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.
N-of-1 trials are prospective clinical randomized cross-over controlled trials with multiple rounds of trial phase alternation designed with regard to a single patient. N-of-1 trials can provide clinical decision-makers with high-level evidence of the comparison of effect of intervention measures. Recently, an international team composed of many scholars published a SPIRIT extension for N-of-1 trials list (SPENT 2019) on the BMJ, with the purposes of clarifying the content design and improving the integrity and transparency of N-of-1 trial protocols. This article showed a detailed interpretation of the 14 main extension sub-items of the SPENT 2019 list with specific cases, aiming to further standardize the publication of domestic N-of-1 trials.
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.
In recent years, the number of randomized controlled trials using cohorts and routinely collected data (e.g., electronic health records, administrative databases, and health registries) has increased. Such trials can ease the challenges of conducting research and save cost and time. Accordingly, to standardize such trials and increase the transparency and completeness of research reports, an international panel of experts developed the CONSORT-ROUTINE (2021) reporting guideline. The reporting guideline was published in 2021 in the BMJ. To help understand and formally apply the reporting guideline and improve the overall quality of this type of study, the present paper introduced and interpreted the development process and reporting checklist of the CONSORT-ROUTINE.
CONSORT Group members update the CONSORT (Consolidated Standards of Reporting Trials) statement by collecting relevant literatures to improve the reporting quality of randomised controlled trials. Recently, they have outlined CONSORT-Equity reporting standards, an extension to the CONSORT statement, which had been developed to improve the reporting of intervention effects in randomised trials where health equity is relevant. It will be helpful to improve social health equity or reduce social health inequities. This paper aims to introduce CONSORT-Equity and interprets its usage by a series of randomised trials where health equity is relevant.
Within person trial is an efficient study design for randomized controlled trials which has been widely used in fields of dentistry, dermatology and ophthalmology. However, due to a series of inherent methodological difficulties, the design, conduct and reporting of within person trials usually requires additional methodological knowledge and considerations from researchers. To standardize and improve the reporting quality of these trials, the BMJ recently published the CONSORT statement extension for within person trials. The present article aimed to provide interpretation of this reporting guideline, and thereby promote its understanding and use among Chinese researchers.
The planning and reporting of synthesis questions in systematic review of intervention have a direct and important impact on the validity of the evaluation and the credibility of the results. Planning helps to reduce bias in the evaluation process and ensure the reproducibility of data synthesis. However, the field of systematic review currently lacks specific checklists and tools to guide how to plan and report these issues. The InSynQ (Intervention Synthesis Questions) checklist is a tool designed for planning and reporting data synthesis issues in systematic reviews of interventions. Its goal is to promote the standardization of systematic review methods, support systematic review participants in planning and comprehensively reporting data synthesis issues and structures, and provide a more accurate evidence base for clinical decision-making.
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.
ObjectiveTo develop reporting guideline for dose-response meta-analysis (DMA), so as to help Chinese authors to understand DMA better and to promote the reporting quality of DMA conducted by them. MethodPubMed, EMbase, The Cochrane Library, CNKI, and WanFang Data were searched from Jan 1st 2011 to Dec 30th 2015 to collect DMA papers published by Chinese authors. The number of these publications by years, whether and what kind of reporting guideline was used, and whether the DMA method claimed in these publications was correct were analysed. Then we drafted a checklist of items for reporting DMA, and organized a discussion meeting with experts from the fields of DMA, evidence-based medicine, clinical epidemiology, and clinicians to collect suggestions for revising the draft reporting guideline for DMA. ResultsOnly 33.73% of the publications clarified it is a DMA on the title and 48.02% of them reported risk of bias. Almost 38.49% of the publications didn't use any reporting guidelines. Fourteen of them claimed an incorrect use of methodology. We primarily took account for 47 potential items related to DMA based on our literature analysis results and existing reporting guidelines for other types of meta-analyses. After the discussion meeting with 6 experts, we revised the items, and finally the G-Dose checklist with 43 items for reporting DMA was developed. ConclusionThere is a lack of attention on reporting guidelines in Chinese authors and evidence suggests these authors may be at risk of incomplete understanding on reporting guidelines. It is strongly recommended to use reporting guidelines for DMA and other types of meta-analyses in Chinese authors.
ObjectiveTo select the key questions of the reporting quality of acupuncture therapy network meta-analysis. MethodsA question pool about reporting quality of acupuncture therapy network meta-analysis was conducted by preliminary literature research and qualitative systematic review. A correspondence questionnaire was designed and the selection of key questions was carried out through two rounds of expert consultation using the Delphi method. ResultsA total of 21 key questions were selected for the network meta-analysis report standard of acupuncture, including whether to report details of acupuncture interventions (e.g., needle type, acupoints used, number of needles inserted, depth of needle insertion, retention time, needling techniques, and treatment duration), diagnostic criteria for diseases or traditional Chinese medicine syndromes, and qualifications of acupuncture practitioners. Of these, the only three key questions answered by the preferred reporting items for systematic reviews and network meta-analysis (PRISMA-NMA) were summary, protocol and registration, and source of funding, while the remaining 19 were specific to acupuncture-related report standards. ConclusionThe conducted key question on reporting guideline of acupuncture network meta-analysis can improve the standardization and rigor of relevant research and better utilize its academic and clinical value.