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【Objective:】 To understand the current situation and influencing factors of ethical knowledge, attitude, and practice (KAP) among clinical researchers, enhance their ethical awareness, and improve the quality of clinical researches. 【Methods:】 A self-designed questionnaire was used to conduct a convenient sampling survey of medical staff who have participated in clinical study. 【Results:】 A total of 6,021 subjects were investigated, with males accounting for 28.46% and females accounting for 71.53%. The average age of them was (37.47±11.46) years old. The total score of ethics and the mean scores of the three dimensions of knowledge, attitude and practice were (70.62±12.99), (59.63±12.50), (79.55±19.62) and (74.92±18.29), respectively. Multiple linear regression analysis showed that researchers with male, tertiary hospitals, doctors, ethics-related part-time jobs, postgraduate education, associate senior title or above, and training experience scored higher (P<0.05). 【Conclusion:】 Ethical attitudes have a significant mediating effect between knowledge and practice, accounting for 62.72% of the total effect. Researchers recognize the importance of ethics, but it is urgent to strengthen their knowledge learning and practical application.
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BackgroundNo clinically proven effective antiviral strategy exists for the epidemic Coronavirus Disease 2019 (COVID-19). MethodsWe conducted a prospective, randomized, controlled, open-label multicenter trial involving adult patients with COVID-19. Patients were randomly assigned in a 1:1 ratio to receive conventional therapy plus Umifenovir (Arbidol) (200mg*3/day) or Favipiravir (1600mg*2/first day followed by 600mg*2/day) for 10 days. The primary outcome was clinical recovery rate of Day 7. Latency to relief for pyrexia and cough, the rate of auxiliary oxygen therapy (AOT) or noninvasive mechanical ventilation (NMV) were the secondary outcomes. Safety data were collected for 17 days. Results240 enrolled COVID-19 patients underwent randomization; 120 patients were assigned to receive Favipiravir (116 assessed), and 120 to receive Arbidol (120 assessed). Clinical recovery rate of Day 7 does not significantly differ between Favipiravir group (71/116) and Arbidol group (62/120) (P=0.1396, difference of recovery rate: 0.0954; 95% CI: -0.0305 to 0.2213). Favipiravir led to shorter latencies to relief for both pyrexia (difference: 1.70 days, P<0.0001) and cough (difference: 1.75 days, P<0.0001). No difference was observed of AOT or NMV rate (both P>0.05). The most frequently observed Favipiravir-associated adverse event was raised serum uric acid (16/116, OR: 5.52, P=0.0014). ConclusionsAmong patients with COVID-19, Favipiravir, compared to Arbidol, did not significantly improve the clinically recovery rate at Day 7. Favipiravir significantly improved the latency to relief for pyrexia and cough. Adverse effects caused Favipiravir are mild and manageable. This trial is registered with Chictr.org.cn (ChiCTR2000030254).
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By analyzing the main problems existing in the current management of medical devices for clinical trials, this study proposes a feasible management model and specific requirements for acceptance, distribution, storage and recovery combining with the characteristics of medical consumable equipment and diagnostic reagent, which provides a favorable guarantee for the authenticity and reliability of clinical trials.
Subject(s)
Clinical Trials as Topic , Equipment and Supplies/standards , Indicators and Reagents/standards , Reproducibility of Results , Research Design/standardsABSTRACT
Guidance and reference are provided for protocol designer. The classification of laser medical devices are introduced. The key points such as the selection of control group, evaluation indicators and method, criteria of inclusion and exclusion, and application of blinded, etc. are discussed, and the importance of management of defects in medical device is emphasized.
Subject(s)
Clinical Trial Protocols as Topic , Equipment and Supplies , Lasers , Research DesignABSTRACT
Based on practice of video-cases teaching,this paper put forwards four sorts of contradictions,which are the contradiction between time limitation of classroom and expressing limi-tation of video cases,the contradiction between relative independence of video cases (part)and con-sistency of teaching objective (entirety),the contradiction between apparentness of video cases (phe-nomenon)and depth of teaching content (essence)and the contradiction between variability of video case class and control of class by teachers. This paper suggested teaching principle of part conforming to entirety. Meanwhile,it indicated that classroom video case teaching should have strict design, closely coordinated class discussion and teachers should be good at guiding and summarizing. Through these efforts,the above four contradictions can be resolved and designed video case teaching obtained good effect.
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@#Objective To investigate the risk factors of cerebral palsy(CP)in children.Methods 1∶2 matched case-control study was carried out in 100 CP children and 200 controls individually matched for sex and age were selected for each case.The data were analyzed with Logistic regression.Results 9 risk factors were suggested from univariate analysis,namely hospital level,educational level of mother and father,premature birth,neonatal asphyxia,ABO hemolysis,lower birth weight,hypoxic-ischemic encephalopathy(HIE)and kernicterus.The risk factors confirmed by multivariate analysis were hospital level,educational level of father,premature birth,neonatal asphyxia,ABO hemolysis,lower birth weight and HIE.Conclusion Relevant risk factors of CP are various.