Evidence Report/Technology Assessment 

Number 55 

Diagnosis, Natural History, and Late Effects of Otitis 

Media With Effusion 

Volume 1. Evidence Report and Evidence Tables 

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

2101 East Jefferson Street 

Rockville, MD 20852 

www.ahrq.gov 

Contract No: 290-97-0001, Task Order No. 04 

Prepared by: 

Southern California Evidence-based Practice Center 

EPC Director 

Paul Shekelle, M.D., Ph.D. 

Principle Investigators 

Glenn Takata, M.D. 

Linda S. Chan, Ph.D. 

Investigators 

Rita Mangione-Smith, M.D. 

Pamela M. Corley, MSLS 

Tricia Morphew, M.S. 

Sally Morton, Ph.D. 

AHRQ Publication No. 03-E023 

May 2003 
This report may be used, in whole or in part, as the basis for development of clinical practice 

guidelines and other quality enhancement tools, or a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 

AHRQ is the lead Federal agency charged with supporting research designed to improve the 

quality of health care, reduce its cost, address patient safety and medical errors, and broaden 

access to essential services. AHRQ sponsors and conducts research that provides evidencebased information on health care outcomes; quality; and cost, use, and access. The 

information helps health care decisionmakers—patients and clinicians, health system leaders, 

and policymakers—make more informed decisions and improve the quality of health care 

services. 
This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

Shekelle P, Takata G, Chan L, et al. Diagnosis, Natural History, and Late Effects of Otitis 

Media with Effusion. Evidence Report/Technology Assessment No. 55 (Prepared by Southern 

California Evidence-based Practice Center under Contract No 290-97-0001, Task Order No. 4). 

AHRQ Publication No. 03-E023. Rockville, MD: Agency for Healthcare Research and Quality. 

May 2003.

ii
Preface 

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of health care in the United States. The reports and assessments provide organizations 

with comprehensive, science-based information on common, costly medical conditions and new 

health care technologies. The EPCs systematically review the relevant scientific literature on 

topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to 

developing their reports and assessments. 

To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for health care quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the health care system as a whole by 

providing important information to help improve health care quality. 

We welcome written comments on this evidence report. They may be sent to: Acting 

Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and 

Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852. 

Carolyn Clancy, M.D. 

Director

Agency for Healthcare Research and Quality 

Jean Slutsky, P.A., M.S.P.H. 

Acting Director, Center for Practice and 

Technology Assessment 

Agency for Healthcare Research and Quality

The authors of this report are responsible for its content. Statements in the report should not be 

construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. 

Department of Health and Human Services of a particular drug, device, test, treatment, or other 

clinical service. 

iii
Structured Abstract 

Objectives. The purpose of this evidence-based report is to review the evidence on the natural 

history of otitis media with effusion (OME), the late effects of early life otitis media on hearing 

and speech and language development, and the operating characteristics of various methods of 

diagnosing OME. OME is defined as “fluid in the middle ear without signs or symptoms of ear 

infection.” The evidence compiled in this report is intended to aid clinicians, health care 

provider organizations, and others to develop clinical practice guidelines or medical review 

criteria for OME. The report also identified areas for future research. 

Search Strategy. The MEDLINE search strategy used both controlled vocabulary MeSH 

(Medical Subject Headings) terms and keywords to ensure that all relevant citations were 

retrieved. Search terms for otitis media with effusion were combined with search terms for 

natural history, speech and language development, hearing, and diagnosis. The otitis media 

module included otitis media, otitis media with effusion, suppurative otitis media, allergic otitis 

media, fluid ear, glue ear, middle ear effusion, mucoid otitis media, nonsuppurative otitis media, 

secretory otitis media, and serous otitis media. The natural history terms included natural course, 

natural history, placebo, placebos, resolution, self-limited, self-limiting, untreated, and a variety 

of terms for spontaneous resolution. The speech and language module included speech and 

language, speech and language disorders, child language, communication, communication 

disorders, language development and tests, voice, and voice disorders. The hearing module 

included hearing and hearing disorders and hearing aids and tests, as well as the text word 

hearing. The diagnosis module used diagnosis and diagnostic techniques and procedures, as well 

as the text words audiometry, diagnosis, diagnostic, otoscopy, tympanometry history, speech and 

language development, hearing, and diagnosis. 

Selection Criteria. Excluded were studies on patients with immunodeficiencies, craniofacial 

anomalies (including cleft palate), primary mucosal disorders, or genetic conditions. Prospective 

cohort studies were included for questions that addressed natural history, speech, language, and 

hearing. Prospective diagnostic studies were used to evaluate the operating characteristics of 

diagnostic methods. 

Data Collection and Analysis. Two physicians or one physician and one health services 

researcher independently screened all titles and/or abstracts for potential inclusion, evaluated the 

quality of the articles, and abstracted data from full-length articles onto pre-designed forms. The 

selection criteria included human studies that addressed a key question about OME in children. 

Excluded were case reports, editorials, letters, reviews, practice guidelines, and non-English 

language publications. 

Main Results. We found that 22.5 to 42.7 percent of OME in children older than 3 years of age 

cumulatively resolves over a period of three months, depending on the definition of OME 

resolution. Based on a limited number of cohort studies, we found no evidence to support an 

impact of early life otits media, defined as a history of otitis media at less than 3 years of age, on 

expressive language, receptive language, or cognitive verbal intelligence at age older than 3 

years. However, this evidence is insufficient to exclude the possibility that a clinically important 

effect does exist, therefore strong conclusions cannot be drawn about the effect of otitis media at 

iv
an early age on subsequent speech and language development. The generalizability of this 

finding on speech and language is suspect because the populations represented by the six cohorts 

utilized in the meta-analyses were primarily those of particular ethnic/racial origin. Moreover, 

the findings cannot be generalized to children with craniofacial defects, primary mucosal 

disorders, immunodeficiencies, genetic conditions, or pre-existing developmental disorders, and 

may not necessarily be generalized to children with persistent bilateral otitis media. Children 

with early life otitis media have a higher risk of conductive hearing loss, defined using a 

threshold greater than or equal to 20 dB at any frequency with or without treatment, at age 6 to 

10 years than children without early life otitis media. The pooled relative risk of conductive 

hearing loss was 2.6 (95% CI: 1.6 to 4.2). We found insufficient data to assess early-life OM on 

permanent (or sensorineural) hearing loss. Among nine diagnostic methods, pneumatic otoscopy 

had the best apparent performance with a sensitivity of 93.8 percent (95% CI: 91.4%, 96.3%) 

and a specificity of 80.5 percent (95% CI: 75.1%, 86.0%). However, tester qualifications were 

reported inconsistently, and training was not specified. 

Conclusions. Although these estimates must be viewed with great caution due to heterogeneity 

that arose from study design and documentation issues for which we could not adjust in our 

analysis, about 22.5 to 42.7 percent cumulatively resolved over a period of three months, 

depending on the definition of OME resolution. Our findings on the possible effects of early life 

otitis media on speech and language development are in general agreement with the 1994 

Agency for Healthcare Research and Quality OME guideline conclusion that rigorous, 

methodologically sound research does not adequately support or refute the possible effect of 

otitis media on speech and language. We found that children with early life otitis media have a 

greater risk of conductive hearing loss at age 6 to10 years. In addition, we found that pneumatic 

otoscopy had the best operating characteristics among the nine alternatives examined, for 

diagnosing the presence of middle-ear effusion in OME at single points in time. 

Considering the abundance of literature addressing otitis media, these findings concerning 

natural history, speech and language development, and hearing are very limited. Future research 

on the natural history of otitis media with effusion must focus on improving study quality. In 

particular, control of therapeutic intervention during the study and the distinction between OME 

persistence and recurrence needs to be addressed. For evaluation of long-term effects of early 

life otitis media on speech, language, or hearing, a coordinated approach that uses uniform

definitions and considers the interactions of multiple risk factors, interventions, and outcome 

measures is recommended. Such an integrated approach is also important for the evaluation of 

diagnostic methods. Further, a systematic review of diagnostic studies that employ algorithms or 

aggregated scores may be useful. 

v 
vi
Contents

Summary......................................................................................................................................... 1 

Evidence Report 

Chapter 1. Introduction................................................................................................................. 9 

 Purpose....................................................................................................................................... 9 

 Scope of Work ........................................................................................................................... 9 

 Definition ................................................................................................................................... 9 

 Diagnosis.................................................................................................................................. 10 

 Epidemiology: Prevalence and Incidence................................................................................ 11 

 Burden of Illness Due to Otitis Media With Effusion ............................................................. 13 

Chapter 2. Methodology............................................................................................................. 15 

Nomination of Technical Experts........................................................................................... 15 

 Topic Assessment and Refinement......................................................................................... 15 

 Identification of Key Questions.............................................................................................. 16 

 Key Question 1: On Natural History ................................................................................. 16 

 Key Question 2: On Speech and Language Development................................................. 17 

 Key Question 3: On Hearing Decrease............................................................................. 17 

 Key Question 4: On Diagnostic Methods......................................................................... 17 

 Identification and Refinement of Causal Pathways, Study Populations, Practice 

Settings, and Target Audience ................................................................................................ 18

 Literature Search..................................................................................................................... 19 

 Review of Retrieved Titles/Abstracts Against Screening Criteria.................................... 21 

 Retrieval and Review of Full Articles............................................................................... 22 

 Review and Assessment of Study Quality.............................................................................. 24 

 Data Abstraction ..................................................................................................................... 25 

 Procedures to Reduce Bias, Enhance Consistency, and Check Accuracy.............................. 25 

 Preparation of Evidence Tables.............................................................................................. 26 

 Supplemental Analysis............................................................................................................ 26 

 Natural History................................................................................................................... 26 

 Effects of Early-Life OM on Long-Term Speech and Language Development................ 27 

 Effects of Early-Life OM on Long-Term Hearing ............................................................ 29 

 Diagnostic Methods for OME............................................................................................ 29

 Identification of Peer Reviewers............................................................................................. 30 

 Peer Review Process............................................................................................................... 31 

Chapter 3. Results....................................................................................................................... 55 

 Key Question 1 ....................................................................................................................... 55 

 Literature Review............................................................................................................... 55 

 Findings.............................................................................................................................. 55 

 Summary............................................................................................................................ 58 

 Key Question 2 ...................................................................................................................... 58 

 Literature Review.............................................................................................................. 58 

 Findings............................................................................................................................. 59 

vii 
 Summary ........................................................................................................................... 61 

 Key Question 3 ...................................................................................................................... 61 

 Literature Review.............................................................................................................. 61 

 Findings............................................................................................................................. 61 

 Summary........................................................................................................................... 62 

Key Question 4 ..................................................................................................................... 63 

 Literature Review............................................................................................................. 63 

 Findings............................................................................................................................ 64 

 Summary.......................................................................................................................... 65 

Chapter 4. Conclusions............................................................................................................. 123 

 Natural History of OME ....................................................................................................... 123 

 Effects of Early-life OM on Long-Term Speech and Language Development.................... 126 

 Effects of Early-life OM on Long-Term Hearing................................................................. 127 

 Diagnostic Methods for OME............................................................................................... 127 

Study Limitations.................................................................................................................. 129 

Question Selection ................................................................................................................ 129 

Study Language .................................................................................................................... 129 

 Study Quality ........................................................................................................................ 130 

 Influencing Factors............................................................................................................... 130 

Chapter 5. Future Research ...................................................................................................... 131 

 General Issues....................................................................................................................... 131 

 Natural History...................................................................................................................... 131 

 Effects of Early-life OM on Long-Term Speech and Language Development.................... 132 

 Effects of Early-life OM on Long-Term Hearing................................................................. 133 

 Diagnostic Methods for OME............................................................................................... 133 

References................................................................................................................................... 135 

Evidence Tables 

Evidence Table 1. Natural History of Otitis Media With Effusion .........................................149 

Evidence Table 2. Early Life OM and Long-Term Speech and Language Development.......187 

Evidence Table 3. Early Life OM and Long-Term Hearing....................................................205 

Evidence Table 4. Diagnostic Methods...................................................................................213 

Figures 

Figure 1. Shrinkage Plot for Rate Difference in Conductive Hearing Loss at 6-10 Years 

Presence of Early Life OM versus Absence of Early Life OM.......................... 116 

Figure 2. Funnel Plot for Rate Difference in Conductive Hearing Loss at 6-10 Years 

Presence of Early Life OM versus Absence of Early Life OM.......................... 117 

Figure 3. Shrinkage Plot for Relative Risk of Conductive Hearing Loss at 6-10 Years 

Positive Early Life OM versus Negative Early Life OM ................................... 118 

Figure 4. Funnel Plot for Log Relative Risk of Conductive Hearing Loss at 6-10 Years 

Positive Early Life OM versus Negative Early Life OM ................................... 119 

viii 
Figure 5. Receiver Operator Characteristic (ROC) Plot for 8 Diagnostic Procedures 

versus Myringotomy ........................................................................................... 120 

Figure 6. Positive and Negative Predictive Values of Pneumatic Otoscopy by 

Prevalence of Otitis Media With Effusion Based on Pooled Estimate of

Sensitivity at 93.8% and Specificity at 80.5%.................................................... 121 

Tables 

Table 1. Technical Expert Panel ......................................................................................... 32 

Table 2. Questions Suggested for Consideration in Evidence Report ................................ 33 

Table 3. Ranking of Potential Key Questions..................................................................... 34 

Table 4. Comments from Technical Expert Panel on Potential Key Questions................. 35 

Table 5. Overall Causal Pathway for OME ........................................................................ 39 

Table 6. Causal Pathway for Key Question 1 on Natural History ...................................... 40 

Table 7. Causal Pathway for Key Question 2 on Speech and Language ............................ 41 

Table 8. Causal Pathway for Key Question 3 on Hearing .................................................. 42 

Table 9. Causal Pathway for Key Question 4 on Diagnostic Methods............................... 43 

Table 10. Ranking of Influencing Factors by Technical Experts ......................................... 44 

Table 11. Reason for Rejection of Titles/Abstracts at Initial Screeng (N=3,200)................ 48 

Table 12. Reason for Rejection of Full-Length Articles at Secondary Review.................... 49 

Table 13. Results of Secondary Screening of Full-Length Articles ..................................... 50 

Table 14. Results of Tertiary Screening of Full-Length Articles for Analysis..................... 51 

Table 15. Peer Review Panel ................................................................................................ 52 

Table 16. Instructions for Reviewing Draft Evidence Report .............................................. 53 

Table 17. Cohorts and Articles Relevant to Question 1 (n=40)............................................ 66 

Table 18. Disposition of Articles From Rosenfeld's Natural History Assessment............... 68 

Table 19. Question 1: Articles Excluded During Data Abstraction...................................... 69 

Table 20. Study Quality for Studies Included in Evidence Table on Natural History.......... 70 

Table 21. Tympanometry Definitions in Natural History Cohorts Utilizing Tympanometry 

as the Sole Diagnostic Method ............................................................................. 71 

Table 22. OME Resolution by Ears in Newly Diagnosed OME of Unknown Duration ...... 73 

Table 23. OME Resolution by Child on Newly Diagnosed OME of Unknown Duration ... 76 

Table 24. Meta-Analysis for <6 Weeks Resolution Rate for Newly Diagnosed OME of 

unknown Duration In Children Older Than 3 Years of Age ................................ 77 

Table 25. Meta-Analysis for <3 Months Cumulative Resolution Rate for Newly 

Diagnosed OME of Unknown Duration In Children Older Than 3 Years 

of Age.................................................................................................................... 78 

Table 26. List of Cohort Studies Included for Question 2.................................................... 79 

Table 27. List of Cohort Studies Not Included for Question 2............................................. 80 

Table 28. Definition of Early Life Positive or Negative OM History in Assessing 

Long-term Speech and Language Development................................................... 81 

Table 29. Study Quality for Studies Included in Evidence Table on Speech and 

Language Development ........................................................................................ 87 

Table 30. Key Characteristics of the Cohort Studies for Question 2.................................... 88 

Table 31. Meta-Analysis for Expressive Language Development ....................................... 92 

Table 32. Meta-Analysis for Receptive Language Development......................................... 93 

ix
Table 33. Meta-Analysis for Cognitive Verbal Intelligence................................................. 94 

Table 34. Cohort Studies at Tertiary Screening and Reasons for Exclusion ........................ 94 

Table 35. List of Cohort Studies Included for Question 3.................................................... 95 

Table 36. List of Cohort Studies Excluded from Question 3................................................ 95 

Table 37. Definition of Early Life Positive or Negative OM History in Assessing 

Long-term Hearing Development......................................................................... 96 

Table 38. Study Quality for Studies Included in Evidence Table on Hearing...................... 99 

Table 39. Characteristics and Outcome Measures of Cohort Studies for Question 3......... 100 

Table 40. Meta-Analysis for Effects of Early Life Otitis Media on Long-term 

Conductive Hearing Loss.................................................................................... 101 

Table 41. List of Cohort Studies Included for Question 4.................................................. 102 

 Table 42. Reason for Exclusion of Diagnostic Studies After Full-Length Article Review 103 

Table 43. Number of Articles by Diagnostic Method and Reference Standard ................. 104 

Table 44. Acoustic Reflectometry versus Myringotomy.................................................... 105 

Table 45. Pneumatic Otoscopy versus Myringotomy......................................................... 105 

Table 46. Portable Tympanometry versus Myringotomy ................................................... 106 

Table 47. Professional Tympanometry (Acoustic Reflex at 500 or 1000 Hz) versus 

Myringotomy ...................................................................................................... 106 

Table 48. Professional Tympanometry (Static Compensated Acoustic Admittance at 0.1) 

versus Myringotomy ........................................................................................... 107 

Table 49. Professional Tympanometry (Static Compensated Acoustic Admittance at 0.2) 

versus Myringotomy ........................................................................................... 108 

Table 50. Professional Tympanometry (Static Compensated Acoustic Admittance at 0.3) 

versus Myringotomy ........................................................................................... 109 

Table 51. Professional Tympanometry (B curve as abnormal) versus Myringotomy........ 110 

Table 52. Professional Tympanometry (B or C2 curve as abnormal) versus 

Myringotomy ...................................................................................................... 111 

Table 53. Summary of Meta Analysis for Diagnostic Comparisons, Excluding 

Duplicated Studies by Same Author................................................................... 112 

Table 54. Study Quality and Test Performer of Diagnostic Studies Used in 

Meta-Analysis..................................................................................................... 113 

Table 55. Country of Origin of Studies Included in Evidence Tables................................ 115 

x 
Overview

This evidence-based report reviews the

evidence on the natural history of otitis media

with effusion (OME), the impact of otitis media

on long-term speech and language development

and on hearing, and the operating characteristics

of various methods of diagnosing otitis media

with effusion. OME is defined as “fluid in the

middle ear without signs or symptoms of ear

infection.” The evidence compiled in this report

is intended to aid clinicians, health care provider

organizations, and others to develop clinical

practice guidelines or medical review criteria for

OME. The report will also identify areas for

future research.

Reporting the Evidence

Based on degree of importance (including level

of controversy) and feasibility of answering the

question, the Technical Expert Panel limited the

scope of this evidence report to four key

questions: 

1) The natural history of otitis media with

effusion (OME)? 

2) The long-term effects of early-life otitis

media, defined as positive otitis media

history at less than three years of age, on

speech and language development? 

3) The long-term effects of early-life otitis

media on hearing?

4) The operating characteristics of various

methods of diagnosing otitis media with

effusion?

Methodology

A 12-member Technical Expert Panel that

consisted of clinical experts, a consumer, and a

representative of a managed care organization

convened to:

• advise the project in the ranking of proposed

key questions and influencing factors

• guide the development of the scope and

definition of OME

• advise in development of the search strategy,

and 

• review and comment on the plan of analysis. 

The Technical Expert Panel and project staff

developed a literature search strategy. Project staff

searched MEDLINE® (1966-January 2000), the

Cochrane Library (through January 2000), and

EMBASE (1980-January 2000). Additional

articles were identified by review of reference lists

in proceedings, published articles, reports, and

guidelines.

The MEDLINE® search strategy used both

controlled vocabulary MeSH® (Medical Subject

Headings) terms and keywords to ensure that all

relevant citations were retrieved. The strategy

included search terms for otitis media with

effusion combined with search terms for natural

history, speech and language development,

hearing, and diagnosis.

The otitis media module included otitis media,

otitis media with effusion, suppurative otitis media,

allergic otitis media, fluid ear, glue ear, middle-ear

effusion, mucoid otitis media, nonsuppurative otitis

media, secretory otitis media, and serous otitis

media.

The natural history terms included natural

course, natural history, placebo, placebos, resolution,

self-limited, self limiting, and untreated, as well as a

variety of terms for spontaneous resolution. 

The speech and language module included

speech and language, speech and language disorders,

child language, communication, communication

Evidence Report/Technology Assessment

Number 55

Diagnosis, Natural History, and Late Effects of Otitis

Media with Effusion

Summary

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES • Public Health Service

Agency for Healthcare Research and Quality
disorders, language development and tests, voice, and voice

disorders.

The hearing module included hearing and hearing

disorders, hearing aids and tests, and the text word

hearing.

The diagnosis module used diagnosis and diagnostic

techniques and procedures, as well as the text words

audiometry, diagnosis, diagnostic, otoscopy, and

tympanometry.

Two physicians or one physician and one health

services researcher independently screened all titles

and/or abstracts for potential inclusion, evaluated the

quality of the articles, and abstracted data from fulllength articles onto pre-designed forms. The selection

criteria included human studies that addressed a key

question about OME in children. Excluded were case

reports, editorials, letters, reviews, practice guidelines,

non-English language publications, and studies on

patients with immunodeficiency disorders or

craniofacial anomalies, including cleft palate. 

For the natural history question, we used only

prospective cohort(s) studies on untreated subjects from

which outcome data were abstractable for children up

through age 12 years. For the speech and language and

hearing questions, we used only prospective cohort

studies that fulfilled the following criteria: the degree of

OME was determined during the first three years of life,

upper age limit was 22 years, the degree of OM was

graded in some way, and the outcome was measured

when the child was older than age three years. For the

diagnostic methods question, we used only prospective

studies on children up through 12 years of age that

fulfilled four criteria: the diagnostic procedure of

interest was performed within 24 hours of the reference

standard, was not an algorithm or combination of

multiple diagnostic procedures, used one of the

acceptable reference standards specified in the scope,

and produced abstractable data.

The first step of all analyses was to obtain a

distribution of studies stratified by the population

characteristics, type of outcome measures, and nontreatment factors. This step provided us with an

overview of the emphasis of past research in this area

and an opportunity to identify gaps and areas for future

research. 

In strata with more than three studies, we performed

a meta-analysis for a pooled random effects estimate of

an outcome with 95% confidence intervals. In addition

to deriving the pooled estimate, we evaluated the

heterogeneity of the study outcomes. For the evaluation

of diagnostic methods, we estimated the sensitivity,

specificity, and positive and negative predictive values

for each diagnostic procedure compared to a particular

reference standard with three or more studies. 

This evidence report was reviewed by the Technical

Expert Panel as well as an 18-member peer review panel

that consisted of content experts, consumers,

representatives of managed care organizations, an expert

in pediatric pharmacology, and methodologists. All

comments received from these individuals were reviewed

and acted upon appropriately.

Findings

Natural History of OME

• No meta-analyses for children under three years of

age were possible, because we could identify only

two studies each for the under six months and the

three-months-to-three-years age groups. For the

over-three-years age group, two sets of metaanalyses showed that 22.5 to 42.7 percent of ears

with OME cumulatively resolved over a period of

three months, depending on the definition of

OME resolution. These estimates must be

viewed with caution due to the clinical

heterogeneity evident in the data synthesized and

due to the weaknesses of design or documentation

of the study cohorts. In particular, in most cases

investigators did not document whether subjects

had received medical or surgical treatment during

the course of the study that could affect OME

outcome or how compliance with non-treatment

was established. Of those investigators who

reported how many children received treatment,

the majority did not stratify their findings by

treatment status.

• A few of the studies analyzed OME resolution by

influencing factors such as gender, care at home

versus daycare, season, side of affected ear, race or

ethnicity, or diagnostic instrument. Because of the

paucity of such studies, quantitative synthesis was

not possible, and we refrain from drawing any

conclusions regarding the effect of these

influencing factors on resolution.

• As measured by scoring of documentation in the

published articles, the quality of 28 cohort studies

on natural history was generally poor.

2
• Half of the studies that attempted to study the

natural history of OME did not control for or did

not document control of interventions, either

medical or surgical, that might affect OME

outcome during the study period. The majority of

these studies did not stratify findings by

intervention status.

• The interval between examinations for OME in

these studies ranged from one day to three years.

For studies with long follow-up intervals, it was

not possible to determine whether the presence of

OME was due to persistence or recurrence. The

criteria for follow-up varied among studies. Most

studies continued follow-up for the duration of the

study period regardless of the OME status at a

particular exam, but four cohorts discontinued

follow-up of individuals who had type A or normal

tympanograms at any exam.

Early-life OM and Long-term Speech

and Language Development

• Studies that addressed the effects of early-life otitis

media on long-term speech and language

development among children differed considerably

with respect to risk factors studied, type of

outcome measured, method of measurement, unit

of measurement, age at outcome determination,

and study design.

• The meta-analyses that could be conducted on

long-term expressive language, receptive language,

and cognitive verbal intelligence showed no effect

of early otitis media as measured during the first

three years of life. These findings may not be

generalizable, since five of the six cohorts that were

included in these three meta-analyses focused

primarily on children from specific ethnic/racial

groups or from particular socioeconomic groups.

Furthermore, the results of these studies cannot be

applied to children with craniofacial defects,

primary mucosal disorders, immunodeficiency

disorders, genetic conditions, or pre-existing

developmental disorders, because children with

these conditions were excluded from this analysis.

In addition, only one of the studies included in

these meta-analyses focused solely on persistent

bilateral otitis media as opposed to unspecified

unilateral or bilateral otitis media.

Early-life OM and Long-term Hearing

• Few studies on the effects of early-life otitis media

on long-term hearing used a prospective cohort

study design.

• Of the eight cohort studies analyzed, one set of four

studies reported percentage of conductive hearing

loss at six to ten years of age. For this analysis, the

threshold for conductive hearing loss was defined

as greater than or equal to 20 dB at any frequency,

with or without treatment of otitis media. 

• The pooled risk of conductive hearing loss at six to

ten years among 346 children who had a positive

history of early-life OM was 22 percent (95% CI:

7% to 36%). In contrast, the pooled risk of

conductive hearing loss at six to ten years of age

among 237 children with no history of early-life

OM was 6 percent (95% CI: 1% to 12%). The

pooled rate difference of conductive hearing loss at

six to ten years of age between children with a

positive OM history and those with a negative

OM history was 11 percent (95% CI: 3% to

19%). Neither the studies pooled for the rate

difference nor the studies pooled for the risk ratio

showed significant heterogeneity in the outcomes.

• The findings were based on four homogeneous,

though very different populations, one from

Finland, another from Sweden, one primarily of

American Indian children, and another primarily

of Eskimo children. The four studies also differed

on the definition and collection of OM history

and on exclusion factors.

• We found insufficient data to assess the impact of

early-life OM on permanent (sensorineural)

hearing loss.

Diagnostic Methods for OME

• Based on our evaluation of 52 diagnostic studies,

we were able to assess the ability of the following

methods to diagnose middle-ear effusion in OME

at a single point in time: acoustic reflectometry at

<5 or >5 reflective units (RU); pneumatic

otoscopy; portable tympanometry; professional

tympanometry using acoustic reflex at 500 or 1000

Hz; professional tympanometry using static

compensated acoustic admittance at 0.1, 0.2, and

0.3; professional tympanometry using B curve as

abnormal; and professional tympanometry using B

3
or C2 curves as abnormal. All comparisons used

myringotomy as the reference standard.

• Among the eight diagnostic methods, the receiveroperator characteristic points (plotting sensitivity

against 1 minus specificity) showed that pneumatic

otoscopy was closest to the optimal operating point

where both sensitivity and specificity would be

100%. However, tester qualifications were reported

inconsistently, and training was not specified. The

pooled sensitivity was 94 percent (95% CI: 91%,

96%) and the pooled specificity was 80 percent

(95% CI: 75%, 86%). These findings were based

on 2,694 children from seven studies that reported

a pooled prevalence of OME of 63 percent (95%

CI: 58%, 67%). The prevalence rate ranged from

56 percent to 71 percent, which indicated

significant heterogeneity among outcomes

(p<0.001). 

Limitations of the Literature

• Natural History of OME: Literature on the

natural history of otitis media with effusion was

difficult to interpret because of its generally poor

quality, the lack of control for therapeutic

interventions, the inability to distinguish persistent

from recurrent OME due to the length of followup intervals, and the varied criteria for continued

follow-up from exam to exam. Differing

definitions of OME resolution and diagnostic

methods made comparison difficult. Few studies

considered the child or the episode as the unit of

analysis, included younger children, or assessed

types of OME other than newly diagnosed OME

of unknown duration. In addition, few studies

addressed the possible effects of influencing factors

on OME resolution.

• Early-life OM and Long-term Speech and

Language Development: The literature on the

long-term effects of early-life otitis media on

speech and language development diverged

considerably with respect to methodology. As a

result, findings could not be combined easily. 

• Early-life OM and Long-term Hearing: Although

the literature on the long-term effects of early-life

otitis media on hearing was abundant, few studies

used a prospective cohort study design. Because of

the limited nature of this evidence and because the

rate of intervention is highly dependent on the

threshold hearing level adopted, the findings of

this analysis should be applied with caution.

• Diagnostic Methods for OME: Nine

comparisons of diagnostic methods enabled

derivations of pooled estimates of diagnostic

accuracy. However, more comparisons could not

be made, including those that would have

evaluated clinical signs and/or symptoms, air

and/or bone threshold audiometry, binaural microtympanoscopy, and non-pneumatic otoscopy.

Diagnostic methods that use algorithms or

aggregated scorings are important but are not

included in this evidence assessment.

Future Research

Future research on the natural history of otitis media

with effusion must focus on improvement of study

quality and establishing the effect of OME on longterm outcomes such as speech, language, and hearing.

In particular, control of therapeutic interventions during

the study and the distinction between OME persistence

and recurrence need to be addressed. Adopting a less

restrictive definition of non-intervention might simplify

the analysis of studies of the natural history of OME. In

addition, researchers, in conjunction with clinicians,

should agree upon standard procedures for follow-up,

including intervals of follow-up, definition of OME

resolution, and diagnostic methods, so that resolution

rates are indeed comparable. Future research must

consider the child as the unit of analysis, since the

outcomes of ultimate interest, such as speech, language,

and hearing, are functional requirements of a child, not

an ear. More research is needed on the role of

influencing factors on the natural history of OME, so

that the clinician on a particular day in a particular

setting can make a better decision when assessing a

particular child with particular characteristics.

Evaluation of long-term effects of early-life otitis

media on speech, language, or hearing requires a

coordinated systematic approach that uses a rational

conceptual framework. Such an approach should

address the risk factors, interventions, and outcome

measures in an integrated fashion. The definition,

classification, and type and unit of measure should be

developed by a team of experts with the goal of

standardizing definitions and approaches. Literature on

findings should report both univariate and multivariate

findings to enhance understanding of the patient and

study characteristics and to allow pooling of data. An

4
integrated approach is also important for the evaluation

of diagnostic methods. Such an approach will provide

guidance for future studies. Future studies of diagnostic

assessments of OME also should consider costeffectiveness analysis, which can take into account the

variable proficiency of clinicians in performing

pneumatic otoscopy as well as the consequences of

testing and patient preferences. Cost-effectiveness

analysis will lead to a more informed decision on the

best diagnostic method for OME. 

Availability of Full Report

The full report from which this summary was taken

was prepared for AHRQ by the Southern California

Evidence-based Practice Center/RAND under contract

No. 290-97-0001. It is expected to be available in

summer 2002. When available, printed copies may be

obtained free of charge from the AHRQ Publications

Clearinghouse by calling 1-800-358-9295. Requesters

should ask for Evidence Report/Technology Assessment

No. 55, Diagnosis, Natural History, and Late Effects of

Otitis Media with Effusion (AHRQ Publication No. 02-

E026). Internet users will be able to access the report

online through AHRQ’s World Wide Web site

www.ahrq.gov.

5
AHRQ Pub. No. 02-E025

June 2002

ISSN 1530-440X
Evidence Report

Chapter 1. Introduction 

Purpose 

The purpose of this evidence-based report is to review the evidence on the diagnosis, natural 

history, and late effects of otitis media with effusion (OME) on long-term speech, language, and 

hearing. The evidence compiled in this report is intended to aid clinicians, health care provider 

organizations, and others to develop clinical practice guidelines or medical review criteria for 

OME. The report will also identify areas for future research. Despite the relatively recent 

publication of the 1994 Otitis Media with Effusion in Children guideline (Stool, Berg, Berman, 

et al., 1994), the technical experts believed that OME remained a topic worthy of evidence-based 

inquiry due to the continued controversy over the care of children with OME and the potential 

availability of new information. 

Scope of Work 

The technical experts initially proposed 20 questions that addressed 10 broad areas related to 

the diagnosis and treatment of otitis media with effusion: (1) allergens, (2) natural history, (3) 

speech and language, (4) diagnostic methods, (5) surgical interventions, (6) hearing, (7) 

antibiotics, (8) steroids, (9) antihistamines and decongestants, and (10) alternative or 

complementary therapies. These twenty questions were ranked based on the following criteria: 

(1) degree of potential impact on OME outcomes and on future guideline development and (2) 

the feasibility of answering the question within the one year time frame and the availability of

new information in the literature. The scope of this report covers the four highest ranked 

questions: (1) the natural history of otitis media with effusion (OME), (2) the long-term impact 

of early-life otitis media on speech and language, (3) the long-term impact of early-life otitis 

media on hearing, and (4) the accuracy of methods of diagnosis of otitis media with effusion. 

Definition 

The definition of otitis media has been a complicated issue. Ben H. Senturia, quoted in 

Bluestone (1999), stated that “In the past, there has been a confusion of terms, in part because of 

a failure to distinguish conceptually between the disease process, otitis media, and one of the 

manifestations of that disease process, namely otitis media with effusion. Otitis media is 

dynamic and at any one time should be considered a single point in a continuum of the disease 

process.” 

Recent comments on the definition of OME point to some of the complex issues involved: 

1. The OME guideline (Stool, Berg, Berman et al., 1994) defined OME as "fluid in the 

middle ear without signs or symptoms of ear infection." The guideline listed the 

following synonyms for OME: serous otitis media, secretory otitis media, allergic otitis 

media, catarrhal otitis media, nonsuppurative otitis media, mucoid otitis media, 

secondary otitis media, hydrotubotympanum, exudative catarrh, tubotympanitis, 

tympanic hydrops, glue ear, fluid ear, middle ear effusion, and tubotympanic catarrh. 

9 
2. Bluestone (1999) defined otitis media with effusion (OME) as “an inflammation of the 

middle ear with liquid collected in the middle-ear space. The signs and symptoms of 

acute infection are absent and there is no perforation of the tympanic membrane.” He 

stated that middle-ear effusions can be acute (< 3 weeks), subacute (3 weeks to 3 

months), or chronic (> 3 months). He also stated that researchers should precisely define 

OME. 

3. Patterson and Paparella (1999) agreed that the different forms of otitis media (OM) are 

“interrelated and occur in a continuum.” They recognized OME as one of the three major 

forms of OM, the other two being chronic OM (active or inactive) and silent OM. They 

classified OME as serous OM, purulent OM, and chronic OM. They divided serous OM 

into acute serous OM, chronic serous OM, and mucoid OM. 

4. Jung and Hanson (1999) agreed that OM consists of various stages. Though they viewed 

purulent otitis media, serous otitis media, and mucoid otitis media as different stages, 

they considered OME to encompass all three, except the early stages of acute otitis media 

(AOM). 

5. Paradise (1995) also agreed that “AOM and OME constitute elements in an otitis media 

disease spectrum, that there often is a transition zone between them and that the two 

conditions sometimes may be indistinguishable from each other diagnostically.” 

For this evidence report, the Technical Expert Panel decided to use the definition used in 

the OME Guideline (Stool, Berg, Berman et al., 1994): “fluid in the middle ear without signs or 

symptoms of ear infection.” 

Diagnosis 

Various methods have been proposed for the diagnosis of OME. The OME guideline panel 

drew several conclusions regarding diagnosis of OME (Stool, Berg, Berman et al., 1994). They 

recommended the use of pneumatic otoscopy as the primary diagnostic method with 

tympanometry as a confirmatory diagnostic method. These recommendations were based on 

limited scientific evidence and strong panel consensus and on limited scientific evidence and 

expert opinion, respectively. The OME guideline panel found no evidence linking the outcome

of algorithms that combine the results of pneumatic otoscopy and tympanometry to the presence 

of middle-ear effusion. In addition, the panel believed that the evidence was insufficient to make 

any recommendation regarding the use of acoustic reflectometry in the diagnosis of OME. 

Finally, the panel decided not to make a recommendation on the use of tuning fork tests in the 

diagnosis of OME due to the lack of adequate studies. The OME guideline panel did not present 

any meta-analyses on diagnostic methods. 

Pneumatic otoscopy is performed with a handheld unit that consists of a light source, a 

magnifying lens, and a speculum. The otoscope allows visual inspection of the tympanic 

membrane as well as the external ear canal. With the speculum securely in place, the degree of 

movement of the tympanic membrane in response to pneumatic pressure may be observed. 

Decreased tympanic membrane mobility in response to pneumatic pressure is believed 

 to be related to the presence of middle-ear effusion as found in OME. (Carlson and Stool, 1999) 

10 
Tympanometry is performed by inserting into the ear a probe that emits a tone and measures 

the amount of sound energy reflected from the tympanic membrane as a function of ear canal air 

pressure. The instrument may or may not be handheld. The output of tympanometric 

measurement may be qualitative, that is, tympanogram patterns, or quantitative, for example 

static admittance, equivalent ear volume, tympanometric width, tympanometric peak pressure, or 

acoustic reflex. The flat or type B tympanogram is believed to be associated with the presence 

of middle-ear effusion. The type A tympanogram is believed to indicate normal middle-ear 

status. The relationship of the type C tympanogram to middle-ear status is less clear. (Carlson 

and Stool, 1999; Nozza, 1996) 

The acoustic middle-ear muscle reflex, either ipsilateral or contralateral, may also be 

measured by acoustic emittance instruments and represents the contraction of the stapedius and 

tensor tympani in response to sound stimulation. Its absence may be related to the presence of 

middle-ear effusion depending on the clinical situation (Nozza, 1996). 

Acoustic reflectometry is performed using a handheld instrument that measures the response 

of the tympanic membrane to a frequency-sweep sound spectrum. The spectral gradient angle, 

which is a function of the frequency and amplitude, may be related to middle-ear effusion 

presence. (Carlson and Stool, 1999; Nozza, 1996) 

Evoked otoacoustic emissions are a measure of ear canal sounds that are generated in the 

cochlea. These sounds have the potential for clinical application (Nozza, 1996). 

Audiometry measures hearing acuity, using behavioral or non-behavioral methods, at various 

sound frequencies. It is known that children may have decreased hearing in the presence of 

middle-ear effusion (Carlson and Stool, 1999). Although no "universal agreement" appears to 

exist regarding the definition of hearing loss, a hearing threshold no worse than 15 decibels (dB) 

is considered normal in children, and 20 dB may be considered normal in older children (Madell, 

1999) 

Epidemiology: Prevalence and Incidence 

Accurate estimates of the prevalence or incidence of OME were not found, since published 

population-based estimates are not available on the specific diagnosis of OME. Data on office 

visits reported from the National Ambulatory Medical Care Survey (NAMCS) provide the best 

indication of prevalence and incidence of the disease, although nonsuppurative, suppurative, and 

unspecified otitis media were all grouped into the term otitis media, and OME was not separated 

from AOM in the analyses (Schappert, 1992; Schappert, 1996; Woodwell, 1997a; Woodwell, 

1997b; Woodwell and Schappert, 1995). Gates (1996), commenting on the NAMCS data, stated, 

“for children it is probably safe to presume that AOME [AOM with effusion, i.e. AOM] is the 

principal disorder noted in these surveys.” The OME Guideline panel of the Agency for Health 

Care Policy and Research [presently the Agency for Healthcare Research and Quality (AHRQ)]

estimated that 25 percent to 35 percent of the NAMCS visits for otitis media were for OME 

(Stool, Berg, Berman et al., 1994a). 

Schappert (1992) reported on the 1975 to 1990 NAMCS data. Visits by patients younger 

than 15 years of age constituted 70.6 percent of all office visits with the principal diagnosis of 

otitis media in 1975, 78.9 percent of all office visits with the principal diagnosis of otitis media 

in 1980, 81.9 percent of all office visits with the principal diagnosis of otitis media in 1985, and 

80.5 percent of all office visits with the principal diagnosis of otitis media in 1990. From 1975 

to 1990, the percent of office visits with otitis media as the principal diagnosis increased among 

those less than 15 years of age; from 7.3 percent to 17.4 percent for children under 2 years old, 

11 
from 10.4 percent to 18.1 percent for the 2-5 year olds, from 6.9 percent to 10.5 percent for the 

6-10 year olds, and from 2.6 percent to 5.2 percent for the 11-14 year olds. The number of visits 

with a principal diagnosis of otitis media per 100 persons per year for the same time period 

(1975 to 1990) increased from 31.5 to 102.1 for children less than 2 years of age, 20.8 to 47.8 for 

those 2-5 years of age, 10.2 to 18.2 for those 6-10 years of age, and 3.3 to 8.0 for those 11-14 

years of age. 

Rosenfeld (1994) noted that about a quarter of OME cases are discovered incidentally during 

well-child examinations. About 60 percent of children would have OME by 2 years old and 80 

percent before school entry. The Agency for Healthcare Research and Quality 1994 OME 

guideline reported that in one study of children 2 to 6 years old in group child care, 53 percent 

had at least one episode of OME during the first year of the study, 61 percent had at least one 

episode during the second year of the study, and 30 percent had recurrent OME (Stool, Berg, 

Berman et al., 1994). 

NAMCS also stratified data by specific physician type. From 1975 to 1990, the percent of 

office visits with a principal diagnosis of otitis media increased for pediatricians from 8.1 

percent to 14.3 percent, for general practitioners and family physicians from 1.3 percent to 3.5 

percent, and for otolaryngologists from 12.8 percent to 20.2 percent. 

Data for 1975 to 1990 were also stratified by age. In 1990, the number of visits with a 

principal diagnosis of otitis media per 100 persons per year among children younger than 2 years 

was 62.9 for pediatricians, 24.0 for general practitioners and family physicians, and 9.1 for 

otolaryngologists. In 1990, the number of visits with a principal diagnosis of otitis media per 

100 persons per year among children 2 to 5 years old was 29.0 for pediatricians, 11.4 for general 

practitioners and family physicians, and 6.6 for otolaryngologists (Schappert, 1992). 

The reports on the NAMCS data for 1993 to 1996 did not stratify by age (Schappert, 1996; 

Woodwell, 1997a; Woodwell, 1997b; Woodwell and Schappert, 1995). However, if the 1993 to 

1996 data were similar to that in 1975 to 1990, it would be reasonable to conclude that the 

majority of these patients were younger than 15 years of age. 

NAMCS office visit data for 1993 to 1996 generally support earlier data. Suppurative and 

unspecified otitis media was the third most frequently listed principal diagnosis in 1993, the 

sixth most frequent in 1994, the fourth most frequent in 1995, and the seventh most frequent in 

1996 for ambulatory care visits to physician offices, hospital outpatient departments, and 

emergency departments (Schappert, 1996; Woodwell, 1997a; Woodwell, 1997b; Woodwell and 

Schappert, 1995). In 1996, visits for a principal diagnosis of otitis media and eustachian tube 

disorders occurred 82.8 percent of the time in physician offices, 5.3 percent in hospital outpatient 

departments, and 11.9 percent in emergency departments (Woodwell, 1997a). 

The NAMCS also provided data on the duration of office visits for otitis media. The percent 

of visits for otitis media of duration 6-15 minutes increased between 1975 to 1990 from 64 

percent to 78 percent and was associated with a decrease in visits less than six minutes from 24 

percent to 13 percent (Schappert, 1992). In terms of surgical procedures, the rate of ambulatory 

surgery visits per 10,000 population for those younger than 15 years of age for otitis media and 

eustachian tube disorders was 86.9 in 1994 and 83.9 in 1995, based on 498,000 and 484,000 

visits respectively (Hall and Lawrence, 1997; Kozak, Hall, Pokras et al., 1997). In 1995, the 

number of myringotomy with tympanostomy tube placements reported by NAMCS was 521,000 

for a rate of 90.2 such procedures per 10,000 children less than 15 years of age (Hall and 

Lawrence, 1997). 

In general, the NAMCS data demonstrated the significance of otitis media—and by 

implication OME—based on the prevalence and incidence of the disease and the frequency and 

duration of visits and surgical interventions. 

12 
Burden of Illness Due to Otitis Media with Effusion 

 

The treatment, complications and sequelae, and adverse effects of otitis media, including 

OME, are a substantial financial burden to the nation. Three estimates of the cost of otitis media 

(OM) are found in the literature (Gates, 1996b; Stool and Field, 1989; Stool, Berg, Berman et al., 

1994). A fourth study reported the cost per episode of “persistent middle ear infection” 

(Berman, Roark, and Luckey, 1994). We have assessed the strengths and weaknesses of these 

four studies and presented our own estimate of otitis media costs in a previous evidence-based 

analysis (Takata, Chan, Shekelle, et al., in press). 

Gates (1996b) placed the annual national total cost of acute otitis media at $3.15 billion for 

the 0- to 4-year old age group in an unspecified date in the early or mid-1990’s and placed the 

cost of treatment of chronic otitis media with effusion at $1.854 billion dollars per year (Gates, 

1996). Stool and Field (1989) put the national cost of otitis media at $2.4-3.4 billion in the 0- to 

6-year old age group in an unspecified year presumably in the middle or late 1980’s. Both Gates 

(1996b) and Stool and Field (1989) assumed prevalences of otitis media that were at variance 

with the only available national data on the utilization of care visits for otitis media. Stool, Berg, 

Berman, et al. (1994) presented the only estimate of the national cost of otitis media using a 

data-based estimate of costs per case. Using claims data from more than 100 health insurers, 

they estimated the overall average cost of treating a 2-year old child with OME in 1991 to be 

$1,330 and the national total cost of OME in 1991 to be $1.09 billion. Berman, Roark, and 

Luckey (1994) estimated the cost of treating persistent middle ear effusion in a 13-month old boy 

at $720-$1,372 under Colorado Medicaid reimbursement levels in 1992 and $1,265-$2,588 

under private practice reimbursement rates. Not all these studies included the indirect cost of 

family caregiving services required due to a child having otitis media. 

An attempt to provide an updated estimate on the cost of otitis media included insights into 

the cost of OME and chronic middle ear infection (Takata, Chan, Shekelle, et al., in press). This 

estimate was derived for the year 1995, referred to children under 18 years of age, and was based 

on reports of national, rather than regional, utilization for otitis media such as the National 

Ambulatory Medical Care Survey and the National Health Interview Survey. Using these 

national data sets, it was estimated that 2.22 million episodes of OME or chronic middle ear 

infection occurred in 1995. It was assumed that eighty percent of these episodes were unrelated 

to acute otitis media. Data from three sources (Stool, Berg, Berman et al., 1994; Berman, 

Rourke, and Lucky, 1994; and the U.S. Bureau of the Census, 1992,1996) were used to estimate 

direct, indirect, and total costs of $1,321, $490.25, and $1,811 for treatment of an episode of 

OME or chronic middle ear infection. For 1995, the total national cost of treating OME or 

chronic middle ear infection would stand at $4.02 billion. 

Whether based on the four prior estimates of otitis media or OME cost or the more recent 

estimate, the economic burden of OME on the nation is large. Any effort to improve costeffective care of OME will result in significant savings in national medical expenditures as well 

as improved quality of care provided to children with OME. 

13 

Chapter 2. Methodology 

Nomination of Technical Experts 

Eleven organizations were contacted for technical expert and peer reviewer nominations. 

They included the American Academy of Family Physicians (AAFP), the American Academy of 

Pediatrics (AAP), the American Academy of Otolaryngology-Head and Neck Surgery 

Foundation (AAO-HNS), the Ambulatory Pediatric Association (APA), the American Academy 

of Audiology (AAA), the American Speech-Language-Hearing Association (ASHA), the Society 

for Ear Nose and Throat Advances in Children (SENTAC), the National Association of Pediatric 

Nurse Associates and Practitioners (NAPNAP), the American Association of Health Plans 

(AAHP), the Foundation for Accountability (FACCT), and Family Voices. 

Upon receiving nominations from the agencies, we identified 12 technical experts to serve on 

the panel. Included were two family physicians, two otolaryngologists, three pediatricians, one 

audiologist, one speech and hearing expert, one managed-care representative, one nurse 

practitioner, and one consumer. Table 1 lists the membership of the Technical Expert Panel. 

Topic Assessment and Refinement 

A draft work plan for the topic assessment and refinement phase was mailed to the technical 

experts and representatives of our partners (the American Academy of Pediatrics, the American 

Academy of Family Practice, and the American Academy of Otolaryngology-Head and Neck 

Surgery) for review and comments together with a preliminary review that provided a summary 

of: 

• Incidence and prevalence of otitis media with effusion, treatment and management 

alternatives, the characteristics and size of the affected populations, and the most affected 

practice settings and providers; 

• The burden of illness associated with otitis media with effusion, including morbidity and 

mortality. 

• Extent to which variation exists in practices associated with the prevention, diagnosis, 

treatment, or diagnosis and treatment of otitis media with effusion. 

We reviewed and compiled four previously conducted evidence-based analyses on otitis 

media with effusion. Particular attention was given to the report of The Otitis Media Guideline 

Panel on “Managing Otitis Media with Effusion in Young Children” (Stool, Berg, Berman et al., 

1994) We distributed these reports to the panel of technical experts for review and for 

preparation of the initial telephone conference call during which assessment and refinement of 

the topics wereassessed and refined. 

 

Identification of Key Questions 

15 
Prior to the first conference call, we asked each technical expert to submit questions for 

consideration in the evidence report. The project team organized the responses and compiled an 

initial list of 20 key questions from the original task order and the letters from the nominating 

agencies (Table 2). This document was distributed to the technical experts after the first 

conference call, together with a polling form requesting the ranking of the top 10 key questions. 

The technical experts were asked to rank 10 of the 20 questions from 10 to 1, using 10 as the 

most important and 1 as the least important. The criteria for ranking were: 

1) importance, which included 

a) potential impact on OME outcomes and 

b) b) potential impact on development of future OME guidelines by the partner 

organizations; and 

2) feasibility, which included 

a) possibility of conducting a literature search, review, and data synthesis in 6 months, 

b) availability of sufficient information (data) in the literature to answer the question, 

and 

c) if applicable, sufficient new information (data) available to affect the results of the 

last systematic review of the question significantly. 

The polling results are tabulated in Table 3 and the comments are included in Table 4. The 

results were distributed to the experts for discussion during the second conference call. 

The four top ranking key questions were selected for consideration in the evidence report. 

After several revisions at the suggestions of the technical experts, the wordings of the four top 

ranking (key) questions are as follows: 

Key question 1: On Natural History

What is the natural history (spontaneous resolution rate over time without treatment) for: 

 OME persisting after a discrete episode of acute otitis media, 

 newly diagnosed OME of unknown duration (unilateral or bilateral), 

 OME persisting for weeks or months (unilateral or bilateral), 

 unilateral OME lasting 3 months or longer, 

 bilateral OME lasting 3 months or longer?

Key question 2: On Speech and Language Development 

a) Do infants and preschool children with longer duration early-life OME have greater 

delays in speech and language development (receptive or expressive) later in life as 

compared to those with shorter duration OME? One specific formulation of this question 

16 
is: Is OME-associated conductive hearing loss in the first 3 years of life a risk factor for 

speech and language developmental delays? 

b) What are the risk factors that modulate the effect of OME on speech and language 

development in infants and preschool children?

Key question 3: On Hearing Decrease 

a) Do infants and preschool children with longer duration early-life OME as compared to 

those with shorter duration OME have permanent (or sensorineural) hearing loss later in 

life? One specific formulation of this question is: Is OME-associated conductive hearing 

loss in the first 3 years of life a risk factor for permanent (or sensorineural) hearing loss 

later in life? 

b) What are the risk factors that interact with the effect of OME on hearing later in life 

(unilateral or bilateral) in infants and preschool children? 

Key question 4: On Diagnostic Methods 

What are the sensitivity, specificity, and predictive values for alternative methods of 

diagnosing OME compared with one of the reference standards? 

These methods include, but are not limited to: 

• signs/symptoms 

• non-pneumatic otoscopy 

• pneumatic otoscopy, validated or un-validated examiner 

• binocular micro-tympanoscopy 

• portable tympanometer 

• professional tympanometer 

• quantitative tympanometry 

• acoustic reflectometry (specify model and year) 

• otoacoustic emissions 

• audiometry, air or. bone conduction thresholds. 

17 
The reference standards to be used in evaluating these diagnostic tests will include 

tympanocentesis, sedated or non-sedated; MRI; myringotomy, sedated or non-sedated; validated 

pneumatic otoscopy; and CT Scan. 

Identification and Refinement of Causal Pathways, Study 

Populations, Practice Settings, and Target Audience 

The project staff developed a causal pathway and a scope for each of the key questions. We

distributed these documents to the panel of technical experts for review and for preparation for 

the initial telephone conference call. During this call, we assessed and refined the topics and 

discussed the proposed key questions, target condition, patient populations, clinical context, 

interventions, and outcomes of interest. The following characteristics of outcomes were 

proposed: 1) outcomes would be divided into short term and long term; 2) long term outcomes 

would consist of percent time with effusion, frequency of acute otitis media, hearing loss, speech 

and language performance, cognition, academic achievement, and other developmental 

outcomes; 3) duration of short term outcomes would be defined as four weeks or less or eight 

weeks or less; and 4) duration of long term outcomes would be defined as greater than one year. 

During this first conference call, the Technical Expert Panel decided to use the OME 

Guideline definition of OME: “fluid in the middle ear without signs or symptoms of ear 

infection”. (Stool, Berg, Berman et al., 1994) Though the technical experts agreed on the 

definition of OME they could not agree on which signs or symptoms should be absent, i.e. what 

signs or symptoms differentiated OME from acute otitis media. During the first conference call, 

the technical experts advised us to avoid the use of the terms ‘acute’, ‘subacute’, or ‘chronic’ as 

descriptors of OME. Instead we should use the duration of OME, such as “under 3 months” 

versus “greater than or equal to 3 months” as descriptors. 

 Before the second conference call, the project team developed a draft of the conceptual 

framework for the proposed key questions. During the second conference call, the framework 

was discussed and the inputs of the experts were incorporated into the revised overall causal 

pathway (Table 5) from which the causal pathways of the final four key questions were 

developed. The causal pathways were distributed to the technical experts for further review and 

comment. The final version causal pathways for the four key questions are presented in Tables 

6 through 9. 

Based on the causal pathways and the discussions during the two conference calls, we 

developed the scope for each of the four key questions. The scope specifically defined the 

disease entity, study population, practice settings (including provider type), time period in 

practice setting, exclusion factors, interventions, influencing factors, outcome measures, 

literature sources, language, and study design for each key question to be included in the 

evidence report. We conducted a second poll of the technical experts on each of these domains 

in which we sought their approval, disapproval, or recommendations for revision on each 

domain. Appendix B presents the version of the scope distributed to the technical experts for 

polling of their comments and approval. Appendix C presents the results of the polling of the 

experts’ comments on the scope. In response to these comments, we further revised the key 

questions, causal pathways, and the various domains of the scope. We incorporated comments 

from technical experts to the extent possible, except those related to other domains, those that 

were obvious misunderstandings or misinterpretations, or those suggestions for deletions or 

additions that could be handled during the analysis phase of the project. Specifically, the project 

18 
team retained several influencing factors recommended for deletion by some experts. The project 

team took note of the deletions and would later stratify the analysis, if possible, by the group of 

factors unanimously recommended by the experts versus those that were not. Such stratified 

analysis would depend on the number of studies that specifically address these factors. We

revised the key questions according to experts’ suggestions. We further revised the scope and 

reworded the key questions according to the final round of comments: the final version of the 

scope is included in Appendix D. 

In preparation for supplemental analysis, we took polls to solicit the technical experts’ 

opinion on the importance of the risk factors identified in the analytical framework. 

Specifically, we asked the experts the following questions for each factor: 

a) Regarding Key Question 1: “Does this factor influence the natural history of OME?” 

b) Regarding Key Question 2: “Does this factor have an independent effect on speech and 

language development separate from its effects on OME or unspecified OM?”

c) Regarding Key Question 3: “Does this factor have an independent effect on long-term

hearing separate from its effects on OME or unspecified OM?”

d) Regarding Key Question 4: “Does this factor have an independent effect on the accuracy 

of a diagnostic method separate from its effects on OME or unspecified OM?”

The experts had a choice of responding “yes”, “no”, or “don’t know.” For each such 

opinion, the experts were asked to indicate the basis of their opinion by choosing one or more of 

the following: “Judgment/Experience,” “Theoretical Construct,” or “Literature”. 

The questionnaire for the two polls is included in Appendix E and the responses of the 12 

technical experts are presented in Appendix F. A summary of the risk factors ranked by the 

importance assigned by the technical experts is presented in Table 10. 

Literature Search 

The Technical Expert Panel and project staff developed a literature search strategy. The 

literature search included the search of three databases: MEDLINE (1966-January2000), the 

Cochrane Library (through January 2000), and EMBASE (1980-January 2000). We identified 

additional articles by review of reference lists in proceedings, published articles, reports, and 

guidelines. 

The project librarian developed an overall search strategy for MEDLINE (Appendix G) that 

incorporated the input from the technical experts and followed the scope of the project. The 

MEDLINE database is produced by the U.S. National Library of Medicine and is widely 

recognized as the premier source for bibliographic coverage of biomedical literature. It 

encompasses information from Index Medicus, Index to Dental Literature, and International 

Nursing, as well as other sources of coverage in the areas of allied health, biological and physical 

sciences, humanities, and information science as they relate to medicine and health care, 

communication disorders, population biology, and reproductive biology. We searched the 

MEDLINE database for publications dating back to 1966. Further, we included articles in the 

English language only for the following reasons. First, our experience with our evidence 

assessment of the management of acute otitis media (Takata, Chan, Shekelle et al., in press; 

19 
Chan, Takata, Shekelle et al., in press) demonstrated a low yield from non-English language 

publications (only two studies accepted out of 97 reviewed and both of theses were also 

published in English). Second, we needed to balance limited resources between reviewing nonEnglish language literature and answering additional key questions. Since empiric evidence of 

the need to include non-English language literature in meta-analyses was mixed (Moher, Pham, 

Klassen et al., 2000) and reviewing non-English literature would be resource intensive, we chose 

to limit our scope to English language literature only. 

The MEDLINE search strategy used both controlled vocabulary terms and keywords. The 

strategy was organized into modules or clusters of search statements. The main groupings 

included: otitis media with effusion (OME), mastoid, otitis media; natural history; speech and 

language; hearing; and diagnosis. These groupings corresponded to the key questions. 

For the “otitis media with effusion” concept, both the controlled vocabulary term otitis media 

with effusion and text word were used. A variety of additional terms were used; such as allergic 

otitis media, fluid ear, glue ear, middle ear effusion, mucoid otitis media, nonsuppurative otitis 

media, secretory otitis media, and serous otitis media. For the “mastoid” concept, both the 

controlled vocabulary and the text word were used. The otitis media module included what is 

referred to as an “explode” of otitis media, which included the controlled vocabulary headings 

“otitis media”, “otitis media with effusion”, and “otitis media, suppurative.” 

The “natural history” module combined “OME” or “mastoid” with a combination of text 

words and controlled vocabulary terms for natural history including “natural course”, “natural 

history”, “placebo”, “placebos”, “resolution”, “self limited”, “self limiting”, “untreated”, and a 

variety of terms for spontaneous resolution. 

Both the “speech and language” module and the “hearing” module combined OME, or 

mastoid, or an explode of “otitis media” with the speech, language, and hearing concepts. The 

speech and language component used the controlled vocabulary terms for speech and language, 

speech and language disorders, child language, communication, communication disorders, 

language development and tests, voice, and voice disorders. In addition, the text words “speech” 

and “language” were added. The hearing module used the controlled vocabulary terms for 

hearing and hearing disorders and hearing aids and tests, as well as the text word “hearing”. 

The “diagnosis” module combined OME or mastoid with a combination of text words and 

controlled vocabulary terms for diagnosis. In addition to the controlled vocabulary terms for 

diagnosis and diagnostic techniques and procedures, a number of text words were added for 

audiometry, diagnosis, diagnostic, otoscopy, and tympanometry. 

We customized the search strategy initially developed for MEDLINE for EMBASE. 

EMBASE, the Excerpta Medica database, produced by Elsevier Science, is a major biomedical 

and pharmaceutical database that indexes over 3,800 international journals. EMBASE is one of 

the most widely used biomedical and pharmaceutical databases. The database currently contains 

over 6 million records, with more than 400,000 citations and abstracts added yearly. We

searched the EMBASE database for citations dating back to 1980. For the search in the 

Cochrane Library, we used “otitis media” as the search term. The Cochrane Library contains 

several databases: (1) The Cochrane Database of Systematic Reviews, which contains Cochrane 

reviews published by the Cochrane Collaboration, an international organization dedicated to 

applying evidence-based-medicine principles to the review of important clinical topics; (2) The 

Cochrane Controlled Trials Register which is a bibliographic database of controlled trials; (3) 

The Database of Abstracts of Reviews of Effectiveness (DARE), which includes structured 

abstracts of systematic reviews that have been critically appraised by reviewers at the NHS 

Centre for Reviews and Dissemination in York and by other experts, for example from the 

American College of Physicians' Journal Club and the journal Evidence-Based Medicine; and (4) 

20 
The Cochrane Review Methodology Database which is a bibliography of articles on the science 

of research synthesis. 

The Cochrane Library search yielded 666 titles/abstracts. The MEDLINE search resulted in 

2,379 titles/abstracts. After eliminating duplicates, we retained 2,207 titles/abstracts for 

screening. The EMBASE search retrieved 1980 citations. After eliminating duplicates, we 

retained 327 for screening. 

We conducted all searches in January 2000 and subjected a total of 3,200 titles/abstracts to 

screening by two physician reviewers. By merging and eliminating duplicates from the 

titles/abstracts from the three databases, we created a database of titles and abstracts. 

EndNote software (EndNote Windows Version 3.0, 1st Edition. Niles Software Inc., 

Berkeley, CA) was used to keep a complete record of all titles/abstracts and identify 

duplications. This software stores, organizes, and tracks references by source (e.g. identified in 

MEDLINE), search strategy (date of search, index code specifying search criteria used), and a 

unique identification (UI) code for each article (assigned by the source used to find article). 

Electronic removal of duplicate citations was supplemented by manual cross-checking. In the 

event an article was identified by an expert panel member or through reference checking, the title 

and author of the reference were entered into MEDLINE through the Ovid search system (Ovid 

Technologies, Inc. 1998, Version: 7.8 Millennium source ID 1.3932.1.156.1.7, Revision: 

1.303.2.8) to determine the UI. If a UI could not be found for the article, an alternate 

identification code was assigned. 

EndNote assigned a record number to each new reference added to the master file. This 

number would not change once an article was added to the list and was used, in addition to the 

UI, to sort references for article retrieval and review. 

Upon completing the literature search and duplicate checking, we exported the master list 

generated from EndNote to a Microsoft Excel spreadsheet for data export and analysis. We

added codes including status of article retrieval, reviewer, and the results of the review. 

 

Review of Retrieved Titles/Abstracts Against Screening Criteria 

After retrieving of titles and abstracts from the literature search, two physician reviewers 

reviewed the abstracts against the inclusion/exclusion criteria to determine eligibility for 

inclusion in the evidence synthesis as defined in the scope and key questions. Titles/abstracts 

were not masked prior to review. A pre-designed screening form was used to record the reviews. 

A meeting was held to review the instructions for screening (Appendix H), including the use of 

the computerized data forms. The reviewers entered the screening results directly into the 

computer and forwarded the results electronically to our data analyst for processing. The 

screening results for each title/abstract were matched between the two reviewers, and 

discrepancies on inclusion or exclusion were resolved in conference calls among the two 

reviewers and the task order coordinator. The data analyst generated summary reports indicating 

those abstracts that passed the screening criteria and those that failed and the reasons for failure. 

We completed screening of the 3,200 titles/abstracts from the Cochrane Library, MEDLINE, 

and EMBASE. After resolution of 376 discrepant citations, 2230 (70%) were rejected and 970 

were accepted for full article review. The reasons for rejection of the 2230 citations are 

presented in Table 11. We also screened the database provided to us by the American Academy 

of Pediatrics (AAP) from its recent review of the topic. Of a total of 1918 titles/abstracts 

screened against our database, we identified 477 duplicates from our ENDNOTE database, 

leaving 1441 records from the AAP files that required further screening by the two reviewers. 

21 
The screening of the 1441 citations from AAP files identified 32 additional citations that 

required full article review. 

The third source of reference material was the six proceedings of the International 

Symposium on Recent Advances in Otitis Media with Effusion from which we identified 159 

additional citations for full article review. 

The fourth source consisted of references in books and articles from which we identified 31 

full articles for further review. 

Retrieval and Review of Full Articles 

The titles/abstracts identified for further review were forwarded to the library for full article 

retrieval. Libraries at both the Los Angeles County - University of Southern California Medical 

Center and the University of Southern California Health Sciences Campus were the primary 

sources of the articles. Those not found were retrieved through the Inter-Library Loan Program. 

Because a large number of titles/abstracts had inadequate information for full evaluation, a 

secondary screening of full articles was conducted. Two physicians or a physician and a health 

services researcher reviewed each article. Articles were not masked prior to review. 

Discrepancies on inclusion/exclusion were resolved between the reviewers. 

Of the 1,250 full length articles to be retrieved, 3 were irretrievable due to incorrect citation 

information. Secondary review of the remaining 1,247 full length articles from the various 

sources resulted in the rejection of 798 articles and acceptance of 449 articles: 141 for question 

1, 112 for question 2, 186 for question 3 and 75 for question 4. Table 12 provides the reasons 

for rejection of the 798 articles and Table 13 summarizes the number of articles accepted during 

the secondary review process. During the fourth conference call, the experts raised the age limit 

to 22 for the responses to questions 2 and 3 to allow for detection of speech, language, and 

hearing problems past age 12, the original upper age limit. As a result, we revisited all 

titles/abstracts and articles that had been rejected because of the age limit, and four previously 

rejected articles were accepted from our original databases. 

After establishing the analytical plan and before data abstraction, a physician and one health 

services researcher carried out a tertiary review of the 449 articles according to a set of 

established criteria for each key question. During this tertiary review, study design and quality 

were also evaluated. 

For Question 1, we used three criteria for tertiary screening: 1) was the study a prospective 

cohort(s) study or a randomized control trial (RCT), 2) whether the control group in the RCT 

used the other ear as the ‘unit of control’ or not, and 3) were the outcome data abstractable? 

 

 

For Questions 2 and 3, we established 5 criteria for tertiary screening: 

1) Was the degree of OME determined for the first 3 years of life, and could the OM 

degree for the period before 3 years of age be linked to a specific outcome? If a study 

began at age 3, the study was not considered to fulfill this criterion. 

2) Was the upper age limit 22 years of age? If a study included subjects older than 22 

years, this criterion could be fulfilled only if outcomes for the 22 years of age and under 

was reported. 

22 
3) Was the degree of OM graded in some way, such as total time with OM, some measure 

of OM persistence, OM recurrence, or some measure of OM severity, and could the OM 

degree grade be linked to a specific outcome? 

4) Was the study prospective? A study is considered prospective if the outcomes were 

measured prospectively. Cross-sectional and case-control studies were specifically 

excluded. A study that followed subjects prospectively for both OM history and 

outcome measures was considered a prospective cohort study. Studies that followed 

subjects prospectively for outcome measures (i.e. over a period of time) but 

retrospectively for OM history were considered to be retrospective-prospective studies 

and were accepted for inclusion. Studies that collected data on the outcome measures at 

one point in time, were considered retrospective cohort studies regardless of whether 

OM history was collected prospectively or retrospectively and were excluded. Studies 

that presented a cross-sectional analysis of prospectively collected data were not 

considered prospective and were excluded. Randomized controlled studies of an 

intervention with longitudinally measured outcomes were considered prospective and 

were included. 

5) Was the outcome measured when the child was older than 3 years of age? 

For Question 4, we established 3 criteria for inclusion during tertiary review: 1) Were the 

diagnostic procedure of interest and the reference standard performed within 24 hours of each 

other? 2) Is the diagnostic procedure not an algorithm or combination of multiple diagnostic 

procedures, 3) Are the reference standards one of those specified in the scope 

(tympanocentesis, MRI, myringotomy, validated pneumatic otoscopy, or CT scan), and 4) Are 

the data abstractable. 

After tertiary review and data abstraction, a total of 114 articles were included in this 

evidence report, five of which addressed more than one key question: 

• 38 cohort studies for question 1, the natural history question; 

• 21 studies for question 2, the speech and language question; 

• 8 studies for question 3, the hearing question; and 

• 52 studies for question 4, the diagnostic method question. 

Table 14 presents the results of tertiary review of the 449 articles. 

Review and Assessment of Study Quality 

We established criteria used for the assessment of study quality prior to the review of 

articles. Only prospective cohort studies were reviewed for Questions 1, 2 and 3 because of 

concerns about the validity of case-control, cross-sectional, and retrospective cohort studies. 

Diagnostic studies were reviewed for Question 4. The criteria used to evaluate the quality of 

23 
both types of studies were modified from the work by the McMaster University Group 

(Jaeschke, Guyatt, and Sackett, 1994; Sackett, 1981; Trout, 1981; Tugwell, 1981). 

The quality of natural history studies was evaluated against the following criteria: 

1) Was the study a prospective cohort study? 

2) Was the outcome(s) of the study clearly defined? 

3) Was the outcome(s) measured at a clearly defined timepoint(s)? 

4) Was the cohort of subjects followed without any intervention? 

6) Was there blinded assessment of the outcome(s) of the study? 

7) Were point estimates and measures of variability provided for the main adverse outcomes 

 measured?

The quality of prospective cohort studies was evaluated against eight components: 

1) Was the study cohort(s) clearly defined, with clearly spelled out inclusion and exclusion 

criteria? 

2) Was the study cohort(s) assembled at a uniform point in the course of the child’s illness? 

3) Were the pathways by which patients entered the study clearly described? 

4) Was complete follow-up achieved? 

5) Were withdrawals and drop-outs described? 

6) Were objective outcome criteria developed and used? 

7) Was the outcome assessment “blind”? 

8) Was adjustment for extraneous factors carried out? 

The quality of diagnostic studies was evaluated against six components: 

1) Was the reference standard appropriate? 

2) Were the test results and the reference standard assessed independently of each other? 

3) Were the readers of the results of the diagnostic test or the reference standard blinded? 

4) Did the patient sample include an appropriate spectrum of mild and severe, treated and 

untreated patients to whom the diagnostic tests were applied in clinical practice? 

5) Were the reproducibility of the test result (precision) and its interpretation (observer 

variation) determined? 

24 
6) Were the methods for performing the test described in sufficient detail to permit 

replication? 

Articles were not masked prior to review. The Task Order Coordinator resolved minor 

discrepancies between the two reviews of each article. Conferences were held to resolve 

discrepancies whenever needed. 

Data Abstraction 

For the articles deemed eligible for inclusion in the Evidence Report, data abstraction was 

carried out by a two-member team that consisted of a physician reviewer and a health services 

researcher. One of the two members abstracted the data onto the evidence table, and the other 

member checked the data for accuracy. Data abstracted included parameters necessary to define 

study groups, inclusion/exclusion criteria, influencing factors, and outcome measures to be used 

in analysis. 

Specific instructions for data abstraction were recorded. For Question 1, the outcome

indicators for abstraction included partial OME resolution (resolution in one ear for bilateral 

OME only), complete OME resolution, relapse/recurrence (fluctuation/dynamic course), AOM 

after OME. For Question 2, the outcome indicators for abstraction were expressive or receptive 

language, expressive or receptive speech, and cognitive verbal intelligence. For Question 3, the 

outcome indicators for abstraction included conductive or sensorineural hearing loss. For 

Question 4, the outcome indicators for abstraction were sensitivity, specificity, positive and 

negative predictive values, and prevalence rate. For all questions, the time or age at which each 

outcome was measured was recorded. The outcome measures included both continuous and 

categorical measures. Continuous measurements included mean time or a median time and the 

categorical measures included proportion with resolution at specified times where both 

numerators and denominators were recorded. A key issue was that individual children, not 

populations, must be tracked. The latter would be acceptable only if we knew for certain that the 

same children were checked at both times. 

Procedures to Reduce Bias, Enhance Consistency, and 

Check Accuracy 

To reduce selection bias, we assigned two physician reviewers to screen and review 

titles/abstracts and full articles at every stage of the selection process. We assigned one physician 

and one health services researcher who was familiar with experimental design and biostatistics to 

abstract data. We assessed completeness of our collection of retrieved articles by cross-checking 

with studies included in other meta-analyses and references listed in review articles. The 

software program EndNote was used to check batches of articles added to the master list for 

duplicate references by comparing author, year title, and reference type. Following the 

importation of the first literature search, we used the software program EndNote to check 

subsequent references for duplication prior to their addition to the master list. After the master 

list was completed, we performed a second, manual, check to ensure no duplication. 

To assess the extent of publication bias, we searched multiple sources and unpublished 

material identified by the Technical Expert Panel and internal content experts. We also studied 

25 
funnel plots—scatter plots of sample size versus the estimated effect size from each study. When 

publication bias existed, a portion of points would be missing from the funnel plot, typically at 

the null effect level. Because graphical evaluation can be subjective, we also conducted an 

adjusted rank correlation test (Begg, 1999) and a regression asymmetry test (Egger, Smith, 

Schneider et al., 1997) as formal statistical tests for publication bias. We conducted these tests 

using the statistical package Stata (StataCorp. 1999). 

The mechanisms used to enhance consistency in screening and data abstraction include the 

use of pre-designed forms with explicit instructions and continuous and prompt resolution of 

discrepancies. Data were entered into a Microsoft Excel spreadsheet directly by the screeners or 

data abstractors. A third project staff cross-checked data for individual studies abstracted by 

each data collector. We resolved discrepancies by rechecking the article or by consensus via 

conference calls. 

Preparation of Evidence Tables 

An evidence table was prepared for each key question. Each evidence table provides a 

comprehensive tabular display of data abstracted from the literature in response to the question. 

It contains the name of the first author, year of publication, study design and quality score, how 

and by whom OME diagnosis was done, when and where the study took place, inclusion and 

exclusion criteria, important influencing factors, sample size, outcome measures and their 

definitions, and study findings. A total of four evidence tables was prepared; they are included 

in the section called Evidence Tables in this report. 

Supplemental Analysis 

Based on the discussions of technical experts during the conference calls and the designated 

time frame for the evidence assessment, a supplemental analysis plan was developed for each 

key question to synthesize the data. 

Natural History

Question 1. What is the natural history (spontaneous resolution rate over time without 

treatment) for the following diagnostic groups: a) OME persisting after a discrete episode of 

acute otitis media, b) newly diagnosed OME of unknown duration (unilateral or bilateral), c) 

OME persisting for weeks or months (unilateral or bilateral), d) unilateral OME lasting 3 months 

or longer, and e) bilateral OME lasting 3 months or longer?

The outcome measures for this questions included complete and/or partial resolution rates, 

relapse/recurrence rates, and incidence of AOM after OME. The scope listed 31 non-treatment 

factors that might affect the course of the illness and confound the outcomes. They included: 

age, gender, ethnicity/race, socioeconomic status, number of hours in child care center, tobacco 

smoke exposure, season, number of children in household, breast-fed status, barotrauma

challenges, OME laterality, hearing level, total duration of OME, age at first OM onset age of 

previous OME, number of previous OMEs, family history of OME, otitis prone (AOM), 

allergies, prior tubes, prior adenoidectomy, developmental delay, caregiver preference for 

treatment, caregiver education, examiner skill, examiner type, health care setting, monitoring 

time, monitoring frequency, monitoring personnel, and monitoring method. 

26 
Furthermore, the type of study is an important consideration for the assessment of natural 

history. A stratified random sample of a broad, well-defined population provides evidence of 

good generalizability, but may be restricted in the amount of clinical information on participants. 

A single (untreated) arm from a clinical trial will usually provide much more clinical evidence 

about OME, but this is usually assessed on a very selected group of children, making 

generalizing the results to the general population more difficult. For this evidence assessment we 

used only prospective cohort studies as these came closest to the ideal of enrolling a sample from

a broad poulation. 

The first step of the analysis was to obtain a distribution of studies stratified by the 5 

diagnostic groups (namely, OME persisting after a discrete episode of acute otitis media, newly 

diagnosed OME of unknown duration (unilateral or bilateral), OME persisting for weeks or 

months (unilateral or bilateral), unilateral OME lasting 3 months or longer, bilateral OME lasting 

3 months or longer), by type of outcome measures, and by non-treatment factors. This 

stratification provided us with an overview of the emphasis of past research in this area and an 

opportunity to identify gaps and areas for future research. 

Using the DerSimonian and Laird random effects model (DerSimonian and Laird 1986) to 

pool rates across studies, we performed a meta-analysis on strata with more than 3 studies for a 

pooled estimate of an outcome with 95% confidence intervals. This method produces a 

summary measure by weighting each study's measure by the inverse of the sum of the withinstudy variance and the between-study variance. This approach allowed both sampling variation 

and between-study heterogeneity to affect the pooled estimate. 

In addition to the pooled estimate, we reported the Q statistic and p-value for the Chi-squared 

test of heterogeneity, which tests the null hypothesis that the individual study results are 

homogeneous (Laird and Mosteller 1990). 

Effects of Early-Life OM on Long-Term Speech and Language 

Development 

Question 2. Do infants and preschool children with longer duration of early-life OME as 

compared to those with shorter duration OME have greater delays in speech and language 

development (receptive or expressive) later in life? One specific formulation of this question is: 

Is OME-associated conductive hearing loss in the first 3 years of life a risk factor for speech and 

language developmental delays? What are the risk factors that interact with the effect of OME 

on speech and language development in infants and preschool children?

For the first part of the question, the outcome of interest was speech and language 

developmental delay and the risk factor of interest was OME-associated conductive hearing loss 

and/or long versus short duration of early-life OME. For this question we included only 

comparative studies. Further, since prospective comparative cohort studies provide better 

evidence than retrospective comparative cohort studies, we conducted our assessment using only 

prospective comparative cohort studies. 

The risk factor of interest was whether a child had or did not have OME-associated 

conductive hearing loss in the first 3 years of life, or whether duration of OME during the first 

three years of life was long or short. For this risk factor, we collected data on five related 

variables: hearing level, total duration of OME≥3 months, number of previous OMEs, duration 

of middle ear effusion (MEE), and repeated or persistent versus infrequent early-life OME. The 

hearing level was used to determine whether a child had OME-associated conductive hearing 

loss in the first 3 years of life. The total duration of OME greater or equal to 3 months was used 

27 
to define length of duration. We used the repeated or persistent versus infrequent early-life 

OME to define the risk. If a study did not classify the study subjects this way and (instead) 

reported data by number of previous OMEs and/or duration of MEE’s, we sought the advice of 

the technical experts to stratify the samples based on these variables. 

The influencing factors of outcome included both treatment and non-treatment factors. Here 

we are using “influencing factors” as a general term including risk factors for OM and/or 

confounding factors for the dependent variables of interest. The non-treatment factors included: 

age at first OM, gender, ethnicity/race, socioeconomic status, number of hours at a child care 

center, quality of child care, early intervention program, tobacco smoke exposure, number of 

children in household, breast-feeding status, OME laterality, allergies, developmental delay, OM 

complications, e.g. perforated TM, cholesteatoma, chronic illness of any type, caregiver 

education, quality of parent-child interaction, examiner skill, examiner type, health care setting, 

age at rechecks, frequency of rechecks, primary care provider, and type of equipment to measure 

hearing. Treatment factors included any combination of the following: tympanostomy tubes, 

adenoidectomy, myringotomy, antibiotics, systemic steroids, decongestant, antihistamine, Nacetyl-cysteine or others.

The outcome measures for this question related to speech and language developmental delay. 

These outcomes were measured by different instruments at different times, by different 

professionals, in different settings. In preparation for information synthesis, with the assistance 

of our speech and language technical expert, we classified the tests used in our final set of 

studies into the five outcome categories: expressive language, receptive language, expressive 

speech, receptive speech, and cognitive verbal intelligence. For analysis, we first stratified 

studies by the type of outcome measures, risk factor measures, and treatment or non-treatment 

risk factors. For any comparison among 3 or more studies, we conducted a meta-analysis. In 

each meta-analysis, we derived a pooled effect size defined as the proportion of standardized 

difference between the positive and negative otitis media groups. We pooled across studies the 

standardized mean differences between the groups and divided by a pooled standard deviation. 

We used a random effects model (DerSimonian and Laird, 1986) and the Hedges estimate of the 

pooled standard deviation (Hedges and Olkin, 1985). We used Stata (StatCorp. Stata Statistical 

Software: Release 6.0. College Station, TX: Stata Corporation. 1999) for the analyses. 

To answer the second part of the question: “What are the risk factors that interact with the 

effect of OME on speech and language development in infants and preschool children?,” we 

planned to conduct meta-regression analysis to identify the risk factors that contribute 

significantly to speech and language delays. For this analysis we would include both 

comparative and single cohort studies. Many technical issues must be addressed to set up data 

appropriately for meta-regression analysis. Due to restriction of the time frame, this part of the 

question was not included in this assessment but should be an area of future research. 

Effects of Early-Life OM on Long-Term Hearing 

Question 3. Do infants and preschool children with longer duration early-life OME as 

compared to those with shorter-duration OME have permanent (or sensorineural) hearing loss 

later in life? One specific formulation of this question is the following: Is OME-associated 

conductive hearing loss in the first 3 years of life a risk factor for permanent (or sensorineural) 

hearing loss later in life? What risk factors interact with the effect of OME on hearing loss later 

in life (unilateral or bilateral) in infants and preschool children? 

28 
The analysis plan for Question 3 followed that for Question 2. In preparation for information 

synthesis, we sought the assistance of our audiology technical expert, to group the tests used in 

our final set of studies into homogeneous categories. 

Our audiology expert advised that (1) an acoustic reflex at 500 or 1000 Hz were both 

acceptable for study, (2) the criterion for abnormal reflex threshold would depend on the study, 

whether ipsilateral or contralateral, and on the frequency used for testing, (3) the abnormal reflex 

criteria should be based on normative data, and (4) quantitative tympanometry should be 

classified as: 

a. Static Compensated Acoustic Admittance including: peak admittance, peak compensated 

admittance, peak compliance, static compliance, static admittance, and peak compliance. 

 

b. Tympanometric Gradient including: gradient, pressure gradient and tympanometric 

gradient (Madsen compliance was excluded because Madsen compliance units were 

arbitrary units and the this instrument was from an era in which the units were not on a 

calibrated scale.) 

c. Tympanometric Width referring to terms containing the words width, referring to 

tympanometry.

Diagnostic Methods for OME 

Question 4. What are the sensitivity, specificity, and predictive values for alternative 

methods of diagnosing OME compared with one of the reference standards? 

The diagnostic methods to be assessed included: a) signs/symptoms, b) non-pneumatic 

otoscopy, c) pneumatic otoscopy, validated or unvalidated examiner, d) binaural (or bilateral) 

micro-tympanoscopy, e) portable tympanometer, f) professional tympanometer, g) quantitative 

tympanometry, h) acoustic reflectometry, i) otoacoustic emissions, and j) audiometry, air or. 

bone conduction thresholds. The reference standards used to evaluate the accuracy of the 

diagnostic methods included: a) tympanocentesis, sedated or non-sedated, b) MRI, c) 

myringotomy, sedated or non-sedated, d) validated pneumatic otoscopy, and e) CT Scan. 

Diagnostic methods based on algorithms, combinations of methods, or combination of 

scores, were not within the scope of this report because the sources of variation of such 

combinational methods would be difficult to detect in published articles and the analysis of them

would not be feasible within our timeframe. Also excluded were studies where the experimental 

diagnostic test and the reference standard test were performed more than 24 hours apart. 

Our strategy for evaluating the diagnostic value of a procedure was to derive pooled 

estimates for sensitivity, specificity, and prevalence rate for each diagnostic procedure and 

reference standard with 3 or more comparison studies. We used the DerSimonian and Laird 

random effects model (DerSimonian and Laird 1986) to derive random effects estimates and 

95% confidence intervals. We also pooled the prevalence rates to determine the heterogeneity of 

the study populations. Using the pooled estimates, we plotted the performance of each 

diagnostic test in terms of sensitivity and (1-specificity) and identified the best performer among 

the tests included in the comparison. We then derived the positive and negative predictive 

values for the best diagnostic test for various prevalence levels. 

To prepare for a meta-analysis for each comparison, we abstracted data from the evidence 

table; one meta-analysis was performed for sensitivity and specificity,. The following data 

29 
elements were entered into the SAS program to be converted into a SAS data set: study ID 

number, author and year of publication, number of adverse outcomes in the experimental group, 

total number of patients in the experimental group, number of adverse outcomes in the control 

group, and total number of patients in the control group. We used a SAS macro software 

program developed by RAND statistical staff to perform all meta-analyses and used the beta-test 

version of the software package “MetaGraphs” (1998, Belmont Research, Inc. 84 Sherman 

Street, Cambridge, MA 02140) for graphing. 

The following statistics were generated from the SAS macro program: (a) study-level 

statistics (incidence rate, relative risk, risk difference, number needed to treat (NNT), odds ratio, 

and their 95 percent confidence intervals); (b) crude estimates and their 95 percent confidence 

intervals for all studies combined; (c) fixed effects estimates and their 95 percent confidence 

intervals for all studies combined; (d) random effects estimates and their 95 percent confidence 

intervals based on the DerSimonian and Laird method for pooling study results, and Chi-squared 

test of homogeneity; (e) weight for each study for both the fixed effects model and random

effects model used to calculate of risk difference and relative risk. 

To use MetaGraph for graphing, we entered the data into ASCII files using the UltraEdit-32 

software. Funnel plots were produced for the purpose of screening possible publication bias, and 

the shrinkage plots were generated to display the effect size of each study and compare it against 

the overall model estimate, together with the 95 percent confidence limits. We evaluated the 

funnel plots graphically for asymmetry that resulted from the non-publication of small, negative 

studies. Because graphical evaluation can be subjective, we also conducted an adjusted rank 

correlation test (Begg, 1999) and a regression asymmetry test (Egger, Smith, Schneider et al., 

1997) as formal statistical tests for publication bias. We conducted these tests in the statistical 

package Stata (StataCorp. 1999). 

Identification of Peer Reviewers 

At the beginning of the project, we requested nominations for technical experts and peer 

reviewers from 12 organizations. A total of 18 nominations were received for the Peer Review 

Panel. Experts in systematic reviews and meta-analysis were selected from a pool of experts 

associated with the Southern California Evidence-Based Practice Center but not involved with 

this project. The Project Staff, in consultation with the Task Order Officer, determined the 

relative mix of reviewers across the three domains (methodology, user, and clinical). In addition 

to domestic experts, we identified four European experts to serve as peer reviewers. The Peer 

Review Panel (Table 15) was composed of 18 members including family physicians, 

pediatricians, otolaryngologists, audiologists, speech-language pathologists, nurse practitioners, 

health planners, consumers, systematic review methodologists, statisticians, and non-U.S. 

experts in otitis media. 

 

Peer Review Process 

A copy of the draft evidence report was mailed to each peer reviewer on the panel, along 

with an instruction sheet (Table 16) for reviewing the draft evidence report. The Peer Review 

Panel was asked to respond within three weeks. Seventeen of the 18 peer reviewers responded 

with comments. A copy of the draft evidence report was also mailed to the members of the 

Technical Expert Panel and all technical experts responded with comments. Upon receipt of all 

responses from the peer reviewers and technical experts, the project staff compiled a summary of 

30 
the comments and changes and revised the draft evidence report. We forwarded all comments to 

the Task Order Officer for review. The peer reviewers’ and technical experts’ comments are 

included in Appendix I, together with the corresponding responses or actions taken by project 

staff. 

31 
Table 1: Technical Expert Panel 

Technical Expert Area of Expertise Affiliation/Location

Larry Culpepper, MD, MPH Family Medicine Boston Medical Center, MA 

Douglas G. Long, MD Family Medicine Manchester Community Health 

 Center, NH 

 

Richard M. Rosenfeld, MD, MPH Otolaryngology SUNY Health Science Center 

Brooklyn, NY 

Norman Wendell Todd, Jr., MD Otolaryngology Emory University, GA 

Allan Lieberthal, MD Pediatrics Southern California Kaiser 

Permanente Medical Group, CA 

Anthony Magit, MD Pediatric Otolaryngology Children’s Hospital San Diego, CA 

Jack Paradise, MD Pediatrics Children’s Hospital, Pittsburgh, PA 

Ross Miller, MD Quality Management CIGNA Health Care, CA

 

Joanne Roberts, PhD Speech and Hearing University of North Carolina, NC 

Lisa L. Hunter, PhD Audiology University of Minnesota, MN 

 

Linda Carlson, MS, RN, CPNP Nurse Practitioner Statesboro, GA 

Fran Goldfarb, MA Consumer Family Voices, Los Angeles, CA 

 

32 
Table 2: Questions Suggested for Consideration in Evidence Report 

1. What is the relative risk of developing OME in the child who has food or inhalant allergies compared to the 

child without food or inhalant allergies 

2. What is the natural history for various types of OME?

3. What is the long-term level of speech and language development in infants and preschool children with

untreated OME? What are the high risk groups?

4. What is the accuracy of various diagnostic methods?

5. When should conservative treatment (non-surgical) be considered a failure?

6. What is the evidence on effectiveness of various diagnostic instruments in deciding on intervention for 

OME?

7. What is the evidence regarding level of hearing decrease and whether unilateral or bilateral hearing 

decrease is an indication for intervention?

8. What is the effectiveness of the use of hearing levels to decide on intervention for OME?

9. Are antibiotics more effective than placebo in treating OME?

10. Are steroids more effective than placebo in treating OME?

11. Do antibiotics add an incremental benefit to steroids in treating OME?

12. Are interventions for allergies (food or inhalant) more effective than placebo in treating OME?

13. Are antihistamines and/or decongestants more effective than placebo in treating OME?

14. Are tympanostomy tubes more effective than other interventions in treating OME?

15. Is adenoidectomy more effective than other interventions in treating OME of greater than 3 months

duration?

16. Is tonsillectomy more effective than other interventions in treating OME of greater than 3 months duration?

17. Is myringotomy more effective than other interventions in treating OME of greater than 3 months duration?

18. Are alternative or complementary therapies more effective than other interventions in treating OME of

greater than 3 months duration?

19. Are prophylactic antibiotics more effective than other interventions in treating OME?

20. What is the effectiveness of monitoring by pneumatic otoscopy, tympanometry, acoustic reflectometry with

spectral gradient, and otoacoustic emissions to decide on intervention for OME?

33 
Table 3: Ranking of Potential Key Questions

Of the 20 questions, each technical expert ranked the top 10 questions from 10 (highest priority) to 1 

(lowest priority), (experts’ identification numbers were randomly assigned). 

Topic of question Rank 

Total 

E

1 

E

2 

E

3 

E

4 

E

5 

E

6 

E

7 

E 

8 

E

9 

E 

10 

E 

11 

E 

12 

1. Food or inhalant allergies 

 

8 5 3

2. Natural history

 

78 10 9 10 9 7 9 4 2 6 7 5

3. Speech and language 

development 

97 8 10 4 8 9 5 8 5 10 10 10 10

4. Accuracy of diagnostic 

methods 

57 5 10 6 10 6 9 8 1 2

5. Conservative treatment 39 9 5 6 4 1 3 1 9 1

6. Diagnostic instruments vs 

intervention 

38 7 8 6 9 8

7. Level of hearing decrease 67.5 7 7 8 4 9 6.5 9 8 9

8. Hearing levels and 

intervention 

16.5 6 1 3 6.5

9. Antibiotics versus placebo 51 6 4 9 6 5 1 7 5 2 6

10. Steroids versus placebo 23 4 7 1 6 5

11. Antibiotics and steroids 22 5 2 3 3 5 4

12. Treatment for allergies vs 

placebo 

2 1 1

13. Antihistamines/decongestants

vs placebo 

10 10

14. Tympanostomy tubes vs 

other interventions 

51 3 1 8 10 2 2 4 4 3 6 8

15. Adenoidectomy vs other 

interventions 

32 7 2 1 5 3 2 2 3 7

16. Tonsillectomy vs other 

interventions 

2 2

17. Myringotomy vs other

interventions 

5 2 3

18. Alternative/complementary

therapies vs other 

interventions 

10 2 7 1

19. Prophylactic antibiotics vs

other interventions 

15 4 3 4 4

20. Effectiveness of diagnostic 

methods for monitoring 

36 8 9 8 8 3

Note: Kendall Coefficient of Concordance = 0.36, p=0.0001. 

34 
Table 4: Comments fro

m Technical Expert Pan

el on Potential Ke

y Questions 

Potential Ke

y Questions Comments/Notes 

1. What is the relative risk of 

developin

g O

ME in the child who 

has foo

d or inhalant allergi

es 

compared to the child without food or inhalant all

ergies? 

• Difficult to obtain evidence• Doesn’t seem to have adequate research base • Assumed to b

e a minor pl

a

yer, but there could b

e a surprise here 

2. What is the n

atural history for 

various types of OME? 

3. What is the long-term level of 

spe

ech and language d

evelopment 

in infants an

d preschool children 

with untreate

d OME? What are 

the high risk groups? 

• Evidence incomplete • Several new prospective studies are available • This is pro

b

a

bly the most important single question for justifying surgical in

• Available results inconsistent and/or contradictory. No definitive answers y

4. What are the accuracy of various 

diagnostic methods? 

• Combine with 6 and 20 • Probably not much d

ata there 

• Add binocular micro-tympanoscopy, MRI, and quantitative tympanometry t

methods of diagnosin

g OME. Binocular micro-tympanoscopy, which I do to 

that I assess in the clinic, is using the surgical "op

erating" microscope to vi

tympanic membrane. I think MRI should be the "gold standard" (see Swartvivo observation with magnetic reson

ance imaging of middle ear effusion in 

experimental underpressures. Ann Otol Rhinol Laryngol 104:522-528, 199diagnose OME by looking at the tympanic membran

e is traditional, but pro

look at the "window on the middle ear". To use fluid found at myringotomy standard" assumes that either (1) no inhalational general anesthetic has bethe patient, or (2) there is n

o effect of inhalational general anesthetic on the 

fluid in that part of the mesotympanum when the myringotomy is done. Sininhalation

al general anesth

etic is usually administere

d to patients g

etting m

the US in 1999, I'm not comfortable with this first assumption. From clinicaI've very unco

mfortable with the secon

d assumption. MRI als

o affords an o

measure the volume of the middle ear system (I'm including mastoid, mesoepitympanu

m and all the spaces n

ormally containing "gas" in this d

efinition 

ear system); smallness of volume of the middle ear system is a well-documcorrelate of severity of otitis media con

dition, and also a correlate of the se

anatomic eustachian and skull base differences of otitis media.) [Th

e MRI d

also h

elp, I think, in answering "Potential Key Question # 2.] Quantitative ty

is a pro

mising technique. ANSI mandated that all new tympanometers (as 

recall) provi

d

e qu

antit

ativ

e information. Such quantitative information, [De

Chic

unpublished data] to

d

ate show advantages

o

ver the qualitative A-B-C Jerger 

35 
Table 4 (Continued)

5. When should conservative

treatment (non-surgical) beconsidered a failure? 

• Unclear question • Very broad category • Unclearly written. What is the conservative treatment • No definitive information on which to base an answer 

6. What is the evidence on 

effectiveness of various diagnostic instruments in deciding onintervention for OME? 

• Same as 4 • Combine with #4 and #20 

7. What is the evidence regarding 

level of hearing decrease and whether unilateral or bilateral hearing decrease is an indication for intervention? 

• Minimal evidence • Combine with 8 • Pairs with question 3 • No definitive information on which to base an answer 

8. What is the effectiveness of the 

use of hearing levels to decide onintervention for OME? 

• Same as 7 • Combine with 7 

9. Are antibiotics more effective than 

placebo in treating OME? 

• Is this still an issue? • Is this still an issue? Has it been addressed with meta-analysis already? • Let’s see if there is any new data out there 

10. Are steroids more effective than 

placebo in treating OME? 

• There wasn’t enough data during the original panel. Is there now?

11. Do antibiotics add an incremental 

benefit to steroids in treatingOME? 

• This area showed some potential promise last time • Should be “Do steroids add an incremental benefit to antibiotics” 

12. Are interventions for allergies (food 

or inhalant) more effective than placebo in treating OME? 

• Minimal evidence • Inadequate research base

13. Are antihistamines and/or

decongestants more effective than placebo in treating OME? 

• If used need to indicate if there is a presence or absence of allergies • Still an issue? Addressed in last OME guidelines 

14. Are tympanostomy tubes more 

effective than other interventions in treating OME?

• Good to test the current recommendation to see if they still have validity • Answers might vary depending on outcome measures 

15. Is adenoidectomy more effective 

than other interventions in treating OME of greater-than 3 months duration? 

• Need to indicate in what age group and if used combine with myringotomy • The key is age of patient. Are there studies for younger children?• Answers might vary depending on outcome measures • Though I think adenoidectomy has some benefit to some patients in helpin

resolution of their otitis media, none of the purported mechanisms make anme. One purported mechanism is to decrease the "cesspool" of the nasop

36 
Table 4 (Continued)

cystic fibrosis patients, who typically have the worse cesspools of any nasohave (on average) less otitis problems than the general population. Anothmechanism is removing the mass of lymphoid tissue in the nasopharynx; bknow of any data that size of adenoid tissue correlates with either the occuseverity of otitis media. Indeed, in my experience with a population who hahighest rates of otitis of any population, adenoid tissue is usually scant. I'd the explanation by which adenoidectomy improves the course of otitis medchildren. (I suspect the explanation is scarring in the adenoid bed, that staposterior lamina of the eustachian cartilage. If this is indeed the explanatioone of the rare occasions that surgery benefits a patient by inducing scarri

16. Is tonsillectomy more effective 

than other interventions in treating OME of greater-than 3 months duration? 

• Still an issue? 

17. Is myringotomy more effective than 

other interventions in treating OME of greater-than 3 months duration? 

• Still an issue 

18. Are alternative or complementary 

therapies more effective than other interventions in treating OME of greater-than 3 months duration? 

• Minimal evidence • Inadequate research base? • Probably won’t find much, but the public will be clamoring for it 

19. Are prophylactic antibiotics more 

effective than other interventions in treating OME?

• Still an issue 

20. What is the effectiveness of

monitoring by pneumatic otoscopy, tympanometry, acoustic reflectometry with spectral gradient, and otoacoustic emissions to decide on intervention for OME? 

• Similar to 6 combined • Combine with #6 and #4 • Add binocular micro-tympanoscopy, MRI, and quantitative tympanometry t

methods of diagnosing OME. See my comments about "Potential Key Que

Epidemiology • The material on epidemiology thus far circulated omits mention of a key fac

predisposing infants and children to otitis media, namely, low socioeconomdata and a discussion, see our report in Pediatrics 1997;99:318-333. 

Definition of AOM • I disagree with the definition of AOM as stated in your recent Definition sec

stated, the definition would call for a diagnosis of AOM in a child with middand rapid onset of either irritability or fever. On the one hand, some infants have none of the 4 listed signs or symptoms, and the diagnosis is made on specific tympanic membrane findings--bulging and/or marked erythema--in findings of middle-ear effusion. On the other hand, some infants with only 

37 
Table 4 (Continued)

than AOM present with rapid onset of fever and/or irritability that may be dunderlying viral respiratory tract infection. If such patients are assumed to hmuch unnecessary antibiotic will be prescribed. The point to be made is thshould not be linked to either the presence or the absence of signs or symfever and irritability that are nonspecific. Ear pain, on the other hand, is respecific. This issue was discussed in Commentary in Pediatrics 1995;96:7

38 
Table 5: Overall Causal Path

w

a

y for OME 

Initial Monitored 

 I

m

m

e

diate

After

 M

onitoring

(pq=potential question) 

Indicators for Treatment (Initial or 

Monitored) (pq5, pq6, pq

2

0) 

signs based on pneumatic otoscopy, 

tympanometry, acoustic reflectometry, 

otoacoustic e

missions, unil

ateral vs. 

bilateral hearing loss (pq7), hearing levels

(pq8) 

Patient 

without 

OME

Patient 

with O

M

E

Risk Factor

s

allergi

es (pq1) 

daycare 

tobacco smoke 

AOM 

not breast fed

craniof

acial 

anomali

es 

Down Syndro

me 

adenoid hyperplasia 

socio-economic 

status 

Patient 

Diagnosed 

with O

M

E

Diagnosing OME (pq

4) 

gold standard

signs/sympt

oms 

non-pneumatic otoscopy

pneumatic otoscopy 

portable tympanometer

professional 

tympanometer

acoustic reflectometry 

otoacoustic e

missions 

audiometry 

MRI 

Binocular microtympanosco

p

y

Quantitative 

tympanometry 

OME Treatment: 

Duration unknown

no treatment (pq2) 

antibiotics (pq9) 

steroids (pq10) 

antibiotics and steroids (pq11) 

interventions for allergies (pq12) 

antihistamines and/or

decongestants (pq13)

Duration lon

g

er than 3 months

tympanosto

m

y tubes (pq14)

adenoidecto

my (pq15) 

tonsillectomy (pq16) 

myringotomy (pq17) 

alternative/complementary 

therapies (pq18) 

prophylactic antibiotics (pq19) 

Non-Tre

atment Factors Influencing 

Outcome

age, socio

economic status, previous O

ME, 

daycare, bilat

eral OME, duration lon

g

er than 2 

weeks, early onset OM, otitis prone, tobacco 

smoke, season, craniofacial anomaly, 

immunodeficiency, genetic syndro

m

es, 

Eskimo, Native American 

partia

comple

ti

A

balanc

H

s

la

acade

A

39 

Fac

Trea

com

aut

d

diso

lang

sens

as 

 cog

scho
Table 6: Causal Pathway for Key Question 1 on Natural History

What is the natural history (spontaneous resolution rate over time without treatment) for: 

 OME persisting after a discrete episode of acute otitis media, 

 newly diagnosed OME of unknown duration (unilateral or bilateral), 

 OME persisting for weeks or months (unilateral or bilateral), 

 unilateral OME lasting 3 months or longer, 

 bilateral OME lasting 3 months or longer? 

Outcomes:

• partial OME resolution 

• complete OME resolution 

• relapse/recurrence 

(dynamic course or

fluctuation)

• AOM

Non-Treatment Factors Influencing Outcomes:

▪ age ▪ gender 

▪ ethnicity/race ▪ socioeconomic status 

▪ hours in child care center ▪ tobacco smoke

▪ season ▪ # children in household 

▪ not breast-fed ▪ Barotrauma challenges 

▪ OME laterality ▪ hearing level 

▪ total duration of OME ▪ age at first OM 

▪ onset age-previous OME ▪ # previous OMEs 

▪ family history of OME ▪ otitis prone (AOM) 

▪ allergies ▪ prior tubes 

▪ prior adenoidectomy ▪ developmental delay 

▪ caregiver preference ▪ caregiver education 

 for treatment 

▪ examiner skill ▪ examiner type 

▪ health care setting ▪ monitoring time 

▪ monitoring frequency ▪ monitoring personnel 

▪ monitoring method 

Patient diagnosed with 

OME with one of the 

following types: 

 OME persisting after 

a discrete episode of 

AOM 

 newly diagnosed 

OME of unknown 

duration 

 OME persisting for 

weeks or months 

 unilateral OME 

lasting 3 months or 

longer 

 bilateral OME lasting 

3 months or longer 

No Treatment 

40 
Table 7: Causal Pathway for Key Question 2 on Speech and Language 

a) Do infants and preschool children with longer duration early life OME as compared to those with 

shorter duration OME have greater delays in speech and language development (receptive or 

expressive) later in life? One specific formulation of this question is: Is OME-associated 

conductive hearing loss in the first 3 years of life a risk factor for speech and language 

developmental delays? 

b) What are the risk factors that interact with the effect of OME on speech and language 

development in infants and preschool children?

Outcomes:

• speech and/or language 

development, expressive or

receptive 

• cognition, measures of 

intelligence (verbal) 

Patient with all 

types of OME or 

OM characterized 

by the presence 

of middle ear 

effusion 

Treatment Factors 

Influencing Outcomes:

Any combination of the 

following: 

• no treatment 

• tympanostomy tubes 

• adenoidectomy 

• myringotomy

• antibiotics 

• systemic steroids 

• decongestant 

• antihistamine

• N-acetyl-cysteine 

• unknown 

• others (list) 

Non-Treatment Factors Influencing Outcomes:

▪ age at first OM ▪ gender 

▪ ethnicity/race ▪ socioeconomic status 

▪ hours at child care center ▪ quality of child care 

▪ early intervention program ▪ # children in household 

▪ tobacco smoke ▪ not breast-fed 

▪ OME laterality ▪ hearing level 

 

▪ total duration of OME ≥3 months) 

▪ # previous OMEs ▪ duration of MEE 

▪ repeated or persistent vs 

 infrequent early life OME 

▪ allergies ▪ developmental delay 

▪ OM complications, e.g. 

 perforated TM, cholesteatoma 

▪ chronic illness of any type 

▪ caregiver education 

▪ quality of parent-child interaction 

▪ examiner skill ▪ examiner type 

▪ health care setting ▪ age at rechecks 

▪ frequency of rechecks ▪ primary provider 

▪ equipment type 

41 
Table 8: Causal Pathway for Key Question 3 on Hearing 

a) Do infants and preschool children with longer early-life OME as compared to those with shorter 

duration OME have permanent (or sensorineural) hearing loss later in life? One specific 

formulation of this question is “Is OME-associated conductive hearing loss in the first 3 years of 

life a risk factor for permanent (or sensorineural) hearing loss later in life?” 

b) What are the risk factors that interact with the effect of OME on hearing later in life (unilateral or

bilateral) in infants and preschool children? 

Outcome:

Long-term hearing 

level, unilateral or 

bilateral 

Non-Treatment Factors Influencing Outcomes:

▪ age at first OM ▪ gender 

▪ ethnicity/race ▪ socioeconomic status 

▪ hours at child care center ▪ quality of child care 

▪ early intervention program 

▪ tobacco smoke ▪ # children in household 

▪ not breast-fed ▪ OME laterality 

▪ hearing level 

▪ total duration of OME ≥3 months) 

▪ # previous OMEs ▪ duration of MEE 

▪ repeated or persistent vs 

 infrequent early life OME 

▪ allergies ▪ developmental delay 

▪ OM complications, 

 e.g. perforated TM, cholesteatoma 

▪ chronic illness of any type 

▪ caregiver education 

▪ quality of parent-child interaction 

▪ examiner skill ▪ examiner type 

▪ health care setting ▪ age at rechecks 

▪ frequency of rechecks ▪ primary provider ▪ equipment type 

Patient with all 

types of OME or 

OM characterized 

by the presence 

of middle ear 

effusion 

Treatment Factors 

Influencing Outcomes:

Any combination of the 

following: 

• no treatment 

• tympanostomy tubes 

• adenoidectomy 

• myringotomy

• antibiotics 

• systemic steroids 

• decongestant 

• antihistamine

• N-acetyl-cysteine 

• unknown 

• others (list) 

42 
Table 9: Causal Pathway for Key Question 4 on Diagnostic Methods 

What are the sensitivity, specificity, and predictive values for alternative methods of diagnosing OME 

compared with one of the gold standards? 

Patient 

presents 

to health 

care 

provider

Patient correctly

diagnosed with 

OME 

Patient 

incorrectly 

diagnosed with 

OME 

Patient 

truly has 

OME 

Patient 

truly does 

not have

OME

Non-Condition Factors 

Influencing Diagnostic 

Performance: 

• ageof child

• OME laterality 

• age at first OM

• anesthetic 

• developmental delay 

• type of examiner 

Patient correctly

diagnosed

without OME

Patient 

incorrectly

diagnosed

without OME

Reference Standards:

• tympanocentesis, sedated

vs non-sedated 

• MRI 

• myringotomy, sedated vs 

non-sedated 

• validated Pneumatic 

otoscopy 

• CT Scan

Diagnostic Methods:

• signs/symptoms 

• non-pneumatic otoscopy 

• pneumatic otoscopy, validated vs unvalidated examiner 

• binaural micro-tympanoscopy 

• portable tympanometer

• professional tympanometer 

• quantitative tympanometry 

• acoustic reflectometry (specify model and 

year) 

• otoacoustic emissions 

• audiometry, air vs. bone conduction 

thresholds

43 
Table 10: Ranking of Influencing Factors by Technical Experts 

44 

Key Question 1: Natural History 

Factors 

Total “Yes” Based on 

Responses of 11 Technical 

Expertsa

total duration of OME (≥3 mos) 10 

otitis prone (AOM) 9 

number of previous OMEs 9 

number of hours attending child care center 9 

tobacco smoke exposure 9 

season of the year 9 

age at first OM 9 

not breast-fed 9 

allergies 8 

age of child 8 

family history of OME 7 

number of children in household 7 

prior tubes 7 

ethnicity/race 6 

barotrauma challenges 6 

prior adenoidectomy 5 

socioeconomic status 5 

laterality, unilateral versus bilateral 4 

gender 3 

skill to diagnose (validated) 3 

age of onset of previous OME 3 

tympanometry 3 

monitoring frequency 2 

monitoring time 2 

MRI 2 

type of examiner 2 

setting of care 1 

parent/caregiver education 1 

hearing level, conductive versus sensorineural 1 

primary provider 1 

acoustic reflectometry 1 

otoscopy 1 

pneumatic otoscopy 1 

parent/caregiver preference for treatment 1 

developmental delay 0 

a

 11 technical experts responded; 1 abstained. 
Table 10 (Continued) 

45

 Key Questions 2: Speech and Language 

Factors 

Total “Yes” Based on 

Responses of 12 

Technical Experts 

developmental delay 11 

quality of child care 10 

hearing level, conductive versus sensorineural 10 

parent/caregiver education 10 

quality of parent-child interaction 10 

socioeconomic status 8 

laterality, unilateral versus bilateral 8 

early intervention program 7 

total duration of OME (≥3 mos) 7 

gender 6 

number of children in household 6 

duration of middle ear effusion 6 

chronic illness of any type 6 

number of hours attending child care center 5 

number of previous OMEs 4 

presence of active ear disease 4 

ethnicity/race 3 

tobacco smoke exposure 3 

OM complications 3 

child temperament 3 

allergies 2 

ambient noise 2 

age at first OM 1 

not breast-fed 1 

skill to diagnose (validated) 1 

type of examiner 0 

setting of care 0 

recheck times 0 

frequency of recheck 0 

primary provider 0 

tympanometry 0 

acoustic reflectometry 0 

pneumatic otoscopy 0 

MRI 0 

equipment 0 

audiometry 0 

 Note: Items in bold were added in the second poll after the first poll. 
Table 10 (Continued) 

46

Key Questions 3: Hearing 

Factors 

Total “Yes” Based on 

Responses of 12 

Technical Experts 

OM complications 10 

laterality, unilateral versus bilateral 7 

hearing level, conductive versus sensorineural 7 

developmental delay 6 

presence of active ear disease 6 

total duration of OME (≥3 mos) 4 

number of previous OMEs 3 

duration of middle ear effusion 3 

chronic illness of any type 3 

ambient noise 3 

allergies 2 

age at first OM 1 

ethnicity/race 1 

socioeconomic status 1 

quality of child care 1 

early intervention program 1 

tobacco smoke exposure 1 

number of children in household 1 

child temperament 1 

equipment 1 

audiometry 1 

gender 0 

number of hours attending child care center 0 

not breast-fed 0 

parent/caregiver education 0 

quality of parent-child interaction 0 

skill to diagnose (validated) 0 

type of examiner 0 

setting of care 0 

recheck times 0 

frequency of recheck 0 

primary provider 0 

Tympanometry 0 

acoustic reflectometry 0 

pneumatic otoscopy 0 

MRI 0 

Note: Items in bold were added in the second poll after the first poll. 
Table 10 (Continued) 

47

Key Question 4: Diagnostic Tests

Factors 

Total “Yes” Based on 

Responses of 11 

Technical Expertsa

age of child 11 

otolaryngologist 6 

nurse practitioner 5 

pediatrician 5 

family physician 5 

laterality, unilateral versus bilateral 5 

anesthetic 5 

age at first OM 5 

developmental delay 4 

physician assistant 4 

others 3 

a

 11 technical experts responded; 1 abstained. 
Table 11: Reason for Rejection of Titles/Abstracts at Initial Screening (N=3,200) 

Reason Code Reason for Rejection Number 

(Percent) of 

Citations 

R0 Written in non-English language 170 ( 5.3%) 

R1 Case report/editorial/letter/

clinical/overview/practice guidelines/consensus

statements 

459 (14.3%) 

R2 Non-human subjects 19 ( 0.6%) 

R3 Study condition not OM 804 (25.1%) 

R4 Age of study population >12 yearsa 57 ( 1.8%) 

R5 Study population exclusively on any one of the following: 

Craniofacial defects, primary mucosal disorders,

Immunodeficiencies, or Down or other genetic 

syndromes

 15 ( 0.5%) 

R7 Any key questions not addressed 697 (21.8%) 

R8 Duplicate citation 9 ( 0.3%) 

a The age limit was later extended to 22 years of age for Questions 2 and 3. 

48 
Table 12: Reason for Rejection of Full-Length Articles at Secondary Review

Reason 

Code 

Reason for 

Rejection 

Cochrane 

and 

Medline 

N=614 

AAP Data

Files 

N=29 

Symposia 

on OME 

N=107 

Technical 

Experts 

N=17 

Articles

and 

books 

N=31

Total 

N=798a

R0 Non-English language 1 0 0 0 0 1 ( 0.1%) 

R1 Case report/editorial/

letter/clinical/

overview/ 

practice guidelines/ 

consensus statements 

142 24 22 4 17 209 (26.2%)

R2 Non-human subjects 4 0 0 0 2 6 ( 0.8%) 

R3 Study condition not 

OM 

33 0 0 2 2 37 ( 4.6%) 

R4 Age of study 

population >22 years 

0 0 2 0 1 3 ( 0.4%) 

R5 Study population

exclusively one of the 

following: craniofacial 

defects, primary 

mucosal disorders,

immunodeficiencies, 

or Down or other 

genetic syndromes 

3 0 1 2 0 6 ( 0.8%) 

R7 Key questions not 

addressed 

354 5 74 9 2 444 (55.6%)

R8 Duplicate citation 39 0 3 0 7 49 ( 6.1%) 

R9 Data not abstractable 

from article 

38 0 5 0 0 43 ( 5.4%) 

a

 3 incorrect citations not included. 

49 
Table 13: Results of Secondary Screening of Full-Length Articles 

Cochrane

and 

Medline 

AAP 

Data

Files 

Symposia 

Proceedings 

on OME 

Technical 

Experts 

Articles

and 

books 

All 

Sources 

Total Citations 3200 1441 159a 39 40 4879 

Number of 

articles

reviewed at 

secondary

screening 

975b 32 159 36 40 1242 

Number 

accepted after 

secondary

screening 

372 3 52 19 5 451 

Question 1 

Question 2 

Question 3 

Question 4 

127 

 74 

157 

 69 

 0 

 1 

 2 

 0 

 14 

 20 

 22 

 4 

 0 

 17 

 2 

 0 

 0 

 0 

 3 

 2 

 141 

 112 

 186 

 75 

Total of above c 427 3 60 19 5 514 

a

 Exact number of citations not determined. b

 Four cases previously rejected because of age limit >12 were added to the original 971 accepted citations. c

 The ‘total of above’ number can exceed the number accepted because an article can address more than one question. 

50 
Table 14: Results of Tertiary Screening of Full-Length Articles for Analysis 

Accepted at 

Secondary Screening 

Abstracted in Evidence Tables 

 449 114 (25%) 

Question 1 

Question 2 

Question 3 

Question 4 

 141 

 112 

 186 

 75 

 38 (27%) 

 21 (19%) 

 8 ( 4%) 

 52 (69%) 

Total of above a 514 119 (23%) 

a

 An article can address more than one question.

51 
Table 15: Peer Review Panel 

Peer Reviewer Area of Expertise Affiliation/Location 

Howard Bauchner, M.D. General Pediatrics Child and Adolescent Health Scholar in 

Residence Agency for Healthcare Research and 

Quality 

Hanan S. Bell, Ph.D. Methodology reviewer Seattle, WA 

Alfred O. Berg, MD, MPH Family Medicine University of Washington, Seattle, WA 

Patricia A. Fall, MS, CRNP Nurse Practitioner Wexford, PA 

George A. Gates, MD Otolaryngology University of Washington, Seattle, WA 

Janice Goertz, RN, CPNP Nurse Practitioner Portage, MI 

Judith Gravel, PhD Hearing and Speech Albert Einstein College of Medicine, Bronx, NY 

 

Mark P. Haggard, Ph.D. Hearing/ Institute for Hearing Research, Nottingham, 

Psychoacoustics UK 

Vic Hasselblad, Ph.D. Meta-analysis reviewer Duke University, Durham, NC 

Tracy Lieu, MD Pediatrician/Health PlanHarvard Pilgrim Health Care, Boston, MA 

Martin C. Mahoney, MD, Ph.D. Family Medicine DeGraff Family Medicine, North Tonawanda, NY 

A. Richard Maw MS FRCS Otolaryngology Bristol Royal Infirmary, Bristol UK 

Robert Ruben, MD Otolaryngology Montefiore Medical Center, Bronx, NY 

Anne GM Schilder, MD, Ph.D. Otolaryngology University Medical Center Utrecht, The 

Netherlands 

Steve Shelov, MD Pediatrics Scarsdale, N.Y 

Sylvan Stool, MD Otolaryngology The Children’s Hospital, Denver, CO 

Robin Yurk, MD, MPH Consumer/Health Plan Community Clinic, Inc. Rockville, MD 

Dr. J.O.M. Zaat (Joost Zaat) Methodology reviewer Purmerend, The Netherlands 

____________________________________________________________________________________
Table 16: Instructions for Reviewing Draft Evidence Report 

Enclosed is a draft evidence report on the diagnosis and treatment of otitis media with effusion. You may 

make your comments either directly on the draft evidence report, or on a separate sheet of paper. If you 

choose to record your comments on a separate piece of paper, please use the page and paragraph

number to identify to which part of the report your comments pertain.

We ask that you consider the following questions while you read this report. We realized that some of the 

questions may not pertain to your area of expertise. Please feel free to comment only on those that you 

feel most suited to answer. 

1. Overall evaluation

Is it clear what we did? You may agree or disagree with our methods, findings, or conclusions, but you 

should be able to understand what we did in order to produce this report. 

2. Methodology

Are the methods we used appropriate: 

a) for identifying the key questions of interest from the panel of technical experts? 

b) for searching and reviewing the identified literature? 

c) for synthesizing the literature? 

3. Evidence

a) Did we miss any crucial pieces of information in our literature search? 

b) Does the evidence support the conclusions? 

4. Utility

Would you find this information to be useful if you had to develop clinical practice guidelines or medical 

review criteria for diagnosis and treatment of otitis media with effusion in children?

53 
Chapter 3. Results 

Key question 1: What is the Natural History (Spontaneous 

Resolution Rate over Time without Treatment) for 

 OME persisting after a discrete episode of acute otitis media, 

 newly diagnosed OME of unknown duration (unilateral or bilateral), 

 OME persisting for weeks or months (unilateral or bilateral), 

 unilateral OME lasting 3 months or longer, 

 bilateral OME lasting 3 months or longer?

Literature Review 

 

After initial screening of 4,879 titles or abstracts, we identified 449 articles for review. After 

secondary screening of the 449 articles, we identified 141 articles that fell within the scope of 

this question. Tertiary screening identified 38 articles on prospective cohort studies for potential 

abstraction. After reassessing articles included in the systematic review by Rosenfeld (1999), we 

included three more articles for potential abstraction. We eliminated one article on r OME 

following acute otitis media which was addressed in a recent evidence analysis. A total of 26 

prospective cohort studies and one retrospective-prospective cohort study were identified among 

these 40 articles. Table 17 lists the studies and cohorts examined. Abstraction was possible 

from 33 of the 40 articles. Table 18 lists the studies referred to by Rosenfeld (1999) and their 

disposition in the present evidence-based analysis. Table 19 lists the articles excluded because 

relevant data could not be abstracted. 

Findings 

 

Evidence Table 1 presents the study characteristics, population characteristics, risk factors, 

and findings for the 27 cohort studies described in 34 articles that responded to this question. 

Table 20 presents the study quality scores for the studies included in Evidence Table 1. The 

quality scores (see Methods) for these studies fell at the low end of the possible range of 

1(lowest) –to 6(highest). Three of the cohort studies had a score of 4, sixteen had a score of 3, 

seven had a score of 2, and one had a score of 1. 

Although we accepted these 27 studies for the natural history analysis, half of them (thirteen) 

failed to document that the subjects had received no medical or surgical treatment during the 

course of the study that could affect the outcome of OME. In the three studies that claimed that 

their subjects received no treatment, the investigators failed to document how adherence was 

maintained or confirmed. In studies of eleven cohorts, the authors mentioned that children 

received antibiotics or underwent surgical procedures that could affect OME outcome. In those 

studies that reported numbers of children who received treatment, the proportion was relatively 

55 
small compared to the total number studied. Except in two studies, results were not stratified by 

treatment condition, even in those articles that reported treatments received by study subjects. 

Further, the majority of studies, but not all, used tympanometry as the sole diagnostic test of 

OME. However, the criteria for each tympanogram type in these studies are similar (Table 21). 

Table 21 lists the pressure and immittance parameters for tympanogram types for those studies 

that used tympanometry as the sole diagnostic criteria for OME. 

Tables 22 and 23 provide OME resolution rates by ear, as reported in the majority of the 

studies, and by child for those studies in which data could be stratified by unit of analysis (ear vs. 

child), age group, and OME type respectively. For clarity, we have listed only those resolution 

intervals with onset at the study’s inception. For clarity, when tympanometry was the diagnostic 

method, counts for tympanogram type B transition to A are shown when provided, while other 

tympanogram transitions are shown in Evidence Table 1. 

Data from a number of studies were reported in a format that made them unusable for 

quantitative syntheses. Ten studies were eliminated from quantitative syntheses, because they 

failed to stratify by age (i.e. less than and greater than 3 years old). Day-to-day variability in 

tympanogram types was described in a cohort of kindergarten children examined on each 

weekday for 30 days (Moller and Tos,1990). Ernston and Sundberg (1984) described a group of 

children who participated in a controlled trial of children with OME that persisted for at least 3 

months; they found that 15.3 percent (11 of 72) of such children had OME resolution by five 

weeks followup. A study of children with OME that persisted for 3 months or more, showed 45 

percent (49 of 109) OME resolution at 2.5 year followup (Leiberman and Bartal,1986). 

However, the investigators acknowledged that middle-ear effusion noted after such a long 

interval could be either persistent or recurrent. Birch and Elbrønd (1984) and Zielhuis, Rach, 

and van den Broek (1990) derived equations to describe the OME resolution rates they observed 

in their cohorts, but we were unable to abstract actual counts from these articles. 

We performed two sets of meta-analyses that matched age groups, unit of analysis, outcome

type, and time to resolution in three or more cohorts. All meta-analyses presented here used the 

‘ear’ as the unit of analysis. Few studies considered the child or the episode as the unit of 

analysis and no meta-analyses were possible. 

Resolution at 6-Week Followup The first set of meta-analyis contains two meta-analyses 

(Table 24). The meta-analyses showed that if the criteria for resolution were tympanogram type 

B or C transition to A or by otoscopy, 42.3 percent (95% CI: 24.1%, 60.6%) of ears with newly 

diagnosed OME of unknown duration in children older than 3 years had resolution by the 6-

week exam. If the criteria for resolution were modified to tympanogram type B transition to A 

or otoscopy, the proportion of ears in children older than 3 years old with resolution at 6-week 

followup was 37.2 percent (95% CI: 1.8%, 72.5%). Spontaneous resolution rates were 

significantly different among the cohorts for both definitions. In these studies, the OME 

resolution rates were calculated by determining the proportion of children without OME at 

followup, whether or not their baseline OME had resolved and recurred at an earlier point. Thus, 

these are not cumulative resolution rates (Sly, Zambie, Fernandes et al., 1980; Lamothe, 

Boudreault, Blanchette et al., 1981).

Resolution at 3-Month Followup The second set of meta-analyses are shown in Table 25. 

The first two meta-analyses assessed resolution of OME by ear by the time of 3-month followup 

in children older than 3 years. If the criteria for resolution were tympanogram type B or C 

transition to A, the proportion of ears with resolution of newly diagnosed OME of unknown 

duration was 42.7 percent (95% CI: 29.3%, 56.1%) among children older than 3 years. If the 

56 
criteria for OME resolution were tympanogram type B transition to A, then the proportion of 

ears with resolution was 22.5 percent (95% CI: 5.9%, 39.0%). Spontaneous resolution rates were 

not significantly different among the studies in either comparison, except for Tos, Holm-Jensen, 

Sörenson, and Mogensen (1982) which had lower resolution rates. Because Fiellau-Nikolajsen 

and Lous (1979), Fiellau-Nikolajsen (1979), and Renvall, Anniansson, and Lidèn (1982) 

terminated followup whenever a child had a type A or normal tympanogram and because Tos, 

Holm-Jensen, Sörenson, and Mogensen (1982) provided data for calculation of the cumulative 

OME resolution rate, this estimate represents a cumulative resolution rate. The last three metaanalyses in Table 25 show the derivation of the cumulative resolution rates. 

Resolution Rates for Younger Age Groups Only two studies examined the resolution rates for 

each of the age groups of less than 6 months and 3-months to 3-years (see Tables 22 and 23). 

Thus, no meta-analyses for children under 3 years of age were performed. 

The Role of Influencing Factors in Resolution Similarly, because very few studies assessed 

the role of factors that might influence resolution, no meta-analyses were performed. The results 

of individual studies are summarized here: 

• Lamothe, Boudreault, Blanchette, and colleagues (1981) and Fiellau-Nikolajsen and Lous 

(1979) assessed the effects of gender and found quicker resolution among females than 

males. 

• Fiellau-Nikolajsen (1979) noted that children who received at-home care had quicker 

resolution of OME than did children in daycare. 

• Sly, Zambie, Fernandes, and colleagues (1980) compared OME resolution in small 

cohorts first studied in February with those first studied in September and found 

resolution to be more rapid in the February cohort. 

• Lamothe, Boudreault, Blanchette, and colleagues (1981) also assessed the effect of the 

side of the affected ear and noted more rapid resolution in affected right ears than 

affected left ears. 

• Portoain-Shuhaiber and Cullinan (1984) stratified by racial/ethnic origin and noted 

quicker resolution of OME in African children than in Indian or Caucasian children. 

• Moller and Tos (1990) found that different tympanometry instruments, which they 

described as impedance tympanoscopy and impedance audiometry, gave different rates of 

OME among the same group of children. 

• Zielhuis, Rach, and van den Broek (1990) found that season and age at the end of the 

episode had a statistically significant effect on OME resolution rates, while gender, upper 

respiratory tract infection, and history of AOM did not, although they presented only 

percentages without denominators. 

Summary 

57 
We found sufficient data only to analyze the rates of resolution of OME among children 

older than 3 years old. No data existed on the role of such factors as duration of OME, initial 

occurrence of AOM, or presence of OME in one vs. both ears. Data on the roles of gender, athome vs. day care, race/ethnicity, time of year, age of onset, or side of ear were too limited to 

draw any conclusions. 

Key Question 2: What Are the Effects of Early-Life OM on 

Long-Term Speech and Language Development? 

• Do infants and preschool children with longer-duration early-life OME as compared to those 

with shorter duration OME have greater delays in speech and language development 

(receptive or expressive) later in life? 

• Is OME-associated conductive hearing loss in the first 3 years of life a risk factor for speech 

and language developmental delays?

• What are the risk factors that interact with the effect of OME on speech and language 

development in infants and preschool children?

Literature Review 

After secondary screening of the 449 articles retrieved for review, we identified 112 articles 

that fell within the scope of this question. Tertiary screening identified 20 studies that fulfilled 

the 5 criteria for analysis. (Table 26) The five criteria included the following: 

 1) OM was diagnosed/assessed before the age of 3 years, 2) speech or language outcome was 

measured at or before the age of 22 years, 3) a prospective cohort study design was used, 4) OM 

was graded, and 5) speech or language outcome was measured beyond 3 years of age. Of the 20 

studies, 17 were prospective cohort studies and three (Freeark, 1992; Fischler, 1985; Paul, 1993) 

were retrospective-prospective studies in which OM history was retrospectively obtained, but 

outcome measures were prospectively obtained. We did not exclude any studies based on their 

quality. 

When we reviewed the studies included in the 1994 OME Guideline for inclusion in our 

analysis (Stool, Berg, Berman et al., 1994), we excluded six of the studies. The Friel-Patti and 

Finitzo (1990) study was excluded, because it was not a prospective cohort study and did not 

report outcomes for children over 3 years of age. The Friel-Patti (1982) study was excluded 

because no outcomes were measured in children over 3 years of age. The studies of Lous and 

Fiellau-Nikolajsen (1988) and Rach, Ziehlhuis, van Baarle, and colleagues (1991 were excluded, 

because the investigators did not measure OM severity before the age of 3 years. The Rach, 

Zielhuis, and van den Broek (1988) study was excluded, because it was not a prospective cohort 

study. The study by Wright, Sell, McConnell, and colleagues (1988) was excluded, because no 

outcomes were measured in children over 3 years of age. Finally, unlike the OME Guideline 

(Stool, Berg, Berman et al., 1994), we included the studies by Klein (1988) and Freeark (1992), 

because study quality was not one of our rejection criteria. 

 Table 27 lists the author, year and cohort of 22 prospective cohort studies that were excluded 

from our analysis because they did not report outcomes for children older than 3 years of age. 

58 
These 22 studies actually included only 12 cohorts. Relevant findings for seven of these 12 

cohorts were included in our assessment. 

Findings 

Evidence Table 2 presents the study characteristics, population characteristics, risk factors, 

and outcome findings for the 20 cohort studies that responded to this question. Speech and 

language outcomes were examined in a total of 12 cohorts of children. Of these 12 cohorts, nine 

included children primarily from specific populations, such as a particular ethnic or racial group 

or a particular socioeconomic group. It is also important to reiterate that cohorts were excluded 

if they consisted exclusively of children with craniofacial defects, primary mucosal disorders, 

immunodeficiencies, or a genetic disorder. None of the studies specifically assessed children 

who already had speech, language, or other developmental delays. One of the studies focused 

specifically on persistent bilateral OM. 

For the purpose of responding to this question, we defined early life otitis media as positive 

otitis media history prior to 3 years of age. Table 28 summarizes the definitions of positive or 

negative history of otitis media used in these studies and the diagnostic method for OM. The 

definition of positive or negative OM history varied among the studies. Some studies used 

percentage of visits during a specified time, some used number of visits with OM, some used 

days spent with effusion, while others combined various criteria. 

The age during which the outcome was measured also varied. This age ranged from one to 3 

years. The diagnostic method and the examiner also varied. Several studies based diagnosis on 

chart review or parents’ record. A few studies used pneumatic otoscopy performed by 

pediatricians, otolaryngologists, or trained professionals. 

The quality of the studies included in the evidence table is summarized in Table 29. Of the 

20 studies, five (25 percent) received a score of six of a possible of eight points; four (20 

percent) scored five points; six (30 percent) scored four points; four (20 percent) scored three 

points, and one (5 percent) scored two points. 

 Table 30 presents a summary of the key characteristics of the 20 cohort studies including the 

cohort, age of OM history, age at outcome measure, major outcome statistical analysis, outcome

measure of interest, diagnostic procedure(s), and notes. The table is organized by the outcome

measures for this key question, namely cognition, expressive language, receptive language, 

expressive speech, and receptive speech. Since multiple outcomes could be included in one 

study, a study may appear in several rows. The entries in the “Test” column should be 

interpreted with caution, because subtests versus global tests were not distinguished. 

The factor we used to determine which studies to examine further by meta-analysis was the 

major outcome measure, which indicates the type of statistical measured used. Whenever three 

or more studies reported the same outcome measure, we considered pooling the data. Based on 

this strategy, we conducted three possible meta-analyses to derive the pooled difference between 

positive and negative early-life otitis media for: expressive language development, receptive 

language development, and development of cognitive verbal intelligence. 

Expressive Language Development Table 31 presents the findings of the three cohort studies 

that addressed expressive language development. All three studies measured OM history prior to 

3 years of age. Although the pooled standardized mean difference showed an increase of about 

14.5 percent (95% C.I.: -49.2%, 20.2%) of a standard deviation in the expressive language 

59 
measure for the group of children with no early-life OM history compared with those with a 

positive history, this pooled estimate is not significantly different from zero. Thus, the available 

data do not support the hypothesis that an OM history prior to 3 years of age has an effect on 

expressive language development. However, the 95% confidence intervals on our pooled results 

do not exclude a clinically important effect size of almost 0.5, meaning no strong conclusions 

can be drawn. The Chi-squared test of heterogeneity showed that the standardized difference 

was not significantly different among the studies. However, the ages at which outcome was 

measured and the tests used were not uniform across the studies. 

Receptive Language Development Table 32 presents the findings of the four cohort studies 

that addressed receptive language development. All four studies measured OM history at less 

than 3 years of age. Although the pooled standardized mean difference showed an increase of 

about 10.3 percent (95% C.I.: -28.9%, 49.5%) of a standard deviation of the receptive language 

measure in the group of children with no early-life otitis media history, this pooled estimate is 

not significantly different from zero. Thus, the available data do not support the hypothesis that 

an OM history prior to 3 years of age has an effect on receptive language development. 

However, the 95% confidence intervals on our pooled results do not exclude a clinically 

important effect size of almost 0.5, meaning no strong conclusions can be drawn. The Chisquared test of heterogeneity showed that the standardized mean difference was not significantly 

different among the studies. However, the age at which outcome was measured and the test used 

were not uniform across the four studies. In addition, although the racial/ethnic composition was 

not reported precisely, one of the studies included primarily African-American children, another 

primarily American Indian children, and the third primarily Caucasian children in private 

practice. 

Cognitive Verbal Intelligence Table 33 presents the findings of the three cohort studies that 

addressed development of cognitive verbal intelligence. All three studies examined cognitive 

verbal intelligence, and all measured OM history at less than 3 years of age. Although the pooled 

standardized mean difference showed an increase of about 23 percent (95% C.I.: -20%, 65%) of 

a standard deviation in the expressive language measure in the group of children with no early 

life OM history, this pooled estimate is not significantly different from zero. Thus, the available 

data do not support the hypothesis that an OM history prior to 3 years of age has an effect on the 

development of cognitive verbal intelligence. However, the 95% confidence intervals on our 

pooled results do not exclude a clinically important effect size of almost 0.5, meaning no strong 

conclusions can be drawn. The Chi-squared test of heterogeneity showed that the standardized 

mean difference was not significantly different among studies. However, the age at which 

outcome was measured and the test used were not uniform across the studies. Further, two of the 

study populations were primarily African-American. The third study population was of lower 

socioeconomic status. 

Summary 

The data do not support an effect of early-life OME on language development or cognitive 

verbal intelligence. However, differences among the cohorts and study conditions and the wide 

60 
95% confidence intervals make it difficult to conclude that there is no effect. We found 

insufficient data to assess early-life OME on speech development. 

Key Question 3: What are the Effects of Early-Life OM on 

Long-Term Hearing? 

• Do infants and preschool children with longer duration early life OME as compared to 

those with shorter duration OME have permanent (or sensorineural) hearing loss later in 

life? One specific formulation of this question is: Is OME-associated conductive hearing 

loss in the first 3 years of life a risk factor for permanent (or sensorineural) hearing loss 

later in life? 

• What are the risk factors that interact with the effect of OME on hearing later in life 

(unilateral or bilateral) in infants and preschool children?

Literature Review 

After secondary screening of the 449 articles we retrieved for review, we identified 186 

articles that fell within the scope of this question. Tertiary screening identified 12 studies that 

fulfilled the five criteria for analysis. The five criteria included 1) OM was diagnosed/assessed 

before the age of 3 years, 2) hearing outcome was measured at or before the age of 22 years, 3) a 

prospective cohort study design was used, 4) OM was graded, and 5) hearing outcome was 

measured after 3 years of age. Of the 12 cohort studies, four were excluded from further analysis. 

The reasons for exclusion of the four studies are presented in Table 34. Table 35 lists the eight 

studies included in the evidence table and considered for analysis. Table 36 lists the author, 

year, and cohort of 10 studies that were not included in the analysis because they failed to report 

findings for children over 3 years of age. 

Findings 

Evidence Table 3 presents the study characteristics, population characteristics, risk factors, 

and findings of the eight cohort studies considered for this question. 

 Table 37 summarizes the definitions of positive and negative history of OM used in these 

studies and the diagnostic method for OM. The definitions of positive and negative OM history 

varied from one study to another. These variations were similar to those identified in the studies 

of speech and language development. 

The study quality of the eight studies included in Evidence Table 3 is summarized in Table 

38. Of the eight studies, 1 (12.5 percent) received a score of 6 of a possible of 8 points; 4 (50 

percent) scored 5 points; 2 (25 percent) scored 4 points; and one (12 percent) scored 2 points. 

The age at which OM history was taken, age at outcome measure, and type of outcome

measure for the 8 cohort studies are displayed in Table 39. With the various combinations of 

age at outcome and type of outcome measure that characterized the studies, only one 

combination, percentage of conductive hearing loss at 6 to10 years of age, was considered 

sufficiently clinically similar to justify statistical pooling: four studies reported this outcome

61 
measure at this age range. Three of the four studies (Fischler 1985, Harsten 1993 and Sorri 1995) 

reported treatment, including oral antibiotics, myringotomy, and tympanostomy tube, for OM 

episodes; Kaplan (1973) did not address treatment. Sorri (1995) used 20 dB as the airconduction threshold above which hearing loss was defined. The other three studies used 25 dB 

as the threshold. 

We conducted two meta-analyses, one including all four studies and another that excluded 

the Sorri 1995 studies, which used a different threshold for hearing loss from that of the other 

three studies. The meta-analysis findings are reported in Table 40. The pooled risk of 

conductive hearing loss among 346 children who had early-life OM was 22 percent (95% CI: 7% 

to 36%), compared with 6 percent (95% CI: 1% to 12%) among 237 children who did not have a 

history of early-life OM. The pooled difference in rate of hearing loss between those with an 

early-life OM history and those without was 11 percent (95% CI: 3% to 19%), and the pooled 

risk ratio was 2.6 (95% CI: 1.6 to 4.2). Thus, an early-life history of OM was significantly 

associated with conductive hearing loss. Neither the studies pooled for the rate difference nor 

the studies pooled for the risk ratio were statistically heterogeneous. Figure 1 presents the 

shrinkage plot and Figure 2 presents the funnel plot for the rate difference and Figure 3 and 

Figure 4 present similar plots for the risk ratio of hearing loss. These figures show that negative 

early-life OM history is more favorable in term of conductive hearing loss at age 6 to 10 years. 

The funnel plots for the risk difference and the risk ratio (Figure 2 and Figure 4, respectively) 

showed no indication of publication bias. Neither the adjusted rank correlation tests (Begg, 

1999) nor the regression asymmetry test (Egger, 1997) indicated publication bias for either 

statistic (p>0.99 for the risk difference; p=0.31 for the risk ratio; p=0.71 for the risk difference; 

p=0.28 for the risk ratio; respectively). However, these results should be interpreted with 

caution. Only four studies were included in the analysis. Moreover, each of these cohorts 

included relatively homogeneous populations of children, one from Finland, another from

Sweden, one primarily of American Indian children, and another primarily of Eskimo children. 

The sensitivity analysis that excluded the Sorri (1995) study did not change the conclusions. 

However, the exclusion of the Sorri study reduced the variability of the rate difference and 

lowered the pooled difference in rate of conductive hearing loss between those with a positive 

OM history and those without from 11 percent (95% CI: 3% to 19%) to 8 percent (95% CI: 4% 

to 13%). 

Summary

The results support that history of early-life OME is associated with increased risk for 

conductive hearing loss. However, the number of studies with similar outcome measures is 

small. We found insufficient data to assess the early-life OM on permanent hearing loss. 

Key Question 4: Diagnostic Methods for OME 

What are the sensitivity, specificity, and predictive values for alternative methods of 

diagnosing OME compared with one of the reference standards? 

62 
These methods include, but are not limited to: 

• signs/symptoms 

• non-pneumatic otoscopy 

• pneumatic otoscopy, validated or non-validated examiner 

• binaural micro-tympanoscopy 

• portable tympanometry 

• professional tympanometry 

• quantitative tympanometry 

• acoustic reflectometry (specify model and year) 

• otoacoustic emissions 

• audiometry, air or bone conduction thresholds. 

Literature Review 

After secondary and tertiary screening of the 449 articles we retrieved for review, we 

identified 75 articles that fell within the scope of this question. When we compared our list with 

the 1994 OME Guideline (Stool, Berg, Berman et al., 1994), we found five studies that were 

included in the 1994 OME Guideline but not in our assessment. We excluded the Kaleida (1992) 

and the Shurin, Pelton and Finkelstein (1977) studies, because data were not abstractable. The 

McDermott and Giebink, Le, and colleagues (1983) and the Teele and Teele (1984) studies were 

excluded, because they did not address the scope of this question. The Lampe, Weir, Spier, and 

colleagues (1985) study was excluded, because it was a duplicate of another study. We included 

three studies that were rejected by the developers of the 1994 OME Guideline, because we did 

not reject any studies based on study quality. These were the studies by Haughton (1977), 

Karma (1989), and Marchart (1986). 

Of the 75 articles accepted for data abstraction, we included 52 studies in our assessment 

(listed in Table 41). Table 42 lists the reasons for exclusion of the 23 remaining articles. 

Evidence Table 4 presents the study characteristics, the characteristics of the study population, 

and the study findings of each of the 52 studies included. 

Of the 52 studies, 33 (63 percent) scored three points or fewer on our six-point quality scale. 

Of the 19 studies that scored more than three points, 15 studies scored four points, three studies 

scored five points, and one study scored six points. Most of the studies in this group are of poor 

quality, a finding that replicates those of Lijmer, Mol, Heisterkamp and colleagues (Lijmer, Mol, 

Heisterkamp et al., 1999). 

63 
Findings 

Evidence Table 4 presents the sensitivity, specificity, positive predictive value, negative 

predictive value, accuracy, and prevalence of OME in the cohort for each comparison of 

diagnostic methods and reference standards listed within the scope of this assessment. 

 Table 43 summarizes the number of comparisons for each diagnostic method and reference 

standard pair. On the basis of these numbers we selected groups of three or more studies for 

meta-analysis, from which we derived pooled random effect estimate, 95% confidence intervals, 

and measure of heterogeneity for sensitivity, specificity, positive predictive value, negative 

predictive value, accuracy, and prevalence. 

 Tables 44 through 52 present the results of the meta-analyses that compare sensitivity, 

specificity, and prevalence rate for acoustic reflectometry at <=5 or >5 RU (reflective units), 

pneumatic otoscopy, portable tympanometry, professional tympanometry using acoustic reflex at 

500 or 1000 Hz, professional tympanometry using static compensated acoustic admittance at 0.1, 

professional tympanometry using static compensated acoustic admittance at 0.2, professional 

tympanometry using static compensated acoustic admittance at 0.3, professional tympanometry 

using B curve as abnormal, and professional tympanometry using B or C2 curves as abnormal, 

respectively, using myringotomy as the reference standard. Findings excluding duplicates are 

summarized in Table 53. The receiver-operator characteristic points that correspond to 

sensitivity versus (1-specificity) are plotted in Figure 5. The receiver operator characteristic 

points showed that pneumatic otoscopy was closest to the optimal operating point where both 

sensitivity and specificity would be 100 percent. 

Among the nine diagnostic methods, pneumatic otoscopy and professional tympanometry 

(using flat or B or C2 curve as abnormal) had the highest sensitivity at 93.8 percent (95% CI: 

91.4, 96.3) and 93.8 percent (95% CI: 91.1, 96.4) compared with myringotomy, respectively. 

The diagnostic test with the highest specificity was professional tympanometry (using static 

compensated acoustic admittance at 0.1) at 95.0 percent (95% CI: 88.5, 100). 

If we consider both sensitivity and (1 minus specificity) in the receiver-operator 

characteristic display in Figure 5, pneumatic otoscopy is closest to the optimal operating point 

where both sensitivity and specificity are 100 percent. The pooled sensitivity was 94 percent 

(95% CI: 91%, 96%), and the pooled specificity was 80 percent (95% CI: 75%, 86%). These 

findings were based on 2,694 children from 7 studies that reported a pooled prevalence of OME 

of 63 percent (95% CI: 58%, 67%). The estimated prevalence rates ranged from 56 percent to 71 

percent, which indicated significant heterogeneity (p<0.001). We used the pooled sensitivity and 

specificity for pneumatic otoscopy and derived the positive and negative predictive values for 

various prevalence levels. Figure 6 provides such a plot. 

Table 54 shows an analysis of the study quality of the diagnostic tests included in the metaanalyses. With the exception of the study by Babonis (Babonis, Weir, Kelly, 1991), which 

scored five, all studies scored four or less out of a maximum of six possible points. The majority 

of the studies did not fulfill criterion four on representativeness of patient sample in clinical 

practice or criterion five on determination of reproducibility of test results. Among the seven 

studies used to derive the pooled estimates of sensitivity and specificity for pneumatic otoscopy, 

two studies scored the minimum of one point, two scored two points, one scored three points, 

and two scored four points. 

64 
 In Table 54, we also compare the qualifications of the examiner performing the diagnostic 

test for each study. Of the seven studies in the comparison between pneumatic otoscopy and 

myringotomy, two studies did not specify the test performer, one study specified that a senior 

registrar and a senior house officer performed the test, and the remaining four specified that 

either a pediatrician or an otolaryngologist performed the test. However, whether the test 

performer was trained or untrained was not specified. 

Summary

The meta-analyses revealed that pneumatic otoscopy and professional tympanometry had the 

highest sensitivity compared with myringotomy. While the diagnostic test with the highest 

specificity was professional tympanometry (using static compensated acoustic admittance at 

0.1), pneumatic otoscopy optimized both sensitivity and specificity. However, the poor quality of 

many of the studies included in the analysis must be considered. Moreover, most studies failed 

to provide enough information to assess the qualifications of testers.

65 
66 

Table 17: Cohorts and Articles Relevant to Question 1 (n=40) 

Cohort Identifier Relevant Articles (ID, authors, year) Comments 

Birch 862 Birch and Elbrønd (1984) 0.75- to 7-year old children followed from 1/1982 to 4Casselbrant I 1000 Casselbrant, Brostoff, Ashoff, and 

Bluestone (1985) 

2929 Casselbrant, Brostoff, Ashoff, and Bluestone (1990) 

2- to 5-year old children followed from 9/1981 to 8/19

Casselbrant II 2929 Casselbrant, Brostoff, Ashoff, and 

Bluestone (1990) 

5- to 12-year old children followed from 9/1984 to 5/1

Ernston 1202 Erston and Sundberg (1984) Children 1- to 11-years old embedded in a controlled Fiellau-Nikolajsen I 

1237 Fiellau-Nikolajsen and Lous (1979) 1235 Fiellau-Nikolajsen (1979) 1242 Fiellau-Nikolajsen (1981) 3051 Lous and Fiellau-Nikolajsen (1988)a

Children in Hjoerring, Denmark first examined in 1976

Fiellau-Nikolajsen II 

1235 Fiellau-Nikolajsen (1979) 1245 Fiellau-Nikolajsen (1983) 

Children in Hjoerring, Denmark first examined in 1978

Fiellau-Nikolajsen III 

1777 Lous and Fiellau-Nikolajsen (1981) Children in Hirtshals and Sindal, Denmark first exami

Holmquist 1494 Holmquist, Fadala, and Qattan (1987) 7- to 9.5-year old children followed 2/1983 to 4/1983. Lamothe 1714 Lamothe, Boudreault, Blancette, 

Tetreault, and Poliquin (1981) 

First graders followed over a 6 week period in 1979. 

Leiberman 1735 Leiberman and Bartal (1986) 2- to 12-year old children who had a follow-up exam a

ventilating tube placement. 

Marchisio 9 Marchisio, Principi, Salpietro, Boschi, Chetri, 

Caramia, Longhi, Reali, Meloni, DeSantis, Sacher, and Cupido (1998) 

Primary school children followed for 12 weeks after tha subset were randomized to a placebo group for anoup. 

Mills 1927 Mills and Vaughan-Jone (1992) Prospective single cohort embedded in a comparative 

14-years old who had a follow-up exam about 2 mont

PortoianShuhaiber 2184 Portoian-Shuhaiber and Cullinan (1984) 5- to 6-year old children followed for 10 weeks in 197Renvall I 2240 Renvall, Lidén, Jungert, and Nilsson 

(1978) 

10- to 11- year old children examined after a 3-year 

Renvall II 2242 Renvall, Anniansson, and Lidén (1982) 4-year old children followed over a 12 week period in Reves 2243 Reves, Budgett, Miller, Wadsworth, and 

Haines (1985) 

3- to 6-year old children followed 11/1983 to 2/1984. 

Roberts 2262 Roberts, Johnson, Carlin, Turczyk, 

Karnutta, and Yaffee (1995) 

Newborns followed for 2 months after birth. 

Robinson 2270 Robinson, Allen, and Root (1988) Infants followed for 6 weeks. 

a The article did not include abstractable data relevant to the specific Question 1 outcome measures. 
67 

Table 17: Cohorts and Articles Relevant to Question 1 (n=40) (Continued) Cohort Identifier Relevant Articles Comments Sly I 2457 Sly, Zambie, Fernandes, and Frazer 

(1980) 

4- to 5-year old children recruited in 2/1977. 

Sly II 2457 Sly, Zambie, Fernandes, and Frazer 

(1980) 

4- to 5-year old children recruited in 9/1977. 

Tos I 1486 Holm-Jensen, Sørenson, and Tos 

(1981) 

2636 Tos (1981) a

543 Tos, Holm-Jensen, Sørenson, and Mogensen (1982) 2639 Tos (1983) a2642 Tos (1984) a4834 Tos (1984) a4835 Tos (1988) a

Children born in 1975 and followed from 5/1979 to 2/

Tos II 2629 Tos (1979) 

2190 Poulsen and Tos (1980) 2631 Tos (1980) a

2634 Tos (1980) 2593 Thomsen and Tos (1981) 2639 Tos (1983) a2642 Tos (1984) a4834 Tos (1984) a4835 Tos (1988) a

Children born in 1976 and followed from 11/1977 to 2

Tos III 2189 Poulsen and Tos (1978) 

2627 Tos (1979) 2631 Tos (1980) a

2634 Tos (1980) 2639 Tos (1983) a2642 Tos (1984) a4834 Tos (1984) a4835 Tos (1988) a

Children born in 1977 and followed from 1-2/1977 to 

Tos IV 1946 Moller and Tos (1990) Children checked daily for 30 days. van Balen 91 van Balen, De Melker, Touw-Otten 

(1996) 

6-month to 6-year old children followed for 3 months 

Williamson 2791 Williamson (1994) 5- to 8-year old children followed from 1988-1989 to 1Wilmot 2795 Wilmot (1988) 6-month to 10-year old children were followed for 12 

OME after AOM. 

Zielhuis 2863 Zielhuis, Rach, and van den Broek 

(1990) 

 2- to 4-years old children followed from 1982-1983. 

a The article did not include abstractable data relevant to the specific Question 1 outcome measures. 
 Table 18: Disposition of Articles From Rosenfeld's Natural History Assessment 

68 

ID Number 

Author Year Included Excluded Reason for Exclusion From Asse

1000 Casselbrant 1985 X1238, 1240 

Fiellau-Nikolajsen 1980 X 1238 is a study of tympanometry a

1240 is the same cohort as in 1245 present sufficient data tracking indepisodes of OME. 

2242 Renvall 1982 X2593 Thomsen 1981 X 2593 uses same cohort as 2190, 2

2642, 4834, and 4835. 

2627 Tos 1979 X2634 Tos 1980 X543 Tos 1982 X 543 uses same cohort as 1486, 26

4834, and 4835. 

2791 Williamson 1994 X2863 Zielhuis 1990 X2857 Zeisel 1995 X 2857 included 13% with purulent O

administration and other interventiopurulent or non-purulent OME. Insindividual cases or episodes of OM

2243 Reves 1985 X91 van Balen 1996 X Randomized controlled trial with an 

watchful waiting period of children 

1777 Lous 1981 X
 Table 18: Disposition of Articles From Rosenfeld's Natural History Assessment 

68 

ID Number 

Author Year Included Excluded Reason for Exclusion From Asse

1000 Casselbrant 1985 X1238, 1240 

Fiellau-Nikolajsen 1980 X 1238 is a study of tympanometry a

1240 is the same cohort as in 1245 present sufficient data tracking indepisodes of OME. 

2242 Renvall 1982 X2593 Thomsen 1981 X 2593 uses same cohort as 2190, 2

2642, 4834, and 4835. 

2627 Tos 1979 X2634 Tos 1980 X543 Tos 1982 X 543 uses same cohort as 1486, 26

4834, and 4835. 

2791 Williamson 1994 X2863 Zielhuis 1990 X2857 Zeisel 1995 X 2857 included 13% with purulent O

administration and other interventiopurulent or non-purulent OME. Insindividual cases or episodes of OM

2243 Reves 1985 X91 van Balen 1996 X Randomized controlled trial with an 

watchful waiting period of children 

1777 Lous 1981 X
 Table 19 Question 1: Articles Excluded During Data Abstraction 

ID# Author Year Reason Not Included 

705 Aniansson 1985 Screening study over 2 years. Some retest of same subjects, 

but no control over treatment. 

3051 Lous 1988 Data not abstractable as presented. Available counts are in 

essential agreement with articles 1235, 1237, and 1242 apart 

from minor differences in number of tympanogram types, e.g. 

type A in Jan 1975 (629 in articles 1235, 1237, and 3051 and 

631 in article 1242) and types B, C1, and C2 in Jun-July 1976 

(32, 31,, and 42 respectively in articles 1235, 1242, and 3051 

and 37, 28, and 40 respectively in article 1237). 

2578 Teele 1980 Data not abstractable; data on persistent OME after AOM are 

not presented and cannot be derived. 

2631 Tos 1980 Article does not present any new information other than the 

actual initial counts of tympanogram types for the 1976 and 

1977 Tos cohorts utilized in the evidence tables for article 

2629 and 2627. 

2636 Tos 1981 Data not abstractable as presented relative to the data on 3- 

and 6-month follow-up presented in article 1486. Individual 

cases of type B, C1, or C2 tympanograms cannot be tracked 

from 2/1979 to 11/1979 or 2/1980. 

2639 Tos 1983 The only relevant new information is that the authors mention 

that in the 1976 cohort, 50% of tympanogram type B changed 

to types A or C over the first 3 months of the study. 

However, the number with type B who presented for the 3-

month follow-up exam is not given so per cent change cannot 

be calculated. 

2642 Tos 1984 Article does not present any abstractable data relevant to Q1. 

4834 Tos 1984 Article does not present any new data relevant to Q1. 

4835 Tos 1988 Article does not present any new data relevant to Q1. 

2795 Wilmot 1988 Article presented data on OME following AOM which was 

eliminated as a condition of interest because it had been 

studied in a recent evidence analysis. 

 

69 
 Table 19 Question 1: Articles Excluded During Data Abstraction 

ID# Author Year Reason Not Included 

705 Aniansson 1985 Screening study over 2 years. Some retest of same subjects, 

but no control over treatment. 

3051 Lous 1988 Data not abstractable as presented. Available counts are in 

essential agreement with articles 1235, 1237, and 1242 apart 

from minor differences in number of tympanogram types, e.g. 

type A in Jan 1975 (629 in articles 1235, 1237, and 3051 and 

631 in article 1242) and types B, C1, and C2 in Jun-July 1976 

(32, 31,, and 42 respectively in articles 1235, 1242, and 3051 

and 37, 28, and 40 respectively in article 1237). 

2578 Teele 1980 Data not abstractable; data on persistent OME after AOM are 

not presented and cannot be derived. 

2631 Tos 1980 Article does not present any new information other than the 

actual initial counts of tympanogram types for the 1976 and 

1977 Tos cohorts utilized in the evidence tables for article 

2629 and 2627. 

2636 Tos 1981 Data not abstractable as presented relative to the data on 3- 

and 6-month follow-up presented in article 1486. Individual 

cases of type B, C1, or C2 tympanograms cannot be tracked 

from 2/1979 to 11/1979 or 2/1980. 

2639 Tos 1983 The only relevant new information is that the authors mention 

that in the 1976 cohort, 50% of tympanogram type B changed 

to types A or C over the first 3 months of the study. 

However, the number with type B who presented for the 3-

month follow-up exam is not given so per cent change cannot 

be calculated. 

2642 Tos 1984 Article does not present any abstractable data relevant to Q1. 

4834 Tos 1984 Article does not present any new data relevant to Q1. 

4835 Tos 1988 Article does not present any new data relevant to Q1. 

2795 Wilmot 1988 Article presented data on OME following AOM which was 

eliminated as a condition of interest because it had been 

studied in a recent evidence analysis. 

 

69 
Table 20 Study Quality for Studies Included in Evidence Table on Natural History

ID Author Year Study Quality Scorea

862 Birch 1984 3 (1,1,1,0,0,0) 

1000 Casselbrant 1985 3 (1,1,1,0,0,0) 

2929 Casselbrant 1990 3 (1,1,1,0,0,0) 

1202 Ernstson 1984 2 (1,0,0,1,0,0) 

1235 Fiellau-Nikolajsen 1979 4 (1,1,1,0,0,1) 

1237 Fiellau-Nikolajsen 1979 4 (1,1,1,0,0,1) 

1242 Fiellau-Nikolajsen 1981 4 (1,1,1,0,0,1)

1245 Fiellau-Nikolajsen 1983 3 (1,1,1,0,0,0) 

1486 Holm-Jensen 1981 3 (1,1,1,0,0,0) 

1494 Holmquist 1987 3 (1,1,1,0,0,0) 

1714 Lamothe 1981 4 (1,1,1,1,0,0) 

1735 Leiberman 1986 2 (1,1,0,0,0,0) 

1777 Lous 1981 3 (1,1,1,0,0,0) 

9 Marchisio 1998 3 (1,1,1,0,0,0) 

1927 Mills 1992 1 (1,0,0,0,0,0) 

1946 Moller 1990 3 (1,1,1,0,0,0) 

2184 Portoian-Shuhaiber 1984 3 (1,1,1,0,0,0) 

2189 Poulsen 1978 3 (1,1,1,0,0,0) 

2190 Poulsen 1980 3 (1,1,1,0,0,0) 

2240 Renvall 1978 3 (1,1,1,0,0,0) 

2242 Renvall 1952 4 (1,1,1,1,0,0) 

2243 Reves 1985 3 (1,1,1,0,0,0) 

2262 Roberts 1995 4 (1,1,1,0,1,0) 

2270 Robinson 1988 1 (1,1,0,0,0,0) 

2457 Sly 1980 3 (1,1,1,0,0,0) 

2593 Thomsen 1981 3 (1,1,1,0,0,0) 

2627 Tos 1979 3 (1,1,1,0,0,0) 

2629 Tos 1979 3 (1,1,1,0,0,0) 

2634 Tos 1980 3 (1,1,1,0,0,0) 

543 Tos 1982 3 (1,1,1,0,0,0) 

91 van Balen 1996 3 (1,1,1,0,0,0) 

2791 Williamson 1994 2 (1,1,0,0,0,0) 

2863 Zielhuis 1990 3 (1,1,1,0,0,0) 

a

 The six components of study quality are: a prospective cohort study; outcome clearly defined; time point at which outcome 

measured clearly defined; subjects followed without any intervention; blinded assessment of outcome; and point and variability

estimates provided for main outcome measures. 1 indicates presence and 0 indicates absence 

70 
 Table 21 Tympanometry Definitions in Natural History Cohorts Utilizing Tympanometry as the Sole Diagnostic Me

Tympanogram Type A As B 

Cohorta

Pressure 

(mmH2O) immitance

Pressure 

(mmH2O) immitance

Pressure 

(mmH2O) immitance Comme

Birch > -100 < 0.25mlc,1

1stapedial reflex absent and ma

Madsen Electronics tympanoscoprobe tone 

Fiellau-Nikolajsen I > -100 > 0.1 d 200 to -4001 ≤ 0.1d 1or indeterminable Fiellau-Nikolajsen II

middle-ear effusion=flat curve omiddle ear reflexes 

Fiellau-Nikolajsen III > -100 multiple

criteria1

1type B=otoadmittance < 0.20m

< 0.04millimhos and absence of Grason-Stadler Middle Ear Anal

Holmquist 50 to -99 flat curve Madsen ZA 330, 226 Hz probe tPortoian-Shuhaiber

abnormal defined as an abnormand/or absent acoustic reflex; G

Analyser (Model 1722) 

Tos I 0 to -99 flat curve Madsen ZO 70 tympanometer, 2Tos II 0 to -99 flat curve Madsen ZO 70 tympanometer, 2Tos III >-100 flat curve1 1<= 0.1e; Madsen ZO 70 impedaTos IV AZ7 99 to –99 flat curve without 

impedance minimum1

1or with a measurable impedanc

gradient < 0.1; Impedance audio(Interacoustics) 

ZS 331 99 to –99 

flat training1

1or compliance below 0.25mlc a

stapedial reflex; Impedance tym(Madsen Electronics) 

Reves -100 to 50 >0.3b < -100 lowb tympanometer 85 AR 11 (AmeriRobinson -149 to +50 >0.2mlc

types As, B, C, and Cs are failurimpedance screener, 226 Hz pr

Sly I and II 

flat curve1

1or compliance < 0.3mlc or peak 

below -100 mmH20; Teledyne A

impedance meter model TA-1D 

van Balen -99 to 200 ≥ 0.2mmhoc ≤ -400 < 0.2mmhocWilliamson 200 to -99 flat curve Grayson-Stadler [sic] Earscan im Zielhuis ≥ -99 ≥ 0.2mlc ≤ -400 < 0.2mlc Grason-Stadler-model 27 

71

asee Table 17 for associated cohort articles bimpedance cadmittance drelative gradient eimpedance slope 
Table 21 Tympanogram Definitions in Natural History Cohorts Utilizing Tympanometry as the Sole Diagnostic Me

Tympanogram Type C C1 C2 

Cohorta

Pressure

(mmH2O) immitance

Pressure

(mmH2O) immitance

Pressure

(mmH2O) immitance Comm

Birch ≤ -100Fiellau-Nikolajsen I 

-100 to -

199 >0.1d

-200 to -

400 >0.1d

Fiellau-Nikolajsen II

middle-ear effusion=flat cuabsent middle ear reflexes 

Fiellau-Nikolajsen III ≤ -100Holmquist 100 to -300Portoian-Shuhaiber

abnormal defined as an abcurve and/or absent acous

Tos I 

-100 to -

199

-200 to -

350 

Tos II 

-100 to -

199 

-200 to -

350 

Tos III 

-100 to -

300 >0.1e

-100 to -

199

-200 to -

350 

Tos IV AZ 7 -100 to – 199 >-200

ZS 331 -100 to – 199 >-200

Reves < -100 >0.3bRobinson types As, B, C, and Cs are Sly I and IIvan Balen 

-199 to -

100 ≥ 0.2mmhoc

-399 to -

200 ≥ 0.2mmhoc

Williamson

-100 to -

199 

-200 to -

400 

 Zielhuis 

-100 to -

199 ≥ 0.2mlc

–200 to –

399 ≥ 0.2mlc

72

asee Table 17 for associated cohort articles bimpedance cadmittance drelative gradient eimpedance slope 
Table 22: OME Resolution by Ears on Newly Diagnosed OME of Unknown Duration

<6-month old cohorts 

Ears Resolved Intervala

Cohort ID 

Diagnostic 

Methodb antibioticc surgeryc <2wk <2m <3m <6m Article(s)

Robertse oto unknown unknown

22/24 

(92%) 

24/24 

(100%) 2262 Roberts 1995

Tos III Tymp unknown unknown

1/4d

(25%) 

1/4 d

(25%) 2627 Tos 1979

a interval calculated from cohort inception and not cumulative, unless otherwise noted b oto=otoscopy, tymp=tympanometry (type B to A transition) c Did any of the patients receive antibiotic or surgery?d interval started at 6-month follow-up ecumulative resolution rate

6-month to 3-year old cohorts 

Ears Resolved Intervala

Cohort ID 

Diagnostic 

Methodb antibioticc surgeryc <6wk <3m <6m <9m <24m Article(s)

Robinson tymp unknown unknown

10 of 25 d

(40.0%) 2270 Robinson 1988

Tos II tymp unknown yes

6/51 1 

(12%)

15/59 2

(25%) 

19/51 3

(37%) 

9/48 4

(19%) 

1 2634 Tos 1980; 2 2190 Poulson 1980; 3 2629 Tos 1979; 4 2593 Thomsen 1981

Tos IIe tymp unknown yes

6/51 1 

(12%)

16/511

(31%) 

24/511

(47%) 1 2634 Tos 1980

73

a interval calculated from cohort inception and not cumulative, unless otherwise noted b oto=otoscopy, tymp=tympanometry (type B to A transition) c Did any of the patients receive antibiotic or surgery?d interval is minimum of 6wk so may be greatere cumulative resolution rate
Table 22 (Continued)

 >3-year old cohorts 

Ears Resolved Intervala

Cohort ID 

Diagnostic 

Methodb antibioticc surgeryc <2wk <3wk <1m <6wk <3m <4m <6m <8m <1y <3y

FiellauNikolajsen Id tymp unknown yes 14/941 (15%) 22/911 (24%) 32/691 (46%) 33/652 (51%)

1

1

N

FiellauNikolajsen IId tymp unknown unknown 7/64 (11%) 16/62 (26%) 1

1

Holmquist tymp unknown unknown

251/51

1 

(49%) 1

Lamothe pneum oto no no

24/64

(38%)

25/53

(47%) 1

Lamothed pneum oto no no 

24/64

(38%)

38/53

(72%) 1

Renvall I tymp unknown unknown

282/335

(84%) 2

Renvall IId tymp no no (25%)

10/40 16/40

(40%) 2

Sly tymp no no

1/9 

(11%)

4/9 

(44%)

6/9 

(67%) 2

Sly II tymp no no 

0/5 

(0%)

0/5 

(0%)

0/5 

(0%) 2

Tos I tymp unknown unknown

3/921

(3%); 

3/872

(4%)

14/931

(15%); 

14/872

(16%)

1

1

Tos Id tymp unknown unknown

3/871

(3%)

17/871

(20%)

1

Williamson tymp unknown yes

35/67

(52%) 

52/67

(78%)

61/67

(91%) 2

74

a interval calculated from cohort inception and not cumulative, unless otherwise noted b oto=otoscopy, pneum oto=pneumatic otoscopy, tymp=tympanometry (type B to A transition) c Did any of the patients receive antibiotic or surgery?dcumulative resolution rates
Table 22 (Continued)

Age not stratifiable 

Ears Resolved Intervala

Cohort ID 

Diagnostic 

Methodb antibioticc surgeryc <1m <2m <3m <4m <5m <6m <3y 

Casselbrant Id algorithm yes yes

92/137

(67%)

109/137

(80%) 

130/137

(95%) 

134/137 

(98%) 

136/137

(99%) 

137/137

(100%) 10

Renvall I tymp unknown unknown

282/335

(84%) 22

a interval calculated from cohort inception and not cumulative, unless otherwise noted b algorithm=algorithm based on pneumatic otoscopy, tympanometry, and acoustic reflex, tymp=tympanometry (type B to A transition) c Did any of the patients receive antibiotic or surgery?dcumulative resolution rate

75
Table 23: OME Resolution by Child on Newly Diagnosed OME of Unknown Duration 

>3-year old cohorts 

Resolved intervala

Cohort ID 

Diagnostic 

Methodb antibioticc surgeryc <2wk <1m <6wk <10wk <3m <4m <6m <8m <1y 

FiellauNikolajsen II tymp unknown unknown 28/81 (35%) 46/80 (58%) 53/78 (68%) Marchisio 

pneum oto, 

tymp unknown no

325/451 

(72%) 

PortoianShuhaiber tymp unknown unknown 65/130 (50%) Sly I tymp no no 

1/7 

(14%)

3/7 

(43%)

5/7 

(71%) 

Sly II tymp no no 

0/3 

(0%)

0/3 

(0%)

0/3 

(0%) 

Williamson tymp unknown yes

22/50

(44%)

38/50

(76%)

45/50

90%) 76 Age not stratifiable 

Resolved intervala

Cohort ID 

Diagnostic 

Methodb antibioticc surgeryc <2m <3m Article(s)

Mills 

pnem oto, 

tymp unknown unknown

57/192 

(30%) 1927 Mills 1992 

Reves tymp unknown unknown

40/68 

(59%) 2243 Reves 1985

van Balen tymp unknown unknown

223/443 

(50%) 91 van Balen 1996 

ainterval calculated from cohort inception unless otherwise noted boto=otoscopy, tymp=tympanometry (type B to A transition) cDid any of the patients receive antibiotic or surgery?
Table 24: Meta-Analysis for <6 Weeks Resolution Rate for Newly Diagnosed OME of Unknown Duration In Children Older Than 3 Years of Age

ArticleID Author Criterion Age at diagnosis Antibiotic used? Surgery performed? Followup interval Number ears resolved Total number ears Resoluation rate in % Random Effects Pooled Estimate (95% CI) 

He

2457 Sly-1980 B or C to A 5yr no unknown <6wk 18 32 56.32457 Sly-1980 B or C to A 5yr no unknown <6wk 11 22 50.0

1714 Lamothe-1981 Otoscopy 6yr no unknown <6wk 25 53 47.2

Total 54 107 44.9 42.3 (24.1, 60.6) 7.8

ArticleID Author Criterion Age at diagnosis Antibiotic used? Surgery performed? Followup interval Number ears resolved Total number ears Resoluation rate in % Random Effects Pooled Estimate (95% CI) 

He

2457 Sly-1980 B to A 5yr no unknown <6wk 6 9 66.72457 Sly-1980 B to A 5yr no unknown <6wk 0 5 0.0

771714 Lamothe-1981 Otoscopy 6yr no unknown <6wk 25 53 47.2

Total 31 67 46.3 37.2 (1.8, 72.5) 16.

Note: Lamothe's study used otoscopy and is included in all meta-analyses
Table 25: Meta-Analysis for <3 Months Cumulative Resolution Rate for Newly Diagnosed OME of Unknown Duration In Children Older Than 3 Yea

ArticleID Author Criterion Age at diagnosis Antibiotic used? Surgery performed? Followup interval Number ears resolved Total number ears Resoluation rate in % Random Effects Pooled Estimate (95% CI) T

1237 Fiellau-Nikolajsen-1979 B or C to A 3-4yr unknown unknown <3mo 154 348 44.31235 Fiellau-Nikolajsen-1979 B or C to A 3-4yr unknown unknown <3mo 83 200 41.5

543 Tos-1982 B or C to A 4yr unknown unknown <3mo 103 393 26.2

2242 Renvall-1982 otoscopy 4yr no unknown <12wk 86 144 59.7

Total 426 1085 39.3 42.7 (29.3,56.1) 

ArticleID Author Criterion Age at diagnosis Antibiotic used? Surgery performed? Followup interval Number ears resolved Total number ears Resoluation rate in % Random Effects Pooled Estimate (95% CI) T

1237 Fiellau-Nikolajsen-1979 B to A 3-4yr unknown unknown <3mo 22 91 24.21235 Fiellau-Nikolajsen-1979 B to A 3-4yr unknown unknown <3mo 16 62 25.8

543 Tos-1982 B to A 4yr unknown unknown <3mo 3 87 3.4

2242 Renvall-1982 otoscopy 4yr no unknown <12wk 16 40 40.0

Total 57 280 20.4 22.5 (5.9,39.0) 

78 
 Table 26: List of Cohort Studies Included for Question 2 

79

ID# Author Year Cohort

1623 Kaplan 1973 Eskimo villages in the Yukon and Kuskokwim River Delta areas o

Alaska 

1255 Fischler 1985 Four Indian reservations in Arizona 4657 Roberts 1986 Frank Porter Graham Child Development Center, Chapel Hill, NC 3118 Roberts 1988 Frank Porter Graham Child Development Center, Chapel Hill, NC 4806 Roberts 1988 Frank Porter Graham Child Development Center, Chapel Hill, NC 4656 Roberts 1989 Frank Porter Graham Child Development Center, Chapel Hill, NC 3117 Roberts 1991 Frank Porter Graham Child Development Center, Chapel Hill, NC 4319 Roberts 1995 Frank Porter Graham Child Development Center, Chapel Hill, NC 1373 Gravel 1992 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of th

Kennedy Center, Albert Einstein College of Medicine, Bronx, NY 

4728 Gravel 1996 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of th

Kennedy Center, Albert Einstein College of Medicine, Bronx, NY 

1941 Mody 1999 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of th

Kennedy Center, Albert Einstein College of Medicine, Bronx, NY 

2295 Ruben 1997 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of th

Kennedy Center, Albert Einstein College of Medicine, Bronx, NY 

1219 Feagans 1987 Medical and Day Care Intervention Project in Pennsylvania 2135 Paul 1993 Portland Language Development Project (PLDP), Oregon 4651 Klein 1988 The Greater Boston Otitis Media Study Group, MA 2583 Teele 1990 The Greater Boston Otitis Media Study Group, MA 1435 Harsten 1993 University Hospital of Lund, Sweden 

877 Black 1993 University of Maryland Medical System, Baltimore, MD 

4675 Owen 1996 University of Texas Medical Branch, TX 1277 Freeark 1992 University-based pediatric clinic in Michigan 
Table 27: List of Cohort Studies Not Included for Question 2 (For Reason of Not Reporting Findings Beyond 3 Yea

80

ID# Author Year Cohort

3119 Roberts 1995 Frank Porter Graham Child Development Center, Chapel Hill, NC 4841 Wallace 1988 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

2739 Wallace 1988 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

2740 Wallace 1988 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

4842 Wallace 1992 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

667 Abraham 1996 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

4796 Petinou 1996 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

2742 Wallace 1996 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

3096 Petinou 1999 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose F

Albert Einstein College of Medicine, Bronx, NY 

4671 Luloff 1993 Longitudinal study investigating the efficacy of drug prophylaxis on otitis me

area, MA 

4673 Tsushima 1993 Longitudinal study investigating the efficacy of drug prophylaxis on otitis me

area, MA 

4674 Wendler-Shaw 1993 Longitudinal study investigating the efficacy of drug prophylaxis on otitis me

area, MA 

875 Black 1988 Maryland Otitis Media Study Group, Baltimore 4708 Downs 1988 Not specified2719 Vernon-Feagans 1996 Ongoing study of health and day-care in a semi-rural area of northeastern U1288 Friel-Patti 1982 Parkland Memorial Hospital, Dallas, TX 4713 Feldman 1996 Pittsburgh-area Child Development/Otitis Media Study Group, PA 4642 Paradise 2000 Pittsburgh-area Child Development/Otitis Media Study Group, PA 2819 Wright 1988 Pneumococcal vaccine study in Nashville, TN 1677 Knishkowy 1991 PROD (Promotion of Growth and Development) Program, Western Jerusale2579 Teele 1984 The Greater Boston Otitis Media Study Group, MA 4664 Feagans 1994 Three day-care facilities in central Pennsylvania, PA 
 Table 28 Definition of Early Life Positive or Negative OM History in Assessing Long-term Speech and Langua

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

877 Black

1993 

OM History defined by number of episodes of OM within the first year of life documented by otologic examination. • Positive OM History: At least 2 

episodes of OM within the first year. A child could receive credit for only one bout of OM within each 29-day period. 

• Negative OM History: Had not 

experienced otitis media during first year of life 

Not provided • Based o

examina

• Examine

1219 Feagans

1987 

OM History described by frequency and duration of OM from 0 to 3 years. They were treated as continuous variables for correlation with outcome. No grouping of children by positive or negative history was done. • Frequency was calculated by counting 

the number of different episodes 

• Duration was calculated by counting 

the total number of days the child had effusion during the first 36 months of life. 

Not provided. • Based o

otoscoptympanoto corrobdiagnos

• OM diag

pediatricnurse pr

81
Table 28 (Continued) 

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

1255 Fischler

1985 

OM History defined by number of OM episodes by age 2 years and over age 2.• The study defined three groups of 

children by OM history by number of episodes before and after age 2. 

• For our assessment, we used groups 1 

and 2 as positive OM history, i.e. (>=2 attacks by age 2) and group 3 as negative OM history (<2 attacks by age 2). 

Any mention of one of the following: • Acute suppurative OM: 

history of ear pain or fussiness with or without fever or ear drainage (less than 5 days), and physical evidence of redness with orwithout immobility, bulging, or a small perforation of theTM. 

• Serous OM: history of ear 

fullness, popping, or hearing loss, or an asymptomatic history; and physical evidence of TM retraction and/or immobility, with or without gray or yellow color or bubbles behind the TM 

• Chronic OM: history of ear 

drainage and perforation present for more than two weeks; and physical evidence of perforation. 

• By medi

of documphysiciadiagnos

1277 Freeark

1992 

OM history severity defined by a) number of separate episodes of OM and b) totalnumber of days of effusion over the first 3 years of life. • High OM: above median of OM 

severity 

• Low OM: below median of OM severity

Not specified • By whom

How diaspecifiedobtained records)

1373 Gravel

1992 

OM groups were defined by otoscopic histories during the first year of life. • OM positive: when bilateral OM was

detected at 30% or more of the baby’s first year visits. 

• OM negative: when middle ear status

was rated as normal in both ears during 80% or more of the first year visits. 

Not specified • Pediatric 

practitiopneumoexaminaschedule

82
 Table 28 (Continued) 

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

4728 Gravel

1996 

Same as 1373 Same as 1373 Same as 13

1435 Harsten

1993 

OM groups were defined by the number of AOM episodes during the first 3 years of life. • OM positive: developed six or more 

episodes of AOM during a 12-month period. 

• OM negative: no AOM episodes and 

less than six other acute respiratory tract infections. 

• AOM was defined as an 

acute episode of earache ina child with red bulgingeardrum(s) or purulent discharge, occasionally febrile and with signs of upper respiratory tract infection. 

• By otom

performeotolaryn

1623 Kaplan •

1973 

OM groups were based on age of onset of first episode of otorrhea. • The study defined 3 groups: group 1-

onset of first otorrhea episode during first year of life; group 2-onset of first otorrhea episode at 2-10 years, and group 3-no history of OM 

• For our assessment, we used group 1 

as positive OM history and group 3 asnegative OM history. 

• Used only episodes of OM 

with otorrhea. 

A resea

the cohoobtained concernabnormarespiratoand revirecords between 

4651 Klein

1988 

OM history was measured by time spentwith effusion during the first 2 years of life and used a ‘window’ of 23 days to eachobservation of effusion, whether accompanied by signs of illness or not. It could be shortened or extended by multiple examinations. • Group 1: time spent with effusion <32 

days during first 2 years of life. 

• Group 2: time spent with effusion 

between 33-108 days during first 2 years of life. 

• Group 3: time spent with effusion >108

days. 

• Criteria for effusion: 

otorrhea, gas-liquid levelsvisible on otoscopy or marked reduction of mobility. Tympanometric criterion: type B curve. 

• By pedia

pneumaage 3 anpneumatympanothrough 

83
Table 28 (Continued) 

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

1941 Mody

1999 

OM history defined by pneumatic otoscopy findings during first year of life • OM positive: children who had 30% or

more of the 13 first-year visits with OM bilaterally 

• OM negative: children who had 80% or 

more of the 13 first-year visits with normal middle ear findings bilaterally. 

• Used a 9-item otoscopic 

checklist to determine “clear”, “suspicious,” or“positive” for OM 

• By traine

pediatric practitiopneumaunder thpediatric 

• The PNP 

descriptcharacteear, usinotoscopmade thof “clear“positive

4675 Owen

1996 

OME history was measured by days or duration with OME durng the first 3 years of life. Middle ear status was monitored by home visits every 2 to 4 weeks, irrespective of symptoms for the first 3 years of life. • At each visit, each ear received a 

diagnosis of normal or OME. If two consecutive visits showed OME, the intervening days were counted as days with OME. If one visit showed OME and the next normal status, or vice versa, half of the intervening days were counted as days with OME. OME duration was defined as the proportion time a subject spent with OME (total OME days divided by total days) in the period examined. 

• Subjects who experienced 6 

continuous weeks of OME in the first year of life were identified as at high risk. 

• OME diagnosis was based 

on type B tympanogram or >= 5 acoustic reflectivity or visible purulent otorrhea without an otoscope. 

• By traine

using auscreeninwith a 26 Acoustic also meacoustic of visits. 

84
Table 28 (Continued) 

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

2135 Paul

1993 

OM history was measured by middle ear involvement defined as either the placement of myringotomy tubes or the presence of six or more ear infectionstreated by a physician before the secondbirthday by parent report. • Positive OM: had middle ear 

involvement 

• Negative OM: lack of such middle ear 

involvement 

• Based on parental reporting • Based o

reporting 

4657 Roberts

1986 

OM history was based on total OME duration in days during first 3 years of life. Duration of each episode of unilateral and bilateral was calculated by subtracting the data of onset of OME from the resolutiondate. Days of total OME was analyzedboth as a continuous and categorical variable. • Group 1: days with total OME 

representing the lower third of the subjects

• Group 2: days with total OME 

representing the middle third of the subjects

• Group 3: days with total OME 

representing the upper third of the subjects. 

• When middle ear fluid was 

seen or when the mobility of the tympanic membrane was markedly reduced or absent, OME was diagnosed. 

• Type B tympanograms with

a flat or gradually risingshape were considered indicative of OME. 

• Type C tympanograms

showing a maximum compliance of less than –100 mm H2O were 

considered indicative of negative middle ear pressure and of an increase likelihood of effusion 

• By pedia

pediatric practitiopneuma60% of ttympanoto corrobdiagnos

4656 Roberts

1989 

Same as 4657 Same as 4657 Same as 46

3118, 4806 

Roberts 1988 

Same as 4657 Same as 4657 Same as 46

3117 Roberts

1991 

Same as 4657 Same as 4657 Same as 46

4318 Roberts

1995 

Same as 4657 Same as 4657 Same as 46

85
Table 28 (Continued) 

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

2295 Ruben

1997 

OM history was based on the findings ofpneumatic otoscopy at every scheduledand sick visit during the first year of life • The OM – group were those who were 

bilaterally free of OM at 80% or more of their first year visits and had no more than one episode of OM during the first year.

• The OM+ group had bilateral OM at 

30% or more of their first year visits, and had from 2 to 6 episodes during the first year.

Not specified • Pneuma

trained apediatric practitio

2583 Teele

1990 

OM history was measured by the number of days with middle ear effusion (MEE) by age 3 years. Unless documented to be shorter, each episode of MEE lasted 29 days. 

• Diagnosis of MEE required

either visualization of a gasliquid mixture through anintact tympanic memberane, otorrhea, or marked reduction in mobility of the TM to both positive and negative pressure. 

• Children whose TM(s) 

showed reduced mobility in response to positive pressure and normal mobility to negative pressure were considered to have only subatmospheric middle ear pressure. 

• The criteria for effusion 

using tympanometric devices included a tracing that showed no peak or a tracing that sagged belowthe baseline (for model 1720B) 

• In privat

board-cepediatric81% of aurban heboard-cepediatric66% of a

• Each ce

otoadmiinitially a model 1children Grason-1722. 

• To resol

diagnoswas use0-3 yearfrequent

86
Table 29 Study Quality for Studies Included in Evidence Table on Speech and 

Language Development 

ID Author(s) Year Study Quality Score a

877 Black 1993 3 (0,0,0,0,1,1,0,1) 

1219 Feagans 1987 5 (1,1,1,0,0,1,0,1) 

1255 Fischler 1985 5 (1,1,0,0,1,1,1,0) 

1277 Freeark 1992 4 (1,0,0,0,0,1,1,1) 

1373 Gravel 1992 5 (1,1,0,0,1,1,1,0) 

4728 Gravel 1996 3 (0,1,0,0,0,1,1,0) 

1435 Harsten 1993 6 (1,1,1,0,1,1,1,0) 

1623 Kaplan 1973 6 (1,1,0,0,1,1,1,1) 

4651 Klein 1988 4 (1,0,1,0,0,1,0,1) 

1941 Mody 1999 4 (1,1,0,0,0,1,0,1) 

4675 Owen 1996 4 (1,1,0,0,0,1,0,1) 

2135 Paul 1993 3 (0,0,1,0,0,1,0,1) 

4657 Roberts 1986 6 (1,0,1,0,1,1,1,1) 

4656 Roberts 1989 6 (1,0,1,0,1,1,1,1) 

4806 Roberts 1988 4 (1,0,1,0,0,1,0,1) 

3118 Roberts 1988 4 (1,0,1,0,0,1,0,1) 

3117 Roberts 1991 2 (0,0,0,0,0,1,0,1) 

4319 Roberts 1995 3 (0,0,0,0,0,1,1,1) 

2295 Ruben 1997 5 (1,1,0,0,1,1,1,0) 

2583 Teele 1990 6 (1,0,1,0,1,1,1,1) 

a

 The eight components of study quality score are: (1) study cohort clearly defined; 

(2) subjects assembled at a uniform time point; (3) pathway of subject entry clearly 

described; (4) complete follow-up achieved; (5) withdrawals/drop-outs described; 

(6) objective outcomes used; (7) outcome assessment blinded; and (8) extraneous

factors adjusted. ‘1’ indicates presence and ‘0’ indicates absence.

87
Table 30: Key Characteristics of the Cohort Studies for Question 2 

88 

ID# Author Year Cohort Age of OM 

History

Age at

Outcome 

Measure

Major 

Outcome 

statistic 

Outcome 

Measure

Test 

4675 Owen 1996 Texas 0-3 years 5 years Correlation Cognition Stanford Binet 4319 Roberts 1995 North Carolina 2 months3 years 12 years Correlation Cognition WISC-R 1623 Kaplan 1973 Alaska 0-1 year 10 years Mean (range) Cognition WISC Str

hea

877 Black 1993 Maryland 8-22 months 4-6 years Mean (SD) Cognition McCarthy 

1373 Gravel 1992 New York 0-1 year 4 years Mean (SD) Cognition Stanford-Binet 4657 Roberts 1986 North Carolina 2 months3 years 3.5-6 years Mean (SD) Cognition McCarthy 4656 Roberts 1989 North Carolina 2 months3 years 8 years Mean (SD) Cognition WISC-R 4651 Klein 1988 Massachusetts 0-2 years 7 years Multivariate Cognition WISC-R 2583 Teele 1990 Massachusetts 0-2 years 7 years Multivariate Cognition WISC-R Ad

gen

3118/ 

4806 

Roberts 1988 North Carolina 2 months3 years 2.5-8 years Correlation Expressive language Elicited language play 

3117 Roberts 1991 North Carolina 2 months3 years 4.5-6 years Correlation Expressive language CELF Str

soc

4675 Owen 1996 Texas 0-3 years 5 years Correlation Expressive 

language 

Goldman-Fristoe test

1255 Fischler 1985 Arizona 0-2 years 6-8 years Mean (SD) Expressive 

language 

TOLD

1373 Gravel 1992 New York 0-1 year 4 years Mean (SD) Expressive 

language 

SICD-R in months

2135 Paul 1993 Oregon 0-2 years 4 years Mean (SD) Expressive 

language 

MLU Str

talk

1219 Feagans 1987 Pennsylvania 0-3 years 5-7 years Multivariate Expressive 

language 

MLU, Paraphrase Re

onl

2583 Teele 1990 Massachusetts 0-2 years 7 years Multivariate Expressive 

language 

WUG test Me

and 

2295 Ruben 1997 New York 0-1 year 2-9 years, 

yearly 

Percent difference 

Expressive language 

Unknown

1277 Freeark 1992 Michigan 0-3 years 3-4 years Proportion Expressive 

language 

Verbal Scale Index Str

Sti
Abbreviations:

CAVAT= Carrow Elicited Language InventoryCELF= Clinical Evaluation of Language Functions MLU= Mean Length of Utterance PPVT-R= Peabody Picture Vocabulary Test-Revised SD= Standard Deviation 

SICD-R= Sequenced Inventory of Communication TOLD= Test of Language Development WISC-R= Wechsler Intelligence Scale for Children-WRAML= Wide Range Assessment of Memory and WUG= “WUG” test (Berko-Gleason) 

89 
90 

Table 30 (Continued) ID# Author Year Cohort Age of OM 

History 

Age at 

Outcome 

Measure 

Major 

Outcome 

statistic 

Outcome 

Measure 

Test 

4728 Gravel 1996 New York 0-1 year 9 years Raw data not 

reported 

Expressive language 

WRAML On

rep

3117 Roberts 1991 North Carolina 2 months3 years 4.5-6 years Correlation Receptive language CELF Str

soc(SE

3117 Roberts 1991 North Carolina 2 months3 years 4.5-6 years Correlation Receptive language PPVT-R Str4675 Owen 1996 Texas 0-3 years 5 years Correlation Receptive 

language 

CAVAT

1255 Fischler 1985 Arizona 0-2 years 6-8 years Mean (SD) Receptive 

language 

TOLD

877 Black 1993 Maryland 8-22 months 4-6 years Mean (SD) Receptive 

language 

PPVT-R

1373 Gravel 1992 New York 0-1 year 4 years Mean (SD) Receptive 

language 

SICD-R in months

2583 Teele 1990 Massachusetts 0-2 years 7 years Multivariate Receptive 

language 

WUG test Ad

gen

2295 Ruben 1997 New York 0-1 year 2-9 years, 

yearly 

Percent difference 

Receptive language 

Unknown

4728 Gravel 1996 New York 0-1 year 9 years No raw data Receptive 

language 

CELF-R Sta

3118/ 

4806 

Roberts 1988 North Carolina 2 months3 years 2.5-8 years Correlation Expressive speech Goldman-Fristoe

2135 Paul 1993 Oregon 0-2 years 4 years Mean (SD) Expressive 

speech 

Goldman-Fristoe Str

talk

2583 Teele 1990 Massachusetts 0-2 years 7 years Multivariate Expressive 

speech 

Goldman-Fristoe Ad

gen

2295 Ruben 1997 New York 0-1 year 2-9 years, 

yearly 

Percent difference 

Expressive speech 

Unknown

3118/ 

4806 

Roberts 1988 North Carolina 2 months3 years 2.5-8 years Correlation Receptive speech Articulation tests 

1941 Mody 1999 New York 0-1 year 9 years Mean (SD) Receptive speech Synthetic speech 

syllables 

1435 Harsten 1993 Sweden 0-3 years 4 years Proportion Receptive speech Linguistic analysis4728 Gravel 1996 New York 0-1 year 9 years No raw data Receptive speech Pediatric Speech 

Intelligibility 

Onres
Abbreviations:

CAVAT= Carrow Elicited Language InventoryCELF= Clinical Evaluation of Language Functions MLU= Mean Length of Utterance PPVT-R= Peabody Picture Vocabulary Test-Revised SD= Standard Deviation SICD-R= Sequenced Inventory of Communication Development-Revised TOLD= Test of Language Development WISC-R= Wechsler Intelligence Scale for Children-Revised WRAML= Wide Range Assessment of Memory and LearningWUG= “WUG” test (Berko-Gleason)

91 
Table 31: Meta-Analysis for Expressive Language Development 

ID Positive OM History Negative OM History

Number 

Author-Year Cohort Age of

OM 

history

Age of

outcome

measure

Name of 

Test N Mean SD N Mean SD

St

1255 Fischler-1985 a Arizona 0-2yr 6-8 yrs TOLD 33 60.0 20.4 71 64.8 28.8 - 1373 Gravel-1992 New York 0-1yr 4yrs SICD-R 8 36.0 5.2 12 39.0 6.2 - 2135 Paul-1993a Oregon 0-2yr 4yrs MLU 8 57.8 3.8 13 54.6 10.7 

Random Effects estimate -

Test of standardized mean difference equals 0: z=0.82; p=0.413. Test of heterogeneity: Chi-squared=1.77 (degrees of freedom=2); p-value=0.412. a Retrospective-prospective studies. Abbreviations: 

OM=Otitis media TOLD=Test of Language Development SICD-R=Sequenced Inventory of Communication Development-Revised MLU=Mean Length of Utterance N=Number of subjects SD=Standard deviation 

92 CI=Confidence interval
Table 32: Meta-Analysis for Receptive Language Development 

ID Positive OM History Negative OM History

Number 

Author-Year Cohort Age of

OM 

history

Age of

outcome

measure

Name of 

Test N Mean SD N Mean SD

877 Black-1993 Maryland 8-22 mos 4-6 yrs PPVT-R 21 83 17 10 72 18 

1255 Fischler a -

1985 

Arizona 0-2yr 6-8 yrs TOLD 33 67 28 71 73 32 

1373 Gravel-1992 New York 0-1yr 4yr SICD-R 8 36 5 13 38 5 2579 Teele-1990 Boston 0-2yr 3yr PPVT-R 52 101 17 80 96 15 

Random effects estimate 

Test of standardized mean difference equals 0: z=0.52; p=0.606. Test of heterogeneity: Chi-squared=6.22 (degrees of freedom=3); p=0.102. a Retrospective-prospective study.

Abbreviations:PPVT-R=Peabody Picture Vocabulary Test-Revised TOLD=Test of Language Development SICD-R=Sequenced Inventory of Communication Development-Revised N=Number of subjects 

93

SD=Standard deviation CI=Confidence interval
Table 33: Meta-Analysis for Cognitive Verbal Intelligence 

ID Positive OM History Negative OM History

Number 

AuthorYear Cohort Age of OM 

history

Age of

outcome

measure

Name of Test

N Mean SD N Mean SD

877 Black-1993 MD 8-22 mos 4-6 yrs McCarthy 21 46.7 11.5 10 41.0 10.7 

1373 Gravel-1992 NY 0-1yr 4yrs Stanford-Binet 9 88.3 15.9 13 84.3 9.4 4657 Roberts1986 NC 2mos- 3yrs 3.5-6yrs McCarthy 19 52.0 8.0 19 52.0 9.0 

Random effects estimat

Test of standardized mean difference equals 0: z=1.05; p=0.292. Test of heterogeneity: Chi-squared=0.99 (degrees of freedom=2); p=0.609. 

94Abbrevations: 

OM=Otitis media N=Number of subjects SD=Standard deviation CI=Confidence intervalTable 34: Cohort Studies at Tertiary Screening and Reasons for Exclusion

ID# Author Year Rejection Reason 

2221 Rahko 1995 Otitis media not measured at less than 3 years of age2762 Webster 1989 Case control study 4728 Gravel 1996 No significant difference observed but no hearing data 4846 Wright 1984 Hearing data at 3-4 years not abstractable. 
Table 35: List of Cohort Studies Included for Question 3 

ID# Author Year Cohort 

147 Sorri 1995 Birth cohort from Northern Finland 

1255 Fischler 1985 Four Indian reservations in Arizona 1373 Gravel 1992 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of th

Center, Albert Einstein College of Medicine, Bronx, NY 

1435 Harsten 1993 University Hospital of Lund, Sweden 1623 Kaplan 1973 Eskimo villages in the Yukon and Kuskokwim River Delta areas of 

Alaska 

2233 Reed 1967 Eskimo villages in the Yukon and Kuskokwim River Delta areas of 

Alaska 

2309 Ryding 1997 University Hospital of Lund, Sweden 2854 Zargi 1992 University of Ljubljana, Ljubljana, Slovenia 

95 Table 36: List of Cohort Studies Excluded from Question 3 (For Reason of Not Reporting Findings Beyond 3 Years 

ID# Author Year Cohort

2264 Roberts 1998 Frank Porter Graham Child Development Center, Chapel Hill, NC 4808 Roberts 1988 Frank Porter Graham Child Development Center, Chapel Hill, NC 

667 Abraham 1996 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose 

Albert Einstein College of Medicine, Bronx, NY 

2740 Wallace 1988 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose 

Albert Einstein College of Medicine, Bronx, NY 

4680 Gravel 2000 LIFE (Longitudinal Infant Follow-up and Evaluation) Program of the Rose 

Albert Einstein College of Medicine, Bronx, NY 

1288 Friel-Patti 1982 Parkland Memorial Hospital, Dallas, TX 2819 Wright 1988 Pneumococcal vaccine study in Nashville, TN 1677 Knishkowy 1991 PROD (Promotion of Growth and Development) Program, Western Jerus1544 Hutchings 1992 Six general practices in Oxford, England4838 VernonFeagans 1996 Three day-care facilities in central Pennsylvania, PA 
Table 37 Definition of Early Life Positiv

e or Negati

v

e OM History in Assessing Long-ter

m Hearing Dev

elopment 

ID# Author 

Year 

Definition of Positiv

e/Negative OM 

History

Definition of OM OM Diagno

14

7

S

orri OM history was obtained from all possible 

sources (he

alth care centers, hospitals, 

and private surgeries). Only children withclear-cut differences in their history wereconsidered. 

1995 

• RAOM group: had >=4 recurrent 

episodes until the age of 2 years. 

• SOM group: had been tre

ated for a 

long standin

g (>=3 months) secretory 

middle ear effusion during the first two years of life. 

• No OM grou

p: had not experience

d an 

acute otitis media episod

e until the age 

of 7 years. 

Not specified Not specifie

12

5

5

Fischler

1985 

• OM History d

efined by number of OM 

episodes by age 2 years and over age 2. 

• The stu

dy defined three groups of 

children by O

M history by number of 

episodes before and after age 2. 

• For our assessment, we used groups 1 

and 2 as positive OM history, i.e. (>=2 attacks by age 2) and group 3 as negative OM history (<2 attacks by age 2). 

Any mention of one of the following: • Acute suppurative OM: 

history of ear pain or fussiness with or without fever or ear drainage (less than 5 days), and physical evidence of redness with orwithout immobility, bulging, or a small perforation of the TM. 

• Serous OM: history of ear 

fullness, popping, or hearing loss, or an asymptomatic history; and physical evidence of TM retraction and/or imm

o

bility, with or 

without gray or yellow color or bubbles behind the TM 

• Chronic OM: history of ear 

drainage and perforation present for m

ore than two 

weeks; and physical evidence of perforation. 

• B

y med

review physicidiagnos

96
Table 37 (Continued)

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

1373 Gravel OM groups were defined by otoscopic 

1992 histories during the first year of life. 

• OM positive: when bilateral OM was

detected at 30% or more of the baby’s first year visits. 

• OM negative: when middle ear status

was rated as normal in both ears during 80% or more of the first year visits. 

Not specified • Pediatric 

practitiopneumoexaminaschedule

1435 Harsten OM groups were defined by the number of 

AOM episodes during the first 3 years of life. 

1993 

• OM positive: developed six or more 

episodes of AOM during a 12-month period. 

• OM negative: no AOM episodes and 

less than six other acute respiratory tract infections. 

• AOM was defined as an 

acute episode of earache ina child with red bulgingeardrum(s) or purulent discharge, occasionally febrile and with signs of upper respiratory tract infection. 

• By otom

performeotolaryn

1623 Kaplan OM groups were based on age of onset of 

1973 first episode of otorrhea. 

• The study defined 3 groups: group 1-

onset of first otorrhea episode during first year of life; group 2-onset of first otorrhea episode at 2-10 years, and group 3-no history of OM 

• For our assessment, we used group 1 

as positive OM history and group 3 asnegative OM history. 

• Used only episodes of OM 

with otorrhea. 

• A resea

the cohoobtained concernabnormarespiratoand revirecords between 

2233 Reed Same study population as 1623. This 

article reported findings at 3-5 years. Article 1623 reported findings at 10 years of age. 

1967 

Same as 1623 Same as 16

97
Table 37 (Continued)

ID# Author 

Year 

Definition of Positive/Negative OM History

Definition of OM OM Diagnos

2309 Ryding OM history groups were defined by the 

number of recurrent AOM during the first 3 years of life. 

1997 

• rAOM group: children with >=6 

episodes of purulent AOM during a 12-month period.

• Healthy group: children with no AOM 

and <6 other RTI episodes during the study period.

• AOM was defined as an 

acute episode of earache ina child with red bulgingeardrum(s) or purulent discharge, occasionally febrile and with signs of upper respiratory tract infection 

• AOM wa

otomicroperformeotolaryn

2854 Zargi OM history based on parental interviews 

and by review of hospital charts and other medical documentation. 

1992 

• Experimental group: children treated 

for recurrent acute unilateral or bilateral suppurative OM at 0-2 years of age. 

• Control group: children who 

experienced <=1 episode of OM in the first 2 years of life 

Not specified Not specified 

98
Table 38 Study Quality for Studies Included in Evidence Table on Hearing 

ID Author Year Study Quality Scorea

147 Sorri 1995 4 (0,1,0,0,1,1,0,1) 

1255 Fischler 1985 5 (1,1,0,0,1,1,1,0) 

1373 Gravel 1992 5 (1,1,0,0,1,1,0,1) 

1435 Harsten 1993 6 (1,1,1,0,1,1,1,0) 

1623 Kaplan 1973 5 (1,1,0,0,1,1,1,0) 

2233 Reed 1967 4 (1,1,0,0,0,1,0,1) 

2309 Ryding 1997 5 (0,1,1,0,0,1,1,1) 

2854 Zargi 1992 2 (1,0,0,0,0,1,0,0) 

a

 The eight components of study quality score are: (1) study cohort clearly defined; 

(2) subjects assembled at a uniform time point; (3) pathway of subject entry clearly 

described; (4) complete follow-up achieved; (5) withdrawals/drop-outs described; 

(6) objective outcomes used; (7) outcome assessment blinded; and (8) extraneous

factors adjusted. ‘1’ indicates presence and ‘0’ indicates absence.

99
100

Table 39: Characteristics and Outcome Measures of Cohort Studies for Question 3 

ID 

Number 

Author Year Age at

OM 

history 

Age at 

outcome 

measure 

Outcome measured in % hearing loss 

Outcome measured in mean pure tone 

Oth

147 Sorri 1995 0-2yrs 7yrs >20 dB pure tone averages, 

type not specified 

Mean airconduction (AC) threshold, right/left ear 

1255 Fischler 1985 0-2yrs 6-8yrs >25 dB at 500Hz; 

>20 dB at 1000 Hz; >20 dB at 2000 Hz; >25 dB at 4000 Hz; >25 dB at 6000 Hz. Pure tone type not specified. 

1373 Gravel 1992 0-1yrs 4 yrs Mean pure tone 

averages obtained at octave frequencies from 500 through 4000 Hz at a minimum, right/left ear 

PedInte(PSmes

1435 Harsten 1993 0-3yrs 4yrs >=25 dB tone-audiometry at 

any frequency, type not specified. 

1435 Harsten 1993 0-3yrs 7yrs >=25 dB tone-audiometry at 

any frequency, type not specified. 

1623 Kaplan 1973 0-1yrs 10yrs >=25 dB air and bone 

conduction 

2233 Reed 1967 0-2yrs 3-5yrs >25 dB pure tone air 

averages 

2309 Ryding 1997 0-3yrs 10yrs Median level of air 

conduction hearing, right/left ear 

2854 Zargi 1992 0-2yrs 6-8yrs >10 dB for air-conduction 

hearing loss 

Sensorineural hearing loss 

Abbreviations: 

dB=decibel PSI=Pediatric Speech Intelligibility S=Primary sentence CM=Competing messages 
Table 40: Meta-analysis for Effects of Early Life Otitis Media on Long-term Conductive Hearing Lossa 

Author Year Age of 

OM 

history

Age at 

Hearing 

Testing

OM+ 

Sample 

Size

OMSample 

Size

OM+ 

Percent 

Hearing 

Loss

OMPercent 

Hearing 

Loss

Rate 

Difference 

in %

95% CI 

Rate 

Difference 

%

Sorri 1995 0-2yrs 7yrs 64 35 51.6 20.0 31.6 (13.5, 49

Fischler 1985 0-2yrs 6-8yrs 96 70 9.4 1.4 7.9 ( 1.5, 14

Harsten 1993 0-3yrs 7yrs 24 56 8.3 5.4 3.0 (- 9.6, 15

Kaplan 1973 0-1yrs 10yrs 162 76 19.8 7.9 11.9 ( 3.2, 20

Random effects estimates 346 237 21.7 6.4 11.3 ( 3.3, 19Test of heterogeneity Chi-square test value 40.3 10.5 7.3 Test of heterogeneity Chi-square test p-value <0.001 0.015 0.064 The following analysis excluded article by Sorri.

Author Year Age of 

OM 

history

Age at 

Hearing 

Testing

OM+ 

Sample 

Size

OMSample 

Size

OM+ 

Percent 

Hearing 

Loss

OMPercent 

Hearing 

Loss

Rate 

Difference 

in %

95% CI 

Rate 

Difference 

%

101Fischler 1985 0-2yrs 6-8yrs 96 70 9.4 1.4 7.9 (1.5,14.4

Harsten 1993 0-3yrs 7yrs 24 56 8.3 5.4 3.0 (-9.6,15.

Kaplan 1973 0-1yrs 10yrs 162 76 19.8 7.9 11.9 (3.2,20.5

Random effects estimates 282 202 13.0 4.2 8.4 (3.6,13.2Test of heterogeneity Chi-square test value 6.8 4.4 1.4 Test of heterogeneity Chi-square test p-value 0.034 0.114 0.508 

a Hearing Loss was at >20-25 dB threshold at any frequency with or without treatment measured at 6-10 years of age. 

 Sorri, Fischler and Harsten did not specify type of pure-tone test used in defining hearing loss. Kaplan used air and bone conduction.

Abbreviations: OM+: positive otitis media history; OM-: negative otitis media history; CI: confidence interval.
Table 41: List of Cohort Studies Included for Question 4 

ID Number Author Year ID Number Author 

759 Avery 1986 1685 Koivunen 766 Babonis 1991 1785 Lovette 784 Barnett 1998 1804 Macknin 810 Beery 1975 1817 Mains 817 Ben-David 1981 1837 Marchant 886 Block 1998 1936 Mitchell 888 Bluestone 1973 2012 Nozza 889 Bluestone 1979 2013 Nozza 989 Cantekin 1977 2048 Orchik 990 Cantekin 1980 2049 Orchik 

1238 Fiellau-Nikolajsen 1980 2050 Orchik 1241 Fiellau-Nikolajsen 1980 2055 Ovesen 1245 Fiellau-Nikolajsen 1983 2058 Oyiborhoro 1250 Finitzo 1992 2118 Paradise 1280 Freyss 1980 4790 Paradise 1282 Fria 1980 4793 Park 4879 Fried 1985 2236 Rees 4878 Gersdorff 1986 4804 Renvall 1384 Grimaldi 1976 2344 Sassen 1397 Haapaniemi 1997 2412 Shaw 1446 Haughton 1977 2545 Szucs 3022 Johnson 1980 2601 Tom 1600 Jonathan 1989 2607 Toner 1632 Karma 1989 2675 van Balen 1646 Kemaloglu 1999 2713 Vaughan-Jones 1650 Kennedy 1982 2758 Watters 

102
Table 42: Reason for Exclusion of Diagnostic Studies After Full-Length Article Review

ID Number Author(s) Year Rejection Reason 

2877 Alho 1998 Data not abstractable 

694 Amedee 1995 Diagnostic procedure and gold standard greater than 24 hou887 Block 1999 Not addressing OME 912 Boswell 1993 No gold standard 968 Buhrer 1985 No gold standard 

1015 Chang 1998 Not a diagnostic study 1149 Douniadakis 1993 No gold standard 1167 Duncan 1982 Diagnostic procedure and gold standard greater than 24 hou1233 Fields 1993 Diagnostic procedure and gold standard greater than 24 hou1236 Fiellau-Nikolajsen 1979 Diagnostic procedure and gold standard greater than 24 hou1239 Fiellau-Nikolajsen 1980 Diagnostic procedure and gold standard greater than 24 hou1281 Fria 1980 Procedure not in scope4749 Kaleida 1992 Data not abstractable 2014 Nozza 1997 Not all referrals had gold standard 2070 Palmu 1999 Only 42/242 ears had myringotomy 2145 Pellett 1997 No gold standard 2385 Schwartz 1987 No gold standard 2434 Silman 1992 No gold standard 2435 Silman 1994 No gold standard 2438 Silva 1997 Data not abstractable 2442 Silverman 1995 No gold standard 2556 Takahashi 1999 Data not abstractable 2786 Williams 1977 Diagnostic procedure and gold standard greater than 24 hou

103
Table 43: Number of Articles by Diagnostic Method and Reference Standard 

Reference Standard

Diagnostic Method

Myringotomy Tympanocentesis

Validated 

pneumatic 

otoscopy 

Acoustic reflectometry 6 1 3 Audiometry-air and bone conduction thresholds 2 Audiometry-air conduction threshold 4 1 Binaural micro-tympanoscopy 2 Non-pneumatic otoscopy 4 Pneumatic otoscopy-examiner validation not specified 3 Pneumatic otoscopy-unvalidated examiner 9 Pneumatic otoscopy-validated examiner 1 Portable tympanometer 8 Professional tympanometry 35 6 6 Quantitative tympanometry 4 Signs/symptoms 

2 

Total 80 8 9 

104

 Note: A record can be counted more than once within a cell (i.e. controlling for intervention group.) 
 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Fried-1985 44 62 71.0

Macknin-1987 84 128 65.6

Babonis-1991 68 118 57.6

Total 196 308 63.6 64.2 (57.0, 71.5) 3.6 0.168

Specificity Fried-1985 36 40 90.0

Macknin-1987 43 70 61.4

Babonis-1991 90 102 88.2

Total 169 212 79.7 80.4 (65.0, 95.9) 18.4 <0.001

Prevalence Fried-1985 62 102 60.8

Macknin-1987 128 198 64.6

Babonis-1991 118 220 53.6

Total 308 520 59.2 59.6 (52.5, 66.7) 5.4 0.067

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Paradise-1976 136 138 98.6

Cantekin-1977 213 230 92.6

Bluestone-1979 242 256 94.5

Karma-1989 726 753 96.4

Mains-1989 102 116 87.9

Toner-1990 108 124 87.1

Finitzo-1992 107 115 93.0

Total 1634 1732 94.3 93.8 (91.4, 96.3) 28.8 <0.001

Specificity Paradise-1976 56 75 74.7

Cantekin-1977 113 140 80.7

Bluestone-1979 131 169 77.5

Karma-1989 277 339 81.7

Mains-1989 84 93 90.3

Toner-1990 87 98 88.8

Finitzo-1992 28 48 58.3

Total 776 962 80.7 80.5 (75.1, 86.0) 27.2 <0.001

Prevalence Paradise-1976 138 213 64.8

Cantekin-1977 230 370 62.2

Bluestone-1979 256 425 60.2

Karma-1989 753 1092 69.0

Mains-1989 116 209 55.5

Toner-1990 124 222 55.9

Finitzo-1992 115 163 70.6

Total 1732 2694 64.3 62.8 (58.3, 67.2) 30.7 <0.001

Table 44: Acoustic Reflectometry (>=5 vs <5 RU) versus Myringotomy

Table 45: Pneumatic Otoscopy versus Myringotomy 

105
 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Orchik-1978 21 39 53.8

Babonis-1991 92 118 78.0

Rees-1992 260 260 100.0

Vaughan-Jones-1992 120 135 88.9

van Balen-1994 147 156 94.2

Koivunen-1997 52 66 78.8

Total 692 774 89.4 84.5 (76.0, 93.1) 39.6 <0.001

Specificity Orchik-1978 35 37 94.6

Babonis-1991 84 102 82.4

Rees-1992 9 50 18.0

Vaughan-Jones-1992 41 65 63.1

van Balen-1994 37 77 48.1

Koivunen-1997 137 175 78.3

Total 343 506 67.8 64.4 (44.3, 84.4) 167.1 <0.001

Prevalence Orchik-1978 39 76 51.3

Babonis-1991 118 220 53.6

Rees-1992 260 310 83.9

Vaughan-Jones-1992 135 200 67.5

van Balen-1994 156 233 67.0

Koivunen-1997 66 241 27.4

Total 774 1280 60.5 58.5 (40.3, 76.7) 268.9 <0.001

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Orchik-1978 35 39 89.7

Orchik-1980 34 39 87.2

Nozza-1992 71 81 87.7

Nozza-1994 106 124 85.5

Total 246 283 86.9 87.1 (83.2, 91.0) 0.6 0.901

Specificity Orchik-1978 29 37 78.4

Orchik-1980 26 37 70.3

Nozza-1992 26 30 86.7

Nozza-1994 61 94 64.9

Total 142 198 71.7 74.8 (64.6, 85.0) 8.2 0.041

Prevalence Orchik-1978 39 76 51.3

Orchik-1980 39 76 51.3

Nozza-1992 81 111 73.0

Nozza-1994 124 218 56.9

Total 283 481 58.8 58.6 (48.5, 68.6) 14.9 0.002

Table 46: Portable Tympanometry (Mixed Criteria) versus Myringotomy

Table 47: Professional Tympanometry (Acoustic Reflex at 500 or 1000 Hz) versus Myringotomy

106
Table 48: Professional Tympanometry (Static Compensated Acoustic Admittance at 0.1) versus Myringotomy

(A) Including both Nozza articles

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Fiellau-Nikolajsen-1980 9 46 19.6

Nozza-1992 25 81 30.9

Nozza-1994 37 137 27.0

Barnett-1998 95 175 54.3

Total 166 439 37.8 33.2 (17.5, 48.9) 38.1 <0.001

Specificity Fiellau-Nikolajsen-1980 42 42 100.0

Nozza-1992 29 30 96.7

Nozza-1994 109 112 97.3

Barnett-1998 104 124 83.9

Total 284 308 92.2 95.0 (88.5, 100) 13.9 0.003

Prevalence Fiellau-Nikolajsen-1980 46 88 52.3

Nozza-1992 81 111 73.0

Nozza-1994 137 249 55.0

Barnett-1998 175 299 58.5

Total 439 747 58.8 59.7 (51.8, 67.7) 14.2 0.003

(B) Excluding Nozza-1992 study

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Fiellau-Nikolajsen-1980 9 46 19.6

Nozza-1994 37 137 27.0

Barnett-1998 95 175 54.3

Total 141 358 39.4 33.9 (12.7, 55.0) 36.9 <0.001

Specificity Fiellau-Nikolajsen-1980 42 42 100.0

Nozza-1994 109 112 97.3

Barnett-1998 104 124 83.9

Total 255 278 91.7 94.1 (83.9, 100) 13.7 0.001

Prevalence Fiellau-Nikolajsen-1980 46 88 52.3

Nozza-1994 137 249 55.0

Barnett-1998 175 299 58.5

Total 358 636 56.3 56.3 (52.5, 60.2) 1.4 0.510

107
Table 49: Professional Tympanometry (Static Compensated Acoustic Admittance at 0.2) versus Myringotomy

(A) Including Both Nozza Studies

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Fiellau-Nikolajsen-1980 21 46 45.7

Nozza-1992 74 81 91.4

Nozza-1994 63 137 46.0

Barnett-1998 110 175 62.9

Total 268 439 61.0 61.8 (39.0, 84.7) 93.4 <0.001

Specificity Fiellau-Nikolajsen-1980 40 42 95.2

Nozza-1992 21 30 70.0

Nozza-1994 103 112 92.0

Barnett-1998 93 124 75.0

Total 257 308 83.4 84.5 (74.0. 95.0) 23.0 <0.001

Prevalence Fiellau-Nikolajsen-1980 46 88 52.3

Nozza-1992 81 111 73.0

Nozza-1994 137 249 55.0

Barnett-1998 175 299 58.5

Total 439 747 58.8 59.7 (51.8, 67.7) 14.2 0.003

(B) Excluding Nozza-1992 Study

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Fiellau-Nikolajsen-1980 21 46 45.7

Nozza-1994 63 137 46.0

Barnett-1998 110 175 62.9

Total 194 358 54.2 52.2 (39.5, 64.8) 10.7 0.005

Specificity Fiellau-Nikolajsen-1980 40 42 95.2

Nozza-1994 103 112 92.0

Barnett-1998 93 124 75.0

Total 236 278 84.9 87.7 (76.8. 98.5) 17.9 <0.001

Prevalence Fiellau-Nikolajsen-1980 46 88 52.3

Nozza-1994 137 249 55.0

Barnett-1998 175 299 58.5

Total 358 636 56.3 56.3 (52.5, 60.2) 1.4 0.510

108
Table 50: Professional Tympanometry (Static Compensated Acoustic Admittance at 0.3) versus Myringotomy

(A) Including both Nozza articles

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Orchik-1978 35 39 89.7

Fiellau-Nikolajsen-1980 16 46 34.8

Nozza-1992 59 81 72.8

Nozza-1994 96 137 70.1

Total 206 303 68.0 67.4 (49.2, 85.7) 41.6 <0.001

Specificity Orchik-1978 15 37 40.5

Fiellau-Nikolajsen-1980 10 42 23.8

Nozza-1992 24 30 80.0

Nozza-1994 90 112 80.4

Total 139 221 62.9 56.4 (27.5, 85.3) 69.4 <0.001

Prevalence Orchik-1978 39 76 51.3

Fiellau-Nikolajsen-1980 46 88 52.3

Nozza-1992 81 111 73.0

Nozza-1994 137 249 55.0

Total 303 524 57.8 58.2 (48.1, 68.3) 15.9 0.001

(B) Excluding Nozza-1992 study

 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Orchik-1978 35 39 89.7

Fiellau-Nikolajsen-1980 16 46 34.8

Nozza-1994 96 137 70.1

Total 147 222 66.2 65.4 (39.1, 91.7) 41.5 <0.001

Specificity Orchik-1978 15 37 40.5

Fiellau-Nikolajsen-1980 10 42 23.8

Nozza-1994 90 112 80.4

Total 115 191 60.2 48.6 (10.2, 87.0) 64.7 <0.001

Prevalence Orchik-1978 39 76 51.3

Fiellau-Nikolajsen-1980 46 88 52.3

Nozza-1994 137 249 55.0

Total 222 413 53.8 53.8 (49.0, 58.6) 0.4 0.811

109
 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Orchik-1978 46 84 54.8

Shaw-1978 48 49 98.0

Johnson-1980 55 74 74.3

Ben-David-1981 195 250 78.0

Kennedy-1982 44 51 86.3

Gersdorff-1986 61 81 75.3

Park-1988 182 248 73.4

Mitchell-1990 57 65 87.7

Toner-1990 107 124 86.3

Finitzo-1992 65 72 90.3

Vaughan-Jones-1992 91 135 67.4

Ovessen-1993 310 342 90.6

Sassen-1994 225 279 80.6

Tom-1994 100 153 65.4

Renvall-1996 87 101 86.1

Watters-1997 679 745 91.1

Total 2352 2853 82.4 80.9 (76.1, 85.7) 196.6 <0.001

Specificity Orchik-1978 52 58 89.7

Shaw-1978 3 10 30.0

Johnson-1980 31 41 75.6

Ben-David-1981 39 61 63.9

Kennedy-1982 21 24 87.5

Gersdorff-1986 27 47 57.4

Park-1988 15 38 39.5

Mitchell-1990 10 19 52.6

Toner-1990 91 98 92.9

Finitzo-1992 19 22 86.4

Vaughan-Jones-1992 61 65 93.8

Ovessen-1993 37 51 72.5

Sassen-1994 59 101 58.4

Tom-1994 47 60 78.3

Renvall-1996 25 26 96.2

Watters-1997 166 210 79.0

Total 703 931 75.5 74.5 (66.9, 82.0) 147.8 <0.001

Prevalence Orchik-1978 84 142 59.2

Shaw-1978 49 59 83.1

Johnson-1980 74 115 64.3

Ben-David-1981 250 311 80.4

Kennedy-1982 51 75 68.0

Gersdorff-1986 81 128 63.3

Park-1988 248 286 86.7

Mitchell-1990 65 84 77.4

Toner-1990 124 222 55.9

Finitzo-1992 72 94 76.6

Vaughan-Jones-1992 135 200 67.5

Ovessen-1993 342 393 87.0

Sassen-1994 279 380 73.4

Tom-1994 153 213 71.8

Renvall-1996 101 127 79.5

Watters-1997 745 955 78.0

Total 2853 3784 75.4 73.6 (69.1, 78.1) 156.6 <0.001

Table 51: Professional Tympanometry (B curve as abnormal) versus Myringotomy

110
 Random Effect Estimate Test of Heterogeneity

Measure Author-Year X N % % 95% CI Q P-Value

Sensitivity Orchik-1978 31 39 79.5

Fiellau-Nikolajsen-1980 42 46 91.3

Kennedy-1982 51 51 100.0

Vaughan-Jones-1992 120 135 88.9

Ovessen-1993 323 342 94.4

Sassen-1994 253 279 90.7

Total 820 892 91.9 93.8 (91.1, 96.4) 9.44 0.093

Specificity Orchik-1978 32 37 86.5

Fiellau-Nikolajsen-1980 37 42 88.1

Kennedy-1982 11 24 45.8

Vaughan-Jones-1992 41 65 63.1

Ovessen-1993 27 51 52.9

Sassen-1994 33 101 32.7

Total 181 320 56.6 61.8 (41.5, 82.1) 89.8 <0.001

Prevalence Orchik-1978 39 76 51.3

Fiellau-Nikolajsen-1980 46 88 52.3

Kennedy-1982 51 75 68.0

Vaughan-Jones-1992 135 200 67.5

Ovessen-1993 342 393 87.0

Sassen-1994 279 380 73.4

Total 892 1212 73.6 67.3 (56.3, 78.2) 90.1 <0.001

 Table 52: Professional Tympanometry (B or C2 curve as abnormal) versus Myringotomy

111
Number Number Measure Random Eff

Measure ID Diagnostic Comparison versus Myringotomy Articles Cases % % 

Sensitivity 1 Acoustic reflectometry (>=5 vs <5) 3 308 63.6 64.2 (5

2 Pneumatic otoscopy 7 1732 94.3 93.8 (93 Portable tympanometry 6 774 89.4 84.5 (75 Professional tympanometry (using static compensated acoustic 

admittance at 0.1) 

3 358 39.4 33.9 (1

6 Professional tympanometry (using static compensated acoustic 

admittance at 0.2)

3 359 54.2 52.2 (3

7 Professional tympanometry (using static compensated acoustic 

admittance at 0.3) 

3 222 66.2 65.4 (3

8 Professional tympanometry (using flat or B curve as abnormal) 16 2853 82.4 80.9 (79 Professional tympanometry (using flat or B or C2 curve as abnormal) 6 892 91.9 93.8 (9

Specificity 1 Acoustic reflectometry (>=5 vs <5) 3 212 79.7 80.4 (6

2 Pneumatic otoscopy 7 962 80.7 80.5 (73 Portable tympanometry 6 506 67.8 64.4 (45 Professional tympanometry (using static compensated acoustic 

admittance at 0.1) 

3 278 91.7 94.1 (

6 Professional tympanometry (using static compensated acoustic 

admittance at 0.2)

3 278 84.9 87.7 (7

112

7 Professional tympanometry (using static compensated acoustic 

admittance at 0.3) 

3 191 60.2 48.6 (1

8 Professional tympanometry (using flat or B curve as abnormal) 16 931 75.5 74.5 (69 Professional tympanometry (using flat or B or C2 curve as abnormal) 6 320 56.6 61.8 (4

Prevalence 1 Acoustic reflectometry (>=5 vs <5) 3 520 59.2 59.6 (5

2 Pneumatic otoscopy 7 2694 64.3 62.8 (53 Portable tympanometry 6 1280 60.5 58.5 (45 Professional tympanometry (using static compensated acoustic 

admittance at 0.1) 

3 636 56.3 56.3 (5

6 Professional tympanometry (using static compensated acoustic 

admittance at 0.2)

3 636 56.3 56.3 (5

7 Professional tympanometry (using static compensated acoustic 

admittance at 0.3) 

3 413 53.8 53.8 (4

8 Professional tympanometry (using flat or B curve as abnormal) 16 3784 75.4 73.6 (69 Professional tympanometry (using flat or B or C2 curve as abnormal) 6 1212 73.6 67.3 (5

Note: Comparison #4 had only two studies and thus not included in the summary

Table 53: Summary of Meta Analysis for Diagnostic Comparisons, Excluding Duplicated Studies by Same Author 
Table 54: Study Quality and Test Performer of Diagnostic Studies Used in Meta-Analysis 

113

Diagnostic Comparison

Author-Year Study

Qualitya

Test Performer 

1. Acoustic reflectometry (>=5 vs <5 RU) with myringotomy

Fried-1985 Macknin-1987Babonis-1991 

1(100000) 4(111001) 5(111011) 

Not specified Pediatrician One of the authors, specialty no

2. Pneumatic otoscopy with myringotomy Paradise-1976

Cantekin-1977Bluestone-1979 Karma-1989 Mains-1989 Toner-1990 Finitzo-1992 

4(111001) 1(100000) 2(100001) 3(100101) 1(100000) 2(100001) 4(111001) 

Pediatrician Not specified Not specified Otolaryngologist/pediatrician Senior registrar and senior housOne of the authors, specialty noPediatric otolaryngologist 

3. Portable tympanometry (mixed criteria) with myringotomy

Orchik-1978 Babonis-1991 Rees-1992 Vaughan-Jones-1992 van Balen-1994 Koivunen-1997 

4(111001) 5(111011) 1(100000) 2(100001) 4(111010) 3(110001) 

Not specified One of the authors, specialty noNot specified Not specified General practitioner with speciadepartment Trained nurse 

4. Professional tympanometer (using acoustic reflex at 500 or 1000 Hz) with myringotomy 

Orchik-1978 Orchik-1980 Nozza-1992 Nozza-1994 

4(111001) 4(111001) 4(111001) 4(111001) 

Not specified Not specified Audiologist/nurses Clinically certified and licensed 

5. Professional tympanometer (using static compensated acoustic admittance at 0.1) with myringotomy

Fiellau-Nikolajsen-1980 Nozza-1992 Nozza-1994 Barnett-1998

4(111001) 4(111001) 4(111001) 4(111001) 

Author Audiologist/nurses Clinically certified and licensed Research assistant 

6. Professional tympanometer (using static compensated acoustic admittance at 0.2) with myringotomy

Fiellau-Nikolajsen-1980 Nozza-1992 Nozza-1994 Barnett-1998

4(111001) 4(111001) 4(111001) 4(111001) 

Author Audiologist/nurses Clinically certified and licensed Research assistant 

a The first number is the total score of the six components. The six components of study quality score are: (1) appropriate reference standard; (2) test a

assessed independently of each other; (3) blinded reading of results; (4) patient sample included an appropriate spectrum as in clinical practice; (5) rep

interpretation of test results determined; and (6) description of test method sufficient to permit replication. ‘1’ indicates presence and ‘0’ indicates abse
Table 54: Study Quality and Test Performer of Diagnostic Studies Used in Meta-Analysis (Continued) 

114

Diagnostic Comparison

Author-Year Study

Quality a

Test Performer 

7. Professional tympanometer (using static compensated acoustic admittance at 0.3) with myringotomy

Orchik-1978 Fiellau-Nikolajsen-1980 Nozza-1992 Nozza-1994 

4(111001) 4(111001) 4(111001) 4(111001) 

Not specified Author Audiologist/nurses Clinically certified and licensed 

8. Professional tympanometer (using flat or B curve as abnormal) with myringotomy 

Orchik-1978 Shaw-1978 Johnson-1980 Ben-David-1981 Kennedy-1982Gersdorff-1986 Park-1988 Mitchell-1990Toner-1990 Finitzo-1992 Vaughan-Jones-1992 Ovessen-1993Sassen-1994 Tom-1994 Renvall-1996Watters-1997 

4(111001) 1(100000) 2(110000) 1(100000) 1(100000) 1(100000) 1(100000) 1(100000) 2(100001) 4(111001) 2(100001) 4(111001) 3(111000) 4(111001) 1(100000) 2(110000) 

Not specified Not specified Audiologist Not specified Audiologist Not specified Not specified Not specified Not specified Certified audiologist Not specified Otolaryngologist Not specified Certified audiologists Not specified Paediatric audiologist 

9. Professional tympanometer (using flat or B or C2 curve as abnormal) with myringotomy 

Orchik-1978 Fiellau-Nikolajsen-1980 Kennedy-1982Vaughan-Jones-1992 Ovessen-1993Sassen-1994 

4(111001) 4(111001) 1(100000) 2(100001) 4(111001) 3(111000) 

Not specified Author Audiologist Not specified Otolaryngologist Not specified 

a The first number is the total score of the six components. The six components of study quality score are: (1) appropriate reference standard; (2) test a

assessed independently of each other; (3) blinded reading of results; (4) patient sample included an appropriate spectrum as in clinical practice; (5) rep

interpretation of test results determined; and (6) description of test method sufficient to permit replication. ‘1’ indicates presence and ‘0’ indicates abse
Table 55: Country of Origin of Studies Included in Evidence Tables 

Country of Origin All Questions 

(n=112) 

Question 1: 

Natural History

(n=33) 

Question 2: 

Speech and 

Language 

(n=20) 

Question 3: 

Hearing 

(n=7) 

Dia

Belgium 2 Canada 1 1Denmark 18 14 England 9 3 Finland 4 1 France 1 Israel 2 1 Italy 1 1Korea 1 Kuwait 1 1Northern Ireland 2 Scotland 2 1 Sweden 6 3 1 2The Netherlands 4 2 Turkey 1 USA 53 6 19 4 not specified 4 

115

Non-USA 55 (51%) 27 (82%) 1 (5%) 3 (43%) USA 53 (49%) 6 (18%) 19 (95%) 4 (57%) 
Figure 1 Shrinkage Plot for Rate Difference in Conductive Hearing Loss at 6-10 Years 

 Presence of early life OM versus Absence of early life OM 

-0.15 0 0.15 0.3 0.45

Rate Difference

Sorri-1995

Fischler-1985

Harsten-1993

Kaplan-1973

Overall

 

Favors Favors

 OM Positive OM Negative 

Effect size: Difference in proportion of ears with hearing loss 

 (Positive early life OM – Negative early life OM) 

 

 Individual effect size; horizontal line is 95% confidence interval

Pooled effect size; width is 95% confidence interval 

116
Figure 2 Funnel Plot for Rate Difference in Conductive Hearing Loss at 6-10 Years 

 Presence of early life OM versus Absence of early life OM

0.1 0.2 0.3

Risk Difference

15

20

25

1/std

error

117
Figure 3 Shrinkage Plot for Relative Risk of Conductive Hearing Loss at Age 6-10 Years

 Positive Early Life OM versus Negative Early Life OM 

0.50 1.00 2.00 5.00 10.00 20.00

Relative Risk

Sorri-1995

Fischler-1985

Harsten-1993

Kaplan-1973

Overall

Favors Favors

 OM Positive OM Negative 

 Effect size: Difference in proportion of ears with hearing loss 

 (Positive early life OM – Negative early life OM) 

 

 Individual effect size; horizontal line is 95% confidence interval 

Pooled effect size; width is 95% confidence interval 

118
Figure 4 Funnel Plot for Log Relative Risk of Conductive Hearing Loss at Age 6-10 Years 

 Positive Early Life OM versus Negative Early Life OM

0.5 1 1.5

Log Relative Risk

1.5

2

2.5

1/std error

119
Figure 4 Funnel Plot for Log Relative Risk of Conductive Hearing Loss at Age 6-10 Years 

 Positive Early Life OM versus Negative Early Life OM

0.5 1 1.5

Log Relative Risk

1.5

2

2.5

1/std error

119
Figure 6 Positive and Negative Predictive Values (PPV and NPV) of Pneumatic Otoscopy 

 by Prevalence of Otitis Media with Effusion Based on Pooled Estimate of Sensitivity at 

93.8 % and Specificity at 80.5%

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

100.0

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Prevalence Rate

Percent

PPV

NPV

121 
Chapter 4. Conclusions 

Despite the recent publication of the 1994 Guidelines on Otitis Media with Effusion in 

Children (Stool, Berg, Berman, et al., 1994), controversy persists over the management and 

treatment of otitis media with effusion (OME). The present evidence report systematically 

reviews the recent literature and provides an update to the 1994 guideline on the diagnosis and 

the late effects of OME on speech, language, and hearing. In addition, while the 1994 OME 

guideline (Stool, Berg, Berman et al., 1994) did not formally assess OME resolution rates, the 

present report reviews the natural history of OME. Although the technical expert panel proposed 

20 potential key questions for this report, our time constraints allowed us to address only the four 

key questions judged by the panel to be most pressing and to have the most significant body of 

recent literature. We did not address any key questions on treatment or management. Of a total 

of 449 articles originally identified for this report, only a small percentage qualified for inclusion 

in the synthesis. Thus, the number of meta-analyses performed was a fraction of those we had 

hoped would inform this report. Our conclusions should be read with this perspective in mind. 

Natural History of OME 

Based on the available evidence, this report assessed the natural history of OME in terms of 

resolution rates. The availability of relevant studies limited our analysis to an assessment of

natural history at two periods of followup and only for children 3 years of age and older; we 

were unable to perform meta-analysis for the under-3 age group. For children older than 3 years 

of age, we were able to conduct two sets of meta-analyses on the resolution of otitis media with 

effusion at two followup intervals. These sets were matched by unit of analysis, age group, and 

OME type and, when possible, diagnostic method. 

The first set of meta-analyses assessed resolution at 6 weeks followup. In children older than 

3 years of age with OME of unknown duration at the onset of the study, 37.2 or 42.3 percent of 

ears with OME were free of OME at 6 weeks followup, without regard to their interval OME 

status, depending on the tympanometric diagnostic criteria for OME resolution. Spontaneous 

resolution rates were significantly different among the cohorts included in the first set of metaanalyses. 

The second set of meta-analyses assessed resolution at 3 months followup. Over a period of 3 

months, in studies with cumulative resolution rates, and in children older than 3 years of age 

with OME of unknown duration, 22.5 or 42.7 percent of ears with OME resolve, depending on 

the tympanometric diagnostic criteria for OME resolution. A disadvantage of using ears as the 

unit of analysis is the clinical interpretation of the resolution rate: the distribution of OME 

resolution using ears cannot be assumed to be the same when children are the unit of analysis. 

Spontaneous resolution rates were not significantly different among the cohorts included in the 

second set of meta-analyses. 

Apart from age, tympanometric criteria for OME diagnosis, and criteria for resolution on 

followup, which were reported in the studies, we did not have sufficient information from the 

studies to consider other influential factors. It was also not possible to know with certainty if 

the children in the various cohorts presented at identical stages in the course of OME. It is 

unclear why the non-cumulative, 6-week resolution rate estimate should overlap the cumulative, 

123
3-month resolution rate estimate to such an extent. The non-cumulative resolution rate would be 

expected to include children whose OME had resolved and then re-accumulated middle-ear 

effusions (which would make the non-cumulative rate greater than the cumulative rate). 

Therefore, we view these estimates of OME resolution with great caution. 

In the Results section, we also described isolated studies of daily followup, resolution of 

OME of at least 3 months duration at study onset, and a study that derived OME resolution rate 

equations. The findings of these studies were too limited to draw any broad conclusions. 

Similarly, a few studies assessed the effects of influencing factors on OME resolution, but, 

again, we hesitate to draw any generalizations based on such limited evidence.

Literature on the natural history of OME was difficult to interpret for several reasons. These 

reasons include its generally poor quality of the research, the lack of control for therapeutic 

interventions, the inability to distinguish persistent as opposed to recurrent OME due to the 

length of followup, and the varied criteria for continued followup from examination to 

examination. We recognize that the meaning of quality summary scores, as measured in this 

analysis by scoring of documentation in the published articles, can be ambiguous (Jüni, Witschi, 

Bloch et al., 1999). Nevertheless, whether as a summary score or considering individual quality 

domains, the quality of the twenty-eight cohort studies on natural history was poor. Twenty-four 

of twenty-seven of these studies had a quality score of three or less on a scale of one (lowest) to 

six (highest), even though our preselection process guaranteed all cohort studies a minimum

score of one. Half of the studies that attempted to assess the natural history of OME did not 

control for or document control of interventions, either medical or surgical, that might affect 

OME outcome during the study period. The majority of these investigations did not stratify 

findings by intervention status. In addition, the intervals between examinations for OME in 

these studies varied from one day to 3 years; and, it was impossible to assess whether the 

“continuing” presence of OME, especially after a long interval, represented persistent or 

recurrent OME. Furthermore, the criteria for followup varied among studies. Most studies 

continued followup for the whole study period regardless of OME status at a particular exam, but 

four cohorts terminated followup of individuals who had type A or normal tympanograms at any 

exam. 

Differing definitions of OME resolution and diagnostic methods also make comparison 

difficult. As noted in the Results chapter, a difference in the definition of OME resolution 

between tympanogram type B or C transition to A and tympanogram type B transition to A 

resulted in a three-fold difference in the estimate of OME resolution in one case. As can be seen 

from our assessment of the operating characteristics of various OME diagnostic methods in the 

response to Key Question 4 in the Results, the apparent OME resolution rate could be greatly 

influenced by the sensitivity and specificity of a test. 

A paucity of research studies made it impossible to address several other issues. These 

included the use of the child or the episode as the unit of analysis. Furthermore, we could not 

assess OME resolution in younger children or the resolution of OME that was not newly 

diagnosed and of unknown duration. 

The literature was lacking in evidence addressing potential factors that might influence OME 

resolution. A few studies analyzed the potential influence on OME resolution of factors such as 

gender, at home care versus daycare, season of onset, side of affected ear, race/et`nicity, or 

diagnostic instrument. Because of the paucity of such studies, quantitative synthesis was not 

possible. Such information is also necessary to allow generalizations to specific clinical 

situations. 

124
Similar to the results of Rosenfeld (1999a), our pooled OME resolution rates could be 

stratified by age and by tympanometric criteria for OME. Although Rosenfeld did not specify 

his tympanometric criteria, his analysis found a one-month OME resolution rate of 52 percent 

(95% CI: 47%, 58%) for OME of unspecified duration in cohort studies with ears as the unit of 

analysis, regardless of age. This finding is similar to our observation of 42.3 percent resolution 

(95% CI: 24.1%, 60.6%) for children older than 3 years of age. This finding was not based on 

cumulative resolution rates but on the disappearance of OME at various points in time in 

children who had OME at the start of the observation period. Further, Rosenfeld (1999a) found 

a two-to 3-month OME resolution rate of 63 percent (95% CI: 60%, 63%) for OME of 

unspecified duration in cohort studies with ears as the unit of analysis, regardless of age. This 

rate is somewhat higher than our estimate of 42.7 percent (95% CI: 29.3%, 56.1%), which was 

based on studies that measured cumulative resolution. 

We restricted our analysis to prospective cohort studies to provide better assessments of the 

natural history of OME in the general population of children. Nevertheless, we recognize that 

information on the natural history of OME may also be gleaned from analysis of the results of 

randomized, controlled trials of treatment of OME, as Rosenfeld (1999a) subsequently reported. 

Such estimates would be more applicable than would cohort studies on the general population of 

children to those who, for whatever reason, are being followed closely for their OME by their 

health provider. Children being screened for OME in the general population might not 

necessarily have presented to the health care system for evaluation. As a result, these children 

might represent a less severe class of OME or at least a different population from those children 

who were already identified with and being followed for OME and who were deemed potential 

candidates for therapeutic intervention. Rosenfeld (1999a) reported OME resolution rates of 12 

percent (95% CI: 8%, 16%), 23 percent (95% CI: 21%, 26%), and 24 percent (95% CI: 17%, 

32%), at two weeks, one month, and one to 3 months followup, respectively, in children with 

OME that had lasted weeks or months and were randomized to the placebo or no-drug arms of 

randomized controlled trials. In addition, he assessed OME resolution rates of children with 

OME that lasted 3 months or longer who were surgical candidates for tympanostomy tubes. He 

found the following OME resolution rates at 6 months, 1 year, 2 years, 3 years, and 4 years for 

children assigned to the no intervention groups: 27 percent (95% CI: 20%, 35%), 32 percent 

(95% CI: 24%, 40%), 31 percent (95% CI: 25%, 37%), 49 percent (95% CI: 37%, 62%), and 59 

percent (95% CI: 46%, 72%). A strength of these studies is that the diagnosis of OME tended to 

rely on pneumatic otoscopy as well as tympanometry, rather than on tympanometry alone. A 

major difficulty of these studies, as with the cohort studies, is the inability to account for 

interventions received from other providers and beyond the control of the investigators. In fact, 

one of these investigators mentioned that “Antibiotic treatment was not controlled for in this 

study” (Maw and Bawden, 1994). Another difficulty, as with the cohort studies, is the inability 

to distinguish persistent from recurrent OME, due to the long intervals between followup 

assessments. 

Finally, the publication of multiple articles based on the study of a single cohort raises a 

complex issue. If multiple studies from one cohort were included once in a meta-analysis, the 

results would be unbiased. However, if findings from a single cohort were included more than 

once in a meta-analysis, then bias would exist. 

125
Effects of Early-life OM on Long-term Speech and Language 

Development 

Our intent was to examine the influence of long and short-duration OME that results in 

hearing loss on delays in speech and language development and the ability of other factors to 

modify the effect of OME. However, we found few studies that addressed these questions. Only 

20 of 112 studies (19%) (on 12 cohorts) met our criteria for consideration for this question. 

These studies further suffered from lack of uniformity with respect to risk factors studied, type of 

outcome measured, method of measurement, unit of measurement, and age at outcome

determination. 

The generalizability of our findings also is questionable, since nine of the twelve cohorts 

primarily included children from specific ethnic/racial groups or particular socioeconomic 

groups. Five of the six studies included in the three meta-analyses were based on such cohorts. 

However, we excluded studies on children with specific medical conditions such as craniofacial 

defects, primary mucosal disorders, immunodeficiencies, and genetic disorders. The available 

literature did not address the effect of pre-existing speech, language, or other developmental 

disorders, and only one study focussed on the effect of bilateral persistent middle-ear effusion. 

Based on our criteria, only nine of the twenty studies (45 percent) were of acceptable 

quality. These studies scored five points or more on an eight-point scale. 

Our analysis was limited to assessing whether early-onset OME resulted in delays in 

expressive and receptive language development and cognitive verbal intelligence. For children 

older than 3 years of age who had a positive history of otitis media during the first 3 years of life, 

our meta-analyses on long-term expressive language (three studies), receptive language (four 

studies), and cognitive verbal intelligence (three studies) showed no effect of early otitis media. 

The 1994 OME guideline (Stool, Berg, Berman et al., 1994) had determined that meta-analysis 

of the 14 “adequate” studies was not possible, because of the wide variety of measurement tools 

used for outcome assessment as well as a lack of standardization of data reporting. We were 

able to identify articles that had appeared since the release of the 1994 OME guidelines. 

Nevertheless, our findings on the possible effects of early-life OM on speech and language 

development are in general agreement with the conclusion of the 1994 OME guideline (Stool, 

Berg, Berman et al., 1994). They concluded that " rigorous, methodologically sound research 

does not adequately support or refute the theory that untreated otitis media with effusion results 

in speech/language delays or deficits." Our findings were also in agreement with those noted in 

the 1994 OME guideline that "Conflicting findings among studies can be accounted for in 

several ways: limitations in the research designs, lack of uniformity of test instrument selection, 

lack of definition of hearing status, and interactions between otitis media with effusion and other 

risk factors," as well as differences in populations studied. Thus, we caution clinicians not to 

generalize these findings to children with the underlying chronic medical conditions that were 

excluded from this study or to those with pre-existing developmental disorders. In addition, 

generalization to children with persistent bilateral OM may not be valid, since only one of the 

studies specifically assessed bilateral as opposed to unilateral or bilateral otitis media. 

Several ongoing, prospective studies are assessing the effect of early otitis media on longterm speech and language development of children older than 3 years. However, the results of 

these studies have not yet been published (Paradise, Dollaghan, Campbell et al., 2000; Feldman, 

Dollaghan, Campbell et al., 1999; Paradise, Rockette, Colborn et al., 1997; Roberts, Burchinal, 

126
Zeisel et al., 1998; Roberts, Burchinal, Jackson et al., 2000). These studies will provide further 

data on which to base an assessment of the effect of OM on speech and language development.

Effects of Early-life OM on Long-term Hearing 

Although the immediate effect of OM on the conductive aspects of hearing is well 

recognized, the long-term effect of early OM on sensorineural hearing has not been well 

established (Madell, 1999). Our findings indicate that early OM may have an effect on longterm hearing. 

Of the eight cohort studies we analyzed, four reported percent of hearing loss at 6 to 10 years 

of age. Children with early-life OM have a 2.6 times higher risk of hearing loss at 6 to 10 years 

of age than do children with no early history of OM with an estimated rate difference of 11 

percent. The rate difference and the risk ratio were not significantly different among the cohorts. 

If early OM does indeed lead to long-term hearing deficits, the clinical implications are 

significant. Depending on the degree of hearing loss, the hypothesized effect of OM on speech 

and language development as mediated through hearing loss may be of greater duration than 

would be explained by the intermittent and transient episodes of conductive hearing loss 

associated with OM. In addition, the question of the effect of OME treatment on long-term

hearing gains greater relevance. 

The literature available for assessment of the long-term effects of early-life OM on hearing is 

both limited and of poor quality. Only four percent (eight of the 186) of the studies that 

addressed OM and hearing qualified for inclusion in our analysis, and only half of these were of 

acceptable quality. The evidence on the effects of early OM on long-term hearing also suffered 

from the same methodological issues as the evidence on the effects of early-life OM on longterm speech and language development. Because of the limited nature of this evidence, and 

because the rate of intervention depends greatly on the threshold hearing level adopted, the 

findings of our analysis should be used with caution. 

Diagnostic Methods for OME 

Previous assessments of diagnostic techniques for OME have recommended several different 

techniques. The 1994 OME Guidelines recommended pneumatic otoscopy (Stool, Berg, 

Berman, et al., 1994). 

Using 52 diagnostic studies, we were able to evaluate the diagnostic accuracy of the 

following eight methods: acoustic reflectometry at ≤5 or >5 RU; pneumatic otoscopy; portable 

tympanometry; professional tympanometry using static compensated acoustic admittance at 0.1, 

0.2, and 0.3; professional tympanometry using B curve as abnormal; and professional 

tympanometry using B or C2 curves as abnormal. All comparisons used myringotomy as the 

reference standard. 

Among the eight diagnostic methods, the receiver-operator characteristic points (plotting 

sensitivity against [1 minus specificity]) for pneumatic otoscopy were closest to the optimal 

point of 100% sensitivity and 100% specificity. The pooled sensitivity for pneumatic otoscopy 

was 94 percent (95% CI: 91%, 96%); the pooled specificity was 80 percent (95% CI: 75%, 

86%); the positive predictive value was 89 percent (95% CI: 87%, 92%); the negative predictive 

value was 89 percent (95% CI: 86%, 93%), and the accuracy was 89 percent (95% CI: 87%, 

127
91%). These findings were based on 2,694 children from seven studies that reported a pooled 

prevalence rate for OME of 63 percent (95% CI: 58%, 67%). The prevalence rates among the 

studies ranged from 56 percent to 71 percent, which was a significant variation (p<0.001). The 

diagnostic test with the highest specificity was professional tympanometry (using static 

compensated acoustic admittance at 0.1) at 95.0 percent (95% CI: 88.5, 100). 

Our findings are in general agreement with the recommendations and findings of the 1994 

OME guideline (Stool, Berg, Berman et al., 1994). The 1994 OME guideline stated that "The 

diagnostic evaluation of suspected otitis media with effusion should include pneumatic otoscopy. 

Otoscopy alone (without the use of the pneumatic otoscope to test tympanic membrane mobility) 

is not recommended." This recommendation was deemed a strong one based on limited 

scientific evidence and strong Panel consensus. Based on limited scientific evidence and expert 

opinion, the 1994 OME guideline also allowed the following option: "Tympanometry may be 

used as a confirmatory test for otitis media with effusion." The OME Guidelines did not include 

quantitative syntheses of the evidence. 

Our analysis considered several references not cited by the 1994 OME guideline; some were 

accepted, and some were rejected. The results of our meta-analyses confirm that pneumatic 

otoscopy had the best operating characteristics among the nine alternatives examined. Our 

findings also confirm that certain, but not all, categories of tympanometry also perform well in 

identifying middle-ear effusion in OME as well as in distinguishing it from other entities. While 

the 1994 OME guideline did not make a recommendation regarding acoustic reflectometry, our 

findings suggest that acoustic reflectometry does not perform as well as pneumatic otoscopy and 

certain types of tympanometry. The use of the spectral gradient angle, as the unit of 

measurement, may improve the sensitivity of acoustic reflectometry compared to the use of

reflectivity, but this observation is based on a single study that found a sensitivity of 95.4 percent 

using a threshold of 95 degrees (Barnett, 1998) (compared to the pooled sensitivity of 64.2 

percent for a threshold reflectivity of 5 found in this study. However, the specificity was 31.5 

percent when a spectral gradient angle of 95 degrees was used as the threshold, compared to the 

pooled specificity of 80.4 percent with a threshold reflectivity of 5 in this study. Unlike the 1994 

OME guideline, which commented on the combination of tympanometry and pneumatic 

otoscopy, we did not assess combinational diagnostic methods or algorithms. 

The finding that pneumatic otoscopy can do as well as or better than tympanometry and 

acoustic reflectometry has significant practical implications. For the typical clinician, pneumatic 

otoscopy should be easier to employ than other diagnostic methods. The important question may 

be what degree of training will be needed for the clinician to be as effective with pneumatic 

otoscopy as were the examiners in the studies reviewed in this report. Also, while we did not do 

a cost-effectiveness analysis, the cost of pneumatic otoscopy, in terms of direct and indirect 

costs, would appear to be less than that for tympanometry or acoustic reflectometry. 

Because of inadequate evidence, we could not conduct evaluations of clinical signs and/or 

symptoms, air and/or bone threshold audiometry, binocular micro-tympanoscopy, and nonpneumatic otoscopy in the diagnosis of OME. In addition, diagnostic methods that use 

algorithms or aggregated scorings are important but were not included in the scope of this 

evidence assessment. The sources of variation of such combinational methods are difficult to 

detect in published articles. In addition, we must emphasize that we assessed the diagnosis of 

OME middle-ear effusion at single points in time rather than the diagnosis of persistent or 

recurrent OME over time. The meta-analyses of diagnostic tools raised several methodological 

concerns. One concern centered on pooling data from studies of diverse populations. The 

128
differences in OME prevalence among the studies point to one aspect of this diversity. In 

addition, we were concerned about the different models of instruments within the broad 

categories of diagnostic methods. We assume instrumentation has improved or at least changed 

over time in the areas of tympanometry and acoustic reflectometry as well as in the other 

diagnostic methods that could not be assessed in depth. 

In addition, as alluded to above, a definitive assessment of diagnostic methods for the 

diagnosis of middle-ear effusion in OME would require an assessment of the cost-effectiveness 

of the different diagnostic procedures. Such an assessment could not be incorporated into our 

analysis due to a limited time frame. Cost-effectiveness analysis would take into account the 

specific impact of test results, including false positives and false negatives, which will depend on 

examiner proficiency and the patient preferences for specific outcomes. Cost-effectiveness 

analysis would also establish optimal operating points or thresholds for diagnostic methods 

measured on both ordinal and continuous scales (Sox, Stern, Owen et al, 1989). 

Study Limitations 

Several limitations of the study applied to the evidence analysis as a whole. These included 

the issues of the selection of key questions, publication language as an exclusion factor, study 

quality, and the analysis of influencing factors. This section addresses these issues. Limitations 

that pertained to individual questions are discussed in the Results section. 

Question Selection 

Several peer reviewers commented on the absence of OME treatment as a topic of inquiry of 

this study. The key questions were selected using a standard consensus methodology, as 

described in the Methods section. The technical experts were asked to consider various factors 

when selecting questions. One of these factors was the importance of the question (as assessed 

by the potential impact on OME outcomes and on development of future OME guidelines). 

Another consideration was feasibility (as assessed by the ability to complete the study in 6 

months and the availability of sufficient information or new information, if a systematic review 

had already been done in the past). Therefore, treatment questions were not arbitrarily included 

or avoided; instead, adherence to our key question selection method led to the questions that 

were included. Whether the methodology for selecting key questions needs to be reconsidered in 

future systematic reviews is a valid question. In addition, whether the composition of a 

particular technical expert panel might influence the selection of key questions is also a valid 

question for future systematic reviews. 

Study Language 

For this analysis, we did not include literature published in other languages, although we did 

consider studies conducted in non-English-speaking nations but published in English-language 

journals. This decision was based on our previous experience of limited yield from non-English 

language publications for our evidence assessment of the management of acute otitis media 

(Takata, Chan, Shekelle et al., in press; Chan, Takata, Shekelle et al., in press). In that 

assessment, we reviewed a total of 97 articles published in non-English-language journals and 

129
found two eligible for inclusion. However, these studies were also reported in English language 

publications. In Table 55, we tabulated the country of origin of the 112 studies included in the 

evidence tables. Of the 108 studies that specified country of origin, 55 (51%) were from (15) 

countries other than the United States. The percentage of studies from countries other than the 

United States was 82 percent (27 of the 33) for the natural history question, 50 percent (24 of 48) 

for the diagnostic methods question, 43 percent (three of seven) for the hearing question, and 5 

percent (1 of 19) for the speech and language development question. We also observed that 

among our peer reviewers, four of whom were European (including two from non-Englishspeaking countries), none mentioned any specific studies from the non-English-language 

literature that they believed should have been included in the analysis, based on our study 

criteria. 

Study Quality 

For two reasons, no prospective cohort studies were excluded based on study quality. First, 

we decided that if sufficient numbers of studies were available, we would study the variability of 

findings by either stratified or sensitivity analyses. Secondly, we recognized the potential 

problems with summary quality scores (Jüni, Witschi, Bloch et al., 1999). For example, we 

recognized that a study may have adhered to a high quality of study design but not have 

documented that design in the article. The abstracted data may be viewed along with our quality 

score, based on the design described in the article, in the evidence tables. 

Influencing Factors 

 

As we mentioned in the Results section, we were unable to conduct in-depth analysis by 

influencing factors for any of our key questions, due to the constraints of the available evidence. 

In particular, our assessment of the effect of early-life otitis media on long-term speech, 

language, and hearing was limited to an assessment of the effect of OME duration. The 

available evidence was not sufficient to allow us to address the second part of the question, 

namely, the influence of other risk factors, using standard analytic techniques within the 

resources and timeframe of this evidence analysis. The technical expert panel had listed many 

demographic (including SES), environmental, and clinical factors that might either act 

independently or interact with OME to affect speech and language. To address this question, a 

meta-regression approach would be required to identify the risk factors that contribute 

significantly to speech, language, and hearing delays in the context of otitis media and could 

include both comparative and single cohort studies. However, many issues must be addressed in 

order to set up data for meta-regression analysis appropriately. Such issues would require a great 

deal more input from technical experts than was possible with the resources available in this 

study. 

 

130
Chapter 5. Future Research 

General Issues 

 The need for future research on otitis media with effusion (OME) and otitis media (OM) can 

be substantiated only by the demonstration of a negative effect of OM on important outcomes 

such as speech, language, and hearing. The available data do not provide such evidence in the 

case of speech and language and, suggest, at most, a possible effect of early-life OM on longterm hearing, based on evidence that may not be generalizable. Thus, future research must still 

establish the effect of early-life OM on speech, language, and hearing. Such future research will 

benefit by addressing the following general issues, which affect study quality and outcomes 

assessment. The definitions of OME and OM and of relevant interventions, influencing factors, 

and outcomes should be standardized. 

A common, testable framework, with flexibility for competing hypotheses, that links 

predisposing factors to OME and OM and then OME or OM to outcomes such as long-term

speech and language development and hearing, should be adopted. This framework should 

include hypotheses on the role of child characteristics, environmental and social influences such 

as socioeconomic status, and medical factors such as interventions, on outcomes. 

Agreement on appropriate follow-up intervals to provide valid estimates of duration or 

frequency of OME and OM is needed to help in comparing results from different studies. 

Additional areas where future research should focus include potential gaps in practice and 

newer outcome measures. Such outcome measures include general health status and quality 

issues such as satisfaction with treatment. 

Natural History 

Future research on the natural history of OME must focus on improvement of study quality 

and establishing the effect of OME on long-term outcomes such as speech, language, and 

hearing. In particular, control of therapeutic intervention during the study and the distinction 

between OME persistence and recurrence need to be addressed. Considering the difficulties of 

conducting a natural history study on OME, a less restrictive definition of nonintervention might 

be considered. Even with a less restrictive definition of nonintervention, studies should consider 

presenting data that has been stratified by the level of intervention each child receives during the 

study period. For example, if a child is allowed to have antibiotics, the exact circumstances 

when antibiotics may be given should be determined a priori, the number of episodes of such 

antibiotic administration should be noted, and the outcome measures reported should be stratified 

by intervention level. However, with a less restrictive definition of nonintervention, the 

researcher runs the risk of conducting a study with little meaning or applicability to natural 

history. 

Researchers and clinicians should agree upon standard procedures for follow-up, including 

intervals of follow-up, so that resolution rates are indeed comparable. As the study by Moller 

and Tos (1990) demonstrated, even daily exams did not necessarily lead to a greater distinction 

between persistence of OME and recurrence; thus, we do not expect this to be an easy issue to 

resolve. The issue of assessment of OME duration or recurrence is as important as the issue of 

diagnosis of OME at a single point in time. 

131 
Researchers need to agree upon a definition of OME resolution and the diagnostic methods 

with which to make that determination. The latter will require further research into the operating 

characteristics of OME diagnostic methods, as we have reported in this evidence report. Further 

enhancements in diagnostic methods must also be achieved. Although perhaps more relevant to 

studies on outcomes other than resolution, more research is needed that views the child as the 

unit of analysis, since the actual outcomes of concern, such as speech, language, and hearing, are 

functional requirements of a child, not an ear. 

Further research on the role of influencing factors, such as socioeconomic status, on the 

natural history of OME may help the clinician in a particular setting make a better decision when 

assessing a child with particular characteristics. Among the influencing factors the technical 

expert panel thought were potentially important, the only factors addressed were age, gender, 

daycare setting, season, and racial/ethnic origin, and those were addressed by only a few studies. 

Study findings will be useful when they are generalizable, either because of their similarity to the 

population served by a particular clinician or because they address children with characteristics 

similar to a specific child the clinician is assessing. However, the issue of OME resolution is 

relevant only if OME has an impact on outcomes of relevance, such as long-term speech, 

language, or hearing. 

Effects of Early-life OM on Long-term Speech and Language 

Development 

For evaluation of long-term effects of early-life otitis media on speech and language 

development, a coordinated uniform approach that uses a rational conceptual framework is 

recommended. Such an approach should address the risk factors, such as socioeconomic status, 

interventions, and outcome measures in an integrated fashion. Conceptual frameworks include 

the Global Language Model, the Interactive Language and Attention Model, and a transactional 

model (Vernon-Feagans, 1999; Roberts and Wallace, 1997). The Global Language Model 

hypothesizes that mild to moderate hearing loss that results from otitis media is the actual causal 

factor that leads to speech and language deficits. The Interactive Language and Attention Model 

also hypothesizes an important role for hearing loss. However, this model also distinguishes 

between early and later developmental effects and the timing of hearing loss in the life of the 

child and places greater emphasis on risk and protective factors that may interact with hearing 

loss as well as directly affecting speech and language development. The transactional model 

ascribes an important role to differences in parent or caregiver response to children with and 

without chronic otitis media on long-term effects. 

Generalizability of study findings will be enhanced in future research if details of risk or 

influencing factors and interventions are well planned and documented. Included in this 

assessment of risk factors should be the issue of hearing loss (both conductive and sensorineural) 

associated with otitis media as a possible cause of long-term speech and language deficits. 

For future systematic reviews, we propose the consideration of an “individual-level-data 

meta-analysis” method (Mathew and Nordstrom, 1999; Stewart and Clarke, 1995; Stewart and 

Parmar, 1993) to study the long-term effects on outcomes such as speech, language, or hearing, 

with many of the suggestions for improvement of study quality noted above. This approach 

would call for the collaboration of investigators from various institutions who have been 

following cohorts of children prospectively to contribute data on individual members of their 

cohorts. Eligible cohorts are identified based on a priori criteria. Risk factors, interventions, 

132 
and outcomes of interest are also defined a priori. The unique feature of “individual-level-data 

meta-analysis” is the ability it confers to retrieve a uniform set of data directly on risk factor, 

intervention, and outcome data, case by case. This case-specific data set could then be analyzed 

using meta-regression or other multivariate techniques. A meta-analysis of updated individual 

patient data has been found to provide the least biased and most reliable means of addressing 

questions that have not been satisfactorily resolved by individual studies (Stewart and Parmar, 

1993). However, the quality of data and the ability for cohort investigators to collect and share 

relevant data are important factors in the success of this approach (Steward and Clarke, 1995). 

In all aspects of analysis, definitions, classifications, and types and units of measure should 

be developed by a team of experts prior to the start of a study. A consensus on the definitions 

and classification of otitis media and on relevant outcome measures will allow for comparisons 

among cohorts. We realize the lack of knowledge as to what specific aspects of speech and 

language development might be affected by early otitis media. Nevertheless, we would 

encourage experts to develop a uniform panel of tests that would measure the broad array of 

possible aspects of speech and language development hypothesized to be affected and could be 

consistently applied in research studies by all investigators. Literature on findings should report 

univariate as well as multivariate analysis findings to allow pooling of data. Many studies 

reported correlation coefficients or regression coefficients, which are difficult to interpret and to 

use in quantitative synthesis. 

Several prospective studies on the effect of early otitis media on long-term speech and 

language development are ongoing (Paradise, Dollaghan, Campbell et al., 2000; Feldman, 

Dollaghan, Campbell et al., 1999; Paradise, Rockette, Colborn et al., 1997; Roberts, Burchinal, 

Zeisel et al., 1998; Roberts, Burchinal, Jackson et al., 2000). Whether these studies answer more 

definitively the questions regarding the effect of otitis media on long-term speech and language 

and delineate areas, apart from the general research issues noted above, for further prospective 

studies on speech and language will be better assessed when the results of these studies are 

reported in the peer-reviewed literature. 

Effects of Early-life OM on Long-term Hearing 

Future research should attempt to confirm whether early-life otitis media leads to more

permanent hearing loss than intermittent and transient conductive hearing loss. The importance 

of hearing loss, whether intermittent and transient or permanent and long-standing, associated 

with early-life otitis media, should be addressed as noted in the section above on the effect of 

early otitis media on speech and language development. Similar methodological 

recommendations, including the “individual-level-data meta-analysis” approach, apply to 

research on long-term hearing effects and speech and language effects of early otitis media. If 

OM does affect long-term hearing, the effect of OM treatment on long-term hearing and its costeffectiveness are of great importance and must be addressed in future prospective studies. 

Diagnostic Methods for OME 

Future research on the diagnosis of OME will need to start with the definition of OME. The 

difficulty in reaching a consensus on the definition of OME was seen in our discussion of this 

issue with our technical expert panel. The technical experts agreed that OME was defined as 

“fluid in the middle ear without signs or symptoms of ear infection,” as proposed by the 1994 

133 
OME guideline (Stool, Berg, Berman et al., 1994). However, they could not agree on which 

signs or symptoms should be absent, i.e. what signs or symptoms differentiated OME from acute 

otitis media. Without such agreement, we believe little progress can be made in improving the 

diagnosis of OME. 

Limiting the assessment of OME diagnostic methods to those that address middle-ear 

effusion specifically, as we did, will require further expert consensus on important conceptual

issues. One issue that was brought to our attention by one of our technical experts and that was 

discussed in depth by our technical expert panel was whether diagnosis of middle-ear effusion in 

the child with OME was different than in the child with acute otitis media. For example, since 

the child with acute otitis media is in discomfort, whatever the symptoms that are ascribed to 

acute otitis media, that child will be more difficult to examine for the presence of middle-ear 

effusion than a child with OME, who by definition is asymptomatic. After much discussion, our 

panel decided that the diagnosis of middle-ear effusion was different in the context of these two 

clinical conditions; however, we are aware that other experts may not agree with this opinion. 

Future systematic reviews will require studies of much higher quality than are currently 

available. In addition, future studies must provide details on the characteristics of the children 

studied and the study setting so that the generalizability of the findings can be assessed. Studies 

confined to children with known middle-ear effusions in tertiary care settings may be easier to 

conduct, but the clinician in general practice is faced with children whose middle-ear status is 

unknown at the time of presentation. Future research must provide information that is applicable 

to the child with unknown middle-ear status in the primary care setting. 

Pneumatic otoscopy might appear to be less costly and more easily employed by the typical 

clinician than other diagnostic options such as tympanometry and acoustic reflectometry. 

Nevertheless, future studies on the diagnostic assessment of OME should consider costeffectiveness analysis, which can take into account the variable proficiency of clinicians in 

performing pneumatic otoscopy as well as the consequences of testing and patient preferences 

(Sox, Stern, Owen et al., 1989). Cost-effectiveness analysis will enable more informed decisions

on the best diagnostic method for OME. The assessment of more complex diagnostic methods 

such as combination tests or algorithms would also benefit from cost-effectiveness analysis. 

Such analysis should be undertaken in the future. 

134 
References 

Abraham SS, Wallace IF, Gravel JS. Early otitis 

media and phonological development at age 2 years.

Laryngoscope. 1996;106:727-732. 

Berman S, Roark R, Luckey D. Theoretical cost 

effectiveness of management options for children

with persisting middle ear effusions. Pediatrics. 

1994;93:353-363. 

Alho OP, Koivunen P, Luotonen J, Linder TE, 

Grenier B. Diagnostic criteria for otitis media in

children. Oto Rhino Laryngologia Nova. 1998;8:123-

128. 

Birch L, Elbrond O. Prospective epidemiological 

investigation of secretory otitis media in children

attending day-care centers. ORL J Otorhinolaryngol

Relat Spec. 1984;46:229-234. 

Amedee RG. The effects of chronic otitis media with 

effusion on the measurement of transiently evoked

otoacoustic emissions. Laryngoscope. 1995;105:589-

595. 

Black MM, Gerson LF, Freeland CA, Nair P, Rubin 

JS, Hutcheson JJ. Language screening for infants 

prone to otitis media. J Pediatr Psychol. 

1988;13:423-433. 

Aniansson G. Screening diagnosis of secretory otitis 

media. Scand Audiol Suppl. 1986;26:65-69. Black MM, Sonnenschein S. Early exposure to otitis 

media: a preliminary investigation of behavioral

Avery CA, Gates GA, Prihoda TJ. Efficacy of outcome. J Dev Behav Pediatr. 1993;14:150-155. 

acoustic reflectometry in detecting middle ear 

effusion. Ann Otol Rhinol Laryngol. 1986;95:472-

476. 

Block SL, Mandel E, McLinn S, et al. Spectral 

gradient acoustic reflectometry for the detection of

middle ear effusion by pediatricians and parents 

[published erratum appears in Pediatr Infect Dis J 

1998 Nov;17(11):1011]. Pediatr Infect Dis J. 

1998;17:560-564; discussion 580. 

Babonis TR, Weir MR, Kelly PC. Impedance 

tympanometry and acoustic reflectometry at 

myringotomy [published erratum appears in

Pediatrics 1991 Jun;87(6):945]. Pediatrics. 

1991;87:475-480. Block SL, Pichichero ME, McLinn S, Aronovitz G,

Kimball S. Spectral gradient acoustic reflectometry: 

detection of middle ear effusion in suppurative acute 

otitis media. Pediatr Infect Dis J. 1999;18:741-744.

Barnett ED, Klein JO, Hawkins KA, Cabral HJ, 

Kenna M, Healy G. Comparison of spectral gradient 

acoustic reflectometry and other diagnostic

techniques for detection of middle ear effusion in 

children with middle ear disease. Pediatr Infect Dis J. 

1998;17:556-559; discussion 580. 

Bluestone CD, Beery QC, Paradise JL. Audiometry

and tympanometry in relation to middle ear effusions 

in children. Laryngoscope. 1973;83:594-604. 

Bluestone CD, Cantekin EI. Design factors in the 

characterization and identification of otitis media and 

certain related conditions. Ann Otol Rhinol Laryngol

Suppl. 1979;88:13-28.

Beery QC, Andrus WS, Bluestone CD, Cantekin EI.

Tympanometric pattern classification in relation to

middle ear effusions. Ann Otol Rhinol Laryngol. 

1975;84:56-64.

Bluestone CD. Definitions, Terminology, and

Classification. In: Rosenfeld RM, Bluestone CD, eds. 

Evidence-Based Otitis Media. Saint Louis: B.C. 

Decker, Inc.; 1999:85-103. 

Begg CB, Mazumdar M. Operating characteristics of 

a rank correlation test for publication bias. 

Biometrics. 1999;50:1088-1101. 

Ben-David J, Podoshin L, Fradis M. Tympanometry

and audiometry in diagnosis of middle-ear effusions.

Ear Nose Throat J. 1981;60:120-123.

Boswell JB, Nienhuys TG. Reflectometric screening 

for otitis media: inconsistencies in a sample of

Australian aboriginal children. Int J Pediatr

Berman S. Medical management of children with Otorhinolaryngol. 1993;25:49-60. 

otitis media with effusion. In: Quie PG, ed. The 

Report on Pediatric Infectious Diseases. New York: 

Churchill Livingstone; 1993:37-38. 

135
Duncan RB. Malleus handle probe: a middle ear 

diagnostic procedure. Ann Otol Rhinol Laryngol. 

1982;91:281-284. 

Buhrer K, Wall LG, Schuster L. The acoustic 

reflectometer as a screening device: a comparison. 

Ear Hear. 1985;6:307-314. 

Egger M, Smith GD, Schneider M, al. e. Bias in 

meta-analysis detected by a simple, graphical test. Br 

Med J. 1997;315:629-634. 

Cantekin EI, Beery QC, Bluestone CD.

Tympanometric patterns found in middle ear 

effusions. Ann Otol Rhinol Laryngol Suppl. 

1977;86:16-20.

Ernstson S, Sundberg L. Erythromycin in the 

treatment of otitis media with effusion (OME). J 

Laryngol Otol. 1984;98:767-769. 

Cantekin EI, Bluestone CD, Fria TJ, Stool SE, Beery 

QC, Sabo DL. Identification of otitis media with

effusion in children. Ann Otol Rhinol Laryngol Suppl. 

1980;89:190-196. Feagans L, Sanyal M, Henderson F, Collier A, 

Appelbaum M. Relationship of middle ear disease in

early childhood to later narrative and attention skills. 

J Pediatr Psychol. 1987;12:581-594. 

Cantekin EI. Algorithm for diagnosis of otitis media 

with effusion. Ann Otol Rhinol Laryngol. 1983;92:6. 

Feagans L, Kipp E, Blood I. The effects of otitis 

media on the attention skills of day-care-attending

toddlers. Dev Psychol. 1994;30:701-708. 

Carlson LH and Stool SE. Diagnosis. In: Rosenfeld

RM and Bluestone CD, editors. Evidence-Based 

Otitis Media. Saint Louis, B.C.: Decker Inc.; 1999. 

p. 105-116. 

Feldman HM, Paradise JL, Colborn DK, et al. Word

production at age 2 years in relation to otitis media 

during the first two years of life. . Proceedings of the

Sixth International Symposium: Recent Advances in 

Otitis Media with Effusion; 1996:328. 

Casselbrant ML, Brostoff LM, Cantekin EI, et al.

Otitis media with effusion in preschool children. 

Laryngoscope. 1985;95:428-436. 

Casselbrant ML, Brostoff LM, Cantekin EI, Ashoff

VM, Bluestone CD. Incidence, prevalence, and 

natural history of otitis media in children in 

Pittsburgh. Ann Otol Rhinol Laryngol. 1990;99:28-

29. 

Feldman HM, Dollaghan CA, Campbell TF, et al. 

Parent-reported language and communication skills at 

one and two years of age in relation to otitis media in

the first two years of life. Pediatrics. 1999;104:e52.

Chan LS, Takata GS, Shekelle P, Morton SC, Mason 

W, Marcy SM. Evidence assessment of management

of acute otitis media: II. Research gaps and priorities 

for future research. Pediatrics. (In Press).

Fields MJ, Allison RS, Corwin P, White PS, Doherty 

J. Microtympanometry, microscopy and 

tympanometry in evaluating middle ear effusion prior 

to myringotomy. N Z Med J. 1993;106:386-387. 

Chang SO, Jang YJ, Rhee CK. Effects of middle ear 

effusion on transient evoked otoacoustic emissions in

children. Auris Nasus Larynx. 1998;25:243-247. 

Fiellau-Nikolajsen M. Tympanometry in 3-year-old

children. Type of care as an epidemiological factor in 

secretory otitis media and tubal dysfunction in

unselected populations of 3-year-old children. ORL J 

DerSimonian R, Laird N. Meta-analysis in clinical Otorhinolaryngol Relat Spec. 1979;41:193-205. 

trial. Control Clin Trials. 1986;7:177-188. 

Fiellau-Nikolajsen M, Lous J. Prospective

tympanometry in 3-year-old children. A study of the 

spontaneous course of tympanometry types in a 

nonselected population. Archives of Otolaryngology. 

1979;105:461-466. 

Douniadakis DE, Nikolopoulos TP, Tsakanikos MD, 

Vassiliadis SV, Apostolopoulos NJ. Evaluation of 

acoustic reflectometry in detecting otitis media in

children. Br J Audiol. 1993;27:409-414.

Downs MP, Walker DD, Northern JL, Gugenheim S. 

Identification of Children with Language Delays Due 

to Recurrent Otitis Media. . Proceedings of the 

Fourth International Symposium: Recent Advances in

Otitis Media with Effusion; 1988:382-384. 

Fiellau-Nikolajsen M, Lous J. Tympanometry in

three-year-old children. A cohort study on the 

prognostic value of tympanometry and operative 

findings in middle ear effusion. ORL J 

Otorhinolaryngol Relat Spec. 1979;41:11-25. 

136
Fiellau-Nikolajsen M. Tympanometry and middle ear 

effusion: a cohort-study in three-year-old children. 

Int J Pediatr Otorhinolaryngol. 1980;2:39-49. 

Fiellau-Nikolajsen M. Tympanometry in three-yearold children. Prevalence and spontaneous course of

MEE. Ann Otol Rhinol Laryngol Suppl. 1980;89:223-

227. 

Fiellau-Nikolajsen M. Serial tympanometry and

middle ear status in 3-year-old children. ORL J 

Otorhinolaryngol Relat Spec. 1980;42:220-232. 

Fiellau-Nikolajsen M, Falbe-Hansen J, Knudstrup P.

Tympanometry in three-year-old children. III.

Correlation between tympanometry and findings at

paracentesis in a prospectively followed population

of otherwise healthy children aged 3--4 years. Scand

Audiol. 1980;9:49-54. 

Fiellau-Nikolajsen M. Tympanometry in three-yearold children. The 3-year follow-up of a cohort study. 

ORL J Otorhinolaryngol Relat Spec. 1981;43:89-103. 

Fiellau-Nikolajsen M. Epidemiology of secretory

otitis media. A descriptive cohort study. Ann Otol

Rhinol Laryngol. 1983;92:172-177. 

Finitzo T, Friel-Patti S, Chinn K, Brown O. 

Tympanometry and otoscopy prior to myringotomy:

issues in diagnosis of otitis media. Int J Pediatr 

Otorhinolaryngol. 1992;24:101-110. 

Fischler RS, Todd NW, Feldman CM. Otitis media 

and language performance in a cohort of Apache 

Indian children. Am J Dis Child. 1985;139:355-360. 

Freeark K, Frank SJ, Wagner AE, Lopez M, Olmsted 

C, Girard R. Otitis media, language development, and 

parental verbal stimulation. J Pediatr Psychol. 

1992;17:173-185. 

Freyss GE, Narcy PP, Manac'h Y, Toupet MG. 

Acoustic reflex as a predictor of middle ear effusion. 

Ann Otol Rhinol Laryngol Suppl. 1980;89:196-199. 

Fria TJ, Sabo DL. Auditory brainstem responses in

children with otitis media with effusion. Ann Otol

Rhinol Laryngol Suppl. 1980;89:200-206. 

Fria TJ, Cantekin EI, Probst G. Validation of an 

automatic otoadmittance middle ear analyzer. Ann

Otol Rhinol Laryngol. 1980;89:253-256. 

Fried M, Kelly J, Zubick H, Vernick D, Strome M. 

Acoustic reflectivity for diagnosis of middle ear 

effusions: Comparison with results of myringotomy.

New Dimensions Otorhinolaryngol- Head Neck Surg. 

1985;2:931-932. 

Friel-Patti S, Finitzo-Hieber T, Conti G, Brown KC. 

Language delay in infants associated with middle ear 

disease and mild, fluctuating hearing impairment. 

Pediatr Infect Dis. 1982;1:104-109. 

Gates GA, Avery CA, Prihoda TJ, Cooper JC, Jr. 

Effectiveness of adenoidectomy and tympanostomy

tubes in the treatment of chronic otitis media with

effusion. N Engl J Med. 1987;317:1444-1451. 

Gates GA. Cost-effectiveness considerations in otitis 

media treatment. In: Lim D, Bluestone CD, 

Casselbrant M, Klein J, Ogra P, eds. Proceedings of

the Sixth International Symposium. Fort Lauderdale, 

FL: B.C. Decker Inc.; 1996a:1-4. 

Gates GA. Cost-effectiveness considerations in otitis 

media treatment. Otolaryngol Head Neck Surg. 

1996b;114:525-530. 

Gersdorff M, Scholtes JL, Yousif A, Robillard TH. 

Secretory otitis media, tympanometry and general 

anesthesia. In: Sade J, ed. Acute and secretory otitis 

media. Amsterdam: Kugler publications; 1986:39-44.

Gravel JS, Wallace IF. Listening and language at 4 

years of age: effects of early otitis media. J Speech 

Hear Res. 1992;35:588-595.

Gravel JS, Wallace IF, Ellis MA, Lee WW, Mody M,

Ruben RJ. Higher-order auditory abilities at nine

years of age and early otitis media. . Proceedings of

the Sixth International Symposium: Recent Advances

in Otitis Media with Effusion; 1996:356-358. 

Gravel JS, Wallace IF. Effects of otitis media with 

effusion on hearing in the first 3 years of life. J Sp 

Lang Hear Res. 2000;43:631-644. 

Grimaldi PM. The value of impedance testing in

diagnosis of middle ear effusion. J Laryngol Otol. 

1976;90:141-152. 

Haapaniemi JJ. Pure-tone audiometric and impedance 

measurements in school-aged children in Finland.

Eur Arch Otorhinolaryngol. 1997;254:269-273. 

Hall MJ, Lawrence L. Ambulatory surgery in the

Unites States, 1995. Advance data from vital and

health statistics; no 296. . Hyattsville (MD): National 

Center for Health Statistics; 1997.

137
Kaplan GJ, Fleshman JK, Bender TR, Baum C, Clark 

PS. Long-term effects of otitis media: a ten-year 

cohort study of Alaskan Eskimo children. Pediatrics. 

1973;52:577-85. 

Harsten G, Nettelbladt U, Schalen L, Kalm O, 

Prellner K. Language development in children with

recurrent acute otitis media during the first three 

years of life. Follow-up study from birth to seven

years of age. J Laryngol Otol. 1993;107:407-412. 

Karma PH, Penttila MA, Sipila MM, Kataja MJ. 

Otoscopic diagnosis of middle ear effusion in acute 

and non-acute otitis media. I. The value of different

otoscopic findings. Int J Pediatr Otorhinolaryngol. 

1989;17:37-49.

Haughton PM. Validity of tympanometry for middle 

ear effusions. Archives of Otolaryngology. 

1977;103:505-513. 

Hedges LV, Olkin I. Statistical Methods for metaanalysis. San Diego: Academic Press; 1985. Kemaloglu YK, Sener T, Beder L, Bayazit Y, Goksu 

N. Predictive value of acoustic reflectometry (angle 

and reflectivity) and tympanometry. Int J Pediatr 

Otorhinolaryngol. 1999;48:137-142. 

Holm-Jensen S, Sorensen CH, Tos M. Repetitive 

tympanometric screenings in 4-year-old children.

Seasonal influence on secretory otitis and tubal 

dysfunction. ORL J Otorhinolaryngol Relat Spec. 

1981;43:164-174. 

Kennedy TL, Gore LB. Middle ear effusions and the 

nitrous oxide myth. Laryngoscope. 1982;92:169-172. 

Klein JO, Chase C, Teele DW, Menyuk P, Rosner 

BA, Group tGBOMS. Otitis media and the 

developoment of speech, language and cognititve 

abilities at seven years of age. In: Lim DJ BC, Klein 

JO, Nelson JD, ed. Recent advances in otitis media

with effusion. Philadelphia: Decker; 1988:396-397. 

Holmquist J, Al Fadala S, Qattan Y. Prevalence of

secretory otitis media among school children in 

Kuwait. J Laryngol Otol. 1987;101:116-119. 

Hutchings ME, Meyer SE, Moore DR. Binaural 

masking level differences in infants with and without 

otitis media with effusion. Hear Res. 1992;63:71-78.

Klein JO, Bluestone CD. Management of otitis media 

in the era of managed care. Adv Pediatr Infect Dis. 

1996;12:351-386. 

Jaeschke R, Guyatt G, Sackett DL. Users' guides to 

the medical literature: III. How to use an article about 

diagnostic test: A. Are the results of study valid? J 

Am Med Assoc. 1994;271:389-391. Knishkowy B, Palti H, Adler B, Tepper D. Effect of

otitis media on development: a community-based

Johnson LP, Parkin JL, Stevens MH, et al. Action of study. Early Hum Dev. 1991;26:101-111. 

general anesthesia on middle ear effusions. Archives 

of Otolaryngology. 1980;106:100-102. Koivunen P, Alho OP, Uhari M, Niemela M, 

Luotonen J. Minitympanometry in detecting middle 

Jonathan DA. Sonotubometry: its role in childhood ear fluid. J Pediatr. 1997;131:419-422. 

glue ear. Clinical Otolaryngology and Allied

Sciences. 1989;14:151-154. Kozak LJ, Hall MJ, Pokras R, Lawrence L. 

Ambulatory Surgery in the Unites States, 1994. 

Advance Data from vital and health statistics. . 

Hyattsville (MD): National Center for Health

Statistics; 1997 Mar. 

Jung TTK. Classification of otitis media and surgical 

principles. Otolaryngol Clin North Am. 1999

Jun;32:369-383. 

Juni P, Witschi A, Bloch R, Egger M. The hazards of 

scoring the quality of clinical trials for meta-analysis. 

J Am Med Assoc. 1999;282:1054-1060. 

Laird NM, Mosteller F. Some statistical methods for 

combining experimental results. Int J Technol Assess

Health Care. 1990;6:5-30.

Kaleida PH, Stool SE, Karabin JC. Assessment of

otoscopic accuracy in diagnosis of middle-ear 

effusion in children ("otoscopic validation"). . 

Proceedings of the Fifth International Symposium: 

Recent Advances in Otitis Media with Effusion; 

1992:41.

Lamothe A, Boudreault V, Blanchette M, Tetreault L, 

Poliquin J. Serous otitis media: a six week

prospective study. J Otolaryngol. 1981;10:371-379. 

Leiberman A, Bartal N. Untreated persistent middle 

ear effusion. J Laryngol Otol. 1986;100:875-878. 

138
Marchisio P, Principi N, Passali D, et al. 

Epidemiology and treatment of otitis media with

effusion in children in the first year of primary 

school. Acta-Otolaryngol-Stockh. 1998;118:557-562. 

Lijmer JG, Mol BW, Heisterkamp S, et al. Empirical 

evidence of design-related bias in studies of

diagnostic tests. JAMA. 1999;282:1061-1066. 

Lous J, Fiellau-Nikolajsen M. Epidemiology and 

middle ear effusion and tubal dysfunction. A oneyear prospective study comprising monthly 

tympanometry in 387 non-selected 7-year-old

children. Int J Pediatr Otorhinolaryngol. 1981;3:303-

317. 

Mathew T, Nordstrom K. On the equivalence of

meta-analysis using literature and using individual 

patient data. Biometrics. 1999;55:1221-1223. 

Maw AR, Bawden R. Factors affecting resolution of 

otitis media with effusion in children. ClinLous J, Fiellau-Nikolajsen M. Early otitis media with Otolaryngol. 1994;19:125-130. 

effusion and reading achievement. Allgemeinmedizin. 

1988;17:81-84. Mills R, Vaughan-Jones R. A prospective study of 

otitis media with effusion in adults and children. Clin

Lovette S. Improved diagnosis of middle ear Otolaryngol Allied Sci. 1992;17:271-274. 

effusions employing the objective otoscope. Ann Otol

Rhinol Laryngol. 1976;85:229-233. Mitchell DB, Ford GR, Albert D, Waldron J.

Acoustic reflectometry as an aid to the diagnosis of

Luloff AK, Menyk P, Teele DW. Effect of persistent glue ear. Br J Clin Pract. 1990;44:557-559. 

otitis media on the speech sound repertoire of infants. 

In: Lim DJ BC, Klein JO, Nelson JK, Ogra P, ed. 

Recent Advances in Otitis Media: Proceedings of the 

Fifth International Symposium: Decker Periodicals;

1993:531-533. 

Mody M, Schwartz RG, Gravel JS, Ruben RJ. 

Speech perception and verbal memory in children

with and without histories of otitis media. J Speech 

Lang Hear Res. 1999;42:1069-1079. 

Macknin ML, Skibinski C, Beck G, Hughes G, 

Kinney S. Acoustic reflectometry detection of middle 

ear effusion. Pediatr Infect Dis J. 1987;6:866-868. 

Moher D, Pham B, Klassen TP, Schulz KF, Berlin 

JA, Jadad AR, Liberati A. What contributions do

languages other than English make on the results of

meta-analyses? J Clinical Epi. 2000; 53:964-72. 

Madell JR. Impact of otitis media on auditory 

function. In: Rosenfeld RM, Bluestone CD, eds.

Evidence-Based Otitis Media. Saint Louis: B.C. 

Decker, Inc.; 1999:337-351. 

Moller H, Tos M. Point and period prevalence of

otitis media with effusion evaluated by daily

tympanometry. J Laryngol Otol. 1990;104:937-41. 

Mains BT, Toner JG. Pneumatic otoscopy: study of

inter-observer variability. J Laryngol Otol. 

1989;103:1134-1135. 

Nozza RJ, Bluestone CD, Kardatzke D, Bachman R. 

Towards the validation of aural acoustic immittance 

measures for diagnosis of middle ear effusion in

children. Ear Hear. 1992;13:442-453. 

Mandel EM, Rockette HE, Bluestone CD, Paradise 

JL, Nozza RJ. Myringotomy with and without 

tympanostomy tubes for chronic otitis media with

effusion. Arch-Otolaryngol-Head-Neck-Surg. 

1989;115:1217-1224. 

Nozza RJ, Bluestone CD, Kardatzke D, Bachman R. 

Identification of middle ear effusion by aural acoustic 

admittance and otoscopy. Ear Hear. 1994;15:310-

323. 

Mandel EM, Rockette HE, Bluestone CD, Paradise 

JL, Nozza RJ. Efficacy of myringotomy with and 

without tympanostomy tubes for chronic otitis media 

with effusion. Pediatr Infect Dis J. 1992;11:270-7.

Nozza RJ. The Assessment of Hearing and MiddleEar Function in Children. In: Bluestone CD, Stool 

SE, and Kenna MA, editors. Pediatric

otolaryngology. Philadelphia: W.B. Saunders 

Company. 1996. p. 165-206. 

Marchant CD, McMillan PM, Shurin PA, et al. 

Objective diagnosis of otitis media in early infancy 

by tympanometry and ipsilateral acoustic reflex

thresholds. J Pediatr. 1986;109:590-595. 

Nozza RJ, Sabo DL, Mandel EM. A role for

otoacoustic emissions in screening for hearing 

impairment and middle ear disorders in school-age 

children. Ear Hear. 1997;18:227-239. 

139
Orchik DJ, Dunn JW, McNutt L. Tympanometry as a 

predictor of middle ear effusion. Arch Otolaryngol. 

1978;104:4-6. 

Orchik DJ, Morff R, Dunn JW. Impedance

audiometry in serous otitis media. Arch Otolaryngol. 

1978;104:409-412. 

Orchik DJ, Morff R, Dunn JW. Middle ear status at 

myringotomy and its relationship to middle ear 

immitance measurements. Ear Hear. 1980;1:324-

328. 

Ovesen T, Paaske PB, Elbrond O. Accuracy of an

automatic impedance apparatus in a population with 

secretory otitis media: principles in the evaluation of

tympanometrical findings. Am J Otolaryngol. 

1993;14:100-104. 

Owen MJ, Johnson DL, Swank PR, Baldwin CD, 

Aker J, Howie VM. Duration of otitis media with

effusion from birth to 3 years of age related to

language and cognititve scores at 5 years. In: Lim DJ 

BC, Casselbrant M, Klein JO, Ogra P, ed. Recent 

Advances in Otitis Media: Proceedings of the Sixth 

International Symposium. Hamilton, Ontario: B.C.

Decker Inc; 1996:329-331. 

Oyiborhoro JM, Olaniyan SO, Newman CW, 

Balakrishnan SL. Efficacy of acoustic otoscope in 

detecting middle ear effusion in children.

Laryngoscope. 1987;97:495-498. 

Palmu A, Puhakka H, Rahko T, Takala AK.

Diagnostic value of tympanometry in infants in

clinical practice. Int J Pediatr Otorhinolaryngol. 

1999;49:207-213. 

Paradise JL, Smith CG, Bluestone CD.

Tympanometric detection of middle ear effusion in

infants and young children. Pediatrics. 1976;58:198-

210. 

Paradise JL, Bluestone CD, Rogers KD, et al. 

Efficacy of adenoidectomy for recurrent otitis media 

in children previously treated with tympanostomytube placement. Results of parallel randomized and 

nonrandomized trials. JAMA. 1990;263:2066-73. 

Paradise JL. Treatment guidelines for otitis media: 

the need for breadth and flexibility. Pediatr Infect Dis 

J. 1995;14:429-35. 

Paradise JL, Smith CG, Sabo DL, et al. 

Tympanometric detection of middle ear effusion in

the first versus the second year of life. . Proceedings 

of the Sixth International Symposium: Recent 

Advances in Otitis Media with Effusion; 1996:155.

Paradise JL, Rockette HE, Colborn DK, et al. Otitis 

media in 2253 Pittsburgh-area infants: prevalence 

and risk factors during the first two years of life [see 

comments]. Pediatrics. 1997;99:318-333. 

Paradise JL. Otitis media and child development: 

should we worry? Pediatr Infect Dis J. 

1998;17:1076-1083; discussion 1099-1100. 

Paradise JL, Dollaghan CA, Campbell TF, et al. 

Language, speech sound production, and cognition in

three-year-old children in relation to otitis media in

their first three years of life. Pediatrics. 

2000;105:1119-1129. 

Park IY, Kim HN, Chung MH, Park KH, Yim SB. 

Diagnostic Reliability of Impedance Audiometry in

Case of Otitis Media with Effusion. . Proceedings of

the Fourth International Symposium: Recent

Advances in Otitis Media with Effusion; 1988:52-54.

Patterson M, Paparella MM. Otitis media with

effusion and early sequelae. Otolaryngol Clin North 

Am. 1999 Jun;32:391-400. 

Paul R, Lynn TF, Lohr-Flanders M. History of

middle ear involvement and speech/language 

development in late talkers. J Speech Hear Res. 

1993;36:1055-1062. 

Pellett FS, Cox LC, MacDonald CB. Use of acoustic 

reflectometry in the detection of middle ear effusion.

J Am Acad Audiol. 1997;8:181-187. 

Petinou K, Mody M, Schwartz RD, Gravel JS, Ellis 

MA, Lee WW. Impact of otitis media on early speech

development: phonetic inventories. . Proceedings of

the Sixth International Symposium: Recent Advances

in Otitis Media with Effusion; 1996:408-410. 

Petinou K, Schwartz RG, Mody M, Gravel JS. The 

impact of otitis media with effusion on early phonetic 

inventories: A longitudinal prospective investigation.

Clin Linguistics Phonetics. 1999;13:351-367.

Portoian-Shuhaiber S, Cullinan TR. Middle ear 

disease assessed by impedance in primary school

children in south London. Lancet. 1984;1:1111-1112. 

Poulsen G, Tos M. Screening tympanometry in 

newborn infants and during the first six months of

life. Scand Audiol. 1978;7:159-166. 

140
Poulsen G, Tos M. Repetitive tympanometric

screenings of two-year-old children. Scand Audiol. 

1980;9:21-28. 

Rahko T, Laitila P, Sipila M, Manninen M, Karma P. 

Hearing and acute otitis media in 13-year-old

children. Acta Otolaryngol. 1995;115:190-192. 

Reed D, Struve S, Maynard JE. Otitis media and

hearing deficiency among Eskimo children: a cohort

study. Am J Public Health Nations Health. 

1967;57:1657-1662. 

Rees GL, Freeland AP. The effect of anaesthesia on 

tympanograms of children undergoing grommet

insertion [see comments]. Clin Otolaryngol Allied

Sci. 1992;17:200-202.

Renvall U, Liden G, Jungert S, Nilsson E. Long-term

observation of ears with reduced middle ear pressure. 

Acta Otolaryngol. 1978;86:104-9. 

Renvall U, Aniansson G, Liden G. Spontaneous

improvement in ears with middle ear disease. Int J 

Pediatr Otorhinolaryngol. 1982;4:245-250. 

Renvall U, Berg U. Reliability of tympanogram. . 

Proceedings of the Sixth International Symposium:

Recent Advances in Otitis Media with Effusion; 

1996:143-146. 

Reves R, Budgett R, Miller D, Wadsworth J, Haines 

A. Study of middle ear disease using tympanometry 

in general practice. Br Med J Clin Res Ed.

1985;290:1953-1956. 

Roberts JE, Sanyal MA, Burchinal MR, Collier AM, 

Ramey CT, Henderson FW. Otitis media in early 

childhood and its relationship to later verbal and 

academic performance. Pediatrics. 1986;78:423-430. 

Roberts JE, Burchinal MR, Koch MA, Collier AM, 

Henderson FW. Otitis Media in Early Childhood and

Its Relationship to Later Speech and Language. . 

Proceedings of the Fourth International Symposium:

Recent Advances in Otitis Media with Effusion; 

1988:385-388. 

Roberts JE, Bruchinal MR, Koch MA, Footo MM,

Henderson FW. Otitis media in early childhood and

its relationship to later phonological development. J 

Speech Hear Dis. 1988;53:416-424.

Roberts JE, Burchinal MR, Collier AM, Ramey CT, 

Koch MA, Henderson FW. Otitis meida in early 

childhood and cognititive, academic, and classroom

performance of the school-aged child. Pediatrics. 

1989;83:477-485. 

Roberts JE, Burchinal MR, Davis BP, Collier AM, 

Henderson FW. Otitis media in early childhood and

later language. J Speech Hear Res. 1991;34:1158-

1168. 

Roberts DG, Johnson CE, Carlin SA, Turczyk V, 

Karnuta MA, Yaffee K. Resolution of middle ear 

effusion in newborns. Arch Pediatr Adolesc Med. 

1995;149:873-877. 

Roberts JE, Burchinal MR, Clarke-Klein SM. Otitis 

media in early childhood and cognitive, academic, 

and behavior outcomes at 12 years of age. J Pediatr 

Psychol. 1995;20:645-660. 

Roberts JE, Burchinal MR, Medley LP, et al. Otitis 

media, hearing sensitivity, and maternal 

responsiveness in relation to language during infancy.

J Pediatr. 1995;126:481-489. 

Roberts JE, Zeisel S, Medley L, et al. Otitis media, 

hearing sensitivity, and language development to

two-year-olds. . Proceedings of the Sixth 

International Symposium: Recent Advances in Otitis 

Media with Effusion; 1996:325-328. 

Roberts JE, Burchinal MR, Zeisel SA, et al. Otitis 

media, the caregiving environment, and language and 

cognitive outcomes at 2 years. Pediatrics. 

1998;102:346-354. 

Roberts JE, Burchinal MR, Jackson SC, et al. Otitis 

media in early childhood in relation to preschool 

language and school readiness skills among African

American children. Pediatrics. 2000; 106:1-11. 

Roberts JE, Wallace IF. Language and otitis media. 

In: Roberts JE, Wallace IF, Henderson FW, eds. 

Otitis media in young children: medical, 

developmental and educational considerations. 

Baltimore (MD): Brooks; 1997:133-161. 

Robinson DO, Allen DV, Root LP. Infant

tympanometry: differential results by race. J Speech 

Hear Disord. 1988;53:341-346. 

Rosenfeld RM, Mandel EM, Bluestone CD. Systemic 

steroids for otitis media with effusion in children [see 

comments]. Arch Otolaryngol Head Neck Surg. 

1991;117:984-989. 

141
Shaw JO, Stark EW, Gannaway SD. The influence of 

nitrous oxide anaesthetic on middle-ear fluid. J 

Laryngol Otol. 1978;92:131-135. 

Rosenfeld RM, Post JC. Meta-analysis of antibiotics 

for the treatment of otitis media with effusion. 

Otolaryngol Head Neck Surg. 1992;106:378-386. 

Silman S, Silverman CA, Arick DS. Acousticimmittance screening for detection of middle-ear 

effusion in children. J Am Acad Audiol. 1992;3:262-

268. 

Rosenfeld RM. Comprehensive management of otitis 

media with effusion. Otolaryngol Clin North Am. 

1994;27:443-455. 

Rosenfeld RM. Natural history of untreated otitis 

media. In: Rosenfeld RM, Bluestone CD, eds. 

Evidence-Based Otitis Media. Saint Louis: B.C. 

Decker Inc.; 1999a:157-177. 

Silman S, Silverman CA, Arick DS. Pure-tone 

assessment and screening of children with middle-ear 

effusion. J Am Acad Audiol. 1994;5:173-182. 

Silva AB, Hotaling AJ. A protocol for 

otolaryngology-head and neck resident training in

pneumatic otoscopy. Int J Pediatr Otorhinolaryngol. 

1997;40:125-131. 

Rosenfeld RM. What to expect from medical therapy. 

In: Rosenfeld RM, Bluestone CD, eds. EvidenceBased Otitis Media. Saint Louis: B.C. Decker Inc.; 

1999b:179-205. 

Silverman CA, Silman S. Acoustic-immittance 

characteristics of children with middle-ear effusion: 

longitudinal investigation. J Am Acad Audiol. 

1995;6:339-345. 

Ruben RJ, Wallace IF, Gravel J. Long-term

communication deficiencies in children with otitis 

media during their first year of life. Acta 

Otolaryngol. 1997;117:206-207. 

Sly RM, Zambie MF, Fernandes DA, Frazer M. 

Tympanometry in kindergarten children. Annals of

Allergy. 1980;44:1-7. 

Ryding M, Konradsson K, Kalm O, Prellner K.

Sequelae of recurrent acute otitis media. Ten-year 

follow-up of a prospectively studied cohort of

children. Acta Paediatr. 1997;86:1208-1213. 

Sorri M, Maki-Torkko E, Alho OP. Otitis media and

long-term follow-up of hearing. Acta Otolaryngol

Stockh. 1995;109:811-816. 

Sacket DL. How to read clinical journals. V: To 

distinguish useful from useless or even harmful

therapy. Can Med Assoc J. 1981;124:1156-1162. 

Sox H, Stern S, Owens D, Abrams HL. Assessment 

of diagnostic technology in health care: Rationale, 

methods, problems, and directions. . Washington, 

D.C.: National Academy Press; 1989. 

Sassen ML, van Aarem A, Grote JJ. Validity of

tympanometry in the diagnosis of middle ear 

effusion. Clin Otolaryngol Allied Sci. 1994;19:185-

189. 

StataCorp. Stata Statistical Software: Release 6.0. : 

Schappert SM. Office visits for otitis media: United College Station, TX: Stata Corporation; 1999. 

States, 1975-90. Advance data from vital and health

statistics. . Hyattsville (MD): National Center for 

Health Statistics; 1992. 

Stewart LA, Parmar MK. Meta-analysis of the 

literature or of individual patient data: is there a 

difference? Lancet. 1993;341:418-422. 

Schappert SM. National ambulatory medical care 

survey: 1994 summary. Advance data from vital and

health statistics. . Hyattsville (MD): National Center 

for Health Statistics; 1996.

Stewart LA, Clarke MJ. Practical methodology of 

meta-analyses (overviews) using updated individual

patient data. Cochrane Working Group. Stat Med. 

1995;14:2057-2079. 

Schappert SM. Ambulatory care visits to physician 

offices, hospital outpatient departments, and 

emergency departments: United States, 1995. . 

Hyattsville (MD): U.S. Department of Health and 

Human Services; 1997. 

Stool SE, Field MJ. The impact of otitis media. 

Pediatr Infect Dis J. 1989;8:S11-S14. 

Stool SE, Berg AO, Berman S, al. e. Otitis media 

with effusion in young children. Clinical Practice 

Guideline, Number 12. . Rockville (MD): Agency for 

Health Care Policy and Research, Public Health

Schwartz DM, Schwartz RH. Validity of acoustic 

reflectometry in detecting middle ear effusion. 

Pediatrics. 1987;79:739-742.

142
Service, U.S. Department of Health and Human 

Services; 1994a July. 

Stool SE, Berg AO, Berman S, al. e. Managing otitis 

media with effusion in ytoung children. Quick

Reference Guide for Clinicians. . Rockville (MD): 

Agency for Health Care Policy and Research, Public 

Health Servies, U.S. Department fo Health and 

Human Services; 1994b July. 

Szucs E, Diependaele R, Clement PA. The accuracy 

of tympanometry assessed by its sensitivity and 

specificity. Acta Otorhinolaryngol Belg. 

1995;49:287-292. 

Takahashi H, Honjo I, Hasebe S, Sudo M, Tanabe M. 

The diagnostic and prognostic value of eardrum

mobility in otitis media with effusion. Eur Arch 

Otorhinolaryngol. 1999;256:189-191. 

Takata GS, Chan LS, Shekelle P, Morton SC, Mason 

W, Marcy SM. Evidence assessment of management

of acute otitis media: I. The role of antibiotics in

treatment of uncomplicated acute otitis media. 

Pediatrics. (In Press).

Teele DW, Klein JO, Rosner BA. Epidemiology of 

otitis media in children. Ann Otol Rhinol Laryngol

Suppl. 1980;89:5-6.

Teele DW, Klein JO, Rosner BA. Otitis media with

effusion during the first three years of life and 

development of speech and language. Pediatrics. 

1984;74:282-287. 

Teele DW, Klein JO, Chase C, Menyuk P, Rosner 

BA. Otitis media in infancy and intellectual ability, 

school achievement, speech, and language at age 7 

years. Greater Boston Otitis Media Study Group. J 

Infect Dis. 1990;162:685-694. 

Thomsen J, Tos M. Spontaneous improvement of

secretory otitis. A long-term study. Acta Otolaryngol. 

1981;92:493-499. 

Tom LW, Tsao F, Marsh RR, Kessler A, Konkle DF. 

Effect of anesthetic gas on middle ear fluid. 

Laryngoscope. 1994;104:832-836. 

Toner JG, Mains B. Pneumatic otoscopy and 

tympanometry in the detection of middle ear

effusion. Clin Otolaryngol Allied Sci. 1990;15:121-

123. 

Tos M, Poulsen G. Tympanometry in 2-year-old

children. Seasonal influence on frequency of

secretory otitis and tubal function. ORL J 

Otorhinolaryngol Relat Spec. 1979;41:1-10. 

Tos M, Poulsen G, Hancke AB. Screening 

tympanometry during the first year of life. Acta

Otolaryngol. 1979;88:388-94.

Tos M. Spontaneous improvement of secretory otitis 

and impedance screening. Arch Otolaryngol. 

1980;106:345-349. 

Tos M, Poulsen G. Screening tympanometry in

infants and two-year-old children. Ann Otol Rhinol

Laryngol Suppl. 1980;89:217-222. 

Tos M, Holm-Jensen S, Sorensen CH. Changes in 

prevalence of secretory otitis from summer to winter 

in four-year-old children. Am J Otol. 1981;2:324-327. 

Tos M, Holm-Jensen S, Sorensen CH, Mogensen C. 

Spontaneous course and frequency of secretory otitis 

in 4-year-old children. Arch-Otolaryngol. 

1982;108:4-10.

Tos M. Epidemiology and spontaneous improvement 

of secretory otitis. Acta Otorhinolaryngol Belg. 

1983;37:31-43.

Tos M. Epidemiology and natural history of secretory

otitis. Am J Otol. 1984;5:459-462. 

Tos M, Stangerup SE, Andreassen UK, Hvid G, 

Thomsen J, Holm-Jensen S. Natural History of

Secretory Otitis Media. . Proceedings of the Third

International Symposium: Recent Advances in Otitis 

Media with Effusion; 1984:36-40. 

Tos M, Stangerup SE, Hvid SG, Andreassen UK. 

Epidemiology and Natural History of Secretory

Otitis. . Proceedings of the Fourth International

Symposium: Recent Advances in Otitis Media with 

Effusion; 1988:29-34. 

Trout KS. How to read clinical journal: IV. To 

determine etiology or causation. Can Med Assoc J. 

1981;124:985-990. 

Tsushima T, Menyuk P, Teele DW. Effects of otitis 

media on syllable realization in the speech of 

children. In: Lim DJ BC, Klein JO, Nelson JD, Ogra 

P, ed. Recent Advances in Otitis Media: Proceedings 

of the Fifth International Symposium: Decker

Periodicals; 1993:573-575. 

143
Tugwell P. How to read clinical journals: III. To

learn the clinical course and prognosis of disease. 

Can Med Assoc J. 1981;124:869-872. 

U.S. BOTC. Statistical abstract of the United States, 

1998. . Springfield (VA): National Technical

Information Services; 1996. 

U.S. BOTC. Statistical abstract of the United States, 

1998. . Springfield (VA): National Technical

Information Services; 1998. 

van Balen FA, de Melker RA. Validation of a 

portable tympanometer for use in primary care. Int J

Pediatr Otorhinolaryngol. 1994;29:219-225. 

van Balen FA, de Melker RA, Touw-Otten FW. 

Double-blind randomised trial of co-amoxiclav

versus placebo for persistent otitis media with

effusion in general practice [see comments]. Lancet. 

1996;348:713-716. 

Vaughan-Jones R, Mills RP. The Welch Allyn

Audioscope and Microtymp: their accuracy and that

of pneumatic otoscopy, tympanometry and pure tone 

audiometry as predictors of otitis media with

effusion. J Laryngol Otol. 1992;106:600-602. 

Vernon-Feagans L, Manlove EE, Volling BL. Otitis 

media and the social behavior of day-care-attending

children. Child Dev. 1996;67:1528-1539. 

Vernon-Feagans L, Emanuel D, Blood I. Otitis media 

and day care: factors hat affect children's language. . 

Proceedings of the Sixth International Symposium:

Recent Advances in Otitis Media with Effusion; 

1996:331-334. 

Vernon-Feagans L. Impact of Otitis Media on

Speech, Language, Cognition, and Behavior. In: 

Rosenfeld RM, Bluestone CD, eds. Evidence-Based

Otitis Media. Saint Louis: B.C. Decker Inc.; 

1999:353-373. 

Wallace IF, Gravel JS, McCarton CM, Ruben RJ. 

Otitis media and language development at 1 year of 

age. J Speech Hear Disord. 1988;53:245-251. 

Wallace IF, Gravel JS, McCarton CM, Stapells DR, 

Bernstein RS, Ruben RJ. Otitis Media and Its Effect 

on Language in Infancy. . Proceedings of the Fourth 

International Symposium: Recent Advances in Otitis 

Media with Effusion; 1988:388-391. 

Wallace IF, Gravel JS, McCarton CM, Stapells DR, 

Bernstein RS, Ruben RJ. Otitis media, auditory 

sensitivity, and language outcomes at one year. 

Laryngoscope. 1988;98:64-70. 

Wallace IF, Gravel JS, Ganon EC, Ruben RJ. Twoyear language outcomes as a function of otitis media 

and parental linguistic styles. . Proceedings of the 

Fifth International Symposium: Recent Advances in 

Otitis Media with Effusion; 1992:527-530. 

Wallace IF, Gravel JS, Schwartz RG, Ruben RJ. 

Otitis media, communication style of primary 

caregivers, and language skills of 2 year olds: a 

preliminary report. J Dev Behav Pediatr. 1996;17:27-

35. 

Watters GW, Jones JE, Freeland AP. The predictive 

value of tympanometry in the diagnosis of middle ear 

effusion. Clin Otolaryngol Allied Sci. 1997;22:343-

345. 

Webster A, Bamford JM, Thyer NJ, Ayles R. The

psychological, educational and auditory sequelae of

early, persistent secretory otitis media. J Child

Psychol Psychiatry. 1989;30:529-546. 

Wendler-Shaw PD, Menyuk P, Teele DW. Effects of 

otitis media in the first year of life on language

production in the second year of life. In: Lim DJ BC,

Klein JO, Nelson JK, Ogra P, ed. Recent Advances in

Otitis Media: Proceedings of the Fifith International 

Syposium. Hamilton, Ontario: Decker Periodicals;

1993:534-536. 

Williams RG, Haughton PM. Tympanometric 

diagnosis of middle ear effusions. J Laryngol Otol. 

1977;91:959-962. 

Williams RL, Chalmers TC, Stange KC, Chalmers 

FT, Bowlin SJ. Use of antibiotics in preventing

recurrent acute otitis media and in treating otitis 

media with effusion. A meta-analytic attempt to

resolve the brouhaha [published erratum appears in 

JAMA 1994 Feb 9;271(6):430] [see comments]. 

JAMA. 1993;270:1344-1351.

Williamson IG, Dunleavey J, Bain J, Robinson D. 

The natural history of otitis media with effusion--a 

three-year study of the incidence and prevalence of

abnormal tympanograms in four South West 

Hampshire infant and first schools. J Laryngol Otol. 

1994;108:930-934. 

Wilmot JF, Cable HR. Persistent effusion following 

acute otitis media: tympanometry and pneumatic 

otoscopy in diagnosis. J R Coll Genl Practitioners. 

1988;38:149-152. 

144
Woodwell DA, Schappert SM. National ambulatory 

medical care survey: 1993 summary. Advance data 

from vital and health statistics. . Hyattsville (MD): 

National Center for Health Statistics; 1995.

Woodwell DA. National ambulatory medical care 

survey: 1995 summary. Advance data from vital and

health statistics. . Hyattsville (MD): National Center 

for Health Statistics; 1997a. 

Woodwell DA. National ambulatory medical care 

survey. Advance data from vital and health statistics. 

. Hyattsville (MD): National Center for Health

Statistics; 1997b. 

Wright P, Thompson J, McConnell KB, Sitton AB, 

Bess FH. Audiologic and Speech Evaluation of a 

Prospectively Followed Cohort of Normal Children:

The Impact of Otitis Media. . Proceedings of the 

Third International Symposium: Recent Advances in 

Otitis Media with Effusion; 1984:338-341. 

Wright PF, Sell SH, McConnell KB, et al. Impact of 

recurrent otitis media on middle ear function,

hearing, and language. J Pediatr. 1988;113:581-587. 

Zargi M, Boltezar IH. Effects of recurrent otitis 

media in infancy on auditory perception and speech.

Am J Otolaryngol. 1992;13:366-372. 

Zeisel SA, Roberts JE, Gunn EB, et al. Prospective 

surveillance for otitis media with effusion among 

black infants in group child care. J Pediatr. 

1995;127:875-880. 

Zielhuis GA, Rach GH, van den Broek P. The natural

course of otitis media with effusion in preschool

children. Eur Arch Otorhinolaryngol. 1990;247:215-

221. 

145
149 

Evidence Table 1. Natural History of Otitis Media with Effusion [The six components of study quality are: a prospective cohort study; outcome clearly defined; time point at which outcome measured clearly defined; sub

intervention; blinded assessment of outcome; and point and variability estimates provided for main outcome measures. 1 indicates presence and 0 indica

rates, not otherwise specified, represent the proportion without OME at follow-up compared to those with OME at baseline.] 

Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

862 Birch and Elbrønd 1984 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

3(111000) 

OME definition: type B 

tympanogram signified middle-ear effusion otherwise not defined 

Group: Children attending a daycare center in a municipality 

under investigation for incidence of OME 

N=373 subjects 

Time: Jan.–Apr./1982 

Place: 10 day-care centers in 

a municipality of about 20,000 inhabitants; Dept. of OtoRhino-Laryngology, University of Aarhus, Denmark 

Inclusion: 

• attending day-care 

centers in investigated municipality 

Exclusion: 

• tympanometry not 

practicable (n=15 children) 

• parental consent not 

given (n=5 children) 

• ill or absent at all 

examinations (n=3 children) 

Type of OME: Newly diagnosed OME of unknown 

duration; OME persisting for weeks or months 

Age: 0.75–7 years, mean 4.5 years 

Examiner(s): unknown 

OME diagnostic method: a B tympanogram defined 

as “compliance below 0.25 ml” signified middle-ear effusion 

Interventions: The authors did not mention control 

for interventions such as antibiotics during the course of the study, though the number receiving surgical procedures was noted. 

Interval of screening: every 2 weeks for twelve 

weeks 

Data equatlikely study Y=Y0

Y= nuY0=nu

t=time k=0.3DerivWeek 

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 
150 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1000 Casselbrant, Brostoff, Cantekin, Doyle, Bluestone, and Fria 1985 [This cohort is also in article 2929.] 

Study Type: prospective 

comparative cohort 

Study Quality Score (0–6): 

3(111000) OME definition: inflammation of 

the middle ear accompanied by collection of liquid in the middle ear cleft without the signs and symptoms of acute infection such as otalgia, fever, and a red or white tympanic membrane that is full or bulging 

Group: Children, 2–5 years of 

age, attending a nursery school and examined from Sep 1981 through Aug 1983 

N=103 [103 children were entered into the study, 66 in the first year and 37 in the second year. 37 of the 66 children entered in the first year were also observed during the second year. Therefore in data analysis, the 103 children were treated as 140 ‘individuals’ to account for the 37 children who were observed for both years.] 

Time: ~9/1981–8/1983 

Place: A nursery school in 

Verona, a suburb of Pittsburgh 

Inclusion: 

• 2–5 years old • nursery school in Verona, 

a suburb of Pittsburgh 

Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 2 year old 23, 3 year old 25, 4 year old 38, 5 

year old 17 

Gender: male 81, female 59 (37 children in years 1 

and 2 were counted twice by the authors) Race/ethnicity: black 4, oriental 1, white 98 

Examiner(s): otolaryngologist, nurse trained in 

tympanometry, and an audiologist; also, validated otoscopists 

OME diagnostic method: an algorithm combining 

pneumatic otoscopy, tympanometry, and acoustic reflex measurements 

Interventions: The authors informed parents if OME 

was present 3 consecutive months. 11 children received tympanostomy tubes, and 26 children were treated for 32 episodes of acute otitis media of which 13 were associated with a new episode of OME. 

Interval of screening: monthly in school and every 4 

months at the Children’s Hospital of Pittsburgh for 2 years after the initial evaluation 

Cumu

(Figu

ResoTime 

<1 m<2 m<3 m<4 m<5 m<6 m[This duratonsettympa
151 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2929 Casselbrant, Brostoff, Cantekin, Ashoff, and Bluestone 1990 [The 2–5-yearold cohort is also in article 1000.] 

Study Type: prospective 

comparative cohort 

Study Quality Score (0–6): 

3(111000) OME definition: not defineda

Group 1: Children, 2–5 years of 

age, attending a nursery school and examined from Sep 1981 through Aug 1983a

Group 2: School children, 5–12 

years of age, attending an elementary school and examined from Sep 1984–May 1985 

N=214 N1=103a 

N2=111 

Time: Group1~9/1981–

8/1983a; 

 Group2~9/1984–5/1985 

Place: A nursery school in 

Verona, a suburb of Pittsburgh, a and Falk 

Elementary School, Pittsburgh, PA Inclusion: • Group 1: 2–5 years old 

and in Verona nursery school 

• Group 2: 5–12 years old 

and in Falk Elementary School 

Exclusion: Nonea

Type of OME: newly diagnosed OME of unknown 

durationa

Age: Group1~2–5 years olda

Group2~5–12 years old 

Examiner(s): otolaryngologist and nurse practitioner 

validated otoscopists, nurse trained in tympanometry, and an audiologista

OME diagnostic method: an algorithm combining 

pneumatic otoscopy, tympanometry, and acoustic reflex measurementsa

Interventions: Intervention was advised if OME 

persisted after 3 months. Up to three months, the authors report no intervention though how control was monitored is not mentioned. a

Interval of screening: monthly after the initial 

evaluationa

Cumuboth 

Time resolu

<1 m<2 m

bActu

percemont

a See 1000 Casselbrant, Brostoff, Cantekin, Doyle, Bluestone, and Fria (1985). 
152 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1202 Ernstson and Sundberg 1984 

Study Type: prospective single 

cohort embedded in a controlled trial (not randomized) 

Study Quality Score (0–6): 

2(100100) OME definition: “nonpurulent 

effusion behind an intact tympanic membrane at otomicroscopy...supported by a type “B” tympanogram” 

Group 1: A~Untreated children 

with OME at least 3 months scheduled for myringotomy 

Group 2: B~Treated children with 

OME at least 3 months scheduled for myringotomy (erythromycin orally 20–30 mg/kg body weight twice a day 10 days preceding surgery) 

N=98 subjects N1=72 N2=26 

Time: not specified 

Place: The ENT Department, 

Central Hospital, Karlskrona, Sweden 

Inclusion: 

• OME on one or both 

sides for at least 3 months 

Exclusion: 

• cleft palate; immotile cilia 

syndrome 

• received antibiotics 

during the period of observation 

Type of OME: OME persisting for weeks or months, 

i.e. at least 3 months, laterality not specified 

Age: 1–11 years 

Laterality: both unilateral and bilateral, proportions 

not specified 

Examiner(s): unknown 

OME diagnostic method: 

otomicroscopy tympanometry 

Interventions: The authors did not mention control 

for interventions such as antibiotics during the preoperative period prior to the 10 days before myringotomy. 

Interval of screening: 2–5 weeks, median 3 weeks, 

between decision to operate and the operation itself. 

OME by ch

ResoTime 

<5 we
153 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

1235 FiellauNikolajsen 1979 [1976 cohort is also in articles 1237, 1242, and 3051. 1978 cohort is also in article 1245.] 

Study Type: two cross-sectional 

studies 

Study Quality Score (0–6): a

OME definition: not defined aGroup 1: Children aged 36–48 

months in January, 1976, living in the municipality of Hjoerring, Denmark 

Group 2: Children aged 36–48 

months in August, 1978, living in the municipality of Hjoerring, Denmark 

N1=503 children, 1001 ears, tested out of 523 a

N2=435 children, 867 ears, tested out of 465 a

Time: Not specifiedaPlace: ENT Clinic, Hjoerring 

Hospital, Denmarka

Inclusion: a • Age: 3 years • residing in Hjoerring, 

Denmark 

• had tympanometric 

screening and rescreening 

Exclusion: Nonea

Type of OME: newly diagnosed OME of unknown 

durationa

Age: 36–48 months oldaGender: Group 1 263 males, 260 females; Group 2 

234 males, 229 femalesa

Daycare: Group 1 18.5% in public day-care center, 

30.0% in private home day-care, 53.5% in own home; Group 2 31.1% in public day-care center, 23.8% in private home day-care, 46.2% in own homea

Examiner(s): unknownaOME diagnostic method: tympanometry 

• A: > –99 mmH20 

• B: ≤ 0.1 relative gradient • C1: –100 to –199 mmH2O 

• C2: <–200 mmH2O 

Interventions: The authors did not mention control of 

interventions. a

Interval of screening: 1, 3 and 6 months after initial 

diagnosis. Other articles on the 1976 cohort note that once type A tympanogram was noted; follow-up was discontinued. 

Cumu

1978 (Tabl

<1 mType 

B to A B to AB to AB/C2 B/C2 B/C2/<1 mType 

B to A B to AB to AB/C2 B/C2 B/C2/<1 mType B to A B to AB to AB/C2 B/C2 B/C2/Conti

a See 1237 Fiellau-Nikolajsen and Lous (1979) and 1245 Fiellau-Nikolajsen (1983). 
154 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

Continued

1235 FiellauNikolajsen 1979 [1976 cohort is also in articles 1237, 1242, and 3051. 1978 cohort is also in article 1245.] 

Cont

<3 mType B to A B to AB to AB/C2 B/C2 B/C2/<3 mType B to A B to AB to AB/C2 B/C2 B/C2/<3 mType B to A B to AB to AB/C2 B/C2 B/C2/
155 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

[S

1237 FiellauNikolajsen and Lous 1979 [This cohort is also in article 1235 1242, and 3051.] 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

4(111001) OME definition: none given but 

tympanogram B and C2 were regarded as abnormal 

Group: Children 3 years of age, 

born in 1972, and living in the municipality of Hjoerring, Denmark 

N=523 children fulfilled criteria; 504 (1005 ears) tested. N for type B at cohort inception=98 ears, 56 males and 14 females. N for type B/C2 at cohort inception=220 ears, 112 males and 108 females. N for type B/C2/C1 at cohort inception=372 ears, 186 males and 186 females. 

Time: Jan–July, 1976 

Place: Municipality of 

Hjoerring, Denmark (provincial town with about 20,000 inhabitants) 

Inclusion: 

• 3 years old born in 1972 

in the municipality of Hjoerring, Denmark 

Exclusion: 

during follow up: Moved out of area; airtight fitting of probe in auditory canal proved impossible; fistula developed in the pars flaccida 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 3 years old (born in 1972) 

Examiner(s): unknown 

OME diagnostic method: tympanometry 

• A: > –100 mmH20 and gradient > 0.1 

• B: 200 to –400 mmH2O or indeterminable and 

≤ 0.1 gradient 

• C1: –100 to –199 mmH2O and >0.1 gradient 

• C2: –200 to –400 mmH2O and >0.1 gradient Interventions: The authors state that “surgical 

procedures were avoided as much as possible.” Six children had adenoidectomy. 

Interval of screening: 1, 3, and 6 months after the 

initial diagnosis. Once a child had a type A tympanogram follow-up was discontinued. 

Cumu

<1 m

Time 

B to A B to AB to AB/C2 B/C2 B/C2/<1 mTime B to A B to AB to AB/C2 B/C2 B/C2/<1 mTime B to A B to AB to AB/C2 B/C2 B/C2/<3 mTime B to A B to AB/C2 B/C2 Conti
156 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

[S

Continued

1237 FiellauNikolajsen and Lous 1979 [This cohort is also in article 1235 1242, and 3051.] 

Conti

<3 mTime 

B to A B to AB/C2 B/C2 <3 mTime B to A B to AB/C2 B/C2 <6 mTime B to A B to AB/C2 B/C2 <6 mTime B to A B to AB/C2 B/C2 <6 mTime B to A B to AB/C2 B/C2 
157 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

1242 FiellauNikolajsen 1981 [This cohort is also in article 1237, 1235 and 3051.] 

Study Type: prospective single 

cohort within two cross-sectional studiesa

Study Quality Score (0–6): 

4(111001) a

OME definition: not defined, but 

tympanogram B and C2 were regarded as abnormala

Group 1: Children born in 1972 

and domiciled in the city of Hjoerring, Denmark in Jan 1976 

Group 2: Children born in 1972 

and domiciled in the city of Hjoerring, Denmark in Jan 1979 

N1=523; 503 tested (in article 1237 n=504 were reported tested out of 523)a

N2=505; 498 tested; 352 screened in 1976)aN for type B at cohort inception=98 ears. N for type B/C2 at cohort inception=220. N for type B/C1/C2 at cohort inception=372. 

Time: 3-year followup 

(1/1976–1/1979) a

Place: Testing done in 

classrooms; the municipality of Hjoerring, Denmarka

Inclusion: a• Age: 3–6 years (cohort 

born in 1972~screened at ages 3 & 6) 

• living in Hjoerring, 

Denmark 

Exclusion: a• showed A tympanograms 

in both ears at a pminimum of one test 

Type of OME: newly diagnosed OME of unknown 

durationa

Age: 3–6 years (cohort born in 1972~screened at 

ages 3 & 6) a

Examiner(s): unknownaOME diagnostic method: tympanometry 

• A: 200 to –99 mmH20 and relative gradient 

> 0.1 

• B: 200 to –400 mmH2O or indeterminable and 

≤ 0.1 relative gradient 

• C1: –100 to –199 mmH2O and >0.1 relative 

gradient 

• C2: –200 to –400 mmH2O and >0.1 relative 

gradient 

Interventions: The authors did not mention control of 

medications. Some received surgical treatment during the follow-up period; 46 paracentesis and adenoidectomy and later 14 of those myringostomy with insertion of grommets; 10 paracentesis and adenoidectomy and later 4 of those myringostomya

Interval of screening: 1, 3, and 6 months after the 

initial diagnosis at 3 years of age as reported in article 1237. This articles describes follow-up at 6 years of age. Once a child had a type A tympanogram follow-up was discontinued. a

CumudenoFigur

<3 yeType 

B to A B to AB to AB/C2 B/C2 B/C1/[The the mintervcommspontWith article yearsinstiturural) to impprognyears not p

a See 1237 Fiellau-Nikolajsen and Lous (1979). 
158 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

1245 FiellauNikolajsen 1983 [This cohort is also in article 1235.] 

Study Type: prospective cohort 

study 

Study Quality Score (0–6): 

3(111000) OME definition: middle-ear 

effusion with intact tympanic membrane and absence of symptoms of acute inflammation 

Group: Children screened 

(underwent audiometry testing and pneumatic otoscopy four times during study period) 

N=404 subjects screened; N had OME at cohort inception=82. 

Time: 1978–1979 (four 

screens: Aug, Sep & Nov, 1978, Feb 1979) Place: Subject identified in 

municipality of Hjoerring (medium-size urban town with a population of approximately 20,000); further testing and surgeries performed at ENT Dept., Hjoerring Hospital, Denmark 

Inclusion: 

• Age: 3 years (36–48 

months) 

• living in municipality of 

Hjoerring, Denmark 

Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 3 years (36–48 months) 

Examiner(s): unknown 

OME diagnostic method: 

tympanometry 

• middle-ear effusion: flat curve, or pressure 

≤100 mmH2O with absent middle ear reflexes 

• no middle-ear effusion Interventions: The authors did not mention control of medications. None reportedly had adenoidectomy, myringotomy, tubes, or paracentesis during the study period. 

Interval of screening: 1, 3, and 6 months after initial 

diagnosis 

Cumu

173) 

ResoTime 

<1 m<3 m<6 m
159 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

1486 Holm-Jensen, Sørenson, and Tos 1981 [This cohort is also in articles 2636, 543, 2639, 2642, 4834, and 4835.] 

Study Type: prospective cohort 

study 

Study Quality Score (0–6): 

3(111000) OME definition: not defined 

though equated to type B tympanogram 

Group: Healthy children, 4 years 

old and born on the first-tenth day of each month in 1975, who resided in two Copenhagen counties 

N=335 children at the first followup exam and 333 children at the second follow-up exam N for type B at cohort inception=102 ears (101 in article 2631) N for type B/C2 at cohort inception=318 ears N for type B/C2/C1 at cohort inception=477 ears 

Time: February, May, and 

August, 1979 Place: two counties in 

Copenhagen, Denmark 

Inclusion: 

• born on the 1st–10th of 

every month in 1975 in two Copenhagen counties 

• healthy Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 4 years 

Examiner(s): unknown 

OME diagnostic method: tympanometry 

• A: 0 to –99 mmH2O 

• B: flat curve • C1: –100 to –199 mmH2O 

• C2: –200 to –350 mmH2O Interventions: The authors did not mention control of 

interventions. 

Interval of screening: 3 and 6 months after initial 

diagnosis 

OME 

deno

<3 mType B to A B to AB to AB/C2 B/C2 B/C2/<6 mType 

B to A B to AB to AB/C2 B/C2 B/C2/
160 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1494 Holmquist, Fadala, and Qattan 1987 

Study Type: prospective cohort 

study 

Study Quality Score (0–6): 

3(111000) OME definition: middle-ear 

effusion behind an intact tympanic membrane 

Group: Children in grade two who 

were examined at baseline and three months later by tympanometry and otoscopy 

N=817 children, 1,634 ears; 788 examined three months later) 

Time: 2/1983–4/1983 

Place: Eight primary schools 

distributed in the four educational areas of Kuwait with one male and one female school selected randomly from each area 

Inclusion: 

• primary schools Exclusion: 

• incomplete data • refused to be submitted 

to examination 

• occluding ear canal wax • tympanic membrane 

perforations 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 7–9.5 years 

Examiner(s): the authors whose roles are not 

specifically identified, one is an MD/PhD, one a surgeon, and one an MS 

OME diagnostic method: tympanometry 

• A: +50 to –99 mmH2O 

• B: flat curve • C: +100 to –300 mmH2O 

Interventions: The authors did not mention control of 

interventions. 

Interval of screening: follow-up 3 months after initial 

diagnosis 

OME 

<3 mType B/C t
161 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1714 Lamothe, Boudreault, Blanchette, Tetreault, and Poliquin 1981 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

4(111100) OME definition: not defined 

Group: first-grade children 

N=958 children of which 68 had OME by otoscopy and pneumatic otoscopy after six week follow-up. N of OME at inception: total=68 target ears, male=29, female=39, left ear=38, and right ear=30. 

Time: 10/9/1979–12/15/1979 

Place: elementary schools in 

the Sherbrooke metropolitan area, Canada 

Inclusion: 

• First graders attending 

elementary schools in the Sherbrooke metropolitan area, Canada 

Target ear at first visit was: A) diagnosed with OME if unilateral, B) most affected if bilateral, C) chosen at random if bilateral and evolution was same in both ears Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: First graders 

Gender: 29 boys, 39 girls 

Examiner(s): otolaryngologist performed otoscopy 

and pneumatic otoscopy; audiologist performed tympanogram and audiogram 

OME diagnostic method: 

otoscopy and pneumatic otoscopy establishing • abnormal: air-fluid level, bubbles or complete 

effusion in the middle ear and hypo- or immobility of the eardrum plus two of the three following signs, eardrum retraction, opaque and thickened eardrum, or slight hyperemia 

tympanometry • abnormal: <= 200 mmH20 or amplitude <= 3 audiogram • abnormal: threshold >= 25 dB Interventions: The authors specifically state the 

patients were left untreated. 

Interval of screening: 3 and 6 weeks after initial 

diagnosis 

OME 

<3 weSubje

Total Male FemaLeft eRight <6 weSubjeTotal Male FemaLeft eRight Cumu

(Figu

<3 we<6 weSubje

Total 
162 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1735 Leiberman and Bartal 1986 

Study Type: retrospectiveprospective single cohort 

Study Quality Score (0–6): 

2 (110000) OME definition: not defined 

Group: Children with persistent 

middle ear effusion who had follow-up after 2-1/2 year delay in insertion of ventilating tubes 

N=79 children, 158 ears 

Time: 2 1/2 years (actual 

dates not specified) Place: The Soroka Medical 

Center in Beer-Sheva, Israel 

Inclusion: 

• children with persistent 

MEE and scheduled for myringotomy and insertion of ventilating tubes which was delayed 2 1/2 years 

Exclusion: 

• otomicroscopic findings 

of fluid and atelectasis, attic retractions, cholesteatoma, perforations, or tympanosclerosis 

Type of OME: OME persisting for weeks or months, 

i.e. 3 months or greater, laterality not specified 

Age: 2–12 years, mean 6 years 

Gender: 1:1 ( male: female ratio) 

Examiner(s): unknown who assessed for OME; 

certified audiologist performed audiometry 

OME diagnostic method: not stated 

Interventions: The authors did not mention control 

for interventions such as antibiotics during the course of the 2-1/2 year delay in surgical intervention. 

Interval of screening: follow-up greater than 2.5 

years after decision to operate for persistent middleear effusion of greater-than 3 months 

OME 

ResoTime 

2.5 ye[Authnoted Followperio
163 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1777 Lous and FiellauNikolajsen 1981 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

3(111000) OME definition: type B 

tympanogram signified middle-ear effusion 

Group: First graders in two 

municipalities (Hirtshals and Sindal, Denmark) who started school in August, 1978 

N=387 children at initial exam with 345 tested at all 10 sessions N=100 with known onset and recovery time. N=31 with unknown onset and recovery time 

Time: 8/1978–8/1979 

Place: First graders in two 

rural municipalities (Hirtshals and Sindal, Denmark) [24 classes at 14 different schools] 

Inclusion: 

• started first grade in 

8/1978 in two rural municipalities (Hirtshals and Sindal, Denmark) 

Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration; OME persisting for weeks or months 

Age: 6 1/2–7 1/2 year (first graders) 

Examiner(s): specially trained audiometricians 

performed the tympanogram and audiology testing 

OME diagnostic method: tympanometry 

• A: pressure > –100 mmH2O 

• B: otoadmittance < 0.20 millimhos, absolute 

gradient < 0.04 millimhos, and absence of ipsilateral acoustic reflex 

• C: ≤ –100 mmH2O 

Interventions: The authors did not mention control of 

medications. One child had adenoidectomy and paracentesis and three had adenoidectomy alone. 

Interval of screening: 1, 3, 4, 6, 7, 8, 9, 10, 12 

months after initial exam 

OME 

<3 mOnseSeas

Sep–Mar–<3 mknowexclu

OnseSeas

Sep–Mar–

a [Ons

onset unkno
164 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

9 Marchisio, Principi, Passali, Salpietro, Boschi, Chetri, Caramia, Longhi, Reali, Meloni, DeSantis, Sacher, and Cupido 1998 

Study Type: prospective single 

cohort embedded in a randomized controlled study 

Study Quality Score (0–6): 

3(111000) OME definition: asymptomatic 

middle-ear effusion, demonstrated by an abnormal appearance of the tympanic membrane, diffusely opaque, with impaired mobility or presence of air-fluid levels associated with a flat, type B tympanometric curve 

Group: Children attending the first 

year of primary school in one of eleven primary schools in Italy 

N=485 children with OME from 3413 screened. N=62 children with OME at 12-week follow-up randomized to placebo. 

Time: October–January during 

1993–4 and 1994–5 Place: Eleven primary schools 

visited by an otoscopist from either one of 9 Pediatric or 2 Otolarynogology departments in different regions of Italy 

Inclusion: 

• Attending year 1 in one of 

eleven participating primary schools in Italy 

• persistent unilateral or 

bilateral middle-ear effusion 

Exclusion: 

• craniofacial abnormality • any major congenital 

malformation 

• serious underlying 

disease 

• acute upper respiratory 

infection including AOM 

• high risk of sensorineural 

hearing loss 

• chronic suppurative OM • perforation of tympanic 

membrane 

• previous ear surgery 

Type of OME: newly diagnosed OME of unknown 

duration; OME persisting for weeks or months, i.e. at least 12 weeks 

Age: 16 were 5 years old, 211 were 6 years old, and 

258 were 7 years old 

Gender: 248 males, 237 females 

Laterality: 219 unilateral, 262 bilateral 

Month of exam: 296 in Oct–Nov, 189 in Dec–Jan 

Examiner(s): validated otoscopist 

OME diagnostic method: 

pneumatic otoscopy • abnormal: abnormal tympanic membrane 

appearance with impaired mobility or air-fluid levels and 

portable tympanometry • B: flat curve Interventions: It appears none of the children 

received antibiotics in the last month of the follow-up period and did not receive any surgical intervention during the follow-up interval. 

Interval of screening: 12 weeks after initial 

diagnosis; then 16 and 20 weeks after initial diagnosis for children randomized to placebo after 12 weeks 

OME 

ResoTime 

<12 w<16 w

 comp parti<20 w comp partia OM

i.e. 12 place12-we(Tabl
165 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1927 Mills and Vaughan-Jones 1992 

Study Type: prospective single 

cohort embedded in a prospective comparative cohort 

Study Quality Score (0–6): 

1(100000) OME definition: not defined 

Group: New cases of childhood 

OME (patients < 15 years of age) who presented at principal author’s clinic between 10/1986–10/1988 

N=192 children 

Time: 10/1986–10/1988 

Place: Clinics, Department of 

Otolaryngology, Ninewells Hospital and Medical School, Dundee, UK 

Inclusion: 

• <15 years old Exclusion: 

• impedance findings 

suggested effusion was in fact due to thickening of the tympanic membrane 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 1–14 years old, mean 5.5 years 

Examiner(s): unknown 

OME diagnostic method: 

pneumatic otoscopy tympanometry 

Interventions: Most of the children had 

myringotomies at the 2 month follow-up. Two children had “conservative treatment” at some unspecified point in time. 

Interval of screening: usually 2 months after initial 

exam 

OME 

ResoTime 

<2 m[Auththe fo
166 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

1946 Moller and Tos 1990 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

3(111000) OME definition: not defined 

Group: Healthy children attending 

a kindergarten in Copenhagen, Denmark 

N=51 children, 100 ears 

Time: 11/1/1989–11/30/1989 

(21 days of screening) Place: A kindergarten in 

Copenhagen, Denmark; Gentofte Hospital/University of Copenhagen 

Inclusion: 

• kindergartners Exclusion: 

• ears with grommets 

inserted (two ears excluded) 

• definite type of 

tympanogram could not be identified 

• child defected from study 

or refused the examination w/either one or the other instrument 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 37–68 months old 

Gender: 21 males, 30 females 

Examiner(s): unknown 

OME diagnostic method: tympanometry 

• A: +99 to –99 mmH2O • B: • AZ 7: flat curve without impedance minimum or 

with a measurable impedance minimum and relative gradient below 0.1 

• ZS 331: flat training or compliance below 0.25 

ml and absent ipsilateral stapedial reflex 

• C1: –100 to –199 mmH2O • C2: >–200 mmH2O Interventions: The authors did not mention control of 

interventions. 

Interval of screening: daily for 30 days 

OME 

of stuV) 

AZ7[Time Reso

<3 da <10 d <15 d <30 d ZS33Time Reso<3 da <10 d <15 d <30 d 
167 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2184 PortoianShuhaiber and Cullinan 1984 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

3(111000) OME definition: abnormal defined 

as an abnormal tympanometric curve and/or absent acoustic reflex 

Group: Children, 5–6 years old, 

attending selected primary schools in SE London 

N=130 children with OME from 318 screened 

Time: March 1979 and May 

1979 Place: Twelve primary schools 

in SE London 

Inclusion: 

• 5–6 years old • attending one of the 

twelve selected schools in SE London 

Exclusion: 

• conditions predisposing 

to glue ear such as Down’s syndrome and cleft palate 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 5–6 years 

Ethnicity: African-American: 57; Indian: 16; White: 

234; unknown: 11. 

Examiner(s): unknown 

OME diagnostic method: 

tympanometric and acoustic reflex measurements 

• abnormal: abnormal curve and/or absent reflex • normal: normal tympanogram curve with 

positive acoustic reflex 

Interventions: The authors did not mention control of 

interventions. 

Interval of screening: 10 weeks after initial diagnosis 

OME 

<10 wEthni

Total AfricaIndian White 
168 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

[See 

2189 Poulsen and Tos 1978 [This cohort is also in 2627, 2631, 2634, 2639, 2642, 4834, and 4835.] 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

3(111000) OME definition: not defined 

Group: Infants born between 

January–April, 1977, in the Gentofte maternity ward 

N=151 screened initially, 109 children (218 ears) at all examinations. N=0 for type B or C2 at cohort inception. 

Time: recruitment 1/1997 to 

4/1997 with last follow-up 6 months after initial exam Place: Copenhagen, Denmark 

Inclusion: 

• healthy newborns born 

between January and April 1977 in the Gentofte maternity ward 

Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: Newborns 

Gender: 82 males, 69 females 

Examiner(s): unknown 

OME diagnostic method: 

tympanometry

• A: >–100 mmH2O 

• B: flat curve with impedance slope ≤0.1 

• C: –100 to –300 mmH2O with impedance slope 

>0.1 

• C1: –100 to –199 mmH2O 

• C2: –200 to –350 mmH2O 

Interventions: The authors did not mention control of 

interventions. 

Interval of screening: 3 and 6 months after initial 

diagnosis at 2–4 days of age 

OME 

ResoTime <3 m<6 mCumu

ResoTime 

<3 m<6 m
169 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

2190 Poulsen and Tos 1980 [This cohort is also in articles 2629, 2631, 2634, 2593, 2639, 2642, 4834, and 4835.] 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

3(111000) OME definition: not defined 

Group: Healthy two-year-old 

children born between the first and tenth day of every month in 1976 residing in two municipalities in the northern part of Copenhagen county 

N=278 children at initial exam but N=240 children who presented at both follow-up exams N for type B at cohort inception=60. N for type B/C2 at cohort inception=172. N for type B/C2/C1 at cohort inception=290. 

Time: 11/1977–5/1978 

Place: Two municipalities in 

the northern part of Copenhagen county, Denmark 

Inclusion: 

• Age: 2 years • born between the 1st and 

the 10th day in every month of 1976 in 2 Copenhagen county municipalities 

• healthy Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 2 year old at final exam 

Examiner(s): unknown 

OME diagnostic method: 

tympanometry 

• A: 0 to –99 mmH2O 

• B: flat curve • C1: –100 to –199 mmH2O 

• C2: –200 to –350 mmH2O Interventions: The authors did not mention control of 

medications. Three children received ear tubes, and three had adenoidectomy. 

Interval of screening: 3 and 6 months after initial 

diagnosis 

OME 

1977 (Tabl

<6 mType B to A B to AB to AB/C2 B/C2 B/C2/
170 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2240 Renvall, Lidén, Jungert, and Nilsson 1978 

Study Type: prospective single 

cohort Study Quality (0–6): 3 (111000) OME definition: not defined. 

Group: Children aged 10–11 years 

who were initially examined at age 7 [only ears with a middle ear pressure <=–100 mm H2O or a flat tympanogram at the initial exam were included] 

N=210 children, 335 ears 

Time: not specified 

Place: Göteborg, Sweden 

Inclusion: 

• 10–11 years (initially 

evaluated at age 7) 

• only includes ear that at 

the initial evaluation (age 7) had middle ear pressure of <=–100 mmH2O or a flat 

tympanogram 

Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 10–11 years (initially evaluated at age 7) 

Examiner(s): otologic examination by experienced 

otologist, audiologic examiner unknown OME diagnostic method:

tympanometry and stapedius reflex measurements and otoscopic exam initial screen • abnormal: ≤–100 mmH2O or flat tympanogram 

follow-up • abnormal: ≤–150 mmH2O or flat tympanogram, 

stapedius reflex threshold > 95 dB H.L., and effusion by otologic exam 

Interventions: The authors did not mention control of 

interventions. 

Interval of screening: 3 years after initial diagnosis 

OME 

<3 yeDiagnMethTympOtolo[The ear phavinthan suggepersis
171 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2242 Renvall, Anniansson, and Lidén 1982 

Study Type: prospective single 

cohort Study Quality (0–6): 4(111100) OME definition: not defined 

Group 3: 4-year-old children with 

abnormal tympanograms after hearing screen and comprehensive evaluation N=5928 initially screened and N=223 ears with abnormal tympanogram. N for type B at cohort inception=58 ears. N for type B/C at cohort inception=223 ears. 

Time: During 1980 

Place: S1~Healthy-babyclinics in Goteborg, Sweden; 

S2~children who failed screening were referred to two oto-audiological health centers in Goteborg 

Inclusion: 

• Age: 4 years • S2~failure criterion >20db Exclusion: None 

Type of OME: Newly diagnosed OME of unknown 

duration 

Age: 4 years 

Examiner(s): unknown 

OME diagnostic method: 

tympanometry, audiology, and otologic exams 

• abnormal: middle-ear pressure ≤–150 mmH2O, 

hearing ≤20 dB HL, and/or retraction pocket on 

otologic exam 

• normal: middle-ear pressure > –150 mmH2O, 

no tympanic membrane retraction, and hearing <= 20 dB HL 

Tympanogram classification: 

• Flat to >150 mmH2O [similar to type B to A] 

• Flat or –150 to –400 mmH2O to >=150 mmH2O 

[similar to type B or C to A] 

Interventions: The children did not receive any 

treatment for four months after initial diagnosis. 

Interval of screening: 6 and 12 weeks after initial 

diagnosis. Those with normal exams at any point did not receive follow-up. 

Cumu

and 3

<6 weType 

B to A B/C t<12 wType B to A B/C t
172 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2243 Reves, Budgett, Miller, Wadsworth, and Haines 1985 

Study Type: prospective single 

cohort Study Quality (0–6): 3(111000) OME definition: not defined 

Group: Children 3 months to 6 

years old on 10/31/1983 recruited from age-sex register and successfully tested by tympanometry 

N=232 children, 452 ears, of whom n=220 had adequate exams 

Time: 11/1983–2/1984 

Place: General practice at a 

health centre in north west London (situated on a council housing estate and serves a deprived population) 

Inclusion: 

• 3 months–6 years on 

10/31/1983 

• listed in age-sex register Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 3 months–6 years on 10/31/1983; <1 year old 

59 ears, 1 year old 73 ears, 2 years old 94 ears, 3 years old 86 ears, 4 years old 82 ears, 5 years or older 58 ears 

Laterality: unilateral 29, bilateral 39 Examiner(s): unknown 

OME diagnostic method: 

tympanometry 

• A: normal pressure (–100 to +50 mmH20), 

normal compliance (>0.3), peak at normal pressure 

• As: normal pressure, low compliance, small 

peak at normal pressure 

• B: low compliance and middle-ear pressure 

< –100 mmH20 or indeterminate, usually flat or 

peak < –100 mmH20 (signified middle-ear 

effusion) 

• C: negative pressure, normal compliance, peak 

at negative pressure 

Interventions: The authors did not mention control of 

interventions. 

Interval of screening: every 2–4 weeks after initial 

diagnosis for 6 months 

OME 

ResoTime 

<3 m
173 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2262 Roberts, Johnson, Carlin, Turczyk, Karnuta, and Yaffee 1995 

Study Type: prospective single 

cohort Study Quality Score (0–6): 

4(111010) OME definition: not defined 

Group: Healthy, full-term infants 

born in MetroHealth Medical Center, Cleveland, Ohio, were enrolled on day 1 of life 

N=68 subjects 

Time: not specified 

Place: Normal newborn 

nursery of MetroHealth Medical Center, a county hospital in Cleveland, Ohio, and a county pediatric clinic 

Inclusion: 

• healthy, full-term 

newborn 

Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: Newborns (max follow-up ~ 2months) 

Race/ethnicity: white 47%, African American 43%, 

Hispanic 10% 

Examiner(s): 2 otoscopists; tympanometry and 

acoustic reflex measurements by an audiologist on day 1 and 3 and by a research assistant at 2 weeks and 2 months 

OME diagnostic method: 

pneumatic otoscopy • middle-ear effusion: tympanic membrane 

mobility markedly decreased or air-fluid level 

tympanometry • middle-ear effusion: peak susceptance < 0 

millisiemens 

• no effusion: > 0 millisiemens acoustic reflex measurement • middle-ear effusion: threshold at 110dB HL or 

absent reflex 

• no effusion: threshold up to 100dB HL Interventions: Asymptomatic infants were not treated 

with antibiotics. No indication of how many infants required intervention. 

Interval of screening: 2 weeks and 2 months after 

birth of infants whose parents chose to receive wellchild care from the research team 

Cumuears 

ResoTime 

<2 we<2 m
174 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2270 Robinson, Allen, and Root 1988 

Study Type: prospective single 

cohort Study Quality (0–6): 1(110000) OME definition: not defined 

Group: Children, primarily lower 

socioeconomic status infants between 3–6 months of age, who underwent tympanometry as part of the study 

N=137 subjects initially tested of whom n=63 had OME). N for B/C/Cs at cohort inception=63. 

Time: not specified 

Place: 12 Health Department 

clinics in two metropolitan Detroit counties (Wayne and Oakland); (8 Oakland County clinics are “well baby” clinics; 4 Wayne County clinics serve Medicaid patients) 

Inclusion: 

• Age: 6–13 months • income limits are 

imposed to qualify for Tx at all clinics involved 

Exclusion: None 

Type of OME: 

Age: 6–13 months, mean 9.7 months (standard 

deviation 2.3 months) 

Gender: 65 male, 72 female 

Race/ethnicity: 63 black, 74 white 

Examiner(s): second-year audiology master of arts 

student 

OME diagnostic method: 

tympanometry 

• A: –149to +50 mmH20 and compliance 

> 0.2 ml 

• failures: all other types As, C, Cs, and B Interventions: The authors did not mention control of 

interventions. 

Interval of screening: minimum 6 weeks from initial 

screen if failed 

OME 

<6 we

Type 

B to A B to AB to AB/C tB/C tB/C tB/C/C

a mini

not re
175 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2457 Sly, Zambie, Fernandes, and Frazer 1980 

Study Type: two prospective single 

cohorts Study Quality Score (0–6): 

3(111000) OME definition: not defined 

Group 1: February, 1977 screening 

children in 4–5 year old classes at Memorial Baptist Kindergarten (n=94 children, 188 ears) Group 2: September, 1977 screening children in 4–5 year old classes at Memorial Baptist Kindergarten N1=94 children, 188 ears N2=94 children, 188 ears 

Time: February and 

September, 1977 Place: Memorial Baptist 

Kindergarten, New Orleans, LA; from the Dept. of Pediatrics, Louisiana State University Medical Center 

Inclusion: 

• Age: 4–5 years • written parental 

permission & child willingness 

Exclusion: 

• presence of functional 

ventilating tube (ear) 

• not able to obtain 

adequate seal in the ear canal (ear) 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: Kindergartners (4–5 years) 

Examiner(s): unknown 

OME diagnostic method: 

tympanometry 

• abnormal: flat type B without discernible peak 

in compliance with decrease in pressure to –400 mmH2O, compliance < 0.3 cc, or peak 

compliance occurred at or below pressure –100 mmH2O 

Interventions: Group 1 antibiotics with or without 

antihistamines and decongestants in 2 children and antihistamines and decongestants in 9, Group 2 antibiotics with or without antihistamines and decongestants in 5 children and antihistamine and/or decongestants in 21. 

Interval of screening: every two weeks after initial 

diagnosis for six weeks 

OME 

(only 

<2 weUnit 

Child Child Ear Ear <2 weUnit Child Child Ear Ear <4 weUnit Child Child Ear Ear <4 weUnit Child Child Ear Ear Conti
176 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

Continued

2457 Sly, Zambie, Fernandes, and Frazer 1980 

Conti

<6 weUnit 

Child Child Ear B Ear B<6 weUnit Child Child Ear Ear Note: same 
177 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

2593 Thomsen and Tos 1981 [This cohort is also in articles 2190, 2629, 2631, 2634, 2639, 2642, 4834, and 4835.] 

Study Type: a

Study Quality (0–6): aOME definition: aGroup: aN=184 children who presented at all 5 follow-up exams N for type B at cohort inception=60. N for type B/C2 at cohort inception=172. N for type B/C2/C1 at cohort inception=477. 

Time: 11/1977 to 2/1980 

Place: a

Inclusion: aExclusion: a

Type of OME: aAge: a

Gender: males 92, females 92 

Examiner(s): unknown 

OME diagnostic method: a

Interventions: aInterval of screening: extended to 5 years old 

OME 

<2 yeType B to A B to AB to AB/C2 B/C2 B/C2/ResoResoTime <3 m<6 m<9 m<12 m<24 mCumu

ResoResoTime 

<3 m<6 m<9 m<12 m<24 m

a See 2190 Poulsen and Tos (1980). 
178 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

[See 

2627 Tos 1979 [This cohort is also in articles 2189, 2631, 2634, 2639, 2642, 4834, and 4835] 

Study Type: a

Study Quality Score (0–6): aOME definition: aGroup: aN=90 children who presented for all 5 follow-up exams N for type B at cohort inception=4 in this article but was 3 in articles 3189 and 2631. N for type B/C2 at cohort inception=27. N for type B/.C2/C1 at cohort inception=91. 

Time: recruitmen1t 1/1997 to 

4/1997 with last follow-up 12 months after initial exam Place: a

Inclusion: aExclusion: a

Type of OME: In this evidence table, we are looking 

at those from the original cohort with tympanogram type B (n=4 in article 2627 and n=3 in article 2189), C1 (n=20 in article 2189), or C2 (n=58 in article 2189) at the 6-month follow-up visit and presented for all 5 follow-up visit. Type B was not seen until the 6-month follow-up visit. Type C1 was seen in 24 patients at 2–4 days of age and 32 at the 3-month follow-up. Type C2 was seen initially in 1 patient at the 3-month follow-up. a

Age: aGender: 50 males, 40 females 

Examiner(s): a

OME diagnostic method: aInterventions: aInterval of screening: 1, 3, 6, 9, and 12 months after 

initial diagnosis at 2–4 days of age. a

OME 

deno(Tabl

<3 mType B to A B to AB to AB/C2 B/C2 B/C2/<6 mType B to A B to AB to AB/C2 B/C2 B/C2/

a See 2189 Poulsen and Tos (1978). 
179 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

2629 Tos 1979 [This cohort is also in articles 2190, 2631, 2634, 2593, 2639, 2642, 4834, and 4835.] 

Study Type: a

Study Quality Score (0–6): aOME definition: aGroup: Healthy two-year-old 

children residing in two Copenhagen county municipalities 

N=278 children at initial exam; N=222 children who presented at all 3 follow-up exams. N for type B at cohort inception=60. N for type B/C2 at cohort inception=172. N for type B/C2/C1 at cohort inception=280. 

Time: 11/1977–8/1978 a

Place: aInclusion: aExclusion: a

Type of OME: aAge: aExaminer(s): aOME diagnostic method: aInterventions: aInterval of screening: 3, 6, and 9 months after initial 

diagnosis a

OME 

deno(Tabl

<9 mType 

B to A B to AB to AB/C2 B/C2 B/C2/

a See 2190 Poulsen and Tos (1980). 
180 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

[S

2634 Tos 1980 [The 1976 cohort is also in articles 2190, 2629, 2631, 2593, 2639, 2642, 4834, and 4835. The 1977 cohort is also in articles 2189, 2627, 2631, 2639, 2642, 4834, and 4835.] 

Study Type: a

Study Quality Score (0–6): aOME definition: aGroup: aN=a

Time: aPlace: aInclusion: aExclusion: a

Type of OME: aAge: aExaminer(s): aOME diagnostic method: a Interventions: a Interval of screening: a

OME 

<3 mType B to A B to AB to A<6 mType B to A B to AB to A<9 mType B to A B to AB to ACumu

<3 m<6 mType 

B to A B to AB to A<9 mType B to A B to AB to A

a See articles 2190 Poulsen and Tos (1980) and 2189 Poulsen and Tos (1978). 
181 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors

543 Tos, HolmJensen, Sørenson, and Mogensen 1982 [This cohort is also in articles 1486, 2636, 2639, 2642, 4834, and 4835.] 

Study Type: a

Study Quality (0–6): aOME definition: aGroup: aN=288 children who attended all 4 follow-up exams N for type B at cohort inception=101 ears (note difference from article 1486). N for type B/C2 at cohort inception=317 ears (note difference from article 1486). N for type B/C2/C1 at cohort inception=477 ears. 

Time: The authors identify this 

study as their 1976 birth cohort, but it is actually their 1975 birth cohort. a

Place: aInclusion: aExclusion: a

Type of OME: a

Age: aExaminer(s): two experienced technicians aOME diagnostic method: aInterventions: aInterval of screening: a

OME 

<3 mType B to A B to AB to AB/C2 B/C2 B/C2/<6 mType B to A B to AB to AB/C2 B/C2 B/C2/<9 mType B to AB to AB/C2 <12 mType B to AB to AB/C2 

a See 1486 Holm-Jensen, Sørenson, and Tos (1981) and 2636 Tos (1981). 
182 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

543 Tos, HolmJensen, Sørenson, and Mogensen 1982 [This cohort is also in articles 1486, 2636, 2639, 2642, 4834, and 4835.] 

Cumu

<3 m<6 mType 

B to A B to AB to AB/C2 B/C2 B/C2/<9 m

Type 

B to AB to AB/C2 <12 m

Type 

B to AB to AB/C2 
183 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

91 van Balen, de Melker, TouwOtten 1996 

Study Type: prospective single 

cohort embedded in a randomized controlled trial 

Study Quality (0–6): 3(111000) 

OME definition: presence of fluid 

in the middle-ear cavity behind an intact tympanic membrane without signs or symptoms of acute infection 

Group: children with bilateral 

OME 

N=433 

Time: recruited 12/1992 to 

8/1994 and then followed for 3 months Place: 57 general practices in 

the Netherlands 

Inclusion: 

• 6 months to 6 years old • bilateral OME Exclusion: none 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 6 months to 6 years old 

Laterality: all bilateral Examiner(s): general practitioner trained in 

tympanometry 

OME diagnostic method: 

tympanometry 

• A: –99 to +200 dPa and max compliance 

>= 0.2 mmho 

• B: <= –400 dPa and max compliance 

< 0.2 mmho 

• C1: –199 to –100 dPa and max compliance 

>=0.2 mmho 

• C2: –399 to –200 dPa and max compliance 

>= 0.2 mmho 

• Middle-ear effusion defined by B or C2 curves. Interventions: Authors stated children received no 

treatment for their ear problems and noted that “In the Netherlands it is not common to treat OME with antimicrobial drugs.” It is possible antibiotics were used during the watchful waiting period. 

Interval of screening: 3 months after initial exam 

OME 

Time 

<3 m[Authcomp
184 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2791 Williamson 1994 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

2(110000) OME definition: not defined 

Group: Children attending four 

adjacent Infant and First schools in South West Hampshire participating schools and screened by tympanometry once per term at a four-month interval until they left primary school 

N=856 subjects 

Time: Recruitment 9/1988–

3/1989; study period ended summer 1991 Place: School medical room in 

four adjacent Infant and First Schools in the SW Hampshire area 

Inclusion: 

• 5–8 years old • attending four attending 

four adjacent Infant and First schools in South West Hampshire 

Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 5–8 years old 

Examiner(s): unknown 

OME diagnostic method: 

tympanometry 

• A: 200 to –99 pressure • B: lack of defined compliance maximum • C1: –100 to –199 pressure • C2: –200 to –400 pressure Interventions: The authors report that 27 children 

had grommets in situ during the study period. This includes 6 children in the Spring 1990 cohort with type B tympanograms whose OME resolution is reported. 

Interval of screening: once per term at a four-month 

interval until the child left primary school 

OME 

tymp

the d

932) 

ResoResoTime 

<4 m<8 m<1 yeResoResoTime <4 m<8 m<1 ye
185 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Inclusion/Exclusion 

Criteria Influencing Factors 

2863 Zielhuis, Rach, and van den Broek 1990 

Study Type: prospective single 

cohort 

Study Quality Score (0–6): 

3(111000) OME definition: type B 

tympanogram signified OME but otherwise not defined 

Group: Preschool children seen in 

follow-up for OME every 3 months from 2–4 years of age (n=609 children had all nine total screenings out of 1328 whose parents agreed to participate) 

N=1328 subjects 

Time: Follow-up from age 2–4 

years in children born between 9/1/1982–8/31/1983 Place: Measurements carried 

out at the children’s home in Nijmegen, The Netherlands 

Inclusion: 

• Age: 4 years • born in Nijmegen during 

the period 9/1/1982–8/31/1983 and living in Nijmegen on their 2nd birthday 

• screened every 3 months 

since 2 years of age 

• parental consent Exclusion: None 

Type of OME: newly diagnosed OME of unknown 

duration 

Age: 4 years old 

Examiner(s): three trained audiologic assistants 

OME diagnostic method: 

tympanometry 

• A: compliance ≥0.2 ml and pressure ≥–99 dPa 

• B: compliance <0.2 ml and pressure ≤ –400 

dPa 

• C1: compliance ≥0.2 ml and pressure –100 

to –199 dPa 

• C2: compliance ≥0.2 ml and pressure –200 

to –399 dPa 

• B: compliance <0.2 ml and pressure 

≤ –400 dPa 

Interventions: The authors did not mention control of 

medications. 56 of the children were treated with ventilating tubes. 

Interval of screening: every 3 months after initial 

screen until 4 years old 

The aresolu

on th y y x r2

Durat M S 5 2

 m 7 9[mixtuOME 

Estim

based given 

Time 

<3 m<6 m
186 

Evidence Table 1. Natural History of Otitis Media with Effusion (Continued) Record# Author Year Findings2863 Zielhuis, Rach, and van den Broek 1990 

Duration of all OME episodes by ear by influencing factors (Table 3) 

3 months 6 months

9 months 

or more

Season at start of OME Autumn 59.7% 19.5% 20.8% 4.8

Winter 65.6% 17.7% 16.7% 4.5

Spring 61.3% 24.2% 14.5% 4.6

Summer 69.0% 20.2% 10.8% 4.3

Age at end of episode 24-29 77.9% 22.1% 0.0% 3.7

30-35 60.4% 19.5% 20.1% 4.836-41 64.4% 20.7% 14.9% 4.542-48 56.6% 19.4% 20.0% 5.0

Sex Male 64.4% 20.9% 14.7% 4.5

Female 63.7% 19.7% 16.6% 4.6

Upper respiratory tract infection Yes 64.4% 19.5% 16.1% 4.6

No 63.8% 22.2% 14.0% 4.5

History of acute otitis media Yes 62.1% 23.0% 14.9% 4.6

No 57.1% 24.5% 18.4% 4.8

0.240.77

p-value

<0.001<0.001

0.44

% with duration of

Factor Category Mean Duration

[mixture of OME diagnosed at initial screen and OME arising during the study period] [Actual counts were not presented and could not be derived.] 
187 

Evidence Table 2. Early Life OM and Long-Term Speech and Language Development [The eight components of study quality score are: study cohort clearly defined; subjects assembled at a uniform time point; pathway of subject entry clearup achieved; withdrawals/drop-outs described; objective outcomes used; outcome assessment blinded; and extraneous factors adjusted. 1 indicates pre

absence.] 

Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion Criteria

Risk Groups 

Predictors 

Outcome Measures 

877 Black 1993 

Prospective Cohorts Study 

Study Quality Score (0–8): 

3 (00001101) 

OM Diagnosis: 

By otologic examination by unspecified examiner. 

OM Groups: 

Group 1: OM+: High Infant Otitis Media (at least two cases of otitis media within the first year of life documented by otologic examination) 

Group 2: OM–: No Infant Otitis Media (Had not experienced otitis media during first year of life) N=31 subjects N1=21 N2=10 

Time: 4-year follow-up (actual 

time of study not specified) 

Place: Inner-city sample in 

Baltimore, Maryland 

Characteristics: 

• 87% had African-American 

primary caregivers 

• 61% had not completed 

high school 

• 81% single women • 91% received medical 

assistance 

• all children were enrolled in 

kindergarten or Head Start I 

Inclusion: 

• Age: 4 years follow-up of 

the original cohort of infants 

• partipated in authors earlier 

study 

• Born at term with 

appropriate weight for gestational age 

• No medical problems 

beyond OM 

Exclusion: None 

Age: 

OM history: first year of life Outcomes: 4–6 years of age 

OM History: At least 2 episodes of OM within the 

first year documented of otologic exam. A child could receive credit for only one bout of OM within each 29-day period. 

Outcome Measures: 

Cognitive development: McCarthy Scales of Children’s Abilities (verbal, perceptual processing, quantitative, memory, and motor). Each has a mean score of 50 and a standard deviation (SD) of 10. Scores on the first 3 scales are summed to give a GCI with a mean (SD) of 100 (15). Language development: Peabody Picture Vocabulary Test-Revised, an assessment of receptive language. Has mean (SD) of 100 (15). 

 

Test McCa Verb Perc Qua Mem MotGCIa PPVTa Genb Pea
188 

Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1219 Feagans 1987 

Prospective cohort study 

Study Quality Score (0–8): 

5 (11100101) 

OM Diagnosis: 

OM diagnosed by 2 pediatricians and 2 nurse practitioners using pneumatic otoscopy. Beginning 1978 tympanometry was used to corroborate the diagnosis 

Group: Children who were part of a medical and day care intervention project N=44 subjects 

Time: 1972–1982 Place: Children were sampled 

from a day care center in Pennsylvania 

Characteristics: 

• Black • Low socioeconomic status; • Attended day care center 

50 weeks per year from 6 weeks to 5 years of age. 

Inclusion: 

• Age: 5–7 years (measures 

at both time points) 

• children who were followed 

from birth to 2nd grade 

• biologically normal at birth • high risk for general 

developmental delays in language and intelligence due to low SES 

Exclusion: None 

Age: 

OM History: 0–3 year of life Outcomes: at 5–7 years of age 

OM History: 

Frequency of OM Duration of OM 

Outcome Measures: 

Mean length of utterance (MLU) at age 5 Mean length of utterance (MLU) at age 6 Paraphrase score at age 5 Paraphrase score at age 6 

Predictors in the study: 

Mother’s IQ at birth Mother’s education Home environment (HOME) at 18 months Language (WPPSI IQ) at age 5 Frequency of OM in 0–3 years of life Duration of OM in 0–3 years of life 

 

Lengt At a At aParap At a At aMulti

MLU: R2 = 0

Parap

WPPfrequMulti

MLU: 

signif

Parap

and d(R2= 
189 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1255 Fischler 1985 

Retrospective-prospective study Study Quality Score (0–8): 

5 (11001110) OM Diagnosis: 

By medical record review of documented physician’s clinical diagnosis. 

OM Groups: 

Group 1: HR/REC (HR-High risk status,REC-recurrences of OM attacks after age 2) ~ >=2 attacks by age 2 yr and >=3 attacks after age 2 yr 

Group 2: HR/NREC ~ >=2 attacks by age 2 yr and <3 attacks after age 2 yr Group 3: NHR/NREC ~ <2 attacks by age 2 yr and <3 attacks after age 2 yr N=167 N1=33 N2=63 N3=71 

Time: Start date~7/1974 

Place: Four Indian reservations 

in Arizona 

Characteristics: • 50% had family income 

under $5000 per year 

• 37% had housing below 

average 

• 13% primarily Apache 

speaking at home 

Inclusion: 

• Age: 6–8 years • healthy Apache Indian 

children who had been followed since birth 

Exclusion: 

• moved during study period • absent or not tested 

because of time constraints 

• medical reasons (specific 

conditions not specified) 

Age: 

OM history: 0–2 years of life Outcome: at 6–8 years 

Examiner(s): 

• Unspecified physicians for diagnosis of otitis 

media; 

• School nurse for hearing tests; • Pediatrician/otolaryngologist for otoscopic 

examinations; 

• Certified speech pathologists for language 

testing. 

OM history: 

Groups defined by number of OM episodes by age 2 Outcome measures: 

• Four subtests of the Test of Language 

Development (TOLD). 

• Two receptive language subtests (picture 

vocabulary [PV] and grammatic understanding [GU]) 

• Two expressive subtests (grammatic 

completion [GC] and oral vocabulary [OV]) 

• Articulation: informally scored as normal or 

suspect 

• Nonverbal intelligence by the block-design 

subtest of the Wechsler Intelligence Scale for Children-Revised (WISC-R) 

[For all subtests raw scores were converted into age standardized scores. Standard scores were based on national norms having mean (SD) of 10 (3).] 

 OM r

TOLD Rece PV  GU TOLD Expre GC  OV WISCNon-v 
190 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1277 Freeark 1992 

Retrospective-Prospective Cohort Study Study Quality Score (0–8): 

4 (10000111) OM Diagnosis: 

By whom, not specified; How diagnosed, not specified. (OM history obtained from medical records). 

OM Groups: 

Group 1: High OM: Above median of OM severity defined by frequency of OM episodes and days with effusion. 

Group 2: Low OM: Below median of OM severity defined by frequency of OM episodes and days with effusion. N=54 subjects N1=26 N2=28 

Time: not specified 

Place: university-based pediatric 

clinic, Michigan 

Characteristics: • 86% white • 82% of mothers and 91% 

of fathers with at least some college education 

• 77% of fathers in lower 

middle to upper middle class occupations or were full-time graduate students 

• 75% of mothers employed Inclusion: 

• Age: 3–4 years • in patient roster of a 

university-based pediatric clinic 

• both parents living in home • parents had at least a high 

school ed. and not receiving public assistance 

• family had no more than 

four children 

• child did not suffer from a 

chronic illness or disability 

Exclusion: None 

Age: 

OM history: 0–3 years of life Outcome: 3–4 years 

Examiner(s): 

Trained examiners for language testing. 

OM History: 

OM severity defined by a) number of separate episodes of otitis and b) total number of days of effusion over the first 3 years. 

Outcome measures: 

Verbal Scale Index (VSI) of the McCarthy Scale of Children’s Abilities – a summary measure of the child’s verbal abilities derived from 6 subtests assessing verbal fluency and memory, word knowledge, and verbal reasoning. 

Stratification Factor: 

Parent Verbal Stimulation (PVS) – total frequency of mothers’ and fathers’ descriptive and reflective statements and questions during the first 10 minutes of the dyadic interaction. 

 

High  Low PTotal Hierashowstimuprediintera
191 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1373 Gravel 1992 Same cohort in 1941, 2295 and 4728. See 1941, 2295, and 4728 for further comments. 

Prospective Cohort Study Study Quality Score (0–8): 

5 (11001110) OM Diagnosis: 

Pediatric nurse practitioners completed pneumo-otoscopic examinations. 

OM Groups: 

Group 1: OM+: Otitis positive children – when bilateral OM was detected at 30% or more of the baby’s first year visits. (Also, had poorer auditory sensitivity by click ABR.) 

Group 2: OM–: Otitis negative children – when middle ear status was rated as normal in both ears during 80% or more of the first year visits. N=23 N1=10 N2=13 

Time: not specified 

Place: Clinical Research Center 

for Communicative Disorders (which draws subjects from the LIFE Program of the R.F. Kennedy Center, Albert Einstein College of Med. Bronx, NY 

Characteristics: • low socioeconomic urban 

neighborhoods based on Hollingshead’s (1975) index 

• none had sensorineural 

hearing loss 

Inclusion: 

• Age: 4 years (measures 

taken during first year of life as well) 

• all children were enrolled 

at 40 wks postconceptional age for follow-up through the LIFE Program 

• either high-risk infant 

graduates of a NICU or FT graduates of the well-baby nursery of Jacobi Hospital 

• English reported as the 

primary language spoken 

Exclusion: 

• neurologically 

compromised 

Age: 

OM history: 0–1 of life Outcome: at 4 years of age 

Examiner(s): 

Not specified 

OM history: 

OM groups were defined by otoscopic histories. Outcome measures: 

Cognitive measures (Stanford-Binet 4th Edition): 

 Composite IQ Score  Verbal reasoning  Abstract/visual reasoning  Quantitative reasoning,  Short-term memory 

Language measure (Sequenced Inventory of Communication Development-Revised (SICD-R) – a standardized measure of communicative functioning combining parental report with direct assessment:  Expressive scale  Receptive scale 

  

Cogn N  Glo VerExpre N  MeRece N  Me
192 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

4728 Gravel 1996 Same study subjects as 1373, 1941, 2295 See 1373, 1941, and 2295 for further comments. 

Prospective Cohort Study Study Quality Score (0–8): 

3 (01000110) OM Diagnosis: 

Pediatric nurse practitioners completed pneumo-otoscopic examinations. 

OM Groups: 

Group 1: Otitis positive children – when bilateral OM was detected at 30% or more of the baby’s first year visits. 

Group 2: Otitis negative children – when middle ear status was rated as normal in both ears during 80% or more of the first year visits. N=17 subjects N1=10 N2=7 

Time: not specified 

Place: Clinical Research Center 

for Communicative Disorders (which draws subjects from the LIFE Program of the R.F. Kennedy Center, Albert Einstein College of Med. Bronx, NY 

Characteristics: • low socioeconomic urban 

neighborhoods based on Hollingshead’s (1975) index 

• all had normal hearing and 

normal middle-ear function on test day 

Inclusion: 

• Age: 9 years • born in the same urban 

hospital 

• auditory testing conducted 

during first year of life and at 9 years of age 

Exclusion: None 

Age: 

OM history: 0–1 of life Outcome: at 9 years of age 

Examiner(s): 

Not specified 

OM history: 

OM groups were defined by otoscopic histories. Outcome measures: 

• Binaural masking level difference (MLD) • Speech-in-competition task-adapted from the 

Pediatric Speech Intelligibility (PSI) test 

• Selected auditory attention task – An 

experimental version of the PSI 

• Story memory tasks – a subset of the 

standardized Wide Range Assessment of Memory and Learning (WRAML) 

• Clinical Evaluation of Language FundamentalsRevised (CELF-R) 

No raThe fOM– 1. 2. 
193 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1435 Harsten 1993 

Prospective Cohort Study Study Quality Score (0–8): 

6 (11101110) OM Diagnosis: 

AOM was diagnosed by otomicropscopy, performed by an otolaryngologist and defined as an acute episode of earache in a child, with red bulging eardrum(s) or purulent discharge, occasionally febrile and with signs of upper respiratory tract infection. 

OM Groups: 

Group 1: Children with recurrent AOM (RAOM defined as at least six episodes of AOM during a 12-month period) during the first 3 years of life 

Group 2: Children without any AOM episode during the first 3 years of life N=42 subjects N1=13 N2=29 

Time: not specified 

Place: University Hospital of 

Lund, Sweden 

Characteristics: • 45% first-borns • 71% mother educated at 

college level 

Inclusion: 

• Age: Birth cohort • monolingual, Swedish 

children, born at University Hospital of Lund 

Exclusion: None 

Age: 

OM history: 0–3 year of life Outcomes: at 4 and 7 year of age 

Examiner(s): 

Otolaryngologist for otomicroscopy, tympanometry, tone-audiograms 

Phoniatrician and clinical linguist for hearing and speech OM history: 

Groups defined by number of episodes of AOM during a 12 month period. Outcomes: 

• Phonology – based on material from the 

phoneme test and producing word pairs of the auditory discrimination task. 

• Grammar – from the Ringsted material

• Interaction – Thematic pictures were used for 

this analysis 

• Grammatical and interactional analysis – based 

on sequential pictures and thematic pictures 

Phon

% (#)  

Age 4 Age 7 Gram

% (#)  

Age 4 Age 7 Intera

% (#) 

 

Age 4 Age 7 RAOM
194 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1623 Kaplan 1973 

Prospective Cohort Study Study Quality Score (0–8): 

6 (11001111) OM Diagnosis: 

A research nurse visited the cohort children 4 times a year during first 2 years and at least 2 times a year for the next 2 years. During each visit, information concerning middle ear abnormality was obtained and medical records of the time between visits were reviewed. Only OM described with otorrhea was used for analysis. 

OM Groups: 

Group 1: age of onset of first otorrhea at 0–1 year of age 

Group 2: age of onset of first otorrhea at age 2–10 years Group 3: no history of otorrhea N=489 N1=291 N2=83 N3=115 

Time: Birth cohort (10/1960–

12/1962); follow-up conducted between 9/1969–7/1971 Place: 28 Eskimo villages 

located in the Yukon and Kuskokwim River Delta areas of Southwestern Alaska 

Characteristics: 

Not described. 

Inclusion: 

• Age: Birth Cohort born 

between 10/1960–12/1962 and followed up between 9/1969–7/1971 

• born in 25 villages w/in 

Alaska specified under place and/or residing in 3 additional villages at follow-up 

Exclusion: 

• Children with pure sensory 

hearing loss were excluded from analysis 

Age: 

OM history: 0–1 year of life Outcome: at 10 years of age 

Examiner(s): 

Experienced audiologist for air and bone conduction measurements 

Two psychologists administered speech and intelligence testing OM history: 

Groups based on onset of first episode of otorrhea during 0–1 year; during 2–10 years or no history. Outcomes: 

• Wechsler Intelligence Scale for Children 

(WISC) – modified 

• Bender-Gestalt test • Draw-A-Person test Stratification Factor: 

Concurrent hearing status: No hearing loss or conductive component or hearing loss at 26+dB 

No H 1st om 

N Verba  Perfo  Cond 1st om N Verba  Perfo  Hear 1st om N Verba  Perfo  
195 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

4651 Klein 1988 

Prospective Cohort Study Study Quality Score (0–8): 

4 (10100101) OM Diagnosis: 

By pediatricians using pneumatic otoscopy until age 3 and both pneumatic otoscopy and tympanometry in years 4 through 7. 

OM Groups: 

Group 1: Time spent with effusion <32 days during first 2 years of life 

Group 2: Time spent with effusion 33–108 days during first 2 years of life Group 3: Time spend with effusion >108 days during first 2 years of life. N=196 subjects Number of subjects by groups not given 

Time: Enrollment of infants 

began in 1975 & continued for 2 yrs (7-year follow-up) Place: Private practices in 

Holliston and Framingham, MA, and an urban health center in East Boston 

Inclusion: 

• Random sample of 

children still active in the practices at age 7. 

Exclusion: 

• parental refusal • nonwhite race • English not the primary 

language spoken at home 

• Seizures • mental retardation, 

cerebral palsy 

• hearing loss >20db at time 

of testing (deferred until able to pass hearing test) 

Age: 

OM history: first 3 years of life (recruited at <3 months of life) 

Outcome: at 7 years of age Examiner(s): 

Pediatricians for OM history. Not mentioned for speech and language testing. 

OM History: 

• Criteria for effusion – otorrhea, gas-liquid levels 

visible on otoscopy or marked reduction of mobility. Tympanometric criterion: type B curve. 

• Time spent with effusion – assigned a ‘window’ 

of 23 days to each observation of effusion, whether accompanied by signs of illness or not. It could be shortened or extended by multiple examinations. 

Outcome measure: 

• Wechsler Intelligence Scale for ChildrenRevised (WISC-R) • Goldman-Fristoe-Woodcock test • WUG test • Peabody Picture Vocabulary Test • Boston Naming Test • A recorded language sample • Metropolitan Achievement Test (reading and 

mathematics) 

No raMultivLeast (SE) socio

 

LS mSE GrouGrouGrouThe iwere scoresignifthe firspeecmorpcompsynta
196 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1941 Mody 1999 Same study as 4780 Mody 1996 Same cohort as 1373, 2295, and 4728. See 1373, 2295, and 4728 for further comments. 

Prospective Cohort Study Study Quality Score (0–8): 

4 (11000101) OM Diagnosis: 

By trained and validated pediatric nurse practitioner (PNP) using a pneumatic otoscope under the supervision of a pediatric otolaryngologist. The PNP recorded a description of TM characteristics for each ear, using a 9-item otoscopic checklist and made the determination of “clear,” “suspicious,” or “positive” for OM. 

OM Group: 

Group 1: OM+: (Children who had 30% or more of the 13 firstyear visits with otitis media bilaterally) 

Group 2: OM–: (Children who had 80% or more of the 13 firstyear visits with normal middle ear findings bilaterally) N=14 subjects N1=7 N2=7 

Time: Follow-up from birth to 9 

years (actual dates not specified) Place: Subjects recruited from 

Longitudinal Infant Follow-up and Evaluation (LIFE) program of the Rose F. Kennedy Center, Albert Einstein College of Medicine, New York, NY 

Characteristics: • 71% high risk births • 64% male • 57% African-American • 36% Hispanic • 64% low SES • 36% middle SES Inclusion: 

• Age: 9 years (followed 

from birth) 

• English is the primary 

language spoken in the home 

• received all medical, 

audiological, and developmental assessments through the LIFE program at monthly evaluations from birth through first year 

• normal hearing and normal 

middle ear function on test day 

Exclusion: 

• neurologically 

compromised as an infant 

Age: 

OM history: first year of life Outcome: at 9 years of age 

Examiner(s): 

Trained and validated pediatric nurse practitioner for OM history; 

Type of examiner(s) not specified for speech and language testing. OM history: 

Defined by pneumatic otoscopy findings during first year of life. Outcome measures: 

• Four nonsense syllables (/sβ /, /zβ /, /kβ /, /gβ /) 

presented auditorily 

• Test on identification and temporal order recall 

using 4 synthetic speech syllables, /ba/, /da/, /sa/ and /a/. 

Mean  

Seria 1  2  3  4 Errorfeatu 

TransErrors Total  0 sh 1 sh 2 shMean ident(TOJ 1. /ba Ide TOJ  TOJ 2. /sa Ide TOJ  TOJ a From 
197 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

4675 Owen 1996 

Prospective Cohort Study Study Quality Score (0–8): 

4 (11000101) OM Diagnosis: 

By trained technicians using automated screening tympanometers with a 226 Hz probe tone. Acoustic reflectivity was also measured using acoustic otoscope at 30% of visits. OME diagnoses were based on type B tympanogram or >= 5 acoustic reflectivity or visible purulent otorrhea without an otoscope. 

OM Groups: 

Group 1: High OME (children who had extended OME across first three years of life) 

Group 2: Early OME (children who had OME which peaked from 0–6 months of age) Group 3: Later OME (children who had OME which peaked from 6–12 months of age) Group 4: Low OME (children who experienced relatively low levels across first 3 yrs of life) N=294 subjects Sample size for each group not specified. 

Time: Infants enrolled in 

program between 1984–1989 (5 yr follow-up) Place: Texas 

Characteristics: • 49% male • 56% Euro-American • 30% African-American • 14% English-speaking 

Hispanic 

• wide socioeconomic range • Half breast fed at birth • 41% had cigarette smoke 

exposure 

• 19% mother smoked • 63% attended day care Inclusion: 

• Age: 5 years (follow-up 

from birth) 

• healthy-term infant from 

English-speaking family 

Exclusion: None 

Age: 

OM history: 0–3 years of life Outcome: at 5 years of age 

Examiner(s): 

Trained technicians for OM history Trained graduate students for language and cognitive testing. 

OM history: 

If 2 consecutive visits showed OME, the intervening days were counted as days with OME. If one visit showed OM and the next normal status, or vice versa, half of the intervening days were counted as days with OME. OME duration was defined as the proportion of time a subject spent with OME (total OME days divided by total days) in the period examined. Outcome measures: 

• Test for Auditory Comprehension of LanguageRevised (TACL-R) • Auditory discrimination subtests of the Carrow 

Auditory Visual Abilities Test (CAVAT) 

• Goldman-Fristoe test for articulation (G-F) • Carrow Elicited Language Inventory (CELI) • Stanford-Binet Fourth Edition for cognition Covariates: 

Gender, Ethnicity, Birth rank, Day care attendance, Duration of breast feeding, Cigarette smoke exposure, SES, Educational stimulation at home, Mother’s intelligence 

Raw The f1. 2. 3. 4. 5. 6. 7. 8. 
198 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

2135 Paul 1993 

Retrospective-Prospective Cohort Study Study Quality Score (0–8): 

3 (00100101) OM Diagnosis: 

Based on parental reporting. 

OM Group: 

Middle ear involvement was defined as either the placement of myringotomy tubes or the presence of six or more ear infections treated by a physician before the second birthday, by parent report. 

Group 1: OM+: defined by middle ear involvement, stratified by normal or late talkers Group 2: OM–: lack of such middle ear involvement, also stratified by normal or late talkers. N=44 subjects N1=20 (8 normal and 12 late talkers) N2=24 (13 normal and 11 late talkers) 

Time: Not specified 

Place: Portland Oregon. 

Subjects are subset of those participating in the Portland Language Development Project (PLDP), a longitudinal study of outcomes of early expressive language delay. 

Characteristics: • all passed speech 

reception screenings 

• 15–33% of each subgroup 

had abnormal tympanograms 

Inclusion: 

• Age: 20–34 at entrance • subjects recruited from 

children participating in the Portland Language Development Project (PLDP) 

Exclusion: None 

Age: 

OM history: first 2 years of life Outcome: at 3 and 4 years of age 

Examiner(s): 

Certified audiologist in sound-treated booth. 

OM History: Based on parental reports. 

Outcome measures: 

• Goldman-Fristoe Test of Articulation at age 3 • Word Articulation subtest of the Test of 

Language Development-Primary at age 4. 

• Sample of free speech collected during a 

15-minute play interaction between mother and child at ages 3 and 4. 

• Speech samples were used to compute mean 

length of utterance (MLU) in morphemes for each sample. 

Stratification groups: 

Children were placed in normal versus late talking (LT) groups on the basis of their expressive vocabulary size as reported by parents on the Language Development Survey (LDS) at intake into the PLDP. 

MLU 

Norm Age  Age Late T Age  Age GoldNorm

 Age  Age Late T

 Age  Age 

a Chil

fewer groupshowabilitimontLang
199 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

4657 Roberts 1986 4656 Roberts 1989 Same study subjects as in 4806/ 3118, 3117, and 4319. See 4806/ 3118, 3117, and 4319 for further comments. 

Prospective Cohort Study Study Quality Score (0–8): 

6 (10101111) OM Diagnosis: 

By pediatricians and pediatric nurse practitioners based on pneumatic otoscopy. 60% time tympanometry was used to corroborate the OME diagnosis. 

OM Groups: Based on total 

OME duration in days during first 3 years of life. 

Group 1: Days with total OME between 0–87 days. Group 2: Days with total OME between 88–181 days. Group 3: Days with total OME over 181 days. N=61 subjects up to 6 years N1=20 N2=20 N3=21 N=44 subjects up to 8 years N1=15 N2=14 N3=15 

Time: 9/1972–12/1984 (followup from birth to third year of 

school) Place: Frank Porter Graham 

Child Development Center, U of North Carolina at Chapel Hill, NC 

Characteristics of 61 subjects

• African American • 57% boys • Average of 10.5 years of 

education of mother 

• Mother’s mean IQ score 

was 84. 

• Hearing was within normal 

limits at time of testing 

Inclusion: 

• Age: 3.5–6 years of age at 

followup 

• participant in longitudinal 

on-site research day-care program 

• attended the Frank Porter 

Graham Child Development Center, 5 full days/wk, 50 wks/yr through 5 yrs of age 

• identified at birth as 

biologically normal 

• Classified as at risk for 

poor school performance 

Exclusion: 

• incomplete data 

Age: 

OM history: 2 months–3 years; Outcome: at 3.5–8 years of age 

Examiner(s): 

Pediatricians and pediatric nurse practitioners for clinical history 

Psychologists for measurements of child development. OM History: 

Duration of each episode of unilateral and bilateral was calculated by subtracting the date of onset of OME from the resolution date. Days of total 

Outcome measures: 

Cognitive capacity: • Stanford-Binet Intelligence Scale • McCarthy Scale of Children’s Abilities 

(McCarthy) 

• Wechsler Preschool and Primary Scale of 

Intelligence (WPPSI) 

• Wechsler Intelligence Scale for ChildrenRevised (WISC-R) verbal scale • Classroom Behavior Inventory (CBI) verbal 

intelligence 

Academic achievement: • Peabody Individualized Achievement Test 

(PIAT) 

• Woodcock-Johnson Psychoeducational Battery 

(WJPB) 

Age 3

McCa

CognVerbaStanfIntelli

Age 4

McCa

CognVerbaAge 5 WPPIntelli

Full-sVerbaPerfoAge 8 

 

 IntelliWISCCBI 
200 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

4806 Roberts 1988 3118 Roberts 1988 Same study subjects as in 4657/ 4656, 3117, and 4319. See 4657/ 4656, 3117, and 4319 for further comments 

Prospective Cohort Study Study Quality Score (0–8): 

4 (10100101) OM Diagnosis: 

By pediatricians and pediatric nurse practitioners based on pneumatic otoscopy. 60% time tympanometry was used to corroborate the OME diagnosis. 

OM Groups Based on total OME 

duration in days during first 3 years of life. Duration of each episode of unilateral and bilateral was calculated by subtracting the date of onset of OME from the resolution date. 

Group 1: lower third–OME days (8–143 days) Group 2: middle third–OME days (144–269 days) Group 3: upper third–OME days (314–931 days) N=55 children tested for speech at different ages. 12 tested once; 7 tested 2 times; 19 tested 3 times; 6 tested 4 times and 11 tested 5 times. N=34 in the language study 

Time: 1975–1986 study period 

(8 yr follow-up reported); speech and language measured between 1982–1986 Place: Frank Porter Graham 

Child Development Center, Un. of North Carolina at Chapel Hill, NC 

Characteristics: • 93% black, 7% white • 67% boys • All passed hearing screen 

and had type A or C tympanogram. 

Inclusion: 

• Age: 8 years (followed 

from <3 months) 

• Attended Frank Porter 

Graham Child Development Center for 5 days/wk, 50 wks/yr until entry into kindergarten 

• Socioeconomically 

disadvantaged 

• identified at birth as 

biologically normal 

• Classified as at risk for 

poor school performance 

• Tested for speech and 

language between 1982–1986 

Exclusion: None 

Age: 

OM history: 2 months–3 years; Outcome: at 2.5–8 years of age 

Examiner(s): 

Pediatricians and pediatric nurse practitioners for clinical history. 

Psychologists for measurements of child development. Master’s level speech-language pathologists and graduate research assistants collected speech data. OM History: 

Days of total OME was analyzed both as a continuous and categorical variable. 

Outcome measures: 

Speech • Goldman-Fristoe Test of Articulation to which 6 

additional words were added. 

Transcription and Phonology • CER – total number of consonants in error • TPP – total number of phonological processes Language – 15-minute elicited conversational speech sample of language play situation. • Number of words per communication unit (cu) • Dependent clauses per cu • Ratio of total different words to total cu • Ratio of total different conjunction words 

(excluding ‘and’ to total cu 

• Number of utterances per turn. 

Speabetwetotal OAge(y

3 4 5 6 7 8 Speabetwedays MeasWordDepeClausDifferWordDifferConjuDifferPronoRegrewith mnumbUnilaprediOMEnonsiOME
201 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

3117 Roberts 1991 Same study subjects as in 4657/ 4656, 4806/3118and 4319. See 4657/ 4656, 4806/ 3118, and 4319 for further comments. 

Prospective Cohort Study Study Quality Score (0–8): 

2 (00000101) OM Diagnosis: 

By pediatricians and pediatric nurse practitioners based on pneumatic otoscopy. 60% time tympanometry was used to corroborate the OME diagnosis. 

OM Groups: Based on total 

OME duration in days during first 3 years of life. Duration of each episode of unilateral and bilateral was calculated by subtracting the date of onset of OME from the resolution date. 

N=63 subjects Subjects were stratified into two groups SES status: Group 1: LSES (Children from families of lower socioeconomic status) Group 2: MSES (Children from families of middle socioeconomic status) N1=33 N2=30 

Time: Cohort of 8–12 children 

entered every 1–2 years between 1978 and 1985 Place: Attended the Frank 

Proter Graham Child Development Center (FPG), a research day-care center, University of North Carolina at Chapel Hill 

Characteristics:  LSES MSES

male 64% 50% black 88% 33% single mom 82% 3% 

• all passed hearing screen, 

had type A or C tympanogram, and did not have OME 

Inclusion: 

• Age: 6 years (follow-up 

from birth) 

• attended the Frank Porter 

Graham Child Development Center 

• identified at birth as 

biologically normal 

• Classified as at risk for 

poor school performance 

Exclusion: None 

Age: 

OM history: 2 months–3 years; Outcome: at 4.5–6 years of age 

Examiner(s): 

Pediatricians and pediatric nurse practitioners for clinical history. 

Psychologists for measurements of child development. Master’s level speech-language pathologists and research assistants for speech data. OM History: 

Days of total OME was analyzed both as a continuous and categorical variable. 

Outcome measures: Language tests 

Age 4–5 years

• Miller-Yoder Language Comprehension Test 

(M-Y) 

• Bankson Language Screening Test (Bankson) • Clinical Evaluation of Language Functions 

(CELF) 

• Peabody Picture Vocabulary Test-Revised 

(PPVT-R) 

At Age 5, 15-minute elicited sample of language play 

situation 

• Words/communication unit (cu) • Dependent clauses per cu • Ratio: total different words to total cu • Ratio: total different conjunction words 

(excluding ‘and’) to total cu 

• Ratio: different pronouns to total cu • Number of utterances per turn. 

Spealangufirst 3 Meas

StandBankM-Y PPVTCELF CELF LangWordDepeClausDifferWordDifferConjuDifferProno
202 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

4319 Roberts 1995 This is a continuation of study by Roberts. 4657 4656 Same study subjects as in 4657/ 4656, 4806/ 3118 and 3117 See 4657/ 4656, 4806/ 3118, and 3117 for further comments. 

Prospective Cohort Study Study Quality Score (0–8): 

3 (00000111) OM Diagnosis: 

By pediatricians and pediatric nurse practitioners based on pneumatic otoscopy. 60% time tympanometry was used to corroborate the OME diagnosis. 

OM Groups: Based on total 

OME duration in days during first 3 years of life. 

Group: African American children enrolled as infants in research child-care program (follow-up to 12 years of age) N=56 of 61 subjects reported in 4657 and 4656. 

Time: Cohort assembled 

9/1972–12/1984, follow-up from birth to 12 years of age) Place: Frank Porter Graham 

Child Development Center, U of North Carolina at Chapel Hill, NC 

Characteristics of 61 subjects: 

• African American • 57% boys • Average of 10.5 years of 

education of mother 

• Mother’s mean IQ score 

was 84. 

• Hearing was within normal 

limits at time of testing 

Inclusion: 

• Age: 12 years of age at 

followup 

• participant in longitudinal 

on-site research day-care program 

• attended the Frank Porter 

Graham Child Development Center, 5 full days/wk, 50 wks/yr through 5 yrs of age 

• identified at birth as 

biologically normal 

• Classified as at risk for 

poor school performance 

Exclusion: 

• incomplete data 

Age: 

OM history: 2 months–3 years; Outcome: at 12 years of age 

Examiner(s): 

Pediatricians and pediatric nurse practitioners for clinical history 

Psychologists for measurements of child development. OM History: 

Duration of each episode of unilateral and bilateral was calculated by subtracting the date of onset of OME from the resolution date. 

Summary measures: • No. OME – total number of OME episodes • ML/OME – mean length in number of days of 

the OME episodes 

• Duration OME – number of days with either 

bilateral or unilateral OME. 

Outcome measures: 

Cognitive capacity: • Wechsler Intelligence Scale for ChildrenRevised (WISC-R) 

• Full-scale IQ • verbal IQ • performance IQ • Freedom from Distractibility Factor 

Academic performance: • Woodcock-Johnson Psychoeducational Battery Behavior • Child Behavior Checklist 

Correoutcoyears At Ag

Meas

Intelli Full  Verb PerfWherand RcoeffienviroThe mbetweML/OFull-Snot siwere 
203 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

2295 Ruben 1997 Same study cohort as 1373, 1941, and 4728 by Gravel See 1373, 1941, and 4728 for further comments. 

Prospective Cohort Study Study Quality Score (0–8): 

5 (11001110) OM Diagnosis: 

Pediatric nurse practitioners completed pneumo-otoscopic examinations. 

OM Groups: 

Group 1: Otitis positive children – when bilateral OM was detected at 30% or more of the baby’s first year visits. 

Group 2: Otitis negative children – when middle ear status was rated as normal in both ears during 80% or more of the first year visits. N=30 subjects N1=18 N2=12 

Time: not specified 

Place: Clinical Research Center 

for Communicative Disorders (which draws subjects from the LIFE Program of the R.F. Kennedy Center, Albert Einstein College of Med. Bronx, NY 

Characteristics: • low socioeconomic urban 

neighborhoods based on Hollingshead’s (1975) index 

Inclusion: 

• Age: 9 years • born in the same urban 

hospital 

• auditory testing conducted 

during first year of life and at 9 years of age 

Exclusion: None 

Age: 

OM history: 0–1 of life Outcome: 2–9 years of age 

Examiner(s): 

Not specified 

OM history: 

OM groups were defined by otoscopic histories. Outcome measures: 

18 measures of communicative function was measured. Data were summarized by calculating the mean score for OM– group and then comparing the score of each child in the OM+ group with that of the mean for the OM– group. Each OM+ score that was >= the mean of the OM– group was counted and the percent of children in the OM+ group who had higher scores than the OM– was calculated for each measure. Differences between the groups were considered meaningful when less than 40% of the OM+ children in the group exceeded the score of the OM– group. 

Percethan tMeas

ExpreExpreExpreReceat 4 ySpeeadaptCompat 6 ySchoReca
204 

 Evidence Table 2. Early Life OM and Long-Term Speech and Language Development (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

2583 Teele 1990 Same cohort as 2579 

Prospective Cohort Study Study Quality Score (0–8): 

6 (10101111) OM Diagnosis: 

By physicians and nurse practitioners using a standard sealed pneumatic otoscope. 

To resolve ambiguous diagnoses, otoadmittance was used sporadically at 0–3 years of age, but frequently at 4–7 years. Group: Children followed prospectively from birth until age 7 years and whose cognitive and linguistic abilities were assessed at age 7 N=194 subjects 

Time: Enrollment of infants 

began 6/1975 (follow-up during first 7 yrs of life) Place: Subjects drawn from 

larger cohort of children enrolled at an urban health center in East Boston and a private practice in the Holliston/Framingham area of MA 

Characteristics: • 54% male • 57% high SES • 69% from private practice Inclusion: 

• Age: 7 years (followed 

from birth) 

• Caucasian Exclusion: 

• seizures • mental retardation • cerebral palsy • two languages spoken in 

home 

• non-white 

Age: 

OM history: 0–2 years Outcome: at 7 years of age 

Examiner(s): 

Physicians and nurse practitioners for clinical history. 

Experienced psychometricians for intelligence and achievement tests Certified speech clinicians administered speech and language tests. OM history: 

Used the number of days with MEE by age 3 years as a predictor variable. Unless documented to be shorter, each episode of MEE lasted 29 days. Outcome measures: 

Cognitive assessment • WISC-R Speech and language 

• Subsample of Goldman-Fristoe and GoldmanFristoe-Woodcock Tests • WUG test • Peabody Picture Vocabulary Test • Boston Naming Test • Complex sentences and set of pictures for story 

telling 

Academic achievement • Metropolitan Achievement Test 

Cognyears gend

 

 Full SVerbaPerfoLingufor SE

 

 Goldm Artic DiscWUG  Rec ExpMorpLexicSpee
205 

Evidence Table 3: Early Life OM and Long-Term Hearing [The eight components of study quality score are: study cohort clearly defined; subjects assembled at a uniform time point; pathway of subject entry clearup achieved; withdrawals/drop-outs described; objective outcomes used; outcome assessment blinded; and extraneous factors adjusted. 1 indicates pres

absence.] 

Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

147 Sorri 1995 

Prospective Cohort Study 

Study Quality Score (0–8): 

4 (01001101) 

OM diagnosis: 

By whom not specified; How not specified. 

OM Groups: 

Group 1: No otitis media until 7 years of age (NoOM) 

Group 2: Recurrent otitis media (>=4 episodes of OM until the age of two) (RAOM) Group 3: Secretory otitis media until the age of two (SOM) N=99 N1=35 N2=51 N3=13 

Time: Birth cohort 1985–1986 Place: Health care centers, 

hospital and private surgeries in Northern Finland 

Inclusion: 

• Age: Born in Northern 

Finland between 1985–1986 (examined through age 2 and at 7 years) 

• history of OM meticulously 

controlled up until the age of 2 yrs 

Exclusion: 

• middle ear effusion at time 

of audiometry at age 7 (14 excluded) 

• 6 children had meningitis, 

1 totally deaf child, 1 w/atresia of the ear canal, 5 lacked cooperation, 5 lacked information after age 2 years 

Age: 

OM history: 0–2 years of life Outcomes: At age 7 years 

Examiner(s): Not specified OM history: 

OM history groups defined by number of recurrent otitis media or serous otitis media. 

Outcomes: 

• Pure tone average, type not specified • Mean air-conduction (AC) thresholds 

NumdB (h

NoOM 

7/35 20% Pure 

NoOM 

3.82±Pure 

NoOM 

3.24±
206 

Evidence Table 3. Early Life OM and Long-Term Hearing (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1255 Fischler 1985 

Retrospective-prospective study 

Study Quality Score (0–8): 

5 (11001110) 

OM Diagnosis: 

By medical record review of documented physician’s clinical diagnosis. 

OM Groups: 

Group 1: HR/REC (HR-High risk status,REC-recurrences of OM attacks after age 2) ~ >=2 attacks by age 2 yr and >=3 attacks after age 2 yr 

Group 2: HR/NREC ~ >=2 attacks by age 2 yr and <3 attacks after age 2 yr Group 3: NHR/NREC ~ <2 attacks by age 2 yr and <3 attacks after age 2 yr N=167 N1=33 N2=63 N3=71 

Time: Start date~7/1974 Place: Four Indian reservations 

in Arizona 

Characteristics: 

• 50% had family income 

under $5000 per year 

• 37% had housing below 

average 

• 13% primarily Apache 

speaking at home 

Inclusion: 

• Age: 6–8 years • healthy Apache Indian 

children who had been followed since birth 

Exclusion: 

• moved during study period • absent or not tested 

because of time constraints 

• medical reasons (specific 

conditions not specified) 

Age: 

OM history: 0–2 years of life Outcomes: At 6–8 years 

Examiner(s): 

• Unspecified physicians for diagnosis of otitis 

media; 

• School nurse for hearing tests; • Pediatrician/otolaryngologist for otoscopic 

examinations; 

• Certified speech pathologists for language 

testing. 

OM history: 

Groups defined by number of OM episodes by age 2 

Outcomes: 

All children received a hearing screen using a recently calibrated pure tone audiometer (dB hearing level American National Standards Institute [ANSI] 1969). Children whose hearing was better than the following thresholds were considered normal: 25 dB at 500 Hz; 20 dB at 1,000 Hz; 20 dB at 2,000 Hz; 25 dB at 4,000 Hz; 25 dB at 6,000 Hz; Otherwise, abnormal or hearing loss. 

Numheari 

OM r

  
207 

 Evidence Table 3. Early Life OM and Long-Term Hearing (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1373 Gravel 1992 

Prospective Cohort Study 

Study Quality Score (0–8):5 (11001101) OM Diagnosis: 

Pediatric nurse practitioners completed pneumo-otoscopic examinations. 

OM Groups: 

Group 1: Otitis positive children – when bilateral OM was detected at 30% or more of the baby’s first year visits. (Also, had poorer auditory sensitivity by click ABR.) 

Group 2: Otitis negative children – when middle ear status was rated as normal in both ears during 80% or more of the first year visits. N=23 N1=10 N2=13 

Time: not specified Place: Clinical Research Center 

for Communicative Disorders (which draws subjects from the LIFE Program of the R.F. Kennedy Center, Albert Einstein College of Med. Bronx, NY 

Characteristics: 

• low socioeconomic urban 

neighborhoods based on Hollingshead’s (1975) index 

• none had sensorineural 

hearing loss 

Inclusion: 

• Age: 4 years (measures 

taken during first year of life as well) 

• all children were enrolled 

at 40 wks postconceptional age for follow-up through the LIFE Program 

• either high-risk infant 

graduates of a NICU or FT graduates of the well-baby nursery of Jacobi Hospital 

• English reported as the 

primary language spoken 

Exclusion: 

• neurologically 

compromised 

Age: 

OM history: 0–1 of life Outcome: at 4 years of age 

Examiner(s): Not specified OM history: 

OM groups were defined by otoscopic histories. 

Outcomes: 

Pediatric Speech Intelligibility (PSI) sentence (S) items/competing messages (CM) ratio Pure-tone averages – based on a conventional clinical staircase procedure (descending-ascending). Thresholds for each ear of all subjects were obtained at octave frequencies from 500 through 4000 Hz (at a minimum) (ANSI, 1969). 

PSI SMean

Pure-

Mean

Pure-

Mean
208 

 Evidence Table 3. Early Life OM and Long-Term Hearing (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1435 Harsten 1993 

Prospective Cohort Study 

Study Quality Score (0–8):6 (11101110) OM Diagnosis: 

AOM was diagnosed by otomicropscopy, performed by an otolaryngologist and defined as an acute episode of earache in a child, with red bulging eardrum(s) or purulent discharge, occasionally febrile and with signs of upper respiratory tract infection. 

OM Groups: 

Group 1: Children with recurrent AOM (RAOM defined as at least six episodes of AOM during a 12-month period) during the first 3 years of life 

Group 2: Children without any AOM episode during the first 3 years of life N= 42 N1=13 N2=29 

Time: not specified Place: University Hospital of 

Lund, Sweden 

Characteristics: 

• 45% first-borns • 71% mother educated at 

college level 

Inclusion: 

• Age: Birth cohort • monolingual, Swedish 

children, born at University Hospital of Lund 

Exclusion: None 

Age: 

OM history: 0–3 year of life Outcomes: at 4 and 7 year of age 

Examiner(s): 

Otolaryngologist for otomicroscopy, tympanometry, tone-audiograms 

Phoniatrician and clinical linguist for hearing and speech 

OM history: 

Groups defined by number of episodes of AOM during a 12-month period. 

Outcomes: 

Tone-audiometry: abnormal defined as >=25 dB threshold at any frequency. (Tone-audiograms were recorded at frequencies from 125 to 8000 Hz.) 

Tone

AbnoheariToneAbnoHeari
209 

 Evidence Table 3. Early Life OM and Long-Term Hearing (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

1623 Kaplan 1973 Same study subjects as 2233 which reported 3–5 year followup. This study reported 10-year follow-up. 

Prospective Cohort Study 

Study Quality Score (0–8):5 (11001110) OM Diagnosis: 

A research nurse visited the cohort children 4 times a year during first 2 years and at least 2 times a year for the next 2 years. During each visit, information concerning middle ear abnormality was obtained and medical records of the time between visits were reviewed. Only OM described with otorrhea was used for analysis. 

OM Groups: 

Group 1: age of onset of first otorrhea at 0–1 year of age 

Group 2: age of onset of first otorrhea at age 2–10 years Group 3: no history of otorrhea N=489 N1=291 N2=83 N3=115 

Time: Birth cohort (10/1960–

12/1962); follow-up conducted between 9/1969–7/1971 

Place: 28 Eskimo villages 

located in the Yukon and Kuskokwim River Delta areas of Southwestern Alaska 

Characteristics: 

Not described. 

Inclusion: 

• Age: Birth Cohort born 

between 10/1960–12/1962 and followed up between 9/1969–7/1971 

• born in 25 villages w/in 

Alaska specified under place and/or residing in 3 additional villages at follow-up 

Exclusion: 

• Children with pure sensory 

hearing loss were excluded from analysis 

Age: 

OM history: 0–1 year of life Outcome: at 10 years of age 

Examiner(s): 

Experienced audiologist for air and bone conduction measurements 

Two psychologists administered speech and intelligence testing 

OM history: 

Groups based on onset of first episode of otorrhea during 0–1 year; during 2–10 years or no history. 

Outcomes: 

Air and bone conduction measurements were made using a portable audiometer recently calibrated to the ISO 1964 standard. All children were tested at frequencies of 250, 500, 1000, 2000, 4000, and 8000 Hz to evaluate air conduction and at frequencies of 500, 1000, 2000, and 4000 Hz to evaluate bone conduction. • Normal hearing: 0 to –25 dB; • Normal hearing with a conductive component: 0 

to –25 dB with a 15 dB air-bone gap; 

• Hearing loss: –26 dB or greater. (Children with pure sensory hearing loss were excluded from analysis.) 

Hear

1st om 

Cond Heari
210 

 Evidence Table 3. Early Life OM and Long-Term Hearing (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

2233 Reed 1967 Same study population as 1623. This article reported findings at 3–5 years. Article 1623 reported findings at 10 years of age. 

Prospective Cohort Study 

Study Quality Score (0–8):4 (11000101) OM Diagnosis: 

A research nurse visited the cohort children 4 times a year during first 2 years and at least 2 times a year for the next 2 years. During each visit, information concerning middle ear abnormality was obtained and medical records of the time between visits were reviewed. Only OM described with otorrhea was used for analysis. 

OM Groups: 

Defined by frequency of otorrhea episodes during first 2 years of life. 

Group 1: None Group 2: <1 episode per year Group 3: 1 or more episode per year N=378 N1=198 N2=180 

Time: Two birth cohorts (born 

between 10/1960–12/1962); follow-up conducted between Sept.-Dec.,1965 

Place: Testing conducted in 

schoolhouses or in a community building in 24 of the original 27 Eskimo villages located in the Yukon and Kuskokwim River Delta areas of SW Alaska where the cohort was born 

Characteristics: 

Not described. 

Inclusion: 

• Age: Follow-up from birth 

to 4 years (0–47 months) 

• Born in one of 27 Eskimo 

villages between 10/1960–12/1962 and available for testing at follow-up 

• audiometric tests 

completed 

Exclusion: 

• Children with pure sensory 

hearing loss was excluded from analysis 

Age: 

OM history: first 2 years of life Outcome: at 3–5 years of age 

Examiners: 

Audiologist 

OM history: 

Groups defined by frequency of otorrhea episodes during first 2 years of life: none, <1 per year of risk, and 1+ per year of risk 

Outcomes: 

Air and bone conduction measurements were made using the Zenith ZA-100-T Diagnostic Portable Audiometer, calibrated to the ISO 1964 standards. Children were classified according to averages of pure tone air hearing thresholds at 500, 1000, and 2000 CPS: • normal: 0 to 25 dB • mild impairment: 26 to 40 dB • moderate to severe impairment: 41 to 70+ dB 

Mild of agOM h

none 

21/1415% 
211 

 Evidence Table 3. Early Life OM and Long-Term Hearing (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

2309 Ryding 1997 

Prospective Cohort Study 

Study Quality Score (0–8):5 (01100111) OM Diagnosis: 

AOM was diagnosed by otomicroscopy, performed by an otolaryngologist and defined as an acute episode of earache in a child, with red bulging eardrum(s) or purulent discharge, occasionally febrile and with signs of upper respiratory tract infection. 

OM Groups: 

Group 1: RAOM Children (>=6 episodes of purulent AOM during a 12-month period) 

Group 2: Healthy Children (no AOM and <6 other RTI episodes during the study period) N=33 N1=12 N2=21 

Time: Birth cohort (born 

between 11/1982–2/1984); 10 yr follow-up 

Place: University Hospital, Lund, 

Sweden 

Characteristics: 

• 45% first-borns • 71% mother educated at 

college level 

Inclusion: 

• 10 years old • member of this birth cohort 

Exclusion: 

• moved out of Lund 

Age: 

OM history: 0–3 years of life Outcome: at 10 years of age 

Examiner(s): 

Audiologist 

Instrument: 

tone audiometry GSI 16 audiometers 

OM history: 

Groups defined by number of recurrent AOM. Recurrent AOM was defined as >= 6 episodes of purulent AOM during a 12-month period. 

Outcomes: 

Children were tested using GSI 16 audiometers with TDH39 earphones calibrated according to ISO 389. Air conduction hearing levels for both ears were individually determined at the frequencies 1000, 1500, 2000, 3000, 4000, 6000, 8000, 500, 250 and 125 Hz, tested in that order. The test was conducted according to the ascending method. Pure tone average (PTA) values for frequencies 500, 1000 and 2000 Hz (PTA: 0.5-2) and 500, 1000, 2000 and 4000 Hz (PTA: 0.5-4) were calculated for each ear. 

Medi

PTA(PTA(MediPTA(PTA(
212 

 Evidence Table 3. Early Life OM and Long-Term Hearing (Continued) Record# Author Year 

Study Quality 

OME Definition 

Group(s) and Sample Size 

Time/Place 

Subject Characteristics 

Inclusion/Exclusion 

Criteria 

Risk Groups 

Predictors 

Outcome Measures 

2854 Zargi 1992 

Retrospective prospective cohort study 

Study Quality Score (0–6):2 (10000100) OME definition: 

Not specified 

Group 1: Experimental – Children treated for recurrent acute unilateral or bilateral suppurative otitis media at 0–2 years of age. Group 2: Control – Children who experienced <=1 episodes of OM in the first 2 years of life) N=62 N1=33 N2=29 

Time: not specified Place: University Department of 

Otorhinolaryngology and Head and Neck Surgery, Ljubljana, Slovenia 

Inclusion: 

• Age: 8–10 years • attended similar preschool, kindergarten, and 

elementary school programs 

• no evidence of mental 

retardation nor behavioral or emotional disorders 

Exclusion: None 

Age: Followup examination at 8–10 years of age Examiner(s): 

Otolaryngologist 

OM history: 

During first two years of life. 

Outcomes: 

At age 8–10 years pure-tone audiometry was performed. The criterion for normal hearing was based on the air-conduction threshold results, which had to be at or above the level of 10 dB. Isolated audiometric dips (notches) to 15 dB at not more than one high frequency (6kHz or 8kHz) were not considered to be sensorineural hearing loss. 

Heari

Sens Cond Both 
213 

Evidence Table 4: Diagnostic Methods [The six components of Study Quality Score are: appropriate reference standard; test and reference standard assessed independently of each other; blinsample included an appropriate spectrum as in clinical practice; reproducibility and interpretation of test results determined; and description of test metho

replication. 1 indicates presence and 0 indicates absence.] 

Record#AuthorYear 

Study Quality

Examiner(s)

Group(s) and Sample Size 

Time/Place/Affiliation

Inclusion/Exclusion Criteria

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints

Gold Standards (GS), Cutpoints 

759 Avery 1986 

Diagnostic study 

Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• pneumatic otoscopy: two 

validated otoscopists 

• acoustic reflectometry 

(Acoustic Otoscope [Endeco Medical]): not specified 

Study Cohort: Children with proven 

chronic OME treated surgically (2-year follow-up) 

N=451 subjects, 4147 observations 

Time: not specified Place: Not specified Affiliation: Otitis Media Study Center, 

Santa Rosa Med. Center & The Univ. of Texas Health Sciences Center, San Antonio, TX 

Inclusion: 

• proven chronic OME and 

treated surgically as part of an ongoing clinical trial 

• ears with intact tympanic 

membranes 

Exclusion: None Patient Characteristics: 

• age range 4–8 years old 

Comparisons: 

1. Acoustic reflectometry  Dx– : ≤ 3 dB  Dx+ : > 3 dB  Validated pneumatic otoscopy  GS– : fluid absent  GS+ : fluid present 

2. Acoustic reflectometry  Dx– : ≤ 4 dB  Dx+ : > 4 dB  Validated pneumatic otoscopy  GS– : fluid absent  GS+ : fluid present 3. Acoustic reflectometry  Dx– : ≤ 5 dB  Dx+ : > 5 dB  Validated pneumatic otoscopy  GS– : fluid absent  GS+ : fluid present 

Unit of Compa

sensitivspecificPPV NPV accuracprevale

Compa

sensitivspecificPPV NPV accuracprevale

Compa

sensitivspecificPPV NPV accuracprevale
214 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

766 Babonis 1991 

Diagnostic study 

Study Quality Score (0–6): 

5 (111011) 

Not defined 

Examiner(s): 

• tympanometry (MicroTymp 

[Welch Allen]) and acoustic reflectometry (model 501 [ENT Medical Devices]): one of the authors, specialty not specified 

• myringotomy: unspecified 

“surgeon” 

Study Cohort: Ears in children 

scheduled for elective myringotomy and PE tube placement 

N=120 potential subjects and 240 potential ears; 220 ears studied. 

Time: 12/1988–11/1989 Place: Not specified Affiliation: Department of Pediatrics, 

Madigan Army Medical Center, Tacoma, WA 

Inclusion: 

• scheduled for elective 

myringotomy and PE tube placement 

Exclusion: 

• poor patient cooperation • mechanical malfunction 

precluding hard-copy recordings 

• patient PE tubes • ears microtic, patient undergoing 

myringotomy and PE tube placement in only 1 ear, and chronic TM perforation 

Patient Characteristics: 

• mean age 37.8 months, median 

30 months, range 6 months to 10 years 9 months 

• male 139 ears 

Comparisons: 

1. Portable tympanometer  Dx– : 59–151 daPa  Dx+ : >151 daPa  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Portable tympanometer  Dx– : A, CI, Ch, As, pA  Dx+ : B  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Acoustic reflectometry  Dx– : ≤ 5 RU  Dx+ : > 5 RU  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit oComp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
215 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

784 Barnett 1998 

Diagnostic study 

Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (Race Car 

Model® [American 

Electromedics]): research assistant 

• acoustic reflectometry 

(EarCheck PRO® [MDI 

Instruments]): research assistant 

• myringotomy: not specified *The two models used to measure acoustic reflectometry gave identical results – only reporting the results for EarCheck PRO 

Study Cohort: Children enrolled in 

study who had a scheduled surgery for or were receiving placement of tympanostomy tubes that day 

N=193 subjects enrolled Visit1~N=150 subjects, 274 ears Visit2~N=155 subjects, 299 ears *150 children were examined at visit 1; surgery was performed on 155 children and 299 ears were examined at visit 2. 

Time: not specified Place: Children’s Hospital, Boston, MA Affiliation: as above Inclusion: 

• Age: 6 months–14 yrs • scheduling surgery for or 

receiving placement of tymp. tubes that day 

Exclusion: 

• craniofacial abnormality • tympanostomy tubes in place or 

having had them placed w/in past 6 months 

• fluid draining from ear 

Patient Characteristics: 

• mean age 4.07 years, range 

0.51–14.6 years 

• male 101 • Caucasian 102, Black 25, Asian 

3, other 25 

Comparisons: 

1. Professional tympanometry  Dx– : peak compliance > 0.1  Dx+ : peak compliance ≤ 0.1  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometry  Dx– : peak compliance > 0.2  Dx+ : peak compliance ≤ 0.2  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Acoustic reflectometry  Dx– : > 95 degr. (spec.grad. angle)  Dx+ : ≤ 95 degrees 

 Myringotomy (sedated)  GS– : Fluid absent  GS+ : Fluid present 

4. Acoustic reflectometry  Dx– : > 49 degrees (spec. grad.) 

 Dx+ : < 49 degrees  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit oComp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
216 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

810 Beery 1975 

Diagnostic study 

Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• tympanometry (GrasonStadler 1720): not specified • myringotomy: not specified 

Study Cohort: Children with history 

of recurrent AOM, or evidence otoscopically of persistent MEE, or both 

N=70 subjects, 129 ears 

Time: not specified Place: Not specified Affiliation: Dept. of Otolaryngology, 

Tufts Univ., MA 

Inclusion: 

• Age: 2–15 years • candidate for bilateral 

myringotomy and insertion of tubes on basis of children’s history with concurrent or recent middle ear disease 

Exclusion: None Patient Characteristics: 

• mean age 6.7 years, range 2–15 

years 

• male 43, female 27 

Comparisons: 

1. Professional tympanometrya

 Dx– : See notes section below  Dx+ : See notes section below; Class II  (at B220) if > 0.3mmh 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit oComp

sensispeciPPV NPV accurpreva

a DM - pos. cutpoint: For trace at B660 Hz: Class I if suscept. <0.4 mmho, Class III, Class IV; For trace at B220 Hz - Class II if susceptance <0.3 mm

DM - negative cutpoint: For trace at B660 Hz - Class I if susc. > or = 0.4 mmh; For trace at B220 Hz - Class II if susceptance ≥0.3 mmho. 
217 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

817 Ben-David 1981 

Diagnostic study 

Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• audiometry (Maico MA-24 and 

Beltone 15 CX): not specified 

• tympanometry (Amplaid 702 

and American 83): not specified 

• myringotomy: operating 

surgeon 

*Air-bone gap was used in this study as the tested diagnostic method. 

Study Cohort: Children who 

underwent tympanometric and audiometric evaluations as well as myringotomy 

N=157 subjects, 311 ears 

Time: not specified Place: Not specified Affiliation: Rothschild Univ. Hospital, 

Haifa, Israel 

Inclusion: 

• Age: 6 months–14 years • evidence of SOM, which failed to 

ease after conservative Tx with decongestants, antibiotics, and systemic steroids 

• candidate for myringotomy and 

tympanostomy-tube insertion 

Exclusion: None Patient Characteristics: 

• age range 6 months–14 years 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A and Type C  Dx+ : Type B  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Audiometry–air and bone conduction  thresholdsb

 Dx– : < 15 db air-bone gap  Dx+ : 15–40 db air-bone gap  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit oComp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a We assumed they considered Type B as positive for effusion and all other types negative although they never state this in the text. b The authors never officially define negative and positive cutoff points for the diagnostic method; we assumed that the cutoff points we have supplied 

their comments in the discussion section. 
218 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

886 Block 1998 

Diagnostic study 

Study Quality Score (0–6): 

6 (111111) 

Examiner(s): 

• tympanometry (American 

Electromedic RaceCar®): not 

specified 

• acoustic reflectometry 

(EarCheck PRO®): not 

specified 

• validated pneumatic otoscopy: 

validated experienced pediatric otoscopists 

Study Cohort: Children who 

participated in study to assess diagnostic accuracy of EarCheck PRO and tympanometry 

*(Three additional studies were reported in this article but none reported findings relevant to key question four.) N=528 subjects, 870 ears 

Time: not specified Place: Validation study recruited from 

four sites: Barstown, KY; Pittsburgh, PA; Scottsdale, AZ; Rochester,NY/ Long. Study ~ Weston Pediatrics, Weston, MA 

Affiliation: Kentucky Pediatric 

Research, Inc.; Children’s Hospital of Pittsburgh; Scottsdale Pediatric Center; Elmwood Pediatric Group (NY); Weston Pediatric Physicians; MDI Instruments, Inc. (MA); Capital Management Consulting, Inc. (MA) 

Inclusion: 

• Age: 6 months–18 yrs • Exclusion: 

Myringotomy tubes last 6 months 

• Perforated tympanic membrane • Cerumen that projected into 

>50% of the radius of the ear canal 

• Any serious or psychologic illness • Immunodeficiencies • craniofacial deformities and/or 

middle ear abnormalities 

Patient Characteristics: 

• Age: 6–11 months (N=27); 

5 years (N=261); 6–10 years (N=161); 11–18 years (N=79) 

• Male 51%, Female 49% 

Comparisons: 

1. Professional tympanometrya

 Dx– : See notes below. Peak-  compensated static acoustic  admittance 0.22–1.5 mmhos  Dx+ : See notes below. Peak  acoustic admittance <0.22  mmhos  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 

2. Acoustic reflectometry  Dx– : >70 degrees SG-AR 

 Dx+ : ≤ 69 degrees SG-AR 

 Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 

Unit oComp

sensispeciPPV NPV accurpreva

(Notethe arComp

sensispeciPPV NPV accurpreva

a DM – negative cutoff: equivalent ear canal volume 0.4–2.3 cc; tympanometric peak pressure +200 to –400 daPa; tympanometric Width <180 daPa; D

tympanometric peak; tympanometric Width >180. 
219 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

888 Bluestone 1973 

Diagnostic study Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• tympanometry (Madesen ZO70 Electroacoustic Impedance 

Bridge): not specified 

• audiometry (Maico portable 

audiometer): not specified 

Study Cohort: Children who were 

studied to determine the relative validity of air-conduction audiometry and tympanometry in predicting presence of middle ear effusion 

N=84 subjects Comparison 1:  52 subjects, 87 ears Comparison 2:  55 subjects, 91 ears 

Time: not specified 

Place: Not specified 

Affiliation: Cleft Palate Center and the 

Depts. Of Otolaryngology and Pediatrics, Univ. of Pittsburgh, PA; Children’s Hospital of Pittsburgh; Dept. of Otolaryngology, Tufts Univ. Boston City Hospital, MA 

Inclusion: 

• Age: 2 months–15 years • history of recurrent AOM, or 

evidence otoscopically of persistent MEE, or both (considered candidates for myringotomy and tympanostomy tube insertion) 

Exclusion: None 

Patient Characteristics: 

• mean age 5.3 years • male 64, female 20 

Comparisons: 

1. Professional tympanometrya

 Dx– : Patterns 1,2, and 3  Dx+ : Patterns 4 and 5  Myringotomy (sedated)  GS– : Effusion absent  GS+ : Effusion present 2. Audiometry – air conduction threshold  Dx– : Below 25 dB  Dx+ : $ 25 dB 

 Myringotomy (sedated)  GS– : Effusion absent  GS+ : Effusion present 

3. Audiometry – air and bone conduction 

thresholds Dx– : Not Defined Dx+ : Not Defined Myringotomy (sedated) GS– : Effusion absent GS+ : Effusion present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

Not d

a Pattern 1 = Normal Compliance, Normal Pressure; 2 = Nml comp, negative pressure; 3 = High comp, nml pressure; 4 = low comp, nml pressure; 5 = 

negative, positive, or indeterminate. 

b Could not be completed because negative and positive cut-points are not defined for Air-Bone Gap. 
220 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

889 Bluestone 1979 

Diagnostic study Study Quality Score (0–6): 

4 (110011) 

Examiner(s): 

• otoscopy: two 

otolaryngologists, two pediatricians 

• tympanometry and middle ear 

muscle reflex (Model Z073 [Madsen Electronics]): by or under the direction of an audiologist, classified independently by two audiologists 

• myringotomy: surgeon Study Cohort: Validity of diagnosing 

OME by otoscopy, tympanometry, and middle ear muscle reflex ~ gold standard: Myringotomy (referenced as Study 2 in article) 

*(an additional study was reported in this article but findings were not relevant to key question four) N=239 subjects, 425 ears 

Time: 

S2 ~ 9/1/1977–2/22/1978 Place: not specified 

Affiliation: Dept. of Otolaryngology, 

Children’s Hospital of Pittsburgh, PA 

Inclusion: 

• Age: 7 months–15 years • patients scheduled for bilateral 

myringotomy and insertion of tympanostomy tubes on basis of a history of recurrent acute and/or persistent OME 

Exclusion: None 

Patient Characteristics: 

As above 

Comparisons: 

1. Pneumatic otoscopy – examiner  Validation not specified  Dx– : OME absent (– cases)  Dx+ : OME present (+ and +/– cases)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometrya

 Dx– : Paradise classification variants  1–6, 9,15  Dx+ : Paradise classification variants  7,8,10–14  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Examiner type (Otolaryngologist)  Pneumatic otoscopy – unvalidated  examiner  Dx– : OME absent (– cases)  Dx+ : OME present (+ and +/– cases)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a Middle ear muscle reflex testing was also evaluated as a diag. method in this study, but wasn’t included in the list of diagnostic test choices. 
221 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

889 Bluestone 1979 

Continued

4. Examiner type (Pediatrician)  Pneumatic otoscopy – unvalidated  examiner  Dx– : OME absent (– cases)  Dx+ : OME present (+ and +/– cases)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 5. Examiner type (Pediatrician)  Pneumatic otoscopy – unvalidated  examiner  Dx– : OME absent (– cases)  Dx+ : OME present (+ and +/– cases)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present) 

ContiUnit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
222 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

989 Cantekin 1977 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (types 

described under each comparison): not specified 

• myringotomy: not specified Study Cohort: Children scheduled for bilateral myringotomy and insertion of tympanostomy tubes for recurrent acute otitis media history or persistent middle ear effusion by otoscopy 

N=68 subjects, 120 ears 

Time: not specified 

Place: Not specified 

Affiliation: Dept. of Otolaryngology, 

Children’s Hospital of Pittsburgh and the Univ. of Pittsburgh, PA 

Inclusion: 

• Age: 18 months–14 years • history of recurrent AOM or 

otoscopic evidence of persistent MEE, or both 

• scheduled for bilateral 

myringotomy and insertion of tympanostomy tubes for recurrent acute otitis media history or persistent middle ear effusion by otoscopy 

Exclusion: None 

Patient Characteristics: 

• median age 6.5 years • male 43, female 25 

Comparisons: 

1. Professional tympanometrya

 (Madsen Electro-Acoustic Impedance  Bridge, model ZO-70)  Dx– : air pressure > –100 mm 

 H2O; compliance <5.0 OR  (See notes.)  Dx+ : air press <–100 mm H2O; 

 compliance > 5 OR 

 (See notes.)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometryb

 (Grason-Stadler Otoadmittance meter,  model 1720)  Dx– : See notes below.  Dx+ : See notes below.  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Negative cutoff point (continued): air pressure <–100 mm H2O; compliance <5.0 Madsen units; gradient > 0.5 Madsen units. Positive Cut Point (con

mm H2O; compliance >5.0 Madsen units; gradient <0.5 Madsen units. 

b Negative cutoff: Class I curve with peak susceptance > or = .4mmho at 660 Hz; Class II curve with peak >.3 mmhos at 220 Hz. Postive cutoff: Class 

660 Hz; Class II curve, peak <.3mmho at 220 Hz; Class III and IV. 
223 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

990 Cantekin 1980 

Diagnostic study Study Quality Score (0–6): 

4 (110011) 

Examiner(s): 

• otoscopy: two 

otolaryngologists 

• tympanometry and middle ear 

muscle reflex (Model ZO73 [Madsen Electronics]): by or under the direction of an audiologist, independently classified by two investigators 

• myringotomy: surgeon Study Cohort: Children who 

underwent myringotomy ~ myringotomy findings were compared to OME diagnosis based on otoscopy, tympanometry and ME muscle reflex 

N=333 subjects, 599 ears 

Time: not specified 

Place: Not specified 

Affiliation: Dept. of Otolaryngology, 

Univ. of Pittsburgh School of Medicine, and Children’s Hospital of Pittsburgh, PA 

Inclusion: 

• Age: 7 months–15 years • patients scheduled for bilateral 

myringotomy and insertion of tympanostomy tubes 

• history of recurrent AOM, or 

otoscopic evidence of persistent OME, or both 

Exclusion: None 

Patient Characteristics: 

• median age 6 years • male 203, female 130 

Comparisons: 

1. Pneumatic otoscopya – unvalidated 

 examiner  Dx– : OME absent  Dx+ : OME present  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Pneumatic otoscopyb – unvalidated 

 examiner  Dx– : OME absent  Dx+ : OME present  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Quantitative tympanometryc

 Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

4. Quantitative tympanometryd

 Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a These are results for otolaryngologist A. b These results are for otolaryngologist B. c ME muscle reflex measured using ipsilateral stimulation and ambient pressure; Stimulus frequency = 1000. d ME muscle reflex measured using ipsilateral stimulation and tympanogram’s peak pressure; Stimulus frequency = 1000. 
224 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

990 Cantekin 1980 

Continued

5. Quantitative tympanometrya Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

6. Quantitative tympanometryb

 Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

7. Quantitative tympanometryc

 Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a ME muscle reflex measured using contralateral stimulation and ambient pressure; Stimulus frequency = 1000. b ME muscle reflex measured using contralateral stimulation and tympanogram’s peak pressure; Stimulus frequency = 1000. c ME muscle reflex measured using ipsilateral stimulation and ambient pressure; Stimulus frequency = 2000. 
225 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

990 Cantekin 1980 

Continued

8. Quantitative tympanometrya Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

9. Quantitative tympanometryb

 Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

10. Quantitative tympanometryc

 Dx– : ME muscle reflex threshold ≤105dB  Dx+ : Absence of ME muscle reflex  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a ME muscle reflex measured using ipsilateral stimulation and tympanogram’s peak pressure; Stimulus frequency = 2000. b ME muscle reflex measured using contralateral stimulation and ambient pressure; Stimulus frequency = 2000. c ME muscle reflex measured using contralateral stimulation and tympanogram’s peak pressure; Stimulus frequency = 2000. 
226 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1238 FiellauNikolajsen 1980 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (Madsen 

Impedance Meter, type ZO-73, testing tone 220Hz): the author 

• myringotomy: two otosurgeons *Same study population as record #1241 Study Cohort: Children whose 

ear(s) persistently showed abnormal screening-tympanometry over 6 months; myringotomic aspiration of any MEE was performed 

N=44 subjects (21 children bilateral, 23 unilateral), 88 ears 

Time: Intitial screening in Aug. 1978; 

operation (if needed) in Feb. 1979 Place: Subjects identified from 

tympanometric screening in a Danish provincial municipality 

Affiliation: ENT Dept. Hjoerring 

Hospital, Denmark 

Inclusion: 

• Age: 3 years at initial screening • one or both ears consistently 

showed abnormal screeningtympanometry in Aug., Sept., Nov. 1978 and Feb. 1979 

• living in municipality of Hjoerring, 

Denmark 

Exclusion: None 

Patient Characteristics: 

• mean age 47.2 months, range 

42–54 months 

• male 23, female 21 

Comparisons : 

1.1 Professional tympanometry  Dx– : Compliance value >.10 ccm  Dx+ : Compliance value ≤.10 ccm 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

1.2 Professional tympanometry  Dx– : Compliance value >.20 ccm  Dx+ : Compliance value ≤.20 ccm 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 1.3 Professional tympanometry  Dx– : Compliance value >.30 ccm  Dx+ : Compliance value ≤.30 ccm 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV Accurpreva

Comp

sensispeciPPV NPV 

Accurpreva

Conti

a Estimated from figure 3. 
227 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1238 FiellauNikolajsen 1980 

Continued 

2. Professional tympanometry  Dx– : Gradient > .05 ccm  Dx+ : Gradient ≤ .05 ccm  Myringotomy (sedated)  GS– : Fluid absent  GS+ : Fluid present 3. Professional tympanometry  Dx– : Gradient > .1 ccm  Dx+ : Gradient ≤ .1 ccm  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

ContiUnit o

Comp

sensispeciPPV NPV accurComp

sensispeciPPV NPV accurpreva

a These values were calculated from percentages that were provided in the text and thus their accuracy is uncertain. 
228 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1241 FiellauNikolajsen 1980 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (Madsen 

Impedance Meter, type ZO-73, testing tone 220Hz): the author 

• myringotomies: two 

otosurgeons 

* This is the same study as 1238. 

However, the data are presented slightly differently. 

Study Cohort: Children who 

showed abnormal tympanometry and underwent myringotomy. 

N=44 subjects, 88 ears 

Time: 8/1978–2/1979 (tested in 

August, 1978 – retests in September and November, 1978 and February,1979) Place: Danish urban municipality 

(Hjoerring munipality: pop. 37,500) 

Affiliation: Dept’s of Otolarygology and 

Audiology, Hjoerring Hospital, Hjoerring, Denmark 

Inclusion: 

• Age: 3 years at study entry (42–

54 months by Feb. 1979) 

• abnormal tympanometric results 

persisting through 6 months 

Exclusion: None 

Patient Characteristics: 

• mean age 47.2 months, range 

42–54 months 

• male 23, female 21 

Comparisons: 

1. Professional tympanometry  Dx– : Type A and C1 tympanogram  Dx+ : Type B and C2 tympanograms  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

a Numbers were calculated from percentages and total “n’s” presented in Table V. 
229 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1245 FiellauNikolajsen 1983 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (Madsen 

tympanometer, model ZO-73, [Madsen Electronics], 220 Hz testing tone): not specified 

• myringotomy: ENT surgeon *This is the same study as 1238. However, the data are presented slightly different. Study Cohort: Children who 

underwent Myringotomy due to persistent abnormal tympanograms across four screens 

*(Grp 1 was derived from an overall sample of 404 subjects) N=44 subjects, 88 ears 

Time: 1978–1979 (four screens: Aug., 

Sep. & Nov., 1978, Feb. 1979) Place: Subjects identified in 

municipality of Hjoerring, Denmark, (medium-size urban town with a population of approximately 20,000) 

Affiliation: ENT Dept., Hjoerring 

Hospital, Denmark 

Inclusion: 

• Age: 3 years (36–48 months) • living in municipality of Hjoerring, 

Denmark 

Exclusion: None 

Patient Characteristics: 

• age range 36–48 months 

Comparisons: 

1. Professional tympanometry  Dx– : Middle ear pressure >–100 mm  H2O or non-flat curve  Dx+ : Middle ear pressure ≤–100 mm 

 H2O or flat curve  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometry  Dx– : Middle ear pressure >–200 mm  H2O or non-flat curve  Dx+ : Middle ear pressure ≤–200 mm 

 H2O or flat curve  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Professional tympanometry  Dx– : Non-flat curve  Dx+ : Flat curve  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
230 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1250 Finitzo 1992 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (Maico 

Screening Immittance Bridge, model No. 610): certified audiologist 

• pneumatic otoscopy: pediatric 

otolaryngologist 

• myringotomy: not specified *No information regarding when tympanometry occurred relative to myringotomy is provided in the methods section. Study Cohort: Children who were to 

undergo myringotomy for the placement of ventilation tubes for recurrent OM or persistent OME 

N=88 subjects, 163 ears 

Time: not specified 

Place: Children’s Medical Center in 

Dallas, Texas 

Affiliation: Methodist Medical Center, 

Dallas, TX; Callier Center for Communication Disorders and Dept. of Otolaryngology, Univ. of Texas, Dallas, TX 

Inclusion: 

• Age: 6 months–9 years • undergoing myringotomy for tube 

placement to treat recurrent OM or persisitent OME 

Exclusion: None 

Patient Characteristics: 

• mean age 31 months • male 59, female 27 

Comparisons: 

1. Pneumatic otoscopya – unvalidated 

 examiner  Dx– : effusion absent  Dx+ : effusion present  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometrya

 Dx– : Type A or A’ tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Of the 94 ears included the majority underwent myringotomy for recurrent AOM rather than OME; results are not stratified according to rationale fo

children, only 16 had persistent OME; the rest had recurrent OM. 
231 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1280 Freyss 1980 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (Madsen ZO 73 

impedance bridge): not specified 

• myringotomy: same 

investigator for all children 

Study Cohort: Children undergoing 

bilateral myringtomy for recurrent otitis media or respiratory tract infection 

N=50 subjects, 99 ears 

Time: not specified 

Place: Not specified 

Affiliation: Univ. of Paris VII, Dept. of 

Oto-laryngology, Hospital Lariboisiere; Dept. of Oto-laryngology, Children’s Hosptial Bretonneau, Paris, France 

Inclusion: 

• Age: 6 months–8 years • undergoing bilateral myringtomy 

for recurrent otitis media or respiratory tract infection 

Exclusion: None 

Patient Characteristics: 

• age range 6 months–8 years 

Comparisons: 

1. Quantitative tympanometry  Dx– : ≤115 dB (at 1000Hz) 

 Dx+ : > 115 dB (at 1000Hz)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Quantitative tympanometry  Dx– : < 2 STAR (suprathreshold  acoustic reflex) (Madsen units)  Dx+ : ≥2 STAR (Madsen units)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Quantitative tympanometry  Dx– : ≤-100 mmH2O Peak Pressure 

 Dx+ : >-100 mmH2O  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
232 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1280 Freyss 1980 

Continued

4. Quantitative tympanometry 

Dx– : ≤ 4 Madsen units Maximum 

 Compliance Dx+ : > 4 Madsen Units Maximum  Compliance  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

5. Quantitative tympanometry  Dx– : <1 Madsen Unit Tympanometric  Gradient  Dx+ : ≥1 Madsen Unit Tympanometric  Gradient  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

ContiUnit o

Comp

sensispeciPPV NPV accurpreva

CompsensispeciPPV NPV accurpreva
233 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1282 Fria 1980 

Diagnostic study Study Quality Score (0–6): 

3 (100101) 

Examiner(s): 

• tympanometry (GrasonStadler, model 1722, 1000Hz 

at 102 dB SPL): not specified 

• myringotomy: not specified Study Cohort: OME ~ Children with 

history of recurrent AOM or otoscopic evidence of persistent OME, or both 

*(N=40 otoscopically normal children were reported in this article but findings were not relevant to key question four) N=172 subjects, 344 ears 

Time: not specified 

Place: Normal children were from the 

ambulatory care center. 

Affiliation: Dept. of Otolaryngology, 

Univ. of Pittsburgh School of Medicine; Audiology Division, Dept. of Otolaryngology, Children’s Hospital of Pittsburgh, Pittsburgh, PA 

Inclusion: 

• Age: 3–15 years • history of recurrent AOM or 

otoscopic evidence of persistent OME, or both 

Exclusion: None 

Patient Characteristics: 

• Grp 1 mean age 8 years, range 

3–15 years, Grp 2 mean age 4 years, range 7 months–13 years 

Comparisons:

a

1. Portable tympanometer  Dx– : Middle Ear Analyzer Regions  1,2, and 3  Dx+ : MEA region 4  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Portable tympanometer  Dx– : acoustic reflex present  Dx+ : acoustic reflex absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Portable tympanometer  Dx– : Pressure Peak Present  Dx+ : Pressure Peak Absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Combines children undergoing myringotomy for recurrent AOM and persistent OME. Groups are not separated in the analyses. 
234 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

4879 Fried 1985 

Diagnostic Study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• pneumatic otoscopy: three 

surgeons 

• acoustic reflectometry 

(Acoustic Otoscope): not specified 

Study Cohort: Children undergoing 

bilateral myringotomy and ventilation tube insertion 

N=59 subjects, 118 ears 

Time: not specified 

Place: Not specified 

Affiliation: Joint Center for 

Otolaryngology, Harvard Medical School, Boston, MA 

Inclusion: 

• Age: 1–13 years • undergoing bilateral myringotomy 

and ventilation tube insertion 

Exclusion: None 

Patient Characteristics: 

• age range 1–13 years 

Comparisons: 

1. Acoustic reflectometry  Dx– : ≤ 4 Reflectivity Units  Dx+ : > 4 Reflectivity Units  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

outcosensispeciPPV NPV accurpreva

a The results table includes 102 ears. However, this study was of 118 ears. The authors do not discuss why the other 16 ears were excluded from the re

article). 
235 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

4878 Gersdorff 1986 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (GrasonStadler 1723 oto-admittance 

meter, 220Hz tone): not specified 

• myringotomy: ENT surgeon Study Cohort: Pathological children 

with serous and secretory otitis media who underwent myringotomy and ventilating tube insertion (50% of these children received denitrogenization before induction of classic inhalation anesthesia) 

*(A control group was studied; however, findings were not relevant to key question four.) N=64 subjects, 128 ears 

Time: not specified 

Place: Not specified 

Affiliation: Dept. of 

Otorhinolaryngology, Dept. of Anesthesiology, University of Louvain, Belgium 

Inclusion: 

• classified as pathological due to 

presence of serous and secretory OM upon clinical examination 

Exclusion: None 

Patient Characteristics: 

• combined mean age 7.5 years 

Comparisons:

a

1. Professional tympanometry  Dx– : Type I tympanogram  Dx+ : Type IV tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometry  Dx– : Typanogram types I, II, III, & V  Dx+ : Typanogram type IV  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Professional tympanometry  Dx– : Tympanogram Type I  Dx+ : Tympanogram types II,III,IV,&V  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a These data are for tympanograms performed before induction of anesthesia only. Tympanogram classifications: Type I~normal; Type II~endotympa

III~endotympanic depression and tympanometric curve rounded by weaker compliance; Type IV~flattened curve; Type V~normal endotympanic pres

tympanometric curve. 
236 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1384 Grimaldi 1976 

Diagnostic study Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• audiometry (Peters AP 5 

audiometer): OME audiologist 

• tympanometry (Peters AP 61 

impedance meter): one audiologist 

• binocular microtympanoscopy: not specified • myringotomy: single surgeon • visual inspection: effusion 

probably or possible = OME 

*Although tympanometry and airconduction audiometry were also assessed in this study, the data cannot be used because they were combined into a diagnostic algorithm rather than being evaluated as individual methods. Study Cohort: Children referred by 

otologists for presumptive middle ear effusions 

N=120 subjects, 209 ears 

Time: 9-month period (actual dates not 

specified) Place: Patients from ENT Dept. of 

King’s College Hospital and referred by otologists based on data from a routine outpatient clinic 

Affiliation: Not specified apart from 

author being from London 

Inclusion: 

• referred by otologists for 

presumptive middle ear effusions 

Exclusion: 

• inadequate audiometric data Patient Characteristics: 

• age not specified, other than 

being children 

Comparisons: 

1. Non-pneumatic otoscopya

Dx– : Effusion absent (includes n=47 

 undecided cases)  Dx+ : Effusion present  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Non-pneumatic otoscopyb

 Dx– : Effusion absent  Dx+ : Effusion present (includes n=47  undecided cases)  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Binocular micro-tympanoscopyc

Dx– : no effusion visualized, undecided 

 group  Dx+ : effusion visualized  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a There were 47 cases where the examiner was undecided; these have been counted as effusion absent (test negative). b There were 47 cases where the examiner was undecided; these have been counted as effusion present (test positive). c This result includes the “undecided” group as normal. 
237 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1384 Grimaldi 1976 

Continued

4. Binocular micro-tympanoscopya

 Dx– : no effusion visualized  Dx+ : effusion visualized; undecided group  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

5. Binocular micro-tympanoscopyb

 Dx– : No effusion visualized  Dx+ : Effusion visualized  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a The results table includes the “undecided” group as abnormal. b There were 47 ears that were not classified as “yes” or “no” pre-operatively; rather they were labeled “undecided.” These 47 are not included in the r
238 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1397 Haapaniemi 1997 

Diagnostic study Study Quality Score (0–6): 

2 (100100) 

Examiner(s): 

• pure-tone audiometry 

(Madsen TBN 80 audiometer [Madsen Electronics]): not specified 

• tympanometry and stapedius 

reflexes (GSI 28 tympanometer [GrasonStadler], 226 Hz tone): not specified 

• otomicroscopy: not specified • paracentesis: not specified Study Cohort: 1st and 4th grade 

children who underwent a routine ENT investigation at school that included: otomicroscopy, pure-tone audiometry, tympanometry and stapedius reflex measurements 

* (8th grade children were also 

studied but their age range was above that specified for key question four) 

N=426 subjects, 850 ears 

Time: not specified 

Place: Elementary schools of Salo, a 

small town in Finland 

Affiliation: Dept. Otolaryngology, Univ. 

Central Hospital of Turku, Finland 

Inclusion: 

• Age represented by grade level: 

First, fourth and eighth grade 

• attending an elementary school in 

Salo, Finland 

Exclusion: None 

Patient Characteristics: 

• 1st grade mean age 7.0 years, 

range 6–9 years; 4th grade mean age 10.2 years, range 10–12 years 

Comparisons: 

1. Professional tympanometry  Dx– : Tympanometric peak  pressure (TPP) ≥ –100 daPa  Dx+ : TPP < –100 daPa  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometry  Dx– : Tympanometric peak pressure  (TPP) ≥ –100 daPa  Dx+: TPP < –100 daPa  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 3. Professional tympanometry  Dx– : Tympanometric peak pressure  (TPP) ≥ –150 daPa 

 Dx+ : TPP < –150 daPa  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Valuetable Unit o

Comp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaConti
239 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1397 Haapaniemi 1997 

Continued

4. Professional tympanometry  Dx– : Tympanometric peak pressure  TPP≥ –150 daPa 

 Dx+ : TPP < –150 daPa  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

5. Professional tympanometry  Dx– : Tympanometric peak pressure  TPP ≥ –200 daPa 

 Dx+ : TPP < –200 daPa  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

6. Professional tympanometry  Dx– : Tympanometric peak pressure  TPP ≥ –200 daPa 

 Dx+: TPP < –200 daPa  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

7. Professional tympanometry  Dx– : non-Type B tympanogram  Dx+ : Type B tympanogram  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Comp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaConti
240 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1397 Haapaniemi 1997 

Continued

8. Professional tympanometry  Dx– : non-Type B tympanogram  Dx+ : Type B tympanogram  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 9. Professional tympanometrya

 Dx– : Cutoff of 0.3 ml is given for  admittance (see notes below)  Dx+ : Cutoff of 0.3 ml is given for  admittance (see notes below)  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

10. Professional tympanometrya

 Dx– : Cutoff of 0.3 ml is given for  admittance (see notes below)  Dx+ : Cutoff of 0.3 ml is given for  Admittance (see notes below)  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Comp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaConti

a For diagnostic cutoffs, an Admittance value of 0.3 ml was given as the cutpoint; however, not sure whether admittance < or = 0.3 ml would be a nega

values > 0.3. 
241 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1397 Haapaniemi 1997 

Continued

11. Professional tympanometrya

 Dx– : Relative gradient > 0.35  Dx+ : Relative gradient ≤ 0.35  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

12. Professional tympanometrya

 Dx– : Relative gradient > 0.35  Dx+ : Relative gradient ≤ 0.35  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

13. Professional tympanometry  Dx– : Ipsilateral Stapedius Reflex (at  1000Hz) at 105 dB – present  Dx+ : Ipsilateral Stapedius Reflex (at  1000Hz) at 105 dB – absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 14. Professional tympanometry  Dx– : Ipsilateral Stapedius Reflex (at  1000Hz) at 105 dB – present  Dx+ : Ipsilateral Stapedius Reflex (at  1000Hz) at 105 dB – absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Comp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaConti

a For diagnostic cutoffs, a Relative Gradient value of 0.35 was given as the cutpoint; however, not sure whether gradient > 0.35 would be a negative re

it is). 
242 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1397 Haapaniemi 1997 

Continued

15. Professional tympanometry  Dx– : Contralateral Stapedius Reflex  (at 1000 Hz) 110dB – present  Dx+ : Contralateral Stapedius Reflex  (at 1000Hz) at 110 dB – absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 16. Professional tympanometry  Dx– : Contralateral Stapedius Reflex  (at 1000 Hz) 110dB – present  Dx+ : Contralateral Stapedius Reflex  (at 1000Hz) at 110 dB – absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 17. Professional tympanometrya

 Dx– : Tympanogram Types A, C1,  and C2  Dx+ : Tympanogram Type B  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Comp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaConti

a These results examine sensitivity of type B tympanograms in detecting OME in children with either transient or prolonged effusion. Prolonged = ef

after myringotomy. Transient = ear healthy 4 weeks after myringotomy. 
243 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1397 Haapaniemi 1997 

Continued

18. Audiometry – air conduction threshold  Dx– : ≤ 15 hearing threshold at .25  to 8 kHz  Dx+ : > 15 dB hearing threshold (at  .25 to 8 kHz)  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 19. Audiometry – air conduction threshold  Dx– : ≤ 15 hearing threshold at .25 to  8 kHz  Dx+ : > 15 dB hearing threshold (at  .25 to 8 kHz)  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 20. Audiometry – air conduction threshold  Dx– : ≤ 20 dB hearing threshold (.25  to 8 kHz)  Dx+ : > 20 dB hearing threshold (.25  to 8 kHz)  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 21. Audiometry – air conduction threshold  Dx– : ≤ 20 dB hearing threshold (.25 to 8  kHz)  Dx+ : > 20 dB hearing threshold (.25 to 8  kHz)  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

ContiComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurpreva
244 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1446 Haughton 1977 

Diagnostic study Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• tympanometry (instrument not 

specified): not specified 

• tympanocentesis: one of 

several surgeons 

Study Cohort: S1~ Ears examined 

in children admitted for aspiration of the middle ear; Haughton study 

*(Two additional studies were reported in this article but none reported findings relevant to key question four) N=239 ears, 104 subjects 

Time: not specified 

Place: A typical ear, nose, and throat 

clinic 

Affiliation: S1~ Dept. of Otolaryngology 

and Head and Neck Surgery, Hull Royal Infirmary, Hull, Great Britain 

Inclusion: 

• Age: 3 years– >=12 years (max 

not specified) 

• admitted for aspiration of the 

middle ear 

Exclusion: None 

Patient Characteristics: 

• 1% 3 years 

 6% 4 years 14% 5 years 23% 6 years 10% 7 years 13% 8 years  8% 9 years 10% 10 years  5% 11 years 10% $ 12 years 

Comparisons: 

1. Professional tympanometry  Dx– : Compliance > .21 ml  Dx+ : Compliance ≤ .21 ml 

 Tympanocentesis (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present 

2. Professional tympanometry  Dx– : Compliance > .25 ml  Dx+ : Compliance ≤ .25 ml 

 Tympanocentesis (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present 

3. Professional tympanometry  Dx– : Compliance > .17 ml  Dx+ : Compliance ≤ .17 ml 

 Tympanocentesis (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present 

4. Professional tympanometry  Dx– : Gradient > .04 ml/50 mm H2O  Dx+ : Gradient ≤ .04 ml/ 50 mm H2O  Tympanocentesis (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
245 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1446 Haughton 1977 

Continued

5. Professional tympanometry  Dx– : Gradient > .03 ml/50 mm H2O  Dx+ : Gradient ≤ .03 ml/ 50 mm H2O  Tympanocentesis (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present 6. Professional tympanometry  Dx– : Gradient > .05 ml/50 mm H2O  Dx+ : Gradient ≤ .05 ml/ 50 mm H2O  Tympanocentesis (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present 7. Professional tympanometry  Dx– : Gradient > .1 ml/50 mm H2O  Dx+ : Gradient ≤ .1 ml/ 50 mm H2O  Tympanocentesis (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present 

ContiUnit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
246 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

3022 Johnson 1980 

Cross-sectional Study Quality Score (0–6): 

2 (110000) 

Examiner(s): 

• tympanometry (impedance 

bridge): audiologist 

• myringotomy: not specified *The primary aim of this study was to examine the changes in tympanogram types resulting from anesthesia. This is not a study focused on determining the sensitivity and/or specificity of tympanometry on detecting OME. Study Cohort: Children undergoing 

myringotomy with placement of ventillation tubes for recurrent AOM or persistent MEE 

N=61 subjects, 121 ears 

Time: not specified 

Place: Ear, Nose, and Throat Clinic at 

the University of Utah Medical Center, Salt Lake City, UT 

Affiliation: Div. of Otolaryngology, Univ. 

of Utah 

Inclusion: 

• Age: 8 months–10 years • recurrent AOM or persistent MEE Exclusion: 

• perforated tympanic membrane 

(one ear excluded) 

Patient Characteristics: 

• mean age 3.5 years • male 40, female 21 

Comparisons: 

1. Professional tympanometrya

 Dx– : Normal tympanogram  Dx+ : Flat tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

a Findings excludes 4 ears that were found to have purulent effusion which is consistent with AOM and not OME and 2 where Professional tympanom

According to Table 1 in the article those with Class 1 or 5 changes initially had normal (non-flat) tympanograms. 
247 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1600 Jonathan 1989 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• otoscopy (instrument not 

specified): not specified 

• tympanometry (instrument not 

specified): not specified 

• audiometry (instrument not 

specified): not specified 

• myringotomy: not specified *This study focused mainly on sonotubometry. Study Cohort: Children admitted for 

routine myringotomies (including in some cases adenoidectomy and/or tonsillectomy) 

*(a control group was studied however findings were not relevant to key question four) N=64 subjects, 126 ears 

Time: not specified 

Place: Grp 1 were operative 

admissions, and Grp 2 were from a general pediatric ward. 

Affiliation: St. George’s Hospital, 

Tooting, London 

Inclusion: 

• Age: 3–14 years • admitted for myringotomy Exclusion: 

• pre-existing perforations Patient Characteristics: 

• mean age 6.2 years, range 3–14 

years; Grp 2 mean age 7 years, range 3–14 years 

• male 35, female 29; 

Comparisons: 

1. Non-pneumatic otoscopya

 Dx– : normal appearance of the tympanic  membrane  Dx+ : abnormal appearance of the  tympanic membrane  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 2. Professional tympanometrya

 Dx– : Tympanogram has any form other  than a flat tracing  Dx+ : Tympanogram is flat  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Audiometry – air conduction threshold a 

Dx– : ≤ 15 dB hearing threshold at all 

 frequencies tested  Dx+ : > 15 dB hearing threshold at all  frequencies tested  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Data neccesary to complete the results table were not provided. 
248 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1632 Karma 1989 

Diagnostic study Study Quality Score (0–6): 

3 (100101) 

Examiner(s): 

• pneumatic otoscopy: 

otolaryngologist in Tampere or pediatrician in Oulu 

• myringotomy (only peformed 

when MEE suspected by pneumatic otoscopy): not specified 

*OME definition:MEE present without other symptoms/signs of acute infection. Grp 1: Children seen by otolaryngologist in Tampere, Finland Grp 2: Children seen by pediatrician in Oulu, Finland N=2911 subjects, 11804 visits N1=1688 subjects, 5949 visits N2=1223 subjects, 5855 visits 

Time: not specified 

Place: Outpatient Clinics of 

Otolaryngology at the Tampere or Pediatrics at the Oulu University Central Hospital, Finland 

Affiliation: Dept. of Clinical Sciences, 

Univ. of Tampere, Finland; National Public Health Institute, Helsinki, Finland 

Inclusion: 

• Age: 0.5–2.5 years • had any ear-related problem or 

suspicion of them and were brought to either the outpatient clinic in Tampere or Oulu 

Exclusion: 

• tympanostomy tubes in one or 

both ears at a visit 

• incomplete data Patient Characteristics: 

• Grp 1 age range 6–11 months 

37%, 12–17 m 41%, 18–23 m 18%, 24–29 m 4%, 30–31 m 0.1%; Grp 2 age range 6–11 m 36%, 12–17 m 38%, 18–23 m 20%, 24–29 m 6%, 30–31 m 0.2% 

Comparisons: 

1. Grp 1  Signs/symptoms  Dx– : TM color normal  Dx+ : TM haemorrhagic  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Grp 1  Signs/symptoms  Dx– : TM color normal  Dx+ : TM strongly red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Grp 1  Signs/symptoms  Dx– : TM color normal  Dx+ : TM moderately red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Unit o

(1–2 yComp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
249 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

4. Grp 1  Signs/symptoms  Dx– : TM color normal  Dx+ : TM slightly red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 5. Grp 1a

 Non-pneumatic otoscopy  Dx– : Tympanic membrane not red  Dx+ : Tympanic membrane red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 6. Grp 1a  Non-pneumatic otoscopy  Dx– : Not red  Dx+ : Distinctly red – hemorrhagic,  strongly or moderately red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

CompsensispeciPPV NPV accurprevaLR+: LR-: Comp

sensispeciPPV NPV accurprevaLR+: LR-: 

Conti

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
250 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

7. Grp 1a

 Non-pneumatic otoscopy  Dx– : TM not cloudy  Dx+ : TM cloudy  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 8. Grp 1a  Non-pneumatic otoscopy  Dx– : TM color normal  Dx+ : TM color abnormal  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 9. Grp 1a  Non-pneumatic otoscopy  Dx– : TM not bulging  Dx+ : TM bulging  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaLR+: LR–: 

Comp

sensispeciPPV NPV accurprevaLR+: LR–: 

Comp

sensispeciPPV NPV accurprevaLR+: LR–: 

Conti

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
251 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

10. Grp 1a

 Non-pneumatic otoscopy  Dx– : TM not retracted  Dx+ : TM retracted  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

11. Grp 1a 

 Non-pneumatic otoscopy  Dx– : TM position normal  Dx+ : TM position abnormal  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 12. Grp 1 

Pneumatic otoscopy – unvalidated examiner Dx– : TM mobility normal Dx+ : TM mobility abnormal Myringotomy (sedated) GS– : fluid absent GS+ : fluid present 

Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaConti

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
252 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

13. Grp 1a

 Pneumatic otoscopy – examiner validation  not specified  Dx– : TM with normal mobility  Dx+ : TM with impaired mobility  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

14. Grp 1  Pneumatic otoscopy – examiner validation  not specified  Dx– : TM with normal mobility  Dx+ : TM mobility distinctly impaired  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 15. Grp 1  Pneumatic otoscopy – examiner validation  not specified  Dx– : TM mobility normal  Dx+ : TM mobility slightly impaired  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: Conti

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
253 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

16. Grp 2  Signs/symptoms  Dx– : TM color normal  Dx+ : TM haemorrhagic  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 17. Grp 2  Signs/symptoms  Dx– : TM color normal  Dx+ : TM strongly red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 18. Grp 2  Signs/symptoms  Dx– : TM color normal  Dx+ : TM moderately red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
254 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

19. Grp 2  Signs/symptoms  Dx– : TM color normal  Dx+ : TM slightly red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 20. Grp 2  Non-pneumatic otoscopy  Dx– : TM color normal  Dx+ : Tympanic membrane red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 21. Grp 2a

 Non-pneumatic otoscopy  Dx– : TM color normal  Dx+ : TM distinctly red – hemorrhagic,  strongly or moderately red  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: Conti

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
255 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

22. Grp 2a

 Non-pneumatic otoscopy  Dx– : TM color normal  Dx+ : TM cloudy  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 23. Grp 2a  Non-pneumatic otoscopy  Dx– : TM color normal  Dx+ : TM color abnormal  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 24. Grp 2 a  Non-pneumatic otoscopy  Dx– : TM not bulging  Dx+ : TM bulging  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: Conti

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
256 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

25. Grp 2a

 Non-pneumatic otoscopy  Dx- : TM not retracted  Dx+ : TM retracted  Myringotomy (sedated)  GS- : fluid absent  GS+ : fluid present 

26. Grp 2a 

 Non-pneumatic otoscopy  Dx– : TM position normal  Dx+ : TM position abnormal  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 27. Grp 2  Pneumatic otoscopy – unvalidated  examiner  Dx– : TM mobility normal  Dx+ : TM mobility abnormal  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaConti

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
257 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1632 Karma 1989 

Continued

28. Grp 2a

 Pneumatic otoscopy – examiner validation  not specified  Dx– : TM mobility normal  Dx+ : TM mobility impaired  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

29. Grp 2a 

Pneumatic otoscopy – examiner validation 

 not specified  Dx– : TM mobility normal  Dx+ : TM mobility distinctly impaired  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

30. Grp 2a 

Pneumatic otoscopy – examiner validation 

 not specified  Dx– : TM mobility normal  Dx+ : TM mobility slightly impaired  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: CompsensispeciPPV NPV accurprevaLR+: LR–: 

a The raw numbers were calculated using a combination of information from tables 2, 3, and 5 in article. 
258 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1646 Kemaloglu 1999 

Diagnostic study Study Quality Score (0–6): 

3 (111000) 

Examiner(s): 

• otoscopy and pneumatic 

otoscopy: the first author 

• tympanometry (AZ7 

electroacoustic impedancemeter [Interacoustics]): not specified 

• acoustic reflectometry 

(acoustic otoscope [ENT Medical Devices]) 

• paracentesis: not specified *Potential problem – only children with OME underwent paracentesis which was how the condition was diagnosed. The children without OME (controls) were diagnosed clinically, i.e., they did not undergo paracentesis. Grp 1: Ears with serous otitis media Grp 2: Normal Ears (age matched children who were free of any ENT problem during 3 month follow-up) N=156 subjects, 300 ears N1=81 subjects, 150 ears N2=75 subjects, 150 ears 

Time: followed for 3 months (actual 

dates not specified) Place: Not specified 

Affiliation: Dept. of ENT, Faculty of 

Medicine, Gazi Univ., Ankara, Turkey 

Inclusion: 

• Grp 1~ears presented retracted 

TM in stage II or III with vascularization & dullness lasting for at least 3 months (effusion detected on paracentesis.) 

• Grp 2~free of any ENT problem 

during follow-up of 3 mos. 

Exclusion: 

• Grp 1~ears with tympanosclerosis 

or pseudomembrane of the TM and those with adhesive OM 

• Grp 1~subjects with recurrent 

otitis media who presented normal TM between intervals of AOM) 

Patient Characteristics: 

• Grp 1 mean age 6.17 years; Grp 

2 mean age 6.42 years 

Comparisons: 

1. Grps 1 & 2  Professional tympanometry  Dx– : A or C tracing on tympanogram  Dx+ : B tracing on tympanogram  Tympanocentesis (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

2. Grps 1 & 2  Acoustic reflectometry  Dx– : Reflectivity < 5  Dx+ : Reflectivity ≥ 5 

 Tympanocentesis (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

3. Grps 1 & 2  Acoustic reflectometry  Dx– : Curve angle > 75 degrees  Dx+ : Curve angle ≤ 75 degrees  Tympanocentesis (sedation unknown)  GS– : fluid absent  GS+ : fluid present 4. Grps 1 & 2  Acoustic reflectometry  Dx– : Curve angle > 90 degrees  Dx+ : Curve angle ≤ 90 degrees  Tympanocentesis (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
259 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1650 Kennedy 1982 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (Madsen Z76): 

audiologist 

• myringotomy: not specified Study Cohort: Myringotomy or 

myringtomy with tubes performed on 75 ears suspected of having OME 

N=75 ears * number of subjects not specified 

Time: not specified 

Place: Not specified 

Affiliation: Dept. of Otolaryngology, 

Geisinger Medical Clinic, Danville, PA 

Inclusion: 

• Ages: 9 months – 13 years • chronic or recurrent OME Exclusion: None 

Patient Characteristics: 

Not specified 

Comparisons: 

1. Professional tympanometry  Dx– : Normal tympanogram  Dx+ : Flat, rollover, or peaked negative  pressure tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometry  Dx– : Normal, rollover, or peaked, or  negative pressure tympanogram  Dx+: Flat, only  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
260 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1685 Koivunen 1997 

Diagnostic study Study Quality Score (0–6): 

3 (110001) 

Examiner(s): 

• tympanometry (MicroTymp 

[Welch Allyn]): a trained nurse 

• myringotomy: operating 

surgeon 

*Article does not state when the tympanogram was performed in relation to the myringotomy, thus it is not clear whether this study fits the criterion of the diagnostic test being performed ≤ 24hrs before 

myringotomy 

Study Cohort: Children referred for 

adenoidectomy, tympanostomy tube placement, or both procedures for recurrent otitis media or glue ear 

*(another group of children were studied but findings were not relevant to key question four) N=162 subjects, 314 ears 

Time: 

Grp 1~8/1992–1/1993; Grp 2~two time periods during 1994 and 1995 (months not specified) Place: Oulu, Finland 

Affiliation: Depts. of Otolaryngology 

and Pediatrics, University of Oulu, Finland 

Inclusion: 

• referred for adenoidectomy, 

tympanostomy tube placement, or both procedures in the Dept. of Otolaryngology, in two time periods during 1994–95 

Exclusion: 

• perforation or presence of 

tympanostomy tubes 

Patient Characteristics: 

• mean age 4.7 years, range 1 

month-16 years; Grp 2 median age 34 months, range 7 months–8 years 

• male 130, female 76 

Comparisons: 

1. Portable tympanometera

 Dx–: Type A and C tympanograms  Dx+:Type B tympanograms  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Portable tympanometerb

 Dx– : Type A and C tympanograms  Dx+:Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Portable tympanometerc

 Dx– : Type A and C tympanograms  Dx+:Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a These results are for the “cooperative” group. These are combined results for children undergoing myringotomy for recurrent AOM and OME; resul

variable. 

b These results are for the “uncooperative” group. These are combined results for children undergoing myringotomy for recurrent AOM and OME; re

variable. 

c These results are for the “cooperative” and “uncooperative” groups combined. Combined results for children undergoing myringotomy for recurrent 

stratified on this variable.
261 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1685 Koivunen 1997 

Continued

4. Age: <24 months  Portable tympanometera

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

5. Age: >=24 months 

 Portable tympanometera

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a These are combined results for children undergoing myringotomy for recurrent AOM & OME; results are not stratified on this variable. Raw numbe

results stratified by age. 
262 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1785 Lovette 1976 

Diagnostic study Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• tympanometry (Model 1720 

[Grason-Stadler]): nearly half by a third-year medical student 

• myringotomy: not specified Study Cohort: children involved in 

study to assess accuracy of detecting MEE by otoscopic tympanometric data alone 

* (another study was reported but findings were not relevant to key question four) N=21 subjects, 42 ears 

Time: not specified 

Place: 

Affiliation: Tufts Univ., School of 

Engineering, Boston, MA; Dept. of Otolaryngology, Children’s Hospital of Pittsburgh, PA 

Inclusion: 

• Age: Not specified • recurrent AOM or persistent MEE, 

or both 

• candidates for myringotomy and 

tympanostomy tube insertion 

Exclusion: None 

Patient Characteristics: 

Not Specified 

Comparisons: 

1. Portable tympanometera

 Dx– : Admittance ≥ 0.25 mmhos 

 Dx+ : Admittance < 0.25 mmhos  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

a This study combines children undergoing myringotomy for recurrent AOM and OME. The results are not stratified on this variable. 
263 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1804 Macknin 1987 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• acoustic reflectometry: 

pediatrician 

• myringotomy: one of the staff 

otologists 

* This study was done on children with recurrent otitis media; they do not state whether this means recurrent OME or AOM. Study Cohort: Children who 

underwent myringotomy and tympanostomy tube placement for recurrent OM and who had reflectometry performed 

N=100 subjects, 198 ears 

Time: not specified 

Place: Not specified 

Affiliation: Dept. of Pediatric and 

Adolescent Medicine and Dept. of Otolaryngology and Communicative Disorders, The Cleveland Clinic Foundation, Cleveland, OH 

Inclusion: 

• Age: 1–11 years (one 16 year old 

female) 

• underwent myringotomy and 

tympanostomy tube placement for recurrent OM and had reflectometry performed 

Exclusion: None 

Patient Characteristics: 

• mean age male 3.5 yrs and 

female 5.6 yrs, range 1–11 yrs except one 16 yr old 

• male 70, female 30 

Comparisons: 

1. Acoustic reflectometrya

 Dx– : Zero reflectivity units (RU)  Dx+ : ≥ 1RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Acoustic reflectometrya

 Dx– : Zero reflectivity units (RU)  Dx+ : ≥ 1 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Acoustic reflectometrya

 Dx– : < 2 reflectivity units (RU)  Dx+ : ≥ 2 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

4. Acoustic reflectometrya

 Dx– : < 2 reflectivity units (RU)  Dx+ : ≥ 2 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaConti

a The values in the results table were calculated using the sensitivity and specificity provided in Table 2 in article; total “ns” of right and left ears exam

respectively) and percentage of ears with fluid (67% and 62% respectively). 
264 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1804 Macknin 1987 

Continued

5. Acoustic reflectometrya

 Dx– : < 3 reflectivity units (RU)  Dx+ : ≥ 3 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

6. Acoustic reflectometrya

 Dx– : < 3 reflectivity units (RU)  Dx+ : ≥ 3 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

7. Acoustic reflectometrya

 Dx– : < 4 reflectivity units (RU)  Dx+ : ≥ 4 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Unit o

Comp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaComp

Unit o

sensispeciPPV NPV accurprevaConti

a The values in the results table were calculated using the sensitivity and specificity provided in Table 2 in article; total “ns” of right and left ears exam

respectively) and percentage of ears with fluid (67% and 62% respectively). 
265 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1804 Macknin 1987 

Continued

8. Acoustic reflectometrya

 Dx– : < 4 reflectivity units (RU)  Dx+ : ≥ 4 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

9. Acoustic reflectometrya

 Dx– : < 5 reflectivity units (RU)  Dx+ : ≥ 5 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

10. Acoustic reflectometrya

 Dx– : < 5 reflectivity units (RU)  Dx+ : ≥ 5 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

11. Acoustic reflectometrya

 Dx– : < 6 reflectivity units (RU)  Dx+ : ≥ 6 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Comp

Unit o

sensispeciPPV NPV accurprevaUnit oComp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti

a The values in the results table were calculated using the sensitivity and specificity provided in Table 2 in article; total “ns” of right and left ears examined 

respectively) and percentage of ears with fluid (67% and 62% respectively). 
266 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1804 Macknin 1987 

Continued

12. Acoustic reflectometrya

 Dx– : < 6 reflectivity units (RU)  Dx+ : ≥ 6 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

13. Acoustic reflectometrya

 Dx– : < 7 reflectivity units (RU)  Dx+ : ≥ 7 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

14. Acoustic reflectometrya

 Dx– : < 7 reflectivity units (RU)  Dx+ : ≥ 7 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

15. Acoustic reflectometrya

 Dx– : < 8 reflectivity units (RU)  Dx+ : ≥ 8 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti

a The values in the results table were calculated using the sensitivity and specificity provided in Table 2 in article; total “ns” of right and left ears examined 

respectively) and percentage of ears with fluid (67% and 62% respectively). 
267 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

1804 Macknin 1987 

Continued

16. Acoustic reflectometrya

 Dx– : < 8 reflectivity units (RU)  Dx+ : ≥ 8 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

17. Acoustic reflectometrya

 Dx– : < 9 reflectivity units (RU)  Dx+ : ≥ 9 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

18. Acoustic reflectometrya

 Dx– : < 9 reflectivity units (RU)  Dx+ : ≥ 9 RU 

 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Conti

Unit o

CompsensispeciPPV NPV accurprevaComp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurpreva

a The values in the results table were calculated using the sensitivity and specificity provided in Table 2 in article; total “ns” of right and left ears examined 

respectively) and percentage of ears with fluid (67% and 62% respectively). 
268 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1817 Mains 1989 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• pneumatic otoscopy: a senior 

registrar and a senior house officer 

• myringotomy: not specified Study Cohort: Children admitted to 

Belfast City Hospital for myringotomy during a consecutive 5 month period 

N=114 subjects, 209 ears 

Time: Patients entered study during a 

consecutive 5 month period (actual dates not specified) Place: Belfast City Hospital 

Affiliation: Not specified 

Inclusion: 

• admitted for myringotomy to the 

Belfast City Hospital during a 5-month period 

Exclusion: None 

Patient Characteristics: 

• age range 20 months–12 years • surgery indication primarily 

persistent middle ear effusion 

Comparisons: 

1. Examiner type: Observera

 Pneumatic otoscopy – unvalidated  examiner  Dx– : TM mobile  Dx+ : TM immobile  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 2. Examiner type: Observerb Pneumatic otoscopy – unvalidated  examiner  Dx– : TM mobile  Dx+ : TM immobile  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Observer described as ‘Senior Registrar.’ b Observer described as ‘Senior House Officer with just several months experience.’ 
269 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1837 Marchant 1986 

Diagnostic study Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• pneumatic otoscope: one of 

two experienced otoscopists 

• tympanometry (otoadmittance 

meter, model 1723 version II [Grason-Stadler]): not specified 

• tympanocentesis: not 

specified 

*Tympanocentesis was only performed on 21 out of 73 infants. These are the only infants where a gold standard diagnostic procedure was performed. Select group where MD felt OM+ and child would benefit from knowing bug. Study Cohort : Infants 2–18 weeks 

old who underwent tympanocentesis 

* (Study Cohort was derived from an overall sample of 73 infants) N=21 subjects, 38 ears 

Time: not specified 

Place: Pediatric Outpatient Clinic at 

Cleveland Metropolitan General Hospital 

Affiliation: Dept’s of Pediatrics and 

Communication Services, Case Western Reserve University, OH; Division of Communication Disorders, Cleveland Metropolitan General Hospital, OH 

Inclusion: 

• Age: <5 months (all infants were 

2–18 weeks of age) 

• attending well-child visit or otitis 

media was suspected after otoscopic examination by primary physician or nurse practitioner 

Exclusion: None 

Patient Characteristics: 

• age range 2–18 weeks 

Comparisons: 

1. Professional tympanometry  Dx– : Peak susceptance > 0 mmho  Dx+ : Peak susceptance ≤ 0  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometry  Dx– : Ipsilateral acoustic reflex threshold 

≤ 100 dB HL 

 Dx+ : Ipsilateral acoustic reflex threshold  absent or > 110 dB HL  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

Unit oComp

sensispeci

PPV NPV accurpreva

CompsensispeciPPV NPV accurpreva

a The authors state that specificity could not be determined from the small number of ears without middle ear effusion on tympanocentesis. 
270 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

1936 Mitchell 1990 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): Unknown 

• tympanometry (Interacoustics 

AZ7 tympanometer [PCWerth]): 

• acoustic reflectometry 

(Acoustic otoscope [Endeco Medical]): 

• audiometry (Kamplex AC4 

audiometer): 

• myringotomy: Study Cohort: Children with 

suspected glue ear were studied over a three-month period pure tone audiometry, tympanometry and acoustic reflectometry were attempted on each ear] 

N=50 subjects, 100 ears 

Time: Three-month period (actual 

dates not specified) Place: Not specified 

Affiliation: Dept. of Otolaryngology, St. 

Thomas’ Hospital, London 

Inclusion: 

• Age: 6 months–14 yrs • suspected glue ear Exclusion: None 

Patient Characteristics: 

• age range 6 months–14 years 

Comparisons: 

1. Professional tympanometry  Dx– : Type A or C tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

2. Acoustic reflectometry  Dx– : AR value ≤ 2  Dx+ : AR value > 2  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 3. Audiometry – air conduction threshold  Dx– : Hearing threshold < 20dB  Dx+ : Hearing threshold ≥ 20dB  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
271 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2012 Nozza 1992 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (GSI-33 

Version I Middle Ear Analyzer [Grason-Stadler], 226 Hz probe tone): Grp 1 audiologist; Grp 2 nurse 

• myringotomy: surgeon • pneumatic otoscopy: nurse 

otoscopist validated at sensitivity and specificity >85% 

* This article includes 2 different studies: (1) examines tympanometry vs. myringotomy and the second examines validated pneumatic otoscopy vs. tympanometry; (2) represents the “general population.” Grp 1: Ears in children undergoing myringotomy and tube surgery for treatment of chronic or recurrent OM Grp 2: Norms~Ears in children who were hospital outpatients and unscreened with respect to history of middle ear disease N=138 subjects, 171 ears N1=61 subjects, 111 ears N2=77 subjects, 144 ears 

Time: not specified 

Place: Grp 1 Same-Day Surgery Unit 

of Children’s Hospital of Pittsburgh, PA; Grp 2 children coming to outpatient allergy clinic 

Affiliation: Children’s Hospital of 

Pittsburgh, PA; Dept.’s of Otolaryngology and Biostatistics, Univ. of Pittsburgh, PA 

Inclusion: 

• Age: Grp 1 1–8 years • Grp 1~undergoing myringotomy 

and tube surgery for treatment of chronic or recurrent OM 

• Grp 2~hospital outpatients who 

were unscreened with respect to history of middle ear disease (more representative of children in general population) 

Exclusion: None 

Patient Characteristics: 

• Grp 1 age range 1–8 years; Grp 2 

mean age 9 years, range 3–16 years 

Comparisons: 

1. Grp 1a

Professional tympanometry (AR alone) 

 Dx– : acoustic reflex present  Dx+ : acoustic reflex absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Grp 1a 

Professional tympanometry 

 Dx– : Pressure gradient >0.1  Dx+ : Pressure gradient ≤0.1  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Grp 1a 

Professional tympanometry 

 Dx– : Pressure gradient >0.2  Dx+ : Pressure gradient ≤0.2  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

4. Grp 1a 

Professional tympanometry 

 Dx– : Peak compensated admittance >0.1  Dx+ : Peak compensated admittance ≤0.1 Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a Values in the results table were determined by using the values provided in the text of this article which state no MEE group = 30 and MEE group = 81. 

with the provided sensitivity and specificity allowed calculation of the numbers. 
272 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2012 Nozza 1992 

Continued Continued

5. Grp 1a

 Professional tympanometry  Dx– : Peak compensated admittance > 0.2  Dx+ : Peak compensated admittance ≤ 0.2  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

6. Grp 1a 

Professional tympanometry 

 Dx– : Peak compensated admittance > 0.3  Dx+ : Peak compensated admittance ≤ 0.3  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

7. Grp 1a 

Professional tympanometry 

 Dx– : Peak compensated admittance > 0.4  Dx+ : Peak compensated admittance ≤ 0.4  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a Values in the above results table were determined by using the values provided in the text of this article which state no MEE group = 30 and MEE group 

information with the provided sensitivity and specificity allowed calculation of the numbers. 
273 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2012 Nozza 1992 

Continued

8. Grp 2a

Professional tympanometry 

 Dx– : acoustic reflex present  Dx+ : acoustic reflex absent  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

9. Grp 2a 

Professional tympanometry 

 Dx– : Pressure gradient >0.1  Dx+ : Pressure gradient ≤ 0.1  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

10. Grp 2a 

Professional tympanometry 

 Dx– : Pressure gradient >0.2  Dx+ : Pressure gradient ≤ 0.2  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

11. Grp 2a 

Professional tympanometry 

 Dx– : Peak compensated admittance > 0.1  Dx+ : Peak compensated admittance ≤ 0.1  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti

a Values in the above results table were determined by using the values provided in the text of this article which state no MEE group = 135 and MEE grou

information with the provided sensitivity and specificity allowed calculation of the numbers. 
274 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2012 Nozza 1992 

Continued

12. Grp 2a

 Professional tympanometry  Dx– : Peak compensated admittance > 0.2  Dx+ : Peak compensated admittance ≤ 0.2  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

13. Grp 2 a 

Professional tympanometry 

 Dx– : Peak compensated admittance > 0.3  Dx+ : Peak compensated admittance ≤ 0.3  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

14. Grp 2a 

Professional tympanometry 

 Dx– : Peak compensated admittance > 0.4  Dx+ : Peak compensated admittance ≤ 0.4  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurpreva

a Values in the above results table were calculated based on numbers provided under results on pg. 312 in article. 
275 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2013 Nozza 1994 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (GSI-33 

Version I Middle Ear Analyzer [Grason-Stadler], 226 Hz probe tone): clinically certified and licensed audiologist 

• pneumatic otoscopy: Pediatric 

Nurse Practitioner validated at sensitivity 85% and specificity 71% 

• myringotomy: several 

surgeons 

This study combines results for children with chronic OM and recurrent otitis media; they do not state which of these categories represents OME or if either of them represents AOM. Grp 1: Myringotomy and Tympanostomy Group~Ears in children brought to operating room at Children’s Hospital of Pittsburgh for M&T surgery Grp 2: Norms1~Ears studied by Nozza et al. N1=171 subjects, 249 ears N2=(subjects?), 130 ears 

Time: not specified 

Place: Grp 1~Same-Day Surgery Unit 

of Children’s Hospital of Pittsburgh, PA 

Affiliation: Children’s Hospital of 

Pittsburgh, PA; Dept’s of Otolaryngology and Biostatistics, Univ. of Pittsburgh, PA 

Inclusion: 

• Grp 1~Age: 1–12 years • Grp 1~chronic or recurrent OM • Grp 1~brought to operating room 

at Children’s Hospital of Pittsburgh for M&T surgery 

Exclusion: None 

Patient Characteristics: 

• median age 3.8 years, 

range 1–12 years 

Comparisons: 

1. Grp 1  Diagnostic Method: unknown  Dx– : tympanometric gradient > 0.2  Dx+ : tympanometric gradient ≤ 0.2  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Grp 1  Diagnostic Method: unknown  Dx– : Tymp. Width ≤ 250 daPa  Dx+ : Tymp. Width > 250 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 3. Grp 1a

Pneumatic otoscopy – validated examiner 

 Dx– : MEE absent  Dx+ : MEE present  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

4. Grp 1  Professional tympanometry  Dx– : Acoustic reflex present  Dx+ : Acoustic reflex absent  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Unit o

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
276 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued Continued

5. Grp 1  Professional tympanometry  Dx– : tympanometric gradient >0  Dx+ : tympanometric gradient ≤ 0  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 6. Grp 1  Professional tympanometry  Dx– : tympanometric gradient >.1  Dx+ : tympanometric gradient ≤ 0.1  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 7. Grp 1  Professional tympanometry  Dx– : tympanometric gradient >0.3  Dx+ : tympanometric gradient ≤0.3  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 8. Grp 1  Professional tympanometry  Dx– : Peak admittance > 0  Dx+ : Peak admittance ≤ 0  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
277 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

9. Grp 1  Professional tympanometry  Dx– : Peak admittance >0.1  Dx+ : Peak admittance ≤0.1  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 10. Grp 1  Professional tympanometry  Dx– : Peak admittance >0.2  Dx+ : Peak admittance ≤0.2  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 11. Grp 1  Professional tympanometry  Dx– : Peak admittance >0.3  Dx+ : Peak admittance ≤0.3  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 12. Grp 1  Professional tympanometry  Dx– : Peak admittance >0.4  Dx+ : Peak admittance ≤0.4  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
278 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

17. Grp 1  Professional tympanometry  Dx– : tympanometric Width ≤300 daPa  Dx+ : tympanometric Width >300daPa  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 18. Grp 1  Professional tympanometry  Dx– : tympanometric Width ≤325 daPa  Dx+ : tympanometric Width >325 daPa  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 19. Grp 1  Professional tympanometry  Dx– : tympanometric Width ≤350 daPa  Dx+ : tympanometric Width >350 daPa  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 20. Grp 1  Professional tympanometry  Dx– : tympanometric Width ≤400 daPa  Dx+ : tympanometric Width >400 daPa  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
279 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

21. Grp 1  Professional tympanometry  Dx– : Acoustic reflex present  Dx+ : Acoustic reflex absent  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 22. Grp 1  Professional tympanometry  Dx– : Tympanometric gradient >0  Dx+ : Tympanometric gradient ≤0  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 23. Grp 1  Professional tympanometry  Dx– : Tympanometric gradient >0.1  Dx+ : Tympanometric gradient ≤0.1  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 24. Grp 1  Professional tympanometry  Dx– : Tympanometric gradient >0.2  Dx+ : Tympanometric gradient ≤0.2  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
280 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

25. Grp 1  Professional tympanometry  Dx– : Tympanometric gradient >0.3  Dx+ : Tympanometric gradient ≤0.3  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 26. Grp 1  Professional tympanometry  Dx– : Peak admittance >0  Dx+ : Peak admittance ≤0  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 27. Grp 1  Professional tympanometry  Dx– : Peak admittance > 0.1  Dx+ : Peak admittance ≤0.1  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 28. Grp 1  Professional tympanometry  Dx– : Peak admittance >0.2  Dx+ : Peak admittance ≤0.2  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
281 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

29. Grp 1  Professional tympanometry  Dx– : Peak admittance >0.3  Dx+ : Peak admittance ≤0.3  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 30. Grp 1  Professional tympanometry  Dx– : Peak admittance >0.4  Dx+ : Peak admittance ≤0.4  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 31. Grp 1  Professional tympanometry  Dx– : Tympanometric Width ≤150 daPa  Dx+ : Tympanometric Width >150 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 32. Grp 1  Professional tympanometry  Dx– : Tympanometric Width ≤200 daPa  Dx+ : Tympanometric Width >200 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
282 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

33. Grp 1  Professional tympanometry  Dx– : Tymp. Width ≤225 daPa  Dx+ : Tymp. Width >225 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 34. Grp 1  Professional tympanometry  Dx– : Tymp. Width ≤275 daPa  Dx+ : Tymp. Width >275 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 35. Grp 1  Professional tympanometry  Dx– : Tymp. Width ≤300 daPa  Dx+ : Tymp Width >300 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 36. Grp 1  Professional tympanometry  Dx– : Tymp. Width ≤325 daPa  Dx+ : Tymp. Width >325 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
283 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

37. Grp 1  Professional tympanometry  Dx– : Tymp. Width ≤350 daPa  Dx+ : Tymp. Width >350 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 38. Grp 2  Professional tympanometry  Dx– : Tymp. Width ≤150 daPa  Dx+ : Tymp. Width >150 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 39. Grp 2  Professional tympanometry  Dx– : Tymp. Width ≤200 daPa  Dx+ : Tymp. Width >200 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 40. Grp 2  Professional tympanometry  Dx– : Tymp. Width ≤250 daPa  Dx+ : Tymp. Width >250 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaConti
284 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2013 Nozza 1994 

Continued

41. Grp 2  Professional tympanometry  Dx– : Tymp. Width ≤150 daPa  Dx+ : Tymp. Width >150 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 42. Grp 2  Professional tympanometry  Dx– : Tymp. Width ≤ 200 daPa  Dx+ : Tymp. Width >200 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 43. Grp 2  Professional tympanometry  Dx– : Tymp. Width ≤250 daPa  Dx+ : Tymp. Width >250 daPa  Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 

ContiUnit o

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurpreva
285 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2048 Orchik 1978 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (electroacoustic 

impedance bridge, Madsen 70–72): performer not specified 

• myringotomy: surgeon Study Cohort: Ears of patients who 

underwent myringotomy for suspected serous otitis media 

N=76 ears * number of subjects not specified 

Time: not specified 

Place: Not specified 

Affiliation: Dept. of Audiology and 

Speech Pathology, Memphis State Univ., TN; East Texas Rehabilitation Center 

Inclusion: 

• Age: 6 months–14 years • underwent myringotomy for 

suspected serous otitis media 

Exclusion: None 

Patient Characteristics: 

• mean age 4.5 years, range 6 

months–14 years 

Comparisons: 

1. Portable tympanometera

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanogram  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid present in moderate or large  amounts 

2. Professional tympanometryb

 Dx– : Acoustic reflex present  Dx+ : Acoustic reflex absent  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

3. not included 4. Professional tympanometry  Dx– : Type A & C1&C3 tympanogram  Dx+ : Types B & C2 tympanograms  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid present in moderate or large  amounts Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

(not in

Comp

sensispeciPPV NPV accurpreva

Conti

a In this results table the type “c” tympanograms are included as normals. b Values derived from false positive % and false negative % reported in Table VI for acoustic reflex and total numbers of normal and abnormal ears as rep
286 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2048 Orchik 1978 

Continued

5. Professional tympanometrya

 Dx– : acoustic reflex present at 500,  2,000, or 4,000 Hz  Dx+ : acoustic reflex absent at 500,  2000, or 4000 Hz  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid moderate/large amounts 

6. Professional tympanometry a

 Dx– : acoustic reflex present at 1000Hz  Dx+ : acoustic reflex absent at 1000 Hz  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid moderate/large amounts 

7. Quantitative tympanometry  Dx– : Static compliance ≥.28cc 

 Dx+ : Static compliance <.28  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid present in moderate or large  amounts 

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Specificity data might be abstractable from this article for these cutpoints. 
287 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2049 Orchik 1978 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (electroacoustic 

impedance bridge): not specified 

• myringotomy: surgeon Study Cohort: Patients who were 

undergoing myringotomy for suspected serous otitis media 

N=75 subjects, 142 ears 

Time: not specified 

Place: not specified 

Affiliation: Div. of Communication 

Disorder, North Texas State Univ.; J.W. Dunn, MD, and Associates, Denton TX 

Inclusion: 

• Age: Not specified • undergoing myringotomy for 

suspected serous otitis media 

Exclusion: None 

Patient Characteristics: 

Not Specified 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A and As tympanograms  Dx+ : Type B tympanograms  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid present in moderate or large  amounts 

2. Professional tympanometryb

 Dx– : Type A, As, C, and Cs tympanograms  Dx+ : Type B tympanograms  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid present in moderate or large  amounts 

3. Professional tympanometryc

 Dx– : Types A and As  Dx+ : Types B, C, and Cs  Myringotomy (sedation unknown)  GS– : fluid absent or minimal  GS+ : fluid moderate/large amounts 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Excluded data presented for type “c” tympanograms. Classified ears with “none” and “minimal” effusion as = no effusion. Classified ears with “moderate

as = +effusion. 

b Type “c” and “cs” tympanograms are included as “normals.” Classified ears with “none” and “minimal” effusion as = no effusion. Classified ears with “m

as = +effusion. 

c Type “c” and “cs” tympanograms are included as “abnormals.” Classified ears with “none” and “minimal” effusion as = no effusion. Classified ears with 

as = +effusion. 
288 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2050 Orchik 1980 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (electroacoustic 

impedance bridge, Madsen ZO-72): not specified 

• myringotomy: surgeon Study Cohort: Ears of patients 

undergoing myringotomy for suspected serous otitis media 

N=76 ears * number of subjects not specified 

Time: not specified 

Place: not specified 

Affiliation: Memphis State Univ, TN; 

J.W. Dunn, MD, and Associates, TX 

Inclusion: 

• Age: 6 months–14 years • undergoing myringotomy for 

suspected serous otitis media, usually for recurrent OM or failure of single OM episode to respond to medical treatment 

Exclusion: None 

Patient Characteristics: 

• mean age 4.5 years, range 6 

months–14 years 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A tympanogram  Dx+ : Type B tympanpgram  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts 

2. Professional tympanometryb

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanograms  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts 

3. Professional tympanometryb

 Dx– : Type A tympanograms  Dx+ : Type B and C tympanograms  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a Excluded data presented for type “c” tympanograms. Ears with “none” and “minimal” effusion classified as = no effusion; ears with “moderate” or “impb Type “c” tympanograms are included as “normals.” Ears with “none” and “minimal” effusion classified as = no effusion; ears with “moderate” or “impa
289 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2050 Orchik 1980 

Continued

4. Professional tympanometry  Dx– : Acoustic refl. present @500 Hz  Dx+ : Acoustic refl. absent @500 Hz  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts 5. Professional tympanometry  Dx– : Acoustic reflex present at 1000 Hz  Dx+ : Acoustic reflex absent at 1000 Hz  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts 6. Professional tympanometry  Dx– : Acoustic reflex present at 2000 Hz  Dx+ : Acoustic reflex absent at 2000 Hz  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
290 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2050 Orchik 1980 

Continued

7. Professional tympanometry  Dx– : Acoustic reflex present at 4000 Hz  Dx+ : Acoustic reflex absent at 4000 Hz  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts 8. Quantitative tympanometry  Dx– : Static compliance $ .28 cc 

 Dx+ : Static compliance < .28 cc  Myringotomy (sedation unknown)  GS– : Fluid absent or minimal  GS+ : Fluid present in moderate or large  amounts 

ContiUnit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
291 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2055 Ovesen 1993 

N/A Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (Tympan-Oscope model zs 330 [Madsen 

Electronics]): ENT physician 

• otomicroscopy: not specified • myringotomy: two other ENT 

specialists 

Study Cohort: Children with 

unilateral or bilateral SOM 

N=222 subjects, 440 ears 

Time: not specified 

Place: Not specified 

Affiliation: Ear Nose and Throat Dept., 

Aarhus Univ. Hospital, Aarhus C, Denmark 

Inclusion: 

• Age: 0.8–14.8 years • two of the following three criteria: 

otomicroscopical findings consistent with SOM during 3 months, >20 dB hearing impairment, and/or adenoid symptoms 

Exclusion: None 

Patient Characteristics: 

• mean age 4.1 years, 0.8–14.8 

years 

• male 132, female 88 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometryb

 Dx– : Type A/C1/C2 tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Professional tympanometryc

 Dx– : Type A or C1 tympanogram  Dx+ : Type B or C2 tympanogram  Myringotomy (sedated)  GS– : Fluid absent  GS+ : Fluid present 

4. Professional tympanometryd

 Dx– : Type A tympanogram  Dx+ : Types B/C1/C2 tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Excludes cases where no operation was performed. It also excludes cases where an operation was performed and the tympanogram was type C1 or C2b Excludes cases where no operation was performed. Type C1 and C2 are classified as “normal” in the above results table. c Excludes cases where no operation was performed. Type A and C1 are classified as “normal”and type B and C2 are classified as “abnormal” in the abovd Excludes cases where no operation was performed. Type A is classified as “normal”and types B, C1, and C2 are classified as “abnormal” in the above r
292 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2058 Oyiborhoro 1987 

Diagnostic study Study Quality Score (0–6): 

3 (100101) 

Examiner(s): 

• acoustic reflectometry 

(acoustic otoscope [Endeco Medical]): not specified 

• pneumatic otoscopy: 

otolaryngologist validated with sensitivity 97.73% and specificity 90.90% 

• tympanometry diagnostic 

impedance audiometer Madsen ZS 77 MB): not specified 

• audiometry (Beltone clinical 

audiotry model 200-C): not specified 

• myringotomy Grp 1: Children who did not have MEE Grp 2: Children who had MEE Grp 3: Subgroup of children in group2 who underwent myringotomy (44 pathologic ears) N1=100 subjects, 200 ears N2=100 subjects, 175 ears N3=23 subjects, 44 ears 

Time: Referred over a 10-month period 

(actual dates not specified) Place: Subjects drawn from the ENT 

clinic at the Dr. Martin Luther King, Jr. Health Center, Bronx, NY 

Affiliation: Columbia Univ., NY; VA 

Medical Center, Cleveland, OH; as above 

Inclusion: 

• Age: 3–12 years • Grp 1: normal hearing and middle 

ear function based upon results from otoscopy, tympanometry and pure tone audiometry) 

• Grp 2: pure tone thresholds 

≥20dB HL (250–8000 Hz); airbone gaps of at least 15 dB HL (250–4000 Hz); type B tympanograms in the ears studied w/no sensorineural components; or demonstrated hearing and immittance abnormalities at least two times in ears studied during the 10-month period of investigation. 

Exclusion: 

• Grp 1~history suggested the 

existence of any known middle ear pathology 

Patient Characteristics: 

• mean age 8.7 years, range 3–12 

years 

• male 90, female 110 

Comparisons: 

1. Grps 1 & 2 combined  Acoustic reflectometry  Dx– : Acoustic otoscope reflectivity<4  Dx+ : Acoustic otoscope reflect. ≥4 

 Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 2. Grps 1 & 2 combined  Acoustic reflectometry  Dx– : Acoustic otoscope reflectivity<3  Dx+ : Acoustic otoscope reflect. ≥3 

 Validated pneumatic otoscopy  GS– : MEE absent  GS+ : MEE present 

3. Grp 3a

 Acoustic reflectometry  Dx– : Acoustic otoscope reflectivity<4  Dx+ : Acoustic otoscope reflect. ≥4 

 Myringotomy (sedation unknown)  GS– : Fluid absent  GS+ : Fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeci

PPV NPV 

accurpreva

a All children in this group had fluid on myringotomy, thus specificity cannot be determined for this group. 
293 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2118 Paradise 1976 

Diagnostic study This ID number includes two separate studies Study Quality Score (0–6): 

STUDY 1: 4 (111001) STUDY 2: 5 (111101) 

Examiner(s): 

• tympanometry (Madsen 

Electroacoustic Impedance Meter, Model ZO 70 [Madsen Electronics]): audiologist 

• pneumatic otoscopy: 

pediatrician 

• myringotomy: by or under 

supervision of one of two otolaryngologists 

Study Cohort: infants and children 

who had been scheduled for myringotomy and insertion of tympanostomy tubes because of recurrent AOM or persistent MEE, or both 

* (group of infants and children not receiving myringotomy were studied but findings were not relevant to key question four) N=107 subjects, 214 ears 

Time: 5/25/1972–5/9/1974 

Place: Grp 1 not specified: Grp 2 

various outpatient waiting areas at Children’s Hospital of Pittsburgh, PA 

Affiliation: Dept. of Pediatrics, 

Community Med., and Otolaryngology, and Speech and Theatre Arts Cleft Palate Center, Univ. of Pittsburgh; Ambulatory Care Center, Children’s Hospital of Pittsburgh 

Inclusion: 

• Age: 10 days–5 years Grp 1: • scheduled for myringotomy and 

insertion of tubes due to recurrent AOM or persistent MEE or both 

Grp 2: • not scheduled for myringotomy • in various outpatient waiting areas 

of the Children’s Hospital of Pittsburgh; available and parents willing to allow participation in study 

Exclusion: None 

Patient Characteristics: 

• age range 10 days–5 years 11 

months 

• Grp 1 male 62, female 45; Grp 2 

male 103, female 70 

• black 66, white 214 

Comparisons: 

1. Pneumatic otoscopya – unvalidated 

 examiner  Dx– : MEE absent  Dx+ : MEE present  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Pneumatic otoscopyb – unvalidated 

 examiner  Dx– : MEE absent  Dx+ : MEE present  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Pneumatic otoscopyc – unvalidated 

 examiner  Dx– : MEE absent  Dx+ : MEE present  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Ears with fluid “suspected” as having effusion are included as false negatives. Fluid-free ears “suspected” as having effusion included as false positive

included as false negatives. 

b Ears with fluid “suspected” as having effusion are included as true positives. Effusion free ears “suspected” as having effusion included as false positiv

examined” is not included. 

c Ears in the “suspect” category are not included. The one ear that was not examined is not included. 
294 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

4790 Paradise 1996 

Diagnostic study Study Quality Score (0–6): 

5 (111110) 

Examiner(s): 

• tympanometry (GrasonStadler GSI 33): two 

audiologists 

• pneumatic otoscopy: tested 

otoscopists which we interpreted as validated otoscopists 

Grp 1: Ears in infants during their first year of Grp 2: Ears in infants during their second year of life (Note: these ears are not necessarily independent.) N=362 subjects, 1296 ears N1=701 ears N2=595 ears * (did not specify how many children in each group) 

Time: not specified 

Place: Children’s Hospital outpatient 

department 

Affiliation: Not specified but authors 

recognized as being from Children’s Hospital of Pittsburgh, PA 

Inclusion: 

• Age: 2–23 months • healthy infants Exclusion: None 

Patient Characteristics: 

Not specified 

Comparisons: 

1. Grp 1– 1st year of life 

 Examiner type (Audiologist #1)

 Professional tympanometry  Dx– : Normal tympanogram  Dx+ : Questionable or Flat Tymp.  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

2. Grp 1– 1st year of life 

 Examiner type (Audiologist #1)

 Professional tympanometry  Dx– : Normal/questionable tymp.  Dx+ : Flat tympanograms  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

3. Grp 1– 1st year of life 

 Examiner type (Audiologist #2)

 Professional tympanometry  Dx– : Normal tympanograms  Dx+ : Questionable or Flat Tymp.  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

4. Grp 1– 1st year of life 

 Examiner type (Audiologist #2)

 Professional tympanometry  Dx– : Normal/questionable tymp.  Dx+ : Flat tympanograms  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
295 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

4790 Paradise 1996 

Continued

5. Grp 2– 2nd year of life 

 Examiner type (Audiologist #1)

 Professional tympanometry  Dx– : Normal tympanograms  Dx+ : Questionable/Flat tymp.  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

6. Grp 2– 2nd year of life 

 Examiner type (Audiologist #1)

 Professional tympanometry  Dx– : Normal/questionable tymp.  Dx+ : Flat tympanograms  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

7. Grp 2– 2nd year of life 

 Examiner type (Audiologist #2)

 Professional tympanometry  Dx– : Normal tympanograms  Dx+ : Questionable/Flat tymp.  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

8. Grp 2– 2nd year of life 

 Examiner type (Audiologist #2)

 Professional tympanometry  Dx– : Normal/questionable tymp.  Dx+ : Flat tympanograms  Validated pneumatic otoscopy  GS– : effusion absent  GS+ : effusion present 

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
296 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

4793 Park 1988 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (Teledyne 

Avionics instrument type TA3D and Grason-Stadler instrument 1723 middle ear analyzer): not specified 

• myringotomy: not specified Study Cohort: Children diagnosed 

as having OME who received myringotomies with and w/out ventilation tubes 

*(a group of 79 healthy children were also studied but findings were not relevant to key question four) N=290 subjects, 528 ears 

Time: Grp 1~not specified; Grp 

2~1981–1986 Place: Korea (specifics not provided) 

Affiliation: not specified 

Inclusion: 

• Grp 1~Age: Not specified • Grp 2~Age: 2–15 years • Grp 1~healthy children, who 

showed <10 db air-bone gap and in whom physical exams were normal 

• Grp 2~OME diagnosed by 

physical exam and impedance audiometry 

• Korean pediatric population Exclusion: None 

Patient Characteristics: 

• Grp 2 age range 2–15 years 

Comparisons: 

1. Male Children

 Professional tympanometry  Dx– : Type A tympanogram  Dx+ : Type B or C tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Male Children

 Professional tympanometry  Dx– : Type A or C tympanograms  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Female Children

 Professional tympanometry  Dx– : Type A tympanogram  Dx+ : Type B or C tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

4. Female Children

 Professional tympanometry  Dx– : Type A or C tympanograms  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
297 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

4793 Park 1988 

Continued

5. Male Children

 Professional tympanometry  Dx– : Type A tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

6. Female Children

 Professional tympanometry  Dx– : Type A tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

ContiUnit o

Comp

sensispeciPPV 

NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
298 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2236 Rees 1992 

Cross-sectional Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (Rexton 

tympanometer): not specified 

• myringotomy: not specified *This study focuses on changes in tympanometry resulting from general anesthesia, not on the sensitivity/specificity of tympanometry for identifying fluid filled ears. Study Cohort: Children admitted to 

ENT Dept. for myringtomy and possible grommet insertion 

N=155 subjects, 310 ears 

Time: 6-month period (actual dates not 

specified) Place: ENT Department of the 

Radcliffe Infirmary, Oxford, UK 

Affiliation: Dept. of Otolaryngology, 

Radcliffe Infirmary, Oxford, UK 

Inclusion: 

• Age: 18 months–11 years • admitted to the ENT Dept. of the 

Radcliffe Infirmary over a 6-month period 

• seen by an otologist within 3 

months of admission 

• with clinically persistent middle 

ear effusion 

• able to tolerate examination and 

tympanometry 

Exclusion: None 

Patient Characteristics: 

• age range 18 months–11 years 

Comparisons: 

1. Portable tympanometera

 Dx– : Type A or C tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Portable tympanometerb

 Dx– : Type A or C tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Results are based on the tympanogram readings 1 hour before myringotomy. b Results are based on the tympanograms obtained immediately before myringotomy. 
299 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

4804 Renvall 1996 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (Model 85AR 

[American Electromedics Corporation]): not specified 

• myringotomy: not specified Study Cohort: Children who 

underwent tympanometry and were candidates for ventilation tube insertion 

N=73 subjects, 127 ears 

Time: not specified 

Place: not specified 

Affiliation: 

Inclusion: 

• Age: 3–12 years • suffered from longstanding serous 

otitis media 

• candidate for tympanocentesis 

and ventilation tube insertion under general anesthesia 

Exclusion: None 

Patient Characteristics: 

• age range 3–12 years 

Comparisons: 

1. Professional tympanometry  Dx– : Peaked tympanogram  Dx+ : Flat tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present\ 

Unit o

Comp

sensispeciPPV NPV accurpreva
300 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2344 Sassen 1994 

Diagnostic study Study Quality Score (0–6): 

3 (111000) 

Examiner(s): 

• tympanometry (type GSI-27A 

and type Tymp-85TT, 226 Hz probe tone, used six weeks in each group and then interchanged): not specified 

• otomicroscopy: three ENT 

surgeons 

• myringotomy: three ENT 

surgeons 

*This study combines children undergoing myringotomy because of recurrent AOM or chronic OME but does not stratify the results according to type of OM. Grp 1: Hospital A ~ Ears in children with middle ear problems who were only undergoing insertion of tympanostomy tubes [not (adeno)-tonsillectomy with myringotomy] Grp 2: Hospital B ~ Ears in children with URIs who were undergoing (adeno)-tonsillectomy with myringotomy Continued on next page

Time: not specified 

Place: Study performed in two hospital: 

Hospital A~ Gemini-Hospital in Den Helder and Hospital B~ St. ElisabethHospital in Leiderdorp, The Netherlands 

Affiliation: Dept. of 

Otorhinolaryngology, Univ. Hospital Leiden, The Netherlands 

Inclusion: 

• Age: 5 months–11 years & 5 

months 

• candidate for insertion of 

ventilation tubes, or adenoidectomy and/or tonsillectomy w/myringotomy 

• Grp 1~middle ear problems (not 

URIs) and undergoing insertion of tympanostomy tubes only 

• Grp 2~URIs and undergoing 

(adeno)-tonsillectomy with myringotomy 

Continued on next page

Comparisons: 

1. Grp 1 and Grp 2  Binocular micro-tympanoscopy  Dx– : Tympanic membrane~normal  Dx+ : Tympanic membrane~abnormal  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Grp 1 and Grp 2  Professional tympanometry–both types  Dx– : Type (A,C1,C2,O)  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Grp 1 and Grp 2  Professional tympanometry–both types  Dx– : Type (A, C1, O) tympanogram  Dx+ : Type B or C2) tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 4. Grp 1 and Grp 2  Age (5 months–2 years)  Professional tympanometry–both types  Dx– : Type (A,C1,C2) tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
301 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2344 Sassen 1994 

Continued

N=266 subjects, 515 ears N1=273 ears N2=242 ears * (did not specify how many children in each group) 

Continued

Exclusion: 

• Grp 1~ URIs • perforation of the tympanic 

membrane 

• history of >6 myringotomies 

and/or >3 insertions of middle ear ventilation tubes 

Patient Characteristics: 

• age range 5 months–11 years 5 

months 

• male 143, female 123 

Continued

5. Grp 1 and Grp 2  Age (5 months–2 years)  Professional tympanometry–both types  Dx– : Type (A, C1) tympanogram  Dx+ : Type (B or C2) tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 6. Grp 1 and Grp 2  Age (2–12 years)  Professional tympanometry–both types  Dx– : Type (A,C1,C2) tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 7. Grp 1 and Grp 2  Age (2–12 years)  Professional tympanometry–both types  Dx– : Type (A, C1) tympanogram  Dx+ : Type (B or C2) tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 8. Grp 1  Professional tympanometry–both types  Dx– : Type (A,C1,C2) tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
302 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2344 Sassen 1994 

Continued

9. Grp 1  Professional tympanometry–both types  Dx– : Type (A, C1, O) tympanogram  Dx+ : Type (B or C2) tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 10. Grp 2  Professional tympanometry–both types  Dx– : Type (A,C1,C2) tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 11. Grp 2  Professional tympanometry–both types  Dx– : Type (A, C1) tympanogram  Dx+ : Type (B or C2) tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

ContiUnit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurprevaCompsensispeciPPV NPV accurpreva
303 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2412 Shaw 1978 

Cross-sectional Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (GrasonStadler 1720 otoadmittance 

meter, 220 and 660 Hz probe tones): not specified 

• myringotomy; not specified *This is a pre-, post-anesthesia study looking at the effects on tympanometry. Study Cohort: Ears in children who 

underwent myringotomy surgery 

N=59 ears * Sample size =39 patients and 68 ears with probable middle-ear fluid. Only 59 ears received surgery but the authors did not state whether all patients in the sample received surgery or if some were excluded when number of ears was reduced from 68 to 59. 

Time: not specified 

Place: Not specified 

Affiliation: Univ. of Illinois, Hearing 

Clinic, Champaign, IL 

Inclusion: 

• Age: 2–11 years • probable middle-ear fluid 

unilaterally or bilaterally based on otologic and audiologic exam 

• underwent myringotomy surgery Exclusion: 

• ears that did not undergo 

myringotomy surgery 

Patient Characteristics: 

• age range 2–11 years 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A tympanogram  Dx+ : Type B and C tympanograms  Myringotomy (sedated)  GS– : Fluid absent  GS+ : Fluid present 

2. Professional tympanometrya

 Dx– : Type A and C tympanogram  Dx+ : Type B tympanograms  Myringotomy (sedated)  GS– : Fluid absent  GS+ : Fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a This is a pre-, post-anesthesia study looking at the effects on tympanometry. Pre-operative results were used. 
304 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2545 Szucs 1995 

Diagnostic study Study Quality Score (0–6): 

1 (100000) 

Examiner(s): 

• tympanometry (Amplaid 720 

type impedance meter): not specified 

• myringotomy: ENT surgeon Study Cohort: Children w/ chronic 

OME and recurrent otitis media 

N=40 subjects, 78 ears 

Time: 6 month period between 5/1992–

12/1992 Place: Ear-Nose and Throat 

Department of Brussels Free University, Brussels, Belgium 

Affiliation: Dept. of 

Otorhinolaryngology, Brussels Free Univ., Belgium 

Inclusion: 

• Age: 1 year 3 months–11 years 4 

months 

• chronic OME and/or recurrent OM Exclusion: 

• although not stated specifically to 

be a criteria none of the children had any accompanying disease 

Patient Characteristics: 

• mean age 5 years 8 months, 

range 1 year 3 months–11 years 4 months 

• male 27, female 13 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A tympanograms  Dx+ : Type B tympanograms  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometryb

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanograms  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

3.Professional tympanometryc

 Dx– : Type A tympanogram  Dx+ : Type B and C tympanograms  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti

a The above results table excludes type “C” tympanograms. b The above results table includes type “C” tympanograms as normal. c The above results table includes type “C” tympanograms. 
305 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2545 Szucs 1995 

Continued

4. Professional tympanometrya

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanogram  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

5. Professional tympanometryb

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanogram  Tympanocentesis (non-sedated)  GS– : fluid absent  GS+ : fluid present 

Conti

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a Adenoid hypertrophy present in this group. b Adenoid hypertrophy absent in this group. 
306 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2601 Tom 1994 

Diagnostic study Study Quality Score (0–6): 

4 (111001) 

Examiner(s): 

• tympanometry (Teledyne 

Screening Meter model no. TA-7A): certified audiologists 

• myringotomy: surgeon *This study combines data for persistent OME and recurrent AOM but does not stratify the results based on this variable. Study Cohort: Children scheduled 

to undergo myringotomy with pressure equalization tube insertion for either OME refractory to medical management or recurrent OM 

N=109 subjects, 213 ears 

Time: not specified 

Place: Not specified 

Affiliation: Div. of Otolaryngology, 

Children’s Hospital of Philadelphia, PA; Div. of Medical Audiology, Children’s Seashore House, PA; Dept. of Otolaryngology, Univ. of Pennsylvania 

Inclusion: 

• Age: 5 months–11 years • scheduled to undergo 

myringotomies w/ pressure equalization tube insertion for either OME refractory to medical management or recurrent OM 

Exclusion: 

• ears discovered either at 

tympanometry or surgery to have small perforations (n=5 ears excluded) 

Patient Characteristics: 

• mean age 3 years 8 months, 

range 5 months–11 years 5 months 

• male 62, female 47 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometryb

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Professional tympanometryc

 Dx– : Type A tympanogram  Dx+ : Types B and C tympanograms  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a The above results table excludes all ears with type “C” tympanograms. b The above results table includes type “C” tympanograms as normal. c The above results table includes type “C” tympanograms as abnormal. 
307 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2607 Toner 1990 

Diagnostic study Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• pneumatic otoscopy: one of 

the authors 

• tympanometry (REXTON 

TYMP82): not specified 

• myringotomy: not specified Study Cohort: Children undergoing 

myringotomy due to indication of MEE 

N=121 subjects, 222 ears 

Time: Consecutive 5-month period 

(actual dates not specified) Place: ENT Department of the Belfast 

City Hospital, Belfast, UK 

Affiliation: as above 

Inclusion: 

• Age: 18 months–12 years • indication of need for 

myringotomy (in the majority ~ due to clinically persistent MEE) 

Exclusion: 

• pneumatic otoscopy and 

tympanometry could not be performed 

• lack of cooperation during test 

procedure or in allowing removal of excessive wax 

Patient Characteristics: 

• age range 18 months–12 years 

Comparisons: 

1. Pneumatic otoscopy – unvalidated  examiner  Dx– : mobile  Dx+ : immobile  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometrya

 Dx– : Type A and C tympanograms  Dx+ : Type B tympanogram  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

3. Professional tympanometryb

 Dx– : Type A tympanogram  Dx+ : Type B and C tympanograms  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

4. Professional tympanometryc

 Dx– : Type A tympanograms  Dx+ : Type B tympanograms  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a The above results table includes type “C” tympanograms as normal. b The above results table includes type “C” tympanograms as abnormal. c The above results table excludes all ears with type “C“ tympanograms. 
308 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2675 van Balen 1994 

Diagnostic study Study Quality Score (0–6): 

4 (111010) 

Examiner(s): 

• tympanometry (AR 85 

[American Electromedics], 226 Hz probe tone, and microtymp [Welch Allyn], 226 Hz probe tone): general practitioner with special training from ENT department with classification problems discussed with Ear, Nose, and Throat surgeons 

• myringotomy: Ear, Nose, and 

Throat surgeon 

Study Cohort: Children selected by 

the Ear, Nose and Throat surgeon for uni- or bilateral myringotomy and/or tympanostomy tube insertion 

N=142 subjects, 284 ears 

Time: 9/1990–8/1991 

Place: Day-care department, University 

Children’s Hospital, Utrecht and the General Hospital, Overvecht, Utrecht, Netherlands 

Affiliation: Dept. of General Practice, 

Univ. of Utrecht, Netherlands 

Inclusion: 

• Age: 6 months–12 years • undergoing uni- or bilateral 

myringtomy and/or tympanostomy tube insertion after referral by General Practitioner 

Exclusion: 

• craniofacial malformations and 

those w/trisomy 21 

Patient Characteristics: 

• age range 6 months–12 years 

Comparisons: 

1. Portable tympanometer  Dx– : Type A and C1 tympanogram curves Dx+ : Type B and C2 tympanogram curves Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva
309 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2713 VaughanJones 1992 

Diagnostic study Study Quality Score (0–6): 

2 (100001) 

Examiner(s): 

• pneumatic otoscopy: not 

specified 

• audiometry (Audioscope 

[Welch Allyn] and Madsen OB822 audiometer): not specified 

• tympanometry (Microtymp 

[Welch Allyn], 226 Hz probe tone, and American Electric Model 85, 256 Hz probe tone): not specified 

• myringotomy: not specified *For pneumatic otoscopy, the authors do not define a negative or positive test result. Study Cohort: Children undergoing 

myringotomy 

N=100 subjects, 200 ears 

Time: not specified 

Place: Audiology Department at 

Ninewells Hospital, Dundee 

Affiliation: Dept. of Otolaryngology, 

Ninewells Hospital, Dundee 

Inclusion: 

• admitted with a diagnosis of OME 

and scheduled to undergo myringotomy 

Exclusion: 

• inadequate view of the tympanic 

membrane or variable audiometric responses 

Patient Characteristics: 

• mean age male 6.3 years, female 

6.2 years 

• male 56, female 44 

Comparisons: 

1. Pneumatic otoscopy – unvalidated  examiner  Dx– : not defined  Dx+ : not defined  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometer  Dx– : Type A,C1 & C2 curves  Dx+ : Type B curves  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 3. Portable tympanometer  Dx– : Type A and C1 curves  Dx+ : Type B and C2 curves  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 4. Professional tympanometry  Dx– : Type A and C1 tympanograms  Dx+ : Type B and C2 tympanograms  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present Continued on next page

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Conti
310 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

Continued

2713 VaughanJones 1992 

Continued

5. Audiometry – air conduction threshold  Dx– : ≤26 dB at 500Hz 

 Dx+ : >26 dB at 500 Hz  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

6. Audiometry – air conduction threshold  Dx– : ≤26 dB at 1000Hz 

 Dx+ : >26 dB at 1000 Hz  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

7. Audiometry – air conduction threshold  Dx– : ≤26 dB at 2000Hz 

 Dx+ : >26 dB at 2000 Hz  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

8. Audiometry – air conduction threshold  Dx– : ≤26 dB at 4000Hz 

 Dx+ : > 26 dB at 4000 Hz  Myringotomy (sedated)  GS– : fluid absent  GS+ : fluid present 

ContiUnit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva
311 

Evidence Table 4. Diagnostic Methods (Continued) 

Record# Author Year 

Study Quality 

Examiner(s) 

Group(s) and Sample Size 

Time/Place/Affiliation 

Inclusion/Exclusion Criteria 

Patient Characteristics 

Comparison(s)

Influencing Factors 

Diagnostic Methods (Dx), Cutpoints 

Gold Standards (GS), Cutpoints 

2758 Watters 1997 

Diagnostic study Study Quality Score (0–6): 

2 (110000) 

Examiner(s): 

• tympanometry (GraysonStadler [sic] GS133 

Tympanometer): pediatric audiologist 

• myringotomy: not specified Study Cohort: Children who 

underwent surgery (grommet insertion) for possible MEE 

N=501 subjects, 955 ears 

Time: 12 month period (11/1/1993–

10/1994) Place: 

Affiliation: Dept’s of Otolaryngology 

and Paediatric Audiology, Radcliffe Infirmary, Oxford, UK 

Inclusion: 

• Age: 11 months–15 years • undergoing surgery (insertion of 

grommets) for possible MEE 

Exclusion: 

• children with a ‘normal’ 

tympanogram in one or both ears and had surgery cancelled 

Patient Characteristics: 

• age range 11 months–15 years 

Comparisons: 

1. Professional tympanometrya

 Dx– : Type A or C tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

2. Professional tympanometryb

 Dx– : Type A tympanogram  Dx+ : Type B or C tympanograms  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

3. Professional tympanometry  Dx– : Type A tympanogram  Dx+ : Type B tympanogram  Myringotomy (sedation unknown)  GS– : fluid absent  GS+ : fluid present 

Unit o

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

Comp

sensispeciPPV NPV accurpreva

a This results table includes type “C” tympanograms as normal.b This results table includes type “C” tympanograms as abnormal.