Responsiveness of the Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Measures to Changes in Disease Status and Quality of Life Among Children and Adolescents With Crohn’s Disease

BACKGROUND: PROMIS Pediatric domains provide self-reported measures of physical, emotional, and social health in children with chronic conditions. We evaluated the responsiveness of the PROMIS Pediatric measures to changes in disease activity and disease-specific, health-related quality of life (HRQOL) in children with Crohn's disease (CD). METHODS: IBD Partners Kids & Teens is an internet-based cohort of children with inflammatory bowel disease (IBD). Participants age 9 to 17 report symptoms related to disease activity (short Crohn's Disease Activity Index sCDAI), the IMPACT-III HRQOL measure, and 5 PROMIS Pediatric domains. We conducted longitudinal analyses using mixed linear models to examine the extent to which PROMIS Pediatric measures respond to changes in sCDAI and IMPACT-III. RESULTS: Our study sample included 544 participants with CD (mean age 13 years, 44% female). All PROMIS Pediatric domains responded to changes in sCDAI, indicating improved physical, emotional, and social health, corresponding to improved disease activity and the converse (P < 0.001). Observed effect estimates ranged from 1.8 for peer relationships to 6.8 for fatigue. Of 246 participants with 2 or more completed reports, disease activity was stable in 527, worse in 72, and improved in 67. Changes in PROMIS Pediatric scores were associated with changes in IMPACT-III (r = -0.43 for anxiety, r = -0.45 for depressive symptoms, r = -0.43 for pain interference, r = -0.59 for fatigue, and r = 0.23 for peer relationships). CONCLUSIONS: This study provides evidence for the longitudinal responsiveness of the PROMIS Pediatric measures to change in disease status and HRQOL in pediatric CD patients.