S85 Validation of a Novel Patient-Reported Outcome Measure to Assess Bowel Urgency in Adult Patients With Crohn’s Disease

Abstract

Background: Bowel urgency (BU), the sudden or immediate need to have a bowel movement, is an important symptom of Crohn’s disease (CD), however there is no patient-reported outcome (PRO) scale validated in this population to assess BU severity. The Urgency Numeric Rating Scale (NRS) is a patient-reported measure of bowel urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point scale, ranging from 0 (no urgency) to 10 (worst possible urgency). Here we evaluated the content validity and psychometric properties of the Urgency NRS. Methods: Qualitative interviews were conducted with moderate-to-severe CD participants to confirm importance and relevance of BU in this population, cognitively debrief the Urgency NRS, and explore score interpretation and CD remission. A quantitative web survey study was conducted to explore the measurement properties of the Urgency NRS. Results: Qualitative Interview: 34 of 35 participants reported BU. It was most bothersome for 44% of participants, 47% of participants reported it daily, and 18% of participants reported experiencing BU with every bowel movement. BU had a severe impact on daily activities, causing many participants to stay home more than preferred. Participants confirmed the relevance, appropriateness, comprehensiveness, and comprehensibility of the item, recall period, response options, and instructions of the Urgency NRS. Small reductions (1 or 2 points) on the Urgency NRS score reflected meaningful improvements. Quantitative survey: The study sample comprised 76 participants (65.8% female). Mean Urgency NRS score was 4.7 (SD 2.26; N = 76) at Week 1, with no floor/ceiling effect. Test-retest reliability was acceptable. Construct and known-groups validity against selected PROs were overall strong and within ranges hypothesized a priori. Conclusion(s): BU is an important symptom of CD. The evidence provided herein demonstrates that the Urgency NRS has content validity, test-retest reliability, and construct validity. The Urgency NRS is a well-defined and reliable PRO instrument that is suitable to be used in clinical studies to evaluate a treatment benefit in patients with CD.