Rosenfeld R, Sajisevi M, Schulz K, CyrD, Wojdyla D, Tucci D, Witsell D Adherence to Tympanostomy Tube Guideline Recommendations Mega-Database Claims Analysis Rosenfeld R, Sajisevi M, Schulz K, CyrD, Wojdyla D, Tucci D, Witsell D SUNY Downstate Medical Center, Brooklyn, NY, USA Duke University School of Medicine, Durham, NC, USA Duke Clinical Research Institute, Durham, NC, USA

Sajisevi M et al. Otolaryngol Head Neck Surg 2017; 156:87-95

Adherence to Tube Guideline Recommendations Study Design Adherence to Tube Guideline Recommendations Truven Health MarketScan Research Database Research-ready, insurance claims database with 230 million patients Data includes outpatient/clinic visits, emergency department visits, prescription drug claims, and private and public health plans Coding strategy derived from key action statements in the AAO-HNS tympanostomy tube guideline (2013) Patients ≤ 12 years with at least 1 OM claim from any clinic visits between January 1, 2010, and December 31, 2012 Explicit definitions of MarketScan surrogate statements corresponding to each of the guideline key recommendations Patients tracked from index diagnosis to index event for each guideline statement; bracketing used for nonconcurrent events

Rosenfeld RM, et al. Otolaryngol Head Neck Surg 2013: July (Supplement)

Sajisevi M et al. Otolaryngol Head Neck Surg 2017; 156:87-95

Sajisevi M et al. Otolaryngol Head Neck Surg 2017; 156:87-95c N = 2,692,742 after exclusions OM < 3m: 1.5% non-adherence OM ≥ 3m: 12% non-adherence Sajisevi M et al. Otolaryngol Head Neck Surg 2017; 156:87-95c

Tympanostomy Tube CPG STATEMENT 1. OME OF SHORT DURATION: Clinicians should not perform tympanostomy tube insertion in children with a single episode of OME <3 months from the date of onset (if known) or date of diagnosis (if onset is unknown). MarketScan surrogate: Patients aged 1-12y with at least 1 visit with OM codes; patients excluded with otorrhea or TM perforation at first visit; PE tube placement assessed with CPT code Patients studied: 2,692,742 Adherence rate: 97.0% Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Tympanostomy Tube CPG STATEMENT 2. HEARING TESTING: Clinicians should obtain an age-appropriate hearing test if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion MarketScan surrogate: Population from statement 1 with OM episode lasting more than 3 months assessed for presence of a hearing test Patients studied: 603,795 (22.4% of subjects) Adherence rate: 81.4% Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Tympanostomy Tube CPG STATEMENT 3. CHRONIC OME WITH HEARING DIFFICULTY: Clinicians should offer tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties. MarketScan surrogate: Population from statement 1 with OM episode lasting more than 3 months assessed for hearing loss by presence of a hearing test; PE tube placement assessed with CPT code Patients studied: 27,913 (1.0% of subjects) Adherence rate: 14.5% Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Tympanostomy Tube CPG STATEMENT 4. CHRONIC OME WITH SYMPTOMS: Clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer 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.   MarketScan surrogate: Population from statement 1 with OM episode lasting more than 3 months assessed for presence of symptoms: balance problems, poor school performance, ear discomfort (no codes for quality of life); PE tube placement assessed with CPT code Patients studied: 109,583 (4.1% of subjects) Adherence rate: 24.1% Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Tympanostomy Tube CPG STATEMENT 6. RECURRENT AOM WITHOUT MEE: Clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media (AOM) who do not have middle ear effusion (MEE) in either ear at the time of initial assessment for tube candidacy. MarketScan surrogate: Population included patient with AOM-related code; hearing loss was used as a surrogate for effusion; PE tube placement assessed with CPT code Patients studied: 105,327 (3.9% of subjects) Adherence rate: 77.6% Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Tympanostomy Tube CPG STATEMENT 7. RECURRENT AOM WITH MEE: Clinicians should offer bilateral tympanostomy tube insertion in children with recurrent acute otitis media (AOM) who have unilateral or bilateral middle ear effusion (MEE) at the time of assessment for tube candidacy. MarketScan surrogate: Population included patient with AOM-related code; hearing loss was used as a surrogate for effusion; PE tube placement assessed with CPT code Patients studied: 894 (< 0.1% of subjects) Adherence rate: 44.3% Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Tympanostomy Tube CPG 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 3 months or longer. MarketScan surrogate: Population from statement 1 with codes for permanent hearing loss, speech delay, autism, syndromes, craniofacial disorders, blindness, cleft palate, or developmental delay; PE tube placement assessed with CPT code Patients studied: 109,583 (40.7% of subjects) Adherence rate: 12.4% Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Tympanostomy Tube CPG STATEMENT 11. ACUTE TYMPANOSTOMY TUBE OTORRHEA: Clinicians should prescribe topical antibiotic eardrops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea MarketScan surrogate: Patients with PE tube assessed for AOM and/or otorrhea and whether they received oral or topical antibiotics; exceptions for oral antibiotics included cellulitis of pinna, bacterial infection, severe infection, and immunocompromise Patients studied: 16,996 (16,242 topical, 754 oral) Adherence rate: 95.4% topical, 34.9% oral Aggregate Evidence Quality: Grade B, well-designed RCTs showing reduced MEE prevalence and improved hearing after tube insertion, observational studies documenting improved QOL, and first principles for optimizing auditory access. Level of Confidence in the Evidence: High. Benefits: Reduced prevalence of MEE, improved hearing and child/caregiver, 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, complications after tube extrusion, failure of tympanostomy tube extrusion, premature tympanostomy tube extrusion, tympanostomy tube medialization, procedural anxiety and discomfort, direct procedural cost Benefit-Harm Assessment: Preponderance of benefit Value Judgments: Assumption that improved auditory access would improve speech and language outcomes, despite inconclusive evidence regarding the impact of middle-ear effusion on speech and language development. Intentional vagueness: The term “hearing difficulty” is used instead of “hearing loss” to emphasize that functional assessment of how a child uses hearing and engages in their environment is important, even if could not be assessed or meets an arbitrary threshold for defining hearing loss based on audiometric criteria. Role of Patient Preferences: Substantial role Exceptions: None Policy level: Recommendation Difference of Opinion: Minor differences regarding (a) the role of caregiver report as a surrogate for audiometric assessment, and (b) whether the action taken by the clinician should be to “recommend” tubes (majority opinion) vs. to “offer” tubes (minority opinion).

Summary of Recommendation Adherence 95% 98% Topical abx for otorrhea No tubes OME < 3 months 44% 52% 78% Recurrent AOM with MEE COME hearing difficulty Recurrent AOM without MEE 12% 14% 18% 35% Tubes and at-risk children Hearing testing Chronic OME w/symptoms No oral abx for otorrhea Sajisevi M et al. Otolaryngol Head Neck Surg 2017; 156:87-95

Sajisevi M et al. Otolaryngol Head Neck Surg 2017; 156:87-95

Adherence to Tube Guideline Recommendations Conclusions Adherence to Tube Guideline Recommendations Analysis shows high compliance and low nonadherence to AAO-HNS guideline recommendations for PE tubes First appropriateness study to use a denominator of children with OM, rather than children with tympanostomy tubes Limitations include coding variability, indirect use of hearing loss as proxy for MEE, and subjectivity in relational logic to translate guideline statements into measurable events Primary QI opportunities identified are: Hearing testing when OME persists longer than 3 months Offering tubes to at-risk children or those with OME-related symptoms Avoiding oral antibiotics when treating acute tube otorrhea