PsAID12 在 2018 年 OMERACT 会议上被临时认可为评估临床试验中银屑病关节炎特异性健康相关生活质量的核心结局测量指标。
PsAID12 Provisionally Endorsed at OMERACT 2018 as Core Outcome Measure to Assess Psoriatic Arthritis-specific Health-related Quality of Life in Clinical Trials.
机构信息
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.
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.
出版信息
J Rheumatol. 2019 Aug;46(8):990-995. doi: 10.3899/jrheum.181077. Epub 2018 Dec 15.
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.
目的
银屑病关节炎（PsA）研究和评估小组（GRAPPA）以及风湿病结局测量（OMERACT）关节炎工作组正在使用 OMERACT 筛选 2.1 仪器选择算法制定一个针对 PsA 临床试验（随机对照试验（RCT）和纵向观察研究（LOS））的核心结局测量集。我们的目标是评估银屑病关节炎疾病影响问卷（PsAID12）在测量特定于 PsA 的健康相关生活质量（HRQOL）的核心领域中的作用。
方法
通过系统文献综述收集 PsAID12 的测量属性证据，并在 LOS 中进行额外分析，为共识过程提供信息。未发表的分析由 OMERACT 技术咨询小组进行独立审查。数据和过程在 OMERACT 会议（澳大利亚 Terrigal，2018 年 5 月）上进行展示、分组讨论和投票。
结果
PsAID12 满足 OMERACT 标准的绿色（可以进行）标准，包括领域匹配、可行性、可靠性和结构/纵向结构有效性。区分度和意义阈值为琥珀色（谨慎但足以继续前进）。工作组的总体建议是对 PsAID12 进行琥珀色/临时认可，用于测量 RCT 和 LOS 中的特定于 PsA 的 HRQOL。在 PsA OMERACT 研讨会上投票的 96 名参与者中，87.5%（84 名）投票赞成这一建议；96 名参与者中有 14 名为患者研究伙伴（PRP），其中 93%（13 名）投票赞成；82 名参与者不是 PRP，其中 87%（71 名）投票赞成。
结论
在 2018 年 OMERACT 会议上，PsAID12 是第一个被临时认可为 PsA 临床试验中特定于疾病的 HRQOL 的核心患者报告结局测量的方法。PsAID12 的区分度和改善阈值将在未来的 RCT 中进行研究。
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