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.
To improve the comprehensive and accurate of overviews of reviews, BMJ published the guideline for overviews of reviews of healthcare interventions: the PRIOR statement. This paper explained the background and core contents of PRIOR statement and interpreted each item with examples to provide references for domestic scholars to write overviews of reviews.
Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.
In recent years, the TRIPOD 2015 statement has shown significant limitations with the gradual application of machine learning methods in the development and evaluation of clinical prediction models. Therefore, TRIPOD 2015 statement has been updated in 2024 as the TRIPOD+AI statement entitled "TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods", aiming to promote the complete, accurate, and transparent reporting of studies that develop a prediction model or evaluate its performance. This article interprets the key contents and items of the TRIPOD+AI in order to provide aids for clinical researchers.
Effectiveness-implementation hybrid designs can test the effectiveness of interventions and the outcomes of implementation strategies concurrently and accelerate the transformation of research results into routine practice. This paper introduced three types of effectiveness-implementation hybrid designs and corresponding reporting guidelines, including standards for reporting implementation studies, cluster randomized design and CONSORT 2010, stepped-wedge cluster randomized design and extended version CONSORT 2018, qualitative research and COREQ reporting guideline, and provide references for domestic researchers to produce research reports on effectiveness-implementation hybrid design.
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.
In recent years, the potential value of clinical big data have been gradually realized, and disease prediction models have begun to become a hot spot in clinical research. Predictive models of different types of diseases play an increasingly important role in individual risk assessment. However, due to the lack of reporting specifications for studies on disease prediction model, the structure and quality of reports are mostly mixed. In 2015, BMJ published a paper entitled "Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement" stated that there should be a uniform study of predictive models for disease diagnosis and prognosis. This article interprets key contents of the statement to promote research and understanding of the report specification.
ObjectiveTo assess the endorsement of the ARRIVE guideline and the Gold Standard Publication Checklist (GSPC) by Chinese journals in animal experiments field and its incorporation into their editorial processes. MethodsChinese journals indexed by SCI, MEDLINE, CSCD or CSTPCD were included. The latest'instruction for authors' (IFA) of each included journals was downloaded and any text mentioning the ARRIVE guideline and GSPC was extracted. Subsequently, a self-designed questionnaire was used to investigate the editor of each included journals. The investigation contents mainly included the basic information of the respondents, the awareness situation on the ARRIVE guideline, GSPC and their incorporation into editorial and peer review processes. Results240 journals in animal experiments field from China were examined. A total of 240 questionnaires were issued, of which, 198 questionnaires were effective (response rate 82.5%). The results showed that all IFAs didn't mention the ARRIVE guideline or GSPC and the awareness rate on the ARRIVE guideline and GSPC in editors of Chinese journals was only 13.1%. Only 10.1% of the editors reported that they required authors to comply with the ARRIVE guideline and GSPC. And editors reported that they incorporated the two guidelines into their peer review (7.1%) and editorial processes (8.1%). ConclusionAt present, all Chinese journals'IFAs didn't mention the ARRIVE guideline or GSPC. The majority of editors surveyed are not familiar with the content of the ARRIVE guideline and GSPC. And it needs to take purposeful measures to promote and popularize them in order to improve the quality of animal experiment reports.
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.
The guideline for reporting meta-epidemiological research, based on PRISMA, aims to increase the reporting quality and transparency of meta-epidemiological studies. This paper introduced and interpreted the 24 reporting items in the guidelines for reporting meta-epidemiological research to provide a reference for standardizing the reporting of meta-epidemiological studies.