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

Objective:To explore and establishment of Qi Deficiency Syndrome Patient Reported Outcome Scale, as the holistic concept of Traditional Chinese Medicine(TCM) a guide, that can reflect the TCM syndrome differentiation thought. Then provide a measurement tool to distinguish whether a specific part of the clinical syndrome of qi deficiency and the special site of qi deficiency syndrome. Thus provide a reference tool for clinical diagnosis quantified and objectivity and evaluation of therapeutic effect of qi deficiency syndrome in TCM. Then establish a clinical efficacy evaluation method with TCM characteristics, to assist selection a reasonable treatment plan.Method:1. To establishment of qi deficiency syndrome diagnostic information library through screening out 258 symptoms related to qi deficiency syndrome based on literature research, as the basis of Qi Deficiency Syndrome Patient Reported Outcome Scale items source.2. To subjective screen out items on the subjective importance with three round Delphi method. The main purpose of the fist round of experts questionnaire survey was judged the 258 symptoms whether can be used as the basis for the diagnosis of qi deficiency 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 3 kinds of joint were used in items selection among database of 200 qi deficiency syndrome patients based on the pre-survey. If 2 or more than 2 methods indicated that the items would be deleted, then formed the Qi Deficiency Syndrome Patient Reported Outcome Scale(The 2 edition).4. Using Qi Deficiency Syndrome Patient Reported Outcome Scale(The 2 edition) collected clinical data of 415 investigators. 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.Results:1. The response rate of the three round of expert questionnaire survey was 100%. There were 89 items on the scale After three rounds of expert advice on the importance of entry screening. There were 15 items on kideny dimension,20 items on lung dimension,56 items on spleen dimension,5 items on stomach dimension,5 items on heart dimension,1 items on gallbladder dimension,5 items on uterus dimension,2 items on intestinal tract dimension,4 items on bladder dimension and 4 items on liver dimension, with the three round of expert questionnaire survey. (The Kendall Wa is 0.300 (x2 value is 414.197, P< 0.01).2. To adjust the items of every dimensions based on the 3 objective screening method. Finally a total of 14 items Q1, Q17, Q32, Q33, Q36, Q45, Q47, Q58, Q66, Q68, Q80, Q81, Q84, Q77 were deleted, and formed the second edition of Qi Deficiency Syndrome Patient Reported Outcome Scale (the 2 eddition) which contain 75 items.3. The split half reliability of the scale was 0.952, bladder dimension split-half reliability coefficient of 0.640 slightly lower, the eight dimensions’s half reliability coefficient are 0.781, 0.901,0.870,0.812,0.809,0.898,0.703and 0.714 respectively, both greater than 0.7. The Cronbach’s a coefficient of the scale was 0.951, and the nine dimensions’s are 0.837,0.919, 0.931,0.726,0.803,0.807,0.885,0.531 and 0.580 respectively, in addition to the bladder and liver dimensions, the Cronbach’s alpha coefficients were greater than 0.7. The non parametric test and factor analysis suggest that Qi Deficiency Syndrome Patient Reported Outcome Scale (the 2 eddition) has a good discriminant validity and good structure validity.Conclusion:1. To establishment of TCM syndrome type universal self rating scale, according to the international scale production standards, as the Chinese medicine theory a guiding ideology and as the qi deficiency a media, than can provide a useful reference tool for qi deficiency syndrome of TCM clinical diagnosis and therapeutic effect evaluation. At the same time, it is also a useful discussion on the quantitative and objective diagnosis of TCM syndrome types. Also provide beneficial reference for the development of universal measuring scale.2. Through the literature research, screening out syndrome in different disease of qi deficiency syndrome. Regulate the symptoms, screening out 258 symptoms that related to qi deficiency syndrome to establish the diagnostic information database, as the item pool of Qi Deficiency Syndrome Patient Reported Outcome Scale.3. Adopt the method of combining subjective and objective to selection and optimize items. Through three rounds of Delphi expert consultation method, the items under the different disease position of qi deficiency syndrome was obtained. A pre-survey was conducted on 200 patients with qi deficiency syndrome. The difficulty analysis, responsiveness analysis and correlation analysis method 3 kinds of joint were used in items selection from the purpose of the difficult degree, effectiveness, representative, independent. Integrated 3 screening methods, then formed the Qi Deficiency Syndrome Patient Reported Outcome Scale(The 2 edition).4. 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, indicating that the scale has good reliability and validity.In summary, the Qi Deficiency Syndrome Patient Reported Outcome Scale can better application in clinic. Provide a measurement tool for qi deficiency, and provide a favorable reference tool for clinical diagnosis and evaluation of therapeutic effect of TCM for qi deficiency syndrome.