Development And Evaluation Of TCM Diagnostic Scale For The Coronary Heart Disease Phlegm Syndrome

Purpose:In this study,we aimed the Coronary Heart Disease Phlegm Syndrome as research object.On the basis of the evidence-based medical literature system evaluation and expert consultation results completed by the research team in the early stage,we used the combination of subjective and objective item selection methods to develop the TCM Diagnostic Scale of Coronary Heart Disease Phlegm Syndrome.And evaluated it from the aspects of reliability and validity,then through the experimental design by using the scale diagnostic sensitivity and specificity of the clinical diagnosis to examine its clinical value.So as to explore quantitative diagnosis methods of TCM syndromes and improve the accuracy of clinical diagnosis.Methods:1.Established items pool and screening entries:Based on the previous work of the research group,through the literature evaluation method of evidence-based medicine to construct the items pool for the diagnosis scale of Coronary Heart Disease Phlegm Syndrome.Further carried out many small-scale expert discussions,clinical patient information survey,Delphi and AHP expert consultation,screen scale entries,and initially established the diagnosis scale of Coronary Heart Disease Phlegm Syndrome.2.Scale reliability and validity evaluation:the feasibility and stability of the clinical investigation results of the initially established Coronary Heart Disease Phlegm Syndrome scale by using a variety of mathematical statistical methods were used to screen and optimize the items of the scale test,and evaluations were made in terms of reliability,validity,feasibility,and responsiveness.Clinical investigation and test on the preliminary scale,3.Scale Diagnostic Efficacy Evaluation:Adopted a diagnostic test design plan,carried out double-blind clinical research tests in the same period,and examine the diagnostic efficacy of the scale from the ROC curve,sensitivity and specificity,and explore the quantitative diagnostic value of the Coronary Heart Disease Phlegm Syndrome Diagnosis Scale.Result:1.Scale entry pool establishment and entry screening results:Based on the preliminary literature review and Delphi method experts opinion consultation results of the research group,the "Chinese medicine diagnosis scale for Coronary Heart Disease Phlegm Syndrome" was initially established,including the general symptom dimensions(Chest,tightness,Chest pain,Head weight,Dizziness,Phlegm,Body tired,Fullness,Body obesity),tongue pulse dimension(Light tongue,Greasy,Slippery pulse,Pulse ridge,Pulse string)a total of 13 items.Scale entry screening results:deleted the entries "Chest pain","Pulse ridge","Pulse string" such as discrete trend method,Cronbach a method,factor analysis method,correlation coefficient method,and retest reliability method."Pulse string",the optimized scale contains a total of 10 items in two dimensions,general symptom dimensions:Chest tightness,Head weight,Dizziness,Ssputum,Body tired,Fullness,and Obesity;tongue pulse dimension:Pale tongue,Greasy tongue,Slippery pulse.2.Evaluation results of scale reliability,validity and response:Reliability evaluation results:the retest reliability of the total table,general symptom dimension,and tongue and pulse image dimensions were 0.976,0.974,and 0.977,respectively,and the Kronbach alpha coefficients of the total table,general symptom dimension,and tongue and pulse image dimensions were 0.669 and 0.641,respectively.,0.534,the results suggest that the reliability of the scale was good.Scale validity evaluation:Through the rational design and scientific implementation of the scale,it was suggested that the convergence validity was better;the general symptom dimension and tongue and pulse image dimension are calculated by the heterogeneous-single ratio method.The ratio is 0.34,which was lower than 0.85,suggesting the scale The discrimination validity was good;the fitting degree of AMOS structural equation,model test chi-square value is 43.354,GFI,AGFI,NFI,IFI,TLI,CIF values were all greater than 0.9,suggesting that the scale fit was good.Evaluation of the validity of the calibration,the correlation coefficients of the Phlegm-turbidity Scale and Phlegm-Stagnation Syndrome Scale,Phlegm-Syndrome Dimension,and Stasis-Syndrome Dimension Correlation Coefficients are 0.864,0832,0.437,p<0.05 respectively.The correlation coefficient of phlegm and blood stasis syndrome phlegm syndrome dimension r=0.703,p<0.05,suggesting that the scale has high correlation validity with the coronary heart disease phlegm and blood stasis syndrome scale and its phlegm syndrome dimension.The correlation coefficient r=0.126 between the Phlegm Turbidity Scale and the Blood Stasis Syndrome Scale,suggesting that the scale has a low correlation with coronary heart disease blood stasis syndrome.Evaluation of reactivity:Phlegm syndrome and non-phlegm syndrome were in the total scale(Z=-6.228,P=0.001<0.05),in the general symptom dimension(Z=-5.495,P=0.001<0.05),in the tongue and pulse dimension The comparison(Z=-4.616,P=0,0001<0.05)was statistically different,and the scale response was good.3.Evaluation results of scale diagnostic efficacy:Scale diagnosis threshold determination result:ROC curve analysis was performed through clinical investigation of 201 qualified subjects.The diagnosis threshold determination result was:area under the curve was 0.825,and 95%confidence interval was(0.762,0.887).When the total score of the scale is 9.5,the maximum Youden index is 0.60,the sensitivity is 80%,and the specificity is 80%.It is suggested that the total critical point of diagnosis of TCM diagnosis scale of coronary heart disease is 9.5 points,the score exceeds 9.5 to be diagnosed as Coronary Heart Disease.4.Evaluation results of diagnostic efficacy of qualified subjects of the scale:The diagnostic efficacy of 70 cases of qualified subjects with coronary heart disease and sputum turbidity syndrome was:sensitivity 80.0%,specificity 85.0%,accuracy 81.4%,suggesting CoronaryHeart Disease Phlegm Syndrome Diagnostic Scale was good for clinical diagnosis.In conclusion:1.The feasibility of the scale and the stability of the measurement were good:this study used scientific and reasonable scale design and strict quality control to ensure that the scale was evaluated on different people,different time points,different regions,and individuals at different time points.Had good feasibility and stability.2.The reliability and validity of the scale were high:the reliability was good:the retest reliability of the total scale was 0.976,and the alpha coefficient of the total scale was 0.669;the validity of the scale was good:MOS structural equation test:Chi-square value was 43.354,GFI,AGFI,NFI,IFI,TLI,CIF values were all greater than 0.9,and the correlation with the calibration standard phlegm and blood stasis syndrome scale r=0.864,the scale can distinguish phlegm and non-phlegm well Card crowd.3.The diagnostic efficiency of the scale was high:the feasibility,reliability,vali dity and responsiveness of the scale were good.After preliminary clinical diagnosis and verification,the sensitivity,specificity and accuracy of the Chinese medicine dia gnostic scale for coronary heart disease phlegm syndrome were good,Could be us ed as a clinical diagnostic tool for clinicians’ reference.At the same time,the resear ch methods used in this study can provide references for the diagnosis of other dise ase syndromes.3.The diagnostic efficiency of the scale was high:the sensitivity of the TCM d iagnosis scale for coronary heart disease phlegm and turbidity syndrome was 80%,t he specificity was 85%,and the accuracy was 81.4%.It could be used as a clinical diagnostic tool with a critical value of 9.5 points.That was,a score exceeding 10 points could be diagnosed as a syndrome of Phlegm of Coronary Heart Disease.