Bradley Catherine S, Visco Anthony G, Weber LeBrun Emily E, Barber Matthew D
From the *Carver College of Medicine, University of Iowa, Iowa City, IA; †Duke University, Durham, NC; ‡University of Florida College of Medicine, Gainesville, FL; and §Cleveland Clinic, Cleveland, OH.
Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):77-82. doi: 10.1097/SPV.0000000000000254.
Pelvic organ prolapse (POP) is a common problem that negatively impacts women's quality of life. A variety of surgeries exist for POP treatment, including procedures performed with and without mesh augmentation. The growing use of mesh in prolapse surgeries in the 2000s was associated with increasing reports of complications, resulting in Food and Drug Administration (FDA) Safety Notifications, and in 2012, the FDA ordered transvaginal mesh manufacturers to conduct prospective studies to evaluate longer-term outcomes. These requirements provided incentives and an environment conducive to collaboration. American Urogynecologic Society leaders collaborated with device manufacturers, the FDA, and other professional organizations to establish the Pelvic Floor Disorders Registry (PFDR), a collection of interrelated registries, which could meet manufacturers' needs but also allow surgeons to track individual and aggregate outcomes for quality improvement. The PFDR was developed and launched by American Urogynecologic Society with objectives of (1) collecting, storing, and analyzing clinical data related to POP treatment; (2) establishing common data elements and quality metrics; and (3) providing a framework for external stakeholders to conduct POP research. The PFDR includes industry-sponsored studies, as well as 2 options for volunteer registry participation, the PFDR-Quality Improvement and PFDR-Research. The PFDR promotes quality improvement and national benchmarking and will provide real-world comparative safety and effectiveness data for prolapse surgeries. The PFDR can serve as a model for collaboration between medical practitioners, researchers, industry, and federal agencies and may allow progress toward our similar goal of high-quality surgical care of women with prolapse.
盆腔器官脱垂（POP）是一个常见问题，会对女性的生活质量产生负面影响。针对POP的治疗有多种手术方式，包括使用和不使用网片增强的手术。21世纪，网片在脱垂手术中的使用日益增加，与此同时并发症报告也越来越多，这导致美国食品药品监督管理局（FDA）发布了安全通知。2012年，FDA命令经阴道网片制造商开展前瞻性研究，以评估长期结果。这些要求提供了激励措施，并营造了有利于合作的环境。美国妇科泌尿学会的领导人与设备制造商、FDA及其他专业组织合作，建立了盆底功能障碍登记处（PFDR），这是一个相互关联的登记处集合，既能满足制造商的需求，又能让外科医生追踪个体和总体结果以改进质量。PFDR由美国妇科泌尿学会开发并推出，其目标包括：（1）收集、存储和分析与POP治疗相关的临床数据；（2）建立通用数据元素和质量指标；（3）为外部利益相关者开展POP研究提供框架。PFDR包括行业赞助的研究，以及志愿者登记参与的两种选择，即PFDR质量改进和PFDR研究。PFDR促进质量改进和全国基准化，并将为脱垂手术提供真实世界的比较安全性和有效性数据。PFDR可以作为医生、研究人员、行业和联邦机构之间合作的典范，并可能有助于我们朝着为脱垂女性提供高质量手术护理的类似目标取得进展。
