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An ethical evaluation index system for clinical approval of medical technology in China: A structural equation model
Jing-Xian Li1, Zhi-Cheng Qiao2, Hong-Xia Ma3
1Collaborative Innovation Center of Network and Big Data Applications, Lingnan Normal University, Zhanjiang, Guangdong Province, 524048, China.
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.
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