The prevention and control of chronic diseases is a major need that urgently needs to be solved in China. Traditional Chinese medicine has unique advantages in preventing and treating chronic diseases. However, insufficient patient engagement may be found in the selection and evaluation of traditional Chinese medicine for the prevention and treatment of chronic diseases. In recent years, patient-centered clinical research has become a hot topic. A patient-centered methodological framework is proposed for the selection and evaluation of traditional Chinese medicine for preventing and treating chronic diseases. It incorporates some patient-centered studies based on the evidence-based medicine practice model, and will provide a scientific basis for screening traditional Chinese medicine for preventing and treating chronic diseases, improving the efficiency of traditional Chinese medicine services, improving price policies, and updating medical insurance catalogs.
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.
SUMSearch and TRIP database are meta search engines for searching clinical evidence. This article introduces major contents and search methods of the SUMSearch and TRIP database, so as to provide quick search resources and technical help for evidence-based practice.
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.
N-of-1 trial design offers a methodologically sound approach to determining optimum treatment for an individual patient and solves some limitations of randomized controlled trials. This design could offer an efficient method of reaching a personal treatment regime tailored to suit individual needs and preferences. The paper introduces practical application, objects and the implementation process of N-of-1 trial, to explore its design points and implementation.
Traditional Chinese medicine (TCM) has some unique advantages in the prevention and treatment of cancer. Due to different ideas and mechanism of between TCM and biomedicine in the prevention and treatment of cancer, the clinial effect evaluation approches of biomedicine could not be used as a beneficial method to scientifically evaluate the effects of TCM. From three angles, this article analyzes the key issues regardsing the evaluation methods of TCM as an adjuvant therapy of cancer. It draws lessons from the idea of quality-adjusted survival (QAS), proposes Two-in-One (TIO) method to evaluate the effects of TCM as adjuvant therapy of cancer, which reflects the combined value of the individual patient dynamic information and provides methodological support for the effect evaluation of TCM.
It is potential for N-of-1 trials to evaluate economics of health care, however, it is still in the exploratory stage. With the advantage of accurate estimation of costs and effects, it is beneficial to promote the application of N-of-1 trials for economic evaluation in the era of precision medicine. In this study, we introduce the necessity, feasibility, selection, calculation of indicators and influence factors of N-of-1 trials for economic evaluation, and in order to provide references for researchers to perform related studies.
The study appeared the comparison between CONSORT and CENT, and promoted the combination with GRADE and N-of-1 trial. Our objective is to further develop the method of N-of-1 trial and to widely use it in clinical researches of some diseases.
An N-of-1 trial was conducted in a single patient. Statistical analysis is one of the most important parts of N-of-1 trials. The methods of statistical analysis for N-of-1 trials were reported in some reviews. However, there was still a lack of comparative analysis of these methods. In this study, we introduced the characteristics of statistical methods commonly used as well as some statistical problems which should be paid attention in N-of-1 trials. It is useful to provide some reference for statistical methods in order to high quality N-of-1 trials.
Bayesian N-of-1 trials is increasingly popular in recent years. This study introduced the principle, statistical requirements, application status, advantages and disadvantages of Bayesian N-of-1 trials. Although the application of Bayesian N-of-1 trials is still limited in small scale and some problems remain to be solved, but it can provide more posterior information, and it can be the most important type of N-of 1 trial in future.