You are on page 1of 14

624407

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

Reprints and permission:
OTOXXX10.1177/0194599815624407Otola

sagepub.com/journalsPermissions.nav

Executive Summary
Otolaryngology–

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:
sagepub.com/journalsPermissions.nav
DOI: 10.1177/0194599815624407
http://otojournal.org
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

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

atelectasis pose. (d) explicit system tube guideline. physical.Rosenfeld et al 203 Table 2. Quality criteria for “Clinical Practice Guideline Development Manual. and the Allied and Complimentary tympanostomy tubes. 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. National guideline. potential impact on An executive summary of the original OME guideline1 was child development. pediatrics. The initial search for systematic reviews identified In developing the update of the evidence-based clinical prac. Medicine Database. of the middle ear) that were excluded from the tympanostomy (c) systematic literature review. 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. Quality criteria for includ- focus on adjuvant procedures (eg.18 topic. This 2004 to January 2015 to include MEDLINE. ing guidelines were (a) an explicit scope and pur- omy) and sequelae of OME (eg. (b) multidisciplinary stakeholder involvement. targeted searches inclusion criteria in many OME studies. however. otitis/exp OR otitis AND The target patient for the guideline is a child aged 2 months media AND (effusion/exp OR effusion). (b) clear objective and methodology. steroids. and (DE “OTITIS MEDIA”) OR “otitis and its sequelae (Table 2). MH “Otitis Media through 12 years with OME. even though OME is the leading indica. Reviews. pediatric otolaryngology. Search terms used were decongestants). The guideline is for lower-level evidence were performed to address gaps from intended for all clinicians who are likely to diagnose and man.” In certain instances. “Otitis Media with Effusion”[Mesh] OR “otitis media with evaluation of hearing and language. Third including reviews were (a) relevance to the guideline Edition” were followed explicitly.1 associated conductive hearing loss.17 Rather. The age range was chosen for con. adenoidectomy. age children with OME. otology. does not apply to patients <2 months or Guidelines Clearinghouse. the goals updated with major modifications. antihistamines. The initial search for clinical practice guidelines line from the AAO-HNS. retraction pockets. and RCTs published benefits for medical therapy (eg.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. identify children who are made for new key action statements. or managed. Suggestions were also are to improve diagnostic accuracy. The final data set retained 4 guidelines that met inclusion criteria. otitis media with effusion. because indications are thoroughly explained in a companion clinical practice guide. audiology. Additional goals relate to OME surveillance. General Methods and Literature Search 2. family date clinical practice guidelines. and it applies to any setting in which The original MEDLINE search was updated from January OME would be identified. otolaryngology. revised. monitored. systematic reviews. Excerpta Medica database. Risk Factors for Developmental Difficulties in Children with OME. speech. the methods outlined in the AAO-HNSF distributed to the panel members. 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. effusion”[tiab] OR “glue ear”[tiab]. 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”. and management of OME effusion”[tiab] OR (OME[tiab] AND otitis) OR “middle ear detected by newborn screening. (c) explicit . 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. and speech language pathology who assessed the key action statements to decide if Purpose they should be kept in their current form. myringot. a Sensory. Cumulative Index to The guideline does not explicitly discuss indications for Nursing and Allied Health. Cochrane Database of Systematic >12 years old. 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. since the prior guideline (2004). or language delays Blindness or uncorrectable visual impairment Cleft palate. for ranking evidence. the systematic searches identified in writing the guideline. cognitive. and (e) explicit system for Methods linking evidence to recommendations. discussions of surgery identified 13 guidelines. Specifically. or behavioral factors that place children who have OME at increased risk for developmental difficulties (delay or disorder). Down) or craniofacial disorders that include cognitive. 1. 138 systematic reviews or meta-analyses that were tice guideline. tion for tympanostomy tube insertion. practice. nursing. most susceptible to developmental sequelae from OME An information specialist conducted 2 systematic literature (Table 2).

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

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

improved hearing.to 6-mo intervals. or learning problems from middle ear effusion because of baseline sensory. physical. Strong recommendation decongestants or both for treating OME. chronic adenoiditis) exists other than OME. language. (against) 8c. nasal obstruction. Recommendation based on observational of follow-up to ensure that hearing is normal when OME studies with a predominance of benefit over harm. Surveillance of chronic Clinicians should reevaluate. such as hearing difficulties.  Patient education Clinicians should educate families of children with OME regarding the Recommendation natural history of OME.  Pneumatic otoscopy The clinician should perform pneumatic otoscopy to assess for OME in a Strong recommendation child with otalgia. (against) 9. otitis media with effusion. (against) 8b. Steroids Clinicians should recommend against using intranasal steroids or Strong recommendation systemic steroids for treating OME. balance (vestibular) problems. Recommendation ≥4 y old or both when surgery is performed for OME in a child 4 years old or older. 7.  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 child. 4a. adenoidectomy. Antihistamines or Clinicians should recommend against using antihistamines. at 3. 5. or behavioral factors (Table 2). 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. 12b. 8a.  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). or structural abnormalities of the eardrum or middle ear are suspected. 12a. Tympanometry Clinicians should obtain tympanometry in children with suspected OME Strong recommendation for whom the diagnosis is uncertain after performing (or attempting) pneumatic otoscopy. hearing loss. 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). poor school performance.   Pneumatic otoscopy The clinician should document the presence of middle ear effusion with Strong recommendation pneumatic otoscopy when diagnosing OME in a child. cognitive. and the possible sequelae. or improved quality of life. 6. need for follow-up. Antibiotics Clinicians should recommend against using systemic antibiotics for Strong recommendation treating OME. 10. 2. 11.206 Otolaryngology–Head and Neck Surgery 154(2) Table 3.  Identifying at-risk children Clinicians should determine if a child with OME is at increased risk for Recommendation speech.  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.  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. or ear discomfort. behavioral problems. significant hearing loss is identified. 13. Summary of Guideline Key Action Statements. 4b. Surgery for children Clinicians should recommend tympanostomy tubes. adenoidectomy should not be performed unless a distinct indication (eg. 3. or both. 1b. Abbreviation: OME. clinicians should document in the Recommendation medical record resolution of OME. . decongestants. Statement Action Strength 1a. 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. children with chronic Recommendation OME OME until the effusion is no longer present. 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).  Outcome assessment When managing a child with OME.

EVALUATING AT-RISK CHILDREN: vational evidence on the benefits of longitudinal fol. D. the canal. reduce loss to follow. physical. identify unsus- . Diagnose OME when movement of the tympanic When OME is absent. reassure parents 4a and 4b •• Risks. Using slight and gentle pressure will avoid unnecessary pain. then firmly cover the tip of the no air leaks. STATEMENT 4b. 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. costs: Time spent in counseling. Pneumatic Otoscopy Tip Rationale After attaching the speculum to the otoscope. Motion is reduced substantially with OME. or behavioral factors (Table 2). 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. squeeze the pneumatic bulb Squeezing the bulb first allows the examiner to apply both negative pressure halfway (about 50% of the bulb width).Rosenfeld et al 207 Table 4. or restricted. Examine tympanic membrane mobility by squeezing and Many children have negative pressure in their middle ear space. 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. positive pressure (squeezing the bulb) and negative (releasing the bulb) pressure are needed to fully assess mobility. so both releasing the bulb very slightly and very gently several times. harms. the tympanic membrane will move briskly with membrane is sluggish. indirect obser. if not known. dampened. but deep insertion that touches the bony ear canal and pain. check the speculum with your finger and let go of the bulb. earlier intervention for hearing loss. 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). cognitive. care coordination. squeeze The bulb should stay compressed after blocking the speculum if there are the pneumatic bulb fully. •• Benefit: More prompt diagnosis of SNHL. •• Quality improvement opportunity: Increase adher. speculum for a tight fit and the bulb and tubing for leaks. the pressure is released). 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. then insert it into (by releasing the bulb) and positive pressure (by further squeezing). but with absence of mobility is not required. otitis media with effusion. 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. or learning problems from middle ear effusion because of baseline sensory. 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. or. Abbreviation: OME. Action Statement Profile for Statement 3 increased risk for speech. patient and family engagement) •• Aggregate evidence quality: Grade C. enough pressure some motion is almost always possible. periosteum can be very painful. Action Statement Profile for Statements up. diagnosis Strategy domain: population/public health) •• Role of patient preferences: Minimal role regarding •• Aggregate evidence quality: Grade C. Recommendation based on observational •• Level of confidence in evidence: Medium studies with a preponderance of benefit over harm. Before inserting the speculum. language. complete minimal pressure. if the bulb opens (eg. 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. positive results. Practical Tips for Performing Pneumatic Otoscopy.

STATEMENT 7. costs: Direct costs of evaluating for OME •• Exceptions: None (eg. prolongation of hearing loss . condition that is usually self-limited (National Qual- evant OME in some children ity Strategy domains: patient safety. Strong recommendation based on systematic review •• Aggregate evidence quality: Grade A. efficient use of •• Benefit-harm assessment: Preponderance of benefit health care resources) over harm •• Aggregate evidence quality: Grade A. with special needs. •• Intentional vagueness: The method of evaluating for patient-friendly education regarding OME. or ear discomfort. •• Exceptions: None provide parents with a fuller understanding of their •• Policy level: Recommendation child’s condition. costs: Delays in therapy for OME that with a strong family history of otitis media or a child persists >3 months. •• Policy level: Recommendation against parental anxiety. costs: Potential to miss clinically rel. a child •• Risks. its natu- OME is not specified but should follow recommen. facilitate shared decisions. the need for follow-up. review of RCTs •• Level of confidence in the evidence: High Action Statement Profile for Statement 7 •• Benefit: Avoid unnecessary tests.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. 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. potential for overtreatment •• Difference of opinions: None •• Benefit-harm assessment: Preponderance of benefit •• Value judgments: The GUG assumed that at-risk STATEMENT 6. SCREENING HEALTHY CHILDREN: •• Risks. systematic •• Value judgments: None review of cohort studies •• Role of patient preferences: Limited. 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. systematic of cohort studies and preponderance of benefit over harm. 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. such as hearing difficulties. poor school performance. 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. Recommendation based on observa- pies and education interventions for at-risk children tional studies and preponderance of benefit over harm. identifying self-limited effusions. harms. •• Intentional vagueness: None ioral problems. and sistent OME could limit the benefit of ongoing thera. behav. educate families about risk factors and cop- ing strategies STATEMENT 5. National Quality copy and tympanometry. avoid unnecessary •• Quality improvement opportunity: Avoid interven- treatment. lies for shared decisions (Table 5. 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. the possible sequelae. but a parent can •• Level of confidence in the evidence: High request screening if desired •• Benefit: Avoid unnecessary referrals. •• Policy level: Recommendation •• Differences of opinion: None Action Statement Profile for Statement 5 •• Quality improvement opportunity: Avoid unnec. emphasize the importance of fol- •• Differences of opinion: None low-up. population/public health) unknown). Action Statement Profile for Statement 6 opmental outcomes •• Quality improvement opportunity: Provide clear. 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. limit parent anxiety tions with potential adverse events and cost for a •• Risks. harms. harms. assumption that early identifica- tion of OME in at-risk children could improve devel. ral history. evaluations. harms. 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. •• Intentional vagueness: The word “routine” is used and interventions. tympanometry). balance •• Value judgments: None (vestibular) problems. take advantage of favorable natu- to indicate that there may be specific circumstances ral history where screening is appropriate—for example. and possible sequelae to empower fami- dations in this guideline regarding pneumatic otos.

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

•• Intentional vagueness: None •• Role of patient preferences: Small Action Statement Profile for Statement 10 •• Exceptions: Patients in whom any of these medi. identify chil- dren who are candidates for tympanostomy tubes STATEMENT 11. systemic ste. quantify •• Difference of opinion: None the severity and laterality of hearing loss to assist in management and follow-up decisions. significant hearing loss is identified. tate caregiver education (National Quality Strategy apy) domains: patient and family engagement. 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. children with chronic OME until the effusion is •• Benefit-harm assessment: Preponderance of benefit no longer present. 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. then decline testing relapse. or over harm structural abnormalities of the eardrum or middle ear are •• Value judgments: Knowledge of hearing status is suspected. observational STATEMENT 9. 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. costs: None •• Benefit-harm assessment: Preponderance of benefit STATEMENT 10. Recommendation based on observational studies important for counseling and managing children with with a preponderance of benefit over harm. SURVEILLANCE OF CHRONIC •• Risks. avoid societal impact of inappropriate anti. harms. avoid delays in defini. •• Policy level: Recommendation mission of resistant pathogens •• Difference of opinion: None •• Risks. even impact on speech and language development. Recommen- though some therapies (eg. efficient use of health care candidacy resources) •• Intentional vagueness: The words age-appropriate •• Aggregate evidence quality: Grade A. harms. •• Exceptions: None biotic prescribing on bacterial resistance and trans. educate caregivers. care coor- •• Differences of opinion: None dination) •• Aggregate evidence quality: Grade C. dation based on observational studies and preponderance of roids) have documented short-term benefits benefit over harm. OME and documented hearing loss about the potential based on high-quality systematic reviews. over harm ity Strategy domain: clinical process/effectiveness) •• Value judgments: Group consensus that there is •• Aggregate evidence quality: Grade C. 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. 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. identify and prioritize at- Action Statement Profile for Statement 9 risk children for additional assessment •• Quality improvement opportunity: Obtains objective •• Risks. costs: Access to audiology. at 3. . language Recommendation based on cohort studies and preponderance •• Level of confidence in the evidence: Medium of benefit over harm.210 Otolaryngology–Head and Neck Surgery 154(2) panostomy tubes) but does have significant cost and OME and optimizing their learning environment. 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. caregivers may tive therapy caused by short-term improvement. •• Role of patient preferences: Small. cost of the OME: Clinicians should reevaluate. •• 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. HEARING TEST: Clinicians should studies. •• Benefit: Raise awareness among clinicians and care- givers.to 6-month audiology assessment intervals. harms. potential adverse events (National Quality Strategy even if this information does not determine surgical domain: patient safety. antibiotics. 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.

improved hear- of RCTs with a preponderance of benefit over harm. adenoidectomy. 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. 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. •• Level of confidence in the evidence: Medium. including tympanostomy tubes. There was an implicit assumption that surveil. harms. clinicians should document other than OME. 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. systematic studies review of RCTs (tubes. or both is based on shared decision making for shared decision making regarding the surveil.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. panic membrane that may require intervention. STATEMENT 12b: SURGERY FOR CHILDREN AGE ≥4 YEARS OLD: Clinicians should recommend tympa. Recommendation based on RCTs and cohort studies with a preponderance of benefit over harm. adenoidec- •• Role of patient preferences: Moderate. Rec. ben- counseling and education of parents/caregiver efits of surgery that include improved hearing. clinical effectiveness) process/effectiveness) •• Aggregate evidence quality: Grade C. as primary therapy for OME. 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 safety. the additional surgical risks of broadly defined at 3 to 6 months to accommodate adenoidectomy (eg. provider and patient preference. “significant” hear. centered outcome assessment when managing ommendation based on systematic reviews of RCTs and obser. 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. avoiding ade- strategies for optimizing the listening-learning envi. costs: Risks of anesthesia and spe- •• Value judgments: Although it is uncommon. or both when surgery is •• Quality improvement opportunity: Focus on patient- performed for OME in a child aged 4 years or older. adenoidectomy should not be performed unless a distinct STATEMENT 13. nasal obstruction. 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. OUTCOME ASSESSMENT: When indication (eg. or improved QOL. sequelae of tympanostomy untreated OME can cause progressive changes in the tubes and adenoidectomy tympanic membrane that require surgical interven. Action Statement Profile for Statement 13 nostomy tubes. cific surgical procedures. and less need for additional tympa- •• Benefit-harm assessment: Preponderance of benefit nostomy tube insertion (after adenoidectomy) over harm •• Risks. •• Benefit-harm assessment: Preponderance of benefit tion. is reported by the child. •• Role of patient preferences (Table 6): Moderate role lance interval in the choice of surgical procedure for children ≥4 •• Exceptions: None years old (tubes. as well as ongoing been shown as a primary intervention for OME. or interferes in •• Intentional vagueness: For children ≥4 years old. reduced •• Risks. adenoidectomy) and obser- •• Level of confidence in the evidence: High vational studies (adenoidectomy) •• Benefit: Detection of structural changes in the tym. the data are inconsistent •• Intentional vagueness: The surveillance interval is and relatively sparse. adenoidectomy. •• Quality improvement opportunity: Promote effective ing chronic OME that can help avoid sequelae by therapy for OME (tubes at all ages. children with OME (National Quality Strategy vational studies with a preponderance of benefit over harm. opportunity tomy. costs: Cost of follow-up prevalence of OME. included in the systematic reviews tion. velopharyngeal insufficiency. clinical process/ Quality Strategy domains: patient safety. the school performance or QOL decision to offer tympanostomy tubes. discussion of •• Benefit: promoting effective therapy. domain: clinical process/effectiveness) . ing. observational •• Aggregate evidence quality: Grade B. chronic adenoiditis) exists managing a child with OME. harms. noidectomy in an age group where benefits have not ronment for children with OME. Recommendation based on systematic reviews in the medical record resolution of OME.

serious problems from the anesthesia. much fluid is present. doctor’s office until it falls out. away (months to years). waiting could delay more There is a very small risk of effective treatments. About 1 or 2 days. infection (that is treated with eardrum and cause it to 2 or 3 in 100 children have a antibiotics). it is designed to assist clinicians by providing an evidence-based frame- •• Benefit-harm assessment: Predominance of benefit work for decision-making strategies. when diving (>6 ft underwater). 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. 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.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. recover? What are the benefits? Gives your child a chance to Relieves fluid and hearing loss Reduces time with fluid in the future. 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. Rather. children may need to have them 50% after adenoidectomy. or delayed recovery. head dunking). It is not intended as a sole source of guidance audiometry. Shared Decision Grid for Parents and Caregivers regarding Surgical Options for Otitis Media with Effusion. Periodic causes hearing loss. bother your child. administrative burden for QOL surveys in managing children with otitis media with effusion. A few hours. Baths. infection (drainage) that is could require a visit to the office or and can rarely damage the treated with eardrops. There collapse. RCTs and •• Role of patient preferences: Small before-and-after studies showing resolution. 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. About 1 in every 4 future ear tubes is reduced by about another treatment is tried. and air travel Baths and swimming are fine. harms. serious problems from the anesthesia. infections (if applicable). fluid is gone. swimming. •• Exceptions: None improved hearing.26 •• Aggregate evidence quality: Grade C. then stores germs. 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.212 Otolaryngology–Head and Neck Surgery 154(2) Table 6. recover on his/her own. Are there any special Baths and swimming are fine. the method of demonstrating cal knowledge expands and technology advances. 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. Disclaimer ment The clinical practice guideline is provided for information and edu- •• Risks. 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. costs: Cost of follow-up visits and cational purposes only. Relieves nasal blockage and place and stays open. How long does it take to Does not apply. or improved QOL after manage. or when swimming in lakes or dirty water. a Adapted from Calkins and colleagues. Air travel precautions? Air travel can result in are fine. general anesthesia. replaced. •• Policy level: Recommendation ment of OME •• Differences of opinion: None •• Level of confidence in the evidence: High •• Benefit: Document favorable outcomes in manage. 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. As medi- outcome is not stated. 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 . promptly and prevents relapse reduces the need for future ear of fluid while the tube is in surgery.

MPH. 2013.73:1441-1446. Allan S. MS. Sciacca Disclosures V. rhinolaryngol. Takata G. Eur J Pediatr. Boudewyns A. Natural history of untreated otitis media. in in Young Children: Clinical Practice Guideline No. Natural His- Charles R. 2014. In addition. nosis and management of acute otitis media. Möller C. Doyle WJ. writer. et al. AHRQ publication Richard M. Kummer. Rosenfeld RM. financial interest in nasal spray for South West Hampshire infant and first schools. The incidence. 2013. Woods Jr. writer. The high preva- of a Harvard Medical School Shore Foundation Faculty Grant. 2008. Steiner MJ. 11. otitis media (not yet in phase I trials). writer. et al. Funding source: American Academy of Otolaryngology—Head 17. determine the appropriate treatment. Shekelle P. writer. Styker. Casselbrant ML.72:491-499. MD: Agency for or to exclude other treatment decisions or methods of care reason. Rosenfeld RM. . Anomalies). Int J Pediatr Oto- Arizona Ear Foundation. A Parent’s Guide to Ear Tubes. Kenna.267:709-714. textbook royalties from Plural 13. text. MD. Ann 2013. writer. 8. eds. methodologist. Head Neck Surg. 2003. Guidelines are not mandates. Jönsson R. Mandel EM. 2005. panel member. Martinciglio G. David Hoelting. MLS. Berg AO. Payne. Williamson I. MD. Otitis Media with American Academy of Otolaryngology—Head and Neck Surgery Effusion: Comparative Effectiveness of Treatments. Doyle. Jennifer J. et al. Bain J. Rockville. Wahl. cross-sectional analysis of otitis media with effusion in children book royalties from Engage Learning (Cleft Palate and Craniofacial with Down syndrome. Rosenfeld. 6. tant chair. Payne. Sponsorships: American Academy of Otolaryngology—Head and 16.148(1):S1-S55. teaching/speaking honoraria from Interacoustics. Evidence-Based Otitis Media. 2003. Lieberthal. panel member. Martines F. 2009. et al. The point prevalence of otitis media with effusion Competing interests: Jennifer J. Seth R. Spencer C. Canada: BC Decker Inc. 1994. writer. Flynn T. Robertson P. Berkman ND. MD. Mandel EM. 12. et al. Sandra the first two years of life. Shin. Ann W. W. Winther B. research funding from National Institute on Deafness and Other Communication Disorders and Centers for rhinolaryngol. Robyn Coggins. Inc and palate as compared to children without clefts. Carroll AE. panel member.5:459-462. Maureen D. Otolaryngology Prep and Practice (Plural Publishing)—and recipient 12. Alper CM. Disease Control and Prevention. practice guideline: tympanostomy tubes in children. MD. We gratefully acknowledge the support of Jean C. 14. Richard A. writer. PHD.113:1645-1657. Berman S. Walsh. Clinical practice tice guideline development manual. 5. 2010. panel member. References 18. writer. Jesse M.173:1319-1325. Van de Heyning P. Schwartz. Lisa lence of otitis media with effusion in children with cleft lip and L. Clinical and Neck Surgery Foundation. Rosenfeld RM. Can- Acknowledgments ada: BC Decker Inc. Healthcare Research and Quality. Hamilton. acknowledge the work of the original guideline development group. Peter M. Hunter. Paradise JL. 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. In: Rosenfeld RM. Martines E. MD: Agency for Healthcare Research and Quality. panel mem. Grundfast. Otitis media in panel member. Kummer. MD. Ham- Foundation staff liaison. PHD. AHRQ publication ably directed to obtaining the same results. consulting fee from Acclarent. must ville. Poe. Clin Evid. panel member.Rosenfeld et al 213 absolute. Blackwell. royalties from the publication among primary school children in Western Sicily. Rock- light of all circumstances presented by the individual patient. MD. which includes Richard M. Lisa Gagnon. Pediatrics. 55. MD. The 3. Wallace IF. Eur Arch Oto- of 2 books—Evidence-Based Otolaryngology (Springer International). Adherence to these guidelines AHCPR publication 94-0622. 2003:147-162. Tos M. Margaret A.130(5):S95-S118. Maureen D. 1997. Chan LS. Rosenfeld. Kenneth M. research funding from Acclarent for incidence and prevalence of abnormal tympanograms in four eustachian tube dilation balloons. Otolaryngol Head Neck Surg. we J Otol. 1984. Hackell. panel member. et al. years followed by weekly otoscopy through the “common cold” Alejandro Hoberman. 101. Karen J. Dunleavey J. Pediatrics. Schwartz SR. employee of American Academy of Otolaryngology—Head and 15. these do not and should not 2. 2253 Pittsburgh-area Infants: prevalence and risk factors during writer. Rosenfeld RM. MPH. 13-EHC091-EF. 2013. ilton. Am for her assistance with the literature searches. season. Rockville. Shiffman RN.131:e964-e999. Martin Mahoney. Larry Culpepper. 476. Wojciechowski M. Colborn DK. Lohmander A. MD. writer. writer. Lieberthal AS. research funding from Acclarent. 2002(7):469- Neck Surgery Foundation. A Publishing (Acoustic Immittance Measures). panel member. MSC. Vila. Maris M. panel member. Williamson IG. panel member. Hunter. Di Piazza F. Dennis S. Culpepper L. American Academy of Otolaryngology—Head and Neck Surgery Bluestone CD. Spencer C. writer. Epidemiology and natural history of secretory otitis. Poe. 9. writer. Bentivegna D. Doyle KJ. MD. Otolaryngol Surg. salaried 1994. Corrigan. et al. Dennis S.108:930-934. Kay D. Lisa L. writer.99:318-333. will not ensure successful patient outcomes in every situation. Int J Pediatr Otorhinolaryngol. Shin.149(1):S1-S35. A. expert witness (case-by. third edition: a quality- guideline: otitis media with effusion. and Barbara Yawn. Rosenfeld RM. 2nd ed. Clinical prac- 1. 10. writer. Stool SE. Corrigan. Laryngoscope. Pynnonen MA. assis- 03-E023. tory and Late Effects of Otitis Media with Effusion: Evidence Author Contributions Report/Technology Assessment No. prevalence and burden of OM in unselected children aged 1-8 MD. Rockette HE. Otitis Media with Effusion purport to be a legal standard of care. et al. MD: Agency for Health Care Policy and Research. Otolaryngol Head Neck driven approach for translating evidence into action. et al. Diagnosis. The natural his- and Cook. Chonmaitree T. 7. J Laryngol Otol. 2004. Epidemiology. The responsible physician. chair. tory of otitis media with effusion: a three-year study of the case basis). 4. The diag- ber. Otitis media with effusion. Neck Surgery Foundation. Maria Veling.

August 8. Davidson C. 2012 annual to identify obstacles to guideline implementation.19:94-101. http://www.175:1033. et al. 24. Cost-effectiveness analysis: will it be accepted? JAMA.gov/workingfor 21. Accessed tice. 1992. Dixon J. Cosway B. Calkins C. Rosenfeld RM. mentability appraisal (GLIA): development of an instrument 25.ahrq.268:132-136. 1035. BMC Med progress report to Congress: national strategy for quality Inform Decis. 2005. JAMA. authors of clinical practice guidelines and the pharmaceutical mote quality. Pediatrics. Shiffman RN. and implementability. Classifying recommendations .org/resources/fluidinear_grid. Detsky AS. Cochran N. Clinical decision making: from theory to prac- quality/nqs/nqs2012annlrpt. 2002. Eddy DM. improvement in health care. American Academy of Pediatrics Steering Committee on Quality Option grid for fluid in the middle ear. 2012. 26. 2015. Building 23. http://www.114:874-877.287:612-617. Venkatraman G. Can Med Assoc J. Relationships between better guidelines with BRIDGE-Wiz: a software assistant to pro. Sources of bias for authors of clinical practice guide- 20. Stelfox HT. Choudhry NK. 22. US Department of Health and Human Services.optiongrid Improvement and Management. Detsky AS. Published May 2014. Accessed March 3. . 2015. Shiffman RN. lines.pdf. Michel G.214 Otolaryngology–Head and Neck Surgery 154(2) 19. J Amer Med industry. transparency.5:23. The guideline imple. 2004. 2006. Elwyn G. Inform Assoc.pdf. for clinical practice guidelines. Brandt C.