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Development and Reliability Assessment of the Presurgical Infant Orthopedics Assessment Tool for Evaluating Clinical
Alvaro Figueroa1, Monica Dominguez2, Puneet Batra3
1Figueroa Orthodontics, Smile Train's Global Medical Advisory Board, Chicago, IL, USA.
Insights
A new PSIO Assessment Tool (PAT) shows promising reliability for evaluating cleft lip and palate treatment outcomes. This tool helps standardize assessments of morphological changes in infants undergoing presurgical infant orthopedics.
Area of Science:
- Craniofacial orthodontics
- Pediatric plastic surgery
- Medical device development
Background:
- Presurgical infant orthopedics (PSIO) aims to improve surgical outcomes for cleft lip and palate (CLP).
- Current methods for assessing PSIO effectiveness lack standardization and reliability due to patient variability and diverse protocols.
- Objective evaluation of PSIO's impact on infant anatomy is crucial for treatment refinement.
Purpose of the Study:
- To develop a novel, phenotype-based clinical outcome assessment tool for PSIO.
- To conduct a preliminary reliability assessment of this new tool, the PSIO Assessment Tool (PAT).
- To evaluate the PAT's ability to measure morphological changes in unilateral and bilateral CLP.
Main Methods:
- A multicenter expert consensus approach was used, involving craniofacial orthodontists.
- The PAT was developed through iterative calibration using standardized pretreatment and post-treatment CLP cases.
- Inter-rater and intrarater reliability were assessed using Fleiss κ and quadratic weighted Cohen's κ statistics.
Main Results:
- The PAT demonstrated good preliminary inter-rater reliability (Fleiss' κ = 0.83 pretreatment; weighted Cohen's κ = 0.75 post-treatment).
- Intrarater reliability was substantial to almost perfect (κ = 0.70–0.81).
- The tool effectively grades cleft width, nasal symmetry, and alveolar alignment.
Conclusions:
- The PSIO Assessment Tool (PAT) shows encouraging preliminary reliability among experienced clinicians.
- The PAT can reliably assess morphological changes related to PSIO in infants with CLP.
- Further multicenter validation is recommended to establish broader clinical applicability.
Abstract:
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.