RTl proposes to serve as the data coordinating center (DCC) for the NICHD Pelvic Floor Disorders Network (PFDN), in support of its mission to improve the care of women with pelvic floor disorders (PFDs) by conducting well-designed, adequately powered studies of diagnosis, prevention, and treatment. We will draw upon our 35 years of experience as a DCC supporting multicenter NIH clinical research networks to provide the Network statistical leadership in study design and data analysis and operational support through data management and logistical services. Specifically, we will (1) collaborate in developing, implementing, and monitoring Network protocols;(2) provide data management, including preparation of public data files;(3) prepare data and safety reports for the Data Safety Monitoring Board and Network committees;(4) collaborate in the analysis of data and publication of results of Network studies;(5) coordinate acquisition of study materials and biological specimen processing;and (6) provide all other logistical support, including Network meetings and communication necessary to run an efficient and productive Network. This application has specific strengths that will enhance the scientific productivity of the PFDN: (1) Scientific leadership of Dr. Dennis Wallace, with more than 18 years experience as a senior clinical biostatistician and Principal Investigator for multisite NIH research networks. (2) Multidisciplinary experts, from RTl and The University of North Carolina, Chapel Hill (UNC), in biostatistics;surgical, behavioral, and quality of life outcomes;cost-effectiveness and program evaluation;and qualitative and quantitative surveys, who will collaborate with PFDN investigators to (a) develop innovative trial designs (conducting formative research for methodological advancements if needed) to address the unique problems in pelvic floor trials;(b) develop and implement new outcome measures;(c) leverage trial data with well-designed secondary observational studies that answer important ancillary questions;and (d) respond quickly to fluctuations in Network analytic needs. (3) A state-of-the art, flexible, and comprehensive web-based distributed data entry and management system that will (a) ensure high-quality data with rapid error resolution and real-time enrollment and adverse event monitoring;(b) provide creative solutions to difficult problems, like collecting patient-reported outcomes;and (c) provide site staff with study management and reporting tools that enhance the scientific quality and efficiency of clinical site trial activities.

Public Health Relevance

The PFDN was established in 2001 to improve the care of women with PFDs by conducting well-designed, rigorous clinical trials and studies of diagnosis, prevention, and treatment. A DCC provides essential biostatistical and clinical trials expertise to such a productive multicenter research enterprise and ensures standardized study design and development, and data collection and analyses, using independent statistical expertise to formulate, design, monitor, and analyze RCTs and provides communications and logistical support between the disparate clinical sites to optimize the efficiency and productivity of the Network.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZHD1-DSR-N (02))
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Parrott, Estella C
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Research Triangle Institute
Research Triangle
United States
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Jelovsek, J Eric; Chagin, Kevin; Lukacz, Emily S et al. (2018) Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery. Obstet Gynecol 132:298-309
Jelovsek, J Eric; Barber, Matthew D; Brubaker, Linda et al. (2018) Effect of Uterosacral Ligament Suspension vs Sacrospinous Ligament Fixation With or Without Perioperative Behavioral Therapy for Pelvic Organ Vaginal Prolapse on Surgical Outcomes and Prolapse Symptoms at 5 Years in the OPTIMAL Randomized Clinical Trial. JAMA 319:1554-1565
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