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Background Mohs micrographic surgery (MMS) is a cost-effective treatment for nonmelanoma skin cancer that bundles costs for surgical excision, tissue processing, and histopathological interpretation. A comprehensive MMS bundle would include all aspects of an episode of care (EOC), including costs of reconstruction, preoperative, and postoperative care. Objective To assess the feasibility of an alternative payment model for MMS and reconstruction. Methods Retrospective chart review and payment analysis for 848 consecutive patients with 1,056 tumors treated with MMS. Average Medicare payment of an EOC was compared with bundles based on specific repair types. Results The bundle for a flap/graft repair averaged $1,028.08 (confidence interval [CI] 95% $951.37-1,104.79), whereas the bundle for a linear closure (LC) averaged $585.07 (CI 95% $558.75-611.38). The average bundle including all repairs was $730.05 (CI 95% $692.31-767.79), which was statistically significant from both the flap/graft and LC bundles. Conclusion Bundling surgical repairs with MMS based on an average payment does not represent the heterogeneity of the care provided and results in either underpayment or overpayment for a substantial portion of cases. Consequently, EOC payments bundling MMS and surgical repairs would inaccurately reimburse physicians for work completed. Current payment methodology allows for accurate payment for this already cost-effective therapy.

Background Despite extensive counseling, patients commonly call with postoperative concerns after Mohs micrographic surgery (MMS). Objective We sought to determine the incidence, reasons, and patient and surgical characteristics that lead to patient-initiated communication after MMS. Materials and methods A retrospective chart review of 1,531 patients who underwent MMS during the observational period was conducted. Demographics and perioperative characteristics of patients who initiated communication were compared with a random sample of matched controls. Results Of the 1,531 patients who underwent MMS, 263 patients (17.2%) initiated 412 communication encounters within 90 days of surgery. Top reasons for patient-initiated communication included wound concerns, bleeding, and postoperative pain. Female patients and those with a larger surgical defect size (cm) were more likely to call postoperatively. Patients who underwent second intention healing, grafts, and interpolation flaps were more likely to initiate communication compared to patients repaired with a linear closure. Conclusion This study identifies the incidence, reasons, and patient and surgical factors predictive of patient-initiated communication after MMS, which may allow for targeted improvements in postoperative counseling, ameliorating patient anxiety, augmenting patient satisfaction, and improved efficiency for the health care team.

Reconstruction of defects involving the upper lip can be challenging. The purpose of this review was to analyze the anatomy and function of the upper lip and provide an approach for reconstruction of upper lip defects. The primary role of the upper lip is coverage of dentition and animation, whereas the lower lip is critical for oral competence, speech, and eating. The orbicularis oris (OO) and several other muscles contribute to upper lip function. There are various insertion points for animation muscles, including the upper lip dermis, OO, and modiolus. Special attention should be paid to the philtrum, Cupid's bow, and vermilion border during reconstruction. Advantages and disadvantages of the Abbe, Estlander, and Karapandzic flaps are presented. Knowledge of mechanics, indications, and properties of local flaps while considering unique characteristics of upper lip anatomy and function are crucial for optimal aesthetic and functional outcomes.

Many women report improvement in psoriasis during pregnancy; others report that psoriasis becomes worse during pregnancy. Balancing effective management of psoriasis against potential risk in pregnancy is important, especially because the severity of psoriasis can have an impact on the pregnancy experience and possibly the outcome. This article discusses current understanding of pregnancy risk profiles of medications used to treat psoriasis.

Chlorhexidine gluconate (CHG) is a widely used antiseptic agent for skin and wound disinfection. The cationic properties of CHG may allow its inactivation and precipitation by anionic agents in commonly used topical agents. We conducted a systematic review by searching through PubMed, Cochrane Library, and Web of Science databases and selected original research articles reporting on CHG incompatibility, defined as inactivation or precipitation. The search yielded 22 publications that demonstrated CHG incompatibility via: 1) reduced antibacterial activity (carbomer, acrylates/C10-C30 alkyl acrylate crosspolymer, dentin, bovine serum albumin, copolymer M239144, sodium lauryl sulfate, heat-killed microbes, triethanolamine, and bark cork); and 2) visible precipitate formation (sodium hypochlorite, EDTA, saline, ethanol, andnystatin). Only three publications reported on CHG incompatibility in dermatology, specifically for carbomer, triethanolamine, and acrylates/C10-C30 alkyl acrylate crosspolymer. Although limited evidence linking CHG incompatibility and anionic agents exists, clinicians should carefully consider the nature of topical agents used if CHG is concurrently applied. Increased awareness of CHG incompatibility may result in better antibacterial activity thus ensuring optimal patient management.

There is an ongoing debate about the reliability of various lower abdominal flaps for breast reconstruction. The authors evaluate in vivo perfusion of these flaps to objectively determine which techniques and which skin island zones had better perfusion.A prospective study was performed on 77 single-pedicle breast reconstructions [pedicled transverse rectus abdominis muscle (TRAM), n = 22; muscle-sparing free TRAM, n = 37; deep inferior epigastric perforator (DIEP), n = 18]. Perfusion was measured intraoperatively using indocyanine green angiography following flap harvest and before transfer. Flow quantification was performed at 12 standardized data points in each of the four zones of the skin island. Patient risk factors for flap ischemia were assessed, perfusion was quantified, and comparisons were made between the various flaps and between zones.Mean perfusion was significantly higher in the 37 free muscle-sparing flaps (24.9) and the 18 DIEP flaps (21.8) when compared with the 22 pedicled TRAM flaps (19.6) (p0.001). Zones I and IV had significantly higher and lower perfusion, respectively (28.4 versus 13.9), when compared with the other zones. There was no significant difference in perfusion between zones II and III (20.6 versus 21.6). Differences in flap flow were significant (p0.001) independent of zonal differences.The authors demonstrated objectively that lower abdominal free flaps based on the inferior epigastric system have better perfusion when compared with pedicled TRAM flaps. There is no appreciable difference in perfusion between zones II and III; however, it is likely related to the perforator location and dominance. Clinical correlation between these absolute perfusion values and flap viability is required.Therapeutic, II.

Summary Background Tumour necrosis factor-α inhibitors (TNFαIs) are used for treatment of inflammatory disorders. There is evidence linking these agents with occurrence of malignancies. For four out of five TNFαIs the Food and Drug Administration (FDA) label states, ‘melanoma has been reported in patients treated with these agents’. Objectives To determine whether a statistically significant association exists between administration of TNFαIs and development of malignant melanoma. Methods We searched the FDA Adverse Event Reporting System (FAERS) database for terms related to melanoma and TNFαIs for detection of safety signals. We also searched a large urban academic electronic medical record (EMR) database for which we calculated the relative risk (RR) of melanoma in subjects exposed to TNFαIs vs. nonexposed subjects. Results There were 972 reports of melanoma associated with a TNFαI identified in the FAERS database, with 69 reports among individuals using more than one TNFαI. A safety signal was detected for infliximab, golimumab, etanercept and adalimumab, but not certolizumab pegol. For TNFαIs as a class of drugs, a safety signal was detectable in the FAERS database, and RR was significant in the EMR database. For the EMR cohort, 6045 patients were exposed to TNFαIs and 35 cases of melanoma were detected. Significance for RR was detected for adalimumab (RR 1·8, P = 0·02) and etanercept (RR 2·35, P = 0·0004 < 0·001). Conclusions We identified a significant association between exposure to TNFαIs and malignant melanoma in two different analyses. Our findings add to existing evidence linking these agents with the occurrence of malignant melanoma. Additional investigations are required to explore this association further along with the risk of melanoma with TNFαI therapy.

To compare and contrast three databases, that is, The International Centre for Nephrogenic Systemic Fibrosis Registry (ICNSFR), the Food and Drug Administration Adverse Event Reporting System (FAERS) and a legal data set, through pharmacovigilance and to evaluate international nephrogenic systemic fibrosis (NSF) safety efforts.The Research on Adverse Drug events And Reports methodology was used for assessment-the FAERS (through June 2009), ICNSFR and the legal data set (January 2002 to December 2010). Safety information was obtained from the European Medicines Agency, the Danish Medicine Agency and the Food and Drug Administration.The FAERS encompassed the largest number (n = 1395) of NSF reports. The ICNSFR contained the most complete (n = 335, 100%) histopathological data. A total of 382 individual biopsy-proven, product-specific NSF cases were analysed from the legal data set. 76.2% (291/382) identified exposure to gadodiamide, of which 67.7% (197/291) were unconfounded. Additionally, 40.1% (153/382) of cases involved gadopentetate dimeglumine, of which 48.4% (74/153) were unconfounded, while gadoversetamide was identified in 7.3% (28/382) of which 28.6% (8/28) were unconfounded. Some cases involved gadobenate dimeglumine or gadoteridol, 5.8% (22/382), all of which were confounded. The mean number of exposures to gadolinium-based contrast agents (GBCAs) was gadodiamide (3), gadopentetate dimeglumine (5) and gadoversetamide (2). Of the 279 unconfounded cases, all involved a linear-structured GBCA. 205 (73.5%) were a non-ionic GBCA while 74 (26.5%) were an ionic GBCA.Clinical and legal databases exhibit unique characteristics that prove complementary in safety evaluations. Use of the legal data set allowed the identification of the most commonly implicated GBCA.This article is the first to demonstrate explicitly the utility of a legal data set to pharmacovigilance research.

Background Different modalities are used to diagnose interstitial lung disease. We compared the effectiveness of minimally invasive surgical biopsy versus high-resolution computed tomography for the diagnosis of interstitial lung disease and report the mortality of the procedure. Methods We reviewed 194 patients undergoing video-assisted thoracoscopic lung biopsies for the suspicion of interstitial lung disease from January 2003 to February 2012 at Emory University. Demographics and patient characteristics were analyzed in addition to final diagnoses and clinical outcomes. Results Concordance of radiographic diagnosis with final diagnosis was poor, matching pathologic diagnosis in 15% of cases, and specific diagnoses were included in the radiographic differential in only 34% of cases. A specific diagnosis was made after surgical biopsy in 88% of cases. Overall mortality of surgical biopsy was 6.7% (13/194). Major risk factors for death were preoperative supplemental oxygen, ventilator dependence, and age ( p p p = 0.03, respectively). Among patients with ventilator dependence preoperatively, the mortality rate was 100% versus 4.8% in patients not ventilator dependent. All biopsy specimens were concordant 91% of the time, and the first two biopsy specimens were concordant 96% of the time. Conclusions Surgical biopsy should remain the gold standard for diagnosis of interstitial lung disease. The mortality is low with proper patient selection. More than two surgical biopsy specimens may not be needed because the concordance rates among pathologic specimens are very high.

Background On 30 January 2012, the US FDA approved vismodegib (Erivedge®, Genentech, CA, USA) for the management of both metastatic and locally advanced basal cell carcinoma. Objective Our objective was to identify evidence of hepatotoxicity with vismodegib in the FDA Adverse Event Reporting System (FAERS) in treated patients in two National Cancer Institute Comprehensive Cancer Centers. Methods FAERS was searched for reports dated 1 January 2009 through 31 December 2015 using terms including hedgehog pathway and vismodegib and hepatic-related terms such as liver, jaundice, and hepatitis, among others. Disproportionality analyses with estimates of proportional reporting ratio and empirical Bayesian geometric mean were conducted. A comprehensive literature review was conducted, and the clinical databases at the University of Texas MD Anderson Cancer Center and Robert H. Lurie Comprehensive Cancer Center of Northwestern University were searched. Results Two cases of severe liver dysfunction were published (Common Terminology Criteria for Adverse Events [CTCAE] class III), and 94 reports of adverse events (AEs) were detected in FAERS, 35 of which were serious AEs. Safety notifications related to hepatotoxicity have not been issued by the manufacturer or the FDA, although vismodegib is listed in LiverTox and the European Medicines Agency website. Conclusion We identified a detectable safety signal for hepatotoxicity for vismodegib within 4 years of FDA approval. Vismodegib should be used in patients with severe liver disease only after careful consideration, and concomitant hepatotoxic medications should be avoided. Rapid dissemination of such safety concerns is expected to result in fewer serious hepatotoxic AEs and more optimal outcomes for patients with cancer receiving vismodegib. Electronic supplementary material The online version of this article (doi:10.1007/s40268-016-0168-2) contains supplementary material, which is available to authorized users.