Core Outcome Set Measurement Selection for Recurrent Acute and Chronic Pancreatitis

Core outcome set (COS) was previously established for recurrent acute and chronic pancreatitis, identifying pain severity, ability to participate in social roles and activities, and pancreatitis-related hospitalizations or acute attacks as mandatory domains for clinical trials.This study aimed to identify and evaluate candidate patient-reported outcome measures (PROMs) for core outcome domains in recurrent acute and chronic pancreatitis by assessing their psychometric properties, with the goal of informing outcome selection for clinical trials. Available psychometric evidence was used to inform evaluation of candidate PROMs across core outcome domains including the COMPAT-SF, Brief Pain Inventory (BPI/BPI-SF), PROMIS Pain Interference (PROMIS-PI), PEI-Q, and PROMIS Social Roles and Activities (SRA) Short Form. PROMs were assessed for psychometric properties including validity, reliability, and responsiveness using established psychometric principles. Findings were integrated to support evidence-informed recommendations for PROMs selection in RAP and CP clinical trials. COMPAT-SF and BPI/BPI-SF are recommended for pain assessment, PEI-Q for exocrine insufficiency, and PROMIS SRA for social role participation. The Patient Global Impression of Change (PGIC) has been broadly accepted and frequently used in clinical trials to support meaningful within-patient change. Adoption of these validated instruments will enhance consistency, patient-centeredness, and the quality of outcomes in future research and therapeutic development for RAP and CP.