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竞争还是互补?伦理考量与随机试验的质量

Competing or complementary? Ethical considerations and the quality of randomized trials.

作者信息

Lumley J, Bastian H

机构信息

University of Oxford.

出版信息

Int J Technol Assess Health Care. 1996 Spring;12(2):247-63. doi: 10.1017/s0266462300009600.

DOI:10.1017/s0266462300009600
PMID:8707498
Abstract

The ethical principles of beneficence (doing the best for one's patients and clients), nonmaleficence (doing no harm), autonomy, justice, and equity, are positively associated with the quality of a trial rather than being opposed to it. Ethical considerations involve such important questions as appropriate design and documentation, participation rates, withdrawals or losses to follow-up, careful monitoring of safety and efficacy, timely completion, generalizability, and publication and dissemination of findings. When conflicts between ethical considerations and the trial's scientific quality do occur, the ethical considerations must be paramount.

摘要

善行(尽力为患者和客户谋福祉)、不伤害(不造成伤害)、自主、公正和平等这些伦理原则与试验质量呈正相关,而非与之相悖。伦理考量涉及诸多重要问题,如适当的设计和记录、参与率、失访或随访损失、对安全性和有效性的仔细监测、及时完成、普遍性以及研究结果的发表和传播。当伦理考量与试验的科学质量确实发生冲突时,伦理考量必须是首要的。

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