Clinical Usefulness of Patient-Reported-Outcome-Measurement Information System in Pediatric Crohn’s Disease: A Cross-Sectional Study

Objectives: This study evaluates the clinical utility of the Patient-Reported Outcomes Measurement Information System (PROMIS®) by comparing it with objective clinical data and validated health-related quality of life (HRQOL) measures in pediatric Crohn’s disease (CD) patients. Study Design: Cross-sectional study. Pediatric CD patients (aged 8-17 years) were enrolled prospectively over eight months from an outpatient pediatric gastroenterology center. We assessed the associations between PROMIS® Pediatric short-form measures, demographic and disease-related data, global clinical assessments, and HRQOL measures. A sub-analysis according to PCDAI score (remission versus active disease) was also conducted. Results: 31 patients included (mean age: 15.3; 58% female) with a mean disease duration of 2.7 years; 80.6% were in remission or with mild disease. PROMIS® scores showed significant correlations with several factors: age negatively correlated with PROMIS® Global Health (r=-0.399; p=0.026) and Life Satisfaction (r=-0.359; p=0.047); gender was associated with PROMIS® Cognitive Function (t=2.20; p=0.038), favoring males; and school level inversely influenced PROMIS® Peer Relationships (F=3.90; p=0.003). Clinical assessments also revealed significant correlations: hemoglobin with PROMIS® Global Health (r=0.356; p=0.049) and Pain Interference (r=-0.360; p=0.046); ferritin with PROMIS® Meaning and Purpose (r=0.435; p=0.016) and Cognitive Function (r=0.450; p=0.011). Disease activity assessments correlated significantly with multiple PROMIS® measures, with better scores in remission patients. Treatment changes, particularly corticosteroids, negatively impacted PROMIS® Anxiety and Life Satisfaction scores. IMPACT-III scores correlated positively with PROMIS® Global Health, Meaning and Purpose, Life Satisfaction, peer relationships and negatively with Depression, Anxiety, Pain interference, and Fatigue. Group analysis indicated better PROMIS® scores and HRQOL scores in remission, as compared to active disease. Conclusion: Consistent with recent evidence, PROMIS® scores reliably reflect disease activity and HRQOL. The meaningful associations with clinical assessment and treatment efficacy, reinforce the clinical relevance and utility of PROs in the patient-centered management of pediatric IBD and highlight the importance of self-reporting as a gold standard tool for assessing health status.