OBJECTIVES: Ulcerative colitis (UC) is an inflammatory bowel disease that causes gastrointestinal (GI) symptoms including rectal bleeding, diarrhea, and increased number of bowel movements. Regulatory bodies encourage the use of Patient-Reported Outcomes (PROs) in UC, understanding that certain unobservable concepts can only be measured via PRO. A conceptual model was created to highlight concepts of importance to UC patients and inform PRO measurement.

METHODS: Qualitative concept elicitation interviews (N=43), that supported the development of the Ulcerative Colitis Patient-Reported Outcomes (UC-PRO), were conducted with adult UC patients with intact colons until saturation was reached. Real world data (RWD) was analyzed from a Disease Specific Program with data from 101 Gastroenterologists and 688 UC patients. This was used to determine the most commonly used therapies, side effects, administration procedure considerations, and treatment consequences. A targeted literature search was then conducted on qualitative and PRO literature to better understand caregiver impact, with final concepts selected by frequency of occurrence and importance to patients.

RESULTS: The model was divided into treatment and disease sections, as seen in a previous Crohn’s disease model. Treatment-related information gathered from RWD was connected to the disease section. The disease portion contains 2 symptom domains (GI and extraintestinal) and 6 disease impact domains (daily activities, physical functioning, work productivity, social functioning, emotional functioning, and sexual functioning), aggregating information from qualitative interviews. Treatment and disease aspects were linked to caregiver impact to provide a single conceptual model.

CONCLUSIONS: There are numerous symptoms and impacts for this patient population. A comprehensive PRO measurement strategy including a disease-specific measure of symptoms such as the UC-PRO and a measure of impacts such as a productivity questionnaire may be needed to fully capture the impact of disease and treatment from the patient’s perspective.