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Background: Functional bowel and bladder disorders are prevalent among children. The impact of assisted infant toilet training on the prevalence of childhood bowel and bladder disorders has not previously been investigated. As self-reported bowel and bladder symptoms can be unreliable, robust tools are essential to evaluate interventions. The ROME Foundation offers diagnostic criteria for functional gastrointestinal disorders, while the International Children's Continence Society (ICCS) provides definitions for functional bladder disorders. Our research group has launched the BABITT study, a two-armed intervention study to investigate whether assisted infant toilet training reduces the prevalence of functional bowel and bladder disorders.

Aim: To construct a questionnaire, assessing bowel and bladder function in children introduced to infant toilet training and to evaluate content validity as well as feasibility.

Methods: In three consecutive steps, a web-based questionnaire was developed. In Step 1, the questionnaire was outlined based on literature review and consensus panel discussions. In Step 2, the questionnaire was validated regarding relevance and simplicity by the content validity index (CVI) method. In Step 3, a pilot phase allowed for assessment of feasibility in the clinical study setting.

Results: In Step 1, the Rome criteria and ICCS frameworks were selected for primary outcomes. After the final assessment round in Step 2, the i-CVI ranged from 0.88-1.00 in most items, in all domains, for both relevance and simplicity. Generally lower scores on simplicity emphasized revisions of this aspect of the items. In the pilot phase Step 3, respondent burden was analysed and feasibility assessed. The response rate at the 2-months questionnaire was 95% and acceptability of the intervention was satisfactory.

Conclusion: A web- based questionnaire for assessment of parent-reported bladder and bowel function in children who are introduced to infant toilet training was developed. The questionnaire emerged as valid and feasible in its context.