Interpretation of the Multi-Dimensional and Multi-Criteria Comprehensive Evaluation Technical Guidelines for Patent Chinese Medicines:Reliability and Validity Testing of the Evaluation Index System
ZHANG Haili
CAO Wenjie
WANG Weili
YANG Yijiu
HU Ziteng
CHEN Yaxin
LIANG Ning
LIU Bin
LI Huizhen
CHE Qianzi
GONG Zhaoyuan
YAN Lijiao
WANG Yanping
SHI Nannan
Abstract：Objective To evaluate the feasibility and scientific validity of the first edition of the index system in the Multi-Dimensional and Multi-Criteria Comprehensive Evaluation Technical Guidelines for Patent Chinese Medicines(PCMs),and to propose optimization suggestions for researchers'reference.Methods A total of 140 PCMs were selected for applied evaluation.Reliability was assessed using Cronbach's α coefficient,split-half reliability coefficient,and Guttman Split-Half coefficient.Validity was tested via item-level content validity index(I-CVI),correlation coefficients,and absolute score differences between high-and low-scoring groups across dimensions.Results The reliability coefficients were satisfactory(Cronbach's α=0.704,split-half=0.763,Guttman=0.709).All I-CVIs ranged from 0.86 to 1(mean=0.96).The correlation coefficients between comprehensive scores and dimensional scores were 0.526～0.783,while inter-dimensional correlations were 0.229～0.447.Significant differences(P<0.05)were observed in absolute scores between high-and low-scoring groups for primary dimensions(range:6.659～23.47),but two secondary dimensions("labeling rationality"and"application innovation")showed inadequate discriminative power(P>0.05)and require refinement.Conclusion The first edition of the index system demonstrates overall feasibility,reliability,and validity,warranting further practical application.
Keywords：Patent Chinese medicinesClinical comprehensive evaluationValidityReliability
Publication Date：2025-06-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：7( 1093-1099 )