REVIEW ARTICLE

Surgical Treatments for Otitis Media With Effusion:

A Systematic Review
AUTHORS: Ina F. Wallace, PhD,a Nancy D. Berkman, PhD,a
Kathleen N. Lohr, PhD,a Melody F. Harrison, PhD,b Adam J. abstract
Kimple, MD, PhD,c and Michael J. Steiner, MDd
BACKGROUND AND OBJECTIVE: The near universality of otitis media
aDivision for Health Services and Social Policy Research, RTI
with effusion (OME) in children makes a comparative review of treat-
International, Research Triangle Park, North Carolina; and
bDivision of Speech and Hearing Sciences, and Departments of ment modalities important. This study’s objective was to compare the
c
Otolaryngology/Head and Neck Surgery and dPediatrics, effectiveness of surgical strategies currently used for managing OME.
University of North Carolina, Chapel Hill, North Carolina
METHODS: We identified 3 recent systematic reviews and searched 4
KEY WORDS
adenoidectomy, comparative effectiveness, myringotomy, otitis
major electronic databases. Eligible studies included randomized con-
media with effusion, surgical treatments, systematic review, trolled trials, nonrandomized trials, and cohort studies that compared
tympanostomy tubes myringotomy, adenoidectomy, tympanostomy tubes (tubes), and watch-
ABBREVIATIONS ful waiting. Using established criteria, pairs of reviewers indepen-
AOM—acute otitis media dently selected, extracted data, rated risk of bias, and graded
CI—confidence interval
CINAHL—Cumulative Index to Nursing and Allied Health Literature strength of evidence of relevant studies. We incorporated meta-analyses
EPC—Evidence-based Practice Center from the earlier reviews and synthesized additional evidence qualitatively.
KQ—key question
OME—otitis media with effusion
RESULTS: We identified 41 unique studies through the earlier reviews
PICOTS—populations, interventions, comparators, outcomes, and our independent searches. In comparison with watchful waiting or
time frames, and settings myringotomy (or both), tubes decreased time with OME and improved
RCT—randomized controlled trial
hearing; no specific tube type was superior. Adenoidectomy alone, as
SOE—strength of evidence
an adjunct to myringotomy, or combined with tubes, reduced OME and
Dr Wallace selected articles for inclusion, extracted data, graded
the strength of evidence, and drafted and revised the improved hearing in comparison with either myringotomy or watchful
manuscript; Dr Berkman selected articles for inclusion, waiting. Tubes and watchful waiting did not differ in language, cogni-
extracted data, graded the strength of evidence, and reviewed tive, or academic outcomes. Otorrhea and tympanosclerosis were
and revised the manuscript; Dr Lohr selected articles for
inclusion and reviewed and revised the manuscript; Drs
more common in ears with tubes. Adenoidectomy increased the risk
Harrison, Kimple, and Steiner selected articles for inclusion, of postsurgical hemorrhage.
extracted data, and reviewed the manuscript; and all authors
CONCLUSIONS: Tubes and adenoidectomy reduce time with OME and
approved the final manuscript as submitted.
improve hearing in the short-term. Both treatments have associated
www.pediatrics.org/cgi/doi/10.1542/peds.2013-3228
harms. Large, well-controlled studies could help resolve the risk-
doi:10.1542/peds.2013-3228
benefit ratio by measuring acute otitis media recurrence, functional
Accepted for publication Nov 1, 2013
outcomes, quality of life, and long-term outcomes. Research is needed
Address correspondence to Ina F. Wallace, PhD, Division for to support treatment decisions in subpopulations, particularly in
Health Services and Social Policy Research, RTI International, PO
Box 12194, Research Triangle Park, NC 27709–2194. E-mail: patients with comorbidities. Pediatrics 2014;133:1–16
wallace@rti.org
PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).
Copyright © 2014 by the American Academy of Pediatrics
FINANCIAL DISCLOSURE: The authors have indicated they have
no financial relationships relevant to this article to disclose.
FUNDING: Funded by the Agency for Healthcare Research and
Quality, US Department of Health and Human Services, through
contract 290-2007-10056-I awarded to RTI International for the
RTI International-University of North Carolina Evidence-based
Practice Center. In addition, Dr Wallace received funding from
RTI International to complete the manuscript.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated
they have no potential conflicts of interest to disclose.

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Otitis media with effusion (OME) is de-
fined as a collection of fluid in the middle
ear without signs or symptoms of acute
ear infection.1 Fluid in the middle ear
decreases tympanic membrane and
middle ear function, leading to conduc-
tive hearing loss, “fullness” in the ear,
and occasional pain from the pressure
changes. Children with OME often have
a conductive hearing loss on pure-tone
audiometry that measures at 25 dB,
a level that is 10 dB worse than the level
for children with normal hearing. OME
occurs commonly during childhood; as
many as 90% of children (80% of in-
dividual ears) have at least 1 episode of
OME by age 10.2 Many episodes of OME
resolve spontaneously within 3 months,
but 5% to 10% of episodes last more than
1 year; 30% to 40% of children have re-
current episodes.1,3,4
Despite the high prevalence of OME, its
long-term impact on child developmental
outcomes, such as speech, language,
intelligence, and hearing remain dis-
puted.5 A recent systematic review of
the natural history of OME found mixed
evidence regarding the impact of OME in
early childhood on later developmental
outcomes.2 Lacking clear evidence that
OME influences children’s development,
clinicians struggle with decision-making
for this common condition. Many chil-
dren with OME are actively treated; the
annual total cost of treating OME in the
United States in 1995 was estimated at
$4 billion2 and may well be higher today.
The near universality of OME in children
and the high cost of its treatment make
it an important topic for a comparative
review of treatment modalities. Ac-
cordingly, the Agency for Healthcare
Research and Quality commissioned
the RTI-University of North Carolina
Evidence-based Practice Center (EPC) to
conduct a systematic review of the
comparative effectivenessandharmsof
treatments for OME. Our review was not
designed to examine whether OME
should be treated.6 Rather, we examined
2 WALLACE et al
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the relative effectiveness of a range of
treatment options (tympanostomy tubes
[tubes], myringotomy, adenoidectomy,
oral or topical nasal steroids, auto-
inflation, complementary and alterna-
tive medicine procedures, variations
in surgical technique or procedures,
and watchful waiting) in patients with
OME of any age.
This article focuses solely on surgi-
cal interventions (ie, myringotomy,
adenoidectomy, and tubes) and their
comparators.IntheUnitedStates,surgical
treatments are common interventions for
persistent or recurrent OME. In contrast,
steroids are not recommended in current
guidelines,7 and a recent review did not
find them to be effective8; autoinflation
is uncommon; and no randomized con-
trolled trials (RCTs) provided evidence
concerning complementary and alterna-
tive medicine procedures. A recent sys-
tematic review of antibiotics did not
support routinely treating children di-
agnosed with OME with antibiotics.9
We attempted to answer 5 key questions
(KQs) concerning treatment compar-
isons for patients with OME: What is the
comparative effectiveness of surgical
treatments and watchful waiting in (1)
affecting clinical outcomes or health
care use and (2) improving functional
and health-related quality of life out-
comes? (3) What are the harms or
tolerability of the different treatment
options? (4) What are the comparative
benefits and harms of treatment
options in subgroups of patients? (5)
Is the comparative effectiveness of
treatment options related to factors
affecting health care delivery or the
receipt of pneumococcal vaccine in-
oculation? In reviewing the evidence
to answer these questions, we were
particularly interested in (1) deter-
mining whether we could find evidence
to examine treatments in patient
groups not included in earlier reviews,
suchaschildrenwithadditionaldiagnoses,
(2) examining a range of functional
outcomes, in addition to short-term
clinical outcomes and harms, and (3)
providing1 crosscuttingreview covering
all surgical strategies that clinicians use
for treating OME.
METHODS
Data Sources and Search Strategy
We first considered systematic reviews
recently completed by the Cochrane
Collaboration or commissioned by a
national government. Three system-
atic reviews investigated tubes and
adenoidectomy and included data from
randomized trials and nonrandomized
studies.10–12 Comparison treatments in-
cluded watchful waiting, myringotomy,
and different tube types and insertion
techniques. We then identified newer
trials and observational studies through
searches of Medline (via PubMed),
Embase, the Cochrane Library, and the
Cumulative Index to Nursing and Allied
Health Literature (CINAHL) for studies
published in English and conducted in
any geographic location or setting. Our
initial search (January 8, 2012) was
updated on August 13, 2012 and August
5, 2013. The Supplemental Information
provides the initial set of search terms;
Appendix A of the full report documents
the complete set of search terms.6
Study Selection and Data
Abstraction
We developed inclusion and exclusion
criteria with respect to a framework
specifying populations, interventions,
comparators, outcomes, timeframes, and
settings (PICOTS). Table 1 presents the
PICOTS for the study. We included studies
of individuals of any age or background
with OME (and concurrent comorbidity);
if other populations were included in
a study, data had to have been analyzed
separately for those with OME.
We used a dual review process to review
each abstract andfull-textarticlebyusing
the inclusion/exclusion criteria. If the
reviewers disagreed about an exclusion
 REVIEW ARTICLE

TABLE 1 Inclusion and Exclusion Criteria for Studies of OME

Domain Description
Population All individuals with OME. Subpopulations include infants; adults; individuals from different racial/ethnic backgrounds; and special
populations of any age, including individuals with craniofacial abnormalities (eg, cleft palate), Down syndrome, existing hearing loss,
delays in speech and language, or a history of AOM or OME.
Interventions • Surgical interventions: tympanostomy tubes (also referred to as pressure-equalization tubes, grommets, and ventilation tubes),
myringotomy (also referred to as paracentesis), and adenoidectomy with or without myringotomy.
Comparator • Different combinations of the above interventions and strategies. These include head-to-head comparisons of 1 or more treatments,
treatment strategies (eg, watchful waiting/delayed treatment versus early treatment), or surgical procedures and techniques
(eg, 1 type of tympanostomy tube or procedure versus another or different adjunct therapies to enhance the main intervention).
We considered head-to-head trial evidence and observational study data.
Outcomes • Clinical outcomes: changes in middle ear fluid, episodes of AOM, hearing thresholds, vestibular function (ie, balance and coordination).
• Health care utilization: number of office visits, number of surgeries, and medication use.
• Functional and quality-of-life outcomes: hearing, auditory processing, speech and language development, cognitive functioning,
academic achievement, attention and behavior, quality of life, and parental satisfaction with care.
• Harms: all reported harms for each treatment option.
Timing Shorter studies looking at outcomes 0 to ,3 mo postintervention.
Longer studies looking at outcomes past 3 mo and into adolescence or adulthood.
Setting Studies conducted in the United States or internationally.
Interventions provided in primary care offices where the patient is seen by a pediatrician, family physician, or nurse practitioner;
subspecialist physician offices where the patient is seen by an otolaryngologist; surgical settings within a hospital or outpatient clinic;
emergency departments; and craniofacial treatment centers.

decision or the primary criteria for
exclusion, they resolved conflicts by
consensus discussion. We abstracted
detailed PICOTS data from newly included
studies and summarized information
from studies included in the earlier
systematic reviews into evidence tables.
Risk-of-Bias Assessment
Two independent reviewers rated the
risk of bias for each newly identified
study by using the Cochrane Risk of Bias
tool for RCTs13; our EPC developed ad-
ditional or alternative questions for
evaluating observational studies; for
studies from the earlier systematic
reviews, we relied on the original
authors’ ratings.10–12 We evaluated the
risk of bias of each of the systematic
reviews using AMSTAR (A Measurement
Tool to Assess Systematic Reviews).14
The 2 reviewers resolved disagree-
ments by consensus discussion. We
assigned risk-of-bias ratings of low,
medium, or high; high risk-of-bias stud-
ies had at least 1 major issue with the
potential to cause significant bias that
might invalidate the results.
Data Synthesis
Evidence for this synthesis included
results from meta-analyses conducted
by the earlier Cochrane Review authors,
additional data from individual studies
in those systematic reviews, and the
new studies from our searches. New
studies did not lend themselves to ei-
ther new pooled analyses or to modi-
fying earlier meta-analyses. Therefore,
we summarized the new evidence
qualitatively.
Strength of the Body of Evidence
Two team members independently
graded the strength of evidence (SOE)
to answer each KQ, for each treatment
comparison, following EPC guidance.15
The overall grade for SOE (high, mod-
erate, low, or insufficient) is based
on ratings for 4 domains: risk of bias,
consistency, directness, and precision.
It reflects reviewers’ confidence
in the ability of a given body of evi-
dence to answer KQs. We resolved
disagreements through consensus
discussions.
RESULTS
Literature Searches and
Characteristics of Included Studies
We identified 5112 unduplicated citations
in our literature searches (this included
surgical and nonsurgical treatment
options); 776 met criteria for full-text
review (Fig 1). We excluded 696 full-text
articles based on our inclusion criteria
(before the risk-of-bias assessment),
leaving 80 included articles, of which 3
were systematic reviews. We recorded
the reason that each excluded full-text
publication failed to satisfy the eligibility
criteria and compiled a comprehensive
list of such studies (Appendix B of
the full report6). Of the 77 articles, 23
were omitted from our analyses for de-
termining benefit because of high risk of
bias in their study design (see Appendix
E of the full report6). One article de-
termined to be at high risk of bias for
determining benefit was included for
harms only.
In this report, we discuss the subset of
studies providing evidence on surgical
interventions: 3 systematic reviews, 41
studiesreportedin55includedarticles.Of
the 55 articles, 24 were included in an
earlier systematic review, 13 were
follow-up studies, and 18 were newly
identified.
Table 2 summarizes the 41 unique
studies that constitute the evidence
base for this article; we specify study
characteristics and risk of bias ratings.
Of these, 5 studies were included in

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FIGURE 1
Flow diagram of study retrieval and selection. a We accepted the risk of bias assessment conducted by the review authors for the studies included in 1 of the 3
earlier systematic reviews (37 articles). We conducted our own risk of bias assessment for 18 new articles not included in 1 of those reviews. b One article
was included for harms only.

more than 1 of the 6 main categories of
comparisons. We assessed the 2 sys-
tematic reviews limited to RCTs as low
risk of bias11,12 and the third as medium
risk of bias.10
Comparative Effectiveness for
Clinical Outcomes
Most studies examined some clinical
outcomes: most commonly, signs and
symptoms of OME and hearing. A few
studies examined subsequent acute
otitis media (AOM). Table 3 documents
findings on effectiveness in terms of
clinical outcomes separately by treat-
ment comparisons; we give results
only when evidence was sufficient to
draw a conclusion.
Tympanostomy Tube Comparisons
Eleven studies (8 RCTs) provided evi-
dence concerning differences in clini-
cal outcomes comparing tubes (by
design, materials, size), insertion
techniques, or topical prophylaxis
therapies by comparing ears in the
same child.16–25 Length of tube re-
tention was longer in tubes that man-
ufacturers identified as “long-term
tubes.” Specifically, Goode T-tubes and
Paparella tubes were retained longer
than Shah and Shepard tubes. Because
of sparse data, diversity of compar-
isons, and inconsistent findings, the
evidence is insufficient for compar-
isons of other design features or for
clinical outcomes.
Tympanostomy Tubes Versus
Myringotomy or Watchful Waiting
Twelve RCTs compared tubes with ei-
ther myringotomy or no surgery (ie,
watchful waiting, delayed treatment); of
these, 10 studies26–35 were included in
previous systematic reviews,10,11 and 2
were new.36,37
Tube placement decreased the time
with middle ear effusion by 32% in
comparison with watchful waiting or
delayed treatment at 1 year after sur-
gery (high SOE). Relative to a combined
comparison group of watchful waiting
or myringotomy, tubes reduced effu-
sion by 13% through 2 years after
surgery (moderate SOE). Evidence was
insufficient for longer follow-up.

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 REVIEW ARTICLE

TABLE 2 Characteristics of Studies of Surgical Interventions for OME

Treatment Comparison Types of Treatments/ Study Designs, Sample Size, Patient
Comparisons Duration, Quality Rating Characteristics
Tympanostomy tube comparisons
14 studies (8 in 1 previous
systematic review)
Wielinga et al 199016 Silicone Goode TT versus RCT by ear Mean age: 79.2 mo
Teflon Armstrong TT n = 15 (30 ears) Male: 60%
Follow-up: average 6.8 y
Medium ROB
Abdullah et al 199417 Silicone Shah permavent TT NRCT by ear Mean age: 72 mo
versus Polyethylene Shah TT n = 25 (50 ears) Male: 64%
Follow-up: 29 mo
Medium ROB
Licameli et al 200818 Phophoryl-choline coated RCT by ear Mean age: 19 mo
fluroplastic Armstrong TT n = 70 (140 ears) Male: 64.3%
versus uncoated fluroplastic Follow-up: 24 mo
Armstrong TT Medium ROB
Iwaki et al 199819 Teflon Shepard TT versus Silicone RCS by ear Mean age: 72.1 mo
Goode T-tube versus Silicone n = 137 (220 ears) Male: 62%
Paraprella II TT Follow-up: 24 mo
Medium ROB
Ovensen et al 200020 TT + acetylcysteine versus RCT by person and ear Mean age: 38 mo
TT + placebo n = 75 (150 ears) Male: 64%
Follow-up: 39 mo
Medium ROB
Slack et al 198760 Shepard TT versus Shah TT RCS by ear Mean age: unknown
versus Paparella TT n = 559 ears (,16 y)
Follow-up: Until extrusion Male: unknown %
or end of study period
High ROB
Hesham et al 201263 TT + mitomycin C versus TT RCT by ear Mean age: 5.8 y
(adenoidectomy in 55% and n = 55 (110 ears) Male: 58%
adenotonsillectomy in 20% Follow-up: .6 mo
when warranted) Medium ROB
Studies in Hellstrom
et al 201110
Hampal et al 199121 Shah TT versus Mini Shah TT RCT by ear Mean age: unknown
n = 116 (3–7 y)
Dingle et al 199373 Follow-up: 1 y Male: unknown %
Medium ROB (Hellstrom)

Heaton et al 199122 Shepard TT versus Sheehy TT RCT by ear Mean age: 72 mo

Hern & Jonathan, 199923
n = 146 (292 ears) Male: 64%
Follow-up: 21–36 mo
Medium ROB (Hellstrom)
Shah TT place in anterosuperior RCT by ear Mean age: unknown
quadrant versus Shah place n = 54 (108 ears) (,12 y)
interoinferior quadrant Follow-up: 26 mo Male: unknown %
Medium ROB (Hellstrom)

Youngs & Gatland, 198824 Shah Teflon TT + aspiration before RCT by ear Mean age: 68 mo
McRae et al 198974 placement versus Shah Teflon n = 55 (110 ears) Male: 65.4%
TT (no aspiration) Follow-up: 18 mo
Medium ROB (Hellstrom)
Pearson et al 199625 Shah Teflon TT + steroid otic drops NRCT by ear Mean age: 75.6 mo
preoperative versus Shah n = 165 (330 ears) Male: 66%
Teflon TT no drops Follow-up: 29 mo
Medium ROB
Kinsella et al 199461 Shepard TT no-touch technique NRCT by ear Mean age: 51 mo
versus Shepard TT touch technique n = 60 (120 ears) Male: 43.3%
Follow-up: 7–10 d
Medium ROB (Hellstrom)

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TABLE 2 Continued
Treatment Comparison
Salam & Cable, 199362
Hampton & Adams, 199675
Tubes versus watchful
waiting or myringotomy
12 studies (10 in 1 previous
systematic review, 6 of
which were in another
previous systematic review)
Koopman et al 200436
Mandel et al 198937
Studies in Browning
et al 201011
Maw et al 199926,a
Wilks et al 200058
Hall et al 200955
MRC Multicentre Otitis
Media Group, 200327
MRC Multicentre Otitis
Media Group, 201254
Rovers et al 200028,a
Rovers et al 200159
Gates et al 198729,a
Gates et al 198946
Mandel et al 199230
Paradise et al 200131,a
Johnston et al 200464
Paradise et al 200556
Paradise et al 200757
Black et al 199032
Dempster et al 199333,a
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Types of Treatments/ Study Designs, Sample Size, Patient
Comparisons Duration, Quality Rating Characteristics
Sheehy TT + otic drops versus RCT by ear Mean age: 55.2 mo
Sheehy TT (no drops) n = 162 (324 ears) Male: 41.4%
Follow-up: 2 wk
Medium ROB
Armstrong TT anterior RCT by ear Mean age: 66 mo
placement versus n = 109 (218 ears) Male: 59.6%
Armstrong TT Follow-up: 6 wk to 29 mo
posterior placement Medium ROB
Unilateral TT + cold knife RCT by ear Mean age: 50.4 mo
myringotomy versus n = 208 (416 ears) Male: 51.9%
laser myringotomy Follow-up: 6 mo
Medium ROB
TT + myringotomy versus RCT Age: 45.7 mo
myringotomy versus n = 109 Male: 66.9%
watchful waiting Follow-up: 3 y
Medium ROB
Bilateral TT versus watchful RCT Mean age: 35.4 mo
waiting n = 182 Male: 48.4%
Follow-up: 18 mo
Low ROB (Hellstrom)
Bilateral TT versus watchful RCT Mean age: 62.7 y
waiting n = 241 Male: 50.6%
Follow-up: 2 y
, High ROBb
Bilateral TT versus watchful RCT Mean Age: unknown
waiting n = 187 Male: 58.8%
Follow-up: 12 mo
Medium ROB (Hellstrom)
Bilateral TT versus myringotomy RCT Mean Age: unknown
n = 236 Male: 59.3%
Follow-up: 2 y
Low ROB (Hellstrom)
Bilateral TT versus RCT Mean age: 45.4 mo
myringotomy versus n = 111 Male: 66.7%
watchful waiting Follow-up: 3 y
, High ROBb
Bilateral TT versus delayed RCT Mean age: 15 mo
treatment n = 429 Male: 56.9%
Follow-up: 3 y of age
Medium ROB (Hellstrom)
Unilateral TT versus RCT (by person and ears) Mean age: 72.6 mo
myringotomyc n = 74 (148 ears) Male: 64.9%
Follow-up: 24 mo
, High ROBb
Unilateral TT versus no RCT (by person and ear) Mean age: 68.4 mo
surgeryc n = 35 (70 ears) Male: 65.7%
Follow-up: 12 mo
, High ROBb
 REVIEW ARTICLE

TABLE 2 Continued
Treatment Comparison Types of Treatments/ Study Designs, Sample Size,
Comparisons Duration, Quality Rating
Maw & Herod, 198634,a; Unilateral TT versus no surgeryc RCT (by person and ear)
Maw & Bawden, 199465 56 (112 ears)
Follow-up: 12 mo
Medium ROB (Hellstrom)
Rach et al 199135 Bilateral TT versus watchful waiting RCT
n = 43
Follow-up: 6 mo
, High ROBb
Patient
Characteristics
Mean age: 63.7 mo
Male: 57.1%
Mean age: unknown
(all preschoolers)
Male: unknown %

TT plus adenoidectomy
versus myringotomy plus
adenoidectomy or
adenoidectomy alone
11 studies (4 in 1 previous
systematic review)
Brown et al 197838 TT (Shepard) + adenoidectomy RCT by ear Mean age: unknown
versus adenoidectomy n = 55 (110 ears) (4–10 y)
Follow-up: 5 y Male: unknown %
Medium ROB

Austin, 199439 TT + adenoidectomy versus RCT by ear Mean age: unknown

adenoidectomy n = 31 (62 ears) Male: unknown %
Follow-up: 3 mo
Medium ROB
Lildholdt, 197940 TT (Donaldson) + adenoidectomy NRCT by ear Mean age: 48 mo
versus adenoidectomy n = 91 (182 ears) Male: 59.3%
Follow-up: until
extrusion or 8 mo
Medium ROB
D’Eredita & Shah, 200641 TT (Shah mini) + adenoidectomy RCT Mean age: 44.4 mo
versus CDLM + adenoidectomy n = 30 Male: 56.7%
Follow-up: 12 mo
Medium ROB
Popova et al 201042 TT (Donaldson) + adenoidectomy RCT Mean age: 60.6 mo
versus myringotomy + n = 30 Male: 53.8%
adenoidectomy Follow-up: 12 mo
Medium ROB
Shishegar & Hobhoghi, TT (Shepard) + adenoidectomy RCT by ear Mean age: unknown
200743 versus myringotomy + n = 30 (60 ears) (4–8 y)
adenoidectomy Follow-up: 6 mo Male: 63.3%
Medium ROB

Vlastos et al 201144 TT (Shepard) + adenoidectomy RCT Mean age: 54 mo

versus myringotomy + n = 52 Male: 55.8%
adenoidectomy Follow-up: 12 mo
Medium ROB
Studies in Hellstrom
et al 201110
Gates et al 198946 TT + adenoidectomy versus RCT Mean age: unknown
myringotomy + adenoidectomy n = 255 (4–8 y)
Follow-up: 2 y Male: 58.5%
Low ROB (Hellstrom)

Maw & Bawden, 199448 TT (Shepard) +adenoidectomy/ RCT by person and ear Mean age: unknown
adenotonsillectomy versus n = 139 (270 ears) (3–9 y)
adenoidectomy/adenotonsillectomy Follow-up: 10 y Male: unknown %
Medium ROB (Hellstrom)

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TABLE 2 Continued
Treatment Comparison
Lildholdt, 198347
Bonding & Tos, 198545
Tos & Stangerup, 198966
Caye-Thomasen et al 200867
Myringotomy comparison
1 study
Ragab, 200549
Myringotomy with
adenoidectomy
comparison
1 study
Szeremeta et al 200050
Adenoidectomy comparisons
8 studies (7 in 1 previous
systematic review)
MRC Multicentre Otitis
Media Group 201254
In van Aardweg et al 201011
Black et al 199032,d
Dempster et al 199333,e
Maw & Herod, 198634,e
Filleau-Nikolajsen
et al 198051
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Types of Treatments/ Study Designs, Sample Size, Patient
Comparisons Duration, Quality Rating Characteristics
TT (Donaldson) + adenoidectomy RCT by ear Mean age: 46.8 mo
versus adenoidectomy n = 150 (300 ears) Male: 56.7%
Follow-up: 5 y
Medium ROB (Hellstrom)
TT (Donaldson) + adenoidectomy NRCT by ear Mean age: unknown
versus myringotomy + n = 224 (448 ears) Male: unknown %
adenoidectomy Follow-up: 6–7 y
Medium ROB (Hellstrom)
Intervention: Radiofrequency RCT by ear Mean age: 60 mo
myringotomy + mitomycin C n = 60 Male: unknown %
Comparison: Radiofrequency Follow-up: 3 mo
myringotomy Medium ROB
Intervention: Laser myringotomy + RCT by ear Mean age: 83.9 mo
adenoidectomy n = 49 (87 ears) Male: unknown %
Comparison: Cold knife Follow-up: 6–48 mo
myringotomy + adenoidectomy Medium ROB
Adenoidectomy + bilateral TT RCT Mean age: 63.6 mo
(Shepard) versus bilateral n = 376 Male: 48.9%
TT (Shepard) versus WW Follow-up: 24 mo
Medium ROB
Adenoidectomy versus no surgery RCT by person and ear Mean age: 75 mo
Adenoidectomy versus Adenoidectomy + unilateral TT n = 149 (149 ears) Male: 58.4%
Adenoidectomy versus unilateral TT Follow-up: 2 y
Adenoidectomy + unilateral TT , High ROBb
versus no surgery
Adenoidectomy + unilateral TT
versus unilateral TT
Adenoidectomy + unilateral TT RCT by person and ear Mean age: 69.6 mo
versus unilateral TT n = 72 (72 ears) Male: 55.6%
Adenoidectomy versus no surgery Follow-up: 12 mo
Medium ROB (Hellstrom)
Adenoidectomy + unilateral TT RCT by person and ear Mean age: 63 mo
(Shepard) versus unilateral n = 103 (103 ears) Male: 66%
TT (Shepard) Follow-up: 12 mo
Adenoidectomy versus no surgery Medium ROB (Hellstrom)
Adenoidectomy + RCT Mean age: unknown
myringotomy n = 42 (3 y old cohort)
versus myringotomy Follow-up: 6 mo Male: 50%
, High ROBb
 REVIEW ARTICLE

TABLE 2 Continued
Treatment Comparison Types of Treatments/ Study Designs, Sample Size, Patient
Comparisons Duration, Quality Rating Characteristics
Gates et al 198729,e Adenoidectomy + RCT Mean age: unknown
Myringotomy versus n = 491 (4–8 y)
Adenoidectomy + TT Follow-up: 2 y Male: 58.9%
(Shepard) versus Low ROB (Hellstrom)
Myringotomy versus
TT (Shepard)
Roydhouse, 198052 Adenoidectomy + TT RCT Mean age: 85 mo
versus TT versus n = 169 Male: 55.9%
medical treatment Follow-up: 6 y
, High ROBb
Casselbrant et al 200953 Adenoidectomy + TT RCT Mean age: 34.6 mo
(Armstrong) versus n = 98 Male: 66.4%
Adenoidectomy + Follow-up: 36 mo
myringotomy versus + , High ROBb
TT (Armstrong)
For studies with more than 1 publication, the first listed is the primary source and the others are supplementary or follow-up articles. CDLM, contact diode laser myringotomy; NRCT,
nonrandomized controlled trial; RCS, retrospective cohort study; ROB, risk of bias; TT, tympanostomy tubes; WW, watchful waiting.
a In Hellstrom et al 2011.10
b Risk of bias analyses performed by authors of systematic review; the authors only included studies that were low or medium, but they did not indicate what the risk of bias was for individual

studies.
c Included only the arm randomized to no adenoidectomy.
d In Browning et al 2010.11
e In Browning et al 201011 and Hellstrom et al 2011.10

Tubes improved hearing in the short-
term: up to 9 months after surgery in
comparison with watchful waiting (3–6
months: 8.8 dB; 6–9 months: 4.2 dB)
(high SOE); up to 6 months after surgery
in comparison with either watchful
waiting or myringotomy (4–6 months:
10 dB) (high SOE). Thereafter, the dif-
ferences in hearing became attenuated
and were not statistically significant at 7
to 12 months compared with watchful
waiting or myringotomy (low SOE) or at
12 to 18 months compared with just
watchful waiting (low SOE). Evidence
was insufficient for longer time periods
and for other clinical outcomes.
Tympanostomy Tubes Plus
Adenoidectomy Versus Myringotomy
Plus Adenoidectomy or
Adenoidectomy Alone
Seven studies that we newly identified38–44
and 4 studies45–48 reported in the
Hellstrom et al10 review examined out-
comes for adenoidectomy plus differ-
ent adjunctive therapies. Specifically,
we compared the effectiveness of
tubes when added to adenoidectomy
with myringotomy or no surgery. Two
small studies failed to find a differ-
ence between tubes plus adenoidectomy
and adenoidectomy alone in reducing
OME recurrence (insufficient evidence).
Results of 3 studies comparing tubes
and adenoidectomy with myringotomy
plus adenoidectomy on OME recurrence
were mixed (insufficient evidence). For
hearing measured at various times,
ranging from 1 month to 6 years, 5
studies failed to find a difference in
hearing between the addition of tubes
versus myringotomy (low SOE for no
difference). We found mixed results
for hearing in studies that compared
the additive impact of tubes with
adenoidectomy alone (insufficient ev-
idence).
Myringotomy Comparisons
One RCT compared 2 different proce-
dures for myringotomy (radiofrequency
myringotomy with and without mito-
mycin C) on both middle ear and
hearing outcomes.49 Most individuals
in each arm received adenoidectomy
(73% and 67%, respectively). Evi-
dence was insufficient for conclud-
ing superiority of either procedure
concerning OME effusion or hearing
outcomes.
Myringotomy Plus Adenoidectomy
Comparisons
One retrospective cohort study com-
pared laser myringotomy with cold
knife myringotomy in children also
receiving an adenoidectomy.50 Be-
cause evidence was limited to 1 ob-
servational study, we concluded that
it was insufficient for determining the
superiority of either myringotomy
approach in relation to OME signs and
symptoms.
Adenoidectomy Versus Other
Interventions
Eight RCTs (11 articles) provided evi-
dence for adenoidectomy compared
with tubes, myringotomy, watchful
waiting, or no adenoidectomy (unilat-
eral ear surgery with nonoperated
ear as comparison) (Table 2). Seven
trials29,32–34,51–53 were from the van den
Aardweg et al systematic review12; the
eighth was the newly published Trial
of Alternative Regimens in Glue Ear
Treatment study.54

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TABLE 3 SOE for Interventions to Improve Clinical Outcome
Intervention and Comparator
TT versus watchful waiting,
delayed treatment, or
myringotomy
TT + adenoidectomy versus
myringotomy + adenoidectomy
or adenoidectomy alone
Adenoidectomy versus no
adenoidectomy (ears in each
group randomized to TT or no
TT; only no TT ears examined
in this comparison)
Adenoidectomy + myringotomy
versus myringotomy
TT + adenoidectomy versus
watchful waiting
MA, meta-analysis; NRCT, nonrandomized controlled trial; OR, odds ratio; TT, tympanostomy tube.
No. of Studies (Sample Sizes)
MA of 3 RCTs (n = 574)
MA of 3 RCTs (n = 426)
MA of 3 RCTs (n = 523) +
1 RCT (n = 248)
MA of 3 RCTs (by ears)
(n = 230)
MA of 3 RCTs (by ears)
(n = 234)
MA of 2 RCTs (n = 328);
MA of 2 RCTs (n = 283)
6 studies: 3 RCTs by
person (n = 431)
2 RCTs (by ears) (n = 338)
1 NRCT (by ears) (n = 193)
MA of 2 RCTs (by ears)
(n = 153); MA of 3
RCTs (by ears) (n = 297)
MA of 3 RCTs (by ears)
(n = 298)
1 RCT (n = 237)
1 RCT (n = 237)
1 study (n = 250)
Outcome and Results SOE
TT decreased persistent middle ear effusion at 1 y High for benefit
compared with watchful waiting or delayed
treatment: 32% less time (95% CI 17% to 48%)
TT decreased persistent middle ear effusion at 2 y Moderate for
compared with watchful waiting or myringotomy: benefit
13% less time (95% CI 8% to 17%)
TT had better measured hearing for up to 9 mo than High for benefit
watchful waiting. MA results: –4.20dB
(95% CI –4.00 to –2.39)
TT had better measured hearing for up to 6 mo than High for benefit
watchful waiting or myringotomy: –10.08
(95% CI –19.12 to –1.05)
No difference was observed between TT and watchful Low for no
waiting or myringotomy in measured hearing at difference
7–12 mo: –5.18dB (95% CI –10.43 to 0.07)
No difference was observed between TT and watchful Low for no
waiting in measured hearing at 12 mo: –0.41dB difference
(95% CI –2.37 to 1.54) and 18 mo –0.02 dB
(95% CI –3.22 to 3.18)
No difference was observed in measured hearing Low for no
between groups at 6 and 12 mo and at more than 3 y. difference
Adenoidectomy produced better OME resolution than no High for benefit
treatment at 6 mo. The risk difference was 0.27 (95%
CI 0.13 to 0.42) measured through otoscopy and 0.22
(95% CI 0.12 to 0.32) measured through tympanometry.
Adenoidectomy produced better OME resolution than no High for benefit
treatment at 12 mo. The risk difference was 0.29
(95% CI 0.19 to 0.39).
Adenoidectomy and myringotomy produced less mean Low for benefit
time with effusion than myringotomy alone at 24 mo:
–0.76 standard mean difference (95% CI –1.02 to –0.49).
Adenoidectomy and myringotomy produced better hearing Low for benefit
than with myringotomy alone at 24 mo measured as
standard mean difference time with hearing level $20:
worse ear: –0.65 (95% CI –0.91 to –0.39);
better ear: –0.66 (95% CI –0.93 to –0.40).
TT plus adenoidectomy improved hearing at 3 to 24 mo. Low for benefit

Adenoidectomy was superior to no
adenoidectomy for resolution of OME
at 6 months postsurgery measured
through otoscopy (risk difference
of 0.27, 95% confidence interval [CI]
0.13–0.42) and through tympanometry
(0.22, 95% CI 0.12–0.32) (high SOE for
both). It was also superior at 12 months
postsurgery measured through tympa-
nometry (risk difference of 0.29, 95% CI
0.19–0.39) (high SOE).
Hearing outcomes were superior with
adenoidectomy compared with no
adenoidectomy in 1 RCTat 6 months but
not at 12 months. In a second RCT,
investigators detected no differences
(insufficient evidence for mixed find-
ings).
One RCT found that adenoidectomy and
myringotomy were superior to myr-
ingotomy alone for reducing time with
effusion and for improving hearing at 24
months (better ear standard mean
difference of –0.66, 95% CI –0.93 to
–0.40) (low SOE). The evidence was in-
sufficient for determining the effec-
tiveness of adenoidectomy plus tubes
in relation to effusion or hearing be-
cause outcome results were mixed.
Hearing outcomes were superior with
adenoidectomy and tubes in compari-
son with watchful waiting at 24 months
(low SOE). Evidence was insufficient
to determine the effectiveness of
adenoidectomy compared with other
treatments for recurrence of AOM.
Comparative Effectiveness for
Functional Outcomes or Quality of
Life
Two treatment comparisons (tubes
versus watchful waiting and tubes plus
adenoidectomy versus myringotomy plus
adenoidectomy) included functional or
quality-of-life outcomes (Table 4).
Four trials (7 articles) reported on
language26,28,31,35,55–57; 2 trials (5 articles)
reported on cognitive development,

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 REVIEW ARTICLE

academic achievement, or both26,31,55–57; Tympanostomy Tubes Plus waiting or myringotomy.28,30,33,36,37,46,54,64,65

and 3 trials (7 articles)26,31,36,37,55–59
reported on behavioral competence.
Tympanostomy Tubes Versus Watchful
Waiting or Myringotomy
Meta-analyses reported by Browning
et al11 included trials conducted
by Maw and colleagues,26,55 Rovers
and colleages,28 Paradise and col-
leagues,31,56,57 and Rach and col-
leagues.35 The meta-analyses comparing
tubes with watchful waiting did not find
any differences in language at 6 and 9
months after treatment (moderate SOE
for no differences). With 1 exception,
trials examining children during pre-
school and elementary school years
failed to find a difference in language
skills (low SOE for no difference).55–57
In the 1 exception, the difference dis-
appeared at 8 years of age. We did
not find differences between tubes
and watchful waiting in any trials
reporting cognitive development, aca-
demic achievement, or quality of life at
any time point (all low SOE for no dif-
ference). Studies reported mixed find-
ings for behavior outcomes at ,1 year
(insufficient evidence); 3 trials reporting
behavior at 1 year or more after treat-
ment reported no difference (low SOE).
No studies comparing tubes with
myringotomy reported on functional
or quality-of-life outcomes (insufficient
evidence).
Adenoidectomy Versus Myringotomy
Plus Adenoidectomy
One trial comparing adenoidectomy
plus the addition of tubes versus myr-
ingotomy did not find differences in
quality of life at any time point (in-
sufficient evidence); no other functional
outcomes were reported.44
Harms of Treatments for OME
Most studies examining surgical com-
parisons reported on harms. Table 5
provides the findings and SOE for
harms by treatment comparisons.
Tympanostomy Tube Comparisons
Eleven studies that compared tube
length or insertion techniques reported
on otorrhea.16–20,22,25,60–63 Longer-term
tubes related to a higher probability of
otorrhea in 3 studies16,19,60 (low SOE).
Evidence about otorrhea was in-
sufficient for other tube comparisons.
For other harms, such as perforation,
cholesteatoma, occlusion, tympa-
nosclerosis, and the presence of
granulation tissue, the evidence was
too limited to determine a direction of
effect (insufficient evidence).
Tympanostomy Tubes Versus Watchful
Waiting or Myringotomy
Nine trials compared side effects for
tubes with side effects for watchful
Otorrhea and tympanosclerosis occurred
more frequently in ears with tube place-
ment than in ears with watchful waiting
or myringotomy (low SOE). Evidence was
insufficient for other harms because of
either conflicting results or data reported
in only a single study.
Tubes Plus Adenoidectomy Versus
Myringotomy Plus Adenoidectomy or
Adenoidectomy Alone
We reviewed 9 trials (11 articles)
thatexamined harmsof theseprocedures,
including repeat tubes, otorrhea, perfo-
ration, and tympanosclerosis.38,40–47,66,67
In 3 trials (4 articles) (all partic-
ipants with adenoidectomy),38,45,47,66
the risk of tympanosclerosis was
higher with tubes than with myr-
ingotomy or no ear surgery (moder-
ate SOE). Results for other harms
were mixed, reported in single stud-
ies, or lacked precision (insufficient
evidence).
Adenoidectomy Versus Other
Interventions
Three RCTs (4 articles)29,46,53,54 reported
harms related to adenoidectomy. Two
of the trials29,46,54 reported 1 case each
(among 416 subjects) of a postoperative
hemorrhage after adenoidectomy (low
SOE). Evidence was insufficient for other
harms.

TABLE 4 SOE for Interventions to Improve Functional Outcomes and Health-Related Quality-of-Life Outcomes
Intervention and No. of Studies
Comparator (Sample Sizes)
TTs versus watchful waiting MA of 3 RCTs (n = 394)
or delayed treatment and 2 RCTs (n = 503)
MA of 3 RCTs (n = 393)
and 2 RCTs (n = 503)
2 RCTs (n = 503)
3 RCTs (n = 710)
2 RCTs (n = 503)
MA, meta-analysis; TT, tympanostomy tubes.
Outcome and Results SOE
No difference was observed in language comprehension at Moderate for
6 to 9 mo postintervention (mean difference, 0.09; 95% CI no difference
20.21 to 0.39) or at preschool and elementary school age.
No difference was observed in language expression at
6 to 9 mo postintervention (mean difference, 0.03; 95% CI
–0.41 to 0.49) or at preschool and elementary school age.
No difference was observed in cognitive development at 9 mo Low for no
postintervention or at preschool and elementary school age. difference
No difference was observed in behavior at 1 y or more Low for no
difference
No difference was observed in academic achievement at Low for no
elementary school age. difference

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TABLE 5 SOE for Harms of Interventions
Intervention and No. of Studies Outcome and Results SOE
Comparator (Sample Sizes)
TT comparisons 1 RCT (n = 30 ears), Otorrhea occurred more frequently in ears with Low for harms of
2 observational longer-term tubes than in ears with shorter-term longer-term tubes
studies (n = 779 ears) tubes after 1 y or more.
TTs versus watchful waiting 5 RCTs (n = 1129) Tympanosclerosis occurred more frequently in ears Moderate for harms
or myringotomy that had tubes, based on examinations after the of tubes
tubes had been extruded.
4 RCTs (n = 960) Otorrhea occurred more frequently in ears with tubes. Low for harms of tubes
TTs plus adenoidectomy versus 3 studies (2 RCTs; 1 NRCT) Tympanosclerosis occurred more frequently in ears Moderate for harms
adenoidectomy plus myringotomy versus (n = 485) with tubes than ears with only adenoidectomy or of tubes
adenoidectomy alone with myringotomy.
Adenoidectomy versus other 2 trials (n = 739) Although rare, adenoidectomy increased the risk of Low for harms of
treatments postsurgical hemorrhage. adenoidectomy
NRCT, nonrandomized controlled trial; TT, tympanostomy tubes.

Comparative Benefits and Harms
for Patient Subgroups
Although we attempted to examine
treatment effectiveness or harms for
key subgroups characterized by clinical
conditions (eg, cleft palate, Down syn-
drome, or sensorineural hearing loss)
or sociodemographic factors (eg, age),
we could not identify studies that cov-
ered most of our subgroups of interest.
In a single study of children with sleep
apnea and OME,44 all of whom had
adenoidectomy to treat that condition,
tubes and myringotomy did not differ
significantly in terms of any measured
outcomes (insufficient evidence).
Factors Affecting Health Care
Delivery or the Receipt of
Pneumococcal Vaccine Inoculation
No study examined issues related to
health insurance coverage, physician
specialty, type of facility of the provider,
geographic location of patients, pres-
ence or absence of continuity of care,
or previous use of pneumococcal virus
inoculation. Thus, evidenceis insufficient
for all such factors.
DISCUSSION
Clinical Findings
In an extensive systematic review
commissioned by the Agency for
Healthcare Research and Quality,6 we
examined the comparative effective-
ness and harms of various surgical
and nonsurgical treatments for OME.
This article focuses on surgical pro-
cedures (tubes, myringotomy, and
adenoidectomy and their comparators,
including watchful waiting and delayed
treatment); these are the most com-
mon modalities for managing OME.
Tubes yield short-term benefits in
comparison with either watchful wait-
ing or myringotomy. The lack of differ-
ences between tubes and either
myringotomy or watchful waiting be-
yond 1 or 2 years after surgery is not
surprising given the natural history of
untreated OME and the duration of
tubes. In an analysis of resolution rates
of OME across prospective studies, the
average resolution rate by ear was 88%
at 10 to 12 months and 97% at 16 to 24
months; the average resolution rate by
child was 95% at 7 to 12 months.68
Tubes did not show benefits for lan-
guage, cognitive, or academic skills at
any point; skills of those who received or
did not receive tubes were generally
within normal limits. Thus, the con-
ductive hearing losses that children
may have experienced did not appear to
translate to difficulties in language-
based skills. These studies support
the findings of Roberts and colleagues5
whose meta-analyses indicated that
OME and its associated hearing loss
had no or very small negative associ-
ations with children’s later language
development. Very recent recom-
mendations, however,7 are that clini-
cians should offer bilateral tubes to
children with bilateral OME for 3
months or longer and documented
hearing difficulties.
OME may lead to the development
of AOM; the most recent guidelines
for managing AOM69 offer tubes as a
treatment of recurrent AOM if effusion
is present. Our evidence, however,
was insufficient to conclude that tubes
reduced episodes of AOM in children
with OME.
Evidence was also insufficient to con-
clude that tubes varying in length of
retention differed in OME recurrence or
in hearing outcomes; no studies com-
paring design features of tubes examined
functional or quality-of-life outcomes. Al-
though most studies comparing tubes
with watchful waiting or myringotomy
used short-term tubes, we could not
determine whether short-term tubes
reduced time with OME, produced fewer
episodes of AOM, or improved hearing.
Evidence for harms of tubes was
limited. In comparison with either
watchful waiting or myringotomy,
tympanosclerosis and otorrhea oc-
curred more frequently in ears with
tubes; we could not determine the se-
verity of these complications, however.
Otorrhea occurred more frequently in
ears with longer-term tubes than with

12 WALLACE et al
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shorter-term tubes. Other harms such
as perforations, cholesteatoma, and at-
rophy were inconsistently investigated
or reported.
Adenoidectomy results in less time with
effusion or better hearing (or both)
when compared with no treatment oras
an adjunct to myringotomy. Evidence
was insufficient to determine the com-
parative effectiveness of adenoidectomy
for reducing the recurrence of AOM
or improving functional outcomes.
Evidence for harms of adenoidectomy
was limited (1 case of hemorrhage
reported in each of 2 trials). Evidence
for whether tubes confer a clinical benefit
when added to adenoidectomy is also
limited. Adding tubes to adenoidectomy
and myringotomy did not improve hear-
ing but was more likely to result in
tympanosclerosis. Children who received
bothtubesandadenoidectomyhadbetter
hearing outcomes than children who
were actively monitored.
No studies meeting our inclusion criteria
addressed subpopulations with coexist-
ing conditions, so this article pertains
mainly to otherwise healthy, typically
developing children. Only 2 studies were
designed to examine treatments in chil-
dren 2 years or younger28,31; in other
studies, investigators did not provide
sufficient information on age of the tar-
get population or included a wide age
range of children. Thus, we could not
ascertain the applicability of the tested
intervention to specific age groups. We
identified no studies of surgical treat-
ments in adults.
Future Research Needs
The evidence base is clearly limited for
infants and adults. It is virtually non-
existent for children with major coex-
isting or congenital conditions, such as
those with cleft palate, Down syndrome,
and sensorineural hearing loss, who
may be disproportionately affected by
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OME. Future research needs to fill these
gaps by examining treatments for
children with such craniofacial anom-
alies or developmental disorders and
for adults.
Several interventions have not been
subjected to rigorous research meth-
ods. Inserting tubes remains a common
procedure, yet little evidence is avail-
able about different types of tubes or
insertion techniques. An ongoing
Swedish trial plans to enroll a large
cohort of children in an RCT comparing
different tubes70; the results from this
trial may provide the needed evidence
regarding which tubes are more (or
less) beneficial. Other researchers are
designing treatments to counteract the
otological effects of gastroesophageal
reflux disease.70,71
Many cases of OME start after episodes
of AOM. Vaccines to prevent pneumo-
coccal disease can decrease the fre-
quency of AOM.72 As rates of vaccination
increase, the character of OME may
change because bacterial infections
will be less likely to play a role in the
disease process. The use of vaccines to
prevent OME was outside the scope of
this review, but research documenting
whether they decrease the rate of OME
in young children would contribute to
understanding prevention of this con-
dition.
Few studies included in this article
were rated as low risk of bias, and
improving methods in future research
is critical. Study design heterogeneity
is a considerable barrier to synthe-
sizing evidence: baseline measures
were not always provided; outcome
measures and time points for collect-
ing outcomes differed. Moreover,
investigators did not routinely report
on reoccurrence of AOM or on func-
tional outcomes; no study measured
discomfort from OME. Studies did not
routinely provide (or document) effect
REVIEW ARTICLE
sizes; many researchers fail to report
their statistical power (the RCTs of the
MRC54 and Paradise et al31 being no-
table exceptions). Missing data were
often not addressed, and even if at-
trition was acknowledged, statistical
procedures were rarely used to cor-
rect for this problem.
CONCLUSIONS
Overall, we found a small and uneven
body of evidence across treatment
comparisons and outcomes. Com-
pared with watchful waiting or
myringotomy, we found strong and
consistent evidence that tubes de-
creased effusion and improved hear-
ing over a short period but did not
affect speech, language, or other
functional outcomes. Weaker evidence
suggested that tube placement also
increased the rate of side effects, such
as otorrhea and tympanosclerosis.
Although adenoidectomy decreases
the number of children with OME in
the short-term relative to watchful
waiting, less is known about its long-
term outcomes, particularly with
respect to functional outcomes. Ad-
ditional research and better methods
are needed to develop a compre-
hensive evidence base to support
decision-making among the various
treatment options, particularly in
subpopulations defined by age and
coexisting conditions.
ACKNOWLEDGMENTS
The authors thank Amy Greenblatt,
Loraine G. Monroe, Karen Crotty,
Andrea Yuen, and Christiane E. Voisin
for their assistance in conducting the
systematic review. They also thank
Meera Viswanathan for her input on
standard Agency for Healthcare Re-
search and Quality EPC protocols. Finally,
we thank Loraine G. Monroe for her as-
sistance in preparing the manuscript.
13
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16 WALLACE et al
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 Surgical Treatments for Otitis Media With Effusion: A Systematic Review
Ina F. Wallace, Nancy D. Berkman, Kathleen N. Lohr, Melody F. Harrison, Adam J.
Kimple and Michael J. Steiner
Pediatrics originally published online January 6, 2014;

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 Surgical Treatments for Otitis Media With Effusion: A Systematic Review
Ina F. Wallace, Nancy D. Berkman, Kathleen N. Lohr, Melody F. Harrison, Adam J.
Kimple and Michael J. Steiner
Pediatrics originally published online January 6, 2014;

The online version of this article, along with updated information and services, is
located on the World Wide Web at:
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Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it
has been published continuously since . Pediatrics is owned, published, and trademarked by the
American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois,
60007. Copyright © 2014 by the American Academy of Pediatrics. All rights reserved. Print
ISSN: .

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