1
A COMPARISON OF AUTOMATED AUDITORY
BRAINSTEM RESPONSE (AABR) WITH INTEGRATED
ELECTRODES AND OTOACOUSTIC EMISSIONS (OAEs)
IN HIGH RISK NEWBORN HEARING SCREENING
DR. MUHAMMAD NOOR AZMI BIN RAMLI
DISSERTATION SUBMITTED IN PARTIAL
FULFILMENT OF THE REQUIREMENTS FOR
THE DEGREE OF MASTER OF MEDICINE
(PAEDIATRIC)
UNIVERSITI SAINS MALAYSIA
2017
2
ACKNOWLEDGEMENT
Alhamdulillah, praise be to ALLAH SWT for giving me the ability, passion and strength to
eventually complete this dissertation. The preparation of this important document would not
have been possible without the support, hard work and endless assistance of a large number of
individuals and institutions.
I would like to extend my heartiest gratitude to my supervisor Associate Professor Dr Salmi
binti Ab Razak, my co-supervisor Professor Dr Hans Rosternberghe, Dr Mohamad Normani
bin Zakaria and Dr Siti Azrin binti Ab Hamid for their advice, assistance and support. Many
thanks to all wonderful people who had involved and helped me in this study namely, all staff
in paediatric ward Nilam 2 and 1 Timur Belakang (1TB). Last but not least, to my dear mother,
Puan Hajjah Che Rohani binti Ibrahim, my wife Puan Sumaiyah binti Abdullah, my childrens,
Lu’ay and Alaa’ and all family members for their constant prayers, love and encouragement in
all my endeavours.
“Anything is possible to a willing heart.”
3
TABLE OF CONTENTS
Page
Acknowledgement ii
Table of Contents iii
List of Tables vi
List of Figures vii
Abbreviations viii
Abstract x
Bahasa Malaysia x
English xiii
1 INTRODUCTION 01
2 LITERATURE REVIEW 05
2.1 Universal Neonatal Hearing Screening 06
2.2 Neonatal Hearing Screening Among High Risk Newborn 07
2.3 Screening Test and Equipment 08
2.3.1. Integrated Electrodes Otoacoustic Emissions 08
2.3.2. MB11 BERAphone 10
2.3.3. Auditory Brainstem Response 12
2.4 The Comparison Between OAEs and AABR 13
2.5 The Comparison Between OAEs and MB11 BERAphone 14
2.6 The Agreement Off OAEs And MB11 BERAphone 16
2.7 The Total Time Spent Between OAEs And MB11
BERAphone
17
4
3
OBJECTIVES OF THE STUDY
3.1 General Objective 19
3.2 Specific Objectives 19
3.3 Research Hypothesis 20
4 METHODOLOGY 21
4.1 Research Design 22
4.2 Participants 22
4.2.1 Inclusion criteria
4.2.2 Exclusion criteria
22
23
4.3 Intervention 23
4.4 Outcomes 24
4.5 Sample size 25
4.6 Ethical approval 27
4.7 Statistical Analysis 27
4.8 Definitions 28
4.9 Study of Flow Chart 29
5
RESULTS
30
5.1 Sample Characteristic 31
5.2 Demographic Data 33
5.2.1 Demographic Characteristic 33
5.2.2 Ethnic Distribution 34
5.3 Risk Factors Among Newborn 35
5
5.4 The Comparison Between OAEs and MB11 BERAphone 36
5.5 The “Refer Rates” of MB11 BERAphone and ABR 37
5.6 The “Refer Rates” of OAEs and ABR 38
5.7 The Agreement Between OAEs And MB11 BERAphone 39
5.8 The Total Time Spare Among Staff Between OAEs and
MB11 BERAphone
40
6
DISCUSSION
41
6.1 Demographic Characteristic and Risk Factor in Newborn 43
6.2 The Comparison Result Between Two Methods 44
6.3 The Refer Rate Of OAEs And MB11 BERAphone with
Screening Using ABR
46
6.4 The Agreement Between Two Methods 49
6.5 The Testing Time 50
6.6 Limitations Of Study 53
7 CONCLUSSION 54
8 RECOMMENDATIONS 56
9 REFERENCES 57
10 APPENDICES 62
Appendix 1 Conceptual Framework 63
Appendix 2 Data Collection Form 64
Appendix 3 Consent Form 65
Appendix 4 Ethics Approval Letter 73
Appendix 5 Agreement Letter for MB11 BERAphone 74
Appendix 6 Gantt Chart of Study 75
6
LIST OF TABLES
TABLE 5.1 Demographic characteristic 32
TABLE 5.2 Risk factors among newborn 34
TABLE 5.3 The contingency of findings using MB11 BERAphone and OAEs 35
TABLE 5.4 The true and false positive rate for hearing loss using OAEs and
ABR 36
TABLE 5.5 The true and false positive rate for hearing loss using MB11
BERAphone and ABR 37
TABLE 5.6 The agreement between passing and referral rate between MB11
BERAphone and OAEs by using Kappa statistics 38
TABLE 5.7 The comparison of total staff time spent for screening programs
between Integrated Electrodes Otoacoustic Emissions (OAEs) and
MB11 BERAphone 39
7
LIST OF FIGURES
FIGURE 2.1 Otoacoustic Emissions 9
FIGURE 2.2 Pass Result 10
FIGURE 2.3 Refer Result 11
FIGURE 5.1 Sample Characteristic 31
FIGURE 5.2 Ethnic Distribution 33
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ABBREVIATIONS
ABR Auditory Brainstem Response
AABR Automated Auditory Brainstem Response
AD Auditory Dyssynchrony
APGAR Appearance, Pulse, Grimace, Activity, Respiration
AN Auditory Neuropathy
DB Decibel
DP Distortion Product
DPOAEs Distortion Product Otoacoustic Emissions
ORL Otorhinolaryngology
G Gram
HREC Human Research Ethics Committee
HUSM Hospital Universiti Sains Malaysia
IQR Inter Quartile Range
JCIH Joint Committee on Infant Hearing
NHS Neonatal Hearing Screening
NICU Neonatal Intensive Care Units
OAEs Otoacoustic Emissions
9
PASW Predictive Analytics Software
PC Personal Computer
UNHS Universal Neonatal Hearing Screening
SPSS Statistical Package of Social Science
SNHL Bilateral Sensorineural Hearing Loss (SNHL)
TEOAEs Transient Evoked Otoacoustic Emissions
TORCH Toxoplasma, Others (syphilis), Rubella, Cytomegalovirus, Herpes
10
ABSTRAK
TAJUK
Perbandingan Antara “Automated Auditory Brainstem Response (AABR)” dan “Integrated
Electrodes and Otoacoustic Emissions (OAEs)” Dalam Saringan Pendengaran Di Kalangan
Bayi Yang Berisiko Tinggi di Hospital Universiti Sains Malaysia (HUSM)
OBJEKTIF
Untuk membandingkan keputusan saringan pendengaran menggunakan AABR ( melalui mesin
MB11 BERAphone) dan “Integrated Electrodes dan Otoacoustic Emissions (OAEs)” di
kalangan bayi yang berisiko tinggi dalam HUSM
TATACARA
Saringan pendengaran ini dilakukan dalam kajian keratan rentas. Seramai 195 bayi yang
berisiko tinggi memenuhi kriteria- kriteria yang telah ditetapkan terlibat di dalam kajian ini.
Bayi yang berisiko tinggi dalam masalah pendengaran diuji menggunakan mesin OAEs dan
diikuti dengan mesin MB11 BERAphone di wad yang sama dan dilakukan setelah pesakit yang
telah dirawat di wad disahkan sihat dan boleh didiscaj dari hospital. Kedua – dua mesin ini
akan menghasilkan signal “lulus” atau “ rujuk” sebagai keputusan. Keputusan yang telah
dikeluarkan tidak memerlukan sebarang kemahiran yang canggih untuk dianalisa.
11
Keputusan yang dibuat oleh kedua – dua mesin ini sebagai “ rujuk” akan disaringkan sekali
lagi dengan menggunakan mesin ABR untuk menentukan keputusan muktamad. Masa akan
direkodkan semasa ujian saringan pendengaran oleh kedua – dua mesin tersebut bagi tujuan
analisa. Bagi mengurangkan ketirisan semasa penggunaan kedua -dua mesin tersebut, kami
menyediakan dua orang penganalisa yang akan membuat saringan ke atas pesakit.
KEPUTUSAN
Seramai 195 bayi (87, 44.6% adalah lelaki dan 108, 55.4% adalah perempuan) terlibat dalam
kajian ini. Risiko kesan sampingan ubat adalah yang paling ramai (51.8%) diiringi dengan
kesan penyakit kuning (51.3%) dan berat lahir < 1500g (27.2%). MB11 BERAphone
mempunyai markah tertinggi bagi lulus ujian saringan pendengaran (89.8%) berbanding
dengan OAEs sebanyak (85.2%). MB11 BERAphone mempunyai peratus yang sedikit bagi
ujian saringan yang “rujuk” iaitu 10.2% berbanding OAEs adalah 14.8%. Ini menunjukkan
perbezaan saringan pendengaran diantara kedua - dua ini adalah tercapai. Bagi “true negative”
untuk MB11 BERAphone adalah (29.4%) lebih tinggi berbanding OAEs iaitu (11.8%). “False
negative” MB11 BERAphone adalah (5.9%) dan OAEs adalah (0.0%). Daripada 195 bayi,
seramai 182 (93.4%) bayi menunjukkan kesepakatan di antara kedua - dua mesin saringan
pendengaran ini dan seramai 13 (6.6%) bayi tiada kesepakatan. Dari situ, sasaran kesepakatan
tercapai (kappa = 0.698, p<0.001). Ujian masa bagi saringan pendengaran yang telah dilakukan
oleh kedua - dua mesin menunjukkan MB11 BERAphone adalah lebih kurang 5 minit (IQR:
25th-75th) dan OAEs adalah lebih kurang 2 minit (IQR: 25th-75th). Ini menunjukkan perbezaan
masa di antara kedua – dua mesin tercapai (p = <0.001).
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KESIMPULAN
Kesimpulannya, saringan pendengaran menggunakan MB11 BERAphone adalah sesuai
digunakan semasa ujian saringan di kalangan bayi –bayi yang berisiko tinggi. Walaupun
terdapat keputusan “false negative” menggunakan MB11 BERAphone dan kemungkinan
keputusan tersebut tidak tepat disebabkan beberapa faktor yang mempengaruhi keputusan
tersebut. Terdapat kesepakatan di antara dua mesin tersebut. Walau bagaimanapun, masa yang
diambil oleh MB11 BERAphone untuk membuat ujian saringan pendengaran setiap bayi
mengambil masa yang agak lama berbanding dengan OAEs. Kami mencadangkan OAEs dan
MB11 BERAphone boleh digunakan bagi peringkat pertama ujian saringan pendengaran,
kemudian bayi boleh disaringkan sekali lagi melalui ABR sekiranya keputusan saringan
pendengaran adalah “rujuk” pada peringkat pertama.
13
ABSTRACT
TITLE
A Comparison of Automated Auditory Brainstem Response (AABR) with Integrated Electrodes
and Otoacoustic Emissions (OAEs) in High Risk Newborn Hearing Screening in Hospital
Universiti Sains Malaysia.
OBJECTIVE
To compare the outcome between AABR (by using MB11 BERAphone method) and
Integrated Electrodes and Otoacoustic Emissions (OAEs) in high risk newborn in Hospital
Universiti Sains Malaysia.
METHODS
This is an observational study which is a cross-sectional study design involving two methods
in the same subject. A total of 195 high risk newborn and who have fulfilled the inclusion and
exclusion criteria will be participate in our study. These high risk babies were subjected to
OAEs and followed by an MB11 BERAphone screening test at the same setting as near to
discharge as possible or once the patient is stable enough to do a hearing screening. Both
instruments produced a “pass” or “refer” result and did not require any special skills for the
interpretation of results. The “refer” result from OAEs and MB11 BERAphone will be screened
using ABR to determine the false positive. The time will be measured by total staff time spent
on each instrument. To minimise the measurement bias, two testers will be used to handle both
screening methods.
14
RESULTS
There were 195 newborns (87, 44.6% boys and 108, 55.4% girls) who participated in this study.
Ototoxic medication was the most common risk factor (51.8%) followed by
hyperbilirubinaemia (51.3%), and birth weight <1500g (27.2%). MB11 BERAphone had a
higher passing rate (89.8%) as compared to OAEs (85.2%). MB11 BERAphone had a lower
refer rate (10.2%) compared to OAEs (14.8%). These differences are statistically significant.
The true negatives are MB11 BERAphone (29.4%) and OAEs (11.8%). False negative MB11
BERAphone (5.9%) and OAEs (0.0%). Out of 195 newborns examined, 182 (93.4%) showed
agreement between the two techniques, whereas in 13 (6.6%) there was no agreement. Inter-
observer agreement was good (kappa = 0.698, p=<0.001). The median test time that was done
for each newborn using MB11 BERAphone was 5 minutes (IQR: 25th-75th) and OAEs was 2
minutes (IQR: 25th-75th). The difference were statistically significant (p = <0.001).
CONCLUSION
The MB11 BERAphone is still a reliable device for auditory brainstem response among high
risk newborn hearing screening. In the presence of false negative in MB11 BERAphone, it
might not really be significant in this study due to a few factors affecting the result. Both
agreements were good. However, the duration of time for hearing screening for each newborn
took a significantly longer time compared to OAEs. Therefore, we recommend that both
methods can be used as a first screening, followed by a screening using ABR for those whose
result was “refer” from the first screening.
15
1. INTRODUCTION
16
CHAPTER 1
1. INTRODUCTION
Hearing is the ability to perceive sound by detecting vibrations. Hearing is performed
primarily by the auditory system in which mechanical waves, known as vibrations are detected
by the ear and transduced into nerve impulses that are perceived by the brain (primarily in the
temporal lobe). Hearing loss is a partial or total inability to hear. Hearing loss may occur in one
or both ears. In children hearing, problems can affect the ability to learn spoken language later
on when they grow. So it is important to detect earlier which of these babies are on the high
risk of hearing impairment.1
Early diagnosis and intervention are necessary for social and linguistic development in
children with congenital hearing loss. The Universal Newborn Hearing Screening (UNHS) has
proven beneficial in detecting hearing impairment shortly after birth and with adequate
habilitation, it gives the child a better chance of normal development. Many techniques are
used for the evaluation of hearing sensitivity and among them we have Integrated Electrodes
Otoacoustic Emissions (OAEs) and also automated auditory brainstem response (AABR).2
Otoacoustic emissions (OAEs) hearing screening is used widely in hospital-based
newborn hearing screening programs. Otoacoustic emissions (OAEs) screening can help to
detect sensorineural hearing loss occurring in the cochlea. It can also call attention to hearing
disorders affecting the pathway to the inner ear. The procedure is performed with a portable
handheld screening unit. A small probe is placed in the child's ear canal. This probe delivers a
low-volume sound stimulus into the ear. The cochlea responds by producing an otoacoustic
emission, sometimes described as an “echo,” that travels back through the middle ear to the ear
canal and is analysed by the screening unit. The otoacoustic emissions (OAEs) screening
17
performed by White et al (1993) on 1,850 neonates showed a sensitivity of around 100% and
a specificity of 73%.1
The automated auditory brainstem response (AABR) screener is a dedicated hearing
screening device which provides information not only about the outer/middle ear and cochlea
but also about the auditory pathway up to the brainstem. AABR screening is highly sensitive.
The screening is based on the measurement of synchronous activity in the auditory nerve up to
the colliculus inferior in the brainstem as a reaction to click stimuli delivered to the ears. It is
useful in infants at risk of hearing impairment, including those admitted to a Neonatal Intensive
Care Unit (NICU).
MB11 BERAphone is one of the automated auditory brainstem response (AABR). The
MB11 BERAphone is a more recently developed hearing screening device. MB11
BERAPhone is the only automatic ABR screener without adhesive electrodes. The click
stimulus used simultaneously reaches cochlear areas generating a more robust and faster
auditory response compared to normal AABR clicks. The MB11 BERAphone test showed very
good specificity 96.8% and sensitivity 100%.3
Auditory Brainstem Response (ABR) is the gold standard test, which is essential to a
correct neonatal screening programme both in patients not passing the test with otoacoustic
emissions (OAEs) and automated auditory brainstem response (AABR). The auditory
brainstem response (ABR) reflects the function of the entire auditory pathway up to the
brainstem. While both ABR and the alternate screening technology of otoacoustic emissions
(OAEs) detect cochlear hearing loss, only ABR detects auditory neuropathy.
18
However, it has some drawbacks such as high cost, difficult instrument transportation,
long execution time, and a need for qualified personnel to interpret the ABR. This study is
conducted due to there being only a few research studies done about the comparison of MB11
BERAphone with OAEs. So far, there is no research study done in Malaysia comparing both
of these instruments.
19
2. LITERATURE REVIEW
20
2. LITERATURE REVIEW
2.1 UNIVERSAL NEONATAL HEARING SCREENING
The ear is one of the important parts of the body in which to function as hearing.
Hearing is one indicator for a baby to grow as a normal child in terms of cognitive development,
as well as neurodevelopment. Early neonatal hearing screening was developed all over the
world to prevent late detection of hearing impairment. Thus, hearing screening was done during
the neonatal period. Hearing loss may have significant adverse effects on the development of
speech, language capabilities and social - emotional development, as well as leading to
worsening educational and occupational performance in adulthood. Regular physical
examinations cannot detect hearing loss, so neonatal hearing screening (NHS) is necessary.
Hearing loss may be sensorineural or conductive, permanent or transient, unilateral or bilateral
and of varying severity. Infants with moderate or worse (>40 dB) bilateral sensorineural
hearing loss (SNHL) have heightened risk of poor speech and language development outcomes
if hearing augmentation/intervention programs are not implemented promptly.4
The incidence of permanent hearing impairment in newborns ranges between 1.0% and
5.5% across regions and countries.5 Many studies have illustrated the validity and reliability of
Universal Neonatal Hearing Screening (UNHS) programs in the early detection of newborn
hearing impairment. More importantly, newborns with hearing loss that is detected early can
receive intervention before 6 months of age, which is critical in allowing them to develop
linguistic, cognitive and logical abilities on par with normal infants. Because of their feasibility
and effectiveness, Universal Neonatal Hearing Screening (UNHS) programs have been
implemented in many countries all over the world; its coverage rate is one of the most important
indicators to evaluate the impact of these programs.5
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2.2 NEONATAL HEARING SCREENING AMONG HIGH RISK NEWBORN
In most countries, newborn hearing screening programmes that screen only high-risk
infants have been in existence for more than 20 years. However, this group of infants with
hearing loss comprises only 50% of newborn population with hearing loss. Therefore, hearing
screening programs that screened only high-risk neonates missed out 50% of hearing impaired
newborns, who are from among infants without any risks factors. The prevalence of hearing
loss is estimated to be between 2.5% and 10% among high-risk infants.1
The risk factors of hearing loss in neonates were first documented in 1994 and then
revised in 2000 by the Joint Committee on Infant Hearing (JCIH). The newborn high risk group
included infants who had asphyxia (low APGAR score, 0–4 at 1 minutes or 0-6 at 5 minutes),
meningitis, congenital or perinatal infections, anatomic defects or stigmata, hyper
bilirubinemia, a family history of hearing loss, low birth weight, ototoxic medications,
syndromes known to be associated with hearing loss and neonatal illnesses requiring
mechanical ventilation.6’7 Other risk factors have been tested, such as maternal drug abuse,
persistent high pulmonary pressure, intra-ventricular haemorrhage, high C reactive protein
levels but were not proven to be significant.7
High risk newborns can be divided into congenital and acquired hearing loss. Mostly,
they have hearing impairment at birth and are potentially identifiable by newborn and infant
hearing screening. The risk factors for congenital hearing loss such as craniofacial anomalies,
syndromes related with hearing loss, a family history of hearing loss, premature baby and in
utero infection. However, some congenital hearing loss may not become evident until later in
childhood. Hearing impairment can also be acquired during neonatal or infancy period for
various reasons. Examples of babies who are at high risk of acquired hearing loss are those
22
who suffer from such conditions such as meningitis, otitis media, mechanical ventilation, hyper
bilirubinaemia and ototoxic medications.8
2.3 SCREENING TEST AND EQUIPMENT
The ideal screening test would have a high sensitivity and a high specificity. A high
sensitivity is particularly important to enable catching up on all infants with significant hearing
loss without a delay in the diagnosis of hearing impairment. A high specificity is required, as
a false positive result could lead to much workload on the diagnostic services (over referrals)
and undue parental anxiety.6 Two objective methods were used in most universal hearing-
screening programs. They are automated otoacoustic emissions (OAEs) and automated ABR
(AABR). They are available as handheld portable equipment with a pass or fail criterion. In
this study, we are using MB11 BERAphone as an AABR and comparing it with otoacoustic
emissions (OAEs). The Auditory Brainstem Response (ABR) is still the gold standard test,
which is essential to correct neonatal screening programme both in patients not passing the test
with otoacoustic emissions (OAEs) and automated auditory brainstem response (AABR),
MB11 BERAphone.9
2.3.1 Integrated Electrodes and Otoacoustic Emissions (OAEs)
OAEs are used to assess cochlear integrity and are physiologic measurements of the
response of the outer hair cells to acoustic stimuli. They serve as a fast objective screening test
for normal preneural cochlear function through the use of probe in the ear canal.6 The presence
of normal responses in an OAEs test is a strong predictor of a full hearing function. The
procedure of OAEs suppression allows for a functional investigation of the efferent
23
olivocochlear system, which plays an important role in auditory information processing.10 The
sensitivity and specificity of the OAEs were found to be 90% and 92.4% when compared to
ABR results and 90.9% and 91.1% when compared to the children’s hearing status,
respectively.11
Currently, two types of evoked OAEs measurements are used for newborn hearing
screening, transient evoked otoacoustic emissions (TEOAEs) and distortion product
otoacoustic emissions (DPOAEs). DPOAEs measurements are better suited to advanced
clinical investigation on adult patients, even though DPOAEs analysis is complex and
interpretation is difficult. The distortion product (DP) technique is more flexible and potentially
more powerful than TEOAEs analysis, having a wider useful frequency range. Waveform
based TEOAEs measurements, as originally used in universal newborn hearing screening
programmes, are also useful as a sensitive initial screen prior to full clinical examination.
TEOAEs are also more sensitive to cochlear status changes manifested in subtle changes in the
TEOAEs waveform. DPOAEs instruments can be used for screening with an appropriately low
stimulus level, but DPOAEs screening instruments are generally not flexible enough for
clinical applications.12
24
Figure 2.1: (A) TEOAEs probe containing miniature sound source and microphone
transducers. The soft disposable tip carries sound ports for the stimulus and for the microphone.
DPOAEs probes have an additional stimulus port. In some probes, all ports feed a single sound
tube. (B) The probe needs to be deeply inserted in the ear canal for maximum OAEs capture
and noise exclusion, with the cable positioned so as to avoid noise production on movement.13
2.3.2 MBII BERAphone
As we know there are two methods commonly used in universal newborn hearing
screening: Otoacoustic emissions (OAEs) and automated auditory brainstem
response (AABR), both methods being automated. AABR is superior to OAEs, among the
screening tests, because the AABR will be able to identify retrocochlear hearing impairments,
such as auditory neuropathy which are missed out on OAEs screening. The AABR test uses a
series of click sounds at 35 dB hearing level and detects brainstem responses to these stimuli.
AABR has also been found to be time and cost effective, with a high sensitivity and a low
failure rate.14
A B
25
The MB11 BERAphone is an AABR which has been found to be an effective neonatal
hearing screening tool. To identify the presence of an ABR response automatically, the device
uses a chirp stimulus and takes a maximum test time of 180 seconds based on an implemented
statistical test algorithm. This implemented test algorithm attempts to detect a response from
the auditory system. The screening test generates a “pass” result when a response is detected.
The screening test generates a “refer” result if there is no response within 180 seconds. The
device is set at a screening stimulus level of 35 dB HL for a pass.15
Based on a study by Andrea Melagrana et al, 2007, the MB11 BERAphone test showed
very good specificity 96.8% (95% CI 94.8—98.7%) and sensitivity 100% (95% CI 93.9—
100%) for diagnosis of hearing loss.3
Figure 2.2: Pass result16
26
Figure 2.3: Refer result16
2.3.3 Auditory Brainstem Response (ABR)
Two methods for neonatal hearing screening based on different physiological
phenomena are available: otoacoustic emissions (OAEs) and auditory brainstem response
(ABR). For the neonatal period, conventional ABR is considered to be the most reliable method
for assessment of the hearing level. Conventional ABR has long been recognised as the most
sensitive method of assessing the auditory acuity of newborns.16 The conventional ABR
method is not widely used for screening because it is time consuming, tends to be too expensive
and needs a well-qualified technician and audiologist to perform the test and evaluate the
results.17 Now, a second-generation Automated ABR infant hearing screener is available for
screening purposes. So in this study, a high risk newborn baby who receives a ‘fail’ during
hearing screening via OAEs and AABR will be screened again using conventional ABR.
27
2.4 THE COMPARISON BETWEEN OAEs AND AABR
The goal of newborn auditory screening is to identify accurately infants with significant
hearing impairment in the most rapid and cost effective way. Currently, the two recommended
methods for screening include evoked otoacoustic emissions (OAEs) and auditory brainstem
response (ABR). Both of these methods do not assess hearing. Rather, they are an objective
means for estimating the likelihood of adequate hearing function in newborns. Several
automated commercial devices have been developed to meet the increasing demand for
newborn hearing screening tests. They developed Automated Auditory Brainstem Response
(AABR), one of advance and modified branch of ABR. They provide a final pass or fail score
without the need for a subjective interpretation of the data. These devices are convenient in that
they may be utilized quickly by personnel who are typically not trained to perform a clinical
assessment of hearing.18
Based on a study by J.I. Benito-Orejas et al, from 2001 to 2003, all the newborns in
their health area (2454 infants) were evaluated with TEOAEs (ILO92, otodynamics) and all
those born from 2004 to 2006 (3117) were evaluated with AABR (AccuScreen, Fischer-
Zoth).18 The population studied included all healthy newborns and those admitted to neonatal
intensive care units (NICU). The results from each study group were compared and analysed
for significant differences. TEOAEs screening yielded 10.2% fail results from the first
screening step; AABR gave 2.6%. In the second screening step, 2.0% of the newborns screened
with TEOAEs were referred, whereas 0.32% of those screened with AABR were referred.
These differences are statistically significant.18
Based on a study by S. Meier et al, they did a study on a comparison of OAEs and
AABR by using Echoscreen-TDA from Fischer-Zoth, and two AABR screeners, the Algo 3
from Natus and the MB11 BERAphone from Maico.19 Transiently evoked otoacoustic
28
emissions (TEOAEs) were measured in one ear of 150 healthy newborns using the Echoscreen-
TDA. Three groups of 50 subjects each were tested additionally for AABR recordings either
with Echoscreen-TDA, Algo 3 or MB11 BERAphone. Their conclusion was that pass rates
were highest with 98% for AABR recordings using the Algo 3 and lowest with 92% for AABR
recordings using the MB11 BERAphone, but these differences were not statistically
significant.19
On the other hand, Bolajoko O. Olusanya et al, their study was about determining the
perinatal predictors of discordant screening outcomes based on a two-stage screening protocol
with transient-evoked otoacoustic emissions (TEOAEs) and automated auditory brainstem
response (AABR) under a hospital-based universal newborn hearing screening program in
Lagos, Nigeria. Their results were that 4718 of the infants enrolled under the program, 1745
(36.9%) completed both TEOAEs and AABR. Of this group, 1060 (60.7%) passed both
TEOAEs and AABR (‘‘true-negatives’’); 92 (5.3%) failed both TEOAEs and AABR (‘‘true-
positive’’), 571 (32.7%) failed TEOAEs but passed AABR (‘‘false-positives’’) while 22
(1.3%) passed TEOAEs but failed AABR (‘‘false-negatives’’).20
2.5 THE COMPARISON BETWEEN OAEs AND MBII BERAPHONE
The goal of newborn hearing screening (NHS) is to identify infants with significant
hearing impairment. A low false-positive rate is central to the success of a NHS program.
Therefore, minimizing false-positive results is critical in developing a more reliable newborn
hearing screening program. The otoacoustic Emissions (OAEs) and/or automated auditory
brainstem response (AABR) are most often used to detect sensory or conductive hearing loss.
Based on a study by Luca Guastini et al, they tested the validity of this automated ABR
screening method (using MB11 BERAphone) and OAEs in a multi-stage newborns hearing
29
screening (NHS). Among the 8,671 newborns tested (males 3,889; females 4,782), only 42
newborns were lost to follow-up and the final false positive rate was of 0.03%.16
Another study conducted by S. Meier et al, was of the comparison of currently available
devices designed for newborn hearing screening, done by using OAEs combining with 3
methods of AABR (the Echoscreen-TDA from Fischer-Zoth, and two AABR screeners, the
Algo 3 from Natus and the MB11 BERAphone from Maico).19 They used transiently evoked
otoacoustic emissions (TEOAEs) and distortion product otoacoustic emissions (DPOAEs),
measured in one ear of 150 healthy newborns and three groups of 50 subjects each and were
tested additionally for AABR recordings either with Echoscreen-TDA, Algo 3 or MB11
BERAphone. They concluded that the device was the easiest for EOAEs measurements with
the Echoscreen-TDA, followed by AABR recordings with the Algo 3 and Echoscreen-TDA
and were most difficult with the MB11 BERAphone. Pass rates were highest with 98% for
AABR recordings using the Algo 3 and lowest with 92% for AABR recordings using the MB11
BERAphone, but these differences were not statistically significant. Connecting the subject
was the most difficult with the MB11 BERAphone, but there were no disposable supply costs.19
Based on a study by Ozlem Konukseven et al, they used a combination in initial stage
of hearing screening by using OAEs and AABR (MB11 BERAphone) for their study to see the
accuracy of the screening. One thousand and nine hundred seventeen babies were tested with
both TEOAEs and AABR in the first day of their life. Out of 1917 neonates, 202 (10.53%)
failed the initial TEOAEs, and 37 (1.97%) failed the initial AABR. Hundred and fifty eight of
the 202 neonates who failed the TEOAEs and all neonates that failed AABR were subjected to
the second test. Four (2.5%) neonates failed the second TEOAEs, and three (1.89%) failed the
second AABR.21
30
A recent study by M. van Dyk et all, 2015 was done at a hospital in South Africa, which
is a comparison of TEOAEs and AABR using MB11 BERAphone. This study evaluated the
outcome of NHS within the first 48 hours. NHS was performed on 150 healthy newborns (300
ears) with TEOAEs and AABR techniques before being discharged from the hospital. Over the
three-stage screen, the AABR had a significantly lower refer rate of 16.7% (24/144 subjects)
compared to the TEOAEs 37.9% (55/145 subjects). Screening refer rate showed a progressive
decrease with increasing age.22
2.6 THE AGREEMENT OF OAEs AND MBII BERAPHONE
There were no specific journal done for the agreement among OAEs and AABR. Based
on Andrea Melagrana et al, the comparison of MB11 BERAphone and Auditory Brainstem
Response in newborns is at an audiologic risk. They had done a sample of newborns evaluated
after the second month of life from October 2002 to February 2005. The study was performed
on full-term newborns who presented with altered otoacoustic emissions and in newborns
considered at audiologic risk admitted to the Otorhinolaryngology (ORL) Unit of Giannina
Gaslini Institute. The sample included 201 children (104 males and 97 females) who underwent
on the same day, an audiologic test using MB11 BERAphone and standard ABR test. The
results were, out of the 388 ears examined, 378 (97.4%) showed agreement between the two
techniques, whereas in 10 (2.6%) there was no agreement. Inter-observer agreement was
excellent (kappa = 0.92, p = 0.0001).3 There is currently no known study by anyone comparing
the OAEs methods with the AABR about the agreement of neonatal hearing screening.
31
2.7 THE TOTAL TIME SPENT BETWEEN OAEs AND MBII BERAPHONE
Although TEOAEs hearing screening was easier and more comfortable to perform than
that of AABR, the differences are becoming less and less important. As new generations of
AABR devices are developed, administration time is decreasing. It is true that screening test
time varies depending on the child’s hearing, the presence of partial obstructions in the external
auditory canal or the middle ear and on test conditions. Based on a study by J.I. Benito-Orejas
et al, which was conducted from 2001 to 2003 in 14 hospitals in Spain with all the newborns
in their health area (2454 infants) being evaluated. They have noted that the average time
needed to carry out automated ABR testing ranges from 8 to 15 minutes and conventional
TEOAEs tests take from 2 to 13 minutes. They calculated, without exact measurements, that
each test took an average of 15 minutes using the specified AABR equipment and about 10
minutes using that of TEOAEs.18
Another study by S. Meier et al, compared the OAEs with 3 other methods of AABR.
They used transiently evoked otoacoustic emissions (TEOAEs) and distortion product
otoacoustic emissions (DPOAEs) and measured in one ear of 150 healthy newborns using the
Echoscreen-TDA. Three groups of 50 subjects each were tested additionally for AABR
recordings either with Echoscreen-TDA, Algo 3 or MB11 BERAphone. From the study, they
noted that the median test time on one ear was less than 30 seconds for OAEs measurements
and 4 to 5 minutes for AABR recordings. 19
32
3. OBJECTIVES
33
3. OBJECTIVES
3.1 The general objective of this study:
To compare MB11 BERAphone and Integrated Electrodes and Otoacoustic Emissions
(OAEs) as a screening tool for hearing loss in high risk newborn
3.2 The specific objectives are:
1. To determine the association of passing and referral rate between MB11 BERAphone
and OAEs in high risk newborn
2. To determine true and false positive rate for hearing loss using MB11 BERAphone and
OAEs with ABR as a gold standard
3. To determine the agreement passing and referral rate between MB11 BERAphone and
OAEs in high risk newborn
4. To compare the total staff time spent for hearing screening program with MB11
BERAphone versus OAEs in high risk newborn
34
3.3 RESEARCH HYPOTHESIS
1. Hyperbilirubinaemia and ototoxic medications are the commonest the risk factor
between MB11 BERAphone and OAEs in high risk newborn
2. There is significant difference of passing and referral rate between MB11 BERAphone
and OAEs in high risk newborn
3. There is high agreement of referral rate between MB11 BERAphone and OAEs in high
risk newborn
4. There is significant different of mean of total staff time spent between MB11
BERAphone and OAEs as screening program in high risk newborn
35
4. METHODOLOGY
36
4. METHODOLOGY
4.1 RESEARCH DESIGN
This was an observational study (a cross sectional study design). The study was conducted at
neonatal unit, Hospital Universiti Sains Malaysia (HUSM), Kubang Kerian, Kelantan from
April 2014 until December 2014.
4.2 PARTICIPANTS
All high risk newborns who were admitted to neonatal unit Hospital Universiti Sains Malaysia
(HUSM) and who had fulfill the inclusion criteria and exclusion criteria.
4.2.1 INCLUSION CRITERIA
The inclusion criteria for the study:
1. Meningitis
2. Birth weight <1500g
3. Craniofacial anomalies
4. Mechanical ventilation > 5 days
5. Low APGAR scores (0–4 at 1 min or 0-6 at 5 min)
6. Family history of hereditary childhood sensory neural hearing loss
7. Hyperbilirubinemia (severe jaundice- total bilirubin >300umol/L, early onset jaundice,
<24hours, rapidly rising jaundice >8.5umol/L/hr) or requiring exchange transfusion.
8. In utero infections (TORCH—toxoplasmosis, others (e.g. syphilis), rubella,
cytomegalovirus, herpes)
37
9. Stigmata or other findings associated with a syndrome known to include sensory
neural and/or conductive hearing loss (eg: Down syndrome)
10. Ototoxic medications including but not limited to aminoglycosides used in multiple
courses or in combination with loop diuretics
4.2.2 EXCLUSION CRITERIA
The exclusion criteria for the study:
1. All healthy new born without a risk factor
2. Lethal congenital malformation
3. Severe neurological deficit since birth
4.3 INTERVENTIONS
This is an observational study which is a cross-sectional study designed to involve two
methods with the same subject. All newborns who were admitted to the neonatal unit in
Malaysia are made as a reference of this study. The source of population are all high risk
newborns who were admitted to the neonatal unit of Hospital Universiti Sains Malaysia
(HUSM), Kelantan and those who have fulfilled the inclusion and exclusion criteria will
participate in our study.
The researcher had explained about the study to the parents and caretakers, and the
inform consent was taken. The high risk babies who have fulfilled the inclusion and exclusion
criteria in the neonatal unit were subjected to OAEs and followed by MB11 BERAphone
screening test at the same setting as near to discharge as possible or once the patient is stable
enough to do a hearing screening. The test was done in their bassinets in the neonatal unit itself.
This is a non-invasive procedure with no sedation given to the babies. To minimise the risk of
38
infection, alcohol swab were used to sterilise the instruments after using them, and before
screening another baby. The de-identification of patients will be ensured.
The neonates were tested in a sleeping or quiet state. The parents are allowed to help
calm their baby during the procedure. Both instruments produced a “pass” or “refer” result and
did not require any special skills for the interpretation of results. The test was repeated two
times in cases with “refer” result to confirm that it is not due to external factors. The “refer”
result from OAEs and MB11 BERAphone will be screened by using ABR to determine the
false positive. The time will be measured by the total time the staff spent on each instrument.
To minimize the measurement bias, two testers will be used to handle both screening methods.
All data were recorded on a data collection sheet and entered into IBM Statistical
Package for Social Sciences (SPSS) Statistics 21 by the main researcher. All documentation
was locked in a secure cabinet and was kept confidential for the length of this study.
4.4 OUTCOMES
The Neonatal Hearing Screening (NHS) programs have the purpose to help identify
hearing loss early, reducing the age of audiological diagnosis and therapeutic intervention. Two
physiological procedures are currently recommended: the evoked Otoacoustic Emissions
(OAEs) and the Automated Auditory Brainstem Response (AABR). However, the Auditory
Brainstem Response (ABR) is still a gold standard for neonatal hearing screening. In this study,
by using both methods, we were screening newborns with high risk factors and comparing the
effectiveness of both methods in term of passing rate, total time spent using both methods, the
agreement of screening methods and referral rate by using ABR as a second screening.
39
4.5 SAMPLE SIZE
Sample size calculation:
1. Based on objective 1 are Mc Nemar Test and kappa agreement.
A. For Mc Nemar Test :
The sample size was calculated using PS software (Dupont & Plummer, 2009) and
online calculation at http://sampsize.sourceforge.net/iface. Based on studies by Meier
et al. (2004) and Abdul Wahid et al. (2012) and by using PS software the minimal
sample size is 65 babies.
Based on studies by Meier et al. (2004) and Abdul Wahid et al. (2012) and by using PS
software:
α 0.05
Power (1-β) 0.9
Failure rate in control (p0) 0.08
Failure rate in tested group (p1) 0.3
Group ratio (m) 1.0
Minimum sample size 65
40
B. For Kappa (concordant observation) and the sample size was calculated using Stata
software (sskdlg). The minimal sample size is about 195 babies.
The sample size was calculated using Stata software (sskdlg):
Expected kappa 0.80
Proportion positive by rater 1 0.92
Proportion positive by rater 2 0.90
Precision 0.15
Minimum sample size 195
2. Based on Objective 3 using Paired T- Test and the sample size cannot be calculated as there
are no data on mean and standard deviation in the previous studies (effect size was unable
to be determined).
The sampling methods are using non-probability sampling in our study. Based on calculation
using Kappa (concordant observation), we decided that our sample is 195 newborns and no
drop outs in our study. In this study the newborns were chosen after being admitted to our
neonatal ward as they had fulfilled the inclusion criteria and were screened via two hearing
screening methods. Data was entered and analysed using SPSS (Statistical Package of Social
Science) software version 21.0.
41
4.6 ETHICAL APPROVAL
The study was approved by the Research and Ethics Committee, School of Medical Sciences,
Universiti Sains Malaysia. A inform consent will be obtained by investigators from parents
before conducting the procedure. The consent form will be uploaded from the Human Research
Ethics Committee (HREC), Universiti Sains Malaysia (USM).
4.7 STATISTICAL ANALYSIS
Data entry and analysis were performed using the IBM Statistical Package for Social Sciences
(SPSS) Statistics version 21.0 software. These data were analysed using the Predictive
Analytics Software (PASW) for Windows version 21.0. Numerical data were presented in
mean (standard deviation), unless data was skewed, then it will be presented in median (IQR =
interquartile range). Categorical data were presented in frequency (percentage). Normal
distribution was checked using histogram with normal distribution curve and Whisker and
boxplots. For comparison for both methods, we used the Mc Nemar test and Measurement of
Kappa for agreement of both methods. A two tailed p value of <0.05 was considered
statistically significant.
42
4.8 DEFINITIONS:
PASS RATES
A ‘‘pass’’ was defined as follows:
(a) Testing provided a ‘‘pass’’ after the first measurement or
(b) The ear probe, coupler earphone or the applicator were removed and repositioned if
testing did not give a pass, and measurements were repeated once to achieve a ‘‘pass’’
result.
REFER RATES
The test was rated as “refer”, if both measurement fail.
TOTAL TESTING TIMES
The total test time include the time for the unit startup, the preparation of the subject, the
measurement, and the unit shut down. The time for the unit startup include the time for starting
up the PC (Personal Computer) or the device only, if no PC was required. Preparation time
include fitting the probe, coupler earphones or the applicator in/around the ear and attaching
the electrodes to the infant. These time segments were measured with a stopwatch by the
observer.19
43
4.9 FLOW CHART
Comparison of Automated Auditory Brainstem Response (AABR) with Integrated Electrodes
and Otoacoustic Emissions (OAEs) in High Risk Newborn Hearing Screening
Source of Population:
All high risk newborns who admitted to neonatal ward, HUSM,
Kelantan
Inclusion criteria
Exclusion criteria
Sample, n = 195
OAEs, n:195
Total Screening
Duration (minutes)
MB 11 BERAphone,
n:195
Total Screening
Duration (minutes)
Data entry, Analysis and Interpretation
using SPSS 21.0
Write up and preparation for thesis
Thesis Submission
Pass Refer
ABR
44
5.RESULTS
45
5. RESULTS:
5.1 SAMPLE CHARACTERISTICS
During the period of study, a total of 195 newborns with high risk were screened in the neonatal
unit, Hospital Universiti Sains Malaysia. All the 195 babies had fulfilled the inclusion and
exclusion criteria and their parents/caretakers have consented. The babies were screened via
Integrated Electrodes Otoacoustic Emissions (OAEs) and Automated Auditory Brainstem
Response (using MB11 BERAphone) on both ears. Each machine was set for the timing and
the result who were “refer” to one or both ears of both these machines were subjected to
auditory brainstem response (ABR) within 3 months after discharge. There were newborns who
were missing in our follow-up for ABR screen. There were a few factors causing them to count
as a loss in our follow-up, which will be elaborated further in the next result and discussion.
46
The flow diagram of the study as shown in figure 5.1.
Source of Population:
All high risk newborns who admitted to neonatal ward, HUSM,
Kelantan
Inclusion criteria
Exclusion criteria
Sample, n = 195
OAEs, n:195
Total Screening
Duration (minutes)
MB 11 BERAphone,
n:195
Total Screening
Duration (minutes)
Data entry, Analysis and Interpretation
using SPSS 21.0
Pass, n:
OAEs: 166
MB11: 175
Refer, n:
OAEs: 29
MB11: 20
ABR, n: 17
Total Refer,
n: 31
Loss of
follow up,
n:14 *One patient may have “refer”/ “pass” both methods
Total Pass,
n: 164
47
5.2 DEMOGRAPHIC DATA
5.2.1 DEMOGRAPHIC CHARACTERISTICS
As shown in table 5.1, the total newborn babies who were involved in this study were 195
babies. Among them, 87 babies are boy and 108 babies are girl. The newborn babies were
recruited from neonatal unit, Hospital Universiti Sains Malaysia and the hearing screening was
done as near to discharge as possible or once the patient is stable enough to do a hearing
screening The distribution as shown in table 5.1. The median age during this study was 7 days
old and base on inter-quartile range (histogram skewed to the right) were between 3 – 14 days
old.
Table 5.1: Demographic profile of newborn baby undergone hearing assessment using
Integrated Electrodes Otoacoustic Emissions (OAEs) and MB11 BERAphone (n=195)
Variables
n
(%)
Gender
Boy 87 44.6
Girl 108 55.4
Ethnic
Malay 191 98.0
Chinese 3 1.5
Indian 0 0.0
Other 1 0.5
Age (days)
Median (IQR) 7 (25th, 75th)
* IQR = interquartile range (25th – 75th )
* Ethnic; other: siamese
48
5.2.2 ETHNIC DISTRIBUTION
A hundred ninety one of these babies were Malay. Three were Chinese and only one was
Siamese. This is graphically shown in Figure 5.2.
Figure 5.2: Ethnic distributions of newborn baby who had undergone hearing assessment
using Integrated Electrodes Otoacoustic Emissions (OAEs) and MB11 BERAphone (n=195)
191
3 1
Ethnic
Malay Chinese Others
49
5.3 RISK FACTORS AMONG NEWBORN
Risk factors were identified in 195 newborns. The most often risk factors were:
administration of ototoxic medications, hyper bilirubinaemia and newborn with a birth
weight of less than 1500 grams. As the list stated below, the newborns have at least one
risk factor.
Tables 5.2: Risk factors of hearing loss among newborns in the neonatal unit, Hospital
Universiti Sains Malaysia (HUSM),( n= 195 )
Risk Factors n (%)
Family history
6
3.1
In utero infection 11 5.6
Syndromes 4 2.1
Birth weight < 1500 gram 53 27.2
Hyper bilirubinaemia 100 51.3
Ototoxic medications 101 51.8
Meningitis 6 3.1
Low Apgar score 5 2.6
Mechanical ventilation > 5d 7 3.6
Craniofacial anomalies 6 3.1
* One patient may have multiple risk factors
50
5.4 THE COMPARISON BETWEEN OAEs AND MBII BERAPHONE
During the screening of 195 newborns with both OAEs and AABR, we found that 164 (84.2%)
newborns were ‘pass’ and 18 (9.2%) newborns results were ‘failed’ with hearing screening
using both methods. There was an association between the results of hearing screening between
two methods. The P value was significant (p= 0.022). The data is as shown in the Table 5.3:
Table 5.3: The contingency table of findings using Integrated Electrodes Otoacoustic
Emissions (OAEs) and MB11 BERAphone
MB11
Pass Refer P valuea
Pass
164
2
(84.2%) (1.0%)
OAEs
Refer 11 18 0.022
(5.6%) (9.2%)
a Mc Nemar Test
*p value <0.05 indicate significant
51
5.5 THE “REFER RATES” OF OAEs AND ABR
Among these 195 high risk newborn, there were 31 newborns having the result “refer” during
screening with both methods. Out of 31 newborns, only 17 newborns went through a second
screening via the gold standard, ABR. Out of 17 newborns, 15 newborns had the result “refer”
via OAEs method whether from one or both ears. The table below showed the result
“refer” from OAEs and the second screening with ABR.
Table 5.4: The true and false positive rate for hearing loss using OAEs and a gold standard
Auditory Brainstem Response (ABR), n = 17
OAEs
Pass Refer
Pass
2 (11.8%)
12 (70.6%)
ABR
Fail 0 (0.0%) 3 (17.6%)
*One patient may have “refer rate” from both methods
52
5.6 THE “REFER RATES” OF MBII BERAPHONE AND ABR
Only 31 newborns had the result of “refer” from both methods. Out of these 31, 17 newborns
need to undergo a second screening via ABR. From that, 11 newborns had the result “refer”
via MB11 BERAphone method whether on one or both ears. The table below shows the result
“refer” from MB11 BERAphone and second screening with ABR:
Table 5.5: The true and false positive rate for hearing loss using MB11 BERAphone and the
gold standard Auditory Brainstem Response (ABR)
MB11
Pass Refer
Pass
5 (29.4%)
9 (52.9%)
ABR
Fail 1 (5.9%) 2 (11.8%)
*One patient may have “refer rate” from both methods
53
5.7 THE AGREEMENT BETWEEN OAEs AND MBII BERAPHONE
As the table below shows, the Kappa statistic is 0.698, although there are 182 cases which
agree between two tests out of the total of 195 cases. There was a substantial agreement
between passing and referral rate of Integrated Electrodes Otoacoustic Emissions (OAEs) and
MB11 BERAphone by using the Kappa statistic.
Table 5.6: The agreement between passing and referral rate between MB11 BERAphone and
OAEs by using Kappa statistics, (n=195).
MB11
Pass Refer P value
Pass
164 (84.2%)
2 (1.0%)
OAEs
Refer 11 (5.6%) 18 (9.2%)
Measure of agreement Kappa
(value)
0.698 <0.001
*If Kappa is “zero”, agreement is only at the level expected by chance.
*If Kappa is “negative, the level of agreement is less than by chance.
*If Kappa: 0-0.2=slight; 0.2-0.4=fair; 0.4-0.6=moderate; 0.6-0.8=substantial; >0.8=almost
perfect
54
5.8 THE TOTAL TIME SPENT AMONG STAFF BETWEEN USING OAEs AND
MBII BERAPHONE
There were two machines used for this hearing screening. The total staff time spent was
recorded by using OAEs machine and MB11 BERAphone. The median for total time using the
OAEs machine was about 2 minutes and the MB11 BERAphone was about 5 minutes duration
during the hearing screening. The table is as shown below:
Table 5.7: The comparison of total staff time spent in minutes for screening programs
between Integrated Electrodes Otoacoustic Emissions (OAEs) and MB11 BERAphone.
Median (IQR)
(minutes)
Z- Statistic
P valuea
OAEs
2 (25th, 75th)
MB11
5 (25th, 75th)
-10.851 <0.001
a Wilcoxon Signed Rank Test
* IQR = interquartile range (25th – 75th)
55
6. DISCUSSION
56
6. DISCUSSION
The incidence of permanent hearing impairment in newborn infants ranges between
1.0% and 5.5 % across regions and countries.5 Hearing loss may have significant adverse
effects on the development of speech, language capabilities and social emotional development,
as well as leading to worsening educational and occupational performance in adulthood.
Regular infant physical examinations cannot detect hearing loss, so neonatal hearing screening
(NHS) is necessary. Many studies have illustrated the validity and reliability of universal
neonatal hearing screening (UNHS) programs in the early detection of newborn hearing
impairment.5
This increase in newborn hearing screening resulted from several factors. Firstly,
largely as a result of the pioneering efforts of Dr Marion Downs, the importance of newborn
hearing screening became recognised as early as 1969, when the Joint Committee on Infant
Hearing was established. Secondly, the identification of hearing loss in the neonatal period
became possible by the late 1980s as a result of the revolutionary work of Dr David Kemp in
the development of the otoacoustic emissions (OAEs) technology that could be applied to the
screening of hearing in infants and the development of automated procedures and equipment
for doing auditory brainstem response (ABR) testing. With the availability of this technology,
Surgeon General C. Everett Koop issued an ambitious challenge in 1988 that by the year 2000,
90% of all infants who were born with significant hearing loss would be identified by 12
months of age.23
There were many studies regarding hearing screening in newborns and some research
comparing methods of hearing screening in which mostly were using otoacoustic emissions
(OAEs) and automated brainstem response (AABR). There were a few studies done by
comparison of methods in high risk newborns. In this study, the neonatal hearing screening
57
was done in Hospital Universiti Sains Malaysia (HUSM), Kubang Kerian, Kelantan by
comparing two methods, OAEs with MB11 BERAphone in high risk newborns.
6.1 Demographic Characteristics and Risk Factors in Newborns
In our study, the median age for high risk newborns during the hearing screening was
7 days old with girls more than boys in the gender distribution. During the study period, we
identified that most of the newborns are Malays, compared to other races. It could be because
in Kelantan, the majority of the population are Malays. We have one patient who is Siamese,
possibly due to Kelantan being a state close to neighbouring Thailand. The most common risk
factors in our study were hyper bilirubinaemia and ototoxic medications. Almost 50% of our
high risk newborns who were screened suffer from both risk factors. The birth weight is less
than 1500 grams, comprising also about 27% among risk factors. In my study, each newborn
screening may have at least one risk factor.
In a study by Wroblewska-Seniuk et al, they aim to evaluate the results of newborn
hearing screening by means of TEOAEs. From their study, the risk factors were identified in
739 newborns and the most often found risk factors were: use of ototoxic drugs, low apgar
score and prematurity. The ototoxic medications were observed as an important risk factor in
most cases were not a single risk factor.13
In the study performed by A. Zamani et al, the incidence of hearing loss in neonates
who were in the NICU for more than 48 hours was about 2-4%. Patients hospitalised in the
NICU must be screened for hearing loss, because these neonates probably have more problems
and multiple risk factors, such as prematurity, low birth weight, use of ototoxic drugs and
mechanical ventilation.24
58
There is one study done in Hospital Universiti Sains Malaysia, Kubang Kerian under
Hidayah S.N et al, about a comparison of OAEs and AABR which involved 73 newborns. In
the study, it showed that ototoxic medication was the most common risk factor followed by
hyperbilirubinaemia and low birth weight.2
The least risk factor in our study was syndromic baby, about 2%. In our study in high
risk newborns, the median of age was 7 days, however, the age of hearing screening ranged
from 2 to 100 days because some preterm infants required a longer stay due to few reasons
such as awaiting weight gain, establishing feeding and etc. In Tersia de Kock et all, the mean
age at first stage screen was 6.1 days (SD 8.1) and the age of hearing screening ranged from 0
to 189.25
6.2 The Comparison Result between Two Methods
The acceptable methods for universal newborn hearing screening include both OAEs
and AABR, either alone or in combination. The OAEs method measures sound waves
generated in the inner ear (cochlea) by miniature microphones placed in the external ear canals.
Although OAEs screening is quicker and easier to perform than AABR, OAEs is affected by
external ear wax or fluid.26 The AABR measures the electroencephalographic waves generated
in response to a click sound by three electrodes pasted to the infant’s scalp.26
While newborn hearing screening provides early detection of babies with hearing loss,
it also helps to differentiate auditory neuropathy (AN) and auditory dyssynchrony (AD) cases
when the screening is performed with both AABR and otoacoustic emissions (OAEs) tests.
Thus, the routine combined the use of AABR and OAEs tests in UNHS programs, especially
for high-risk infants, and is thought to provide better detection of newborns with AN/AD.27
59
In this study, we are comparing both methods by using OAEs and MB11 BERAphone
in high risk newborns. The result in our study by using a comparison between OAEs and MB11
BERAphone showed both methods agree that 164 (84.2%) out of 195 newborn passed the test
during hearing screening. A total of 31 (15.4%) newborns ‘failed’ during this hearing screening
using both methods. From 31 newborns who failed this hearing screening, only 18 (9.2%) were
showed fail results by both machines. By using MB11 BERAphone only 20 newborns were
refer rate compared to using the OAEs, about 29 were refer rate. This shows that using MB11
BERAphone (AABR) has a lower refer rate compared to OAEs. However, there was an
association between the results of hearing loss examination between two methods. The P value
was significant (p= 0.022).
M. van Dyk et al in their study, over the three-stage screen AABR (MB11 BERAphone)
had a significantly lower refer rate of 16.7% (24/144 subjects) compared to TEOAEs 37.9%
(55/145 subjects). For both TEOAEs and AABR, refer rate per ear screened 24 hours post birth
was significantly lower than for those screened before 24 hours. For infants screened before 12
hours post birth, the AABR refer rate per ear (51.1%) was significantly lower than the TEOAE
refer rate (68.9%).22 Based on a study by S.Noor et al, by comparison, OAEs and AABR
showed significant differences. TEOAEs screening yielded 10.2% fail results from the first
screening step, while AABR gave 2.6%. In the second screening step, 2.0% of the newborns
screened with TEOAEs were referred, whereas 0.32% of those screened with AABR were
referred.2 In NICU babies, the different aetiologies have different referral rates. The presence
of OAEs provides direct evidence of the existence of an active mechanism in the cochlea.
However, OAEs will be absent if there is a significant external and/or middle ear problems.
Besides that, the OAEs test must be done in an environment where it is quiet, the infants are in
a calm condition and the probe tip is snugly fitted in order to get reliable results. 2
60
The AABR test measures the electrical activity beyond the cochlea until the lower
brainstem level and in contrast to the OAEs test it is less affected by the outer, middle and/or
inner ear disorders. Therefore, the utilisation of AABR technology rather than OAEs will
further improve the values of passing rate and false positive. However, similarly to OAEs, the
results of AABR test is also subjected to the influence of factors such as the environmental
noise, child condition and equipment condition during the testing. 2
6.3 The Refer Rate of OAEs and MBII BERAphone with Second Screening Using ABR
Auditory Brainstem Response (ABR) is the gold standard test, which is essential to a
correct neonatal screening programme both in patients not passing the test with otoacoustic
emission and in patients coming from NICU. However, it has some drawbacks such as high
cost, difficult instrument transportation, long execution time, and a need for qualified personnel
to interpret the ABR.3 Because of that, they modified it to provide an easier way in which it
developed automated auditory brainstem response. In this study, we were using OAEs and
MB11 BERAphone as the first screening. The resulting “refer” will be screened again by using
this afore-mentioned gold standard as the second screening.
In our study from 195 high risk newborns, 31 newborns had the result “refer” during
first screening using both methods: OAEs and MB11 BERAphone. From that we gave them an
appointment for the second screening, using ABR within 3 months. Out of 31 high risk
newborns whose results were “refer” with both methods, only 17 newborns had undergone the
second screening within 3 months and 14 newborns were loss from the follow up. It was about
45% of our study by using second stage of screening was lost to this loss of follow up.
Internationally, loss to follow-up is one of the greatest challenges experienced in newborn
61
hearing screening programmes, with follow-up rates in the region of 50% often being
reported.25
In Koenraad Smets et al, they showed that 25% from their study have loss follow up
due to the babies passing away, multiple congenital anomalies required first line ABR and
some have no apparent reason for not being screened.28 In this study, 14 of our patients who
were loss to our follow up, and they have a few reasons to explain it. The reasons were: loss of
their contact numbers, staying far away from our place of study, difficulty in transportation,
infant death and a few patients just refused to come for further screening due uncertain reasons.
Based on our study by using ABR for the second screening, the true positive result is
(OAEs: 17.6%, MB11: 11.8%), true negative (OAEs: 11.8%, MB11: 29.4%), and false positive
(OAEs: 70.6%, MB11: 52.9%). However, the false negative in OAEs was 0.0% compared to
MB11 BERAphone which was 5.9%. From this study, MB11 BERAphone had a better result
compared to OAEs. Unfortunately, the MB11 BERAphone had false negative result compared
to the OAEs in which this gave significant impact of effectiveness of the MB11 BERAphone
when screening the babies. This produced a warning that the chance of missed patients with
hearing impairment is higher in MB11 BERAphone compared to usage of the OAEs. In our
study, the MB11 BERAphone also has a lower false positive rate compared with OAEs.
In a study by Luca Guastini et al, they have noted that by using MB11 BERAphone
there was lower false positive rate compared to OAEs. But the conventional auditory brainstem
response is still the most reliable method for assessing the hearing level and minimising the
false-positive rate. They have noted that AABR is easy to use, fast and with a good compliance,
but the device is unable to provide accurate and certain diagnosis on the degree of hearing loss
to allow a proper treatment.16
62
Adrea Melagrana et al, were using MB11 BERAphone screening with ABR on
audiologic risk newborns and showed that the MB11 BERAphone test yielded no false
negatives and 10 false positives which resulted as normal at ABR. The MB11 BERAphone test
showed very good specificity 96.8% and sensitivity 100%, positive predictive value 88.2% and
negative predictive value 100% for diagnosis of hearing loss.3
In our study, it showed that the referral rate in MB11 BERAphone was lower compared
to OAEs. A few studies also showed the same as results as ours did. The research by Ozlem
Konukseven et all, showed that a first stage screening using the AABR method, it has the lowest
false positive rate, referral rate and high specificity.21
Bolajoko O. Olusanya et al, stated that the 4718 infants enrolled under the program
1745 (36.9%) completed both TEOAEs and AABR. Of this group, 22 (1.3%) passed TEOAEs
but failed AABR (‘‘false-negatives’’).20 Similar to our study, one patient passed during
screening via MB11 BERAphone, however the result showed false negative via ABR. There
are possibly a few reasons why the MB11 BERAphone is showing a false negative result in
our study. First, it is possible due to lack of experience and technique by our testers who were
using this machine especially when it took more time to screen the baby to maintain the
effectiveness of this machine. Second, there is a possibility that due to the movements of the
babies or them not really being calm during screenings caused some effects on the results.
Third, it is possible due to uncertain medical conditions that will be affecting their hearing
function later on. Some available evidence also suggests that some false-negatives are likely to
be associated with both pathological and medical conditions in which the infant cannot avoid
during screening.20 For example, while the prevalence of AN/AD varies widely across studies,
rates of up to 15% have been reported among infants with permanent hearing loss or less than
1% among ‘‘at risk’’ population in developed countries.27
63
Other potential contributors to false-negatives based on evidence from the literature
include progressive or delayed-onset hearing loss possibly from asymptomatic
cytomegalovirus (CMV) as well as acquired hearing loss following the use of ototoxic drugs
after TEOAEs screening.20 In this study, it showed that the false negative rates is lower
compared with false positive rates and supported with data from UNHS. However, both
outcomes are sources of concern in any screening program particularly for ‘‘irreversible’’
conditions like sensorineural hearing loss that is also associated with social stigma.
6.4 The Agreement between two methods
The first important finding was that, though patients’ age ranged from 2 to 100 days,
the results obtained with the two tests were very similar. In our study, out of the 195 high risk
newborns examined, 182 (93.3%) showed agreement between the two techniques, whereas in
13 (6.6%) there was no agreement. The inter-observer agreement was good (kappa = 0.698, p
= <0.001). The inter-observer agreement was described by using Cohen’s k statistics. Results
were expressed as k values and could be classified according to the scale of Landis and Koch
as follows: slight (0.0—0.20), moderate (0.41—0.60), good (0.61—0.80), and excellent
(0.81—1.00).29 In our study, it showed a p value less than <0.001 and was considered
statistically significant, and all p values were based upon two tailed tests.
There was a study which showed the kappa agreement in which in Andrea Melagrana
et al conducted a hearing screening using MB11 BERAphone with ABR in audiologic risk, and
their agreement showed an excellent and statistically significant result (kappa = 0.92 , p =
0.0001).3 Another study done by E. van den Berg et al, showed good kappa agreement (kappa
= 0.709) between MB11 BERAphone and AABR in a pilot study.14
64
6.5 The Testing Time
For the neonatal period, conventional ABR is considered to be the most reliable method
for assessment of hearing level. The conventional ABR method is not widely used for screening
because it is time consuming and it needs a well qualified technician and audiologist to perform
the test and evaluate the results. Now, a second-generation Automated ABR infant hearing
screener is available for screening purposes. Most of the babies were screened within neonatal
period, which is before hospital discharge in nearly all cases. The time necessary for screening
is supposed to be 4 to 7 minutes for second-generation devices in an inpatient setting.17 In our
study, we were testing the total time spent by staff required to screen the ears each baby using
OAEs and MB11 BERAphone. We are trying to compare the time required between two
methods.
In HLM van Straaten et al, they had done a study about ALGO AABR in neonatal
hearing screening in which they used the second generation AABR. In this study, they noted
that the mean screening time in the NICU setting seems to be somewhat longer than in universal
neonatal hearing screening. Since the introduction of the second-generation AABR screening
devices the mean screening time has been reduced from 26 to 13 minutes, mainly as a result of
a reduction in preparation time.17
In our result, it showed that the total time spent by staff during screening of each high
risk newborn baby were different between OAEs and MB11 BERAphone. The total test time
which included the time for the unit start-up, the preparation of the subject, the measurement,
and the unit shut down. By using OAEs during screening, the median total test time was 2
minutes (IQR: 25th – 75th) as compared to the MB11 BERAphone AABR test with a median of
5 minutes (IQR: 25th – 75th). There were differences of time duration while screening these
high risk newborns using both methods. In this study, we noted that by using OAEs, it required
65
less time compared to the MB11 BERAphone. Statistically, the comparing of time between
two methods was significant, with p value <0.001. This is important to know to minimise the
time spent by staff for the screening per day.
However, in a study M. Hahn et al, by comparing ALGO AABR and OAEs, they found
that Automated ABR was to be less time-consuming than TEOAEs screening even in the Quick
Screen mode. The median total test time, preparation and follow-up time included, was 9
minutes as compared to TEOAEs screening, with the median of 12 minutes.30
Over the years with the experience of technicians and audiologists, the duration became
less for the hearing screening. A study by Luca Guastini et al evaluated an automated auditory
brainstem response in a multi-stage hearing screening and it shows several advantages of
screening by the AABR with MB11 BERAphone (non-invasive), acoustic stimulus not related
to the external ear canal condition, easy, quick the testing time per infant ranges from 1 to 5
minutes.16 M. Cebulla et all, conducted a study on mean detection time for MB11 BERAphone
but the screening does not include the time required for preparation or documentation. A
maximum test time of 180 seconds was possible for the recording of each test. The test times
showed a median value of 28 seconds and a range of 15 to 112 seconds (5 – 95th percentile).31
Even though the MB11 BERAphone took more time compared to the OAEs, it took
less time duration compared to other AABR and ABR. In Meier et al’s study, they compared
the testing times between OAEs, AABR and also ABR. Based on their study, it showed that
the time to start up the unit was longer for Algo 3 and MB11 BERAphone, both of which also
required a computer, than for Echoscreen. Median preparation and measuring time was shorter
for OAEs measurements compared to AABR recordings. The preparation time for AABR
recordings with the MB11 BERAphone was shorter than the preparation time for AABR with
the Echoscreen and Algo 3, because the MB11 BERAphone does not use electrodes which
66
need to be fixed separately. The measuring time of AABR with the Algo 3 was longer compared
to the other AABR units. The median time for measurement without preparation was 7 to 13
seconds for the Echoscreen- TDA using OAEs, 68 to 77 seconds using ABR, 50 seconds for
the MB11 BERAphone and 167 seconds for the Algo 3 device.19
It is supported with the study by E. van den Berg et al, the mean MB11 BERAphone
test time was shorter 11.4 minutes (SD 6.6) than with the ALGOTM portable 13.9 minutes (SD
8.1) eventhough it was not significant (p < 0.08) with a maximum difference of 18 minutes.32
However sometimes the testing time depends on a few reasons:
1) It takes a longer duration because the newborns may be aroused and become noisy, so
that either the test became interrupted and had to be repeated later, or much more time
will be needed in order to complete the test.
2) The technician in charge: whether it was performed by otolaryngologists, which is not
a common practice in most countries when testing is performed by individuals with
minimal qualifications.33
3) The most commercially available equipment the recorded parameters are continuously
evident and refreshed on screen, and may be easily estimated in order to stop the
examination manually.33 This would result in significant time saving and improving the
overall efficiency of the screening program.
So we believe that if the test is performed by a professional as soon as possible with modern
methods, the average recording time is further reduced, because the newborns are less likely to
be aroused and become noisy, interfering with the test procedure.
67
6.6 LIMITATION OF STUDY
1) The sample of study may not be big enough to get a better result.
2) Almost 50% of patients who yield the result “refer” during hearing screening using
OAEs and MB11 BERAphone were loss to follow up for second screening by using
gold standard ABR. There were a few reasons:
a. Loss of their contact number. We gave their appointments within 3 months, but
during that time the parent already changed their phone number.
b. One patient passed away in the ward before discharge.
c. The mothers were in confinement for about 1 or 2 months in Kelantan, then
after completion, they returned to their homes in other states out of Kelantan
and continue follow up in other hospital.
d. Some parents refused to let their baby undergo a second hearing screening due
to uncertain reasons.
3) The total testing time spent using both methods can be biased if the person in charge of
the screening is not familiar with both methods, especially the MBII BERAphone.
68
7. CONCLUSION
69
7. CONCLUSION
There were 195 newborns (87, 44.6% boy and 108, 55.4% girl) who participated in this
study. Ototoxic medication was the most common risk factor (51.8%) followed by
hyperbilirubinaemia (51.3%) and low birth weight (27.2%). Usage of the MB11 BERAphone
had a higher passing rate (89.8%) as compared with the OAEs (85.2%). Usage of the MB11
BERAphone had a lower refer rate (10.2%) compared to the OAEs (14.8%). These differences
are statistically significant. The true negatives are MB11 BERAphone (29.4%) and OAEs
(11.8%). In the presence of false negative in MB11 BERAphone, this will give provide
significant impact to this machine concerning the effectiveness for hearing screening. Out of
195 newborns examined, 182 (93.4%) showed agreement between the two techniques, whereas
13 (6.6%) there was no agreement. Inter-observer agreement was good (kappa = 0.698,
p=<0.001). The median test time conducted on each newborn using MB11 BERAphone was 5
minutes (IQR: 3-5 minutes) and OAE was 2 minutes (IQR: 2-3 minutes). The differences were
statistically significant (p = <0.001).
The MB11 BERAphone is a rather reliable device for auditory brainstem response
among high risk newborns hearing screening. Both agreements were good. However, the
duration for hearing screening for each newborn significantly took a longer time compared
OAEs. Therefore, we recommend that both methods are to be used as a first screening, followed
by a screening via ABR, to those whose result was “refer” from first screening.
70
8. RECOMMENDATIONS
1) Suggestion of a larger sample population of high risk newborns for comparison of
OAEs and MB11 BERAphone to obtain a better result.
2) To get equal distributions of sample among risk factors newborns to reduce bias of the
result.
3) Suggestion of conducting a test for sensitivity and specificity between OAEs and MB11
BERAphone via using the gold standard ABR.
4) To reduce limitation of study during second hearing screening by using ABR as a gold
standard, my suggestion is to get a more detailed demographic data of the patient, with
contact numbers of both parents and to provide the appointment during the mother’s
confinement period to minimize loss of follow up patient.
71
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72
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14. Berg, E. Van Den, Deiman, C. & Straaten, H. L. M. Van. (2010). MB11 BERAphone 1
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20. Olusanya, B. O. & Bamigboye, B. A. (2010). Is discordance in TEOAE and AABR
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29. Landis, J. R. & Koch, G. G. (1977). The Measurement of Observer Agreement for
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76
10. APPENDICES
77
Appendix 1
A Comparison of Automated Auditory Brainstem Response (AABR) with Integrated
Electrodes and Otoacoustic Emissions (OAEs) in High Risk Newborn Hearing Screening
Source population: (All high risk newborn in neonatal unit
HUSM)
Sample, n: 195 (Inclusion and exclusion criteria)
Both OAEs and MB11 BERAphone
Refer one or both ears Pass both ears
ABR Total time of screening
Data collection and analysis
True positive False positive
78
Appendix 2 DATA COLLECTION
CODE:
Date:
Time:
Place:
Risk Factors:
Family history In utero infection
Birth weight <1500g Apgar score
Ototoxic medication Mechanical ventilation >5days
Hyperbilirubinemia Craniofacial anomalies
Syndromic baby Meningitis
Instrument:
1) Otoacoustic Emission (OAEs)
Time:
Time start:
Time end:
o Total testing time :
Result:
Pass Refer:
2) MB11 BERAphone
Time:
Time start:
Time end:
o Total testing time :
Result:
Pass Refer:
ABR:
Normal Positive
79
Appendix 3
JAWATANKUASA ETIKA PENYELIDIKAN (MANUSIA) - JEPeM
HUMAN RESEARCH ETHICS COMMITTEE - HREC
________________________________________________________________________________
Consent Form
LAMPIRAN A
MAKLUMAT KAJIAN
Tajuk Kajian: Comparison of Automated Auditory Brainstem Response (AABR) with Integrated
Electrodes and Otoacoustic Emissions (OAEs) in High Risk Newborn Hearing
Screening
Nama Penyelidik:
Profesor Madya Dr Salmi Abd Razak
Profesor Dr Hans Van Rostenberghe
Dr Muhammad Noor Azmi Ramli
No. Pendaftaran MMC : 48601
PENGENALAN
Anda dipelawa untuk menyertai satu kajian penyelidikan secara sukarela yang melibatkan dua jenis
alat kajian: Automated Auditory Brainstem Response (AABR) – BERAphone dan Otoacoustic
Emissions (OAEs). Kedua – dua peralatan ini adalah di gunakan untuk mengenal pasti masalah
pendengaran di kedua – dua belah telinga pesakit. Ia di gunakan bagi membolehkan masalah
pendengaran dapat di kenal pasti terlebih awal. Kedua dua peralatan ini bagus di gunakan untuk
saringan pendengaran supaya pesakit mendapat saringan pendengaran dengan lebih efektif. Sebelum
anda bersetuju untuk menyertai kajian penyelidikan ini, adalah penting anda membaca dan memahami
borang ini. Sekiranya anda menyertai kajian ini, anda akan menerima satu salinan borang ini untuk
disimpan sebagai rekod anda.
Penyertaan anda di dalam kajian ini dijangka mengambil masa sehingga 12 minggu. Seramai 195
pesakit akan menyertai kajian ini.
TUJUAN KAJIAN
Kajian ini bertujuan adalah untuk menentukan sama ada, semasa tempoh kajian selama 12 minggu,
saringan pendengaran yang menggunakan peralatan BERAphone dan OAEs terhadap pesakit adalah
supaya:
Pesakit mendapat saringan pendengaran dengan lebih efektif lagi supaya tiada sebarang
kesulitan berlaku
Bagi mengelakkan pesakit yang mengalami masalah pendengaran tidak terlepas dari
saringan
BORANG ETIKA - 02
80
Terdapat kemungkinan maklumat yang dikumpulkan semasa kajian ini akan dianalisa oleh pihak
penyelidik pada masa depan untuk menilai BERAphone dan OAEs untuk kegunaan lain yang mungkin
atau untuk tujuan perubatan atau saintifik lain yang selain dari yang kini dicadangkan.
KELAYAKAN PENYERTAAN
Doktor yang bertanggungjawab dalam kajian ini atau salah seorang kakitangan kajian telah
membincangkan kelayakan untuk menyertai kajian ini dengan anda. Adalah penting anda berterus
terang dengan doktor dan kakitangan tersebut tentang sejarah kesihatan anak anda. Anak anda tidak
seharusnya menyertai kajian ini sekiranya anak anda tidak memenuhi semua syarat kelayakan.
Beberapa keperluan untuk menyertai kajian ini adalah –
Anak yang baru lahir
Anak anda adalah seorang pesakit yang di rawat di unit bayi “noenatal unit”
Anak anda mempunyai risiko masalah pendengaran seperti:
o Masalah kekuningan “jaundice”
o Lahir tidak cukup matang
o Sejarah masalah pendengaran dalam keluarga
o Risiko jangkitan kuman dalam kandungan
o Risiko kesan daripada ubat yang menyebabkan masalah pendengaran
o Jangkitan di selaput otak
o Lahir dengan rendah “Apgar Score”
o Terdapat masalah struktur muka yang tidak normal
o Memerlukan bantuan mesin pernafasan lebih dari 5 hari
o Terdapat struktur yang tidak normal sejak lahir yang mempunyai risiko untuk masalah
pendengaran
Anak anda tidak boleh menyertai kajian ini sekiranya –
Sekiranya anak anda lahir dengan sihat dan cukup bulan yang tiada risiko untuk mendapat
masalah pendengaran
PROSEDUR-PROSEDUR KAJIAN
Kajian dengan menggunakan peralatan BERAphone dan OAEs akan dilakukan bila pesakit mempunyai
risiko untuk mendapat masalah pendengaran yang di masukkan ke dalam wad bayi. Saringan
pendengaran akan di lakukan setelah pesakit yang telah di rawat di wad di sahkan sihat dan boleh di
discaj dari hospital. Pada hari pesakit di discaj dari hospital saringan pendengaran akan di lakukan oleh
staf – staf yang berpengalaman.
RISIKO
Kajian ini sangat mudah dan senang di lakukan dan tidak mempunyai banyak masalah komplikasi ke
atas pesakit. Peralatan yang di buat saringan ke atas pesakit akan di bersihkan terlebih dahulu sebelum
saringan di lakukan bagi mengelakkan sebarang jangkitan luar berlaku.
Jika apa-apa maklumat penting yang baru dijumpai semasa kajian ini yang mungkin mengubah
persetujuan anda untuk terus menyertai kajian ini, anda akan diberitahu secepat mungkin.
81
MELAPORKAN PENGALAMAN KESIHATAN
Jika anak anda mengalami apa-apa kecederaan, kesan buruk, atau apa-apa pengalaman kesihatan
yang luar biasa semasa kajian ini, pastikan anda memberitahu Dr Muhammad Noor Azmi Ramli (No.
Pendaftaran Penuh Majlis Perubatan Malaysia: 48601) di talian 017-6849513 secepat mungkin. Anda
boleh membuat panggilan pada bila-bila masa, siang atau malam, untuk melaporkan pengalaman
sedemikian.
PENYERTAAN DALAM KAJIAN
Penyertaan anak anda dalam kajian ini adalah secara sukarela. Anda berhak menolak untuk menyertai
kajian ini atau anda boleh menamatkan penyertaan anda pada bila-bila masa, tanpa sebarang hukuman
atau kehilangan manfaat yang sepatutnya anda perolehi.
Penyertaan anak anda juga mungkin boleh diberhentikan oleh doktor yang terlibat dalam kajian ini
tanpa persetujuan anda. Sekiranya anak anda berhenti menyertai kajin ini, doktor yang terlibat di dalam
kajian ini atau salah seorang kakitangan akan berbincang dengan anda mengenai apa-apa isu
perubatan berkenaan dengan pemberhentian penyertaan anak anda.
MANFAAT YANG MUNGKIN [Manfaat terhadap Individu, Masyarakat, Universiti]
Prosedur kajian ini akan diberikan kepada anak anda tanpa kos. Anda mungkin menerima maklumat
tentang kesihatan anak anda daripada pemeriksaan fizikal dan ujian makmal yang dilakukan dalam
kajian ini. Hasil atau maklumat kajian ini diharapkan, dapat memberi manfaat kepada pesakit-pesakit
pada masa hadapan. Anak anda tidak akan menerima sebarang pampasan kerana menyertai kajian
ini. Namun sebarang keperluan perjalanan berkaitan dengan penyertaan ini akan diberi.
PERSOALAN
Sekiranya anda mempunyai sebarang soalan mengenai prosedur kajian ini atau hak-hak anda, sila
hubungi;
<Dr Muhammad Noor Azmi Ramli > & <No.MMC: 48601>
<Jabatan Pediatrik>
<Pusat Pengajian Sains Perubatan>
<USM Kampus Kesihatan>
<No Tel: 09- 7673000><017-6849513>
Sekiranya anda mempunyai sebarang soalan berkaitan kelulusan Etika atau sebarang pertanyaan dan
masalah berkaitan kajian ini, sila hubungi;
Puan Mazlita Zainal Abidin
Setiausaha Jawatankuasa Etika Penyelidikan (Manusia) USM
Pusat Inisiatif Penyelidikan -Sains Klinikal & Kesihatan
USM Kampus Kesihatan.
No. Tel: 09-767 2355 / 09-767 2352
Email : [email protected]
82
KERAHSIAAN
Maklumat perubatan anda akan dirahsiakan oleh doktor dan kakitangan kajian. Ianya tidak akan
dedahkan secara umum melainkan jika ia dikehendaki oleh undang-undang.
Data yang diperolehi dari kajian yang tidak mengenalpasti anda secara perseorangan mungkin akan
diterbitkan untuk tujuan memberi pengetahuan baru.
Rekod perubatan anda yang asal mungkin akan dilihat oleh pihak penyelidik, Lembaga Etika kajian ini
dan pihak berkuasa regulatori untuk tujuan mengesahkan prosedur dan/atau data kajian klinikal.
Maklumat perubatan anda mungkin akan disimpan dalam komputer dan diproses dengannya.
Dengan menandatangani borang persetujuan ini, anda membenarkan penelitian rekod, penyimpanan
maklumat dan pemindahan data seperti yang dihuraikan di atas.
TANDATANGAN
Untuk dimasukkan ke dalam kajian ini, anda atau wakil sah anda mesti menandatangani serta
mencatatkan tarikh halaman tandatangan (Borang Keizinan Pesakit di LAMPIRAN S dan LAMPIRAN
P).
83
LAMPIRAN S
Borang Keizinan Pesakit/ Subjek
(Halaman Tandatangan)
Tajuk Kajian: Comparison of Automated Auditory Brainstem Response (AABR) with Integrated
Electrodes and Otoacoustic Emissions (OAEs) in High Risk Newborn Hearing
Screening
Nama Penyelidik: Profesor Madya Dr Salmi Abd Razak (No Pendaftaran Penuh:30493) Profesor Dr Hans Van Rostenberghe (No Pendaftaran Penuh:31042) Dr Muhammad Noor Azmi Ramli (No Pendaftaran Penuh: 48601) Untuk menyertai kajian ini, anda atau wakil sah anda mesti menandatangani mukasurat ini. Dengan
menandatangani mukasurat ini, saya mengesahkan yang berikut:
Sa ya te lah m em baca sem ua m ak lum at da lam Borang Mak lumat dan Ke iz inan Pesak i t i n i t e rm asuk apa-apa m ak lum at berka i tan r is iko yang ada da lam ka j ian dan saya te lah pun d iber i m asa yang m encukup i un tuk m em per t im bangkan mak lum at te rsebut .
Sem ua soa lan -soa lan saya te lah d i jawab dengan m em uaskan. Sa ya, secara sukare la , berse tu ju m enyer ta i ka j ian pen ye l id ikan in i ,
m em atuh i sega la p rosedur ka j ian dan m em ber i m ak lum at yang d iper lukan kepada dok tor , para ju rurawat dan juga kak i tangan la in yang berka i tan apab i la d im in ta .
Sa ya bo leh m enam atkan penyer taan sa ya da lam ka j ian in i pada b i la -b i l a m asa.
Sa ya te lah pun m ener im a sa tu sa l inan Borang Mak lum at dan Ke iz inan Pesak i t un tuk s im panan per ibad i saya .
Nama Pesakit Nama Singkatan & No. Pesakit
No. Kad Pengenalan Pesakit (Baru) No. K/P (Lama)
Tandatangan Pesakit atau Wakil Sah Tarikh ( )
(Masa jika perlu)
84
Nama & Tandatangan Individu yang Mengendalikan Tarikh ( )
Perbincangan Keizinan
Nama Saksi dan Tandatangan Tarikh (dd/MM/yy)
Nota: i) Semua subjek/pesakit yang mengambil bahagian dalam projek penyelidikan ini tidak dilindungi insuran.
85
LAMPIRAN P
Borang Keizinan bagi Penerbitan Bahan yang berkaitan dengan Pesakit/ Subjek
(Halaman Tandatangan)
Tajuk Kajian: Comparison of Automated Auditory Brainstem Response (AABR) with Integrated
Electrodes and Otoacoustic Emissions (OAEs) in High Risk Newborn Hearing
Screening
Nama Penyelidik: Profesor Madya Dr Salmi Abd Razak (No Pendaftaran Penuh:30493) Profesor Dr Hans Van Rostenberghe (No Pendaftaran Penuh:31042) Dr Muhammad Noor Azmi Ramli (No Pendaftaran Penuh: 48601) Untuk menyertai kajian ini, anda atau wakil sah anda mesti menandatangani mukasurat ini.
Dengan menandatangani mukasurat ini, saya memahami yang berikut:
Bahan yang akan d i t e rb i tkan tanpa d i lam pi rkan dengan nam a saya dan se t iap percubaan yang akan d ibuat un tuk m em ast ikan ke tanpanam aan saya. Sa ya m em aham i , wa laubaga im anapun, ke tanpanam aan yang sem purna t idak dapat d i j am in . Kem ungk inan ses iapa yang m enjaga saya d i hosp i ta l a tau saudara dapat m engena l i saya.
Bahan yang akan d i te rb i tkan da lam penerb i tan m ingguan/bu lanan/dw ibu lanan/suku tahunan/dwi tahunan m erupakan sa tu pen yebaran yang luas dan te rsebar ke se luruh dun ia . Kebanyakan penerb i tan in i akan te rsebar kepada dok tor -dok tor dan juga bukan dok tor te rm asuk ah l i sa ins dan ah l i j u rna l .
Bahan te rsebut j uga akan d i lam pi rkan pada lam an web ju rna l d i se lu ruh dun ia . Sesetengah lam an web in i bebas d ikun jung i o leh sem ua orang.
Bahan te rsebut j uga akan d igunakan sebaga i penerb i tan te m patan dan d isam paikan o leh ramai dok tor dan ah l i sa ins d i se luruh dun ia .
Bahan te rsebut j uga akan d igunakan sebaga i penerb i tan buku o leh penerb i t j u rna l .
Bahan te rsebu t t idak akan d igunakan untuk peng ik lanan a taupun bahan untuk m em bungkus .
Sa ya juga m em ber i ke iz inan bahawa bahan te rsebut bo leh d igunakan sebaga i
penerb i tan la in yang d im in ta o leh penerb i t dengan k r i te r ia ber iku t :
Bahan te rsebu t t idak akan d igunakan untuk peng ik lanan a tau bahan untuk m em bungkus .
Bahan te rsebut t idak akan d igunakan d i luar kon teks – contohn ya: Gam bar t idak akan d igunakan untuk m enggam barkan sesuatu ar t ike l yang t idak berka i tan dengan sub jek da lam fo to te rsebut .
86
Nama Pesakit Nama Singkatan atau No. Pesakit
No. Kad Pengenalan Pesakit T/tangan Pesakit Tarikh ( )
Nama & Tandatangan Individu yang Mengendalikan Tarikh ( )
Perbincangan Keizinan
Nota: i) Semua subjek/pesakit yang mengambil bahagian dalam projek penyelidikan ini tidak dilindungi insuran.
87
Appendix 3
Jw\•atankul\•• l:ltlka l'eny~Jldlkan Manutla USM (J£PtM) tlunuon lte- &aroh Ethic, Comnoittoo USM (lllUtC)
Our,l\el. : Oot•
IJSM/JEPo~/278.3.(5) t)~' Mor~h ~0~4
Or. Muhammad Noor Alml R1mll Oeportmem of Pedlwles School of Medlc_ol S~~I\CQS Unwe($jtl S~lns Ma!IIV$la l6~~0 (ul>\lng Kerian, ~eiant;tn.
Unhersld &al ... ~~· K•mf'lu• K'"11¥~an. 101.50 K\fbin((>K&-.,.n. K•lbun. M•tayab. '1"1 Ci09 • 'fti1 $900 lllMh. ~5" /t!S~
...-. ~·1(!7 ·~·· &)!l,.m . .,[email protected] www.rcte•rch.wm.my
Tllc H\Jm&n Rtsearch EthiO$ Committee, Uollver$itl Salns Malayiia (FWA Reg. No: 00007718; IRB ll.es. No: 00004494) h•s •pproved In principle the study mention-ed below:
_j eo,n..,~son of Automat<# ~ Btairut~ Response (AABft) will\ ln"'8'•ted EliWO<Ie$ and I OtQiiCOU\tio Em~J!OAEslln H1811 R~Si(New'born ~·~f'ISCteetWlB- _I
ProUKol No I Prlndplo tnvestlptor J Or. M""""mad Noor .WOI Ra!nr. j Date. of approval Mc«01r~~~ ltcvoe\\'e'd :rf ~~mn•I!CW. Jl.tttlv~Rrtell11f<l P(~
n"' Mo•d,J 2014 1~~r1011 ,..-J~!f%014 II"Mmh'-OJ4
~~~~::.:.~nvenR~ J Or. Moh<j NOfll)OnlbiW!a Or. Npuarwarry~ad
-- --Hooplt.>J v • .,...,,d Malll)'1la.
SOln$ 1 OllO'OhtudySialt I Mat<I\2014-August20_~_· ___ __.1
I-~-M_nd_•_'~-port---~---------'-N-•_m_b•_~_sa_m_~_~l~b~------------J' Tl\e following Item Vl have been reoeivtland reviewed:·
( .1') EthiCal Appro"'! Application Form ("') R"st>arch Proposal (v') Parents/Guardian Information Slfeet and Consent Form ('/) Data Collection Eorm
lnvestigaror(s) ar<~required to: a) follow instructions, guidelines and rcquireme11ts of tlte Human Researdl Ethics Comndttl!li;·'tl\11!
Salns Malaysia (JEReM) b) report any protocql deviations/violations to ·Humall Research Ethics Committee (JEPeM) c) comply with International Conference on Harmonization- Guidelines forGood:CIIrlleai·Pt\Jctl*'
and the eclaratlon ofHelslnkl d) notetha Humar. R6~earcl\ [thlcs Committee (JEP.eM) may a_udit the approved study.
PROFESSOR DR. MOHD$HUKRI OTHMAN Deputy Chairma.o ttuman Research EthiC$ Committee
88
Appendix 4
4 Jun 2014
UNIVEHSm SAINS MALAYSIA
Pharmanlaga Logistics Sdn. Bhd. No. 7, Lorong Kelull18 Kawasan Perlndustrian Bukit Raja Selatan P.O Box 2030 Pusat Blsnes Buklt Raja 40000 Shah Alam Selangor (UIP: Enclk Masri Muhammad Vusof)
'fuan
I Jaba~n Pediatrik Depatiment ol Paedlatda
I jab;u:ut Pcdiatrik
Kampus Kesihatan UniveBiti Sains Malaysia 16150 Kubang Kerillro. l(elantan. Malay!ia. Tel:6097673000 EJ<t !6563 www.me<li<wsm.my/-paed .. ttiesl
Surat Pengesahan Plnjaman Peralatan MAICO Beraphone MB11 AABR Newbol:n Hearing Screening
Perkara di alas adalah dirujuk.
2. Unluk makluman tuan, Dr. Muhammad Noor Azmi bin Ram8 (No.J<P: 03-5967) merupakan pelajar Sarjana Perubatan (Pediatrlk) Unjverslli Kampus Kesihatan Kelanfan S:edang menjalankan penyelldikan Comparison of Automated Auditory Bra.instein Response !AJ>.Bf~J
Electrodes And Otocoustic Emissions In High Risk Newborn Hearing S~=~t~ ini sedang menggunakan Peralatan MAICO Beraphone MB11 AA8R 1
Screening yang dipinjamkan oleh pioak Pharmaniaga selama 6 bulan mullli·lllii hingga September 2014.
Sekian untuk makluman plhak tuan.
Terlma kasih.
"BERKHIDMAT UNTUK NEGARA" Memastikan Kelestarian Hari Esok,
{;· 'c PROF. MADYA D~.J~RIZAN H A MAJID Pemangku Ketua Jaliatan Pedialrik Pusat Pengajjan Sains Perubatan Universiti Sains Malaysia Kampus Kesihatan
89
Appendix 5
Gantt Chart of Research Activities: Comparison of Automated Auditory Brainstem Response
(AABR) with Integrated Electrodes and Otoacoustic Emissions (OAEs) in High Risk Newborn
Hearing Screening
PROJECT ACTIVITIES
2014
2017
Research Activities J F M A M J J A S O N D J F M A M J J A S O N D
Staff training
Participants
recruitment and
intervention
Data Analysis /
Interpretation
Writing final report
Presentation
Writing and submit
journal papper
Milestone of Research Activities:
1. February 2014 untill Mac 2014: To train the staff using MB11 BERAphone and OAEs before
data collection
2. April 2014 untill December 2014: Completion of Patient Recruitment and Data Collection
3. January 2017 untill April 2017: Completion of Data Analysis and interpretation
4. May 2017 untill November 2017: Completion of writing and submit journal paper, presentation
and final report
