Evaluation Study On Reliability,Validity And Diagnostic Efficacy Of Two Diagnostic Criteria On Syndrome Of Intermingled Phlegm And Blood Stasis In Coronary Heart Disease

Purposes:To evaluate the reliability,validity and diagnostic efficacy of two diagnostic criteria of intermingled phlegm and blood stasis syndrome in coronary heart disease(CHD),and revise the threshold.Methods:There are two diagnostic criteria for phlegm-blood stasis syndrome of CHD in different forms,which are referred to as "phlegm-dampness syndrome+blood stasis syndrome" and"phlegm-blood stasis syndrome".Part 1:Evaluate the reliability and validity of the scales based on 973 Epidemiological Survey data.Confirmatory factor analysis are used to evaluate the structural validity of the scales.Cronbach’s a coefficient and Spearman-Brown coefficient are used to evaluate the internal consistency reliability and split-half reliability of the scales,respectively.Part 2:Evaluate the diagnostic efficacy of two criteria based on prospective diagnostic test.The sensitivity,specificity and accuracy are calculated by the diagnostic four-grid table,and the best diagnostic threshold is obtained by receiver operator characteristic curve(ROC)analysis.Results:Part 1:(1)The Cronbach’s a coefficients of "phlegm-dampness syndrome+blood stasis syndrome" diagnostic scale,phlegm-dampness syndrome scale,blood stasis syndrome scale are 0.826,0.767and 0.744,respectively,and the Spearman-brown coefficients are 0.672,0.754,and 0.710,respectively.All the load coefficients of the structural equation model of the scale pass the parameter significance test,and the correlation between latent variables is significant.(2)The Cronbach’s a coefficients of the "phlegm-blood stasis syndrome" diagnostic scale is 0.619,and the Spearman-brown coefficient is 0.604.All the load coefficients of the structural equation model of the scale passed the parameter significance test.Part 2:(1)The"phlegm-dampness syndrome+blood stasis syndrome" diagnostic criteria is composed of the phlegm-dampness syndrome criteria and the blood stasis syndrome criteria.The area under the curve(AUC)of the phlegm-dampness syndrome criteria is 0.835,95%confidence interval(CI)is 0.724～0.946(P<0.01);after revising the diagnostic threshold to "≥5 points" according to the maximum value of Youden Index(0.62),the sensitivity(SEE),specificity(SPE)and accuracy(ACC)are 90%,72%and 86.4%respectively;The diagnostic threshold of blood stasis syndrome remains at "≥6 points";Therefore,after adopting the new diagnostic threshold of "phlegm-dampness syndrome index≥5 points and blood stasis syndrome index≥6 points",the SEN,SPE and ACC of the new diagnostic threshold of "phlegm-dampness syndrome+blood stasis syndrome" diagnostic criteria are 32.91%,97.56%and 55%,respectively.(2)The AUC of the "phlegm and blood stasis syndrome" diagnostic criteria is 0.806,and the 95%CI is 0.73-0.882(P<0.01);After revising the diagnostic threshold to "≥9 points" according to the maximum value of Youden Index(0.525),the SEN,SPE and ACC of the criteria are 69.62%,82.93%and 74.17%,respectively.Conclusion:1.Reliability and Validity Evaluation:The two diagnostic scales of phlegm-blood stasis syndrome of CHD have certain reliability and effectiveness.2.Diagnostic Efficiency Evaluation:After adjusting the diagnostic threshold to"phlegm dampness syndrome index ≥5 points",the diagnostic efficiency of the phlegm-dampness syndrome criteria is good,while the threshold of the blood stasis syndrome criteria remained unchanged("blood stasis syndrome index≥6 points")and the diagnostic performance was good;However,the new diagnostic threshold of the "phlegm-dampness syndrome+blood stasis syndrome" diagnostic criteria is "phlegm dampness syndrome index≥5 points and blood stasis syndrome index≥6 points",the diagnostic efficiency is only slightly improved.After adjusting the diagnostic threshold of "phlegm and blood stasis"diagnostic criteria as a whole to "phlegm and blood stasis syndrome index≥9 points",the diagnostic efficiency is significantly improved.3.Comparison of the Two Criteria:In the two diagnostic criteria of phlegm-blood stasis syndrome of CHD,the "phlegm and blood stasis syndrome" in the overall form of complex syndrome reflects better diagnostic efficiency.However,this conclusion still needs further research and verification.