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ryngology–Head and Neck SurgeryRosenfeld et al
2015© The Author(s) 2010

Reprints and permission:

Executive Summary

Clinical Practice Guideline:  Otitis Media Head and Neck Surgery
2016, Vol. 154(2) 201­–214
© American Academy of
with Effusion Executive Summary (Update) Otolaryngology—Head and Neck
Surgery Foundation 2015
Reprints and permission:
DOI: 10.1177/0194599815624407
Richard M. Rosenfeld, MD, MPH1, Jennifer J. Shin, MD, SM2,
Seth R. Schwartz, MD, MPH3, Robyn Coggins, MFA4,
Lisa Gagnon, MSN, CPNP5, Jesse M. Hackell, MD6,
David Hoelting, MD7, Lisa L. Hunter, PhD8, Ann W. Kummer, PhD, CCC-SLP8,
Spencer C. Payne, MD9, Dennis S. Poe, MD, PhD10, Maria Veling, MD11,
Peter M.Vila, MD, MSPH12, Sandra A. Walsh13, and Maureen D. Corrigan14

Sponsorships or competing interests that may be relevant to content are •• New evidence from 4 clinical practice guidelines, 20
disclosed at the end of this article.
systematic reviews, and 49 randomized controlled
trials (RCTs)
Abstract •• Emphasis on patient education and shared decision
making with an option grid for surgery and new
The American Academy of Otolaryngology—Head and Neck tables of counseling opportunities and frequently
Surgery Foundation has published a supplement to this issue asked questions
of Otolaryngology—Head and Neck Surgery featuring the up- •• Expanded action statement profiles to explicitly state
dated “Clinical Practice Guideline: Otitis Media with Effusion.” quality improvement opportunities, confidence in the
To assist in implementing the guideline recommendations, evidence, intentional vagueness, and differences of
this article summarizes the rationale, purpose, and key action opinion
statements. The 18 recommendations developed emphasize •• Enhanced external review process to include public
diagnostic accuracy, identification of children who are most comment and journal peer review
susceptible to developmental sequelae from otitis media with •• Additional information on pneumatic otoscopy and
effusion, and education of clinicians and patients regarding the tympanometry to improve diagnostic certainty for
favorable natural history of most otitis media with effusion otitis media with effusion (OME)
and the lack of efficacy for medical therapy (eg, steroids, an- •• Expanded information on speech and language
tihistamines, decongestants). An updated guideline is needed assessment for children with OME
due to new clinical trials, new systematic reviews, and the lack •• New recommendations for managing OME in chil-
of consumer participation in the initial guideline development dren who fail a newborn hearing screen, evaluating
group. at-risk children for OME, and educating and counsel-
ing parents
Keywords •• A new recommendation against using topical intra-
otitis media with effusion, middle ear effusion, tympanostomy nasal steroids for treating OME
tubes, adenoidectomy, clinical practice guideline •• A new recommendation against adenoidectomy for
a primary indication of OME in children <4 years
Received November 30, 2015; accepted December 7, 2015. old, including those with prior tympanostomy tubes,
unless a distinct indication exists (nasal obstruction,
Differences from Prior Guideline chronic adenoiditis)
This clinical practice guideline is an update and replacement for •• A new recommendation for assessing OME out-
a guideline codeveloped in 2004 by the American Academy of comes by documenting OME resolution, improved
Otolaryngology—Head and Neck Surgery Foundation (AAO- hearing, or improved quality of life (QOL)
HNSF), the American Academy of Pediatrics (AAP), and the •• New algorithm to clarify decision making and action
American Academy of Family Physicians (AAFP).1 An update statement relationships
was necessitated by new primary studies and systematic reviews
that might suggest a need for modifying clinically important
recommendations. Changes in content and methodology from Introduction
the prior guideline include the following: OME is defined as the presence of fluid in the middle ear
(Table 1) without signs or symptoms of acute ear infection.2,3
•• Addition of consumer advocates to the guideline The condition is common enough to be called an “occupa-
development group tional hazard of early childhood”4 because about 90% of
Downloaded from by guest on February 4, 2016

Rosenfeld. USA. Massachusetts. 12Department of Otolaryngology–Head and Neck Surgery. Ohio. OME episodes. Washington. USA. secretory. USA. Pennsylvania.16 between the ages of 6 months and 4 years. including those epi. Texas. acute otitis media (AOM) is the rapid onset of mobility of the tympanic membrane and serves as a barrier to signs and symptoms of inflammation in the middle ear. Chairman and Professor of Otolaryngology. In lay terms. Corresponding Author: Richard M. about 1 in 8 are found include ear fluid and serous. USA. poor school performance. 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. 8Cincinnati Children’s Hospital Medical Center. ranging from 60% to 85%. is About 2. or nonsuppurative to have fluid in one or both ears. and 5% to 10% of episodes last ≥1 year. USA. Missouri. 13Consumers United for Evidence-based Healthcare.2 million diagnosed episodes of OME occur annu.13 ally in the United States at a cost of $4. USA. USA. USA. behavioral OME may occur during an upper respiratory infection. OME may cause structural damage to the tym- an inflammatory response following AOM. Tympanogram An objective measure of how easily the tympanic membrane vibrates and at what pressure it does so most easily (pressure admittance function). audiologic assessment by an audiologist.sagepub.7 The indirect Most episodes of OME resolve spontaneously within 3 costs are likely much higher since OME is largely asymptomatic months.202 Otolaryngology–Head and Neck Surgery 154(2) Table 1. MD. USA. SUNY Downstate Medical Center.Virginia. USA. automated or manual. Pittsburgh. OME is ≥3 months16 and may be associated with hearing loss. 2016 . Massachusetts. Charlottesville. 10Department of Otology and Laryngology. Brooklyn. Hearing assessment A means of gathering information about a child’s hearing status. If the middle ear is filled with fluid (eg. California. Term Definition Otitis media with effusion (OME) The presence of fluid in the middle ear without signs or symptoms of acute ear infection. or reduced QOL. 4Society for Middle Ear Disease. Conductive hearing loss Hearing loss from abnormal or impaired sound transmission to the inner ear. OME). or as Less often. 5Connecticut Pediatric Otolaryngology. 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. Harvard Medical School. USA.6 Synonyms for OME primary school are screened for OME.14 sodes in children with hearing difficulties or school performance Persistent middle ear fluid from OME results in decreased issues. recurrent AOM. but can be caused by other middle ear abnormalities as tympanic membrane perforation or ossicle abnormalities Sensorineural hearing loss Hearing loss that results from abnormal transmission of sound from the sensory cells of the inner ear to the brain. however. most often panic membrane that requires surgical intervention. Harvard Medical School and Boston Children’s Hospital. Davis. life. 2Division of Otolaryngology.15 At least 25% of OME episodes persist for often with ear pain and a bulging eardrum. Nebraska. the movement is minimal or sluggish. to the right if positive). 3Department of Otolaryngology. >50% of children will experience OME.9 In the first year of The high prevalence of OME—along with many issues.5. New York. balance often called “ear fluid” and AOM “ear infection. if the middle ear is filled with air but at a higher or lower pressure than the surrounding atmosphere. NY 11201. Middle ear effusion Fluid in the middle ear from any cause. 11 University of Texas–Southwestern Medical Center/Children’s Medical Center–Dallas. problems. vibration is impaired. In contrast. St Louis. Seattle.11 The prevalence of OME in otitis media. 4 episodes of OME every year. USA. Pender. Alexandria. SUNY Downstate Medical Center. Abbreviations and Definitions of Common Terms. but when there is fluid in the middle ear. Dallas. USA. Madison. Boston. much higher. Brooklyn. on >60% by age 2 years. Downloaded from oto.10 When children aged 5 to 6 years in average.17 spontaneously because of poor eustachian tube function. increasing to including difficulties in diagnosis and assessing its duration.” (vestibular) problems. USA. Does not include use of noisemakers or other nonstandardized methods. Acute otitis media (AOM) The rapid onset of signs and symptoms of inflammation of the middle by guest on February 4. ear discomfort. and the result is a flat or nearly flat tracing.Virginia.Virginia Mason Medical Center.8 most sound conduction. New York. Long Island College Hospital. Connecticut.12. Pomona. 9University of Virginia Health System. 1 Department of Otolaryngology. 14American Academy of Otolaryngology—Head and Neck Surgery Foundation. which is often associated with effusion in the middle ear. but about 30% to 40% of children have repeated and many episodes are therefore undetected.2. children with Down syndrome or cleft palate. MPH. Boston. 6Pomona Pediatrics. A normal eardrum moves briskly with applied pressure. Chronic OME OME persisting for ≥3 months from the date of onset (if known) or from the date of diagnosis (if onset is unknown).0 billion. 7American Academy of Family Physicians. Washington University School of Medicine in St Louis. Cincinnati. children have OME before school age5 and they develop. or hearing testing by a physician or allied health professional using screening or standard equipment. Email: richrosenfeld@msn. the peak on the graph will be shifted in position based on the pressure (to the left if negative. which may include caregiver report.

(d) explicit system tube guideline. General Methods and Literature Search 2. otology. and (DE “OTITIS MEDIA”) OR “otitis and its sequelae (Table 2). does not apply to patients <2 months or Guidelines Clearinghouse. Quality criteria for “Clinical Practice Guideline Development Manual. Risk Factors for Developmental Difficulties in Children with OME. and educate clinicians and patients regarding the searches using a validated filter strategy to identify clinical favorable natural history of most OME and the lack of clinical practice guidelines. revised. nursing. and it applies to any setting in which The original MEDLINE search was updated from January OME would be identified. practice. because indications are thoroughly explained in a companion clinical practice guide. the methods outlined in the AAO-HNSF distributed to the panel members. atelectasis pose. Cumulative Index to The guideline does not explicitly discuss indications for Nursing and Allied Health. The initial search for systematic reviews identified In developing the update of the evidence-based clinical prac. 1. since the prior guideline (2004). Reviews. 138 systematic reviews or meta-analyses that were tice guideline. speech. The initial search for clinical practice guidelines line from the AAO-HNS. systematic reviews. most susceptible to developmental sequelae from OME An information specialist conducted 2 systematic literature (Table 2). Third including reviews were (a) relevance to the guideline Edition” were followed explicitly. National guideline. physical. pediatrics. media with effusion” OR (OME AND otitis) OR “middle ear sistency with the precursor guideline1 and to correspond with effusion” OR “glue ear. with or without associated syndrome Developmental delay Abbreviation: OME. Suggestions were also are to improve diagnostic accuracy. 2016 .1 associated conductive hearing loss. otolaryngology.17 Rather. The guideline is for lower-level evidence were performed to address gaps from intended for all clinicians who are likely to diagnose and man. and (e) explicit system for Methods linking evidence to recommendations. or managed. targeted searches inclusion criteria in many OME studies. otitis/exp OR otitis AND The target patient for the guideline is a child aged 2 months media AND (effusion/exp OR effusion). The reviewers concluded that the original create explicit and actionable recommendations to implement guideline action statements remained valid but should be these opportunities in clinical practice. age children with OME. audiology. pediatric otolaryngology. tion for tympanostomy tube insertion. retraction pockets. even though OME is the leading indica.18 topic. antihistamines. or behavioral factors that place children who have OME at increased risk for developmental difficulties (delay or disorder). discussions of surgery identified 13 guidelines. potential impact on An executive summary of the original OME guideline1 was child development. or language delays Blindness or uncorrectable visual impairment Cleft palate. or removed The purpose of the multidisciplinary guideline is to identify and to identify new research that might affect the guideline quality improvement opportunities in managing OME and to recommendations. and management of OME effusion”[tiab] OR (OME[tiab] AND otitis) OR “middle ear detected by newborn screening.sagepub. a Sensory. the goals updated with major modifications. Specifically. (b) multidisciplinary stakeholder involvement. The final data set retained 4 guidelines that met inclusion criteria. Quality criteria for includ- focus on adjuvant procedures (eg. and speech language pathology who assessed the key action statements to decide if Purpose they should be kept in their current form. and the Allied and Complimentary tympanostomy tubes. MH “Otitis Media through 12 years with OME. adenoidectomy. cognitive. however. Medicine Database. Excerpta Medica database.a Permanent hearing loss independent of OME Suspected or confirmed speech and language delay or disorder Autism spectrum disorder and other pervasive developmental disorders Syndromes (eg. (b) clear objective and by guest on February 4. (c) explicit Downloaded from oto. with or without developmental with Effusion” OR TI (OME and effusion) OR TI “otitis disabilities or underlying conditions that predispose to OME media with effusion”. effusion”[tiab] OR “glue ear”[tiab]. and significant practice variations in sent to a panel of expert reviewers from the fields of general management—makes OME an important condition for up-to. “Otitis Media with Effusion”[Mesh] OR “otitis media with evaluation of hearing and language. monitored. identify children who are made for new key action statements. ing guidelines were (a) an explicit scope and pur- omy) and sequelae of OME (eg. Search terms used were decongestants). the systematic searches identified in writing the guideline. of the middle ear) that were excluded from the tympanostomy (c) systematic literature review. This 2004 to January 2015 to include MEDLINE.Rosenfeld et al 203 Table 2. myringot. steroids.” In certain instances. otitis media with effusion. for ranking evidence. Additional goals relate to OME surveillance. and RCTs published benefits for medical therapy (eg. Down) or craniofacial disorders that include cognitive. family date clinical practice guidelines. Cochrane Database of Systematic >12 years old. The age range was chosen for con.

A major goal of the panel was to be transparent statement. how tability Appraisal to appraise adherence to methodologic stan. and (c) clear methodology with randomized recommendation. New key action statements were person meeting. Making recommendations about health practices involves speech language pathology. was covered in full by the AAO-HNSF. and (3) agreed not to discuss any aspect of the was used to facilitate creating actionable recommendations guideline with industry before publication. Guidelines are never intended to supersede professional 3. differences of opinion. are intended to reduce inappropriate variations in clinical care. panelists and evidence profiles. excep- opment requires that the evidence supporting a policy be tions to the statement. and explicit about how values were applied and to document ties. ments of any value judgments.19 were reminded that conflicts of interest extend beyond finan- The updated guideline then underwent GuideLine Implemen. regardless of guideline recommendations. ence call and were updated at each subsequent call and in- ment does not apply. risks. cial relationships and may include personal experiences. Connecticut) the panel. audiology. mize harm. 2016 . otology. and reviewed the literature search results. A scheduled review followed by an “action statement profile” that explicitly states process will occur 5 years from publication or sooner if new. Less frequent variation in practice is expected for the guideline topic. Evidence-based view of each evidence-based statement in this guideline can statements reflect both the quality of evidence and the balance be found in Table 3. The GUG had several conference calls ciated with management options. The evidence-based approach to guideline devel. identified other quality improvement opportuni. evidence for a particular topic. Guidelines evidence (high.24 potential obstacles to implementation. and a repeat identified. Last. to improve clarity of recommendations. Downloaded from oto.20 The GUG received summary appraisals and modified an advanced draft of the Guideline Key Action Statements guideline based on the appraisal. and to predict established “stake” in an issue. a participant earns a living. Yale (2) recused themselves from a related discussion if asked by Center for Medical Informatics. reviewed priate therapy. any differences of opinion. clarification of any intentional vagueness by the panel. diminish unnecessary and inappro- scope and objectives of updating the guideline. Options offer the most opportunity for prac- allocation to treatment groups. the panel of potential conflicts before any related discussion. harms. (b) publication in a peer-reviewed a strong recommendation than what might be expected with a journal. The initial search for RCTs identified 86 RCTs that judgment. benefit. tial conflicts could remain on the panel if they (1) reminded dence and the associated balance of benefit and harm. and any exclusion to which the action state. National Quality Strategy domain based on the original pri- orities). they may be viewed as a relative constraint were distributed to panel members for review. level of confidence in Classification of Evidence-Based Statements. medium. Financial Disclosure and Conflicts of Interest.23 the panel concluded that individuals with poten- for creating actionable statements based on supporting evi. of benefit and harm that is anticipated when the statement is The final data set retained was 20 systematic reviews followed. and reduce the unnecessary use of systemic comments from the expert panel review for each key action antibiotics. profiles regarding the quality improvement opportunity. and a benefits-harm assessment. The total final data set tice variability. Values applied by the GUG and one in-person meeting.22 rics. costs. and journal editorial peer review.sagepub. or meta-analyses that met inclusion criteria. After review and discussion of these developed with an explicit and transparent a priori protocol disclosures. by guest on February 4. there are state- to produce optimal health outcomes for patients. The AAO-HNSF assembled a guideline update group Guidelines represent the best judgment of a team of experi- (GUG) representing the disciplines of otolaryngology–head enced clinicians and methodologists addressing the scientific and neck surgery. and (d) valid data extraction methods. family medicine. followed by the strength received during multidisciplinary peer review.204 Otolaryngology–Head and Neck Surgery 154(2) search strategy.25 aggregate evidence quality. pediatric otolaryngology. allergy and immunology. the role of patient preferences. level Potential conflicts of interest for all panel members in the past of confidence in the evidence. the process. Each key action statement is comment.18 Information was added to the action statement panel members. The cost of ment profile for consistency with our current development developing this guideline. The final draft of the updated Each evidence-based statement is organized in a similar fash- clinical practice guideline was revised based on comments ion: a key action statement in bold. rather.21 Clinicians should always act and decide in a retained 49 RCTs that met inclusion criteria. way that they believe will best serve their individual patients’ interests and needs. The evidence profile for each statement in the earlier guideline was then converted into an expanded action state. and value judgments on the desirability of various outcomes asso- consumer advocacy. the quality improvement opportunity (and corresponding compelling evidence warrants earlier consideration. Electronic decision support software (BRIDGE-Wiz. open public of the recommendation in italics. inten. New Haven. and summarized and that an explicit link statement of the strength of the recommendation. appraised. during which they defined the sought to minimize harm. low). 5 years were compiled and distributed before the first confer- tional vagueness. including travel expenses of all standards. on individual clinician discretion in a particular clinical cir- ity criteria for including RCTs were (a) relevance to cumstance. Additionally. advanced practice nursing. and the participant’s previously dards. An over- between evidence and statements be defined. and to mini. Qual.

Rosenfeld et al 205 The role of patient. or type B. lack of access. adverse effects studies with a preponderance of benefit over harm. reduce tympanometry is not specified and could be the clini- false-positive diagnoses that lead to unnecessary cian or another health professional. where the management obtain tympanometry in children with suspected OME decision is made by a collaborative effort between the clini. reduce false. FAILED NEWBORN HEARING lized for diagnosing OME. or both. and frequency and duration of treatment. For some otoscopy is a prerequisite for managing children with statements. which •• Differences of opinion: None in turn leads to better patient adherence and by guest on February 4. although the role of patient preference for a range of treat. for whom the diagnosis is uncertain after performing (or cian and an informed patient—is extremely useful. costs: Cost. PNEUMATIC OTOSCOPY: The cli. minor procedural •• Policy level: Strong recommendation discomfort •• Differences of opinion: None •• Benefit-harm assessment: Preponderance of benefit •• Value judgments: Pneumatic otoscopy is underuti. accurate diagnosis of OME using pneumatic making decisions deserves further clarification. where the evidence base demonstrates clear ben. costs: Costs of training clinicians in •• Exceptions: Patients with recent ear surgery or pneumatic otoscopy. harms. (Table 4. systematic •• Risks. with a consistent reference standard for tympanom- etry as a primary diagnostic method STATEMENT 1b. the practice STATEMENT 2. STATEMENT 3. Strong medium regarding the value as an adjunct to pneu- recommendation based on systematic review of diagnostic matic otoscopy studies with a preponderance of benefit over harm. confirm a sus- Action Statement Profile for Statements pected diagnosis of OME. •• Policy level: Strong recommendation tate patient understanding and shared decision making. false-positive diagnoses from trauma nonintact tympanic membrane. Strong recommendation based on systematic review of from systematic review of cross-sectional studies diagnostic studies with a preponderance of benefit over harm. In cases where evidence is weak or benefits unclear. •• Level of confidence in evidence: High regarding nician should perform pneumatic otoscopy to assess for the value of tympanometry for primary diagnosis. equipment review of cross-sectional studies with a consistent calibration and maintenance. intraoperative decision •• Role of patient preferences: Very limited making). especially in primary care SCREEN: Clinicians should document in the medical Downloaded from oto. parent. efficient. Strong recommendation related to patient preference include (but are not limited to) based on extrapolation of systematic reviews of diagnostic absolute benefits (number needed to treat). National Quality Strategy domain: clinical tracing has the poorest prognosis). (number needed to harm). portable or table top tympanometry is at the discre- ment mobility of the tympanic membrane. •• Value judgments: None negative diagnoses caused by effusions that do not •• Intentional vagueness: The individual who performs have obvious air bubbles or an air-fluid level. Action Statement Profile for Statement 2 •• Quality improvement opportunity: Improve diagnos- Key Action Statements tic accuracy for OME and raise awareness regarding the value of tympanometry as an objective mea- STATEMENT 1a. TYMPANOMETRY: Clinicians should of shared decision making—again. misinterpretation of reference standard findings •• Level of confidence in evidence: High •• Benefit-harm assessment: Preponderance of benefit •• Benefit: Improve diagnostic certainty. clinicians should provide patients with clear and •• Exceptions: None comprehensible information on the benefits. domain: clinical process/effectiveness) sion with pneumatic otoscopy when diagnosing OME in a •• Aggregate evidence quality: Grade B. OME efit. readily available equipment. harms. This will facili. cost of drugs or procedures. OME in a child with otalgia. •• Intentional vagueness: None ments may not be relevant (eg. 2016 . a flat. obtain prognostic information on likelihood of underutilized means of assessing middle ear status timely spontaneous resolution (eg. •• Benefit: Improved diagnostic accuracy. sure of middle ear status (National Quality Strategy nician should document the presence of middle ear effu.sagepub. educational value process/effectiveness) in confirming pneumatic otoscopy findings •• Aggregate evidence quality: Grade A. whether to use tests and costs. tion of the clinician cost-effective •• Role of patient preferences: Limited •• Risks. and/or caregiver preferences in settings. extrapolation child. Factors attempting) pneumatic otoscopy. hearing loss. membrane perforation (high equivalent ear canal vol- nostic accuracy for OME with a readily available but ume). docu. differentiate OME (normal equivalent ear canal volume) vs tympanic •• Quality improvement opportunity: To improve diag. PNEUMATIC OTOSCOPY: The cli. obtain objective informa- 1a and 1b tion regarding middle ear status.

 Antihistamines or Clinicians should recommend against using antihistamines.  Patient education Clinicians should educate families of children with OME regarding the Recommendation natural history of OME. (against) 8b. 8a. 13. Strong recommendation decongestants or both for treating OME. improved hearing. or ear discomfort. Surveillance of chronic Clinicians should reevaluate. Tympanometry Clinicians should obtain tympanometry in children with suspected OME Strong recommendation for whom the diagnosis is uncertain after performing (or attempting) pneumatic otoscopy.sagepub.  Outcome assessment When managing a child with OME. physical. or both. children with chronic Recommendation OME OME until the effusion is no longer present.206 Otolaryngology–Head and Neck Surgery 154(2) Table 3. Surgery for children Clinicians should recommend tympanostomy tubes when surgery is Recommendation <4 y old performed for OME in a child less than 4 years old. at 3. cognitive. hearing loss. Failed newborn hearing Clinicians should document in the medical record counseling of parents Recommendation screen of infants with OME who fail a newborn hearing screen regarding the importance of follow-up to ensure that hearing is normal when OME resolves and to exclude an underlying sensorineural hearing loss. Steroids Clinicians should recommend against using intranasal steroids or Strong recommendation systemic steroids for treating OME. 12b. clinicians should document in the Recommendation medical record resolution of OME. record counseling of parents of infants with OME who resolves and to exclude an underlying sensorineural hear- fail a newborn hearing screen regarding the importance ing loss (SNHL). Antibiotics Clinicians should recommend against using systemic antibiotics for Strong recommendation treating OME.  Identifying at-risk children Clinicians should determine if a child with OME is at increased risk for Recommendation speech. 3.   Pneumatic otoscopy The clinician should document the presence of middle ear effusion with Strong recommendation pneumatic otoscopy when diagnosing OME in a child. 4b.  Pneumatic otoscopy The clinician should perform pneumatic otoscopy to assess for OME in a Strong recommendation child with otalgia. or improved quality of life. need for follow-up. 10. 11. (against) 9. and the possible sequelae. Recommendation ≥4 y old or both when surgery is performed for OME in a child 4 years old or older. such as hearing difficulties. 7.  Speech and language Clinicians should counsel families of children with bilateral OME and Recommendation documented hearing loss about the potential impact on speech and language development. 6. Summary of Guideline Key Action Statements. 2016 .  Hearing test Clinicians should obtain an age-appropriate hearing test if OME Recommendation persists for ≥3 mo OR for OME of any duration in an at-risk 6-mo intervals. decongestants. or structural abnormalities of the eardrum or middle ear are suspected. Statement Action Strength by guest on February 4. behavioral problems. language.  Screening healthy children Clinicians should not routinely screen children for OME who are not at Recommendation (against) risk (Table 2) and do not have symptoms that may be attributable to OME. nasal obstruction. Watchful waiting Clinicians should manage the child with OME who is not at risk with Strong recommendation watchful waiting for 3 mo from the date of effusion onset (if known) or 3 mo from the date of diagnosis (if onset is unknown). or behavioral factors (Table 2). 12a. balance (vestibular) problems. 1b. Abbreviation: OME. or learning problems from middle ear effusion because of baseline sensory. Recommendation based on observational of follow-up to ensure that hearing is normal when OME studies with a predominance of benefit over harm. otitis media with effusion.  Evaluating at-risk children Clinicians should evaluate at-risk children (Table 2) for OME at the time Recommendation of diagnosis of an at-risk condition and at 12 to 18 mo of age (if diagnosed as being at risk prior to this time). 5. 4a. 2. chronic adenoiditis) exists other than OME. Surgery for children Clinicians should recommend tympanostomy tubes. adenoidectomy should not be performed unless a distinct indication (eg. adenoidectomy. significant hearing loss is identified. Downloaded from oto. poor school performance. (against) 8c.

harms. earlier intervention for hearing by guest on February 4. IDENTIFYING AT-RISK CHILDREN: nostomy tubes) and from more active and accurate Clinicians should determine if a child with OME is at surveillance of middle ear status. Clinicians should evaluate at-risk children (Table 2) for low-up for effusions in newborn screening programs OME at the time of diagnosis of an at-risk condition and and the prevalence of SNHL in newborn screening at 12 to 18 months of age (if diagnosed as being at risk failures with OME prior to this time). the canal. •• Quality improvement opportunity: Increase adher. Using slight and gentle pressure will avoid unnecessary pain.Rosenfeld et al 207 Table 4. patient and family engagement) •• Aggregate evidence quality: Grade C. so both releasing the bulb very slightly and very gently several times. care coordination. Before inserting the speculum. Practical Tips for Performing Pneumatic Otoscopy. Choose a speculum that is slightly wider than the ear canal A speculum that is too narrow cannot form a proper seal and will give false- to obtain an air-tight seal. Insert the speculum deep enough into the ear canal to Limiting insertion to the cartilaginous (outer) portion of the ear canal obtain an air-tight seal but not deep enough to cause is painless. enough pressure some motion is almost always possible. cognitive. observational the need for counseling but a large role for shared studies regarding the high prevalence of OME in at- decision making in the specifics of how follow-up is risk children and the known impact of hearing loss implemented and in what specific care settings on child development. dampened. Examine tympanic membrane mobility by squeezing and Many children have negative pressure in their middle ear space. Motion is reduced substantially with OME. D. •• Benefit: More prompt diagnosis of SNHL. or.sagepub. Action Statement Profile for Statements up. then firmly cover the tip of the no air leaks. or learning problems from middle ear effusion because of baseline sensory. the pressure is released). or behavioral factors (Table 2). or restricted. periosteum can be very painful. diagnosis Strategy domain: population/public health) •• Role of patient preferences: Minimal role regarding •• Aggregate evidence quality: Grade C. STATEMENT 4b. squeeze the pneumatic bulb Squeezing the bulb first allows the examiner to apply both negative pressure halfway (about 50% of the bulb width). but with absence of mobility is not required. expert opinion on the abil- •• Exceptions: None ity of prompt diagnosis to alter outcomes •• Policy level: Recommendation •• Level of confidence in the evidence: Medium •• Differences of opinion: None •• Benefit: Identify at-risk children who might benefit from early intervention for OME (including tympa- STATEMENT 4a. paren- tal anxiety from increased focus on child hearing •• Quality improvement opportunity: Raise awareness issues of a subset of children with OME (Table 2) who are •• Benefit-harm assessment: Preponderance of benefit disproportionately affected by middle ear effusion •• Value judgments: None as compared with otherwise healthy children and to •• Intentional vagueness: The method and specifics of detect OME in at-risk children that might have been follow-up are at the discretion of the clinician but missed without explicit screening but could affect should seek resolution of OME within 3 months of their developmental progress (National Quality onset. Rec- ence to follow-up and ensure that an underlying SNHL ommendation based on observational studies with a prepon- is not missed (National Quality Strategy domains: derance of benefit over harm. Abbreviation: OME. if not known. reassure parents 4a and 4b •• Risks. squeeze The bulb should stay compressed after blocking the speculum if there are the pneumatic bulb fully. physical. costs: Time spent in counseling. Recommendation based on observational •• Level of confidence in evidence: Medium studies with a preponderance of benefit over harm. indirect obser. otitis media with effusion. positive pressure (squeezing the bulb) and negative (releasing the bulb) pressure are needed to fully assess mobility. the tympanic membrane will move briskly with membrane is sluggish. language. EVALUATING AT-RISK CHILDREN: vational evidence on the benefits of longitudinal fol. identify unsus- Downloaded from oto. 2016 . if the bulb opens (eg. complete minimal pressure. then insert it into (by releasing the bulb) and positive pressure (by further squeezing). speculum for a tight fit and the bulb and tubing for leaks. check the speculum with your finger and let go of the bulb. but deep insertion that touches the bony ear canal and pain. Diagnose OME when movement of the tympanic When OME is absent. positive results. Action Statement Profile for Statement 3 increased risk for speech. Pneumatic Otoscopy Tip Rationale After attaching the speculum to the otoscope. reduce loss to follow.

WATCHFUL WAITING: Clinicians essary tests and treatment for a highly prevalent should manage the child with OME who is not at risk with and usually self-limited condition (National Qual. and possible sequelae to empower fami- dations in this guideline regarding pneumatic otos. 2016 . lies for shared decisions (Table 5. condition that is usually self-limited (National Qual- evant OME in some children ity Strategy domains: patient safety. •• Policy level: Recommendation •• Differences of opinion: None Action Statement Profile for Statement 5 •• Quality improvement opportunity: Avoid unnec. prolongation of hearing loss Downloaded from oto. and sistent OME could limit the benefit of ongoing thera. balance •• Value judgments: None (vestibular) problems.208 Otolaryngology–Head and Neck Surgery 154(2) pected OME and reduce the impact of OME and who is suspected to be at risk but does not yet have a associated hearing loss on child development formal at-risk diagnosis •• Risks. limit parent anxiety tions with potential adverse events and cost for a •• Risks. •• Policy level: Recommendation against parental anxiety. evaluations. tympanometry). the need for follow-up. poor school performance. costs: Potential to miss clinically rel. Strong recommendation based on systematic review •• Aggregate evidence quality: Grade A. potential for overtreatment •• Difference of opinions: None •• Benefit-harm assessment: Preponderance of benefit •• Value judgments: The GUG assumed that at-risk STATEMENT 6. •• Intentional vagueness: The word “routine” is used and interventions. facilitate shared decisions. such as hearing difficulties. population/public health) unknown). ral history. SCREENING HEALTHY CHILDREN: •• Risks. PATIENT EDUCATION: Clinicians children (Table 2) are less likely to tolerate OME should educate families of children with OME regarding than would the otherwise healthy child and that per. Recommendation based on observa- pies and education interventions for at-risk children tional studies and preponderance of benefit over harm. a time interval of 12 to 18 Strategy domain: patient and family engagement) months is stated to give the clinician flexibility and •• Aggregate evidence quality: Grade C. or ear discomfort. educate families about risk factors and cop- ing strategies STATEMENT 5. emphasize the importance of fol- •• Differences of opinion: None low-up. avoid unnecessary •• Quality improvement opportunity: Avoid interven- treatment. the possible by guest on February 4. the natural history of OME. Recommendation against •• Role of patient preferences: Limited based on RCTs and cohort studies with a preponderance of •• Exceptions: None harm over benefit.sagepub. assumption that early identifica- tion of OME in at-risk children could improve devel. National Quality copy and tympanometry. harms. STATEMENT 7. identifying self-limited effusions. watchful waiting for 3 months from the date of effusion onset ity Strategy domains: efficient use of health care (if known) or 3 months from the date of diagnosis (if onset is resources. observational to ensure that evaluation takes place at a critical time studies in the child’s development •• Level of confidence in the evidence: High •• Role of patient preferences: None •• Benefits: Reduce anxiety. review of RCTs •• Level of confidence in the evidence: High Action Statement Profile for Statement 7 •• Benefit: Avoid unnecessary tests. costs: Delays in therapy for OME that with a strong family history of otitis media or a child persists >3 months. a child •• Risks. •• Exceptions: None provide parents with a fuller understanding of their •• Policy level: Recommendation child’s condition. with special needs. •• Intentional vagueness: None ioral problems. Action Statement Profile for Statement 6 opmental outcomes •• Quality improvement opportunity: Provide clear. take advantage of favorable natu- to indicate that there may be specific circumstances ral history where screening is appropriate—for example. systematic •• Value judgments: None review of cohort studies •• Role of patient preferences: Limited. harms. harms. efficient use of •• Benefit-harm assessment: Preponderance of benefit health care resources) over harm •• Aggregate evidence quality: Grade A. systematic of cohort studies and preponderance of benefit over harm. costs: Direct costs of evaluating for OME •• Exceptions: None (eg. but a parent can •• Level of confidence in the evidence: High request screening if desired •• Benefit: Avoid unnecessary referrals. •• Intentional vagueness: The method of evaluating for patient-friendly education regarding OME. costs: Time for education Clinicians should not routinely screen children for OME •• Benefit-harm assessment: Preponderance of benefit who are not at risk and do not have symptoms that may be over harm attributable to OME. harms. its natu- OME is not specified but should follow recommen. behav.

hearing levels. but the effect is usually small and goes away when the fluid clears up. so you should not give your child antibiotics. STEROIDS: Clinicians should recommend against using intranasal steroids or systemic steroids for treat. emotional distress. ANTIBIOTICS: Clinicians should rec- •• Benefit-harm assessment: Preponderance of benefit ommend against using systemic antibiotics for treating over harm OME. Fluid is much more likely to persist when it has been there for at least 3 mo or when it is found during a regular checkup visit and the start date is unknown. decongestants. The best way to prevent problems is to see the doctor every 3 to 6 mo until the fluid goes away. decongestants. or alternative (natural) therapies. 8b. but during a cold. or both for treating OME. repeat it. or need for tym- Downloaded from oto. Will the fluid turn into an ear infection? The fluid cannot directly turn into an ear infection. so your doctor will often recommend watchful waiting away on its own? for the first 3 mo. Is it possible that the ear fluid will just go Fluid often goes away on its own. there is usually no problem. How might the ear fluid affect my child? The most common symptoms of ear fluid are mild discomfort. Will medications or other therapies help the Medical treatment does not work well. delayed speech. irritability.sagepub. such as after a cold or ear infection. It may help to keep your child awake when the plane is landing and encourage him or her to swallow to even out the pressure. Speak very clearly. What can I do at home to help the fluid go Keep your child away from secondhand smoke. Strong recommendation against based on systematic cal therapy that does not affect long-term outcomes review of RCTs and preponderance of harm over benefit. even when struggling with hearing problems or other issues related to the fluid. Be sure to follow-up with your doctor to make sure the fluid goes away completely Does it matter how long the fluid has been The fluid is most likely to go away quickly if it has been there <3 mo or has a known start there? time. fluid go away? antihistamines. and 8c STATEMENT 8a. especially in a group setting or with background noise. also called otitis media with effusion. complementary medicine. which gives a flat reading when the ear is by guest on February 4.Your doctor can measure the amount of fluid with a tympanogram. is a buildup of mucus or liquid behind the ear drum without symptoms of infection. review of RCTs and preponderance of harm over benefit. •• Quality improvement opportunity: Discourage medi- ing OME. STATEMENT 8b. because the fluid may still be there and could later cause problems. so be patient and understanding. it increases your child’s risk of getting an ear infection because the fluid makes it easier for germs to grow and spread. Does the fluid cause hearing loss? The fluid can make it harder for your child to hear. tions in an often self-limited condition •• Intentional vagueness: None STATEMENT 8c. who may be antihistamines. steroids (by mouth or in the nose). Do I still need to follow up with my doctor. herbal remedies. it can hurt when the plane is coming down. young children often do not express themselves well. Question Answer What is ear fluid? Ear fluid. and if your child does not understand something. Can my child travel by airplane if ear fluid is If the ear is completely full of fluid. Frequently Asked Questions: Treating and Managing Ear Fluid. fullness in the ear.Rosenfeld et al 209 Table 5. ANTIHISTAMINES OR DECON- •• Role of patient preferences: Small GESTANTS: Clinicians should recommend against using •• Exceptions: At-risk children (Table 2). special diets. and mild hearing problems. for OME (resolution. If your child is >12 mo old and still uses a pacifier. Hearing difficulties can be frustrating for your child. clumsiness. Strong recommendation against based on systematic •• Value judgments: Importance of avoiding interven. balance problems. No benefits have ever been shown for chiropractic. •• Policy level: Strong recommendation •• Differences of opinion: None Action Statement Profile for Statements 8a. but when the fluid is present? partial or mixed with air. Fluid that lasts even if my child seems fine? a long time can damage the ear and require surgery. Also. How can I help my child hear better? Stand or sit close to your child when you speak and be sure to let him or her see your face. offered tympanostomy tubes earlier than 3 months if Strong recommendation against based on systematic review of there is a type B tympanogram in one or both ears RCTs and preponderance of harm over benefit. especially in closed spaces. or trouble learning in school. Some children also have disturbed sleep. 2016 . Yes. or drugs to reduce acid reflux. stopping the pacifier in the daytime may help the fluid go away. such as the car away? or in the house.

HEARING TEST: Clinicians should studies. over harm ity Strategy domain: clinical process/effectiveness) •• Value judgments: Group consensus that there is •• Aggregate evidence quality: Grade C. children with chronic OME until the effusion is •• Benefit-harm assessment: Preponderance of benefit no longer present. costs: Time spent in counseling information on hearing status that could influence •• Benefit-harm assessment: Preponderance of benefit counseling and management of OME (National Qual. systematic likely an underappreciation of the impact of bilateral review of RCTs showing hearing loss in about 50% hearing loss secondary to OME on speech and lan- of children with OME and improved hearing after guage development tympanostomy tube insertion. significant hearing loss is identified. •• Role of patient preferences: Small. tate caregiver education (National Quality Strategy apy) domains: patient and family engagement. OME and documented hearing loss about the potential based on high-quality systematic reviews. harms. potential adverse events (National Quality Strategy even if this information does not determine surgical domain: patient safety. then decline testing relapse. •• Intentional vagueness: None •• Role of patient preferences: Small Action Statement Profile for Statement 10 •• Exceptions: Patients in whom any of these by guest on February 4. extrapolation of studies regarding the impact obtain an age-appropriate hearing test if OME persists for of permanent mild hearing loss on child speech and ≥3 months OR for OME of any duration in an at-risk child. dation based on observational studies and preponderance of roids) have documented short-term benefits benefit over harm. care coor- •• Differences of opinion: None dination) •• Aggregate evidence quality: Grade C. cost of the OME: Clinicians should reevaluate. at 3. •• Exceptions: None biotic prescribing on bacterial resistance and trans.sagepub. Downloaded from 6-month audiology assessment intervals. but •• Level of confidence in the evidence: High a full discussion of the specifics of testing is beyond •• Benefit: Avoid side effects and reduce cost by not the scope of this guideline administering medications. language Recommendation based on cohort studies and preponderance •• Level of confidence in the evidence: Medium of benefit over harm. observational studies •• Intentional vagueness: None showing an impact of hearing loss associated with •• Role of patient preferences: None OME on children’s auditory and language skills •• Exceptions: None •• Level of confidence in the evidence: Medium •• Policy level: Recommendation •• Benefit: Detect unsuspected hearing loss. quantify •• Difference of opinion: None the severity and laterality of hearing loss to assist in management and follow-up decisions. avoid delays in defini.210 Otolaryngology–Head and Neck Surgery 154(2) panostomy tubes) but does have significant cost and OME and optimizing their learning environment. identify chil- dren who are candidates for tympanostomy tubes STATEMENT 11. observational STATEMENT 9. costs: None •• Benefit-harm assessment: Preponderance of benefit STATEMENT 10. antibiotics. •• Policy level: Recommendation mission of resistant pathogens •• Difference of opinion: None •• Risks. •• Benefit: Raise awareness among clinicians and care- givers. efficient use of health care candidacy resources) •• Intentional vagueness: The words age-appropriate •• Aggregate evidence quality: Grade A. harms. Recommendation based on observational studies important for counseling and managing children with with a preponderance of benefit over harm. avoid societal impact of inappropriate anti. costs: Access to audiology. 2016 . harms. caregivers may tive therapy caused by short-term improvement. even impact on speech and language development. educate caregivers. systematic audiologic testing are used to recognize that the spe- review of well-designed RCTs cific methods will vary with the age of the child. or over harm structural abnormalities of the eardrum or middle ear are •• Value judgments: Knowledge of hearing status is suspected. SPEECH AND LANGUAGE: Clini- over harm (in recommending against therapy) cians should counsel families of children with bilateral •• Value judgments: Emphasis on long-term outcomes. •• Quality improvement opportunity: Raise awareness cations are indicated for primary management of a of the potential impact of hearing loss secondary to coexisting condition with OME OME on a child’s speech and language and facili- •• Policy level: Strong recommendation (against ther. systemic ste. SURVEILLANCE OF CHRONIC •• Risks. Recommen- though some therapies (eg. identify and prioritize at- Action Statement Profile for Statement 9 risk children for additional assessment •• Quality improvement opportunity: Obtains objective •• Risks.

sagepub. as well as ongoing been shown as a primary intervention for OME. •• Benefit-harm assessment: Preponderance of benefit tion. 2016 . systematic studies review of RCTs (tubes. sequelae of tympanostomy untreated OME can cause progressive changes in the tubes and adenoidectomy tympanic membrane that require surgical interven. adenoidectomy) and obser- •• Level of confidence in the evidence: High vational studies (adenoidectomy) •• Benefit: Detection of structural changes in the tym. or both is based on shared decision making for shared decision making regarding the surveil. ben- counseling and education of parents/caregiver efits of surgery that include improved hearing. children with OME (National Quality Strategy vational studies with a preponderance of benefit over harm. the data are inconsistent •• Intentional vagueness: The surveillance interval is and relatively sparse. OUTCOME ASSESSMENT: When indication (eg. •• Role of patient preferences (Table 6): Moderate role lance interval in the choice of surgical procedure for children ≥4 •• Exceptions: None years old (tubes. avoiding ade- strategies for optimizing the listening-learning envi. including tympanostomy tubes. clinical process/ Quality Strategy domains: patient safety. included in the systematic reviews tion. cific surgical procedures. and less need for additional tympa- •• Benefit-harm assessment: Preponderance of benefit nostomy tube insertion (after adenoidectomy) over harm •• Risks. harms. SURGERY FOR CHILDREN <4 •• Policy level: Recommendation YEARS OLD: Clinicians should recommend tympanostomy •• Difference of opinion: None tubes when surgery is performed for OME in a child <4 years old. centered outcome assessment when managing ommendation based on systematic reviews of RCTs and obser. as primary therapy for OME. nasal obstruction.Rosenfeld et al 211 Action Statement Profile for Statement 11 Action Statement Profile for Statements 12a and 12b •• Quality improvement opportunity: Emphasize that regular follow-up is an important aspect of manag. costs: Cost of follow-up prevalence of OME. is reported by the child. observational •• Aggregate evidence quality: Grade B. “significant” hear. costs: Risks of anesthesia and spe- •• Value judgments: Although it is uncommon. reduced •• Risks. adenoidectomy. or improved QOL. ing. or both) •• Policy level: Recommendation •• Exceptions: Adenoidectomy may be contraindicated •• Differences of opinion: None in children with cleft palate or syndromes associated with a risk of velopharyngeal insufficiency STATEMENT 12a. adenoidectomy identifying children who develop signs or symptoms age ≥4 years) and discourage therapy with limited or that would prompt intervention (National Quality no benefits (adenoidectomy age <4 years) (National Strategy domains: patient by guest on February 4. harms. •• Quality improvement opportunity: Promote effective ing chronic OME that can help avoid sequelae by therapy for OME (tubes at all ages. velopharyngeal insufficiency. chronic adenoiditis) exists managing a child with OME. more complex anesthesia) were felt to outweigh the ing loss is broadly defined as one that is noticed by uncertain benefits in this group the caregiver. because of limited data on long-term benefits of detection of new hearing difficulties or symptoms these interventions and heterogeneity among RCTs that would lead to reassessing the need for interven. domain: clinical process/effectiveness) Downloaded from oto. improved hear- of RCTs with a preponderance of benefit over harm. Action Statement Profile for Statement 13 nostomy tubes. •• Level of confidence in the evidence: Medium. There was an implicit assumption that surveil. clinical effectiveness) process/effectiveness) •• Aggregate evidence quality: Grade C. discussion of •• Benefit: promoting effective therapy. the school performance or QOL decision to offer tympanostomy tubes. adenoidectomy should not be performed unless a distinct STATEMENT 13. STATEMENT 12b: SURGERY FOR CHILDREN AGE ≥4 YEARS OLD: Clinicians should recommend tympa. or both when surgery is •• Quality improvement opportunity: Focus on patient- performed for OME in a child aged 4 years or older. adenoidec- •• Role of patient preferences: Moderate. provider and patient preference. opportunity tomy. clinicians should document other than OME. Recommendation based on RCTs and cohort studies with a preponderance of benefit over harm. Rec. noidectomy in an age group where benefits have not ronment for children with OME. the additional surgical risks of broadly defined at 3 to 6 months to accommodate adenoidectomy (eg. over harm lance and early detection/intervention could prevent •• Value judgments: Although some studies suggest complications and would also provide opportunities benefits of adenoidectomy for children <4 years old for ongoing education and counseling of caregivers. Recommendation based on systematic reviews in the medical record resolution of OME. adenoidectomy. or interferes in •• Intentional vagueness: For children ≥4 years old. panic membrane that may require intervention.

Periodic causes hearing loss. head dunking). a clump every 3 to 6 mo in your to reduce fluid buildup that of tissue in the back of the nose that doctor’s office. recover on his/her own. away (months to years). or improved QOL after manage. much fluid is present. general anesthesia. costs: Cost of follow-up visits and cational purposes only. There collapse. RCTs and •• Role of patient preferences: Small before-and-after studies showing resolution. then checking the ears in hearing tests may also be checking the tube in your your doctor’s office to be sure the ear performed. About hospital). How long does the Regular checkups until the The operation takes about 10 The operation takes about 30 min and treatment take? fluid in the middle ear goes to 20 min and usually requires requires general anesthesia. bother your child. or delayed recovery.26 •• Aggregate evidence quality: Grade C. Are there any special Baths and swimming are fine. Shared Decision Grid for Parents and Caregivers regarding Surgical Options for Otitis Media with Effusion. recover? What are the benefits? Gives your child a chance to Relieves fluid and hearing loss Reduces time with fluid in the future. replaced. infection (that is treated with eardrum and cause it to 2 or 3 in 100 children have a antibiotics). the method of demonstrating cal knowledge expands and technology advances. or when swimming in lakes or dirty water. As medi- outcome is not stated.a Frequently Asked Watchful Waiting Ear (Tympanostomy) Tube Questions (Surveillance) Placement Adenoidectomy Are there any age Watchful waiting can be done Ear tubes can be done at any age Adenoidectomy is not recommended restrictions? at any age below age 4 y for treating ear fluid that persists for at least 3 mo What does it involve? Checking the eardrum Placing a tiny tube in the eardrum Removing most of the adenoids. About 1 in every 4 future ear tubes is reduced by about another treatment is tried. Relieves nasal blockage and place and stays open. Baths. harms. when diving (>6 ft underwater). and air travel Baths and swimming are fine.sagepub. waiting could delay more There is a very small risk of effective treatments. If the fluid does tiny hole in the eardrum that is a very small risk of abnormal voice not eventually go away does not close after the tube (too much air through the nose) or on its own then watchful falls out and may need surgery. The guideline is not intended to over harm replace clinical judgment or establish a protocol for all individuals •• Value judgments: None with this condition and may not provide the only appropriate •• Intentional vagueness: The time frame for assessing approach to diagnosing and managing this program of care. clinical indicators OME resolution (otoscopy or tympanometry) is at and guidelines are promoted as conditional and provisional propos- the discretion of the clinician als of what is recommended under specific conditions but are not Downloaded from oto. infection (drainage) that is could require a visit to the office or and can rarely damage the treated with eardrops.212 Otolaryngology–Head and Neck Surgery 154(2) Table 6. Disclaimer ment The clinical practice guideline is provided for information and edu- •• Risks. Rather. Some children need can result in ear pain or damage to the ear pain or damage to the earplugs if water bothers eardrum depending on how much fluid eardrum depending on how their ears in the bathtub (with is present. infections (if applicable). What are the potential Persistent fluid can reduce About 1 in 4 children get an ear There is a small chance of bleeding (that risks and side effects? hearing. fluid is gone. A few hours. serious problems from the anesthesia. doctor’s office until it falls out. 2016 . a Adapted from Calkins and colleagues. children may need to have them 50% after adenoidectomy. What usually happens in The fluid and hearing loss Most tubes fall out in about 12 The chance that your child may need the long term? eventually go away or to 18 mo. then stores germs. Air travel precautions? Air travel can result in are fine. swimming. About 1 or 2 days. promptly and prevents relapse reduces the need for future ear of fluid while the tube is in by guest on February 4. How long does it take to Does not apply. it is designed to assist clinicians by providing an evidence-based frame- •• Benefit-harm assessment: Predominance of benefit work for decision-making strategies. •• Policy level: Recommendation ment of OME •• Differences of opinion: None •• Level of confidence in the evidence: High •• Benefit: Document favorable outcomes in manage. administrative burden for QOL surveys in managing children with otitis media with effusion. •• Exceptions: None improved hearing. It is not intended as a sole source of guidance audiometry. serious problems from the anesthesia.

Kay D. Martinciglio G. 2014. Shin. The natural his- and Cook. Maureen D. Berkman ND. MD: Agency for Healthcare Research and Quality. 13-EHC091-EF. 4. in in Young Children: Clinical Practice Guideline No. Rock- light of all circumstances presented by the individual patient. writer. 9.149(1):S1-S35. MD. methodologist. Epidemiology. consulting fee from Acclarent. Kummer. Rosenfeld RM. textbook royalties from Plural 1 3. Berman S. panel mem. 101. Martines F. MS. Hunter. In addition. these do not and should not 2. Flynn T. et al. Jönsson R. Sponsorships: American Academy of Otolaryngology—Head and 16. 2010. Rockville. Corrigan. tant chair. Otitis Media with American Academy of Otolaryngology—Head and Neck Surgery Effusion: Comparative Effectiveness of Treatments. Colborn DK. Rockville. Payne. A Parent’s Guide to Ear Tubes. AHRQ publication Richard M. MD. The 3. Hackell. research funding from Acclarent. 2009. Funding source: American Academy of Otolaryngology—Head 17. Laryngoscope. 2003:147-162. 6. writer. Kenna. Compara- Foundation emphasizes that these clinical guidelines should not be deemed to include all proper treatment decisions or methods of care tive Effectiveness Review No. nosis and management of acute otitis media.131:e964-e999. assis- 03-E023. et al. et al. 476. Maris M. financial interest in nasal spray for South West Hampshire infant and first schools. MD. years followed by weekly otoscopy through the “common cold” Alejandro Hoberman. Clinical prac- 1. Lisa lence of otitis media with effusion in children with cleft lip and L. Karen J. Maria Veling. panel member. Spencer C. 2253 Pittsburgh-area Infants: prevalence and risk factors during writer. Martin Mahoney. J Laryngol Otol. Wojciechowski M.173:1319-1325. Di Piazza F. 2004. Martines E. A. panel member. Dunleavey J. text. expert witness (case-by. Blackwell. writer. David Hoelting.130(5):S95-S118. MD. AHRQ publication ably directed to obtaining the same results. et al. Shekelle P. 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