Formulate Development And Assessment Of Perimenopausal Syndrome Patient Reported Outcome Scale Of TCM Based On Syndrome Element

Objective:Based on the principle of syndrome differentiation,developing Scale PRO with the characteristics of TCM and putting the patients in the center as references for the evaluation of the clinical efficacy of perimenopausal syndrome,to assist selection a reasonable treatment plan.Method:1.according to the literature search and relevant teaching materials,organizing the syndromes of Perimenopausal syndrome and syndrome elements,and symptoms through standardized process.2.To subjective screen out items with three round Delphi method,early formed scale.3.The difficulty analysis,responsiveness analysis and correlation analysis method were used in items selection based on the pre-survey.4.Using perimenopausal syndrome of traditional Chinese medicine PRO scale to collect clinical data and establish a database,The split-half reliability method and Cronbach's alpha coefficient were applied to evaluate the reliability of the scale.And the discriminant validity and construct validity were applied to evaluate the validity of the scale.Result:1.through the early literature retrieval and collation,it is concluded that the main factors of the disease in perimenopausal syndrome patients are kidney,liver,heart and spleen;disease syndrome factor mainly to yin deficiency,yang deficiency,and qi stagnation.2.after three rounds of Delphy expert consultations,the perimenopausal syndrome of traditional Chinese medicine PRO scale item initially formatted which contains the kidney,liver and heart,spleen,yin deficiency and Yang deficiency of 12 dimensions,There were 20 items on kidney dimension,23 items on liver dimension,?items on heart dimension,9 items on spleen dimension,20 items on yin deficiency dimension,6 items on yang deficiency,10 items on qi stagnation dimension,2 items on hyperactivity of yang dimension,5 items on hot deficiency dimension,10 items on qi deficiency dimension,12 items on blood deficiencydimension,and 2 items on blood stasis dimension.3.To subjective screen out items of every dimensions based on the 3 objective screening method.Finally a total of 6items Q16,Q23,Q47,Q57,Q63,Q65 were deleted,and formed the second edition of Permenopausal syndrome PRO scale of TCM which contain 60 items.4.The examination of the Scale:The split half reliability of the scale was 0.899,spleen dimension and blood deficiency dimension was lower,other dimensions are greater than 0.7;The Cronbach's a coefficient of the scale was 0.880,spleen dimension and blood deficiency dimension was lower,The Cronbach's a coefficient of other dimensions are between 0.6-0.8,showing the scale has the good internal consistency;the patients with perimenopausal syndrome and healthy perimenopausal women with non parametric test,both has significant statistical difference(P<0.01)in the whole scale score and the score of each dimension,has good discriminant validity;Factor analysis revealed 11 factors,the contribution rate of 64.207%,the structure is reasonable.Conclusion:The establishment of Permenopausal syndrome PRO scale of TCM with a good reliability and validity.This research will provide a tool for evaluation of curative effect and clinical syndrome differentiation in TCM.