Randomized controlled trials in otolaryngology journals.

OBJECTIVE

To identify trends in randomized controlled trials (RCTs) in leading otolaryngology journals.

STUDY DESIGN AND SETTING

We reviewed all RCTs of treatment efficacy from 2000 through 2005 in 4 major otolaryngology journals. Data included study quality, author's conclusions, adverse events, and study support/funding.

RESULTS

Of 5467 total articles, 202 (3.7%) were RCTs of treatment efficacy. Slightly more than half of the trials were supported by for-profit organizations (25%), not-for-profit groups (21%), or both (7%). Intent-to-treat analysis was used in 58 percent of trials, P values in 88 percent, and confidence intervals in 11 percent. Conclusions favoring the experimental group were unrelated to presence or absence of industry funding, and conclusions suggesting equivalence were unrelated to sample size.

CONCLUSIONS

RCTs are uncommon in otolaryngology journals, but they demonstrate frequent use of intent-to-treat analysis, no evidence of publication bias for funded studies, and no evidence of low power in studies suggesting equivalence.

SIGNIFICANCE

This study has implications for both the otolaryngology researcher designing studies and the practicing clinician interpreting them.