tympanostomy tubes and developmental outcomes at 9 to 11 years of age

7/28/2019 Tympanostomy Tubes and Developmental Outcomes at 9 to 11 Years of Age

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original article

The n e w e n g l a n d j o u r n a l o f medicine

n engl j med 356;3 www.nejm.org january 18, 2007248

Tympanostomy Tubes and Developmental

Outcomes at 9 to 11 Years of AgeJack L. Paradise, M.D., Heidi M. Feldman, M.D., Ph.D.,

Thomas F. Campbell, Ph.D., Christine A. Dollaghan, Ph.D.,Howard E. Rockette, Ph.D., Dayna L. Pitcairn, M.A., Clyde G. Smith, M.S.,

D. Kathleen Colborn, B.S., Beverly S. Bernard, R.N., B.S., Marcia Kurs-Lasky, M.S.,Janine E. Janosky, Ph.D., Diane L. Sabo, Ph.D., Rollanda E. OConnor, Ph.D.,

and William E. Pelham, Jr., Ph.D.

From the University of Pittsburgh (J.L.P.,H.M.F., T.F.C., C.A.D., H.E.R., M.K.-L.,

J.E.J., D.L.S., R.E.O.) and Childrens Hos-pital of Pittsburgh (J.L.P., H.M.F., T.F.C.,D.L.P., C.G.S., D.K.C., B.S.B., D.L.S.) both in Pittsburgh; Stanford UniversitySchool of Medicine, Stanford, CA (H.M.F.);the University of Texas, Dallas (T.F.C.,C.A.D.); the University of California, River-side (R.E.O.); and the State Universityof New York at Buffalo, Buffalo (W.E.P.).Address reprint requests to Dr. Paradiseat Childrens Hospital of Pittsburgh, 3705

Fifth Ave., Pittsburgh, PA 15213, or [email protected].

N Engl J Med 2007;356:248-61.Copyright 2007 Massachusetts Medical Society.

A B S T RA C T

BACKGROUND

Developmental impairments in children have been attributed to persistent middle-eareffusion in their early years of life. Previously, we reported that among children young-er than 3 years of age with persistent middle-ear effusion, prompt as compared withdelayed insertion of tympanostomy tubes did not result in improved cognitive, lan-guage, speech, or psychosocial development at 3, 4, or 6 years of age. However, otherimportant components of development could not be assessed until the children wereolder.

METHODS

We enrolled 6350 infants soon after birth and evaluated them regularly for middle-

ear effusion. Before 3 years of age, 429 children with persistent effusion were ran-domly assigned to undergo the insertion of tympanostomy tubes either promptly orup to 9 months later if effusion persisted. We assessed literacy, attention, social skills,and academic achievement in 391 of these children at 9 to 11 years of age.

RESULTS

Mean (SD) scores on 48 developmental measures in the group of children who wereassigned to undergo early insertion of tympanostomy tubes did not differ significantlyfrom the scores in the group that was assigned to undergo delayed insertion. Thesemeasures included the Passage Comprehension subtest of the Woodcock ReadingMastery Tests (mean score, 9812 in the early-treatment group and 9912 in the de-layed-treatment group); the Spelling, Writing Samples, and Calculation subtests of

the WoodcockJohnson III Tests of Achievement (9613 and 9716; 10414 and10515; and 9913 and 9913, respectively); and inattention ratings on visual andauditory continuous performance tests.

CONCLUSIONS

In otherwise healthy young children who have persistent middle-ear effusion, asdefined in our study, prompt insertion of tympanostomy tubes does not improvedevelopmental outcomes up to 9 to 11 years of age. (ClinicalTrials.gov number,NCT00365092.)

The New England Journal of Medicine

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Tympanostomy Tubes and Developmental Outcomes at 9 to 11 Years of Age

n engl j med 356;3 www.nejm.org january 18, 2007 249

During the past four decades, in-

vestigators have reported that conductivehearing loss associated with persistent oti-

tis media in young children can result in long-termimpairment of their development.1,2 To preventor minimize developmental impairment, officialguidelines have until recently recommended that

young children in whom middle-ear effusion haspersisted for as long as 3 months3 or 4 months4undergo myringotomy with insertion of tympanos-tomy tubes in order to clear the effusion and re-store hearing acuity to a normal level.

In 1991, because evidence regarding the devel-opmental effects of otitis media early in life wasinconclusive,2 and because of the lack of evidencethat insertion of tympanostomy tubes in childrenwith persistent middle-ear effusion affects theirdevelopment favorably, we began a study to ad-dress those issues. Previously, we reported that

prompt as compared with delayed insertion oftympanostomy tubes before 3 years of age in studyparticipants who had persistent effusion did nothave a favorable effect on their cognitive, language,speech, or psychosocial development at 3, 4, or6 years of age5-7; on their phonological memory at4 or 6 years of age6,7; or on their auditory process-ing skills at 6 years of age.7 However, it remaineduncertain whether developmental effects that werenot present or could not be measured reliably by6 years of age might emerge or become discern-ible as the children grew older. Of particular in-terest were domains of development previouslyreported by others to be unfavorably affected bypersistent otitis media early in life literacy,8-11attention,11-16 and academic achievement.14,17

On what basis might adverse outcomes in thosedomains be expected? To develop literacy, childrenmust learn to isolate phonemes within words andmatch them to letter sounds to form representa-tions of written words, tasks that may requirefiner discrimination among speech sounds thandoes the development of oral language. Accord-

ingly, it seems possible that children who hadprolonged periods of hearing loss early in life butwhose oral language development remained un-affected would nonetheless encounter diff icultylater with reading or spelling. That difficultymight contribute to other learning difficulties, andthose in turn, to problems in behavior. Similarly,if children had been receiving decreased, distort-ed, or inconsistent auditory signals when they wereyounger, they might have tuned out sound and

become inattentive and distractible, and these ef-fects might first come into play in the classroomand first be measurable objectively as the childrengrew older. Finally, both learning diff iculties andimpaired attention would be likely to limit chil-drens academic achievement. We describe here ourfindings concerning literacy, auditory processing,

attention, behavior, social skills, and academicachievement in the children in our study at 9 to11 years of age.

Methods

General Procedures

Our study included two main components. In onecomponent, children with persistent middle-eareffusion were randomly assigned to undergo eitherprompt insertion of tympanostomy tubes or de-layed insertion if the effusion persisted. In the oth-

er component, we examined the relationship be-tween the cumulative duration of effusion and laterdevelopmental outcomes in a subgroup of childrenwho did not meet the randomization criteria re-garding the persistence of effusion. We have de-scribed the study procedures in detail previous-ly.2,5-7 From June 1991 through December 1995,we enrolled 6350 healthy infants who were 2 to61 days of age at Childrens Hospital of Pittsburgh,Mercy Hospital of Pittsburgh, and six pediatricgroup practices in the Pittsburgh area. The studywas limited to children whose only household lan-guage was English. The study was approved by thereview boards of the two hospitals, and we ob-tained written informed consent from one or bothparents or guardians of each enrolled infant.

We monitored the childrens middle-ear statusuntil they were 3 years of age. We used the termmiddle-ear effusion to encompass all types ofotitis media, including acute otitis media and tubeotorrhea. We estimated the duration of episodesof effusion on the basis of diagnoses made at hos-pital or office visits and interpolations for inter-

vals between visits, and we conducted audiomet-ric testing frequently. Hearing was abnormal inapproximately half the children with unilateraleffusion and in approximately three quarters ofthose with bilateral effusion.5

Eligibility Criteria for Randomization

Children were eligible to participate in the clinicaltrial if, between the ages of 2 months and 3 years,they had middle-ear effusion that persisted for 90





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Th e n e w e n g l a n d j o u r n a l o f medicine


days in the case of bilateral effusion or 135 days inthe case of unilateral effusion. Children with in-termittent effusion for a specified proportion ofa longer period were also eligible, as described pre-viously.5 For example, children were eligible if theyhad had bilateral effusion for at least 67% of thepreceding 180-day period or unilateral effusion

for at least 67% of the preceding 270-day period.A total of 429 children who met one of these crite-ria and whose parents or guardians gave writteninformed consent were stratified according to prac-tice site, age (in 6-month categories), and wheth-er the children met the eligibility criteria on thebasis of bilateral or unilateral effusion. They werethen assigned randomly, within those strata andin balanced blocks of four children, to undergo in-sertion of tympanostomy tubes either promptly(the early-treatment group) or 6 months later if bi-lateral effusion persisted or 9 months later if uni-

lateral effusion persisted (the delayed-treatmentgroup). Children for whom consent for randomiza-tion was not obtained were treated according toparental choice and followed for the duration of thestudy. During the first 12 months after random-ization, 45% of the children in the delayed-treat-ment group had middle-ear effusion for more than50% of the days, as compared with 14% of the chil-dren in the early-treatment group.5

Subgroup of Children Who were Not eligible

for Randomization

We randomly selected a subgroup of 241 childrento represent the demographic characteristics of thestudy population as a whole and to represent thespectrum of children ranging from those with nomiddle-ear effusion to those with a duration of ef-fusion that fell just short of meeting the criteriafor randomization. Our objective was to assess thecorrelations between the duration of effusion inthese children and their outcomes and to comparetheir outcomes with those of the children who un-derwent randomization. In this subgroup of chil-

dren, the estimated cumulative duration of middle-ear effusion (unilateral and bilateral combined)ranged from no effusion to 66% of the first yearof life and to 45% of the f irst 3 years of life.2

Developmental Tests and Procedures

We assessed development in the children at the ear-liest mutually convenient date between their 9thand 12th birthdays and, if possible, when theirhearing-level thresholds were 15 dB or less in each

ear at 1000, 2000, and 4000 Hz. Assessments wereconducted in a specified order.

We used the following measures to assess lit-eracy: the Woodcock Reading Mastery Tests Revised, normative updated version,18 for readingprogress; the number of words in a grade-levelpassage read correctly in 1 minute for oral-reading

fluency19,20; and the Spelling and Writing Samplessubtests of the WoodcockJohnson III Tests ofAchievement, Standard Battery,21 for writing skills.To assess phonological awareness, we used theElision and Rapid Letter Naming subtests of theComprehensive Test of Phonological Processing,22and to assess auditory processing ability, the chil-drens version of the Hearing in Noise Test.23,24To assess attention, impulsivity, and psychosocialfunction, we used the Disruptive Behavior Disor-ders Rating Scale,25 the Child Behavior Checklist,26the Impairment Rating Scales,27 and the Social

Skills Scale of the Social Skills Rating System,28each completed separately by parents and teachers,and computer-based visual and auditory continu-ous performance tests.29,30 To assess intelligenceand academic achievement, we used the WechslerAbbreviated Scale of Intelligence31 and the Calcu-lation subtest of the WoodcockJohnson III Testsof Achievement, Standard Battery.21 The individ-ual assessments are described briefly in Table 1.The examiners and analysts were unaware of thechildrens medical histories and treatment-groupassignments.

Statistical Analysis

We calculated the duration of middle-ear effusionin children beginning from the age of 2 months.In the randomized clinical trial, to detect differ-ences of 0.33 SD or greater on any outcome mea-sure with a statistical power of 80%, we calculatedthat we would need to enroll 182 children in eachgroup. Analyses were performed according to theintention-to-treat principle. In the subgroup ofchildren who were not eligible for randomization,

the sample of 241 children was suff icient to detectcorrelations of 0.25, at a power of 91%, betweenscores on developmental tests and the estimatedcumulative proportion of days with middle-ear ef-fusion. Because correlations involving days withbilateral effusion differed litt le from correlationsinvolving total days with effusion (i.e., bilateral plusunilateral), the reported results are for total dayswith any effusion.

All scoring of tests and data entries were dou-





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Table 1. Developmental Tests and Procedures.

Assessment Description

Woodcock Reading Mastery Tests Revised, normative updated version

Word Identification subtest The child identifies words in isolation.

Word Attack subtest The child applies phonic and structural analysis to pronounce pseudowords.

Passage Comprehension subtest The child silently reads one or two sentences with a missing word indicated by a blankspace and supplies a word that makes sense.

Oral reading fluency test The number of words in each of three grade-level passages that a child reads correctly in1 minute is recorded. The median of the three values is the childs score.

Woodcock-Johnson III Tests of Achievement,Standard Battery

Spelling subtest The child spells words from dictation and uses appropriate capitalization and syntax, appropri-ate plural forms, comparatives, and superlatives.

Writing Samples subtest The child responds to a brief prompt; items begin with one-word responses and progressto complete sentences of increasing complexity.

Comprehensive Test of Phonological Processing

Elision subtest The examiner asks the child to say a word (e.g., Say farm ), and after the child repeatsthe word, he or she is asked to say the word again without a specific phoneme (e.g.,Now say farm without saying /f/). A total of 20 such tasks are presented.

Rapid Letter Naming subtest The child is asked to name letters that are randomly arranged on a page, and the examinerrecords the number of seconds required for the child to name all the letters.

Hearing in Noise Test (childrens version) The child repeats a series of seven sentences, one sentence at a time, in a quiet environmentand with competing noise at a steady loudness of 65 dB presented by means of a speakerfrom the front at 0 degrees, from the right at 90 degrees, and from the left at 90 degrees.For each condition, a separate series of sentences is used, and each sentence is presentedat increasing levels of loudness until the child can hear and repeat it. For each competing-noise condition, the score is the value obtained by subtracting 65 dB from the averageloudness in decibels.

Disruptive Behavior Disorder Rating Scale A parent and a teacher independently rate the child on 43 items consisting of symptoms ofattention deficithyperactivity disorder, oppositional defiant disorder, and conduct dis-order.

Child Behavior Checklist A parent and a teacher independently rate the childs overall behavioral and emotionalproblems by responding to 120 items and scoring each statement as not true, some-what or sometimes true, or very true or often true. The results are organized into eightspecific scales: Withdrawn, Somatic Complaints, Anxious/Depressed, Social Problems,Thought Problems, Attention Problems, Delinquent Behavior, and Aggressive Behavior.

Impairment Rating Scales With the use of visual-analogue scales, a parent and a teacher independently rate thechilds relationships with parents, peers, siblings, and teachers; the effect of any prob-lems on the family; classroom behavior; academic functioning; self-esteem; and overallfunctioning by marking an X on a line. The line for each domain is divided into sevenequal parts, and numerical scores (06) are assigned to the parents and the teachersratings. Ratings for the individual items correlate highly with ratings for overall func-tioning.

Social Skills Scale of the Social SkillsRating System

A parent and a teacher independently rate the child on Cooperation, Assertion, and Self-Control, and the parent also rates the child on Responsibility. Items are rated accordingto perceived frequency (never, sometimes, very often).

Continuous Performance Test Accuracy, reaction time, inattention, and impulsivity are measured. Scores reflect the num-bers of errors of omission and of commission.

Visual The child watches a computer screen that displays a series of letters. The child presses the

space bar on the keyboard when the target letter is preceded by the valid cue, and notunder any other circumstances.

Auditory The child presses the space bar when he or she hears X preceded by A, and not underany other circumstances.

Wechsler Abbreviated Scale of Intelligence

Vocabulary, Block Design, PictureArrangement, and Similarities subtests

For each subtest, the number of correct responses is calculated.

WoodcockJohnson III Tests of Achievement,Standard Battery

Calculation subtest The child writes single numbers and adds, subtracts, multiplies, divides, and performscombinations of these basic operations.





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429 Underwent randomization159 Consent withheld

by parents or guardians

588 Eligible forrandomization 5762 Ineligible forrandomization

6350 Children enrolled

112 Followed to 3 yr of age241 (Representative subgroup)

followed to 3 yr of age

216 Assigned to earlytreatment

213 Assigned to delayedtreatment

211 Followed to 3 yr of age 198 Followed to 3 yr of age

241 Underwent developmentaltesting at 3 yr of age




234 Underwent developmen-tal testing at 4 yr of age








223 Underwent developmen-tal testing at 9 to 11 yr of age

127 Underwent developmentaltesting at 9 to 11 yr of age



Tympanostomy tubes inserted:56 within 30 days after

randomization122 within 60 days after


randomization152 by 3 yr of age156 by 4 yr of age158 by 6 yr of age164 by 911 yr of age31 had not received tubes

by 911 yr of age

Tympanostomy tubes inserted:4 within 30 days after



randomization65 by 3 yr of age75 by 4 yr of age79 by 6 yr of age88 by 911 yr of age

108 had not received tubesby 911 yr of age

Tympanostomy tubes inserted:19 by 3 yr of age22 by 4 yr of age25 by 6 yr of age28 by 911 yr of age99 had not received tubes

by 911 yr of age

Tympanostomy tubes inserted:5 by 3 yr of age5 by 4 yr of age6 by 6 yr of age8 by 911 yr of age

215 had not received tubesby 911 yr of age

l

Figure 1. Enrollment, Randomization, and Follow-up of the Children and the Time of Insertion of Tympanostomy Tubes.

Forty-two of the children who returned for developmental evaluation at the age of 9 to 11 years 3 in the early-treatment group of the randomized clinical trial, 11 in the delayed-treatment group, and 28 in the group for whom

consent for randomization was withheld were lost to follow-up before the age of 3 years or did not undergo oneor more of the scheduled evaluations at 3, 4, and 6 years of age.





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Table 2. Demographic Characteristics of Children Who Underwent Testing, According to Study Component.*

Characteristic

RandomizedClinical Trial

(N = 391)

Group for Whom Consentfor Randomization

Was Withheld(N = 127)

Subgroup Not Eligiblefor Randomization

(N = 223)

no. of children (%)

Location of study siteUrban area 191 (49) 82 (65) 51 (23)

Small town or rural 140 (36) 26 (20) 86 (39)

Suburban 60 (15) 19 (15) 86 (39)

Sex

Male 225 (58) 74 (58) 112 (50)

Female 166 (42) 53 (42) 111 (50)

Age at time of assessment

9 yr 180 (46) 75 (59) 23 (10)

10 yr 187 (48) 45 (35) 165 (74)

11 yr 24 (6) 6 (5) 35 (16)

12 yr 0 1 (1) 0

Race or ethnic group

Black 145 (37) 62 (49) 34 (15)

White 234 (60) 62 (49) 183 (82)

Other or indeterminate 12 (3) 3 (2) 6 (3)

Maternal level of education

At study entry

Less than high school graduate 51 (13) 24 (19) 20 (9)

High school graduate 308 (79) 93 (73) 156 (70)

College graduate 32 (8) 10 (8) 47 (21)

At time of current assessment

Less than high school graduate 16 (4) 12 (9) 6 (3)

High school graduate 308 (79) 97 (76) 153 (69)

College graduate 65 (17) 18 (14) 64 (29)

Unknown 2 (1) 0 0

Health insurance status

At study entry

Public 249 (64) 93 (73) 68 (30)

Private 139 (36) 33 (26) 152 (68)

None 3 (1) 1 (1) 3 (1)

At time of current assessment

Public 167 (43) 60 (47) 50 (22)

Private 215 (55) 63 (50) 169 (76)

None 9 (2) 4 (3) 4 (2)

* Because of rounding, percentages may not sum to 100. P


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ble-checked. All analyses were performed by theauthors with the use of two-tailed tests, with aP value of 0.05 or less considered to indicate sta-tistical signif icance. We used chi-square tests toevaluate between-group differences in proportionsof children. We used analysis of variance to testfor differences between mean results, Pearsonpairwise correlation analysis to test for correla-tions, and linear regression analysis to adjust for

potentially confounding variables and to test forinteractions. We did not adjust for the multiplecomparisons performed.

Results

Study Sample and Treatment Groups

A total of 391 of the 429 children who underwentrandomization (91%), 127 of the 159 childrenwhose parents or guardians declined randomiza-

tion (80%), and 223 of the 241 children in the sub-group not eligible for randomization (93%) under-went developmental assessment at 9 to 11 yearsof age. At the time of testing, 84% of the childrenin the early-treatment group and 45% of the chil-dren in the delayed-treatment group had under-gone tube insertion (Fig. 1).

Table 2 shows selected demographic character-istics of the children who underwent assessment.

Larger proportions of children in the group thatunderwent randomization than in the subgroupnot eligible for randomization were black, young-er than 10 years of age, from urban areas, andfrom families of lower socioeconomic status (de-termined on the basis of maternal level of educa-tion and type of health insurance). In the ran-domized clinical trial, there were no significantdifferences in characteristics between the testedchildren in the early-treatment group and those in

Table 3. Clinical Characteristics of the Tested Children Who Underwent Randomization.*

Characteristic

Early-TreatmentGroup

(N = 195)

Delayed-TreatmentGroup

(N = 196)

no. of children (%)

Year of life during which randomization criteria were met

First 79 (41) 85 (43)

Second 91 (47) 92 (47)

Third 25 (13) 19 (10)

Laterality and sequence of middle-ear effusion serving as the basis formeeting randomization criteria

Bilateral

Continuous 39 (20) 36 (18)

Discontinuous 38 (19) 36 (18)

Unilateral

Continuous 33 (17) 31 (16)

Discontinuous 85 (44) 93 (47)

Abnormal result of hearing test on 1 occasion before randomization

Yes 160 (82) 138 (70)

No 21 (11) 36 (18)

Results incomplete or not reliable or testing not performed 14 (7) 22 (11)

Percentage of time with bilateral middle-ear effusion in 6-mo periodbefore randomization criteria were met

25 29 (15) 35 (18)

2650 81 (42) 69 (35)

5175 70 (36) 77 (39)

7699 12 (6) 11 (6)

100 3 (2) 4 (2)





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the delayed-treatment group or between the 391children who were tested and the 38 children whowere not. Table 3 shows the clinical characteris-tics of the children who underwent randomiza-tion; there were no significant differences betweenthe treatment groups. The mean scores of the par-ticipants in the study on 32 of the 48 developmen-tal measures are shown in Table 4. (Only scores for

Total Problems on the Child Behavior Check-lists, not individual scale scores, are shown.)

Randomized Clinical Trial

No significant differences in the results favored theearly-treatment group over the delayed-treatmentgroup, either before or after adjustment for thechildrens sex and age on measures for which nor-mative standard scores were not available. We test-ed for interactions to determine whether scores on

any of the 48 outcome measures differed in rela-tion to whether the children met the randomiza-tion criteria of the study during their first, second,or third year of life; whether they met the criteriaon the basis of bilateral continuous middle-ear ef-fusion, unilateral continuous effusion, bilateraldiscontinuous effusion, or unilateral discontinu-ous effusion; and, in the 355 children who received

hearing tests during one or more episodes of ef-fusion before undergoing randomization, wheth-er one or more of those tests had abnormal results(as defined in Table 3) or showed a pure-tone aver-age threshold of 30 dB or more or 40 dB or more.In 10 of the 240 instances, there were significantinteractions; after adjustment for these interac-tions, no results significantly favored the early-treatment group.

Among the children who underwent random-

Table 3. (Continued.)

Characteristic

Early-TreatmentGroup

(N = 195)

Delayed-TreatmentGroup

(N = 196)

no. of children (%)

Percentage of time with bilateral middle-ear effusion in 6-mo period

before randomization criteria were met, in subgroup of chil-dren meeting the criteria on the basis of unilateral effusion

25 29 (25) 34 (27)

2650 57 (48) 56 (45)

5175 31 (26) 30 (24)

7699 1 (


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Table4.

ScoresonDevelopmentalTestsat9to11YearsofAge.*

Test

RandomizedClinicalTrial(N=391

)

ChildrenforWhom

ConsentforRandomization

WasWithheld(N=127)

SubgroupNotEligible

forRandomization

(N=223)

Ea

rly-Treatment

Group

(N=195)

Delayed-

TreatmentGroup

(N=196)

9

5%CI

meanscore(no.ofchildren)

meanscore(no.ofchildren)

Literacy

WoodcockReadingMasteryTestsRevised,

normativeupdatedversion

WordIdentificationsubtest

9

811(195)

9912(196)

3

.3to1.3

9812(127)

10110(223)

WordAttacksubtest

10

313(195)

10414(196)

4

.3to1.1

10313(127)

10613(223)

PassageComprehensionsub

test

9

812(195)

9912(196)

3

.4to1.2

9812(127)

10110(223)

Oralreadingfluencytest

Childreningrade3

7

836(37)

8741(37)

26

.9to8.4

8630(28)

6211(2)

Childreningrade4

8

936(87)

8938(97)

10

.3to11.1

9234(63)

10934(81)

Childreningrade5

9

736(54)

10237(51)

19

.3to8.3

9441(29)

11436(115)

Childreningrade6

10

232(12)

9643(9)

27

.4to39.0

9316(5)

10639(24)

WoodcockJohnsonIIITestsofAchievement,StandardBattery

Spellingsubtest

9

613(194)

9716(196)

3

.9to2.0

9614(127)

10112(223)

WritingSamplessubtest

10

414(192)

10515(195)

4

.1to1.7

10313(125)

10815(223)

Phonologicalawareness

ComprehensiveTestofPhonologicalProcessing**

Elisionsubtest

8.64.9(195)

8.73.0(196)

0

.9to0.7

8.92.9(127)

9.23.4(223)

RapidLetterNamingsubtest

9.32.5(193)

9.62.4(196)

0

.8to0.2

9.62.4(127)

10.12.6(223)

Auditoryprocessing

ChildrensversionoftheHearinginNoiseTest

Competingnoisefromthefront(dB)

0.41.7(195)

0.61.6(196)

0.06to0.58

0.61.6(127)

0.81.5(223)

Competingnoisefromtheright(dB)

7.03.0(195)

7.02.4(196)

0.54to0.54

6.72.7(127)

8.12.5(223)

Competingnoisefromtheleft(dB)

6.42.5(195)

6.82.5(196)

0.04to0.95

6.52.3(127)

7.22.4(223)





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Attention,

impulsivity,andpsychosocialfunction

DisruptiveBehaviorDisordersR

atingScale

Inattentionfactor

Parentsrating

0.700.63(194)

0.650.66(196)

0.07to0.18

0.620.61(126)

0.560.59(223)

Teachersrating

0.710.74(190)

0.670.75(192)

0.11to0.19

0.740.77(122)

0.500.66(216)

Impulsivityandoveractivityfactor

Parentsrating

0.670.57(194)

0.570.54(196)

0.01to0.21

0.560.51(126)

0.470.44(223)

Teachersrating

0.480.63(190)

0.400.52(192)

0.04to0.20

0.500.60(122)

0.300.49(216)

Oppositionaldefiantfactor

Parentsrating

0.570.58(194)

0.520.53(196)

0.06to0.16

0.440.47(126)

0.440.45(223)

Teachersrating

0.330.56(190)

0.330.58(192)

0.11to0.11

0.430.66(122)

0.230.46(215)

ChildBehaviorChecklist

TotalProblemsscore,parentsrating

5112(194)

4912(196)

0.1to4.8

4812(127)

4711(223)

TotalProblemsscore,teachersrating

5211(189)

5011(191)

0.9to3.4

5212(123)

4711(217)

ImpairmentRatingScales

Overallfunctioning,parents

rating

0.821.42(194)

0.681.33(196)

0.13to0.41

0.641.21(127)

0.460.98(233)

Overallfunctioning,teachersrating

2.042.24(190)

1.782.19(192)

0.18to0.70

1.932.23(123)

1.161.74(217)

SocialSkillsRatingSystem***

SocialSkillsscale,parentsv

ersion

9619(194)

9818(194)

6.0to1.4

9818(126)

10217(223)

SocialSkillsscale,teachersversion

9813(184)

9913(186)

4.5to0.9

9714(120)

10215(211)

VisualContinuousPerformance

Test

Inattention

9

.78.5(195)

9.58.5(196)

1.5to1.9

10.18.6(127)

7.17.4(223)

Impulsivity

8

.816.5(195)

8.215.6(196)

2.7to3.7

10.120.0(127)

6.113.9(223)

AuditoryContinuousPerforman

ceTest

Inattention

11

.17.2(155)

11.48.0(153)

2.0to1.4

11.67.3(100)

8.77.0(128)

Impulsivity

3

.38.7(154)

4.212.1(153)

3.2to1.5

2.34.2(100)

1.75.5(128)





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ization, there were no significant differences inmean scores between those who received tympa-nostomy tubes before 3 years of age (irrespectiveof the treatment assignment) and those who didnot. There were also no significant differencesbetween the mean scores of children who under-went randomization and those of children for

whom randomization was declined.

Observational Cohort

In the subgroup of children who were not eligiblefor randomization, unadjusted correlations be-tween the scores on each outcome measure (fororal reading fluency, the two children in grade 3were excluded) and the cumulative duration ofmiddle-ear effusion in the children during theirfirst, second, and third years of life and their first2 and first 3 years of life were all less than 0.27.For most children (142 of 235), these correlations

were less than 0.10, and for most children (183 of235), the correlations were nonsignificant. Afteradjustment for demographic variables, there weresignificant correlations between the duration ofeffusion during one or more of the periods con-sidered and scores on 4 of the 19 formal test mea-sures and 16 of the 28 measures based on reportsby parents and teachers (data not shown). In eachcase, a longer duration of effusion was associat-ed with a less favorable score. However, the per-centage of variance in scores that was explainedby the duration of middle-ear effusion, apart fromthat explained by the demographic variables, waslow, ranging from 1.8% to 6.4% (mean, 3.0%).Also, after adjustment for demographic variables,the scores on 39 of the 47 comparable outcomemeasures did not differ significantly betweenthe children in the subgroup not eligible for ran-domization and the children who underwent ran-domization. Six of the eight exceptions are shownin Table 4; the remaining two exceptions involvedscores on individual Child Behavior Checklistscales.

Discussion

We describe follow-up developmental f indings ina cohort of children in relation to the cumulativeduration of middle-ear effusion before the age of3 years and receipt or nonreceipt of tympanosto-my tubes. In a clinical trial in which the childrenwho had persistent effusion during that age peri-od were assigned randomly to undergo prompt

insertion of tympanostomy tubes or delayed inser-tion if the effusion persisted, there were no sig-nificant differences at 9 to 11 years of age in scoresfavoring early treatment over delayed treatment onany of the 48 developmental measures we used. For46 of the measures, the associated 95% confidenceintervals afforded assurance that the presence of

any difference that was 0.33 SD or larger favoringthe early-treatment group would probably havebeen detected. These findings affirm our observa-tion made when the children were younger. Thatis, early tympanostomy tube placement as com-pared with delayed tube placement in the childrenin whom effusion continued unremittingly did notresult in a significant effect on the childrens cog-nitive or psychosocial development or on their pho-nological and auditory processing skills.2,5-7,32 Ourfindings also extend that observation to includemeasures of the childrens literacy, attention, so-

cial skills, and academic achievement.Among the children in whom the duration of

middle-ear effusion did not meet the eligibilitycriteria for enrollment in the clinical trial, corre-lations between the duration of effusion duringvarious periods in the first 3 years of life and devel-opmental outcomes were generally weak and notsignificant results that are consistent with ourfindings when the children were younger.2,6,7,32For the significant correlations, the percentage ofvariance in the results that was explained by theduration of effusion was negligible. Nevertheless,these significant correlations, along with certainoutcomes that were better for these children thanfor the children who underwent randomization,raise the possibility that prolonged effusion hadsome adverse developmental effects. A more likelyexplanation for these f indings, however, is resid-ual confounding, given the more favorable socio-economic status of the children in the subgroupthat was not eligible for randomization and thefact that low socioeconomic status was a majorrisk factor both for early-life otitis media in these

children33

and for less than optimal developmen-tal outcomes in children in this and other stud-ies.2,6,7,32,34

Our study included close monitoring of chil-drens middle-ear status throughout their first3 years of life, a broad array of developmentalassessments, and a high rate of follow-up. Theconsistency of the results in different age peri-ods not only aff irms the validity of our findingsbut also suggests that developmental differences





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between the treatment groups will not emerge atlater ages.

As we have noted previously,2,6,7 our findingscannot be generalized to children who are nototherwise healthy or have disabling conditionssuch as sensorineural hearing loss or Downs syn-drome; to children with longer periods of effusion

than those we studied; or to children in whom ef-fusion is consistently accompanied by extremedegrees of hearing loss. However, such childrenare seen infrequently in general clinical practice.

Given the consistency of our current findingswith those reported when the children wereyounger, we conclude that for otherwise healthychildren who are younger than 3 years of age andhave asymptomatic middle-ear effusion that ispersistent, as defined in our study, prompt inser-tion of tympanostomy tubes does not improve thedevelopmental outcomes as compared with de-

layed insertion in children in whom effusion con-tinues unremittingly. Accordingly, in children suchas those we studied, watchful waiting for at least6 additional months when effusion is bilateral and

for at least 9 additional months when effusion isunilateral is the preferred management option.Such conservative management was recommend-ed in a recent practice guideline that cited ourfindings in children at 3 years of age, but thisguideline was formulated before our findings inthe children at later ages were reported.35

Supported by grants from the National Institute of Child Healthand Human Development and the Agency for Healthcare Researchand Quality (HD26026 and HD42080), from the University ofPittsburgh Competitive Medical Research Fund, and from theChildrens Hospital of Pittsburgh Research Advisory Committeeand by gifts from GlaxoSmithKline and Pfizer.

No potential conflict of interest relevant to this article was re-ported.

We thank the following physicians for integrating this studyinto their of fice pract ices: D.J. Cahill, J. Scibilia, and J.A. Vogel,Jr., in Beaver; M. Diamond and T.D. Skelly in Brentwood; A.V.Agustin and E.A. Vogeley in Gibsonia; H.A. Altman, J.K. Green-baum, K.R. Keppel, and D.J. Vigliotti in Kittanning; S.L. Tysonand C.J. Welkon in Mt. Lebanon; K.G. Pai and H.M. Rubin inPleasant Hills; and B.J. Bradford at Mercy Hospital of Pitts-burgh all in Pennsylvania. We also thank Andrew R. Grein-er for assistance with the continuous performance tests andthe many other persons who served as clinicians for the studysubjects or assisted in other clinical, administrative, or analyticcapacities.

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tympanostomy tubes and developmental outcomes at 9 to 11 years of age

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