An ethical evaluation index system for clinical approval of medical technology in China: A structural equation model study.

Jing-xian LI; Zhi-cheng Qiao; Hong-xia MA; Yi-ting LI; En-chang LI; Peng-cheng JI; Gang Huang

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An ethical evaluation index system for clinical approval of medical technology in China: A structural equation model study.

Author: Jing-Xian LI ¹ ; Zhi-Cheng QIAO ² ; Hong-Xia MA ³ ; Yi-Ting LI ⁴ ; En-Chang LI ⁵ ; Peng-Cheng JI ⁵ ; Gang HUANG ⁶
Author Information

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.
Publication Type:Journal Article
Keywords: ethical review; factor analysis; medical technology; structural equation model
From: Chinese journal of integrative medicine 2017;23(6):474-480
CountryChina
Language:English
Abstract:
OBJECTIVETo construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China.
METHODSExploratory 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.
RESULTSThere 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.
CONCLUSIONThis study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.