| ObjectiveCross-sectional survey method was used to collect the information of four diagnoses of epilepsy patients and the dialectical of neurology experts.Through statistical methods,Zhou Xinjie' s "TCM Syndrome Questionnaire for Epilepsy" was revised and evaluated,and the "Epilepsy TCM Syndrome Scale"was formulated.Methods1?To prepare the TCM Syndrome Questionnaire for Epilepsy used in this study:on the basis of Zhou Xinjie' s " TCM Syndrome Questionnaire for Epilepsy",add a small number of items,rewrite the structure of the questionnaire,and take the integers of the entries.2.The cross-sectional survey:The cross-sectional study method was used to collect the basic data of epilepsy patients in the outpatient department and inpatient department of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine,and to collect the information of four diagnoses by using the TCM Syndrome Questionnaire for Epilepsy.TCM clinical neurology experts conduct "expert differentiation".3?Item screening:Based on the obtained statistical data,the following seven methods are used to filter the items.CDFrequency distribution method:retaining ietms with frequency greater than 5%;?Discrete trend method:retaining items with standard deviation ?0.7;?Correlation coefficient method:retaining ietms with Spearman rank correlation coefficient absolute value?0.35;?Factor analysis method:use of the main Ingredient method,the maximum variance rotation is performed,the maximum number of iterations is 25,the eigenvalue is greater than 1 as the extraction criterion,and the item with the load amount ?0.4 on the corresponding common factor is retained;?The discrimination analysis method:using the chi-square test,retaining the items with P value<0.05;?Cronbach' s alpha coefficient method:after removing an item,the entry of the Cronbach' s a coefficient is considered to be deleted;?Stepwise regression method:Logistic regression Backward Wald method is used to filter the variables through several iterations to stabilize the equation,retain the items of P<0.05,and combine the above seven methods to retain the entries of at least 3 methods.4?Assignment of items and determination of diagnostic thresholds:Logistic regression is used to assign weights to items,and the optimal diagnostic threshold is determined by ROC curve,and the Epilepsy TCM Syndrome Scale is revised.5?"Epilepsy TCM Syndrome Scale" reliability,validity evaluation:The Guttman Split-Half coefficient R is used to reflect the split-half reliability.The Cronbach' s alpha coefficient reflects the internal consistency reliability.The content validity is analyzed from the TCM professional knowledge,the scale development process and the clinical pre-survey results.The structural validity was evaluated by factor analysis.6?Diagnostic test of "Epilepsy TCM Syndrome Scale":The information of the four diagnosed epilepsy patients will be returned to the scale,and the scores of each syndrome will be calculated,and the "scale syndrome differentiation" will be obtained.Diagnostic tests were conducted with"expert differentiation" as the "gold standard".The evaluation indicators included sensitivity,specificity,accuracy,positive predictive value,negative predictive value,Yoden index and Kappa value.Results1?To prepare the "TCM Syndrome Questionnaire for epilepsy " used in this study:Based on Zhou Xinjie's questionnaire,"Excessive Motor Automated Syndrome","Non-Excessive Autonomic Syndrome","Positive Emotion",and"Negative Emotion" were added.According to the fire syndrome,wind syndrome,closed syndrome,phlegm syndrome,stasis syndrome,heart qi deficiency syndrome,spleen qi deficiency syndrome,kidney yin deficiency syndrome,kidney yang deficiency syndrome,9 syndromes are divided into 9 subscales;The value of the item is integerized.2?The cross-sectional survey results:From April 2017 to January 2019,a total of 169 eligible patients with epilepsy were included.Each patient' s"expert syndrome" has one or more syndromes,including 67 cases of fire syndrome,117 cases of wind syndrome,148 cases of closed syndrome,122 cases of phlegm syndrome,58 cases of stasis syndrome,27 cases of heart blood deficiency syndrome,94 cases of spleen qi deficiency syndrome,37 cases of kidney yin deficiency syndrome and 34 cases of kidney yang deficiency syndrome.3?Item screening:After screening by 7 statistical methods,a total of 93 entries were retained,of which 16 were shared in 2 or more subscales.The number of each sub-scale items are as follows:fire syndrome 14,wind syndrome 5,closed syndrome 6,phlegm syndrome 13,stasis syndrome 7,the heart blood deficiency syndrome 5,the spleen qi deficiency syndrome 13,the kidney yin deficiency syndrome 11,the kidney yang deficiency syndrome 11.4?Weight assignment,and diagnostic threshold results:The contribution degree of the logistic regression equation variable is used as the weight of the item.The diagnostic thresholds of the nine subscales are as follows:firesyndrome 4.05 points,wind syndrome 10.6 points,closed syndrome 11.75 points,phlegm syndrome 5.05 points,stasis syndrome 8.25 points,heart blood deficiency syndrome 7.25 points,spleen qi deficiency syndrome 5.9 points,kidney yin deficiency syndrome 5.55 points,kidney yang deficiency syndrome 5.15 points.5?The results of the reliability and validity of the scale:the overall split-half reliability of the scale is 0.313,and the overall Cronbach's ?coefficient is 0.757.The content validity of the scale is good.The factor analysis method has a KMO value of 0.464.6?Diagnostic test results:sensitivity,specificity,and accuracy of each syndrome are:fire syndrome(91.2%,72.3%,79.9%),wind syndrome(76.1%,44.2%,66.3%),closed syndrome(91.3%),80.0%,89.9%),phlegm syndrome(70.7%,84.8%,72.8%),stasis syndrome(37.9%,87.4%,70.4%),heart blood deficiency syndrome(59.3%,83.1%,79.3%),spleen qi deficiency syndrome(67.0%,90.7%,77.5%),kidney yin deficiency syndrome(89.2%,72.0%,75.7%),kidney yang deficiency syndrome(88.2%,91.1%,90.6%).ConclusionsBased on the clinical investigation,the revision of the TCM Syndrome Questionnaire for Epilepsy was completed,and the Epilepsy TCM Syndrome Scale was preliminarily formulated.All the items passed the comprehensive evaluation requirements,including frequency distribution,discrete trend method,correlation coefficient method,factor analytical method,discrimination analysis method,Cronbach' s alpha coefficient method and stepwise regression method.Each syndrome component has a certain score of the item and a diagnostic threshold.The sensitivity,specificity,and accuracy of the clinical diagnostic test are mostly good.Therefore,the Epilepsy TCM Syndrome Scale can be used as a diagnostic tool for epilepsy TCM syndromes,providing a reference for clinical syndrome differentiation and quantitative research.In addition,the structural validity of the scale is low,which may be related to the characteristics of TCM syndrome differentiation methods. 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