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.
Implementation science is a relatively emergent and growing research area. Implementation research can assist to transform what is possible in theory to reality in practice and address the challenge of implementing proven interventions in the real world. Implementation research has a wide range of usages and complex research problems, so appropriate research methods, designs, and outcomes variables are required to address different research objectives. To better conduct implementation research, this paper systematically introduces the research designs, outcome variables, and reporting guideline of the implementation research in health care, based on the purposes and research questions of implementation research.
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.
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.
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.
Based on the PRISMA 2009 checklist, the study analyzed current status and reporting quality of systematic reviews of animal experiments, and consulted experts in relevant fields to form an initial entry pool of reporting checklists for systematic reviews of animal experiments in traditional Chinese medicine (PRISMA-ATCM). Then, the initial entry pool was improved through 2 rounds of Delphi expert consultation. Finally, the items were revised through the consensus meeting, and the final PRISMA-ATCM was formed. Of the 27 items on the PRISMA checklist, 12 were revised and expanded, specifically relating to TCM interventions and animal characteristics. The publication of the PRISMA-ATCM will improve the transparency and standardization of systematic reviews of animal experiments in Chinese medicine.
Objective The purpose of the extension of the RIGHT statement for introductions and interpretations of clinical practice guidelines (RIGHT for INT) was to promote the development of comprehensive and clear article those introduced and interpreted clinical practice guidelines. MethodsThe RIGHT for INT checklist was developed following methods recommended by the EQUATOR Network. The development process included three stages. In the first stage, a multidisciplinary team of experts was recruited by email and WeChat and further divided into three groups (a steering group, a consensus group, and a secretariat group); in the second stage, the initial items were collected by literature review and brainstorming; and in the third stage, the final items were formed through a Delphi survey and expert consultation. ResultsA total of 40 initial items were collected through literature review and brainstorming. A final checklist of 27 items was formed after the Delphi survey and expert consultation. ConclusionThe RIGHT for INT checklist provides guidance for guideline interpreters on how to introduce and interpret clinical practice guidelines in a scientific and comprehensive manner.
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.
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.