Surrogate endpoints, defined as biomarkers or intermediate outcomes utilized in clinical trials to replace the ultimate targeted outcomes, have witnessed a growing prevalence in both clinical trials and drug-device approvals in recent years. To standardize the application and reporting of surrogate endpoints in clinical trial protocols and associated studies, relevant scholars published the SPIRIT-Surrogate and CONSORT-Surrogate reporting guidelines in the BMJ in July 2024. This article provides an interpretation of these guidelines in conjunction with published case studies, with the aim of offering references for domestic researchers, elevating the overall quality of related clinical trials, and eventually facilitating the enhancement of domestic healthcare level.
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.
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.
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.
In order to standardize the reporting of sham acupuncture and improve the quality of reporting of sham acupuncture, Beijing University of Chinese Medicine has developed a specific reporting guideline for sham acupuncture: SHam Acupuncture REporting (SHARE) which contains ten categories with nineteen items. This paper introduces the development methods and main contents of the guidelines to provide a reference for researchers to correctly understand and reasonably apply the guidelines.
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.
Living systematic reviews (LSR) represent an evolving methodology for systematic review that is continuously updated to incorporate new evidence in a timely manner, ensuring that healthcare professionals and policymaker shave access to the most last information to make optimal decisions. The global publication of LSR has been a rapid increase. But the quality of reporting remains to be enhanced. In 2024, the PRISMA-LSR working group, in conjunction with the characteristics of LSR to form the reporting standards for living systematic reviews, which plays a significant role in promoting the transparent, complete, and accurate reporting of LSR. It has been published in the BMJ journal. This article interpreted PRISMA-LSR with representative examples, aiming to provide a reference for the standardization of LSR by domestic scholars.
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.
The selection of outcome measurement instruments (OMI) is a prerequisite for accurately collecting health outcome data. Conducting a systematic review of OMI can provide an important reference for researchers and practitioners to select the most appropriate OMI. In order to improve the reporting quality of the systematic review of OMI, foreign researchers published the PRISMA-COSMIN reporting guideline in the J Clin Epidemiol in June 2024. This article introduces the research team, development process, and items of the reporting guideline, and analyzes the items with examples. We hope our attempt could help domestic researchers improve the overall quality of OMI systematic reviews.