The method of evaluating clinical efficacy of traditional Chinese medicine is one of the hotspots in the field of traditional Chinese medicine in recent years. How to dynamically evaluate individual efficacy is one of the key scientific problems to explain the clinical efficacy of traditional Chinese medicine. At present, there are no recognized methods of evaluating individual efficacy of traditional Chinese medicine. In this study, we provided a method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials after analyzing the current status of researches on methods of evaluating individual efficacy of traditional Chinese medicine. This method has the advantages of both N-of-1 trials and Bayesian multilevel models. It is feasible to evaluate individual efficacy of traditional Chinese medicine from the perspective of the design and analysis method. This study can provide an important basis for enriching and improving the methodology of evaluating individual efficacy of traditional Chinese medicine.
Recently, the increasing risk of drug development has impelled pharmaceutical enterprises to improve ways of research and exploitation. Adaptive design has been proposed for decades. Although the theory of this design is not perfect, it has been recognized and applied worldwide as a decreasing risk of drug development to a certain extent. The traditional fixed design in western medicine isn’t entirely suitable for traditional Chinese medicine (TCM), while the adaptive design with integrity and variability features provides a new idea for TCM development. Hereby the application of adaptive design in TCM is regarded as an important procedure for promoting TCM modernization, and it has a wide prospective.
ObjectiveUsing SYRCLE tool (the SYstematic Review Centre for Laboratory animal Experimentation) to evaluate the risk of bias of animal studies in stroke field published in Chinese journals, identify problems of these studies in design, implementation and measurement, in order to provide references for improving the quality of animal studies in China. MethodsWe searched databases including CBM, VIP, CNKI and WanFang Data from inception to December 31st, 2014. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included animal studies using SYRCLE tool developed by the National Centre for the Replacement, Refinement and Reduction of Animals in Research. ResultsA total of 582 studies were included. The assessment results showed that the number of reported items with "Low Risk" in SYRCLE, which have 22 items, reported in >50% of the 4 items and in <30% the 16 items in articles of animals experiments. More than 99% of the studies fulfilled the 3 items and more than 17% of the articles to meet the 10 items while less than 1% of the documents met the 17 items. The quality of studies increased excepted the period of 2010 to 2014. The methodological quality of animal experiments presented a trend of increasing and no significant differences were found in CSCD indexed or not. ConclusionThe methodological quality of animal experiments of stroke is poor in China in terms of the selection bias, implementation bias, measurement bias, withdraw bias and reporting bias.
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.
The two factors that affect enrollment of participants and the process of intervention in randomizedcontrolled pragmatic trials are similar to the situation of clinical practice, thus its effects are similar to the situation ofclinical practice. Therefore, when one estimates an intervention’s effect on a patient, it will be more similar to a real clinicalsituation than results taken from an explanatory trial. Due to the introduction of interventions and process variables usedin a pragmatic trial that conform to traditional Chinese medicine and acupuncture practices, more and more interest isgrowing among researchers in the traditional Chinese medicine field. This article introduces the principles and conceptsof the pragmatic trial, and the key points of design via some samples.
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.
Data management system is a major factor affecting the quality of clinical trial. Development of data management system include a steering group and data safety and monitoring board, data collection, database, performance of the data safety and monitoring, as well as locking of database. This article provides key issues of the five parts so as to help researchers understand the clinical trial data management system.
Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in three aspects including providing evidence, research design and execution. In addition, data analysis facilitated generating efficient and robust evidence which was in support of decision making. Finally, some enlightenment may be offered for Traditional Chinese Medicine evaluation methods based on the synergies of both study types.