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

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.

The Diagnostic Value of Eosinophil Count And Platelet-To-Lymphocyte Ratio In Eosinophilic Gastroenteritis

Objective: To evaluate the diagnostic value of eosinophil (EO) count and platelet-to-lymphocyte ratio (PLR) in eosinophilic gastroenteritis (EGE). Methods: In total, 91 patients with EGE and 83 age–sex matched patients without EGE were selected as study subjects during January 2018 to December 2020. Data on blood cell count, and serum, C-reactive protein (CRP), and albumin levels were obtained from the Wuxi children's hospital electronic medical record system; the neutrophil-to-lymphocyte ratio (NLR), PLR, and CRP-to-albumin ratio (CAR) in the peripheral blood were recorded. Independent sample t-test, non-parametric test, or χ2 test was used according the data type to compare the difference between two groups, and receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic value for EGE. Results: The EO counts and PLR were significantly higher in the EGE group than those in the control group, whereas differences in the white blood cell, lymphocyte, neutrophil, and platelet counts, and the CRP level, NLR, and CAR were not significant. After treatment(Corticosteroids, 1mg/kg.d, lasting for 2 weeks）, the EO counts and PLR in the EGE group decreased gradually and the difference was significant. The diagnostic value of EO counts and PLR was determined with an area under the ROC curve as 0.756 and 0.616, sensitivity was 75.00% and 34.29%, and specificity was 74.29% and 92.31%, respectively. Conclusions EO and PLR represent potential predictive markers for diagnosing EGE.