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Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollows
Lisa Donofrio1, Jean Carruthers, Bhushan Hardas
1*Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; †Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; ‡Allergan plc, Irvine, California; §Division of Dermatology, University of California, Los Angeles, Los Angeles, California; ‖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 infraorbital hollows (i.e., tear troughs) before and after treatment in practice and clinical studies.
Objective:
To describe the development and validation of the 5-point photonumeric Allergan Infraorbital Hollows 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 = 297) 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, 0.90 [0.79-1.02] for clinically different image pairs and 0.33 [0.19-0.46] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.70, primary end point).
Conclusion:
The Allergan Infraorbital Hollows Scale is a validated and reliable scale for physician rating severity of hollowing in the infraorbital area.
