From the Division of Rheumatology, Department of Medicine, and the Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota; Division of Rheumatology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Rheumatology, Duke University School of Medicine, Durham, North Carolina; Kezar Life Sciences, South San Francisco; Amgen Inc., Thousand Oaks, California; Swedish-Providence-St. John's Health Systems and University of Washington, Seattle, Washington; Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Department of Rheumatology and Immunology, Singapore General Hospital, Singapore, Singapore; University of Leeds, Leeds; University of Oxford, Oxford; Royal National Hospital for Rheumatic Diseases; University of Bath, Bath, UK; Musculoskeletal Health and Outcomes Research, St. Michael's Hospital; Institute for Work and Health; Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute and the Institute for Health Policy Management and Evaluation, University of Toronto; Department of Medicine, University of Toronto, Women's College Hospital; Department of Medicine, University of Toronto, Toronto Western Hospital, Toronto; Cochrane Musculoskeletal Group, Ottawa Hospital Research Institute, Centre for Practice-Changing Research; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario; Pfizer Inc., Montreal, Quebec, Canada; Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen; Department of Rheumatology, Odense University Hospital, Odense, Denmark; Department of Medical Humanities, Patient Research Partner, Amsterdam University Medical Centre, Amsterdam, the Netherlands; Department of Rheumatology, St. Vincent's University Hospital; Conway Institute for Biomolecular Research, University College Dublin, Ireland; Royal Prince Alfred Hospital Medical Centre, Sydney, Australia.
A. Duarte-García, MD, Division of Rheumatology, Department of Medicine, Mayo Clinic, and Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic; Y.Y. Leung, MD, MBChB, Department of Rheumatology and Immunology, Singapore General Hospital; L.C. Coates, PhD, MBChB, University of Leeds, and University of Oxford; D. Beaton, PhD, MSc, BScOT, 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; R. Christensen, PhD, MSc, Musculoskeletal Statistics Unit: The Parker Institute, Bispebjerg and Frederiksberg Hospital, and Department of Rheumatology, Odense University Hospital; E.T. Craig, MD, MPH, Division of Rheumatology, Department of Medicine, University of Pennsylvania; M. de Wit, PhD, Department of Medical Humanities, Patient Research Partner, Amsterdam University Medical Centre; L. Eder, MD, PhD, Department of Medicine, University of Toronto, Women's College Hospital; L. Fallon, PhD, Pfizer Inc.; O. FitzGerald, MD, MBChB, Department of Rheumatology, St. Vincent's University Hospital, and Conway Institute for Biomolecular Research, University College Dublin; D.D. Gladman, MD, Department of Medicine, University of Toronto, Toronto Western Hospital; N. Goel, MD, Patient Research Partner, Division of Rheumatology, Duke University School of Medicine, and Kezar Life Sciences; R. Holland, MBChB, Royal Prince Alfred Hospital Medical Centre; C. Lindsay, PharmD, Patient Research Partner, Amgen Inc.; L. Maxwell, PhD, Cochrane Musculoskeletal Group, Ottawa Hospital Research Institute, Centre for Practice-Changing Research; P. Mease, MD, Swedish-Providence-St. John's Health Systems and University of Washington; A.M. Orbai, MD, MHS, Division of Rheumatology, Johns Hopkins University School of Medicine; B. Shea, PhD, Ottawa Hospital Research Institute, and School of Epidemiology and Public Health, University of Ottawa; V. Strand, MD, Biopharmaceutical Consultant; D.J. Veale, MD, St. Vincent's University Hospital, and University College Dublin; W. Tillett, PhD, MBChB, Royal National Hospital for Rheumatic Diseases, and the University of Bath; A. Ogdie, MD, MSCE, Division of Rheumatology, Department of Medicine, University of Pennsylvania. Dr. Duarte-García and Dr. Leung are co-first authors. W. Tillett and Dr. Ogdie are co-senior authors.
J Rheumatol. 2019 Aug;46(8):996-1005. doi: 10.3899/jrheum.181089. Epub 2019 Feb 15.
The Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials and longitudinal observational studies has recently been updated. The joint counts are central to the measurement of the peripheral arthritis component of the musculoskeletal (MSK) disease activity domain. We report the Outcome Measures in Rheumatology (OMERACT) 2018 meeting's approaches to seek endorsement of the 66/68 swollen and tender joint count (SJC66/TJC68) for inclusion in the PsA Core Outcome Measurement Set (COS).
Using the OMERACT Filter 2.1 Instrument Selection Process, the SJC66/TJC68 was assessed for (1) domain match, (2) feasibility, (3) numerical sense (construct validity), and (4) discrimination (test retest reliability, longitudinal construct validity, sensitivity in clinical trials, and thresholds of meaning). A protocol was designed to assess the measurement properties of the SJC66/TJC68 joint count. The results were summarized in a Summary of Measurement Properties table developed by OMERACT. OMERACT members discussed and voted on whether the strength of the evidence supported that the SJC66/TJC68 had passed the OMERACT Filter as an outcome measurement instrument for the PsA COS.
OMERACT delegates endorsed the use of the SJC66/TJC68 for the measurement of the peripheral arthritis component of the MSK disease activity domain. Among patient research partners, 100% voted for a "green" endorsement, whereas among the group of other stakeholders, 88% voted for a "green" endorsement.
The SJC66/TJC68 is the first fully endorsed outcome measurement instrument using the OMERACT Filter 2.1 and the first instrument fully endorsed within the PsA COS.
最近更新了用于随机对照试验和纵向观察研究的银屑病关节炎（PsA）核心领域集。关节计数是衡量肌肉骨骼（MSK）疾病活动领域周围关节炎成分的核心。我们报告了 2018 年 OMERACT 会议寻求认可 66/68 个肿胀和压痛关节计数（SJC66/TJC68）纳入 PsA 核心结局测量集（COS）的方法。
使用 OMERACT 筛选器 2.1 仪器选择过程，对 SJC66/TJC68 进行了以下评估：（1）领域匹配，（2）可行性，（3）数值意义（构念效度），和（4）区分度（测试重测信度、纵向构念效度、临床试验敏感性和意义阈值）。设计了一个方案来评估 SJC66/TJC68 关节计数的测量特性。结果总结在 OMERACT 制定的“测量特性总结表”中。OMERACT 成员讨论并投票决定，证据的强度是否支持 SJC66/TJC68 通过 OMERACT 筛选器作为 PsA COS 的结局测量工具。
OMERACT 代表认可使用 SJC66/TJC68 来衡量 MSK 疾病活动领域的周围关节炎成分。在患者研究伙伴中，100%投票赞成“绿色”认可，而在其他利益相关者组中，88%投票赞成“绿色”认可。
SJC66/TJC68 是第一个使用 OMERACT 筛选器 2.1 完全认可的结局测量工具，也是第一个在 PsA COS 中完全认可的工具。
