Clinical Practice Guideline: Tympanostomy Tubes in Children

Richard M. Rosenfeld, MD, MPH; Seth R. Schwartz, MD, MPH; Melissa A. Pynnonen, MD, MSc; David E. Tunkel, MD; Heather M. Hussey, MPH; Jeffrey S. Fichera, PA-C; Alison M. Grimes, AuD; Jesse M. Hackell, MD; Melody F. Harrison, PhD; Helen Haskell, MA; David S. Haynes, MD; Tae W. Kim, MD; Denis C. Lafreniere, MD; Katie LeBlanc, MTS, MA; Wendy L. Mackey, APRN, BC; James L. Netterville, MD; Mary E. Pipan, MD; Nikhila P. Raol, MD; Kenneth G. Schellhase, MD, MPH This month, the AAO-HNSF will publish its latest clinical practice guideline, “Tympanostomy Tubes in Children,” as a supplement to Otolaryngology–Head and Neck Surgery. Recommendations developed address patient selection, as well as surgical indications for, and management of, tympanostomy tubes in children. The guideline was developed using the a priori protocol outlined in the AAO-HNS Clinical Practice Guideline Development Manual.1 The complete guideline is available at http://oto.sagepub.com. To assist in implementing the guideline recommendations, this article summarizes the rationale, purpose, and key action statements. Recommendations in a guideline can be implemented only if they are clear and identifiable. This goal is best achieved by structuring the guideline around a series of key action statements, which are supported by amplifying text and action statement profiles. For ease of reference only, the statements and profiles are included in this brief summary. Please refer to the complete guideline for the important information in the amplifying text that further explains the supporting evidence and details of implementation for each key action statement. For more information about the AAO-HNSF’s other quality knowledge products (clinical practice guidelines and clinical consensus statements), our guideline development methodology, or to submit a topic for future guideline development, please visit: http://www.entnet.org/guidelines. IntroductionInsertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Each year, 667,000 children younger than 15 years receive tympanostomy tubes, accounting for more than 20 percent of all ambulatory surgery in this group.2 By age 3, nearly one of every 15 children (6.8 percent) will have tympanostomy tubes, increasing by more than two-fold with day care attendance.3 Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. All of these conditions are encompassed by the term otitis media (middle ear inflammation), which is second in frequency only to acute upper respiratory infection (URI) as the most common illness diagnosed in children by healthcare professionals.5 Children younger than 7 years are at increased risk of otitis media because of their immature immune systems and poor function of the Eustachian tube, a slender connection between the middle ear and back of the nose that normally ventilates the middle ear space and equalizes pressure with the external environment.6 Despite the frequency of tympanostomy tube insertion, there are currently no clinical practice guidelines in the United States that address specific indications for surgery. When children require surgery for otitis media with effusion (OME), insertion of tympanostomy tubes is the preferred initial procedure, with candidacy dependent primarily upon hearing status, associated symptoms, and the child’s developmental risk.7 Placement of tympanostomy tubes significantly improves hearing, reduces effusion prevalence,8 may reduce the incidence of recurrent acute otitis media (AOM), and provides a mechanism for drainage and administration of topical antibiotic therapy for persistent AOM. Additionally, research indicates tympanostomy tubes also can improve disease-specific quality of life (QOL) for children with chronic OME, recurrent AOM, or both.9 Risks and potential adverse events of tympanostomy tube insertion are related to general anesthesia usually required for the procedure, and the effect of the tympanostomy tube on the tympanic membrane and middle ear.10 Tympanostomy tube sequelae are common, but 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 about two percent of children after placement of short-term tympanostomy tubes.10 When making clinical decisions, the risks of tube insertion must be balanced against the risks of prolonged or recurrent otitis media, which include suppurative complications, damage to the tympanic membrane, adverse effects of antibiotics, and potential developmental sequelae of hearing loss. The frequency of tympanostomy tube insertion combined with variations in accepted indications for surgery create a pressing need for evidence-based guidelines to aid clinicians in identifying the best surgical candidates and optimizing subsequent care. PurposeThe primary purpose of this clinical practice guideline is to provide clinicians with evidence-based recommendations on patient selection, as well as surgical indications for, and management of, tympanostomy tubes in children. This guideline is intended for any clinician involved in managing children, aged six months to 12 years, with tympanostomy tubes or being considered for tympanostomy tubes in any care setting, as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals, as represented by this multidisciplinary guideline development group. Although children considered at risk for developmental delays or disorders are often excluded for ethical reasons from clinical research involving tympanostomy tubes, the guideline development group decided to include them in the scope because these patients may derive enhanced benefit from tympanostomy tubes.11 This decision was based on clinical experience of the guideline development group and a recommendation from a multidisciplinary guideline on OME that, “Clinicians should distinguish the child with OME who is at risk for speech, language, or learning problems from other children with OME, and should more promptly evaluate hearing, speech, language, and need for intervention,” including tympanostomy tubes.7 Risk factors for developmental difficulties (delay or disorder) include: permanent hearing loss independent of OME, suspected or confirmed speech and language delay or disorder, Autism-spectrum disorder and other pervasive developmental disorders, syndromes (e.g., Down) or craniofacial disorders that include cognitive, speech, or language delays, blindness or uncorrectable visual impairment, cleft palate with or without associated syndrome, or developmental delay. In planning the content of the guideline, the development group broadly discussed indications for tube placement, perioperative management, care of children with indwelling tubes, and outcomes of tympanostomy tube surgery. Given the lack of current published guidance on surgical indications, despite a substantial evidence base of randomized trials and systematic reviews on which to base such guidance, the group decided early in the development process to identify situations where tube insertion would be optional, recommended, or not recommended. Additional emphasis was placed on opportunities for quality improvement, particularly regarding shared decision-making and care of children with existing tubes. Key Action Statements STATEMENT 1. OME OF SHORT DURATION: Clinicians should not perform tympanostomy tube insertion in children with a single episode of OME of less than three months duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown). Recommendation against based on systematic review of observational studies of natural history and an absence of any randomized controlled trials on efficacy of tubes for children with OME less than three months duration and a preponderance of benefit over harm.Action Statement Profile Aggregate evidence quality: Grade C, based on a systematic review of observational studies and control groups in RCTs on the natural history of OME and an absence of any RCTs on efficacy of tympanostomy tubes for children with OME less than two months duration Level of confidence in evidence: High Benefits: Avoidance of unnecessary surgery and its risks, avoidance of surgery in children for whom the benefits of tympanostomy tubes have not been studied and are uncertain, avoidance of surgery in children with a condition that has reasonable likelihood of spontaneous resolution, cost savings Risks, harms, costs: Delayed intervention in children who do not recover spontaneously and/or in children who develop recurrent episodes of MEE Benefit-harm assessment: Preponderance of benefit Value judgments: Exclusion of children with OME less than two months duration from all published RCTs of tube efficacy was considered compelling evidence to question the value of surgery in this population, especially considering the known risks of tympanostomy tube surgery Intentional vagueness: None Role of patient (caregiver) preferences: Limited, because of good evidence that otherwise healthy children with OME of short duration do not benefit from tympanostomy tube insertion Exceptions: At-risk children; see Statements 6 and 7 for explicit information on at risk children Policy level: Recommendation Differences of opinion: None STATEMENT 2. HEARING TESTING: Clinicians should obtain an age-appropriate hearing test if OME persists for three months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion. Recommendation based on observational and cross-sectional studies with a preponderance of benefit over harm.Action Statement Profile Aggregate evidence quality: Grade C, based on observational and cross-sectional studies assessing the prevalence of conductive hearing loss with OME Level of confidence in evidence: High Benefits: Documentation of hearing status, improved decision making regarding the need for surgery in chronic OME, establishment of baseline hearing prior to surgery, detection of coexisting sensorineural hearing loss Risks, harms, costs: Cost of the audiologic assessment Benefit-harm assessment: Preponderance of benefit Value judgments: None Intentional vagueness: The words “age-appropriate” audiologic testing are used to recognize that the specific methods will vary with the age of the child, but a full discussion of the specifics of testing is beyond the scope of this guideline. Role of patient (caregiver) preferences: Some, caregivers may decline testing Exceptions: None Policy level: Recommendation Differences of opinion: None STATEMENT 3. CHRONIC BILATERAL OME WITH HEARING DIFFICULTY: Clinicians should offer tympanostomy bilateral tube insertion to children with bilateral OME for three months or longer AND documented hearing difficulties. Recommendation based on randomized controlled trials and observational studies, with a preponderance of benefit over harm. Action Statement Profile Aggregate evidence quality: Grade B, based on well-designed RCTs showing reduced MEE prevalence and improved hearing after tympanostomy tube insertion; observational studies documenting improved quality of life; and extrapolation of research and basic science principles for optimizing auditory access. Level of confidence in the evidence: High. Benefits: Reduced prevalence of MEE, improved hearing, improved child and caregiver QOL, optimization of auditory access for speech and language acquisition, elimination of a potential barrier to focusing and attention in a learning environment Risks, harms, costs: Risk of anesthesia, sequelae of the indwelling tympanostomy tubes (e.g. otorrhea, granulation tissue, obstruction), complications after tube extrusion (myringosclerosis, retraction pocket, persistent perforation), failure of or premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, and direct procedural costs Benefit-harm assessment: Preponderance of benefit over harm Value judgments: Assumption that optimizing auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of MEE on speech and language development Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that a functional assessment of how a child uses hearing and engages in their environment is important, regardless of what specific threshold is used to define hearing loss based on audiologic criteria Role of patient (caregiver) preferences: Substantial role for shared decision-making regarding the decision to proceed with, or to decline, tympanostomy tube insertion Exceptions: None Policy level: Recommendation Difference of opinion: Minor differences regarding the role of caregiver report as a surrogate for audiologic assessment and whether the action taken by the clinician should be to “recommend” tubes (minority opinion) vs. to “offer” tubes (majority opinion) STATEMENT 4. CHRONIC OME WITH SYMPTOMS: Clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for three months or longer (chronic OME) AND symptoms that are likely attributable to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life. Option based on randomized controlled trials and before-and-after studies with a balance between benefit and harm. Action Statement Profile Aggregate evidence quality: Grade C, based on before-and-after studies on vestibular function and QOL, RCTs on reduced MEE after tubes for chronic OME, and observational studies regarding the impact of MEE on children as related, but not limited to, school performance, behavioral issues, and speech delay Level of confidence in evidence: High for vestibular problems and QOL; medium for poor school performance, behavioral problems, and ear discomfort, because of study limitations and the multifactorial nature of these issues Benefits: Reduced prevalence of MEE, possible relief of symptoms attributed to chronic OME, elimination of MEE as a confounding factor from efforts to understand the reason or cause of a vestibular problem, poor school performance, behavioral problem, or ear discomfort Risks, harms, costs: None related to offering surgery, but if performed, tympanostomy tube insertion includes risks from anesthesia, sequelae of the indwelling tympanostomy tubes (otorrhea, granulation tissue, obstruction), complications after tube extrusion (myringosclerosis, retraction pocket, persistent perforation), premature tympanostomy tube extrusion, retained tympanostomy tube, tympanostomy tube medialization, procedural anxiety and discomfort, and direct procedural costs Benefit-harm assessment: Equilibrium Value judgments: Chronic MEE has been associated with problems other than hearing loss; intervening when MEE is identified can reduce symptoms. The group’s confidence in the evidence of a child benefitting from intervention was insufficient to conclude a preponderance of benefit over harm and instead found at equilibrium Intentional vagueness: The words “likely attributable” are used to reflect the understanding that the symptoms listed may have multifactorial causes, of which OME may be only one factor, and resolution of OME may not necessarily resolve the problem Role of patient (caregiver) preferences: Substantial role for shared decision-making regarding the decision to proceed with, or to decline, tympanostomy tube insertion Exceptions: None Policy level: Option Differences of opinion: None STATEMENT 5. SURVEILLANCE OF CHRONIC OME: Clinicians should reevaluate, at three- to six-month intervals, children with chronic OME who do not receive tympanostomy tubes, until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected. Recommendation based on observational studies, with a preponderance of benefit over harm.Action Statement Profile Aggregate evidence quality: Grade C, based on observational studies Level of confidence in evidence: High Benefits: Detection of structural changes in the tympanic membrane that may require intervention, detection of new hearing difficulties or symptoms that would lead to reassessing the need for tympanostomy tube insertion, discussion of strategies for optimizing the listening-learning environment for children with OME, as well as ongoing counseling and education of parents/caregiver Risks, harms, costs: Cost of examination(s) Benefit-harm assessment: Preponderance of benefit over harm Value judgments: Although it is uncommon, untreated OME can cause progressive changes in the tympanic membrane that require surgical intervention. There was an implicit assumption that surveillance and early detection/intervention could prevent complications and would also provide opportunities for ongoing education and counseling of caregivers Intentional vagueness: The surveillance interval is broadly defined at three to six months to accommodate provider and patient preference; “significant” hearing loss is broadly defined as one that is noticed by the caregiver, reported by the child, or interferes in school performance or quality of life. Role of patient (caregiver) preferences: Opportunity for shared decision making regarding the surveillance interval Exceptions: None Policy level: Recommendation Difference of opinion: None STATEMENT 6. RECURRENT AOM WITHOUT MEE: Clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media who do not have middle ear effusion in either ear at the time of assessment for tube candidacy. Recommendation against based on systematic reviews and randomized controlled trials with a preponderance of benefit over harm. Action Statement Profile Aggregate evidence quality: Grade A, based on a meta-analysis of RCTs, a systematic review of RCT control groups regarding the natural history of recurrent AOM, and other RCTs Level of confidence in evidence: High Benefits: Avoid unnecessary surgery and its risks, avoid surgery in children for whom RCTs have not demonstrated any benefit for reducing AOM incidence or in children with a condition that has reasonable likelihood of spontaneous resolution, cost savings Risks, harms, costs: Delay in intervention for children who eventually require tympanostomy tubes, need for systemic antibiotics among children who continue to have episodes of recurrent AOM Benefit-harm assessment: Preponderance of benefit over harm Value judgments: Implicit in this recommendation is the ability to reassess children who continue to have AOM despite observation and to perform tympanostomy tube insertion if MEE is present (Statement 7); risk of complications or poor outcomes from delayed tube insertion for children who continue to have recurrent AOM is minimal Intentional vagueness: The method of confirming the absence of middle ear effusion should be based on clinician experience and may include tympanometry, simple otoscopy, and/or pneumatic otoscopy Role of patient (caregiver) preferences: Limited, because of favorable natural history and good evidence that otherwise healthy children with recurrent AOM without MEE do not have a reduced incidence of AOM after tympanostomy tube insertion Exceptions: At-risk children, children with histories of severe or persistent AOM, immunosuppression; prior complication of otitis media (mastoiditis, meningitis, facial nerve paralysis); multiple antibiotic allergy or intolerance. Policy level: Recommendation Differences of opinion: None STATEMENT 7. RECURRENT AOM WITH MEE: Clinicians should offer bilateral tympanostomy tube insertion in children with recurrent AOM who have unilateral or bilateral MEE at the time of assessment for tube candidacy. Recommendation based on randomized controlled trials with minimal limitations and a preponderance of benefit over harm. Action Statement Profile Aggregate evidence quality: Grade B, based on RCTs with minor limitations Level of confidence in evidence: Medium; some uncertainty regarding the magnitude of clinical benefit and importance, because of heterogeneity in the design and outcomes of clinical trials. Benefits: Mean decrease of approximately three episodes of AOM per year, ability to treat future episodes of AOM with topical antibiotics instead of systemic antibiotics, reduced pain with future AOM episodes, improved hearing during AOM episodes Risks, harms, costs: Risks from anesthesia, sequelae of the indwelling tympanostomy tubes (otorrhea, granulation tissue, obstruction), complications after tube extrusion (myringosclerosis, retraction pocket, persistent perforation), premature tympanostomy tube extrusion, retained tympanostomy tube tympanostomy tube medialization, procedural anxiety and discomfort, and direct procedural costs Benefit-harm assessment: Preponderance of benefit over harm Value judgments: In addition to the benefits seen in RCTs, the presence of effusion at the time of assessment served as a marker of diagnostic accuracy for AOM Intentional vagueness: The method of confirming the presence of middle ear effusion should be based on clinician experience and may include tympanometry, simple otoscopy, and/or pneumatic otoscopy. Role of patient (caregiver) preferences: Substantial role for shared decision-making regarding the decision to proceed with, or to decline, tympanostomy tube insertion. Exceptions: None Policy level: Recommendation Differences of opinion: None STATEMENT 8. AT RISK CHILDREN: Clinicians should determine if a child with recurrent AOM or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors. Recommendation based on observational studies with a preponderance of benefit over harm. Action Statement Profile Aggregate evidence quality: Grade C, based on observational studies Level of confidence in evidence: High for Down syndrome, cleft palate, and permanent hearing loss; medium for other risk factors. Benefits: Facilitation of future decisions about tube candidacy, identification of children who might benefit from early intervention (including tympanostomy tubes), identification of children who might benefit from more active and accurate surveillance of middle ear status as well as those who require more prompt evaluation of hearing, speech, and language Risks, harms, costs: None Benefit-harm assessment: Preponderance of benefit over harm Value judgments: Despite the limited high quality evidence about the impact of tubes on this population (nearly all RCTs exclude children who are at risk) the panel considered it important to use at risk status as a factor in decision making about tube candidacy, building on recommendations made in the OME guideline.5 The panel assumed that at risk children would be less likely to tolerate OME or recurrent AOM than would the otherwise healthy child. Intentional vagueness: None Role of patient (caregiver) preferences: None, since this recommendation deals only with acquiring information to assist in decision-making. Exceptions: None Policy level: Recommendation Differences of opinion: None STATEMENT 9. TYMPANOSTOMY TUBES AND AT RISK CHILDREN: Clinicians may perform tympanostomy tube insertion in at risk children with unilateral or bilateral OME that is unlikely to resolve quickly as reflected by a type B (flat) tympanogram or persistence of effusion for three months or longer. Option based on a systematic review and observational studies with a balance between benefit and harm. Action Statement Profile Aggregate evidence quality: Grade C based on a systematic review of cohort studies regarding natural history of type B tympanograms and observational studies examining the impact of MEE on at risk children Level of confidence in evidence: Moderate to low, because of methodologic concerns with the conduct, outcome reporting, and follow up of available observational studies. Benefits: Improved hearing, resolution of MEE in at risk children who would otherwise have a low probability of spontaneous resolution, mitigates a potential obstacle to child development Risks, harms, costs: Risk of anesthesia, sequelae of the indwelling tympanostomy tubes (otorrhea, granulation tissue, obstruction), complications after tube extrusion (myringosclerosis, retraction pocket, persistent perforation), failure of or premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, and direct procedural costs Benefit-harm assessment: Equilibrium Value judgments: Despite the absence of controlled trials identifying benefits of tympanostomy tube placement in at-risk children (such children were excluded from the reviews cited), the panel agreed that tympanostomy tubes were a reasonable intervention for reducing the prevalence of MEE that would otherwise have a low likelihood of prompt spontaneous resolution. Untreated persistent MEE would place the child at high risk for hearing loss from suboptimal conduction of sound through the middle ear, which could interfere with subsequent speech and language progress Intentional vagueness: None Role of patient (caregiver) preferences: Substantial role for shared decision-making with caregivers regarding whether or not to proceed with tympanostomy tube insertion Exclusions: None Policy level: Option Differences of opinion: None regarding the action statement; a minor difference of opinion about whether children with Down syndrome or cleft palate should be considered independently of children with speech and language delays/disorders STATEMENT 10. PERIOPERATIVE EDUCATION: In the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow up schedule, and detection of complications. Recommendation based on observational studies, with a preponderance of benefit over harm. Action Statement Profile Aggregate evidence quality: Grade C, based on observational studies with limitations Level of confidence in evidence: Medium; there is good evidence and strong consensus on the value of patient education and counseling, in general, but evidence on how this education and counseling impacts outcomes of children with tympanostomy tubes is limited. Benefits: Define appropriate caregiver expectations after surgery, enable caregivers to recognize complications early, and improve caregiver understanding of the importance of follow-up. Risks, harms, costs: None Benefit-harm assessment: Preponderance of benefit over harm Value judgments: Importance of patient education in promoting optimal outcomes Intentional vagueness: None Role of patient (caregiver) preferences: None, since this recommendation deals only with providing information for proper management. Exceptions: None Policy level: Recommendation Differences of opinion: None STATEMENT 11. ACUTE TYMPANOSTOMY TUBE OTORRHEA: Clinicians should prescribe topical antibiotic eardrops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea. Strong recommendation based on randomized controlled trials with a preponderance of benefit over harm. Action Statement Profile Aggregate evidence quality: Grade B, based on RCTs demonstrating equal efficacy of topical versus oral antibiotic therapy for otorrhea and improved outcomes with topical antibiotic therapy when different topical preparations are compared Level of confidence in evidence: High Benefits: Increased efficacy by providing appropriate coverage of otorrhea pathogens, including Pseudomonas aeruginosa and methicillin-resistant S. aureus (MRSA), avoidance of unnecessary overuse and adverse effects of systemic antibiotics, including bacterial resistance Risks, harms, costs: Additional expense of topical otic antibiotics compared to oral antibiotics, potential difficulties in drug delivery to the middle ear if presence of obstructing debris or purulence in the ear canal Benefit-harm assessment: Preponderance of benefit over harm Value judgments: Emphasis on avoiding systemic antibiotics due to known adverse events and potential for induced bacterial resistance Intentional vagueness: None Role of patient (caregiver) preferences: Limited, because there is good evidence that topical antibiotic eardrops are safer than oral antibiotics and have equal efficacy. Exceptions: Children with complicated otorrhea, cellulitis of adjacent skin, concurrent bacterial infection requiring antibiotics (e.g., bacterial sinusitis, group A strep throat), or those children who are immunocompromised Policy level: Strong recommendation Difference of opinion: None STATEMENT 12. WATER PRECAUTIONS: Clinicians should not encourage routine, prophylactic water precautions (use of earplugs or headbands; avoidance of swimming or water sports) for children with tympanostomy tubes. Recommendation against based on randomized controlled trials with limitations, observational studies with consistent effects, and a preponderance of benefit over harm. Action Statement Profile Aggregate evidence quality: Grade B, based on one randomized controlled trial and multiple observational studies with consistent effects Level of confidence in evidence: High Benefits: Allows for normal activity and swimming, reduced anxiety, cost savings Risk, harm, cost: Potential for slight increase in otorrhea rates in some children Benefit-harm assessment: Preponderance of benefit over harm Value Judgments: Importance of not restricting or limiting children’s water activity in the absence of proven, clinically significant benefits of routine water precautions Intentional vagueness: The word “routine” is used to soften the recommendation since individual children may benefit from water precautions in specific situations (e.g., lake swimming, deep diving, recurrent otorrhea, head dunking in the bathtub, or otalgia from water entry into the ear canal). Role of patient (caregiver) preferences: Significant role in deciding whether or not to use water precautions based on the child’s specific needs, comfort level, and tolerance of water exposure. Exceptions: Children with tympanostomy tubes and 1) an active episode of otorrhea, or 2) recurrent or prolonged otorrhea episodes, and those with a history of problems with prior water exposure Policy level: Recommendation Differences of opinion: None DisclaimerThe clinical practice guideline is provided for information and educational purposes only. It is not intended as a sole source of guidance in managing children with tympanostomy tubes or being considered for tympanostomy tubes. Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. The guideline is not intended to replace clinical judgment or establish a protocol for all individuals with this condition and may not provide the only appropriate approach to diagnosing and managing this program of care. As medical knowledge expands and technology advances, clinical indicators and guidelines are promoted as conditional and provisional proposals of what is recommended under specific conditions, but are not absolute. Guidelines are not mandates; these do not and should not purport to be a legal standard of care. The responsible physician, in light of all circumstances presented by the individual patient, must determine the appropriate treatment. Adherence to these guidelines will not ensure successful patient outcomes in every situation. The AAO-HNS, Inc. emphasizes that these clinical guidelines should not be deemed to include all proper treatment decisions or methods of care, or to exclude other treatment decisions or methods of care reasonably directed to obtaining the same results. References Rosenfeld RM, Shiffman RN, Robertson P. Clinical Practice Guideline Development Manual, Third Edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg. Jan 2013;148(1 Suppl):S1-55. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. Jan 28 2009(11):1-25. Kogan MD, Overpeck MD, Hoffman HJ, Casselbrant ML. Factors associated with tympanostomy tube insertion among preschool-aged children in the United States. Am J Public Health. Feb 2000;90(2):245-250. Casselbrant ML, Kaleida PH, Rockette HE, et al. Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial. Pediatr Infect Dis J. Apr 1992;11(4):278-286. National Ambulatory Health Care Survey 2008: Top 5 diagnoses at visits to office-based physicians and hospital outpatient departments by patient age and sex: United States 2008. In: CDC, ed 2008. Bluestone CD, Swarts JD. Human evolutionary history: consequences for the pathogenesis of otitis media. Otolaryngol Head Neck Surg. Dec 2010;143(6):739-744. Rosenfeld RM, Culpepper L, Doyle KJ, et al. Clinical practice guideline: Otitis media with effusion. Otolaryngol Head Neck Surg. May 2004;130(5 Suppl):S95-118. Browning GG, Rovers MM, Williamson I, Lous J, Burton MJ. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2010(10):CD001801. Rosenfeld RM, Bhaya MH, Bower CM, et al. Impact of tympanostomy tubes on child quality of life. Arch Otolaryngol Head Neck Surg. May 2000;126(5):585-592. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. Apr 2001;124(4):374-380. Rovers MM, Black N, Browning GG, Maw R, Zielhuis GA, Haggard MP. Grommets in otitis media with effusion: an individual patient data meta-analysis. Arch Dis Child. May 2005;90(5):480-485.