Richter Holly E, Visco Anthony, Brubaker Linda, Sung Vivian, Nygaard Ingrid, Arya Lily, Menefee Shawn, Zyczynski Halina M, Schaffer Joseph, Rogers Rebecca G, Kenton Kimberly, Paraiso Marie F R, Fine Paul, Mazloomdoost Donna, Gantz Marie G
From the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.
Department of Obstetrics and Gynecology, Duke University, Durham, NC.
Urogynecology (Phila). 2024 Oct 1;30(10):854-869. doi: 10.1097/SPV.0000000000001571.
This review aimed to describe research initiatives, evolution, and processes of the Eunice Kennedy Shriver National Institute of Child Health and Human Development-supported Pelvic Floor Disorders Network (PFDN). This may be of interest and inform researchers wishing to conduct multisite coordinated research initiatives as well as to provide perspective to all urogynecologists regarding how the PFDN has evolved and functions.
Principal investigators of several PFDN clinical sites and Data Coordinating Center describe more than 20 years of development and maturation of the PFDN.
Over two decades, the PFDN used an intentionally driven approach to answering clinically important questions to inform the surgical and nonsurgical care of women with pelvic floor disorders (PFDs) including pelvic organ prolapse, urinary incontinence, and fecal incontinence. From its inception, the PFDN refined network procedures and processes affecting trial design, protocol development, and standardization of outcomes and publications. This strategy resulted in a credible, robust, and productive portfolio of randomized clinical trials, secondary analyses, prospective cohort, and supplementary studies emphasizing the use of validated patient-reported outcomes, longer-term outcomes, an increase in translational science aims, and standardized long-term collection of adverse events.
The processes the PFDN has developed and implemented have led to impactful research initiatives in women's PFDs. Patient participants and research coordinators have been an integral part of this contribution. Through consistent funding and committed investigators, the state of science in the surgical and nonsurgical care and understanding of PFD pathophysiology has been advanced.
本综述旨在描述尤妮斯·肯尼迪·施莱佛国家儿童健康与人类发展研究所支持的盆底功能障碍网络(PFDN)的研究计划、发展历程及流程。这可能会引起希望开展多中心协作研究计划的研究人员的兴趣,并为所有妇科泌尿医生提供关于PFDN如何发展及运作的视角。
PFDN多个临床站点的主要研究者及数据协调中心描述了PFDN二十多年的发展与成熟过程。
在二十多年间,PFDN采用了一种有针对性的方法来回答具有临床重要性的问题,以为患有盆底功能障碍(PFD)(包括盆腔器官脱垂、尿失禁和大便失禁)的女性的手术和非手术治疗提供依据。从一开始,PFDN就完善了影响试验设计、方案制定以及结果和出版物标准化的网络程序和流程。这一策略产生了一系列可靠、强大且富有成效的随机临床试验、二次分析、前瞻性队列研究和补充研究,强调使用经过验证的患者报告结局、长期结局、增加转化科学目标以及标准化长期不良事件收集。
PFDN制定和实施的流程已促成了对女性盆底功能障碍具有重大影响的研究计划。患者参与者和研究协调员是这一贡献的重要组成部分。通过持续的资金支持和敬业的研究者,手术和非手术治疗的科学水平以及对盆底功能障碍病理生理学的理解都得到了提升。