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SUPPLEMENT TO

Otolaryngology–Head and Neck Surgery

MAY 2004 VOLUME 130 NUMBER 5

linical practice guideline: Otitis media with effusionICHARD M. ROSENFELD, MD, MPH, LARRY CULPEPPER, MD, MPH, KAREN J. DOYLE, MD, PHD, KENNETH M. GRUNDFAST, MD,LEJANDRO HOBERMAN, MD, MARGARET A. KENNA, MD, ALLAN S. LIEBERTHAL, MD, MARTIN MAHONEY, MD, PHD,ICHARD A. WAHL, MD, CHARLES R. WOODS, JR, MD, MS, and BARBARA YAWN, MSC

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he clinical practice guideline on otitis media withffusion (OME) provides evidence-based recom-endations on diagnosing and managing OME in

hildren. This is an update of the 1994 clinical prac-ice guideline “Otitis Media With Effusion in Younghildren,” which was developed by the Agency forealthcare Policy and Research (now the Agency

or Healthcare Research and Quality). In contrast tohe earlier guideline, which was limited to childrenged 1 to 3 years with no craniofacial or neurologicbnormalities or sensory deficits, the updateduideline applies to children aged 2 months

hrough 12 years with or without developmentalisabilities or underlying conditions that predispose

o OME and its sequelae. The American Academyf Pediatrics, American Academy of Family Physi-ians, and American Academy of Otolaryngology–ead and Neck Surgery selected a subcommitteeomposed of experts in the fields of primary care,tolaryngology, infectious diseases, epidemiology,earing, speech and language, and advancedractice nursing to revise the OME guideline.he subcommittee made a strong recommenda-ion that clinicians use pneumatic otoscopy as therimary diagnostic method and distinguish OME

rom acute otitis media (AOM).he subcommittee made recommendations that cli-icians should (1) document the laterality, duration of

ichard M. Rosenfeld, MD, SUNY-HSC Brooklyn, Depart-ment of Pediatric Otolaryngology, 339 Hicks Street,Brooklyn, NY 11201; e-mail, [email protected].

194-5998/$30.00opyright © 2004 by the American Academy of Otolaryn-gology–Head and Neck Surgery Foundation, Inc., and theAmerican Academy of Pediatrics

oi:10.1016/j.otohns.2004.02.002

ffusion, and presence and severity of associatedymptoms at each assessment of the child with OME;2) distinguish the child with OME who is at risk forpeech, language, or learning problems from otherhildren with OME and more promptly evaluate hear-

ng, speech, language, and need for intervention inhildren at risk; and (3) manage the child with OMEho is not at risk with watchful waiting for 3 months

rom the date of effusion onset (if known), or from theate of diagnosis (if onset is unknown).he subcommittee also made recommendationshat (4) hearing testing be conducted when OMEersists for 3 months or longer, or at any time that

anguage delay, learning problems, or a significantearing loss is suspected in a child with OME; (5)hildren with persistent OME who are not at riskhould be reexamined at 3- to 6-month intervalsntil the effusion is no longer present, significantearing loss is identified, or structural abnormalitiesf the eardrum or middle ear are suspected; and6) when a child becomes a surgical candidate,ympanostomy tube insertion is the preferred initialrocedure. Adenoidectomy should not be per-

ormed unless a distinct indication exists (nasal ob-truction, chronic adenoiditis); repeat surgery con-ists of adenoidectomy plus myringotomy, with orithout tube insertion. Tonsillectomy alone or myr-

ngotomy alone should not be used to treat OME.he subcommittee made negative recommenda-ions that (1) population-based screening programsor OME not be performed in healthy, asymptom-tic children and (2) antihistamines and deconges-

ants are ineffective for OME and should not besed for treatment; antimicrobials and corticoste-oids do not have long-term efficacy and shouldot be used for routine management.he subcommittee gave as options that (1) tympa-

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S96 ROSENFELD et al May 2004

ometry can be used to confirm the diagnosis ofME and (2) when children with OME are referredy the primary clinician for evaluation by an oto-

aryngologist, audiologist, or speech-language pa-hologist, the referring clinician should documenthe effusion duration and specific reason for referralevaluation, surgery), and provide additional rele-ant information such as history of AOM and devel-pmental status of the child. The subcommitteeade no recommendations for (1) complementarynd alternative medicine as a treatment for OMEased on a lack of scientific evidence document-

ng efficacy and (2) allergy management as areatment for OME based on insufficient evidencef therapeutic efficacy or a causal relationship be-

ween allergy and OME. Last, the panel compiled aist of research needs based on limitations of thevidence reviewed.he purpose of this guideline is to inform cliniciansf evidence-based methods to identify, monitor,nd manage OME in children aged 2 months

hrough 12 years. The guideline may not apply tohildren older than 12 years because OME is un-ommon and the natural history is likely to differ

rom younger children who experience rapid de-elopmental change. The target population in-ludes children with or without developmental dis-bilities or underlying conditions that predispose toME and its sequelae. The guideline is intended forse by providers of health care to children, includ-

ng primary care and specialist physicians, nursesnd nurse practitioners, physician assistants, audi-logists, speech-language pathologists, and childevelopment specialists. The guideline is applica-le to any setting in which children with OME woulde identified, monitored, or managed.his guideline is not intended as a sole source ofuidance in evaluating children with OME. Rather, it

s designed to assist primary care and other clini-ians by providing an evidence-based framework

or decision-making strategies. It is not intended toeplace clinical judgment or establish a protocol forll children with this condition, and may not provide

he only appropriate approach to diagnosing andanaging this problem. (Otolaryngol Head Neck

urg 2004;130:S95.)

titis media with effusion (OME) as discussedn this guideline is defined as the presence of fluidn the middle ear without signs or symptoms ofcute ear infection.1,2 OME is considered distinctrom acute otitis media (AOM), which is defineds a history of acute onset of signs and symptoms,

he presence of middle-ear effusion, and signs andymptoms of middle-ear inflammation. Persistentiddle-ear fluid from OME results in decreasedobility of the tympanic membrane and serves asbarrier to sound conduction.3 About 2.2 million

iagnosed episodes of OME occur annually in thenited States, yielding a combined direct and in-irect annual cost estimate of $4.0 billion.2

OME may occur spontaneously because of poorustachian tube function, or as an inflammatoryesponse following AOM. About 90% of children80% of individual ears) have OME at some timeefore school age,4 most often between ages 6onths and 4 years.5 In the first year of life, more

han 50% of children will experience OME, in-reasing to more than 60% by age 2 years.6 Manypisodes resolve spontaneously within 3 months,ut about 30% to 40% of children have recurrentME and 5% to 10% of episodes last 1 year or

onger.1,4,7

The primary outcomes considered in the guide-ine include hearing loss; effects on speech, lan-uage, and learning; physiologic sequelae; healthare utilization (medical, surgical); and quality ofife.1,2 The high prevalence of OME, difficulties iniagnosis and assessing duration, increased risk ofonductive hearing loss, potential impact on lan-uage and cognition, and significant practice vari-tions in management8 make OME an importantondition for the use of up-to-date evidence-basedractice guidelines.

ETHODSeneral Methods and LiteratureearchIn developing an evidence-based clinical prac-

ice guideline on managing OME, the Americancademy of Pediatrics (AAP), American Acad-

my of Family Physicians, and American Acad-my of Otolaryngology–Head and Neck Surgeryorked with the Agency for Healthcare Research

nd Quality (AHRQ) and other organizations. Thisffort included representatives from each partner-ng organization along with liaisons from audiol-gy, speech-language pathology, informatics, anddvanced practice nursing. The most current liter-ture on managing children with OME was re-iewed, and research questions were developed touide the evidence review process.

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Otolaryngology–Head and Neck SurgeryVolume 130 Number 5 ROSENFELD et al S97

The AHRQ report on OME from the Southernalifornia Evidence-Based Practice Center (EPC)

ocused on key questions of natural history; diag-ostic methods; and long-term speech, language,nd hearing outcomes.2 Searches were conductedhrough January 2000 in MEDLINE, EMBASE,nd the Cochrane Library. Additional articles weredentified by review of reference listings in pro-eedings, reports, and other guidelines. The EPCccepted 970 articles for full review after screen-ng 3200 abstracts. The EPC reviewed articlessing established quality criteria9,10 and includedandomized trials, prospective cohorts, and valida-ions of diagnostic tests (validating cohort studies).

The AAP subcommittee on OME updated theHRQ review with articles identified by an elec-

ronic MEDLINE search through April 2003 andith additional material identified manually by

ubcommittee members. Copies of relevant arti-les were distributed to the subcommittee for con-ideration. A specific search for articles relevant toomplementary and alternative medicine (CAM)as performed using MEDLINE and AMED

hrough April 2003. Articles relevant to allergynd OME were identified using MEDLINEhrough April 2003. The subcommittee met 3imes over a 1-year period, ending in May 2003,ith interval electronic review and feedback on

ach guideline draft to ensure accuracy of contentnd consistency with standardized criteria for re-orting clinical practice guidelines.11

In May 2003 the Guidelines Review Group ofhe Yale Center for Medical Informatics used theuideline Elements Model12 to categorize contentf the present draft guideline. Policy statementsere parsed into component decision variables

nd actions, then assessed for decidability andxecutability. Quality appraisal using establishedriteria13 was performed with Guideline Elementsodel-Q Online.14,15 Implementation issues were

redicted using the Implementability Rating Pro-le, an instrument under development by the Yaleuidelines Review Group (R. Shiffman, MD,ritten communication, May 2003). OME sub-

ommittee members received summary results andodified an advanced draft of the guideline.The final draft practice guideline underwent ex-

ensive peer review by numerous entities identi-ed by the subcommittee. Comments were com-

iled and reviewed by the subcommitteeochairpersons. The recommendations containedn the practice guideline are based on the bestvailable published data through April 2003.here data are lacking, a combination of clinical

xperience and expert consensus was used. Acheduled review process will occur at 5 yearsrom publication or sooner if new compelling ev-dence warrants earlier consideration.

lassification of Evidence-basedtatementsGuidelines are intended to reduce inappropriate

ariations in clinical care, produce optimal healthutcomes for patients, and minimize harm. Thevidence-based approach to guideline develop-ent requires that the evidence supporting a pol-

cy be identified, appraised, and summarized andhat an explicit link between evidence and state-ents be defined. Evidence-based statements re-ect the quality of evidence and the balance ofenefit and harm that is anticipated when the state-ent is followed. The AAP definitions for evi-

ence-based statements16 are listed in Tables 1nd 2.

Guidelines are never intended to overrule pro-essional judgment; rather, they may be viewed asrelative constraint on individual clinician discre-

ion in a particular clinical circumstance. Lessrequent variation in practice is expected for atrong recommendation than might be expectedith a recommendation. Options offer the mostpportunity for practice variability.17 All clini-ians should always act and decide in a way thathey believe will best serve their patients’ interestsnd needs, regardless of guideline recommenda-ions. Guidelines represent the best judgment of aeam of experienced clinicians and methodologistsddressing the scientific evidence for a particularopic.16

Making recommendations about health prac-ices involves value judgments on the desirabilityf various outcomes associated with managementptions. Values applied by the OME subcommit-ee sought to minimize harm and diminish unnec-ssary therapy. Emphasis was placed on promptlydentifying and managing children at risk forpeech, language, or learning problems to maxi-ize opportunities for beneficial outcomes. Direct

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osts were also considered in the statements con-erning diagnosis and screening, and to a lesserxtent in other statements.

1A. PNEUMATIC OTOSCOPY: Clinicianshould use pneumatic otoscopy as the primaryiagnostic method for OME. OME should beistinguished from AOM. Strong Recommenda-

ion based on systematic review of cohort studiesnd preponderance of benefit over harm.1B. TYMPANOMETRY: Tympanometry

an be used to confirm the diagnosis of OME.ption based on cohort studies and a balance ofenefit and harm.

able 1. Guideline definitions for evidence-based statements

Statement Definition Implication

Strong recommendation A strong recommendation means the subcommitteebelieves that the benefits of the recommended ap-proach clearly exceed the harms (or that the harmsclearly exceed the benefits in the case of a strongnegative recommendation) and that the quality ofthe supporting evidence is excellent (Grade A orB).* In some clearly identified circumstances,strong recommendations may be made based onlesser evidence when high-quality evidence is im-possible to obtain and the anticipated benefitsstrongly outweigh the harms.

Clinicians should follow a strongrecommendation unless a clearand compelling rationale for analternative approach is present.

Recommendation A recommendation means the subcommittee believesthat the benefits exceed the harms (or that theharms exceed the benefits in the case of a negativerecommendation), but the quality of evidence isnot as strong (Grade B or C).* In some clearlyidentified circumstances, recommendations may bemade based on lesser evidence when high-qualityevidence is impossible to obtain and the antici-pated benefits outweigh the harms.

Clinicians should also generallyfollow a recommendation, butshould remain alert to new infor-mation and sensitive to patientpreferences.

Option An option means that either the quality of evidencethat exists is suspect (Grade D)* or that well-donestudies (Grade A, B, or C)* show little clear ad-vantage to one approach versus another.

Clinicians should be flexible in theirdecision making regarding appro-priate practice, although they mayset bounds on alternatives; patientpreference should have a substan-tial influencing role.

No recommendation No recommendation means there is both a lack ofpertinent evidence (Grade D)* and an unclear bal-ance between benefits and harms.

Clinicians should feel little con-straint in their decision makingand be alert to new published evi-dence that clarifies the balance ofbenefit versus harm; patient pref-erence should have a substantialinfluencing role.

able 2. Evidence quality for grades of evidence

Grade Evidence quality

A Well-designed randomized, controlledtrials or diagnostic studies performedon a population similar to the guide-line’s target population

B Randomized, controlled trials or diag-nostic studies with minor limitations;overwhelmingly consistent evidencefrom observational studies

C Observational studies (case control andcohort design)

D Expert opinion, case reports, reasoningfrom first principles (bench researchor animal studies)

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Diagnosing OME correctly is fundamental toroper management. Moreover, OME must be dif-erentiated from AOM to avoid unnecessary anti-icrobial use.18,19

OME is defined as fluid in the middle ear with-ut signs or symptoms of acute ear infection.2 Theympanic membrane is often cloudy with dis-inctly impaired mobility,20 and an air-fluid levelr bubble may be visible in the middle ear. Con-ersely, diagnosing AOM requires a history ofcute onset of signs and symptoms, the presencef middle-ear effusion, and signs and symptoms ofiddle-ear inflammation. The critical distinguish-

ng feature is that only AOM has acute signs andymptoms. Distinct redness of the tympanic mem-rane should not be a criterion for antibiotic pre-cribing because it has poor predictive value forOM and is present in about 5% of ears withME.20

The AHRQ evidence report2 systematically re-iewed the sensitivity, specificity, and predictivealues of 9 diagnostic methods for OME. Pneu-atic otoscopy had the best balance of sensitivity

nd specificity, consistent with the 1994 guide-ine.1 Meta-analysis revealed a pooled sensitivityf 94% (95% CI, 91%-96%) and specificity of0% (95% CI, 75%-86%) for validated observerssing pneumatic otoscopy versus myringotomy ashe gold standard. Pneumatic otoscopy shouldherefore remain the primary method of OMEiagnosis because the instrument is readily avail-ble in practice settings, cost effective, and accu-ate in experienced hands. Nonpneumatic oto-copy is not advised for primary diagnosis.

The accuracy of pneumatic otoscopy in routinelinical practice may be less than that shown inublished results because clinicians have varyingraining and experience.21,22 When the diagnosisf OME is uncertain, tympanometry or acousticeflectometry should be considered as an adjuncto pneumatic otoscopy. Tympanometry with atandard 226-Hz probe tone is reliable for infantsged 4 months or older and has good interobservergreement of curve patterns in routine clinicalractice.23,24 Younger infants require specializedquipment with a higher probe tone frequency.ympanometry generates costs related to instru-ent purchase, annual calibration, and test admin-

stration. Acoustic reflectometry with spectral gra-

ient analysis is a low-cost alternative toympanometry that does not require an airtighteal in the ear canal; however, validation studiesrimarily have used children aged 2 years or olderith a high prevalence of OME.25-27

While no research studies have examinedhether pneumatic otoscopy causes discomfort,

xpert consensus suggests that the procedure doesot have to be painful, especially when symptomsf acute infection (AOM) are absent. A nontrau-atic examination is facilitated by using a gentle

ouch, restraining the child properly when neces-ary, and inserting the speculum only into theuter one third (cartilaginous portion) of the earanal.28 The pneumatic bulb should be slightlyompressed before insertion because OME is of-en associated with a negative middle-ear pressure,hich can be more accurately assessed by releas-

ng the already compressed bulb. The otoscopeust be fully charged, the bulb (halogen or xenon)

right and luminescent,29 and the insufflator bulbttached tightly to the head to avoid the loss of anir seal. The window must also be sealed.

Evidence Profile: Pneumatic Otoscopy● Aggregate evidence quality: A, diagnostic

studies in relevant populations● Benefit: improved diagnostic accuracy; inex-

pensive equipment● Harm: cost of training clinicians in pneumatic

otoscopy● Benefits-harms assessment: preponderance of

benefit over harm● Policy level: strong recommendationEvidence Profile: Tympanometry● Aggregate evidence quality: B, diagnostic

studies with minor limitations● Benefit: increased diagnostic accuracy be-

yond pneumatic otoscopy; documentation● Harm: acquisition cost, administrative bur-

den, recalibration● Benefits-harms assessment: balance of benefit

and harm● Policy level: option

1C. SCREENING: Population-based screen-ng programs for OME are not recommendedn healthy, asymptomatic children. Recommen-ation based on randomized, controlled trials, and

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ohort studies with a preponderance of harm overenefit.

This recommendation concerns population-ased screening programs of all children in a com-unity or a school without regard to any preex-

sting symptoms or history of disease. Thisecommendation does not address hearing screen-ng or monitoring of specific children with previ-us or recurrent OME.OME is highly prevalent in young children.

creening surveys of healthy children ranging inge from infants to age 5 years show a 15% to0% point prevalence of middle-ear effu-ion.5,7,30-36 Among children examined at regularntervals for a year, about 50% to 60% of childare center attendees32 and 25% of school-agedhildren37 were found to have a middle-ear effu-ion at some time during the examination period,ith peak incidence during the winter months.Population-based screening has not been found

o influence short-term language outcomes,33 andts long-term effects have not been evaluated in aandomized clinical trial. Therefore, the recom-endation against screening is based not only on

he ability to identify OME, but more importantlyn a lack of demonstrable benefits from treatinghildren so identified that exceed the favorableatural history of the disease. The New Zealandealth Technology Assessment38 could not deter-ine whether preschool screening for OME was

ffective. More recently, the Canadian Task Forcen Preventive Health Care39 reported that insuffi-ient evidence was available to recommend in-luding or excluding routine early screening forME. Although screening for OME is not inher-

ntly harmful, potential risks include inaccurateiagnoses, overtreating self-limited disease, pa-ental anxiety, and the costs of screening andnnecessary treatment.Population-based screening is appropriate for

onditions that are common, can be detected by aensitive and specific test, and benefit from earlyetection and treatment.40 The first 2 requirementsre fulfilled by OME, which affects up to 80% ofhildren by school entry2,5,7 and can be easilycreened with tympanometry (see Recommenda-ion 1B). Early detection and treatment of OMEdentified by screening, however, has not beenhown to improve intelligence, receptive lan-

uage, or expressive language.2,39,41,42 Therefore,opulation-based screening for early detection ofME in asymptomatic children has not been

hown to improve outcomes and is not recom-ended.Evidence Profile: Screening● Aggregate evidence quality: B, randomized,

controlled trials with minor limitations andconsistent evidence from observational stud-ies

● Benefit: potentially improved developmentaloutcomes, which have not been demonstratedin the best current evidence

● Harm: inaccurate diagnosis (false positive,false negative), overtreating self-limited dis-ease, parental anxiety, cost of screening andunnecessary treatment

● Benefits-harms assessment: preponderance ofharm over benefit

● Policy level: recommendation against

2. DOCUMENTATION: Clinicians shouldocument the laterality, duration of effusion,nd presence and severity of associated symp-oms at each assessment of the child with OME.ecommendation based on observational studiesnd strong preponderance of benefit over harm.Documentation in the medical record facilitates

iagnosis and treatment, and communicates perti-ent information to other clinicians to ensure pa-ient safety and reduce medical errors.43 Manage-ent decisions in children with OME depend on

ffusion duration and laterality plus the nature andeverity of associated symptoms. Therefore, theseeatures should be documented at every medicalncounter for OME. Although no studies havepecifically addressed documentation for OME,here is room for improvement in documentationf ambulatory care medical records.44

Ideally, the time of onset and laterality of OMEan be defined through diagnosis of an antecedentOM, a history of acute onset of signs or symp-

oms directly referable to fluid in the middle ear,r the presence of an abnormal audiogram or tym-anogram closely following a previously normalest. Unfortunately, these conditions are oftenacking, and the clinician is forced to speculate onhe onset and duration of fluid in the middle ear(s)

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n a child found to have OME at a routine officeisit or school screening audiometry.In about 40% to 50% of cases of OME, neither

he affected children nor their parents or caregiv-rs describe significant complaints referable to aiddle-ear effusion.45,46 In some children, how-

ver, OME may have associated signs and symp-oms caused by inflammation or the presence offfusion (not acute infection) that should be doc-mented, such as

● Mild intermittent ear pain, fullness or “pop-ping”

● Secondary manifestations of ear pain in in-fants, which may include ear rubbing, exces-sive irritability, and sleep disturbances

● Failure of infants to respond appropriately tovoices or environmental sounds, such as notturning accurately toward the sound source

● Hearing loss, even when not specifically de-scribed by the child, suggested by seeminglack of attentiveness, behavioral changes,failure to respond to normal conversationallevel speech, or the need for excessively highsound levels when using audio equipment orviewing television

● Recurrent episodes of AOM with persistentOME between episodes

● Problems with school performance● Balance problems, unexplained clumsiness,

or delayed gross motor development47-50

● Delayed speech or language developmentThe laterality (unilateral vs bilateral), duration

f effusion, and the presence and severity of as-ociated symptoms should be documented in theedical record at each assessment of the childith OME. When OME duration is uncertain, the

linician must take whatever evidence is at handnd make a reasonable estimate.

Evidence Profile: Documentation● Aggregate evidence quality: C, observational

studies● Benefits: defines severity, duration has prog-

nostic value, facilitates future communicationwith other clinicians, supports appropriatetiming of intervention, and if consistently uni-lateral may identify a problem with specificear other than OME (eg, retraction pocket orcholesteatoma)

● Harm: administrative burden

● Benefits-harms assessment: preponderance ofbenefit over harm

● Policy level: recommendation

3. CHILD AT RISK: Clinicians should dis-inguish the child with OME who is at risk forpeech, language, or learning problems fromther children with OME, and should moreromptly evaluate hearing, speech, language,nd need for intervention. Recommendationased on case series, preponderance of benefitver harm, and ethical limitations in studyinghildren with OME who are at risk.

The panel defines the child at risk as one who ist increased risk for developmental difficultiesdelay or disorder) because of sensory, physical,ognitive, or behavioral factors listed in Table 3.hese factors are not caused by OME but canake the child less tolerant of hearing loss or

estibular problems secondary to middle-ear effu-ion. In contrast the child with OME who is not atisk is otherwise healthy and does not have any ofhe factors in Table 3.

Earlier guidelines for managing OME have ap-lied only to young children who are healthy andxhibit no developmental delays.1 Studies of theelationship between OME and hearing loss orpeech/language development typically excludehildren with craniofacial anomalies, genetic syn-romes, and other developmental disorders.herefore, the available literature mainly applies

o otherwise healthy children who meet inclusionriteria for randomized, controlled trials. Few, ifny, existing studies dealing with developmental

able 3. Risk factors for developmental difficulties*

Permanent hearing loss independent of otitis mediawith effusion

Suspected or diagnosed speech and language delayor disorder

Autism-spectrum disorder and other pervasive devel-opmental disorders

Syndromes (eg, Down) or craniofacial disorders thatinclude cognitive, speech, and language delays

Blindness or uncorrectable visual impairmentCleft palate, with or without associated syndromeDevelopmental delay

Sensory, physical cognitive, or behavioral factors that place childrenho have otitis media with effusion at increased risk for develop-ental difficulties (delay or disorder).

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equelae caused by hearing loss from OME can beeneralized to children who are at risk.Children who are at risk for speech or language

elay would likely be further affected by hearingroblems from OME,51 even though definitivetudies are lacking. For example, small compara-ive studies of children or adolescents with Downyndrome52 or cerebral palsy53 show poorer artic-lation and receptive language associated with aistory of early otitis media. Large studies arenlikely to be forthcoming because of method-logic and ethical difficulties inherent in studyinghildren who are delayed or at risk for furtherelays. Therefore, clinicians who manage childrenith OME should determine whether other condi-

ions coexist that put a child at risk for develop-ental delay (Table 3), and then take these con-

itions into consideration when planningssessment and management.

Children with craniofacial anomalies (eg, cleftalate, Down syndrome, Robin sequence,HARGE association) have a higher prevalencef chronic OME, hearing loss (conductive andensorineural), and speech or language delay thano children without these anomalies.54-57 Otherhildren may not be more prone to OME but areikely to have speech and language disorders, suchs those children with permanent hearing loss in-ependent of OME,58,59 specific language impair-ent,60 autism-spectrum disorders,61 or syn-

romes that adversely affect cognitive andinguistic development. Some retrospective stud-es52,62,63 have found that hearing loss caused byME in children with cognitive delays, such asown syndrome, has been associated with lower

anguage levels. Children with language delays orisorders with OME histories perform poorer onpeech perception tasks than do children withME histories alone.64,65

Children with severe visual impairments maye more susceptible to the effects of OME becausehey depend on hearing more than children withormal vision.51 Any decrease in their most im-ortant remaining sensory input for languagehearing) may significantly compromise languageevelopment and their ability to interact and com-unicate with others. All children with severe

isual impairments should be considered moreulnerable to OME sequelae, especially in the

reas of balance, sound localization, and commu-ication.Management of the child with OME who is at

ncreased risk for developmental delays shouldnclude hearing testing and speech and languagevaluation, and may include speech and languageherapy concurrent with managing OME, hearingids or other amplification devices for hearing lossndependent of OME, tympanostomy tube inser-ion,54,63,66,67 and hearing testing after OME re-olves to document improvement, because OMEan mask a permanent underlying hearing loss andelay detection.59,68,69

Evidence Profile: Child At Risk● Aggregate evidence quality: C, observational

studies of children at risk; D, expert opinionon the ability of prompt assessment and man-agement to alter outcomes

● Benefits: optimizing conditions for hearing,speech, and language; enabling children withspecial needs to reach their potential; avoid-ing limitations on the benefits of educationalinterventions because of hearing problemsfrom OME

● Harm: cost, time, and specific risks of medi-cations or surgery

● Benefits-harms assessment: exceptional pre-ponderance of benefits over harm based onsubcommittee consensus because of circum-stances to date precluding randomized trials


4. WATCHFUL WAITING: Clinicianshould manage the child with OME who is nott risk with watchful waiting for 3 months fromhe date of effusion onset (if known) or from theate of diagnosis (if onset is unknown). Recom-endation based on systematic review of cohort

tudies and preponderance of benefit over harm.This recommendation is based on the self-lim-

ted nature of most OME, which has been wellocumented in cohort studies and in controlroups of randomized trials.2,70

The likelihood of spontaneous resolution ofME is determined by the cause and duration of

ffusion.70 For example, about 75% to 90% ofesidual OME after an AOM episode resolvespontaneously by 3 months.71-73 Similar outcomesf defined onset during a period of surveillance in

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cohort study are observed for OME.32,37 An-ther favorable situation involves improvementnot resolution) of newly detected OME defined ashange in tympanogram from type B (flat curve)o non-B (anything other than a flat curve). About5% of children so defined improve by 3onths,70 but one third will have OME relapseithin the next 3 months.4 Although a type B

ympanogram is an imperfect measure of OME81% sensitivity and 74% specificity vs myringot-my), it is the most widely reported measure suit-ble for deriving pooled resolution rates.2,70

About 25% of newly detected OME of un-nown prior duration in children aged 2 to 4 yearsesolves by 3 months when resolution is defined as

change in tympanogram from type B to type/C1 (peak pressure �200 daPa).2,70,74-77 Reso-

ution rates may be higher for infants and younghildren in whom the preexisting duration of ef-usion is generally shorter, and particularly forhose observed prospectively in studies or in theourse of well-child care. Documented bilateralME of 3 months’ duration or longer resolves

pontaneously after 6 to 12 months in about 30%f children aged primarily 2 years or older, withnly marginal benefits if observed longer.70

Any intervention for OME (medical or surgical)ther than observation carries some inherent harm.here is little harm associated with a specifiederiod of observation in the child who is not at riskor speech, language, or learning problems. Whenbserving children with OME, clinicians shouldnform the parent or caregiver that the child mayxperience reduced hearing until the effusion re-olves, especially if bilateral. Clinicians may dis-uss strategies for optimizing the listening andearning environment until the effusion resolves.hese strategies include speaking in close prox-

mity to the child, facing the child and speakinglearly, repeating phrases when misunderstood,nd providing preferential classroom seating.78,79

The recommendation for a 3-month period ofbservation is based on a clear preponderance ofenefit over harm and is consistent with the orig-nal OME guideline intent of avoiding unneces-ary surgery.1 At the discretion of the clinician,his 3-month period of watchful waiting may in-lude interval visits at which OME is monitoredsing pneumatic otoscopy, tympanometry, or

oth. Factors to consider in determining the opti-al interval(s) for follow-up include clinical judg-ent, parental comfort level, unique characteris-

ics of the child and/or his environment, access tohealth care system, and hearing levels if known.After documented resolution of OME in all

ffected ears, further follow-up is unnecessary.Evidence Profile: Watchful Waiting● Aggregate evidence quality: B, systematic re-

view of cohort studies● Benefit: avoid unnecessary interventions, take

advantage of favorable natural history, avoidunnecessary referrals and evaluations

● Harm: delays in therapy for OME that willnot resolve with observation; prolongation ofhearing loss



5. MEDICATION: Antihistamines and de-ongestants are ineffective for OME and areot recommended for treatment. Antimicrobi-ls and corticosteroids do not have long-termfficacy and are not recommended for routineanagement. Recommendation based on system-

tic review of randomized, controlled trials andreponderance of harm over benefit.Therapy for OME is appropriate only if persis-

ent and clinically significant benefits can bechieved beyond spontaneous resolution. Al-hough statistically significant benefits have beenemonstrated for some medications, they are shorterm and relatively small in magnitude. Moreover,ignificant adverse events may occur with all med-cal therapies.

The prior OME guideline1 found no data sup-orting antihistamine-decongestant combinationsn treating OME. Meta-analysis of 4 randomizedrials showed no significant benefit for antihista-

ines or decongestants versus placebo. No addi-ional studies have been published since 1994 tohange this recommendation. Adverse effects ofntihistamines and decongestants include insom-ia, hyperactivity, drowsiness, behavioral change,nd blood pressure variability.

Long-term benefits of antimicrobial therapy forME are unproved despite a modest short-termenefit for 2 to 8 weeks in randomized trials.1,80,81

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nitial benefits, however, can become nonsignifi-ant within 2 weeks of stopping the medication.82

oreover, about 7 children would need to bereated with antimicrobials to achieve one short-erm response.1 Adverse effects of antimicrobialsre significant and may include rashes, vomiting,iarrhea, allergic reactions, alteration of thehild’s nasopharyngeal flora, development of bac-erial resistance,83 and cost. Societal consequencesnclude direct transmission of resistant bacterialathogens in homes and child care centers.84

The prior OME guideline1 did not recommendral steroids for treating OME in children. A latereta-analysis85 showed no benefit for oral steroid

ersus placebo within 2 weeks, but did show ahort-term benefit for oral steroid plus antimicro-ial versus antimicrobial alone in 1 out of 3 chil-ren treated. This benefit became nonsignificantfter several weeks in a prior meta-analysis1 andn a large randomized trial.86 Oral steroids canroduce behavioral changes, increased appetite,nd weight gain.1 Additional adverse effects maynclude adrenal suppression, fatal varicella infec-ion, and avascular necrosis of the femoral head.3

lthough intranasal steroids have fewer adverseffects, one randomized trial87 showed statisticallyquivalent outcomes at 12 weeks for intranasaleclomethasone plus antimicrobials versus antimi-robials alone for OME.

Antimicrobial therapy, with or without steroids,as not been demonstrated to be effective in long-erm resolution of OME, but in some cases thisherapy can be considered an option because ofhort-term benefit in randomized trials, when thearent or caregiver expresses a strong aversion tompending surgery. In this circumstance a singleourse of therapy for 10 to 14 days may be used.he likelihood that the OME will resolve long

erm with these regimens is small, and prolongedr repetitive courses of antimicrobials or steroidsre strongly not recommended.

Other nonsurgical therapies that are discussedn the OME literature include autoinflation of theustachian tube, oral or intratympanic use of mu-olytics, and systemic use of pharmacologicgents other than antimicrobials, steroids and an-ihistamine-decongestants. Insufficient data existor any of these therapies to be recommended inreating OME.3

Evidence Profile: Medication● Aggregate evidence quality: A, systematic re-

view of well-designed randomized, controlledtrials

● Benefit: avoid side effects and reduce cost bynot administering medications; avoid delaysin definitive therapy caused by short-term im-provement then relapse

● Harm: adverse effects of specific medicationsas listed previously; societal impact of anti-microbial therapy on bacterial resistance andtransmission of resistant pathogens

● Benefits-harms assessment: preponderance ofharm over benefit

● Policy level: recommendation against

6. HEARING AND LANGUAGE: Hearingesting is recommended when OME persists for

months or longer, or at any time that lan-uage delay, learning problems, or a significantearing loss is suspected in a child with OME.anguage testing should be conducted for chil-ren with hearing loss. Recommendation basedn cohort studies and preponderance of benefitver risk.

earing TestingHearing testing is recommended when OME

ersists for 3 months or longer, or at any time thatanguage delay, learning problems, or a significantearing loss is suspected. Conductive hearing lossften accompanies OME1,88 and may adverselyffect binaural processing,89 sound localization,90

nd speech perception in noise.91-94 Hearing lossaused by OME may impair early language acqui-ition,95-97 but the child’s home environment has areater impact on outcomes98; recent randomizedrials41,99,100 suggest no impact on children withME who are not at risk identified by screening or

urveillance.Studies examining hearing sensitivity in chil-

ren with OME report that average pure toneearing loss at 4 frequencies (500, 1000, 2000, and000 Hz) ranges from normal hearing to moderateearing loss (0-55 dB). The 50th percentile isbout 25 dB hearing level (HL) and about 20% ofars exceed 35 dB HL.101,102 Unilateral OME withearing loss results in overall poorer binauralearing than in infants with normal middle-ear

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unction bilaterally.103,104 Although based on lim-ted research, there is evidence that children expe-iencing the greatest conductive hearing loss forhe longest periods may be more likely to exhibitevelopmental and academic sequelae.1,95,105

Initial hearing testing for children aged 4 yearsr older can be done in the primary care setting.106

esting should be performed in a quiet environ-ent, preferably in a separate closed or sound-

roofed area set aside specifically for that purpose.onventional audiometry with earphones is per-

ormed with a fail criterion of �20 dB HL at 1 orore frequencies (500, 1000, 2000, 4000 Hz) in

ither ear.106,107 Methods not recommended asubstitutes for primary care hearing testing includeympanometry and pneumatic otoscopy102; care-iver judgment regarding hearing loss108,109;peech audiometry; and tuning forks, acoustic re-ectometry, and behavioral observation.1

Comprehensive audiologic evaluation is recom-ended for children who fail primary care testing,

re younger than 4 years, or cannot be tested in therimary care setting. Audiologic assessment in-ludes evaluating air-conduction and bone-con-uction thresholds for pure tones, speech detectionr speech recognition thresholds,102 and measur-ng speech understanding if possible.94 The

ethod of assessment depends on the develop-ental age of the child and might include visual

einforcement or conditioned orienting responseudiometry for infants aged 6 to 24 months, playudiometry for children aged 24 to 48 months, oronventional screening audiometry for childrenged 4 years and older.106 The auditory brain stemesponse and otoacoustic emission are tests ofuditory pathway structural integrity, not hearing,nd should not substitute for behavioral pure toneudiometry.106

anguage TestingLanguage testing should be conducted for chil-

ren with hearing loss (pure tone average greaterhan 20 dB HL on comprehensive audiometricvaluation). Testing for language delays is impor-ant because communication is integral to all as-ects of human functioning. Young children withpeech and language delays during the preschoolears are at risk for continued communication

roblems and later delays in reading and writ-ng.110-112 In one study, 6% to 8% of childrenged 3 years and 2% to 13% of kindergartners hadanguage impairment.113 Language interventionan improve communication and other functionalutcomes for children with histories of OME.114

Children who experience repeated and persis-ent episodes of OME and associated hearing lossuring early childhood may be at a disadvantageor learning speech and language.79,115 Althoughhekelle et al2 concluded there was no evidence toupport the concern that OME during the first 3ears of life was related to later receptive or ex-ressive language, this meta-analysis should benterpreted cautiously because it did not examinepecific language domains, such as vocabulary,nd because the independent variable was OMEnd not hearing loss. Other meta-analyses79,115

ave suggested at most a small negative associa-ion of OME and hearing loss on children’s recep-ive and expressive language through the elemen-ary school years. The clinical significance ofhese effects for language and learning is unclearor the child not at risk. For example, in oneandomized trial,100 prompt insertion of tympa-ostomy tubes for OME did not improve develop-ental outcomes at age 3 years, regardless of

aseline hearing levels. In another randomizedrial,116 however, prompt tube insertion achievedmall benefits for children with bilateral OME andearing loss.Clinicians should ask the parent or caregiver

bout specific concerns regarding their child’s lan-uage development. Children’s speech and lan-uage can be tested at ages 6 to 36 months byirect engagement of a child and interviewing thearent using the Early Language Milestonecale.117 Other approaches require interviewingnly the child’s parent or caregiver, such as theacArthur Communicative Development Inven-

ory118 and the Language Development Survey.119

or older children the Denver Developmentalcreening Test II120 can be used to screen generalevelopment, including speech and language.omprehensive speech and language evaluation is

ecommended for children who fail testing orhenever the child’s parent or caregiver expresses

oncern.121

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Evidence Profile: Hearing and Language● Aggregate evidence quality: B, diagnostic

studies with minor limitations; C, observa-tional studies

● Benefit: to detect hearing loss and languagedelay and identify strategies or interventionsto improve developmental outcomes

● Harm: parental anxiety, direct and indirectcosts of assessment, false-positive results

● Balance of benefit and harm: preponderanceof benefit over harm


7. SURVEILLANCE: Children with persis-ent OME who are not at risk should be reex-mined at 3- to 6-month intervals until theffusion is no longer present, significant hear-ng loss is identified, or structural abnormali-ies of the eardrum or middle ear are suspected.ecommendation based on randomized, con-

rolled trials and observational studies with a pre-onderance of benefit over harm.

If OME is asymptomatic and is likely to resolvepontaneously, intervention is unnecessary even ifME persists for more than 3 months. The clini-

ian should determine if risk factors exist thatould predispose to undesirable sequelae or pre-ict nonresolution of the effusion. As long asME persists, the child is at risk for sequelae andust be periodically reevaluated for factors thatould prompt intervention.The 1994 OME guideline1 recommended sur-

ery for OME persisting 4 to 6 months with hear-ng loss, but requires reconsideration because ofater data on tubes and developmental sequelae.122

or example, selecting surgical candidates usinguration-based criteria (eg, OME more than 3onths or exceeding a cumulative threshold) does

ot improve developmental outcomes in infantsnd toddlers who are not at risk.41,42,99,100 Further,he 1994 OME guideline did not specifically ad-ress managing effusion without significant hear-ng loss persisting more than 6 months.

Asymptomatic OME usually resolves spontane-usly, but resolution rates decrease the longer theffusion has been present,36,76,77 and relapse isommon.123 Risk factors that make spontaneousesolution less likely include124,125

● Onset of OME in the summer or fall season

● Hearing loss greater than 30 dB HL in thebetter-hearing ear

● History of prior tympanostomy tubes● Not having had an adenoidectomyChildren with chronic OME are at risk for struc-

ural damage of the tympanic membrane126 be-ause the effusion contains leukotrienes, prosta-landins, and arachidonic acid metabolites thatnvoke a local inflammatory response.127 Reactivehanges may occur in the adjacent tympanic mem-rane and mucosal linings. A relative underventi-ation of the middle ear produces a negative pres-ure that predisposes to focal retraction pockets,eneralized atelectasis of the tympanic membrane,nd cholesteatoma.

Structural integrity is assessed by carefully ex-mining the entire tympanic membrane, which, inany cases, can be accomplished by the primary

are clinician using a handheld pneumatic oto-cope. A search should be made for retractionockets, ossicular erosion, and areas of atelectasisr atrophy. If there is any uncertainty that allbserved structures are normal, the patient shoulde examined using an otomicroscope. All childrenith these tympanic membrane conditions, regard-

ess of OME duration, should have a comprehen-ive audiologic evaluation.

Conditions of the tympanic membrane that gen-rally mandate inserting a tympanostomy tube areosterosuperior retraction pockets, ossicular ero-ion, adhesive atelectasis, and retraction pocketshat accumulate keratin debris. Ongoing surveil-ance is mandatory because the incidence of struc-ural damage increases with effusion duration.128

As noted in Recommendation 6, children withersistent OME for 3 months or longer shouldave their hearing tested. Based on these results,linicians can identify 3 levels of action based onearing levels obtained for the better-hearing earsing earphones, or in sound field using speakersf the child is too young for ear-specific testing.

1. Hearing levels �40 dB (at least a moderatehearing loss). Comprehensive audiologicevaluation is indicated if not previously per-formed. If moderate hearing loss is docu-mented, and persists at this level, surgery isrecommended because persistent hearingloss of this magnitude that is permanent in

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nature has been shown to impact speech,language, and academic performance.129-131

2. Hearing levels 21 to 39 dB (mild hearingloss). Comprehensive audiologic evaluationis indicated if not previously performed.Mild sensorineural hearing loss has been as-sociated with difficulties in speech, lan-guage, and academic performance inschool,129,132 and persistent mild conductivehearing loss from OME may have similarimpact. Further management should be indi-vidualized based on effusion duration, sever-ity of hearing loss, and parent or caregiverpreference, and may include strategies to op-timize the listening and learning environ-ment (Table 4) or surgery. Repeat hearingtesting should be performed in 3 to 6 monthsif OME persists at follow-up evaluation ortympanostomy tubes have not been placed.

3. Hearing levels �20 dB (normal hearing).Repeat hearing test should be performed in 3to 6 months if OME persists at follow-upevaluation.

In addition to hearing loss and speech or lan-uage delay, other factors may influence the deci-ion to intervene for persistent OME. Roberts etl98,133 showed that the caregiving environment isore strongly related to school outcome than wasME or hearing loss. Risk factors for delays in

peech and language development caused by aoor caregiving environment included low mater-

able 4. Strategies for optimizing the listening-earning environment for children with OME andearing loss*

Get within 3 feet of the child before speaking.Turn off competing audio signals, such as unneces-

sary music and television in the background.Face the child and speak clearly, using visual clues

(hands, pictures) in addition to speech.Slow the rate, raise the level, and enunciate speech

directed at the child.Read to or with the child, explaining pictures and

asking questions.Repeat words, phrases, and questions when misun-

derstood.Assign preferential seating in the classroom near the

teacher.Use a frequency modulated personal or sound field

amplification system in the classroom.

Modified with permission from Roberts et al.78-79

al educational level, unfavorable child care envi-onment, and low socioeconomic status. In suchases, these factors may be additive to the hearingoss in affecting lower school performance andlassroom behavior problems.

Persistent OME may be associated with physi-al or behavioral symptoms, including hyperactiv-ty, poor attention, and behavioral problems inome studies134-136 and reduced child quality ofife.46 Conversely, young children randomized toarly versus late tube insertion for persistent OMEhowed no behavioral benefits from early sur-ery.41,100 Children with chronic OME also haveignificantly poorer vestibular function and grossotor proficiency when compared with non-OME

ontrols.48-50 Moreover, vestibular function, be-avior, and quality of life can improve after tym-anostomy tube insertion.47,137,138 Other physicalymptoms of OME that, if present and persistent,ay warrant surgery include otalgia, unexplained

leep disturbance, and coexisting recurrent AOM.ubes reduce the absolute incidence of recurrentOM by about 1 episode per child per year, but

he relative risk reduction is 56%.139

The risks of continued observation of childrenith OME must be balanced against the risks of

urgery. Children with persistent OME examinedegularly at 3- to 6-month intervals, or sooner ifME-related symptoms develop, are most likely

t low risk for physical, behavioral, or develop-ental sequelae of OME. Conversely, prolongedatchful waiting of OME is not appropriate when

egular surveillance is impossible or when thehild is at risk for developmental sequelae ofME because of comorbidities (Table 3). For

hese children, the risks of anesthesia and surgerysee Recommendation 9) may be less than contin-ed observation.Evidence Profile: Surveillance● Aggregate evidence quality: C, observational

studies and some randomized trials● Benefit: avoiding interventions that do not

improve outcomes● Harm: allowing structural abnormalities to

develop in the tympanic membrane, underes-timating the impact of hearing loss on a child,failing to detect significant signs or symptomsthat require intervention

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8. REFERRAL: When children with OMEre referred by the primary care clinician forvaluation by an otolaryngologist, audiologist,r speech-language pathologist, the referringlinician should document the effusion dura-ion and specific reason for referral (evaluation,urgery), and provide additional relevant infor-ation such as history of AOM and develop-ental status of the child. Option based on panel

onsensus and a preponderance of benefit overarm.This recommendation emphasizes the impor-

ance of communication between the referring pri-ary care clinician and the otolaryngologist, au-

iologist, and speech-language pathologist.arents and caregivers may be confused and frus-

rated when a recommendation for surgery is madeor their child because of conflicting informationbout alternative management strategies. Choos-ng among management options is facilitatedhen primary care physicians and advanced prac-

ice nurses who best know the patient’s history ofar problems and general medical status providehe specialist with accurate information. Althoughhere are no studies showing improved outcomesrom better documentation of OME histories, theres a clear need for better mechanisms to conveynformation and expectations from primary carelinicians to consultants and subspecialists.140-142

When referring a child for evaluation to antolaryngologist, the primary care physicianhould explain the following to the parent or care-iver of the patient:

● Reason for referral—Explain that the child isseeing an otolaryngologist for evaluation,which is likely to include ear examination andaudiologic testing, and not necessarily simplyto be scheduled for surgery.

● What to expect—Explain that surgery may berecommended and let the parent know that theotolaryngologist will further explain the op-tions, benefits, and risks.

● Decision-making process—Explain that thereare many alternatives for management andthat surgical decisions are elective; the parent

or caregiver should be encouraged to expressto the surgeon any concerns they may haveabout recommendations made.

When referring a child to an otolaryngologist,udiologist, or speech-language pathologist, theinimum information that should be conveyed inriting includes the following:● Duration of OME—State how long fluid has

been present.● Laterality of OME—State whether 1 or both

ears have been affected.● Results of prior hearing testing or tympanom-

etry.● Suspected speech or language problems—

State if there had been a delay in speech andlanguage development or if the parent or acaregiver has expressed concerns about thechild’s communication abilities, schoolachievement, or attentiveness.

● Conditions that might exacerbate the delete-rious effects of OME—State if the child hasconditions such as permanent hearing loss,impaired cognition, developmental delays,cleft lip or palate, or unstable or nonsupport-ive family or home environment.

● AOM history—State if the child has a historyof recurrent AOM.

Additional medical information that should berovided to the otolaryngologist by the primaryare clinician includes:

● Parental attitude toward surgery—State if theparents have expressed a strong preferencefor or against surgery as a management op-tion.

● Related conditions that might require con-comitant surgery—State if there have beenother conditions that might warrant surgery ifthe child is going to have general anesthesia(eg, nasal obstruction and snoring that mightbe an indication for adenoidectomy, or ob-structive breathing during sleep that mightmean tonsillectomy is indicated).

● General health status—State if there are anyconditions that might present problems forsurgery or administering general anesthesiasuch as congenital heart abnormality, bleed-ing disorder, asthma or reactive airway dis-ease, or family history of malignanthyperthermia.

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After evaluating the child, the otolaryngologist,udiologist, or speech-language pathologist shouldnform the referring physician regarding their di-gnostic impression, plans for further assessment,nd recommendations for ongoing monitoring andanagement.Evidence Profile: Referral● Aggregate evidence quality: C, observational

studies● Benefit: better communication, improved de-

cision making● Harm: confidentiality concerns, administra-

tive burden, increased parent or caregiveranxiety

● Benefits-harms assessment: balance of benefitand harm

● Policy level: option

9. SURGERY: When a child becomes a sur-ical candidate, tympanostomy tube insertion ishe preferred initial procedure; adenoidectomyhould not be performed unless a distinct indi-ation exists (nasal obstruction, chronic ade-oiditis). Repeat surgery consists of adenoidec-omy plus myringotomy, with or without tubensertion. Tonsillectomy alone or myringotomylone should not be used to treat OME. Recom-endation based on randomized, controlled trialsith a preponderance of benefit over harm.Surgical candidacy for OME depends largely on

earing status, associated symptoms, the child’sevelopmental risk (Table 3), and the anticipatedhance of timely spontaneous resolution of theffusion. Candidates for surgery include childrenith OME lasting 4 months or longer with persis-

ent hearing loss or other signs and symptoms,ecurrent or persistent OME in children at riskegardless of hearing status, and OME and struc-ural damage to the tympanic membrane or middlear. Ultimately the recommendation for surgeryust be individualized, based on consensus be-

ween the primary care physician, otolaryngolo-ist, and parent or caregiver that a particular childould benefit from intervention. Children withME of any duration who are at risk are candi-ates for earlier surgery.Tympanostomy tubes are recommended for ini-

ial surgery because randomized trials show aean 62% relative decrease in effusion prevalence

nd an absolute decrease of 128 effusion days perhild during the next year.139,143-145 Hearing lev-ls improve by a mean of 6 to 12 dB while theubes remain patent.146,147 Adenoidectomy plus

yringotomy (without tube insertion) has compa-able efficacy in children aged 4 years or older,143

ut is more invasive with additional surgical andnesthetic risks. Similarly, the added risk of ade-oidectomy outweighs the limited, short-term ben-fit for children aged 3 years or older without priorubes.148 Consequently, adenoidectomy is not rec-mmended for initial OME surgery unless a dis-inct indication exists, such as adenoiditis, postna-al obstruction, or chronic sinusitis.

About 20% to 50% of children who have hadympanostomy tubes have OME relapse after tubextrusion that may require additional sur-ery.144,145,149 When a child needs repeat surgeryor OME, adenoidectomy is recommended (unlesshe child has an overt or submucous cleft palate)ecause it confers a 50% reduction in the need foruture operations.143,150,151 The benefit of ade-oidectomy is apparent at age 2 years,150 greatestor children aged 3 years or older, and independentf adenoid size.143,151,152 Myringotomy is per-ormed concurrent with adenoidectomy. Myrin-otomy plus adenoidectomy is effective for chil-ren aged 4 years or older,143 but tube insertion isdvised for younger children, when potential re-apse of effusion must be minimized (eg, childrent risk), or when pronounced inflammation of theympanic membrane and middle-ear mucosa isresent.Tonsillectomy or myringotomy alone (without

denoidectomy) is not recommended to treatME. Although tonsillectomy is either ineffec-

ive152 or of limited efficacy,148,150 the risks ofemorrhage (about 2%) and additional hospital-zation outweigh any potential benefits unless aistinct indication for tonsillectomy exists. Myr-ngotomy alone, without tube placement or ade-oidectomy, is ineffective for chronic OME144,145

ecause the incision closes within several days.aser-assisted myringotomy extends the ventila-

ion period several weeks,153 but randomized trialsith concurrent controls have not been conducted

o establish efficacy. In contrast, tympanostomyubes ventilate the middle ear for an average of 12o 14 months.144,145

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Anesthesia mortality has been reported to bebout 1:50,000 for ambulatory surgery,154 but theurrent fatality rate may be lower.155 Laryngo-pasm and bronchospasm occur more often inhildren receiving anesthesia than adults. Tympa-ostomy tube sequelae are common156 but areenerally transient (otorrhea) or do not affectunction (tympanosclerosis, focal atrophy, or shal-ow retraction pocket). Tympanic membrane per-orations, which may require repair, are seen in% of children after placement of short-termgrommet-type) tubes and 17% after long-termubes.156 Adenoidectomy has a 0.2% to 0.5% in-idence of hemorrhage150,157 and 2% incidence ofransient velopharyngeal insufficiency.148 Otherotential risks of adenoidectomy, such as nasopha-yngeal stenosis and persistent velopharyngeal in-ufficiency, can be minimized with appropriateatient selection and surgical technique.There is a clear preponderance of benefit over

arm when considering the impact of surgery forME on effusion prevalence, hearing levels, sub-

equent incidence of AOM, and the need for re-peration after adenoidectomy. Information aboutdenoidectomy in children younger than 4 years,owever, remains limited. Although the cost ofurgery and anesthesia is nontrivial, it is offset byeduced OME and AOM after tube placement andy reduced need for reoperation after adenoidec-omy. About 8 adenoidectomies are needed tovoid a single instance of tube reinsertion; how-ver, each avoided surgery probably represents aarger reduction in the number of AOM and OMEpisodes, including those in children who did notequire additional surgery.150

Evidence Profile: Surgery● Aggregate evidence quality: B, randomized,

controlled trials with minor limitations● Benefit: improved hearing, reduced preva-

lence of OME, reduced incidence of AOM,and less need for additional tube insertion(after adenoidectomy)

● Harm: risks of anesthesia and specific surgi-cal procedures, sequelae of tympanostomytubes



10. COMPLEMENTARY AND ALTERNA-IVE MEDICINE: No recommendation isade regarding CAM as a treatment for OME.o recommendation based on lack of scientificvidence documenting efficacy and an uncertainalance of harm and benefit.

The 1994 OME guideline1 made no recommen-ation regarding CAM as a treatment for OME,nd no subsequent controlled studies have beenublished to change this conclusion. The currenttatement of “no recommendation” is based onack of scientific evidence documenting efficacylus a balance of benefit and harm.Evidence concerning CAM is insufficient to

etermine if the outcomes achieved for OME dif-er from those achieved by watchful waiting andpontaneous resolution. There are no randomized,ontrolled trials with adequate sample size on thefficacy of CAM for OME. While many caseeports and subjective reviews on CAM treatmentf AOM were found, little is published on OMEreatment or prevention. Homeopathy158 and chi-opractic treatments159 were assessed in pilot stud-es with small numbers of patients that failed tohow clinically or statistically significant benefits.onsequently, there is no research base on which

o develop a recommendation concerning CAMor OME.

The natural history of OME in childhood (dis-ussed previously) is such that almost any inter-ention can be “shown” to have helped in annecdotal, uncontrolled report or case series. Thefficacy of CAM, or any other intervention forME, can only be shown with parallel group

andomized, controlled trials with valid diagnosticethods and adequate sample size. Unproved mo-

alities that have been claimed to provide benefitn middle-ear disease include osteopathic and chi-opractic manipulation, dietary exclusions (such asairy), herbal and other dietary supplements, acu-uncture, traditional Chinese medicine, and home-pathy. None of these modalities, however, haveet been subjected to a published, peer-reviewedlinical trial.

The absence of any published clinical trials alsoeans that all reports of CAM adverse effects are

necdotal. A systematic review of recent evi-ence160 found significant serious adverse effectsf unconventional therapies for children, most of

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hich were associated with inadequately regu-ated herbal medicines. One report on malpracticeiability associated with CAM therapies161 did notpecifically address childhood issues. Allergic re-ctions to echinacea occur but seem to be rare inhildren.162 A general concern about herbal prod-cts is the lack of any governmental oversight intoroduct quality or purity.160,163,164 Further, herbalroducts may alter blood levels of allopathic med-cations, including anticoagulants. A possible con-ern with homeopathy is the worsening of symp-oms, which is viewed as a positive, early sign ofomeopathic efficacy. The adverse effects of ma-ipulative therapies (such as chiropractic treat-ents and osteopathy) in children are difficult to

ssess because of scant evidence, but a case seriesf 332 children treated for AOM or OME withhiropractic manipulation did not mention anyide effects.165 Quadriplegia has been reported,owever, following spinal manipulation in an in-ant with torticollis.166

Evidence Profile: Complementary and Alter-ative Medicine

● Aggregate evidence quality: D, case serieswithout controls

● Benefit: not established● Harm: potentially significant, depending on

the intervention● Benefits-harms assessment: uncertain balance

of benefit and harm● Policy level: no recommendation

11. ALLERGY MANAGEMENT: No recom-endation is made regarding allergy manage-ent as a treatment for OME. No recommen-

ation based on insufficient evidence ofherapeutic efficacy or a causal relationship be-ween allergy and OME.

The 1994 OME guideline1 made no recommen-ation regarding allergy management as a treat-ent for OME and no subsequent controlled stud-

es have been published to change this conclusion.he current statement of “no recommendation” isased on insufficient evidence of therapeutic effi-acy or a causal relationship between allergy andME, plus a balance of benefit and harm.A linkage between allergy and OME has long

een speculated but to date remains unquantified.he prevalence of allergy among OME patients

as been reported to range from less than 10% toore than 80%.167 Allergy has long been postu-

ated to cause OME through its contribution toustachian tube dysfunction.168 The cellular re-ponse of respiratory mucosa to allergens has beenell studied. Therefore, like other parts of respi-

atory mucosa, the mucosa lining the middle-earleft is capable of an allergic response.169,170 Sen-itivity to allergens varies among individuals, andtopy may involve neutrophils in type I allergiceactions that enhance the inflammatory re-ponse.171

The correlation between OME and allergy haseen widely reported, but no prospective studiesave examined the effects of immunotherapyompared with observation alone or other man-gement options. Reports of OME cure after im-unotherapy or food elimination diets172 are im-

ossible to interpret without concurrent controlroups because of the favorable natural history ofost untreated OME. The documentation of al-

ergy in published reports has been defined incon-istently (medical history, physical examination,kin-prick testing, nasal smears, serum IgE andosinophil counts, inflammatory mediators in ef-usions). Study groups have been drawn primarilyrom specialist offices, likely lack heterogeneity,nd are not representative of general medical prac-ice.

Evidence Profile: Allergy Management● Aggregate evidence quality: D, case series

without controls● Benefit: not established● Harm: adverse effects and cost of medication,

physician evaluation, elimination diets, anddesensitization

● Benefits-harms assessment: balance of benefitand harm

● Policy level: no recommendation

ESEARCH NEEDSiagnosis● Further standardize the definition of OME.● Assess the performance characteristics of

pneumatic otoscopy as a diagnostic test forOME when performed by primary care phy-sicians and advanced practice nurses in theroutine office setting.

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● Determine the optimal methods for teachingpneumatic otoscopy to residents and clini-cians.

● Develop a brief, reliable, objective methodfor diagnosing OME.

● Develop a classification method for identify-ing the presence of OME for practical use byclinicians that is based on quantifiable tym-panometric characteristics.

● Assess the usefulness of algorithms combin-ing pneumatic otoscopy and tympanometryfor detecting OME in clinical practice.

● Conduct additional validating cohort studiesof acoustic reflectometry as a diagnosticmethod for OME, particularly in childrenyounger than 2 years.

hild At Risk● Better define the child with OME who is at

risk for speech, language, and learning prob-lems.

● Conduct large, multicenter observational co-hort studies to identify the child at risk who ismost susceptible to potential adverse sequelaeof OME.

● Conduct large, multicenter observational co-hort studies to analyze outcomes achievedwith alternative management strategies forOME in children at risk.

atchful Waiting● Define the spontaneous resolution of OME in

infants and young children (existing data arelimited primarily to children aged 2 years orolder).

● Conduct large-scale, prospective cohort stud-ies to obtain current data on the spontaneousresolution of newly diagnosed OME of un-known prior duration (existing data are pri-marily from the late 1970s and early 1980s).

● Develop prognostic indicators to identify thebest candidates for watchful waiting.

● Determine if the lack of impact from promptinsertion of tympanostomy tubes on speechand language outcomes seen in asymptomaticyoung children with OME identified byscreening or intense surveillance can be gen-eralized to older children with OME or to

symptomatic children with OME referred forevaluation.

edication● Clarify which children, if any, should receive

antimicrobials, steroids, or both for OME.● Conduct a randomized, placebo-controlled

trial on the efficacy of antimicrobial therapy,with or without concurrent oral steroid, inavoiding surgery in children with OME whoare surgical candidates and have not receivedrecent antimicrobials.

● Investigate the role of mucosal surface bio-films in refractory or recurrent OME and de-velop targeted interventions.

earing and Language● Conduct longitudinal studies on the natural

history of hearing loss accompanying OME.● Develop improved methods for describing

and quantifying the fluctuations in hearing ofchildren with OME over time.

● Conduct prospective controlled studies on therelation of hearing loss associated with OMEto later auditory, speech, language, behav-ioral, and academic sequelae.

● Develop reliable, brief, objective methods forestimating hearing loss associated with OME.

● Develop reliable, brief, objective methods forestimating speech or language delay associ-ated with OME.

● Evaluate the benefits and administrative bur-den of language testing by primary care cli-nicians.

● Agree on the aspects of language that arevulnerable to, or affected by, hearing losscaused by OME, and reach a consensus on thebest tools for measurement.

● Determine if OME and associated hearingloss place children from special populationsat greater risk for speech and language delays.

urveillance● Develop better tools for monitoring children

with OME, suitable for routine clinical care.● Assess the value of new strategies for moni-

toring OME, such as acoustic reflectometryperformed at home by the parent or caregiver,in optimizing surveillance.

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● Improve our ability to identify children whowould benefit from early surgery instead ofprolonged surveillance.

● Promote early detection of structural abnor-malities in the tympanic membrane associatedwith OME that may require surgery to pre-vent complications.

● Clarify and quantify the role of parent orcaregiver education, socioeconomic status,and quality of the caregiving environment asmodifiers of OME developmental outcomes.

● Develop methods for minimizing loss to fol-low-up during OME surveillance.

urgery● Define the role of adenoidectomy in children

aged 3 years or younger as a specific OMEtherapy.

● Conduct controlled trials on the efficacy oftympanostomy tubes for developmentaloutcomes in children with hearing loss,other symptoms, or speech and languagedelay.

● Conduct randomized, controlled trials of sur-gery versus no surgery that emphasize pa-tient-based outcome measures (quality of life,functional health status) in addition to objec-tive measures (effusion prevalence, hearinglevels, AOM incidence, reoperation).

● Identify the optimal ways to incorporate par-ent or caregiver preference into surgical de-cision making.

omplementary and Alternativeedicine● Conduct randomized, controlled trials on the

efficacy of CAM modalities for OME.● Develop strategies to identify parents or care-

givers who use CAM therapies for theirchild’s OME, and encourage surveillance bythe primary care clinician.

llergy Management● Evaluate the causal role of atopy in OME.● Conduct randomized, controlled trials on the

efficacy of allergy therapy for OME that aregeneralizable to the primary care setting.

ONCLUSIONThis evidence-based practice guideline offers

ecommendations for identifying, monitoring, andanaging the child with OME. The guideline em-

hasizes appropriate diagnosis and provides op-ions for various management strategies includingbservation, medical intervention, and referral forurgical intervention. These recommendationshould provide primary care physicians and otherealth care providers with assistance in managinghildren with OME.

UBCOMMITTEE ON OTITIS MEDIAITH EFFUSION

ichard M. Rosenfeld, MD, MPH, Cochairperson,AAP, AAO-HNS

arry Culpepper, MD, MPH, Cochairperson,AAFParen J. Doyle, MD, PhD, AAO-HNSenneth M. Grundfast, MD, AAO-HNSlejandro Hoberman, MD, AAPargaret A. Kenna, MD, AAO-HNSllan S. Lieberthal, MD, AAPartin Mahoney, MD, PhD, AAFPichard A. Wahl, MD, AAPharles R. Woods, Jr, MD, MS, AAParbara Yawn MD, MSc, AAFP

ONSULTANTS. Michael Marcy, MDichard N. Shiffman, MD

IAISONSinda Carlson, MS, CPNP, National Associationof Pediatric Nurse Practitioners

udith Gravel, PhD, American Academy of Audi-ology

oanne Roberts, PhD, American Speech-Lan-guage-Hearing Association

TAFFaureen Hannley, PhD, AAO-HNSarla T. Herrerias, MPH, AAPellinda K. Schoof, MHA, CPHQ, AAFP

ONFLICTS OF INTEREST. Michael Marcy, MD: consultant to Abbott Lab-oratories; consultant to GlaxoSmithKline(vaccines).

R



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