外科临床研究规范:IDEAL框架解读

Standards of surgical clinical researches:Introduction of IDEAL framework

我国外科临床研究领域已有不少突破,但总体质量相对不高,主要体现在方法学的规范性、合理性和严谨性欠缺。因手术技术和设备应用的固有特点,在外科领域开展高质量临床研究须建立一套相适应的方法学体系。IDEAL协作网针对外科技术和设备创新提出了一套系统的方法学框架,即"IDEAL框架"。其主体分为5个序贯阶段:设计(idea)、开发(development)、探索(exploration)、评价(assessment)和长期随访(long-term follow up)。不同阶段所面临的困难、需解决的问题和采用的研究设计各有不同,须逐步推进。IDEAL框架虽然并非最完美,但仍是当前外科临床研究的最佳设计构架。在规范开展外科临床研究过程中,我们应积极思考如何改进和提高外科临床研究的方法学。

Many breakthroughs in the field of surgical clinical researches have been achieved in China,but the overall quality is relatively limited,largely because of the insufficiency in standardization,rationality and scientificity of methodology.In consideration of the nature of surgical procedures and equipments,it is necessary to establish a set of methodological system,suitable for the high-quality clinical research in the surgical field.IDEAL collaboration has put forward a systematic methodological framework for innovation in surgical procedure and equipment.For the clinical research on surgical innovation,the IDEAL framework can be divided into five sequential stages,namely,Idea,Development,Exploration,Assessment and Long-term follow-up.In different stages,the difficulties to be faced,the problems to be solved,and the research design to be adopted are diverse and progressive.Although the IDEAL framework is not perfect,it is currently the best framework for surgical clinical research.While performing surgical clinical research,we should continue to think about how to improve the surgical clinical research methodology.