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Marla C Dubinsky,1 Louise Newton,2 Laure Delbecque,3 Theresa Hunter,4 Aiste Guobyte,5 April N Naegeli,4 Shehan McFadden,5 Jill Donaldson,6 Tara Symonds,2 James D Lewis7 1Icahn School of Medicine, Mount Sinai, NY, USA; 2Clinical Outcomes Solutions, Folkestone, UK; 3Eli Lilly and Company, Brussels, Belgium; 4Eli Lilly and Company, Indianapolis, IN, USA; 5Clinical Outcomes Solutions, Chicago, IL, USA; 6Crohn’s and Colitis Foundation, New York, NY, USA; 7Perelman School of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USACorrespondence: Laure Delbecque, Principal Research Scientist, Eli Lilly and Company, Brussels, Belgium, Tel +32 (0)499 72 31 37, Email delbecque_laure@lilly.comPurpose: Achieving and maintaining symptom control is a key treatment goal in ulcerative colitis (UC). Bowel urgency is an important symptom of UC, thus measurement of urgency is critical. This research explored the patient experience of UC and “remission” in UC, with a focus on urgency, and cognitively debriefed the Urgency Numeric Rating Scale (NRS), including score interpretation and examination of meaningful improvement.Patients and Methods: Semi-structured hybrid concept elicitation and cognitive debriefing interviews with adults with moderately-severely active UC were conducted to explore experiences of UC and urgency, as well as examine meaningful improvement and score interpretation of the Urgency NRS. Purposive sampling was used to identify 20 eligible adult participants with UC. Concept elicitation data were analyzed using thematic analysis, and a deductive approach was used to analyze cognitive debriefing data. Thematic analysis was also applied to meaningful change-related data.Results: Twenty participants were interviewed (average age = 42.6 years old, 50% male); 14 with moderately active (70.0%) and 6 with severely active UC (30.0%). Disease remission was not consistently defined by participants and description varied in terms of definition (absence vs not complete absence of symptoms), duration (months vs days) and key symptoms to consider. Urgency was a prominent symptom for all participants, with 8 (40.0%) identifying it as the most bothersome aspect of UC. No issues were identified with the Urgency NRS. Participants were able to define different levels of urgency severity, describe how they relate to daily life impacts, and score them differently on the Urgency NRS. Participants were also able to reflect urgency improvement on the NRS and discuss how small changes in numeric ratings of urgency can reflect meaningful change in the symptom burden of their UC.Conclusion: The Urgency NRS is a content valid and interpretable measure to assess bowel urgency severity.Keywords: ulcerative colitis, qualitative, bowel urgency, content validity |
