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.
This article introduces a dynamical stratified blocked randomized algorithm when the static stratified blocked randomized algorithm is not suitable to resolve the problem caused by uncertain stratified factors and levels during calculation of the sample size at the stage of clinical trial design. Prior to the start of the clinical trial, a list of random numbers is created by blocked randomized algorithm. During field implementation, a block of random numbers is dynamically allocated to a stratify level. Thereafter, a subject is randomized into different groups in that block. The study of Chinese medicine for gastric cancer anemia and blood hypercoagulability is used as an example to illustrate how to design and implement dynamic stratified block randomized algorithm. The results show that the dynamic stratified block randomized algorithm is more flexible and adaptable than the static stratified blocked randomized algorithm. However, its application is more complex and requires higher standards in clinical trials.
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.
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.
In recent years, clinical research shows the trend of globalization. Due to characteristics of the huge number and relative concentration of patients, the wide variety of diseases, a high patient enrolment rate, lower trials costs, and so on, China and India become a focus of this trend. However, China and India also have their own advantages in the aspects of diseases, infrastructure, policies, regulations, regulatory environment, language, and culture. The key question to address is: how to increase the shares in the trial market in the future and to enhance the international status of China’s clinical research? Before we answer this question, we must understand the present situations of clinical research resources in China and India. So, we searched the relevant literature at home and abroad by computer and hand to analyze advantages and efficiency of clinical research resources in China and India.
Repeated measurement quantitative data is a common data type in clinical studies, and is frequently utilized to assess the therapeutic effects of the intervention measures at a single time point in clinical trials. This study clarifies the concepts and calculation methods for sample size estimation of repeated measurement quantitative data, in order to explore the research question of "comparing group differences at a single time point", from three perspectives: the primary research questions in clinical studies, the main statistical analysis methods and the definitions of the primary outcome indicators. Discrepancies in sample sizes calculated by various methods under different correlation coefficients and varying numbers of repeated measurements were examined. The study revealed that the sample size calculation method based on the mixed-effects model or generalized estimating equations accounts for both the correlation coefficient and the number of repeated measurements, resulting in the smallest estimated sample size. Secondly, the sample size calculation method based on covariance analysis considers the correlation coefficient and produces a smaller estimated sample size than the t-test. The t-test based sample size calculation method requires an appropriate approach to be selected according to the definition of the primary outcome measure. The alignment between the sample size calculation method, the statistical analysis method and the definition of the primary outcome measure is essential to avoid the risk of overestimation or underestimation of the required sample size.
ObjectiveTo systematically review the application status of Delphi method in clinical research of traditional Chinese medicine (TCM).MethodsPubMed, EMbase, CNKI, WanFang Data and VIP databases were electronically searched to collect original research and methodological research on Delphi method in TCM from inception to August 30th, 2020. Two reviewers independently screened literature, extracted data, and then, descriptive analysis was performed by using qualitative methods.ResultsA total of 612 articles involving 573 original studies and 39 methodological studies were included, which involved 167 types of diseases. The primary research purposes were disease diagnosis and treatment, syndrome research, scale development, evaluation research, index research, clinical investigation, methodology research, and other 8 categories. 487 papers reported the implementation process and results of Delphi method in varying degrees.ConclusionsDelphi method is widely used in clinical research of TCM, however, there are deficiencies in the specific implementation process.
Stem cell transplantation is one of the main methods to treat thromboangiitis obliterans (TAO). In recent years, research on the treatment mechanism of stem cell transplantation has made some progress. The results of a number of stem cell clinical trials specifically for TAO have been published. Some new stem cell types have gradually been used in the clinic. There is no major dispute over security. In addition, research shows that the efficacy of stem cell transplantation is affected in many ways, and some factors have a certain predictive effect on the possibility of amputation after transplantation. This paper reviews the clinical research progress of stem cell transplantation for TAO, and aims to provide some basis for the better use of stem cell transplantation in the treatment of TAO.
This article reviewed other literatures in the quality management of clinical trials and summarized author’s experience in quality control of clinical trials which the author conducted as principle investigator over the past years. It provides a reference for fresh investigators before they conduct their own clinical trials.