Credit for Truly Novel Ideas? A Critical Approach to the Intellectual Authorship in Surgery.

The formation of new ideas and techniques in medicine and surgery is crucial to bettering the medical field and the quality of medical care. The transmission of these new ideas is a source of pride and recognition for physicians who devote their lives to patient care. The quality and integrity of the medical literature that results from seminal medical ideas are an essential but unregulated field. From time to time, there are discussions in the medical literature about the authorship of an idea/strategy/technique. In this digital era, where communication works at an unmeasurable speed, the authenticity of medical communication requires honesty and verification. The possibility of unreliable or false information exists, and the need to verify "new" information as accurate and honest is crucial. Rhythm, genuine, and fake (fair/unfair) information circulates at high speed, and suddenly everything one encounters is represented as "true and often represented as new." Regarding medical science and particularly surgery - we are overloaded daily with new techniques, new names, new strategies, and everything. Several questions regarding the authenticity of any publication or scientific communication exist. A critical approach is done in this article.

Infrastructure platform for privacy-preserving distributed machine learning development of computer-assisted theragnostics in cancer.

INTRODUCTION: Emerging evidence suggests that data-driven support tools have found their way into clinical decision-making in a number of areas, including cancer care. Improving them and widening their scope of availability in various differing clinical scenarios, including for prognostic models derived from retrospective data, requires co-ordinated data sharing between clinical centres, secondary analyses of large multi-institutional clinical trial data, or distributed (federated) learning infrastructures. A systematic approach to utilizing routinely collected data across cancer care clinics remains a significant challenge due to privacy, administrative and political barriers. METHODS: An information technology infrastructure and web service software was developed and implemented which uses machine learning to construct clinical decision support systems in a privacy-preserving manner across datasets geographically distributed in different hospitals. The infrastructure was deployed in a network of Australian hospitals. A harmonized, international ontology-linked, set of lung cancer databases were built with the routine clinical and imaging data at each centre. The infrastructure was demonstrated with the development of logistic regression models to predict major cardiovascular events following radiation therapy. RESULTS: The infrastructure implemented forms the basis of the Australian computer-assisted theragnostics (AusCAT) network for radiation oncology data extraction, reporting and distributed learning. Four radiation oncology departments (across seven hospitals) in New South Wales (NSW) participated in this demonstration study. Infrastructure was deployed at each centre and used to develop a model predicting for cardiovascular admission within a year of receiving curative radiotherapy for non-small cell lung cancer. A total of 10,417 lung cancer patients were identified with 802 being eligible for the model. Twenty features were chosen for analysis from the clinical record and linked registries. After selection, 8 features were included and a logistic regression model achieved an area under the receiver operating characteristic (AUROC) curve of 0.70 and C-index of 0.65 on out-of-sample data. CONCLUSION: The infrastructure developed was demonstrated to be usable in practice between clinical centres to harmonize routinely collected oncology data and develop models with federated learning. It provides a promising approach to enable further research studies in radiation oncology using real world clinical data.

Multimodal Facial Aesthetic Treatment on the Appearance of Aging, Social Confidence, and Psychological Well-being: HARMONY Study.

BACKGROUND: A global approach to facial rejuvenation involves multiple treatment modalities. OBJECTIVES: The aim of this study was to evaluate the impact of multimodal facial aesthetic treatment on self-reported psychological and social outcomes. METHODS: HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost. Fillers were injected on Day 1, with touch-ups performed on Day 14. OnabotulinumtoxinA was injected at Month 3 into glabellar lines and/or crow's feet lines. Patients applied bimatoprost to eyelashes once daily for 17 weeks. Mean change from baseline on FACE-Q Psychological Well-being and Social Confidence Scales, FACE-Q Aging Appearance Appraisal Scale, and FACE-Q Age Appraisal Visual Analog Scale were assessed. RESULTS: Of 100 patients treated, 93 were evaluated at 4 months posttreatment. Significant improvement vs baseline was observed on the FACE-Q Scales for Psychological Well-being (mean change, -19.9; P < 0.00001), Social Confidence (mean change, -18.2; P < 0.00001), and Aging Appearance (mean change, -28.5; P < 0.0001). On average, patients' self-assessed age was 0.1 years older than actual age at baseline and 4.5 years younger at Month 4 (P < 0.001 vs baseline). Forty-two patients experienced adverse events, all mild to moderate. CONCLUSIONS: Multimodal, full facial aesthetic treatment improves patients' self-reported psychological well-being, social confidence, aging appearance, and perceptions of chronologic age.

A novel method to determine linac mechanical isocenter position and size and examples of specific QA applications.

The most important geometric characteristic of stereotactic treatment is the accuracy of positioning the target at the treatment isocenter and the accuracy of directing the radiation beam at the treatment isocenter. Commonly, the radiation isocenter is used as the reference for the treatment isocenter, but its method of localization is not strictly defined, and it depends on the linac-specific beam steering parameters. A novel method is presented for determining the linac mechanical isocenter position and size based on the localization of the collimator axis of rotation at arbitrary gantry angle. The collimator axis of rotation position is determined from the radiation beam center position corrected for the focal spot offset. The focal spot offset is determined using the image center shift method with a custom-design rigid phantom with two sets of ball-bearings. Three specific quality assurance (QA) applications and assessment methods are also presented to demonstrate the functionality of linac mechanical isocenter position and size determination in clinical practice. The first is a mechanical and radiation isocenters coincidence test suitable for quick congruence assessment of these two isocenters for a selected energy, usually required after a nonroutine linac repair and/or energy adjustment. The second is a stereotactic beam isocentricity assessment suitable for pretreatment stereotactic QA. The third is a comprehensive linac geometrical performance test suitable for routine linac QA. The uncertainties of the method for determining mechanical isocenter position and size were measured to be 0.05 mm and 0.04 mm, respectively, using four available photon energies, and were significantly smaller than those of determining the radiation isocenter position and size, which were 0.36 mm and 0.12 mm respectively. It is therefore recommended that the mechanical isocenter position and size be used as the reference linac treatment isocenter and a linac mechanical characteristic parameter respectively.

Assessment of error in the MV radiation isocenter position calculated with the Elekta XVI software.

The assessment of the coincidence of imaging and radiation isocenters is an important task of regular quality assurance of medical linear accelerators (linacs) as recommended in national and international quality assurance guidelines. A previously reported investigation of the accuracy of the Elekta XVI software to localize the linac radiation isocenter, by comparing statistically with other independent software, has shown some discrepancies at the sub-mm level. A further investigation is carried out here using a set of reference images and mathematical operations to observe how the Elekta XVI software analyses them. Symmetric mathematical operations on reference images should result in symmetrical outcomes. Three different rotation functions are used in increasing degree of complexity to characterize the Elekta XVI software error in the linac radiation isocenter position. No independent algorithms or phantoms are used in this methodology. The magnitude and direction of the radiation isocenter localization error has been determined to be consistently 0.13 mm or 0.14 mm in the longitudinal direction towards the target depending on the case. The radiation isocenter localization error comprises two separated errors of the Ball Bearing Center by 0.13 mm and MV Field Center by either 0.00 mm or -0.01 mm in the longitudinal direction towards the target. The calculation of the MV Field Center is influenced by the polymethyl methacrylate rod supporting the ball-bearing. The precise value and the root cause of the error cannot be assessed due to the rounding effect of the results reported by the Elekta XVI software and lack of access to the source code.

An international survey on the clinical use of rigid and deformable image registration in radiotherapy.

OBJECTIVES: Rigid image registration (RIR) and deformable image registration (DIR) are widely used in radiotherapy. This project aims to capture current international approaches to image registration. METHODS: A survey was designed to identify variations in use, resources, implementation, and decision-making criteria for clinical image registration. This was distributed to radiotherapy centers internationally in 2018. RESULTS: There were 57 responses internationally, from the Americas (46%), Australia/New Zealand (32%), Europe (12%), and Asia (10%). Rigid image registration and DIR were used clinically for computed tomography (CT)-CT registration (96% and 51%, respectively), followed by CT-PET (81% and 47%), CT-CBCT (84% and 19%), CT-MR (93% and 19%), MR-MR (49% and 5%), and CT-US (9% and 0%). Respondent centers performed DIR using dedicated software (75%) and treatment planning systems (29%), with 84% having some form of DIR software. Centers have clinically implemented DIR for atlas-based segmentation (47%), multi-modality treatment planning (65%), and dose deformation (63%). The clinical use of DIR for multi-modality treatment planning and accounting for retreatments was considered to have the highest benefit-to-risk ratio (69% and 67%, respectively). CONCLUSIONS: This survey data provides useful insights on where, when, and how image registration has been implemented in radiotherapy centers around the world. DIR is mainly in clinical use for CT-CT (51%) and CT-PET (47%) for the head and neck (43-57% over all use cases) region. The highest benefit-risk ratio for clinical use of DIR was for multi-modality treatment planning and accounting for retreatments, which also had higher clinical use than for adaptive radiotherapy and atlas-based segmentation.

Demystifying the Deep Plane Facelift: What It Means Anatomically and Why It Works.

Rhytidectomy is a common procedure performed by facial plastic surgeons. On well-selected patients, rhytidectomy rejuvenates the aging face by repositioning soft tissues and improving facial shape. The fundamental goal of rhytidectomy, or facelift surgery, is to provide a more youthful facial appearance by elevating soft tissues that often descend with aging. The success and longevity of any rhytidectomy procedure are based on the individual patient's anatomy and aging and on the mobilization, elevation, and fixation of the soft tissues during the facelift procedure. Although surgeons often use many terms to describe a given facelift technique, anatomical terms are best used to name the facelift procedure, as the plane of dissection and the vector of elevation are what determines the end result. This paper attempts to simplify and demystify the deep plane facelift procedure and to describe the anatomy that makes this technique successful.

Morphing as a Selection Tool in the Rhinoplasty Consult: A Cross-Sectional Study.

Despite the recognized value of morphing in the literature, this preoperative tool has never been studied in the context of selection process in rhinoplasty. The main purpose of this article is to identify the use of morphing as a filter for unsuitable patients, the attrition rate from the initial consultation to surgery, and whether patients' appreciation on morphing influence their decision-making process. Three-hundred thirty-four consecutive patients, seeking rhinoplasty, underwent two-dimensional computer imaging and completed a 14-question survey about their opinion on morphing. Based on the presence or absence of patient/physician consensus on the expected outcomes during simulation, patients were divided into accepted or rejected candidates for surgery. Accepted candidates were scheduled for rhinoplasty and subdivided into those who underwent surgery, those who postponed their surgery (static), and those who cancelled their procedure. Their responses to the survey were compared between different patients' categories. Forty-four patients (13.2%) were rejected for rhinoplasty since consensus was not achieved during morphing. From 290 accepted patients, 178 underwent their operation (53.3%), 74 patients (22.1%) postponed their rhinoplasty, and 38 (11.4%) cancelled their surgery. Fifty-seven percent of rejected patients and 42% of the static group were not satisfied with the proposed results of morphing, in contrast with 16% of the operated group. Sixty-four percent of rejected patients, and 47% of the static group were not reassured after morphing, compared with 26% of the operated group. Presence or absence of consensus during morphing can guide the surgeon regarding a given patients' suitability for surgery. Patient satisfaction and reassurance with the morphed images can be a good predictor of patients who will proceed to surgery, calling attention to the value of morphing as a selection tool for surgeons and patients alike.

Relationship Between Vertical Glabellar Lines and the Supratrochlear and Supraorbital Arteries.

BACKGROUND: Glabellar soft tissue filler injections have been shown to be associated with a high risk of causing injection-related visual compromise. OBJECTIVES: The aim of this study was to identify the course of the superficial branch of the supratrochlear and of the deep branch of the supraorbital artery in relation to the ipsilateral vertical glabellar line and to test whether an artery is located deep to this line. METHODS: Forty-one healthy volunteers with a mean age of 26.17 [9.6] years and a mean BMI of 23.09 [2.3] kg/m2 were analyzed. Ultrasound imaging was applied to measure the diameters, distance from skin surface, distance between the midline, distance between vertical glabella lines, and the cutaneous projection of the supratrochlear/supraorbital arteries at rest and upon frowning. RESULTS: The mean distance between the superficial branch of the supratrochlear artery and the ipsilateral vertical glabellar line was 10.59 [4.0] mm in males and 8.21 [4.0] mm in females, whereas it was 22.38 [5.5] mm for the supraorbital artery in males and 20.73 [5.6] mm in females. Upon frowning, a medial shift in supratrochlear arterial position of 1.63 mm in males and 1.84 mm in females and of 3.9 mm in supraorbital arterial position for both genders was observed. The mean depth of the supratrochlear artery was 3.34 [0.6] mm at rest, whereas the depth of the supraorbital artery was 3.54 [0.8] mm. CONCLUSIONS: The hypothesis that injecting soft tissue fillers next to the vertical glabellar line is safe because the supratrochlear artery courses deep to the crease should be rejected. Additionally, the glabella and the supraorbital region should be considered as an area of mobile, rather than static, soft tissues.

Optimizing the Chin and Jawline Appearance: Does Surgery or Injection Make Sense?

The chin is a crucial landmark and mandates careful consideration for facial appearance. Optimal chin appearance requires evaluation and treatment in three dimensions: anteroposterior, transverse, and vertical planes. The optimization of chin deficiencies requires understanding of bony anatomy as well as the relationship of the adjacent facial structures including the lip, teeth, and nose. The practitioner should be familiar with techniques in injection, placement of alloplastic implants, as well bony genioplasty.

Aesthetic Treatment Positively Impacts Social Perception: Analysis of Subjects From the HARMONY Study.

BACKGROUND: The impact of facial aesthetic treatments not only enhances physical appearance but also psychological well-being. Accordingly, patient-reported outcomes are increasingly utilized as an important measure of treatment success. Observer-reported outcomes are a relevant yet often overlooked measure of treatment benefit. OBJECTIVES: The authors aimed to evaluate the impact of panfacial aesthetic treatment on the perception of an individual in a variety of social contexts. METHODS: A total 2000 men and women (aged 18-65 years) participated in an online study designed to capture the blinded observer's social perception of pretreatment and posttreatment patients who received panfacial aesthetic treatment in the HARMONY study. Perceptions relevant to character traits, age, attractiveness, and social status were evaluated. Observers were divided into 2 groups. Single image respondents (n = 1500) viewed 6 single, randomized patient images (3 pretreatment, 3 posttreatment), and paired image respondents (n = 500) viewed 6 pretreatment and posttreatment image pairs. RESULTS: Single image respondents reported significantly (P < 0.05) higher levels of agreement that posttreatment subjects appeared to possess more positive character traits (eg, healthy and approachable), were more socially adept, younger, more attractive, more successful at attracting others, and possessed a higher social status. Paired image respondents also reported a higher level of agreement for posttreatment images being aligned with positive character traits, representative of a younger and more attractive individual, and one with a higher social status. CONCLUSIONS: The results suggest that the positive impact of minimally invasive panfacial treatment extends beyond enhancing physical appearance and highlights the importance of social perception and observer-reported outcomes in aesthetic medicine.

Beam focal spot position determination for an Elekta linac with the Agility® head; practical guide with a ready-to-go procedure.

A novel phantomless, EPID-based method of measuring the beam focal spot offset of a linear accelerator was proposed and validated for Varian machines. In this method, one set of jaws and the MLC were utilized to form a symmetric field and then a 180o collimator rotation was utilized to determine the radiation isocenter defined by the jaws and the MLC, respectively. The difference between these two isocentres is directly correlated with the beam focal spot offset of the linear accelerator. In the current work, the method has been considered for Elekta linacs. An Elekta linac with the Agility® head does not have two set of jaws, therefore, a modified method is presented making use of one set of diaphragms, the MLC and a full 360o collimator rotation. The modified method has been tested on two Elekta Synergy® linacs with Agility® heads and independently validated. A practical guide with instructions and a MATLAB® code is attached for easy implementation.

Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study.

BACKGROUND: Individuals seeking aesthetic treatment have concerns regarding multiple facial areas. OBJECTIVES: Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments. METHODS: Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow's feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale. RESULTS: Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients. CONCLUSIONS: Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance.

Future Applications of Deoxycholic Acid in Body Contouring.

Deoxycholic acid (KybellaTM, Allergan Pharmaceuticals, Irvine, CA) is a novel injectable treatment used for the cosmetic reduction of redundant submental fat. By inducing adipose cell lysis, the soft tissue alteration induces subsequent contour change and sharpening of the cervicomental angle.The safety and efficacy have been well established in several prospective clinical trials and subsequent FDA approval for this purpose. This has provided an effective and less invasive alternative to surgical liposuction with virtually no recovery time and less overall discomfort. Given its success for use in this context, a logical step would be to extrapolate to other regions of the body where cosmetic deformity is caused by excessive adipose tissue. In the current article, the authors propose potential options for further use in various targeted areas where subcutaneous fat may be amenable to reduction with deoxycholic acid injection, understanding that such uses would be off-label and require an understanding of the regional anatomy and possible complications. J Drugs Dermatol. 2017;16(1):43-46.

Beam focal spot position: The forgotten linac QA parameter. An EPID-based phantomless method for routine Stereotactic linac QA.

Modern day Stereotactic treatments require high geometric accuracy of the delivered treatment. To achieve the required accuracy the IGRT imaging isocenter needs to closely coincide with the treatment beam isocenter. An influence on this isocenter coincidence and on the spatial positioning of the beam itself is the alignment of the treatment beam focal spot with collimator rotation axis. The positioning of the focal spot is dependent on the linac beam steering and on the stability of the monitor chamber and beam steering servo system. As such, there is the potential for focal spot misalignment and this should be checked on a regular basis. Traditional methods for measuring focal spot position are either indirect, inaccurate, or time consuming and hence impractical for routine use. In this study a novel, phantomless method has been developed using the EPID (Electronic Portal Imaging Device) that utilizes the different heights of the MLC and jaws. The method has been performed on four linear accelerators and benchmarked against an alternate ion chamber-based method. The method has been found to be reproducible to within ±0.012 mm (1 SD) and in agreement with the ion chamber-based method to within 0.001 ± 0.015 mm (1 SD). The method could easily be incorporated into a departmental routine linac QA (Quality Assurance) program.

Clinical Outcome and Patients' Satisfaction Study After Otoplasty Using Hybrid Techniques in Adult Patients.

OBJECTIVES: There are limited data on the effect of otoplasty on health-related quality of life (HRQoL) in prominent ears. There are no data on the effect of otoplasty on Glasgow Benefit Inventory (GBI) of otoplasty using hybrid techniques in adult patients. METHODS: This study involved 28 patients who underwent otoplasty using combined procedures. We chose the GBI because it is a sensitive tool for detecting changes in health status following an intervention. Patients older than 13 years received the GBI, being retrospective well-validated questionnaires for measuring the effect of otorhinolaryngologic interventions, and particularly plastic surgery procedures, on HRQoL. An individual questionnaire was created by the standard GBI. We combined posterior auricular skin excision, Mustarde suture technique, and conchomastoid suture techniques for maximizing the cosmetic improvements. RESULTS: According to the results of this study, good outcomes with patient satisfaction were achieved with this hybrid procedure. We found a conspicuous improvement in GBI total score as well as in the general health subscale after otoplasty. This indicates the beneficial impact on the healthy self-perception of this surgical procedure with prominent ears. CONCLUSIONS: In our retrospective assessment, GBI turned out to be a very useful and valuable tool in the evaluation of otoplasty. We demonstrated a long-lasting improvement in HRQoL after otoplasty for the prominent ears. Hybrid techniques are effective and satisfying treatment methods with high success rates for patients with prominent ears.

ATX-101 for reduction of submental fat: A phase III randomized controlled trial.

BACKGROUND: ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat. OBJECTIVE: We sought to evaluate the efficacy and safety of ATX-101. METHODS: In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes. RESULTS: Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P < .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P < .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site. LIMITATIONS: Follow-up was limited to 44 weeks. CONCLUSION: ATX-101 is an alternative treatment for SMF reduction.

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

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.

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.

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.