Creation and Validation of a Photonumeric Scale for Assessment of Infraorbital Hollows.

BACKGROUND: Validated clinical scales are needed to assess aesthetic improvement of the infraorbital hollows (IOHs) after treatment with dermal fillers. OBJECTIVE: To develop an IOHs scale and establish its reliability and sensitivity for grading subjects in clinical trials or routine practice. METHODS AND MATERIALS: The Teoxane IOHs Scale (TIOHS), a 5-grade photonumeric scale, was developed based on real-subject photographs and validated through photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreements during the TIOHS validation were excellent. The mean intrarater-weighted Kappa score between the 2 sessions of photographic validation was 0.92, while inter-rater interclass correlation coefficient (ICC) was 0.92 for the combined sessions. The average intrarater-weighted Kappa score and inter-rater ICC for the live validation reached 0.80 and 0.76, respectively. In addition, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference in 82% and 86% of cases, respectively. CONCLUSION: The intrarater Kappa scores and inter-rater ICCs met their predetermined acceptance criteria of >0.70. The TIOHS is a repeatable and reproducible clinician-reported outcome for health care providers to classify IOHs in clinical trials and routine patient care. A 1-grade difference on the TIOHS can detect a clinically meaningful difference in infraorbital hollowing.

Nodular Scleroderma: Characterization of a Distinct Clinical Phenotype.

Nodular scleroderma is a rare variant of systemic sclerosis (SSc) characterized by fleshy, indurated nodules commonly distributed over the upper and lower extremities and in the trunk. Most scientific publications of the nodular and keloid variants of scleroderma use the terms interchangeably. However, nodular scleroderma has been recently differentiated from keloid forms. Although few cases of isolated local involvement have been reported, nodular scleroderma more commonly presents in conjunction with other manifestations of SSc. We performed a review of all cases of nodular scleroderma reported in the literature to characterize their clinical features. This review indicated that Nodular Scleroderma is usually associated with a Diffuse SSc phenotype and develops during the early progressive skin involvement. Patients with the Nodular Scleroderma phenotype display antinuclear antibodies with speckled or nucleolar patterns, a low frequency of positive SSc-specific antibodies, and typical SSc multiorgan involvement. However, a very low frequency of pulmonary hypertension was found in these patients. Although immunosuppressive or antifibrotic treatment may improve skin thickening and organ involvement, the characteristic nodules are refractory to treatment with these agents. This is the first review, to our knowledge, characterizing the nodular phenotype in patients with SSc.

Comparing the application of various engineered xenografts for skin defects: A systematic review.

INTRODUCTION: Xenografts are a now a cornerstone in the management of wound dressings. Promising results were achieved since 1960 in the application of skin substitute for skin defects. OBJECTIVE: The objective of this study was to evaluate the efficacy of various xenografts. METHODS: A literature research was conducted using the following query: 'Porcine skin dermatology substitute', 'bovine skin dermatology substitute', 'xenograft skin substitute dermatology', 'xenografts skin defect', 'porcine skin defect', 'bovine skin defect'. RESULTS: The review yielded 35 articles pertaining to the topic. Main indications for porcine and bovine xenograft application were burn wounds and post-traumatic wounds, respectively. Mean discharge date or length of stay was at the 6th day after porcine application, and the time of graft healing was reported for 33.7% (n = 510) of patients. Promising results were seen with Matriderm and split-thickness skin graft. Most wounds achieved an excellent cosmetic result with full range of motion and a smooth contour appearance. A great variety of tissue substitutes exist, and the choice of graft application should depend on a patient's factors, product availability, wound type, size, and physician's factors. CONCLUSION: In summary, xenografts are more economic and affordable but have higher risk of infections compared to allografts.

Xenografts in the post-operative wound management of interpolation flaps.

INTRODUCTION: Safeguarding the integrity of the donor site during the initial suspension phase of an interpolation flap is difficult. There are a variety of approaches and no consensus on post-operative management of the donor site or pedicle following the creation of the flap. The use of xenografts at the donor site of postauricular interpolation flaps simplifies post-operative wound care and prevents infection, desiccation of tissue, reduces pain, and assists with hemostasis. METHODS: A porcine acellular dermal skin substitute can be utilized for the purpose of care-free interpolation flap wound care. First, the flap is designed and raised using standard surgical technique. The porcine xenograft is then sutured into the donor site and to the exposed subcutaneous side of the flap pedicle using nylon suture material. The flap then is interpolated and sutured into the surgical defect of the auricle. Silicone gel is applied to the surface of the xenograft. A pressure dressing is then placed over the surgical site. RESULTS: A total of 4 patients had postauricular interpolation flaps to the ipsilateral helix. All four patients had a xenograft placed at the donor site and flap pedicle at the time of the flap creation and suspension. No infections and no incidence of post-operative bleeding requiring intervention were noted. CONCLUSION: Utilizing a dermal skin substitute as a biological dressing for an interpolation flap prior to division and inset of the flap provides a useful alternative to traditional wound care during this interim period.

Creation and validation of a photonumeric scale for assessment of lip fullness.

BACKGROUND: Validated, objective clinical scales are needed to assess aesthetic improvement of the lips after augmentation with dermal fillers. OBJECTIVE: To develop a lip fullness rating scale and establish its reliability for grading subjects in clinical trials or routine practice, and sensitivity for detecting clinically meaningful changes. METHODS: The Teoxane Lip Fullness Scale (TLFS), a proprietary, 5-grade photonumeric scale, was developed by clinical experts based on real subject photographs and was validated through both photographic and live subjects' evaluation. RESULTS: Clinician intra- and inter-rater agreement for the TLFS was substantial to almost perfect. Mean intra-rater weighted Kappa score between the two rounds of photographic validation was 0.92, and inter-rater agreement was substantial with an ICC of 0.93 for the combined rounds. Average intra-rater weighted Kappa score and inter-rater ICC for the live validation were equally high, reaching 0.91 and 0.89 respectively. Additionally, evaluators identified clinically significant differences between photographs of subjects presenting a 1-grade or 2-grade difference on the scale in 90% and 98% of cases, respectively. CONCLUSIONS: The intra-rater Kappa scores and inter-rater ICC met their pre-determined acceptance criteria of >0.70 in the photographic and live validation. The TLFS was shown to be a repeatable and reproducible Clinician Reported Outcome (Clin-RO) for healthcare providers to classify lip fullness both in clinical trials and in routine patient care. A 1-grade difference on the TLFS can detect a clinically meaningful difference in lip fullness.

Juvenile gangrenous vasculitis of the scrotum: systematic review.

Juvenile gangrenous vasculitis of the scrotum (JGVS) is a rare entity with scant reports in the literature. The disease course, treatment, and prevalence have not been well described in the literature. It's hypothesized that JGVS is a variant of pyoderma gangrenosum or a male counterpart of Lipschütz ulcer. This review will analyze the current literature on JGVS and provide a current guide based on the best available data. The initial search of databases yielded 107 studies of which 14 pertained to the topic. The majority of the included studies were case reports (n = 9) reported in Spain. A total of 17 patients were included in the study. The mean age of patients was 22.45 years (range, 13-35 years). The majority of patients presented with multiple, acute, painful, well-circumscribed, round scrotal ulcerations. The majority of patients presented with flu-like symptoms. An increased level of awareness of JGVS diagnosis is now warranted among physicians. Despite the analogies with Lipschütz ulcer, we believe that JGVS is a distinct entity.

Pathophysiology, clinical findings, and management of Fox-Fordyce disease: A systematic review.

BACKGROUND: Fox-Fordyce (FFD), also known as apocrine military, is an uncommon chronic inflammation of the apocrine sweat glands. It is characterized by pruritic, papular eruptions in apocrine-gland-bearing regions. FFD was described a century ago, but the exact pathogenesis of the disease and the management are not well understood. AIMS: This paper provides a wide understanding of the pathophysiology, clinical findings, and management of Fox-Fordyce disease. Its aim is to help the physician to diagnose and manage this entity accordingly. METHODS: A research was done using PubMed database on 12 April 12, 2020, and in order to retrieve all case reports, case series, cohort studies, randomized, and nonrandomized clinical trials were included describing FFD among patients. RESULTS: A total of 43 articles and 68 patients were included in the study. The majority of patients were young females. The disease was bilateral in 90%, affected the axillae and to a lesser extent the pubic and the periareolar areas and rarely the thoracic area, the abdominal area, and the face. FFD followed a relapsing and remitting course, and an evident improvement in disease course was noted after menopause. CONCLUSION: The typical FFD patient is a post-pubertal female and pre-menopause, presenting with pruritic papules in apocrine-gland-bearing regions. FFD can be sporadic or occurs in family, and it can be asymptomatic in 1/(3-4) of patients and can be triggered by laser hair removal and hormonal changes. Further randomized clinical trials assessing different treatment of FFD are now warranted.

Skin disorders associated with the COVID-19 pandemic: A review.

INTRODUCTION: In December 2019, a new coronavirus has emerged out of China, the SARS-CoV-2 virus, causing a disease known as COVID-19, which steadily has progressed into a pandemic. This coronavirus affects many organs, including the skin, whose manifestations are a consequence of the disease itself, as well as the preventative measures taken to avoid the infection. This paper reviews the cutaneous manifestations which currently have been encountered during this pandemic. METHODS: A search was conducted on PubMed, and all relevant articles were included. RESULTS: The results show the occurrence of many cutaneous findings, ranging from those related to the infection itself and to various dermatitides related to the use of personal protective equipment (PPE) utilized by healthcare workers while attending to infected patients. DISCUSSION: Recognizing these findings is important for the accurate diagnosis of those infected with COVID-19 as well as the prompt treatment of the side effects caused by PPE that might further impair the effectiveness of healthcare workers.

What's New in Cosmetic Dermatology.

Topical silicone gel is more beneficial than petrolatum-based products as an all-purpose wound dressing for granulating and sutured wounds, regardless of cause. Vaginal laser rejuvenation is effective in relieving genitourinary syndrome of menopause, stress urinary incontinence, vaginal relaxation syndrome, and related vulvar disorders. New cosmetic indications in the upper face for onabotulinumtoxinA have been approved by the Food and Drug Administration, whereas off-label treatments in the lower face increase in popularity. Clinical trials of uncomplexed daxibotulinumtoxinA demonstrate safety and efficacy lasting more than 6 months.

Travel as a teaching and learning tool.

Throughout history, physicians have traveled extensively to acquire new knowledge or to learn the latest therapeutic techniques from colleagues and academicians. This "wanderlust" persists in many who want to understand the world around them and learn from others, physicians or nonphysicians. Before the era of instantaneous online telecommunication, dermatologists would enhance their education by traveling abroad to learn from world-renowned experts in Europe and elsewhere and return with a treasure trove of knowledge and new skills. With the Internet, webinars, and teledermatology, the attraction for travel has diminished, mainly due to our ever-increasing demanding world of obligations; however, face-to-face interaction with colleagues of a different culture and educational background still has an inexorable educational value. To facilitate such endeavors, many insightful educators have taken the opportunity to establish several international societies and academies, where on-site educational activities can take place. Currently, a few of the more active and popular dermatologic organizations that are conducting meetings around the world are the International League of Dermatologic Societies; International Society of Dermatology; North American Clinical Dermatologic Society; International Society of Dermatologic Surgery; International Academy of Cosmetic Dermatology; and European Society of Cosmetic and Aesthetic Dermatology, all of which exemplify "travel as a teaching tool."

Cosmetic aspects of pregnancy.

There are a vast number of changes to the female body that occur during pregnancy, to which any pregnant woman will attest. The changes, although considered, for the most part, physiological and not pathological, are quite distressing to many women. This chapter serves to review those changes and comment on their physiological origins. Most of these changes can be definitively or inferentially linked to the dramatic hormonal changes that take place to support a pregnancy. Comments are also made about treatment as they pertain to pregnant women. In addition, a brief discussion about performing cosmetic procedures during pregnancy is included.

Commentary: botulinum toxin in clinical medicine.

The recent introduction of botulinum toxin (BTX) into clinical medicine has revolutionized the practice of medicine and surgery forever. Who would have ever thought that the world's most deadly of all toxins would be used for therapeutic purposes? The discovery of the beneficial effects of BTX has transformed the lives of many unfortunate individuals who have suffered from a variety of unrelated disorders, which have been virtually impossible to treat. With the help of BTX, these and hopefully many other ailments will be easily managed with a few simple injections.

Six Sigma: not for the faint of heart.

Six Sigma is an excellent quality and performance improvement tool. Like any tool, the results of using it are highly dependent on whether you use it with competence and on the right problem. This article will help you decide if your problem is well-suited for a Six Sigma approach and will suggest the optimum approach for planning and implementing Six Sigma methodology. Performance improvement methods can be grouped into two broad categories, based on the problem to be addressed. When the problem is relatively minor and localized, "evolutionary" methods may be suitable (e.g., quality circles, problem-solving staff meetings, continuous quality improvement [CQI], total quality management [TQM]). These tools work best when modest incremental improvements are sought, when major process redesign is not thought to be necessary, and when the avoidance of workplace disruption is desired. Reengineering and Six Sigma are the best-known examples of the "revolutionary" performance improvement methods. These methods should be used when major (drastic, do or die, etc.) improvements are needed. Problems that cross departmental boundaries need these methods. When a process is so dysfunctional that you feel like you need to tear up the standard operating procedure (SOP) and start all over again, you need a revolutionary method. A Six Sigma project requires a major expenditure of money and employee time, and a willingness to make some hard decisions about jobs, employee retention and relationships among stakeholders. An institution's culture should be considered as part of the decision about using Six Sigma. If the institution has a history of making data-driven decisions, or at least has displayed openness to operating in that manner, Six Sigma has a good chance of success. A radiology-driven Six Sigma project should not be undertaken until a comprehensive written description of the scope of the project is approved by the radiology department leadership team and by the appropriate higher-level institutional leaders. This document should address the specific outcomes desired, the resources available, a rough tentative timeline, and any political constraints imposed on the project (e.g., inviolate HR policies, compatibility with enterprise strategic goals). The document should be comprehensive enough and explicit enough to be useful as a major component of the bid package for hiring a consultant or for writing the job description for the hiring of an in-house expert. A full-time project manager should be designated if an in-house expert is not hired. This person should be a senior leader in the department, but not the department director. Leading a Six Sigma project is a full-time job in itself and cannot be performed as an additional duty. Although it may be tempting to appoint a senior staff technologist or nurse, keep in mind that the project manager must have sufficient authority to expect cooperation from departmental supervisors without resorting to frequent appeals to the department director. Contact the institution's CIO and ask that a knowledgeable person on the IT staff be appointed to serve as the IT liaison for the project. This person should have in-depth familiarity with the HIS and the ways that it interfaces with the RIS (if the RIS is not a module within the HIS). Most importantly, this liaison must understand the exact data definitions and the origins of the data that are passed between the HIS and the RIS. The steering committee should consist of at least one physician and one department-level administrator from outside of the radiology department. From within the radiology department, there should be at least one radiologist and one senior modality manager (whose modality is not the primary focus), the project manager, and the manager of a radiology component that is a focus of the project (e.g., the film library manager). The consultant should be an ex officio member without vote. The steering committee should be small enough to be manageable, yet large enough to provide insight from both the radiology department and the rest of the institution. Because of the size of the steering committee and the difficulty of bringing so many people together for meetings, the day-to-day governance of the project will be provided by an informal "operations committee." When we consider "change" in the context of a Six Sigma project, we talk about a wide variety of topics, but they can be summarized usefully as dealing with processes, policies, physical plant and equipment, personnel, and politics (or culture). The first three of these lend themselves to quantitative analysis, or at least rigorously qualitative analysis. The final two, however, are subjective, ill-defined or not readily acknowledged, and fraught with potentially major challenges when it becomes necessary to implement changes in the first three. The Six Sigma process, as taught by GE, consists of five phases summarized by the acronym DMAIC: Define, Measure, Analyze, Improve and Control. This article deals mostly with the time period from first consideration of a possible Six Sigma project through the early part of the Define phase. It also discusses pitfalls that must be considered anytime throughout a project, from first thoughts of conducting a project until recommended changes become ingrained in the department's operations. Six Sigma compares baseline or historical data to data obtained after implementation of Six Sigma-driven changes in order to determine if desired changes in performance have been achieved. When historical data are not available, the Six Sigma team must collect baseline data as one of their earliest tasks. A Six Sigma project can easily last 18 to 24 months or longer. We must be sure that the data we collect during Month 18 are collected identically to the data we collected at baseline. A major performance improvement project is likely to require 12 to 24 months or longer. Upper management initially may be reluctant to appoint the "cream of the crop" to the project teams. Success is predicated on having the most knowledgeable personnel involved in the project. Without them, the chances of success are reduced. A Six Sigma project's length always exceeds the attention span of the vast majority of its participants. The department director and project manager must anticipate this and devote special efforts to maintaining motivation and momentum after the initial flurry of activity. The complexity of a Six Sigma project will be greatly increased, and all of the pitfalls discussed here will be exacerbated, if your facility has multiple sites. At the simplest, the multiple sites will introduce complications in getting personnel to come to project meetings. The complications will escalate if the sites are under different management, such as a confederated health system. The project manager and the consultant will expend additional time and effort dealing with these issues, which likely will lengthen the project unavoidably. The project manager must spend time with the department's external customers who have significant stakes in the project. At a minimum, this should include relatively formal meetings with other department directors or subordinate managers and key physician and nurse leaders, and attendance at their managerial or staff meetings (you may need to ask to be invited). Although paper or e-mail surveys can be helpful, only sustained personal contact with a stakeholder will truly allow you to understand how they interact with radiology and what their concerns are. As with daily operational management, a performance improvement project requires attention to policies, procedures, processes, physical plant and infrastructure, personnel, and perhaps most importantly, to politics.

Using Six Sigma to improve the film library.

The film library of a film-based radiology department is a mission-critical component of the department that is frequently underappreciated and under-staffed. A poorly performing film library causes operational problems for not only the radiology department, but for the institution as a whole. Since Six Sigma techniques had proved successful in an earlier CT throughput improvement project, the University of Texas M.D. Anderson Cancer Center Division of Diagnostic Imaging decided to use Six Sigma techniques to dramatically improve the performance of its film library. Nine mini-project teams were formed to address the basic operating functions of the film library. The teams included film library employees, employees from other sections of radiology, employees from stakeholders outside of radiology, and radiologists and referring physicians, as appropriate to the team's mission. Each Six Sigma team developed a process map of the current process, reviewed or acquired baseline quantitative data to assess the current level of performance, and then modified the process map to incorporate their recommendations for improving the process. An overall project steering committee reviewed recommendations from each Six Sigma team to assure that all of the teams' efforts were coordinated and aligned with the overall project goals. The steering committee also provided advice on implementation strategies, particularly for changes that would have an immediate effect on stakeholders outside of the radiology department. After implementation of recommendations, quantitative data were collected again to determine if the changes were having the desired effect. Improvement in both quantitative metrics and in employee morale have been experienced. We continue to collect data as assurance that the improvements are being sustained over the long haul. Six Sigma techniques, which are as quantitatively-based as possible, are useful in a service-oriented organization, such as a film library. The primary problem we encountered was that most of the important film library customer services are not automatically captured in the RIS or in any other information system. We had to develop manual data collection methods for most of our performance metrics. These collection methods were burden-some to the frontline employees who were required to collect the data. Additionally, we had to invest many hours of effort into assuring that the data were valid since film library employees rarely have the educational background to readily grasp the importance of the statistical methods employed in Six Sigma. One of the most important lessons we learned was that film library employees, including supervisory personnel, must be held accountable for their performance in a manner that is objective, fair and constructive. The best methods involved feedback collected by the employees themselves in the ordinary course of their duties. Another important lesson we learned was that film library employees, as well as stakeholders outside of the film library, need to understand how important the film library is to the smooth functioning of the entire institution. Significant educational efforts must be expended to show film library employees how their duties affect their film library co-workers and the institution's patients. Physicians, nurses and employees outside of the film library must do their part too, which requires educational efforts that highlight the importance of compliance with film library policies.