Bhushan Hardas

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

BACKGROUND A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing 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 = 298) 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, 1.1 [0.94–1.26] for clinically different image pairs and 0.67 [0.51–0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint). CONCLUSION The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit.

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). CONCLUSION The Allergan Forehead Lines Scale is a validated and reliable scale for physician rating of static horizontal forehead lines.

Development and validation of a photonumeric scale for evaluation of facial skin texture

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness 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 = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96–1.23] for clinically different image pairs and 0.53 [0.38–0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness.

Development and validation of a photonumeric scale for evaluation of facial fine lines

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial fine lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Fine Lines Scale. METHODS The Allergan Fine 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 = 289) 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% CI] absolute score difference, 1.06 [0.92–1.21] for clinically different image pairs and 0.50 [0.38–0.61] for not clinically different pairs). Intrarater agreement between the 2 live subject validation sessions was almost perfect (weighted kappa = 0.85). Interrater agreement was substantial during the second rating session (0.76, primary end point). CONCLUSION The Allergan Fine Lines Scale is a validated and reliable scale for physician rating of severity of superficial fine lines.

Development and validation of a photonumeric scale for assessment of chin retrusion

BACKGROUND A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Chin Retrusion Scale. METHODS The Allergan Chin Retrusion 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 = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS A difference of ≥1 point on the scale was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference, 1.07 [0.94–1.20] for clinically different image pairs and 0.51 [0.39–0.63] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.68, primary end point). CONCLUSION The Allergan Chin Retrusion Scale is a validated and reliable scale for physician rating of severity of chin retrusion.

Five-year Safety Data for More than 55,000 Subjects following Breast Implantation: Comparison of Rare Adverse Event Rates with Silicone Implants versus National Norms and Saline Implants

Background: The U.S. Food and Drug Administration has required postapproval studies of silicone breast implants to evaluate the incidence of rare adverse events over 10 years after implantation. Methods: The Breast Implant Follow-Up Study is a large 10-year study (>1000 U.S. sites) evaluating long-term safety following primary augmentation, revision-augmentation, primary reconstruction, or revision-reconstruction with Natrelle round silicone breast implants compared with national norms and outcomes with saline implants. Targeted adverse events in subjects followed for 5 to 8 years included connective tissue diseases, neurologic diseases, cancer, and suicide. Results: The safety population comprised 55,279 women (primary augmentation, n = 42,873; revision-augmentation, n = 6837; primary reconstruction, n = 4828; and revision-reconstruction, n = 741). No targeted adverse events occurred at significantly greater rates in silicone implant groups versus national norms across all indications. The standardized incidence rate (observed/national norm) for all indications combined was 1.4 for cervical/vulvar cancer, 0.8 for brain cancer, 0.3 for multiple sclerosis, and 0.1 for lupus/lupus-like syndrome. Silicone implants did not significantly increase the risk for any targeted adverse events compared with saline implants. The risk of death was similar with silicone versus saline implants across all indications. The suicide rate (10.6 events per 100,000 person-years) was not significantly higher than the national norm. No implant-related deaths occurred. Conclusions: Results from 5 to 8 years of follow-up for a large number of subjects confirmed the safety of Natrelle round silicone implants, with no increased risk of systemic disease or suicide versus national norms or saline implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Development and validation of a photonumeric scale for evaluation of infraorbital hollows

BACKGROUND A validated scale is needed for objective and reproducible comparisons of infraorbital hollows (i.e., tear troughs) before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Infraorbital Hollows 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 = 297) 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, 0.90 [0.79–1.02] for clinically different image pairs and 0.33 [0.19–0.46] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.70, primary end point). CONCLUSION The Allergan Infraorbital Hollows Scale is a validated and reliable scale for physician rating severity of hollowing in the infraorbital area.

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

BACKGROUND A validated scale is needed for objective and reproducible comparisons of horizontal neck lines before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Transverse Neck Lines Scale. METHODS The Allergan Transverse Neck 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 rating validation study (N = 297) 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, 1.22 [1.09–1.35] for clinically different image pairs and 0.57 [0.42–0.72] for not clinically different pairs). Intrarater agreement between the 2 live-subject rating validation sessions was substantial (mean weighted kappa = 0.78). Interrater agreement was substantial during the second rating session (0.73, primary end point). CONCLUSION The Allergan Transverse Neck Lines Scale is a validated and reliable scale for rating of severity of neck lines.

Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study

BACKGROUND VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVE To evaluate the safety and effectiveness of VYC-15L for lip and perioral enhancement versus a nonanimal stabilized HA with lidocaine (Restylane-L; NASHA). METHODS This prospective multicenter study randomized 225 adults with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) to treatment with VYC-15L or NASHA; optional touch-up was administered 30 days later. Subjects were followed for 1 year. The primary effectiveness end point was noninferiority of VYC-15L versus NASHA by mean change in LFS score from baseline to Month 3. RESULTS The primary end point was met. At Month 3, LFS responder rates were 80.3% for VYC-15L versus 70.8% for NASHA. LFS responder rates exceeded 60% through 1 year with VYC-15L. Perioral lines severity improved for 65.4% and 66.2% of VYC-15L subjects at Month 3 and Year 1, respectively. At Month 3, 96.1% and 88.2% of subjects reported improvement in FACE-Q Satisfaction With Lips and Satisfaction With Lip Lines, respectively. Severe injection site responses were reported less frequently with VYC-15L than NASHA. CONCLUSION VYC-15L was safe and effective for lip and perioral enhancement, with treatment effects lasting through 1 year.

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

Many published scale validation studies determine inter‐rater reliability using the intra‐class correlation coefficient (ICC). However, the use of this statistic must consider its advantages, limitations, and applicability. This paper evaluates how interaction of subject distribution, sample size, and levels of rater disagreement affects ICC and provides an approach for obtaining relevant ICC estimates under suboptimal conditions. Simulation results suggest that for a fixed number of subjects, ICC from the convex distribution is smaller than ICC for the uniform distribution, which in turn is smaller than ICC for the concave distribution. The variance component estimates also show that the dissimilarity of ICC among distributions is attributed to the study design (ie, distribution of subjects) component of subject variability and not the scale quality component of rater error variability. The dependency of ICC on the distribution of subjects makes it difficult to compare results across reliability studies. Hence, it is proposed that reliability studies should be designed using a uniform distribution of subjects because of the standardization it provides for representing objective disagreement. In the absence of uniform distribution, a sampling method is proposed to reduce the non‐uniformity. In addition, as expected, high levels of disagreement result in low ICC, and when the type of distribution is fixed, any increase in the number of subjects beyond a moderately large specification such as n = 80 does not have a major impact on ICC.