LAUSR

Physicians rely on accurate reporting of both efficacy and safety in randomized controlled trials (RCTs), reflecting benefits and harms of therapy. However, harms reporting, generally in the form of adverse events (AE), is often omitted or incomplete. “Framing” through asymmetrical reporting of harms vs. benefits can lead physicians to underestimate harms. Further, harms reporting language may be vague, which limits understanding of the prevalence of AEs and their impact on quality-of-life. These factors may impede optimal decision-making and worsen patient outcomes. In response to concerns about inadequate safety reporting in RCTs, in 2004, the Consolidated Standards of Reporting Trials (CONSORT) Group published guidelines for complete and accurate reporting of harms. Implementation of these guidelines was initially poor. More recent adherence has not been described, though overall quantification of results remains suboptimal. We evaluated current patterns in RCT reporting of harms compared to benefits and determined if funding, region, specialty, or type of intervention influences AE reporting.