P049 RESPONSIVENESS OF THE PATIENT-REPORTED OUTCOME MEASUREMENT INFORMATION SYSTEM (PROMIS) TO CHANGES IN DISEASE STATUS AND QUALITY OF LIFE AMONG PEDIATRIC PATIENTS WITH CROHN’S DISEASE

Abstract

Abstract Background Patient Reported Outcome Measurement Information System (PROMIS) provides valid, self-reported measures of physical, emotional, and social health that can inform research and clinical care in children with chronic conditions. Prior research in pediatric Crohn’s disease (CD) has demonstrated robust correlations between PROMIS and disease activity. However, responsiveness, defined as sensitivity to clinical change, has not been yet been thoroughly evaluated. Aims We sought to evaluate the responsiveness of the PROMIS Pediatric measures relative to changes in 1) disease activity and 2) disease-specific health-related quality of life (HRQOL). Methods IBD Partners Kids & Teens is an internet-based cohort of children with 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 PROMIS domains of Anxiety, Depression, Pain Interference, Fatigue, and Peer Relationships. We conducted longitudinal analyses using mixed linear models to examine the extent to which PROMIS measures were responsive to changes in SCDAI and IMPACT III, adjusting for time and taking into account the clustering of individual participants. A change threshold of 70 points in SCDAI was used as a minimally important difference (MID). We also graphically depicted changes in PROMIS domains corresponding to improved, stable, or worsened disease activity and evaluated changes in PROMIS versus changes in IMPACT III using Pearson’s correlation. Results Our study sample included 544 participants with CD (mean age 13 years, 44% female) from 44 states. All PROMIS domains were responsive to changes in SCDAI, indicating improved physical, emotional, and social health corresponding to improved disease activity (Table 1, p< 0.001). Observed effect estimates ranged from 1.9 for Peer Relationships to 6.9 for Fatigue, in line with estimates of MID in both adult IBD and other pediatric chronic conditions. Of 246 participants with 2 or more completed reports (689 pairs of consecutive reports), disease activity was stable in 527, worse in 72, and improved in 67. Figure 1 demonstrates changes in PROMIS scores as a function of change in disease activity. Changes in PROMIS scores were also strongly associated with changes in IMPACT 35 scores (R=-0.5 for Anxiety, R=-0.5 for Depression, R=-0.6 for Pain Interference, R= -0.7 for Fatigue, and R=0.35 for Peer Relationships). Conclusion This study provides evidence for the longitudinal responsiveness of the PROMIS Pediatric measures to change in disease status and HRQOL in pediatric CD patients. The results support use of the PROMIS Pediatric measures in clinical outcomes research.