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. 2021 Nov 24;16(1):495.
doi: 10.1186/s13023-021-02107-6.

Development and content validation of a symptom assessment for eosinophilic gastritis and eosinophilic gastroenteritis in adults and adolescents

Calvin N Ho  1 , Sean O'Quinn  2 , Julie Bailey  3 , Oren Meyers  3 , Ashley F Slagle  4 , Evan S Dellon  5 , Catherine Datto  2
Affiliations

Development and content validation of a symptom assessment for eosinophilic gastritis and eosinophilic gastroenteritis in adults and adolescents

Calvin N Ho et al. Orphanet J Rare Dis. .

Abstract

Background: A patient reported outcome (PRO) instrument with evidence of validity and reliability for assessing symptoms of eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE) is needed to measure treatment benefit in clinical trials. The aim of this research is to develop an EG/EGE symptom PRO instrument for patients aged 12 and above.

Methods: The Symptom Assessment for Gastrointestinal Eosinophilic Diseases (SAGED) was developed through a literature review, discussions with expert clinicians, and concept elicitation and cognitive debriefing interviews with patients. Patients (n = 28) were recruited based on confirmed diagnosis and self-reported symptoms. The final instrument was translated and linguistically validated with additional cognitive debriefing interviews (n = 105).

Results: SAGED is a 24-h recall questionnaire consisting of eight items evaluating the core symptoms of EG and EGE (abdominal pain, nausea, bloating, early satiety, loss of appetite, vomiting, and diarrhea). Seven of the eight items are evaluated on an 11-point numerical rating scale ranging from 'none' to 'worst imaginable'. Cognitive debriefing interviews showed that adults and adolescents understand the content and are able to select a response that reflects their experience. The linguistic validation process produced 21 translations that are understandable to patients and conceptually equivalent to the source version.

Conclusions: SAGED is suitable for measuring symptom improvement in adult and adolescent patients with EG and/or EGE. The content validity of SAGED has been established through best practices in qualitative research for PRO instrument development. The psychometric properties of SAGED will be evaluated in a future study.

Keywords: Eosinophilic duodenitis; Eosinophilic gastritis; Eosinophilic gastroenteritis; Patient reported outcomes.

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Conflict of interest statement

ESD has received research funding from AstraZeneca, Adare/Ellodi, Allakos, Arena, GSK, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, and Shire/Takeda, and educational grants from Allakos, Banner, and Holoclara. ESD has also served as a consultant for AstraZeneca, Abbott, Abbvie, Adare/Ellodi, Aimmune, Allakos, Amgen, Arena, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, GSK, Gossamer Bio, Holoclara, Landos, Morphic, Nutricia, Parexel/Calyx, Regeneron, Revolo, Robarts/Alimentiv, Salix, Sanofi, and Shire/Takeda. CNH, SOQ, and CD are employees of and own stocks and shares in AstraZeneca. JRB and OM are employees of IQVIA Real World Solutions, Patient Centered Solutions, which received funding from AstraZeneca to complete the study. AFS has served as a consultant for IQVIA.

Figures

Fig. 1
Fig. 1
Overview of interview waves
See this image and copyright information in PMC

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