Real world study and its potential application in hernia and abdominal wall surgery

doi:10.3877/cma.j.issn.1674-392X.2021.02.001

Abstract

Abstract:

In recent years, real word study gets attention extensively, and has become one of the important evidence sources affecting clinical practice. There is a huge amount of hernia operations and a large number of real world data in China. Furthermore, with the official launch of Chinese Hernia College Registry and Follow-up System in 2017, a solid foundation for the real world study has been established. This review introduces basic concepts, study designs and statistical analysis methods of real world study. The application value and practical instructions in hernia and abdominal wall surgery is explored,to provide reference for surgeons to understand and conduct real world study correctly.

Key words: Real world study, Hernia and Abdominal wall Surgery, Clinical practice, Potential application

Cuihong Jin, Yingmo Shen, Changfu Qin, Jie Chen. Real world study and its potential application in hernia and abdominal wall surgery[J]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2021, 15(02): 119-122.

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References 41

[1]	Vere J, Gibson B. Evidence-based medicine as science[J]. J Eval Clin Pract, 2019, 25(6): 997-1002.
[2]	Ammenwerth E. Evidence-based Health informatics: how do we know what we know?[J]. Methods Inf Med, 2015, 54(4): 298-307.
[3]	Hager A, Lindblad S, Brommels M, et al. Sharing patient-controlled real-world data through the application of the theory of commons: action research case study[J]. J Med Internet Res, 2021, 23(1): e16842.
[4]	HerniaSurge Group. International guidelines for groin hernia management.[J]. Hernia, 2018, 22(1): 1-165.
[5]	Kyle-Leinhase I, Köckerling F, Jørgensen LN, et al. Comparison of hernia registries: the CORE project[J]. Hernia, 2018, 22(4): 561-575.
[6]	Gouws J, Nel D, Bougard HC, et al. Building a national hernia registry in South Africa: initial ventral hernia repair results from a diverse healthcare sector[J]. Hernia, 2020.
[7]	Stechemesser B, Jacob DA, Schug-Paβ C, et al. Herniamed: an internet-based registry for outcome research in hernia surgery[J]. Hernia, 2012, 16(3): 269-276.
[8]	秦昌富，申英末，李炳根, 等. 中国疝病注册登记随访系统发展现状及数据初步分析[J]. 中华消化外科杂志, 2018, 17(11): 1087-1089.
[9]	Köckerling F, Maneck M, Günster C, et al. Comparing routine administrative data with registry data for assessing quality of hospital care in patients with inguinal hernia[J]. Hernia, 2020, 24(1): 143-151.
[10]	Helgstrand F, Thygesen LC, Bisgaard T, et al. Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance[J]. Br J Surg, 2020, 107(9): 1130-1136.
[11]	Baumfeld Andre E, Reynolds R, Caubel P, et al. Trial designs using real-world data: the changing landscape of the regulatory approval process.[J]. Pharmacoepidemiol Drug Saf, 2020, 29(10): 1201-1212.
[12]	Breckenridge AM, Breckenridge RA, Peck CC. Report on the current status of the use of real-world data(RWD) and real-world evidence(RWE) in drug development and regulation[J]. Br J Clin Pharmacol, 2019, 85(9): 1874-1877.
[13]	Snyder JM, Pawloski JA, Poisson LM. Developing real-world evidence-ready datasets: time for clinician engagement[J]. Curr Oncol Rep, 2020, 22(5): 45.
[14]	Makady A, de Boer A, Hillege H, et al. What is real-world data? a review of definitions based on literature and stakeholder interviews[J]. Value Health, 2017, 207(7): 858-865.
[15]	Jin F, Yao C, Yan X, et al. Gap between real-world data and clinical research within hospitals in China: a qualitative study[J]. BMJ Open, 2020, 10(12): e038375.
[16]	Lavigne JE, Lagerberg T, Ambrosi JW, et al. Study designs and statistical approaches to suicide and prevention research in real-world data[J]. Suicide Life Threat Behav, 2021 Feb;51(1): 127-136.
[17]	Fang Y, He W, Wang H, et al. Key considerations in the design of real-world studies[J]. Contemp Clin Trials, 2020, 96: 106091.
[18]	Basu A, Axelsen K, Grabowski DC, et al. Real-world data: policy issues regarding their access and use[J]. Med Care, 2016, 54(12): 1038-1044.
[19]	李春晓，陈玉欢，凌霄, 等. 基于真实世界大数据的中药注射剂比较效益研究方法的思考[J]. 中医杂志, 2020, 61(14): 1234-1237, 1241.
[20]	吴丽娜，谢雁鸣，刘峘, 等. 结肠恶性肿瘤证候分布及用药特点的真实世界研究[J]. 中国中药杂志, 2020, 45(5): 1174-1179.
[21]	Köckerling F, Lorenz R, Hukauf M, et al. Influencing factors on the outcome in female groin hernia repair: a registry-based multivariable analysis of 15601 patients[J]. Ann Surg, 2019, 270(1): 1-9.
[22]	童松贵，杨洁. 腹股沟嵌顿斜疝发生的危险因素及不同手术方式的治疗效果[J/OL]. 中华疝和腹壁外科杂志(电子版), 2020, 14(4): 424-427.
[23]	李征威，张玉新，王磊, 等. 成人腹股沟嵌顿疝发生肠坏死的危险因素分析[J/OL]. 中华疝和腹壁外科杂志(电子版), 2020, 14(4): 433-437.
[24]	Perez AJ, Strassle PD, Sadava EE, et al. Nationwide analysis of inpatient laparoscopic versus open inguinal hernia repair[J]. J Laparoendosc Adv Surg Tech A, 2020, 30(3): 292-298.
[25]	RanaG, Armijo PR, Khan S, et al. Outcomes and impact of laparoscopic inguinal hernia repair versus open inguinal hernia repair on healthcare spending and employee absenteeism[J]. Surg Endosc, 2020, 34(2): 821-828.
[26]	Bullen NL, Massey LH, Antoniou SA, et al. Open versus laparoscopic mesh repair of primary unilateral uncomplicated inguinal hernia: a systematic review with meta-analysis and trial sequential analysis[J]. Hernia, 2019, 23(3): 461-472.
[27]	Ramjist JK, Dossa F, Stukel TA, et al. Reoperation for inguinal hernia recurrence in Ontario: a population-based study[J]. Hernia, 2019, 23(4): 647-654.
[28]	Merola G, Cavallaro G, Iorio O, et al. Learning curve in open inguinal hernia repair: a quality improvement multicentre study about Lichtenstein technique[J]. Hernia, 2020, 24(3): 651-659.
[29]	Shibuya S, Fujiwara N, Ochi T, et al. The learning curve of laparoscopic percutaneous extraperitoneal closure(LPEC) for inguinal hernia: protocoled training in a single center for six pediatric surgical trainees[J]. BMC Surg, 2019, 19(1): 6.
[30]	Köckerling F, Hoffmann H, Mayer F, et al. What are the trends in incisional hernia repair? Real-world data over 10 years from the Herniamedregistry[J]. Hernia, 2020.
[31]	Omar YK, Naseem Bou-Ayash, Fahri Gokcal. Robotic transabdominalpreperitoneal repair of complex inguinal hernias[J]. Inter J Abdominal Wall Hernia Surg, 2021, 4(1): 1-6.
[32]	Carbonell AM, Warren JA, Prabhu AS, et al. Reducing length of stay using a robotic-assisted approach for retromuscular ventral hernia repair: a comparative analysis from the americas hernia society quality collaborative[J]. Ann Surg, 2018, 267(2): 210-217.
[33]	LaPinska M, Kleppe K, Webb L, et al. Robotic-assisted and laparoscopic hernia repair: real-world evidence from the Americas Hernia Society Quality Collaborative(AHSQC)[J]. Surg Endosc, 2021, 353(3): 1331-1341.
[34]	Rognoni C, Cuccurullo D, Borsoi L, et al. Clinical outcomes and quality of life associated with the use of a biosynthetic mesh for complex ventral hernia repair: analysis of the "Italian Hernia Club" registry[J]. Sci Rep, 2020, 10(1): 10706.
[35]	Köckerling F, Simon T, Hukauf M, et al. The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes[J]. Ann Surg, 2018, 268(6): 1097-1104.
[36]	Orsini LS, Berger M, Crown W, et al. Improving Transparency to build trust in real-world secondary data studies for hypothesis testing-why, what, and how: recommendations and a road map from the real-world evidence transparency initiative[J]. Value Health, 2020, 23(9): 1128-1136.
[37]	WedamS, Fashoyin-Aje L, Bloomquist E, et al. FDA Approval summary: palbociclib for male patients with metastatic breast cancer[J]. Clin Cancer Res, 2020, 26(6): 1208-1212.
[38]	Wu J, Wang C, Toh S, et al. Use of real-world evidence in regulatory decisions for rare diseases in the United States-Current status and future directions[J]. Pharmacoepidemiol Drug Saf, 2020, 29(10): 1213-1218.
[39]	Schizas D, Apostolou K, Hasemaki N, et al. Obturator hernias: a systematic review of the literature[J]. Hernia, 2020, 251(1): 193-204.
[40]	Sartori A, De Luca M, Noaro G, et al. Rare Intraoperative and postoperative complications after transabdominal laparoscopic hernia repair: results from the multicenter wall hernia group registry[J]. J Laparoendosc Adv Surg Tech A, 2021, 313(3): 290-295.
[41]	Ecker BL, Kuo LE, Simmons KD, et al. Laparoscopic versus open ventral hernia repair: longitudinal outcomes and cost analysis using statewide claims data[J]. Surg Endosc, 2016, 30(3): 906-915.

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