New photographic grading scales focus on perioral aesthetic features
Dr. Cohen, director, AboutSkin Dermatology and Derm Surgery, Englewood, Colo., says he identified the need for developing a validated grading scale to quantify the severity of aesthetic features of the perioral area as he began planning a dose-response study of onabotulinumtoxinA (Botox, Allergan) for treatment of perioral lines with animation.
Working in collaboration with several other physicians and researchers at Allergan, several four-point, lip-specific photographic scales were developed based on review of two-dimensional images of healthy volunteers. One scale rates the severity of vertical perioral lines at rest (POL), a second is for vertical perioral lines at maximum contraction (POLM), and the third describes the oral commissures, including marionette lines (OCS). Each scale includes grades of none, mild, moderate, and severe, and features three exemplary photos for each grade level.
Validation testing of the scales was undertaken in a study during which eight physicians specializing in aesthetic dermatology or plastic surgery used the instruments to rate 55 pre-screened subjects in live reviews. The physicians repeated the task in a second round to assess intra-rater variability, and the subjects were also asked to rate themselves at each round using the severity scales.
Statistical analyses using Pearson correlation coefficient testing showed almost perfect inter-rater agreement for all three scales at both rounds, while intra-rater agreement for each scale was substantial or almost perfect, Dr. Cohen says.
For the subjects' self-assessment ratings, these study subjects themselves had intra-rater agreement ranging from moderate to substantial, and there was also substantial agreement for all three scales between the subject and physician raters at both rounds, says Dr. Cohen, who subsequently used the POL and POLM scales in a multicenter dose-ranging clinical trial of onabotulinumtoxinA injection into the oris orbicularis muscle that he performed with Steve Dayan, M.D., Chicago, and Sue Ellen Cox, M.D., Chapel Hill, N.C.
"It was an interesting experience to address a gap in our clinical assessment tools — the lack of a perioral rating scale — and it was satisfying to be successful in starting from the ground up and developing scales for the perioral area with good reliability that were subsequently used in the setting of a clinical trial," Dr. Cohen says.
"Validated rating scales have an important role in supporting claims of efficacy from clinical studies of aesthetic treatments and allow inter-study comparisons.
"However, I also find they are a useful aid in clinical practice, both as a patient education tool pre-procedure, especially for discussing realistic expectations of treatments, and for evaluating or reinforcing to patients their improvement after procedures," he says.