Ulcerative Colitis-Symptom Questionnaire: Valid for Use in Adults with Moderately to Severely Active Ulcerative Colitis.

ABSTRACT:

Background

Due to wide-ranging impacts of Ulcerative Colitis (UC), regulatory authorities emphasize the importance of including validated patient-reported symptom severity measures in clinical trials.

Aim

To describe the development and validation of the Ulcerative Colitis-Symptom Questionnaire (UC-SQ).

Methods

The UC-SQ was developed in a qualitative study involving a targeted literature review, semi-structured concept elicitation interviews, and combined concept elicitation/cognitive interviews. Measurement properties, including item-level analyses, factor structure, reliability, validity, responsiveness, and clinically meaningful change were evaluated using data from a phase 2b, randomized trial in adults with UC (N = 113).

Results

Fourteen symptom concepts

SUBMITTER: Panes J 

PROVIDER: S-EPMC10188579 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature