更新OMERACT筛选标准：对影像学和可溶性生物标志物的影响
Updating the OMERACT filter: implications for imaging and soluble biomarkers.
作者信息
D'Agostino Maria-Antonietta, Boers Maarten, Kirwan John, van der Heijde Désirée, Østergaard Mikkel, Schett Georg, Landewé Robert B, Maksymowych Walter P, Naredo Esperanza, Dougados Maxime, Iagnocco Annamaria, Bingham Clifton O, Brooks Peter M, Beaton Dorcas E, Gandjbakhch Frederique, Gossec Laure, Guillemin Francis, Hewlett Sarah E, Kloppenburg Margreet, March Lyn, Mease Philip J, Moller Ingrid, Simon Lee S, Singh Jasvinder A, Strand Vibeke, Wakefield Richard J, Wells George A, Tugwell Peter, Conaghan Philip G
机构信息
From Versailles-Saint Quentin En Yvelines University, Department of Rheumatology, Ambroise Paré Hospital, APHP, Boulogne-Billancourt, France; Departments of Epidemiology and Biostatistics, and Rheumatology, VU University Medical Center, Amsterdam, The Netherlands; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Glostrup, Copenhagen, Denmark; Department of Internal Medicine 3 and Institute for Clinical Immunology, University of Erlangen-Nuremberg, Erlangen, Germany; Department of Clinical Immunology and Rheumatology, Academic Medical Center, University of Amsterdam and Atrium Medical Center, Amsterdam, The Netherlands; Department of Medicine, University of Alberta, Edmonton, Alberta, Canada; Department of Rheumatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Paris-Descartes University, Medicine Faculty, APHP, Cochin Hospital, Rheumatology B, Paris, France; Rheumatology Unit, Sapienza Università di Roma, Rome, Italy; Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA; University of Melbourne, Medicine, Dentistry and Health Sciences, Melbourne, Australia; St. Michael's Hospital, Mobility Program Clinical Research Unit; Institute for Work and Health; University of Toronto, Department of Health Policy, Management and Evaluation, Department of Rehabilitation Science and Department of Occupational Science and Occupational Therapy, Toronto, Ontario, Canada; Pierre et Marie Curie University (UPMC) - Paris, GRC-UPMC 08 (EEMOIS); AP-HP Pitié Salpêtrière Hospital, Department of Rheumatology, Paris; Université de Lorraine, Université Paris Descartes, EA 4360 APEMAC, Nancy and Inserm CIC-EC, CHU de Nancy, Nancy, France; Department of Nursing, University of the West of England, Bris
出版信息
J Rheumatol. 2014 May;41(5):1016-24. doi: 10.3899/jrheum.131313. Epub 2014 Mar 1.
OBJECTIVE
The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment.
METHODS
A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondyloarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure.
RESULTS
Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials.
CONCLUSION
General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0.
目的
风湿病疗效评估指标（OMERACT）筛选标准为风湿病临床研究中疗效评估指标的验证提供了一个框架。然而，由于成像和生化指标的技术特性，它们可能面临额外的验证挑战。OMERACT 11的成像与可溶性生物标志物会议旨在为成像或生化测量仪器的迭代开发提供指导，以便其可用于治疗评估。
方法
提出了一种层次结构，反映了验证成像或生化测量仪器所需的三个维度：结果领域、研究设置和仪器性能。在任何维度上沿着轴移动都反映了验证程度的提高。对于给定的测试仪器，三轴结构评估该仪器在多大程度上是所选领域的有效测量指标，它评估的是患者中心变量还是疾病中心变量，以及在其应用背景下其技术性能是否足够。然后使用原始的OMERACT筛选标准和新提出的结构对目前用于类风湿关节炎、脊柱关节炎和膝骨关节炎的一些成像和可溶性生物标志物进行了评估。分组讨论小组严格审查了候选生物标志物符合所提出的逐步方法的程度，以此来检验所提出的三维结构的实用性。
结果
虽然总体上对所提出结构的价值有广泛认可，但也提出了一些改进领域，包括明确达到一定验证水平的标准以及如何处理将该结构扩展到临床试验以外领域的问题。
结论
对于用于评估成像和可溶性生物标志物验证的三轴结构提议获得了普遍支持；然而，还需要开展更多工作，以更好地评估其在OMERACT筛选标准2.0中的地位。
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