Development And Evaluation Of Outcome Evaluation Scale Based On Patient Report

Patient Reported Outcome (PRO) is one of the important parts of therapeutic effect evaluation, and is also the main basis of diagnosis and treatment of traditional Chinese medicine (TCM). TCM therapy is effective on Tuoju, and it could improve both physiological and psychological condition of Tuoju patients. At present, PRO is widely used in therapeutic effect evaluation. PRO index has been widely applied in the clinical curative effect evaluation, but evaluation methods need to be standardized.ObjectivesIn order to standardize the use of clinical PRO indexes in Tuoju disease, we develop the PRO Scale of Tuoju according to the guideline published by Food and Drug Administration (FDA), clinical characteristics of Tuoju, social survey and psychometrics principles. And evaluate the feasibility, reliability, validity and reactivity of this scale. Develop a quantitative, effective, sensitive and repeatable method, which could provide ideas of TCM clinical efficacy evaluation system, and improve the quality of research on Tuoju disease.Methods1) Development of scale:① Form a research team, define concept of the scale and construct a rigorous conceptual framework of the scale. ② The item pool was founded by PRO indexes extracted from literatures, medical records, and patient interview. In order to standardize the data extraction, the hospital medical records data collection table and literatures data collection table will be made. ③ Frequency method:Choose the items whose frequency is more than 5% from the items pool, and combine with patient interview and research team discussion, form the items of expert consultation questionnaire. ④ Delphi method:In each of the two rounds of expert consultation, choose the items ranking in the top 80% according to analysis result of the positive response coefficient, degree of convergence and degree of concordance between expert’s opinions. ⑤ Clinical investigation:Options distribution method, discrete Trend method, cronbach’s a coefficient, correlation coeffi cient, and factor analysis were used. Items were deleted or revised when they didn’t meet the criteris resulted from more than 3 methods. ⑥ Form the draft scale.2) Validation of the scale:① Feasibility, included acceptance rate, completion rate and completion time. ② Reliability:included slip-half reliability and internal consistency reliability. Slip-half reliability was represented by correlation coefficient of two half-scales, which is created by parity of item numbers. Internal consistency reliability was represented by Cronbach’s a. ③ Validity:included content validity, criterion-related validity and construct validity. Content validity was evaluated by the rigorous process of scale development. Criterion-related validity was evaluated by correlation coefficient of SF-36 scale and PRO scale. Construct validity was evaluated by CFI of confirmatory factor analysis. ④ Responsibility:included total responsibility and domain responsibility. The first and second time of survey results were analyzed by pair test to evaluate responsibility of scale.3) The PRO scale was initially applied to analyze the difference between ASO, DF, TAO, and the difference between each syndrome of Tuoju.Results1) Development of scale:① Concept of the scale:A measurement based on a report that directly came from the Tuoju patients about the status of their health condition and satisfaction. Domain of the scale:The domain of the scale including physiological, psychological, functional and satisfaction domain. ② Items pool:40 items was collected from 623 materials, including 410 clinical study literatures and 213 medical records. ③ Item screening:19 items whose frequency more than 5% were selected. Most of them were local symptoms of lower limb. After research team discussion,18 items were reserved. And 12 items involved psychological domain, social function domain and patient satisfaction domain were added. Finally,30 items was selection into expert consultation. ④ Delphi method: Positive response coefficients from the experts in two rounds consultation were 100% and 96.87%, respectively. According to the degree of convergence and concordance in opinions from the experts,27 items were selected after the first consultation, and 26 items were selected after the second consultation, ⑤ Clinical investigation:26 items were retained, and items showed a good coincidence in concentration, sensitivity, representative, internal consistency. According to information from clinical investigation, improve the expression of some items. ⑥ Form a 25-item Tuoju scale contained basic information part and disease investigation part, with preface and instructions.2) Validation of scale: ① Feasibility analysis:The acceptance rate of the scale was 96.73%, and completion rate was 99.03%, and the mean completion time was 12.68±6.55 minutes. ② Reliability:Slip-half reliability was represented by Spearman-Brown coefficient, which was 0.933. And internal consistency reliability was represented by Cronbach’s a, which was 0.915. ③ Validity:Standard validity, the correlation coefficient related to SF-36 was 0.502, and for construct validity, the CFI was 0.88. In addition, for content validity, The scale was developed with rigorous process according to FDA guidance and characteristics of Tuoju disease. ④ Responsibility:Pair test of total score, physiological domain, psychological domain, functional domain were significant different (P<0.05).3) PRO results analysis:The difference of PRO between ASO, DF, TAO was not significant (P>0.05). The difference of cold-dampness obstruction syndrome, blood stasis syndrome, dampness and heat poison syndrome, deficiency of qi and blood syndrome of Tuoju was significant (P<0.05).Conclusion1) Patient-reported Outcome Scale of Tuoju patients with 25 items was developed, and including physiological domain, psychological domain, functional domain, satisfaction domain.2) The scale had good feasibility, reliability, validity, and responsibility.3) According to survey results of the PRO scale, there is significant difference between each syndrome of Tuoju. This is fundation of further study on syndrome evaluation.