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

Amy E. Hale, Division of Gastroenterology and Nutrition, Boston Children's Hospital, Boston. Massachusetts; Department of Psychiatry, Harvard Medical School, Boston, Massachusetts.
Monique Germone, Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado; Departments of Psychiatry and Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado.
Lisa Fahey, Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Marisa Stahl, Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado; Department of Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado.
Maureen M. Leonard, Center for Celiac Research and Treatment, Division of Gastroenterology, Hepatology and Nutrition, Mass General Hospital for Children Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.
Arunjot Singh, Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Temara Hajjat, Department of Pediatrics, the Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio; The University of Cincinnati, Cincinnati, Ohio.
Daniel Mallon, Division of Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio; University of Cincinnati, Cincinnati, Ohio.
Benny Kerzner, Division of Gastroenterology, Hepatology and Nutrition, Children's National Hospital. Washington, DC; George Washington University School of Medicine and Health Sciences, Washington, DC.
Catherine Raber, Division of Gastroenterology, Hepatology and Nutrition, Children's National Hospital. Washington, DC.
Vahe Badalyan, Division of Gastroenterology, Hepatology and Nutrition, Children's National Hospital. Washington, DC; George Washington University School of Medicine and Health Sciences, Washington, DC.
Pooja Mehta, Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado; Department of Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado.
Edwin Liu, Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado; Department of Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado.
Mary Shull, Colorado Center for Celiac Disease, Digestive Health Institute, Children's Hospital Colorado; Department of Pediatrics, University of Colorado, School of Medicine, Aurora, Colorado.
Imad Absah, Division of Pediatric Gastroenterology, Hepatology and Nutrition, Mayo Clinic, Rochester, MN USA.
Dale Lee, Division of Pediatric Gastroenterology and Hepatology; Seattle Children's Hospital, Seattle, WA.
Tracy Ediger, Division of Gastroenterology, Hepatology and Nutrition at Nationwide Children's Hospital and Department of Pediatrics, The Ohio State University College of Medicine.
Ritu Verma, Department of Pediatrics, Section of Gastroenterology, Hepatology and Nutrition, The University of Chicago, Chicago, Illinois.
Hilary Jericho, Stanford University, Palo Alto, CA.
Nasim Khavari, Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Celiac Disease Center, Stanford University, Lucile Packard Children's Hospital, Palo Alto, CA.
Jackie Jossen, Department of Pediatrics, Morgan Stanley Children's Hospital, Columbia University, New York, NY.
Randi L. Wolf, Department of Health Studies and Applied Educational Psychology, Program in Nutrition, Teachers College, Columbia University, New York, New York.
Madison Wong, Harvard Celiac Disease Research Program, Boston Children's Hospital, Boston, Massachusetts.
Stephanie Regis, Harvard Celiac Disease Research Program, Boston Children's Hospital, Boston, Massachusetts.
Vanessa Weisbrod, Celiac Disease Foundation, Woodland Hills, CA.
Jocelyn Anne Silvester, Division of Gastroenterology and Nutrition, Boston Children's Hospital, Boston, Massachusetts; Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.

Document Type

Journal Article

Publication Date

7-30-2025

Journal

The American journal of gastroenterology

DOI

10.14309/ajg.0000000000003675

Keywords

Celiac disease; adherence; gluten exposure risk; gluten-free diet; treatment

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 three phases. First, items were generated and refined via a modified Delphi process. Next, psychometrics, factor structure, and validity was examined in a sample of caregivers of pediatric patients <18 years old with CeD at 12 pediatric celiac centers. Lastly, the final measure was tested on an independent sample population using confirmatory factor analysis (CFA) 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 CFA data from 484 caregivers, the final measure included a total of a single screening question and 9 validated items representing two domains (Home, Outside). Repeat testing on a separate sample (N=369) confirmed factor structure and validity of the final measure (CFI = 0.96, TLI = 0.95, RMSEA = 0.06). DISCUSSION: The Gluten Exposure Risk Assessment is a valid screening measure, completed by caregivers, for assessment of gluten exposure in children and adolescents with CeD following a gluten-free diet. GERA is a useful tool for evaluating the potential of risk for gluten exposure and potential need for intervention.

Department

Pediatrics

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