Letter to the Editor

(1)

Promotion and Disease Prevention Objectives. Washington, DC: US Gov-ernment Printing Office; 1990

3. Infant Health and Development Program. Enhancing the outcomes of low-birth-weight, premature infants. A multisite, randomized trial. JAMA. 1990;263:3035-3042

4. NIH Consensus Panel Report. Newsletter. Ambulatory Pediatr Assoc. 1993;29:18-28

5. Joint Committee on Infant Hearing. 1990 Position Statement. AAP News. April 1991;7:6,14. Reprinted in Policy Reference Guide, 6th edition. Elk

Grove Village, IL: American Academy of Pediatrics; 1993:343-346

6. Bess FH, Paradise J. Universal screening for infant heating impairment:

not simple, not risk-free, not necessarily beneficial, and not presently

justified. Pediatrics. 1994;93:330-334

7. American Speech-Language-Heating Association. Guidelines for audio-logic screening of newborn infants who are at-risk for heating impair-ment. ASHA. 1989;31:89-92

8. Mahoney TM, Eichwald JG. The ups and “Downs” of high-risk hearing

screening: The Utah statewide program. Semin Hear. 1987;8:155-163 9. Epstein 5, Reilly JS. 5ensorineural hearing loss. Pediatr Clin North Am.

198936:1501-1520

10. Stein L, Clark 5, Kraus N. The hearing-impaired infant: patterns of identification and habilitation. Ear Hear. 1983;4:232-236

1 1. Elssmann S. Matkin N, Sabo M. Early identification of congenital sen-sorineural hearing impairment. Hear

J.

19879:13-17

12. Shah C, Chandler D, Dale R. Delay in referral of children with impaired

hearing. Volta Rev. 1978;80:207

13. Kenworthy 01, Triggs E, Perrin J, Bess F. Current-screening practices of primary care physicians. Paper presented at the Conference on Otitis

Media and Development: Screening, Referral and Treatment. 1987; Vanderbilt University, Nashville, TN

14. Diefendorf AO, Weber BA. Identification of hearing loss: programmatic and procedural considerations. In: Roush J, Matkin N, ads. Infants and Toddlers with Hearing Loss: Family-Centered Identification, Assessment and Intervention. Baltimore, MD: York Press; 1994:43-64

15. White KR, Behrens TR, ads. The Rhode Island Hearing Assessment

Project: implications for universal newborn hearing screening. Semin Hear. 1993;14:l-119

16. Watkin P, Baldwin M, McEnery G. Neonatal at risk screening and the identification of deafness. Arch Dis Child. 1991;66:1130-1135

In

Reply.-We are pleased that our challenge’ of the National Institutes of Health Consensus Conference recommendation2 that all infants be

screened for hearing impairment within the first 3 months of life,

and preferably before discharge from the newborn nursery, has

generated so much response. We thank Dr Miller for his

approv-ing comments and particularly for his suggestions concerning

screening-related research. We also welcome the provocative

ro-joinders from the proposed screening program’s advocates, first,

because in answering their various criticisms we hope to shed

further light on key component issues, and second, because heightened attention in these pages to the problem of hearing loss

in young infants can only lead to heightened general vigilance and

therefore earlier case detection.

OVERVIEW OF THE ISSUES

Unarguably, all infants with handicapping degrees of hearing

impairment should ideally be identified as early as possible.

How-ever, it is important to emphasize at the outset that universal

screening within the first 3 months of life will identify relatively

few infants with hearing impairment who would not have been identified by screening all newborns who meet high-risk-register criteria3 and/or are admitted to an intensive-care nursery (HRR/ ICN infants). On the other hand, the added cost of universal

screening-in monetary terms and, more importantly, in harm

done-could be immense.

Collectively, the respondents advocating an early infant screen-ing program have underrated the problems it would pose in implementation and follow-through, overstated its potential ben-efits, and virtually ignored its indirect costs and risks.

Regarding implementation andfollow-through, the advocates have

glossed over complex issues involving in-hospital personnel

ro-quirements and logistics, particularly in the face of the rapidly growing, if not virtually universal practice of discharging

new-borns within 24 to 48 hours of birth. They have also largely failed to address procedures for fulfilling

standard

screening-program

requirements, particularly 1) assuring in advance the availability

of

adequate resources-facilities, personnel,

and

financing-for

accomplishing recommended interventions; 2) establishing and

maintaining mechanisms for maximizing and monitoring

compli-ance; and 3) educating and counseling parents of infants with

false-positive test results and evaluating the near- and long-term impact of those results.

In projecting benefits, the advocates have, variously, 1)

broad-ened the definition of handicapping hearing loss to include chil-dren with milder degrees of sensorineural loss (in whom unto-ward developmental effects, and

the

effectiveness of early

intervention, are uncertain) thereby arriving at higher estimates of

prevalence than the 0.1% (1:1000) rate we used in calculating

expected outcomes of the recommended screening protocol; 2)

neglected to distinguish between cases in which hearing loss is

present at birth and therefore would be potentially detectable by the screening program proposed, and cases in which hearing loss

develops only later and therefore would not be detectable by

screening early in infancy; 3) failed to note that relatively early identification is already being accomplished in many locales; 4)

projected more optimistic estimates of the validity of the proposed screening protocol than are justified

by a comprehensive

overview

of experience

to date;

5) failed to make clear the differences to be

expected

in cost-yield relationships between screening HRR/ICN

infants

and

screening

healthy,

non-HRR/ICN infants; and 6)

as-sumed a greater degree of certainty about the efficacy of early intervention for infants with hearing impairment than is justified by available evidence.

Regarding

costs and

risks, the respondents

advocating

universal

screening have failed to confront the fact that, of the hundreds of thousands of initial test failures by infants each year that would

result

from

the proposed

screening

program,

over

95% would be

falso-positives by even the most optimistic estimates of test

valid-ity. Thus, few of the advocates mentioned, and none

acknowl-edged as substantial concerns, the quantum of needless parental

anxiety, potentially harmful labeling, and other psychological

dis-turbance

that the proposed

program might generate among

fam-iies of normally-hearing infants. Finally, none of the advocates

adverted to another, more consequential risk of universal infant

screening

that

we cited

in our commentary,’ namely, the risk of

unnecessary

or

harmful

diagnostic

procedures

or treatments

car-ried out on children.

INDWIDUAL ISSUES

Here we address, summarizing for brevity, the various

argu-ments

advanced

by the respondents

advocating

universal

screen-ing. Parentheses indicate by whom the respective arguments were

advanced.

Prevalence

of Hearing

Loss

Respondent argument: Ifone includes mild to moderate unilateral and bilateral sensorineuraihearing loss, the overallprevalence may be as high as 0.6%, rather than the 0.1% rate that we used (Gravel et al; Hall; Northern; Robinette). Including mild to moderate loss is justified by studies showing speech and language delays secondary to the mild conductive loss that accompanies otitis media (Vohr).

Reply:

True

prevalence

is poorly

understood.

Prevalence

rates

will

vary depending

on the population

tested,

the

type

and degree

of hearing

loss, the tests used

to measure

hearing,

and the ages at

which

the hearing

tests

were

administered.

As noted

previously,

the higher

estimates

of prevalence

cited

include

cases

in which

sensorineural

loss would

not yet have

developed

or been

detect-able during

early

infancy.

Regarding mild

to moderate

hearing

loss,

studies

attributing speech

and language

delays to mild conductive loss secondary to

otitis media

have

had

major

limitations

and cannot

be

considered

conclusive.46

For

that reason, and because

the

developmental

effects

of milder

degrees

of sensorineural

loss also are

uncertain, it seems inappropriate at present to include infants with such loss in

the target

population

of any screening

program.

Regarding moderate to profound unilateral and bilateral

sen-sorineural

loss-for

which

we agree screening would be

justified

if

the screening

protocol

gave

satisfactory

outcomes-prevalence

in

the ICN

is around 2 to 4%,7

whereas

estimates

of prevalence

in

the well-baby

nursery

range

from 0.05 to

0.l%,”

ie, about

#{188}o

the

prevalence

in the ICN.

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www.aappublications.org/news

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LETfERS

TO

THE

EDITOR

Identification of Hearing Loss

Respondent argument: Half or more of the children with significant hearing impairment are not identified by the

HRR

(Dennis et al; Gravel et al; Hayes; Robinette).

Reply:

There

is no assurance that a universal screening pro-gram would identify many or most of such children not identified by the HHR. Many cases of significant hearing impairment are not present at birth. Some that develop later-eg, as a consequence of genetic abnormality, congenital or postnatal infection, exposure to ototoxic drugs, or persistent pulmonary hypertension-would or-dinarily not be detectable by any type of newborn screening.’2’5

Further, some of the cases not identified by the HRR would be

identified by routinely screening all babies in the ICN. For exam-ple, in the Rhode Island project, to be discussed in

greater

detail

later,

eight

of the

11 cases identified as having sensorineural hearing loss were HRR/ICN infants.18

Respondent argument: On average, children in the United States with severe to profound hearing impairment are not identified until approxi-mately 2#{189}years of age (Koop, Robinette).

Reply:

That

statistic

was

also

cited

in the NIH Consensus

Statement.2 However, indications exist that the average age of

identification of such children is decreasing in many locales,

prob-ably due to increased screening of HRR/ICN infants

and

to

en-hanced awareness of hearing loss on the part of families,

pedia-tricians,

and

other

primary-care

providers.

Recently

the reported

average age of identification has been less than 11 months in Utah,’7 14 months in the Chicago area,’8 and 16 to 17 months at Boys Town Institute.’9 Currently, the average age is 14 to 16 months at the Bill Wilkerson Center in Nashville. Thus it appears that, even without universal screening, we may be closing in on Dr

Koop’s goal of 12 months by the year 2000.

Advantages

of Screening

Newborns

Respondent argument: Our current health care system provides no opportunity for systematic screening of children’s hearing until the children enter the public school system; most primary-care providers do not routinely evaluate hearing at well-baby visits (Gravel et al). Univer-sal hearing screening before discharge from the newborn nursery would relieve physicians of the obligation to arrange systematic screening subsequently (Stewart and Davis-Freeman).

Reply: As noted previously, many cases of sensorineural hear-ing loss are not present or detectable in the newborn period.

Therefore,

passing

the

newborn screen may, in some cases, impart

a false sense

of

security, and testing will of necessity be required

at later ages to achieve optimal identification. Clearly, far greater

efforts

than

have

been applied heretofore need to be applied

toward educating both primary health care providers and parents

to be on the alert for hearing

loss

in infants. The monetary costs of such efforts should be far less than the costs of a universal

new-born

screening

program.

Physicians’ offices, hospital clinics,

pub-lic health well-baby clinics, and day-care centers constitute set-tings in which such educational efforts could logically take place. That the average age of identification has been reduced in some locales speaks to the possibility that such efforts can be successful.

Test

Performance

of the

Proposed

2-Stage

Screening

Protocol

Respondent argument: The

evoked

otoacoustic emissions (EOAE) test, the first stage of the proposed 2-stage test protocol, is a better screening test than we indicated in our commentary.’ We failed to reference the appropriate supporting research (Koop). The percentage of infants failing EOAE screening is far

lower

than the 10% value we projected’ (European Concerted Action Group). Moreover, newer data from the Rhode Island project-the pilot project on whose results the

NIH Consensus Statement recommendations were largely based-show better results than the 27% first-stage failure rate reported originally;’6 the rate is currently down to 8.6% statewide (Vohr) and 5% at Women and Infants Hospital of Rhode Island (Robinette and personal commu-nication, Betty R. Vohr, MD).

Reply:

Other than those from the Rhode Island project, the

studies of EOAE testing cited by Dr Koop”#{176} were carried

out

under controlled conditions by skilled examiners; one cannot as-sume that comparable results would be obtained

under

standard

nursery conditions by paraprofessionals. These studies indeed documented high levels of test sensitivity, but the test failure rates

averaged about 20%. Other investigators have reported failure

rates

of

22

to

43% if testing is conducted during the first 24 hours

of

life; one group concluded that newborns should not be screened

before

4

days of age. Even after the first few days of life, other

centers

have reported findings far different from those now being

cited

from

Rhode

Island;

EOAE

failure

rates

at

these

centers

have

ranged

from

33 to 78%.26

Because

increasingly

in the United

States most normal newborns are discharged by 2 days, or even I day of age, it seems unlikely that EOAE failure rates nationwide

would

be much

lower

than

the range

of values

just cited.

Finally,

one must

note that a test failure

rate even as low as

5%,

combined

with a

prevalence

even

as high

as 2:1000,

would

result

in 96%

of

the test failures

being

false-positives.

Respondent argument: Contrary to our admonition that auditory brain stem response

(ABR)

testing

is problematic, ABR techniques, both conventional and automated, are readily accepted by most clinicians (Dennis et al; Hall; Northern).

The specificity

of ABR screening, the second stage of the proposed 2-stage protocol, is not 90%, as both the NIH Consensus Statement2 and we had cited,’ but, rather, at least 95% (Northern; Raffin and Matz; Stewart and Davis-Free,nan).

Reply:

To be acceptable,

a

screening

tool should

be simple

and

easily

and

quickly

operated,

and

its findings should be

easy

to

interpret. Conventional ABR testing does

not meet

those

criteria,

although

automated

ABR testing

probably

does. The data

suggest-ing

that

the

specificity

of ABR

testing

is as high

as 95% were

collected in university-based hospital programs on small and

bi-ased samples-ie, mostly high-risk infants-by skilled audiolo-gists whose clinical and academic interests have centered on

au-ditory electrodiagnosis. Specificity

values

are

likely

to be

substantially

lower

when ABR testing is carried out on large

numbers of normal infants in community hospitals by

parapro-fessional

personnel.

Here

even the estimate of 90% may be

overly

optimistic.

Beyond

specificity

values,

it

is well

known

that

the

proportion of children eventually shown to have sensorineural

hearing loss is lower than early life

ABR failure

rates

would

indicate.’#{176}21

Respondent argument: Failure ratesfor automated ABR testing inthe well-baby population are 5% or less, resulting in substantially lower over-referral rates than the 99% value cited both in the NIH Consensus Statement2 and in our commentary’ (Dennis et al; Hall).

Reply:

Failure

rates

as low

as 5% have

been reported in

two

papers

recently

at

seminars.373 Whether

these

values

can be

rep-licated on a larger-scale basis with nonprofessional staff

has not

yet

been determined. Typically, more errors can be expected with routine screening.

Practicability

of the

Screening

Protocol

Respondent

argument:

EOAE

testing can be easily and quickly

per-f

ormed in a nursery setting by paraprofessionals, supervised by an audiologist (Vohr).

Reply:

That

paraprofessionals

in

the Rhode

Island

project

are

supervised

by audiologists

is but

one

indicator

that

an EOAE

screening

program

in

a hospital

nursery

is not to be undertaken

lightly

or without

substantial

commitment.

The following

excerpts

from a description

of the Rhode

Island

program

by

its

develop-ers#{176}

provide

further

insight

into what

may be called

for:

“. ..regular monitoring

of all screeners

...

(was)

critical

....

Screeners

who

worked

fewer

than

10 hours

per

week

...

produced

a comparatively

high

percentage

of invalid

ro-sults. ...Testing

could

be accomplished

more

rapidly

if

low-frequency background noise was reduced. ...

It was

also

important

to attempt

to reduce

the infant

physiological

noise

that

occurs

because

of mucus,

loud

sucking,

whimpering, respiratory distress, or crying. ...

Infants

were

...

snugly

swaddled

with

a blanket

and

patted

and

caressed

until

an

appropriate

state

was

achieved.

.. . if

the

infant

remained

restless,

a pacifier

was offered

and the lights

were

dimmed. if

none

of these

maneuvers

produced

the desired

results,

the

infant

was

rescheduled

for later

in the day

or the following

day.

Recognizing

the key factors

in the infant’s

behavior

that

indicated a probability of completing a valid screen in a

reasonable

time was an ongoing challenge for the scheduling

and

screening

staff.

...Screening every live birth

for hearing

loss ...

involves

all aspects

of existing

hospital

procedures,

staffing

arrangements,

and facilities.

...It is absolutely

essen-tial

to have

systematic

training

and certification

of screeners

as well as regular monitoring (by

an audiologist)

thereafter.

If

(3)

these steps are not taken, there will be an unnecessarily high

rate of invalid results

Costs

and

Risks

Respondent argument: The costs of newborn hearing

screening

are

relatively low. We accept as necessary the costs of screening for phenylk-etonuria (PKU) hypothyroidism, and sickle-cell disease; why not also for hearing loss? (Dennis et al; Vohr).

Reply: The consequences of delay in the detection of hearing loss, serious though they may be, cannot be fairly equated with the disastrous consequences of failure to detect PKU or hypothyroid-ism in the neonatal period, or of undiagnosed sepsis in the infant

with sickle-cell disease. Moreover, the current combined cost of

metabolic and sicklo-cell screening is less than $10, compared with

$30 or more for only the first-stage EOAE screen. Finally, the

false-positive rates in screening for

P1W

and hypothyroidism are

substantially lower than in infant hearing screening.

Respondent argument: Newborn hearing screening programs have been successfully implemented in many hospitals without the adverse consequences we projected in our commentary.’ The risk consists only of unnecessary worrying by parents and caregivers in the cases of infants who prove to be false-positives (Gravel et al).

Reply: No newborn hearing screening program, to our

knowl-edge, has actually investigated adverse consequences among false-positive infants or their families. Two types of adverse

out-come warrant concern. First, it seems likely that, of the large numbers of false-positive infants identified by screening, many

will be subjected to discomfort, costs, and risks as a consequence of additional diagnostic and inappropriate therapeutic proco-dures. In particular, we would be concerned that many will show

evidence of conductive hearing loss that will be ascribed (rightly or wrongly) to otitis media with effusion, and that some of these infants will be subjected inappropriately to tympanostomy-tube

placement. That this risk is real is supported both by our own observations and by a recent report” documenting, in a large, insured population of children, that the operation is frequently

recommended for inappropriate indications.

Second, it seems likely that in many cases the false-positive identification itself will harm parents and children. A number of reports42.43 and reviews’ document the extent to which parental

misunderstanding and anxiety concerning the false-positive state

may persist as important problems long after the diagnosis in

question has been dismissed. The newborn period, in particular,

appears to be a sensitive time when identifying the infant as abnormal, even if only temporarily, may result in the infant’s being “labeled” unfavorably or in other long-term adverse effects

on the parent-child relationship and/or the child’s psychological development.45

Follow-up,

Access,

and

Compliance

Respondent argument: Before initiating screening, each program should be encouraged to resolve issues concerning accessibility and availability of facilities for suitable follow-up and compliance (Stewart and Davis-Freeman). On the other hand, a newborn predischarge screen is one mechanism for beginning to address both access barriers

and

poor compliance (Vohr).

Reply: “Encouraged” is not sufficient. Accessibility and avail-ability of both diagnostic and treatment facilities, as well as the

likelihood of reasonable compliance, are key prerequisites for

ini-tiating a screening program.47 To undertake a program without

these elements reasonably assured in advance not only will

un-dercut the objective of the program-to benefit children-and

waste its efforts, but will result inevitably in much parental

con-fusion, frustration, and anxiety. Access barriers and poor compli-ance are societal and health-system problems

that

screening

pro-grams cannot solve.

Respondent argument: Because of differing health-system, socioeco-nomic, and geographic circumstances behveen European countries and the United States, there should be fewer reservations about newborn hearing screening in Europe (European Concerted Action Group).

Reply: Fewer, perhaps, but reservations nonetheless, because the adverse effects of false-positive identification would likely

constitute risks as substantial in Europe as in the United States.

Neuropsychological

Considerations

Respondent argument: Morphological

changes

in central neural path-ways have been shown to result from early experimental acoustic depri-vation (European

Concerted

Action

Group).

Reply: The studies referred to are

interesting,

but they have

been carried out only on birds and rats; extrapolating the findings to humans would be problematic.

Respondent argument: Phonetic perception in infants

undergoes

im-pressive development during

the

first 6

months

of life, constituting

a reason for detecting hearing loss

early

(European

Concerted

Action Group; Robinette).

Reply: The evidence cited is credible and important. However, no parallel evidence exists that

the first

6

months constitute a critical period, and that satisfactory phonetic perception cannot

develop later.

Efficacy of Intervention

Respondent argument: Our commentary’ did not sufficiently ac-knowledge

the

effectiveness and benefits of early intervention, once children with hearing impairment have been

identified.

The educational

(regular versus

special

classrooms) and quality-of-life savings would more than compensate for

the costs of screening

(European Concerted Action Group; Hayes; Robinette; Stewart and Davis-Freeman; Vohr).

Reply: The possibility of optimizing habilitation, communica-tion skills, and quality of life for even a few individuals constitutes a strong argument for early identification. Early identification, followed by intervention that at present is deemed appropriate, makes intuitive sense, and surely all health professionals, we included, support

it.

Nonetheless it must be acknowledged that,

for the reasons outlined

in

our commentary,’ available empirical

evidence to support the effectiveness of early intervention is far

from conclusive.

Respondent

argument:

If evidence of the effectiveness of early inter-vention is not conclusive enough to justify universal screening, why is it conclusive enough to justify screening at-risk newborns (Robinette)?

Reply: Our objection to universal screening

is

not based on the weakness of evidence supporting intervention; we simply call

attention to that weakness while agreeing that, for infants with

confirmed

hearing impairment, one

must

intervene in whatever

manner seems best at the moment. Rather, our objection to

uni-versal screening

is

based

on I)

lack of evidence, and skepticism,

that it will result in more effective identification and better even-tual outcomes than targeted HHR/ICN screening; and 2) concern about the harm that could result from universal screening, as discussed previously.

It is important to appreciate that among normal newborns, as

compared with high-risk newborns, the proportion likely to be

benefited by screening is much lower and the proportion likely to

be harmed is much higher. Another factor favoring the screening of high-risk newborns but not normal newborns is that high-risk

newborns have substantially longer hospital stays, so that they can

be tested at times when test results

are substantially

more valid

than during the first day or two of life, by which time normal

newborns are generally discharged.

Feasibility

and

Ethics

of Research

on Screening

Respondent

argument:

The questions

and concerns about screening that we raised in

our commentary’

are

not amenable to study because of ethical and moral constraints. One cannot withhold intervention from young children with known hearing loss in a planned, prospective

investigation.

The

NIH

Consensus panel was

obliged to choose between

maintaining the status quo and setting avision for thefuture. Ifwe

have

any alternative, constructive suggestions, what are they? (European Concerted Action Group; Gravel et al; Hayes; P..affin and Matz).

Reply: As suggested in Dr Miller’s response, the effectiveness of an early infant hearing screening program certainly can

be

sub-jected to experimental study-without

resort

to withholding

in-tervention from young children with known hearing loss-and

should be

subjected to experimental study before deciding whether to launch such a program nationwide. The underlying principles and essential features of randomized trials of screening programs have been

well delineated

by

Sackett,

Haynes,

and Tugwell.47

A

randomized trial of hearing screening would require a large

population of newborns. Eligibility would be limited to

those

who

were apparently normal

and

risk-free,

with those

who met HRR

criteria and/or who were admitted to an ICN having

been

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962

LE1TERS

TO

THE

EDITOR

cluded and screened because of their at-risk status. The normal newborns would be randomly assigned to be offered

(experimen-tal group) or not offered (control group) the screening protocol. Control infants would receive clinical care in the conventional,

pro-trial manner, but the parents of all infants in both study groups would receive, at baseline and periodically, standardized

educational materials about the importance of remaining alert to

possible signs of hearing loss in their infants. The outcomes of all infants randomized to be screened-including those whose

par-ents either declined the offer, dropped out later, or failed to

comply with recommended interventions-would be compared with the outcomes of all control infants. Screened infants would be

subcategorized according to their designated status on completing the screening protocol-ie, truo-positive, false-positive, or

nega-live. The outcomes analyzed over the course of follow-up would

include, at minimum, the proportions of infants correctly and incorrectly identified as having hearing loss, and the ages of the

identifications; the numbers of diagnostic and therapeutic

proco-dures; measures of children’s functional status, behavior, and psychosocial adjustment; measures of parental stress and anxiety;

and monetary costs.

The cost of a study such as this would be high, but far less than

the first-year costs alone of a nationwide screening program and the diagnostic and therapeutic procedures itwould generate.

if

the

study showed that screening had resulted in favorable benefits

overall in relation to risks and costs, one could then proceed to implement a nationwide program with confidence. If, on the other hand, the results showed no clear advantage of screening,

im-mense effort and cost for years to come could properly be avoided.

As pointed out by Sackeft et al,47 “the widespread implementation of untested methods of early diagnosis renders their subsequent rigorous evaluation much more difficult and less decisive; indeed

it may even become impossible to correct the original error.”

CURRENT RECOMMENDATIONS

Because of the potential benefits of early detection of hearing

loss and the potential risks of delayed detection, and because the prevalence of sensorineural hearing loss is far higher in infants

who meet HRR criteria than in normal newborns, we

recom-mended in our commentary’ and continue to recommend that

screening, using automated ABR methods, be performed on all

HRR infants. Importantly, although most newborns admitted to an ICN

also

will meet HRR criteria, in our recommendation we

neglected to make specific reference to ICN infants who do not meet HRR criteria; such infants should have

been

induded and

also

should be screened.

In contrast to HRR/ICN infants, apparently normal newborns

ought not be subjected to hearing

screening

(except as subjects in a properly designed study). Some of the difficulties and pitfalls

inherent in attempting to screen and follow-up such infants have

recently been underscored by Galambos, a pioneer in the study

and use of ABR testing in newborns, and his co-workers. In

expressing skepticism about universal screening, based on their

extensive experience with ICN infants, they wrote, “After the ICN

infants have been taken away, few of the infants left behind in the normal nursery will be deaf, because normal infants almost al-ways have normal hearing.” To detect those rare deaf infants in the normal nursery, a vigorous campaign directed at educating primary-care providers and parents to be continually alert to the possibility of hearing loss makes far more sense and would cost far less than a program of universal screening.

FRED

H.

Bess,

PiD

Division

of Hearing

and

Speech

Sciences

Vanderbilt

University

School

of Medicine

and

the Bill

Wilkerson

Center

Nashville,

TN

JACK

L.

PARADISE,

MD

Department of Pediatrics

University

of Pittsburgh

School

of Medicine and the

Children’s

Hospital

of Pittsburgh

Pittsburgh, PA

REFERENCES

1. Bess FH, Paradise JL. Universal screening for infant hearing

impairment: not simple, not risk-free, not necessarily beneficial and not

presently justified. Pediatrics. 199493:330-334

2. NIH Consensus Statement. Early Identification of Hearing Impairment in Infants and Young Children. March 1-3, 1993;11:1-24

3. Joint Committee on Infant Hearing. 1990 Position statement. AAP News. April 1991;7:6-14. Reprinted in Policy Reference Guide, 6th ed. Elk Grove

Village, IL: American Academy of Pediatrics; 1993:343-346

4. Ventry IM. Effects of conductive hearing loss: fact or fiction. ISpeech Hear Dis. 1980;45:143-156

5. Paradise JL Otitis media during early life: how hazardous to develop-ment? A critical review of the evidence. Pediatrics. 198168:869-873

6. Paradise JL, Rogers KD. On otitis media, child development, and

tym-panostomy tubes: new answers or old questions? Pediatrics. 1986;77: 88-92

7. American Speech-Language-Hearing Association. Guidelines for audio-logic screening of newborn infants who are at-risk for hearing

impair-ment. ASHA. 198931:89-92

8. Turner RG. Modeling the cost and performance of early identification protocols. I Am Aced Audiol. 19912:195-205

9. Turner RG, Cone-Wesson BK. Prevalence rates and cost-effectiveness of

risk fado In Bess FH, Hall ifi JW, eds. Screening Children for Auditory Function. Nashville, TN: Bifi Wilkerson Center Press; 1992:79-104 10. Newton VE. Aetiology of bilateral sensori-neural hearing loss in young

children. ILaryngol Otol. 1985;10(suppl):40-41

11. Plinkert PK, Sesterhenn C, Arold R, Zenner HP. Evaluation of otoacous-tic emissions in high-risk infants by using an easy and rapid objective auditory screening method. EurArch Otorhinolaryngol. 1990247:356-360

12. Nield TA, Schrier S. Ramos AD, Platzker ACG, Warburton D.

Unex-pected hearing loss in high-risk infants. Pediatrics. 1986;78:417-422 13. Salamy A, Eldredge L, Tooley WH. Neonatal status and hearing loss in

high risk infants.

J

Pediatr. 1989;114:847-852

14. Walton B’, Hendricks-Munoz K. Profile and stabthty of sensorineural

hearing loss in persistent pulmonary hypertension of the newborn. I

Speech Hear Res. 199134:1362-1370

15. Fowler KB, Dahle A, Boppana SB, Stagno S, Britt WJ, Pass RF. The

importance ofcongenital cytomegalovirus infection in identifying child-hood hearing impairment. Abstract. Pediatr Res. 199434(4, Part 2)296A

16. White KR, Vohr BR, Behrens TR. Universal newborn hearing screening using transient evoked otoacoustic emissions: results of the Rhode Island Hearing Assessment Project. Semin Hear. 1993;14:18-29

17. Mahoney TM, Eichwald JG. The ups and “DOWNS” of high-risk hear-ing screenhear-ing: the Utah statewide program. Semin Hear. 19878:155-163

18. Stein LK,Jabaley T, Spitz R, Stoakley D, MCGeeT. The hearing-impaired

infant: patterns of identification and habilitation revisited. Ear Hear. 1990;11:201-205

19. Mace AL, Wallace KL, Whan MA, Stelmachowicz PG. Relevant factors in the identification of hearing loss. Ear Hear. 1991;12:287-293

20. Bonfils P, UzielA, PujolR. Screening for auditory dysfunction in infants by evoked otoacoustic emissions. Arch Otolaryngol Head Neck Surg.

1988;114:887-890

21. Stevens JC, Webb HD, Hutchinson J, Connell J,Smith MF, Buffin JT. Click evoked otoacoustic emissions compared with brain stem electric

response. Arch flis Child. 1989i4:1105-1111

22. Kennedy CR, Kimm L, Cafareffi Dees D, et al. Otoacoustic emissions and auditory brainstem responses in the newborn. Arch Dis Child. 1991;66:1124-1129

23. Saloman G, Anthonisen B, Groth J,Thomsen PP. Otoacousfic hearing screening in newborns: optimization. In: Bess FH, Hall Ill JW, eds. Screening Children for Auditory Function. Nashville, TN: Bill Wilkerson

Center Press; 1992:191-206

24. Chang KW, Vohr BR, Norton SJ, Lekas MD. External and middle ear

status related to evoked otoacoustic emission in neonates. Arch Otolar-yngol Head Neck Surg. 1993;119276-282

25. Kok MR, van Zanten GA, Brocaar NW, Wallenburg Hc3. Click-evoked

oto-acoustic emissions in 1036 ears of healthy newborns. Audiol. 1993;

32:213-224

26. Uppenkamps S, Jakel M, Talartschick B, Buschel J, Koilmeister B.

Evo-zierte otoakustische emissionen als screening test fur die horprufung bei neu-und fruhgeborenen? Laryngoorhinootologie. 1992;71:575-.529 27. Jacobson fF, Jacobson CA. The effects of noise in transient EOAE

newborn hearing screening. let I Pediatr Otorhinolaryngol. 199429: 235-248

28. Hall JW, BaerJE, Chase PA, Rupp KA. Transient and distortion product otoacoustic emissions in infant hearing screening. Paper presented at

annual meeting of the American Academy of Audiology; April 1994;

Richmond, VA

29. TaIfJH, Cox EL TEOAE hearing screenings in the special care nursery.

Paper presented at annual meeting of the American Academy of

Audiology; April 1994; Richmond, VA

at Viet Nam:AAP Sponsored on September 1, 2020

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30. Jacobson JT, Morehouse CR, Johnson MJ. Strategies for infant auditory

brainstem response assessment. Ear Hear. 19823:263-270

31. Dennis JM, Sheldon R, Toubas P. McCaffee MA. Identification of hear-ing loss in the neonatal intensive care unit population. Am I Otol. 19845:201-205

32. Ruth PA, Dey-Sigman 5, Mills JA. Neonatal ABR hearing screening. Hearing

J.

198538:39-45

33. Jacobson

Fr,

Jacobson CA, Spahr RC. Automated and conventional ABR

screening techniques in high-risk infants. I Am Aced Audiol. 1990;l:

187-195

34. Kileny PR. ALGO-1 automated infant hearing screener: preliminary

results. Semin Hear. 1987;8:125-131

35. Ransohoff DF, Feinstein AR. Problems of spectrum and bias in

evalu-ating the efficacy of diagnostic tests. N Engi IMed. 1978299:926-930 36. Durieux-Srnith A, Picton 1W, Edwards CG, MacMurray B,Goodman

JT. Brainstem electric-response audiometry in infants of a neonatal

intensive care unit. Audiol. 198726:2M-297

37. Davis S. Hearing screening at Baptist Memorial Hospital, Memphis, TN.

Paper presented at Universal Infant Hearing Screening National

Seminar; November 1993; Nashville, TN

38. Joseph JM, Herrmann BS, Thornton AR, Pye RK. Well-baby heating

screening using automated ABR. Paper presented at the

American-Speech-Language-Heating Association Annual Convention; November

1993; Anaheim, CA

39. Holtzman NA. Whatdrives neonatalscreening programs? N EnglJMed. 1991 ;325:802-804

40. Johnson MJ, Maxon AB, White KR, Vohr BR. Operating a hospital-based universal newborn heating screening program using transient evoked

otoacoustic emissions. Semin Hear. 1993;14:46-56

41. Kleinman LC, Kosecoff J,DUbOiS RW, Brook RH. The medical appro-priateness of tympanostomy tubes proposed for children younger than

16 years in the United States. JAMA. 994;271:1250-1255

42. Sorenson JR. Levy HL, Mangione, TW, Sepe SJ. Parental response to repeat testing of infants with “false-positive’ results in a newborn

screening program. Pediatrics. 1984;73:183-187

43. Tluczek A, Mischler EH, Farrell PM, et al. Parents’ knowledge of neo-natal screening and response to false-positive cystic fibrosis testing. I Dev Be/wv Pediatr. 1992;13:181-186

44. Feldman W. How serious are the adverse effects of screening? J Gen Intern Med. 19905(suppl):S50-S53

45. Clayton EW. Issues in state newborn screening programs. Pediatrics. 199290:641-M6

46. Clayton EW. Screening and the treatment of newborns. Houston Law Review. 199229:85-148

47. Sackett DL, Haynes RB, Tugwell P. Clinical Epidemiology: A Basic Science for Clinical Medicine. Boston: Little, Brown & Co; 1985:302-310

48. Galambos R. Wilson MJ, Silva PD. Identifying heating loss in the

intensive care nursery: a 20-year summary. J Am Aced Audiol. 19945: 151-162

Homeopathy

Study

Questions

To the

Editor.-After reading the double blind control study regarding the

treatment of acute childhood diarrhea with homeopathic medicine published in the May 1994 issue, I am pleased to see Pediatrics

publish a practical clinical study that will help pediatricians utilize treatment previously thought to be useless. Specifically,

homeop-athy has been looked upon with skepticism for many years as a

form of voodoo medicine.

As a board-certified pediatrician, I have practiced primary care pediatrics for 15 years and, for the past 7 years, have been

evalu-ating children with problems such as attention deficit

hyperactiv-ity disorder and recurrent ear infections, but taking a different

approach than is generally accepted. Specifically I am finding

that

food allergies and hypersensitivities are not a myth or a form of medical quackery as is generally perceived by many pediatricians.

Recent studies carried out showing that sugar and aspartame have

no statistical benefit on hyperactivity are oversimplistic.

Just as the homeopathy study utilized six different treatments

based

on individual differences, I do not believe one particular food can be specifically implicated. A significant number of

chil-dren with hyperactivity and recurrent ear infections can be

af-fected by various foods, additives, and molds. The key is to look

at the foods and additives ingested at least twice a week as well as

a positive history for pollen and mold allergies.

It is my opinion that many past studies on food allergies are not

in touch with the reality of what I am seeing on a daily basis. I believe it is

time

for academic researchers to work with clinicians and design better studies that are more practical for the pediatric

population at large. Unfortunately, the academic community is all too frequently carrying out esoteric studies

that

have little or nothing to do with helping children feel and act better.

Hopefully, Pediatrics will build on the recent homeopathy study

and encourage more studies in areas that have

in

the past been

considered without merit and start proving that some previously unaccepted modes of treatment actually do have medical benefits.

To

the

Editor.-RICHARD E. LAYrON,

MD

Towson,

MD 21204

Several aspects of Jacobs et al’s study of homeopathic

medi-cines in the treatment of childhood diarrhea deserve further corn-ment.’ It is known that nutritional management of acute diarrhea can have a large impact on duration of illness; specifically, the timing and composition of the introduction of foods after rehy-dration can have a major impact on stool output and length of

illness.2’3 As a result, clinical

trials

of acute diarrhea in which

treatment

groups are fed the “child’s normal diet” (as was the case

in this report) or the “standard hospital diet” are subject to major confounding effects,

ie,

was

the change

in

stool output due to the

intervention under study or a dietary factor not measured or taken

into account? In addition, the outcome measures selected by the authors are not those

(versus statistical) significance of their finding of fewer stools on day three of illness should be addressed, since the finding of equal stooling rates on subsequent days casts doubt on the importance of this result.

Although we are open to the possibility of alternative medical

or dietary therapies improving case management of diarrhea, we are hopeful that their evaluation will continue along the scientific standards used to evaluate other new agents.

Ci-misropi-mi

DUGGAN,

MD

RONALD

E.

Kiru,

MD

Division

of Pediatric

Gastroenterology

and Nutrition

Massachusetts

General

Hospital

Boston,

MA

02114-2698

REFERENCES

1. Jacobs J,Jimenez M, Gloyd 55, et al Treatment of acute childhood

diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua. Pediatrics. 199493:719-725

2. Santosham M, Fayad IM, Hashem M, et al. A Comparison of rice-based oral rehydration solution and “early feeding” for the treatment of acute

diarrhea in infants. J Pediatr. 1990;116:868-875

3. Khin-Maung U, Wai N, Myo-Khin, Mu-Mu-Khin, Tin U, Thane-Toe. Effect on clinical outcome of breast feeding during acute diarrhea. Br Med J. 1985290:587-589

4. Diarrhoeal Diseases Control Programme. Guidelines for planning

din-ical trials in diarrhoeal diseases. World Health Organization. Document CMT/87.2

To the Edit

or.-The article by Jacobs et al’ regarding treatment of acute

child-hood diarrhea with homeopathic medicine as an adjunct to the

World Health Organization Oral Rehydration Solution (ORS) omits some essential measurements needed for comparison with

previous literature reports and pertinent references from the last

15 years.

The authors ignored the whole body of literature on rice- or

cereal-based ORS (CB-ORS) that dealt with much larger patient

samples and more precise measurements.2

These

reports

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1994;94;959

Pediatrics

Fred H. Bess and Jack L. Paradise

Letter to the Editor

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1994;94;959

Pediatrics

Fred H. Bess and Jack L. Paradise

Letter to the Editor

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