Development And Evaluation Of The Medical Efficacy Evaluation Scale For Yang Deficiency Syndrome

Purpose:The purpose of this study was to develop a medical efficacy evaluation scale for Yang deficiency syndrome,to provide a simple and easy-to-operate self-evaluation quantitative tool for patients with Yang deficiency syndrome,and to provide a specific module for the TCM syndrome combination efficacy evaluation scale.At the same time,in the development process of the scale,the methods and techniques for the development of the therapeutic evaluation scale are summarized.Materials and methods: Based on the development guide of international scales,based on PRO concept and TCM theory,with reference to the development experience of domestic and international scales,the initial theoretical framework of Yang deficiency syndrome was constructed through standard collection,textbook combing and literature review.Based on the initial theoretical framework of Yang deficiency syndrome,through the semi-structured patient interviews,the entries are extracted to form an entry pool.Through expert panel discussion,distinguishing the attributes of the syndrome items,writing questions,setting options to form the initial scale of the Yang deficiency certificate,and further modifying the theoretical framework of the Yang deficiency certificate.Through the clinical investigation method,the objective statistical analysis is combined with the subjective expert consensus to select the items to form the Yang deficiency syndrome final selection scale.The clinical investigation method was used to evaluate the feasibility,reliability,validity,response and efficacy evaluation of the final scale.Results : The initial theoretical framework of the Yang deficiency syndrome was constructed,and the initial scale of the Yang deficiency certificate containing three dimensions and ten items was formed.The initial scale is used for item screening,ten items are reserved,and ten items are all original dimensions,forming a Yang deficiency certificate final selection scale.200 subjects were selected from the final evaluation scale.The acceptance rate of the scale was 94.0%,the completion rate was 100%,and the average time for filling the questionnaire was 2.5 minute.There is no ceiling floor effect in all entries.The test-retest reliability of all entries was greater than 0.7(0.846-0.969)(P < 0.01).The Cronbach’s alpha coefficient of the three dimensions of total table and cold,fatigue and water drink are all greater than 0.4(0.756,0.653,0.759,0.426);ten items are deleted in turn,and the Cronbach’s α of the total table decreases;ten items are deleted in turn,except for individual The Cronbach’s α of the dimension to which the item belongs increases,and the Cronbach’s α of the dimension of the remaining items decreases.The correlation coefficient of all items and their total scores and scales,and the total scores of each dimension and scale were greater than 0.4(P<0.01).Factor analysis extracted three components(male factors),and the cumulative variance contribution rate was 65.752%;the factors of the two entries were different from the theoretical framework of the construction.The （？) ± S of each item and total score of the Yang deficiency syndrome patients in the different age groups was higher than that of the healthy people group.For patients with Yang deficiency syndrome of different systemic diseases,the （？) ± S results of each item and the total score of the scale were similar,and the individual items were slightly different.For patients with Yang deficiency syndrome who were treated for more than one week,the （？) ± S scores of the scores and the total scores of the scores decreased after treatment.Conclusion:The medical efficacy evaluation scale of Yang deficiency syndrome has been formed,including three dimensions of cold,fatigue and water fluid.There are ten items in the scale,chills,warmth,cold limbs,hot diet,spiritual lassitude,fatigue,physical weakness,limb swelling,and loose stools.The scale comprehensively summarizes the clinical manifestations of patients with Yang deficiency syndrome,as well as the inconvenience and impact on patients’ daily life,and systematically evaluates the quality of life of patients with Yang deficiency syndrome.The scale has good feasibility,reliability,validity,responsiveness and clinical efficacy evaluation performance.