efficacy of oae/abr protocol in identifying hearing loss national early hearing detection and...
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EFFICACY of OAE/ABR PROTOCOL in IDENTIFYING
HEARING LOSS
National Early Hearing Detection and Intervention Meeting
Washington, D.C.February 20, 2004
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Funded by the Centers for Disease Control and
Prevention
under a Cooperative Agreement with:
The Association of Teachers of Preventive Medicine
with a sub-agreement to:The University of Hawai`i
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CORE STAFF
Jean Johnson DrPH - Principal Investigator
Karl White, PhD - Research Coordinator
Judith E. Widen, PhD - Diagnostic Evaluation Coordinator
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SITE CO-PRINCIPAL INVESTIGATORS
Judith Gravel, PhD: Jacobi Medical Center (Bronx, New York)
Michele James-Trychel, MEd: Arnold Palmer Hospital (Florida)
Antonia B. Maxon, PhD: Lawrence & Memorial (Connecticut)
Teresa Kennalley, MA: Via Christi Regional Medical Center (Kansas)
Lynn Spivak, PhD: Long Island Jewish Health System (New York)
Maureen Sullivan-Mahoney, MA: Good Samaritan Hospital (Ohio)
Betty Vohr, MD: Women & Infants Hospital (Rhode Island)
Yusnita Weirather, MA: Kapi`olani Medical Center (Hawai`i)
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CDC CONSULTANTS
Krista Biernath, MD Technical Advisor
Lee Ann Ramsey, BBA, GCPH
Program Advisor
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Background:
Conclusion of the National Institutes of Health (NIH) Consensus Panel:
“ (3) the preferred model for screening should begin with an evoked otoacoustic emissions test and should be followed by an auditory brainstem response test for all infants who fail the evoked otoacousticemissions test.”
NIH Consensus Statement March 3, 1993
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RESEARCH QUESTION
Does this two-stage procedure
miss
a significant number of babies with
a congenital hearing loss?
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CRITERIA for SELECTION of CRITERIA for SELECTION of BIRTHING SITESBIRTHING SITES
2,000 or more births per year
Established newborn hearing screening program with at least six month history of success
Historical refer rates of less than 10% for OAE and 4% for ABR
Success in obtaining follow-up on 90% or more of referrals
Ethnic and socio-economic distribution similar to US population
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PROJECTED SAMPLE SIZE
53,889 Annual Births
1,616 Eligible (Refer on OAE, Pass ABR)
1,500 Consent to participate; and family speaks either English or Spanish
1,000 Babies return for complete diagnostic testing
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BIRTHING CENTERS 2001 - 2003 BIRTH CENSUS
Name of Hospital Enrollment Period Number of Births Arnold Palmer 06/01/2001 – 12/31/2002 16,608
Good Samaritan 06/01/2001 – 01/31/2003 9,393
Jacobi Medical 09/20/2001 – 01/31/2003 4,747
Lawrence & Memorial 06/27/2001 – 03/31/2003 1,380
Long Island Jewish 05/01/2001 – 01/31/2003 10,424
Kapi`olani Medical 05/15/2001 – 01/31/2003 9,252
Via Christi 05/01/2001 – 01/31/2003 6,217
Women & Infants 05/01/2001 – 01/31/2003 16,623
Huntington 05/01/2001 – 01/31/2003 3,384
Northshore 05/01/2001 – 01/31/2003 10,224
Total Birth Census for Enrollment Period 88,252
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PROCESSPROCESS
Eligible babies identified following newborn hearing screening.
Parents contacted and research study explained.
Consent obtained from families. Enrollment data collected. Contact maintained with family at 2, 4, &
6 months of age via post cards.
Baby seen for audiological diagnostic evaluation between 7-9 months of adjusted age.
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DATA BEING COLLECTED
Birthdate Bronchio-pulmonary Dsplasia
Gender Mechanical Ventilation >7 Days
Birth Weight ECMO
Gestational Age Number of Children in Home
APGAR Scores Number of Adults in Home
Days in NICU Total Household Income
Malformations of the Head and Neck Child’s Race/Ethnicity
Syndrome Associated with Hearing Loss Health Insurance
In-utero Infections Family History of Hearing Loss
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CURRENT ENROLLMENT STATUS
1,572 Infants Enrolled as of September 2003
Exceeded Target Enrollment
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PERCENTAGE of CURRENT SAMPLE at EACH
PARTICIPATING HOSPITAL
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2 5 1280
146
281
361429
512
603679
750810
873933
9871,043
1,117
1,214
1,3021,377
1,4471,517
1,5601,561
0
200
400
600
800
1000
1200
1400
1600
1800
Jan-
01
Mar
-01
May
-01
Jul-0
1
Sep-0
1
Nov-0
1
Jan-
02
Mar
-02
May
-02
Jul-0
2
Sep-0
2
Nov-0
2
Jan-
03
Month & Year of Birth
Cu
mu
lati
ve F
req
uen
cy
CUMULATIVE ENROLLMENTAs of September 2003Goal: 1,500 infants
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CHILD ETHNICITY(Percentage of Current Sample)
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HEALTH INSURANCE STATUS
(percentage of current sample)
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6.9
3.6
10.1 10.8 9.8
12.9
31.6
0
5
10
15
20
25
30
35
<5000$ 5,000 -9,999$
10,000 -19,999$
20,000 -29,999$
30,000 -39,999$
40,000 -49,999$
50,000 and >
Income in baby's household/year
Per
cen
tAnnual Income in Baby’s
Household
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AUDIOLOGICAL DIAGNOSTIC EVALUATION
Visual reinforcement audiometry
Tympanometry
EOAE – either TOAE or DPOAE
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VRA PROTOCOLVRA PROTOCOL
Well-defined, detailed Well-defined, detailed protocolprotocol
Responses at 500, 1K, 2K, Responses at 500, 1K, 2K, 4K Hz4K Hz
Response levels of 15 dB HLResponse levels of 15 dB HL
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885 Diagnostic EvaluationsCompleted
DIAGNOSTIC EVALUATIONS
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1847
101137
185224
268308
337366
401435
478518
555
602
659
716758
793818
846866 874 883 885
0
100
200
300
400
500
600
700
800
900
1000
Behavioral Evaluations by Month Completed
Cu
mu
lati
ve
Fre
qu
ency
Behavioral Evaluations as of January 29, 2004
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DIAGNOSTIC EVALUATIONS(percentage completed at each participating
hospital)
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EXPANDED STUDY
Comparison Group: Refer/Refer Babies who failed both OAE and ABR
and were referred for a diagnostic evaluation
Same enrollment data
Results of audiological diagnostic evaluations
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VALUE of EXPANDED VALUE of EXPANDED STUDYSTUDY
Enables study to determine what Enables study to determine what proportion that babies with a hearing proportion that babies with a hearing loss from the refer/pass group represent loss from the refer/pass group represent of all babies identified with hearing loss of all babies identified with hearing loss in the sample cohort.in the sample cohort.
Additional data provides an accurate Additional data provides an accurate estimate of the proportion of all babies estimate of the proportion of all babies with congenital hearing loss who are with congenital hearing loss who are being missed by the two-stage OAE/ABR being missed by the two-stage OAE/ABR protocol.protocol.
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3 5 11 3163 81
112145
177209
239272291
312337
367374389422
443484
529557
583
0
100
200
300
400
500
600
700
Jan-
01
Mar-
01
May
-01
Jul-0
1
Sep-01
Nov-01
Jan-
02
Mar-
02
May
-02
Jul-0
2
Sep-02
Nov-02
Jan-
03
Month & Year of Birth
Cu
mu
lati
ve F
req
uen
cy
ATPM EXPANDED STUDY:Cumulative EnrollmentAs of January 2004
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Number of Inactivated Infants Number of Inactivated Infants by Monthby Month
152
214237
277 278
322 330346 353
377
0
50
100
150
200
250
300
350
400
Jan Feb Mar April May June July Aug Sep Oct
Months
Nu
mb
er o
f in
act
iva
ted
in
fan
ts
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REVISED TIME LINEREVISED TIME LINE
Enrolled babies through January Enrolled babies through January 2003.2003.
Complete evaluations by January Complete evaluations by January 2004.2004.
Investigators analyze data in March Investigators analyze data in March 2004.2004.
Present results in May 2004.Present results in May 2004.
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Are we missing Are we missing babies with babies with
existing existing screening screening
equipment? equipment?
If so how many If so how many and of what type? and of what type?
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What is the What is the significance of significance of variable pass-variable pass-
refer rates refer rates associated with associated with
different different screening screening devices devices
(AOAE and (AOAE and AABR)?AABR)?
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What Kind of Babies will be found
Congenital hearing loss
Late-onset loss
Study Design Improvements
Diagnostic ABR for all babies who failed OAE regardless of AABR result
Larger sample size
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Would the follow-Would the follow-up of high- risk up of high- risk babies improve babies improve
the sensitivity of the sensitivity of the screening the screening
tests in detecting tests in detecting mild forms of mild forms of hearing loss?hearing loss?
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What is the cost What is the cost effectiveness of effectiveness of
different different screening screening protocols?protocols?
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Does ASSR have Does ASSR have a role in the a role in the
screening and screening and assessment of assessment of
infants?infants?
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Auditory Auditory NeuropathyNeuropathy
How many of the babies in How many of the babies in our sample who passed AOAE our sample who passed AOAE would have been identified as would have been identified as
at risk for AN if we had at risk for AN if we had tested all with AABR?tested all with AABR?
Should we use different Should we use different screening protocols in the screening protocols in the
NICU than WBN?NICU than WBN?