INFANT HEARING SCREENING
INTRODUCTION:
A direct comparison of guidelines issued by USPSTF, OMAR, CTFPHC, AAP and
ICSI for infant hearing screening are provided in the tables, below. Table 1
<http://www.guideline.gov/COMPARISONS/#table1> compares the scope and the
content of each guideline. Table 2
<http://www.guideline.gov/COMPARISONS/#table2> compares specific
recommendations made by each organization regarding universal newborn infant
screening prior to hospital discharge (USPSTF, OMAR, AAP); on-going hearing
screening following hospital discharge as a means of surveillance (USPSTF,
OMAR, CTFPHC, ICSI); and screening methods (USPSTF, OMAR, CTFPHC, AAP,
ICSI). The rating schemes used to classify the strength of the evidence
supporting USPSTF, CTFPHC and ICSI recommendations, are provided at the end
of Table 2 <http://www.guideline.gov/COMPARISONS/#table2> . Table 3
<http://www.guideline.gov/COMPARISONS/#table3> compares the potential
benefits and harms outlined by the guideline developers associated with the
implementation of each of the guidelines.
The following comparisons are restricted to recommendations for infants and
young children (< 3 years); they do not include recommendations for older
children, adolescents, or adults. The guidelines issued by USPSTF, OMAR and
AAP specifically address the issue of screening for hearing impairment in
infants. USPSTF also evaluates hearing screening across the life span.
CTFPHC and ICSI address all preventive/screening services, including routine
infant hearing screening, that should be included in periodic health
examinations. Because this synthesis focuses on hearing screening in
infants, only those recommendations related to infant screening in the
USPSTF guideline, and hearing screening in the CTFPHC and ICSI guidelines,
are presented.
Note, the CTFPHC guideline considers the recommendations released by OMAR.
USPSTF presents recommendations released by OMAR (1993) and CTFPHC (1994),
as well as others.
Following the content comparison in Tables 1-3, the areas of agreement and
difference among the guidelines are identified. In general, the sensitivity
(proportion of infants with hearing loss identified by the screening test)
and the specificity (the proportion of infants without hearing loss that
pass the screening test) of different screening methods as well as the
cost-effectiveness of universal newborn hearing screening are important
factors to consider when evaluating difference among these guidelines. The
rationale behind disparate recommendations that cannot be attributed to the
evidence base available at the time of guideline development is also
explored in the discussion of the areas of disagreement.
Abbreviations used in the text and tables follow:
* ABR, Auditory brainstem response
* AAP, American Academy of Pediatrics
* CTFPHC, Canadian Task Force on Preventive Health Care
* EOAE, Evoked otoacoustic emissions
* ICSI, Institute for Clinical Systems Improvement
* OAE, Otoacoustic emissions
* OMAR, Office of Medical Applications of Research
* UNHS, Universal newborn hearing screening
* USPSTF, United States Preventive Services Task Force
GUIDELINE CONTENT COMPARISON
A direct comparison of guidelines issued by USPSTF, OMAR, CTFPHC, AAP, and
ICSI for infant hearing screening are provided in Tables 1-3. The Office of
Medical Applications of Research (OMAR) convened a consensus conference to
specifically address issues surrounding early identification of hearing
impairment in infants and children. Their conclusions relate to the practice
of universal newborn hearing screening (UNHS) prior to hospital discharge
following birth, as well as to which screening tests should be used. The
guidelines issued by the United States Preventive Services Task Force
(USPSTF) and the American Academy of Pediatrics (AAP) likewise present
recommendations regarding UNHS prior to hospital discharge, as well as which
screening tests should be used. All three of these organizations provide exp
licit reasoning behind their judgments. In addition, two of the guidelines
(OMAR and USPSTF) provide recommendations regarding the role of the parent
and/or primary care physician in ongoing surveillance for hearing impairment
following hospital discharge. In contrast, the Canadian Task Force on
Preventive Health Care (CTFPHC) and the Institute for Clinical Systems
Improvement (ICSI) present guidelines for specific preventive health
services that should be included in periodic health examinations. Their
recommendations only briefly address hearing screening in the context of
routine health examinations. In addition, the CTFPHC presents a brief
discussion of which test should be used and why, while the ICSI guideline
does not. Neither CTFPHC nor ICSI address the issue of universal newborn
hearing screening prior to hospital discharge after birth.
In addition to infant hearing screening, the USPSTF guideline presents
recommendations for the use of pure-tone audiometry, and screening methods
for detecting hearing loss in older individuals (i.e., written patient
questionnaires, clinical history-taking and physical examination, audiometry
with hand-held devices, and simple clinical techniques such as the whispered
voice test). AAP presents recommendations for the tracking and follow-up
elements of universal newborn hearing programs, as well as for the ongoing
evaluation of state-monitored systems.
In the following sections, the areas of agreement and difference between the
guidelines are evaluated with respect to: 1) hearing screening in early
infancy; 2) the issue of UNHS prior to hospital discharge; 3) ongoing
surveillance in the primary care setting and through parental concern; and
4) recommended screening methods.
Areas of Agreement
Hearing screening in early infancy
All five guidelines are in general agreement with the policy of screening
infants for hearing loss either prior to hospital discharge (OMAR, AAP) or
through ongoing surveillance at well baby visits (ICSI, CTFPHC, USPSTF).
OMAR and AAP endorse universal newborn hearing screening, with a goal of
identifying all infants with hearing loss prior to the age of 3 months and
initiating treatment by 6 months. Because of the unique accessibility of
almost all infants in the newborn nursery (excepting those born in
alternative birthing facilities such as the home) both of these
organizations recommend that screening take place prior to hospital
discharge after birth. AAP also recommends that screening be available for
all out-of-hospital births. Similarly, ICSI and CTFPHC recommend systematic
hearing evaluation within the first month of life as well as at subsequent
well-baby visits. Although these organizations do not provide
recommendations for universal newborn screening prior to hospital discharge,
they do recommend that a hearing evaluation be performed on all infants at
the first well-baby visit (within 1 month after birth – CTFPHC; within the
first 2 weeks - ICSI). One notable exception regards recommendations issued
by USPSTF (see Areas of Differences). Although USPSTF recommends that
clinicians examining any infant or young child remain alert for symptoms or
signs of hearing impairment, the guideline developers recommend that only
infants with risk factors for hearing impairment be screened prior to
hospital discharge after birth.
Routine hearing screening following hospital discharge (surveillance)
CTFPHC and ICSI both recommend repeated examination of infants for hearing
loss over the first 2 years of life. In addition, both groups support the
use of subjective/behavioral methods as opposed to physiologic methods like
EOAE and ABR testing. USPSTF and OMAR likewise agree that clinicians
examining any infant or young child should remain alert for symptoms or
signs of hearing impairment, although neither group makes a formal
recommendation regarding which screening method is preferred for routine
health examinations. AAP recommends that physicians provide hearing
screening throughout early childhood for those infants at increased risk for
hearing loss (e.g., history of trauma, meningitis) and for those
demonstrating clinical signs of possible hearing loss.
Areas of Differences
Universal infant hearing screening prior to hospital discharge
Recommendations by USPSTF, OMAR and AAP differ regarding the endorsement of
universal newborn screening prior to hospital discharge. As noted above,
OMAR and AAP recommend the implementation of universal screening prior to
hospital discharge after birth in all infants based on evidence that
undetected hearing impairment during infancy and early childhood interferes
with the development of speech and verbal language skills. USPSTF on the
other hand, states that there is insufficient evidence to recommend for or
against universal screening of asymptomatic infants, noting that the cost
and feasibility of universal screening are not fully known. USPSTF does not
dispute that reduced hearing during infancy is associated with developmental
delay in speech and language. They simply state that no controlled clinical
trials have yet evaluated the efficacy of early screening in terms of
long-term function and quality of life outcomes. In addition, USPSTF state
that current screening methods (ABR and EOAE), while having reasonably high
sensitivity and specificity, yield a substantial number of false positive
results as a result of the low prevalence of hearing loss in asymptomatic
infants.
USPSTF states that recommendations for screening high-risk infants can be
made on other grounds, including the higher prevalence of hearing loss among
high-risk infants. USPSTF therefore recommends that all high-risk infants be
screened for hearing loss prior to hospital discharge and/or before the age
of 3 months. OMAR and AAP note that a policy of screening only high-risk
infants will neglect approximately 50% of infants with hearing loss.
The role of parental concern in on-going surveillance
CTFPHC, USPSTF and OMAR all emphasize the role of parental concern in
guiding more formal hearing tests. OMAR specifically states that parental
concern about hearing should be sufficient reason to initiate a prompt
formal hearing evaluation. CTFPHC states that parental inquiry about infant
hearing status should be part of the routine health examinations. USPSTF
recommends that clinicians remain alert to parental/caregiver concern
regarding hearing, speech, language or developmental delay. Contrary to
these guidelines, AAP states that reliance on physician observation and/or
parental recognition as a sole means of identifying infants with hearing
loss has not been successful in detecting hearing loss in the first year of
life.
Screening methods
There are differences between the guidelines with respect to the screening
technology that is endorsed. OMAR and AAP agree that, although additional
research is necessary to determine which screening test is ideal, EOAE
and/or ABR are presently the screening methods of choice. AAP defers
recommending a preferred screening test, while OMAR specifically endorses
the use of EOAE followed by ABR stating that EOAE, with its high sensitivity
(ability of the screening test to identify infants with hearing loss) would
rapidly and inexpensively pass the majority of infants tested. ABR, with its
relatively high specificity (ability to pass infants that do not have a
hearing loss), is recommended by OMAR as the follow-up method for those
infants that failed the EOAE test. Although there is disagreement between
USPSTF, and the other guidelines in terms of which infants should be tested
(see UNHS prior to hospital discharge above), USPSTF agrees that a
physiological test should be used. The USPSTF guideline states that ABR
testing is the most accurate method available with sensitivity and
specificity rates reported as high as 97-100% and 86-96%, respectively. They
further state that ABR testing may be useful for all infants who meet at
least one of the high-risk criteria or for those who fail EOAE testing.
CTFPHC and ICSI on the other hand, endorse routine screening of hearing in
infants during the first two years of life using subjective and/or
behavioral assessment. ICSI does not explicitly state which screening method
they endorse, just that screening is recommended through subjective
assessment. Conversely, CTFPHC specifically endorses the use of parental
questioning and the “clap test” as opposed to screening with EOAE or ABR.
CTFPHC refers to evidence laid out in the OMAR consensus statement in making
their recommendation regarding screening method. Specifically, they note
that the OMAR consensus statement acknowledges a high false positive rate
using either ABR or EOAE testing and that much of the evidence supporting
the use of these techniques is descriptive, and that no randomized trials
have been done to support their use over and above parental inquiries and
the clap test.
Guidelines Reviewed
1. United States Preventive Services Task Force (USPSTF). Screening
for hearing impairment.
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=179> In:
Guide to clinical preventive services. 2nd ed. Baltimore (MD): Williams &
Wilkins; 1996. 393-406 [88 references]
2. Office of Medical Applications of Research (OMAR). Early
identification of hearing impairment in infants and young children.
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=431> NIH
Consens Statement 1993 Mar 1-3;11(1):1-24. The document, "Recommendations of
the NIDCD Working Group on Early Identification of Hearing Impairment on
Acceptable Protocols for Use in State-Wide Universal Newborn Hearing
Screening Programs," (Bethesda (MD): National Institute on Deafness and
Other Communication Disorders (NIDCD); 1997 Sep. 2 p.) is considered to be a
supplement to the original guideline.
3. Canadian Task Force on Preventive Health Care (CTFPHC). Well-baby
care in the first 2 years of life.
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=1256> In:
Canadian guide to clinical preventive health care. Ottawa: Health Canada;
1994 Mar. 258-66 [12 references]
4. American Academy of Pediatrics (AAP). Newborn and infant hearing
loss: detection and intervention.
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=1382>
Pediatrics 1999 Feb;103(2):527-30 [30 references]
5. Institute for Clinical Systems Improvement (ICSI). Preventive
services for children.
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=1520>
Bloomington (MN): Institute for Clinical Systems Improvement; 2000 Mar. 36
p. [19 references]
TABLE 1: OVERVIEW OF GUIDELINES FOR INFANT HEARING SCREENING
OBJECTIVE AND SCOPE
USPSTF
(1996)
* To provide recommendations for screening for hearing impairment
OMAR
(1993, updated 1997)
To address the following:
* The advantages of early identification of hearing impairment and the
consequences of late identification of hearing impairment
* Which children should be screened for hearing impairment and when
* The advantages and disadvantages of current screening methods
* Which model for hearing screening and follow-up is preferred
* Future directions for research in diagnosis and management of hearing
impairment in infants and young children
CTFPHC
(1994, reviewed 1998)
* To make recommendations about well-baby care for Canadian infants during
their first 2 years of life, updating a report published in 1990
AAP
(1999)
* To endorse the implementation of universal newborn hearing screening
* To review the primary objectives, important components, and recommended
screening parameters that characterize an effective universal newborn
hearing screening program
ICSI
(2000)
* To clearly identify those preventive services which are essential to
provide to all low risk or asymptomatic patients on the basis of either good
or fair evidence for inclusion in a periodic health evaluation
* To identify those services that should not be included in light of
similarly strong evidence
TARGET POPULATION
USPSTF
(1996)
* Asymptomatic and high-risk infants
* Asymptomatic children and adolescents
* Working-age adults, including those exposed to excessive noise levels
* Older adults
OMAR
(1993, updated 1997)
Newborn infants and young children
CTFPHC
(1994, reviewed 1998)
Infants (birth to 2 years)
AAP
(1999)
Newborn infants
ICSI
(2000)
Low-risk, asymptomatic individuals from birth to 18 years of age
INTENDED USERS
USPSTF
(1996)
Physicians, nurses, nurse practitioners, physician assistants, allied health
care practitioners, students
OMAR
(1993, updated 1997)
Physicians, speech-language pathologists, nurses, nurse practitioners,
physician assistants, allied health care practitioners, health plans
CTFPHC
(1994, reviewed 1998)
Physicians, nurses, nurse practitioners, physician assistants, allied health
care practitioners, students
AAP
(1999)
Physicians, audiologist, speech and language therapists, nurses, nurse
practitioners, physician assistants, allied health care practitioners,
health plans, other
ICSI
(2000)
Physicians, nurses, nurse practitioners, physician assistants, allied health
care practitioners
INTERVENTIONS AND PRACTICES CONSIDERED
USPSTF
(1996)
Screening:
* Hearing screening of high-risk infants
* Ongoing surveillance via well baby visits and parental observation
Screening Methods:
* ABR
* EOAE
* High-risk registrar
Other:
* Pure-tone audiometry for screening adults and cooperative children
* Screening methods for detecting hearing loss among older persons
OMAR
(1993, updated 1997)
Screening:
* Universal screening for hearing loss among infants before 3 months of age
* Ongoing surveillance for hearing loss throughout infancy and early
childhood
Screening Methods:
* ABR
* EOAE
Education:
* Education of primary caregivers and primary health care providers on early
signs of hearing impairment
CTFPHC
(1994, reviewed 1998)
Screening:
* Routine hearing screening as part of the periodic health examination in
the first 2 years of life
Screening Methods:
* Parental enquiries and/or the clap test
* ABR and EOAE are considered but not recommended
Other:
* Frequency of well-baby care visits
* Parental counseling on safety, nutrition and behavioral problems
* Identification and treatment of physical, developmental and parenting
problems
AAP
(1999)
Screening:
* Universal screening for hearing loss among all newborn infants
Screening Methods:
* ABR
* EOAE
Other:
* Tracking and follow-up elements of a UNHS program
* Identification and intervention practices
* On-going evaluation of the UNHS program by state monitored systems
ICSI
(2000)
Screening:
* Routine hearing screening as part of the periodic health examination in
the first 2 years of life
Other:
* Frequency of well-baby care visits
* Additional screening maneuvers
* Counseling and education
* Immunization practices
TABLE 2: SCREENING RECOMMENDATIONS
Guideline
Hearing screening prior to hospital discharge after birth?
USPSTF
(1996)
* There is insufficient evidence to recommend for or against routine
screening of asymptomatic neonates for hearing impairment using EOAE or ABR.
(C-Recommendation)
* Recommendations to screen high-risk infants may be made on other grounds,
including the relatively high prevalence of hearing impairment, parental
anxiety or concern, and the potentially beneficial effect on language
development from early treatment of infants with moderate or severe hearing
loss. For many high-risk conditions, hearing testing is commonly considered
to be part of diagnostic evaluation and management.
* Risk factors for congenital or perinatally acquired hearing loss include:
family history of hereditary childhood sensorineural hearing loss;
congenital perinatal infection with herpes, syphilis, rubella,
cytomegalovirus, or toxoplasmosis; malformations involving the head or neck
(e.g., dysmorphic and syndromal abnormalities, cleft palate, abnormal
pinna); birth weight below 1,500 g; bacterial meningitis; hyperbilirubinemia
requiring exchange transfusion; severe perinatal asphyxia (Apgar scores of
0-4 at 1 minute or 0-6 at 5 minutes, absence of spontaneous respirations for
10 minutes, or hypotonia at 2 hours of age); ototoxic medications; and
findings associated with a syndrome known to include hearing loss.
* High-risk infants should ideally be screened prior to leaving the hospital
after birth, but those not tested at birth should be screened before age 3
months with the goal being to initiate rehabilitation by age 6 months as
clinically indicated.
OMAR
(1993, updated 1997)
* The panel recommends that all infants admitted to the neonatal intensive
care unit as well as high-risk infants from the well-baby nursery (i.e.,
craniofacial anomalies, family history of hearing loss, and diagnosis of
intrauterine infection) be screened for hearing loss prior to discharge.
* In addition, the panel recommends that universal screening be implemented
for all infants within the first 3 months of life. Because of the unique
accessibility of almost all infants in the newborn nursery, the consensus
panel recommends screening of all newborns, both high and low risk, for
hearing impairment prior to hospital discharge.
* To improve the accuracy and efficiency of the test, screening should take
place as close to discharge as possible.
* All babies that who fail the initial screen should be rescreened by ABR
methodology. Babies who fail the ABR screen should be referred for
diagnostic evaluation to verify the existence and to determine the type and
severity of hearing impairment, and to initiate a remediation program for
the child and family.
* Treatment should be initiated by 6 months of age.
CTFPHC
(1994, reviewed 1998)
* Not addressed
AAP
(1999)
* The task force on Newborn and infant hearing endorses the implementation
of universal newborn hearing screening. Newborn screening has as its goal
that 100% of the target population, consisting of all newborns, will be
tested in both ears prior to the age of 3 months, with appropriate
intervention prior to the age of 6 months. Screening should be conducted
before discharge from the hospital whenever possible.
ICSI
(2000)
* Not addressed
Guideline
Routine hearing screening following hospital discharge (surveillance)
USPSTF
(1996)
* Clinicians examining any infant or young child should remain alert for
symptoms or signs of hearing impairment, including parent/caregiver concern
regarding hearing, speech, language, or developmental delay.
OMAR
(1993, updated 1997)
* Because 20-30 percent of children who have hearing impairment develop
hearing loss during early childhood (subsequent to hospital discharge after
birth), an ever-vigilant pluralistic approach must be taken to screen and
identify hearing loss in young children.
* The first approach must include eliciting and acknowledging parental
concern. Parental concern about hearing should be sufficient reason to
initiate prompt formal hearing evaluation.
* Another necessary approach includes ongoing evaluation of speech and
language development at routine child health supervision visits using formal
assessment tools.
* Education of primary caregivers and primary health care providers on early
signs of hearing impairment is essential.
CTFPHC
(1994, reviewed 1998)
* Good evidence exists to include repeated examinations of hearing in the
periodic health examination of well babies, especially in the first year
[Grade A, Evidence level II-2, III].
AAP
(1999)
* Physicians should provide recommended hearing screening, not only during
early infancy but also through early childhood for those children at risk
for hearing loss (e.g., history of trauma, meningitis) and for those
demonstrating clinical signs of possible hearing loss.
ICSI
(2000)
* Hearing testing is recommended for well-baby visits (Schedule of visits:
first 2 weeks, 2, 4, 6-9, 15 months). Evidence supporting this conclusion is
of class: R
Guideline
What type of screening test should be used?
USPSTF
(1996)
* ABR testing may be useful for all infants who meet at least one of the
high-risk criteria or for those who fail EAOE testing. (See Hearing
screening prior to hospital discharge after birth? above for high-risk
criteria).
OMAR
(1993, updated 1997)
* The preferred model for screening should begin with an EOAE test and
should be followed by an ABR test for all infants who fail the EOAE test.
* Behavioral testing (such as visual reinforcement audiometry or conditioned
orienting response), usually at 6 months of age or later, may be used to
detect hearing impairment in almost all infants prior to the acquisition of
speech and language.
CTFPHC
(1994, reviewed 1998)
* Parental questioning and the clap test.
* Although repeated examination of hearing is recommended, there is
insufficient evidence at this time to recommend that routine use of ABR or
EOAE for hearing screening of healthy babies should replace regular
assessment of hearing during well-baby visits using parental questioning and
the clap test.
AAP
(1999)
* The methodology should detect, at a minimum, all infants with significant
bilateral hearing impairment, i.e., those with hearing loss > 35-decibel in
the better ear.
* The methodology used in screening should have a false-positive rate, i.e.,
the proportion of infants without hearing loss who are labeled incorrectly
by the screening process as having significant hearing loss, of < 3%. The
referral rate for formal audiologic testing after screening should not
exceed 4%.
* The methodology used in screening ideally should have a false-negative
rate (i.e., the proportion of infants with significant hearing loss missed
by the screening program), of zero.
* Until a specific screening method(s) is proved to be superior, the Academy
defers recommendation as to a preferred method. Currently, acceptable
methodologies for physiologic screening include EOAE and ABR, either alone
or in combination. Both methodologies are noninvasive, quick (< 5 minutes),
and easy to perform, although each assesses hearing differently.
* Although EOAE screening is even quicker and easier to perform than ABR,
EOAE may be affected by debris or fluid in the external and middle ear,
resulting in referral rates of 5% to 20% when screening is performed during
the first 24 hours after birth. ABR screening requires the infant to be in a
quiet state, but it is not affected by middle or external ear debris.
* Referral rates < 3% may be achieved when screening is performed during the
first 24 to 48 hours after birth. Referral rates < 4% are generally
achievable with EOAE combined with automated ABR in a two-step screening
system or with automated ABR alone. In a two-step system using EOAE as the
first step, referral rates of 5% to 20% for repeat screening with ABR or
EOAE may be expected. The second screening may be performed before discharge
or on an outpatient basis within 1 month of age.
ICSI
(2000)
* Hearing testing is recommended through subjective assessment. Evidence
supporting this conclusion is of class: R
Guideline
Rating Scheme
USPSTF
(1996)
Recommendation Grade:
A. There is good evidence to support the recommendation that the condition
be specifically considered in a periodic health examination.
B. There is fair evidence to support the recommendation that the condition
be specifically considered in a periodic health examination.
C. There is insufficient evidence to recommend for or against the inclusion
of the condition in a periodic health examination, but recommendations may
be made on other grounds.
D. There is fair evidence to support the recommendation that the condition
be excluded from consideration in a periodic health examination.
E. There is good evidence to support the recommendation that the condition
be excluded from consideration in a periodic health examination.
OMAR
(1993, updated 1997)
Not stated
CTFPHC
(1994, reviewed 1998)
Recommendation Grade:
A. Good evidence to support the recommendation that the condition be
specifically considered in a periodic health examination.
B. Fair evidence to support the recommendation that the condition be
specifically considered in a periodic health examination.
C. Poor evidence regarding inclusion or exclusion of the condition in a
periodic health examination, but recommendations may be made on other
grounds.
D. Fair evidence to support the recommendation that the condition be
specifically excluded from consideration in a periodic health examination.
E. Good evidence to support the recommendation that the condition be
specifically excluded from consideration in a periodic health examination.
Level of Evidence:
I - Evidence from at least 1 properly randomized controlled trial (RCT).
II-1 - Evidence from well-designed controlled trials without randomization.
II-2 - Evidence from well-designed cohort or case-control analytic studies,
preferably from more than 1 centre or research group.
II-3 - Evidence from comparisons between times or places with or without the
intervention. Dramatic results in uncontrolled experiments could also be
included here.
III - Opinions of respected authorities, based on clinical experience,
descriptive studies or reports of expert committees.
AAP
(1999)
Not stated
ICSI
(2000)
Rating Scheme for the Strength of the Evidence
Evidence Grading System: Classes of Research Reports:
1. Primary Reports of New Data Collection:
Class A:
* Randomized, controlled trial
Class B:
* Cohort study
Class C:
* Non-randomized trial with concurrent or historical controls
* Case-control study
* Study of sensitivity and specificity of a diagnostic test
* Population-based descriptive study
Class D:
* Cross-sectional study
* Case series
* Case reports
1. Reports that Synthesize or Reflect upon Collections of Primary Reports
Class M:
* Meta-analysis
* Decision analysis
* Cost-benefit analysis
* Cost-effectiveness study
Class R:
* Review article
* Consensus statement
* Consensus report
Class X:
* Medical opinion
TABLE 3: BENEFITS AND HARMS
Guideline
POTENTIAL BENEFITS
POTENTIAL HARMS
USPSTF
(1996)
* In high-risk infants, earlier detection and treatment of hearing
impairment may prevent developmental delay in speech and language function.
* False Positives: Although screening mechanisms have reasonable sensitivity
and specificity, a substantial number of infants will be misclassified
because the prevalence of hearing impairment in asymptomatic neonates is
low.
OMAR
(1993, updated 1997)
* In general, early identification and intervention of hearing impairment in
infants will minimize and/or prevent deficits in speech and language
acquisition, academic achievement, and social/emotional development that
might otherwise occur in infants with unidentified hearing loss.
* The benefits to be gained from early intervention may vary, depending on
the severity and type of hearing impairment. Children with sensorineural
hearing loss who receive early amplification, when indicated, and a
comprehensive rehabilitation program may show improved speech and language
skills, school achievement, self-esteem, and psychosocial adaptation when
compared to hearing-impaired children who do not receive amplification until
2 to 3 years of age.
* The addition of screening in the well-baby nursery as a part of well-baby
care will increase cost.
* Relative to EOAE, ABR screening and follow-up is expensive and requires
trained personnel.
* High false positive rates associated with both EOAE and ABR result in
over-referral of infants with normal hearing and undue parental anxiety.
* Disadvantages associated with behavioral screening of infants > 6 months
of age include the following: (1) requires skilled personnel and is
time-consuming; (2) evaluation of older infants requires reasonable access
to a testing facility; (3) testing is difficult in developmentally delayed
infants who are the highest risk; and, (4) some infants would not be treated
until after 1 year of life because of a lack of lead time to implement
intervention.
CTFPHC
(1994, reviewed 1998)
* The early detection of certain physical problems, such as deafness, can
lead to effective interventions that prevent important physical and
emotional difficulties. For instance, if profound hearing loss is not
identified within the first year of life, the likelihood that the child will
have intelligible speech and attain educational standards commensurate with
intellectual ability will be greatly reduced.
* A cohort study showed that children with profound hearing loss (at least
70 dB in the speech frequencies) had better sentence construction if hearing
aids and training were introduced before 3 years of age.
* None stated
AAP
(1999)
* Screening by high-risk registry alone (e.g., family history of deafness)
can only identify ~50% of newborns with significant congenital hearing loss.
Reliance on physician observation and/or parental recognition has not been
successful in the past in detecting significant hearing loss in the first
year of life.
* Universal screening has as its goal that 100% of infants with significant
congenital hearing loss shall be identified by 3 months of age and shall
have appropriate and necessary intervention initiated by 6 months of age.
* False Positives: A proportion of infants without hearing loss will be
labeled incorrectly by the screening process as having significant hearing
loss. These infants will require additional testing. The goals of universal
screening programs include maintaining this false-positive rate at < 3% and
the referral rate for formal audiologic testing after screening at < 4%.
ICSI
(2000)
* No benefits were discussed relating to hearing screening for infants.
* None stated
Updates in Progress: A third USPSTF was appointed in September 1998 by the
Agency for Health Care Policy and Research (now known as the Agency for
Healthcare Research and Quality [AHRQ]). Individual USPSTF recommendations
are currently being updated, with plans that all recommendations will be
reviewed and updated by 2002. CTFPHC reviewed the evidence for infant
hearing screening in 1994 and endorsed the recommendations again in 1998. A
review of the evidence for screening of newborn infants specifically is
currently in progress. The ICSI guideline will be updated June-July 2001
with Committee approval expected in September 2001.
_____
Edward E. Rylander, M.D.
Diplomat American Board of Family Practice.
Diplomat American Board of Palliative Medicine.