Jing-Xian Li1, Zhi-Cheng Qiao2, Hong-Xia Ma3, Yi-Ting Li4, En-Chang Li5, Peng-Cheng Ji5, Gang Huang6. 1. Collaborative Innovation Center of Network and Big Data Applications, Lingnan Normal University, Zhanjiang, Guangdong Province, 524048, China. 2. Department of Finance, College of Economics, Jinan University, Guangzhou, 510632, China. 3. Department of Pediatric, Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong Province, 524001, China. 4. Teaching and Research Section of Health Care Management, School of Health Management and Education, Capital Medical University, Beijing, 100069, China. 5. Chinese Journal of Medical Ethics, Xi'an Jiaotong University, Xi'an, 710061, China. 6. Collaborative Innovation Center of Network and Big Data Applications, Lingnan Normal University, Zhanjiang, Guangdong Province, 524048, China. huanggang6108@126.com.
Abstract
OBJECTIVE: To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. METHODS: Exploratory factor analysis (EFA) and first-order confirmatory factor analysis (CFA) based on a structure equation model (SEM), higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre l5.3. RESULTS: There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. CONCLUSION: This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.
OBJECTIVE: To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. METHODS: Exploratory factor analysis (EFA) and first-order confirmatory factor analysis (CFA) based on a structure equation model (SEM), higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre l5.3. RESULTS: There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. CONCLUSION: This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.
Keywords:
ethical review; factor analysis; medical technology; structural equation model