Information on adverse events in randomised clinical trials assessing drug interventions published in four medical journals with high impact factors.

Background: The impact of the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 2004 and aimed to improve the quality of the safety information presented in clinical trials, remains uncertain.

Objective: To assess the incorporation of the CONSORT statement extension's recommendations in randomised clinical trials (RCTs) evaluating drug therapies published in high-impact medical journals.

Methods: Using Medline, 122 RCTs published in 2009 were selected from BMJ, JAMA, Lancet, and NEJM.