ObjectiveTo construct the theoretical model of syndrome differentiation of chronic heart failure in traditional Chinese medicine based on "disease-syndrome pattern-syndrome elementsyndrome".Through structural equation model differentiation and quantitative analysis,in order to provide an objective,standardized and operable tool for the diagnosis of heart failure in traditional Chinese medicine.Methods1.Formation of an item pool,construction of the theoretical framework for syndrome differentiation of chronic heart failure,and formulation of a survey questionnaireBased on literature research,retrospective analysis of cases,Delphi method and related authoritative data and other methods for constructing the pool of syndrome differentiation,summarizing syndrome types,syndrome elements,Syndrome law,form a pool of items,construct a " disease-syndrome pattern-syndrome element-syndrome" theoretic framework of chronic heart failure syndrome differentiation.After discussions with experts,prepare the "Symptom and Syndrome Differentiation Questionnaire for Chronic Heart Failure" and complete the revision of the initial questionnaire.2.Multi-center clinical investigationsThrough multi-center clinical investigations,cases were included in stratification according to different ages,genders,and cardiac function classifications.3.Screening of entriesFilter items through subjective and objective methods.The subjective screening method selected Delphi method to create the "Chronic Heart Failure Expert Consultation Questionnaire",and a total of 35 experts from 12 hospitals evaluated and screened each item in the form of an online questionnaire.Objectively,using SPSS 26.0 software,using frequency analysis method,discrete trend method,Cronbach’s coefficient analysis method,correlation analysis method,factor analysis method and other classical statistical methods to screen.4.Scientific evaluationThe scale is scientifically evaluated through feasibility analysis,reliability evaluation,and validity evaluation.The reliability evaluation uses SPSS 26.0 software to calculate the Cronbach coefficient and split-half reliability,and the validity evaluation uses AMOS26.0software to conduct dialectical and quantitative evaluation through the latent variable structural equation model.5.Item assignment and diagnosis threshold determinationUsing SPSS 26.0 software,Logistic regression method was used to assign scores to items,ROC curve was used to determine the diagnostic threshold,and the heart failure syndrome differentiation scale was initially compiled.Results1.Based on a variety of entry pool construction methods,screen the six major syndrome elements of heart failure disease,Qi deficiency,Yin deficiency,Yang deficiency,blood stasis,fluid retaining,and phlegm turbidity,including mental fatigue,heavy body,fatigue,shortness of breath,lazy speech,Low voice,easy fatigue from activities,shortness of breath,chest tightness,cough,expectoration,phlegm in the throat,foreign body sensation in the pharynx,palpitations,upset,dizziness,abdominal distension,nausea,chills,warmth,cold limbs,cold abdomen,Waist and knees soreness,hot hands,feet and heart,waist and knees soreness,spontaneous sweating,night sweats,cold sweats,pale or shabby complexion,pale complexion,dull complexion,zygomatic redness,dark purple lips,blue nails,faulty skin,tingling,Fixed pain,pain refusal to press,night pain,edema,appetite,dry mouth,dry throat,thirst,dry mouth not wanting to drink,sticky mouth,poor sleep,sleepiness,lethargy,sticky stool,loose stool,urination The entry pool of 53 syndromes,such as longness,difficulty urinating,and frequent nocturia,and constructing the "disease-syndrome pattern-syndrome element-syndrome" theoretic framework of chronic heart failure based on the correlation between syndromes and syndrome elements.2.Multi-center study: A total of 257 patients were included in this study,with an average age of 70.48±13.395 years.Among them,there were 138 males and 119 females;63 cases(24.9%)of cardiac function level II,119 cases(46.3%)of cardiac function level III,and 74 cases(28.8%)of cardiac function level IV.3.Entry screening: Delphi method prompts to delete zygomatic red and peeling moss entries,frequency analysis prompts to retain all entries,discrete trend analysis prompts,Cronbach coefficient analysis prompts to retain all entries,correlation coefficient analysis prompts to delete mental fatigue,pale complexion or Multiple items such as Shaohua,low voice,shortness of breath,spontaneous sweating,and light tongue;factor analysis prompted the deletion of loose stool items;and after the final discussion by the experts,some syndrome items that did not meet the conditions were deleted.Finally,after discussion by experts,items such as nausea,sore waist and knees,cold sweats,pale complexion,blue nails,dry mouth and unwillingness to drink,sticky mouth,sticky stools,loose stools,long and long urine,poor urination,frequent nocturia,etc.,Keep the following items:(1)Qi deficiency syndrome element: mental fatigue,pale or shabby complexion,lazy speech,low voice,shortness of breath,fatigue from activities,spontaneous sweating,and pale tongue.(2)Yin deficiency syndrome element: upset,hot hands,feet,heart,zygomatic redness,dry mouth,dry throat,thirst,night sweats,poor sleep,red tongue,little/no moss/peeling.(3)Yang deficiency syndrome element: chills,warmth,cold limbs,cold abdomen,cold waist and knees,drowsiness,lethargy,fat tongue.(4)Blood stasis element element: tingling,fixed pain,refusing to press the pain,very painful at night,dull complexion,dark purple lips,wrong nails,dark purple tongue.(5)Fluid retaining syndrome element: edema,heavy body,abdominal distension,poor appetite,pale tongue,fat tongue.(6)Phlegm turbidity syndrome elment: cough,expectoration,dizziness,foreign body sensation in pharynx,greasy moss.4.Scientific evaluation: feasibility analysis: the recovery rate of the chronic heart failure syndrome differentiation questionnaire is 100%,no items are missing,the response time is reasonable,and the feasibility is strong;reliability evaluation: Cronbach of the chronic heart failure syndrome differentiation questionnaire The coefficient is 0.934 and the split-half reliability is 0.731,suggesting that the questionnaire has high reliability and the overall evaluation index has strong reliability;validity evaluation: the structural equation model of chronic heart failure is formed after item selection,and the AMOS software is used to perform the fit analysis.The results indicate that the fit index of each syndrome element in the model is good [(1)Qi deficiency syndrome: Goodness of Fit Index(GFI)=0.935,Comparative Fit Index(CFI)=0.916,Root Mean Square of Approximation Error(RMSEA)=0.115;(2)Yin deficiency syndrome: goodness of fit index(GFI)=0.911,comparative fit index(CFI)=0.887,root mean square approximate error(RMSEA)=0.123;(3)Yang deficiency syndrome: goodness of fit index(GFI)= 0.907,comparative fit index(CFI)=0.841,root mean square approximate error(RMSEA)=0.171;(4)Blood stasis syndrome: goodness of fit index(GFI)=0.82,comparative fit index(CFI)=0.687,approximate Root mean square error(RMSEA)=0.215;(5)Fluid retaining syndrome:goodness of fit index(GFI)=0.994,comparative fit index(CFI)=0.989,root mean square approximate error(RMSEA)=0.049;(6)Sputum turbidity syndrome: Goodness of Fit Index(GFI)=0.993,Comparative Fit Index(CFI)=0.994,Root Mean Square Approximation Error(RMSEA)=0.056].5.According to Logistic regression and ROC curve analysis,the diagnosis model of various syndromes of chronic heart failure is obtained:(1)Qi deficiency syndrome = mental fatigue × 2 + pale complexion or Shaohua × 2 +lazy words × 4 + low voice × 2 + shortness of breath × 1 + easy activity × 3 + spontaneous sweat × 2 + pale tongue × 2,diagnostic threshold 25.5 points.(2)Yin deficiency syndrome = upset × 1 + hand,foot,heart heat × 3 + zygomatic red ×5 + dry mouth × 3 + dry throat × 2 + thirst × 2 + night sweats × 2 + poor sleep × 2 + red tongue × 3 + coating Less/none/stripping × 3,the diagnostic threshold is 18.5 points.(3)Yang deficiency syndrome = chills × 3 + warmth × 2 + cold limbs × 2 + cold abdomen × 3 + cold waist and knees × 2 + sleepiness and lethargy × 2 + fat tongue × 4.The diagnostic threshold is 18.5 points.(4)Blood stasis syndrome = tingling×2 + fixed pain×2 + pain refusal×2 + pain at night×3 + dull complexion×3 + dark lips×2 + skin nails×3 + dark purple tongue×3,The diagnostic threshold is 13.5 points.(5)Fluid retaining syndrome=edema×3+body weight×1+abdominal distension×2+anorexia×3+light tongue×2+tongue fat×2,the diagnostic threshold is 8.5points.(6)Phlegm turbidity syndrome = cough × 2 + expectoration × 3 + dizziness × 2 +pharyngeal foreign body sensation × 3 + greasy moss × 3,the diagnostic threshold is 8.5points.ConclusionBased on the combination of subjective and objective evaluation,traditional statistics and latent variable structural equation model verification,it is suggested that the Questionnaire on Syndrome Differentiation of Chronic Heart Failure has good reliability and validity,and can be used for the objective research of syndrome differentiation of chronic heart failure.It provides an objective,standardized,and operable tool for clinical differentiation of chronic heart failure. |