New interventions are rapidly progressing into clinical practice through the preclinical study stage. The animal experiments should be comprehensive and critically evaluated for their pivotal role in this process. To integrate the evidence of animal studies by systematic review throws light on intervention outcomes and could decrease risk of participants in human trials. The methodological weakness of animal studies is easy to highlight but robust methods to synthesize evidence is essential. Here, we discuss some problems in systematic review of animal experiments and whether animal models of diverse species contribute to bias of meta-analysis conclusions.
Evidence synthesis is the use of standardized, clear and rigorous methods to bring together and merge existing research data, knowledge and information, focusing on specific research questions, in order to provide a basis for relevant medical and health decision-making. At present, there are many types of evidence synthesis methods, the number of related applied researches has proliferated, however, it is easy to confuse different methods, which leads to problems such as misuse and abuse. The choice of inappropriate synthesis method will reduce the credibility and applicability of evidence. Clarifying the path and link of the selection of evidence synthesis methods will play a positive role in promoting the standardization of evidence-based evaluation. Thus, this paper briefly describes the development and classification of evidence synthesis methods, and reviews 18 representative evidence synthesis methods and its application examples in the medical field including systematic review. It also introduces the "Right Review", an evidence synthesis method selection tool that has been developed and put into use in recent years, and clarifies the limitations of the current selection tools and methods. At the same time, referring to existing tools, theories, and models, the selection path for different evidence synthesis methods and the decision process of evidence synthesis are proposed to provide reference for researchers to choose the evidence synthesis method reasonably.
Rapid, living evidence-based points, as a new model promoting the rapid translation of evidence, aim to integrate the current best evidence, clinical status, public/patient preferences and values, and provide concise and practical guidance rapidly to important questions concerned in clinical medicine and public health. This paper introduces the methodological framework for the development of "Rapid, Living Evidence-Based Points" from 4 aspects: initiation and planning, evidence search and review, development, update, publication and dissemination of evidence-based points, in order to provide a reference for domestic scholars in developing rapid, living evidence-based points.
As precision medicine continues to gain momentum, the number of predictive model studies is increasing. However, the quality of the methodology and reporting varies greatly, which limits the promotion and application of these models in clinical practice. Systematic reviews of prediction models draw conclusions by summarizing and evaluating the performance of such models in different settings and populations, thus promoting their application in practice. Although the number of systematic reviews of predictive model studies has increased in recent years, the methods used are still not standardized and the quality varies greatly. In this paper, we combine the latest advances in methodologies both domestically and abroad, and summarize the production methods and processes of a systematic review of prediction models. The aim of this study is to provide references for domestic scholars to produce systematic reviews of prediction models.
The use of core outcome sets reduces heterogeneity in the reporting of outcomes in clinical trials, increasing the value and significance of research. This paper first introduces and interprets “core outcome sets for myocardial infarction (COS-MI) in clinical trials of traditional Chinese medicine and Western medicine”, in order to help Chinese researchers better understand and use it. Second, this study surveyed the use of COS-MI in MI related clinical trials from January 1, 2023 to June 1, 2024, showing that 91% (10/11) of the 35 acute myocardial infarction clinical studies included reported core outcomes, and the median percentage of using core outcome sets was only 36% (4/11). As the publication time of the core outcome set is close to the literature search time, the understanding of domestic researchers about it is still unclear. Further research is needed to explore the application of core outcome sets for myocardial infarction in clinical trials of traditional Chinese medicine and Western medicine, providing a reference for its update and improvement.
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
Objective To improve the sensitivity and broaden the applicability of N-of-1 trials in traditional Chinese medicine (TCM), the clinical application and methodology of single-case experimental designs (N-of-1trials, multiple-baseline designs; MBDs) were expounded, compared, and discussed. Methods This paper introduced the current utility of N-of-1 trials in TCM research, introduced MBDs, and compared the methodologies of N-of-1 trials, MBDs and crossover design. Finally, two design schemes to improve the sensitivity and applicability of N-of-1 trials were illustrated. Results N-of-1 trials conformed to the TCM concept of treatment based on syndrome differentiation; however, due to the complex composition of TCM, the results were easily affected by carryover effect. In MBDs, the intervention was introduced in a staggered way, no washout period was needed, and the required sample size was small. MBDs were generally used to preliminarily indicate the effect of intervention; however, the statistical analysis was relatively complicated, and there were few MBDs used in clinical trials of TCM at present. Compared with crossover trials, single-case experimental designs had advantages and disadvantages. N-of-1 trials might best reflect the individualized treatment of TCM and a suitable statistical model (e.g., hierarchical Bayesian statistical method) was expected to improve the sensitivity and applicability of N-of-1 trials in TCM. Combining clinical trial designs (e.g., the combination of N-of-1 trials and MBDs) would complement the limitations of N-of-1 trials, and expand the scope of conditions applicable for study. Conclusion N-of-1 trials have both advantages and disadvantages in TCM research. Improved statistical models or combined study designs will improve the sensitivity and broaden the applicability of N-of-1 trials in TCM.
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.
Objective To evaluate the methodological and reporting quality of systematic reviews/meta-analyses related to the efficacy and safety of corticosteroid-assisted treatment for severe pneumonia. Methods PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, WanFang Data and VIP databases were searched by computer, and the systematic reviews/meta-analyses of corticosteroid hormone as an auxiliary means for the treatment of severe pneumonia which were published from establishment of the databases to October 25th, 2018 were searched. A Measurement Tool to Assess Systematic Review-2 (AMSTAR-2) was used to assess the methodological quality of the included studies, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was used to evaluate the quality of literature reports. Results A total of 16 systematic reviews/meta-analyses were included, all of which were non-Cochrane systematic reviews. In terms of methodological quality assessed by AMSTAR-2, there was no plan in all studies; only one study explained the reasons for inclusion in the study type; eight studies did not describe the dose and follow-up time of the intervention/control measures in detail; three studies did not indicate the evaluation tools and did not describe the risk bias; six studies did not explicitly examine publication bias. In terms of reporting quality assessed by PRISMA, all studies had no pre-registered study protocol or registration number; thirteen studies did not describe the specific amount of articles retrieved from each database; three studies did not present their retrieval strategies or excluded reasons in detail; no funding sources were identified in included studies; eight studies reported both whether the study was funded and whether there was a conflict of interest. Conclusions At present, there are many systematic review/meta-analysis studies on the efficacy and safety of corticosteroid-assisted treatment for severe pneumonia, and the overall quality of the study has been gradually improved. However, the common problems in the study are relatively prominent. The follow-up period and dose of intervention in the study of severe pneumonia are different, so the baseline is difficult to be unified. Suggestions: strengthening the training of researchers, standardize the research process, and report articles in strict accordance with the PRISMA statement; subgroup analysis being conducted according to the dose and duration of the hormone.