1.Sleep quality survey and influencing factors analysis in officers and soldiers stationed and trained at plateau
Xuyang MENG ; Qiao ZHANG ; Jia WANG ; Wei XIONG ; Lihua WANG ; Ju MA ; Lei HAN ; Xudong LUO ; Huilong WANG ; Runping ZHAO ; Tao WANG
Chongqing Medicine 2017;46(25):3571-3573
Objective To investigate the sleep quality of inland military officers and soldiers stationed and trained at plateau and its possible influence factors.Methods A total of 459 military officers and soldiers stationed and trained at plateau were performed the on site psychological assessment by adopting the psychological stress self-evaluation test (PSET),Pittsburgh Sleep Quality Index (PSQI),work related fatigue feelings (WRFFQ) and self compiled general data questionnaire.Results (1) The mean value of overall sleep quality in militaries stationed and trained at plateau was 5.61-±-3.48.40.5 % of respondents had good sleep quality,25.3% had poor sleep quality and 34.2% had general sleep quality.(2)The fatigue and psychological stress scores in the militaries with poor sleep quality were significantly higher than those in the militaries with good sleep quality (t1 =10.70,t2 =-9.68,P<0.01).(3)The psychological stress,fatigue degree,confidence level of self-assessment health status had significantly positive correlation(r =0.517,0.488,0.259,0.352,P< 0.01).(4) The psychological stress,fatigue degree,confidence level of self-assessment health status entered the PSQI total score regression equation,moreover the predictive variation amount was 36.1%.Conclusion The psychological stress status and fatigue level in the militaries at plateau affect the sleep quality,and the confidence degree and health status assessment of officers and soldiers on exercise also produce the active influence on sleep.
2.Comparative study on the registration management systems of innovative medical devices in China and the United States
Qianqian ZHAO ; Keyu CHEN ; Ziyan MENG ; Runping MA ; Qiufan SUN ; Lewen FU ; Zekun LIU ; Longping YANG ; Qing LI
Chinese Journal of Medical Science Research Management 2024;37(5):434-440
Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.