摘要
目的:建立原发性高血压肾阴阳两虚证中医诊断量表,并对其信度和效度进行测试。方法:按照国际通用量表研制的程序化方法,提取、筛选高血压患者四诊证候信息,形成原发性高血压肾阴阳两虚证诊断量表基本框架,以古今文献研究为基础确立四诊条目池,德尔菲专家问卷法初筛量表条目,进行小范围预测试,获得第一版量表,并对其进行系统分析以进一步筛选条目。以该诊断量表为调查工具,以山东中医药大学附属医院心内科门诊原发性高血压患者为调查对象,做调查问卷,考查量表信度与效度。采用6种统计学方法对临床流行病学统计结果进行条目细筛,若某一条目不符合其中的任一统计方法,即予删除。结果:最后形成了具有14个条目的高血压肾阴阳两虚证中医诊断量表。原发性高血压肾阴阳两虚证诊断量表的重测信度在0. 700~0. 909,分半信度相关系数R=0. 872,同质性信度3个维度的克朗巴赫系数为0. 807、0. 853、0. 764,内部相关系数3个维度与总量表的相关系数分别为0. 909、0. 940、0. 827,区分效度肾阴阳两虚组与非肾阴阳两虚组正态性检验,肾阳虚、肾阴虚、总量表积分P=0. 000,结构效度3个公因子的方差累计贡献率为64. 191%,旋转因子模型结构与量表的条目设置吻合。结论:运用量表制作方法对中医证候诊断进行规范化研究具有一定的可行性,该量表具有良好的信度和效度。
Objective: To establish a TCM diagnostic scale for essential hypertension with deficiency of kidney yin and yang,and to test its reliability and validity. Methods: According to the programmed method developed by the International General Scale,the information of the four diagnostic syndromes of hypertension patients was extracted and screened to form the basic framework of the diagnostic scale of kidney yin-yang deficiency of essential hypertension. Based on the research of ancient and modern literature,the four diagnostic items pool was established,and the items of the scale were screened by Delphi expert questionnaire. The first edition of the scale was obtained by small-scale prediction test,and the items were systematically analyzed for further screening.The reliability and validity of the diagnostic scale were Department of Cardiology of Affiliated Hospital of Shandong. Six statistical methods were used to screen the items of clinical epidemiological statistics. If an item did not conform to any of the statistical methods,it would be deleted. Results: Finally,a 14-item TCM Diagnostic Scale for hypertensive kidney yin-yang deficiency syndrome was developed. The test-retest reliability of the diagnostic scale for kidney yin-yang deficiency syndrome in essential hypertension ranged from 0. 700 to 0. 909. The half-reliability correlation coefficient was R = 0. 872. The Cronbach coefficients of three dimensions of homogeneity reliability were 0. 807,0. 853 and 0. 764,respectively. The correlation coefficients between the three dimensions of internal correlation coefficient and the total table were 0. 909,0. 940 and 0. 827 respectively. Differentiation Validity between Kidney Yin-Yang Deficiency Group and Non-Kidney Yin-Yang Deficiency Group was normality test. Kidney-yang deficiency,kidney-yin deficiency and total table integral P = 0. 000. The cumulative variance contribution rate of the three common factors of structural validity was 64. 191%. The rotating factor model structure was consistent with the item setting of the scale.Conclusion: It is feasible to make a standardized study of TCM syndrome diagnosis with the method of scale making,and it has proved that the scale has good reliability and validity. It is a sensitive,effective and credible measuring tool,which deserves further examination.
引文
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