膝骨关节炎中医证候PRO量表的信度效度及反应度评价

Reliability validity and responsibility of patient reported outcome measure on TCM syndrome for knee osteoarthritis

目的:评价膝骨关节炎(KOA)中医证候患者报告结局(PRO)量表的性能。方法:使用KOA中医证候PRO量表对100例来自中国中医科学院广安门医院的膝骨关节炎患者进行间隔4周的问卷调查,以Cronbach’sα系数和奇偶分半系数评价量表的信度;以项目区分度、因子分析、Spearman相关系数评价量表的内容效度、结构效度、校标效度;以效应尺度和配对t检验评价量表的反应度。结果:Cronbach’sα系数为0.840;奇偶分半系数为0.851,量表具有良好的信度。KOA中医证候PRO量表中10个条目与总分之间的相关系数大于0.44,1个条目为0.353;KOA中医证候PRO量表与WOMAC骨关节炎指数的相关系数为0.748;KOA中医证候PRO量表的效应尺度为0.81,配对t检验显示治疗前后差异具有统计学意义(P<0.01)。结论:KOA中医证候PRO量表具有良好的信度、效度及反应度,可应用于临床评价中医治疗膝骨关节炎的疗效。

Objective: To evaluate the of reliability validity and responsibility of patient reported outcome(PRO) measure of TCM syndrome for knee osteoarthritis(KOA). Methods: One hundred patients with knee osteoarthritis from Guang’anmen Hospital of China Academy of Chinese Medical Sciences were investigated with KOA TCM Syndrome Pro Scale at 4 weeks intervals. The reliability of the scale was evaluated by Cronbach’s α coefficient and odd-even half coefficient, and the content validity and structure of the scale were evaluated by item discrimination, factor analysis and Spearman correlation coefficient. Validity, calibration validity;response of the scale was evaluated by effect scale and paired t test. Results: The PRO’s Cronbach’s α coefficient of the scale was 0.840;parity split-half alpha coefficient of the scale was 0.851, which means the scale has good reliability. The correlation coefficients between 10 items and total score of KOA TCM syndrome PRO scale were greater than 0.44, 1 item’s score is 0.353. The correlation coefficient between PRO and WOMAC was 0.748, the effect scale of KOA TCM syndrome PRO scale was 0.81, and the paired t test showed that there were significant differences before and after treatment(P<0.01). Conclusion: Through the comprehensive analysis of the reliability, validity and responsiveness of the PRO scale, it can be concluded that the scale has good clinical application value. It can be used to evaluate the curative effect of TCM in the treatment of knee osteoarthritis.