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.
Cluster randomized trial (CRT) is one of the most common design for complex intervention. This paper mainly introduced:the definition of CRT, two designs of CRT including the completely randomization and the restricted randomization (such as stratified randomization and matching randomization), and the statistical analysis methods (such as the general statistical analysis and mixed effect model/multi-level model). This paper also introduced how to estimate the sample size of a CRT, how to report a CRT, and how to apply it into a clinical or community study.
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.
This paper mainly introduces the design, advantages, disadvantages and its application of single case of randomized controlled trials (N-of-1 trials), and also introduces the commonly used data analysis methods of N-of-1 trials including nonparametric test and parameter test methods (t-test, paired t-test, analysis of variance), mixed-effects model, and meta-analysis. N-of-1 trials are suitable for individualized treatment, and could be expected to be widely used in the research of modern medicine and traditional Chinese medicine.
Objective To explore the effect of the intensive CT on the deep inferior epigastric perforator (DIEP) flap design strategy. Methods From June 2007 to March 2008, 7 patients received reconstructive operation of the vertical DIEP flap, among whom there were 5 females with congenital absence of vagina and 2 males with peno-scrotal Paget’s disease,aged 18-62 years old. Before the operation, the intensive CT scans were appl ied to all the petients in search for DIEP. The flaps were designed according to the radiological findings. The scrotum and penis defects were reconstructed in 2 cases and vaginal reconstruction was performed in 5 cases. The flap dimension ranged from 15 cm × 7 cm to 22 cm × 5 cm. The donor site was closed directly. Results A total of 10 ideal perforating branches of all the 7 DIEP flaps were found before the operation, with the diameter of over 1.5 mm. Of the 7 flaps, 4 had 1 perforating branch and the other 3 had 2 perforating branches. All 7 flaps survived completely. The incisions of 6 patients obtained heal ing by first intention. Only 1 patient with Paget’s disease had erosion at the scrotum incision and partial necrosis 7 days after the operation, and then healed after discontinuous dressing change. The incisions at the donor site obtained heal ing by first intension. Two patients complained about draw-off at the lower abdomen on the operated side, which was basically rel ieved at 7 days after the operation. All patients were followed up for 1 to 10 months (4.5 months on average). No operation-related compl ication was observed after operation. Six patients were satisfied with the reconstructive results. Only 1 patient was dissatisfied with the buried pennies and requested a revision. Conclusion The intensive CT scans play an important role in the DIEP flap design. It can not only make the flap safer, but also decrease operation time and improve efficiency.
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.
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.
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.
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.