Harms provide important context for healthcare practitioners about the benefit-risk ratio of interventions. To improve transparency and credibility in the published results from randomized trials, the reporting of harms associated with an intervention needs to be explicit regarding what is patient-important, which may be different from that reported by clinicians submitting adverse event reports

Following the concerns about inadequate reporting of harm outcomes in randomized trials and systematic reviews the Outcome Measures in Rheumatology (OMERACT) Safety Working Group is advancing the work to identify additional harm aspects for assessment in rheumatology trials