Ana-Maria Orbai1,2, Maarten de Wit3,4, Philip J Mease3,4, Kristina Callis Duffin3,4, Musaab Elmamoun3,4, William Tillett3,4, Willemina Campbell3,4, Oliver FitzGerald3,4, Dafna D Gladman3,4, Niti Goel3,4, Laure Gossec3,4, Pil Hoejgaard3,4, Ying Ying Leung3,4, Chris Lindsay3,4, Vibeke Strand3,4, Désirée M van der Heijde3,4, Bev Shea3,4, Robin Christensen3,4, Laura Coates3,4, Lihi Eder3,4, Neil McHugh3,4, Umut Kalyoncu3,4, Ingrid Steinkoenig3,4, Alexis Ogdie3,4. 1. From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Department of Dermatology, University of Utah, Salt Lake City, Utah; Quintiles, Duke University School of Medicine, Durham, North Carolina; Division of Immunology, Stanford University, Palo Alto, California; Cleveland Clinic, Cleveland, Ohio; University of Pennsylvania, Philadelphia, Pennsylvania, USA; VU Medical Centre, Amsterdam; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; Royal National Hospital for Rheumatic Diseases; Royal National Hospital for Rheumatic Diseases, Bath; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals UK National Health Service (NHS) Trust, Leeds, UK; Toronto Western Hospital; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network; Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto; Ottawa Hospital Research Institute, School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey. aorbai1@jhmi.edu. 2. A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center, and University of Washington School of Medicine; K. Callis Duffin, MD, Department of Dermatology, University of Utah; M. Elmamoun, MBBS, MRCPI, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; W. Tillett, BSc, MB ChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; W. Campbell, BEd LLB, Patient Research Partner, Toronto Western Hospital; O. FitzGerald, MD, FRCPI, FRCP(UK), Newman Clinical Research Professor, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, and Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network; N. Goel, MD, Patient Research Partner, Quintiles, Duke University School of Medicine; L. Gossec, MD, PhD, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology; P. Hoejgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; C.A. Lindsay, PharmD, Patient Research Partner; V. Strand, MD, Division of Immunology, Stanford University; D.M. van der Heijde, MD, PhD, Department of Rheumatology, Leiden University Medical Center; B. Shea, MSc, PhD, Senior Methodologist, Ottawa Hospital Research Institute, Adjunct Professor, School of Epidemiology, Public Health and Preventative Medicine, Faculty of Medicine, University of Ottawa; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L. Coates, MB ChB, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust; L. Eder, MD, PhD, Women's College Research Institute, Women's College Hospital, University of Toronto; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; U. Kalyoncu, MD, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; I. Steinkoenig, BA, Patient Research Partner, Cleveland Clinic; A. Ogdie, MD, MSCE, University of Pennsylvania. aorbai1@jhmi.edu. 3. From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Department of Dermatology, University of Utah, Salt Lake City, Utah; Quintiles, Duke University School of Medicine, Durham, North Carolina; Division of Immunology, Stanford University, Palo Alto, California; Cleveland Clinic, Cleveland, Ohio; University of Pennsylvania, Philadelphia, Pennsylvania, USA; VU Medical Centre, Amsterdam; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands; Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland; Royal National Hospital for Rheumatic Diseases; Royal National Hospital for Rheumatic Diseases, Bath; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals UK National Health Service (NHS) Trust, Leeds, UK; Toronto Western Hospital; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network; Women's College Research Institute, Women's College Hospital, University of Toronto, Toronto; Ottawa Hospital Research Institute, School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, Ontario, Canada; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS); AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; The Parker Institute, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Department of Internal Medicine, Division of Rheumatology, Hacettepe University, Ankara, Turkey. 4. A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center, and University of Washington School of Medicine; K. Callis Duffin, MD, Department of Dermatology, University of Utah; M. Elmamoun, MBBS, MRCPI, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; W. Tillett, BSc, MB ChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; W. Campbell, BEd LLB, Patient Research Partner, Toronto Western Hospital; O. FitzGerald, MD, FRCPI, FRCP(UK), Newman Clinical Research Professor, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; D.D. Gladman, MD, FRCPC, Professor of Medicine, University of Toronto, and Senior Scientist, Krembil Research Institute, and Director, Psoriatic Arthritis Program, University Health Network; N. Goel, MD, Patient Research Partner, Quintiles, Duke University School of Medicine; L. Gossec, MD, PhD, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, GRC-UPMC 08 (EEMOIS), and AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology; P. Hoejgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; C.A. Lindsay, PharmD, Patient Research Partner; V. Strand, MD, Division of Immunology, Stanford University; D.M. van der Heijde, MD, PhD, Department of Rheumatology, Leiden University Medical Center; B. Shea, MSc, PhD, Senior Methodologist, Ottawa Hospital Research Institute, Adjunct Professor, School of Epidemiology, Public Health and Preventative Medicine, Faculty of Medicine, University of Ottawa; R. Christensen, BSc, MSc, PhD, Head of Unit, Professor of Clinical Epidemiology, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L. Coates, MB ChB, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust; L. Eder, MD, PhD, Women's College Research Institute, Women's College Hospital, University of Toronto; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; U. Kalyoncu, MD, Department of Internal Medicine, Division of Rheumatology, Hacettepe University; I. Steinkoenig, BA, Patient Research Partner, Cleveland Clinic; A. Ogdie, MD, MSCE, University of Pennsylvania.
Abstract
OBJECTIVE: To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS). METHODS: At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants. RESULTS: We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda. CONCLUSION: The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.
OBJECTIVE: To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS). METHODS: At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants. RESULTS: We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient's global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda. CONCLUSION: The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.
Authors: William Tillett; Lihi Eder; Niti Goel; Maarten De Wit; Dafna D Gladman; Oliver FitzGerald; Willemina Campbell; Philip S Helliwell; Laure Gossec; Ana-Maria Orbai; Alexis Ogdie; Vibeke Strand; Neil J McHugh; Philip J Mease Journal: J Rheumatol Date: 2015-05-01 Impact factor: 4.666
Authors: Jessica A Walsh; Molly L McFadden; Michael D Morgan; Allen D Sawitzke; Kristina Callis Duffin; Gerald G Krueger; Daniel O Clegg Journal: J Rheumatol Date: 2014-07-15 Impact factor: 4.666
Authors: Dorcas E Beaton; Caroline B Terwee; Jasvinder A Singh; Gillian A Hawker; Donald L Patrick; Laurie B Burke; Karine Toupin-April; Peter S Tugwell Journal: J Rheumatol Date: 2015-09-15 Impact factor: 4.666
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Authors: Ana-Maria Orbai; Richard Holland; Ying Ying Leung; William Tillett; Niti Goel; Robin Christensen; Neil McHugh; Laure Gossec; Maarten de Wit; Pil Højgaard; Laura C Coates; Philip J Mease; Julie Birt; Lara Fallon; Oliver FitzGerald; Alexis Ogdie; Beverly Shea; Vibeke Strand; Kristina Callis Duffin; Peter Tugwell; Dorcas Beaton; Dafna D Gladman Journal: J Rheumatol Date: 2018-12-15 Impact factor: 4.666
Authors: Alí Duarte-García; Ying Ying Leung; Laura C Coates; Dorcas Beaton; Robin Christensen; Ethan T Craig; Maarten de Wit; Lihi Eder; Lara Fallon; Oliver FitzGerald; Dafna D Gladman; Niti Goel; Richard Holland; Chris Lindsay; Lara Maxwell; Philip Mease; Ana Maria Orbai; Beverley Shea; Vibeke Strand; Douglas J Veale; William Tillett; Alexis Ogdie Journal: J Rheumatol Date: 2019-02-15 Impact factor: 4.666
Authors: Ying Ying Leung; Ana-Maria Orbai; Alexis Ogdie; Pil Hojgaard; Richard Holland; Niti Goel; Jeffrey Chau; Laura C Coates; Vibeke Strand; Dafna D Gladman; Philip J Mease; Robin Christensen; William Tillett Journal: J Rheumatol Date: 2020-02-01 Impact factor: 5.346
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