1 usefullness of n ewborn h earing s creening by oaes yusuf k. kemaloğlu, md, prof. gazi un. fac....

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Usefullness of Newborn Hearing Screening by OAEs

Yusuf K. Kemaloğlu, MD, Prof.

Gazi Un. Fac. of Medicine

Dept. of ENT-HNS

Ankara, Turkey

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This speech was presented in ‘Round Table entitled "Global Screening

of hearing in newborns. Is it feasible?" (International Pediatric Otorhinolaryngology

Conference in Athene, Grece, 16-19 Mayıs 2004).

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* Each newborn should be screened before discharge;* Audiologic diagnosis should be completed before 3 mo. of age;* (Re)Habilitation and training should start before 6 mo. of age.

• American National Institutes of Health Concensus Statement (1993)

• European Consensus Statement on Universal Newborn Hearing Screening (1998)

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NHS requirements:

• Test technique:– Physiologic mesurements (not behavioral)

– Predictive value (normal vs abnormal)

– Objective criteria in practice (passed – fail)

– Low false positivity

• Program:– Screening before discharge – Follow-up– Intervention

Early

Hearing

Detection &

Intervention

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Is NHS universally usefull?Effective in use?

Helpful?

• Early diagnosis of the child with hearing impairement and hence provide better results in language and communication skills

• Diagnosis of more children with hearing impairement (unilateral cases)

• More accurate and practical diagnosis (OAEs

and ABR) with lower cost

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Hearing loss in newborns

• Incidence: 1-6 / 1000 newborns

1-3 / 1000 healthy newborns

2-4 / 100 newborns in INCU

• Referal rate: 1- 14 % by OAEs

A large population will be followed up and referred to advanced evaluation and intervention

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Example of Turkey

1.300.000 newborns / year

More than 1.300 – 2.600 newborns with hearing loss

39.000 referals per year

1-2 / 1000 healthy newborns (Belgin, 2002)

1.1 / 1000 healthy newborns (Gazi Un, Ankara, 2004)

2 / 100 newborns in INCU (Gazi Un, Ankara, 2004)

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• Objective autamated devices• Trained health workers (nurses)

• Implantation of the program to conventional health system

• Payment by health insurance • Software• Arrangement of the guidelines & support of the

authorities• Audiology departments supporting the program

NHS requirements:

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• Number of the children early diagnosed before screening:– 50 % of children with bilateral hearing loss were in 2-3

y. of age

• Age of diagnosis before screening: – over 12 months

Does NHS make any sense?

Example of Turkey in 1990:

- parents suspicion: 1.7 y.

- audiological diagnosis: 3.4 y.(Belgin et al, 1991)

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• YES:

After screening age of diagnosis improved to 2-4 mo. of age (Harrison et al, 2003)

Does NHS make any sense?

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Yoshinaga-Itano et al. (1998):

Children with hearing loss identified by age 6 months had significantly higher receptive, expressive, and total language quotients than those of children identified at 7-12, 13-18, 19-24, and 25-34 months.

This statistical difference was independent of the following demographic variables: age, sex, ethnicity, communication mode, degree of hearing loss, socioeconomic status, and presence or absence of other disabilities.

(White & White-1987,

Apuzzo & Yoshinaga-Itano-1995,

Robinshaw-1995)

Does early detection of hearing loss make any sense for children?

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Test efficiancy of NHS: TEOAEs or A-ABR

• False positivity: Referal rate – TEOAs:

• EEC problems• MEE

• False negativity: Missed cases– TEOAs:

• Auditory neuropaty

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• TEOAs : Outer hair cell– Amatuzzi et al (2001): Selective inner hair cell

damage

– Perry et al. (2002): 2-3 % false negativity by OAEs

– Psarommatis et al (1997): 1.96 % in NICU

Test efficiancy of NHS: TEOAEs or A-ABR

Risk factors for Auditory neuropathy:

- Hypoxia

- Hyperbilirubinemia (20 mg/dl <)

- Metabolic disorders

- ..

Two (40 %) of 5

newborns (TEOAEs +)

with bilirubine level

higher than 20 ml/dl

failed in ABR.

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- How much does it cost to society?- Does NHS decrease overall cost of management of children with bilateral hearing loss?

• Cost effectivenss:- How much money will be spent to detect one child

with bilateral severe hearing loss?- How much money will be spent to detect one

additional child with bilateral severe hearing loss which could not be detected by screening of the risky babies?

- How much money will be saved when a child diagnosed earlier than 6 mo compared to late diagnosis (12 mo<, 24 mo<)?

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Cost effectiveness of NHS

- How much money will be spent to detect one child?

- How much money will be spent to detect one additional child?

• Keren et al. (2002): – Passive detection of 30 cases: 69.000 USD

– Selective screening protocol (additional 36 cases): 600.000 USD

– NHS (additional 33 cases): 1.5 billion USD

• Lemons et al. (2002):– Establishing TEOAE: 49.000 USD / per infant: 32 USD

– Establishing AABR: 47.000 USD / per infant: 34 USD

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• Boshuizen et al. (2001):– Screening per infant by AABR: 39 pounds– Screening per infant by TEOAE: 25 pounds– Extra cost of detecting a unil. case: 1500 to 4000 pounds

• Messner et al (2001):– Volunterer-based scren. per infant (AABR): 27 USD

Cost effectiveness of NHS- How much money will be spent to detect one child?- How much money will be spent to detect one additional child?

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Table 2: Assumptions for Cost Estimate• Insert the name(s) of the newborn hearing screening equipment you are analyzing• Insert the # of babies born each year in your hospital• Insert the estimated # of babies that will be screened each year• What do you estimate the prevalence per 1000 of hearing loss to be?• Over how many years do you want to amortize the cost of the equipment?• Insert the total cost of:

– newborn hearing screening equipment /  computer for screening equipment and/or data management

•   Cart or stand for equipment /  Printer for data management /  Label printer• Insert the per baby cost of:

– Probe tips / ABR electrodes etc / probe replacement /  Calibration and/or warranty

• Insert the hourly wage (including fringe benefits and overhead) of screening program staff– Coordinator / Screener(s) / Clerk(s) / Audiologist(s)

• Insert estimated minutes per baby for various tasks (the best way is to divide the average hours spent on that task by the # of babies born, screened, or whatever):

– Inpatient screening / Outpatient screening / Coordination / Audiological Review / Clerical work

• How many hours per year does a full time employee actually work?• Estimated coverage, referral, and follow-up rates:

– % of babies not screened before discharge / referral rate at time of hospital discharge / % of babies needing outpatient screen who are actually screened / referral rate for outpatient screening (%) / % of babies screened before discharge who need a diagnostic evaluation

• Number of babies who will need a diagnostic evaluation• Cost of tracking & data management software for the year• Estimated cost of diagnostic evaluation per baby:

http://www.infanthearing.org/resources/cost/costtable1.html

Cost effectiveness of NHS

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Cost of NHS in Gazi Un. Hospital (Ankara Turkey)

• Cost per baby born (TEOAE): 14 USD

• Cost per baby identified (TEOAE): 3.700 USD

Cost of NHS in ‘Hospital Turkey’

• Cost per baby born (TEOAE): 7,5 USD

• Cost per baby identified (TEOAE): 5.000 USD

• Annual cost of program: 9.700.000 USD

Cost-effectiveness of NHS

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Cost - effectiveness:- Does NHS decrease overall cost of management

of children with bilateral hearing loss?

- How much money will be saved when a

child diagnosed earlier than 6 mo

compared to late diagnosis (12 mo<, 24 mo<)?

Shorter habilitation or training period ?

Less or no need special education?

Higher academic success causing more qualified contribution to society

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Is NHS useful?• Yes:

– It is practical, convinient and predictive.

– It imporved age of diagnosis of hearing loss beneath to 6 mo. of age, which is critical for speech and language development.

• But:– Its cost is considerable high

– Many problems occur during realisation of NHS since it is not only screening program; a follow-up and intensive intervention are of major importance for success of NHS.

– Combination of ABR and OAEs is necessary at least in selective populations.

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Gazi University NHS Program

NewbornsNICU

First test: TEOAE

Discharge – first visit (7 –14 days)

Second month

First month Second test: TEOAE + Timpanometry

Third test: TEOAE + Timpanometry + otologic examination

ABR Hearing devices

4-5 months

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Gazi University NHS Program

2002 December to present– Secreened newborns: 2180

• Healthy newborns: 1886

• NICU: 294

– Total number of • Newborns (alive): 2423

• Newborns in NICU: 325

– Success ratio of the screening:• Healthy newborns : 89.89 %

• Newborns in NICU: 90.46 %

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Missed cases: 243* Early discharge without giving any information

– Holidays: 181 (75 %)

– Living in another city: 164 (67.5 %)

* Rejection to screening by physicians: 61 (25 %)

* Insufficient documentation: 46 (19 %)

Gazi University NHS Program

Solution proposes:

•Screening by own staf of obstetric and NICU dep.

• Training medical personal in the hospital

• An effective soft ware

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• Fails in the first testHealthy newborns: 183 (9.76 %)

- Unilateral : 121 (6.41 %)

- Bilateral : 62 (3.28 %)

Newborns in NICU: 62 (21.09 %)

- Unilateral : 24 (8.16 %)

- Bilateral : 38 (12.92 %)

Gazi University NHS Program

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2nd test Fails

Healthy newborns: 183 141 (77 %) 19 (13.47 %)

Newborns in NICU: 62 41 (66 %)24 (58.53 %)

Gazi University NHS Program

Missed: 23 %

Missed: (34 %) – 21 %10 babies dead

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Gazi University NHS Program

3rd test Fails

Healthy newborns: 19 12 (63 %) 8 (66.67 %)

Newborns in NICU: 24 18 (75 %) 8 (44.44 %)

ABR Fails

Healthy newborns: 8 5 (62.5 %) 2 (40 %) 1.06 /1000

Newborns in NICU: 8 7 (87.5 %) 6 (85.7 %) 2.04 /100

+ 2 cases in which ABR was – but TEOAE + : 2.72 /100

12/2002 – 4/2003 Gazi Un., Ankara, Turkey: 3.66 / 1000

4.57 / 1000

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Missed cases in follow-up: 80

Gazi University NHS Program

- Another center: 11 (13.75 %)

- Parents’ own decision: 23 (28.75 %)

- ‘child is OK in hearing’ : 13 ‘more important health prob.’ : 10

- Physicians decision: 21 (26.25 %)

-‘no problem in hearing’: 14 ‘unnecesseray’: 7

- Other reasons: 10

-- Unkonwn: 15

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– To be continued:• Giving more education

– Health workers within the hospital – The parents

• Perform screening by own staff in obstetric department

• Use better documentation / e-documentation• Use ABR screening in selective NICU babies

Gazi University NHS Program In Future

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Gazi University NHS Program

NewbornsNICU

TEOAE: First test: TEOAE + ABR

Discharge – first visit (7 –14 days)

Second month

First month Second test: TEOAE + Timpanom.

Third test: TEOAE + Timpanometry + otologic examination

ABRHearing devices

4-5 months

Discharge

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National NHS Program in Turkey‘Ulusal Yenidoğan İşitme Tarama Programı’

• Since 2003 November• Pilot study:

– Health Minestery &– Dokuzeylül University, Izmir– Gazi University, Ankara– Hacettepe University, Ankara– Marmara University, Istanbul

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–Dokuzeylül University, Izmir

–Gazi University, Ankara

–Hacettepe University, Ankara

–Marmara University, Istanbul

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*

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*

*

*

*

*

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• Preparation of the project– Maternity hospitals of the Health Minestery

• New in-law issued by Health Minestery• Training of two nurses in each hospital and 1 GP

in each city• Information compaign in each city • Development of a software• Deliver of the screening devices to the hospitals

National NHS Program in Turkey‘Ulusal Yenidoğan İşitme Tarama Programı’

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Thank you for your attention