EULAR 仪器 RAID.7 在评估类风湿关节炎疾病影响的各个领域的有效性和可靠性：一项对 671 名患者的横断面研究。
Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients.
机构信息
Rheumatology Department, Centro Hospitalar e Universitario de Coimbra EPE, Coimbra, Portugal
iCBR-Coimbra Institute for Clinical and Biomedical Research, University of Coimbra Faculty of Medicine, Coimbra, Portugal.
出版信息
RMD Open. 2021 Feb;7(1). doi: 10.1136/rmdopen-2020-001539.
OBJECTIVE
The rheumatoid arthritis impact of disease (RAID) questionnaire comprises seven patient-important domains of disease impact (pain, function, fatigue, sleep disturbance, emotional well-being, physical well-being, coping). RAID was validated as a pooled-weighted score. Its seven individual items separately could provide a valuable tool in clinical practice to guide interventions targeting the patient's experience of the disease. The aim was to separately assess the psychometric properties of each of the seven numeric rating scale (NRS) of the RAID (RAID.7).
MATERIAL AND METHODS
Post hoc analyses of data from the cross-sectional RAID study and from the Rainbow study, an open-label 12-week trial of etanercept in patients with RA. Construct validity of each NRS was assessed cross-sectionally in the RAID data set by Spearman's correlation with the respective external instrument of reference. Using the rainbow data set, we assessed reliability through intraclass correlation coefficient between the screening and the baseline visits and responsiveness (sensitivity to change) by standardised response mean between baseline and 12 weeks.
RESULTS
A total of 671 patients with RA with features of established disease were analysed, 563 and 108 from RAID and Rainbow, respectively. The NRS correlated moderately to strongly with the respective external instrument of reference (r=0.62-0.81). Reliability ranged from 0.64 (0.51-0.74) (pain) to 0.83 (0.76-0.88) (sleep disturbance) and responsiveness from 0.93 (0.73-1.13) (sleep disturbance) to 1.34 (1.01-1.64) (pain).
CONCLUSION
The separate use of the individual NRS of RAID (RAID.7) is valid, feasible, reliable and sensitive to change, representing an opportunity to improve the assessment and treatment of disease impact with minimal questionnaire burden.
TRIAL REGISTRATION NUMBER
NCT00768053.
目的
类风湿关节炎疾病影响（RAID）问卷包含疾病影响的七个患者重要领域（疼痛、功能、疲劳、睡眠障碍、情绪健康、身体健康、应对能力）。RAID 经过验证为汇总加权评分。其七个单独项目可以分别为临床实践提供有价值的工具，以指导针对患者疾病体验的干预措施。目的是分别评估 RAID 的七个数字评定量表（NRS）中的每一个的心理测量特性（RAID.7）。
材料和方法
对横断面 RAID 研究和 Rainbow 研究的数据进行事后分析，Rainbow 研究是一项在类风湿关节炎患者中进行的依那西普 12 周开放性试验。在 RAID 数据集中，通过 Spearman 相关系数与各自的外部参考仪器，对每个 NRS 的结构有效性进行横断面评估。使用 Rainbow 数据集，我们通过筛查和基线访视之间的组内相关系数评估可靠性，并通过基线和 12 周之间的标准化反应均值评估反应性（变化敏感性）。
结果
共分析了 671 例具有明确疾病特征的类风湿关节炎患者，分别来自 RAID（563 例）和 Rainbow（108 例）研究。NRS 与各自的外部参考仪器呈中度至高度相关（r=0.62-0.81）。可靠性范围从疼痛（0.64，0.51-0.74）到睡眠障碍（0.83，0.76-0.88），反应性从睡眠障碍（0.93，0.73-1.13）到疼痛（1.34，1.01-1.64）。
结论
RAID 的单独使用的每个 NRS（RAID.7）是有效的、可行的、可靠的且对变化敏感，为改善疾病影响的评估和治疗提供了机会，同时减少问卷负担。
试验注册号
NCT00768053。
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