Development And Evaluation Of Syndrome Differentiation Scale Of Coronary Heart Disease Stable Angina Pectoris (Phlegm And Blood Stasis Syndrome)

Purpose：To initially established a new syndrome diagnostic instrument forangina with syndrome of phlegm and blood stasis, and to evaluate the feasibility,reliability and validity. The clinical diagnostic accuracy was alsopreliminarily verified. Though this study, a new simple, convenient andquantifiable diagnosis instrument was established for patients of angina withsyndrome of phlegm and blood stasis.Material and method：According to the combination of syndrome and disease,and the international guidance for instrument development, an item pool wasgenerated based on the information extracted from a literature review, criteriacollection, teaching material sort out, expert interview and patient interview.A focus group and an expert panel were established. Information in the item poolwas arranged and categorized by the expert panel according to the hypothesizedconceptual framework developed, questions were compiled during the process. Then,a cognitive interview and a pilot study were conduced for furthermore adjustmentsof semanteme. The draft instrument was established while a consensus was reachedby the focus group. A clinical study was conducted to screen items by statisticsanalysis and then the final instrument was established. The feasibility,reliability and validity were studied for the instrument. The diagnosticaccuracy was also preliminarily verified in clinical combing with the resultsof diagnostic cutoff and diagnostic model.Results：The final instrument consisted2dimensions as disease and syndrome;3facets as phlegm, blood stasis and spleen Qi deficiency;10items as chestpain, stuffiness in chest, palpitation, shortness of breath, somber complexion,purple lips, glomus and fullness, poor appetite, sliminess in the mouth and Heavybody. A total of98.37%subjects completed the instrument, and no ceiling orfloor effect existed. The test-retest reliability for the instrument, diseasedimension, syndrome dimension, phlegm facet, blood stasis facet and spleen Qi deficiency facet was0.942、0.903、0.953、0.924、0.952、0.932respectively. TheCronbach’s αfor the instrument, disease dimension and syndrome dimension was0.816、0.687、0.782respectively and the Spearman correlation coefficientbetween total score and each items were all above0.4. Two factors were extractedthrough the exploratory factor analysis, the cumulative proportion of variancewas49.790%, the factor extracted were accordance with the hypothesizeddimensions. The angina dimension was related with the CCS angina class (p=0.000),the Spearman correlation coefficient was0.313. The syndrome dimension wasrelated with the blood lipid for total cholesterol and low density lipoprotein(p＜0.05), the Spearman correlation coefficient was0.150and0.099respectively.Items of the instrument could distinguish different people well. The diagnosticcutoff was8.5for the syndrome dimension. the diagnostic accuracy of thesyndrome dimension was95.45%, the sensitivity was97.14%, and the specificitywas88.89%; For subjects of Ⅲ,Ⅳ degree, the diagnostic accuracy was94.737%and for subjects of Ⅰ,Ⅱ degree was100%.Conclusion：1. The instrument was validated and reliable.2. It is indicated that the instrument had high diagnostic accuracy, sensitivityand specificity through the clinical verification, so it can be preliminary usedin clinical study. What’s more, inadequate was also existed to be completedfor the instrument.