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

doi:10.1007/s11655-016-2628-5

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

Chin J Integr Med. 2017 Jun;23(6):474-480. doi: 10.1007/s11655-016-2628-5. Epub 2016 Dec 21.

Authors

Jing-Xian Li¹, Zhi-Cheng Qiao², Hong-Xia Ma³, Yi-Ting Li⁴, En-Chang Li⁵, Peng-Cheng Ji⁵, Gang Huang⁶

Affiliations

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.

PMID: 28004302
DOI: 10.1007/s11655-016-2628-5

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.

Keywords: ethical review; factor analysis; medical technology; structural equation model.

MeSH terms

Biomedical Technology / ethics*
Biomedical Technology / legislation & jurisprudence*
China
Factor Analysis, Statistical
Humans