Validation of the novel Eosinophilic Esophagitis Impact Questionnaire.
Journal
Journal of patient-reported outcomes
ISSN: 2509-8020
Titre abrégé: J Patient Rep Outcomes
Pays: Germany
ID NLM: 101722688
Informations de publication
Date de publication:
27 Nov 2023
27 Nov 2023
Historique:
received:
03
07
2023
accepted:
02
11
2023
medline:
29
11
2023
pubmed:
27
11
2023
entrez:
27
11
2023
Statut:
epublish
Résumé
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. 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. 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. The EoE-IQ's measurement properties are acceptable, making it a valid, reliable measure of the HRQOL impacts of EoE among adults and adolescents. ClinicalTrials.gov, NCT03633617. Registered August 14, 2018, https://clinicaltrials.gov/study/NCT03633617 .
Sections du résumé
BACKGROUND
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
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
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
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
BACKGROUND
ClinicalTrials.gov, NCT03633617. Registered August 14, 2018, https://clinicaltrials.gov/study/NCT03633617 .
Identifiants
pubmed: 38010430
doi: 10.1186/s41687-023-00654-z
pii: 10.1186/s41687-023-00654-z
pmc: PMC10682344
doi:
Banques de données
ClinicalTrials.gov
['NCT03633617']
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
120Informations de copyright
© 2023. The Author(s).
Références
United European Gastroenterol J. 2018 Feb;6(1):38-45
pubmed: 29435312
Aliment Pharmacol Ther. 2011 Oct;34(7):790-8
pubmed: 21806649
Am J Gastroenterol. 2016 Apr;111(4):493-9
pubmed: 26881974
Gut. 2013 Apr;62(4):489-95
pubmed: 22619364
Aliment Pharmacol Ther. 2019 May;49(9):1116-1125
pubmed: 30887555
J Patient Rep Outcomes. 2017;1(1):3
pubmed: 29757322
Dis Esophagus. 2018 Apr 1;31(4):
pubmed: 29088336
World J Gastrointest Pharmacol Ther. 2016 May 6;7(2):207-13
pubmed: 27158535
Health Qual Life Outcomes. 2006 Oct 11;4:79
pubmed: 17034633
Aliment Pharmacol Ther. 2013 Sep;38(6):634-42
pubmed: 23837796
United European Gastroenterol J. 2017 Apr;5(3):335-358
pubmed: 28507746
Best Pract Res Clin Gastroenterol. 2015 Oct;29(5):739-748
pubmed: 26552773
J Clin Gastroenterol. 2011 Oct;45(9):769-74
pubmed: 21552137
Clin Gastroenterol Hepatol. 2018 Nov;16(11):1714-1729.e3
pubmed: 29908360
Endoscopy. 2022 Jul;54(7):635-643
pubmed: 34674209
Eval Health Prof. 2005 Jun;28(2):160-71
pubmed: 15851771
BMC Gastroenterol. 2012 Sep 25;12:135
pubmed: 23009120
Clin Gastroenterol Hepatol. 2021 Apr;19(4):699-706.e4
pubmed: 32272243
Gastroenterology. 2018 Jan;154(2):319-332.e3
pubmed: 28774845
N Engl J Med. 2022 Dec 22;387(25):2317-2330
pubmed: 36546624
Gastroenterology. 2018 Jan;154(2):346-359
pubmed: 28756235
Clin Gastroenterol Hepatol. 2018 Apr;16(4):495-503.e8
pubmed: 28655543