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

Affiliations

• ¹ 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.
• ² L. Klokker, PT, MSc, PhD, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; D.B. Berthelsen, PT, MSc, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; T. Woodworth, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; K. Andersen, MSc, PhD Fellow, Department of Family Medicine, McGill University; D.E. Furst, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; D. Devoe, BA, MSc, PhD Student, Research Associate, Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine; P. Williamson, MSc, PhD, Professor of Medical Statistics, Institute of Translational Medicine, University of Liverpool; M.E. Suarez-Almazor, MD, PhD, Barnts Family Distinguished Professor, Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center; V. Strand, MD, Biopharmaceutical Consultant; A.L. Leong, MBA, President and CEO, Healthy Motivation, and Director of Strategic Relations, Global Alliance for Musculoskeletal Health, Bone and Joint Decade; N. Goel, MD, Vice President, Strategic Drug Development, Advisory Services, Quintiles and Adjunct Assistant Professor, Division of Rheumatology, Duke University School of Medicine; M. Boers, MSc, MD, PhD, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center; P.M. Brooks, MD, FRACP, Honorary Professor Fellow, Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne; L. March, PhD, University of Sydney; V.S. Sloan, MD, UCB Bio Sciences Inc., and Clinical Associate Professor of Medicine, Rutgers-Robert Wood Johnson Medical School; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; L.S. Simon, MD, SDG LLC; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital. L. Klokker and D.B. Berthelsen are first co-authors.
• ³ 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. [email protected].
• ⁴ L. Klokker, PT, MSc, PhD, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; D.B. Berthelsen, PT, MSc, Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; T. Woodworth, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; K. Andersen, MSc, PhD Fellow, Department of Family Medicine, McGill University; D.E. Furst, MD, David Geffen School of Medicine, Division of Rheumatology, UCLA; D. Devoe, BA, MSc, PhD Student, Research Associate, Health Services Research, Department of Medicine, University of Calgary, Cumming School of Medicine; P. Williamson, MSc, PhD, Professor of Medical Statistics, Institute of Translational Medicine, University of Liverpool; M.E. Suarez-Almazor, MD, PhD, Barnts Family Distinguished Professor, Section of Rheumatology and Clinical Immunology, University of Texas MD Anderson Cancer Center; V. Strand, MD, Biopharmaceutical Consultant; A.L. Leong, MBA, President and CEO, Healthy Motivation, and Director of Strategic Relations, Global Alliance for Musculoskeletal Health, Bone and Joint Decade; N. Goel, MD, Vice President, Strategic Drug Development, Advisory Services, Quintiles and Adjunct Assistant Professor, Division of Rheumatology, Duke University School of Medicine; M. Boers, MSc, MD, PhD, Professor of Clinical Epidemiology, Department of Epidemiology and Biostatistics, Amsterdam Rheumatology and Immunology Center, VU University Medical Center; P.M. Brooks, MD, FRACP, Honorary Professor Fellow, Centre for Health Policy Melbourne School of Population and Global Health, University of Melbourne; L. March, PhD, University of Sydney; V.S. Sloan, MD, UCB Bio Sciences Inc., and Clinical Associate Professor of Medicine, Rutgers-Robert Wood Johnson Medical School; P. Tugwell, OC, LRCP, MRCS, MD, MSc, FRCPS, FRCP(UK), FCAHS, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute; L.S. Simon, MD, SDG LLC; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Biostatistics and Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital. L. Klokker and D.B. Berthelsen are first co-authors. [email protected].