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Quality of Life Research
Published in: Quality of Life Research 5/2024

Open Access 05-03-2024 | Ulcerative Colitis

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

Authors: Chong Kim, Fiona L. Brown, Caroline Burk, Milena Anatchkova, Nashmel Sargalo, Ankita Kaushik

Published in: Quality of Life Research | Issue 5/2024

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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 consensus-based standards for the selection of health measurement instruments (COSMIN) criteria.

Results

The conceptual model grouped the 52 symptom concepts and 72 proximal and distal impacts into eight, two, and five dimensions, respectively. Of 65 PRO measures identified, eight underwent conceptual analysis. Measures covering the most concepts and assessed for psychometric properties were the Inflammatory Bowel Disease Questionnaire, Symptoms and Impacts Questionnaire for UC, UC-PRO symptoms modules, UC-PRO impact modules, and Crohn’s and UC Questionnaire; all had good or excellent support for content validity. The UC-PRO Signs and Symptoms fully met FDA guidance and COSMIN criteria for content validity and most psychometric properties.

Conclusion

Existing PRO measures assess concepts relevant to patients with UC, but all PRO measures reviewed require further psychometric evaluation to demonstrate they are fit for purpose.
Appendix
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Metadata
Title
Patient experiences in ulcerative colitis: conceptual model and review of patient-reported outcome measures
Authors
Chong Kim
Fiona L. Brown
Caroline Burk
Milena Anatchkova
Nashmel Sargalo
Ankita Kaushik
Publication date
05-03-2024
Publisher
Springer International Publishing
Published in
Quality of Life Research / Issue 5/2024
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-024-03612-4

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