Validation of the novel Eosinophilic Esophagitis Impact Questionnaire
Validation of the novel Eosinophilic Esophagitis Impact Questionnaire
About this item
Full title
Author / Creator
Publisher
Cham: Springer International Publishing
Journal title
Language
English
Formats
Publication information
Publisher
Cham: Springer International Publishing
Subjects
More information
Scope and Contents
Contents
Background
Eosinophilic esophagitis (EoE) has a detrimental effect on health-related quality of life (HRQOL). The Eosinophilic Esophagitis Impact Questionnaire (EoE-IQ) is a novel patient-reported outcome (PRO) measure assessing the impact of EoE on HRQOL. To assess suitability of the EoE-IQ, its measurement properties were evaluated.
Methods
Using baseline and week 24 data from the pivotal, randomized, placebo-controlled, multinational phase 3 R668-EE-1774 trial (NCT03633617) of dupilumab, we evaluated EoE-IQ’s measurement properties (including reliability, construct and known-groups validity, and ability to detect change) and established the threshold for change in scores that can be considered clinically meaningful.
Results
The analysis population comprised 239 adults and adolescents with EoE. Mean age was 28.1 (standard deviation, 13.14) years; 63.6% were male, and 90.4% were White. Reliability estimates for the EoE-IQ average score exceeded acceptable thresholds for patients who were stable as indicated by ratings of Patient Global Impression of Severity (PGIS) and Change (PGIC) (intraclass correlation coefficients, 0.75 and 0.81). Construct validity correlations with other EoE-specific PRO scores were moderate at baseline (|r|= 0.44–0.60) and moderate to strong at week 24 (|r|= 0.61–0.72). In known-groups analysis, EoE-IQ average score discriminated among groups of patients at varying EoE severity levels defined by PGIS scores. A ≥ 0.6-point reduction in EoE-IQ average score (where scores range from 1 to 5, with higher scores indicating worse HRQOL) from baseline to week 24 can be considered clinically meaningful.
Conclusions
The EoE-IQ’s measurement properties are acceptable, making it a valid, reliable measure of the HRQOL impacts of EoE among adults and adolescents.
Trial registration
: ClinicalTrials.gov, NCT03633617. Registered August 14, 2018,
https://clinicaltrials.gov/study/NCT03633617
....
Alternative Titles
Full title
Validation of the novel Eosinophilic Esophagitis Impact Questionnaire
Authors, Artists and Contributors
Identifiers
Primary Identifiers
Record Identifier
TN_cdi_doaj_primary_oai_doaj_org_article_1b7481e2e558427caf083d9f4e61fcd6
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_doaj_primary_oai_doaj_org_article_1b7481e2e558427caf083d9f4e61fcd6
Other Identifiers
ISSN
2509-8020
E-ISSN
2509-8020
DOI
10.1186/s41687-023-00654-z