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.
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.
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.
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.
Objective To systematically review the prevalence of depression and anxiety among health care workers in designated hospitals during the COVID-19 pandemic. Methods The Cochrane Library, PubMed, EMbase, Web of Science, CNKI, WanFang Data, VIP, and CBM databases were electronically searched to collect cross-sectional studies on the prevalence of depression and anxiety among health care workers from December 2019 to April 2021. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using Stata 14.0 software. Results A total of 21 cross-sectional studies were included, involving 38 372 participants. Meta-analysis results showed that during the COVID-19 epidemic, the prevalence of depression and anxiety among health care workers in designated hospitals were 31.00% (95%CI 0.25 to 0.37) and 44.00% (95%CI 0.34 to 0.53). The results of subgroup analysis showed that individuals of female, married, bachelor degree or above, nurses, junior professional titles, and non-first-line medical staff had higher prevalence of depression and anxiety. Conclusions During the COVID-19 pandemic, the incidence of depression and anxiety among health care workers in designated hospitals remain high. Therefore, more attention should be paid to the mental health of health care workers in designated hospitals. Due to the limited quantity and quality of included studies, more high-quality studies are needed to verify the above conclusions.
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.
ObjectiveTo establish a reasonable risk evaluation tool in order to guide the clinical prevention of accidental extubation. MethodsWe collected all the tube types in our hospital, and according to the extubation consequence severity and risks, we designed the extubation risk factor items and formed the professional tables for scoring. Sixteen medical experts and 16 nursing experts were chosen to determine the scores for two rounds following the "Delphi" method. Five patients that had extubation accidentally were selected for evaluation, and 56 clinical cases provided feedbacks after evaluation. Then, the risk was set into 3 ranks:light (≤ 8 points), medium (9-12 points) and high (≥ 13 points). Finally, literature review and collection of the prevention measures were carried out, and the final "Accidental Extubation Risk Evaluation Table" was completed. ResultsAltogether, 283 patients were evaluated using the table in 23 departments of the hospital, among whom 121 were at mild risk, 76 were at medium risk and 86 were at high risk. Measures were taken accordingly, and no accidental extubation occurred. ConclusionThe evaluation table is reasonable, with which accidental extubation risk evaluation is standardized, and the safety of catheter nursing is enhanced.
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.
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.
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.