Clinical usefulness of patient-reported-outcome-measurement information system in Pediatric Crohn's Disease: a cross-sectional study.

OBJECTIVES

This study evaluated 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 subanalysis according to the PCDAI (remission versus active disease) was also conducted.

RESULTS

Thirty-one patients (mean age: 15.3; 58% female) with a mean disease duration of 2.7 years were included; 80.6% were in remission or had mild disease. The PROMIS score was significantly correlated with several factors: age was negatively correlated with the PROMIS Global Health Scale (r=-0.399; p = 0.026) and Life Satisfaction (r=-0.359; p = 0.047); sex was associated with the PROMIS Cognitive Function Scale (t = 2.20; p = 0.038), favoring males; and school level was inversely related to the PROMIS Peer Relationships (F = 3.90; p = 0.003). Clinical assessments also revealed significant correlations between hemoglobin and PROMIS Global Health (r = 0.356; p = 0.049) and pain interference (r=-0.360; p = 0.046) and between ferritin and 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 patients in remission. Treatment changes, particularly corticosteroid treatment, negatively impacted the PROMIS Anxiety and Life Satisfaction scores. IMPACT-III scores correlated positively with PROMIS Global Health, Meaning and Purpose, Life Satisfaction, and peer relationships scores and negatively with Depression, Anxiety, Pain interference, and Fatigue scores. Group analysis indicated better PROMIS scores and HRQOL scores in remission than in active disease remission.

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-reports as a gold standard tool for assessing health status.