Validity and Responsiveness of the Patient‐reported Outcomes Measurement Information System in Children With Ulcerative Colitis

OBJECTIVES: Patient-reported outcome measures allow children to directly report on their health and well-being. We assessed the construct validity and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric measures in children and adolescents with ulcerative colitis (UC). METHODS: Through the Inflammatory Bowel Disease Partners Kids & Teens' Internet-based cohort, children with UC reported symptoms related to disease activity (Pediatric Ulcerative Colitis Activity Index), IMPACT-III health-related quality of life measure, and 5 PROMIS Pediatric measures (anxiety, depressive symptoms, pain interference, fatigue, and peer relationships). We included participants aged 9 to 17 years and conducted cross-sectional and longitudinal, mixed-linear regression analyses to examine the extent to which PROMIS Pediatric scores are associated with and respond to changes in Pediatric Ulcerative Colitis Activity Index and IMPACT-III. RESULTS: We evaluated 91 participants with UC (mean age 13 years, 57% girls). Better PROMIS Pediatric scores were associated with lower disease activity, in both cross-sectional and longitudinal analyses. For a change from moderate/severe to remission, observed effect estimates were -5.1 points for anxiety, -5.0 for depressive symptoms, -14.7 for pain interference, -13.7 for fatigue, and 5.3 for peer relationships (P < 0.05 for all domains). Better PROMIS Pediatric scores were associated with improved IMPACT-III scores (P values