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Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Temple
Jean Carruthers1, Derek Jones, Bhushan Hardas
1*Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; †Division of Dermatology, University of California at Los Angeles, Los Angeles, California; ‡Allergan plc, Irvine, California; §Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; ‖UC Davis Medical Group, Sacramento, California; ¶Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; #Peloton Advantage, LLC, Parsippany, New Jersey.
Background:
A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies.
Objective:
To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing Scale.
Methods:
The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart.
Results:
A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.1 [0.94-1.26] for clinically different image pairs and 0.67 [0.51-0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint).
Conclusion:
The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit.
