Developing an OMERACT core outcome set for assessing safety components in rheumatology trials: The OMERACT safety working group

Abstract

Objective. Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. Methods. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms we..