ObjectiveThis study aimed to develop and validate a cleft-specific proxy clinical screening instrument for children up to 8 years old with orofacial clefts: the CleftChild-8. Our objective was to implement this questionnaire as a preparatory tool for cleft team consultations, enabling early identification of patient needs, facilitating communication with caregivers, and improving the quality and efficiency of care.DesignThis was a multicenter prospective cohort study to develop an instrument to be interpreted at the item level in an iterative process with relevant domains selection, item pool generation, caregivers and expert feedback, and psychometric testing.SettingThe study took place in 5 orofacial clefts referral centers in the Netherlands.ParticipantsParticipants were parents or caregivers of children born with syndromic and nonsyndromic cleft lip and/or palate and younger than 8 years old.ResultsBetween 2023 and 2025, the CleftChild-8 working version was completed by 414 parents/caregivers. Psychometric analyses supported a four-factor structure with good to excellent internal consistency (α = 0.75-0.92) and demonstrated known-groups validity across cleft types. The final 42-item questionnaire covers feeding and dentition, otology and sleep, speech, and psychosocial functioning.ConclusionThe Cleftchild-8 is a valid instrument to support cleft consultations by prioritizing the needs of patients and their families through reviewing responses to individual items and open-ended questions. The Cleftchild-8 can assist cleft teams to efficiently identify key concerns and tailor consultations accordingly.
Bachini et al. (Wed,) studied this question.