Developing a core outcome set for anthropometric evaluation for presurgical infant orthopaedics for unilateral cleft lip and palate: e-Delphi consensus.

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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