In order to mediate the contradiction between the high quantity and low quality of Traditional Chinese Medicine (TCM) clinical research, to avoid blind research and waste of resources, and to promote the benign development of TCM clinical research, we proposed carrying out health research priority setting on the TCM clinical research. This paper defined the main content of TCM clinical research and briefly introduced the research status of priority setting methods. We described a five-step process of the TCM priority setting research: setting the research scope and plan, establishing the working group, mapping the research field, identifying priority research areas, reporting, evaluating and updating the research. It is expected that this area will receive the attention of relevant researchers, policy makers and research funders.
Natural language processing (NLP) is the embodiment of computer intelligence in acquiring knowledge, understanding, processing and expressing consciously and actively. It is the scientific key to promoting the informatization of medical practice and research. This paper reviews the development history and research basis of NLP, and focuses on the current application of NLP and large language models in biomedicine and traditional Chinese medicine (TCM), including the intelligent reading, information extraction and feedback of medical texts and ancient books of TCM, as well as the construction of medical knowledge graph and question-answering system. NLP is the technical support to explore the treasure house of TCM, which is of great practical significance to further promote the development of efficient and high-quality core values of TCM and to improve the service capacity.
A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can also enhance the value of trials and reduce cost waste to some extent. Recently, Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed the COMET handbook (version 1.0). This handbook discussed the problems of COS research and made some recommendations. This paper interprets the COMET handbook (version 1.0) and analyses its insight on the construction of TCM clinical research COS, combined with the characteristics of TCM clinical research, in order to provide a reference for related researchers.
To solve the problems such as the incomplete and non-standard reporting outcomes in clinical trials, international methodologists have simultaneously launched guidelines for reporting outcomes in trial protocols and reports in 2022 on the basis of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the Consolidated Standards of Reporting Trials (CONSORT) statement 2010. The SPIRIT-Outcomes 2022 extension and CONSORT-Outcomes 2022 extension recommend outcome-specific reporting items should be included prospectively in trial protocols and reports, regardless of trial design or population. This paper introduces and interprets the two guidelines for reporting outcomes, and discusses their significance and enlightenment to the research in the field of traditional Chinese medicine. For example, using the outcome reporting guidelines will help clinical researchers comprehensively consider issues related to outcomes when reporting protocols or results, which may improve the quality of research design and reporting. For core outcome set, the five core elements of outcomes may help researchers extracting and analyzing outcomes, which will standardize research; the explanation of medical terminology in the outcome reporting guidelines will contribute to the improvement of methodology in the field of traditional Chinese medicine.
There are many problems in the selection of outcomes in clinical trials of traditional Chinese medicine (TCM), such as insufficient research on the applicability of outcomes, insufficient research of individualized outcomes for syndrome differentiation and treatment, incomplete selection methods for overall/comprehensive evaluation outcomes, lack of evidence in the importance of outcomes for researchers, and insufficient reflection of the humanistic value of outcomes. Although the core outcome sets (COS) may help clinical trialists to select outcomes to a certain extent, the COS has not been widely used at present, and the judgment of the importance of the outcomes in the COS is mainly based on the personal experience of the participants. The lack of methodology will also lead to multiple COS in the same disease area. The authors believe that it is necessary to improve the methodology of outcomes research, especially in the development of COS. Developing evidence and humanistic values framework may be a potential way to help researchers select core outcomes in clinical efficacy evaluation of TCM.
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.
It is crucial to select outcomes in clinical trials. Appropriate outcomes can improve value and significance of trials and reduce the cost of investment. This paper describes how to develop core outcome sets and core outcome measurement instrument sets with the theory of mixed methods research, so as to standardize the choice of outcomes and outcome measurement instruments in clinical trials.
Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.
Core outcome set (COS) is an agreed and minimal set of outcomes that should be measured and reported in all clinical trials in specific areas of health or healthcare, which can reduce the heterogeneity of outcomes in similar clinical trials, so that much more trials can merge in systematic reviews. Meanwhile, using COS may be easy to identify potential selective reporting bias in clinical trials. The research of COS has been developed for more than 30 years in western countries. At present there are much more researchers focusing on this area in China. However the status and progress of COS remain unclear. This paper reviewed the quantity of COS, the disease distributions of COS, the geographical locations involved in the development of COS, as well as the methodological progress of COS, so as to clarify the general situation of COS.
The Core Outcome Measures in Effectiveness Trials (COMET) Working Group has published a series of research and reporting guidelines related to core outcome sets since it was established. This article introduces and interprets the Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement which is developed by the COMET and published in February 2019. It will then be compared with Core Outcome Set-STAndards for Reporting (COS-STAR) and Core Outcome Set-STAndards for Development (COS-STAD), which have been introduced to China. The significance of these guidelines for the development of core outcomes in the field of traditional Chinese medicine is discussed, so as tp draw researchers' attention to this area.