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Functional bowel and bladder disorders are prevalent among children. In 2019 our research group launched the BABITT study (Bowel and Bladder function in Infant Toilet Training), a randomized intervention study to investigate whether introduction to assisted infant toilet training reduces the prevalence of functional bowel and bladder disorders in children up to 4 years of age. Diagnostic criteria for gastrointestinal disorders are defined by the ROME Foundation, while the International Children’s Continence Society (ICCS) provides definitions of functional bladder disorders. Preceding the larger ongoing BABITT study, the aim of this present observational study is to construct, assess content validity and evaluate feasibility of a questionnaire for parent report.

METHODS: A web-based questionnaire was developed in three consecutive steps. In Step 1, the questionnaire was outlined based on literature review and expert panel discussions. In Step 2, the questionnaire was validated for relevance and simplicity by content validity index (CVI) using 4-point Likert scales. With dichotomized data, an index level ≥ 0.78 was considered as acceptable. In Step 3, the respondent burden was analysed and a pilot phase allowed for evaluation of feasibility in the clinical study setting.

RESULTS: In Step 1, the Rome IV criteria and ICCS frameworks were selected for items comprising the primary outcomes in the BABITT study. After the final assessment round in Step 2, the item-level content validity index (I-CVI) was excellent, ranging from 0.88 to 1.00 in most items, in all domains, for both relevance and simplicity. In the pilot phase Step 3, the response rate was 95% and the parents' acceptance of replying to the questionnaire was satisfactory.

CONCLUSION: A web-based questionnaire was developed to evaluate parent-reported bladder and bowel function in children who are introduced to assisted infant toilet training. The BABITT questionnaire emerged as valid and feasible in its context.