加强患者参与及修订核心集的必要性——2014年OMERACT银屑病关节炎工作组报告
Enhanced Patient Involvement and the Need to Revise the Core Set - Report from the Psoriatic Arthritis Working Group at OMERACT 2014.
作者信息
Tillett William, Eder Lihi, Goel Niti, De Wit Maarten, Gladman Dafna D, FitzGerald Oliver, Campbell Willemina, Helliwell Philip S, Gossec Laure, Orbai Ana-Maria, Ogdie Alexis, Strand Vibeke, McHugh Neil J, Mease Philip J
机构信息
From the Royal National Hospital for Rheumatic Diseases, Bath, UK; Toronto Western Hospital; Psoriatic Arthritis Program, University Health Network, Toronto Western Research Institute, Toronto, Ontario, Canada; St. Vincent's University Hospital, Dublin, Ireland; Quintiles; Duke University School of Medicine; Durham, North Carolina, USA; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; Chapel Allerton Hospital, Leeds, UK; Sorbonne Universités, Université Pierre et Marie Curie-Paris 6 (UPMC Univ Paris 6), Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, Maryland; Division of Immunology/Rheumatology, Stanford University School of Medicine, Portola Valley, California, USA; University of Bath, Bath, UK; Swedish Medical Center, University of Washington, Seattle, Washington; Hospital of the University of Pennsylvania (HUP), Philadelphia, Pennsylvania, USA.W. Tillett, MB, ChB, BSc, MRCP, PhD, Research Fellow, Royal National Hospital for Rheumatic Diseases; L. Eder, MD, PhD, Postdoctoral Research Fellow, Toronto Western Hospital; M. de Wit, PhD, OMERACT Patient Research Partner, The Netherlands; D.D. Gladman, MD, FRCPC, Director, Psoriatic Arthritis Program, University Health Network, Senior Scientist, Toronto Western Research Institute; O. FitzGerald, MD, FRCPI, FRCP( UK), Consultant Rheumatologist and Newman Clinical Research Professor, St. Vincent's University Hospital; N. Goel, MD, OMERACT Patient Research Partner, Quintiles, and Duke University School of Medicine; W. Campbell, BEd, LLB, OMERACT Patient Research Partner; P.S. Helliwell, DM, PhD, FRCP, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital; L. Gossec, MD, PhD, Sorbonne Universités, UPMC Univ Paris 6, Institut Pierre Louis d'Epidémiologie et de Sant
出版信息
J Rheumatol. 2015 Nov;42(11):2198-203. doi: 10.3899/jrheum.141156. Epub 2015 May 1.
OBJECTIVE
To discuss the need for revision of the "core set" of domains to be included for assessment in psoriatic arthritis (PsA) randomized controlled trials and longitudinal observational studies, review work undertaken since the 2012 meeting of Outcome Measures for Rheumatology 11 (OMERACT 11) to include patient perspectives in this revision, and reassess proposed composite measures in the context of new research data and the OMERACT Filter 2.0 framework.
METHODS
The OMERACT 12 (2014) PsA working group presented work completed over the last 2 years to incorporate patient involvement in PsA outcomes research, review the endorsed PsA core set based on the patient perspective as well as new research findings, and further develop PsA responder indices. Breakout groups then discussed 2 topics: (1) the need to revise the PsA core set, and opportunities to add, move, or merge existing domains to improve existing redundancy; and (2) how to incorporate the core set in a composite index. Breakout groups fed back to the working group before participant voting.
RESULTS
Meeting participants endorsed the need to revise the PsA core set according to the OMERACT Filter 2.0 framework (100%), and the inclusion of disease impact (94%) and fatigue (72%) in the inner circle. Breakout group feedback suggested the core set revision was an opportunity to consolidate pathophysiologic aspects such as arthritis, enthesitis, dactylitis, spondylitis as "inflammatory musculoskeletal disease," and nail and skin psoriasis as "psoriasis activity."
CONCLUSION
Future work will focus on updating the PsA core set and development of responder indices with ongoing, meaningful involvement of patient research partners.
目的
探讨修订银屑病关节炎（PsA）随机对照试验和纵向观察性研究中用于评估的领域“核心集”的必要性，回顾自2012年风湿病结局测量会议11（OMERACT 11）以来为将患者观点纳入此次修订所开展的工作，并结合新的研究数据和OMERACT Filter 2.0框架重新评估拟议的综合测量指标。
方法
OMERACT 12（2014年）PsA工作组展示了过去两年完成的工作，内容包括让患者参与PsA结局研究、基于患者观点以及新的研究结果回顾已认可的PsA核心集，以及进一步制定PsA缓解指标。分组讨论组随后讨论了两个主题：（1）修订PsA核心集的必要性，以及增加、调整或合并现有领域以改善现有冗余的机会；（2）如何将核心集纳入综合指数。分组讨论组在参与者投票前向工作组反馈。
结果
会议参与者认可根据OMERACT Filter 2.0框架修订PsA核心集的必要性（100%），以及在内圈纳入疾病影响（94%）和疲劳（72%）。分组讨论组的反馈表明，核心集修订是一个整合病理生理方面的机会，例如将关节炎、附着点炎、指（趾）炎、脊柱炎合并为“炎性肌肉骨骼疾病”，将指甲和皮肤银屑病合并为“银屑病活动”。
结论
未来的工作将集中于更新PsA核心集，并在患者研究伙伴持续且有意义的参与下制定缓解指标。
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