1 This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the 2 University of Pennsylvania Perelman School of Medicine to continue to serve as the Data 3 Coordinating Core (DCC) for the Multi-disciplinary Approach to the Study of Chronic Pelvic Pain 4 (MAPP) Research Network. This proposal brings together a highly experienced DCC team, 5 currently supporting the NIDDK's MAPP Research Network (www.mappnetwork.org), 6 including urology co-investigators with extensive expertise in chronic pelvic pain, chronic 7 prostatitis, and interstitial cystitis. The DCC will continue to provide biostatistical study design 8 and analysis support, comprehensive data management and research computing services for 9 ongoing and new protocols, selected Discovery Site projects, and close collaboration with the 10 Tissue Analysis &Technology Core (TATC).
The specific aims of the DCC are to 1) provide 11 scientific leadership and coordination in the design and implementation of inter-disciplinary 12 research projects across the MAPP Research Network~ 2) provide biostatistical expertise in 13 research designs, outcome measures and analytical strategies for clinical and translational 14 research investigations of urologic chronic pelvic pain syndromes (UCPPS)~ 3) provide 15 comprehensive DCC administrative support for the MAPP Research Network, promoting effective 16 communications, coordinating teleconferences, meetings, working groups, and document 17 development and management~ 4) collaborate with the Tissue Analysis and Technology Core 18 (TATC) on best practices for data collection, specimen tracking and storage, as well as to 19 support technical processes between the DCC and TATC~ 5) promote network-wide quality 20 assurance standards, practices and tools, including a comprehensive, secure www-based data 21 management system (DMS) for collection and centralized storage of all multi-site study data~ 6) 22 support the MAPP Research Network Ancillary Projects, assisting in their design, as well as 23 implementing a process for the submission, review and development of ancillary studies~ 7) 24 establish a new MAPP Network Integrated Basic/Translational Science Working Group to develop 25 collaborative basic cellular and molecular scientific studies of UCPPS that are ancillary to current 26 network protocols and complementary to the network's overall study goals. The DCC will 27 continue to leverage their considerable biostatistical and scientific expertise, coordinating and 28 project leadership, as well as urological expertise, to promote DCC best practices for the ongoing 29 conduct of clinical and translational science research projects, and design and planning for MAPP 30 Phase II protocols within the MAPP Research Network.
Ongoing MAPP epidemiological studies have shown that other conditions that share chronic pain as a major symptom are often associated with Urologic Chronic Pelvic Pain Syndrome (UCPPS), including fibromyalgia (FM), irritable bowel syndrome (IBS), and chronic fatigue syndrome (CFS). Emerging intriguing associations, and their implications for UCPPS symptom improvement or worsening, are still underway within extensive data analyses being conducted by the MAPP Data Coordinating Core (DCC) team, and have not been adequately addressed. In particular, risk factor implications of biomarkers, infectious etiological agents, and neuroimaging findings are still being investigated.
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