Evaluation of the PAN-PROMISE Symptom Scale in a Randomized Controlled Trial of Fluid Resuscitation in Acute Pancreatitis.

Abstract

Introduction: The PAN-PROMISE symptom score is the first patient-reported outcome in acute pancreatitis (AP). It was developed and validated in a prospective cohort of patients to be used as an endpoint in research. The aim of this study was to assess the performance of the score in a large randomized controlled trial and its association with well-established AP endpoints.

Methods: This is an ancillary study of the WATERFALL trial, where PAN-PROMISE was evaluated at baseline, 24, 48, and 72 hours. The study examined the association between PAN-PROMISE with established endpoints in AP: severity, pancreatic and/or peripancreatic fat necrosis (necrosis), infected necrosis, intensive care unit admission, persistent organ failure, prolonged hospital stay, and mortality. Areas under the receiver operating characteristic curve were calculated and used to compare baseline PAN-PROMISE and baseline Bedside Index for Severity in AP (BISAP) for the prediction of these endpoints.

Results: In total, 248 patients from the WATERFALL trial were included. A statistically significant association was found between PAN-PROMISE and severity, necrosis, persistent organ failure, intensive care unit admission, and prolonged hospital stay at all checkpoints ( P < 0.05). Higher scores were also significantly associated with infected pancreatic necrosis at 24, 48, and 72 hours and death at baseline and 24 hours. The PAN-PROMISE baseline score had slightly higher areas under the receiver operating characteristic curve than BISAP for severity and necrosis, but the results were not statistically significant.

Discussion: In the context of a randomized controlled trial, the PAN-PROMISE score, a patient-centered measure, has been validated with established AP outcomes and as an endpoint for future clinical trials.