University of Oxford Oxford, England, United Kingdom
Marla C. Dubinsky, MD1, Theresa Hunter Gibble, PhD, MPH2, Richard E. Moses, DO, JD2, Brittany Klooster, MPH3, Madison C. Bernstein, BA3, Marisa Walker, MPH3, Kaelyn Rupinski, BS3, Leighann Litcher-Kelly, PhD4, Cem Kayhan, MD2, Simon Travis, MD, PhD5 1Mount Sinai Kravis Children’s Hospital, New York, NY; 2Eli Lilly and Company, Indianapolis, IN; 3Adelphi Values, Boston, MA; 4Adelphi Values, Patient-Centered Outcomes, Boston, MA; 5University of Oxford, Oxford, England, United Kingdom
Introduction: The Urgency Numeric Rating Scale (UNRS) is a single-item patient-reported outcome (PRO) measure assessing bowel urgency (BU) severity in ulcerative colitis (UC) patients. The UNRS has documented evidence of content validity and psychometric performance, including reliability and validity. The original UNRS with a 24-hour recall period was used to evaluate mirikizumab treatment benefits in patients with moderately to severely active UC in the Phase 3 LUCENT trials. The aim of the present work was to evaluate new recall periods to facilitate the introduction of the UNRS into clinical practice.
Methods: Qualitative interviews with 10 adults diagnosed with moderate-severe UC evaluated interpretation and relevancy of two recall periods for the UNRS (the past 3 days and the past 7 days; 7-day recall UNRS shown in Figure 1). Interpretations were analyzed against a priori definitions created by developers to determine if recall periods were interpreted as intended, along with participant responses of which recall period was more relevant to their BU experience. Interviews were audio-recorded, transcribed, and coded thematically using qualitative analytic software.
Results: Mean sample age was 53.1 years; 50% were female. UC severity was equally split between moderate and severe patients. Eight participants interpreted the 7-day recall period (n=8/10 80%) as intended (n=1 did not interpret as intended, n=1 did not provide sufficient information). Similarly, eight participants interpreted the 3-day recall period (n=8/8, 100%) as intended (n=2 were not asked). Six participants (n=6/10, 60%) reported that the 7-day recall period was more relevant to their experience of BU and two participants (n=2/10, 20%) reported that the 3-day recall period was more relevant. One participant (n=1/10, 10%) reported that both the 7-day and 3-day recall periods were relevant. One (n=1/10, 10%) reported that neither 7- nor 3-day recall periods were relevant to their experience, but suggested providing a time range for the recall period (i.e., the past 2-3 or 4-7 days).
Discussion: Findings suggest that both 3-day and 7-day recall periods to evaluate BU are appropriately understood by patients with moderate-severe UC. These results expand on existing UNRS literature and suggest that the UNRS with a 3- or 7-day recall period may be introduced into clinical practice.
Figure: Figure 1. Urgency NRS with 7-day recall period
