RESUMO
OBJECTIVES: Carbohydrate intolerances may affect a majority of the worlds-population but there is no validated, test-specific assessment of carbohydrate-induced symptoms during breath tests. We aimed to develop and validate a questionnaire for evaluation and quantification of carbohydrate intolerance. METHODS: A visual analog scale-questionnaire with five complaints (pain, nausea, bloating, flatulence, and diarrhea) was designed. The time frame of symptoms was 'current' (for baseline symptoms) and 'since filling out the last questionnaire'. Validity was determined in focus-group style interviews and during breath tests in an original (n = 342) and follow-up patient groups (n = 338). RESULTS: The questionnaire had good face validity, content validity ratio according to Lawshe was 1. Intraclass correlation coefficients (n = 195; 30-min' interval) demonstrated excellent reliability (P < 0.001), Cohen's d (measure of effect size) was small (≤0.19 for each symptom). Convergent and discriminant validity were supported against patient interviews. Questionnaire-derived results highly correlated with a medical interview (P < 0.001; n = 338). Responsiveness to change was verified during breath tests despite small effect sizes (≤0.32). Additional cross-validation and external validation studies (follow-up in-house: n = 182; external: n = 156) demonstrated generalizability and identified relevant numbers of patients in whom there was no co-occurrence of carbohydrate malabsorption and intolerance. CONCLUSIONS: The adult Carbohydrate Perception Questionnaire is a valid instrument for the assessment of gastrointestinal symptoms after carbohydrate ingestion with excellent psychometric properties. It allows standardized, test-specific diagnosis of carbohydrate intolerance and evaluation of the relation between malabsorption and intolerance. It shall be useful for future studies on treatment of carbohydrate intolerance.