The methodological framework of surgical innovation: the introduction of IDEAL framework and recommendation_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

YU Jiajie ^1,3 , SHAN Fei ² , Peter McCulloch ³ , Allison Hirst ³ , HU Jiankun ⁴ , SUN Xin ^1,5 ,  LI Youping ¹ , LIU Lunxu ⁶ , LIU Xuemei ⁷ , DONG Lianguo ⁸ , CHEN Jimei ⁹ , QIAO Guibin ¹⁰ , LI Hecheng ¹¹

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, 100142, P.R.China;
3. IDEAL Collaboration, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 9DU, United Kingdom;
4. Department of Gastrointestinal Surgery & Laboratory of Gastric Cancer, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
5. Real World Data Research and Innovation Center of Boao Lecheng, Qionghai, 571435, Hainan, P.R.China;
6. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
7. Chinese Clinical Journal of Thoracic and Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
8. Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, P.R.China;
9. Guangdong Provincial Cardiovascular Institute, Guangdong Provincial People’s Hospital, Guangdong Provincial Key Laboratory of South China Structural Heart Disease, Guangzhou, 510080, P.R.China;
10. Department of Thoracic Surgery, Guangdong Provincial People’s Hospital, Guangzhou, 510080, P.R.China;
11. Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, P.R.China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

Surgical innovation; framework and recommendation; IDEAL; clinical trial

DOI：

10.7507/1007-4848.202011088

Video：

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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.

Citation： YU Jiajie, SHAN Fei, Peter McCulloch, Allison Hirst, HU Jiankun, SUN Xin, LI Youping, LIU Lunxu, LIU Xuemei, DONG Lianguo, CHEN Jimei, QIAO Guibin, LI Hecheng. The methodological framework of surgical innovation: the introduction of IDEAL framework and recommendation. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2021, 28(2): 131-136. doi: 10.7507/1007-4848.202011088 Copy

1.	Horton R. Surgical research or comic opera: questions, but few answers. Lancet, 1996, 347(9007): 984-985.
2.	Slim K. Limits of evidence-based surgery. World J Surg, 2005, 29(5): 606-609.
3.	Barkun JS, Aronson JK, Feldman LS, et al. Evaluation and stages of surgical innovations. Lancet, 2009, 374(9695): 1089-1096.
4.	Glasziou P, Chalmers I, Rawlins M, et al. When are randomised trials unnecessary? Picking signal from noise. BMJ, 2007, 334(7589): 349-351.
5.	Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials, 2009, 10: 9.
6.	Jacquier I, Boutron I, Moher D, et al. The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg, 2006, 244(5): 677-683.
7.	Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet, 2009, 374(9695): 1097-1104.
8.	Vandenbroucke JP. Observational research, randomized trials, and two views of medical science. PLoS Med, 2008, 5: e67.
9.	Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ, 1996, 312(7040): 1215-1218.
10.	Vakharia VN, Rodionov R, McEvoy AW, et al. Improving patient safety during introduction of novel medical devices through cumulative summation analysis. J Neurosurg, 2018, 130(1): 213-219.
11.	McCulloch P, Cook JA, Altman DG, et al. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ, 2013, 346: f3012.
12.	Ergina PL, Barkun JS, McCulloch P, et al. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ, 2013, 346: f3011.
13.	Cook JA, McCulloch P, Blazeby JM, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ, 2013, 346: f2820.
14.	Sedrakyan A, Campbell B, Merion JG, et al. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ, 2016, 353: i2372.
15.	Verkooijen HM, Kerkmeijer LGW, Fuller CD, et al. R-IDEAL: A framework for systematic clinical evaluation of technical innovations in radiation oncology. Front Oncol, 2017, 7: 59.
16.	Beard D, Hamilton D, Davies L, et al. Evidence-based evaluation of practice and innovation in physical therapy using the ideal-physio framework. Phys Ther, 2018, 98(2): 108-121.
17.	Hirst A, Philippou Y, Blazeby J, et al. No surgical innovation without evaluation: evolution and further development of the IDEAL framework and recommendations. Ann Surg, 2019, 269(2): 211-220.
18.	陕飞, 尹道馨, 李子禹, 等. 外科临床研究方法学指引—IDEAL 框架及指南介绍与解读. 中国实用外科杂志, 2020, 40(1): 93-101.
19.	Sampietro-Colom L, Martin J, Chief editor. Hospital-based Health Yechnology assessment: the next frontier. In: Sampietro-Colom L, Martin J, eds. Hospital-based Health Technology Assessment. Cham, Switzerland: Springer, 2016. 3-11.
20.	Heikens JT, Gooszen HG, Rovers MM, et al. Stages and evaluation of surgical innovation: a clinical example of the ileo neorectal anastomosis after ulcerative colitis and familial adenomatous polyposis. Surg Innov, 2013, 20(5): 459-465.
21.	Levin L, Krahn M, Goeree R, et al. Excite—a new collaborative model of pre-market evaluation of health technologies. Value Health, 2013, 16: A264.
22.	McCulloch P, Feinberg J, Philippou Y, et al. Progress in clinical research in surgery and IDEAL. Lancet, 2018, 392(10141): 88-94.
23.	Khachane A, Philippou Y, Hirst A, et al. Appraising the uptake and use of the IDEAL framework and recommendations: A review of the literature. Int J Surg, 2018, 57: 84-90.
24.	Agha RA, Hirst A, Khachane A, et al. A protocol for the development of reporting guidelines for IDEAL stage studies. Int J Surg Protoc, 2018, 9: 11-14.
25.	Bilbro NA, Hirst A, Paez A, IDEAL Collaboration Reporting Guidelines Working Group. The IDEAL reporting guidelines: A Delphi consensus statement stage specific recommendations for reporting the evaluation of surgical innovation. Ann Surg, 2020, [Epub ahead of print].
26.	Bhangu A, Kolias AG, Pinkney T, et al. Surgical research collaboratives in the UK. Lancet, 2013, 382(9898): 1091-1092.
27.	New service: advice on IDEAL stage study design. Available from: http://www.ideal-collaboration.net/2020/06/new-service-for-advice-on-ideal-stage-study-design/.

1. Horton R. Surgical research or comic opera: questions, but few answers. Lancet, 1996, 347(9007): 984-985.
2. Slim K. Limits of evidence-based surgery. World J Surg, 2005, 29(5): 606-609.
3. Barkun JS, Aronson JK, Feldman LS, et al. Evaluation and stages of surgical innovations. Lancet, 2009, 374(9695): 1089-1096.
4. Glasziou P, Chalmers I, Rawlins M, et al. When are randomised trials unnecessary? Picking signal from noise. BMJ, 2007, 334(7589): 349-351.
5. Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials, 2009, 10: 9.
6. Jacquier I, Boutron I, Moher D, et al. The reporting of randomized clinical trials using a surgical intervention is in need of immediate improvement: a systematic review. Ann Surg, 2006, 244(5): 677-683.
7. Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet, 2009, 374(9695): 1097-1104.
8. Vandenbroucke JP. Observational research, randomized trials, and two views of medical science. PLoS Med, 2008, 5: e67.
9. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ, 1996, 312(7040): 1215-1218.
10. Vakharia VN, Rodionov R, McEvoy AW, et al. Improving patient safety during introduction of novel medical devices through cumulative summation analysis. J Neurosurg, 2018, 130(1): 213-219.
11. McCulloch P, Cook JA, Altman DG, et al. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ, 2013, 346: f3012.
12. Ergina PL, Barkun JS, McCulloch P, et al. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ, 2013, 346: f3011.
13. Cook JA, McCulloch P, Blazeby JM, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ, 2013, 346: f2820.
14. Sedrakyan A, Campbell B, Merion JG, et al. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ, 2016, 353: i2372.
15. Verkooijen HM, Kerkmeijer LGW, Fuller CD, et al. R-IDEAL: A framework for systematic clinical evaluation of technical innovations in radiation oncology. Front Oncol, 2017, 7: 59.
16. Beard D, Hamilton D, Davies L, et al. Evidence-based evaluation of practice and innovation in physical therapy using the ideal-physio framework. Phys Ther, 2018, 98(2): 108-121.
17. Hirst A, Philippou Y, Blazeby J, et al. No surgical innovation without evaluation: evolution and further development of the IDEAL framework and recommendations. Ann Surg, 2019, 269(2): 211-220.
18. 陕飞, 尹道馨, 李子禹, 等. 外科临床研究方法学指引—IDEAL 框架及指南介绍与解读. 中国实用外科杂志, 2020, 40(1): 93-101.
19. Sampietro-Colom L, Martin J, Chief editor. Hospital-based Health Yechnology assessment: the next frontier. In: Sampietro-Colom L, Martin J, eds. Hospital-based Health Technology Assessment. Cham, Switzerland: Springer, 2016. 3-11.
20. Heikens JT, Gooszen HG, Rovers MM, et al. Stages and evaluation of surgical innovation: a clinical example of the ileo neorectal anastomosis after ulcerative colitis and familial adenomatous polyposis. Surg Innov, 2013, 20(5): 459-465.
21. Levin L, Krahn M, Goeree R, et al. Excite—a new collaborative model of pre-market evaluation of health technologies. Value Health, 2013, 16: A264.
22. McCulloch P, Feinberg J, Philippou Y, et al. Progress in clinical research in surgery and IDEAL. Lancet, 2018, 392(10141): 88-94.
23. Khachane A, Philippou Y, Hirst A, et al. Appraising the uptake and use of the IDEAL framework and recommendations: A review of the literature. Int J Surg, 2018, 57: 84-90.
24. Agha RA, Hirst A, Khachane A, et al. A protocol for the development of reporting guidelines for IDEAL stage studies. Int J Surg Protoc, 2018, 9: 11-14.
25. Bilbro NA, Hirst A, Paez A, IDEAL Collaboration Reporting Guidelines Working Group. The IDEAL reporting guidelines: A Delphi consensus statement stage specific recommendations for reporting the evaluation of surgical innovation. Ann Surg, 2020, [Epub ahead of print].
26. Bhangu A, Kolias AG, Pinkney T, et al. Surgical research collaboratives in the UK. Lancet, 2013, 382(9898): 1091-1092.
27. New service: advice on IDEAL stage study design. Available from: http://www.ideal-collaboration.net/2020/06/new-service-for-advice-on-ideal-stage-study-design/.

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