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.
目的 提高胸心血管外科患者ICU转出交接班质量，避免护理差错和纠纷。 方法 2010年1月－6月，针对患者转运出现的问题，在查阅文献及专家咨询的情况下，设计制定胸心血管外科ICU患者转出交接单，对患者转出ICU时的病情、用药、并发症等信息进行完善，同时规范交接班签字手续。采用调查问卷方式，对交接单运用效果进行评价。 结果 转出交接单的应用，提高了病房护士对ICU护士交接班质量满意度，除“医嘱单正确执行”、“签字和药物交接班清楚”与运用前满意程度无差异外，其余条目满意程度均有所增加，增加率波动在3.7%～33.4%。 结论 转出交接单使用能够提高ICU患者术后转运交接质量，预防护理差错和纠纷，确保证患者安全。
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.
Antimicrobial peptides (AMPs) are a class of peptides widely existing in nature with broad-spectrum antimicrobial activity. It is considered as a new alternative to traditional antibiotics because of its unique mechanism of antimicrobial activity. The development and application of natural AMPs are limited due to their drawbacks such as low antimicrobial activity and unstable metabolism. Therefore, the design and optimization of derived peptides based on natural antimicrobial peptides have become recent research hotspots. In this paper, we focus on ribosomal AMPs and summarize the design and optimization strategies of some related derived peptides, which include reasonable primary structure modification, cyclization strategy and computer-aided strategy. We expect to provide ideas for the design and optimization of antimicrobial peptides and the development of anti-infective drugs through analysis and summary in this paper.
As one of the standard electrophysiological signals in the human body, the photoplethysmography contains detailed information about the blood microcirculation and has been commonly used in various medical scenarios, where the accurate detection of the pulse waveform and quantification of its morphological characteristics are essential steps. In this paper, a modular pulse wave preprocessing and analysis system is developed based on the principles of design patterns. The system designs each part of the preprocessing and analysis process as independent functional modules to be compatible and reusable. In addition, the detection process of the pulse waveform is improved, and a new waveform detection algorithm composed of screening-checking-deciding is proposed. It is verified that the algorithm has a practical design for each module, high accuracy of waveform recognition and high anti-interference capability. The modular pulse wave preprocessing and analysis software system developed in this paper can meet the individual preprocessing requirements for various pulse wave application studies under different platforms. The proposed novel algorithm with high accuracy also provides a new idea for the pulse wave analysis process.
In order to improve the understanding of pragmatic randomized controlled trial (pRCT), to promote high-quality implementation of such trials, and to provide technical guidance for researchers to conduct such trials scientifically, the working group of China REal world data and studies ALliance (ChinaREAL) hereby develop a technical guidance. The guidance provides technical specifications of pRCT in terms of the concept and scope of application, planning and study design, conduct, data management and quality control, statistical analysis, and ethical issues. It emphasizes that the trial sites and settings, patient population, interventions, controls, outcomes, follow-ups and other factors should be considered when planning and designing. Meanwhile, the guidance recommends that estimation of sample sizes for different types of trial designs should be based on individual pRCTs, and it also provides suggestions for data management, quality control, principles of statistical analysis, analysis requirements for each type of trial designs, and ethical considerations.
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 explore the technique of preoperative evaluation of video electroencephalography (VEEG) electrode fixation method.MethodsThe electrode fixation method was modified using a simple and easy-to-manufacture 3M decompression sticker designed by ourselves.ResultsUsing the modified electrode fixation method, compared with the traditional fixation method, the electrode displacement, shedding rate and pain score of the children were significantly lower (P<0.05). The incidence of skin pressure sore by traditional fixation method was 7.03%. The rate of improvement after release was 3.37%. Although it was not statistically significant, the incidence of pressure ulcers were reduced.ConclusionsEffectively reduce the adverse reactions such as electrode displacement, shedding, pain and skin pressure sore caused by wearing the electrode for a long time. It has the advantages of being simple, fast, safe, stable and humanized, and it is worthy of clinical promotion.