- Fecal Incontinence
|Validity and Responsiveness of the Patient-Reported Outcomes Measurement Information System in Children with Ulcerative Colitis
J Pediatr Gastroenterol Nutr. 2021 Feb 24. doi: 10.1097/MPG.0000000000003101.Online ahead of print.
Erica J Brenner 1, Millie D Long, Courtney M Mann, Li Lin, Wenli Chen, Camila Reyes, Kirsten M Bahnson, Bryce B Reeve, Michael D Kappelman
Objectives: Patient-reported outcome (PRO) 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 (PUCAI)], IMPACT-III health-related quality of life measure, and five PROMIS Pediatric measures (anxiety, depressive symptoms, pain interference, fatigue, and peer relationships). We included participants aged 9-17 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 PUCAI and IMPACT-III.
Results: We evaluated 91 participants with UC (mean age 13 years, 57% female). 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 <0.01), and changes in scores were moderately correlated with changes in IMPACT-III over time (adjusted p values <0.01).
Conclusions: This study provides evidence for the construct validity and longitudinal responsiveness of the PROMIS Pediatric measures in pediatric UC patients, thus supporting their use in clinical research and patient care.