评估和手术创新的阶段
Jeffrey S Barkun1, Jeffrey K Aronson, Liane S Feldman
1McGill University Health Centre, Montreal, QC, Canada. jeffrey.barkun@muhc.mcgill.ca
Lancet (London, England)
|September 29, 2009
概括
手术创新需要仔细评估,以确保患者安全和有效采用. 本文介绍了一种新的五阶段模型,用于评估新型外科手术程序,超越试错.
科学领域:
- 手术实践和创新 进行手术
- 医疗器械评估 医疗器械评估
- 医疗保健政策 医疗保健政策
背景情况:
- 外科创新至关重要,但由于实践的复杂性,评估是具有挑战性的.
- 基于证据的新程序的采用是必不可少的,与试错方法形成鲜明对比.
- 需要一个监管框架来保护患者免受新手术程序的潜在危害.
研究的目的:
- 为开发和评估创新的外科手术程序提出一个结构化,五阶段的范式.
- 为系统评估外科创新提供一个框架.
- 促进基于证据的新手术技术的引入和采用.
主要方法:
- 开发一个五阶段的外科创新的范式.
- 概述创新生命周期的概念框架.
- 关于外科创新的评估和监管的文献综述.
主要成果:
- 一个拟议的五阶段范式,详细说明了创新的外科手术程序的开发途径.
- 确定评估外科创新的关键考虑因素.
- 强调采用基于证据的原则.
结论:
- 拟议的五阶段范式为外科创新提供了一个结构化的方法.
- 为了安全有效地实施新的外科手术程序,需要进行系统的评估.
- 该框架支持在外科实践中基于证据的决策.
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