ObjectiveTo compare drug clinical trials between China, the United States, Europe and Japan in terms of study type, design, completion and results publication.MethodsWe randomly selected 190 clinical trials that were registered in ClinicalTrials.gov from 2009 to 2014, and followed up to December 31st, 2019. Comparisons were made for the type of sponsor, phase, design, and completion status by the sponsor’s country.ResultsAmong all included clinical trials, trials from the United States, Europe, Japan and China accounted for 50.5%, 34.2%, 9.0% and 6.3%, respectively. Among these trials, 71.1% had been completed and 69.5% disclosed results had been published publicly prior to the end of follow-up, and differences between countries were statistically significant (P<0.05). Two-thirds of the trials in China were phase Ⅲ/Ⅳ trials; in contrast, most of the clinical trials in the United States and Europe were phase Ⅰ/Ⅱ trials. The proportion of using double-blind, randomized controlled trial design was the highest in the United States (46.9%) and the lowest in China (8.3%). Chinese sponsors were mostly hospitals/universities (58.3%), while in other countries drug trials were mostly sponsored by the industry and in Japan the proportion was as high as 94.0%.ConclusionsThe number of drug trials registered in ClinicalTrials.gov from China is small and these trials are less likely to be completed and have results published/disclosed. Pharmaceutical companies in China should pay more attention to the public registration of their clinical trials, particularly those in early phases, and improve trial design and management.
Objective To design a new custom-made artificial semi-knee joint based on rapid prototyping(RP) technique and to explore a method to solve necroses of allocartilage in hemi-joint allotransplantation. Methods Based on the extracted 3D contour image of the articular cartilage of femoral condyle, the custom-made artificial semi-knee joint was designed with Surfacer 9.0 image processingsoftware. The artificial semi-knee joint design used the femoral condylar 3D contour of the patient as the outer face and the subchondral bone 3D contour of allograft bone as inner face. One dado for medullary nailand two for special designing cages which were used to fix the cartilage into the allograft were added on the inner face. After being converted into RP data format, the computerassisted design was imported into the LPS600 rapid prototyping machine, and the prototype was achieved. Furthermore, the prototype could be modified by hand according to the design. Then the RP model was used as a positive mould to build up a silica gel negativemould, and the negative mould was sent to the factory to manufacture Ti-6Al-4V alloy articular cartilage through ordinary mould-melted founding process. Finally, the whole metal cartilage was completed after melting two special cages on it andpolishing it. Results A new custom-made artificial semi-knee joint was made ad used to treat a 14-year old patient. The custom-made artificial semi-knee joint and the subchondral bone were a perfect match. The operative result was satisfactory. The patient could walk 5 weeks after operation. The bone healing of the auto-bone and allo-bone was achieved 6 months later. A follow-up period lasting 1 yearshowed that the knee joint played a good function. Conclusion The artificial semi-knee joint is a good match for the allograft boneand a good idea to solve necroses of allocartilage in hemijoint allotransplantation.
ObjectiveTo introduce a self-designed adjustable operation frame and explore the feasibility and safety in the treatment of severe kyphosis secondary to ankylosing spondylitis with posterior osteotomy.MethodsBetween March 2016 and May 2018, 7 cases of severe kyphosis secondary to ankylosing spondylitis were treated with posterior osteotomy using self-designed adjustable operation frame with prone position. There were 5 males and 2 females with an average age of 49.4 years (range, 40-55 years). The disease duration was 10-21 years (mean, 16.7 years). The apical vertebrae of kyphosis were located at T11 in 2 cases, T12 in 1 case, L1 in 1 case, and L2 in 3 cases. Among the 7 cases, 2 were classified as typeⅠ, 4 as type ⅡB, and 1 as type ⅢA according to 301 classification system. There was no neurological deficit of all cases; but 1 case suffered bilateral hip joints ankylosed in non-functional position. The parameters of chin-brow vertical angle (CBVA), global kyphosis (GK), thoracolumbar kyphosis (TLK), lumbar lordosis (LL), sagittal vertical axis (SVA) were measured; and the operation time, the intraoperative blood loss, and the complications were also collected and analyzed.ResultsAll operations completed successfully. The operation time was 310-545 minutes (mean, 409.7 minutes) and the intraoperative blood loss was 1 500-2 500 mL (mean, 1 642.9 mL). There were 2 cases treated with one-level osteotomy of sagittal translation, 1 case of radiculopathy symptom of L3, and 3 cases of tension of abdominal skin. All patients were followed up 20-35 months (mean, 27.9 months). There were significant differences in CBVA, GK, TLK, LL, and SVA between pre- and post-operation (P<0.05); but no significant difference between 1 week after operation and last follow-up (P>0.05). All the osteotomies and bone grafts fused well and no complications of loosening and breakage of internal fixator occurred during the follow-up.ConclusionIn the posterior osteotomy for correction of severe kyphosis secondary to ankylosing spondylitis, the self-designed adjustable operation frame is convenient for the patient to be placed in prone position. It is safe, feasible, and effective to perform osteotomy correction with the aid of the self-designed adjustable operation frame.
Objective To explore the therapeutic effect of rehabilitation therapy combined with computer-aided design and computer-aided manufacture (CAD/CAM) of orthopedic insoles on deputy scaphoid inflammation. Methods We selected the patients with deputy scaphoid inflammation who had treated in Sichuan Province Orthopedic Hospital between July 2018 and February 2020. The patients were randomly divided into control group and experimental group by drawing lots. The control group received rehabilitation therapy, while the experimental group received rehabilitation therapy combined with CAD/CAM orthopedic insoles. The clinical efficacy was tested at the 5th and 12th weeks after treatment, and the foot pain was assessed by Visual Analogue Scoring (VAS), and the foot function was assessed by the American Orthopaedic Foot and Ankle Association (AOFAS) scale. Results A total of 78 patients were included, and 3 patients dropped out. There was no significant difference in sex, age, weight or course of disease between the two groups (P>0.05). Before treatment, there was no statistically significant difference in VAS score (t=0.329, P=0.743) or AOFAS score (t=0.431, P=0.668) between the two groups. At the 5th and 12th weeks after treatment, the VAS score of the experimental group was lower than that of the control group (t=4.517, 5.299; P<0.001), and the AOFAS score was higher than that of the control group (t=6.239, 5.779; P<0.001). Over time, the VAS score of the two groups decreased (P<0.05), while the AOFAS score increased (P<0.05). Conclusion Rehabilitation therapy combined with CAD/CAM of orthopedic insoles have better curative effect than traditional rehabilitation therapy for deputy scaphoid inflammation.
For the transportation process of rescuing wounded personnel on naval vessels, a new type of shoulder type exoskeleton stretcher for individual soldier was designed in this paper. The three-dimensional model of the shoulder type exoskeleton stretcher for individual soldier was constructed using three dimensional modeling software. Finite element analysis technique was employed to conduct statics simulation, modal analysis, and transient dynamics analysis on the designed exoskeleton stretcher. The results show that the maximum stress of the exoskeleton stretcher for walking on flat ground is 265.55 MPa, which is lower than the allowable strength of the fabrication material. Furthermore, the overall deformation of the structure is small. Modal analysis reveals that the natural frequency range of the exoskeleton stretcher under different gait conditions is 1.96 Hz to 28.70 Hz, which differs significantly from the swing frequency of 1 Hz during walking. This indicates that the designed structure can effectively avoid resonance. The transient dynamics analysis results show that the maximum deformation and stress of exoskeleton stretcher remain within the safety range, which meets the expected performance requirements. In summary, the shoulder type exoskeleton stretcher for individual soldier designed in this study can solve the problem of requiring more than 2 people to carry for the existing stretcher, especially suitable for narrow spaces of naval vessels. The research results of this paper can provide a new solution for the rescue of wounded personnel on naval vessels.
Network meta-analysis (NMA) is a statistical technique that integrates data from multiple clinical studies and compares the efficacy and safety of multiple interventions, which can provide pro and con ranking results for all intervention options in the evidence network and provide direct evidence support for clinical decision-making. At present, NMA is usually based on the aggregation of the same type of data set, and there are still methodological and software difficulties in achieving cross-study design and cross-data format data set merging. The crossnma package of R programming language is based on Bayesian framework and Markov chain Monte Carlo algorithm, extending the three-level hierarchical model to the standard NMA data model to achieve differential merging of varied data types. The crossnma package fully considers the impact of risk bias caused by the combination of different types of data on the results by introducing model variables. In addition, the package provides functions such as result output and easy graphing, which makes it possible to combine NMA across study designs and evidence across data formats. In this study, the model based on crossnma package method and software operation will be demonstrated and explained through the examples of four individual participant datasets and two aggregate datasets.
Objective To optimize the medical humanities training course in postgraduate medical education. Methods From 2018 to 2020, based on instructional system design (ISD) model of the “analyze-design-exploit-implement-assess” 5 steps, the current situation and existing problems were analyzed through literature review, and the postgraduate trainees’ cognitions and demands for the training course were surveyed. According to the content of the questionnaire, the curriculum was designed and implemented, and the curriculum satisfaction survey was conducted. Results A total of 532 postgraduate trainees participated in the cognitions and demands questionnaire survey, and the postgraduate trainees had high demands for humanistic training courses (88.53%). A total of 827 postgraduate trainees participated in the curriculum satisfaction survey. The trainees’ satisfaction to the training courses was more than 90%. Conclusion The medical humanities training courses based on ISD model get good results, which can provide a useful reference for the curriculum design of medical humanities education in each stage.
Observational studies based on real-world data are providing increasing amount of evidence for evaluating therapeutic outcomes, which is important for timely decision-making. Although time and costs for data collection could be saved using real-world data, it is significantly more complex to design real world researches with lower risk of bias. In order to enhance the validity of causal inference and to reduce potential risk of bias in real world studies, the Working Group of China Real world data and studies Alliance (China REAL) has formulated recommendations for designing observational studies to evaluate therapeutic outcomes based on real-world data. This guidance introduces design types commonly used in real world research; recommends key elements to consider in observational studies, including sample selection, specifying and allocating exposures, defining study entry and endpoints, and pre-designing statistical analysis protocols; and summarizes potential biases and corresponding control measures in real-world studies. These recommendations introduces key elements in designing observational studies using real-world data, for the purpose of improving the validity of causal inference. However, the application scope of these recommendations may be limited and warrant constant improvement.
ObjectiveTo provide a reference for the implementation of risk management in other medical institutions by introducing the practical experience of building a medical risk management system in West China Hospital of Sichuan University.MethodsBased on Donabedian’s SPO model, the practical experience in the construction of West China Hospital of Sichuan University was summarized from the aspects of structure, process, and results.ResultsThe establishment of medical risk management system made the hospital adverse event management effect good, and the risk management indicators were good. The average number of medical disputes in hospitals from 2016 to 2018 was 103.33, the average number of medical disputes per 100 medical practitioners was 7.01, the average number of medical disputes per 10 000 surgical cases was 6.55, and the average number of medical disputes per 10 000 cases was 0.18.ConclusionThe construction of medical risk management system is conducive to enhancing the awareness of medical risk prevention among medical institutions, continuously improving the quality of medical care and medical safety of hospitals, ensuring patient safety, promoting harmony between doctors and patients, and promoting the realization of healthy China.
The use of clinical predictive modeling to guide clinical decision-making and thus provide accurate diagnosis and treatment services for patients has become a clinical consensus and trend. However, the models available for clinical use are more limited due to unstandardised research methods and poor quality of evidence. This paper introduces the development process of clinical prediction models from six aspects, data collection, model development, performance evaluation, model validation, model presentation and model updating, as well as the clinical prediction model research report statement and risk of bias assessment tools in order to provide methodological references for domestic researchers.