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

Jiajie YU; Fei Shan; Mcculloch Peter; Hirst Allison; Jiankun HU; Xin Sun; Youping LI; Lunxu Liu; Xuemei Liu; Lianguo Dong; Jimei Chen; Guibin Qiao; Hecheng LI

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

VernacularTitle: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
Author: Jiajie YU ^{1
,

2} ; Fei SHAN ^{3
,

4} ; McCulloch Peter ⁵ ; Hirst Allison ⁵ ; Jiankun HU ^{6
,

7} ; Xin SUN ^{1
,

8} ; Youping LI ⁹ ; Lunxu LIU ¹⁰ ; Xuemei LIU ¹¹ ; Lianguo DONG ¹² ; Jimei CHEN ^{13
,

14} ; Guibin QIAO ^{15
,

16} ; Hecheng LI ¹⁷
Author Information

1. 1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China
2. 3. IDEAL Collaboration, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 9DU, United Kingdom
3. Gastrointestinal Cancer Center, Peking University Cancer Hospital &
4. Institute, Beijing, 100142, P.R.China
5. IDEAL Collaboration, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 9DU, United Kingdom
6. Department of Gastrointestinal Surgery &
7. Laboratory of Gastric Cancer, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China
8. 5. Real World Data Research and Innovation Center of Boao Lecheng, Qionghai, 571435, Hainan, P.R.China
9. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China
10. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China
11. Chinese Clinical Journal of Thoracic and Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China
12. Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, P.R.China
13. Guangdong Provincial Cardiovascular Institute, Guangdong Provincial People&rsquo
14. s Hospital, Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangzhou, 510080, P.R.China
15. Department of Thoracic Surgery, Guangdong Provincial People&rsquo
16. s Hospital, Guangzhou, 510080, P.R.China
17. Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, P.R.China
Publication Type:Journal Article
Keywords: Surgical innovation; framework and recommendation; IDEAL; clinical trial
From: Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2021;28(02):131-136
CountryChina
Language:Chinese
Abstract: 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 five-stage 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.