Psychometric evaluation of PROMIS® fatigue and cognitive function short forms customized for adults living with primary sclerosing cholangitis.

PURPOSE: The study goal is to evaluate the psychometric properties of Patient-Reported Outcomes Measurement Information System® (PROMIS®) Fatigue and Cognitive Function Short Forms customized for use in adults with primary sclerosing cholangitis (PSC). METHODS: Participants completed a survey through the PSC Partners Patient Registry. The survey included the customized PROMIS short forms, the PROMIS Global Health scale, the PROMIS Sleep-related Impairment short form, and self-reported sociodemographic and clinical data. The factor structure was evaluated with confirmatory factor analysis, and reliability indices included coefficient alpha for internal consistency and intra-class correlations for test-retest reliability. Construct validity was evaluated based on the associations of the customized short forms with related patient-reported outcomes and the ability to differentiate between known groups. RESULTS: Participants included 287 adults, including 55% female, 93% White race, with a mean age of 52 years. Both Fatigue and Cognitive Function short forms were confirmed to be unidimensional, with internal consistency reliability of 0.98 and 0.97, and test-retest reliability of 0.92 and 0.89, respectively. The correlation between Fatigue and Cognitive Function scores was - 0.76, and had strong associations with physical health, mental health, sleep-related impairment, work productivity, and daily activities. Both customized short forms found statistically significantly worse fatigue and cognitive functioning in women, those with cirrhosis, and with a hepatic decompensation event in the past 12 months. CONCLUSION: This study provided strong evidence for the construct validity and reliability of the PROMIS Fatigue and Cognitive Function short forms customized for adults with PSC. These PSC-specific outcome measures will benefit clinical research.