Psychometric Validation of PROMIS Measures in Acute and Chronic Pancreatitis.

OBJECTIVE

Patient-reported outcome (PRO) measures are essential for evaluating symptom burden and quality of life (QoL) in acute and chronic pancreatitis (AP/CP), yet many instruments used in this patient population lack robust psychometric evidence. The Patient-Reported Outcomes Measurement Information System (PROMIS) offers standardized measures designed for comparability across populations, but their suitability for AP/CP has not been comprehensively evaluated. The objective of this study was to assess the psychometric properties of PROMIS-29, PROMIS-Global Health, and PROMIS Pain Quality scales in individuals with AP/CP and provide an overview of psychometric standards that facilitate selection of PROs for use in clinical research and patient care.

METHODS

Data were drawn from 1,927 participants enrolled in PROCEED, a multi-site longitudinal study across the pancreatitis spectrum, including healthy controls, chronic abdominal pain, acute/recurrent acute pancreatitis and definite CP. Factor models and regressions were used to psychometrically evaluate univariate construct validity, known-groups validity, convergent validity, reliability, structural validity and population invariance.

RESULTS

PROMIS measures exceeded all psychometric benchmarks tested. Scores were approximately normally distributed and comprehensively covered the range of each symptom domain. Correlations with other commonly used QoL measures supported convergent validity. PROMIS scores discriminated effectively among diagnostic subgroups and exhibited excellent structural validity and internal consistency reliability. Population invariance assessments indicated that scores are comparable across age, sex, race, and diagnostic subgroups.

CONCLUSIONS

This study provides strong preliminary evidence that PROMIS measures meet rigorous psychometric standards that supports their use in patient research and care in AP/CP. Their adoption may enhance measurement consistency and support core outcome sets in clinical research and trials of AP/CP.