Evaluation of PROMIS Measures for Pediatric Inflammatory Bowel Disease (IBD)

The NIH-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) network has developed 20 pediatric instruments, both child-report and parent-proxy editions. Concurrent validity evaluations of the instruments have established that they are ready for integration into clinical research. The next step is to determine the clinical validity of the measures by examining the association with indicators of disease severity and clinical change to enhance their interpretation. The purpose of the study was to evaluate the construct validity of PROMIS pediatric measures by examining their concurrent and longitudinal associations with clinical indicators of inflammatory bowel disease (IBD) activity. This is a concurrent cohort study that involved a cross-sectional and longitudinal evaluation of self-reported health and disease activity for children and youth with IBD, both ulcerative colitis and Crohn’s disease. Children and youth aged 8-23 years with IBD were recruited from 14 pediatric gastroenterology care centers from the ImproveCareNow learning network. We enrolled 1,049 children/youth to complete the baseline questionnaire, and a subset of those children/youth (n=493) participated in the follow-up survey. Parents of children aged 8-17 years of age participated in a parent survey. The profile of PRO measures included PROMIS pediatric Fatigue, Pain Interference, Psychological Stress, Global Health, and Life Satisfaction.