Table 11Characteristics of studies: Tympanostomy tubes and adenoidectomy versus watchful waiting or myringotomy and adenoidectomy or adenoidectomy alone

Study, Study Type, CountryArm (N)Diagnosis CriteriaWait Period Between Diagnosis and StudyInclusion/Exclusion CriteriaLength of Study FollowupAge
Risk of Bias
Brown et al., 1978109

RCT by ear

G1: Shepard TT + adenoidectomy (N=55)
G2: Adenoidectomy (N=55)
Medical history, Otoscopy, AudiometryNot specifiedNot specified48 hrs, 3, 6, 9, 12 months, 5 years4–10 yearsMedium
Austin, 1994110

NRCT by ear

United States
G1: TTa + adenoidectomy (N=31)
G2: Adenoidectomy (N=31)
AudiometryNot specifiedInclude: OME; Indication for adenotonsillectomy; resistant to ENT or pediatric management3 monthsNRMedium
Lildholdt, 1979111

NRCT by ear

G1:Donaldson TT+ adenoidectomy (N=91)
G2: Adenoidectomy (N=91)
Tympanometry and audiometryNot specifiedInclude: Bilateral OME; minimal between ear difference in pressure and hearing

Exclude: Previous ear surgery
Until extrusion, 8 monthsMean:
4 years
(1–10 years)
D’Eredita and Shah, 2006112

RCT by person

G1: Shah mini TT + adenoidectomy (N=15)
G2: CDLM + adenoidectomy (N=15)
Tympanometry3 monthsInclude: OME for 3 months
Exclude: History of prior surgery, craniofacial syndrome, MR or cognitive disorder
12 monthsMean:
4 years
(2–6 years)
Popova et al., 2010113

RCT by person

G1: Donaldson TT + adenoidectomy (N=42)
G2: Myringotomy + adenoidectomy (N=36)
Pneumatic otoscopy and tympanometry3 monthsInclude: OME for 3 months; conductive HL >20 dB

Excluded: Previous ear or throat surgery; craniofacial syndromes; destructive middle ear disease; conductive HL attributed to destructive middle ear changes; sensorineural HL
12 monthsMean:
G1: 60 months
G2: 61 months
Shishegar and Hobhoghi, 2007114

RCT by ear

G1: Shepard TT + adenoidectomy (n=30)
G2: Myringotomy + adenoidectomy (N=30)
Otoscopy, tympanometry, audiometryNot specifiedInclude: OME unresponsive to medical therapy

Exclude: Prior ear surgery or adenoidectomy; cleft palate; perforated TM
6 months4–8 yearsMedium
Vlastos et al., 2011115

RCT by person

G1: Shepard TT + adenoidectomy (N=25)
G2: Adenoidectomy + myringotomy (N=27)
Otoscopy, tympanometry, pure tone audiometryNot specifiedInclude: Bilateral OME; scheduled for adenoidectomy due to sleep apnea; >3 yrs age

Excluded: chronic OME; previous ear surgery; language delays; behavioral problems; anatomic changes
12 monthsMean:
G1: 4.6 years
(3–7 years)
G2: 4.4 years
(3–7 years)
Hellstrom et al., 201121

Systematic Review

Gates et al., 1989102
Lildholdt, 1983106
Bonding, 1985105
Maw, 1994107
Arms differ across comparisons (Arms appear in tables 13 and 33,)

4 studies (N=1,054 participants)
Varies by studyMinimum of 3 monthsInclude: RCTs (individual or ear), NRCTs, and cohort studies published between 1966 and 2007 of TT effectiveness on hearing, QOL, language development, and complicationsVariousChildren or adolescentsMedium

CDLM = Contact diode laser myringotomy dB = decibel; ENT = ear, nose, and throat; G = group; HL = hearing loss; hrs = hours; MR = mental retardation; N = number; NR = not reported; NRCT = nonrandomized controlled trial; OME = otitis media with effusion; QOL = quality of life; RCT = randomized controlled trial; TM = tympanic membrane; TT = tympanostomy tubes; yrs = years


Tympanostomy tube type not specified.

Tympanostomy tube type not specified.

From: Results

Cover of Otitis Media With Effusion: Comparative Effectiveness of Treatments
Otitis Media With Effusion: Comparative Effectiveness of Treatments [Internet].
Comparative Effectiveness Reviews, No. 101.
Berkman ND, Wallace IF, Steiner MJ, et al.

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