About the Safety Working Group
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
Peter Brooks
Co-Chair
Robin Christensen
Co-Chair
Caroline Flurey
Co-Chair
Lee Simon
Co-Chair
Dorthe Bang Berthelsen
Fellow
Pam Richards
Patient Research Partner
Marieke Voshaar
Patient Research Partner
Safety Overview Video
RECENT WORKING GROUP PUBLICATIONS
Stakeholder Endorsement Advancing the Implementation of a Patient-Reported Domain for Harms in Rheumatology Clinical Trials: Outcome of the OMERACT Safety Working Group
Harms Reported by Patients in Rheumatology Drug Trials: A Systematic Review of Randomized Trials in the Cochrane Library from an OMERACT Working Group
Improving Benefit-Harm Assessment of Therapies from the Patient Perspective: OMERACT Pre-meeting Towards Consensus on Core Sets for Randomized Controlled Trials
Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials
Patient Perspectives on DMARD Safety Concerns in Rheumatology Trials: Results from Inflammatory Arthritis Patient Focus Groups and OMERACT Attendee Discussions
Developing an OMERACT Core Outcome Set for Assessing Safety Components in Rheumatology Trials: The OMERACT Safety Working Group