简体中文版功能评分指数在下腰痛患者中的应用及信度效度测量

Application and validation of the simplified Chinese version of functional rating index for patients with low back pain

目的探讨中文版功能评分指数（SC-FRI）对下腰痛患者的应用价值,评估其用于国人的信度和效度。方法按照国际指南将FRI翻译成中文并进行跨文化调试。采用经调试确定的SC-FRI、中文版Oswestry功能障碍指数（SC-ODI）、SF-36健康调查量表（SF-36）和视觉模拟量表（VAS）对2010年12月至2011年3月于长海医院骨科门诊就诊、符合病例选择标准的115例下腰痛患者进行疼痛和功能状态的自我评估。检验其内部一致性、重测信度、同时标准效度和结构效度。结果 SC-FRI有非常高的完成率（96%）,无天花板和地板现象,具有良好的内部一致性（Cronbachα系数=0.897,去除一个条目后为0.851~0.890）和重测信度（组内相关系数ICC=0.948,95%CI=0.917~0.968）。同时标准效度分析证实SC-FRI与SC-ODI、VAS有高度相关性（r=0.958,0.852）;结构效度结果提示SC-FRI和SF-36中的躯体功能、躯体疼痛、社会功能、物理职能、总体健康有较高相关性（r=-0.802,-0.698,-0.573,-0.565,-0.435）。结论 SC-FRI具有十分良好的信度和效度,简单易行,可用于对国内下腰痛患者疼痛和功能状态的评估。

Objective To evaluate the application and validity of the simplified Chinese version of functional rating index（SC-FRI） for patients with low back pain（LBP） in China. Methods The translation and cross-cultural adaptation were performed according to the international guidelines. The SC-FRI was administered to 115 patients with LBP diagnosed in Orthopaedic Clinic in Changhai Hospital from December 2010 to March 2011 along with the simplified Chinese version of Oswestry disability index（SC-ODI）, 36-item short form health survey（SF-36）, and visual analogue scale（VAS）, to self-evaluate their pain and functional health status. Psychometric testing included internal consistency, test-retest reliability, concurrent criterion validity and construct validity. Results A high completion rate of 96% and no floor or ceiling effects were noted for SC-FRI. The internal consistency was good（Cronbach’sα = 0.897 for the overall SC-FRI; range, 0.851-0.890 if an item was deleted）. Test-retest reliability was excellent, with an intraclass correlation coefficient of 0.948（95% confidence interval, 0.917-0.968）. Concurrent criterion validity assessment demonstrated that SC-FRI significantly correlated with SC-ODI（r = 0.958） and VAS（r = 0.852）. Construct validity was confirmed by the significant Pearson correlation between SC-FRI and physical functioning, bodily pain, social functioning, role-physical and general health domains of SF-36 respectively（r =-0.802,-0.698,-0.573,-0.565,-0.435）. Conclusions SC-FRI has excellent reliability and validity for evaluating of pain and functional health status of Chinese-speaking patients with LBP. Being simple and easy to use, SC-FRI should be recommended in clinical and research practice in China.