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Measuring the Risk of Gluten Exposure: Development of the Gluten Exposure Risk Assessment in Pediatric Patients
Amy E Hale1,2, Monique Germone3,4, Lisa Fahey5,6
1Division of Gastroenterology and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.
Insights
A new screening tool called the Gluten Exposure Risk Assessment (GERA) helps identify children with Celiac Disease (CeD) at risk for gluten exposure. This validated measure aids in assessing adherence to a gluten-free diet (GFD) and guides necessary interventions.
Area of Science:
- Pediatric Gastroenterology
- Clinical Psychology
- Dietary Adherence Research
Background:
- Celiac Disease (CeD) management necessitates a strict gluten-free diet (GFD).
- Assessing GFD adherence and identifying gluten exposure risks in pediatric CeD patients is challenging.
- No validated screening tools currently exist for pediatric gluten exposure risk.
Purpose of the Study:
- To develop and validate a screening measure for assessing gluten exposure risk in pediatric CeD patients.
- To provide a tool for caregivers to evaluate potential gluten exposure.
- To identify children who may require further intervention to manage their GFD.
Main Methods:
- The Gluten Exposure Risk Assessment (GERA) was developed through a modified Delphi process.
- Psychometric properties, factor structure, and validity were examined in caregivers of pediatric CeD patients.
- Confirmatory factor analysis (CFA) and test-retest reliability were used to validate the final measure.
Main Results:
- An initial 134 items were refined to a 10-item measure (1 screening question, 9 validated items) across two domains (Home, Outside).
- Psychometric and CFA data from 484 caregivers supported the measure's structure.
- Validation in an independent sample (N=369) confirmed the factor structure and reliability (CFI = 0.96, TLI = 0.95, RMSEA = 0.06).
Conclusions:
- The Gluten Exposure Risk Assessment (GERA) is a validated caregiver-completed screening tool for assessing gluten exposure risk in pediatric CeD.
- GERA assists in identifying children at risk for gluten exposure despite a GFD.
- This tool can guide clinical decisions regarding interventions for improved GFD adherence.
Introduction:
Treatment of celiac disease (CeD) requires a strict gluten-free diet (GFD). Adherence is difficult to assess and influenced by many factors. Identification of potential gluten exposures is essential, but no validated screening measures exist in pediatrics. The aim of this study was to develop and validate a measure screening for gluten exposure risk in pediatric patients with CeD.
Methods:
The Gluten Exposure Risk Assessment (GERA) was developed in 3 phases. First, items were generated and refined by a modified Delphi process. Next, psychometrics, factor structure, and validity were examined in a sample of caregivers of pediatric patients younger than 18 years with CeD at 12 pediatric celiac centers. Finally, the final measure was tested on an independent sample population using confirmatory factor analysis and test-retest data.
Results:
A total of 134 items were generated representing up to 6 domains, with 36 items selected for initial testing. Based on psychometrics and confirmatory factor analysis data from 484 caregivers, the final measure included a total of a single screening question and 9 validated items representing 2 domains (Home, Outside). Repeat testing on a separate sample (N = 369) confirmed factor structure and validity of the final measure (Comparative Fit Index = 0.96, Tucker-Lewis index = 0.95, root mean square error of approximation = 0.06).
Discussion:
The GERA is a valid screening measure, completed by caregivers, for assessment of gluten exposure in children and adolescents with CeD following a GFD. GERA is a useful tool for evaluating the potential of risk of gluten exposure and potential need for intervention.
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