Ying-Ying Leung1, Ana-Maria Orbai2, Pil Hojgaard3, Richard Holland4, Ashish J Mathew5, Niti Goel6, Jeffrey Chau7, William Tillett8, Christine Lindsay9, Alexis Ogdie10, Laura C Coates11, Dafna D Gladman12, Robin Christensen13, Philip Mease14, Vibeke Strand15. 1. Singapore General Hospital, Duke-NUS Medical School, Singapore; Duke-NUS Medical School, Singapore. Electronic address: katyccc@hotmail.com. 2. Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 3. Department of Rheumatology, Holbaek Hospital, Denmark; Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark. 4. Concord Repatriation General Hospital, Sydney, Australia. 5. Centre for Prognosis Studies in Rheumatic Diseases, Division of Rheumatology, Department of Medicine, University of Toronto, Toronto, Ontario Canada; Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Immunology & Rheumatology, Christian Medical College, Vellore, India. 6. Patient Research Partner, USA; Duke University School of Medicine, USA; Employed by Abcuro Inc, Durham, North Carolina, USA. 7. Patient Research Partner, Hong Kong. 8. Royal National Hospital for Rheumatic Diseases, University of Bath, Bath, United Kingdom. 9. Patient Research Partner, USA; Employed by Aurinia Pharma US Inc, Prosper, Taxas, USA. 10. Medicine and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 11. National Institute for Health Research Clinician Scientist, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, United Kingdom. 12. Medicine, University of Toronto; Schroeder Arthritis Institute; Krembil Research Institute; Psoriatic Arthritis Program, University Health Network, Toronto Western Hospital; Toronto, Ontario, Canada. 13. Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark. 14. Rheumatology Research, Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington, USA. 15. Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.
Abstract
OBJECTIVES: Physical function is one of the core domains to be measured in all trials in psoriatic arthritis (PsA). We aimed to evaluate two instruments for physical function in PsA: The Health Assessment Questionnaire-disability index (HAQ-DI) and the physical functioning subscale of the Medical Outcome Survey Short-Form 36 items (SF-36 PF). METHODS: We followed guidelines set out by the OMERACT Filter 2.1. A working group was formed to evaluate each instrument for domain match and feasibility to reach consensus. Two systematic literature reviews (SLRs) were conducted to identify the relevant articles supporting measurement properties of both instruments. Five additional measurement properties were appraised: construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, and threshold of meaning. New evidence was synthesized to fill the gap. Data were presented to the OMERACT technical advisory group (TAG) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) community for endorsement. RESULTS: The results for seven measurement properties for HAQ-DI and SF-36 PF were presented in Summary of Measurement Property (SOMP) tables. The working group proposed "Provisional Endorsement" for both instruments. The body of evidence was approved by the OMERACT TAG. In two Delphi exercises among GRAPPA members, HAQ-DI received 93.9% and 97.5% endorsement votes, while that for SF-36 PF were 86.7% and 77.3%. CONCLUSION: Both HAQ-DI and SF-36 PF were provisionally endorsed for the measurement of physical function in PsA trials, using the OMERACT Filter 2.1.
OBJECTIVES: Physical function is one of the core domains to be measured in all trials in psoriatic arthritis (PsA). We aimed to evaluate two instruments for physical function in PsA: The Health Assessment Questionnaire-disability index (HAQ-DI) and the physical functioning subscale of the Medical Outcome Survey Short-Form 36 items (SF-36 PF). METHODS: We followed guidelines set out by the OMERACT Filter 2.1. A working group was formed to evaluate each instrument for domain match and feasibility to reach consensus. Two systematic literature reviews (SLRs) were conducted to identify the relevant articles supporting measurement properties of both instruments. Five additional measurement properties were appraised: construct validity, test-retest reliability, longitudinal construct validity, clinical trial discrimination, and threshold of meaning. New evidence was synthesized to fill the gap. Data were presented to the OMERACT technical advisory group (TAG) and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) community for endorsement. RESULTS: The results for seven measurement properties for HAQ-DI and SF-36 PF were presented in Summary of Measurement Property (SOMP) tables. The working group proposed "Provisional Endorsement" for both instruments. The body of evidence was approved by the OMERACT TAG. In two Delphi exercises among GRAPPA members, HAQ-DI received 93.9% and 97.5% endorsement votes, while that for SF-36 PF were 86.7% and 77.3%. CONCLUSION: Both HAQ-DI and SF-36 PF were provisionally endorsed for the measurement of physical function in PsA trials, using the OMERACT Filter 2.1.
Authors: Dorcas E Beaton; Lara J Maxwell; Beverley J Shea; George A Wells; Maarten Boers; Shawna Grosskleg; Clifton O Bingham; Philip G Conaghan; Maria Antonietta D'Agostino; Maarten P de Wit; Laure Gossec; Lyn M March; Lee S Simon; Jasvinder A Singh; Vibeke Strand; Peter Tugwell Journal: J Rheumatol Date: 2019-02-01 Impact factor: 4.666
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: Pil Højgaard; Louise Klokker; Ana-Maria Orbai; Kim Holmsted; Else M Bartels; Ying Ying Leung; Niti Goel; Maarten de Wit; Dafna D Gladman; Philip Mease; Lene Dreyer; Lars E Kristensen; Oliver FitzGerald; William Tillett; Laure Gossec; Philip Helliwell; Vibeke Strand; Alexis Ogdie; Caroline B Terwee; Robin Christensen Journal: Semin Arthritis Rheum Date: 2017-09-09 Impact factor: 5.532
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