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.

Duke Scholars

Author Courtney Mann  

Author Bryce B. Reeve Population Health Sciences