• Louise Klokker, Peter Tugwell, Daniel E Furst, Dan Devoe, Paula Williamson, Caroline B Terwee, Maria E Suarez-Almazor, Vibeke Strand, Thasia Woodworth, Amye L Leong, Niti Goel, Maarten Boers, Peter M Brooks, Lee S Simon, and Robin Christensen.
• From the Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Department of Medicine, School of Epidemiology, Public Health and Community Medicine, University of Ottawa, Ottawa, Ontario; Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta, Canada; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Immunology and Rheumatology, Stanford University, Stanford, California; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA); Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Strategic Drug Development, Advisory Services, Quintiles and Division of Rheumatology, Duke University School of Medicine, Durham, North Carolina; SDG LLC, Cambridge, Massachusetts, USA; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Epidemiology and Biostatistics and the EMGO Institute for Health and Care Research, Amsterdam; Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center, Amsterdam, the Netherlands; Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne, Australia.
• J Rheumatol. 2017 Dec 1; 44 (12): 1916-1919.

ObjectiveFailure 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.MethodsThe safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved.ResultsMembers of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions.ConclusionThe OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

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