Objective To analyze the substitution mechanism of surrogate endpoints for traditional Chinese medicine (TCM) clinical efficacy evaluation of chronic heart failure (CHF). Methods To obtain data from the occurrence of surrogate endpoints and cardiogenic death of patients with CHF in 7 hospitals. The causal relationship between surrogate endpoints and cardiogenic mortality was inferred by the Bayesian network model, and the interaction among surrogate endpoints was analyzed by non-conditional logistic regression model. Results A total of 2 961 patients with CHF were included. The results of Bayesian network causal inference showed that cardiogenic mortality had a causal relationship with the surrogate endpoints including NYHA classification (P=0.46), amino-terminal pro-B-type natriuretic peptide (NT-proBNP) (P=0.24), left ventricular ejaculation fraction (LVEF) (P=0.19), and hemoglobin (HB) (P=0.11); non-conditional logistic regression analysis showed that NYHA classification had interaction with NT-proBNP, LVEF, and HB prior to and after adjusting confounders. Conclusions The substitution capability of surrogate endpoints for TCM clinical efficacy evaluation of CHF for cardiogenic mortality are NYHA classification, NT-proBNP, LVEF, and HB in turn, and there is a multiplicative interaction between the main surrogate endpoint NYHA classification and the secondary surrogate endpoints including NT-proBNP, LVEF, and HB, suggesting that when the two surrogate endpoints with interaction exist at the same time, it can enhance the substitution capability of surrogate endpoints for cardiogenic mortality.
ObjectiveTo systematically review the application status of Delphi method in clinical research of traditional Chinese medicine (TCM).MethodsPubMed, EMbase, CNKI, WanFang Data and VIP databases were electronically searched to collect original research and methodological research on Delphi method in TCM from inception to August 30th, 2020. Two reviewers independently screened literature, extracted data, and then, descriptive analysis was performed by using qualitative methods.ResultsA total of 612 articles involving 573 original studies and 39 methodological studies were included, which involved 167 types of diseases. The primary research purposes were disease diagnosis and treatment, syndrome research, scale development, evaluation research, index research, clinical investigation, methodology research, and other 8 categories. 487 papers reported the implementation process and results of Delphi method in varying degrees.ConclusionsDelphi method is widely used in clinical research of TCM, however, there are deficiencies in the specific implementation process.
ObjectiveTo systematically summarize and evaluate the existing evidence of Qishen Yiqi dropping pill (QSYQ) in the treatment of chronic heart failure (CHF), and to evaluate its quality. MethodsThe PubMed, Cochrane Library, EMbase, Web of Science, CNKI, CBM, WanFang Data databases were electronically searched to collect systematic reviews/meta-analyses(SRs/MAs) related to objectives from inception to December 31, 2022. Two researchers independently screened the literature and extracted data, and assessed the methodological quality, risk of bias, reporting quality, and quality of evidence of included SRs/MAs by using Assessment of Multiple Systematic Reviews 2 (AMSTAR-2), the Risk of Bias in Systematic(ROBIS) scale, the list of Preferred Reporting Items for Systematic Reviews and Meta-Analysis(PRISMA), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. ResultsThis overview included 17 SRs/MAs. The methodological quality, reporting quality, risk of bias, and quality of evidence for outcome measures of SRs/MAs were all unsatisfactory. All SRs/MAs were of low quality according to the results of the AMSTAR-2 assessment. And only a small number of SRs/MAs were assessed as low risk of bias based on the results of the ROBIS assessment. The evaluation results of the PRISMA checklist showed that the report quality of the 24 studies included was relatively complete. According to the GRADE system evaluation results, 94% of the 84 outcome indicators were low-quality and very low-quality evidence. Limitations were the main factors leading to their degradation, followed by publication bias, inconsistency, imprecision and indirectness. ConclusionAt present, QSYQ has good clinical efficacy in the treatment of CHF, but the standardization and scientificity of clinical research and secondary research reports are insufficient, resulting in low quality of clinical recommendations evidence. In the future, it is necessary to further standardize and improve the quality of clinical and secondary research.