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 overview of systematic reviews (SRs) of Yiqi Fumai (YQFM) injection in the treatment of chronic heart failure (CHF). MethodsThe PubMed, Cochrane Library, EMbase, Web of Science, CNKI, CBM and WanFang Data databases were electronically searched to collect SRs of YQFM injection in the treatment of CHF from January 1, 2007 to October 31, 2022. Two reviewers independently screened literature, extracted data and assessed methodological quality, risk of bias, report quality and evidence quality by using AMSTAR-2, ROBIS scale, PRISMA, and GRADE system. ResultsA total of 7 SRs were included. The evaluation results showed that the quality of all SRs was low, a few SRs were assessed as having a low risk of bias, and all SRs were relatively completely reported. A total of 46 results were extracted from the included SRs, including 3 with moderate quality evidence, 12 with low quality evidence and 31 with very low quality evidence. ConclusionYQFM may be an effective and safe treatment, but current evidence quality is low.
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.
ObjectiveTo systematically evaluate the predictive models for re-admission in patients with heart failure (HF) in China. MethodsStudies related to the risk prediction model for HF patient re-admission published in The Cochrane Library, PubMed, EMbase, Web of Science, CNKI, VIP, Wanfang, and CBM were searched from their inception to April 30, 2024. The prediction model risk of bias assessment tool (PROBAST) was used to assess the risk of bias and applicability of the included literature, extract relevant data, and evaluate the model quality. ResultsNineteen studies were included, involving a total of 38 predictive models for HF patient re-admission. Comorbidities such as diabetes, chronic renal insufficiency, left ventricular ejection fraction, New York Heart Association cardiac function classification, N-terminal pro B-type natriuretic peptide/brain natriuretic peptide, and medication adherence were identified as primary predictors. The area under the receiver operating characteristic curve ranged from 0.547 to 0.962. Thirteen studies conducted internal validation, one study conducted external validation, and five studies performed both internal and external validation. Seventeen studies evaluated model calibration, while five studies assessed clinical feasibility. The presentation of the models was primarily in the form of nomograms. All studies had a high overall risk of bias. ConclusionMost predictive models for HF patient re-admission in China demonstrate good discrimination and calibration. However, the overall research quality is suboptimal. There is a need to externally validate and calibrate existing models and develop more stable and clinically applicable predictive models to assess the risk of HF patient re-admission and identify relevant patients for early intervention.
Based on evidence-based medicine (EBM) and from the viewpoint of providing scientific evidence for clinical application, we found that Traditional Chinese Medicine (TCM) was short of adequate evidence to support its therapeutic effects due to lack of high quality clinical research. Data management plays a very important role in clinical research. Lack of adequate data management may lead to low quality clinical research. Thus, it is of great importance to establish a set of standards for data management so as to improve the quality of clinical research. Based on the real practice in Myocardial Infarction Secondary Prevention Study in TCM (MISPS-TCM), this article introduces methods on data audit in clinical trials of TCM.
Drug administration is an extremely important aspect in the design and conduct of randomized controlled trials, which can influence the reliability and quality of the trials’ results. This topic covers issues such as blinding, preparation, packaging, labeling, shipping, dispensing and returning of test articles. Good drug administration procedures should ensure the smooth implementation of large-scale multi-center randomized controlled trials and increase their reliability and usefulness.