Chen X Z, Hu J K, Yu J J, Sun X
Department of Gastrointestinal Surgery & Laboratory of Gastric Cancer, West China Hospital, Sichuan University, Chengdu 610041, China.
Evidence-based Medicine Center of China, Chengdu 610041, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2020 Feb 25;23(2):123-128. doi: 10.3760/cma.j.issn.1671-0274.2020.02.005.
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.
中国在外科临床研究领域取得了许多突破,但整体质量相对有限,这主要是由于方法学的标准化、合理性和科学性不足。考虑到外科手术和设备的性质,有必要建立一套适合外科领域高质量临床研究的方法学体系。IDEAL协作提出了一个关于手术程序和设备创新的系统方法框架。对于外科创新的临床研究,IDEAL框架可分为五个连续阶段,即构思、开发、探索、评估和长期随访。在不同阶段,面临的困难、需要解决的问题以及要采用的研究设计各不相同且循序渐进。尽管IDEAL框架并不完美,但它是目前外科临床研究的最佳框架。在进行外科临床研究时,我们应不断思考如何改进外科临床研究方法学。