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
(range)
Risk of Bias
Brown et al., 1978109

RCT by ear

Wales
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

Denmark
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)
Medium
D’Eredita and Shah, 2006112

RCT by person

Italy
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)
Medium
Popova et al., 2010113

RCT by person

Bulgaria
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
Medium
Shishegar and Hobhoghi, 2007114

RCT by ear

Iran
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

Greece
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)
Medium
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

a

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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