外科创新技术/器械临床研究方法学——IDEAL框架与推荐系列文章之一:IDEAL框架与推荐介绍

The methodological framework of surgical innovation:the introduction of IDEAL framework and recommendation

外科技术和器械的快速创新是外科临床研究和实践的重要内容,其评价总体思路与药物干预类似,但具体方法学存在很大差异。2009年IDEAL协作网提出一套适用于外科创新干预的方法学框架—IDEAL框架,将外科创新技术发展分为5个阶段,涵盖从概念提出到推广应用的全生命周期。2019年,协作网更新IDEAL框架,在原有基础上增加临床前评价(Pre-IDEAL),梳理明确各阶段研究目的、核心问题和伦理依据。作为IDEAL框架和推荐系统的首篇文章,本文将详细介绍IDEAL推荐和框架的产生、发展、具体内容、应用推广现状,旨在促进该方法在国内外科临床研究领域的应用和传播。

Surgical innovation is an important part of surgical research and practice.The evaluation of surgical innovation through the stages is similar to those for drug development,but with important differences.The Idea,Development,Exploration,Assessment,and Long-term follow-up(IDEAL)Framework and Recommendations represent a new paradigm for the evaluation of surgical intervention and devices which was developed in 2009.The IDEAL is a fivestage framework involving the nature stages of surgical innovation,together with recommendations for surgical research pathway.The Framework and Recommendations were updated and published in 2019,which added a pre-IDEAL stage if necessary.The updated IDEAL also underlines the purpose,key question and ethical issues for each stage.In the first paper of IDEAL Framework and Recommendations series,we conducted a comprehensive introduction of IDEAL(e.g.the development,updates and application of IDEAL)to promote the dissemination and application of IDEAL in China.