类风湿关节炎 flares 问卷的内容效度、结构效度、信度和反应度：OMERACT 2016 研讨会报告。
Content and Construct Validity, Reliability, and Responsiveness of the Rheumatoid Arthritis Flare Questionnaire: OMERACT 2016 Workshop Report.
机构信息
From McGill University, Montreal, Quebec; University of British Columbia, Vancouver, British Columbia, Canada; Johns Hopkins University, Baltimore, Maryland; Hospital for Special Surgery, New York, New York; University of California, Los Angeles; Healthy Motivation, Santa Barbara, California, USA; Cardiff University, Cardiff; University of the West of England, Bristol, UK; Schlosspark-Klinik University Medicine, Berlin, Germany; Parker Institute, Copenhagen University, Copenhagen, Denmark; Sint Maartenskliniek, Nijmege; Vrije Universiteit (VU), Amsterdam, the Netherlands; Pierre et Marie Curie University, Paris; University of Lorraine, Lorraine, France; University of Sydney, Sydney, Australia.
S.J. Bartlett, PhD, McGill University, and Johns Hopkins University; S.P. Barbic, PhD, University of British Columbia; V.P. Bykerk, MD, Hospital for Special Surgery; E.H. Choy, MD, Cardiff University; R. Alten, MD, Schlosspark-Klinik University Medicine; R. Christensen, PhD, Parker Institute, Copenhagen University; A. den Broeder, MD, PhD, Sint Maartenskliniek; B. Fautrel, MD, PhD, Pierre et Marie Curie University; D.E. Furst, MD, University of California; F. Guillemin, MD, PhD, University of Lorraine; S. Hewlett, PhD, RN, University of the West of England; A.L. Leong, MBA, Healthy Motivation; A. Lyddiatt, Patient Research Partner; L. March, MD, PhD, University of Sydney; P. Montie, Patient Research Partner; C. Pohl, MD, Schlosspark-Klinik University Medicine; M. Scholte Voshaar, MSc, VU; T.G. Woodworth, MD, University of California; C.O. Bingham III, MD, Johns Hopkins University.
出版信息
J Rheumatol. 2017 Oct;44(10):1536-1543. doi: 10.3899/jrheum.161145. Epub 2017 Aug 15.
OBJECTIVE
The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop a reliable way to identify and measure RA flares in randomized controlled trials (RCT). Here, we summarized the development and field testing of the RA Flare Questionnaire (RA-FQ), and the voting results at OMERACT 2016.
METHODS
Classic and modern psychometric methods were used to assess reliability, validity, sensitivity, factor structure, scoring, and thresholds. Interviews with patients and clinicians also assessed content validity, utility, and meaningfulness of RA-FQ scores.
RESULTS
People with RA in observational trials in Canada (n = 896) and France (n = 138), and an RCT in the Netherlands (n = 178) completed 5 items (11-point numerical rating scale) representing RA Flare core domains. There was moderate to high evidence of reliability, content and construct validity, and responsiveness. Factor analysis supported unidimensionality. Rasch analysis showed acceptable fit to the Rasch model, with items and people covering a broad measurement continuum and evidence of appropriate targeting of items to people, ordered thresholds, minimal differential item functioning by language, sex, or age. A summative score across items is defensible, yielding an interval score (0-50) where higher scores reflect worsening flare. The RA-FQ received endorsement from 88% of attendees that it passed the OMERACT Filter 2.0 "Eyeball Test" for instrument selection.
CONCLUSION
The RA-FQ has been developed to identify and measure RA flares. Its review through OMERACT Filter 2.0 shows evidence of reliability, content and construct validity, and responsiveness. These properties merit its further validation as an outcome for clinical trials.
目的
制定出可靠的方法来识别和测量随机对照试验中的类风湿关节炎（RA）发作，这是风湿关节炎疗效测量（OMERACT）小组的主要目标。本文总结了 RA 发作问卷（RA-FQ）的制定和现场测试结果，并汇报了 2016 年 OMERACT 会议的投票结果。
方法
采用经典和现代心理测量学方法评估可靠性、有效性、敏感性、结构因素、评分和阈值。对患者和临床医生的访谈也评估了 RA-FQ 评分的内容有效性、实用性和意义。
结果
在加拿大的观察性试验（n = 896）和法国（n = 138），以及荷兰的 RCT（n = 178）中，有 RA 的患者完成了 5 个项目（11 分数字评分量表），代表 RA 发作的核心领域。有中度到高度证据表明可靠性、内容和结构有效性以及反应性。因子分析支持单维性。Rasch 分析表明，与 Rasch 模型拟合良好，项目和患者涵盖了广泛的测量连续体，并且项目针对患者的目标适当，有序的阈值，语言、性别或年龄的最小差异项目功能。对项目的综合评分是合理的，得出一个区间评分（0-50），分数越高表示发作越严重。RA-FQ 通过了 OMERACT 过滤器 2.0 的“眼球测试”，获得了 88%的与会者的认可，这是一种仪器选择的标准。
结论
RA-FQ 已经开发出来用于识别和测量 RA 发作。通过 OMERACT 过滤器 2.0 的审查，它显示了可靠性、内容和结构有效性以及反应性的证据。这些特性证明了它作为临床试验结果的进一步验证的价值。
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