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252


The Impact of the COVID-19 Pandemic on Physician-Pharmaceutical Office-Based Interactions

Marson, Justin W; Litchman, Graham H; Rigel, Darrell S
BACKGROUND:COVID-19 has had significant negative economic ramifications on dermatologic care delivery, including curtailing live on-site physician-pharmaceutical-representative interactions (PPRI). OBJECTIVE:To determine the impact of COVID-19 and pandemic regulations on current and future PPRI. METHODS:Cross-sectional survey-based study that analyzed data from 400 surveyed dermatologists using a pre-validated questionnaire sent via email. Data regarding PPRI were collected over 1 week in July 2020 to compare demographics and practice standards from April 2019, April 2020, July 2020, and predictions for 2021. RESULTS:Virtual-only PPRI increased from 7.8% in April 2019 to 26.5% during April 2020 (mean difference, 18.8%; 95% confidence interval, 13.6%–23.9%). Virtual-only PPRI remained elevated at 24.5% while hybrid PPRI increased, eventually surpassing the April 2019 mark (27.0%). These trends persisted among all studied practice types and levels of experience. Practices predicted no significant percent differences in participation in PPRI (87.3% vs 90.3%; P=0.0834), but a significant shift in method of delivery where the odds ratio of incorporating a virtual component into PPRI in 2021 increased by a factor of 3. LIMITATIONS/CONCLUSIONS:Relatively small sample size, especially among subgroups. Responses may have been retrospective estimates. There may also be selection bias given slightly increased representation of more experienced dermatologists. CONCLUSION/CONCLUSIONS:PPRI materially decreased during the initial COVID-19 peak but will likely return to baseline volume moving forward with a significant component being hybrid PPRI. Further studies may better elucidate the economic and clinical impact associated with these changes and their effect on dermatologists’ ability to provide patients with samples and educational materials. J Drugs Dermatol. 2021;20(2):215-223. doi:10.36849/JDD.2021.5651.
PMID: 33538568
ISSN: 1545-9616
CID: 4776552

The Continuing Impact of COVID-19 on Dermatology Practice: Office Workflow, Economics and Future Implications

Litchman, Graham H; Marson, Justin W; Rigel, Darrell S
PMCID:7526524
PMID: 33010326
ISSN: 1097-6787
CID: 4626422

Validation of a 40-Gene Expression Profile Test to Predict Metastatic Risk in Localized High-Risk Cutaneous Squamous Cell Carcinoma

Wysong, Ashley; Newman, Jason G; Covington, Kyle R; Kurley, Sarah J; Ibrahim, Sherrif F; Farberg, Aaron S; Bar, Anna; Cleaver, Nathan J; Somani, Ally-Khan; Panther, David; Brodland, David G; Zitelli, John; Toyohara, Jennifer; Maher, Ian A; Xia, Yang; Bibee, Kristin; Griego, Robert; Rigel, Darrell S; Plasseraud, Kristen Meldi; Estrada, Sarah; Sholl, Lauren Meldi; Johnson, Clare; Cook, Robert W; Schmults, Chrysalyne D; Arron, Sarah T
BACKGROUND:Current staging systems for cutaneous squamous cell carcinoma (cSCC) have limited positive predictive value (PPV) for identifying patients who will experience metastasis. OBJECTIVE:To develop and validate a gene expression profile (GEP) test for predicting risk for metastasis in localized, high-risk cSCC with the goal of improving risk-directed patient management. METHODS:Archival formalin-fixed paraffin-embedded primary cSCC tissue and clinicopathologic data (n=586) were collected from 23 independent centers in a prospectively designed study. A GEP signature was developed using a discovery cohort (n=202) and validated in a separate, non-overlaping, independent cohort (n=324). RESULTS:A prognostic, 40-gene expression profile (40-GEP) test was developed and validated, stratifying high-risk cSCC patients into classes based on metastasis risk: Class 1 (low-risk), Class 2A (high-risk), and Class 2B (highest-risk). For the validation cohort, 3-year metastasis-free survival (MFS) rates were 91.4%, 80.6%, and 44.0%, respectively. A PPV of 60% was achieved for the highest-risk group (Class 2B), an improvement over staging systems; while negative predictive value, sensitivity, and specificity were comparable to staging systems. LIMITATIONS/CONCLUSIONS:Potential understaging of cases could affect metastasis rate accuracy. CONCLUSION/CONCLUSIONS:The 40-GEP test is an independent predictor of metastatic risk that can complement current staging systems for patients with high-risk cSCC.
PMID: 32344066
ISSN: 1097-6787
CID: 4412182

The Immediate Impact of COVID-19 on US Dermatology Practices

Litchman, Graham H; Rigel, Darrell S
PMCID:7228885
PMID: 32422226
ISSN: 1097-6787
CID: 4443842

Impact of a prognostic 40-gene expression profiling test on clinical management decisions for high-risk cutaneous squamous cell carcinoma

Litchman, Graham H; Fitzgerald, Alison L; Kurley, Sarah J; Cook, Robert W; Rigel, Darrell S
PMID: 32372702
ISSN: 1473-4877
CID: 4430212

A demonstration of the excellent tolerability and safety of a lanolin alcoholecontaining wound healing ointment [Meeting Abstract]

Draelos, Zoe Diana; Rigel, Darrell S.; Kircik, Leon
ISI:000598634300646
ISSN: 0190-9622
CID: 4730212

Impact of Gene Expression Profile Testing on the Management of Squamous Cell Carcinoma by Dermatologists

Rebeca, Teplitz; Giselle, Prado; Litchman, Graham H.; Rigel, Darrell S.
Background: The incidence of cutaneous squamous cell carcinoma (cSCC) is increasing likely due to improved detection and a growing elderly population. Although the prognosis of cSCC is excellent with complete surgical excision, many patients who go on to develop metastasis are initially classified as low-risk. The most commonly used staging systems, American Joint Committee on Cancer (AJCC) and Brigham Women's Hospital (BWH), have low sensitivity and low positive predictive value for predicting metastasis. A gene expression profile test (cSCC-GEP) is in development to identify patients with cSCC at high risk for metastasis and death.
PMID: 31584775
ISSN: 1545-9616
CID: 4118782

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 41 788 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

Corrigendum: Impact on clinical practice of a non-invasive gene expression melanoma rule-out test: 12-month followup 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 revised version of the article corrected Figure 2. This change appears in the revised online PDF copy of this article.
PMID: 31329399
ISSN: 1087-2108
CID: 3986782

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