Abstract

A prospective validation study was conducted at a large tertiary care center with two recruitment sites: (1) newborn nursery, (2) pediatric craniofacial surgery clinic. Eligible children were aged 0-12 months with no history of hydrocephalus, intracranial tumors, intracranial hemorrhage, intracranial hardware, or prior craniofacial surgery. Successful artificial intelligence diagnosis required identification of the presence and severity of positional plagiocephaly. A total of 89 infants were prospectively enrolled from the craniofacial surgery clinic (n = 25, 17 male infants [68%], eight female infants [32%], mean age 8.44 months) and newborn nursery (n = 64, 29 male infants [45%], 25 female infants [39%], mean age 0 months). The model obtained a diagnostic accuracy of 85.39% compared with a standard clinical examination with a disease prevalence of 48%. Sensitivity was 87.50% [95% CI, 75.94-98.42] with a specificity of 83.67% [95% CI, 72.35-94.99]. Precision was 81.40%, while likelihood ratios (positive and negative) were 5.36 and 0.15, respectively. The F1-score was 84.34%. The smartphone-based artificial intelligence algorithm accurately diagnosed positional plagiocephaly in a clinical environment. This technology may provide value by helping guide specialist consultation and enabling longitudinal quantitative monitoring of cranial shape.

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