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SPECIAL

ARTICLE

Workshop

on Effects

of Otitis

Media

on the

Child*

Charles

D. Bluestone,

MD, Jerome

0. Klein, MD, Jack L. Paradise,

MD,

Heinz Eichenwald,

MD, Fred H. Bess, PhD,

Marion

P. Downs,

MA, DHS, Morris Green,

MD,

Jean Berko-Gleason,

PhD, Ira M. Ventry,

PhD,

Susan W. Gray, PhD, Betty Jane McWilliams,

PhD, and

George

A. Gates,

MD

GOALS, DEFINITIONS, AND CLASSIFICATION

OF OTITIS MEDIA

-Charles D. Bluestone, MD

The goal of this Workshop was to assess current knowledge concerning the effects of otitis media on the child. Experts in pediatrics, infectious disease,

otolaryngology, audiology, speech, linguistics, and

psychology met in Chicago on Aug 25, 1982 to

participate in this Workshop. A summary of the

discussions is presented here.

Otitis media is broadly defined as an inflamma-tion of the middle ear without reference to etiology or pathogenesis.1 Otitis media with effusion is an inflammation ofthe middle ear in which a collection of liquid (i.e., middle ear effusion) is present in the

middle ear space (no perforation of the tympanic membrane is present). Atelectasis of the tympanic membrane, which may or may not be associated with otitis media, is defined as either collapse or retraction of the tympanic membrane. Acute otitis

media implies a rapid and short onset of signs and

symptoms lasting approximately 3 weeks. From 3 weeks to 3 months, the process may be resolving or subacute. If middle ear effusion persists beyond 3 months, the condition is classified as chronic otitis

media with effusion.

Many terms have been used for acute otitis me-dia, such as “suppurative,” “purulent,” or “bacte-rial” otitis media; however, a “serous” effusion may also have an acute onset. Otitis media with effusion unaccompanied by signs and symptoms of acute inflammation has also had a plethora of other names: “serous,” “secretory,” “nonsuppurative,”

and “glue ear” have been the most commonly used.

EPIDEMIOLOGY AND NATURAL HISTORY OF

OTITIS MEDIA

-Jerome

0. Klein, MD

Otitis media is one of the most common infec-tious diseases of

childhood.

By

3 years of age, more than two thirds of Boston children have had at least one episode and one third have had three or more

Received for publication Nov 11, 1982; accepted Nov 22, 1982.

aThis workshop was convened in Chicago, Aug 25, 1982 and was co-sponsored by the Otitis Media Research Center (grant 5 P01 NS16337), Children’s Hospital of Pittsburgh; and Eli Lilly Co., Indianapolis. Moderator: Charles D. Bluestone, MD, De-partment of Otolaryngology, Children’s Hospital of Pittsburgh, Pittsburgh. Participants: Jerome 0. Klein, MD (co-editor), De-partment of Pediatrics, Boston University, Boston; Jack L. Paradise, MD (co-editor), Departments of Pediatrics and Corn-rnunity Medicine, University of Pittsburgh School of Medicine, Pittsburgh; Heinz F. Eichenwald, MD, Department of Pediat-rics, University of Texas Health Sciences Center at Dallas, Dallas; Fred H. Bess, PhD, Department of Hearing and Speech Sciences, Vanderbilt University School of Medicine, Nashville,

TE; Marion Downs, MA, DHS, Department of Otolaryngology, University of Colorado School of Medicine, Denver; Morris

Green, MD, Department of Pediatrics, University of Indiana

School of Medicine, Indianapolis; Jean Berko-Gleason, PhD, Department of Psychology, Boston University, Boston; Ira M. Ventry, PhD, Department of Audiology, Teacher’s College, Co-lumbia University, New York; Susan W. Gray, PhD, Department of Psychology, Vanderbilt University School of Medicine, Nash-ville; Betty Jane McWilliams, PhD, Cleft Palate Center and Department of Communications, University of Pittsburgh, Pittsburgh; George A. Gates, MD, Department of Otorhinolar-yngology, The University of Texas Health Science Center at San Antonio, San Antonio, TX.

Reprint requests to (C.D.B.) Department of Otolaryngology, Children’s Hospital of Pittsburgh, 125 De Soto St, Pittsburgh, PA 15213.

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1 I I I I

. - A

t- BC,N122

.- AC, N=161

episodes of otitis media.2 In the office practices of physicians who provide care to children, otitis me-dia is the most frequent diagnosis for illness and

the most frequent reason, after well baby and child

care, for office visits. In a recent survey in Boston of more than 17,000 office visits during the first year of life, otitis media was responsible for

approx-imately one

third

of visits for illness and approxi-mately one fifth of all office visits.3

In the Boston study, some features were associ-ated with increased risk of single or recurrent (three

or more) episodes of otitis media: boys were affected more frequently than were girls; whit children had

a higher incidence of otitis than black children, but the category “other,” including Hispanic children, had the highest incidence; children living in

house-holds with many members were more likely to have otitis media than were children in households with fewer members; and children with siblings or par-ents who had a history of chronic otitis media had a higher incidence of otitis media than did children with siblings or parents without a history of the disease.2

In certain populations, both the incidence and severity of otitis media are great. The disease ap-pears to be particularly severe among American Indians and Alaskan and Canadian Eskimos; otor-rhea occurs in a majority of affected children.4

Among Australian aboriginal children, a form of disease termed necrotizing otitis media occurs, with the rapid development of discharge and a large

permanent eardrum perforation.5

Middie ear effusion persists for weeks to months after an episode of acute otitis media. Appropriate antimicrobial agents sterilize the middle ear effu-sion but do not clear the fluid from the middle ear space. Analysis of the experience of the Boston children after the first episode of otitis media in-dicated that 70% still had middie ear effusion at the conclusion of antimicrobial therapy at 2 weeks,

40% had effusion at 1 month, 20% had effusion at

2 months, and 10% had effusion at 3 months.2 We examined many variables for possible effect on duration of effusion. Only the method of feeding was significantly correlated with duration of

effu-sion. Children who were breast-fed had duration of effusion that was significantly shorter than chil-dren who were bottle-fed; longer periods of breast-feeding were associated with shorter periods of

ef-fusion.

The incidence of symptomatic otitis media de-dines with age. Otitis media is less common in children after 7 years of age. However, point

prey-alence studies in the United States6 and Scandi-navia7’8 indicate that up to 28% of apparently asymptomatic children may be identified by tym-panometry as having middle ear effusion during an

examination period. Repeated examinations re-vealed that effusions cleared spontaneously in most

children within a few months.

HEARING LOSS ASSOCIATED WITH MIDDLE

EAR EFFUSION

-Fred

H. Bess, PhD

Hearing loss is the most common complication and sequela of middle ear disease. The loss is usu-ally conductive, but sensorineural involvement also occurs. The prevalence of hearing loss depends on

its definition. Although difficulties exist in

deter-mining prevalence from published reports because of limited information about testing conditions, calibration of equipment, definition of hearing loss, and diagnosis of disease, estimates of prevalence

nevertheless can be made by selecting data from

some of the better controlled investigations.

A typical audiometric profile accompanying otitis media with effusion is shown in Fig. 1. The profile for air conduction is relatively flat, with slight peaking at 2,000 Hz.9 The average degree of air

conduction loss through the speech frequency range

(500 Hz, 1 kHz, 2 kHz) is 27.6 dB; the bone

con-duction values averaged 3

dB;

the mean air bone gap was thus 24.6 dB.

The hearing loss associated with middle ear ef-fusion is variable in degree. Data from three studies’#{176}12 involving 627 ears indicate the following hearing loss categories: within the speech frequency range, 7.7% showed an average loss of 10 dB or less;

91.5% exhibited losses between 16 and 40 dB; and only 0.8% showed losses of 50 dB or more. If hearing

loss is defined as an average of 21

dB

or more in

(I) -J ‘U

U

LU

0

z

.J LU > LU -I 0 1

0

I

(I)

LU

I 0 I

4

100

FREOUENCY IN HERTZ

125 250 500 1000 2000 4000 8000

0

20

40

60

80

-Fig 1. Composite audiogram of subjects diagnosed as having otitis media with effusion. Mean air conduction

(AC) values represent 161 ears, whereas mean bone

con-duction (BC) thresholds constitute 122 ears (adapted

(3)

the speech frequency range, the prevalence for these subjects would be 55%, but if hearing loss is defined

as 31

dB

or more, the prevalence would be 26%. It has been a long-standing premise among phy-sicians and audiologists that a correlation exists between the viscosity of the effusion and the degree of hearing loss. It is now understood that hearing

loss is dependent on the volume of the effusion rather than the physical properties of the effu-sion.12’13

Hearing loss also may accompany high negative pressure even if effusion is not present.’4’7 Cooper et al17 studied the audiometric status of 1,133 ears and noted that the air bone gap increases as the middle ear pressure decreases. Conductive losses of

10

dB

or greater occurred in more than 50% of the ears with negative middle ear pressure.

It is possible that in some instances, hearing loss may result from chronic otitis media.182’ Studies in animals show that toxic products can pass through the round window membrane, damage the cochlea, and produce a high-frequency sensori-neural hearing 1055.2223

COMPLICATIONS AND SEQUELAE OF OTITIS

MEDIA

-Charles D. Bluestone, MD

The complications and sequelae of otitis media predominantly involve the middle ear and adjacent structures within the temporal bone, but in rare instances intracranial complications also may

oc-cur. The aural and intratemporal complications and sequelae include hearing loss (as discussed above), perforation or retraction pocket of the tympanic membrane, tympanoscierosis, adhesive otitis me-dia, ossicular discontinuity and fixation, chronic suppurative otitis media, cholesteatoma, mastoidi-tis, petrositis, labyrinthitis, facial paralysis, and cholesterol granuloma.

In otitis media, perforation of the tympanic mem-brane is usually secondary to acute infection, but may also occur in the course of chronic effusions. Spontaneous perforation has been considered more common in certain population groups such as American Indians and Eskimos, and may be higher in children from whom antimicrobial therapy has been withheld.24 The effect on hearing of a small

perforation, regardless of its location and in the absence of other middle ear abnormalities, is not significant. However, a large perforation can be associated with an appreciable conductive hearing loss, eg, 20 to 30

dB.

Tympanoscierosis is characterized by the pres-ence of white plaques in the tympanic membrane and nodular deposits in the submucosal layers of the middle ear.25 It may be a sequela of chronic

middle

ear

inflammation

or the

result

of trauma,

eg, from a tympanostomy tube. Conductive hearing loss may occur if the ossicles become embedded in the deposits.

Adhesive otitis media is thickening of the mucous

membrane by proliferation of fibrous tissue which frequently causes fixation of ossicles, resulting in a conductive hearing loss. No data on the prevalence

of adhesive otitis media in children exist, but the condition is not uncommon in those who have had recurrent acute or chronic otitis media with effu-sion. Adhesive otitis media also may result in ossi-cular discontinuity due to osteitis, especially of the long process of the incus, which may, in turn, result in conductive hearing loss. When there is a ret

rac-tion pocket (severe localized atelectasis) in the pos-terosuperior portion of the pars tensa of the

tym-panic membrane, adhesive changes may bind the eardrum to the ossicles and cause resorption. Once

this

occurs, the development of a cholesteatoma becomes possible.26

Chronic suppurative otitis media is inflammation of the middle ear and mastoid in which chronic perforation and discharge (otorrhea) are present. In a study conducted by the School Health Service

in Great Britain, the proportion of children found

to have chronic otitis media at the periodic medical inspections was approximately 9/1,000.27

Cholesteatoma

is an accumulation

of

desquamat-ing keratinizing stratified squamous epithelium

within the middle ear or other pneumatized por-tions of the temporal bone. The incidence of cho-lesteatoma in Iowa was estimated to be 6/100,000; up to 9 years of age, the incidence was 4.7/100,000; and between 10 and 19 years, 9.2/100,000, the high-est for all age groups. Cholesteatoma is relatively more common in children with cleft palate; in one

study,

9.2% developed cholesteatoma. This seems not unexpected, as chronic otitis media with

effu-sion is universal in infants with unrepaired cleft

palate28 and remains common following repair.29’3#{176}

This progression of the disease may also have

rel-evance to children with chronic otitis media with effusion who do not have a cleft of the palate.

The incidence of mastoiditis has become low since

the introduction of antimicrobial agents, but the disease still occurs, mainly in untreated cases of acute otitis media.

Labyrinthitis occurs when infection spreads from the middle ear into the inner ear. Acute suppurative labyrinthitis has become rare since the widespread

use of antibiotics.

However,

acute

serous

(4)

reviewed the audiograms of patients who had sur-gery for chronic otitis media with perforation and found a significant degree of bone conduction loss in the younger age groups. There was a marked difference in the presence and degree of sensori-neural hearing loss in the affected ear, as compared to the normal ear, in patients of all age groups who had unilateral disease. Fluctuating sensorineural hearing loss has been described in patients with otitis media and has been thought to be due to either endolymphatic hydrops32 or to a perilym-phatic fistula.33

Facial para1ysi may occur in the course of acute otitis media. During the period 1960 to 1980, at least 35 cases of facial paralysis associated with acute otitis media at either the Children’s Hospital or the Eye and Ear Hospital of Pittsburgh were reported.

Suppuration in the middle ear or mastoid, or

both, may extend into the intracranial cavity,

pro-ducing the following suppurative intracranial

corn-plications: meningitis, extradural abscess, subdural empyema, focal encephalitis, brain abscess, lateral (sigmoid) sinus thrombosis, and otitic hydroceph-alus.3436

COMPLICATIONS

AND SEQUELAE

OF

NONSURGICAL

AND SURGICAL

MANAGEMENT

OF OTITIS MEDIA

-Charles D. Bluestone, MD

Complications and sequelae are associated with both nonsurgical and surgical methods of manage-ment of otitis media. It has been estimated that there were approximately 21 million patient visits for otitis media to health professionals last year (National Drug Therapeutic Index, IMS America, New York). Adverse side effects of antimicrobial agents and other drugs occur commonly, but data

concerning the frequency of reactions such as di-arrhea, skin rash, hepatitis, vasculitis, nephritis, serum sickness, anaphylaxis, and even death, are

sparse. Data are also sparse concerning complica-tions of surgical procedures.

Myringotomy and tympanocentesis are simple

and safe procedures. Otorrhea following myringo-tomy for acute otitis media is the desired outcome, but the discharge may become profuse and cause

eczematoid external otitis. Although they occur Un-commonly, the most frequent sequelae of the pro-cedure are persistent perforation, atrophic scar, or tympanosclerosis. Dislocation of the ossicles, 5ev-ering the facial nerve, or puncturing an exposed jugular bulb are dreaded complications but are rare in experienced hands.

Myringotomy with insertion of tympanostomy tubes is currently the most common surgical pro-cedure requiring general anesthesia performed in

children. Common complications of this procedure include scarring of the tympanic membrane (tym-panosclerosis) and localized or diffuse membrane

atrophy and persistent or recurrent otorrhea

(Ta-ble). Much less commonly, a perforation may

re-main at the insertion site following extrusion of the

tube, or more rarely, an implantation

cholestea-toma may develop.

Adenoidectomy performed either separately or in combination with tonsillectomy is the most com-mon major surgical procedure employed to prevent

otitis media.43 In 1979, approximately 634,000

pro-cedures

on the tonsils and adenoids were performed in the United States44; a large but undetermined number were performed for management of otitis

media.

Although

considered

by

many

to be minor

procedures, they carry a significant risk. The death rate has been estimated as between 1 in 3,000 and 1 in 27,000. In the United States, this would result in between 40 and 350 deaths per year. No data are available concerning morbidity rates of tonsil and

adenoid surgery; these rates are obviously many

times greater than the death rates and include permanent neurologic damage following intraoper-ative or postoperative respiratory or cardiac arrest, hemorrhage, injury to the eyes, pharynx, and teeth, velopharyngeal insufficiency, nasopharyngeal

ste-nosis,

and psychological

problems.46

Tympanoplasty -or mastoidectomy, or both, are

TABLE. Incidence of Complications and Sequelae Following Tympanostomy Tube Insertion for Otitis Media with

Effusion in Children

Investigator(s) No. of Subjects (Ears) Follow-up (yr)

mci dence (%)

Tympano- Otorrhea Persistent. Cholesteatoma sclerosis Perforation

Kilby et a137 52 (52) 2 28* NAt 1.9 0

Brown et al 55 (55) 5 42* NA 0 0

Draf and Schulz39 677 (876) NA NA 12.5 0.1 1.6

Muenker#{176} 631 (1,060) NA 50 15.0 2.5 0.9

Barfoed and Rosborg’’ 102 (173) 7 61 34.0 3.0 0

Lildholdt42 150 (150) 5 52* 30.0 0 0

* J contralateral ears in which no tympanostomy tubes had been inserted, incidence was 21%, 0%, and 11.3%.42

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Frequency in Cycles per Second

125 250 500 1000 2000 4000 8000

40

\ I MU)

- %,,

0 0

0

z

4

0

I

(II _

sh ,‘

--Softest Speech Energy

Average Speech Energy

Mean of

ad tosses

Loudest Speech Energy performed infrequently but are the most common major surgical procedures performed on the ears of children.47 The operation involves recognized risks of indeterminate incidence, including facial paral-ysis, sensorineural hearing loss, and risks

associ-ated

with administration of general anesthesia.

AUDIOLOGIST’S OVERVIEW OF SEQUELAE OF

EARLY OTITIS MEDIA

-Marion P. Downs, MA, DHS

If hearing loss interferes in any way with norrnal development in young children, it is incumbent upon

the rnanaging physician to identify the develop-rnental delay and to provide intervention.

Long-standing hearing losses in children have been classically associated with decreased cognitive skills and lowered school attainment.48’49 Only re-cently have studies appeared suggesting that even mild and fluctuating hearing losses due to otitis

media, when sustained in infancy, may affect later

language functioning of children. Such mild losses

are shown in Fig. 2 in relation to the range of

normal speech.9”1 The speech signal is degraded as a result.50’51

Some 30 studies involving 3,500 children have shown a consistent association of early fluctuant hearing losses with later decreased learning skills.4’50’5277 Although design weaknesses abound, one study made comparisons of children with and without otitis within a circumscribed racial group55; another compared siblings within one

socioeco-

:::-3C

:

ii

::

ii

-:

::::

3,J

60

70

80

-“9

--‘ez

-

-7s

-

---

;7

-::

E

E

E

E

E

Fig 2. Range of speech energy related to standard

au-diogram. Shaded area shows range of sound energy pres-ent in normal speech with dashed line indicating average of speech energy (adapted from Skinner51). Line

con-nected by solid circles shows mean of hearing losses from

otitis media (OM) according to Kokko9. It can be seen that softer speech sounds may not be heard when otitis media is present.

nomic group74; another study contrasted findings

within two disparate socioeconomic groups76;

an-other culled experimental and control groups from

an entire school district’s third grade62; another

looked at groups in

grades

3 to 6 in a school

dis-trict.77 No amount of cavilling over experimental design can obviate the fact that serious attention must be given to these findings.

But what is more relevant to the physician’s

responsibility is the demonstration that language delays due to mild hearing loss from otitis media

can be identified in the first years of life. Friel-Patti et a178 applied language evaluations (Re-ceptive Expressive Emergent Language Scale

[REEL];

Sequenced

Inventory of Communication

Development [SICD]) at 12, 18, and 24 months to a group of infants who had been in intensive care on low-birth-weight measures and who developed documented recurrent otitis media. A parallel group with documented normal ear history was followed in the same way. Of the 14 infants who had no evidence of otitis media, delayed language of less than 6 months was considered to be present in two subjects and in one child, the delay was greater

than 6 months. By comparison, of the 14 subjects

who were identified as being “otitis-prone,” four

were thought to have a delay in language of less than 6 months, and in six infants, the delay was greater than 6 months. The numbers in this study are small, but the point is made that language delays from otitis can be identified. A tool for such screening has been suggested by Down and Blager.79

When language delay is present, some form of intervention is mandatory, for 75% of children with language problems by 5 years of age can be expected still to be language-delayed at 9 years.#{176}The Con-sortium for Longitudinal Studies81 has shown that early mother-child intervention, from birth to 3 years of age, is efficacious and productive of lasting

effects. Therefore, it is recommended that after 3

months of otitis media without cure, a protocol of

educational intervention concurrent with ongoing

medical or surgical treatment be followed: (1) a home language stimulation program, and (2) con-sideration of hearing aid use in selected cases.79 It has been our experience that such programs result

in marked gains in performance in children with

recurrent otitis media.

Early otitis probably has a complex effect that has not yet been sorted out. As described in the Perry Preschool Project,8’ different environments

influence cognitive ability in different ways, and

different individual reactions to the environment provide another variable. Questions raised by the

presence of other variables include: (1) How is

maternal-infant bonding affected by otitis media?

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(3) Are parental communication strategies

af-fected? Are the factors of reciprocal interplay

de-scribed by Schachter broken down? (4) How do

the acoustics of speech affect learning? What

amount of degradation of the speech signal can be

tolerated?5#{176} (5) Are there systemic effects of otitis media? Is this the vital factor in reducing learning?

These questions must be answered before we can

understand

the

dimensions of the problem of mild, recurrent hearing loss associated with otitis media.

RESEARCH DESIGN ISSUES IN STUDIES OF

EFFECTS OF MIDDLE EAR EFFUSION

-Ira M. Ventry, PhD

In a 1980 article on the effects of conductive

hearing loss, I made the following statement: “A

careful evaluation of published research on the

relation between conductive hearing impairment

and

language

and learning difficulties suggests that the relationship has been poorly documented, that

methodologic flaws have contaminated the data and

confounded the reported results, and that there is

a continuing need .

..

for ongoing research in this area.M Although additional studies have been

pub-lished

in the interim, none of these studies has

caused

me to change my opinion. I still maintain that no causal link has been established between early recurrent middle ear effusion and any

behav-ioral phenomenon of interest, such as language

delay, learning problems, or the like.

What I find most distressing in my review of

research in this area is that there is no evidence of

increased research

sophistication

or improved

re-search methodology over the last 10 to 15 years. It

is remarkable, indeed, that in the 13 years since

publication of the work of Holm and Kunze,53 there

have been no refinements in research design, no

innovative statistical treatment of data, no

imagi-native or even state-of-the-art assessments of

lan-guage.

In fact,

there

has been

backsliding.

For

in-stance, Holm and Kunze acknowledged the

limita-tions of their design in a way that is infrequently seen in current research reports.

What to do? First, researchers ought to reread

the report of Hanson and Ulvestadm for the many

valuable suggestions and insights made by the

var-ious contributors. Second, researchers should

aban-don the between-subjects retrospective design. The

shortcomings of this design are numerous and the

time spent in handling these shortcomings is

prob-ably better spent in working with other more

pro-ductive research designs. Next, far greater use

should be made of both experimental and

descrip-tive within-subject designs. In the former design,

an independent variable that presumably reflects a

consequence of middle ear effusion can be

manip-ulated to study the effects of that manipulation on

some dependent variable. The latter design can

represent a longitudinal study, a type of study

fre-quently advocated but never used to study the

ef-fects of middle ear effusion. Fourth, there should

be

increased use of correlational designs. Of the many studies that have attempted to explore the behavioral consequences of middle ear effusion, not

one has employed even basic, much less advanced,

correlational techniques-this, despite the fact that

statisticians and research methodologists have

sug-gested that certain types of correlational research can lead to cause-and-effect statements. A sophis-ticated extension of correlational research is ex-emplified by path analysis. Duffy et al.87 recently

described

the application of path analysis to speech

and language disorders. I would suggest that the

application of path analysis to research on the

effects of middle ear effusion may finally provide

some of the answers we have been seeking. Fifth,

no matter what type of research design is used,

considerable attention must be given to controlling those factors that can threaten the internal validity of the research.m Internal validity is the sine qua

non

of all

research designs. Finally, I believe that research on the effects of middle ear effusion should be in the hands of qualified researchers. The issues

involved are of such consequence that they require

the skill, experience, and sophistication of individ-uals who have been trained to do behavioral re-search.

Are there causal links between early and

recur-rent middle ear effusion and delayed speech and

language

development, educational retardation, learning disabilities, or cognitive development? We simply do not have the answers at present. Whether

we have the answers in the future depends, in large

part, on our commitment to research excellence.

OTITIS MEDIA AND LANGUAGE DEVELOPMENT

-Jean Berko-Gleason, PhD

There are many suggestions in the literature that chronic otitis media with effusion in infants and

young children is associated with, or even causes,

atypical or delayed language development. Inas-much as adequate control of language is a prereq-uisite for attaining many different types of con-cepts, such children are also considered at risk for academic failure once they enter school, especially in reading and other subjects that rely upon lin-guistic skill. Two groups of children are not consid-ered in this paper: those with only occasional acute bouts of otitis media with effusion for whom there

is no evidence of being at risk; and those who have

permanent loss of hearing, for whom there is ample

evidence of frequent linguistic and academic prob-lems.89’9#{176}The children who are considered here are

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fluctuating hearing loss during the critical period

of language development because of otitis media

with effusion, with a typical criterion for inclusion in a study being that the child have had at least six episodes before the age of 6 years.’9’

In such children, the rationale for postulating

adverse effects on language development is based

on what we know about the way children acquire

language. For instance, long before they begin to

speak, normal infants are able to make fine

pho-netic discriminations and to distinguish the speech

sounds of the language around them. During early

language acquisition, the child learns the sound

system of the language as well as how to form such

things as plurals or past tenses; this may require

hearing the difference between words like plays and place, or help and helped. An inconsistent auditory

signal resulting from fluctuating hearing loss may

make the stream of speech difficult to segment and

impede the child’s ability to form linguistic cate-gories.

A number of studies attempting to document the

effects of conductive hearing loss on children’s

lin-guistic and academic skills were reviewed by

Rapin89 in 1979. Most of them were retrospective

and dealt with school-aged populations who were

tested with standard instruments, such as the

Illi-nois Test of Psycholinguistic Abilities and the Pea-body Picture Vocabulary Test. General conclusions

were that children with a history of otitis media

with effusion have normal sounding spontaneous speech, with a history of delay rather than deviance

in acquisition, but that they have problems with

reading and limited vocabularies and syntax, as

compared with children without a history of otitis

media with effusion. Caution must be exercised in

interpreting these studies, many of which contain serious design errors. Others dealt with populations

such as Alaskan Eskimos4 or Australian

aborig-ines55 who were not tested in their own language,

and who were already at risk because of

sociocul-tural factors. Results were often contradictory, even

when attempts were made to control for social class

influences.92 Only a study by Needleman56 included

preschool children as subjects, and none of the

studies was developmental and longitudinal in

na-ture.

A more recent paper by Bax93 reported a 5-year

study carried out in London with 870 children who were seen at age 6 weeks, 6 months, 1, 1#{189},2, 3, and

4#{189}years. He reported a highly significant relation-ship between language delay at 2 years and reported

incidence of otitis media with effusion in the

pre-vious 6 months. At age 3 years, the percentage of

children with otitis media with effusion among

those showing language delay was twice as high as

among the group of children that showed normal

language development; the difference was no longer statistically significant. This study relied heavily

on parental report, and unfortunately did not

pro-vide information on the children’s later language

and scholastic performance. Finally, a study by

Bennett and associates adds a new perspective to

previous findings. These authors examined a group

of learning-disabled children and compared their

current and past middle ear status with that of a

group of control children without academic prob-lems. They found that not only

did

the

learning-disabled children have a higher incidence of past

otitis media with effusion, they also had

signifi-cantly more current middle ear malfunction than

control children. They suggest that chronic

unde-tected middle ear problems may be implicated in

some cases of learning disability.

It is clear from even such a brief summary that

the question of the relationship between early otitis

media with effusion and subsequent language

de-velopment has not been adequately addressed. We

know that some young children with otitis media

with effusion later exhibit linguistic difficulties, but

we do not know whether the effects are permanent

or reversible. Nor do we know what factors might

assure normal language development in the

pres-ence of otitis media with effusion. It is likely that the quality of parent-child interaction is an impor-tant factor. Our current view sees language

devel-opment as an interactive process, with much of the

burden falling on the specialized input that adults

provide children who are developing language.

Some of the questions raised can be answered by

prospective studies of young children with otitis

media with effusion; such studies must include

psy-cholinguistically sophisticated testing as well as

careful attention, not only to the child’s emerging language, but to the linguistic environment as well.

COGNITIVE DEVELOPMENT IN RELATION TO

OTITIS MEDIA

-Susan

W. Gray, PhD

In considering the effects of otitis media upon

the child’s cognitive development, the paramount

issues are ones of measurement and of the design

of appropriate research. Measurement over time of hearing loss in relation to otitis media is far from simple. Longitudinal assessment of the cognitive

status of a child even with normal hearing also

presents difficulties. Cognitive development is a

broad term that subsumes the growth of problem

solving, thinking, judgment, and reasoning, or the

so-called higher mental processes.94 I shall limit

most of my remarks to the index of cognitive

de-velopment most closely associated with

(8)

Tests of intelligence are highly useful tools but

cover only certain manifestations of cognitive

de-velopment and tell us nothing about underlying

mechanisms or structures. With infants and

tod-dlers, possibly the age groups of most concern here,

intelligence tests generally have little value for

long-range prediction. Most tests are heavily

de-pendent on receptive and expressive language.

Tests designed for special populations such as the

deaf

pose issues of appropriate reference norms.

Thus, intelligence tests are hardly comprehensive

instruments with which to attempt to answer the

questions we raise here. Horowitz95 suggested that

other assessment approaches may be more fruitful,

but such forms of assessment are not ready-made;

they require painstaking construction. In addition,

classic experimental design does not lend itself

readily to problems that are developmental and

clinical in nature. Alternative strategies are needed,

but are limited in their applicability and general

acceptance by the research community. If a

re-searcher finds some or no relationship with otitis

media, it may be that the chosen instruments and methodology were inappropriate or inadequate for

the task.

Despite such problems-and they are

considera-ble-it may be possible to pose some questions that

admit of an empirical answer. Anecdotal data,

cer-tam

interesting but flawed studies on hearing loss,M

and extrapolation from other research suggest some

general lines of inquiry. For many questions, suffi-cient resources will not be available for definitive

answers. Perhaps the accumulation of less

ambi-tious studies, if variables are carefully defined, will

gradually make it possible to answer such queries as these:

1. Are there sensitive periods of development

when fluctuating and occasional hearing loss may

have especially negative consequences? An example

might be the period around 18 months, inasmuch

as language acquisition and social interaction are dominant themes in the life of a toddler.

2. Where intellective deficits are observed, do

they indicate delay or permanent damage? Some

recent reports suggest much more reversibility of

early

delay

arising from restricted environment

in-put than was once thought to be the case. It may

not be difficult to compensate for temporary

hear-ing loss.

3. If cognitive deficits occur, are they direct ef-fects of hearing loss, or, rather, are they mediated

by changes in the child’s motivational patterns and

in the perceptions of others? Evidence suggests that undiagnosed hearing loss creates strain in relation-ships with parents and teachers.97 Inconsistencies in the child’s ability to hear and in the reactions of others conceivably might have pervasive and lasting

effects upon the child’s motivation to achieve.

These are only three queries among many of

practical or theoretical interest. The notion that

otitis media has negative effects upon cognitive

development is intuitively appealing, but sound

em-pirical evidence so far appears to be lacking.

EFFECT OF OT1TIS MEDIA ON ARTICULATION

DEVELOPMENT IN CHILDREN

-Betty Jane McWilliams, PhD

The assumption that repeated episodes of otitis

media, with its variably expressed, often fluctuating

hearing losses, are detrimental to articulatory

de-velopment in children finds easy acceptance among

many professional people. It is a hypothesis that

has face validity because everyone knows that

se-vere communicative impairment is invariably

as-sociated with profound hearing losses. Thus, it is

sensible to assume that less serious losses cause

less severe communicative problems and that

artic-ulation is logically an aspect of speech that is ad-versely affected.

Holme and Kunze53 and Needleman56 concluded

that articulation errors were greater in children

with histories of repeated episodes of otitis media than in children who did not present such histories. Consistent with these findings, tentative

observa-tions have been made of children with cleft palate

in whom otitis media is universal.28’98’99 However, Ventry and Paradise1#{176}#{176}have raised serious

ques-tions about the nature of the research leading to

conclusions about otitis media and its effects on

development. The status of our knowledge about

the influences of these mild to moderate conductive

hearing losses on articulatory maturation remains

equally controversial.

There is no doubt about the intimate relationship

between hearing, language, and speech

develop-ment. Northern and Lemme101 highlight this

inter-action when they say that mild hearing losses (HL)

in the range of 15 to 40 dB HL, such as are usually

associated with otitis media, may result in the

child’s missing voiceless consonants. Losses

be-tween 25 and 40 dB HL after the first year of life

may, in their view, be especially detrimental to

articulation.

Clinical evidence suggests that articulation

de-velopment is influenced by conductive hearing loss,

but that the relationship is undoubtedly modified

by many variables that have yet to be identified. These probably include the severity of the loss; the length of time it persists; its consistency; the tim-ing, success, and frequency of treatment; the overall

developmental integrity of the child; the ability of

the family to provide an adequate speech

(9)

au-ditory training are provided if they are needed; and countless psychosocial factors not yet specified. In short, it appears that some children with 25 dB losses for specified periods of time may have mild

articulatory impairment, the nature of which

re-mains to be precisely explored, while others may

not, suggesting a multifactorial causation, with hearing loss as one of several causal factors. That

picture may change as the losses become greater or

more persistent or, perhaps, as they fluctuate more

extensively. Clinical experience suggests that such

variations must be studied even though the design problems posed are almost insurmountable.

Until the appropriate research has been carried

out, we suspect but cannot prove, that most of the

articulation disorders that may be related to otitis

media are mild and tend to disappear with

increas-ing age. Otitis media is not usually the explanation for intractable articulatory deficits. However, under certain conditions, still unknown, otitis media may

be responsible for significant alterations in the

pattern of articulation development in younger

children. The age at which the hearing losses are

most influential is another mystery, but it is likely to be within the first 2 to 3 years of life.

Until we have more acceptable evidence about

the influence of otitis media in childhood, we should refrain from its simplistic use as an explanation for developmental variations in children.

LONG-TERM EFFECTS OF SHORT-TERM

HEARING LOSS-MENACE OR MYTH?

-Jack L. Paradise, MD

In two recent commnications,1#{176}#{176}”#{176}2I reviewed the then available literature on possible

relation-ships between otitis media during early life and later impairments of intellectual, speech, language,

and psychological development. In those reports, I

concluded, first, that no such associations had been established; second, that should they be established, serious problems would remain in demonstrating

causality; and third, that any developmental

im-pairments that did result from early conductive

losses would probably be reversible if normal hear-ing were restored.

The problems of the studies reported up to that

time were, to an extent, inherent in their retrospec-tive design, but other issues were involved as well. Collectively, the limitations and deficits consisted of the following: uncertain validity of the diagnosis early in life of either the presence of otitis media or its absence; lack of data concerning subjects’ hear-ing levels early in life; persistence of impaired hear-ing at the time of developmental testing; question-ably suitable matching of experimental and control

subjects with regard to variables known to affect

developmental outcome; small numbers of study

subjects, or nonrepresentativeness of subjects, or

both; the use of developmental tests that were

inappropriate or of uncertain reliability and

valid-ity; inadequate blinding; and selective emphasis of

data. Finally, a fundamental obstacle faced by any

study comparing developmental outcomes in chil-dren who had much otitis media with outcomes in children who had little, is the possibility that com-monly underlying factors exist that predispose both

to otitis media morbidity and to developmental

impairments.

More recently, a few additional studies of interest have been reported. Teele et al76 administered tests

of language function to children followed

prospec-tively from birth. Those who had experienced 130

or more days of middle ear effusion, and those who

had experienced fewer than 30 days, were

com-pared. In suburban, private practice subjects, scores were significantly lower in those with persistent than with short-term effusions, but no such

differ-ences were noted among low-income, urban clinic

subjects. Inasmuch as only an abstract was

pub-lished, judgment about the study must await a more

comprehensive report.

Sak and Ruben,74 in an attempt to minimize

possible confounding variables, compared 18 sibling pairs between 8 and 1 1 years of age. One sibling of

each pair had had a documented history of

recur-rent middle ear effusion dating from before 5 years of age, whereas the other sibling had had no middle ear effusion whatever. The subjects were evaluated using a battery of audiologic, psychological, lan-guage, and achievement tests. Both groups tested

in the ‘bright-normal range, without any real

defi-cits, but those who had had otitis media showed, as a group, slightly lower verbal IQs, slightly poorer

auditory reception, and slightly lower spelling

achievement than their matched sibling controls.

Unfortunately, from the standpoint of

interpreta-tion, 72% of the otitis siblings compared with 44%

of the control siblings were boys, a difference that might have contributed to the small differences in

developmental scores between the two groups;

moreover, minor middle ear abnormalities, as

evi-denced by audiometric and tympanometric data,

were more prevalent among the otitis siblings than

among the control siblings. Thus, the so-called

“deficits”-if there were deficits-might

conceiva-bly have been related to recent middle ear disease

rather than to early middle ear disease.

Hoffman-Lawless et al’#{176}3compared 7- and

9-year-old children who had had documented middle

ear disease and surgical placement of

tympanos-tomy tubes prior to 5 years of age, with control

subjects who had had no known middle ear disease.

(10)

early otitis and control groups in five tests of

au-ditory processing ability. The findings were thus

inconsistent with those of Sak and Ruben.

Finally, Friel-Patti et al78 examined the relation-ship between frequent episodes of otitis media early

in life and language development as assessed at 12,

18, and 24 months. The infants, who had been

selected from either intensive-care or

low-birth-weight nurseries, and who came from

predomi-nantly low socioeconomic groups, received periodic

otoscopic examinations, auditory brainstem

re-sponse testing, and tympanometric assessment.

Frequent episodes of otitis media were correlated

with a higher prevalence of language delay, but no

correlation was found between hearing impairment

and language delay. This again raises the question

whether early otitis media on the one hand, and

language delay on the other, have predisposing

de-terminants in common without themselves being

causally related.

In summary, no convincing evidence currently

exists that adverse developmental consequences

re-sult from otitis media limited to the first few years

of life. However, because contrary evidence is also

lacking, and because otits media is such a prevalent

disorder, appropriately designed studies are

ur-gently needed to investigate this question further.

SOCIOECONOMIC IMPACT OF OTITIS MEDIA

-George A. Gates, MD

Social and economic consequences of recurrent

or persistent otitis media may be important but

have not often been discussed in the literature.

There may be good reasons for this void. First, such

topics have not been generally regarded as -part of

the sphere of interest or expertise of the biomedical

scientist. It would be desirable to encourage the

social scientist to become involved in this area.

With the rise of consumer activist groups and the

social demystification of the practice of medicine, it is surprising that this has not occurred. Second,

there are limited data that must be culled from a

variety of sources. Third, people perceive problems

differently and what appears as a large problem to

one family may be accepted without a second

thought by another. Much depends upon one’s

at-titude, background, and prior experience in this

regard. Fourth, just as otitis media varies in

sever-ity, so too must the socioeconomic impact upon the

patient and family.

I

divide socioeconomic factors into three groups

according to whether they affect primarily the child, the family, or the community.

The child with otitis media may be distracted

from his surroundings because of pain, decreased

hearing, malaise, and the annoying autophony that

accompanies conductive hearing loss. Adjustment

to these symptoms requires differing strategies at

different times because the symptoms usually

fluc-tuate greatly. The anxiety and general

unpleasant-ness associated with hospitals, doctors, office visits,

hearing tests, painful examinations, needles,

bad-tasting medication, awful-smelling anesthetic gases, and separation from parents, home, and friends probably leave remembrances that are, to say the least, discomforting. Undoubtedly, these

traumas can be minimized by guidance, education,

and caring attitudes on the part of all concerned.

Symptoms of otitis media may interfere with

con-centration, a tolerant attitude, and a desire to excel.

I suspect that children with otitis media become

fussy and irritable and find it difficult to

concen-trate on lessons. Most likely they catch up with their school work when they feel better, but un-doubtedly some do not. We all recognize that there

are prime learning experiences that once passed do

not readily present themselves again. It would be

unfortunate, indeed, if one were to miss such an opportunity because of illness.

Most families have direct experience with otitis

media inasmuch as it affects 85% of children at

least once.104 The larger the number of children in the household, the more likely that they will de-velop otitis media, especially as viral upper respi-ratory tract infection that may be a precursor of

most cases’#{176}5 usually passes from sibling to sibling.

The family must contend with earaches in the middle of the night, irritable children who don’t sleep normally, visits to the emergency room and doctor’s office for examination and treatment, con-sultations, hearing tests, and, finally, surgery when

all else fails. Not only is there a strain on the

pocketbook, but also, there is a substantial

emo-tional drain as well. Will my child hear normally?

Will school work be affected? When will the

prob-lem stop? These are but a few of the parental anxieties that have been expressed to all of us who have taken care of these children.

It is impossible to calculate the national bill for

treatment of otitis media for we do not know how

many office and clinic visits are made for treatment

of otitis media, nor do we have any grasp of the

costs involved. However, for purposes of argument,

suppose that 85% of the 3.5 million children born

in 1979 in the United States have one episode of

otitis media, 50% have a second episode, 30% have a third, and 25% have six episodes. By compressing all of these into 1 year, this cohort would then account for 8.4 million episodes. Extrapolating from the report of Teele et al,’#{176}there might be as many

as 12.84 million episodes, however. Given that each

episode might engender one initial visit and one

(11)

tympanocenteses ($15), 0.01 myringotomies ($25),

0.5 tympanograms ($10), .01 audiograms ($20), and

0.5 otology consultations ($40), the annual bill

would amount to $454 to 695 million. Of course,

these calculations are hypothetical, but if you were

to fill in the amounts appropriate to your

commu-nity, you would have a general sense as to the fiscal impact of the disorder.

The costs of the surgical procedures must

like-wise be estimated because they vary so widely. I

surveyed a small number of otolaryngologists from

across the country and found that the average sur-gical fee for bilateral myringotomy and insertion of tubes was $277, the anesthesiologist’s fee was $166,

and the hospital charges for an outpatient surgery

amounted to approximately $500. The composite

charge would be about $1,000. The number of such

procedures is not known. The Commission on

Professional Hospital Activities noted that there

were 219,000 procedures coded as myringotomy

done in the 5,764 short-term acute care hospitals

in the United States in 1981.107 The 1979 National

Hospital Discharge Survey conducted by the

Na-tional Center for Health Statistics’#{176}8 indicated that

225,000 myringotomy procedures were done in

8,017 hospitals. That these two surveys produced such disparate results is probably due to the differ-ences in the data base, sample size, and survey

methodology. Both probably greatly underestimate

the actual total due to the number of procedures

performed on outpatients or in ambulatory surgical

centers that are not included. Given that the actual

total might be as high as 400,000 cases annually,

the total bill, including $30 million extra for

ad-enoidectomy, would be in the neighborhood of $430

million. The combined annual cost of treatment of

otitis media could therefore be projected to be as much as $1 billion.

The community ultimately pays for the costs of health care inasmuch as those expenses are met with funds that might have been expended

else-where. The cost of research into prevention and

treatment of otitis media should also be borne by

the community because it is the community that will ultimately benefit from advances.

CONCLUSIONS

Otitis media with effusion is one of the most

common diseases of childhood. Concern about the

disease is based not only on its frequency, but also

on its acute morbidity, its suppurative and

struc-tural complications and sequelae, and its

accom-panying hearing losses of variable degree and

du-ration. Treatments currently used in the

manage-ment of otitis media may, depending on their

na-ture, embody substantial risks as well as

consider-able costs. In general, many of the treatments are

undertaken in the face of inadequate knowledge of

the course of otitis media and its short- and

long-term morbidity and sequelae, and uncertainty

re-garding the relative efficacy and risks of the medical and surgical methods of therapy. In particular, this

is true of the management of middle ear effusion of

prolonged duration in otherwise healthy children;

consensus even is lacking about what specific hear-ing thresholds constitute clinically significant

hear-ing loss at various ages during infancy and child-hood. Little doubt exists that at least temporary

developmental impairments result from hearing

loss of moderate or severe degree that is

long-standing and unremitting, but no convincing

evi-dence exists at present to relate developmental

impairments to single or multiple episodes of short-term hearing loss or to mild hearing loss

irrespec-tive of duration. Future studies directed toward

better understanding of the effects of otitis media, and of the variable hearing loss that accompanies it, will require the participation of investigators from varied disciplines and the application of rig-orous principles of research design.

The Workshop conferees recommend that

chil-dren should receive, as part of every visit to the

health care professional for illness or well-child care, an examination with a pneumatic otoscope to determine the possible existence of otitis media. At present all children who have acute symptomatic otitis media should receive an appropriate

antimi-crobial agent for an adequate period. All children

with middle ear effusion should be reexamined pe-riodically until the condition has cleared. Manage-ment guidelines have been described in recent re-views.102’109

ACKNOWLEDGMENT

The authors thank Sandra Arjona for editorial

prepa-ration of the manuscript.

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Figure

Fig 2.::thatRangeofspeechenergyrelatedtostandardau-diogram.Shadedareashowsrangeof soundenergypres-entin normalspeechwithdashedlineindicatingaverageofspeechenergy(adaptedfromSkinner51).Linecon-nectedbysolidcirclesshowsmeanofhearinglossesfromotitismedia(OM)accordingtoKokko9.Itcanbeseensofterspeechsoundsmaynotbeheardwhenotitismediais present.

References

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It can be concluded that assessment based on Indonesian National Qualifications Framework at attitudes and values, knowledge and skills in the course of Biological Evaluation

The use of abductive reasoning helped me to not only reconstruct my coding frame, but I also gained a deeper understanding of my data, unbound by the structure of the

damental research progresses made on the somatic side, still much less is known about psychological distress in patients with CRC receiving oral capecitabine, especially in the form

Arteriography was immediately performed to create a portogram via the APF from the stump of the anterior hepatic artery, and portography clearly revealed hepatofugal portal vein

Depending on national circumstances, and on the policy actions that might already have been taken by public authorities in the context of a national strategy for financial