Development And Assessment Of Spleen Qi Deficiency Syndrome PRO Scale

[Objective] we would work out Spleen Qi Deficiency Syndrome PRO scale,which using clinical evaluation. And through clinical investigation, we could test the feasibility of the scale, reliability, validity and responsiveness, The PRO scale is going to help doctors understand the pain of the spleen deficiency patients. Besides it can offer doctors treatment plan and clinical treatmen.[significance] Spleen deficiency syndrome,as a common clinical TCM designate, is common manifestations of many diseases, especially chronic non-communicable diseases.it has a longer duration, cure difficult,and seriously affects the patient’s quality of life. Patient’s own feelings appears to be very important for Evaluation of the effect. Patient Reported Outcome,(PRO) scale is an evaluation of measurement tools for all aspects of their own health patients. The PRO scale to obtain clinical data from the patient’s point of view, to provide a reference for the diagnosis and treatment of clinical practice has very important significance. Developed the TCM Spleen Qi Deficiency Syndrome PRO Scale is very necessary.[Methods] Under the guidance of traditional Chinese medicine (TCM) theory and the direction of psychometrics. The formation of conceptual framework of Spleen Qi Deficiency Syndrome PRO scale is according to clinical features of Spleen Qi Deficiency Syndrome,and the United States Food and Drug Administration (FDA) the PRO scale of production principles and processes, and combined with the WHO concept of health, TCM holistic concept and physiological functions of the spleen. Through access to literature, books and existing relevant standards entry Retrospective, patients interviews with three steps and combined with clinical practice, statistical analysis, repeated one by one by the research team to discuss the formation of the initial pool of entries. To classified, merge and split amend entry entry pool formed in accordance with the conceptual framework of the spleen deficiency PRO scale, Entry and research group selected the response option combination and complement the the PRO scale of other constituent elements, designed to form the "spleen deficiency syndrome patients PRO primaries Scale"and Use it to carry out small-scale survey, Finishing further modifications made Deficiency Syndrome PRO scale ", Use the scale clinical investigation,and Collected cases of split-half reliability analysis, internal consistency analysis, factor analysis, statistical analysis of paired T-test, analysis of variance and Scientific assessment of the feasibility, reliability, validity and responsiveness. Reliability assessment including test-retest reliability, the sub-half reliability and internal consistency of assessment; assessment of the validity include construct validity assessment; The reaction degree assessment is divided into assessment scales distinguish spleen deficiency with the ability of non-spleen-deficiency patients and the ability to distinguish between before and after treatment.[Results] Spleen deficiency syndrome PRO scale from four areas of the six areas, and46entries。The clinical survey investigated the spleen deficiency syndrome and300patients and non spleen deficiency syndrome and100cases, a retest of300cases100cases of spleen deficiency patients, recovery of100%effectively complete a scale of492cases,98.4%completion rate. The completion of Scale longest is25minutes, the shortest was16minutes, and the average completion time of20.31minutes. The scale overall retest correlation coefficient of0.980. Various fields retest correlation coefficients were physiological field of0.979and0.991of the psychological field, the independence of the field of0.875, the social sphere0.969, all>0.8. all p-value less than0.01。 Between two consecutive fill Scale split-half reliability coefficients were0.926and0.925. Population before and after twice the scale Cronbach’a coefficient of0.916and0.905, various fields Cronbach’a coefficient of0.909and0.895of the physical domain, psychological field of0.981and0.941, the independence of the field of0.295and0.343, the social sphere0.727and0.742, respectively.In addition to the independence of the field in various fields were>0.7. Construct validity,13common factor variance cumulative contribution rate of66.257%,1,5,6,7,11,13factor may represent the physiological field, the second factor represents the psychological field, the3factor represents the social sphere,4,8factor on behalf of the independence of the field. And Summarized the various factors represent different entry Scale conceptual framework corresponds to most of the entries in their particular fields of factor loadings>0.4, Significant factor loadings on their respective areas <factor loadings in their respective fields. In reactivity,Using a paired t-test scale investigation of the reaction of the same group of patients before and after the two measurements, the results show that the scale overall and individual p-value<0.01, indicating that the scale can effectively distinguish the difference of the two. Using analysis of variance test to examine the reaction of non spleen qi deficiency, spleen deficiency patients overall and physiology of the field of p-value0.000results in scale, indicating that the scale of the non spleen qi deficiency patients with spleen deficiency patients distinguish[Conclusion] Based on the scientific results of the exam, to prove that the scale has good feasibility, reliability, validity and responsiveness. Scale can be used as the evaluation criteria of efficacy of TCM spleen deficiency syndrome.