Development of the celiac disease symptom diary version 2.1^© (CDSD 2.1^©) patient-reported outcome measure.

ABSTRACT:

Purpose

For patients with celiac disease (CeD), the only current management option is adherence to a strict gluten-free diet (GFD); however, many patients on a GFD continue to experience symptoms with a significant impact on quality of life. Potential new treatments for CeD are under development and a validated patient-reported outcome measure is required to evaluate their utility in clinical trials. The purpose of this article is to provide a history of the development of the Celiac Disease Symptom Diary (CDSD) 2.1^© for use in clinical trials.

Methods

Qualitative and quantitative studies were conducted from 2010 to 2021, including concept elicitation and cognitive debriefing interviews with adult and adolescent participants with CeD (N = 93) diagnosed via biopsy

SUBMITTER: Howard K 

PROVIDER: S-EPMC11599373 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature