This study aimed to provide suggestions for future researchers to select and optimize sham acupuncture reporting guidelines in acupuncture clinical trials. Through qualitative analysis, we compared the basic information and concrete contents between Acupuncture Controls gUideline for Reporting humAn Trials and Experiments (ACURATE) and SHam Acupuncture REporting guidelines in clinical trials (SHARE) developed by researchers from China and Korea. In addition, the similarities and differences of the two guidelines were illustrated through a specific case. We found that the two guidelines had their own characteristics and emphasis in content, but both emphasized the reports of detailed information and background factors of sham acupuncture compared with the previous STRICTA and TIDieR-Placebo checklist. In terms of item division, we found that the ACURATE split the same topic into several items to emphasize the importance of each item content. SHARE emphasized the comprehensive reports of sham acupuncture by combining several items into a single item. In terms of item content, ACURATE also focused on combination therapy, the information regarding sham acupuncture provided to participants, and any differences in treatment settings between versus/sham acupuncture, which had some referential meaning for setting sham acupuncture control. SHARE also focused on sham acupuncture detailed information, practitioner, and modifications, etc. Case analysis showed that there were some "not reported" or "partially reported" items in both guidelines. Therefore, it is suggested that researchers can use the above two guidelines to complement and learn from each other to report sham acupuncture. In addition, it is necessary for researchers to verify the operability and practicability of the above two guidelines, and provide suggestions for optimizing and updating them in the future.
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.
ObjectiveTo investigate the awareness situation on the ARRIVE guideline and the Gold Standard Publication Checklist (GSPC) of animal experiments in researchers in animal experiments field in Lanzhou city, in order to improve the promotion of the two reporting guidelines in China. MethodsA self-designed questionnaire was used to investigate the clinical graduate students and teachers in medical college in Lanzhou city. The investigation contents mainly included the basic information of the respondents, the awareness situation on the ARRIVE guideline, GSPC and other medical reporting guidelines. SPSS 21.0 software was used for data analysis. ResultsA total of 329 questionnaires (40 were from teachers and 289 were from graduate students) were issued, of which, 287 questionnaires were effective. The results showed that the awareness rate on the ARRIVE guideline and GSPC in clinical graduate students and teachers in medical college in Lanzhou city were 11.8% and 12.5%, respectively, and there was no significant difference between students and teachers in awareness rate (P=0.903). The survey approaches, the age, education, job, and the organization of the respondents were all not the influence factors of awareness rate (P>0.05). The respondents knew about the reporting guidelines mainly through the website (33.4%), related studies (21.2%) and academic reports (17.4%). ConclusionThe awareness rate on the ARRIVE guideline and GSPC is relative low in researchers in animal experiments field in Lanzhou city, and it needed to take purposeful measures to promote and popularize them.
ObjectiveSham acupuncture control is a commonly employed method to assess the specific effects of acupuncture in clinical trials. However, due to the absence of specific reporting standards, the reporting quality of sham acupuncture in these trials is low. In order to standardize the reporting of sham acupuncture and improve the reporting quality of sham acupuncture, our project team has developed SHam Acupuncture REporting guidelines and a checklist in clinical trials (SHARE). MethodsThe development process included four parts: we conducted literature research to form initial items of sham acupuncture reporting; two rounds of Delphi surveys were carried out to evaluate the reporting necessity of these initial items; two expert consensus meetings were held to further discuss and agree upon the Delphi results and approve the SHARE checklist; a pilot testing was conducted to assess the feasibility and practicality of the list and make necessary revisions to generate the final SHARE checklist. ResultsThe SHARE checklist consisted of 10 categories with 19 items. The requirements for reporting sham acupuncture primarily focused on sham acupuncture detailed information as well as relevant background factors. ConclusionThe SHARE serves as specialized reporting guidelines for sham acupuncture that offers clear guidance on comprehensive and concise reporting of sham acupuncture.
ObjectiveTo select the key questions of the reporting quality of acupuncture therapy network meta-analysis. MethodsA question pool about reporting quality of acupuncture therapy network meta-analysis was conducted by preliminary literature research and qualitative systematic review. A correspondence questionnaire was designed and the selection of key questions was carried out through two rounds of expert consultation using the Delphi method. ResultsA total of 21 key questions were selected for the network meta-analysis report standard of acupuncture, including whether to report details of acupuncture interventions (e.g., needle type, acupoints used, number of needles inserted, depth of needle insertion, retention time, needling techniques, and treatment duration), diagnostic criteria for diseases or traditional Chinese medicine syndromes, and qualifications of acupuncture practitioners. Of these, the only three key questions answered by the preferred reporting items for systematic reviews and network meta-analysis (PRISMA-NMA) were summary, protocol and registration, and source of funding, while the remaining 19 were specific to acupuncture-related report standards. ConclusionThe conducted key question on reporting guideline of acupuncture network meta-analysis can improve the standardization and rigor of relevant research and better utilize its academic and clinical value.
As the volume of medical research using large language models (LLM) surges, the need for standardized and transparent reporting standards becomes increasingly critical. In January 2025, Nature Medicine published statement titled by TRIPOD-LLM reporting guideline for studies using large language models. This represents the first comprehensive reporting framework specifically tailored for studies that develop prediction models based on LLM. It comprises a checklist with 19 main items (encompassing 50 sub-items), a flowchart, and an abstract checklist (containing 12 items). This article provides an interpretation of TRIPOD-LLM’s development methods, primary content, scope, and the specific details of its items. The goal is to help researchers, clinicians, editors, and healthcare decision-makers to deeply understand and correctly apply TRIPOD-LLM, thereby improving the quality and transparency of LLM medical research reporting and promoting the standardized and ethical integration of LLM into healthcare.
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.
在缺乏数据进行 Meta 分析的系统评价中，通常使用替代合成方法，但这些方法却很少被报道，而模糊的方法阐述可能会导致人们质疑系统评价结果的真实性。无 Meta 分析数据合成（SWiM）报告规范是用于指导采用了替代合成方法评估干预措施效应的系统评价进行清晰报告的规范。本文介绍了 SWiM 规范的研制过程及 9 个 SWiM 报告条目及其相应的解释与示例。
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.