Table 6Characteristics of studies: Tympanostomy tube comparisons

Study, Study Type, CountryArm
N Randomized
Diagnosis CriteriaWait Period Between Diagnosis and StudyInclusion/Exclusion CriteriaLength of FollowupAge (Range)Risk of Bias
Wielinga et al.,199083

RCT by ear

Ireland
G1: Goode Silicon tube (N=15)
G2: Teflon Armstrong tube (N=15)
Otoscopy, PTA, tympanometry≤ 6 monthsInclude:
OME, 6 months
unsuccessful treatment with standard decongestive meds; mucoid secretion
Mean:
6.8 years
Male mean:
7 years

Female mean:
6 years
Medium
Abdullah et al., 199484

NRCT by ear

England
G1: Trimmed high-grade silicone Shah permavent tube (N=25)
G2: Polyethylene Shah tube (N=25)
NRNRInclude:
Age 3–10 years, de novo MEE

Exclude:
History of significant AOM
29 monthsMean:
6 years
(3–10 years)
Medium
Licameli et al., 200885

RCT by ear

United States
G1: Phophorylcholine-coated fluoroplastic Armstrong tube (N=70)
G2: Uncoated fluoroplastic Armstrong tube (N=70)
NR3–4 monthsInclude: OME with 3–4 months medical management

Exclude: Prior TT
24 monthsMean: 19 months
(8–51 months)
Medium
Iwaki et al., 199886

Observational by ear

Japan
G1: Teflon Shepard tube (N=75)
G2: Silicone Goode-T tube (N=39)
G3: Silicone Paparella II tube (N=106)
Audiometry, tympanometry and clinical history6 monthsInclude: 25 dB air-bone gap conductive HL, failed politerization and unsuccessful conservative management, retracted and glue-colored TM

Exclude: children with craniofacial problems
24 monthsMean:
G1: 6.2
G2: 6.2
G3: 5.8
(3–12 years)
Medium
Ovesen et al., 200087

RCT by person and by ear

Demark
G1: TTa + N-acetylcysteine instilled (N=37)
G2: TTa + placebo vehicle (N=38)
Otiomicroscopic examinations including tympanometry3 monthsInclude: OME, pressure <200mmHg

Exclude: Recent antibiotics or AOM at time of surgery
39 monthsMean:
38 months
(1–7 years)
Medium
Slack et al., 198745b

Retrospective cohort by ear
G1: Shepard TT (N=214)
G2: Shah TT (N=70)
G3: Paparella TT (N=275)
NRNRInclude: Children < 16 years old; TT inserted for OME in 1983Until extrusion or end of study periodChildren < 16 years oldHigh
Hellstrom et al., 201121

Systematic Review

Hampal et al., 1991,75 Heaton et al.,1991,76 Hern and Jonathan, 1999,77 Youngs and Gartland, 1988,78 Pearson et al., 1996,79 Kinsella et al., 1994,80b Salam and Cable, 1993,81b and Hampton and Adams, 199682b
Arms differ across 9 studies
(arms appear in Table 7 and Table 31)
(N=828 participants)
Varies by studyMinimum of 3 monthsInclude: RCTs (individual or ear), NRCTs, and cohort studies published between 1966 and 2007 of effectiveness of TT on hearing, language development, QOL and of complicationsVariousChildren or adolescents, one study included an unknown mix of adults and children79Medium

AOM = acute otitis media; dB = decibels; G = group; HL= hearing loss; MEE = middle ear effusion; mmHg = millimeters of mercury; mos = months; N = number; NR = not reported; NRCT = nonrandomized controlled trial; OME = otitis media with effusion; PTA = pure-tone audiometry; QOL = quality of life; RCT = randomized controlled trial; TM = tympanic membrane; TT = tympanostomy tubes; tx = treatment

a

Tympanostomy tube type not specified.

b

Study included for harms (KQ 3) only.

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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