1.Considerations of ethical issues in clinical trials for medical equipments from the perspective of the Belmont Report
Chengdong JI ; Yan JIANG ; Ming ZHU ; Weimin WU ; Juerong ZHOU ; Kan ZHANG
Chinese Journal of Medical Science Research Management 2013;(2):84-88
Clinical trial is the most direct and the most effective way to test the performance of medical equipments.The Belmont Report is the statement of the basic moral principles and guidelines,used to help solve the moral problems produced in scientific researches involving human subjects.This apaper examines the ethical issues in clinical trials for medical equipments from the perspective of the Belmont report.It first introduces the background and basic concepts of Belmont report,background concept and the concept and the basic process of medical equipment clinical trials.Then the three principles of the Belmont Report is presented and how to apply the Report to solve ethical problems arising in medical equipment trials.Application of informed consent risk and benefits assessment,and selection of subjects participants and the distribution of research results to address the ethical issues arising in clinical trials.
2.Risk factor analysis for postmenopausal osteoporosis in Shanghai
Li YOU ; Zhengyan SHENG ; Jinyu CHEN ; Junming DAI ; Shizhong WANG ; Heng WU ; Chen JI ; Jian ZHOU ; Ling PAN ; Lin CHEN ; Qingming SONG ; Juerong MA ; Xiaoming JIANG
Chinese Journal of Geriatrics 2009;28(9):769-773
Objective To investigate the risk factors for postmenopausal osteoporosis in Shanghai.Methods Five hundred postmenopausal community-dwelling women aged 45-80 years were recruited. The case-control study was performed from June 2008 to September 2008.A total number of 250 women with postmenopausal osteoporosis identified with their bone mineral density (BMD) were selected as case group, and 250 non-osteoporosis women were selected as control group. BMD was measured by dual energy X-ray absorption (DEXA). Results Univariate logistic regression analysis showed that age, eduction level, occupation, years since menopause, BMI, use of calcium,historyofnon-violencefracture,fall,diabetesmellitus,chronicgastricdiseases, gastrointestinal resection and diarrhea were related to osteoporosis.Multiple logistic regression showed that age, years since menopause and nutritional status were the risk factors for osteoporosis. ConclusionsThe occurrence of osteoporosis is related with many factors in postmenopausal women in Shanghai, and women with early menopause, low BMI and older age should pay more attention to the prevention and treatment of osteoporosis.