Weber LeBrun Emily, Adam Rony A, Barber Matthew D, Boyles Sarah Hamilton, Iglesia Cheryl B, Lukacz Emily S, Moalli Pamela, Moen Michael D, Richter Holly E, Subak Leslee L, Sung Vivian W, Visco Anthony G, Bradley Catherine S
From the University of Florida College of Medicine, Gainesville, FL.
Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):70-6. doi: 10.1097/SPV.0000000000000237.
Pelvic floor disorders affect up to 24% of adult women in the United States, and many patients with pelvic organ prolapse (POP) choose to undergo surgical repair to improve their quality of life. While a variety of surgical repair approaches and techniques are utilized, including mesh augmentation, there is limited comparative effectiveness and safety outcome data guiding best practice. In conjunction with device manufacturers, federal regulatory organizations, and professional societies, the American Urogynecologic Society developed the Pelvic Floor Disorders Registry (PFDR) designed to improve the quality of POP surgery by facilitating quality improvement and research on POP treatments. The PFDR will serve as a resource for surgeons interested in benchmarking and outcomes data and as a data repository for Food and Drug Administration-mandated POP surgical device studies. Provider-reported clinical data and patient-reported outcomes will be collected prospectively at baseline and for up to 3 years after treatment. All data elements including measures of success, adverse events, and surgeon characteristics were identified and defined within the context of the anticipated multifunctionality of the registry, and with collaboration from multiple stakeholders. The PFDR will provide a platform to collect high-quality, standardized patient-level data from a variety of nonsurgical (pessary) and surgical treatments of POP and other pelvic floor disorders. Data from this registry may be used to evaluate short- and longer-term treatment outcomes, patient-reported outcomes, and complications, as well as to identify factors associated with treatment success and failure with the overall goal of improving the quality of care for women with these conditions.
在美国，盆底功能障碍影响着多达24%的成年女性，许多盆腔器官脱垂（POP）患者选择接受手术修复以改善生活质量。虽然采用了多种手术修复方法和技术，包括网片增强术，但指导最佳实践的比较有效性和安全性结果数据有限。美国妇科泌尿学会与设备制造商、联邦监管机构和专业协会合作，开发了盆底功能障碍登记处（PFDR），旨在通过促进POP治疗的质量改进和研究来提高POP手术的质量。PFDR将作为对基准和结果数据感兴趣的外科医生的资源，以及作为美国食品药品监督管理局规定的POP手术设备研究的数据存储库。提供者报告的临床数据和患者报告的结果将在基线时前瞻性收集，并在治疗后长达3年的时间内收集。所有数据元素，包括成功指标、不良事件和外科医生特征，都是在登记处预期的多功能性背景下，并在多个利益相关者的合作下确定和定义的。PFDR将提供一个平台，从POP和其他盆底功能障碍的各种非手术（子宫托）和手术治疗中收集高质量、标准化的患者层面数据。该登记处的数据可用于评估短期和长期治疗结果、患者报告的结果和并发症，以及识别与治疗成功和失败相关的因素，总体目标是提高患有这些疾病的女性的护理质量。
