Development and Validation of a Rome III Functional Gastrointestinal Disorders Questionnaire for Infants and Toddlers

ABSTRACT Objective: Functional gastrointestinal disorders (FGIDs) in infants and toddlers are common, but no questionnaire is available for use in clinic and research. The purpose of the present study was to develop and validate a questionnaire assessing symptoms associated with FGIDs in infants and toddlers. Methods: Questions were developed based on the Rome III diagnostic criteria for FGIDs. A group of parents of children with FGIDs and experts in FGID reviewed the questionnaire for content, understandability, and completeness (face validity). Initial content validity was established by comparing physician and questionnaire diagnoses in a group of 332 consecutive new patients at a tertiary care clinic. Results: Ten parents and 8 experts identified no major problems, indicating good face validity. Of 332 consecutive new patients, age 1 month to 4 year of age, 172 subjects (52% of the sample) qualified for a FGID by parent responses to the questionnaire (mean age = 1.23 year, 53% girls). All of these subjects also received an FGID diagnosis by their physician. Agreement between parent and doctor was fair to substantial (κ = 0.18–0.76), except for infant rumination and functional diarrhea in infants, which showed poor overlap. Conclusions: The newly developed Rome III questionnaire for infants and toddlers had good initial face and content validity. This questionnaire will be an important addition to clinical care and research of infant/toddler FGIDs. Replication of these findings in primary care is needed.