Prompt insertion of tympanostomy tubes in infants and toddlers with persistent middle ear effusion did not improve developmental outcomes at 9-11 years of age

doi:10.1136/ebm.12.3.80

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Evidence-Based Medicine 2007;12:80; doi:10.1136/ebm.12.3.80
Copyright © 2007 by the BMJ Publishing Group Ltd.

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Therapeutics

Prompt insertion of tympanostomy tubes in infants and toddlers with persistent middle ear effusion did not improve developmental outcomes at 9–11 years of age

Paradise JL, Feldman HM, Campbell TF, et al. Tympanostomy tubes and developmental outcomes at 9 to 11 years of age. N Engl J Med 2007;356:248–61.[Abstract/Free Full Text]

Q In infants and toddlers with persistent middle ear effusion, is prompt insertion of tympanostomy tubes (ITTs) more effective than delayed ITTs for developmental outcomes at 9–11 years of age?

Clinical impact ratings GP/FP/Primary care $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Paediatrics $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Surgery—earnose throat $*$ $*$ $*$ $*$ $*$ $*$ ${star}$

Key Words: child development • middle ear ventilation • otitis media with effusion

The first 150 words of the full text of this article appear below.

METHODS
Design: randomised controlled trial.

Allocation: {concealed^*}.

Blinding: blinded (outcome assessors, data analysts, and {data collectors}).^*

Follow up period: up to 11 years.

Setting: 2 hospitals and 6 paediatric group practices in or near Pittsburgh,USA.

Patients: 429 children (about 58% boys) who were 2 months to 3 years ofage and met 1 of the following criteria: persistent bilateralmiddle ear effusion for 90 days, persistent unilateral effusionfor 135 days, or intermittent effusion for specified proportionsof longer periods (eg, intermittent bilateral effusion $>=$ 121 daysduring a 180 day period, or intermittent unilateral effusion $>=$ 181 days during a 270 day period).

Intervention: prompt ITTs (n = 216) or delayed ITTs if effusion persisted(6 mo for bilateral effusion or 9 mo for unilateral effusion)(n = 213).

Outcomes: 48 developmental measures (see www.evidence-basedmedicine.com).

Patient follow up: 91% (intention to treat analysis).

MAIN RESULTS
At the time of . . . [Full text of this article]

Morten Lindbaek, MD

University of Oslo,
Oslo, Norway