High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
Statistical graph is an indispensable part of scientific papers. It is helpful to promote the communication, dissemination, and application of academic achievements by presenting research results intuitively and accurately through standardized and beautiful visual graphs. The safety of a medical intervention is the basic premise of its clinical application, and randomized controlled trial (RCT) as an important design to determine the efficacy and safety of medical interventions, it is extremely important to accurately present the information on the safety outcomes of interventions found therein. However, the research found that the reports of RCTs didn’t adequately use visual graphs to present harms data. In order to promote clinical researchers to better use visual graphs to present harms data, international scholars recently published a consensus study in BMJ, which identified and recommended 10 statistical graphs for presenting harms data in RCTs. In order to facilitate domestic scholars to understand and apply the consensus, this article interprets the consensus and recommendations, and it is expected to provide help for improving the quality of harms visualization in domestic papers of RCTs.
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.