全关节置换临床试验的结果领域与测量指标：我们能否使其协调统一？一项OMERACT合作计划。
Outcome Domains and Measures in Total Joint Replacement Clinical Trials: Can We Harmonize Them? An OMERACT Collaborative Initiative.
作者信息
Singh Jasvinder A, Dohm Michael, Sprowson Andrew P, Wall Peter D, Richards Bethan L, Gossec Laure, Hawker Gillian A, Riddle Daniel L, Buchbinder Rachelle
机构信息
From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
出版信息
J Rheumatol. 2015 Dec;42(12):2496-502. doi: 10.3899/jrheum.141201. Epub 2015 Apr 1.
OBJECTIVE
To develop a plan for harmonizing outcomes for people undergoing total joint replacement (TJR), to achieve consensus regarding TJR outcome research.
METHODS
The TJR working group met during the 2014 Outcome Measures in Rheumatology (OMERACT) 12 meeting in Budapest, Hungary. Multiple conference calls preceded the face-to-face meeting. Brief presentations were made during a 1.5-h meeting, which included an overview of published systematic reviews of TJR trials and the results of a recent systematic review of TJR clinical trial outcome domains and measures. This was followed by discussion of potential core set areas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associated with the measurement of these domains.
RESULTS
Working group participants discussed which TJR clinical trial outcome domains/areas map to the inner versus outer core for core domain set. Several challenges were identified with TJR outcomes including how to best measure function after TJR, elucidating the source of the pre- and post-TJR joint pain being measured, joint-specific versus generic quality of life instruments and the importance of patient satisfaction and revision surgery as outcomes. A preliminary core domain set for TJR clinical trials was proposed and included pain, function, patient satisfaction, revision, adverse events, and death. This core domain set will be further vetted with a broader audience.
CONCLUSION
An international effort with active collaboration with the orthopedic community to standardize key outcome domains and measures is under way with the TJR working group. This effort will be further developed with new collaborations.
目的
制定一项计划，使接受全关节置换术（TJR）的患者的治疗结果趋于一致，就TJR结果研究达成共识。
方法
TJR工作组在匈牙利布达佩斯举行的2014年风湿病结局测量（OMERACT）12会议期间召开了会议。在面对面会议之前进行了多次电话会议。在一次1.5小时的会议上进行了简短的汇报，内容包括已发表的TJR试验系统评价概述以及最近一项TJR临床试验结局领域和测量方法系统评价的结果。随后讨论了TJR临床试验的潜在核心领域/范围（根据OMERACT筛选标准2.0）以及这些领域测量所面临的挑战。
结果
工作组参与者讨论了哪些TJR临床试验结局领域/范围对应于核心领域集的内核心与外核心。确定了TJR结局存在的几个挑战，包括如何最佳测量TJR后的功能、阐明所测量的TJR前后关节疼痛的来源、关节特异性与通用生活质量工具以及患者满意度和翻修手术作为结局的重要性。提出了TJR临床试验的初步核心领域集，包括疼痛、功能、患者满意度、翻修、不良事件和死亡。这个核心领域集将在更广泛的范围内进一步审核。
结论
TJR工作组正在开展一项国际合作，与骨科界积极协作，以规范关键结局领域和测量方法。这项工作将通过新的合作进一步推进。
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