The Variations and Deviations in the Use of Tympanostomy Tubes for Children with Otitis Media Salomeh Keyhani MD MPH Lawrence C. Kleinman MD MPH Michael Rothschild MD Joseph M Bernstein MD Rebecca Anderson MPH Melissa Simon Mark Chassin MD MPP MPH Funding: Agency for Health Care Research and Quality

Background Otitis Media (OM) is the most common illness with which children present to the doctor. OME, AOM Tympanostomy tube insertion is the most common procedure requiring general anesthesia for children in the US. Rationale? Previous research identified significant over utilization of tympanostomy tubes.

Guidelines-OME 1994 Guidelines (AHRQ) 1) Antibiotic therapy or bilateral myringotomy with insertion of tympanostomy tubes to manage bilateral otitis media with effusion that has lasted a total of 3 months in an otherwise healthy child age 1 through 3 years who has a bilateral hearing deficit. 2) Insertion of tympanostomy tubes to manage bilateral otitis media with effusion that has lasted a total of 4 to 6 months in an otherwise healthy child age 1 through 3 years who has bilateral hearing deficit.

Guidelines-RAOM Expert Panel Tympanostomy tubes are indicated for patients with a high frequency of infection. High frequency was defined by more than 4 infections in the 6 months preceding surgery or 6 or more infections in 12 months and greater than 2 infections in 6 months preceding surgery.

Objective To report on the clinical characteristics of a cohort of New York City children who received tympanostomy tubes in 2002

Methods-Study Population We conducted a retrospective study of all tympanostomy tubes placed in 2002 in five New York City metropolitan area hospitals. Identified all children under the age of 18 who underwent tympanostomy tube insertion that occurred between January 1, 2002 and December 31, 2002 in 5 NYC hospitals. Patients who received ICD9 Code as either the primary or secondary procedure were included in the cohort.

Hospital 1 Hospital 2 Hospital 3 Hospital 4 Hospital TT Insertions 1046 Cases in Cohort Exclusions 6 Adults 18 wrong coding 1 missing chart 682 cases with complete data 270 cases missing PCP chart 35 cases Missing ENT Chart 59 cases Missing hospital chart Clinical Analysis 16 craniofacial procedures

Data Collection Socio-demographic information (age, sex, race) Clinical information (otoscopic findings, hearing loss, speech delay, etc) Data collected from each visit for every child in the study from hospital, primary care and otolaryngologist charts for all 12 months prior to surgery.

Key Data Collection Assumptions When OME was last documented in an ear, we assumed it to be present for 60 more days (or until the date of surgery) unless the chart documented that it had cleared in a subsequent visit. When AOM was last noted on exam, we assumed the child did not have a normal otoscopic exam for 28 days unless a subsequent exam documented otherwise.

Baseline Socio-demographic and Clinical Characteristics Mean, Median Age (years)3.8, 3.3 Female (%)42.8 White (%)61 Insured (%)95.2 At Risk Condition (%)17 Prior Tubes (%)26.5 Any other procedure at time of Tube Insertion (%) 21.7

Otolaryngologist’s Reported Indication for Surgery-682 Cases Otitis Media with Effusion (OME)-60.4% Eustachian Tube Dysfunction (ETD)-10.6% Recurrent Acute Otitis Media (RAOM)-20.7% RAOM/OME-3.1% Other-5.2%

Summary Data-Extent of Disease MeanMedianIQR # infections 6 months prior to TT # infections 12 months prior to TT Consecutive days bilateral effusion Consecutive days unilateral effusion Cumulative days bilateral effusion Cumulative days unilateral effusion Total Number of visits Number of PCP visits Coefficient of variation ranged from 51% to 129%

Summary Data-Extent of Disease All CasesYes (%) Speech Delay?28.5 Marked Otoscopic Findings?3.3 Severe disruption of family life?2.2 Cased with OME Any abnormal audiogram?77.9 Bilateral abnormal audiogram (mild)26.2 Bilateral abnormal audiogram (severe)14.8

Duration of effusion (months) by subpopulations of children whose primary reason for surgery was OME Cumulative Months Unilateral Effusion Cumulative Months Bilateral Effusion Consecutive Months Unilateral Effusion Consecutive Months Bilateral Effusion Measure of Effusion None Concurrent Surgery History of Prior Tubes At Risk Condition Months

Mean number of episodes of AOM in the year prior to surgery by subpopulations of children whose primary reason for surgery was RAOM None Concurrent Surgery History of Prior Tubes At Risk Condition Potential Extenuating Circumstances

1994 Guideline? Limiting cases to 186 children with OME1-3 years of age: 90.9% Not Concordant with guideline 9.1% Concordant with guideline

Limitations Missing data Medical records We needed to translate the intermittent assessments from the charts into the continuous variables we used in our analysis. We rely on the otoscopic skills of a group of community practicing clinicians for diagnosis.

Conclusions A substantial amount of practice departs from expert recommendations.

Implications The extent of variation in treating this familiar condition with limited treatment options suggests both the importance and difficulty of managing common clinical practice to comport with guidelines.

Implications Future research needs to explore both the optimal course of treatment and why clinical practice so frequently deviates from accepted guidelines.

Key Data Collection Assumptions Episode OME Day 1 30 days Episode AOM on Day days Total Days AOM --28 OME days