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加拿大乳房植入物登记处的建议。

Recommendations for a Canadian Breast Implant Registry.

作者信息

Rea Victoria M S, Gowda Raveena, Nicholson Emma, Isaac Kathryn V

机构信息

Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.

Department of Surgery, Division of Plastic Surgery, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

Plast Surg (Oakv). 2025 Jul 15:22925503251355977. doi: 10.1177/22925503251355977.

Abstract

Use of breast implants has nearly doubled for reconstructive and aesthetic surgery throughout North America. This growing demand highlights the need for breast implant registries to monitor safety and quality of care. Despite wide adoption of implant registries in other countries, there is currently no Canadian system to track implantation of breast prostheses. This review aimed to inform the development and implementation of a Canadian breast implant registry (BIR). A systematic review was conducted to include searches of Medline Ovid, Web of Science, Embase Ovid and grey literature databases. Data were extracted for: patient participation, registry structure, data quality, funding and reporting outputs. Of 1577 articles, a total of 19 met inclusion criteria. The Dutch, Australian, American, German, United Kingdom and Korean implant registries were analyzed. Opt-out systems were commonly used and correlated with higher capture rates. Data input relied on physician or surgeon data entry. Funding was private for the Dutch BIR through a patient or insurance surcharge, and government funding was used in the United Kingdom, Australian and Korean registries. Finally, all registries disseminated outcomes via annual reports. Based on strategies used in existing registries, it is recommended a Canadian BIR have an opt-out structure, funding from a combination of government or private stakeholders, use a standardized data set and annual reporting.

摘要

在北美,用于重建和美容手术的乳房植入物使用量几乎翻了一番。这种不断增长的需求凸显了建立乳房植入物登记系统以监测护理安全性和质量的必要性。尽管其他国家广泛采用了植入物登记系统,但目前加拿大尚无跟踪乳房假体植入情况的系统。本综述旨在为加拿大乳房植入物登记处(BIR)的开发和实施提供参考。进行了一项系统综述,包括检索Medline Ovid、Web of Science、Embase Ovid和灰色文献数据库。提取了以下数据:患者参与情况、登记结构、数据质量、资金和报告产出。在1577篇文章中,共有19篇符合纳入标准。对荷兰、澳大利亚、美国、德国、英国和韩国的植入物登记处进行了分析。通常采用退出系统,且退出系统与更高的捕获率相关。数据输入依赖于医生或外科医生的数据录入。荷兰BIR的资金来自患者或保险附加费,属于私人性质,而英国、澳大利亚和韩国的登记处则使用政府资金。最后,所有登记处都通过年度报告公布结果。基于现有登记处采用的策略,建议加拿大BIR采用退出结构,由政府或私人利益相关者联合提供资金,使用标准化数据集并进行年度报告。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40fe/12264254/5103925a3eb9/10.1177_22925503251355977-fig1.jpg

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