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Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Hand
Derek Jones1, Lisa Donofrio, Bhushan Hardas
1*Division of Dermatology, University of California at Los Angeles, Los Angeles, California; †Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; ‡Allergan plc, Irvine, California; Departments of §Ophthalmology and Visual Sciences, and ‖Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; ¶UC Davis Medical Group, Sacramento, California; #Peloton Advantage, LLC, Parsippany, New Jersey.
Background:
A validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies.
Objective:
To describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit 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 = 296) 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, 1.12 [0.99-1.26] for clinically different image pairs and 0.45 [0.33-0.57] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.83). Interrater agreement was almost perfect during the second session (0.82, primary end point).
Conclusion:
The Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit.
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