Based on previous evidence-based researches and teaching experience, our team conducted literature and book review, and summarized 4 requirements, 1) effect measure calculation and conversion, 2) registration of evidence-based research, 3) evidence-based research database and 4) quality evaluation tools and reporting guidelines. We developed an online platform of evidence-based medicine research helper using the front-end and back-end technology, which can be accessed using www.ebm-helper.cn. Currently, the online tool has included 46 scenarios for effect measure calculation and conversion, introduction of 7 evidence-based research registration platforms, 26 commonly used databases for evidence-based research and 29 quality evaluation tools and reporting guidelines. This online tool can help researchers to solve specific problems encountered in different stages of evidence-based medicine research. Promoting the application of this platform in evidence-based medicine will help researchers to use the tool scientifically and improve research efficiency.
Clinical prediction models typically utilize a combination of multiple variables to predict individual health outcomes. However, multiple prediction models for the same outcome often exist, making it challenging to determine the suitable model for guiding clinical practice. In recent years, an increasing number of studies have evaluated and summarized prediction models using the systematic review/meta-analysis method. However, they often report poorly on critical information. To enhance the reporting quality of systematic reviews/meta-analyses of prediction models, foreign scholars published the TRIPOD-SRMA reporting guideline in BMJ in March 2023. As the number of such systematic reviews/meta-analyses is increasing rapidly domestically, this paper interprets the reporting guideline with a published example. This study aims to assist domestic scholars in better understanding and applying this reporting guideline, ultimately improving the overall quality of relevant research.
An intervention with clinical application must be effective and safe, therefore, when evaluating interventions, the benefit-harm ratio should be considered, and only those interventions with more benefits than harms have application value. To evaluate the benefits and harms of an intervention evidence of both benefits and harms should be reported in clinical trials. To promote better reporting of harms in randomized controlled trials, the CONSORT group had added an entry on harms in the 2001 version of the CONSORT statement, and then in 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated, the reporting of harms is still inadequate. The CONSORT group has updated《Better reporting of harms in randomized trial: an extension of the CCONSORT statement.》, published《CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials》. This article presents and explains the Harms 2022, with the aim of helping researchers better understand and use the statement, with a view to improving the reporting quality of harms in clinical trials.
The utilisation of statistical analysis plan (SAP) has the potential to enhance the reliability, transparency, and impartiality of statistical analysis procedures in the context of clinical studies. These plans are primarily designed for late phase clinical studies, namely phase Ⅱ and phase Ⅲ randomised controlled trials. The extended SAP reporting guidelines for early phase clinical studies, i.e., phase Ⅰ clinical studies and phase Ⅱ non-randomised controlled trials, have been expanded from the original reporting guidelines in six key areas: trial purpose, design, Bayesian statistics, data simulation, sample size, and the application of ICH E9 (R1). The expanded reporting guidelines facilitate the standardisation of SAP for early phase clinical trials, enhance the transparency and reproducibility of early phase clinical studies, and thereby improve the quality of early phase clinical studies. This, in turn, plays a pivotal role in later phase clinical studies.
ObjectiveTo investigate the application status of survival analysis in studies published in Chinese oncology journals, and assess their reporting quality and summarize the existing problems, so as to promote the application of survival analysis and reporting quality. MethodsStudies that used survival analysis were collected from 1 492 studies published in Chinese Journal of Oncology, Chinese Journal of Clinical Oncology, Chinese Journal of Radiation Oncology and Chinese Journal of Cancer Prevention and Treatment in 2013. The application status of survival analysis of included studies was analysed and their reporting quality was evaluated. ResultsA total of 242 survival analysis studies were included. Among them, the utilization rates of Kaplan-Meier method, life table method, log-rank test, Breslow test and Cox proportional hazards model were 91.74%, 3.72%, 78.51%, 0.41% and 46.28%, respectively. 112 studies did multivariate analysis through Cox proportional hazards model. A total of 396 end points and 10 different types of survival time were reported. Overall survival (OS) was reported in 233 studies (92.15%). Survival terms were defined to 158 end points (39.90%) of 103 studies (42.56%). The follow-up rates were mentioned in 155 studies (64.05%), of which 4 studies were under 80% and the lowest was 75.25%, 55 studies were 100%. The main problems of survival analysis studies published in Chinese journals were as follows:None of the studies which used Cox proportional hazards model reported the proportional hazards assumption. None of the studies used the method of parametric survival analysis. 130 studies (53.72%) did not use the method of multiple factor analysis. 139 studies (57.44%) did not define the survival terms. Only 11 of 100 studies which reported loss to follow-up had stated how to treat it in the analysis. None of the studies reported the methods of calculating sample size. None of the studies reported the censoring proportion. ConclusionThe methods of survival analysis are used in a low rate in studies published in Chinese oncology journals, and the overall reporting quality of survival analyses is poor. So the reporting guideline of survival analysis should be developed and the authors should be encouraged to cooperate with professional statisticians, in order to improve the design, analysis and reporting quality of survival analysis studies.
The PRISMA aims to enhance the transparency and reporting quality of systematic reviews. PRISMA 2020 is an update version of PRISMA 2009, which was published in BMJ in March, 2021. This article compared the PRISMA 2020 and PRISMA 2009, interpreted PRISMA 2020 with representative examples, aiming to help Chinese scholars better understand and apply this reporting guideline, thus to improve the reporting quality of systematic reviews.
To enhance the quality and transparency of oncology real-world evidence studies, the European Society for Medical Oncology (ESMO) has developed the first specific reporting guidelines for oncology RWE studies in peer-reviewed journals "the ESMO Guidance for Reporting Oncology Real-World Evidence (GROW)". To facilitate readers understanding and application of these reporting standards, this article introduces and interprets the development process and main contents of the ESMO-GROW checklist.
Consensus reporting items for studies in primary care (CRISP) is a newly developed measurement tool developed abroad to standardize primary health care research, so as to improve the quality of reporting and enhance the applicability, comprehensiveness, transparency and operability of reporting. The report contains 24 Entries that follow the Introduction, Methods, Results, Discussion (IMRaD) format, and is primarily concerned with describing the research team, the patients, the study subjects, the health status, the clinical experience, the health care team, the interventions, the study interventions, and the findings in the PHC study / implementation of results, etc. This article introduces and interprets the reporting guidelines to help researchers better understand and apply this statement to improve the quality of reporting in primary health care research