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1.
Dermatol Online J ; 26(4)2020 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-32621677

RESUMEN

Erosive pustular dermatosis of the scalp (EPDS) occurs in elderly individuals with significant actinic damage. EPDS also occurs in association with surgery; however, significant studies determining an association of EPDS with type of surgical closure is absent. This review examines whether the closure method following cutaneous surgery performed on the scalp is associated with development of EPDS. Databases were reviewed and studies describing EPDS after cutaneous surgery met inclusion criteria. Articles were excluded if EPDS developed after trauma or non-surgical procedures. Descriptive analyses were performed on the data. Thirteen case reports and 6 case series involving 32 patients met inclusion criteria. Fourteen articles (73.7%) stated that EPDS developed in the same location as, or near to, the closure site. Thirteen patients (40.6%) developed EPDS following skin grafting. Three patients (9.4%) developed EPDS following secondary intention healing, two patients (6.3%) following repair by primary intention, and one patient (3.1%) following repair with a local skin flap. Thirteen cases (40.6%) did not specify closure type. This review revealed that surgical procedures performed on the scalp utilizing skin grafts for closure may be increasingly associated with the development of EPDS compared to other closure types.

4.
J Drugs Dermatol ; 19(6): 639-645, 2020 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-32574024

RESUMEN

BACKGROUND: The Food and Drug Administration (FDA) has approved several new dermatologic drugs in the last decade. The public response to their approval has not yet been evaluated. OBJECTIVE: To analyze the United States stock market response surrounding FDA approval of new dermatologic drugs between 2008 and 2018. METHODS: A list of 34 FDA approved dermatologic drugs for publicly traded companies was compiled from the CenterWatch New Dermatology Drugs List and the FDA Annual Reports on New Drugs. Company and stock market data was acquired from the Center for Research in Security Prices (CRSP) United States Stock database. Cumulative abnormal returns (CAR) were calculated as the difference between raw returns and expected value-weighted returns. Data analyses were performed using SAS 9.4 (Cary, NC). RESULTS: The average CAR for the 21-day window period surrounding FDA approval of new dermatologic drugs was +1.71%. Drugs approved for the treatment of hyperhidrosis (+17.7%), bacterial skin infections (+7.18%), and rosacea (+6.83%) added the most market value. LIMITATIONS: The market value added to private or internationally traded companies could not be assessed. CONCLUSION: FDA approval of dermatologic drugs generally has a positive market response. Information on market reaction may provide important insights for investors, pharmaceutical companies, and researchers. J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.5033.

5.
Arch Dermatol Res ; 2020 Apr 09.
Artículo en Inglés | MEDLINE | ID: mdl-32274574

RESUMEN

Little is known regarding the burden of sunburns leading to emergency department (ED) visits in the United States (US). The objectives of this research were to characterize the burden of sunburn ED visits, investigate predictors of severe sunburns, and evaluate risk factors for increased cost of care in patients presenting to the ED for sunburn. In this nationally representative cross-sectional study of the National Emergency Department Sample (NEDS, 2013-2015), multivariable models were created to evaluate adjusted odds for sunburn ED visits, seasonal/regional variation in sunburn ED visits, adjusted odds for second and third degree sunburns, and risk factors for increased ED expenditure. 82,048 sunburn ED visits were included in this study. On average, the cost of care for a sunburn ED visit was $1132.25 (± $28.69). The prevalence and cost of ED visits due to sunburn increased during the summer months. Controlling for sociodemographic factors, comorbidities, and hospital characteristics, patients presenting to the ED for all sunburns (and for severe sunburns) were most likely to be lower income young adult men. Older, higher income patients in metropolitan hospitals had more expensive ED visits. This research provides nationally representative estimates of visits to the ED due to sunburn in the US, as well as evaluates determinants for severe sunburns and more expensive sunburn ED visits. Ultimately, characterizing the national burden of ED visits due to sunburn is critical in the development of interventions to reduce the impact of sunburn ED visits on the US healthcare system.

6.
Lasers Surg Med ; 2020 Mar 27.
Artículo en Inglés | MEDLINE | ID: mdl-32221981

RESUMEN

BACKGROUND AND OBJECTIVES: Device innovation in dermatology is increasing. Medical devices identified as "substantially equivalent" to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device clearance via the 510(k) pathway. STUDY DESIGN/MATERIALS AND METHODS: We performed a retrospective review of the FDA's 510(k) database between January 1, 1996 and December 31, 2018. Dermatologic devices were included based on product code and classified by the application. Approval pathways and decision characteristics were compared among dermatologic device categories. RESULTS: Of the 76,607 records screened, 4,637 met inclusion criteria. Laser/thermal devices comprised the largest category (64.2%), followed by wound (24.0%) and light-based devices (5.8%). The majority of 510(k) pathway submissions were traditional (89.2%) compared with alternative (10.8%) submission types (P = 0.003). Devices that were deemed substantially equivalent without limitations (98.5%) were the most common among all device categories. Rates of device clearance over the study period increased for all categories except laser/thermal devices. CONCLUSIONS: Dermatologic devices are increasingly cleared via the FDA's 510(k) pathway through "substantial equivalence" with minimal requirements for premarket clinical data. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

7.
Clin Infect Dis ; 70(3): 509-517, 2020 Jan 16.
Artículo en Inglés | MEDLINE | ID: mdl-30874793

RESUMEN

BACKGROUND: Limited information exists regarding the burden of emergency department (ED) visits due to scabies in the United States. The goal of this study was to provide population-level estimates regarding scabies visits to American EDs. METHODS: This study was a retrospective analysis of the nationally representative National Emergency Department Sample from 2013 to 2015. Outcomes included adjusted odds for scabies ED visits, adjusted odds for inpatient admission due to scabies in the ED scabies population, predictors for cost of care, and seasonal/regional variation in cost and prevalence of scabies ED visits. RESULTS: Our patient population included 416 017 218 ED visits from 2013 to 2015, of which 356 267 were due to scabies (prevalence = 85.7 per 100 000 ED visits). The average annual expenditure for scabies ED visits was $67 125 780.36. The average cost of care for a scabies ED visit was $750.91 (±17.41). Patients visiting the ED for scabies were most likely to be male children from lower income quartiles and were most likely to present to the ED on weekdays in the fall, controlling for all other factors. Scabies ED patients that were male, older, insured by Medicare, from the highest income quartile, and from the Midwest/West were most likely to be admitted as inpatients. Older, higher income, Medicare patients in large Northeastern metropolitan cities had the greatest cost of care. CONCLUSION: This study provides comprehensive nationally representative estimates of the burden of scabies ED visits on the American healthcare system. These findings are important for developing targeted interventions to decrease the incidence and burden of scabies in American EDs.

8.
J Dermatolog Treat ; 31(2): 200-203, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-30799667

RESUMEN

Introduction: Powered muscle stimulators have been popularized in recent years due to their muscle toning effects. This study aims to describe marketing trends and reporting of adverse effects of powered muscle stimulators.Methods: We performed a cross-sectional retrospective analysis of records from the United States FDA database for 510(k) premarket approval of powered muscle stimulators between January 1, 2000 and December 31, 2018. The FDA MAUDE database was reviewed for adverse events reported with device usage.Results: One hundred and seventeen devices received 510(k) premarket approval between 2000 and 2018, with the first approval occurring in 2001. Initially, devices were marketed to assist with muscle toning and strengthening, but more recent indications include the treatment of pain, increased local muscle blood circulation, and prevention of post-surgical venous thrombosis. Thirty-six adverse event reports have been submitted and published in the MAUDE database over the past 10 years by 11% of manufacturers.Discussion: Powered muscle stimulators are growing increasingly popular amongst consumers and healthcare providers due to their ease of use and perceived esthetic, muscle strength, and pain relief benefits. Additional investigation to determine optimal treatment parameters and potential adverse effects is necessary due to the growing popularity of these devices.


Asunto(s)
Músculos/fisiología , Estimulación Eléctrica Transcutánea del Nervio/instrumentación , Estudios Transversales , Bases de Datos Factuales , Aprobación de Recursos , Estética , Humanos , Estudios Retrospectivos , Estimulación Eléctrica Transcutánea del Nervio/métodos , Estados Unidos , United States Food and Drug Administration
9.
Dermatol Surg ; 2019 Dec 11.
Artículo en Inglés | MEDLINE | ID: mdl-31834072

RESUMEN

BACKGROUND: Although there is a large body of evidence demonstrating the safety and efficacy of Mohs micrographic surgery (MMS) in adults, little is known regarding the safety and efficacy of MMS in children and adolescents. METHODS: The authors searched all publications from 1993 to 2018 reporting on the use of MMS for the treatment of cutaneous neoplasms in patients aged 0 to 18 years. Patient demographics, surgical characteristics, outcomes, and complications were extracted from each report. RESULTS: Forty-one publications describing 58 patients were included in the final analysis. The mean age was 8.3 years, and the most commonly treated tumor was dermatofibrosarcoma protuberans. There were no recurrences noted at a mean follow-up of 2 years. Two (3.4%) patients experienced complications after MMS. CONCLUSION: In this systematic review, the authors present aggregate data demonstrating high safety and efficacy of MMS in children and adolescents. Further research is necessary to develop guidelines for the use of MMS in children and adolescents.

10.
Am J Clin Oncol ; 42(11): 830-836, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-31569167

RESUMEN

OBJECTIVES: Although adolescents and young adults (AYA) suffer disproportionately from cutaneous melanoma (CM), little is known regarding the burden of CM leading to hospitalization in AYA. The objective of this study was to elucidate sociodemographic/hospitalization characteristics of AYA CM inpatients, determine which factors lead to the greater length of stay (LOS) and cost of care for AYA CM inpatients, and evaluate trends in the prevalence, LOS, and cost of care for AYA CM hospitalizations. MATERIALS AND METHODS: A retrospective cohort study of nationally representative data from the 2009 to 2015 National Inpatient Sample. Multivariable survey-weighted logistic regression models were used to determine sociodemographic factors associated with AYA CM hospitalization. Multivariable survey-weighted linear regression models were used to determine characteristics associated with the greater cost of care and LOS in AYA CM inpatients. RESULTS: A total of 8986 AYA CM inpatients were included in this study. The prevalence of AYA CM hospitalizations is decreasing over time while the cost of care is increasing. On average, AYA CM hospitalizations were 3.3 days long and cost $38,018.40. Controlling for all covariates, male sex, older age, non-Hispanic white race, higher income, private insurance, and elective admissions were associated with AYA hospitalization due to CM (P<0.0001). Male sex was associated with longer LOS (P=0.007) and cost of care (P=0.01) among AYA hospitalized for CM. CONCLUSIONS: Despite a decreasing prevalence of CM hospitalizations in AYA inpatients, the economic burden of these hospitalizations is increasing. Substantial sex-based differences exist in the inpatient burden of AYA CM. Further research is required to elucidate the causes of these differences and prevent AYA hospitalization due to CM.


Asunto(s)
Costo de Enfermedad , Hospitalización/economía , Tiempo de Internación/economía , Melanoma/economía , Neoplasias Cutáneas/economía , Adolescente , Factores de Edad , Estudios de Cohortes , Bases de Datos Factuales , Femenino , Hospitalización/estadística & datos numéricos , Hospitales Universitarios , Humanos , Incidencia , Masculino , Melanoma/patología , Melanoma/cirugía , Pronóstico , Estudios Retrospectivos , Neoplasias Cutáneas/patología , Neoplasias Cutáneas/cirugía , Estados Unidos , Adulto Joven
11.
Dermatol Surg ; 2019 Sep 02.
Artículo en Inglés | MEDLINE | ID: mdl-31490307

RESUMEN

BACKGROUND: Knowledge regarding the inpatient burden of cutaneous squamous cell carcinoma (cSCC) is limited. OBJECTIVE: To provide nationally representative estimates for hospitalization characteristics due to cSCC and determine predictors for increased length of stay (LOS) and cost of care. METHODS/MATERIALS: A retrospective cohort study of the 2009 to 2015 National Inpatient Sample. Weighted multivariate logistic/linear regression models were created to evaluate sociodemographic factors associated with cSCC hospitalization and to assess characteristics associated with cost of care and LOS. RESULTS: This study included 15,784 cSCC and 255,244,626 non-SCC inpatients (prevalence = 6.2/100,000 inpatients). On average, cSCC hospitalizations lasted 5.8 days and cost $66,841.00. Cutaneous squamous cell carcinoma most often occurred on the scalp (30.57%), face (21.08%), and lower limb (11.93%). Controlling for all other factors, cSCC inpatients presented to larger/urban/teaching hospitals and were most often older non-Hispanic white women. More chronic conditions/diagnoses/procedures and nonwhite race were associated with greater cost of care and LOS. Cost of care and LOS significantly differed between cSCCs of different anatomical sites. The most common procedures performed were skin grafts (27.96%), excisions (25.83%), and lymph node biopsies (11.39%). CONCLUSION: This study highlights the substantial burden of inpatient cSCC in the United States. Further research is necessary to prevent cSCC hospitalizations and improve inpatient dermatologic care for cSCC.

12.
Dermatol Online J ; 25(6)2019 Jun 15.
Artículo en Inglés | MEDLINE | ID: mdl-31329393

RESUMEN

Gottron papules, a heliotrope rash, scalp and extremity erythema, pruritus, and fatigue are the characteristic signs and symptoms of amyopathic dermatomyositis (ADM). Amyopathic dermatomyositis is considered a distinct entity from dermatomyositis (DM) because the characteristic muscle weakness and muscle enzyme elevations of DM are absent in ADM. With respects to treatment, ADM treatments have traditionally included topical corticosteroids and/or systemic immunosuppressants and immunomodulators. Herein we present a patient with refractory ADM that was responsive to low-dose naltrexone therapy.


Asunto(s)
Dermatomiositis/tratamiento farmacológico , Naltrexona/administración & dosificación , Antagonistas de Narcóticos/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Naltrexona/uso terapéutico , Antagonistas de Narcóticos/uso terapéutico
14.
Cureus ; 11(5): e4586, 2019 May 02.
Artículo en Inglés | MEDLINE | ID: mdl-31309011

RESUMEN

Knowledge surrounding inpatient dermatologic procedure costs is limited; therefore to learn more, we performed a cross-sectional analysis of dermatologic procedures contained in a publicly available Washington State Comprehensive Hospital Abstract Reporting System database from 2014. Dermatologic procedure utilization and cost were evaluated based on several parameters including demographics, length of hospital stay, payments, and payers. SAS 9.4 was used for the analysis. A total of 14,768 patients underwent dermatologic procedures in 2014 and 81.0% were white. The average age was 53 years (SD = 0.17), and the average payment for all patients who underwent dermatologic procedures was $85,059.48 (SD = $1,284.34). The average hospital length of stay was 8.91 days (SD = 0.07). The most common admission type was elective (66.2%), the most common admit source was a non-healthcare facility point of origin (78.2%), the most common primary payer was Medicare (36.2%), and the most common procedure was incision and drainage of skin and subcutaneous tissue (26.5%), followed by closure of skin and subcutaneous tissue of other sites (20%). This analysis demonstrated that inpatient dermatologic procedures are a significant driver of inpatient health care costs, and it is critical to determine factors that increase inpatient costs related to dermatologic procedures in order to develop strategies for reducing healthcare costs.

16.
Cureus ; 11(3): e4230, 2019 Mar 11.
Artículo en Inglés | MEDLINE | ID: mdl-31123652

RESUMEN

Introduction Innovations in cancer treatment coupled with an increasing number of cancer patients have led to the growth of brachytherapy devices. The objective of this study is to characterize the development and safety of brachytherapy devices marketed in the United States (US) over the last 15 years. Methods We reviewed records from a public US Food and Drug Administration (FDA) database detailing premarket approval of brachytherapy devices. All 510(k) submissions approved between January 1, 2000 and October 31, 2018 were examined. To assess the safety of these devices, we searched the manufacturer and user facility device experience (MAUDE) database for related adverse events. Results Twenty-two brachytherapy devices received 510(k) premarket approval, with the first device approved in 2005. Of the 22 devices, 20 (91%) were marketed with specific indications. The most common indications include treatment of skin cancers and keloids (n=7), breast cancer (n=4), and gynecologic/rectal cancers (n=2). A review of the MAUDE database revealed 64 reports of adverse events associated with brachytherapy devices. Common adverse effects include poor device design, use error, and device malfunction that led to the delivery of an inaccurate dose of radiation. Discussion Although there are some single-center, short-term studies demonstrating adequate local control and satisfactory cosmesis with brachytherapy, data on long-term outcomes are lacking. Further research is warranted to define appropriate practice guidelines for brachytherapy devices in the treatment of various malignancies.

17.
JAMA Dermatol ; 155(7): 812-818, 2019 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-31090874

RESUMEN

Importance: The prevalence of keratinocyte carcinoma (KC) exceeds that of all other malignant neoplasms combined. Despite the steady rise of payments for medical malpractice liability claims over time, data regarding the characteristics of malpractice litigation for KC are scarce. Objective: To identify state and federal appellate medical malpractice liability cases for KC and determine the factors associated with the verdicts. Design, Setting, and Participants: This retrospective review of KC-related malpractice litigation under state or federal jurisdiction reviewed the LexisNexis Academic database of state and federal cases, legal reviews, and case law. All appellate medical malpractice cases at the state and federal levels involving basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) from January 1, 1968, through December 31, 2018, were identified. Main Outcomes and Measures: Demographic characteristics of the cases and plaintiffs, verdict, health care specialty of the defendant, setting of the litigation, rationale for the lawsuit and verdict, factors associated with the case outcome, and monetary payout in cases won by the plaintiff. Results: In total, 83 cases were included in our analysis (34 BCC cases and 49 SCC cases; 47 [57%] male plaintiffs). Sixty-two cases (75%) were decided in favor of the defendant. More KC-related malpractice cases were won by defendants in more recent years than were won by plaintiffs (mean year, 2004 [SD, 11 years] vs 1998 [SD, 14 years]; P = .03). Twenty-five cases (30%) each occurred in the Northeast and the South, and 45 (54%) involved private practices. Most cases involved KCs occurring on the face, head, and/or neck (39 [47%]), the genitalia (22 [27%]), or the extremities (15 [18%]). More than half of defendants were dermatologists (19 [23%]), family medicine physicians (15 [18%]), or oncologists (8 [10%]). Jurisprudence for KC-related malpractice cases most often occurred at the state level (49 [59%]). The most common causes of litigation were failure to diagnose (18 [22%]), misdiagnosis (18 [22%]), and delay in treatment (11 [13%]). More female than male plaintiffs won their malpractice cases (11 of 35 [31%] vs 5 of 43 [12%]; P = .03). More cases involving SCC than BCC led to a decision favoring the plaintiff (13 of 47 [28%] vs 3 of 31 [10%]; P = .05). In cases won by the plaintiff, the median monetary payout was $179 654 and the mean payout was $909 801 (range, $11 537-$5 320 161). Conclusions and Relevance: This study sheds light on the characteristics and settings of KC malpractice litigation claims, which is vital information for discovering potential areas of quality improvement, patient safety initiatives, and education for patients and health care professionals.

18.
JAMA Dermatol ; 155(6): 694-699, 2019 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-30892572

RESUMEN

Importance: Despite the increasing incidence of chronic cutaneous ulcers (CCUs), limited information exists regarding their incremental economic burden. Objective: To provide nationally representative estimates regarding the incremental health care cost of CCUs, controlling for comorbidities and sociodemographic characteristics. Design, Setting, and Participants: This retrospective analysis used 9 years of longitudinal data from the Medical Expenditure Panel Survey (MEPS; January 1, 2007, through December 31, 2015). Patients with CCUs were identified using Agency for Healthcare Research and Quality-produced software that included several codes from the International Classification of Disease, 9th Revision Clinical Modification, for chronic ulcers of the skin. A cross-validated 2-part generalized linear model estimated the adjusted incremental expenditure for individuals with CCUs while controlling for comorbidities and sociodemographic covariates. Data were analyzed from July 1 through September 1, 2018. Main Outcomes and Measures: Incremental cost of CCUs, total cost of care, and expenditures associated with inpatient care, outpatient care, prescription medications, emergency department visits, and home health care. Results: A total of 288 698 patients (52.4% female; mean [SD] age, 38.2 [22.4] years) were included, of whom 1786 had CCUs and 286 912 did not. Patients with CCUs were more likely to be female (1078 [60.4%]), non-Hispanic (1388 [77.7%]), previously or currently married (1440 [80.6%]), and covered by Medicaid/Medicare (852 [47.7%]) and had a lower income (954 [53.4%]) when compared with patients without CCUs (P < .001 for all). The mean (SD) annual cost of care per patient with CCUs was greater than 4 times that of patients without CCUs ($17 958 [$1031.90] vs $4373.20 [$48.48]). After controlling for Charlson comorbidity index and sociodemographic factors measured in MEPS, the cost of care for patients with CCUs was 1.73 times as high as that of patients without CCUs (95% CI, 1.53-1.96; P < .001), and patients with CCUs were estimated to incur $7582.00 (95% CI, $6201.47-$8800.45) more in annual health care expenditures. When accounting for the prevalence of CCUs (0.6%), CCUs were associated with more than $16.7 billion per year in population-level US health care expenditures. Among patients with CCUs, mean annual expenditures rose from the 2010-2012 to 2013-2015 periods in association with prescription medications ($3117.26 to $6169.12), outpatient care ($3568.06 to $5920.75), and home health care ($1039.54 to $1670.56). Conclusions and Relevance: Results of this study suggest that chronic cutaneous ulcers are associated with substantial incremental increases in annual health care expenditure. Expenses for patients with CCUs are increasing, particularly with regard to outpatient cost of care and prescription medication expenditure. As health care costs rise, investigators must identify strategies to prevent and treat CCUs.


Asunto(s)
Costos de la Atención en Salud/estadística & datos numéricos , Gastos en Salud/estadística & datos numéricos , Úlcera Cutánea/economía , Adolescente , Adulto , Anciano , Atención Ambulatoria/economía , Enfermedad Crónica , Femenino , Hospitalización/economía , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Medicamentos bajo Prescripción/economía , Prevalencia , Estudios Retrospectivos , Úlcera Cutánea/epidemiología , Úlcera Cutánea/terapia , Estados Unidos , Adulto Joven
20.
Dermatol Online J ; 25(1)2019 Jan 15.
Artículo en Inglés | MEDLINE | ID: mdl-30710908

RESUMEN

Acne vulgaris affects a large portion of the population and drives many patients to seek over-the-counter (OTC) treatments. Light-emitting diode (LED) therapy has recently emerged as a potential therapeutic option for inflammatory acne. We used the U.S. Food and Drug Administration (FDA) 510(k) premarket submission database to assess the growth in OTC LED therapy devices for treatment of acne. We also used Google Trends data in searches for "acne light therapy mask" to characterize growth in consumer interest in these devices. Overall, 35 LED devices received pre-market approval from 2000 to 2018, with a peak in approvals in 2016. Similarly, there was a dramatic increase in public interest in these devices in 2016. Only two devices were associated with company-approved trials. The current regulatory process requires little evidence to substantiate specified uses and a better understanding of practice guidelines and the efficacy of this treatment modality is required.


Asunto(s)
Acné Vulgar/terapia , Aprobación de Recursos , Fototerapia/instrumentación , Estudios Transversales , Humanos , Estudios Retrospectivos , Motor de Búsqueda , Estados Unidos , United States Food and Drug Administration
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