1.Chinese Translation of the Stanford Expectations of Treatment Scale and Its Application Evaluation on Traditional Chinese Medicine for Diarrhea-Predominant Irritable Bowel Syndrome with Liver-Constraint and Spleen-Deficiency Syndrome
Shibing LIANG ; Yingying ZHANG ; Zhijie WANG ; Zeyu YU ; Mei HAN ; Huijuan CAO ; Guoyan YANG ; Shihuan CAO ; Hongjie CHENG ; Qiaoyan ZHANG ; Youzhu SU ; Yufei LI ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(19):1994-2001
ObjectiveTo adapt the Stanford Expectations of Treatment Scale(SETS) into Chinese(C-SETS) and test the feasibility, validity and reliability of its application in patients with diarrhea-predominant irritable bowel syndrome(IBS-D) with liver-constraint and spleen-deficiency syndrome treated with traditional Chinese medicine(TCM). MethodsWe obtained authorisation from the developer of the SETS, and followed the principle of "two-way translation" to translate the SETS by literal translation and back translation to form the C-SETS. Ninety-six IBS-D patients with liver-constraint and spleen-deficiency syndrome were enrolled as respondents and filled out C-SETS before receiving treatment; the feasibility was assessed by the recall rate, completion rate and the duration of filling out the scale; the reliability was assessed by Cronbach's α; the structural validity was assessed by exploratory and confirmatory factor analysis, and the content validity was assessed by correlation analysis. ResultsThe C-SETS consists of 10 items, with the 1st, 3rd, and 5th rating items constituting the Positive Expectations subscale, and the 2nd, 4th, and 6th rating items constituting the Negative Expectations subscale, each of which is rated on a 7-point Likert Scale. The recall of C-SETS was 100%(96/96), the completion rate was 89.58%(86/96); Cronbach's α for the Positive and Negative Treatment Expectations subscales were 0.845 and 0.854, respectively; exploratory factor analysis showed that the coefficient of commonality for all six entries was larger than 0.4, and that the six entries could be used by both factors to explain 77.092% of the total variance; validation factor analysis showed that the goodness-of-fit index, comparative fit index, root mean square of approximation error, canonical fit coefficient, and chi-square degrees of freedom ratio took the values of 0.943, 1.003, 0, 0.943, and 0.626, respectively; and the results of Spearman's analysis suggested that the C-SETS had good content validity. ConclusionThe C-SETS has well feasibility, reliability, and validity, which initially proves that it can be used as a tool to assess the treatment expectation of patients with IBS-D with liver-constraint and spleen-deficiency syndrome before receiving TCM treatment.
2.Analysis of influencing factors on the inclusion of Chinese patent medicines in the national reimbursement drug list
Shihuan CAO ; Wanxian LIANG ; Lining ZHANG ; Haijing GUAN ; Xuejing JIN
China Pharmacy 2024;35(22):2709-2715
OBJECTIVE To analyze the factors affecting the inclusion of Chinese patent medicines in China’s National reimbursement drug list (NRDL), and assist these medicines in fully reflecting their actual value in the reimbursement admission process. METHODS From the official website of the China’s National Healthcare Security Administration, the application materials of Chinese patent medicines outside the list that passed the formal review from 2021 to 2023 were obtained, including basic information on the medicines, safety, efficacy, innovation and heritage information, and supplemented with references from the pharmacopeia and the Yaozhi Database. Economic information and enterprise information were obtained through websites such as the Yaozhi Database. Univariate analysis, multivariate Logistic regression analysis and stepwise regression analysis were conducted on the initial application information and admission outcomes of the medicines. Sensitivity analysis was also performed on medicines that applied multiple times in different years as independent samples. RESULTS & CONCLUSIONS There were 27 Chinese patent medicines that passed the formal review from 2021 to 2023, involving 37 applications. The univariate analysis results showed that medicines with descriptions of traditional Chinese medicine (TCM) syndrome types, clear adjustment information for medication plans for specific population groups, short time to market in the indications of the package insert, registered as Class 1 to 6 following or class Ⅰ innovative TCM/class Ⅲ ancient classic prescription compound TCM registered, and those produced by enterprises listed in the “Top 100 Chinese Pharmaceutical Industry Enterprises” list for the current year were more likely to be included in the NRDL (P<0.05). The results of the multivariate Logistic regression analysis were not statistically significant, but the stepwise regression results indicated good consistency with the univariate analysis. The results of the sensitivity analysis were consistent with the trend of basic analysis. It is recommended that Chinese patent medicine enterprises further clarify the description of product instructions, expand innovation capabilities, inherit and develop ancient classic prescriptions, and promptly complete clinical trial evidence.