Patient experiences in ulcerative colitis: conceptual model and review of patient-reported outcome measures.

ABSTRACT:

Purpose

To identify symptoms and their impacts on daily functioning and health-related quality of life (HRQoL) experienced by adult patients with ulcerative colitis (UC) and evaluate patient-reported outcome (PRO) measures for UC clinical studies.

Methods

A conceptual model of symptoms and impacts of UC were developed from a literature review. PRO measures were identified from the literature, clinical trials databases, health technology assessment submissions, and regulatory label claims, and were selected for conceptual analysis based on disease specificity and use across information sources. PRO measures covering the most concepts when mapped against the conceptual model were assessed for gaps in psychometric properties using Food and Drug Administration (FDA) guidance and

SUBMITTER: Kim C 

PROVIDER: S-EPMC11045605 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature