communicates the message that the desirable effects of adherence to the recommendation outweigh the undesirable effects. This means that in most situations the recommendation can be adopted as policy.

Conditional recommendations

These are made when there is greater uncertainty about the four factors above or if local adaptation has to account for a greater variety in values and preferences, or when resource use makes the intervention suitable for some, but not for other locations. This means that there is a need for substantial debate and involvement of stakeholders before this recommendation can be adopted as policy.

When not to make recommendations

When there is lack of evidence on the effectiveness of an intervention, it may be appropriate not to make a recommendation.

- Recommendations

- Clinical Indicators for Monitoring

1. Documentation of Middle Ear Effusion:

   - Indicator: The clinician should document the presence of middle ear effusion using pneumatic otoscopy and tympanometry when diagnosing otitis media with effusion (OME) in a child.

2. Timely Initiation of Watchful Waiting:

   - Indicator: The clinician should manage children having OME with watchful waiting for 3 months from the date of effusion onset (if known) or 3 months from the date of diagnosis (if onset is unknown), before taking the decision of surgical interference.

3. Follow-up and Counseling:**

   - Indicator: The clinician should document counseling of parents of infants with OME who fail newborn screening, emphasizing the importance of follow-up to ensure normal hearing when OME resolves. Additionally, the clinician should educate children with OME and their families about the natural history of OME, the need for follow-up, and possible sequelae.

These indicators cover aspects such as documentation, diagnostic procedures, treatment decisions, and patient education, providing a comprehensive approach to monitoring physician adherence to the clinical guidelines.

Updating the guideline

To keep these recommendations up to date and  ensure  its validity it will be periodically updated. This will be done whenever a strong new evidence is available  and  necessitates updation.

Research Needs

1. Assess the usefulness of algorithms combining pneumatic otoscopy and tympanometry for detecting OME in clinical practice.

2. Develop prognostic indicators to identify the best candidates for watchful waiting.

3. Evaluate whether there is a causal role of atopy in OME.

- References

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- Annexes

Table 4: Sensory, physical, cognitive, or behavioral factors that place children who have otitis media with effusion at increased risk for developmental difficulties (delay or disorder).

Figure 1: Algorithm showing the relationship of guideline key action statements. OME, otitis media with effusion; QOL, quality of life.