Development and Reliability Assessment of the Presurgical Infant Orthopedics Assessment Tool for Evaluating Clinical Outcomes of Presurgical Infant Orthopedics

ObjectivePresurgical infant orthopedics (PSIO) is used to optimize anatomical outcomes in infants with cleft lip and palate to facilitate favorable surgical results. However, standardized, reliable tools to assess PSIO effectiveness are lacking due to phenotypic variability and diverse treatment protocols. This study aimed to develop and perform a preliminary reliability assessment of a novel phenotype-based clinical outcome assessment tool, the PSIO Assessment Tool (PAT), to assess PSIO-related morphological changes in unilateral and bilateral cleft lip with or without palate.vdDesignTool Development and Reliability Assessment Study.SettingMulticentre expert consensus involving craniofacial orthodontists from diverse global regions.ParticipantsStandardized pretreatment and post-treatment clinical cases of unilateral and bilateral cleft lip and alveolus with or without palate were used for calibration and reliability assessment.InterventionA panel of 7 expert craniofacial orthodontists collaboratively developed the PAT through iterative calibration using clinical cases. The tool assesses cleft severity pretreatment and morphological correction post-treatment, grading cleft width, nasal symmetry, and alveolar alignment.Main Outcome Measure(s)Reliability was evaluated via inter-rater and intrarater agreement using Fleiss κ and quadratic weighted Cohen's κ statistics.ResultsThe PAT demonstrated good preliminary inter-rater and intrarater reliability, with inter-rater Fleiss' κ of 0.83 for pretreatment grading and weighted Cohen's κ of 0.75 for post-treatment grading. Intrarater reliability was substantial to almost perfect (κ = 0.70-0.81).ConclusionsThe PAT demonstrated encouraging preliminary reliability among experienced craniofacial orthodontists evaluating standardized PSIO records. Further multicenter studies are needed to establish broader validity and clinical applicability.