Measuring the Risk of Gluten Exposure: Development of the Gluten Exposure Risk Assessment in Pediatric Patients

Amy E Hale^{1

2}, Monique Germone^{3

4}, Lisa Fahey^{5

6}, Marisa Stahl^{3

7}, Maureen M Leonard^{8

9}, Arunjot Singh^{5

6}, Temara Hajjat^{10

11}, Daniel Mallon^{10

11}, Benny Kerzner¹², Catherine Raber¹², Vahe Badalyan¹², Pooja Mehta^{3

7}, Edwin Liu^{3

7}, Mary Shull^{3

7}, Imad Absah¹³, Dale Lee¹⁴, Tracy Ediger¹⁵, Ritu Verma¹⁶, Hilary Jericho¹⁷, Nasim Khavari¹⁸, Jackie Jossen¹⁹, Randi L Wolf²⁰, Madison Wong²¹, Stephanie Regis²¹, Vanessa Weisbrod²², Jocelyn A Silvester^{1

9}; RAISE-CD

Collaborators, Affiliations

Affiliations

¹ Division of Gastroenterology and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.
² Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.
³ Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado, Aurora, Colorado, USA.
⁴ Departments of Psychiatry and Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado, USA.
⁵ Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
⁶ Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁷ Department of Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado, USA.
⁸ Center for Celiac Research and Treatment, Division of Gastroenterology, Hepatology and Nutrition, Mass General Hospital for Children, Boston, Massachusetts, USA.
⁹ Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
¹⁰ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio, USA.
¹¹ University of Cincinnati, Cincinnati, Ohio, USA.
¹² Division of Gastroenterology, Hepatology and Nutrition, Children's National Hospital, Washington, District of Columbia, USA.
¹³ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.
¹⁴ Division of Pediatric Gastroenterology and Hepatology, Seattle Children's Hospital, Seattle, Washington, USA.
¹⁵ Division of Gastroenterology, Hepatology and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
¹⁶ Section of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, The University of Chicago, Chicago, Illinois, USA.
¹⁷ Stanford University, Palo Alto, California, USA.
¹⁸ Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Celiac Disease Center, Stanford University, Lucile Packard Children's Hospital, Palo Alto, California, USA.
¹⁹ Department of Pediatrics, Morgan Stanley Children's Hospital, Columbia University, New York, New York, USA.
²⁰ Department of Health Studies and Applied Educational Psychology, Program in Nutrition, Teachers College, Columbia University, New York, New York, USA.
²¹ Harvard Celiac Disease Research Program, Boston Children's Hospital, Boston, Massachusetts, USA.
²² Celiac Disease Foundation, Woodland Hills, California, USA.

PMID: 40736693
DOI: 10.14309/ajg.0000000000003675

Measuring the Risk of Gluten Exposure: Development of the Gluten Exposure Risk Assessment in Pediatric Patients

Amy E Hale et al. Am J Gastroenterol. 2025.

. 2025 Jul 31.

doi: 10.14309/ajg.0000000000003675. Online ahead of print.

Authors

Affiliations

¹ Division of Gastroenterology and Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA.
² Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, USA.
³ Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado, Aurora, Colorado, USA.
⁴ Departments of Psychiatry and Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado, USA.
⁵ Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
⁶ Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁷ Department of Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado, USA.
⁸ Center for Celiac Research and Treatment, Division of Gastroenterology, Hepatology and Nutrition, Mass General Hospital for Children, Boston, Massachusetts, USA.
⁹ Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA.
¹⁰ Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio, USA.
¹¹ University of Cincinnati, Cincinnati, Ohio, USA.
¹² Division of Gastroenterology, Hepatology and Nutrition, Children's National Hospital, Washington, District of Columbia, USA.
¹³ Division of Pediatric Gastroenterology, Hepatology and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.
¹⁴ Division of Pediatric Gastroenterology and Hepatology, Seattle Children's Hospital, Seattle, Washington, USA.
¹⁵ Division of Gastroenterology, Hepatology and Nutrition, Nationwide Children's Hospital, Columbus, Ohio, USA.
¹⁶ Section of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, The University of Chicago, Chicago, Illinois, USA.
¹⁷ Stanford University, Palo Alto, California, USA.
¹⁸ Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Celiac Disease Center, Stanford University, Lucile Packard Children's Hospital, Palo Alto, California, USA.
¹⁹ Department of Pediatrics, Morgan Stanley Children's Hospital, Columbia University, New York, New York, USA.
²⁰ Department of Health Studies and Applied Educational Psychology, Program in Nutrition, Teachers College, Columbia University, New York, New York, USA.
²¹ Harvard Celiac Disease Research Program, Boston Children's Hospital, Boston, Massachusetts, USA.
²² Celiac Disease Foundation, Woodland Hills, California, USA.

PMID: 40736693
DOI: 10.14309/ajg.0000000000003675

Abstract

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.

Keywords: adherence; celiac disease; gluten exposure risk; gluten-free diet; treatment.

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References

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Measuring the Risk of Gluten Exposure: Development of the Gluten Exposure Risk Assessment in Pediatric Patients

Collaborators

Affiliations

Measuring the Risk of Gluten Exposure: Development of the Gluten Exposure Risk Assessment in Pediatric Patients

Authors

Collaborators

Affiliations

Abstract

References

Grants and funding

LinkOut - more resources

Full Text Sources