外科临床研究方法学指引——IDEAL框架及指南介绍与解读

外科临床研究是临床实践重要组成部分。由于外科治疗具有侵袭性、复杂性、个体化、高度依赖操作者技能等特点，因此,其评估与药物治疗存在显著差异，但是仍然缺少相应的方法学框架和指南。IDEAL框架与指南［The Idea，Development, Exploration，Assessment，and Long-term Follow-up（IDEAL）Framework and Recommendations］旨在针对外科手术创新、有创性医疗器械和其他复杂治疗干预措施建立科学、严谨的评价路径，并根据不同的技术发展阶段对研究方法、报告规范等进行推荐。

Methodological guidance for surgical research-introduction and interpretation of the IDEAL framework and recommendations

Methodological guidance for surgical research - introduction and interpretation of the IDEAL framework and recommendations SHAN Fei*, YIN Dao-xin, LI Zi-yu, et al. *Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing 100142, China;IDEAL Collaboration, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 9DU, United Kingdom
Corresponding authors:JI Jia-fu，E-mail：jijiafu@hsc.pku.edu.cn;SUN Xin，E-mail：sunx79@hotmail.com
Abstract High-quality surgical research is indispensable to improve clinical practice. Surgical researchers faced special methodological and practical challenges rooted in the complex nature of surgical interventions. Surgeon related factors like variety in expertise, experience and preference also affected the standardization of surgical procedures, hurting the validity of the evaluations. These unique features made surgical interventions significantly different from pharmacological interventions. The traditional pathway to evaluate pharmacological interventions cannot be directly applied to assess surgical innovation. The Idea, Development, Exploration, Assessment, and Long-term Follow-up (IDEAL) Framework and Recommendations, reflecting the international and multidisciplinary efforts of the IDEAL Collaboration, was developed to provide a scientific and integrated evaluation pathway for surgical innovations, invasive medical devices and other complex therapeutic interventions. In this paper, we are going to introduce the IDEAL framework and recommendations to Chinese surgeons, surgical researchers, funders and policy makers. Based on published IDEAL literature, we briefed the development of IDEAL and updates on the framework. We illustrated the key differences between a surgical and pharmacological intervention (e.g., defining the invention, undertaking iterative modification, managing learning curve and quality control). We described the main purpose and key question to be addressed by each stage. We explained the recommended study designs, endpoints and reporting guidelines to use. We highlighted the ethical issues to consider at each stage, and also explained how the stages fit together to make a complete pathway for evaluation through the whole lifecycle of surgical interventions or devices. We hope this paper can help Chinese surgical professionals to understand IDEAL framework and guidelines better and apply to research practice and carry out high-quality surgical clinical research.