Patient reported outcomes in acute pancreatitis

An international prospective cohort study

Outcome variables in acute pancreatitis

Currently, there is no specific treatment for AP, so the cornerstone for the management of AP are supportive measures: analgesia, fluid therapy and nutritional support. When testing new therapies for AP there is an important practical problem: as the variables considered by physicians to be most clinically relevant (persistent organ failure and mortality) occur infrequently (10 and 5% respectively), studies designed to assess the efficacy for new treatments require a very large sample of patients, hundreds or thousands, which in many cases discourages researchers. Although variables like mortality are obviously important, there may be other variables that are important for the patients.

Patient Reported Outcome Measures

The patient should be considered as the center of any health system. PROMS (Patient Reported Outcome Measures) has been defined as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else (1). PROMS are gaining importance as a tool to design outcome variables. Interventions based on PROMS have been associated to increased adherence and better results (2).

(1) U.S Department of Health and Human Services Food and Drug Administration Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; U.S. FDA, Clinical/Medical. 2009

(2) Crossing the Quality Chasm-A New Health System for the 21st Century. 1st Ed. Washington, DC: National Academies Press; 2001. Institute of Medicine,