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2 WALLACE et al
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decision or the primary criteria for by the earlier Cochrane Review authors, options); 776 met criteria for full-text
exclusion, they resolved conflicts by additional data from individual studies review (Fig 1). We excluded 696 full-text
consensus discussion. We abstracted in those systematic reviews, and the articles based on our inclusion criteria
detailed PICOTS data from newly included new studies from our searches. New (before the risk-of-bias assessment),
studies and summarized information studies did not lend themselves to ei- leaving 80 included articles, of which 3
from studies included in the earlier ther new pooled analyses or to modi- were systematic reviews. We recorded
systematic reviews into evidence tables. fying earlier meta-analyses. Therefore, the reason that each excluded full-text
we summarized the new evidence publication failed to satisfy the eligibility
Risk-of-Bias Assessment qualitatively. criteria and compiled a comprehensive
Two independent reviewers rated the list of such studies (Appendix B of
risk of bias for each newly identified Strength of the Body of Evidence the full report6). Of the 77 articles, 23
study by using the Cochrane Risk of Bias Two team members independently were omitted from our analyses for de-
tool for RCTs13; our EPC developed ad- graded the strength of evidence (SOE) termining benefit because of high risk of
ditional or alternative questions for to answer each KQ, for each treatment bias in their study design (see Appendix
evaluating observational studies; for comparison, following EPC guidance.15 E of the full report6). One article de-
studies from the earlier systematic The overall grade for SOE (high, mod- termined to be at high risk of bias for
reviews, we relied on the original erate, low, or insufficient) is based determining benefit was included for
authors’ ratings.10–12 We evaluated the on ratings for 4 domains: risk of bias, harms only.
risk of bias of each of the systematic consistency, directness, and precision.
reviews using AMSTAR (A Measurement In this report, we discuss the subset of
It reflects reviewers’ confidence studies providing evidence on surgical
Tool to Assess Systematic Reviews).14 in the ability of a given body of evi-
The 2 reviewers resolved disagree- interventions: 3 systematic reviews, 41
dence to answer KQs. We resolved studiesreportedin55includedarticles.Of
ments by consensus discussion. We disagreements through consensus
assigned risk-of-bias ratings of low, the 55 articles, 24 were included in an
discussions.
medium, or high; high risk-of-bias stud- earlier systematic review, 13 were
ies had at least 1 major issue with the follow-up studies, and 18 were newly
RESULTS identified.
potential to cause significant bias that
might invalidate the results. Literature Searches and Table 2 summarizes the 41 unique
Characteristics of Included Studies studies that constitute the evidence
Data Synthesis We identified 5112 unduplicated citations base for this article; we specify study
Evidence for this synthesis included in our literature searches (this included characteristics and risk of bias ratings.
results from meta-analyses conducted surgical and nonsurgical treatment Of these, 5 studies were included in
more than 1 of the 6 main categories of Tympanostomy Tube Comparisons Tympanostomy Tubes Versus
comparisons. We assessed the 2 sys- Eleven studies (8 RCTs) provided evi- Myringotomy or Watchful Waiting
tematic reviews limited to RCTs as low dence concerning differences in clini- Twelve RCTs compared tubes with ei-
risk of bias11,12 and the third as medium cal outcomes comparing tubes (by ther myringotomy or no surgery (ie,
risk of bias.10 design, materials, size), insertion watchful waiting, delayed treatment); of
techniques, or topical prophylaxis these, 10 studies26–35 were included in
Comparative Effectiveness for therapies by comparing ears in the previous systematic reviews,10,11 and 2
Clinical Outcomes same child.16–25 Length of tube re- were new.36,37
Most studies examined some clinical tention was longer in tubes that man- Tube placement decreased the time
outcomes: most commonly, signs and ufacturers identified as “long-term with middle ear effusion by 32% in
symptoms of OME and hearing. A few tubes.” Specifically, Goode T-tubes and comparison with watchful waiting or
studies examined subsequent acute Paparella tubes were retained longer delayed treatment at 1 year after sur-
otitis media (AOM). Table 3 documents than Shah and Shepard tubes. Because gery (high SOE). Relative to a combined
findings on effectiveness in terms of of sparse data, diversity of compar- comparison group of watchful waiting
clinical outcomes separately by treat- isons, and inconsistent findings, the or myringotomy, tubes reduced effu-
ment comparisons; we give results evidence is insufficient for compar- sion by 13% through 2 years after
only when evidence was sufficient to isons of other design features or for surgery (moderate SOE). Evidence was
draw a conclusion. clinical outcomes. insufficient for longer follow-up.
4 WALLACE et al
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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 Types of Treatments/ Study Designs, Sample Size, Patient
Comparisons Duration, Quality Rating Characteristics
Maw & Herod, 198634,a; Unilateral TT versus no surgeryc RCT (by person and ear) Mean age: 63.7 mo
Maw & Bawden, 199465 56 (112 ears) Male: 57.1%
Follow-up: 12 mo
Medium ROB (Hellstrom)
Rach et al 199135 Bilateral TT versus watchful waiting RCT Mean age: unknown
n = 43 (all preschoolers)
Follow-up: 6 mo Male: unknown %
, High ROBb
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
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)
Myringotomy with
adenoidectomy
comparison
1 study
Szeremeta et al 200050 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 comparisons
8 studies (7 in 1 previous
systematic review)
MRC Multicentre Otitis Adenoidectomy + bilateral TT RCT Mean age: 63.6 mo
Media Group 201254 (Shepard) versus bilateral n = 376 Male: 48.9%
TT (Shepard) versus WW Follow-up: 24 mo
Medium ROB
In van Aardweg et al 201011
Black et al 199032,d 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
Dempster et al 199333,e 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)
Maw & Herod, 198634,e 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)
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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- small studies failed to find a differ- concerning OME effusion or hearing
term: up to 9 months after surgery in ence between tubes plus adenoidectomy outcomes.
comparison with watchful waiting (3–6 and adenoidectomy alone in reducing
months: 8.8 dB; 6–9 months: 4.2 dB) OME recurrence (insufficient evidence). Myringotomy Plus Adenoidectomy
(high SOE); up to 6 months after surgery Results of 3 studies comparing tubes Comparisons
in comparison with either watchful and adenoidectomy with myringotomy One retrospective cohort study com-
waiting or myringotomy (4–6 months: plus adenoidectomy on OME recurrence pared laser myringotomy with cold
10 dB) (high SOE). Thereafter, the dif- were mixed (insufficient evidence). For knife myringotomy in children also
ferences in hearing became attenuated hearing measured at various times, receiving an adenoidectomy.50 Be-
and were not statistically significant at 7 ranging from 1 month to 6 years, 5 cause evidence was limited to 1 ob-
to 12 months compared with watchful studies failed to find a difference in servational study, we concluded that
waiting or myringotomy (low SOE) or at hearing between the addition of tubes it was insufficient for determining the
12 to 18 months compared with just versus myringotomy (low SOE for no superiority of either myringotomy
watchful waiting (low SOE). Evidence difference). We found mixed results approach in relation to OME signs and
was insufficient for longer time periods for hearing in studies that compared symptoms.
and for other clinical outcomes. the additive impact of tubes with
adenoidectomy alone (insufficient ev- Adenoidectomy Versus Other
Tympanostomy Tubes Plus idence). Interventions
Adenoidectomy Versus Myringotomy Eight RCTs (11 articles) provided evi-
Plus Adenoidectomy or Myringotomy Comparisons dence for adenoidectomy compared
Adenoidectomy Alone One RCT compared 2 different proce- with tubes, myringotomy, watchful
Seven studies that we newly identified38–44 dures for myringotomy (radiofrequency waiting, or no adenoidectomy (unilat-
and 4 studies45–48 reported in the myringotomy with and without mito- eral ear surgery with nonoperated
Hellstrom et al10 review examined out- mycin C) on both middle ear and ear as comparison) (Table 2). Seven
comes for adenoidectomy plus differ- hearing outcomes.49 Most individuals trials29,32–34,51–53 were from the van den
ent adjunctive therapies. Specifically, in each arm received adenoidectomy Aardweg et al systematic review12; the
we compared the effectiveness of (73% and 67%, respectively). Evi- eighth was the newly published Trial
tubes when added to adenoidectomy dence was insufficient for conclud- of Alternative Regimens in Glue Ear
with myringotomy or no surgery. Two ing superiority of either procedure Treatment study.54
Adenoidectomy was superior to no (insufficient evidence for mixed find- (low SOE). Evidence was insufficient
adenoidectomy for resolution of OME ings). to determine the effectiveness of
at 6 months postsurgery measured One RCT found that adenoidectomy and adenoidectomy compared with other
through otoscopy (risk difference myringotomy were superior to myr- treatments for recurrence of AOM.
of 0.27, 95% confidence interval [CI] ingotomy alone for reducing time with
0.13–0.42) and through tympanometry effusion and for improving hearing at 24 Comparative Effectiveness for
(0.22, 95% CI 0.12–0.32) (high SOE for months (better ear standard mean Functional Outcomes or Quality of
both). It was also superior at 12 months difference of –0.66, 95% CI –0.93 to Life
postsurgery measured through tympa- –0.40) (low SOE). The evidence was in- Two treatment comparisons (tubes
nometry (risk difference of 0.29, 95% CI sufficient for determining the effec- versus watchful waiting and tubes plus
0.19–0.39) (high SOE). tiveness of adenoidectomy plus tubes adenoidectomy versus myringotomy plus
Hearing outcomes were superior with in relation to effusion or hearing be- adenoidectomy) included functional or
adenoidectomy compared with no cause outcome results were mixed. quality-of-life outcomes (Table 4).
adenoidectomy in 1 RCTat 6 months but Hearing outcomes were superior with Four trials (7 articles) reported on
not at 12 months. In a second RCT, adenoidectomy and tubes in compari- language26,28,31,35,55–57; 2 trials (5 articles)
investigators detected no differences son with watchful waiting at 24 months reported on cognitive development,
10 WALLACE et al
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TABLE 4 SOE for Interventions to Improve Functional Outcomes and Health-Related Quality-of-Life Outcomes
Intervention and No. of Studies Outcome and Results SOE
Comparator (Sample Sizes)
TTs versus watchful waiting MA of 3 RCTs (n = 394) No difference was observed in language comprehension at Moderate for
or delayed treatment and 2 RCTs (n = 503) 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.
MA of 3 RCTs (n = 393) No difference was observed in language expression at
and 2 RCTs (n = 503) 6 to 9 mo postintervention (mean difference, 0.03; 95% CI
–0.41 to 0.49) or at preschool and elementary school age.
2 RCTs (n = 503) No difference was observed in cognitive development at 9 mo Low for no
postintervention or at preschool and elementary school age. difference
3 RCTs (n = 710) No difference was observed in behavior at 1 y or more Low for no
difference
2 RCTs (n = 503) No difference was observed in academic achievement at Low for no
elementary school age. difference
MA, meta-analysis; TT, tympanostomy tubes.
Comparative Benefits and Harms ness and harms of various surgical development. Very recent recom-
for Patient Subgroups and nonsurgical treatments for OME. mendations, however,7 are that clini-
Although we attempted to examine This article focuses on surgical pro- cians should offer bilateral tubes to
treatment effectiveness or harms for cedures (tubes, myringotomy, and children with bilateral OME for 3
key subgroups characterized by clinical adenoidectomy and their comparators, months or longer and documented
conditions (eg, cleft palate, Down syn- including watchful waiting and delayed hearing difficulties.
drome, or sensorineural hearing loss) treatment); these are the most com- OME may lead to the development
or sociodemographic factors (eg, age), mon modalities for managing OME. of AOM; the most recent guidelines
we could not identify studies that cov- Tubes yield short-term benefits in for managing AOM69 offer tubes as a
ered most of our subgroups of interest. comparison with either watchful wait- treatment of recurrent AOM if effusion
In a single study of children with sleep ing or myringotomy. The lack of differ-
is present. Our evidence, however,
apnea and OME,44 all of whom had ences between tubes and either
was insufficient to conclude that tubes
adenoidectomy to treat that condition, myringotomy or watchful waiting be-
reduced episodes of AOM in children
tubes and myringotomy did not differ yond 1 or 2 years after surgery is not
with OME.
significantly in terms of any measured surprising given the natural history of
untreated OME and the duration of Evidence was also insufficient to con-
outcomes (insufficient evidence).
tubes. In an analysis of resolution rates clude that tubes varying in length of
of OME across prospective studies, the retention differed in OME recurrence or
Factors Affecting Health Care
Delivery or the Receipt of average resolution rate by ear was 88% in hearing outcomes; no studies com-
Pneumococcal Vaccine Inoculation at 10 to 12 months and 97% at 16 to 24 paring design features of tubes examined
months; the average resolution rate by functional or quality-of-life outcomes. Al-
No study examined issues related to
child was 95% at 7 to 12 months.68 though most studies comparing tubes
health insurance coverage, physician
Tubes did not show benefits for lan- with watchful waiting or myringotomy
specialty, type of facility of the provider,
guage, cognitive, or academic skills at used short-term tubes, we could not
geographic location of patients, pres-
any point; skills of those who received or determine whether short-term tubes
ence or absence of continuity of care,
or previous use of pneumococcal virus did not receive tubes were generally reduced time with OME, produced fewer
inoculation. Thus, evidenceis insufficient within normal limits. Thus, the con- episodes of AOM, or improved hearing.
for all such factors. ductive hearing losses that children Evidence for harms of tubes was
may have experienced did not appear to limited. In comparison with either
DISCUSSION translate to difficulties in language- watchful waiting or myringotomy,
based skills. These studies support tympanosclerosis and otorrhea oc-
Clinical Findings the findings of Roberts and colleagues5 curred more frequently in ears with
In an extensive systematic review whose meta-analyses indicated that tubes; we could not determine the se-
commissioned by the Agency for OME and its associated hearing loss verity of these complications, however.
Healthcare Research and Quality,6 we had no or very small negative associ- Otorrhea occurred more frequently in
examined the comparative effective- ations with children’s later language ears with longer-term tubes than with
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shorter-term tubes. Other harms such OME. Future research needs to fill these sizes; many researchers fail to report
as perforations, cholesteatoma, and at- gaps by examining treatments for their statistical power (the RCTs of the
rophy were inconsistently investigated children with such craniofacial anom- MRC54 and Paradise et al31 being no-
or reported. alies or developmental disorders and table exceptions). Missing data were
Adenoidectomy results in less time with for adults. often not addressed, and even if at-
effusion or better hearing (or both) Several interventions have not been trition was acknowledged, statistical
when compared with no treatment oras subjected to rigorous research meth- procedures were rarely used to cor-
an adjunct to myringotomy. Evidence ods. Inserting tubes remains a common rect for this problem.
was insufficient to determine the com- procedure, yet little evidence is avail-
parative effectiveness of adenoidectomy able about different types of tubes or CONCLUSIONS
for reducing the recurrence of AOM insertion techniques. An ongoing
Overall, we found a small and uneven
or improving functional outcomes. Swedish trial plans to enroll a large
body of evidence across treatment
Evidence for harms of adenoidectomy cohort of children in an RCT comparing
comparisons and outcomes. Com-
was limited (1 case of hemorrhage different tubes70; the results from this
pared with watchful waiting or
reported in each of 2 trials). Evidence trial may provide the needed evidence
myringotomy, we found strong and
for whether tubes confer a clinical benefit regarding which tubes are more (or
consistent evidence that tubes de-
when added to adenoidectomy is also less) beneficial. Other researchers are
creased effusion and improved hear-
limited. Adding tubes to adenoidectomy designing treatments to counteract the
ing over a short period but did not
and myringotomy did not improve hear- otological effects of gastroesophageal
affect speech, language, or other
ing but was more likely to result in reflux disease.70,71
functional outcomes. Weaker evidence
tympanosclerosis. Children who received Many cases of OME start after episodes suggested that tube placement also
bothtubesandadenoidectomyhadbetter of AOM. Vaccines to prevent pneumo- increased the rate of side effects, such
hearing outcomes than children who coccal disease can decrease the fre- as otorrhea and tympanosclerosis.
were actively monitored. quency of AOM.72 As rates of vaccination Although adenoidectomy decreases
No studies meeting our inclusion criteria increase, the character of OME may the number of children with OME in
addressed subpopulations with coexist- change because bacterial infections the short-term relative to watchful
ing conditions, so this article pertains will be less likely to play a role in the waiting, less is known about its long-
mainly to otherwise healthy, typically disease process. The use of vaccines to term outcomes, particularly with
developing children. Only 2 studies were prevent OME was outside the scope of respect to functional outcomes. Ad-
designed to examine treatments in chil- this review, but research documenting ditional research and better methods
dren 2 years or younger28,31; in other whether they decrease the rate of OME are needed to develop a compre-
studies, investigators did not provide in young children would contribute to hensive evidence base to support
sufficient information on age of the tar- understanding prevention of this con- decision-making among the various
get population or included a wide age dition. treatment options, particularly in
range of children. Thus, we could not Few studies included in this article subpopulations defined by age and
ascertain the applicability of the tested were rated as low risk of bias, and coexisting conditions.
intervention to specific age groups. We improving methods in future research
identified no studies of surgical treat- is critical. Study design heterogeneity ACKNOWLEDGMENTS
ments in adults. is a considerable barrier to synthe- The authors thank Amy Greenblatt,
sizing evidence: baseline measures Loraine G. Monroe, Karen Crotty,
Future Research Needs were not always provided; outcome Andrea Yuen, and Christiane E. Voisin
The evidence base is clearly limited for measures and time points for collect- for their assistance in conducting the
infants and adults. It is virtually non- ing outcomes differed. Moreover, systematic review. They also thank
existent for children with major coex- investigators did not routinely report Meera Viswanathan for her input on
isting or congenital conditions, such as on reoccurrence of AOM or on func- standard Agency for Healthcare Re-
those with cleft palate, Down syndrome, tional outcomes; no study measured search and Quality EPC protocols. Finally,
and sensorineural hearing loss, who discomfort from OME. Studies did not we thank Loraine G. Monroe for her as-
may be disproportionately affected by routinely provide (or document) effect sistance in preparing the manuscript.
14 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
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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: .