NIDDK Data Repository 10/2010 CPCRN Data Archive The CHRONIC PROSTATITIS COLLABORATIVE RESEARCH NETWORK (CPCRN) data archive contains the study protocol and related descriptive documentation; study forms; and data collected by the study. The data files are organized into the following four directories: 1. Documentation 2. Forms 3. Data 4. Dataset Integrity Check 1. Documentation Directory The Documentation directory contains documentation of the CPCRN protocol and descriptive documentation, including: MOP: a subdirectory containing the Manual of Operation (MOP) o Cohort_Mop.pdf --- the manual of operation for the Chronic Prostatitis Cohort (CPC) Study o cpc-cp.mop.doc --- the manual of operation for the Chronic Prostatitis Cohort Control Patients (CPC-CP) substudy Protocol: a subdirectory containing the following seven files: o CPCprotocol2edition.pdf: the CPC study protocol o cpc_control.doc: the CPC Control Group study protocol o CPC Visit Schedule Amendment.pdf: the Visit Schedule Amendment o ProtocolAmendmentsJan99.pdf: the Protocol Amendment o appendices.doc: the original protocol appendices o appendixa.doc: the protocol appendix A Amendments o appendixfandglab2.doc the protocol appendix F and G Amendments 2. Forms Directory The Forms directory contains the 42 forms used for data collection. The forms are described in Tables 1. Table 1: Study Forms Form bcchk bcrem briefclinic cmed Version 1.0 Description Brief Clinic Contact Checklist Brief Clinic Reminder Brief Clinic Contact Checklist Concomitant Medications 1 NIDDK Data Repository comp cont cpcrn_cohort_data_ entry_forms def dpcs ecchk ecrem epi exam excl extensiveclinic fgtm fgtsc howto ihc incl info lab med miss phone prior ref rein rus schk scr screening semen serum swab sxind tchk telephone track trem uro void with 10/2010 Patient Completion Patient Contact Information CPCRN Cohort Data Entry Forms Deferral Checklist Data Processing Cover Sheet Extensive Clinic Contact Checklist Extensive Clinic Reminder Epidemiologic History Physical Exam Exclusion Checklist Extensive Clinic Contact Checklist Four Glass Test Microscopy Four Glass Test Specimen Cultures How To Complete Your Voiding Log Interim Health Care Inclusion Checklist Uroflow Study - Patient Information Lab Tracking Log Medical History Missing Contact Telephone Log Prior Treatments and Procedures Patient Refusal Log Patient Reinstatement Resource Utilization Survey Screening Contact Checklist Screening Confirmation Screening Contact Checklist Semen Sample Serum Sample Urethral Swab Symptom Index Telephone Contact Checklist Telephone Interview Form that combines the “Telephone Contact Checklist” and “Symptom Index” Forms. Status Tracking Log Telephone Interview Reminder Uroflow Study Voiding Log Patient Withdrawal 3. Data Directory The Data directory contains the CPCRN datasets organized in two subdirectories: 3.1 Datasets Version 1.0 2 NIDDK Data Repository 10/2010 The Datasets subdirectory contains the CPCRN datasets organized in raw data collected by study Forms, as well as analysis datasets by study phases, and the sas program files used for generating the analysis datasets: “rawdata”: subdirectory containing 37 data files collected by the study Forms. The data files with their associated forms are described in Tables 2. Table 2: Study data files with their associated Forms Data file none none none cmed_pckt comp_sngl none none def_pckt none none none epi_pckt exam_pckt excl_pckt none fgtm_pckt fgtsc_pckt fgtsc_pckt_02a fgtsc_pckt_03a fgtsc_pckt_05a fgtsc_pckt_07a fgtsc_pckt_09a fgtsc_pckt_10a fgtsc_pckt_12a fgtsc_pckt_14a none ihc_pckt incl_pckt none none med_pckt none none prior_pckt none rein_sngl Version 1.0 Form bcchk bcrem briefclinic cmed comp cont cpcrn_cohort_da ta_entry_forms def dpcs ecchk ecrem epi exam excl extensiveclinic fgtm fgtsc Description Brief Clinic Contact Checklist Brief Clinic Reminder Brief Clinic Contact Checklist Concomitant Medications Patient Completion Patient Contact Information CPCRN Cohort Data Entry Forms howto ihc incl info lab med miss phone prior ref rein How To Complete Your Voiding Log Interim Health Care Inclusion Checklist Uroflow Study - Patient Information Lab Tracking Log Medical History Missing Contact Telephone Log Prior Treatments and Procedures Patient Refusal Log Patient Reinstatement Deferral Checklist Data Processing Cover Sheet Extensive Clinic Contact Checklist Extensive Clinic Reminder Epidemiologic History Physical Exam Exclusion Checklist Extensive Clinic Contact Checklist Four Glass Test Microscopy Four Glass Test Specimen Cultures 3 NIDDK Data Repository 10/2010 rus_03 rus_05 rus_07 rus_10 rus_form rus_form_log none scr_pckt none semen_pckt semen_pckt_07a semen_pckt_09a serum_pckt swab_pckt sxind_pckt none none rus Resource Utilization Survey schk scr screening semen Screening Contact Checklist Screening Confirmation Screening Contact Checklist Semen Sample serum swab sxind tchk telephone none none uro_pckt void_pckt with track trem uro void with Serum Sample Urethral Swab Symptom Index Telephone Contact Checklist Telephone Interview Form that combines the “Telephone Contact Checklist” and “Symptom Index” Forms. Status Tracking Log Telephone Interview Reminder Uroflow Study Voiding Log Patient Withdrawal “Baseline” o baseline062810: a summary analysis data file for all data collected at baseline. “Longitudinal” o longitude: a summary analysis data file for all data collected at longitudinal study phase “Case control” o anal: a summary analysis data file for all data collected for the “CPC Control Group Study” “mkdata” – this subdirectory contains sas program files used to generate the analysis data files from the raw data collected from the study Forms o “Baseline” o “Longitudinal” o “Case control” formats.sas7bcat – format file for the datasets formats.cport – need description 3.2 SAS programs and results - this subdirectory contains sas program files used to generate the analysis data files from the raw data collected from the study Forms “Baseline” o Demographic and clinical characteristics baseline1final.lst Version 1.0 4 NIDDK Data Repository 10/2010 baseline1final.sas baseline1final.log o Leukocyte and bacterial counts Baseline2final.lst Baseline2final.sas Baseline2final.log “Longitudinal” o longitudinal_final.lst o longitudinal_final.sas o longitudinal_final.log “Case control” o casecon_final.lst o casecon_final.sas o casecon_final.log 4. Data Set Integrity Check (DSIC) The CPCRN Data Archive also contains a report of an examination of the repository for completeness by statisticians and quality control specialists at the Repository. The published data from the CPCRN study were compared to values recalculated from the CPCRN data in the NIDDK repository to check for dataset completeness. Version 1.0 5