Impact and Lack of Impact of the 2004
Clinical Academies’ Guidelines on the
Medical Management of Otitis Media in
the United States
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
Evaluation of OM Guidelines
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Clinical and Policy Context
The Clinical Academies’ Guidelines
Data and Analysis
Findings
Conclusion
Clinical Context: Otitis Media
 Acute Otitis Media
– Symptomatic disease acute onset
– Presents typically with fever and ear pain
– Infectious etiology: bacterial or viral
– “Ear Infection”
 Otitis Media with Effusion
– Often asymptomatic, hearing loss frequent
– Rarely infectious (may follow AOM)
– “Fluid in the ear” or “Glue Ear” (UK)
Policy Context
 Antibiotic resistance increasing
 ca. 1998 CDC strategic decision to focus on
↓ Abx use by pediatricians
 Otitis Media most common illness in children
– #2 in medicine (HTN)
The Guidelines
 2004 AAP/AAFP Guideline on AOM recommends
watchful waiting as a preferred initial Rx in some
circumstances
– Clinical Data:
∃ Large subset of children for whom delaying Abx does
not result in lasting harm
– Abx shorten course of AOM by 1 day on average
 2004 update of 1994 AAP/AAFP/AAO-HNS
OME Guideline removes Abx option except as last
ditch effort to avoid surgery that parents don’t want
– Clinical Data:
Treat seven children with Abx to eliminate one child with
effusion
2004 AAP/AAFP AOM Guideline
Age < 6 months
Age 6 m to 2 years
Severe
Not Severe
Certain Dx
Uncertain Dx
Antibiotics
Antibiotics
Antibiotics
Antibiotics
Antibiotics
WW
Antibiotics
WW
WW
WW
Age > 2 years
Severe
Not Severe
• Certain dx is all 3 of: rapid onset, signs of middle ear
effusion, and symptoms of middle ear inflammation.
• Severe: moderate to severe otalgia and/or fever > 39oC in past 24 hours.
• Observation (watchful waiting) option is only appropriate when follow-up
can be assured and antibiotics started if symptoms persist or worsen.
Study Overview
 Did antibiotic use for AOM or OME change
as a result of (in association with) the 2004
OM Guidelines?
 Interrupted Time Series
– Segmented regression analysis of nationally
representative data of ambulatory medical care
Data
 Ambulatory visits for children birth through
16 years old from 2 National Center for
Health Statistics annual surveys
 National Ambulatory Medical Care Survey
(NAMCS)
– Doctors offices
 National Hospital Ambulatory Medical Care
Survey (NHAMCS)
– Hospital Clinic visits
– Emergency Department visits
Segmented Regression Analysis
CounterFACTUAL
GUIDELINE EFFECT
(2004)
Washout
Period
FACTUAL
ABX Use in AOM
Abstract Period
Proportion AOM with ABX
1
0.9
0.8
0.7
0.6
0.5
1992
1994
1996
1998
2000
2002
2004
2006
2008
Findings: AOM
Trend Before:
-0.2% /yr (p=0.45)
Trend After:
-2.0% /yr (p=0.57)
Effect size:
+4.3% (p=0.35)
Factual :
82.3%
Counter Factual
82.0%
Guideline impact
+ 0.3%
AOM: Ratio of Abx Use in Children
Older than 2 yrs to Children < 2 yrs
Abx use 2 or older / < 2
1.4
1.2
1
0.8
0.6
0.4
0.2
0
1992
1994
1996
1998
2000
2002
2004
2006
AOM: Ratio of Abx Use in Children
Older than 2 yrs to Children < 2 yrs
Trend Before*:
↓ 0.005 /yr (p=0.13)
Trend After*:
↑ 0.12 /yr (p=0.88)
Effect size:
↓ 0.009 (p=0.01)
Factual :
1.28
Counter Factual
1.04
Guideline impact
+ 0.24
*Difference p<.01
OME
Proportion OME with ABX
1
0.75
0.5
0.25
0
1992
1994
1996
1998
2000
2002
2004
2006
Findings OME
Trend Before*:
↓ 1.9% /yr (p=0.004)
Trend After*:
Effect size:
↑ 9.9% /yr
(p=0.30)
- 6.3% (p=0.60)
Factual :
51.6%
Counter Factual
38.1%
Guideline impact
+13.5%
*Difference p<.01
Antibiotic Use for Isolated URI
 Upper Respiratory Infection without OM,
strep throat, pneumonia, UTI
 In 2006: 3.96 million children (22.4 %)
received antibiotics
 Segmented Regression
– ↓ 0.8% per year before guideline (p=0.38)
– Guideline effect ↓ 2.6% (p=0.88)
– ↑ 1.1% per year after guideline (p=0.92)
– Factual 22.4% Counterfactual 22.8% (NS)
Conclusions
 Physicians in the US have not changed
fundamentally their use of antibiotics for
either acute otitis media or otitis media with
effusion subsequent to the guidelines
 If anything use in the targeted population for
AOM (over 2 years) appears to have gone
up relative to use in younger kids
 Many children receive antibiotics for
conditions (e.g. URI) for which their use is
inappropriate
Implications for Policy,
Delivery or Practice
 Guidelines that prioritized societal risk of
bacterial resistance over a demonstrable but
modest benefit to the individual child were not
successful in changing behavior
 Pediatricians and family physicians may not
be ready to follow the lead of their clinical
societies in prioritizing population risks over
individual patient benefit
Questions for You
 Why do you think that the focus has been on
reducing an effective use of antibiotics for children
when antibiotics are so widely used for
inappropriate reasons?
 Can you think of an equivalent example of a
national society or a federal campaign focusing on
reducing useful (appropriate) services in adults?
 Were the Guidelines correct in their prioritization?
Thank you
OMV Decreasing
Otitis Media Visits By Year: 1994 - 2006
Abstract Period
30,000,000
20,000,000
10,000,000
0
1994
1996
1998
2000
2002
2004
2006
Slope = -621,654 (± 108,549), p = .0002
Proportion AOM with ABX
0.9
0.88
0.86
0.84
0.82
0.8
1992 1994 1996 1998 2000 2002 2004 2006 2008
2004 OME Guideline
Targeting children 2 months through 12 years
Watchful
Waiting
Recommended
•For the first 90 days of an effusion in children
who are not at risk (see text for definition) and
continue surveillance at 3 to 6 month intervals until the effusion is
no longer present, significant hearing loss is identified, or
structural abnormalities of the TM or middle ear are suspected
•All children for whom there is no consensus
in favor of surgery among primary care
physician, parent, and otolaryngologist
Antibiotics •Not recommended unless as a short
(10-14 day course) when a parent has
strong aversion to impending surgery
Tympanostomy Tubes Recommended
Tympanostomy Tubes Optional
Tympanostomy Tubes Mandatory
•After 90 days, persistent hearing loss > 40 dB
•OME lasting 4 months or longer with persistent hearing loss or other signs and symptoms
•Recurrent or persistent OME in children at risk regardless of hearing status, and
•If consensus between the primary care physician, otolaryngologist, and parent or caregiver
•OME with posterosuperior retraction pockets, ossicular erosion, adhesive atelectasis, and
retraction pockets that accumulate keratin debris
1994 AAP/AAFP/AAO-HNS
OME Guideline
Targeting otherwise healthy children
1 through 3 years old
Watchful Waiting •Effusion Present Less than 90
Recommended days, OR
•Absence of bilateral hearing loss
> 20 dB, OR
•Unilateral OME
Antibiotics Optional •Bilateral Effusion Present 90 –
120 days, AND
•Bilateral hearing loss > 20 dB
2004 OME Guideline
 Targets 2 months to 12 years old
 Antibiotics not recommended unless a parent has strong
aversion to impending surgery
 Initial surgery: Tympanostomy Tubes
 Structural damage to the tympanic membrane or middle ear
 Only if consensus between ENT, PCP, and parent
 Otherwise healthy: Consider them after 4 months if persistent
symptoms / hearing loss, recommended after 6 months
 Sooner in “at Risk” children
–
–
–
–
–
–
–
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
OM is Ubiquitous
 Most common illness in children
 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.