Journal
DERMATOLOGIC SURGERY
Volume 42, Issue 10, Pages S195-S202Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/DSS.0000000000000850
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Funding
- Allergan plc, Dublin, Ireland
- Allergan plc.
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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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