Creation and validation of a photonumeric scale for assessment of lip fullness

Autor: Patrick Trevidic, Wayne Carey, Anthony V. Benedetto, John H. Joseph, Laura Eaton, Stéphanie Antunes, Pauline Maffert
Rok vydání: 2022
Předmět:
Zdroj: Journal of Cosmetic Dermatology. 21:949-955
ISSN: 1473-2165
1473-2130
DOI: 10.1111/jocd.14761
Popis: Validated, objective clinical scales are needed to assess aesthetic improvement of the lips after augmentation with dermal fillers.To develop a lip fullness rating scale and establish its reliability for grading subjects in clinical trials or routine practice, and sensitivity for detecting clinically meaningful changes.The Teoxane Lip Fullness Scale (TLFS), a proprietary, 5-grade photonumeric scale, was developed by clinical experts based on real subject photographs and was validated through both photographic and live subjects' evaluation.Clinician intra- and inter-rater agreement for the TLFS was substantial to almost perfect. Mean intra-rater weighted Kappa score between the two rounds of photographic validation was 0.92, and inter-rater agreement was substantial with an ICC of 0.93 for the combined rounds. Average intra-rater weighted Kappa score and inter-rater ICC for the live validation were equally high, reaching 0.91 and 0.89 respectively. Additionally, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference on the scale in 90% and 98% of cases, respectively.The intra-rater Kappa scores and inter-rater ICC met their pre-determined acceptance criteria of0.70 in the photographic and live validation. The TLFS was shown to be a repeatable and reproducible Clinician Reported Outcome (Clin-RO) for healthcare providers to classify lip fullness both in clinical trials and in routine patient care. A 1-grade difference on the TLFS can detect a clinically meaningful difference in lip fullness.
Databáze: OpenAIRE
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