• J Rheumatol · Sep 2019

    Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials.

    • Louise Klokker, Dorthe B Berthelsen, Thasia Woodworth, Kathleen M Andersen, Daniel E Furst, Dan Devoe, Paula R Williamson, Maria E Suarez-Almazor, Vibeke Strand, Amye L Leong, Niti Goel, Maarten Boers, Peter M Brooks, Lyn March, Victor S Sloan, Peter Tugwell, Lee S Simon, and Robin Christensen.
    • From the Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark; David Geffen School of Medicine, Division of Rheumatology, University of California at Los Angeles (UCLA), Los Angeles; Division of Immunology and Rheumatology, Stanford University, Stanford; Healthy Motivation, and Global Alliance for Musculoskeletal Health, Bone and Joint Decade, Santa Barbara, California; Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center, Houston, Texas; Division of Rheumatology, Duke University School of Medicine, Durham; UCB Bio Sciences Inc., Raleigh, North Carolina; Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey; SDG LLC, Cambridge, Massachusetts, USA; Department of Family Medicine, McGill University, Montreal, Quebec; Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine, Calgary, Alberta; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Institute of Translational Medicine, University of Liverpool, Liverpool, UK; 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, Melbourne; University of Sydney, Sydney, Australia.
    • J Rheumatol. 2019 Sep 1; 46 (9): 1173-1178.

    ObjectiveThe Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology.MethodsSystematically searching the MEDLINE database on January 24, 2017, we identified full-text articles that could be used for harm outcomes in rheumatology. Domains/items from the identified instruments were described and the content synthesized to provide a preliminary framework for harm outcomes.ResultsFrom 435 possible references, 24 were read in full text and 9 were included: 7 measurement instruments were identified. Investigation of domains/items revealed considerable heterogeneity in the grouping and approach.ConclusionThe ideal way to assess harm aspects from the patients' perspective has not yet been ascertained.

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