Development and Validation of a Photonumeric Scale for Evaluation of Static Horizontal Forehead Lines.
BACKGROUND
A validated scale is needed for objective and reproducible comparisons of static forehead lines before and after treatment in practice and clinical studies.


OBJECTIVE
To describe the development and validation of the 5-point photonumeric Allergan Forehead Lines Scale.


METHODS
The Allergan Forehead Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 295) completed during 2 sessions occurring 3 weeks apart.


RESULTS
A difference of ≥1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.06 [0.91-1.21] for clinically different image pairs and 0.38 [0.26-0.51] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was almost perfect (mean weighted kappa = 0.87). Interrater agreement was almost perfect during the second rating session (0.86, primary end point).


CONCLUSIONS
The Allergan Forehead Lines Scale is a validated and reliable scale for physician rating of static horizontal forehead lines.
*Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada; †Department of Dermatology, Yale University School of Medicine, New Haven, Connecticut; ‡Allergan plc, Irvine, California; §Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, British Columbia, Canada; ‖UC Davis Medical Group, Sacramento, California; ¶Division of Dermatology, University of California at Los Angeles, Los Angeles, California; #Peloton Advantage, LLC, Parsippany, New Jersey.
Alastair
A
Carruthers
Lisa
L
Donofrio
Bhushan
B
Hardas
Diane K
DK
Murphy
Jean
J
Carruthers
Jonathan M
JM
Sykes
Derek
D
Jones
Lela
L
Creutz
Ann
A
Marx
Sara
S
Dill
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005546:Forehead / Q000033:anatomy & histology / Q000473:pathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D010781:Photography; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D055815:Young Adult
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