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.
Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.
ObjectiveTo systematically review the effect of compound Danshen dripping pills combined with Western medicine on inflammatory factors and cardiac function after percutaneous coronary intervention (PCI) in patients with acute myocardial infarction.MethodsDatabases including CNKI, WanFang Data, VIP, CBM, PubMed, Web of Science, EMbase and The Cochrane Library were searched for randomized controlled trials of compound Danshen dripping pills combined with Western medicine in the treatment of acute myocardial infarction after PCI. The retrieval time was from the establishment of the databases to June 11th, 2020. Two reviewers independently screened literature, extracted data and evaluated the risk bias of included studies. RevMan 5.3 software was used for meta-analysis.ResultsA total of 16 studies were included, involving 2 069 patients. The results of the meta-analysis showed that the combination of compound Danshen dripping pills could increase the left ventricular ejection fraction (MD =−4.74, 95%CI 4.07 to 5.42, P<0.01), decrease the B-type natriuretic peptide (SMD=−3.81, 95%CI −5.06 to −2.57, P<0.01), the level of interleukin-6 (SMD=−3.20, 95%CI −4.54 to −1.86, P<0.01) and level of tumor necrosis factor-a (SMD=−4.96, 95%CI −7.03 to −2.89, P<0.01).ConclusionsCurrent evidence suggests that the combination of compound Danshen dropping pills has potential benefits in inhibiting inflammation and improving cardiac function after PCI. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
Sharing clinical trial data can increase the transparency of clinical trials and improve the its authenticity. The current requirements of clinical research data transparency is not fully adequate, and it is still difficult to create an environment in which the sharing of the clinical trial data becomes the norm. The article analyzed various concerns on data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, and looking forward to minimize the risks and maximize the benefits of data sharing.
Evidence produced by clinical trial is the main basis for health care decision-making at all levels. In recent years, some problems been revealed in the national data audit of new drug clinical trials have sounded the alarm for the quality of clinical research in China. In addition to strengthening the implementation of clinical trial process management and supervision, we call attention to the coherence and consistency of trial design and implementation, including the promotion of clinical trial design in the agenda of improving the quality of the trials and putting forward reasonable suggestions. We hope that our work could make research ideas clear from the source of a clinical trial, with a view to avoid violating protocol behavior and provide standardized recommendations for improving the quality of clinical trials in China.
Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate the researcher compliance is the key problem in clinical research. Based on the current situation of poor compliance of clinical researchers, this paper summaried the information of five different dimensions that affects the researcher compliance in clinical research, clarified the relevant factors that may affect the researcher compliance in the process of clinical research, and analyzed the influence of the factors related to the researcher compliance on the quality control of clinical research, hence establishing a foundation for further research on control strategies and evaluation techniques of researcher compliance.
Scientism and humanism are two main views on the development of medicine, which run through both theory and practice. Under the guidance of the modern medical concept of " bio-psycho-social”, the views of scientism and humanism on medicine have reached an unprecedented level of development and integration, which jointly determine the connotations and demands of current medicine. As one of the current mainstream medical models, evidence-based medicine (EBM) has played an important role in the management of current medical theories and practices. Meanwhile, EBM has also encompassed views of scientism and humanism in its own development and has successfully shaped the knowledge and methodological system. EBM will continue to gain insight into the characteristics of views of scientism and humanism in the future of medicine to improve itself and should pay more attention to the development of humanism view. As an important branch discipline of EBM, evidence-based Chinese medicine may become a model of the perfect combination of scientism view and humanism view.
Evidence-based medicine (EBM) provides a reliable evidence decision-making model for the medical field. The concepts and methods of EBM are gradually extended to other disciplines. At present, the paradigm of evidence-based science (EBS) is formally proposed, which is not only based on a methodological cooperation between different disciplines, but also a deeper potential driving force in optimizing the operation process of knowledge. The advantages of EBS helps promote its extension to other disciplines through standardization concepts and systematic methods, through which the common theories and supporting organization of EBS are formed. Under the guideline of EBS, the evidence-based concepts and methods will play a supportive role in scientific development.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.