乳腺纤维腺瘤肝郁气滞证中医诊断量表的效度与信度分析

Validity and Reliability Test of Traditional Chinese Medicine Diagnostic Scale for Liver Constraint and Qi Stagnation Syndrome of Breast Fibroadenoma

目的评价乳腺纤维腺瘤肝郁气滞证中医诊断量表的信度及效度。方法使用前期研究构建的含有12个证候条目的肝郁气滞证中医诊断量表,对125例乳腺纤维腺瘤患者进行量表调查,通过结构效度、聚敛效度、区分效度分析量表的效度;通过内部一致性信度、分半信度、重测信度评价量表信度。结果发放量表125份,剔除量表条目总完成度低于90%的量表4份,共回收121份有效量表,有效回收率为96.8%。量表的测评时间为(7.96±0.34)min,纳入量表条目无缺失值。结构效度分析结果显示,探索性因子分析中抽取3个公因子时达到最大总方差解释为59.479%,设置排除因子载荷系数绝对值≥0.5,将该量表分为3个维度,即主症、次症、舌脉;验证性因子分析中卡方值/自由度值(χ2/df)为1.075(<3),近似误差均方根(RMSEA)为0.025(<0.05);拟合优度指数(GFI)为0.925,比较拟合优度指数(CFI)为0.990,递增拟合指数(IFI)为0.990,Tucker-Lewis指数(TLI)为0.987,均>0.9。聚敛效度分析结果显示,所有条目因子载荷均>0.5,各维度平均方差提取值均>0.4、组合信度均>0.7。区分效度分析结果显示,三因子结构方程模型的拟合指数较二因子模型、单因子模型良好(P<0.01)。信度检验结果显示,量表总体内部一致性系数为0.830,总体分半信度系数为0.784,总体重测信度为0.929。结论乳腺纤维腺瘤肝郁气滞证中医诊断量表具有良好的信度及效度,能够满足临床诊断使用的实际需求。

Objective To evaluate the reliability and validity of the traditional Chinese medicine(TCM)diag-nostic scale for liver constraint and qi stagnation syndrome of breast fibroadenoma.Methods A total of 125 patients with breast fibroadenoma were investigated by using the TCM diagnostic scale for liver constraint and qi stagnation syn-drome with 12 syndrome items.The validity of the scale was tested by structural validity,convergence validity and discriminant validity analysis.The internal consistency reliability,split-half reliability and retest reliability of the scale were calculated to evaluate the reliability.Results Of all 125 questionnaires,four with completion rate less than 90%were excluded,and 121 questionnaires were valid,with an effective recovery rate of 96.8%.The comple-tion time of the scale questionnaire was 7.96±0.34 minutes,and there was no missing item values of the included questionnaires.Structural validity analysis showed that the maximum cumulative variance contribution rate was 59.479%when three common factors were extracted in the exploratory factor analysis;the absolute value of the exclu-sion factor load coefficient was set as≥0.5,and then the scale could be divided into three dimensions,namely primary symptoms,secondary symptoms,and tongue and pulse.In terms of confirmatory factor analysis,the chi-square valuel degree of freedom(x/df)was 1.075(<3),and the root mean square error of approximation(RMSEA)was 0.025(<0.05);the goodness-of-fit index(CFI)was 0.925,and the comparative goodness-of-fit index(CFI)was 0.990,while the incremental goodness-of-fit index(IFI)was 0.990,the Tucker-Lewis(TLI)was 0.987,and all values were greater than 0.9.Convergence validity analysis showed that allitems factor loadings were greater than 0.5,with the average variance extraction values greater than 0.4,and the combined reliability greater than 0.7.The discrimi-nant validity analysis showed that three-factor model fitting index was better than that of two-factor and single-facotr models(P<0.01).The overall internal consistency coefficient of the diagnostic scale was 0.830,and the total split-half reliability coefficient was 0.784,with the total test-retest reliability of 0.929 through reliability test.Conclu-sion The TCM diagnostic scale for liver constraint and qi stagnation syndrome of breast fibroadenoma has good reli-ability and validity,which can meet the actual needs of clinical diagnosis.