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.
Dose-response meta-analysis (DRMA) is one of the branches of meta-analysis, which has provided important evidence for clinical research. Since introducing into China, it has gained great attention. In order to improve the reporting quality of DRMA, Dr. Chang Xu et al. developed the reporting guideline for DAMA——G-Dose Checklist. It was published in Chinese Jouranl of Evidence-based Medicine in 2016. This paper interprets the checklists so as to promote the understanding and use of it.
N-of-1 trials are prospective clinical randomized cross-over controlled trials with multiple rounds of trial phase alternation designed with regard to a single patient. N-of-1 trials can provide clinical decision-makers with high-level evidence of the comparison of effect of intervention measures. Recently, an international team composed of many scholars published a SPIRIT extension for N-of-1 trials list (SPENT 2019) on the BMJ, with the purposes of clarifying the content design and improving the integrity and transparency of N-of-1 trial protocols. This article showed a detailed interpretation of the 14 main extension sub-items of the SPENT 2019 list with specific cases, aiming to further standardize the publication of domestic N-of-1 trials.
Clinical prediction models typically utilize a combination of multiple variables to predict individual health outcomes. However, multiple prediction models for the same outcome often exist, making it challenging to determine the suitable model for guiding clinical practice. In recent years, an increasing number of studies have evaluated and summarized prediction models using the systematic review/meta-analysis method. However, they often report poorly on critical information. To enhance the reporting quality of systematic reviews/meta-analyses of prediction models, foreign scholars published the TRIPOD-SRMA reporting guideline in BMJ in March 2023. As the number of such systematic reviews/meta-analyses is increasing rapidly domestically, this paper interprets the reporting guideline with a published example. This study aims to assist domestic scholars in better understanding and applying this reporting guideline, ultimately improving the overall quality of relevant research.
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.
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.
To standardize and improve the reporting quality of implementation studies, BMJ published the standards for reporting implementation studies (StaRI). This paper introduces the background and process of StaRI development, and interprets the core content of StaRI. It is expected that StaRI will provide support for domestic researchers to carry out implementation studies and writing implementation research 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.
In recent years, the number of randomized controlled trials using cohorts and routinely collected data (e.g., electronic health records, administrative databases, and health registries) has increased. Such trials can ease the challenges of conducting research and save cost and time. Accordingly, to standardize such trials and increase the transparency and completeness of research reports, an international panel of experts developed the CONSORT-ROUTINE (2021) reporting guideline. The reporting guideline was published in 2021 in the BMJ. To help understand and formally apply the reporting guideline and improve the overall quality of this type of study, the present paper introduced and interpreted the development process and reporting checklist of the CONSORT-ROUTINE.