[1] Agency for Healthcare Research and Quality. Registries for Evaluating Patient Outcomes: A User's Guide | Effective Health Care Program[EB/OL].(2007-05-16)[2022-08-01]. https://effectivehealthcare.ahrq.gov/products/registries-guide/research/. [2] International Medical Device Regulators Forum. International Medical Device Regulators Forum. Principles of International System of Registries Linked to Other Data Sources and Tools[EB/OL].(2016-09-30)[2022-08-01]. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160930-principles-system-registries.pdf. [3] ZHENG CS, LIU BY, FANG YG.Analysis of the research status of registry-based randomized controlled trials[J]. Journal of Traditional Chinese Medicine, 2020, 61(12): 1054-1058. [4] International Medical Device Regulators Forum. Methodological Principles in the Use of International Medical Device Registry Data | International Medical Device Regulators Forum[EB/OL](2017-03-16)[2022-08-01]. https://www.imdrf.org/documents/methodological-principles-use-international-medical-device-registry-data. [5] International Medical Device Regulators Forum. Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making[EB/OL].(2018-03-27)[2022-08-01]. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-180327-usability-tools-n46.pdf. [6] U.S. Food & Drug Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices[EB/OL].(2017-08-31)[2022-08-01]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices. [7] National Medical Product Administration. Announcement of Technical Guidelines of Real-world Data for Clinical Evaluation of Medical Devices (on Trial) (No. 77 of2020) [EB/OL]. (2020-11-26)[2022-08-01]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201126090030150.html. [8] BRINDIS RG, FITZGERALD S, ANDERSON HV, et al.The American college of cardiology-national cardiovascular data registry (ACC-NCDR): building a national clinical data repository[J]. J Am Coll Cardiol, 2001, 37(8): 2240. [9] ACHARYA T, SALISBURY AC, SPERTUS JA, et al.In-hospital outcomes of percutaneous coronary intervention in America's Safety Net: insights from the NCDR Cath-PCI Registry[J]. JACC Cardiovasc Interv, 2017, 10(15): 1475-1485. [10] GILL DRJ, PAGE RS, GRAVES SE, et al.The rate of 2nd revision for shoulder arthroplasty as analyzed by the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR)[J]. Acta Orthop, 2021, 92(3): 258-263. [11] PAXTON EW, INACIO M, SLIPCHENKO T, et al.The kaiser permanente national total joint replacement registry[J]. Perm J, 2008, 12(3): 12-16. [12] BLOEMHEUVEL EM, VAN STEENBERGEN LN, SWIERSTRA BA.Low revision rate of dual mobility cups after arthroplasty for acute hip fractures: report of 11,857 hip fractures in the Dutch Arthroplasty Register (2007-2019)[J]. Acta Orthop, 2020, 92(1): 35-38. [13] Cookies on GOV. UK. National Joint Registry Annual Report 2020[EB/OL].(2020-10-19)[2022-08-01]. https://data.gov.uk/dataset/a4e819dc-b08c-4e7b-a617-b60d1fb34b6f/national-joint-registry-annual-report-2020. [14] CARROLL JD, MACK MJ, VEMULAPALLI S, et al.STS-ACC TVT registry of transcatheter aortic valve replacement[J]. Ann Thorac Surg, 2021, 111(2): 701-722. [15] NOORI VJ, ARANSON NJ, MALAS M, et al.Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative[J]. J Vasc Surg, 2021, 73(3): 975-982. [16] CRONENWETT JL, KRAISS LW, CAMBRIA RP.The society for vascular surgery vascular quality initiative[J]. J Vasc Surg, 2012, 55(5): 1529-37. [17] Canadian Institute for Information. Hip and Knee Replacements in Canada: CJRR Annual Report,2020-2021[EB/OL].(2022-06-02)[2022-08-01]. https://www.cihi.ca/sites/default/files/document/hip-knee-replacements-in-canada-cjrr-annual-report-2020-2021-en.pdf. [18] BOHM ER, DUNBAR MJ, BOURNE R.The Canadian joint replacement registry-what have we learned?[J]. Acta Orthop, 2010, 81(1): 119-121. [19] BOURKE BM, BEILES CB, THOMSON I, et al.Development of the australasian vascular surgical Audit[J]. J Vasc Surg, 2012, 55: 164-170. [20] BEILES CB, WALKER S.Mortality after open aortic aneurysm surgery by Australasian surgeons trained in the endovascular era[J]. ANZ J Surg, 2016, 86(7-8): 544-548. [21] CARROLL JD, EDWARDS FH, MARINAC-DABIC D, et al.The STS-ACC transcatheter valve therapy national registry a new partnership and infrastructure for the introduction and surveillance of medical devices and therapies[J]. Journal of the American College of Cardiology, 2013, 62(11): 1026-1034. [22] SEDRAKYAN A, PAXTON EW, PHILLIPS C, et al.The international consortium of orthopaedic registries: overview and summary[J]. J Bone Joint Surg Am, 2011, 93(3): 1-12. [23] BECK AW, SEDRAKYAN A, MAO J, et al.International consortium of vascular registries. variations in abdominal aortic aneurysm Care: A report from the international consortium of vascular registries[J]. Circulation, 2016, 134(24): 1948-1958. [24] Vascular Society. Vascular Society for Great Britain and Ireland[EB/OL].(2022-07-06)[2022-08-01]. https://www.vascularsociety.org.uk/default.aspx. [25] TAN J, CHENG LL, WANG W, et al.Real world study using observational designs: plan for patient registry study and development of registry database[J]. Chinese Journal of Evidence-Based Medicine, 2017, 17(12): 1365-1372. [26] TAN J, PENG XX, SHU XC, et al.Technical guidance for developing patient registry databases[J]. Chinese Journal of Evidence-Based Medicine, 2019, 19(7): 771-778. [27] ZHOU L, OUYANG WW, LI G, et al.Analysis of the current situation of registry studies in China[J]. Chinese Journal of Evidence-Based Medicine, 2019, 19(6): 702-707. [28] HUO Y, LIU ZP.Construction and prospection of percutaneous coronary intervention quality control system[J]. Tianjin Medical Journal, 2015, 43(8): 833-836. [29] YU Y, ZHAI W, LIN W, et al.Current status and analysis of overseas and domestic medical device registry study[J]. China Medical Device Information, 2021, 27(1):1-3, 167. [30] YAO HW, LI XW, CUI L, et al.Annual report of Chinese colorectal cancer surgery database in 2019: a nationwide registry study[J]. Chinese Journal of Practical Surgery, 2020, 40(1):106-110, 116. [31] ClinicalTrials.gov. A multi-center registry study: the follow-up the complications for trans-vaginal mesh surgery full text view[EB/OL].(2019-07-23)[2022-08-02]. https://clinicaltrials.gov/ct2/show/NCT04025047?term=mesh&recrs=a&cond=Pelvic+Organ+Prolapse&draw=2&rank=4. [32] Ministry of Industry and Information Technology, et al. Notice of ten departments on printing and distributing the 14th Five-year Plan for the Development of Medical Equipment Industry[EB/OL].(2021-12-21)[2022-08-02]. http://www.gov.cn/zhengce/zhengceku/2021-12/28/content_5664991.htm. [33] Gov. Opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices[EB/OL].(2017-10-08)[2022-08-02]. http://www.gov.cn/zhengce/2017-10/08/content_5230105.htm. [34] Gov. The 14th Five-Year National Plan on Drug Safety and High-quality Development Promoting[EB/OL].(2022-01-02)[2022-08-02]. http://www.gov.cn/xinwen/2022-01/02/content_5667258.htm. [35] WANG YJ, JING J, MENG X, et al.The third China national stroke registry (CNSR-III) for patients with acute ischaemic stroke or transient ischaemic attack: design, rationale and baseline patient characteristics[J]. Stroke Vasc Neurol, 2019, 4(3): 158-164. [36] GU DC, ZHEN Z, ZHAO W, et al.Establishment of Chinese cardiovascular surgery registry database[J]. Chinese Circulation Jurnal, 2017, 232(10): 1010-1014. [37] State Administration for Market Regulation. Administrative measures for monitoring and reevaluation of adverse events of medical devices[EB/OL].(2018-08-13)[2022-08-02]. https://gkml.samr.gov.cn/nsjg/bgt/202106/t20210624_331375.html. [38] ZHANG L, JIA W, JI N, et al.Construction of the national brain tumor registry of China for better management and more efficient use of data: a protocol[J]. BMJ Open, 2021, 11(1): e040055. [39] U.S. Food and Drug Administration. Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment[EB/OL].(2005-03-22)[2022-08-02]. https://www.fda.gov/media/71546/download. |