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Comparison of the Distribution of Morphological Disorganization of Pigmented Lesions in a Community-based Practice versus a University-based Clinical Setting as Measured by a Multispectral Digital Skin Lesion Analysis Device: Impact on Diagnosis

Winkelmann, Richard R; Nikolaidis, Gregory; Rigel, Darrell S; Tucker, Natalie; Speck, Laura
OBJECTIVE: To observe how a multispectral digital skin lesion analysis device was used by dermatologists in a community-based clinical setting and determine differences from a university-based environment. DESIGN: Use of multispectral digital skin lesion analysis was incorporated into a community-based practice by 12 dermatologists across six clinics over seven consecutive days with the data provided by the device integrated as an adjuvant to their clinical evaluation for their pigmented lesion management decisions. Multispectral digital skin lesion analysis results were collected electronically for lesions prior to biopsy, and histopathological evaluation was performed for the biopsied lesions. Multispectral digital skin lesion analysis and pathology results were then compared to assess the degree of morphological disorganization. SETTING/PARTICIPANTS: Study of 160 consecutive patients in community-based clinical setting. MEASUREMENTS: Proportion of "low" and "high" disorganization lesions identified by multispectral digital skin lesion analysis. RESULTS: Of the 344 pigmented skin lesions analyzed by multispectral digital skin lesion analysis, 255 were high disorganization, 113 of which were biopsied. Of the 89 lesions evaluated by multispectral digital skin lesion analysis to be low disorganization, seven were biopsied and all pathology was benign. Data demonstrate a higher rate of multispectral digital skin lesion analysis low disorganization readings for pigmented skin lesions (32% for single use per patient lesions, p<0.0001; 26% for all lesions, p<0.0001) than observed in the pigmented lesions clinics providing data for the university-based clinical study (10%). CONCLUSION: Multispectral digital skin lesion analysis in the community-based clinical setting may outperform specificity results from the university-based clinical trial study, perhaps because of a higher proportion of subtle lesions encountered at high-risk pigmented lesion clinics of participating major academic centers as compared with those in a community-based practice setting.
PMCID:4345928
PMID: 25741398
ISSN: 1941-2789
CID: 1480742

Assessing frequency and quality of US dermatologist sunscreen recommendations to their patients

Winkelmann, Richard R; Rigel, Darrell S
PMID: 25687313
ISSN: 0190-9622
CID: 1466032

Performance of a multispectral digital skin lesion analysis device for melanoma detection in a private practice clinical setting [Meeting Abstract]

Nikolaidis, Gregory; Rigel, Darrell; Speck, Laura
ISI:000360583900513
ISSN: 0190-9622
CID: 2734062

Assessment of a Diagnostic Predictive Probability Model Provided by a Multispectral Digital Skin Lesion Analysis Device for Melanoma and Other High-risk Pigmented Lesions and its Impact on Biopsy Decisions

Winkelmann, Richard R; Yoo, Jane; Tucker, Natalie; White, Richard; Rigel, Darrell S
OBJECTIVE: Risk prediction models for primary malignant melanoma thus far have relied on qualitative patient information. The authors propose a quantitative diagnostic predictive probability model using Multispectral Digital Skin Lesion Analysis for melanoma and other high-risk pigmented lesions and evaluate its effectiveness optimizing biopsy decisions by dermatologists. DESIGN: Data from 1,632 pigmented lesions analyzed by a Multispectral Digital Skin Lesion Analysis device were used to perform a logistic regression analysis. This new quantitative melanoma or melanoma/atypical melanocytic hyperplasia/high-grade dysplastic nevus probability model was then evaluated to determine its impact on dermatologist decisions to biopsy pigmented lesions clinically suggestive of melanoma. Participants were given an electronic keypad and answered "yes" or "no" if they would biopsy each of 12 pigmented lesions when presented first with patient history, clinical images, and dermoscopic images and again when subsequently shown Multispectral Digital Skin Lesion Analysis data. SETTING/PARTICIPANTS: Study of 191 dermatologists at a medical conference. MEASUREMENTS: Sensitivity, specificity, biopsy accuracy, overall biopsy rate, and percentage dermatologists biopsying all five melanomas. RESULTS: Dermatologists were significantly more sensitive, specific, and accurate while decreasing overall biopsy rates with Multispectral Digital Skin Lesion Analysis probability information. CONCLUSION: Integration of Multispectral Digital Skin Lesion Analysis probability information in the biopsy evaluation and selection process of pigmented lesions has the potential to improve melanoma sensitivity of dermatologists without the concomitant costs associated with additional biopsies being performed.
PMCID:4285445
PMID: 25584133
ISSN: 1941-2789
CID: 1436182

The incidence of nonmelanoma skin cancer: Can we make an impact?

Rigel, Darrell S
PMID: 24746589
ISSN: 0190-9622
CID: 923222

Understanding efficacy end-points in studies of field-directed therapy for actinic keratosis

Wolf, John E Jr; Rigel, Darrell S
BACKGROUND: The rates of short-term clearance of actinic keratoses appear to be comparable in clinical trials of topical treatments used in field therapy, but direct comparisons of efficacy results can be problematic. Trials use different efficacy end points, have different study designs, involve different anatomic sites, and enroll different patient populations. In addition, because adherence in real-world clinical practice differs from that observed in clinical trials, conclusions drawn from efficacy outcomes can be misleading. The objective of this review was to examine the efficacy end points used in studies of topical therapy for actinic keratosis, address other factors influencing efficacy outcomes in these studies, and discuss the possible influence of nonadherence on effectiveness. METHODS: Review of the available literature on topical therapy for actinic keratosis. RESULTS: The end points used to determine efficacy of therapies for actinic keratosis include a disparate group of outcomes, which can often make comparison between studies impossible. CONCLUSIONS: Efficacy end points of clinical studies designed to assess the treatment of actinic keratosis should be standardized to facilitate between-trial comparisons, and studies should focus on the end points that are most clinically relevant.
PMID: 23962263
ISSN: 0011-9059
CID: 503652

The importance of early diagnosis and treatment of actinic keratosis

Rigel, Darrell S; Stein Gold, Linda F
Chronic, long-term sun exposure results in genetic changes in epidermal keratinocytes and the development of various skin lesions ranging from actinic keratosis (AK) to skin cancer. AK lesions may first appear as rough, scaly spots on sun-exposed skin, and, although most individual AK lesions do not become invasive cancers, the majority of invasive squamous cell carcinomas originate from AK. Genetic analysis demonstrates that ultraviolet radiation-induced mutations and changes in gene expression are present in squamous cell carcinoma, AK, and clinically normal-appearing perilesional sun-exposed skin, which supports the progressive nature of keratinocyte transformation. The presence of certain clinical features, such as large size, ulceration, or bleeding, suggests an increased risk of disease progression. The risk is also increased by evidence of extensive solar damage, advanced age, and immunosuppression. Early diagnosis and consideration for treatment are indicated to clear actinically damaged sites and diminish the risk of invasive squamous cell carcinoma.
PMID: 23228303
ISSN: 0190-9622
CID: 203932

The positive impact of providing information from a computer-aided multispectral digital skin lesion analysis system on melanoma biopsy sensitivity [Meeting Abstract]

Rigel, Darrell; Cockerell, Clay; Yoo, Jane; Robinson, June; Roy, Mrinalini; White, Richard
ISI:000302319800587
ISSN: 0190-9622
CID: 2734092

High-SPF sunscreens (SPF >/= 70) may provide ultraviolet protection above minimal recommended levels by adequately compensating for lower sunscreen user application amounts

Ou-Yang, Hao; Stanfield, Joseph; Cole, Curtis; Appa, Yohini; Rigel, Darrell
BACKGROUND: The manner in which consumers apply sunscreens is often inadequate for ultraviolet protection according to the labeled sun protection factor (SPF). Although sunscreen SPFs are labeled by testing at an application density of 2 mg/cm(2), the actual protection received is often substantially less because of consumer application densities ranging from 0.5 to 1 mg/cm(2). High-SPF sunscreens may provide more adequate protection even when applied by consumers at inadequate amounts. OBJECTIVE: We sought to measure the actual SPF values of various sunscreens (labeled SPF 30-100) applied in amounts typical of those used by consumers. METHODS: Actual SPF values were measured on human volunteers for 6 sunscreen products with labeled SPF values ranging from 30 to 100, applied at 0.5, 1.0, 1.5, and 2.0 mg/cm(2). RESULTS: There was a linear relationship between application density and the actual SPF; sunscreens with labeled SPF values of 70 and above provided significant protection, even at the low application densities typically applied by consumers. Sunscreens labeled SPF 70 and 100 applied at 0.5 mg/cm(2) provided an actual SPF value of, respectively, 19 and 27. LIMITATIONS: The study was conducted in a laboratory setting under standardized conditions and results are extrapolated to actual in-use situations. CONCLUSION: Sunscreens with SPF 70 and above add additional clinical benefits when applied by consumers at typically used amounts, by delivering an actual SPF that meets the minimum SPF levels recommended for skin cancer and photodamage prevention. In contrast, sunscreens with SPF 30 or 50 may not produce sufficient protection at actual consumer usage levels.
PMID: 22463921
ISSN: 0190-9622
CID: 185552

Current and developing techniques to diagnose melanoma

Russak, Julie E; Rigel, Darrell S
PMID: 22800558
ISSN: 0733-8635
CID: 178183