浅谈患者偏好在医疗器械产品受益-风险评估中的应用  

Study of Patient Preference in Benefit-Risk Determinations of Medical Device Product

作　　者：石莉 梁文 金丹 陈福军 赵挺 SHI Li;LIANG Wen;JIN Dan;CHEN Fu-jun;ZHAO Ting(Liaoning Food and Drug Administration Technical Evaluation Center,Liaoning Shenyang 110003)

机构地区：[1]辽宁省检验检测认证中心认证审评院,辽宁沈阳110036

出　　处：《中国医疗器械信息》2020年第19期7-8,50,共3页China Medical Device Information

摘　　要：随着社会经济的发展,人们生活水平不断提高,公众的健康意识与健康需求由被动接受向主动选择转变。在此情景之下,患者偏好的重要性日益突显。文章探讨了患者偏好的概念、特点,及其在医疗器械监管领域的应用,旨在为我国医疗器械科学审评引入患者偏好的研究提供参考。With the development of society and economy,people’s living standards are constantly improving,and the public’s health awareness and health needs are changing from passive acceptance to active selection.In this context,the importance of patient preference is increasingly highlighted.This paper discusses the concept and characteristics of patient preference and its application in the field of medical device registration and administration,in order to provide a reference for the research of introducing patient preference into medical device scientific review in China.

关 键 词：医疗器械 患者偏好 受益- 风险 科学审评 知情同意 

分 类 号：R197.39[医药卫生—卫生事业管理]