Evaluation of the patient-reported outcomes measurement information system in a large cohort of patients with inflammatory bowel diseases

Background & aims: Patient-reported outcomes (PROs) convey important aspects of health status, complementing physician-reported measures. The PRO Measurement Information System (PROMIS) provides valid, widely available measures applicable to patients with chronic illness and the general population. We sought to evaluate these measures in a large cohort of patients with inflammatory bowel disease (IBD).

Methods: By using data from the Crohn's and Colitis Foundation Association Partners internet cohort, we performed cross-sectional and longitudinal analyses to evaluate associations between PROMIS measures and validated disease activity indices (Short Crohn's Disease Activity Index and Simple Clinical Colitis Activity Index) and the Short IBD Questionnaire quality-of-life instrument.

Results: A total of 10,634 individuals (6689 with Crohn's disease and 3945 with ulcerative colitis or indeterminate colitis) completed PRO testing. Compared with the general population (mean PROMIS score, 50), IBD patients in this cohort reported more depression (mean, 54), anxiety (mean, 52), fatigue (mean, 56), sleep disturbance (mean, 52), and pain interference (mean, 53); and they had less social satisfaction (mean, 48). In each PROMIS domain, there was worse functioning with increasing levels of disease activity and worsening Short IBD Questionnaire scores (P < .001 for all). Longitudinal analyses showed improved PROMIS scores with improved disease activity and worsening PROMIS scores with worsening disease (P < .001 for all comparisons).

Conclusions: In a cross-sectional and longitudinal study, we observed differences between patients with IBD and the general population in several important aspects of health. The improvement in diverse health outcome measures with improved disease control provides strong support for the construct validity of PROMIS measures in the IBD population. Their use should advance patient-centered outcomes research in IBD.