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 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. Objective 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-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. Methods-Study Population • We conducted a retrospective study of all tympanostomy tubes placed in 2002 in five New York City metropolitan area hospitals. To report on the clinical characteristics of a cohort of New York City children who received tympanostomy tubes in 2002 • 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 20.01 as either the primary or secondary procedure were included in the cohort. Exclusions Data Collection 6 Adults Hospital 1 16 craniofacial procedures Hospital 2 1087 TT Insertions Hospital 3 • Socio-demographic information (age, sex, race) 18 wrong coding 1 missing chart • Clinical information (otoscopic findings, hearing loss, speech delay, etc) Hospital 4 1046 Cases in Cohort Hospital 5 Clinical Analysis 682 cases with complete data 270 cases missing PCP chart 35 cases Missing ENT Chart 59 cases Missing hospital chart 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. 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% • 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. Baseline Socio-demographic and Clinical Characteristics Mean, Median Age (years) Female (%) White (%) Insured (%) At Risk Condition (%) Prior Tubes (%) Any other procedure at time of Tube Insertion (%) 3.8, 3.3 42.8 61 95.2 17 26.5 21.7 Summary Data-Extent of Disease Mean Median IQR # infections 6 months prior to TT 1.7 1 0-3 # infections 12 months prior to TT 2.6 2 1-4 Consecutive days bilateral effusion 27.2 14 0-42 Consecutive days unilateral effusion 35.6 23 2-53 Cumulative days bilateral effusion 86.2 77 36-121 Cumulative days unilateral effusion 109 103 59-152 Total Number of visits 15.9 14 10-21 Number of PCP visits 12.1 11 6-17 Coefficient of variation ranged from 51% to 129% Summary Data-Extent of Disease All Cases Speech Delay? Marked Otoscopic Findings? Severe disruption of family life? Duration of effusion (months) by subpopulations of children whose primary reason for surgery was OME Yes (%) 28.5 3.3 2.2 4.5 4 None Concurrent Surgery History of Prior Tubes At Risk Condition 3.5 Cased with OME Months 3 2.5 Any abnormal audiogram? 77.9 Bilateral abnormal audiogram (mild) 26.2 Bilateral abnormal audiogram (severe) 14.8 2 1.5 1 0.5 0 Cumulative Months Unilateral Effusion Cumulative Months Bilateral Effusion Consecutive Months Consecutive Months Unilateral Effusion Bilateral Effusion Measure of Effusion Mean number of episodes of AOM in the year prior to surgery by subpopulations of children whose primary reason for surgery was RAOM 1994 Guideline? Limiting cases to 186 children with OME1-3 years of age: 4 3.5 90.9% Not Concordant with guideline 9.1% Concordant with guideline 3 2.5 2 1.5 1 0.5 0 None Concurrent Surgery History of Prior Tubes At Risk Condition Potential Extenuating Circumstances 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 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. 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 AOM on Day 50 30 days 30 days Episode OME Day 1 Total Days AOM --28 OME --110 30 days 30 days