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Pigmented Skin Lesion Biopsies After Computer-Aided Multispectral Digital Skin Lesion Analysis

Winkelmann, Richard R; Tucker, Natalie; White, Richard; Rigel, Darrell S
BACKGROUND: The incidence of melanoma has been rising over the past century. With 37% of patients presenting to their primary care physician with at least 1 skin problem, primary care physicians and other nondermatologist practitioners have substantial opportunity to make an impact at the forefront of the disease process. New diagnostic aids have been developed to augment physician analysis of suspicious pigmented skin lesions (PSLs). OBJECTIVE: To determine the effects of computer-aided multispectral digital skin lesion analysis (MSDSLA) on dermatologists' and nondermatologist clinicians' decisions to biopsy suspicious PSLs after clinical and dermatoscopic evaluation. METHODS: Participants were shown 6 images of PSLs. For each PSL, participants were asked 3 times if they would biopsy the lesion: first after reviewing a clinical image of the PSL, again after reviewing a high-resolution dermatoscopic image, and again after reviewing MSDSLA probability findings. An answer was right if a melanoma or high-risk lesion was selected for biopsy or a low-risk lesion was not selected for biopsy. An answer was wrong if a melanoma or high-risk lesion was not selected for biopsy or a low-risk lesion was selected for biopsy. Clinicians' decisions to biopsy were evaluated using chi(2) analysis for proportions. RESULTS: Data were analyzed from a total of 212 participants, 177 of whom were dermatologists. Overall, sensitivity of clinical image review was 63%; dermatoscopic image review, 5%; and MSDSLA, 83%. Specificity of clinical image review was 59%; dermatoscopic image review, 40%; and MSDSLA, 76%. Biopsy decision accuracy was 61% after review of clinical images, 52% after review of dermatoscopic images, and 80% after review of MSDSLA findings. The number of lesions participants indicated that they would biopsy increased significantly, from 52% after reviewing clinical images to 63% after reviewing dermatoscopic images (P<.001). However, the overall number of specimens that participants indicated they would biopsy did not change significantly after they reviewed MSDSLA findings (53%). CONCLUSION: Sensitivity, specificity, and biopsy decision accuracy increased after clinicians reviewed MSDSLA findings. The use of objective, computer-based diagnostic aids such as MSDSLA during clinical evaluations of ambiguous PSLs could aid clinicians' decisions to biopsy such lesions.
PMID: 26501759
ISSN: 1945-1997
CID: 2039272

The Impact of Multispectral Digital Skin Lesion Analysis on German Dermatologist Decisions to Biopsy Atypical Pigmented Lesions with Clinical Characteristics of Melanoma

Winkelmann, Richard R; Hauschild, Axel; Tucker, Natalie; White, Richard; Rigel, Darrell S
OBJECTIVE: To determine the impact of multispectral digital skin lesion analysis on German dermatologist biopsy decisions of atypical pigmented skin lesions. DESIGN: Participants were shown high-resolution clinical images of 12 atypical pigmented skin lesions previously analyzed by multispectral digital skin lesion analysis. Participants were asked if they would biopsy the lesion based on clinical images and high-resolution dermoscopy images and again when subsequently shown multispectral digital skin lesion analysis probability information. SETTING/PARTICIPANTS: Forty-one dermatologists at a skin cancer conference in Germany in September 2014. MEASUREMENTS: Sensitivity, specificity, diagnostic accuracy, percent biopsying all melanomas, and overall biopsy rates. RESULTS: Sensitivity for the detection of melanoma following clinical evaluation was 64 percent. After receipt of multispectral digital skin lesion analysis probability information, sensitivity decreased nonsignificantly to 62 percent. Specificity with clinical evaluation was 57 percent and increased to 73 percent using multispectral digital skin lesion analysis. Overall biopsy accuracy increased from 60 percent with clinical evaluation to 68 percent with multispectral digital skin lesion analysis. The percentage of low-grade dysplastic nevi chosen for biopsy decreased from 43 percent after clinical evaluation to 27 percent with multispectral digital skin lesion analysis. Finally, the overall percentage of lesions biopsied decreased from 52 percent with clinical evaluation to 42 percent after multispectral digital skin lesion analysis. CONCLUSION: Multispectral digital skin lesion analysis can be used reliably to detect melanoma as well as clinical evaluation. Dermatologists can confidently use multispectral digital skin lesion analysis to significantly improve specificity and reduce their overall number of biopsies while increasing overall diagnostic accuracy.
PMCID:4633209
PMID: 26557216
ISSN: 1941-2789
CID: 1834582

Impact of Guidance Provided by a Multispectral Digital Skin Lesion Analysis Device Following Dermoscopy on Decisions to Biopsy Atypical Melanocytic Lesions

Winkelmann, Richard R; Yoo, Jane; Tucker, Natalie; White, Richard; Rigel, Darrell S
OBJECTIVE: To determine how a multispectral digital skin lesion analysis (MSDSLA) device data affects the biopsy performance of dermatologists and non-dermatologist practitioners following clinical and dermoscopic pigmented lesion evaluation. DESIGN: MSDSLA employs near infrared light to image and analyze pigmented skin lesions. MSDSLA generates a "classifier score" based on morphological disorganization. Using a logistical regression model, 1) a probability of being melanoma and, 2) a probability of being melanoma, atypical melanocytic hyperplasia, or a high grade dysplastic nevus is computed. PARTICIPANTS were shown clinical images of 12 lesions (2 melanomas in situ, 3 invasive melanomas, and 7 low grade DNs). They were asked first if they would biopsy the lesion based on clinical images, again after observing dermoscopy images, and once more when presented with MSDSLA probability information. SETTING: National dermoscopy conference. PARTICIPANTS: Sixty-four healthcare providers; 30 dermatologists and 34 non-dermatologist practitioners. MEASUREMENTS: Sensitivity, specificity, diagnostic accuracy, biopsy rates Results: For the 30 dermatologists, sensitivity was 65 percent after clinical evaluation (C) and 65% post-dermoscopy (D) but improved to 91% after MSDSLA. For the 34 non-dermatologist practitioners, sensitivity improved from 66 percent (C) to 70 percent (D) to 95 percent after MSDSLA. With MSDSLA information, dermatologist specificity increased from 40 percent (D) to 58 percent while non-dermatologist practitioners specificity increased from 34 percent (D) to 55 percent. Diagnostic accuracy of malignant and benign lesions decreased for both groups 55 percent (C) to 51 percent (D) for dermatologists and 54 percent (C) to 49 percent (D) for non-dermatologist practitioners. However, diagnostic accuracy increased to 72 percent for dermatologists and 72 percent for non-dermatologist practitioners with MSDSLA data. Non-melanoma biopsy percentages by dermatologists increased from 53 percent (C) to 60 percent (D), but decreased to 42 percent when provided with MSDSLA data. Similarly, non-dermatologist practitioners' biopsy percentages of nonmelanomas increased from 55 percent (C) to 66 percent (D) and decreased to 45 percent with MSDSLA. CONCLUSION: Decisions to biopsy atypical melanocytic lesions were more sensitive and specific when MSDSLA information was provided for both dermatologists and nondermatologist practitioners. Both groups were also less likely to biopsy nonmelanomas after MSDSLA evaluation. The authors' results suggest providing practitioners with MSDSLA data leads to improved biopsy accuracy decreasing the number of nonessential biopsies for nonmelanocytic lesions even after dermoscopic evaluation.
PMCID:4587891
PMID: 26430487
ISSN: 1941-2789
CID: 1790032

Response to CME article "Screening, early detection, education, and trends for melanoma: Current status (2007-2013) and future directions. Part I. Epidemiology, high-risk groups, clinical strategies, and diagnostic technology" [Letter]

Winkelmann, Richard R; Rigel, Darrell S
PMID: 25773423
ISSN: 0190-9622
CID: 1505862

Polypodium leucotomos extract: a status report on clinical efficacy and safety

Winkelmann, Richard R; Del Rosso, James; Rigel, Darrell S
Various extracts of polypodium leucotomos (PLE) applied topically or taken orally have been shown to have several beneficial antioxidant, photoprotectant, antimutagenic, and immunoregulatory effects. Modern studies have evaluated the efficacy of PLE orally as a photoprotective agent and for use in several photo-aggravated dermatologic disorders such as polymorphous light eruption, other photodermatoses, and melasma. No articles have been published evaluating the safety of PLE. We performed a PUBMED search for any randomized clinical trials related to PLE, or anapsos, a synonym. The primary safety endpoint of the review was any mention of an adverse event, side effect, or toxicity. Overall, 19 human and 6 basic science studies were included spanning over 40 years of research. Oral PLE was administered at daily doses ranging from 120 mg to 1080 mg. No adverse effects were reported in laboratory studies. In humans, side effects (gastrointestinal complaints and pruritus) were mild to moderate and found only in very small numbers of patients overall (16/1016 [2%]). This review concludes PLE is well tolerated at all doses administered and associated with a negligible risk of side effects

J Drugs Dermatol. 2015;14(3):254-259.
PMID: 25738847
ISSN: 1545-9616
CID: 1480672

Negative predictive value of pigmented lesion evaluation by multispectral digital skin lesion analysis in a community practice setting

Winkelmann, Richard R; Rigel, Darrell S; Kollmann, Emily; Swenson, Nicole; Tucker, Natalie; Nestor, Mark S
OBJECTIVE: To determine if the high negative predictive value of a multispectral digital skin lesion analysis that has been previously found in an academic-based trial would be similar in a community-based setting with its expected different distribution of pigmented lesions. DESIGN: Data were collected from patients undergoing routine skin examinations over a one-year period at a community-based practice in Florida. All lesions that were selected for biopsy to rule out melanoma were also imaged with multispectral digital skin lesion analysis prior to biopsy. Histopathological diagnoses and multispectral digital skin lesion analysis results were reviewed and compared with findings from a prior primarily academic center-based multispectral digital skin lesion analysis trial. SETTING/PARTICIPANTS: Community-based clinical setting in Florida. MEASUREMENTS: Negative predictive value, sensitivity, and specificity. RESULTS: One hundred thirty-seven consecutive lesions were selected for biopsy and also analyzed via multispectral digital skin lesion analysis. All 21 cases with multispectral digital skin lesion analysis "Low Disorganization" readings were all histologically benign (100% negative predictive value, 95% lower confidence boundary = 96.9%). The negative predictive value and the sensitivity were not significantly different than what was found in the prior academic-based multispectral digital skin lesion analysis trial. Multispectral digital skin lesion analysis also correctly identified all high-risk lesions, which were subsequently confirmed via histology to be one invasive melanoma and 15 moderately dysplastic nevi (100% sensitivity). Specificity with multispectral digital skin lesion analysis was significantly higher than reported in the academic-based multispectral digital skin lesion analysis trial (18% vs. 10%, p=0.02). CONCLUSION: Because of the high negative predictive value achieved by multispectral digital skin lesion analysis, lesions with readings of "Low Disorganization" may be considered for observation versus biopsy. Similar to what was noted in the academic center setting, multispectral digital skin lesion analysis may help dermatologists reduce the number of unnecessary biopsies while improving diagnostic accuracy.
PMCID:4382141
PMID: 25852810
ISSN: 1941-2789
CID: 1528542

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

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

The impact of guidance provided by a multispectral digital skin lesion analysis (MSDSLA) device following dermatoscopy on dermatologist and nondermatologist decisions to biopsy atypical melanocytic lesions [Meeting Abstract]

Rigel, Darrell; Winkelmann, Richard; Tucker, Natalie; White, Richard
ISI:000360942901430
ISSN: 0190-9622
CID: 1788752

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