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.
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.
This paper introduces the development and changes of clinical practice guidelines based on the enlightenment of the Reporting Items for Practice Guidelines in Health Care (RIGHT), and provides policy recommendations.
Objective
To evaluate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine published inChinese Journal of Integrated Traditional and Western Medicine, and to analyze changes.
Methods
We searched CNKI to collect RCTs published inChinese Journal of Integrated Traditional and Western Medicine (CJITWM) in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004.
Results
A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate (>80%) included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. There has been no participant flow.
Conclusion
The quality of reporting, methodology, and ethics of RCTs published inChinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still needed to be further improved.
With the increasingly prominent contradiction between limited health resources and the growing population, priority setting of health research, as a response, has received widespread attention from health systems worldwide. As the results of priority setting at different levels increase year by year, some questions in the results reporting are also constantly emerging. For example, the process of producing the results is vague, too dependent on individual subjective judgment, the participation of individual stakeholder groups is limited or lack of voice, unable to identify potential conflicts of interest, and so on. It does not only seriously affect the effectiveness and rationality of the results themselves, but also create intangible obstacles to their promotion and adoption. In 2019, BMC Medical Research Methodology published ‘Reporting guideline for priority setting of health research (REPRISE)’, which makes uniform specifications for more comprehensive and consistent reporting of results in priority areas. This paper interpreted the background, formulation process and key contents of the REPRISE guideline, with an aim to promote the application of the reporting guideline in China.
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 systematically sort out acupuncture therapy research report specification issues and provide a reference for the selection of key problems in the specification of acupuncture therapy network meta-analysis reports. MethodsComputer searches of PubMed, Embase, Web of Science, Cochrane Library, CNKI, WanFang Data, and VIP databases were conducted to collect studies related to reporting norms for acupuncture therapy, with a search time from inception to November 2022. Questions were constructed according to the SPIDER model and inclusion and exclusion criteria were developed. CASP was used to evaluate the methodological quality of the included literature, and a qualitative systematic evaluation thematic synthesis method was used to analyze, summarize, and integrate the questions on reporting norms for acupuncture therapy research evidence to create a pool of question entries. ResultsA total of 66 papers covering four countries were included, including 17 papers from qualitative studies and 49 papers from quantitative studies. The CASP evaluation results showed that the overall quality of the included studies was high, and the quality of the English studies was higher than that of the Chinese studies. The thematic synthesis method resulted in 22 question entries in 7 categories. The 7 categories of questions included title, abstract, preface, methods, results, discussion and other report specification questions. The 22 entries included "Is there a need to report specific types of acupuncture therapy", "Is there a need to report based on the type of original study and its number", etc. ConclusionThere are many problems with reporting norms in existing acupuncture studies, so it is necessary to collate and summarize the key issues of reporting norms for acupuncture network meta-analysis to provide a scientific and theoretical basis for the development of reporting guidelines for acupuncture network meta-analysis.
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.
