@article{60101d6557d24d6db5ec4be90a466f94,
title = "PsAID12 provisionally endorsed at OMERACT 2018 as core outcome measure to assess psoriatic arthritis-specific health-related quality of life in clinical trials",
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.",
keywords = "Core set, Grappa, OMERACT, Outcome measures, Psoriatic arthritis",
author = "Orbai, {Ana Maria} and Richard Holland and Leung, {Ying Ying} and William Tillett and Niti Goel and Robin Christensen and Neil McHugh and Laure Gossec and {De Wit}, Maarten and Pil H{\o}jgaard and Coates, {Laura C.} and Mease, {Philip J.} and Julie Birt and Lara Fallon and Oliver FitzGerald and Alexis Ogdie and Beverly Shea and Vibeke Strand and Duffin, {Kristina Callis} and Peter Tugwell and Dorcas Beaton and Gladman, {Dafna D.}",
note = "Funding Information: 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 Universit{\'e}; Rheumatology Department, Piti{\'e} Salp{\^e}tri{\`e}re 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{\textquoteright}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{\textquoteright}s University Hospital and Conway Institute for Biomolecular Research, University College Dublin, Dublin, Ireland. AMO is a Jerome L. Greene Foundation Scholar and is supported in part by a research grant from the US National Institute of Arthritis and Musculoskeletal and Skin Diseases of the US National Institutes of Health under award number P30-AR070254 (Core B), a Rheumatology Research Foundation Scientist Development award, and a Staurulakis Family Discovery award. Publisher Copyright: The Journal of Rheumatology Copyright {\textcopyright} 2019. All rights reserved.",
year = "2019",
month = aug,
day = "1",
doi = "10.3899/jrheum.181077",
language = "English (US)",
volume = "46",
pages = "990--995",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "8",
}