Presentation of OME

Bibliographic detailsStudy type and evidence levelAim of studyNo. of patients and patient characteristicsOutcome and resultsReviewer comments
Maw (1988)13
{36960}
Prospective survey

EL = 3
  1. to identify the age at which hearing loss was first suspected in children with OME,
  2. time of subsequent presentation in the hospital,
  3. subjective presenting features of OME in an ENT department, and
  4. identify the individual to whom the condition first presented or the method by which hearing loss was suspected
Total no. of patients = 280
Children between 2 and 11 years of age referred specifically to the ENT department of a tertiary hospital for consideration of treatment and inclusion in an ongoing study. The population included children with bilateral OME and significant hearing loss (severe disease group, n = 180) and where effusion cleared from one or both ears during the 3 month observation period (mild disease group, n = 100)
Comparison of features between severe and mild disease group

Age of suspected hearing loss (in %)
less than 3 years: 12.3 vs 5.2
3–5 years: 54.6 vs 41.2
5–7 years: 30.0 vs 45.4
more than 7 years: 3.1 vs 8.2

Age of presentation in ENT department (in %)
less than 3 years: 0.6 vs 0
3–5 years: 15.9 vs 14.3
5–7 years: 55.3 vs 45.9
more than 7 years: 28.2 vs 39.8

Subjective presenting feature of OME (in %)
Hearing impairment: 61.6 vs 66.3
Learning difficulty: 8.7 vs 0
Speech/language problems: 7.6 vs 4.2
Routine screening tests: 20.9 vs 27.4

Individual or method of first suspecting hearing loss (in %)
Mother: 53.4 vs 48.4
Father: 1.7 vs 0
Teacher: 5.5 vs 2.1
GP: 2.2 vs 2.1
Routine screening tests: 20.0 vs 26.8

Periodicity and seasonal variation of hearing loss (in %)
Intermittent: 23.0 vs 43.0
Continuous: 77.0 vs 57.0
Spring/Summer: 1.1 vs 2.0
Autumn/Winter: 43.5 vs 48.0
Source of funding: not given

High risk of bias
No control for confounding variables
Incomplete information about the questionnaire (validity, piloting, application)
Keles (2004)18
{36973}
Prospective survey

EL = 3
  1. determine prevalence of OME
  2. analyse its effect on academic
  3. investigate correlation between frequency of OME and BCG vaccination performance
Total no. of patients = 3675
Primary school children, clinically healthy, living in same region and with similar socio-economic status.
First grade (n = 2042) and second grade (n = 1633).
Mean age of first grade students: 84 (2.7) months, Male: 62%
Mean age of second grade students: 96 (2.1) months, Male: 61.4%

Exclusion criterion:
Children with sinusitis, diabetes, immunodeficiency, and VT inserted.
Prevalence of OME (first vs second grade)
3.1% vs 1.5% (P < 0.05)

Males with OME (first vs second grade)
59.3% vs 64%

Concordance between otoscopy and tympanometry in diagnosing OME (first vs second grade)
93.7% vs 88%

Comparison of academic performance (students without OME vs with OME)
Bad 2.2% vs 3.3%
Borderline 5.7% vs 6.7%
Fair 30.5% vs 32.5%
Good 37.2% vs 34.8%
Very good 24.4% vs 22.4%
P > 0.05 for all

Comparison of academic performance of OME cases (first vs second grade)
Bad 3.1% vs 4.0%
Borderline 6.2% vs 8.0%
Fair 35.9% vs 28.0%
Good 34.3% vs 32.0%
Very good 20.3% vs 28.0%
P > 0.05 for all
Source of funding: not given

Representative population
Moderate chance of bias
Questionnaire not validated, piloted.
Silva (1982)14
New Zealand
{36981}
Cohort study

EL = 2+
Comparison of speech, language and motor development, intelligence, and behavioural characteristics of children with bilateral OME with those with no otological abnormalities.Total no. of patients = 404
Children 5 years of age, born between April 1972 and March 1973, assessed for otological status every second year from the age of 3 years, similar socio-economic status

Normal group (n = 357)
Bilateral OME group (n = 47)
Comparison between normal group vs bilateral OME group – Mean score (SD)

Speech articulation: 17.6 (3.92) vs 16.3 (4.88), P < 0.05
Verbal comprehension: 51.2 (6.41) vs 49.1 (5.27), P < 0.01
Verbal expression: 50.3 (7.18) vs 49.3 (5.84), P > 0.05
Intelligence quotient scores: 106.6 (16.14) vs 99.8 (15.4), P < 0.01
Motor development: 35.5 (8.19) vs 32.8 (7.87), P < 0.01

Maladaptive behavior (total 15 aspects): P < 0.05 for aspects of dependency, short attention span, weak goal orientation, restless, fidgety, destructive, often disobedient, and not liked by children
Funding: government

Minimal chances of bias
Confounding variables partially controlled
Blinding of outcome assessors
Silva (1986)15
New Zealand
{36982}
Cohort study

EL = 2+
Longitudinal follow-up of study by Silva et al. (1982)14
Comparison of hearing, intelligence, language development, speech articulation, reading attainment, and behaviour problems of children with no otological abnormalities to those with bilateral OME
Total no. of patients = 367
Population same as in study by Silva et al. (1982)14

Normal (n = 297 to 323)

Bilateral OME group (n = 39 to 44)
Comparison of normal vs bilateral OME group

Mean hearing threshold levels (in dB)
5 years: 4.6 vs 20.1
7 years: 10.0 vs 12.8
9 years: 8.7 vs 11.6
11 years: 7.9 vs 11.5
P < 0.001 for all

Mean Z scores for intelligence
3 years: 0.04 vs −0.11
5 years: 0.11 vs −0.29
7 years: 0.10 vs 0.03
9 years: 0.10 vs 0.01
11 years: 0.05 vs −0.03
P = 0.202 (comparison of sums of means)

Mean Z scores for verbal comprehension
3 years: 0.09 vs −0.21
5 years: 0.08 vs −0.36
7 years: 0.06 vs 0.04
9 years: 0.01 vs −0.14
P = 0.044 (comparison of sums of means)

Mean Z scores for verbal expression
3 years: 0.08 vs −0.20
5 years: 0.03 vs −0.10
7 years: 0.08 vs −0.30
9 years: 0.09 vs −0.08
P = 0.030 (comparison of sums of means)

Mean Z scores for speech test
5 years: 0.04 vs −0.41
7 years: 0.09 vs −0.34
9 years: 0.12 vs −0.46
P = 0.0001 (comparison of sums of means)

Mean Z score for reading test
7 years: 0.10 vs −0.30
9 years: 0.07 vs −0.21
11 years: 0.06 vs −0.25
P = 0.023 (comparison of sums of means)

Mean Z scores for behaviour (parents scale)
5 years: −0.02 vs 0.34
7 years: −0.10 vs 0.19
9 years: −0.09 vs 0.13
11 years: −0.08 vs −0.01
Higher score indicate more behaviour problems
P = 0.067 (comparison of sums of means)

Mean Z scores for behaviour (teachers’ scale)
5 years: −0.08 vs 0.26
7 years: −0.07 vs 0.49
9 years: −0.08 vs 0.25
11 years: −0.03 vs 0.24
Higher score indicate more behaviour problems
P = 0.067 (comparison of sums of means)
Funding: Government

Minimal chances of bias
Confounding variables partially controlled
Outcome assessors blinded
Peters (1994)19
Netherlands
{36983}
Cohort study

EL = 2+
Evaluating the effect of OME on reading and spelling abilityTotal no. of patients = 270
Children from a birth cohort who were screened between 2 to 4 years of age through quarterly tympanometry examination and later followed up at 7–8 years of age.

OME group - with no treatment at 2–4 years (n = 151)

Treated group - children with VT inserted at 2–4 years (n = 37)

Control group, no OME (n = 82)
Comparison of mean scores (SD) between OME group vs Control grp

Spelling – for words
64.1 (25.1) vs 70.4 (23.6)
P < 0.05

Spelling – for pseudowords
60.4 (25.3) vs 66.7.4 (23.2)
P < 0.001

Spelling – one-minute test
42.0 (19.9) vs 41.5 (17.5)
P > 0.05

Reading – comprehension for correct sentences
85.2 (12.9) vs 88.4 (12.2)
P > 0.05

Reading – comprehension for incorrect sentences
84.7 (17.4) vs 86.1 (15.8)
P > 0.05

Comparison of mean scores (SD) of teacher ratings between OME group vs Control group

Writing scale
3.1 (1.0) vs 3.5 (1.0)
P < 0.05

Reading scale
3.3 (0.8) vs 3.5 (0.9)
P > 0.05

Arithmetic scale
3.0 (0.8) vs 3.2 (1.0)
P > 0.05
Funding: Stichting
Kinderpostzegels Nederland

Minimal chances of bias
Confounding variables controlled partially
High drop-out rate
Gravel (2000)16
USA
{36992}
Cohort study

EL = 2+
  1. examine the effects of OME on hearing sensitivity during the first 3 years of life
  2. assess whether OME that resolves in 1 year has a long-term cumulative effect on hearing at later ages
  3. investigate patterns of OME and hearing loss as a function of gender, birth risk, and socioeconomic status
Total no. of patients = 114
Children enrolled in a hearing project by the age of 2.5 months with hearing assessment and middle-ear function evaluated every 2 months till 3 years of age. (males 52%, full-term 82%, African American 48%, SES mid to high 59%)

Normal (n = 56)

Bilaterally OME positive (n = 20)

Unilaterally OME positive (n = 8)

Mixed OME (n = 5)

Infrequent OME (n = 25)
Difference between groups in mean average hearing levels
Year 1
F(4,109) = 4.44, P = 0.002)

Year 2
F(4,109) = 17.2, P < 0.0001)

Year 3
F(4,109) = 12.28, P < 0.0001)

Difference in mean hearing levels (SD) between Normal and Bilateral OME group
Year 1
13.9 (4.8) vs 20.0 (7.3)
P < 0.05

Year 2
11.7 (3.4) vs 18.3 (4.4)
P < 0.05

Year 3
11.3 (2.7) vs 18.6 (6.2)
P < 0.05

Average hearing levels across 3 years for 3 groups - normal, OME in year 1 only, OME in year 1 & 2

Difference between groups
F (2,49) = 12.54
P < 0.0001

Change in average hearing levels over time
F (2,48) = 26.21
P < 0.0001

Analysis of OME and hearing as a function of gender, birth risk status and socioeconomic status
No difference
P > 0.05 for all three variables
Funding: National Institutes of Health

Moderate chance of bias
Confounding variables controlled (partially)
High drop-out rate
Casselbrant (2000)20
USA
{36996}
Cohort study

EL = 2+
To determine possible changes in vestibular and balance test results associated with a history of recurrent or persistent OME, but without any concurrent effusion.Total no. of patients = 71
Children aged 4 years free of middle ear effusion at the time of testing, enrolled in an earlier study at the age 24–35 months and with monthly evaluation of middle ear status.
Mean age 48.6 months, boys 59%, white 67.6%.

Group A with no significant history of middle ear effusion (n = 31)

Group B with significant history of middle ear effusion (n = 40)
Comparison of Mean (SD) of gain in Rotational Testing

Stimulus at 0.02 Hz, 50/sec
0.55 (0.15) vs 0.49 (0.19)
P = 0.10

Stimulus at 0.1 Hz, 50/sec
0.64 (0.15) vs 0.54 (0.17)
P = 0.06

Stimulus at 0.1 Hz, 150/sec
0.57 (0.14) vs 0.44 (0.13)
P = 0.007

Comparison of Mean (SD) of phase degrees in Rotational Testing phase

Stimulus 0.02 Hz, 50/sec
23.1 (8.5) vs 28.0 (7.8)
P = 0.10

Stimulus 0.1 Hz, 50/sec
7.7 (3.7) vs 8.3 (3.9)
P = 0.62

Stimulus 0.1 Hz, 150/sec
9.4 (5.6) vs 9.8 (4.9)
P = 0.78

Comparison of Mean (SD) of asymmetry in degrees/sec in Rotational testing

Stimulus 0.02 Hz, 50/sec
1.50 (0.84) vs 1.89 (1.30)
P = 0.54

Stimulus 0.1 Hz, 50/sec
2.94 (2.29) vs 1.65 (1.27)
P = 0.07
Stimulus 0.1 Hz, 150/sec
2.70 (1.8) vs 2.09 (1.71)
P = 0.30

Comparison of Moving posture platform testing

No difference in Normalized EquiTest scores for 6 conditions tested between Group A and Group B (P > 0.10 for all conditions)
Funding: Part of thesis

Moderate chances of bias
Confounding variables not adjusted
High drop-out rate
Roberts (2004)17
{37009}
Systematic Review/Meta-Analysis

EL = 2+
Comparison of receptive language, expressive language, vocabulary, syntax, language use, and speech.Prospective studies or RCT with documented OME or associated hearing loss before the age of 5 years, and with measured outcomes.

Total no. of included studies= 14 studies (both correlational and individual group comparison studies)
Receptive language vs OME and hearing loss at 3 years (3 correlation studies)
R (95% CI)= − 0.03 (−0.27, 0.22)
P = 0.81

Receptive language vs OME and hearing loss at 2–5 years (7 group studies)
R (95% CI)= −0.24 (−0.41, −0.07)
P = 0.003

Receptive language vs OME and hearing loss at 1–2 years (3 correlation studies)
R (95% CI)= −0.17 (−0.29, −0.05)
P = 0.005

Expressive language vs OME and hearing loss at 3 years (3 correlation studies)
R (95% CI)= −0.07 (−0.22, 0.08)
P = 0.35

Expressive language vs OME and hearing loss at 2–5 years (6 group studies)
R (95% CI)= −0.24 (−0.41, −0.07)
P = 0.006

Expressive language vs OME and hearing loss at 1–2 years (3 correlation studies)
R (95% CI)= −0.30 (−0.43, −0.16)
P < 0.001

Receptive vocabulary vs OME at 3 years (4 correlation studies)
R (95% CI)= −0.05 (−0.23, 0.13)
P = 0.56

Receptive vocabulary vs OME at 3 years (4 group studies)
R (95% CI)= −0.16 (−0.37, 0.05)
P = 0.144

Expressive vocabulary vs OME at 3–5 years (3 correlation studies)
R (95% CI)= −0.05 (−0.16, 0.05)
P = 0.192

Expressive syntax vs OME at 3–5 years (3 correlation studies)
R (95% CI)= −0.07 (−0.18, 0.04)
P = 0.330

Speech development vs OME at 3 years (3 group studies)
R (95% CI)= −0.15 (−0.32, 0.01)
P = 0.065
Source of funding: Government

Detailed description of methodology
Quality appraisal of individual studies not done
Meta-analysis of similar studies done
Higson (2005)22
{36958}

Qualitative Study

EL =2++
To quantify similarities and differences in how the signs, symptoms, and developmental impact of OME are attributed and construed between teachers, parents and ENT surgeons.Total no. of patients = 450

Primary school teachers of children aged between 3 and 7 years in two educational authorities (n = 118)
ENT specialists - random sample (n = 178)
Parents - attending one of four ENT departments of tertiary level hospitals (n = 67), visiting their GP's for advice on OME (n = 28), and through publication in a parenting magazine (n = 48) or newspaper (n = 11).
Weighting to Language and education
Overall trend
teachers > surgeons > parents
P < 0.004 for teachers > surgeons & teachers > parents

Weighting to Hearing
Overall trend
parents > teachers > surgeons
P < 0.004 for parents > teachers & parents > surgeons

Weighting to Behaviour
Overall trend
teachers > parents > surgeons
P < 0.004 for teachers > surgeons & parents > surgeons

Weighting to Balance
Overall trend
surgeons > parents > teachers
P < 0.004 for surgeons > parents & surgeons > teachers
Source of funding: Not given

Comments:
Good quality descriptive study
Bennett, Haggard (1999)21
UK
{37015}
Longitudinal Cohort study

EL = 2+
To find association between a history of middle ear disease and psychosocial outcomes.Total no. of patients at 5 years = 12000 and total no. of patients at 10 years = 5000

All births in the UK between 5 and 11 April 1970, with data available for evaluating the exposure and outcome variables at 5 and 10 years of age.
Prevalence of ear discharge 11.5% and of hearing difficulty 8.4%.
Effect (SD units) of hearing difficulty on continuous behavior scores (parent reported) at 5 years
Crude effect
Antisocial: 0.13
Neurotic: 0.22
Hyperactive: 0.19
Poor conduct: 0.08

Adjusted effect
Antisocial:0.12 (0.06, 0.18)
Neurotic: 0.22 (0.14, 0.25)
Hyperactive: 0.19 (0.12, 0.25)
Poor conduct: 0.07 (0.01, 0.13)

Effect (SD units) of ear discharge on continuous behaviour scores (parent reported) at 5 years
Crude effect
Antisocial: 0.15
Neurotic: 0.20
Hyperactive: 0.13 Poor conduct: 0.14

Adjusted effect
Antisocial:0.08 (0.03, 0.13)
Neurotic: 0.14 (0.09, 0.19)
Hyperactive: 0.07 (0.02, 0.13)
Poor conduct: 0.07 (0.02, 0.12)

Effect (odds ratio) of hearing difficulty on dichotomous behaviour scores (parent reported) at 5 years
Crude effect
Antisocial:1.41 (1.20, 1.70)
Neurotic: 1.53 (1.27, 1.80)
Hyperactive: 1.53 (1.27, 1.84)
Poor conduct: 1.37 (1.13, 1.66)

Adjusted effect
Antisocial:1.44 (1.18, 1.76)
Neurotic: 1.52 (1.26, 1.85)
Hyperactive: 1.56 (1.29, 1.89)
Poor conduct: 1.37 (1.12, 1.67)

P value < 0.01 for all
Source of funding: Not given
Exposure indirectly related to OME
Chance of information bias
Confounding variables partially controlled
Sheahan (2003)73
{37527}
Prospective Survey

EL = 3
To examine the incidence, natural history, treatment, and outcome of middle ear disease in children with cleft palateAll subjects with cleft lip and palate registered on the database at a children’s hospital (n = 584). The response rate to the questionnaire was 68.0% (397/584) and the medical records of these children were also reviewed to get more information. Final sample size = 359, [178 children (49.6%) with cleft palate only, 62 (17.3%) with cleft lip only, and 119 (33.1%) with both]. Median age = 7 years (range 5 months − 27 years)
191 (53.2%) males, 168 (46.8%) females
Incidence of middle ear disease & interventioncleft lip only vs cleft palate only vs cleft lip and palate

H/O any ear problem
16% vs 68% vs 76%

H/O recurrent ear infections
8% vs 45% vs 46%

H/O VT insertion
3% vs 56% vs 61%

H/O2 ventilation tubes
2% vs 38% vs 37%

Tympanoplasty/Mastoidectomy
2% vs 9% vs 7%

Below normal hearing
3% vs 30% vs 29%

Incidence of age-related middle ear disease in children with cleft palate only or cleft lip and palate

H/O any ear problem, H/O ear infections & H/O VT insertion years: 31%, 11% & 3%
2–3 years: 54%, 23% & 37%
4–6 years: 86%, 59% & 64%
7–9 years: 75%, 44% & 66%
10–12 years: 95%, 65% & 83%
13–15 years: 79%, 56% & 79%
16+ years: 79%, 52% & 64%

Ear problems in preceding year & current hearing below normal
years: 25% & 14%
2–3 years: 37% & 20%
4–6 years: 56% & 40%
7–9 years: 44% & 31%
10–12 years: 46% & 46%
13–15 years: 26% & 24%
16+ years: 21% & 24%

% of subjects with below normal current hearing related to age of onset of ear problems
0 years: 52%
1 year: 45%
2 years: 45%
≥ 3 years: 32%

Relationship between number of VT insertion and subjects with current hearing level below normal

One vs None
18.5% vs 11.3%
OR: 1.78 (P = 0.198)

Two vs None
42.6% vs 11.3%
OR: 5.82 (P = 0.000)

Three or more vs None
60% vs 11.3%
OR: 12.25 (P = 0.000)

Relationship between number of VT insertion and subjects with surgery for chronic OM

One vs None
5.6% vs 3.2%
OR: 1.76 (P = 0.46)

Two vs None
4.3% vs 3.2%
OR: 1.33 (P = 0.74)

Three or more vs None
21.5% vs 3.2%
OR: 8.23 (P = 0.000)
Source of funding: Not given
Moderate chance of bias
Confounding variables not controlled
No details about questionnaire validity

From: Evidence tables

Cover of Surgical Management of Otitis Media with Effusion in Children
Surgical Management of Otitis Media with Effusion in Children.
NICE Clinical Guidelines, No. 60.
National Collaborating Centre for Women’s and Children’s Health (UK).
London: RCOG Press; 2008 Feb.
Copyright © 2008, National Collaborating Centre for Women’s and Children’s Health.

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