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Developing a core outcome set for anthropometric evaluation for presurgical infant orthopaedics for unilateral cleft
Tatiana Castillo1, Peralta Pedrero María Luisa1, Patricia Clark1
1Programa de Maestría y Doctorado en Ciencias Médicas, Odontológicas y de la Salud en la Universidad Nacional Autónoma de México, Av. Universidad 3000 Circuito, CP 04510 Mexico city, México; Fundación de Anomalías Craneofaciales Fernando Ortiz Monasterio, Ciudad de México, México. Hospital Angeles del pedregal, Camino Sta. Teresa 1055-S, Heroes de Padierna, Héroes de Padierna, CP 10700 Mexico City, Mexico.
Insights
A core outcome set of 18 anthropometric measures was developed to evaluate presurgical infant orthopaedics (PSIO) effectiveness in unilateral cleft lip palate (UCLP). This standardized tool aids in assessing PSIO quality before primary cleft lip repair.
Area of Science:
- Craniofacial Surgery
- Pediatric Plastic Surgery
- Cleft Lip and Palate Research
Background:
- Presurgical infant orthopaedics (PSIO) aims to improve anatomical outcomes in infants with cleft lip and palate before surgical repair.
- The effectiveness of PSIO in unilateral cleft lip palate (UCLP) requires standardized outcome measures for reliable evaluation.
- Current anthropometric assessments for PSIO lack a consensus-based core set, hindering comparative studies.
Purpose of the Study:
- To develop a core outcome set (COS) for reporting anthropometry-based outcomes in studies evaluating PSIO in UCLP.
- To establish a standardized framework for measuring the effectiveness of PSIO interventions prior to primary cleft lip repair.
Main Methods:
- A comprehensive literature search identified anthropometric measures relevant to PSIO in UCLP.
- Delphi methodology involving 10 subject-matter experts was employed over three rounds.
- A consensus was reached on a core outcome set with a validity coefficient of ≥80% for selected measures.
Main Results:
- A total of 101 anthropometric measures were initially identified.
- The consensus process validated a core outcome set comprising 18 essential anthropometric measures.
- These measures include specific nasal and lip dimensions, as well as arch and palatal measurements.
Conclusions:
- Standardized outcome measures are crucial for evaluating and ensuring the quality of treatment in cleft lip and palate (CLP) care.
- The developed core outcome set provides a clinically useful and cost-effective tool for PSIO effectiveness studies.
- This validated COS facilitates consistent and reliable assessment of PSIO interventions in UCLP.
Introduction:
Presurgical infant orthopaedics (PSIO) in infants with cleft lip and palate focuses on improving the anatomical conditions of the lip, palate and nose before the first lip surgery; however, its effectiveness has not been proven.
Objective:
To develop a core outcome set for reporting anthropometry-based outcomes in studies appraising the PSIO before primary cleft lip repair in unilateral cleft lip palate (UCLP).
Method:
Literature search to identify anthropometric measures. The operational definition and schematic representation of each were elaborated, grouping those apparently the same. By using Delphi methodology with a consensus of 10 subject-matter experts, three rounds were conducted to select a core outcome set of anthropometric measures with a validity V coefficient ≥80% among considered necessary to evaluate the PSIO in UCLP.
Results:
A total of 101 anthropometric measures were identified in the literature to evaluate PSIO in UCLP. Of these, consensus validated the content of the core outcome set, which comprises 18 anthropometric measures, including columella height, nasal tip projection, projection alar length, width of nostril, nasal basal width, angle of columella, cleft lip segment, height of the non-cleft lip, height of the cleft lip, intersegment distance, arch length, greater segment length, lesser segment length, lateral deviation of the incisal point, posterior width of palatal cleft, arch width, grater segment rotation and lesser segment rotation.
Conclusions:
Standardised outcome measures are necessary to evaluate and ensure the quality of treatment in CLP. The core outcome set for anthropometric evaluation validated by consensus subject-matter experts is a clinically useful and low-cost tool for PSIO effectiveness studies.
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