Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Hand

Abstract

BACKGROUNDA validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies.OBJECTIVETo describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit Scale.METHODSThe 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.RESULTSA 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).CONCLUSIONThe Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit.

Development and Validation of a Photonumeric Scale for Evaluation of Transverse Neck Lines

“…During the first and second live scale validation sessions, each physician rater evaluated all subjects on all scales (7 additional scales for other anatomic features were evaluated at the same sessions and are reported separately 16 – 22 ). Raters had separate evaluation stations with an examination lamp, table, a stool for subject seating, supplies, and the photonumeric scale mounted and displayed for use in subject evaluation.…”

Performance of intraclass correlation coefficient (ICC) as a reliability index under various distributions in scale reliability studies

“…The example used for illustration in this paper is a multiple scales reliability study designed to validate 5 photonumeric scales for measuring volume deficits and aging in the following areas: forehead lines, fine lines, hand volume deficit, skin roughness, and temple hollowing. [24][25][26][27][28] Each of the 5 scales has 5 grades of severity (ie, 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe) to measure volume deficit and aging. Because multiple scales are being assessed simultaneously, it is difficult to obtain uniform distributions of subjects across all 5 grades of the 5 scales as is apparent in Table 1.…”

Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Temple

“…During the first and second live validation sessions, each physician rater evaluated all subjects on all scales (7 additional scales for other anatomic features were evaluated at the same sessions and are reported separately 16 – 22 ). Raters had separate evaluation stations with an examination lamp, table, a stool for subject seating, supplies, and the photonumeric scale mounted and displayed for use in subject evaluation.…”