| ObjectiveTo establish preliminary TCM syndrome and the item pool according to the literature search and expert reviewers.Establish the final TCM syndrome and the qualitative item pool after entry.To make connection in TCM syndrome with symptom items through introduction of syndrome element,for establishing a theoretical model,which provide theoretical basis for the subsequent diagnosis model;According to the pre established qualitative item pool,combined with related literature,books and group discussion,expert marking,developing diagnosis questionnaire clinical investigation,which can provide data for subsequent diagnosis model.Take syndrome elements for the latent variables,and take the pre clinical cases as the data source to explore TCM diagnosis model method,then establish syndrome element differentiation diagnosis model methodology,expect establishing intelligent man-machine conversation platform with the use of computerized adaptive test,then make the TCM diagnosis standardized,immediately and simply.MethodsThe first part:the establishment of theoretical model and clinical investigation1 Set up working group of this projectDue to the research of this subject involved many fields,invite experts who are in related fields into this study to establish the work team,and follow the direction of the whole professional supervision and research progress.2 Preset the core and basic features of the projectPreset the core of this project for establishing TCM diagnosis technology,explore the item response theory and structural equation model diagnosis method of popularizing suitable;basic characteristics is to preset the object of this study(Functional Ddyspepsia and Iirritable Bowel Syndrome),the crowd who fit this study,subject,tool type and purpose,the number of entries and the answer time.3 Construct a preliminary conceptual frameworkThe conceptual framework is constructed with the methods of the literature,group discussion,patient interviews,and expert interview.The conceptual framework is used to determine the initial structure of this project,to guide the follow-up study,to determine the desired results.4 Construct a preliminary syndrome of traditional Chinese MedicineThe construction of TCM syndromes is the core part of this study,a comprehensive search of the literature and related materials,the establishment of a comprehensive traditional medicine syndrome bank as comprehensive as possible.5 Construct a preliminary item bankA comprehensive search of the literature,teaching materials and the previous scales,then screened this item bank by binning,winnowing,group discussion and expert qualitative review.6 Develop the TCM syndrome differentiation and diagnosis of functional gastrointestinal diseasesThe experts of the group are completely away from the study as the research object,the research team receive the characteristics and the contents from the diagnosis item pool,classify each item with Likert frading method,classify the item into two classification(yes/no)which can not be divided into four grades,then constitute a preliminary questionnaire.Based on professional knowledge and experience,experts' group look through the items one by one,then modify the questionnaire and start the pre clinical investigation.In terms of the interviews of the patients,doctors and nurses,construct the final questionnaire about the Functional Gastrointestinal Disease.7 Collect the clinical casesTo investigate cases which are met the inclusion criteria through the cross sectional study and prospective survey methods,fill in the questionnaire,record data,then input the data into the computer.Finally,take statistical analysis of the data.8 Statistical methods8.1 Sample sizeBased on the preliminary expectations of statistical methods,determine the sample size was 500 patients eventually.8.2 Basic statistics of clinical cases The basic data of this clinical cases is statistic by descriptive statistics,using Excel software to input data,table,and mapping.Use the SPSS 17.0 statistical software to statistic the clinical cases including sex,age segment,diploma,professional,distribution of TCM syndromes and the advisor by by frequency counting method.The second part:the establishment and optimization of the diagnosis model1 Entry screen1.1 Item response theory(IRT)Make the analysis of item response theory(IRT)in the R language,to valuate the item difficulty and discrimination,combined the screening criteria,develop item selection criteria which is suitable for TCM diagnosis,we can be into the next step of this research after the screening entry.1.2 Cronbach coefficient analysis methodSPSS 22 software was used to carry out the Cronbach coefficient analysis,to evaluate the reliability of the items,make a preliminary "syndrome element symptoms" entry set,then enter the next step.2 Exploratory factor analysisIn SPSS 22,do the exploratory factor analysis,according to the "syndrome-symptom item set" established before,reduce the dimensionality of the item bank.To find the core factor of these items through principal component analysis.This project take the TCM syndrome differentiation ideas as a guide,to explore the syndrome in factor analysis for the latent variables in the theory of traditional Chinese medicine under the framework of the quantitative exploration of "syndrome-symptom" model.By using the principal component extraction analysis in the early establishment of the "functional gastrointestinal disease of TCM syndrome element-syndrome as a reference,to determine the number of factors,establish the model.Based on the load factor level,make the model adjustment and factor explanation.The items which there is clear significance for the disease diagnosis(primary and secondary symptoms of related standards organizations).The syndrome which there is no correlation with the disease of TCM syndrome is finally deleted.Finally,the preliminary control model of syndrome element-symptom is constracted.3 Confirmatory factor analysisAMOS 21 software was used to verify the confirmatory factor analysis,the model was verified,according to the fit index,complete the model fitting evaluation,then establish the final”syndrome element-symptom" control model.4 Multidimensional item response theory(MIRT)According to the "syndrome elements-symptoms" control models and the theoretical model by expert review,to adjustment the "syndrome elements ?symptoms" control model,make the TCM model of structure which is covered symptom-syndrome element-syndrome.To construct the TCM model with MIRT method by using R language,make the syndrome element as the dimension to analyze the quantitative relationship between each item and each syndrome element,and to adjust the model by the evaluation of the model on the basis of the model fitting parameters,then eventually establish the preliminary functional gastroenteropathy TCM quantitative diagnosis model.5 Multidimensional index(MDISC)Evaluate the items of the model by using multidimensional index,and get the various objectives multidimensional index,and select the entries again according to the MDISC,optimize the diagnosis model.6 Preliminary expectationBased on the multi dimensional computer adaptive test,to establish an intelligent man-machine dialogue platform which provides the basis for the follow-up diagnosis model test.ResultsThe first part:the establishment of theoretical model and clinical investigation1 Conceptual frameworkThrough the conventional literature search,expert and patient interviews determine top-down conceptual framework,with functional gastrointestinal disease for top-level concept,take Western medicine diagnosis of functional dyspepsia(FD)diarrhea predominant irritable bowel syndrome(IBS-D)as the main research object,the sub concept is the diagnosis of traditional Chinese medicine concept stomachache,stomach stiffness and diarrhea,the TCM affiliated TCM syndromes and the underlying symptom items can be connected by syndrome element,form the basic conceptual framework of this study.2 Construction of item bank2.1 SourceThe TCM syndrome of FD and IBS-D are formulated in various organizations consensus standards and Chinese textbook Department of internal medicine;The item of the item bank is from the literature search,the relevant scales,add then supplement the consensus,standards and materials in the lack of symptom items.We mainly consider about that the successful development of the former more functional gastrointestinal disease scales,so TCM syndromes and symptoms sources we adhere to the "doctrine".On the one hand,the core of this study is to research the method of establishing the model of TCM syndrome differentiation,it is better that the pre establishment early according to the standards,so the study of TCM syndrome mainly comes from the organization specified in standard or consensus guidelines for diagnosis.On the other hand,the characteristics and the contents of symptoms have been studied in detail,they can be suitable for the health care or patients with the use of PRO or DRO scales,without too much adjustment,ad in the same time this can save a lot of time.2.2 Construction of item bankPut all the TCM syndrome and symptom items without deletion from the source into the item bank,construct the TCM syndromes and item bank.This step,the main requirements of the comprehensiveness of the item bank,so put all the symptoms into library entry,the item bank would be screened,deleted,changed and increaseed after the follow-up study.2.3 Qualitative optimization of item bankQualitative optimization of TCM syndromes and symptoms,structure processing of item entries by binning,delete and revise buplicate entries by winnowing,delete similar items,modify or add items through group discussion,and then modify or add entries through the final review by experts qualitative,finally,complete the qualitative optimization of item bank.This step,review item qualitively through a number of meetings to discuss,make the item bank completely and condedsely.It is better to the clinical investigation follow-up,and also it is easy to subsequent data analysis.3 Determination of syndrome elementsAccording to the basic theory of traditional Chinese medicine and the etiology and pathogenesis of symptoms,in terms of the group discussion and expert qualitative review,statistic and modify FGIDs TCM syndrome-syndrome element and symptom item-syndrome element.It is very important about the research of syndrome element in this study,it can not be subdivided.Our expectation is to connect the symptoms and syndromes of traditional Chinese medicine with the syndrome element,because the TCM clinical dialectical thinking can be highlight in this kind of way of study of syndromes of traditional Chinese medicine,but also can increase the difficulty of statistical methods.4 Development of Functional Gastrointestinal Disease of Traditional Chinese Medicine Diagnosis QuestionnaireLikert classification for each entry of the syndrome differentiation and diagnosis entry.According to the literature and reference books,make the classification easy to understand as possible as we can,form the questionnaire Functional Gastrointestinal Disease of Traditional Chinese Medicine Diagnosis Questionnaire.In clinical investigation,find out that there is individual entries needed to be adjusted in the questionnaire.On the one hand,there are too many items in the questionnaire,and apparently it is wasting time for us and the patients,this hindered the progress of clinical investigation.On the other hand,we can receive patients' feedback on the description of the entries that they can' t understand the meaning completely in the investigation,so further research still needs to adjust the questionnaire.5 Sample sizeIt is too short to make the questionnaire,so only a total of 1124 cases were collected,the sample is not enough theoretically,but it is the previous research of the National Natural Science Foundation of China,and we will continue to collect cases in the future.To exploration diagnosis model methodology in terms of this sample in this research.6 Sources of clinical case collectionPatients diagnosed all from the Guangzhou University of Chinese Medicine First Affiliated Hospital of the spleen and stomach diseases hospitalized patients of five professors,by a number of research students assisted to fill out the questionnaire,and collect cases after input the data in computer.7 The basic data of clinical cases7.1 Each disease caseA total of 1124 cases were collected,723 cases(64.32%)of FD cases,344 cases(30.96%)of IBS-D,64 cases(5.69%)with other functional gastrointestinal diseases.Previously reported in the literature function of gastrointestinal disease clinical total prevalence rate of nearly 50%,and it is most common with the non erosive reflux disease FD,functional constipation and IBS in functional gastrointestinal disorders,and IBS-D is the most common in IBS,it is feasible to choose FD and IBS as the object of study in this study,the cases about constipation is also the most common which is collected in other diseases,it is consistent with previous research reports.7.2 Age distributionThe age of This study according to the youth(18-45 years old),middle-aged(46-59 years)and elderly(60 years old and above)piecewise,after the statistics,about the 1124 cases,young patients account for the most,a total of 789 cases(70.20%),and also the most cases about FD and IBS patients are young patients,respectively 505(69.85%)and 233 patients(69.14%).It is reported in the previous studies about IBS-D that juvenile onset in the majority,and there is no significant correlation between age and the study results about FD.This study suggest that FD and IBS onset age more in young.This outcome accord with previously report about the IBS-D,at the same time also suggested that maybe there is correlation between FD and the age.7.3 Sex compositionGender composition in this study in general,male 521 cases(46.35%),female 603 cases(53.65%),of which male(43.85%),female 406 cases(56.15%)in FD cases,male 178 cases(52.82%),female 159 cases(41.18%)in IBS-D cases.It is reported in the previous studies that the pathogenesis of IBS-D and FD were female,and there is the ratio of male and female(1:2)reports about IBS-D.In this study females is more than males in FD,and the number of male and female is similar in IBS-D,the cause of the similar number may be related with the insufficient samples.7.4 DiplomaA total of 1124 cases,469 cases(41.73%)of university diploma.There is 282 cases(39%)of University Diploma in FD and 149 cases(44.21%)of University Diploma in IBS-D.It is reported in the previous studies that it is not sure there is relation between diploma and FD or not.In this study,the university diploma patients of more than 40%.And it is reported that the prevalence rate is higher than the developing countries on IBS,higher in urban than in rural areas,and this result is consistent with our study.7.5 OccupationOf the 1124 cases,the mental worker is the maximum occupation of 501 cases(44.57%),the mental worker is the maximum occupation of 307 cases(42.46%)on FD,the mental worker is the maximum occupation of 156 cases(46.29%)on IBS-D.There are so many cases of students in this study,and in the past,functional gastrointestinal disorders of college students is researched more and more.At present,more and more college students get ill with functional gastrointestinal disease,and this also suggests that the higher diploma crowd prevalence rate is relatively high.7.6 Syndromes distributionA total of 1124 cases,the most of the former three TCM Syndromes are liver stagnation and spleen deficiency syndrome(259 cases,23.04%),X67 spleen deficiency and dampness stagnation syndrome(210 cases,18.69%)and PX32 weakness of the spleen and stomach syndrome(111 cases,9.88%).Patient with this disease mostly is young people,young people under increasing pressure in work,life and social.Alter ego that emotion is not smooth,correlation between liver and spleen,long stagnation of the liver qi and deficiency of the spleen,so patients with syndrome of stagnation of liver qi and deficiency of spleen majority.According to the basic theory of traditional Chinese medicine,spleen hi dry wet evil and liver spleen correlation theory,the characteristics of coupled with Lingnan wet,spleen deficiency and dampness stagnation syndrome is the second most common syndromes is not difficult to explain.This ill patient of disease of liver and spleen in the majority,adverseness of hepatic Qi made the spleen and stomach,Lingnan wet,so many patients with spleen deficiency,spleen viscera related disease for a long time,so see weakness of the spleen and stomach syndrome.7.7 Collection of case guidanceThe main guiding Professor include Professor Shaoxian Lao,Professor Xinmei Xu,Professor Weihong Kuang,Professor Fengbin Liu,and Professor Shuangyou Tao.The professors are all experienced clinical experts and professors,and Professor Shaoxian Lao and Professor Xinmei Xu are the national doctor of traditional Chinese medicine,this can ensure the accuracy of diagnosis of clinical cases.The second part:the establishment and optimization of the diagnosis model1 Item screening1.1 Item Response Theory(IRT)In the R language,analyse the discrimination and difficulty of items with the use of Graded Response Model(GRM).Make a new standard which is feasible for TCM in terms of the basic theory of traditional Chinese medicine,then obtain the parameters of each item.It is not sure that this method is feasible for this study,but it is more in line with clinical practice of TCM theoretically.1.2 Cronbach coefficient analysis methodIn SPSS 22.0,analyse the reliability of each item with Cronbach's coefficient method,and get the overall Cronbach coefficient(0.957),this study make the syndrome element for the latent variables,which is used to research syndrome element-symptom model,it is suggested that there is consistency on all items of the syndrome element with Cronbach's coefficient method,which is more than 0.8.It is that there is good internal consistency about the entry as a whole and permit prime symptom.2 Exploratory factor analysisIn SPSS 22,do exploratory factor analysis.Find the core factors of these items,explore the quantitative syndrome element-symptom model,use the principal component extraction factor analysis to determine the number of factors,on the basis of the variety of basic theory,definite each factor,adjust and explain according to the load factor.Finally obtain the preliminary syndrome element-symptom model(version 1).It is a must that each factor between free and clip in exploratory factor analysis,and this is not consistent with the traditional Chinese medicine dialectical thinking,but on the other hand,relatively speaking,this method can simplify the Chinese medicine dialectical thinking.This can provide the basis for further research,at the same time,the way that we set in advance some items can not be screening is not a complete departure from the TCM method,and make this method simplified.3 Confirmatory factor analysisDo confirmatory factor analysis in Amos 21.0,obtain the syndrome element-symptom control model.Then adjust the control model according to the fitting index and theoretical model of TCM twice,eventually establish TCM diagnosis model(model A).This step,it is always poor about the fit indices,but it is described that fitting index reflect only the fitting degree of theoretical model in Amos,it is feasible in the explanation of the theory of TCM,fitting index is not required to have to meet the requirements.4 Multidimensional item response theory(MIRT)In the R language,construct the model with MITR,and evaluate,analyze and adjust the model on the basis of model parameter,then establish the final functional gastrointestinal disease quantitative syndrome differentiation diagnosis model.This research,do MIRT analysis through two ways:one is in that establish the diagnosis model(Model B)with the use of MIRT after the early screening of IRT analysis;Another way is that do MIRT on the bases of exploratory factor analysis,the proposed merger correction model,with the remaining entries based on MIRT analysis,Syndrome differentiation and diagnosis model(model C).Through the statistical analysis and theory,considering the latter is more in line with the expectations,more in line with dialectical thinking of traditional Chinese medicine clinical.This study suggests that the combination of SEM and MIRT establish a method for the study of TCM diagnosis model is feasible,but also more fit the expectations of mind,character Chinese medicine clinical dialectical thinking,can be used as a method to establish the follow-up disease diagnosis model.5 Multidimensional index(MDISC)According to the calculation formula of MDISC,the index of each dimension is calculated.According to the quality of MDISC,the items are classified,and the quality difference(MDISC less than 0.5)is removed and the diagnosis model is further optimized.The third part:Establishment and validation of diagnostic model1 Diagnosis modelAccording to the theoretical model,combined with TCM basic theory,pay attention to TCM diagnosis thinking,on the basis of modern measurement theory analysis basis,according to the second part of the model exploration results determined by structural equation model with multidimensional item response theory analysis method model,using logistic regression analysis method to establish the final diagnosis model.2 Collection of clinical caseAccording to the entries on a step diagnosis model,diagnosis model validated questionnaires are made,with diarrhea type irritable bowel syndrome(diarrhea)as the object of study collected clinical cases.3 1 9 10 2 2 and 3 were collected from clinical cases in 23 cases,male 14 cases(60.9%),female 9 cases(39.1%).The average age of 35 years old,the oldest was 69 years old,the minimum age is 18 years old;college diploma in 13(56.5%),Diploma in 3(13%),high school diploma(13%),junior high school diploma(8.7%),primary school diploma(8.7%);mental workers(43.5%),mixed workers(39.1%),labourers(4.3%),and other professional people(13%),liver stagnation and spleen deficiency syndrome in 9 cases(39.1%),spleen deficiency and dampness stagnation syndrome in 6 cases(26.1%),the spleen and stomach weak certificate 5 patients(21.7%),spleen and stomach damp heat syndrome in 2 cases(8.7%),spleen and stomach deficiency cold syndrome in 1 case(4.3%).3 Validation of modelEntry of 23 cases verified cases sample data,the software SPSS22.0,using logistic regression analysis,obtained the sample score of each,compared in 23 samples syndrome score,the establishment of syndrome of stagnation of liver qi and spleen deficiency syndrome and spleen wet resistance syndrome model equation,and obtain the following results:area under the liver stagnation and spleen deficiency syndrome curve equation of 0.786,diagnosis of general;spleen deficiency and dampness stagnation syndrome equation curve area 0.510.The diagnostic accuracy rate is poor.Considering the unsatisfactory results,the sample size is not enough,so the follow-up need to increase the sample size to do further research.4 Preliminary expectationIn the R language to establish multidimensional computerized adaptive test page,the questionnaire of various items and classification answer input page,each item parameters are introduced,forming multidimensional cat parameter management background,app and the web version of the intelligent man-machine dialogue platform to provide basis and foundation for the subsequent implementation.Conclusion1 It is feasible to establish the computer adaptive diagnostic items database of functional gastrointestinal disease by collecting the TCM syndromes and symptom,with the introduction of syndrome elements,the TCM syndrome and symptoms entries can be connected,the theoretical model can be established based on the theory of TCM theory and the experts' opinion.2 The FGIDs rules of TCM clinical investigation questionnaire can be successful developed according to the qualitative items,combined with literature search and books and experts discussion.3 To record data after collection of the clinical cases,and input the data into the computer.Make the statistics analysis by using Excel,SPSS,AMOS software and R language,at the same time,taking the opinions of experts into account,explore the method of TCM diagnosis,take the final evaluation of the diagnosis model finally.Establish the diagnosis model which is accord with the Chinese medicine clinical dialectical thinking.Construct the initial formation of functional gastrointestinal disease quantitative syndrome differentiation diagnosis model.Provide a basis for the subsequent verification work,and provide a feasible diagnosis method for diagnosis of syndrome differentiation of other TCM diseases.4 According to the results of the evaluation of the model,established in line with the final diagnosis models for TCM clinical dialectical thinking,the formation of functional gastrointestinal disease(liver stagnation and spleen deficiency syndrome,spleen deficiency and dampness stagnation syndrome)quantitative syndrome differentiation diagnosis model collected clinical verification,the evaluation and verification of the results.Provide the basis for the follow-up validation work of this subject,and provide a feasible method for the diagnosis and differentiation of TCM diseases.5 The lack of this study is that there is still some subjective bias in the establishment of the early theoretical model,and the clinical cases on the verification work about the establishment of the diagnosis model are too few,so it can not be accurately assess the diagnostic accuracy of the model.We expected that it is possible to develop the click version of the page in the R language,in order to provide the basis and foundation for the subsequent implementation of app and the web version of intelligent human-computer dialogue. |
PDF Full Text Request