The clinical practice guideline on otitis media with effusion (OME) provides evidence-based recommendations on diagnosing and managing OME in children. This is an update of the 1994 clinical practice guideline "Otitis Media With Effusion in Young Children," which was developed by the Agency for Healthcare Policy and Research (now the Agency for Healthcare Research and Quality). In contrast to the earlier guideline, which was limited to children 1 to 3 years old with no craniofacial or neurologic abnormalities or sensory deficits, the updated guideline applies to children aged 2 months through 12 years with or without developmental disabilities or underlying conditions that predispose to OME and its sequelae. The American Academy of Pediatrics, American Academy of Family Physicians, and American Academy of Otolaryngology-Head and Neck Surgery selected a subcommittee composed of experts in the fields of primary care, otolaryngology, infectious diseases, epidemiology, hearing, speech and language, and advanced-practice nursing to revise the OME guideline.
The subcommittee made a strong recommendation that clinicians use pneumatic otoscopy as the primary diagnostic method and distinguish OME from acute otitis media.
The subcommittee made recommendations that clinicians should 1) document the laterality, duration of effusion, and presence and severity of associated symptoms at each assessment of the child with OME, 2) distinguish the child with OME who is at risk for speech, language, or learning problems from other children with OME and more promptly evaluate hearing, speech, language, and need for intervention in children at risk, and 3) manage the child with OME who is not at risk with watchful waiting for 3 months from the date of effusion onset (if known) or diagnosis (if onset is unknown).
The subcommittee also made recommendations that 4) hearing testing be conducted when OME persists for 3 months or longer or at any time that language delay, learning problems, or a significant hearing loss is suspected in a child with OME, 5) children with persistent OME who are not at risk should be reexamined at 3- to 6-month intervals until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected, and 6) when a child becomes a surgical candidate (tympanostomy tube insertion is the preferred initial procedure). Adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis); repeat surgery consists of adenoidectomy plus myringotomy with or without tube insertion. Tonsillectomy alone or myringotomy alone should not be used to treat OME.
The subcommittee made negative recommendations that 1) population-based screening programs for OME not be performed in healthy, asymptomatic children, and 2) because antihistamines and decongestants are ineffective for OME, they should not be used for treatment; antimicrobials and corticosteroids do not have long-term efficacy and should not be used for routine management.
The subcommittee gave as options that 1) tympanometry can be used to confirm the diagnosis of OME and 2) when children with OME are referred by the primary clinician for evaluation by an otolaryngologist, audiologist, or speech-language pathologist, the referring clinician should document the effusion duration and specific reason for referral (evaluation, surgery) and provide additional relevant information such as history of acute otitis media and developmental status of the child. The subcommittee made no recommendations for 1) complementary and alternative medicine as a treatment for OME, based on a lack of scientific evidence documenting efficacy, or 2) allergy management as a treatment for OME, based on insufficient evidence of therapeutic efficacy or a causal relationship between allergy and OME. Last, the panel compiled a list of research needs based on limitations of the evidence reviewed.
The purpose of this guideline is to inform clinicians of evidence-based methods to identify, monitor, and manage OME in children aged 2 months through 12 years. The guideline may not apply to children more than 12 years old, because OME is uncommon and the natural history is likely to differ from younger children who experience rapid developmental change. The target population includes children with or without developmental disabilities or underlying conditions that predispose to OME and its sequelae. The guideline is intended for use by providers of health care to children, including primary care and specialist physicians, nurses and nurse practitioners, physician assistants, audiologists, speech-language pathologists, and child-development specialists. The guideline is applicable to any setting in which children with OME would be identified, monitored, or managed.
This guideline is not intended as a sole source of guidance in evaluating children with OME. Rather, it is designed to assist primary care and other clinicians by providing an evidence-based framework for decision-making strategies. It is not intended to replace clinical judgment or establish a protocol for all children with this condition and may not provide the only appropriate approach to diagnosing and managing this problem.
The primary outcomes considered in the guideline include hearing loss; effects on speech, language, and learning; physiologic sequelae; health care utilization (medical, surgical); and quality of life.1,2 The high prevalence of OME, difficulties in diagnosis and assessing duration, increased risk of conductive hearing loss, potential impact on language and cognition, and significant practice variations in management8 make OME an important condition for the use of up-to-date evidence-based practice guidelines.
In developing an evidence-based clinical practice guideline on managing OME, the American Academy of Pediatrics (AAP), American Academy of Family Physicians, and American Academy of Otolaryngology-Head and Neck Surgery worked with the Agency for Healthcare Research and Quality (AHRQ) and other organizations. This effort included representatives from each partnering organization along with liaisons from audiology, speech-language pathology, informatics, and advanced-practice nursing. The most current literature on managing children with OME was reviewed, and research questions were developed to guide the evidence-review process.
The AHRQ report on OME from the Southern California Evidence-Based Practice Center (EPC) focused on key questions of natural history, diagnostic methods, and long-term speech, language, and hearing outcomes.2 Searches were conducted through January 2000 in Medline, Embase, and the Cochrane Library. Additional articles were identified by review of reference listings in proceedings, reports, and other guidelines. The EPC accepted 970 articles for full review after screening 3200 abstracts. The EPC reviewed articles by using established quality criteria9,10 and included randomized trials, prospective cohorts, and validations of diagnostic tests (validating cohort studies).
In May 2003, the Guidelines Review Group of the Yale Center for Medical Informatics used the Guideline Elements Model12 to categorize content of the present draft guideline. Policy statements were parsed into component decision variables and actions and then assessed for decidability and executability. Quality appraisal using established criteria13 was performed with Guideline Elements Model-Q Online.14,15 Implementation issues were predicted by using the Implementability Rating Profile, an instrument under development by the Yale Guidelines Review Group (R. Shiffman, MD, written communication, May 2003). OME subcommittee members received summary results and modified an advanced draft of the guideline.
The final draft practice guideline underwent extensive peer review by numerous entities identified by the subcommittee. Comments were compiled and reviewed by the subcommittee cochairpersons. The recommendations contained in the practice guideline are based on the best available published data through April 2003. Where data are lacking, a combination of clinical experience and expert consensus was used. A scheduled review process will occur 5 years from publication or sooner if new compelling evidence warrants earlier consideration.
Guidelines are intended to reduce inappropriate variations in clinical care, produce optimal health outcomes for patients, and minimize harm. The evidence-based approach to guideline development requires that the evidence supporting a policy be identified, appraised, and summarized and that an explicit link between evidence and statements be defined. Evidence-based statements reflect the quality of evidence and the balance of benefit and harm that is anticipated when the statement is followed. The AAP definitions for evidence-based statements16 are listed in Tables 1 and 2.
Making recommendations about health practices involves value judgments on the desirability of various outcomes associated with management options. Value judgments applied by the OME subcommittee were made in an effort to minimize harm and diminish unnecessary therapy. Emphasis was placed on promptly identifying and managing children at risk for speech, language, or learning problems to maximize opportunities for beneficial outcomes. Direct costs also were considered in the statements concerning diagnosis and screening and to a lesser extent in other statements.
This is a strong recommendation based on systematic review of cohort studies and the preponderance of benefit over harm.
This option is based on cohort studies and a balance of benefit and harm.
The AHRQ evidence report2 systematically reviewed the sensitivity, specificity, and predictive values of 9 diagnostic methods for OME. Pneumatic otoscopy had the best balance of sensitivity and specificity, consistent with the 1994 guideline.1 Meta-analysis revealed a pooled sensitivity of 94% (95% confidence interval: 91%–96%) and specificity of 80% (95% confidence interval: 75%–86%) for validated observers using pneumatic otoscopy versus myringotomy as the gold standard. Pneumatic otoscopy therefore should remain the primary method of OME diagnosis, because the instrument is readily available in practice settings, cost-effective, and accurate in experienced hands. Non–pneumatic otoscopy is not advised for primary diagnosis.
Although no research studies have examined whether pneumatic otoscopy causes discomfort, expert consensus suggests that the procedure does not have to be painful, especially when symptoms of acute infection (AOM) are absent. A nontraumatic examination is facilitated by using a gentle touch, restraining the child properly when necessary, and inserting the speculum only into the outer one third (cartilaginous portion) of the ear canal.28 The pneumatic bulb should be compressed slightly before insertion, because OME often is associated with a negative middle-ear pressure, which can be assessed more accurately by releasing the already compressed bulb. The otoscope must be fully charged, the bulb (halogen or xenon) bright and luminescent,29 and the insufflator bulb attached tightly to the head to avoid the loss of an air seal. The window must also be sealed.
Aggregate evidence quality: A, diagnostic studies in relevant populations.
Benefit: improved diagnostic accuracy; inexpensive equipment.
Harm: cost of training clinicians in pneumatic otoscopy.
Benefits-harms assessment: preponderance of benefit over harm.
Aggregate evidence quality: B, diagnostic studies with minor limitations.
Benefit: increased diagnostic accuracy beyond pneumatic otoscopy; documentation.
Harm: acquisition cost, administrative burden, and recalibration.
Benefits-harms assessment: balance of benefit and harm.
This recommendation is based on randomized, controlled trials and cohort studies, with a preponderance of harm over benefit.
This recommendation concerns population-based screening programs of all children in a community or a school without regard to any preexisting symptoms or history of disease. This recommendation does not address hearing screening or monitoring of specific children with previous or recurrent OME.
OME is highly prevalent in young children. Screening surveys of healthy children ranging in age from infancy to 5 years old show a 15% to 40% point prevalence of middle-ear effusion.5,7,30–36 Among children examined at regular intervals for a year, ~50% to 60% of child care center attendees32 and 25% of school-aged children37 were found to have a middle-ear effusion at some time during the examination period, with peak incidence during the winter months.
Population-based screening has not been found to influence short-term language outcomes,33 and its long-term effects have not been evaluated in a randomized, clinical trial. Therefore, the recommendation against screening is based not only on the ability to identify OME but more importantly on a lack of demonstrable benefits from treating children so identified that exceed the favorable natural history of the disease. The New Zealand Health Technology Assessment38 could not determine whether preschool screening for OME was effective. More recently, the Canadian Task Force on Preventive Health Care39 reported that insufficient evidence was available to recommend including or excluding routine early screening for OME. Although screening for OME is not inherently harmful, potential risks include inaccurate diagnoses, overtreating self-limited disease, parental anxiety, and the costs of screening and unnecessary treatment.
Population-based screening is appropriate for conditions that are common, can be detected by a sensitive and specific test, and benefit from early detection and treatment.40 The first 2 requirements are fulfilled by OME, which affects up to 80% of children by school entry2,5,7 and can be screened easily with tympanometry (see recommendation 1B). Early detection and treatment of OME identified by screening, however, have not been shown to improve intelligence, receptive language, or expressive language.2,39,41,42 Therefore, population-based screening for early detection of OME in asymptomatic children has not been shown to improve outcomes and is not recommended.
Aggregate evidence quality: B, randomized, controlled trials with minor limitations and consistent evidence from observational studies.
Benefit: potentially improved developmental outcomes, which have not been demonstrated in the best current evidence.
Harm: inaccurate diagnosis (false-positive or false-negative), overtreating self-limited disease, parental anxiety, cost of screening, and/or unnecessary treatment.
Benefits-harms assessment: preponderance of harm over benefit.
This recommendation is based on observational studies and strong preponderance of benefit over harm.
Ideally, the time of onset and laterality of OME can be defined through diagnosis of an antecedent AOM, a history of acute onset of signs or symptoms directly referable to fluid in the middle ear, or the presence of an abnormal audiogram or tympanogram closely after a previously normal test. Unfortunately, these conditions are often lacking, and the clinician is forced to speculate on the onset and duration of fluid in the middle ear(s) in a child found to have OME at a routine office visit or school screening audiometry.
The laterality (unilateral versus bilateral), duration of effusion, and presence and severity of associated symptoms should be documented in the medical record at each assessment of the child with OME. When OME duration is uncertain, the clinician must take whatever evidence is at hand and make a reasonable estimate.
Aggregate evidence quality: C, observational studies.
Benefits: defines severity, duration has prognostic value, facilitates future communication with other clinicians, supports appropriate timing of intervention, and, if consistently unilateral, may identify a problem with specific ear other than OME (eg, retraction pocket or cholesteatoma).
This recommendation is based on case series, the preponderance of benefit over harm, and ethical limitations in studying children with OME who are at risk.
The panel defines the child at risk as one who is at increased risk for developmental difficulties (delay or disorder) because of sensory, physical, cognitive, or behavioral factors listed in Table 3. These factors are not caused by OME but can make the child less tolerant of hearing loss or vestibular problems secondary to middle-ear effusion. In contrast the child with OME who is not at risk is otherwise healthy and does not have any of the factors shown in Table 3.
Earlier guidelines for managing OME have applied only to young children who are healthy and exhibit no developmental delays.1 Studies of the relationship between OME and hearing loss or speech/language development typically exclude children with craniofacial anomalies, genetic syndromes, and other developmental disorders. Therefore, the available literature mainly applies to otherwise healthy children who meet inclusion criteria for randomized, controlled trials. Few, if any, existing studies dealing with developmental sequelae caused by hearing loss from OME can be generalized to children who are at risk.
Children who are at risk for speech or language delay would likely be affected additionally by hearing problems from OME,51 although definitive studies are lacking. For example, small comparative studies of children or adolescents with Down syndrome52 or cerebral palsy53 show poorer articulation and receptive language associated with a history of early otitis media. Large studies are unlikely to be forthcoming because of methodologic and ethical difficulties inherent in studying children who are delayed or at risk for further delays. Therefore, clinicians who manage children with OME should determine whether other conditions coexist that put a child at risk for developmental delay (Table 3) and then take these conditions into consideration when planning assessment and management.
Children with severe visual impairments may be more susceptible to the effects of OME, because they depend on hearing more than children with normal vision.51 Any decrease in their most important remaining sensory input for language (hearing) may significantly compromise language development and their ability to interact and communicate with others. All children with severe visual impairments should be considered more vulnerable to OME sequelae, especially in the areas of balance, sound localization, and communication.
Aggregate evidence quality: C, observational studies of children at risk; D, expert opinion on the ability of prompt assessment and management to alter outcomes.
Benefits: optimizing conditions for hearing, speech, and language; enabling children with special needs to reach their potential; avoiding limitations on the benefits of educational interventions because of hearing problems from OME.
Harm: cost, time, and specific risks of medications or surgery.
Benefits-harms assessment: exceptional preponderance of benefits over harm based on subcommittee consensus because of circumstances to date precluding randomized trials.
This recommendation is based on systematic review of cohort studies and the preponderance of benefit over harm.
The recommendation for a 3-month period of observation is based on a clear preponderance of benefit over harm and is consistent with the original OME guideline intent of avoiding unnecessary surgery.1 At the discretion of the clinician, this 3-month period of watchful waiting may include interval visits at which OME is monitored by using pneumatic otoscopy, tympanometry, or both. Factors to consider in determining the optimal interval(s) for follow-up include clinical judgment, parental comfort level, unique characteristics of the child and/or his environment, access to a health care system, and hearing levels (HLs) if known.
After documented resolution of OME in all affected ears, additional follow-up is unnecessary.
Aggregate evidence quality: B, systematic review of cohort studies.
Benefit: avoid unnecessary interventions, take advantage of favorable natural history, and avoid unnecessary referrals and evaluations.
Harm: delays in therapy for OME that will not resolve with observation; prolongation of hearing loss.
This recommendation is based on systematic review of randomized, controlled trials and the preponderance of harm over benefit.
Therapy for OME is appropriate only if persistent and clinically significant benefits can be achieved beyond spontaneous resolution. Although statistically significant benefits have been demonstrated for some medications, they are short-term and relatively small in magnitude. Moreover, significant adverse events may occur with all medical therapies.
The prior OME guideline1 found no data supporting antihistamine-decongestant combinations in treating OME. Meta-analysis of 4 randomized trials showed no significant benefit for antihistamines or decongestants versus placebo. No additional studies have been published since 1994 to change this recommendation. Adverse effects of antihistamines and decongestants include insomnia, hyperactivity, drowsiness, behavioral change, and blood-pressure variability.
The prior OME guideline1 did not recommend oral steroids for treating OME in children. A later meta-analysis85 showed no benefit for oral steroid versus placebo within 2 weeks but did show a short-term benefit for oral steroid plus antimicrobial versus antimicrobial alone in 1 of 3 children treated. This benefit became nonsignificant after several weeks in a prior meta-analysis1 and in a large, randomized trial.86 Oral steroids can produce behavioral changes, increased appetite, and weight gain.1 Additional adverse effects may include adrenal suppression, fatal varicella infection, and avascular necrosis of the femoral head.3 Although intranasal steroids have fewer adverse effects, one randomized trial87 showed statistically equivalent outcomes at 12 weeks for intranasal beclomethasone plus antimicrobials versus antimicrobials alone for OME.
Antimicrobial therapy with or without steroids has not been demonstrated to be effective in long-term resolution of OME, but in some cases this therapy can be considered an option because of short-term benefit in randomized trials, when the parent or caregiver expresses a strong aversion to impending surgery. In this circumstance, a single course of therapy for 10 to 14 days may be used. The likelihood that the OME will resolve long-term with these regimens is small, and prolonged or repetitive courses of antimicrobials or steroids are strongly not recommended.
Aggregate evidence quality: A, systematic review of well-designed, randomized, controlled trials.
Benefit: avoid side effects and reduce cost by not administering medications; avoid delays in definitive therapy caused by short-term improvement then relapse.
Harm: adverse effects of specific medications as listed previously; societal impact of antimicrobial therapy on bacterial resistance and transmission of resistant pathogens.
This recommendation is based on cohort studies and the preponderance of benefit over risk.
Hearing testing is recommended when OME persists for 3 months or longer or at any time that language delay, learning problems, or a significant hearing loss is suspected. Conductive hearing loss often accompanies OME1,88 and may adversely affect binaural processing,89 sound localization,90 and speech perception in noise.91–94 Hearing loss caused by OME may impair early language acquisition,95–97 but the child's home environment has a greater impact on outcomes98; recent randomized trials41,99,100 suggest no impact on children with OME who are not at risk as identified by screening or surveillance.
Children who experience repeated and persistent episodes of OME and associated hearing loss during early childhood may be at a disadvantage for learning speech and language.79,115 Although Shekelle et al2 concluded that there was no evidence to support the concern that OME during the first 3 years of life was related to later receptive or expressive language, this meta-analysis should be interpreted cautiously, because it did not examine specific language domains such as vocabulary and the independent variable was OME and not hearing loss. Other meta-analyses79,115 have suggested at most a small negative association of OME and hearing loss on children's receptive and expressive language through the elementary school years. The clinical significance of these effects for language and learning is unclear for the child not at risk. For example, in one randomized trial,100 prompt insertion of tympanostomy tubes for OME did not improve developmental outcomes at 3 years old regardless of baseline hearing. In another randomized trial,116 however, prompt tube insertion achieved small benefits for children with bilateral OME and hearing loss.
Aggregate evidence quality: B, diagnostic studies with minor limitations; C, observational studies.
Benefit: to detect hearing loss and language delay and identify strategies or interventions to improve developmental outcomes.
Harm: parental anxiety, direct and indirect costs of assessment, and/or false-positive results.
Balance of benefit and harm: preponderance of benefit over harm.
This recommendation is based on randomized, controlled trials and observational studies with a preponderance of benefit over harm.
If OME is asymptomatic and is likely to resolve spontaneously, intervention is unnecessary even if OME persists for more than 3 months. The clinician should determine whether risk factors exist that would predispose the child to undesirable sequelae or predict nonresolution of the effusion. As long as OME persists, the child is at risk for sequelae and must be reevaluated periodically for factors that would prompt intervention.
The 1994 OME guideline1 recommended surgery for OME persisting 4 to 6 months with hearing loss but requires reconsideration because of later data on tubes and developmental sequelae.122 For example, selecting surgical candidates using duration-based criteria (eg, OME >3 months or exceeding a cumulative threshold) does not improve developmental outcomes in infants and toddlers who are not at risk.41,42,99,100 Additionally, the 1994 OME guideline did not specifically address managing effusion without significant hearing loss persisting more than 6 months.
Children with chronic OME are at risk for structural damage of the tympanic membrane126 because the effusion contains leukotrienes, prostaglandins, and arachidonic acid metabolites that invoke a local inflammatory response.127 Reactive changes may occur in the adjacent tympanic membrane and mucosal linings. A relative underventilation of the middle ear produces a negative pressure that predisposes to focal retraction pockets, generalized atelectasis of the tympanic membrane, and cholesteatoma.
Structural integrity is assessed by carefully examining the entire tympanic membrane, which, in many cases, can be accomplished by the primary care clinician using a handheld pneumatic otoscope. A search should be made for retraction pockets, ossicular erosion, and areas of atelectasis or atrophy. If there is any uncertainty that all observed structures are normal, the patient should be examined by using an otomicroscope. All children with these tympanic membrane conditions, regardless of OME duration, should have a comprehensive audiologic evaluation.
As noted in recommendation 6, children with persistent OME for 3 months or longer should have their hearing tested. Based on these results, clinicians can identify 3 levels of action based on HLs obtained for the better-hearing ear using earphones or in sound field using speakers if the child is too young for ear-specific testing.
HLs of 21 to 39 dB (mild hearing loss): A comprehensive audiologic evaluation is indicated if not previously performed. Mild sensorineural hearing loss has been associated with difficulties in speech, language, and academic performance in school,129,132 and persistent mild conductive hearing loss from OME may have a similar impact. Further management should be individualized based on effusion duration, severity of hearing loss, and parent or caregiver preference and may include strategies to optimize the listening and learning environment (Table 4) or surgery. Repeat hearing testing should be performed in 3 to 6 months if OME persists at follow-up evaluation or tympanostomy tubes have not been placed.
HLs of ≥20 dB (normal hearing): A repeat hearing test should be performed in 3 to 6 months if OME persists at follow-up evaluation.
In addition to hearing loss and speech or language delay, other factors may influence the decision to intervene for persistent OME. Roberts et al98,133 showed that the caregiving environment is more strongly related to school outcome than was OME or hearing loss. Risk factors for delays in speech and language development caused by a poor caregiving environment included low maternal educational level, unfavorable child care environment, and low socioeconomic status. In such cases, these factors may be additive to the hearing loss in affecting lower school performance and classroom behavior problems.
The risks of continued observation of children with OME must be balanced against the risks of surgery. Children with persistent OME examined regularly at 3- to 6-month intervals, or sooner if OME-related symptoms develop, are most likely at low risk for physical, behavioral, or developmental sequelae of OME. Conversely, prolonged watchful waiting of OME is not appropriate when regular surveillance is impossible or when the child is at risk for developmental sequelae of OME because of comorbidities (Table 3). For these children, the risks of anesthesia and surgery (see recommendation 9) may be less than those of continued observation.
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, underestimating the impact of hearing loss on a child, and/or failing to detect significant signs or symptoms that require intervention.
This option is based on panel consensus and a preponderance of benefit over harm.
Reason for referral: Explain that the child is seeing an otolaryngologist for evaluation, which is likely to include ear examination and audiologic testing, and not necessarily simply to be scheduled for surgery.
What to expect: Explain that surgery may be recommended, and let the parent know that the otolaryngologist will explain the options, benefits, and risks further.
Decision-making process: Explain that there are many alternatives for management and that surgical decisions are elective; the parent or caregiver should be encouraged to express to the surgeonany concerns he or she may have about the recommendations made.
Duration of OME: State how long fluid has been present.
Laterality of OME: State whether one or both ears have been affected.
Results of prior hearing testing or tympanometry.
Suspected speech or language problems: State whether there had been a delay in speech and language development or whether the parent or a caregiver has expressed concerns about the child's communication abilities, school achievement, or attentiveness.
Conditions that might exacerbate the deleterious effects of OME: State whether the child has conditions such as permanent hearing loss, impaired cognition, developmental delays, cleft lip or palate, or an unstable or nonsupportive family or home environment.
AOM history: State whether the child has a history of recurrent AOM.
Parental attitude toward surgery: State whether the parents have expressed a strong preference for or against surgery as a management option.
Related conditions that might require concomitant surgery: State whether there have been other conditions that might warrant surgery if the child is going to have general anesthesia (eg, nasal obstruction and snoring that might be an indication for adenoidectomy or obstructive breathing during sleep that might mean tonsillectomy is indicated).
General health status: State whether there are any conditions that might present problems for surgery or administering general anesthesia, such as congenital heart abnormality, bleeding disorder, asthma or reactive airway disease, or family history of malignant hyperthermia.
After evaluating the child, the otolaryngologist, audiologist, or speech-language pathologist should inform the referring physician regarding his or her diagnostic impression, plans for additional assessment, and recommendations for ongoing monitoring and management.
Benefit: better communication and improved decision-making.
Harm: confidentiality concerns, administrative burden, and/or increased parent or caregiver anxiety.
This recommendation is based on randomized, controlled trials with a preponderance of benefit over harm.
Surgical candidacy for OME largely depends on hearing status, associated symptoms, the child's developmental risk (Table 3), and the anticipated chance of timely spontaneous resolution of the effusion. Candidates for surgery include children with OME lasting 4 months or longer with persistent hearing loss or other signs and symptoms, recurrent or persistent OME in children at risk regardless of hearing status, and OME and structural damage to the tympanic membrane or middle ear. Ultimately, the recommendation for surgery must be individualized based on consensus between the primary care physician, otolaryngologist, and parent or caregiver that a particular child would benefit from intervention. Children with OME of any duration who are at risk are candidates for earlier surgery.
Tympanostomy tubes are recommended for initial surgery because randomized trials show a mean 62% relative decrease in effusion prevalence and an absolute decrease of 128 effusion days per child during the next year.139,143–145 HLs improve by a mean of 6 to 12 dB while the tubes remain patent.146,147 Adenoidectomy plus myringotomy (without tube insertion) has comparable efficacy in children 4 years old or older143 but is more invasive, with additional surgical and anesthetic risks. Similarly, the added risk of adenoidectomy outweighs the limited, short-term benefit for children 3 years old or older without prior tubes.148 Consequently, adenoidectomy is not recommended for initial OME surgery unless a distinct indication exists, such as adenoiditis, postnasal obstruction, or chronic sinusitis.
Approximately 20% to 50% of children who have had tympanostomy tubes have OME relapse after tube extrusion that may require additional surgery.144,145,149 When a child needs repeat surgery for OME, adenoidectomy is recommended (unless the child has an overt or submucous cleft palate), because it confers a 50% reduction in the need for future operations.143,150,151 The benefit of adenoidectomy is apparent at 2 years old,150 greatest for children 3 years old or older, and independent of adenoid size.143,151,152 Myringotomy is performed concurrent with adenoidectomy. Myringotomy plus adenoidectomy is effective for children 4 years old or older,143 but tube insertion is advised for younger children, when potential relapse of effusion must be minimized (eg, children at risk) or pronounced inflammation of the tympanic membrane and middle-ear mucosa is present.
Anesthesia mortality has been reported to be ~1:50 000 for ambulatory surgery,154 but the current fatality rate may be lower.155 Laryngospasm and bronchospasm occur more often in children receiving anesthesia than adults. Tympanostomy tube sequelae are common156 but are generally transient (otorrhea) or do not affect function (tympanosclerosis, focal atrophy, or shallow retraction pocket). Tympanic membrane perforations, which may require repair, are seen in 2% of children after placement of short-term (grommet-type) tubes and 17% after long-term tubes.156 Adenoidectomy has a 0.2% to 0.5% incidence of hemorrhage150,157 and 2% incidence of transient velopharyngeal insufficiency.148 Other potential risks of adenoidectomy, such as nasopharyngeal stenosis and persistent velopharyngeal insufficiency, can be minimized with appropriate patient selection and surgical technique.
Aggregate evidence quality: B, randomized, controlled trials with minor limitations.
Benefit: improved hearing, reduced prevalence of OME, reduced incidence of AOM, and less need for additional tube insertion (after adenoidectomy).
Harm: risks of anesthesia and specific surgical procedures; sequelae of tympanostomy tubes.
There is no recommendation based on lack of scientific evidence documenting efficacy and an uncertain balance of harm and benefit.
The 1994 OME guideline1 made no recommendation regarding CAM as a treatment for OME, and no subsequent controlled studies have been published to change this conclusion. The current statement of "no recommendation" is based on the lack of scientific evidence documenting efficacy plus the balance of benefit and harm.
Evidence concerning CAM is insufficient to determine whether the outcomes achieved for OME differ from those achieved by watchful waiting and spontaneous resolution. There are no randomized, con-trolled trials with adequate sample sizes on the efficacy of CAM for OME. Although many case reports and subjective reviews on CAM treatment of AOM were found, little is published on OME treatment or prevention. Homeopathy158 and chiropractic treatments159 were assessed in pilot studies with small numbers of patients that failed to show clinically or statistically significant benefits. Consequently, there is no research base on which to develop a recommendation concerning CAM for OME.
The natural history of OME in childhood (discussed previously) is such that almost any intervention can be "shown" to have helped in an anecdotal, uncontrolled report or case series. The efficacy of CAM or any other intervention for OME can only be shown with parallel-group, randomized, controlled trials with valid diagnostic methods and adequate sample sizes. Unproved modalities that have been claimed to provide benefit in middle-ear disease include osteopathic and chiropractic manipulation, dietary exclusions (such as dairy), herbal and other dietary supplements, acupuncture, traditional Chinese medicine, and homeopathy. None of these modalities, however, have been subjected yet to a published, peer-reviewed, clinical trial.
Aggregate evidence quality: D, case series without controls.
Harm: potentially significant depending on the intervention.
Benefits-harms assessment: uncertain balance of benefit and harm.
There is no recommendation based on insufficient evidence of therapeutic efficacy or a causal relationship between allergy and OME.
The 1994 OME guideline1 made no recommendation regarding allergy management as a treatment for OME, and no subsequent controlled studies have been published to change this conclusion. The current statement of "no recommendation" is based on insufficient evidence of therapeutic efficacy or a causal relationship between allergy and OME plus the balance of benefit and harm.
The correlation between OME and allergy has been widely reported, but no prospective studies have examined the effects of immunotherapy compared with observation alone or other management options. Reports of OME cure after immunotherapy or food-elimination diets172 are impossible to interpret without concurrent control groups because of the favorable natural history of most untreated OME. The documentation of allergy in published reports has been defined inconsistently (medical history, physical examination, skin-prick testing, nasal smears, serum immunoglobulin E and eosinophil counts, inflammatory mediators in effusions). Study groups have been drawn primarily from specialist offices, likely lack heterogeneity, and are not representative of general medical practice.
Harm: adverse effects and cost of medication, physician evaluation, elimination diets, and desensitization.
Further standardize the definition of OME.
Assess the performance characteristics of pneumatic otoscopy as a diagnostic test for OME when performed by primary care physicians and advanced-practice nurses in the routine office setting.
Determine the optimal methods for teaching pneumatic otoscopy to residents and clinicians.
Develop a brief, reliable, objective method for diagnosing OME.
Develop a classification method for identifying the presence of OME for practical use by clinicians that is based on quantifiable tympanometric characteristics.
Assess the usefulness of algorithms combining pneumatic otoscopy and tympanometry for detecting OME in clinical practice.
Conduct additional validating cohort studies of acoustic reflectometry as a diagnostic method for OME, particularly in children less than 2 years old.
Better define the child with OME who is at risk for speech, language, and learning problems.
Conduct large, multicenter, observational cohort studies to identify the child at risk who is most susceptible to potential adverse sequelae of OME.
Conduct large, multicenter, observational cohort studies to analyze outcomes achieved with alternative management strategies for OME in children at risk.
Define the spontaneous resolution of OME in infants and young children (existing data are limited primarily to children 2 years old or older).
Conduct large-scale, prospective cohort studies to obtain current data on the spontaneous resolution of newly diagnosed OME of unknown prior duration (existing data are primarily from the late 1970s and early 1980s).
Develop prognostic indicators to identify the best candidates for watchful waiting.
Determine whether the lack of impact from prompt insertion of tympanostomy tubes on speech and language outcomes seen in asymptomatic young children with OME identified by screening or intense surveillance can be generalized to older children with OME or to symptomatic children with OME referred for evaluation.
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, in avoiding surgery in children with OME who are surgical candidates and have not received recent antimicrobials.
Investigate the role of mucosal surface biofilms in refractory or recurrent OME and develop targeted interventions.
Conduct longitudinal studies on the natural history of hearing loss accompanying OME.
Develop improved methods for describing and quantifying the fluctuations in hearing of children with OME over time.
Conduct prospective controlled studies on the relation of hearing loss associated with OME to later auditory, speech, language, behavioral, and academic sequelae.
Develop reliable, brief, objective methods for estimating hearing loss associated with OME.
Develop reliable, brief, objective methods for estimating speech or language delay associated with OME.
Evaluate the benefits and administrative burden of language testing by primary care clinicians.
Agree on the aspects of language that are vulnerable to or affected by hearing loss caused by OME, and reach a consensus on the best tools for measurement.
Determine whether OME and associated hearing loss place children from special populations at greater risk for speech and language delays.
Develop better tools for monitoring children with OME that are suitable for routine clinical care.
Assess the value of new strategies for monitoring OME, such as acoustic reflectometry performed at home by the parent or caregiver, in optimizing surveillance.
Improve our ability to identify children who would benefit from early surgery instead of prolonged surveillance.
Promote early detection of structural abnormalities in the tympanic membrane associated with OME that may require surgery to prevent complications.
Clarify and quantify the role of parent or caregiver education, socioeconomic status, and quality of the caregiving environment as modifiers of OME developmental outcomes.
Develop methods for minimizing loss to follow-up during OME surveillance.
Define the role of adenoidectomy in children 3 years old or younger as a specific OME therapy.
Conduct controlled trials on the efficacy of tympanostomy tubes for developmental outcomes in children with hearing loss, other symptoms, or speech and language delay.
Conduct randomized, controlled trials of surgery versus no surgery that emphasize patient-based outcome measures (quality of life, functional health status) in addition to objective measures (effusion prevalence, HLs, AOM incidence, reoperation).
Identify the optimal ways to incorporate parent or caregiver preference into surgical decision-making.
Conduct randomized, controlled trials on the efficacy of CAM modalities for OME.
Develop strategies to identify parents or caregivers who use CAM therapies for their child's OME, and encourage surveillance by the primary care clinician.
Evaluate the causal role of atopy in OME.
Conduct randomized, controlled trials on the efficacy of allergy therapy for OME that are generalizable to the primary care setting.
This evidence-based practice guideline offers recommendations for identifying, monitoring, and managing the child with OME. The guideline emphasizes appropriate diagnosis and provides options for various management strategies including observation, medical intervention, and referral for surgical intervention. These recommendations should provide primary care physicians and other health care providers with assistance in managing children with OME.
Dr Marcy serves as a consultant to Abbott Laboratories GlaxoSmithKline (vaccines).
This document was approved by the American Academy of Otolaryngology-Head and Neck Surgery Foundation, Inc. and the American Academy of Pediatrics, and is published in the May 2004 issue of Pediatrics.