Increased Tympanostomy Tube Use
Contrasts with Fewer Ambulatory
Visits for Otitis Media in the US:
1996 – 2006
Lawrence C Kleinman, MD, MPH
Leonardo Trasande, MD, MPP
Salomeh Keyhani, MD, MPH
Mount Sinai School of Medicine
New York, NY
Dr. Kleinman has no financial or
other conflicts to disclose
Outline





Overview of Otitis Media
Context: Studies of TT Appropriateness
Data and Analysis
Findings
Conclusion
Otitis Media
 Most common illness in Children in US
 Two distinct syndromes
– Acute otitis media (AOM)
– Otitis Media with Effusion (OME)
 OM is Ubiquitous
– 67% of children have >1 AOM, by 2 years old *
– 90% of closely observed children have > 1
episode OME by 2 years †
* Teele DW, Klein JO, Rosner BA and the Greater Boston Otitis Media Study
Group. JAMA 1983, PEDIATRICS, 1984.
† Paradise et al. PEDIATRICS, 1997.
Tympanostomy Tubes
 Most common surgery in children
 Benefits are uncertain in many cases
– High levels of inappropriateness found twice
Appropriateness Findings
 National sample of insured children*, 1990-91
– 23% Inappropriate (i.e. Risks > Benefits)
 Five NY City area hospitals†, 2002
– 1994 Academies’ Guidelines on OME
(for subsample 1 through 3 y.o. with isolated OME)
 Recommended 7.5 %
 Not Recommended 92.5 %
– 2004 Academies’ Guidelines on OME (not published)
 Recommended 5.6 %
 Not Recommended 94.4 %
•Kleinman et al, The Medical Appropriateness of Tympanostomy Tubes Proposed
for Children Under 16 in the United States. JAMA, 1994
† Keyhani, Kleinman, Rothschild, et al. Overuse of Tympanostomy Tubes in New York
metropolitan area: evidence from 5 hospital cohort. BMJ, 2008
Study Data
 Children Age 0 through 16 Years
 Sources
– Population Data: US Census
– Surgical procedures
 National Survey of Ambulatory Surgery (NSAS)
– Available for 1994 - 96, and 2006
– Medical visits (annual)
 National Ambulatory Medical Care Survey (NAMCS)
– Doctors offices
 National Hospital Ambulatory Medical Care Survey
(NAMCS)
– Hospital Clinics and EDs
Analysis
 Absolute and Relative Measures
– Total Counts
– Per Capita: Tympanostomies per 1000 children
– Per 100 ambulatory otitis media visits (OMV)
 Time series regression analysis
– Analyze changes from 1994-96 and 1996-2006
in single model using SAS Proc AutoReg
OMV Decreasing
Otitis Media Visits By Year: 1994 - 2006
30,000,000
20,000,000
10,000,000
0
1994
1996
1998
2000
2002
2004
2006
1994 – 1996: Slope = -670,977 (± 1.184 M), p = 0.58
1996 – 2006: Slope = -667,008 (± 199,114), p = .007
Use of TT now increasing
US Children < 16 years
1994 – 1996:
Slope = -24,912
p = .09
TT Surgeries per Year
650,000
1996 – 2006
Slope = 17,304
p = .02
400,000
1994
1995
1996
2006
TT per capita and per 100 OMV, US
6
TT per 1000 children
8
4
2
TT per 1000 children
TT per 100 OMV
4
1994 – 1996: Slope = - 0.46 (± .04)
p = .06
1996 – 2006: Slope = 0.22 (± .01)
p = .02
TT per 100 OMV
1994 – 1996: Slope = - 0.09 (± .13)
p = .61
1996 – 2006: Slope = 0.18 (± .03)
p = .09
0
0
1994
1995
1996
2006
12
8
TOTAL
PRIVATE
PUBLIC
NONE
Table of Pairwise p-values (larger of pair in bold)
1996
Private vs Public
Private vs. No Insurance
Public vs No Insurance
.09
<.001
<.001
2006
Private vs Public
Private vs. No Insurance
Public vs No Insurance
Pairwise from 1996 to 2006
Private (increase)
<.001
Public (decrease)
.19
No Insurance (decrease)
<.001
2006
1996
2006
1996
2006
1996
0
2006
4
1996
Surgeries per 1000 Children
Increase is only among privately
insured children
.001
<.001
<.001
Summary of Findings
 Population 0-16 Increased slightly
– Increased 4.4 % (66.5 M → 69.4 M)
 Ambulatory Visits for OM 1996 – 2006
– Decreased 27% (24.0 M → 17.5 M)
 667,008, p=0.007
 Tympanostomy Tubes 1996 – 2006
– Increased 35% (493K – 668K)
 17,304 per year, p=0.02
– Increased 28% per capita
– Increased 85% relative to Ambulatory Visits for OM
Conclusions
 Utilization for Otitis Media is decreasing
 Tympanostomy Tube use is increasing
 Increase in TT is
– disproportionate to either population growth or
ambulatory medical service utilization for OM
– disproportionate in that it was all among
privately insured children
 TT use among publicly insured and uninsured
actually decreased 1996 to 2006
Final Thoughts
 Context: Tympanostomy Tubes Overused
– We don’t know why practice deviates from criteria
 Epidemiological Trend:
Disproportionate increase in TT use
– In other of our data: No associated decrease in antibiotic use
 Did focus on reducing antibiotic use unintentionally
increase use of TT for children with OM
– Passive : Less focus on surgical management, or
– Active: Clinical belief that more surgery would reduce antibiotic
use
Is the United States experiencing
an epidemic of Tympanostomy
Tube Surgery?
 Evidence suggests:
Yes, at least for privately insured children
 Alternative:
We know so little about treating the most common
disease in children with tubes that we can’t say
 Either way:
urgent need for
– HSR and HPR to understand why, followed by
– Quality management to implement what we learn
regarding the use of tympanostomy tube
Thank you
Major Indication for TT is OM
 Insured children, 1990-91*
– 23% Recurrent AOM
– 29% Persistent OME
– 45% Both, 3% Neither
 Children from 5 NYC Hospitals, 2002†
– 21% Recurrent AOM
– 60% Persistent OME
– 11% Eustachian Tube Dysfunction,
3% Both OME and AOM
* Kleinman et al, The Medical Appropriateness of Tympanostomy Tubes Proposed
for Children Under 16 in the United States. JAMA, 1994
† Keyhani, Kleinman, Rothschild, et al. Overuse of Tympanostomy Tubes in New York
metropolitan area: evidence from 5 hospital cohort. BMJ, 2008
YEAR
Variable 1
Variable 2
1994
0
0
1995
1
0
1996
2
0
1997
2
1
1998
2
2
1999
2
3
2000
2
4
2001
2
5
2002
2
6
2003
2
7
2004
2
8
2005
2
9
2006
2
10
Regress Outcome on V1 and V2
1994: Y = β0
1995: Y = β0 + β1, Δ= β1
1996: Y = β0 + 2*β1, Δ= β1
2006: Y = β0 + 2*β1 + 10*β2 ,
Δ=10*β2
Slope 1994-96 = β1
Slope 1996-06 = β2
YEAR
Variable 1
Variable 2
1994
0
0
1995
1
0
1996
2
0
1997
-
-
1998
-
-
1999
-
-
2000
-
-
2001
-
-
2002
-
-
2003
-
-
2004
-
-
2005
-
-
2006
2
1
Regress Outcome on V1 and V2
1994: Y = β0
1995: Y = β0 + β1, Δ= β1
1996: Y = β0 + 2*β1, Δ= β1
2006: Y = β0 + 2*β1 + β2 , Δ= β2
Slope 1994-96 = β1
Slope 1996-06 = β2 /10
New York State
Chidlren Under 16 with Ambulatory Tympanostomy
Tube Insertions: New York State 1996-2006
25000
20000
15000
10000
5000
0
1996
1998
2000
2002
2004
2006
Appropriateness, 1990-91*
Definition: of Appropriateness
“expected health benefits exceed the expected negative
health consequences by a sufficiently wide margin that the
tympanostomy is worth performing ‘
 Insured children, 1990-91
– Using Explicit Criteria from an expert multidisciplinary panel
 42% Appropriate (i.e. Benefits > Risks)
Appropriateness, 2002*
Explicit Criteria
Concordant
Appropriate Uncertain
Not Concordant
Inappropriate
All Children (N=682)
7.0 %
22.3 %
69.7 %
OME (N= 452)
8.6%
10.8 %
80.6 %
Recommended
Not
Recommended
1994 Guidelines (N=172)
7.5 %
92.5 %
2004 Guidelines
5.6 %
94.4 %
Academy’s Guidelines
2004 OME Guideline
 2 months to 12 years old
 Tympanostomy Tubes
– Otherwise healthy: Consider them after 4 months if persistent
symptoms / hearing loss, recommended after 6 months
– Sooner in “at Risk” children
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hearing loss independent of OME
language or speech disorder
autism and other developmental symptoms
Down syndrome or other craniofacial syndromes
visual impairment
cleft palate
developmental delay
– Structural damage to the tympanic membrane or middle ear
Clinical Findings - - OME
 50 % of effusions were present for less than
3 months at the time surgery was proposed
 25 % of children with OME did not have any
effusion documented before the day surgery
was proposed
 75 % of children with effusion did not have
documented hearing loss
Typical Inappropriate Indication
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Child less than three years old
Effusion documented for less than 1 month
No recurrent otitis media
With or without a trial of antibiotics
Comparing Recommendations
AHCPR Guideline more restrictive: 1447
UR Firm Criteria more restrictive:
5
Criteria Development (1994)
 Panel of 9 national experts
– 5 Pediatricians, 4 Otolaryngologists
 Considered 80 potential indications for
tympanostomy
 2 round process: literature + judgment
 Indications rated on 9 point scale
1
2
3
4
5
6
INAPPROPRIATE EQUIVOCAL
7
8
9
APPROPRIATE
Prospective Utilization Review
6429 cases January 1990 – June 1991
 Step 1: Nurse Review
– Interviews office staff for clinical data
– Computer guided
 If found inappropriate at step 1:
– Step 2: Physician Review
Step 2 Physician Review
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Board certified reviewers
Verify step 1 data accurate and complete
Identify new clinical data
Identify extenuating circumstances
Overturn or sustain step 1 finding of
inappropriate
Explicit Criteria
 Clinical factors: OME
– Age of patient
– Duration of effusion
– Otoscopic findings
– Hearing Loss
– Results of antibiotic treatment
 Clinical factors: Recurrent OM
– Frequency of recurrence
– Failure of antibiotic prophylaxis