Formulate Development And Assessment Of Qi Stagnation Syndrome Patient Reported Outcome Scale

Objective:Developed in Qi Stagnation Syndrome Patient Reported Outcome Scale based on the scale of scientific method. Then provides a measurement tool to distinguish whether a specific part of the clinical syndrome of qi stagnation and the special site of qi stagnation syndrome,.Methods:1. To establishment of qi stagnation syndrome diagnostic information library through screening out 123 symptoms and 68 signs related to qi syndrome syndrome based on literature research, as the basis of Qi Stagnation Syndrome Patient Reported Outcome Scale items source.2. To subjective screen out items with three round Delphi method. The main purpose of the fist round of experts questionnaire survey was judged the 123 symptoms whether can be used as the basis for the diagnosis of qi stagnation syndrome. The main purpose of the second round of experts questionnaire survey was judged the item belongs to which disease location. And the main purpose of the third round of experts questionnaire survey was judged the importance of each item.3. The difficulty analysis, responsiveness analysis and correlation analysis method were used in items selection among 105 qi stagnation syndrome patients based on the pre-survey. If more than 2 methods indicated that the items would be deleted, then formed the Qi Stagnation Syndrome Patient Reported Outcome Scale4. Using Qi Stagnation Syndrome Patient Reported Outcome Scale collected clinical data of 415 investigators. Using split-half reliability method and Cronbach’s alpha coefficient to evaluate reliability of the scale. And using the discriminant validity and construct validity to evaluate validity of the scale.Results:1. The response rate of the three round of expert questionnaire survey was 100%. There were 51 items on the scale.There were 24 items on liver dimension,6 items on gallbladder dimension,11 items on stomach dimension,9 items on intestinal tract dimension,10 items on heart dimension,5 items on lung dimension and 4 items on uterus dimension with the three round of expert questionnaire survey.2. To adjust the items of every dimensions based on the 3 objective screening method. Finally a total of 5 items Q11、Q15、Q39、Q40、Q51 were deleted, and formed the second edition of Qi Stagnation Syndrome Patient Reported Outcome Scale which contain 46 items.3. The split half reliability of the scale was 0.956, the split half reliability of each dimension was higher than 0.7; The Cronbach’s a coefficient of the scale was 0.920, and the Cronbach’s a coefficients of each dimension was higher than 0.6. The non parametric test suggest that scale has a good discriminant validity, and factor analysis suggest that scale has good structure validityConclusion:The establishment of Qi Stagnation Syndrome Patient Reported Outcome Scale with a good reliability and validity based on the literature research and Delphi method, as well as the clinical epidemiological investigation. This research will provide a tool for clinical syndrome differentiation in TCM.