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电子触摸屏WOMAC 3.1骨关节炎指数在罗非昔布短期临床试验中的反应性。

Responsiveness of the electronic touch screen WOMAC 3.1 OA Index in a short term clinical trial with rofecoxib.

作者信息

Theiler R, Bischoff-Ferrari H A, Good M, Bellamy N

机构信息

Rheumatology Clinic and Institute for Physical Medicine and Rehabilitation, Stadtspital Triemli, Zurich, Switzerland.

出版信息

Osteoarthritis Cartilage. 2004 Nov;12(11):912-6. doi: 10.1016/j.joca.2004.08.006.

DOI:10.1016/j.joca.2004.08.006
PMID:15501407
Abstract

BACKGROUND

The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a self-administered validated questionnaire for patients with osteoarthritis (OA) of the hip or knee. The electronic touch screen version of the WOMAC (e-WOMAC) has been previously shown to be highly correlated with the original paper format. However, whether the e-WOMAC would be suitable for monitoring the effects of drug treatment is unknown.

AIM

To validate the longitudinal use of the e-WOMAC questionnaire and its ability to detect changes in WOMAC-scores induced by drug treatment in outpatient care.

METHODS

Fifty-three outpatients, men and women (mean age: 64 years; SD+/-9.5), with symptomatic osteoarthritis of hip or knee were included in an open label study with rofecoxib. At three visits over 3 weeks, responsiveness of the WOMAC 3.1 regarding the three subscales, pain, stiffness and function, were compared for the original paper format and the computer touch screen format (QUALITOUCH) using a Likert scale. WOMAC scores were transformed to the 0-100 scale. ANOVA for repeated measures was used for analysis and effect sizes by subscale were compared for both formats.

RESULTS

Responsiveness for all three subscales was similar between formats. In both formats, pain and stiffness were significantly reduced with rofecoxib as early as 7 days, while functional ability was significantly increased (P<0.01 for all aggregate subscale scores) with continuing improvement until the end of study. The effect sizes by subscale between Day 1 and 21 were not statistically different between the paper and the electronic version of the questionnaire and showed similar clinically meaningful improvements in WOMAC scores over 3 weeks.

CONCLUSION

In this longitudinal intervention study, the e-WOMAC OA Index 3.1 showed similar responsiveness in detecting clinically meaningful changes than the original paper format.

摘要

背景

西安大略和麦克马斯特大学骨关节炎指数(WOMAC)是一种针对髋或膝骨关节炎(OA)患者的自我管理的有效问卷。先前已证明WOMAC的电子触摸屏版本(e-WOMAC)与原始纸质版本高度相关。然而,e-WOMAC是否适用于监测药物治疗效果尚不清楚。

目的

验证e-WOMAC问卷的纵向使用情况及其在门诊护理中检测药物治疗引起的WOMAC评分变化的能力。

方法

53例有症状的髋或膝骨关节炎门诊患者(男女均有,平均年龄:64岁;标准差±9.5)纳入一项关于罗非昔布的开放标签研究。在3周内的3次就诊时,使用李克特量表比较原始纸质版本和计算机触摸屏版本(QUALITOUCH)的WOMAC 3.1在疼痛、僵硬和功能这三个子量表方面的反应性。WOMAC评分转换为0至100分制。采用重复测量方差分析进行分析,并比较两种版本各子量表的效应量。

结果

两种版本在所有三个子量表上的反应性相似。在两种版本中,罗非昔布治疗后,疼痛和僵硬在第7天就显著减轻,而功能能力显著提高(所有汇总子量表得分P<0.01),并持续改善直至研究结束。问卷纸质版和电子版在第1天和第21天各子量表的效应量无统计学差异,且在3周内WOMAC评分均显示出相似的具有临床意义的改善。

结论

在这项纵向干预研究中,e-WOMAC骨关节炎指数3.1在检测具有临床意义的变化方面显示出与原始纸质版本相似的反应性。

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