Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis.

ABSTRACT:

Background

Patient-reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies.

Aims

To develop PRO tools for use in Crohn's disease (CD) and ulcerative colitis (UC) following guidance issued by the US FDA and the ISPOR (International Society for Pharmacoeconomics and Outcomes Research).

Methods

Concept elicitation and cognitive interviews were conducted in adult patients (≥18 years) across the United States and Canada. Semi-structured interview guides were used to collect data, and interview transcripts were coded and analysed. Concept elicitation results were considered alongside existing literature and clinical expert opinion to identify candidate PRO

SUBMITTER: Dulai PS 

PROVIDER: S-EPMC7317756 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature