Structured template and reporting tool for real world evidence (STaRT-RWE) was developed by a team led by professor Shirley V Wang of Brigham and Women's Hospital, Harvard Medical School, which is to plan and report on the implementation of real world evidence (RWE) studies on the safety and efficacy of treatments. The template, published in the journal BMJ in January 2021, has been endorsed by the International Society of PharmacoEpidemiology and the Transparency Initiative promoted by the International Society of Pharmacoeconomics and Outcome Research. This article interprets its entries to promote the understanding and application of STaRT-RWE by domestic scholars engaged in real world study, and help to improve the transparency, repeatability, and accuracy of RWE research.
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.
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.
The preferred reporting items for comprehensive evaluation of Chinese patent medicine (PRICE-CPM) regulate the specific requirements of forming integrity, clear, and transparent reports from title to conclusion. It contains six domains with twenty-one items and seventy-two sub-items and is important to promote the integrity, scientificity, transparency, and applicability of relevant reports. Additionally, it indicates that comprehensive evaluation results reports of post-marketing Chinese patent medicine should refer to PRICE-CPM. Therefore, this article provides a detailed interpretation of the report list and references for future users.
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.
背景 随机对照试验（randomized controlled trials，RCTs）常用于评估社会和心理干预措施的效果，这些结果亦常被用于制定决策。有关社会及心理干预措施试验结果的准确、完整和透明的报告，对了解针对这些干预措施的临床试验设计、实施、结果及这些结果的应用至关重要。然而，关于社会和心理干预措施的 RCT 报告质量仍不理想。CONSORT（consolidated standards of reporting trials）声明改善了生物医学领域 RCT 的报告质量，同样，行为和社会科学方面也需要类似的高质量报告规范。我们的目标是基于 RCT 报告规范 2010 年声明（Consolidated Standards of Reporting Trials 2010 Statement，CONSORT 2010）的官方扩展版，制定适用于社会和心理干预措施（social and psychological interventions，SPI）的 RCT 报告规范（CONSORT-SPI 2018）。 方法 我们遵循最佳方案制定报告规范的扩展版。首先，我们对现有报告规范进行了系统评价。随后，我们进行了有 384 位国际参与者参加的德尔菲在线调查。2014 年 3 月，我们举行了为期 3 天的共识会议，由 31 位专家参与，确定针对社会和心理干预措施的 RCT 报告的检查清单内容。专家们仔细讨论了先前与社会和心理干预措施 RCT 相关的研究和方法学问题。然后，投票决定对 CONSORT 2010 条目的修改或扩展。 结果 CONSORT-SPI 2018 检查清单扩展了 CONSORT 2010 的 25 个条目中的 9 个，包括：背景和目标、试验设计、受试者、干预措施、统计方法、受试者流程、基线数据、结果和估计及资助来源。此外，与会者还添加了一个与利益相关方参与度有关的新条目，此外，也修改了与受试者招募和及其后续维持相关的流程图。 结论 作者应使用 CONSORT-SPI 2018 来改善社会和心理干预相关的 RCT 的报告质量。期刊应修改编辑政策和程序，要求作者使用报告规范准备相关稿件，要求同行评议者使用报告规范评审相关稿件，以使读者能够评估研究的质量，评价研究结果的推广性，并重复有效的干预措施。
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.
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.
Consensus reporting items for studies in primary care (CRISP) is a newly developed measurement tool developed abroad to standardize primary health care research, so as to improve the quality of reporting and enhance the applicability, comprehensiveness, transparency and operability of reporting. The report contains 24 Entries that follow the Introduction, Methods, Results, Discussion (IMRaD) format, and is primarily concerned with describing the research team, the patients, the study subjects, the health status, the clinical experience, the health care team, the interventions, the study interventions, and the findings in the PHC study / implementation of results, etc. This article introduces and interprets the reporting guidelines to help researchers better understand and apply this statement to improve the quality of reporting in primary health care research