Compared with traditional medical devices, artificial intelligence medical devices face greater challenges in the process of clinical trials due to their related characteristics of artificial intelligence technology. This paper focused on the challenges and risks in each stage of clinical trials on artificial intelligence medical devices for assisted diagnosis, and put forward corresponding coping strategies, with the aim to provide references for the performance of high-quality clinical trials on artificial intelligence medical devices and shorten the research period in China.
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.
The data collection form is a bridge in-between the original studies and the final systematic reviews. It’s the basis for data analyses, directly related to the results and conclusions of systematic reviews, and plays an important role in systematic reviews. There are strict requirements of data collection forms in making Cochrane systematic reviews. In this article, the authors introduce their experiences regarding to the design of data collection form.
【Abstract】 Objective To study the shoulder anatomy characteristics of the Chinese people and to design a newkind of humeral prosthesis, which could real ize the adjustment in three-dimensional space and be adjusted repeatedly, based on Chinese humeral anatomy characteristics. Methods A double-gear structure as a rotating part was adopted to design the structure of this new kind humeral prosthesis. Results The humeral prosthesis could satisfy both the needs of Chinese individual shoulder characteristics and the Westerners’ demands. Conclusion A novel concept of shoulder prosthesis design with a b appl ication value in design and development of the new prosthesis is proposed.
N-of-1 trial design offers a methodologically sound approach to determining optimum treatment for an individual patient and solves some limitations of randomized controlled trials. This design could offer an efficient method of reaching a personal treatment regime tailored to suit individual needs and preferences. The paper introduces practical application, objects and the implementation process of N-of-1 trial, to explore its design points and implementation.
With the encouragement of national policy on drug and medical device innovation, multi-center clinical trials and multi-regional clinical trials are facing an unprecedented opportunity in China. Trials with a multi-center design are far more common at present than before. However, it should be recognized there still exists shortcomings in current multi-center trials. In this paper, we summarize the problems and challenges and provide corresponding resolutions with the aim to reduce heterogeneity between study centers and avoid excessive center effects in treatment. It is urgent to develop design, implementation and reporting guidelines to improve the overall quality of multi-center clinical trials.
Simulation-based medical education is becoming increasingly common. In this paper, the status and goal of SBME development is analyzed after a brief introduction of SBME. Secondly, the essentiality and possibility of bringing SBME to a situated paradigm are clarified, because there are rich implications for situated cognition as the theory foundation of SBME. As a main discussion point, eight practical situated designing principles for SBME in theoretical and practical contexts are then expounded. Finally, a specific attitude toward the relationship between theory and practice for the SBME teachers is also elucidated.
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.
Health Technology Assessment International (HTAi), in conjunction with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), initiated a joint Task Force and published guideline and a checklist for deliberative processes for health technology assessment (HTA). Currently, there is a lack of guidance for designing and implementing deliberative processes of HTA in China, so this paper performs a detailed interpretation of the guideline and checklist, with a view to providing a reference for China's HTA and deliberative process, in order to promote the dissemination and application of the HTA methodology, and advance the construction of domestic HTA deliberative processes capacity and institutional mechanism.
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.