1.Revision of the family resilience assessment scale in patients with stroke and its reliability and validity test
Lina YANG ; Ying QIAN ; Anqi YE ; Minjun YANG ; Yiyi ZHOU
Chinese Journal of Behavioral Medicine and Brain Science 2023;32(10):945-950
Objective:To revise the family resilience assessment scale (FRAS) in patients with stroke and to evaluate its psychometric properties and applicability.Methods:FRAS was authorized and translated into Chinese.The scale items were revised based on the interview results of 13 patients with stroke and 11 caregivers and the opinions of 20 experts in related fields.A convenience sampling method was used to sample neurology and neurosurgery inpatients from 2 tertiary hospitals in Hangzhou twice from June to November 2022, with 325 questionnaires (sample 1) distributed the first time for item analysis and exploratory factor analysis, and 285 questionnaires (sample 2) distributed the second time for confirmatory factor analysis, criterion validity and reliability test.Data analysis was conducted by SPSS 26.0 and AMOS 24.0.Results:The exploratory factor analysis extracted 6 common factors(family beliefs, family spirit, family connection, family resources, family communication, family collaboration) with 32 items.Confirmatory factor analysis showed that the model fit well( χ2/ df=2.67, RMSEA=0.025, CFI=0.98, GFI=0.90, IFI=0.98, RMR=0.031). The cronbach's α coefficient of the total scale was 0.96, and 0.82-0.92 for the dimensions.The 2-week retest reliability was 0.99.The total scale score was positively correlated with the validity scale (family resilience scale) ( r=0.882, P<0.001). Conclusion:The family resilience scale for patients with stroke has good reliability and validity and can be used to assess the family resilience of patients with stroke.
2.Scientific supervision and subject-oriented development of China clinical research
Anqi YU ; Ye LENG ; Huiyao HUANG ; Yu TANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(10):1384-1389
At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.