Background As part of the core outcome set (COS), the core traditional Chinese medicine (TCM) syndrome set can improve the consistency of syndrome efficacy evaluation outcomes in TCM clinical research. Previous studies proposed and empirically verified a method of developing core TCM syndrome sets based on complex syndromes under the disease-syndrome combination research model. However, this method is developed on the basis of syndrome types, which has the limitation that the finally included syndrome types are too single to adapt to the complexity of clinical syndromes. Therefore, it is urgent to optimize the existing development method to balance the complexity of clinical syndromes and methodological feasibility. Methods This study adopted qualitative research methods to obtain opinions from TCM clinicians and researchers on developing methods, efficacy evaluation criteria, and construction forms through expert steering committee meetings and semi-structured interviews. The sample size of semi-structured interviews was determined until data saturation was reached, and thematic analysis was used to analyze the transcription results. Results In the expert steering committee meeting, 60% (3/5) of the experts believed that developing in the form of syndrome elements was more operable; in the semi-structured interviews, 77.78% (7/9) of the experts supported developing in the form of syndrome elements, considering it convenient to use. Meanwhile, the research team added an expert semi-structured interview link in the development process, which complemented the cross-sectional survey used in previous studies to jointly improve the original list of TCM syndrome elements. Conclusion The method of developing core TCM syndrome sets based on syndrome elements formed in this study can consider clinical practice while improving the unity of TCM syndrome efficacy evaluation standards, which is helpful to promote the standardized development of TCM clinical research.
Evidence-based research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.
To investigate the shortsegment pedicle screw in treating degenerative L4 spondylolisthesis and the relationship of the preliminarily bending degree of the titanium rod with the lumbar lordosisangle, the slipping angle and the slipping percentage and to evaluate the clinical coincidence and curative effects of the preliminarilybent rod. MethodsFrom September 2005 to March 2007, 31 female patients (age, 40-70 years; average, 58.3 years) were admitted for surgical treatment of their L4 degenerative spondylolisthesis (MeyerdingⅠ°, Ⅱ°)． Their lumbar lordosis angle （x1）, slipping angle (x2), and slipping percentage (x3) were measured in the L4,5 segment before operation. During the operation, the titanium rod bent beforehand according to the corresponding standards was inserted. The angle of the bent rod (Y) was measured, and then the multiple linear regression equation was established. The regression equation was applied to the surgical treatment of the 30 patients.Results According to the criteria in the JOA scoring system, the 31 patients had scores of 8.300± 1.080 and 26.916±1.859 before operation and after operation, respectively. There was a significant difference between before operation and after operation（Plt;0.05）. The established multiple linear regression equation was as follows:Y=0.1390-0.327logx1+0.463x2+0.288x32．The operating time was 51.290±3.408 min in the 30 patients who underwent an insertion of the preliminarilybent rod during the operation; however, the operating time was 102.360±5.004 min in the 31 patients who underwent an insertion of the bent rod that was made based on experience during the previous operations. There was a significant difference in the operating time between the two kinds of the rods （Plt;0.05）. Estimated according to 90%, 95% and 99% of the areas under the normalcurve, the clinical coincidence rates in the preliminarily bending degrees of the titanium rod in the 30 patients were 80.00％，90.00％ and 96.67％, respectively.Conclusion The titanium rod that has been bent into a certain angle before operation according to the established criteria can definitely diminish its strain during operation and efficiently shorten the operating time．Thiskind of the titanium rod has a good coincidence in clinical application and can be effectively used in clinical practice.It is worth reference during the clinical operation.
ObjectiveTo investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.MethodsUsing hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.ResultsThe total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.ConclusionsThe number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
ObjectiveTo construct a strategy for classification of clinical research data security for real-world research, based on the features of clinical research data.MethodsBased on the laws, regulations, and data security classification method in relevant fields, the clinical research data was classified into five security levels. Then, the method was gradually perfected through three times of revisions, which followed the advice from experts who were experienced in many relative areas, such as clinical medicine, clinical research methodology, clinical research management, ethics, genetics and public health data application and management.ResultsExperts’ opinions gradually converged through several times of consultation. The clinical research data was finally classified into five security levels with explicit definition and security policy for each security level. Thirty-three data categories, which covered demographic information, clinical examination, diagnosis, treatment information, genetic information, health economics information, medical data and information on research processes that have been published, were included in the five security levels.ConclusionsSince there is an increasing trend of data scale and the data security classification and management are necessary to ensure the data security and appropriately utilization of data. The method of clinical research data classification proposed in this paper can provide beneficial references for the further improvement of data security in the future.
ObjectiveTo investigate the current situation of domestic registry studies, and to provide basis for future research.MethodsWorld Health Organization (WHO) registration platform, ClinicalTrials.gov registration platform and other registration platforms were searched to collect the registered registration studies in Mainland China from inception to July 31st, 2018. Two researchers collected and collated data, analyzed by descriptive statistical methods, and then python-igraph package in Python 3.5 was used to draw the network diagram.ResultsA total of 247 studies were retrieved, mainly for disease registry and pharmaceutical product registry. Cohort and case-series were the principally study design. The research focused on chronic diseases such as cardiovascular and cerebrovascular diseases, and research sites were based on the economically developed area, for example, Beijing, Shanghai and Guangdong. The network diagram of study design and disease system shows that cohort research design is widely used in the nervous system and circulatory system; the network diagram of the research sites and disease system found that Beijing mainly studied circulatory and nervous system diseases, Shanghai mainly studied circulatory system diseases, and Guangdong relatively studied more on nervous system and urinary system diseases.ConclusionThe increasing number of registry studies in China reflects the importance of long-term outcome assessment of diseases.
Objective To identify, describe, and evaluate the evidence of traditional Chinese medicine (TCM) interventions for cancer-related fatigue (CRF) using an evidence mapping approach. Methods The CNKI, WanFang Data, VIP, SinoMed, PubMed, Web of Science and Embase databases were electronically searched to collect studies on TCM interventions for CRF from inception to June 4, 2024. Evidence mapping was employed to present the characteristics of study populations, interventions, studies included in systematic review/meta-analysis (SR/MA), and conclusions. Results A total of 94 randomized controlled trials (RCT) and 17 SR/MA/network MA were included. The number of publications has shown an overall fluctuating upward trend in the past 15 years. The RCT included literature with a high focus on mixed cancers, involving a total of 51 TCM therapeutic measures, including 40 herbal treatments, 5 external TCM treatments, and 5 TCM integrative therapies. The outcome indicators were classified into 14 categories, with the most frequent ones being CRF scores, TCM syndrome scores, clinical efficacy, quality of life scores, immune function indicators, adverse event rates, and serum indicators. The SR/MA included 7-81 original studies with sample sizes of 551-7 547 cases, involving 5 intervention measures: herbal medicine (9 studies), moxibustion (3 studies), TCM injection (2 studies), moxibustion (2 studies), and acupuncture (1 study). The quality of RCT and SR/MA was generally low, and the evidence quality was low. Most studies showed that TCM interventions for CRF had potential efficacy, but there was still a lack of definitive clinical evidence. Conclusion The results suggest that TCM interventions for CRF have advantages but also problems. There is still a lack of high-quality research. More large-sample, multicenter RCT and high-quality SR/MA are needed to further explore the advantages of TCM interventions for CRF and provide strong support for the effectiveness and safety of TCM interventions for CRF.
In order to fully implement the ethical principles of biomedical researches and to better safeguard the legitimate rights and interests of the subjects, this paper begins from the research design and closely combines with the ethical practice of biomedical research review, seriously analyzes the key implementation points of the ethical free and compensation principles in biomedical research, including intervention study, random allocation, follow-up research and new medical techniques and so on, also will provide the beneficial reference for comprehensive formulation of enforcement regulation of ethics principle of biomedical research in the future.