Welcome Georgios Papachristou (University of Pittsburgh) Introduction to CAPER David Whitcomb (University of Pittsburgh) Review of Acute Pancreatitis Registry Previous experience with collaborative studies Vikesh Singh (Johns Hopkins University) Discussion among participants
Introduction to CAPER
Acute Pancreatitis Registry “An international multicenter collaboration”
Acute Pancreatitis Registry • Design, Objectives • Observational prospective study • Development of a large cohort of pts to study: o Severity Risks (Age, Gender, Obesity) o Biomarkers & Scores (BUN, Hct, SIRS) o Management (IV Fluids, ICU, Nutritional Support, Interventions) o Severity Classification (RAC, DBC) o Outcomes (OF, PNec, LOS, Mortality)
• Pilot Study • Platform for future collaborations for RCTs and funding
Practical points • Approval by Ethics Committee o Are any centers with active IRB? o This is a minimal risk (non-interventional) study o Data transfer agreement if applicable
• Identification of eligible patients o UPMC: Lipase reports, PB service o Other options: through the ER
• Prospective data collection o Timely recording
• Access and technical aspects of REDCap
• Secure web based application for managing online databases • FDA CFR Part 11 compliance / HIPAA compliance central data repository in University of Pittsburgh Servers • Access: Secure unique access, Data trails
• Data Access Groups • Training for coordinators
• Reviewing data collection, progress
• Data import, export • Data extraction, Analysis
Previous experience
Questioners Demographics • Age/Sex/Race/BMI • Charlson Comorbidity Index • Smoking/Alcohol • Pre-existing DM Medications • NSAIDS use the last 7 days • Statin use
Questioners AP characteristics • Etiology • Number of prior AP episodes • Date and time of pain onset • Date and time of Initial Admission • Transfer status Early prognostic markers and scores • BUN • HCT On admission and 24 hours • CRP • SIRS
Questioners Management • IV Fluids in the first 24hrs • ICU care • Nutritional support • Early intervention within 2 weeks • Delayed drainage/debridement
Questioners Clinical Outcomes • Organ Failure • Pancreatic Necrosis • Symptomatic local complications • Duration of parenteral narcotics • Total hospital LOS • Mortality • Revised Atlanta Classification • Determinant-based classification
Questioners F/u btw 30 and 90 days: • Number of ER visits related to AP since discharge • Number of hospitalizations related to AP since discharge • New onset diabetes • Medications (0=n, 1=insulin, 3=oral antidiabetic drugs) • Pancreatic insufficiency (PI) • Pancreatic enzymes
Step#2 within 2 weeks • Via e-mail: • Confirm interest in participating • Provide feedback on Protocol and Questioners (available on CAPER website) • Assign PI and “research coordinator” • Progress with IRB & Data transfer Agreement • Plan for patient identification & follow-up
Step#3 in 1 month • Follow up Webinar with each center’s PI/Research coordinator participating • Potential date Saturday, April 4th at the same time
Acute Pancreatitis Registry. âAn international multicenter collaborationâ. Page 4 of 18. CAPER AP registry Webinar.pdf. CAPER AP registry Webinar.pdf. Open.
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