| Objective:The standard of Classification and Determination of Constitution in TCM has been applied in 235 "preventive treatment of disease" centers from 30 provinces and municipalities(autonomous regions)since it was officially issued by China Association of Chinese Medicine on April 9,2009.Also it was widely used in research,clinic,and health management service for urban and rural residents.While everything needs to keep pace with the times,continually develop and improve.Some problems were founded in Traditional Chinese Medicine Constitution Scale(TCMCS)in the process of applying TCMCS.Besides,TCMCS research team received feedback on TCMCS needed to be improved and some published articles also pointed out that there were some problems with the TCMCS.Hence,TCMCS research team urgently need to revise and improve 2009 version of TCMCS in order to make TCMCS as an objective and effective tool for standardized assessing body constitution types of Chinese citizens with a higher identification and accuracy.Methods:1.Collecting application and revision suggestions on TCMCS by sending questionnaires to 100 ordinary people,181 authors who applied TCMCS in research and 137"preventive treatment of disease" centers.Specialists’ suggestions were collected by sending emails,face-to-face or telephone interviews.Data acquisition and then statistical analysis were conducted for analyzing problems existed in TCMCS as well as make sure the directions and contents of further revision.2.Revising TCMCS was based on the 2009 edition’s Classification and Determination of Constitution in TCM.Meanwhile,revision suggestions of the people in each filed,connotation of nine TCM constitutions proposed by Professor Wangqi and items weight analysis results of 21948 epidemiology data of 2009 edition’s TCMCS were all given full consideration.3.Traditional Chinese Medicine Constitution(TCMC)survey by using revised TCMCS were conducted for 1376 Chinese citizens of 18-65 years.Items analysis,reliability analysis and validity analysis were performed for assessing revised TCMCS and related items.Revised TCMCS was revised again according to the statistical analysis results.4.TCMC test were conducted by using the second revised TCMCS for 68 health examination populations who were form physical examination center,China-japan friendship hospital,Beijing.Professor Wangqi re-tested the 68 populations in the case of blinding to the results of TCMCS test.Assessing the accuracy and reliability of the second revised TCMCS through comparing coincidence rate between TCMCS test results and artificial cognition results.Meanwhile,further revision and adjustment for the second revised TCMCS were conducted based on the comparison’s results.Results:1.Analysis results of prophase survey data showed that each field’s people all confirmed the role and value of TCMCS,but they also pointed out the problems existed in TCMCS and specific revised suggestions.Clinical workers,researchers and experts all indicated the following problems:① Some items should be merged or deleted due to semantic duplication.② Some items should be deleted because of the poor specificity and poor relevance between items and sub-scales.③ Some items should be explained or defined again due to its unclear expression or too broadly definition.④Some characteristics of TCMCs were significant for recognizing different body constitutions but not yet added to TCMCS,which were recommended to add them to the TCMCS.⑤ All reverse questioning items were suggested to be changed as direct questions so that the tedious of reverse scoring can be avoided.⑥ Items of individual design were recommended so that the phenomenon of some items being repeatedly used in different sub-scales can be avoided.⑦ Contents of options were too broadly,which was suggested to be explained clearly.⑧Scoring system was too complicated,which needed to calculate original score firstly and then calculate conversion score,thirdly calculate score according to a standard formula,finally judge as certain TCMC according to the standard of Classification and Determination of Constitution in TCM.The way of scoring should be simplified or accumulate scoring directly.Items,options and scoring system were revised under the guidance of professor Wangqi.Also,the revision of TCMCS was taken full consideration of the original TCMCS and revision suggestions from each fields’ people.Revised TCMCS contained 9 sub-scales and 54 items,among these,Balanced constitution,Qi-deficiency constitution,Yang-deficiency constitution,Yin-deficiency constitution,Phlegm-wetness constitution,Wetness-heat constitution,and Blood-stasis constitution were all consisted of 6 items;Qi-depressed constitution was consisted of 7 items and Inherited special constitution was consisted of 5 items.All items were direct scoring and the scoring system was through accumulating scores.People can be judged as certain TCMC when his or her score≥60%of the highest total score of certain sub-scales(total score of Balanced constitution≥70%)and also meet the criteria of high weigh item≥4.2.The preliminary results showed that ①Item analysis:critical ratio of all items of each sub-scales was more than 3(P<0.05),all correlation coefficients between each item and total score were more than 0.4(P<0.05),The correlation coefficients of none items in sub-scales by correlation analyzing were more than 0.8.All these showed that all items have good discrimination,higher homogeneity between items and sub-scales,and no similar items appeared in each sub-scales.②Reliability analysis:Cronbach’s a of the whole revised TCMCS was 0.901,Cronbach’s α of each sub-scales were ranged from 0.613 to 0.786,which showed that the revised TCMCS had a good internal consistency.Re-test reliability analysis showed that intraclass correlation coefficients(ICC)of the whole revised TCMCS were 0.774(P<0.00),ICC of each sub-scales were ranged from 0.758-0.834,which showed that the revised TCMCS had a good stability.③Validity analysis:results of principal component analysis(PCA)and factor analysis showed the Kaiser-Meyer-Olkin(KMO)was equal to 0.922 with Bartlett’s test of sphericity was equal to 20702.803(P=0.000<0.01),which stated that the revised TCMCS was suited for conducting factor analysis.Nine common factors were extracted and accounted for 48.37%,among these,factor loading of three items were lower than 0.3 which showed that these items were poor quality and these three items included item of Yin-deficiency constitution"Did the palms of your hands or soles of your feet feel hot?",item of Blood-stasis constitution "Did your sublingual venous stasis and purple?",item of Balanced constitution "Did your weight properly?".④Criterion validity test was conducted for assessing the accuracy of TCMCS with choosing SF-36 as criterion,the results showed that Balanced constitution was positively correlated to SF-36(correlation coefficient was 0.37,P<0.000),while all unbalanced constitution were negatively correlated to SF-36(correlation coefficient was-0.308~-0.606,P<0.000),which showed that the revised TCMCS can accurately assessing TCMC types of participants.3.There was 60%coincide rate between the results of using the second revised TCMCS and the results of artificial cognition by Professor Wangqi.50(81.7%)participants were determined as single TCMC and 10(18.3%)were judged as mixed TCMC by Professor Wangqi’s artificial cognition,while 26(43.3%)participants were judged as single TCMC and 34(56.67%)were judged as mixed TCMC by TCMCS.It showed that the second revised TCMCS can certainly reflected the characteristic of participants’TCMC,but its ability of catching key identification points of each type of TCMC was weaker as compare with artificial cognition.It may be the reason why more mixed TCMC appeared in scale-test group than artificial cognition group.Hence,TCMC research team set the score criteria of high weight item need to be equal or beyond 4 based on the results of item weight analysis.Besides,participants’ score need to meet the score determination standard of Balanced Constitution and unbalanced constitutions.Conclusion:TCMCS was renamed as Wangqi ’s nine TCMCS after revision,which was consisted of nine sub-scales,54 items and applied to Chinese citizen of 18-65 years.Wangqi’s nine TCMCS has a good reliability and validity,which can predict the TCMC types of Chinese citizens and also can be as an identification tool of TCMC to be spread and used. |