Development And Evaluation Of TCM Efficacy Evaluation Scale For Qi Stagnation Syndrome

Purpose: The purpose of this study was to develop a Chinese medicine efficacy evaluation scale for qi stagnation syndrome and evaluated its feasibility,reliability,validity and responsiveness,to provide a reference index for the study of single syndrome of qi stagnation syndrome.This scale provides a relatively accurate and unified quantitative tool for self diagnosis and efficacy evaluation of patients with qi stagnation syndrome,and provides specific modules for disease syndrome combination scale and syndrome syndrome syndrome combination scale.Material and method:In this study,referring to the FDA international scale development guidelines and the research group’s experience in scale development,a research group was established to construct the theoretical framework of qi stagnation syndrome and form the item pool through literature analysis,patient interview and discussion group.According to the results of expert discussion,we screened the effective items and determined the dimensions.According to the effective items,we compiled the corresponding questions and formed the primary selection scale of qi stagnation syndrome.We used cross-sectional survey to pre investigate the patients with qi stagnation syndrome.According to the patients’ understanding and feedback of different problems during the pre survey,we adjusted the scale and made statistical analysis according to the survey results.Then,through expert discussion,combined with the pre survey results and statistical results,we modified the primary scale of qi stagnation syndrome and finally determined the TCM efficacy evaluation scale of qi stagnation syndrome.We set up the evaluation model of qi stagnation syndrome scale,evaluated the scale through preliminary clinical investigation,and verified the accuracy of the scale.Results:Through literature analysis and patient interviews,we initially formed the initial scale of TCM efficacy evaluation of qi stagnation syndrome,which consists of 3 dimensions and 12 items.The initial scale was screened,and 12 items were retained to form the final scale of qi stagnation syndrome.200 patients with qi stagnation syndrome and 41 healthy people were investigated.The recovery rate of the scale was 97.17%,and the completion rate was100%.The filling time of the scale was 2-3 minutes,and there was no ceiling or floor effect in all items;The test-retest reliability of each item was greater than 0.7(0.877-0.981)(P < 0.01);The Cronbach’s α coefficients of the internal consistency reliability of the total scale and the dimensions of emotional distress,visceral stagnation and limb stagnation were greater than0.4(0.755,0.781,0.627,0.494),after deleting each item,the Cronbach’s α coefficient of the total score decreased;Spearman correlation coefficient of each item and dimension,total table,each dimension and total Table > 0.4(P < 0.01);The three component factors extracted by exploratory factor analysis were only "bad throat",which was different from the grouping of extracted components by item screening.The Cronbach’s α coefficient and Spearman’s correlation coefficient of the new dimension of grouping based on extracted components were greater than 0.4 and 0.4 respectively(P < 0.01);The average value of each item and total score of patients with qi stagnation syndrome was higher than that of healthy group,with statistical difference;After 14 days of traditional Chinese medicine decoction treatment,the items and total scores of the patients decreased after treatment,with statistical difference;Conclusion:In this study,we initially developed the TCM efficacy evaluation scale of qi stagnation syndrome,which includes three dimensions: Emotional disorder,Chest qi stagnation and Abdominal qi stagnation,and 12 entries: Pressure,Low,Anxiety,Irritability,Chest pain,Sigh,Laziness because of qi Stagnation,Local pain,Abdominal pain,Farting and burping,Throat discomfort,Hands and feet feel cold or hot.After preliminary research,it is proved that the scale has good feasibility,reliability,validity and responsiveness,and its preliminary clinical application has certain curative effect evaluation function.