The methodological framework of surgical innovation: The interpretation of IDEAL reporting guideline_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

YU Jiajie ^1,2 , Allison Hirst ² , Peter McCulloch ² , SHAN Fei ³ , HU Jiankun ⁴ , SUN Xin ^1,5 , LIU Lunxu ⁶ , LIU Xuemei ⁷ , DONG Nianguo ⁸ , CHEN Jimei ⁹ , QIAO Guibin ¹⁰ , LI Hecheng ¹¹ , LIU Hao ¹² ,  LI Youping ¹

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 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. Department of Cardiac Surgery, 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;
12. Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;

Corresponding author：

LI Youping, Email: yzmylab@hotmail.com

Keywords：

Reporting guideline; IDEAL; framework and recommendation; surgery

DOI：

10.7507/1007-4848.202012079

Video：

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Abstract Full text Figures/Tables Video References Cited by

Adherence to reporting guidelines contributes to report methodology and outcomes of research distinctly and transparently. There are some checklists with specific study types related to surgery on the EQUATOR Network’s website. However, the IDEAL framework focuses on stepwise evaluation of surgical innovation through all stages with some key elements, which those existing guidelines may not mention. This likely results in the inaccuracy in reporting in studies attempting to follow the IDEAL recommendations and suggests a pressing need for IDEAL reporting guidelines. Considering these limitations, the IDEAL developed the IDEAL reporting guidelines between October 2018 and May 2019. The paper aimed to provide interpretation of IDEAL reporting guideline, and promote its understanding and use among Chinese researchers.

Citation： YU Jiajie, Allison Hirst, Peter McCulloch, SHAN Fei, HU Jiankun, SUN Xin, LIU Lunxu, LIU Xuemei, DONG Nianguo, CHEN Jimei, QIAO Guibin, LI Hecheng, LIU Hao, LI Youping. The methodological framework of surgical innovation: The interpretation of IDEAL reporting guideline. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2021, 28(3): 263-270. doi: 10.7507/1007-4848.202012079 Copy

1.	喻佳洁, 陕飞, McCulloch P, 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.
2.	McCulloch P, Feinberg J, Philippou Y, et al. Progress in clinical research in surgery and IDEAL. Lancet, 2018, 392(10141): 88-94.
3.	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.
4.	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.
5.	Bilbro NA, Hirst A, Paez A, et al. 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, 2021, 273(1): 82-85.
6.	Equator network. Available from: https://www.equator-network.org/reportingguidelines.
7.	Agha RA, Borrelli MR, Farwana R, et al. The SCARE 2018 statement: Updating consensus Surgical CAse REport (SCARE) Guidelines. Int J Surg, 2018, 60: 132-136.
8.	Agha RA, Borrelli MR, Farwana R, et al. The PROCESS 2018 statement: Updating consensus Preferred Reporting Of CasE Series in Surgery (PROCESS) Guidelines. Intl J Surg, 2018, 60: 279-282.
9.	Agha R, Abdall-Razak A, Crossley E, et al. STROCSS 2019 guideline: strengthening the reporting of cohort studies in surgery. Int J Surg, 2019, 72: 156-165.
10.	Boutron I, Altman DG, Moher D, et al. CONSORT statement for randomized trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med, 2017, 167: 40-47.
11.	Avery K, Blazeby J, Wilson N, et al. Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study). BMJ Open, 2019, 9: e029574.
12.	How to develop a reporting guideline? Available from https://www.equator-network.org/toolkits/developing-a-reporting-guideline/.
13.	Chen J, Li Y, Wang Z, et al. Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study. BJOG An Int J Obstet Gynaecol, 2018, 125(3): 354-364.
14.	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.
15.	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.
16.	Harvey KL, Mills N, White P, et al. The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction. BMJ Open, 2020, 10(1): e033641.11.
17.	Ludman PF, Moat N, de Belder MA, et al. Transcatheter aortic valve implantation in the United Kingdom. Circulation, 2015, 131(13): 1181-1190.
18.	Merwe AVan Der, Graewe F, Zuhlke A, et al. Penile allotransplantation for penis amputation following ritual circumcision: a case report with 24 months of followup. Lancet, 2017, 390: 1038-1047.
19.	Brannstrom M, Johannesson L, Dahm-Kahler P, et al. First clinical uterus transplantation trial: a six-month report. Fertil Steril, 2014, 101(5): 1228-1236.

1. 喻佳洁, 陕飞, McCulloch P, 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.
2. McCulloch P, Feinberg J, Philippou Y, et al. Progress in clinical research in surgery and IDEAL. Lancet, 2018, 392(10141): 88-94.
3. 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.
4. 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.
5. Bilbro NA, Hirst A, Paez A, et al. 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, 2021, 273(1): 82-85.
6. Equator network. Available from: https://www.equator-network.org/reportingguidelines.
7. Agha RA, Borrelli MR, Farwana R, et al. The SCARE 2018 statement: Updating consensus Surgical CAse REport (SCARE) Guidelines. Int J Surg, 2018, 60: 132-136.
8. Agha RA, Borrelli MR, Farwana R, et al. The PROCESS 2018 statement: Updating consensus Preferred Reporting Of CasE Series in Surgery (PROCESS) Guidelines. Intl J Surg, 2018, 60: 279-282.
9. Agha R, Abdall-Razak A, Crossley E, et al. STROCSS 2019 guideline: strengthening the reporting of cohort studies in surgery. Int J Surg, 2019, 72: 156-165.
10. Boutron I, Altman DG, Moher D, et al. CONSORT statement for randomized trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med, 2017, 167: 40-47.
11. Avery K, Blazeby J, Wilson N, et al. Development of reporting guidance and core outcome sets for seamless, standardised evaluation of innovative surgical procedures and devices: a study protocol for content generation and a Delphi consensus process (COHESIVE study). BMJ Open, 2019, 9: e029574.
12. How to develop a reporting guideline? Available from https://www.equator-network.org/toolkits/developing-a-reporting-guideline/.
13. Chen J, Li Y, Wang Z, et al. Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study. BJOG An Int J Obstet Gynaecol, 2018, 125(3): 354-364.
14. 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.
15. 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.
16. Harvey KL, Mills N, White P, et al. The Pre-BRA (pre-pectoral Breast Reconstruction EvAluation) feasibility study: protocol for a mixed-methods IDEAL 2a/2b prospective cohort study to determine the safety and effectiveness of prepectoral implant-based breast reconstruction. BMJ Open, 2020, 10(1): e033641.11.
17. Ludman PF, Moat N, de Belder MA, et al. Transcatheter aortic valve implantation in the United Kingdom. Circulation, 2015, 131(13): 1181-1190.
18. Merwe AVan Der, Graewe F, Zuhlke A, et al. Penile allotransplantation for penis amputation following ritual circumcision: a case report with 24 months of followup. Lancet, 2017, 390: 1038-1047.
19. Brannstrom M, Johannesson L, Dahm-Kahler P, et al. First clinical uterus transplantation trial: a six-month report. Fertil Steril, 2014, 101(5): 1228-1236.

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