原发性高血压肾阴阳两虚证诊断量表的研制及信度与效度检验
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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.
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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[13]巫秀美,倪宗瓒.因子分析在问卷调查中信度效度评价的应用[J].中国慢性病预防与控制,1998,6(1):28.
[14]丁英钧,李平,王颖辉,等.基于德尔菲法的糖尿病肾病中医辨证专家意见分析[J].中华中医药杂志,2010,25(10):1554-1557.
[15]一帆.经典测验理论[J].教育测量与评价(理论版),2009,2(7):26.
[16]孟凡波,杨传华,齐冬梅,等.高血压肝阳上亢证诊断量表条目筛选的研制[J].南京中医药大学学报,2012,28(3):225-228.
[2]中华人民共和国卫生部.中药新药临床研究指导原则(试行)[S].北京:中国医药科技出版社,2002:73-77.
[3]沈自尹,王文健.中医虚证辨证参考标准[J].中国中西医结合杂志,1986,6(10):598.
[4]冷方南.中医证候辨治规范[M].北京:人民卫生出版社,1989:89.
[5]方药中,邓铁涛.实用中医内科学[M].上海:上海科学技术出版社,1986:42.
[6]赵拥军,陈景武,唐军.主成分分析与因子分析法在医院管理质量综合评价中的应用研究[J].中国卫生统计,2006,23(5):403-406.
[7]王可,何鹏,张娟,等.因子分析法在医疗工作质量评价中的应用[J].中国卫生统计,2012,29(6):897-899
[8]孟虹,刘阳,张勘,等.用因子分析法分析临床医学中心绩效评价体系的结构效度[J].第二军医大学学报,2007,28(1):94-97.
[9]马利.基于数据挖掘的聚类分析和传统聚类分析的对比研究[J].数理医药学杂志,2008,21(5):530-531.
[10]秦浩,陈景武.医学量表条目的筛选考评方法及其应用[J].中国行为医学科学,2006,15(4):375-376.
[11]曾五一,黄炳义.调查问卷的可信度和有效度分析[J].统计与信息论坛,2005,20(6):11-15.
[12]柯惠新.调查研究中的统计分析法[M].北京:北京广播学院出版社,1992:72.
[13]巫秀美,倪宗瓒.因子分析在问卷调查中信度效度评价的应用[J].中国慢性病预防与控制,1998,6(1):28.
[14]丁英钧,李平,王颖辉,等.基于德尔菲法的糖尿病肾病中医辨证专家意见分析[J].中华中医药杂志,2010,25(10):1554-1557.
[15]一帆.经典测验理论[J].教育测量与评价(理论版),2009,2(7):26.
[16]孟凡波,杨传华,齐冬梅,等.高血压肝阳上亢证诊断量表条目筛选的研制[J].南京中医药大学学报,2012,28(3):225-228.