The methodological framework of surgical innovation: The empirical evidence of IDEAL framework_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

XUE Xinyu ¹ ,  YU Jiajie ^1,2 , Peter McCulloch ² , Allison Hirst ² , LI Youping ¹ , SHAN Fei ³ , HU Jiankun ⁴ , SUN Xin ^1,5

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
2. IDEAL Collaboration, Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 9DU, United Kingdom;
3. Gastrointestinal Cancer Center, Peking University Cancer Hospital & Institute, Beijing, 100142, P. R. China;
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 Bo'ao Lecheng, Qionghai, 571435, Hainan, P. R. China;

Corresponding author：

YU Jiajie, Email: yujiajie@wchscu.cn

Keywords：

IDEAL; framework and recommendation; surgery; empirical evidence

DOI：

10.7507/1007-4848.202107067

Video：

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IDEAL framework and recommendations provide a scientific and integrated evaluation pathway for surgical innovations and other complex therapeutic interventions, and underline that the preliminary studies are needed to prepare for a successful randomized controlled trial. IDEAL framework provides a series of recommendations in terms of nature stages of surgical innovation. We have reported the introduction and reporting guidelines of the IDEAL framework and recommendations in our IDEAL series paper. This paper aimed to provide some empirical evidence, focusing specifically on stages 2a and 2b, to help surgeons and researchers to understand how to imply IDEAL framework and recommendations into their clinical practice.

Citation： XUE Xinyu, YU Jiajie, Peter McCulloch, Allison Hirst, LI Youping, SHAN Fei, HU Jiankun, SUN Xin. The methodological framework of surgical innovation: The empirical evidence of IDEAL framework. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(7): 834-839. doi: 10.7507/1007-4848.202107067 Copy

1.	Horton R. Surgical research or comic opera: Questions, but few answers. Lancet, 1996, 347(9007): 984-985.
2.	McCulloch P, Feinberg J, Philippou Y, et al. Progress in clinical research in surgery and IDEAL. Lancet, 2018, 392(10141): 88-94.
3.	Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet, 2009, 374(9695): 1097-1104.
4.	McCulloch P, Cook JA, Altman DG, et al. IDEAL framework for surgical innovation 1: The idea and development stages. BMJ, 2013, 346: f3012.
5.	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.
6.	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.
7.	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.
8.	喻佳洁, 陕飞, Peter McCulloch, 等. 外科创新技术/器械临床研究方法学—临床研究方框架与推荐系列文章之一: IDEAL框架与推荐介绍. 中国胸心血管外科临床杂志, 2021, 28(2): 131-136.
9.	喻佳洁, Allison Hirst, Peter McCulloch, 等. 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二: IDEAL 报告规范解读. 中国胸心血管外科临床杂志, 2021, 28(3): 263-270.
10.	Pennell CP, Hirst AD, Campbell WB, et al. Practical guide to the Idea, Development and Exploration stages of the IDEAL Framework and Recommendations. Br J Surg, 2016, 103(5): 607-615.
11.	Elsanousi OM, Mohamed MA, Salim FH, et al. Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Int J Surg, 2019, 68: 134-141.
12.	Park YK, Song SK, Kim BW, et al. Prognostic significance of microvascular invasion in tumor stage for hepatocellular carcinoma. World J Surg Oncol, 2017, 15(1): 225.
13.	Powerski MJ, Erxleben C, Scheurig-Münkler C, et al. Hepatopulmonary shunting in patients with primary and secondary liver tumors scheduled for radioembolization. Eur J Radiol, 2015, 84(2): 201-207.
14.	Metcalfe C, Avery K, Berrisford R, et al. Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial. Health Technol Assess, 2016, 20(48): 1-68.
15.	Blencowe NS, Strong S, McNair AG, et al. Reporting of short-term clinical outcomes after oesophagectomy: A systematic review. Ann Surg, 2012, 255(4): 658-666.
16.	Verhage RJ, Hazebroek EJ, Boone J, et al. Minimally invasive surgery compared to open procedures in esophagectomy for cancer: A systematic review of the literature. Minerva Chir, 2009, 64(2): 135-146.
17.	Avery KNL, Metcalfe C, Berrisford RG, et al. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer—The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study: Protocol for a randomized controlled trialsive or Open) study: Protocol for a randomized controlled trial. Trials, 2014, 15: 200-209.
18.	de Salis I, Tomlin Z, Toerien M, et al. Qualitative research to improve RCT recruitment: Issues arising in establishing research collaborations. Contemp Clin Trials, 2008, 29(5): 663-670.
19.	Sarker S, Chang A, Albrani T, et al. Contructing hierarchical task analysis in surgery. Surg Endosc, 2008, 22(1): 107-111.
20.	Core Outcome Measures in Effectiveness Trials. URL: https://www.comet-initiative.org/. Accessed on 2021-07-09.

1. Horton R. Surgical research or comic opera: Questions, but few answers. Lancet, 1996, 347(9007): 984-985.
2. McCulloch P, Feinberg J, Philippou Y, et al. Progress in clinical research in surgery and IDEAL. Lancet, 2018, 392(10141): 88-94.
3. Ergina PL, Cook JA, Blazeby JM, et al. Challenges in evaluating surgical innovation. Lancet, 2009, 374(9695): 1097-1104.
4. McCulloch P, Cook JA, Altman DG, et al. IDEAL framework for surgical innovation 1: The idea and development stages. BMJ, 2013, 346: f3012.
5. 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.
6. 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.
7. 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.
8. 喻佳洁, 陕飞, Peter McCulloch, 等. 外科创新技术/器械临床研究方法学—临床研究方框架与推荐系列文章之一: IDEAL框架与推荐介绍. 中国胸心血管外科临床杂志, 2021, 28(2): 131-136.
9. 喻佳洁, Allison Hirst, Peter McCulloch, 等. 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二: IDEAL 报告规范解读. 中国胸心血管外科临床杂志, 2021, 28(3): 263-270.
10. Pennell CP, Hirst AD, Campbell WB, et al. Practical guide to the Idea, Development and Exploration stages of the IDEAL Framework and Recommendations. Br J Surg, 2016, 103(5): 607-615.
11. Elsanousi OM, Mohamed MA, Salim FH, et al. Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series. Int J Surg, 2019, 68: 134-141.
12. Park YK, Song SK, Kim BW, et al. Prognostic significance of microvascular invasion in tumor stage for hepatocellular carcinoma. World J Surg Oncol, 2017, 15(1): 225.
13. Powerski MJ, Erxleben C, Scheurig-Münkler C, et al. Hepatopulmonary shunting in patients with primary and secondary liver tumors scheduled for radioembolization. Eur J Radiol, 2015, 84(2): 201-207.
14. Metcalfe C, Avery K, Berrisford R, et al. Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial. Health Technol Assess, 2016, 20(48): 1-68.
15. Blencowe NS, Strong S, McNair AG, et al. Reporting of short-term clinical outcomes after oesophagectomy: A systematic review. Ann Surg, 2012, 255(4): 658-666.
16. Verhage RJ, Hazebroek EJ, Boone J, et al. Minimally invasive surgery compared to open procedures in esophagectomy for cancer: A systematic review of the literature. Minerva Chir, 2009, 64(2): 135-146.
17. Avery KNL, Metcalfe C, Berrisford RG, et al. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer—The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study: Protocol for a randomized controlled trialsive or Open) study: Protocol for a randomized controlled trial. Trials, 2014, 15: 200-209.
18. de Salis I, Tomlin Z, Toerien M, et al. Qualitative research to improve RCT recruitment: Issues arising in establishing research collaborations. Contemp Clin Trials, 2008, 29(5): 663-670.
19. Sarker S, Chang A, Albrani T, et al. Contructing hierarchical task analysis in surgery. Surg Endosc, 2008, 22(1): 107-111.
20. Core Outcome Measures in Effectiveness Trials. URL: https://www.comet-initiative.org/. Accessed on 2021-07-09.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

The methodological framework of surgical innovation: The empirical evidence of IDEAL framework

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