Ana-Maria Orbai1,2, Richard Holland3,4, Ying Ying Leung3,4, William Tillett3,4, Niti Goel3,4, Robin Christensen3,4, Neil McHugh3,4, Laure Gossec3,4, Maarten de Wit3,4, Pil Højgaard3,4, Laura C Coates3,4, Philip J Mease3,4, Julie Birt3,4, Lara Fallon3,4, Oliver FitzGerald3,4, Alexis Ogdie3,4, Beverly Shea3,4, Vibeke Strand3,4, Kristina Callis Duffin3,4, Peter Tugwell3,4, Dorcas Beaton3,4, Dafna D Gladman3,4. 1. From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Division of Immunology, Stanford University, Palo Alto, California; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Global Patient Outcomes and Real World Evidence, Eli Lilly and Co., Indianapolis, Indiana; University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, Bath; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Sorbonne Université; Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP, Paris, France; VU Medical Centre, Amsterdam, the Netherlands; Global Medical Affairs, Pfizer Inc., Montreal, Quebec; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute for Health Policy Management and Evaluation, University of Toronto; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland. aorbai1@jhmi.edu. 2. A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; R. Holland, MB, ChB, Royal Prince Alfred Hospital Medical Centre; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; W. Tillett, BSc, MBChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; N. Goel, MD, Patient Research Partner, Department of Medicine, Duke University School of Medicine, and Kezar Life Sciences; R. Christensen, BSc, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, and Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; L. Gossec, MD, PhD, Sorbonne Université, and Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P. Højgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine; J. Birt, PharmD, Global Patient Outcomes and Real World Evidence, and Eli Lilly and Co.; L. Fallon, PhD, Global Medical Affairs, Pfizer Inc.; 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; A. Ogdie, MD, MSCE, University of Pennsylvania; B. Shea, PhD, Clinical Epidemiology Program, Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; V. Strand, MD, Biopharmaceutical Consultant; K. Callis Duffin, MD, Department of Dermatology, University of Utah; P. Tugwell, 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; D. Beaton, BScOT, PhD, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, University of Toronto; 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. aorbai1@jhmi.edu. 3. From the Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore; Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Division of Immunology, Stanford University, Palo Alto, California; Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington; Global Patient Outcomes and Real World Evidence, Eli Lilly and Co., Indianapolis, Indiana; University of Pennsylvania, Philadelphia, Pennsylvania; Department of Dermatology, University of Utah, Salt Lake City, Utah, USA; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore; Royal National Hospital for Rheumatic Diseases, Bath; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Sorbonne Université; Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP, Paris, France; VU Medical Centre, Amsterdam, the Netherlands; Global Medical Affairs, Pfizer Inc., Montreal, Quebec; Clinical Epidemiology Program, Ottawa Hospital Research Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute for Health Policy Management and Evaluation, University of Toronto; University of Toronto; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto, Ontario, Canada; Department of Rheumatology, St. Vincent's University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland. 4. A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; R. Holland, MB, ChB, Royal Prince Alfred Hospital Medical Centre; Y.Y. Leung, MD, PhD, Department of Rheumatology and Immunology, Singapore General Hospital; W. Tillett, BSc, MBChB, PhD, MRCP, Royal National Hospital for Rheumatic Diseases; N. Goel, MD, Patient Research Partner, Department of Medicine, Duke University School of Medicine, and Kezar Life Sciences; R. Christensen, BSc, MSc, PhD, Professor of Biostatistics and Clinical Epidemiology, and Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; N. McHugh, MBChB, MD, FRCP, FRCPath, Royal National Hospital for Rheumatic Diseases; L. Gossec, MD, PhD, Sorbonne Université, and Rheumatology Department, Pitié Salpêtrière Hospital, AP-HP; M. de Wit, PhD, Patient Research Partner, VU Medical Centre; P. Højgaard, MD, The Parker Institute, Bispebjerg and Frederiksberg Hospital; L.C. Coates, MBChB, PhD, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford; P.J. Mease, MD, Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine; J. Birt, PharmD, Global Patient Outcomes and Real World Evidence, and Eli Lilly and Co.; L. Fallon, PhD, Global Medical Affairs, Pfizer Inc.; 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; A. Ogdie, MD, MSCE, University of Pennsylvania; B. Shea, PhD, Clinical Epidemiology Program, Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; V. Strand, MD, Biopharmaceutical Consultant; K. Callis Duffin, MD, Department of Dermatology, University of Utah; P. Tugwell, 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; D. Beaton, BScOT, PhD, Musculoskeletal Health and Outcomes Research, St. Michael's Hospital and Institute for Work and Health, and Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and the Institute for Health Policy Management and Evaluation, University of Toronto; 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.
Abstract
OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL). METHODS: PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018). RESULTS: PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes." CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.
OBJECTIVE: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) psoriatic arthritis (PsA) working group is developing a Core Outcome Measurement Set for PsA clinical trials [randomized controlled trials (RCT) and longitudinal observational studies (LOS)] using the OMERACT Filter 2.1 instrument selection algorithm. Our objective was to assess the Psoriatic Arthritis Impact of Disease questionnaire (PsAID12) for the measurement of the core domain PsA-specific health-related quality of life (HRQOL). METHODS:PsAID12 measurement property evidence gathered in a systematic literature review, and additional analyses conducted in LOS, were used to inform a consensus process. Analyses that had not been published were independently reviewed by the OMERACT technical advisory group. Data and process were presented, discussed in breakout groups, and voted on at the OMERACT conference (Terrigal, Australia, May 2018). RESULTS:PsAID12 fulfilled the green (good to go) OMERACT standards for domain match, feasibility, reliability, and construct/longitudinal construct validity. Discrimination and thresholds of meaning were amber (caution but good enough to go forward). The overall working group recommendation was amber/provisional endorsement of PsAID12 for measuring PsA-specific HRQOL in RCT and LOS. Of 96 participants who voted at the PsA OMERACT workshop, 87.5% (84) voted "yes" to endorse this recommendation; 14 of the 96 were patient research partners (PRP) and 93% of them (13) voted "yes"; 82 participants were not PRP and 87% of them (71) voted "yes." CONCLUSION: At OMERACT 2018, PsAID12 was the first patient-reported outcome measure provisionally endorsed as a core outcome measure for disease-specific HRQOL in PsA clinical trials. PsAID12 discrimination and improvement thresholds will be studied in future RCT.
Authors: William Tillett; Ana-Maria Orbai; Alexis Ogdie; Ying Ying Leung; Vibeke Strand; Dafna D Gladman; Philip J Mease; Laura C Coates Journal: Ann Rheum Dis Date: 2017-07-26 Impact factor: 19.103
Authors: Laure Gossec; Maarten de Wit; Uta Kiltz; Juergen Braun; Umut Kalyoncu; Rossana Scrivo; Mara Maccarone; Laurence Carton; Kati Otsa; Imre Sooäär; Turid Heiberg; Heidi Bertheussen; Juan D Cañete; Anselm Sánchez Lombarte; Andra Balanescu; Alina Dinte; Kurt de Vlam; Josef S Smolen; Tanja Stamm; Dora Niedermayer; Gabor Békés; Douglas Veale; Philip Helliwell; Andrew Parkinson; Thomas Luger; Tore K Kvien Journal: Ann Rheum Dis Date: 2014-06 Impact factor: 19.103
Authors: Maarten Boers; John R Kirwan; George Wells; Dorcas Beaton; Laure Gossec; Maria-Antonietta d'Agostino; Philip G Conaghan; Clifton O Bingham; Peter Brooks; Robert Landewé; Lyn March; Lee S Simon; Jasvinder A Singh; Vibeke Strand; Peter Tugwell Journal: J Clin Epidemiol Date: 2014-02-28 Impact factor: 6.437
Authors: Rubén Queiro; Juan D Cañete; Carlos Montilla; Miguel Abad; María Montoro; Susana Gómez; Ana Cábez Journal: Arthritis Res Ther Date: 2017-03-29 Impact factor: 5.156
Authors: Ana-Maria Orbai; Maarten de Wit; Philip J Mease; Kristina Callis Duffin; Musaab Elmamoun; William Tillett; Willemina Campbell; Oliver FitzGerald; Dafna D Gladman; Niti Goel; Laure Gossec; Pil Hoejgaard; Ying Ying Leung; Chris Lindsay; Vibeke Strand; Désirée M van der Heijde; Bev Shea; Robin Christensen; Laura Coates; Lihi Eder; Neil McHugh; Umut Kalyoncu; Ingrid Steinkoenig; Alexis Ogdie Journal: J Rheumatol Date: 2017-02-01 Impact factor: 4.666
Authors: Ana-Maria Orbai; Maarten de Wit; Philip Mease; Judy A Shea; Laure Gossec; Ying Ying Leung; William Tillett; Musaab Elmamoun; Kristina Callis Duffin; Willemina Campbell; Robin Christensen; Laura Coates; Emma Dures; Lihi Eder; Oliver FitzGerald; Dafna Gladman; Niti Goel; Suzanne Dolwick Grieb; Sarah Hewlett; Pil Hoejgaard; Umut Kalyoncu; Chris Lindsay; Neil McHugh; Bev Shea; Ingrid Steinkoenig; Vibeke Strand; Alexis Ogdie Journal: Ann Rheum Dis Date: 2016-09-09 Impact factor: 19.103
Authors: Carolyn E Schwartz; Roland B Stark; David Cella; Katrina Borowiec; Katherine L Gooch; Ivana F Audhya Journal: Orphanet J Rare Dis Date: 2021-11-22 Impact factor: 4.123
Authors: Ying Ying Leung; Ana-Maria Orbai; Maarten de Wit; Andra Balanescu; Emmanuelle Dernis; Martin Soubrier; Lihi Eder; Josef S Smolen; Laura C Coates; Laure Gossec Journal: Arthritis Care Res (Hoboken) Date: 2021-03-13 Impact factor: 4.794