Section of Musculoskeletal Disease, University of Leeds, Leeds, UK.
J Rheumatol. 2011 Jul;38(7):1496-501. doi: 10.3899/jrheum.110278.
Work within the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) to develop and validate composite disease activity measures in PsA has progressed. At the Outcome Measures in Rheumatology Clinical Trials (OMERACT) 8 meeting, a core set of domains to be assessed in randomized controlled trials (RCT) and longitudinal observational studies (LOS) of PsA was agreed upon. At OMERACT 10, work to date regarding proposed composite responder indices was presented. Five proposed composite responder definitions for PsA were reviewed and discussed including new data from the GRACE (GRAppa Composite Exercise) study. There was agreement that the work to date was promising, and that developing composite outcome measures for use in RCT and LOS was important. Further work was required, including data on followup timepoints and less common phenotypes of PsA, to ensure that all subgroups were represented within GRACE. During discussion on the concept of composite measures for PsA, based on predominant/little/no involvement in several domains (such as skin versus joints, enthesitis, dactylitis, spondyloarthritis) it was acknowledged that a simple summative score encompassing all domains of PsA would be difficult to construct psychometrically and may not be appropriate. Ideally, any composite measure should retain the ability to differentiate between activity in individual domains, such as enthesitis or skin psoriasis, so that the influence of each can be assessed independently. Further work is required within the GRACE dataset to develop an optimal composite measure for PsA. Several proposals to date have shown preliminary validity according to the OMERACT filter.
在研究和评估银屑病关节炎(GRAPPA)小组内,已经取得了进展,制定和验证了银屑病关节炎的综合疾病活动指标。在风湿病临床研究结局测量(OMERACT)会议 8 上,同意了一套在银屑病关节炎的随机对照试验(RCT)和纵向观察研究(LOS)中需要评估的核心领域。在 OMERACT 会议 10 上,提出了关于拟议综合应答指标的最新进展。对五种拟议的银屑病关节炎综合应答定义进行了审查和讨论,包括来自 GRACE(GRAppa 综合锻炼)研究的新数据。大家一致认为,迄今为止的工作有很大的前景,制定用于 RCT 和 LOS 的综合结局指标非常重要。需要进一步开展工作,包括有关随访时间点和较少见的银屑病关节炎表型的数据,以确保在 GRACE 中代表所有亚组。在讨论银屑病关节炎的综合措施概念时,考虑到在几个领域(如皮肤与关节、附着点炎、指炎、脊柱关节炎)的主要/轻微/无参与情况,人们认识到,构建涵盖所有银屑病关节炎领域的简单综合评分在心理测量学上可能很困难,并且可能不合适。理想情况下,任何综合措施都应保留区分个别领域(如附着点炎或皮肤银屑病)活动的能力,以便能够独立评估每个领域的影响。需要在 GRACE 数据集内开展进一步的工作,为银屑病关节炎开发最佳的综合措施。迄今为止的一些建议根据 OMERACT 筛选标准显示出初步的有效性。