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.
Digital health technology implementation has grown rapidly in recent years. To standardize the quality of digital health implementation research and increase the transparency and integrity of reporting, Perrin published iCHECK-DH: guidelines and checklist for the reporting on digital health implementations in 2023. This article interprets the contents of the list with a view to improving the reporting quality of digital implementation studies to develop more effective digital health interventions and achieve better health outcomes.
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.
Objective To summarize and analyze the working experience of hospital performance evaluation and reporting system in America, so as to provide decision support to China on such work as establishing objective, scientific and effective hospital performance evaluation system, strengthening government’s supervision to health service, and promoting hospitals’ sound development.Methods American official websites and databases were searched to include relative policies, reports and documents on hospitals’ performance evaluation. Results Typical hospital performance evaluation and reporting system in America included National Healthcare Quality Report (NHQR), Consumer Assessment of Healthcare Providers and System (CAHPS), Healthcare Effectiveness Data and Information Set (HEDIS), Leapfrog Group Evaluation System and Thomson Reuters 100 Top Hospitals. Conclusion The enlightenments of American performance performance evaluation systems to China include: a) more attention should be paid to performance evaluation; b) combined evaluation models and results application methods should be considered; c) comparatively scientific evaluation methods and comprehensive evaluation contents should be established.
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.
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 evaluate the reporting quality of systematic reviews (SRs)/meta-analyses on acupuncture focusing on literature screening results and explore the influencing factors of the complete reporting.MethodsPubMed, EMbase, CNKI, WanFang Data, and VIP databases were searched to collect SRs/meta-analyses on acupuncture from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and evaluated the reporting quality of literature screening results of SRs/meta-analyses on acupuncture based on PRISMA statement. Logistic regression model analysis was applied to explore the influencing factors of the complete reporting rate of literature screening results. Statistical analysis was performed by using Excel 2016 and SPSS 16.0 software.ResultsA total of 1 227 SRs/meta-analyses were included. Only 62.3% SRs fully reported the four parts of literature screening results. The parts with a low reporting rate included the number of studies assessed for eligibility (73.2%) and the reasons for exclusions at each stage (67.0%). And the reporting rate of the literature screening flowchart was also low (63.6%). The reporting rate of literature screening results in Chinese SRs was lower than that in English SRs, and there was significantly statistical difference (P<0.001). Multivariate logistic regression analysis showed that the type of published journal, publication year, pages of article and the number of searched databases were correlated with the complete reporting rate of literature screening results (P<0.001).ConclusionsThe complete reporting rate of the literature screening results of SRs on acupuncture is low, especially in Chinese SRs. The complete reporting rate of literature screening results is significantly higher for SRs published after PRISMA statement, in SCI journals, with longer length and more searched databases.
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.