Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement.

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Functional Foods in Dermatology.

Functional foods, defined as whole foods that provide health benefits beyond their nutritional value, may provide multiple dermatologic benefits. Research studies have documented multiple benefits, including enhanced skin barrier function, improved wound healing, radiance, photoprotection, and hormonal regulation. Although the majority of research to date has involved small-scale human interventions or animal models, promising findings have been noted. A number of potential molecular mechanisms have been described, such as the ability of some foods to combat oxidative stress and thus reduce visible and histologic skin changes in response to UV radiation. Additional mechanisms have been described for wound healing, photo-carcinogenesis, and other outcomes. In this review, we discuss the potential dermatologic role of functional foods in order to advocate for larger-scale, evidence-based, human studies to expand this promising field.

Using Artificial Intelligence to Assess the Teratogenic Risk of Vitamin A Supplements.

Vitamin A in high doses has been found to be highly teratogenic, leading to severe fetal abnormalities if exposure occurs during pregnancy. Hence, prescription vitamin A acne medications like isotretinoin are highly regulated via programs such as iPledge, which intend to avert fetal exposure to isotretinoin and to educate healthcare providers, pharmacists, and patients about the significant risks associated with isotretinoin and its appropriate usage conditions. However, over-the-counter (OTC) vitamin A supplements are not subject to these requirements, and calculating the vitamin A content of these supplements can be difficult due to the lack of Food and Drug Administration (FDA) regulations and inconsistencies in labeling. If the necessary information is provided, ChatGPT, a generative artificial intelligence (AI) tool, can help the general public calculate the vitamin A content of supplements. Nonetheless, supplement manufacturers do not always provide the data necessary for these calculations.

Cognitive Ergonomics: A Review of Interventions for Outpatient Practice.

Doctoring is difficult mental work, involving many cognitively demanding processes such as diagnosing, decision-making, parallel processing, communicating, and managing the emotions of others. According to cognitive load theory (CLT), working memory is a limited cognitive resource that can support a finite amount of cognitive load. While the intrinsic cognitive load is the innate load associated with a task, the extraneous load is generated by inefficiency or suboptimal work conditions. Causes of extraneous cognitive load in healthcare include inefficiency, distractions, interruptions, multitasking, stress, poor communication, conflict, and incivility. High levels of cognitive load are associated with impaired function and an increased risk of burnout among physicians. Cognitive ergonomics is the branch of human factors and ergonomics (HFE) focused on supporting the cognitive processes of individuals within a system. In health care, where the cognitive burden on physicians is high, cognitive ergonomics can establish practices and systems that decrease extraneous cognitive load and support pertinent cognitive processes. In this review, we present cognitive ergonomics as a useful framework for conceptualizing an oft-overlooked dimension of labor and apply theory to practice by summarizing evidence-based cognitive ergonomics interventions for outpatient care settings. Our proposed interventions are structured within four general recommendations: 1. minimize distractions, interruptions, and multitasking; 2. optimize the use of the electronic health record (EHR); 3. optimize the use of health information systems (HIS); and 4. support good communication and teamwork. Best practices in cognitive ergonomics can benefit patients, minimize practice inefficiency, and support physician career longevity.

Predictors of Skin, Hair, and Nail Supplement Use: Analysis of National Health and Nutrition Examination Survey (NHANES) Cross-Sectional Data.

OBJECTIVES: Approximately half of US adults use dietary supplements, often for dermatologic purposes. When survey respondents in a nationally representative population were asked the reasons for their use of a specific supplement, 87% chose "for healthy skin, hair, and nails." Despite widespread use, supplements have potential risks and lack regulatory safeguards. Because most supplement users choose to use them without the advice of a healthcare professional, it is important to identify factors predicting use. This study examined demographic predictors of skin, hair, and nail supplement use among 2015-2016 US National Health and Nutrition Examination Survey respondents, a nationally representative sample. METHODS: Weighted descriptive analysis using χ2 tests examined group differences among respondents who took skin, hair, and nail supplements and those who did not take supplements in the past 30 days. Multivariable logistic regression models were performed to identify predictors of skin supplement use. RESULTS: Statistically significant differences in sex, education, income, and insurance status were observed between dermatologic supplement users and nonsupplement users (P < 0.0001). Factors significantly increasing the likelihood of skin supplement use included age between 30 and 60 years (odds ratio [OR] 1.788, 95% confidence interval [CI] 1.439-2.222), age older than 60 years (OR 4.983, 95% CI 3.838-6.469), having a college degree or above (OR 2.696, 95% CI 1.952-3.724), attending some college or above (OR 1.844, 95% CI 1.364-2.494), having an annual income of >$75,000 (OR 1.285, 95% CI 1.029-1.605), and having health insurance (OR 1.559, 95% CI 1.236-1.967). Male respondents were half as likely to use supplements, compared with females (OR 0.579, 95% CI 0.488-0.687). CONCLUSIONS: Factors such as age, education, income, and sex predict supplement use. Knowledge of such trends may help practitioners counsel patients on potential supplement risks and the many unknowns related to their use. Any patient could be using skin, hair, and nail supplements over the counter, including pregnant and older adult populations, as well as generally healthy patients. This would help protect patients from the possible dangers of supplements, including laboratory test interference and teratogenicity.

When Patient Rudeness Impacts Care: A Review of Incivility in Healthcare.

Healthcare workers increasingly face incivility and rude behaviors from patients, families, and visitors. Although these are less severe than other types of mistreatment, studies have documented that they may still impact healthcare worker well-being and patient care. Defining and measuring incivility can be challenging because current research relies on the perceptions of the targets. Furthermore, there is often overlap among different types of mistreatment, and much of it goes unreported by those who experience it. Nevertheless, multiple studies have documented that incivility is common in healthcare and has been associated with burnout and intent to leave. In clinical settings, multiple consequences for patient care have been documented, including adverse consequences in the diagnostic and intervention performance of teams, as well as team processes. One theory is that incivility incidents divert cognitive resources away from the intervention and that these experiences may interfere with higher-order reasoning. Although limited research has been performed in the areas of prevention, response to incidents of incivility, and best practices for ameliorating the effects of incivility, some promising interventions have been reported in the literature.

Breast Cancer Cryoablation Fundamentals Past and Present: Technique Optimization and Imaging Pearls.

Surgical treatment for breast cancer has evolved from radical mastectomy to modified radical mastectomy to breast-conserving surgery. As the de-escalation of surgical treatment for breast cancer continues, nonsurgical treatment for early-stage breast cancer with favorable ancillary features (low grade, positivity for hormone receptors) is being explored. Of the nonsurgical treatment options, cryoablation has demonstrated the greatest appeal, proven to be effective, safe, well tolerated, and feasible in an outpatient setting with local anesthetic alone. Results of past and interim results of current trials of cryoablation of stage I low-grade breast cancer with curative intent are promising, with an overall clinical success rate of 98% and recurrence rates consistent with those expected following lumpectomy. Cryoablation is also an alternative palliative treatment for patients who cannot tolerate or who have disease that is refractory to or recurs after standard-of-care breast cancer treatment and may have immunological therapeutic effects, warranting future research. Understanding the indications and optimal technique for breast cancer cryoablation and understanding typical imaging findings after cryoablation are essential to ensure the success of the procedure in carefully selected patients.

Practice Efficiency in Dermatology: Enhancing Quality of Care and Physician Well-Being.

A focus on improved efficiency can impact both patient care and physician well-being. Efficiency is one of the six domains of healthcare quality. It is also recognized as one of the three main pillars of professional fulfillment. Quality improvement measures in the area of efficiency are focused on reducing waste, specifically related to physicians' time, energy, and cognitive demands. Interventions and practices reported in the literature or communicated by dermatologists have documented efforts centered on patient care workflows, documentation, communication, and other areas. Team-based care models maximize the skill sets of other trained providers, while workflow changes encompassing process standardization, communication, and task automatization have improved patient safety and efficiency. Strategies to promote documentation efficiency have centered on eliminating extraneous documentation alongside the use of templates, text expander functionality, and dictation tools. The use of in-office or virtual scribes, when provided with adequate training and consistent feedback, has improved charting time, accuracy, and physician satisfaction. Although upfront investments in time and financial resources may be required, quality improvement in efficiency can benefit healthcare quality, patient safety, and physician satisfaction.

Healthcare Workers' Well-Being: A Systematic Review of Positive Psychology Interventions.

Given persistent occupational stressors and multiple challenges in the delivery of healthcare, there is an increased focus on the well-being of healthcare workers. Responding to these challenges will require a multipronged approach, focusing on system level, organization, and individual actions. Positive psychology interventions (PPIs) represent a promising area for individual action. This systematic review indicates that PPI, delivered via many methods, holds promise for improving the well-being of healthcare workers, although there is a clear need for additional randomized controlled trials utilizing defined and standardized outcome measures. In this review, the most commonly evaluated PPIs were mindfulness-based or gratitude-based interventions. These were delivered via different methods, with many administered in the workplace and commonly in the form of courses ranging from two days to eight weeks. Researchers documented measurable improvements in multiple studied outcomes, noting reductions in symptoms of depression, anxiety, burnout, and stress. Some interventions increased well-being, job and life satisfaction, self-compassion, relaxation, and resilience. Most studies emphasized that these are simple, accessible, low-cost interventions. Limitations included some nonrandomized or quasi-experimental designs, alongside generally small sample sizes and varying methods of intervention delivery. Another concern is the lack of standardized outcome assessments and long-term follow-up data. As almost all studies included were performed before the pandemic, further research will be required post-pandemic. Overall, however, PPI shows promise as one arm of a multipronged approach to improving the well-being of healthcare workers.

Skin, hair, and nail supplements advertised on Instagram.

Teens and young adults increasingly utilize social media for health information. Dermatologic supplements, advertised on social media, may be pharmacologically active and risk adverse effects. Instagram was searched, and 100 posts from March 2021 were evaluated for ingredients, health claims, account verification status, and endorsements. Only 4% of posts were made by verified accounts, and 1% of posts contained a visible Supplement Facts label. The Food and Drug Administration does not regulate dietary supplements. Ingredients such as vitamin A found in posts can pose teratogenic risk. Other potentially dangerous ingredients included saw palmetto and biotin. To accurately counsel patients who may retrieve health information from Instagram, it is important for practitioners to be familiar with social media claims.

Do You Know How to Assess Risks Posed by Over-the-Counter Vitamin A Supplements?

Dietary supplements are regulated as foods by the US Food and Drug Administration (FDA) and, despite their potentially harmful effects, are not subject to labeling rules that apply to prescription medications. This commentary responds to a case about vitamin A supplement safety. The commentary compares regulation of vitamin A-derivative prescription medications, such as isotretinoin, to regulation of high-dose vitamin A supplements, illuminating both products' potential for causing birth defects. Label analysis is key to educating patients about risks of vitamin A-containing supplements. The commentary also suggests the need for more FDA oversight of the dietary supplement industry.

Demographics of Dietary Supplement Use for Skin: An Analysis of NHANES Cross-Sectional Data.

Dietary supplement use is common, with reported use by over half of US adults. This cross-sectional study utilized 2015–2016 National Health and Nutrition Examination Survey data. A total of 9971 respondents were surveyed, of which 3704 reported taking dietary supplements for "healthy skin, hair, and nails." Of those reporting skin supplement use, the majority had health insurance and some college education or above. Many respondents were 19 or younger, were of non-Hispanic White race, had a household income of more than $100,000 per year, and some were pregnant. More than two-thirds of the respondents decided to take the supplements on their own rather than at the advice of a healthcare professional, which is quite alarming. This study helps identify demographic groups more likely to consume skin, hair, and nail supplements. Overall, physicians should educate their patients on dietary supplements to avoid drug-supplement interactions and address the factors that influence the use of over-the-counter skin supplements. J Drugs Dermatol. 2022;21(4):434-436.doi:10.36849/JDD.5744.

Acne Supplements Sold Online.

INTRODUCTION: As no centralized database of acne supplements is available, we aimed to provide an overview of these products, with a focus on safety. OBJECTIVES: The objectives of this study were to document the number, formulation, contents, and marketing strategies utilized by acne supplements sold online. METHODS: An online search was conducted between March and May 2020. Products were included in the study if they used the terms: "whitehead", "blackhead", or "acne". Data were extracted from the website, box, and Supplement Facts label. RESULTS: 49 products were identified, which contained 146 unique ingredients. These included vitamins, minerals, food extracts, botanical extracts, amino acids, animal products, and distinct microbial strains. Few (4.1%) products were tested by third parties. CONCLUSIONS: This survey of acne supplements available online raised concerns regarding lack of warning labels, teratogenicity, exceedingly large levels of vitamins and minerals, and lack of third-party testing. Given the limited regulation and oversight of dietary supplements, it is imperative that physicians educate patients on the potential risks of these products.

Readability, Quality, and Timeliness of Patient Online Health Resources for Contact Dermatitis and Patch Testing.

BACKGROUND: Contact dermatitis (CD) causes significant impact on patient quality of life. It is the most common occupational skin disease, accounting for more than US $1 billion of medical costs. Patch testing (PT) is the criterion standard for diagnosis of allergic CD. Patients are increasingly using the Internet to obtain health information; however, the readability, quality, and timeliness of online health resources for CD and PT are unknown. OBJECTIVE: The objective was to determine the readability, quality, and timeliness of the most frequently accessed patient online health resources for CD and PT. METHODS: A Google search was performed on March 20, 2021, using the terms "contact dermatitis," "contact eczema," "patch testing," and "patch test." Websites were evaluated using several well-validated tools/criteria. RESULTS: Contact dermatitis and PT websites had only 2 of the 48 websites combined that met the recommended sixth-grade reading level for patients, with the majority characterized as "very poor" to "fair" quality. There was no correlation found between quality and readability of the CD and PT websites. CONCLUSIONS: There is a need for improvement of online CD and PT health resources. Dermatologists should take the lead to vet websites and enhance online resources to improve patient care.

Stress and Skin: An Overview of Mind Body Therapies as a Treatment Strategy in Dermatology.

Stress has multiple and wide-ranging physiologic and clinical impacts on skin disease. This has led to an interest in mind body therapies as potential adjunct treatments for skin disease. The stress response results in the activation of the endocrine, neurologic, and immune systems, with a resulting cascade of impacts, that are both systemic and cutaneous. The 2 main arms of the stress response are the sympathetic nervous system and the hypothalamic-pituitary-adrenal axis. The resultant release of cortisol, catecholamines, and neuropeptides has multiple effects. Clinically, these have been shown to increase skin inflammation, increase itching, impair skin barrier function, impair wound healing, and suppress immunity. Mind body therapies are those that focus on the interaction between the mind and the body, with the goal to influence physical function and impact health. These have been shown to ameliorate some of the harmful physiologic changes attributed to stress or to reduce harmful behaviors. In some cases, such as with biofeedback, they may also result in beneficial physiologic changes. Treatments such as meditation, biofeedback, hypnosis, guided imagery, and others have been evaluated in the treatment of skin disease and have shown some benefits. Although randomized controlled trials are limited, these interventions have shown beneficial effects on itching, psychosocial outcomes, and even skin severity. These interventions have been evaluated in diseases such as atopic dermatitis, psoriasis, trichotillomania, and others. Given the potential benefits, improvements in psychosocial outcomes, and a low risk profile, referral to qualified practitioners or multidisciplinary clinics should be considered for some patients.

Diabetes Detection and Prevention in Dermatology.

We are currently in the midst of an international epidemic of diabetes mellitus (DM) and prediabetes. The prevalence of DM in the United States is estimated at 9.4% of the population across all ages, while an estimated 1 in 3 Americans (33.9%) has prediabetes. According to the WHO, about 60 million people suffer from diabetes in the European Region. Dermatologists may play an important role in tackling this epidemic via efforts to improve early detection of both diabetes and prediabetes. Dermatologists often treat patients with, or at risk of, diabetes. This includes patients who present with cutaneous manifestations such as acanthosis nigricans, as well as patient populations at increased risk, including those with psoriasis, hidradenitis suppurativa, and polycystic ovarian syndrome. Simple screening guidelines can be used to identify patients at risk, and screening can be performed via a single non-fasting blood test. The diagnosis of prediabetes is a key feature in diabetes prevention, as interventions in this group can markedly reduce progression towards diabetes. In addition to referral to a primary care physician, dermatologists may refer these patients directly to structured behavioral lifestyle intervention programs known as diabetes prevention programs. A significant portion of the population lacks routine care by a primary care physician, and current data indicates need for improvement in diabetes screening and prevention among patient groups such as those with psoriasis. These factors highlight the importance of the dermatologist's role in the detection and prevention of diabetes.

Labeling Laws for Personal Care Products: Potential Pitfalls for The Consumer.

Consumers of personal care products must be made aware of the potential pitfalls that arise from current labeling practices and regulations. For example, terms such as "hypoallergenic", "sensitive skin", and "baby product" lack legal definitions, and terms such as "fragrance-free" are frequently misinterpreted. Personal care products are a general category that includes such items as cosmetics, drugs, dietary supplements, and consumer goods. This overview of current US FDA regulations of products in this category reviews pertinent regulatory policies and highlights potential consumer pitfalls when evaluating product labels. In particular, current labeling laws permit the use of language that may be incomplete, misinterpreted, or applied solely for marketing purposes. It is important that consumers understand the meaning of labeling terms, the regulations that govern them, and especially understand the potential pitfalls related to these terms.

Risk of Birth Defects From Vitamin A "Acne Supplements" Sold Online.

BACKGROUND: Dietary supplements are popular among US consumers and claim to address a variety of conditions, including acne. Acne supplements containing vitamin A are of particular interest, due to the potentially teratogenic effects of vitamin A doses over 10,000 IU. OBJECTIVE: This study examined dosage, pregnancy risks, and labeling of vitamin A-containing acne supplements available online. METHODS: An Internet search of acne supplements sold online was conducted between March and May 2020. Supplement labels and websites were analyzed for vitamin A content and pregnancy warnings, and then divided into categories based on dosage and teratogenic risk. RESULTS: A total of 49 acne supplements was found, and of these 26 (53%) contain vitamin A. Three supplements are likely teratogenic, 4 contain vitamin A doses exceeding the daily level of intake that meets the nutritional needs of most people, and 15 have an unknown teratogenic risk. Among the 6 supplements with over 10,000 IU vitamin A, 2 have no pregnancy warning at all, including the supplement with the highest vitamin A dose found in this study. CONCLUSIONS: Dietary supplements are not subject to the same stringent regulations as drugs, and as such, consumers may be unaware of pregnancy risks. Furthermore, FDA requirements on labeling of vitamin A supplements may lead to consumer confusion regarding dosage. As such, we encourage stricter labeling requirements for vitamin A-containing supplements, including pregnancy warnings for high-dose supplements and clearer dosage labeling.

Diet and Skin Barrier: The Role of Dietary Interventions on Skin Barrier Function.

Multiple research studies have examined the role of specific dietary interventions and their effects on skin barrier function. The skin barrier is one of the body's first lines of protection against environmental insults, and disruption of this natural line of defense can result in xerosis, irritation, chronic dermatitis, and other cutaneous effects. Multiple laboratory, animal, and human studies have demonstrated that certain dietary interventions have the potential to impact skin barrier function. Measurements of skin barrier function include stratum corneum hydration and transepidermal water loss. In this review, we examine this research and provide an overview of the effects of prebiotics, probiotics, fatty acids, and emerging research on other substances.

Risks of Skin, Hair, and Nail Supplements.

Skin, hair, and nail supplements, sometimes referred to as "beauty supplements" or "ingestible skin care," are a large and growing industry. These products may contain vitamins and minerals, sometimes in very high doses. They may also contain herbs, hormones, microbes, or animal derivatives such as fish oils and collagen powders. Dietary supplements are regulated as foods, not as drugs, by the US Food and Drug Administration (FDA). Therefore, manufacturers do not need to provide any proof of safety, efficacy, or quality prior to sale. This is of serious concern, as many adverse effects due to supplement components have been reported. The potential risks cover multiple categories. These include acute toxicities, such as choking, as well as chronic toxicities, such as increased risk of diabetes. Teratogenicity and interactions with drugs and laboratory testing have been documented in research studies. Other risks include potentially increased risk of cancer with long-term use, allergic reactions, and others. It is vital that physicians educate their patients on these risks. As no post-marketing surveillance programs are required for supplements, our understanding of supplement risks is incomplete. Physicians should be wary of these risks and encourage further research and regulation.