Dataset Information

Dysphagia Days as an Assessment of Clinical Treatment Outcome in Eosinophilic Esophagitis.

ABSTRACT:

Introduction

The aim of this study was to evaluate Dysphagia Days as a measure of symptom improvement in patients with eosinophilic esophagitis from the HEROES study.

Methods

Dysphagia Days, defined as a yes answer to the following question: During any meal today, did food go down slowly or get stuck in your throat or chest? was assessed for cendakimab vs placebo.

Results

A statistically significant reduction in the mean number of Dysphagia Days experienced was observed with cendakimab 360 mg vs placebo at week 16 (-4.67 vs -1.83; P = 0.0115); an even greater improvement was observed in steroid-refractory patients vs placebo (-4.48 vs -0.04; P = 0.0079).

Discussion

Dysphagia Days represents a relevant clinical end point to capture dysphagia-related symptoms.

SUBMITTER: Hirano I

PROVIDER: S-EPMC10045973 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Dysphagia Days as an Assessment of Clinical Treatment Outcome in Eosinophilic Esophagitis.

Hirano Ikuo I Rothenberg Marc E ME Zhang Sandra S de Oliveira Claudia C Charriez Christina M CM Coyne Karin S KS Bacci Elizabeth Dansie ED Dellon Evan S ES

The American journal of gastroenterology 20221220 4

<h4>Introduction</h4>The aim of this study was to evaluate Dysphagia Days as a measure of symptom improvement in patients with eosinophilic esophagitis from the HEROES study.<h4>Methods</h4>Dysphagia Days, defined as a yes answer to the following question: During any meal today, did food go down slowly or get stuck in your throat or chest? was assessed for cendakimab vs placebo.<h4>Results</h4>A statistically significant reduction in the mean number of Dysphagia Days experienced was observed wit ...[more]

PMID: 36647838

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Project description:BackgroundThe Dysphagia Symptom Questionnaire (DSQ) is a patient-reported outcome measure that assesses the frequency and severity of dysphagia in patients with eosinophilic esophagitis (EoE); however, it has only been validated for use in patients with EoE aged 11-40 years. This study examined the content validity of the DSQ and its usability on an electronic handheld device in children aged 7-10 years with EoE.MethodsIn this qualitative, observational cohort study, participants were recruited to partake in two rounds of interviews. During visit 1, a cognitive interview examined EoE-associated concepts and the appropriateness of the DSQ for assessing dysphagia. Participants completed the DSQ daily for 2 weeks, and DSQ scores were calculated. After 2 weeks, a second interview assessed the usability of the DSQ on the electronic device and the burden associated with completing it daily.ResultsOverall, 16 participants were included (aged 7-8 years: n = 8; aged 9-10 years: n = 8); most were male (75%) and white (81%), and the mean (standard deviation [SD]) age was 8.4 (1.3) years. The most commonly reported EoE-associated concept was 'trouble with swallowing' (63% [10/16]). Most participants reported that the questions were 'easy to complete' and 'relevant to someone with EoE and dysphagia'. Overall, participants reported understanding the questions and associated responses; however, further probing demonstrated inconsistent comprehension. Key challenging concepts included 'solid food', 'trouble swallowing', 'vomit', and 'relief'; some participants also reported difficulty differentiating between pain levels (31% [4/13]). Most caregivers reported that their child had experienced dysphagia (94% [15/16]); however, mean (SD) DSQ scores over the study period were low (7.3 [7.4]), suggesting infrequent and mild dysphagia, or a lack of comprehension of the questions. Most participants reported that completing the DSQ on the electronic device was easy (93% [14/15]) and they would be willing to complete it for longer than 2 weeks (73% [11/15]).ConclusionsDifficulties with comprehension and comprehensiveness suggest that the DSQ may not be sufficiently comprehensive for use in all patients in this population, and wording/phrasing changes are required before use in a clinical trial setting.

Dataset Information

Dysphagia Days as an Assessment of Clinical Treatment Outcome in Eosinophilic Esophagitis.

Introduction

Methods

Results

Discussion

Publications

Dysphagia Days as an Assessment of Clinical Treatment Outcome in Eosinophilic Esophagitis.

Similar Datasets

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