Structured template and reporting tool for real world evidence (STaRT-RWE) was developed by a team led by professor Shirley V Wang of Brigham and Women's Hospital, Harvard Medical School, which is to plan and report on the implementation of real world evidence (RWE) studies on the safety and efficacy of treatments. The template, published in the journal BMJ in January 2021, has been endorsed by the International Society of PharmacoEpidemiology and the Transparency Initiative promoted by the International Society of Pharmacoeconomics and Outcome Research. This article interprets its entries to promote the understanding and application of STaRT-RWE by domestic scholars engaged in real world study, and help to improve the transparency, repeatability, and accuracy of RWE research.
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.
Primary liver cancer is the sixth most common malignancy and the third leading cause of cancer-related death worldwide, and hepatocellular carcinoma (HCC) constitutes the majority of primary liver cancer cases. The Liver Imaging Reporting and Data System (LI-RADS) was introduced to standardize the lexicon, acquisition, interpretation, reporting, and data collection of imaging results in patients at increased risk for HCC. LI-RADS allows effective categorization of focal liver lesions, and has been applied in the full clinical spectrum of HCC from diagnosis, biological behavior characterization, prognosis prediction, to treatment response assessment. This review aimed to summarize the recent applications of CT/MRI LI-RADS in the diagnosis, biological behavior characterization and prognosis prediction of HCC, discuss current challenges and shed light on potential future directions.
The consolidated standards of reporting trials (CONSORT) is an internationally recognized guideline for reporting randomized controlled trials (RCTs), aiming to enhance the transparency, completeness, and reliability of trial findings. In response to the ongoing evolution of clinical trial methodology, the CONSORT group has issued updates to the CONSORT statement in 2001, 2010, and most recently in 2025. This article provides an applied interpretation of the background and key components of the CONSORT 2025 statement through the lens of a representative randomized controlled trial, with the aim of offering practical guidance and reference for domestic researchers utilizing this reporting tool.
ObjectiveTo systematically sort out acupuncture therapy research report specification issues and provide a reference for the selection of key problems in the specification of acupuncture therapy network meta-analysis reports. MethodsComputer searches of PubMed, Embase, Web of Science, Cochrane Library, CNKI, WanFang Data, and VIP databases were conducted to collect studies related to reporting norms for acupuncture therapy, with a search time from inception to November 2022. Questions were constructed according to the SPIDER model and inclusion and exclusion criteria were developed. CASP was used to evaluate the methodological quality of the included literature, and a qualitative systematic evaluation thematic synthesis method was used to analyze, summarize, and integrate the questions on reporting norms for acupuncture therapy research evidence to create a pool of question entries. ResultsA total of 66 papers covering four countries were included, including 17 papers from qualitative studies and 49 papers from quantitative studies. The CASP evaluation results showed that the overall quality of the included studies was high, and the quality of the English studies was higher than that of the Chinese studies. The thematic synthesis method resulted in 22 question entries in 7 categories. The 7 categories of questions included title, abstract, preface, methods, results, discussion and other report specification questions. The 22 entries included "Is there a need to report specific types of acupuncture therapy", "Is there a need to report based on the type of original study and its number", etc. ConclusionThere are many problems with reporting norms in existing acupuncture studies, so it is necessary to collate and summarize the key issues of reporting norms for acupuncture network meta-analysis to provide a scientific and theoretical basis for the development of reporting guidelines for acupuncture network meta-analysis.
ObjectiveTo acquaint the development process and item composition of the appraisal tools and reporting standards of clinical pathways worldwide, in order to improve the development and evaluation of clinical pathways. MethodsWe searched databases including PubMed, EMbase, Web of Science, CBM, CNKI and WanFang Data for articles about the appraisal tools and reporting standards of clinical pathways from inception to Jan, 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and compared the difference in development process and item composition among included appraisal tools and reporting standards of clinical pathways. ResultsA total of 7 appraisal tools and reporting standards were included. Among them, 3 were from UK, 1 from China, 1 from Australia, 1 from Belgium, and 1 from Saudi Arabia. All included appraisal tools contained 4 to 15 domains and 14 to 99 items. Based on the comparison of different domains and items of included appraisal tools, "Clinical Pathway Management Guidelines" published by the National Health and Family Planning Commission of the People's Republic of China and the research of Vannhaecht, we identified 17 key elements of clinical pathway as follows:organizational commitment, pathway project management, format of doc, content of pathway, multidisciplinary involvement, variance management, EBM/guidelines, maintenance of pathway, accountability, patient involvement, development of pathway, additional support systems & documents, operational arrangement, implementation, outcome management, safety and organization of the care process. ConclusionCurrently, the appraisal tools and reporting standards of clinical pathways are rudimentary, so we desperately needs to establish mature appraisal tool and reporting standard of clinical pathways to guide the development and implementation of clinical pathway, so as to improve their application effects in clinical practice and medical quality.
The reporting quality of systematic reviews and meta-analyses is fundamental to the value of evidence in evidence-based medicine. As the internationally endorsed standard, the PRISMA statement and its extensive suite of extensions are crucial for standardizing reporting and enhancing transparency. However, a comprehensive, systematic understanding of its entire framework and profound challenges remains inadequate in the academic community. This review aims to systematically delineate and deeply analyze the complete PRISMA reporting guideline framework, evaluate its application value, uncover its implementation challenges, and forecast its future development directions. This paper traces PRISMA's evolution from its predecessor, QUOROM, to PRISMA 2020, highlighting key shifts in its core principles. It systematically constructs a multi-dimensional framework for the PRISMA family for the first time, categorizing its extensions by foundational versions, study design/analysis types, reporting process stages, disciplinary domains, and specific areas of focus, complemented by a forward-looking analysis of tools currently under development. The review delves into the deep-seated challenges in PRISMA's implementation, including misconceptions, inconsistent application, cross-disciplinary adaptability, and methodological limitations. It proposes that its future lies in balancing standardization with flexibility, enhancing globalized application, and deeply integrating with emerging technologies like artificial intelligence. The PRISMA framework has evolved from a mere reporting checklist into a core methodological architecture that promotes standardization throughout the entire evidence synthesis lifecycle. The continuous optimization and proper application of this framework are of critical theoretical and practical significance for enhancing the overall quality and impact of evidence synthesis research globally.
Artificial intelligence has been extensively applied in healthcare services recently, and clinical decision support systems driven by artificial intelligence are one of the applications. Early-stage clinical evaluation of artificial intelligence (AI)-based clinical decision support systems lies between preclinical development (in silico), offline validation, and large-scale trials, but few AI-related clinical studies have addressed human factors evaluations and reported the implementation environment, user characteristics, selection process and algorithm identification of AI systems. In order to bridge the development-to-implementation gap in clinical artificial intelligence and to promote the transparent and standardized reporting of early-stage clinical studies of AI-based decision support systems. A reporting guideline for the developmental and exploratory clinical investigations of decision support systems driven by artificial intelligence (DECIDE-AI) was published in 2022. This paper aimed to interpret the background, development process and key items of the DECIDE-AI guideline and promote its understanding as well as dissemination in China.
Evidence mapping is a new type of comprehensive evidence research method that systematically collects, evaluates, and synthesizes existing evidence to clarify research status and gaps, thereby promoting scientific research and decision-making. After nearly 20 years of development, the methodology of evidence mapping has been continuously improved, and has gained wide attention and recognition from the international community. China has paid much attention to evidence mapping at an early stage, but there are relatively few theoretical and practical researches, and the concept definition is inconsistent. This paper introduces the methodology of evidence mapping production and reporting for researchers to use for reference, with a view to further promoting the research and development of evidence mapping in China.
Objective The aim of this study is to construct reporting standards for acupuncture network meta-analysis, providing guidance to enhance the quality of evidence reported in acupuncture therapy research. Methods A Delphi questionnaire was developed based on the preliminary research and literature findings, 20 experts were selected for correspondence to determine the final checklists of items, and then finalized the list of report items. Results A total of two rounds of Delphi questionnaires were made. The expert positivity coefficient (100%), the expert familiarity (0.80) and the expert authority (0.83) were the same in both rounds, the Kendall's coordination coefficients were 0.117 (P<0.001) and 0.332 (P<0.001), respectively, which ultimately led to the formation of the 7 fields of title, abstract, introduction, methods, results, discussion and other, including 23 specific items of the acupuncture-related therapies NMA standards. Conclusion The PRINMA-A statement will help to improve the reporting quality of evidence on acupuncture-related therapies, promote the dissemination and translation of evidence on acupuncture-related therapies.