诊断治疗类医疗器械临床应用的实效研究

摘要

As the role of medical devices in healthcare services is getting more and more important, the outcomes research of medical devices, that is, the assessment of the effectiveness, efficiency and safety of clinical use of medical devices, has gradually become an important part of the health technology assessment. This article briefly introduces the methodology of outcomes research and its applications in drug development and other fields, analyzes the differences between the outcomes research of medical devices and drugs, and summarizes several feasible methods of outcomes research on diagnostic and therapeutic devices.%随着医疗器械在临床应中所占地位越来越高,开展医疗器械的实效研究,即医疗器械在临床使用中的效果评价也逐渐成为卫生技术评价中的重要组成部分.基于实效研究的方法学以及在药物等领域应用的阐述,对医疗器械与药物实效研究的差异进行分析,探讨诊断治疗类医疗器械实效研究的思路和方法.