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Impact on clinical practice of a non-invasive gene expression melanoma rule-out test: 12-month follow-up of negative test results and utility data from a large US registry study
Ferris, Laura K; Rigel, Darrell S; Siegel, Daniel M; Skelsey, Maral K; Peck, Gary L; Hren, Catherine; Gorman, Christopher; Frumento, Tana; Jansen, Burkhard; Yao, Zuxu; Rock, Jim; Knezevich, Stevan R; Cockerell, Clay J
The Pigmented Lesion Assay (PLA, sensitivity 91-95%, specificity 69-91%, negative predictive value ?99%) is a commercially available, non-invasive gene expression test that helps dermatologists guide pigmented lesion management decisions and rule out melanoma. Earlier studies have demonstrated high clinical utility and no missed melanomas in a 3-6-month follow-up period. We undertook the current investigations to provide 12-month follow-up data on PLA(-) tests, and to further confirm utility. A 12-month chart review follow-up of 734 pigmented lesions that had negative PLA results from 5 US dermatology centers was performed. Thirteen of these lesions (1.8%) were biopsied in the follow-up period and submitted for histopathologic review. None of the lesions biopsied had a histopathologic diagnosis of melanoma. The test's utility was studied further in a registry (N=1575, 40 US dermatology offices, 62 participating providers), which demonstrated that 99.9% of PLA(-) lesions were clinically monitored, thereby avoiding a surgical procedure, and 96.5% of all PLA(+) lesions were appropriately biopsied, most commonly with a tangential shave. This long-term follow-up study confirms the PLA's high negative predictive value and high utility in helping guide the management of pigmented lesions to avoid unnecessary surgical procedures.
PMID: 31220892
ISSN: 1087-2108
CID: 3954542
Online sunscreen purchases: Impact of product characteristics and marketing claims [Letter]
Prado, Giselle; Ederle, Ashley E; Shahriari, Shawhin R K; Svoboda, Ryan M; Farberg, Aaron S; Rigel, Darrell S
BACKGROUND:Sunscreens, unlike prescription medications, are purchased by consumers directly from retailers. The proportion of online sunscreen sales is increasing. It is therefore important for dermatologists to know what factors influence online sunscreen purchases to optimize appropriate recommendations. METHODS:Data on the top 100 best-selling sunscreens from an online retailer were collected. Variables included cost, formulation, product claims, ingredients, consumer ratings, and number of reviews. Ordinal logistic regression was used to analyze the impact of collected variables on position on the best-seller list. RESULTS:Ninety-six of the 100 search results could be defined as actual sunscreens with a total of 41Â 788 reviews. The median price per ounce was $3.02 (range $0.34-$309.18). The most popular formulations were lotions. The most common unregulated claim was "non-greasy" found in 57.3% of sunscreens. For 26 unregulated product claims analyzed, the mean number of claims per sunscreen was 5.2. Using an ordinal regression model, the following factors were found to significantly influence sunscreen sales: number of reviews, the claim "decreases the risk of skin cancer and early aging," and the presence of six or more unregulated claims. CONCLUSIONS:Multiple sunscreen options exist for consumers with varying price points, active ingredients, and formulations. Consumers who purchase online prefer sunscreens with a higher number of reviews and more unregulated marketing claims. FDA-regulated claims such as "decreases the risk of skin cancer and early aging" are not as impactful in this purchasing cohort. To facilitate usage, dermatologists should be cognizant of factors that influence sunscreen selection among this group.
PMID: 31095785
ISSN: 1600-0781
CID: 3919942
What's New in Melanoma
Prado, Giselle; Svoboda, Ryan M; Rigel, Darrell S
Melanoma is rapidly evolving because of advances in noninvasive diagnosis, targeted therapies, and improved prognostic methods. This article discusses what is new in melanoma risk factors, prevention, clinical management, and targeted treatment. The incidence continues to increase worldwide, whereas mortality is steadily improving. This trend reinforces the importance of dermatologists comprehensively understanding all aspects of melanoma. Further research is needed to continue making a material impact on outcomes for patients.
PMID: 30850038
ISSN: 1558-0520
CID: 3724262
Patient knowledge of FDA-mandated sunscreen labeling terminology: a cross-sectional survey
Prado, Giselle; Svoboda, Ryan M; Teplitz, Rebeca W; Farberg, Aaron S; Rigel, Darrell S
BACKGROUND:Insufficient understanding of sunscreen labeling terminology is a barrier to effective use. The FDA issued the "final rule" on sunscreen labeling in 2011, in an effort to promote effective usage. However, relatively little is known about patient knowledge of sunscreen labeling terminology. This study assesses the sunscreen labeling knowledge of dermatology patients, with an emphasis on understanding of the FDA-mandated wording. METHODS:A validated survey was administered to consecutive dermatology office patients. Respondents answered questions about sunscreen use practices, sunscreen knowledge, and demographics. To assess their sunscreen knowledge, they responded to questions on the concepts of sun protection factor, broad spectrum, and waterproof. RESULTS:334 patients completed surveys. Only 8.7% of patients correctly answered all 3 questions related to sunscreen labeling terminology. Patients with a personal history of skin cancer were more likely to answer more than half of the questions correctly (p=0.004). Older persons and those with darker skin types were most likely to answer all questions incorrectly. CONCLUSION/CONCLUSIONS:General understanding of sunscreen labeling was poor, and a minority of consumers comprehended the key features of sunscreen labeling. This knowledge gap appeared to be slightly smaller in the subpopulation of patients with a personal history of skin cancer.
PMID: 30383894
ISSN: 1600-0781
CID: 3399992
Assessment of Clinician Accuracy for Diagnosing Melanoma Based on Electrical Impedance Spectroscopy Score Plus Morphology Versus Lesion Morphology Alone
Svoboda, Ryan M; Prado, Giselle; Mirsky, Rachel S; Rigel, Darrell S
PMID: 30227189
ISSN: 1097-6787
CID: 3300532
Measurement of bioimpedance to assess for margin positivity in nonmelanoma skin cancer Mohs surgical specimens [Meeting Abstract]
Svoboda, R; Gharia, M; Gregory, W; Shell, J; Rigel, D
Background and objectives: The incidence of cutaneous malignancy in the United States continues to rise. Mohs micrographic surgery is increasingly utilized to treat both nonmelanoma skin cancer (NSMC) and melanoma. This tissue-sparing method produces the highest cure rates while leading to an esthetic result. However, due to the need for intraoperative pathologic assessment, these procedures can be time-consuming and may average several hours. New technology aimed at more quickly assessing specimen margins for malignant cells has the potential to cut down on operative times and improve efficiency. Bioimpedance has been shown to be a promising method of detecting malignant cells in other cancers, specifically breast cancer and prostate cancer. The purpose of this study was to assess the ability of a novel ex vivo bioimpedance system (MarginScan; NovaScan, Milwaukee, Wisconsin) to detect malignant cells at the margins of removed NMSC Mohs specimens.
Method(s): A total of 151 specimens of NMSC removed during Mohs micrographic surgery were evaluated both using traditional pathologic methods and bioimpedance.
Result(s): Overall, 44/151 (29%) of specimens displayed positive margins by pathology and 45/151 (30%) margin specimens were probable, highly probable, or suspicious for malignant cells by bioimpedance. There were 2 false negative and 1 false positive results by the bioimpedance method, indicating an overall concordance rate of 98.0% between bioimpedance and pathologic assessment. The sensitivity and specificity of the bioimpedance method were 95.1% and 99.1%, respectively. The positive and negative predictive values were 97.7% and 98.1%, respectively.
Conclusion(s): Ex vivo measurement of bioimpedance in NMSC specimens removed during Mohs micrographic surgery appears to have a high rate of concordance for diagnosing margin positivity compared with traditional pathologic assessment. This technique may present a viable alternative to microscopic evaluation of positive margins in NMSC Mohs specimens.
Copyright
EMBASE:2000995151
ISSN: 0190-9622
CID: 4385102
Clinical and economic implications of a noninvasive molecular pathology assay for early detection of melanoma [Meeting Abstract]
Hornberger, J; Rigel, D
Background: More than 90% of ~2.5 million surgical biopsies performed to rule out melanoma in the U.S. alone are benign and classified as neither invasive melanomas nor melanomas in situ by histopathology. A recently described adhesive patch skin biopsy based noninvasive gene expression test (pigmented lesion assay; PLA) demonstrated utility and differentiated benign from malignant pigmented skin lesions with a test performance that exceeded visual inspection (VI) and a sensitivity that matching the criterion standard of dermatopathology. However, cost and outcome implications of using this molecular test versus VI have not been evaluated.
Objective(s): To determine potential cost savings and impact on outcome of PLA use versus VI in patients with pigmented cutaneous lesions suggestive of melanoma. Design and setting: Health economic analyses were performed from average U.S. insurance reimbursement values, comparing the real-world impact of the PLA with VI. Data sources were from published clinical validation and utility studies as well as from routine use of the test in U.S. dermatology practices, augmented by fee schedules of CMS.
Result(s): The biopsy ratio declined from 12.5 for VI to 2.4 for PLA use; correspondingly, the number needed to excise (NNE) declined from 2.85 for VI to 1.37 for PLA use. The 1.77-fold increase in specificity of PLA over VI also resulted in lower costs for initial biopsy ($211), subsequent excisions ($86), surveillance management ($77), and management of melanoma ($508). There was $31 average savings from avoidance of lost work productivity, and improvement in patient experience as assessed by quality adjusted life years (gain of 0.016 years). Conclusions and relevance: The higher accuracy of PLA use versus VI resulted in fewer unnecessary procedures and office visits, while not compromising early melanoma detection. The consequence effects are potentially reduced direct medical costs, reduced work productivity loss, and improved patient experience and care.
Copyright
EMBASE:2000994870
ISSN: 0190-9622
CID: 4385142
Using a novel topical adhesive as an alternative to superficial sutures for wound closure following dermatologic excisional procedures: A case series [Meeting Abstract]
Svoboda, R; Zuckerman, J; Rigel, D
Background: The topical adhesive 2-octyl cyanoacrylate has been used as an alternative to sutures for closure of skin in a variety of surgical procedures. While there have been benefits in terms of ease of application and cosmetic result, a high incidence of allergic contact dermatitis and exothermic reactions has been a barrier to use. Objectives. To investigate the feasibility of using a novel formulation of 2-octyl cyanoacrylate (Actabond-Bergen Medical Products, Morris Plains, New Jersey) for skin closure after surgical excision of cutaneous lesions.
Method(s): We examined the results of office-based surgical excision procedures using a novel formulation of 2-octyl cyanoacrylate for skin closure. Photographs were taken preoperatively, intraoperatively (open wound, before adhesive application, following adhesive application), and 2 weeks after surgery. At follow-up, all incisions were examined for cosmetic result, skin edge separation, erythema, and abscess formation. Patient satisfaction was also assessed.
Result(s): Ten lesions in 9 consecutive patients undergoing cutaneous excision by two surgeons were included in the study. The average age of included patients was 42. Lesions were excised from the trunk (6) and extremities (4). Lesion types included 3 dysplastic nevi, 3 sebaceous cysts, 3 lipomas, and 1 squamous cell carcinoma. At 2-week follow-up, all wounds were healed without any signs of dehiscence or infection. All wounds demonstrated esthetic closure without suture tracts. None of the patients developed allergic contact dermatitis or burns. On a 1-10 scale, respondents' average satisfaction with the method was 7.7. For patients who had previous skin suture closures, 83% preferred adhesive. Conclusion and relevance. A novel formulation of 2-octyl cyanoacrylate topical adhesive demonstrated feasibility as a potential alternative to the use of sutures for skin closure. In this small case series, all patients had an excellent esthetic result with no complications. Compared with previous iterations of 2-octyl cyanoacrylate, there were no allergic or exothermic reactions in this pilot series. Larger studies need to be performed to further determine advantages that may exist using this closure method compared with standard techniques.
Copyright
EMBASE:2000994678
ISSN: 0190-9622
CID: 4385162
Factors affecting dermatologists' decision to use a 31-gene expression profiling test to assess metastatic risk for melanoma patients [Meeting Abstract]
Svoboda, R; Glazer, A; Rigel, D
Background: Genetic evaluation of melanoma is becoming increasingly important. A 31-gene expression profiling (31-GEP) test (Decision-DX; Castle Biosciences, Friendswood, Texas) to predict metastatic risk in patients with cutaneous malignant melanoma (CMM) has previously been validated and is available for clinical use. The impact of this test on clinical decision making has been studied. However, little is known about which clinical factors impact dermatologists' decisions to utilize the test.
Objective(s): To determine which factors impact clinicians' decisions to utilize the 31-GEP test for metastatic risk stratification in patients with CMM. Design, setting, and participants: 181 dermatologists attending a national conference completed a series of questions based around four clinical vignettes using an audience response system. The vignettes and associated questions were designed to determine the impact of three factors-Breslow thickness, ulceration, and sentinel lymph node biopsy (SLNBx) status-on the decision to order the test.
Main Outcomes and Measures: Percentage of respondents who would order the 31-GEP test in the various clinical scenarios was quantified. Chi-squared testing assessed differences in the proportion of respondents who would order the test at baseline and in the presence of ulceration or a negative SLNBx.
Result(s): For tumors with a Breslow thickness >=0.5 mm, a majority of respondents reported that they would recommend the 31-GEP test. Ulceration was associated with a statistically significant increase in the percentage of clinicians who would recommend the assay for all but the thickest (>=2.1 mm) tumors. For a thin tumor (0.26 mm), the presence of ulceration changed the percentage of clinicians who would order the test from a minority to a majority (22% to 67%; P <.001). A negative SLNBx was only associated with a statistically significant increase in the percentage of clinicians who would recommend the test for the thinnest tumors (22% to 34%; P =.033). Conclusions and relevance: Ulceration appears to be the most important factor impacting clinicians when deciding to order the 31-GEP test. Despite the fact that 2/thirds of CMM patients who develop metastases initially have a negative SLNBx, negative SLNBx status does not seem to be a significant stimulus to ordering the test. Given this finding, future research should aim to better understand the reasons for choosing to use this technology in this SLNBx negative population.
Copyright
EMBASE:2000995136
ISSN: 0190-9622
CID: 4385112
Management Decisions Made by Physician Assistants and Nurse Practitioners in Cutaneous Malignant Melanoma Patients: Impact of a 31-Gene Expression Profile Test
Mirsky, Rachel; Prado, Giselle; Svoboda, Ryan; Glazer, Alex; Rigel, Darrell
Importance: The 31 gene-expression profiling test (31-GEP) has been shown to provide useful prognostic information in patients with cutaneous melanoma. The test dichotomizes patients into lower risk (Class 1) or higher risk (Class 2) for melanoma metastasis. Previous studies have demonstrated the clinical utility of the test in impacting dermatologists’ management decisions. Physician assistants and nurse practitioners (PA/NPs) account for a significant portion of dermatologic providers. The impact of a 31-GEP assay on clinical management has not been evaluated in this group.
PMID: 30500144
ISSN: 1545-9616
CID: 3659202