This is an application for the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania Medical Center to serve as the Biostatistics Support Center (BSC) for the Chronic Prostatitis Clinical Research Group (CPCRG). In order to investigate etiologic, diagnostic, prognostic and therapeutic hypotheses for Chronic Abacterial Prostatitis-Chronic Pelvic Pain Syndrome (CPPS), the BSC will provide administrative, biostatistical, epidemiological and data management leadership for the CPCRG in the design/conduct of collaborative research programs. During Phase I, the BSC will guide (i) the design of an observational, longitudinal Chronic Prostatitis Data Base (CPDB) Study, recruitment of eligible patients into the CPDB Study, and collection of extensive data on symptoms, functional status, quality of life, and laboratory specimens. The BSC will provide epidemiological and biostatistical expertise in study design, pain measurement, and methods (ii) to study patient self-reported symptoms, develop and validate survey instruments, produce a symptom severity index of CPPS, and validate the diagnostic criteria established by the NIDDK workshop panel on CPPS. The BSC will also guide (iii) the development of validation protocols to study objective diagnostic findings in men with CPPS, investigate the validity of state-of-the-art laboratory techniques, and develop and conduct standardized protocols for studies of the biological characteristics of semen and expressed prostatic secretions (EPS). The BSC will assist the CPCRG (iv) to develop and validate outcomes measures for CPPS, including indices of pain and quality of life that are responsive to longitudinal change. During Phase II, the BSC will collaborate with the CPCRG to develop protocols and conduct clinical trials and other epidemiological studies of CPPS. The BSC will provide an efficient data management system, accessible through the popular World Wide Web (WWW) technology deployed on existing hardware at the Clinical Research Centers (CRCs), to facilitate data entry, verification and validation at the CRCs, and secure data transmission over the internet to the CPDB server at the BSC. This system will support subject enrollment, randomization and data collection at the CRCs, and tracking of subjects, data, and specimens at the BSC. The BSC will execute procedures for data security and access, data quality control, storage and back-up, and will provide periodic reports of accrual, follow-up, and data quality. The BSC will organize meetings of the Steering Committee, coordinate the development and distribution of the Protocol and Manual of Operations for the longitudinal CPDB, for each of the validation protocols and for each of the clinical trials/studies. The BSC also will conduct training sessions for the research coordinators, conduct data quality site visits to the CRCs, and provide the Steering Committee with interim data summaries, final statistical analyses and collaboration on all scientific publications.
