Development and content validation of patient-reported outcomes tools for ulcerative colitis and Crohn's disease in adults with moderate-to-severe disease.

ABSTRACT:

Background

Ulcerative colitis (UC) and Crohn's disease (CD) are associated with a range of symptoms that adversely affect health-related quality of life. This research aimed to develop and validate two patient-reported outcome (PRO) tools to assess signs and symptoms in patients with moderate-to-severe UC or CD.

Methods

PRO-UC and PRO-CD Diaries were developed in accordance with US Food and Drug Administration (FDA) recommendations. Data were collected from concept elicitation interviews (in which patients described their symptoms and experience of the disease) and further refined through cognitive interviews (in which patients assessed the relevance and clarity of questions in the tools).

Results

Interviews were conducted with 12 patients for each indication. Five sy

SUBMITTER: Nag A 

PROVIDER: S-EPMC9078017 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature