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.
Based on previous evidence-based researches and teaching experience, our team conducted literature and book review, and summarized 4 requirements, 1) effect measure calculation and conversion, 2) registration of evidence-based research, 3) evidence-based research database and 4) quality evaluation tools and reporting guidelines. We developed an online platform of evidence-based medicine research helper using the front-end and back-end technology, which can be accessed using www.ebm-helper.cn. Currently, the online tool has included 46 scenarios for effect measure calculation and conversion, introduction of 7 evidence-based research registration platforms, 26 commonly used databases for evidence-based research and 29 quality evaluation tools and reporting guidelines. This online tool can help researchers to solve specific problems encountered in different stages of evidence-based medicine research. Promoting the application of this platform in evidence-based medicine will help researchers to use the tool scientifically and improve research efficiency.
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.
To enhance the quality and transparency of oncology real-world evidence studies, the European Society for Medical Oncology (ESMO) has developed the first specific reporting guidelines for oncology RWE studies in peer-reviewed journals "the ESMO Guidance for Reporting Oncology Real-World Evidence (GROW)". To facilitate readers understanding and application of these reporting standards, this article introduces and interprets the development process and main contents of the ESMO-GROW checklist.
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.
Chinese medicine case report, a special method, records the experience of practitioners and guides students to inherit and develop Chinese medicine. It can transfer a large amount of medical and humanistic information and contribute to the development of Chinese medicine. It is a literary style that has been widely accepted and helps to document and disseminate the culture of Chinese medicine. With the advent of big data and information, more Chinese medicine case reports have been published. However, many have insufficient quality to properly guide and apply in the clinical practice, which might be caused by little guidance of Chinese medicine case report standards published. This paper summarized the case report standards, synthesized and appraised the feasibility and problems specific for improving the quality of Chinese medicine case reports, and proposed suggestions and guidance for developing the standardization of Chinese medicine medical case reports.
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.
The standards for reporting of diagnostic accuracy for studies in journal or conference abstracts (STARD for Abstracts) was developed for guiding the reporting of abstracts of diagnostic accuracy studies, which was published in BMJ in August 2017. The study mainly introduced and interpreted the items of STARD for Abstracts, in order to help domestic researchers to perform and report the abstracts of diagnostic accuracy studies by STARD for Abstracts.
