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.
To standardize and improve the reporting quality of implementation studies, BMJ published the standards for reporting implementation studies (StaRI). This paper introduces the background and process of StaRI development, and interprets the core content of StaRI. It is expected that StaRI will provide support for domestic researchers to carry out implementation studies and writing implementation research reports.
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.
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.
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.
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.
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.
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.
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.
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.