Investigating the Impact of Additional Congenital Malformations on Speech Outcomes at age Five in Children with a Cleft Palate.

Objective: To determine whether children born with a cleft palate ± lip (CP ± L) and additional congenital differences (ACDs - including 'Congenital malformations and deformations' as coded in ICD-10), are less likely to meet the three national speech outcome standards at age five compared to children with CP ± L and no ACDs.

Design: An observational study, utilizing national data from the UK Cleft Registry and Audit NEtwork (CRANE) Database linked to national administrative data of hospital admissions.

Setting: National Health Service, England.

Patients: 2191 children (993 female, 1198 male) with CP ± L, born 2006-2012 in England, with complete speech data and consent to data linkage.

Outcome measure: Perceptual speech analysis utilised the Cleft Audit Protocol for Speech - Augmented (CAPS-A) rating and United Kingdom National Speech Outcome Standards (Speech Standard 1 (SS1), Speech Standard 2a (SS2a) and Speech Standard 3 (SS3)).

Results: Of 2191 children, 759 (35%) had at least one ACD. Presence of one ACD did not significantly impact speech outcomes but two or more ACDs reduced the odds of achieving all three speech standards: SS1 aOR 0.602 (CI 0.45-0.82, P = .002), SS2a aOR 0.563 (CI 0.41-0.77, P = .001), SS3 aOR 0.606 (0.43-0.84, P = .003). When exploring ACDs by ICD-10 groupings, congenital malformations of the 'Eye, ear, face and neck', 'Circulatory system', 'Digestive system', 'Musculoskeletal system' and 'Other congenital malformations' reduced a child's odds of achieving the speech standards.

Conclusions: ACDs, in the absence of a known syndrome, have a significant impact on speech outcome at age five. Incorporating these factors into risk-adjustment models for service level outcome reporting is recommended.