Match the primary skin lesion to its relevant description
Description Show For individuals who have pigmented lesions being evaluated for melanoma who receive MSDSLA, the evidence includes 2 prospective diagnostic accuracy studies of MelaFind, a retrospective analysis of MelaFind in a clinical setting, and additional studies of other MSDSLA devices. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, other test performance measures, and change in disease status. The diagnostic accuracy study found that MSDSLA had a sensitivity of 98.2% for recommending biopsy of melanoma lesions (8% of the pigmented lesions were melanoma). The average specificity of MSDSLA was 9.5% compared with 3.7% among clinicians. However, the study only included lesions already determined by a clinician to be sufficiently suspicious to warrant excision. No prospective studies conducted in a clinical setting have evaluated the utility of MSDSLA as a diagnostic tool in the initial evaluation of pigmented lesions. In addition, given the absence of firm evidence about the clinical validity of MSDSLA, a chain of evidence cannot be built to support conclusions about the magnitude of benefits and harms of MSDSLA use in practice. The manufacturer discontinued support and commercialization of the MelaFind device in 2017. The evidence is insufficient to determine the effects of the technology on health outcomes. Background Differentiating melanoma lesions from benign pigmented lesions in the clinical setting is challenging. Diagnostic aids such as the ABCDE rule have been developed to assist clinicians when they visually inspect suspicious lesions. The diagnostic accuracy of the ABCDE criteria varies depending on whether they are used singly or together. Use of a single criterion is sensitive but not specific, which would result in many benign lesions being referred or biopsied. Conversely, use of all criteria together is specific but not sensitive, meaning that a number of melanomas are missed. There is interest in noninvasive approaches that will improve the diagnosis of malignant skin lesions. One technique is dermatoscopy (also called dermoscopy), which enables the clinician to perform direct microscopic examination of diagnostic features in pigmented skin lesions. Devices consist of a 10+ magnifier lens in combination with a liquid medium or polarized light to eliminate reflection and allow for more-detailed examination of suspicious skin lesions. The available evidence from prospective randomized controlled trials and other studies has suggested that dermatoscopy used by specialists may lead to a decrease in the number of benign lesions excised and, when used by primary care physicians, may lead to fewer benign lesions being referred to specialists. Another technology that could improve melanoma detection and outcomes is multispectral digital skin lesion analysis (MSDSLA). A U.S. Food and Drug Administration (FDA)‒approved MSDSLA device uses a handheld scanner to shine visible light on the suspicious lesion. The light is of 10 wavelengths, varying from blue (430 nm) and near infrared (950 nm). This light can penetrate up to 2.5 mm under the surface of the skin. The data acquired by the scanner are analyzed by a data processor; the characteristics of each lesion are evaluated using proprietary computer algorithms. Lesions are classified as positive (i.e., high degree of morphologic disorganization) or negative (i.e., low degree of morphologic disorganization) according to the algorithms. Positive lesions are recommended for biopsy. For negative lesions, other clinical factors are considered in the decision of whether to refer for biopsy. The FDA-approved system (see the Regulatory Status section) is intended only for suspicious pigmented lesions on intact skin and for use by trained dermatologists. Regulatory Status "MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e., not for use on nonpigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent with previous trauma, lesions where the skin is intact (i.e., nonulcerated or nonbleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter and lesions not on special anatomic sites (i.e., not for use on acral, palmar, plantar, mucosal or subungual areas)." FDA product code: OYD. Policy
Policy Guidelines 0400T Multi-spectral digital skin lesion analysis of clinically atypical cutaneous pigmented lesions for detection of melanomas and high risk melanocytic
atypia; one to five lesions Benefit Application Rationale Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition. The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources. This review addresses the use of MSDSLA for the evaluation of pigmented lesions suspicious for malignancy. No published evidence was identified on the use of MSDSLA for monitoring skin lesions or for evaluating cancerous lesions referred for surgery. The following is a summary of the key literature to date. MSDSLA FOR EVALUATING PIGMENTED SKIN LESIONS Several algorithms have been developed to identify skin lesions that should be referred for biopsy based on dermoscopy.4,5,6 The question addressed in this evidence review is: Does using MSDSLA improve the net health outcome in individuals with pigmented skin lesions? The following PICOTS were used to select literature to inform this review. Patients Interventions Comparators Outcomes True positive tests results could lead to a correct biopsy of malignant lesions. True negative tests would potentially reduce unnecessary biopsies. No direct harms of the device are expected. False-positive test results could lead to unnecessary increased screening or biopsy. False-negative test results could lead to delays in diagnosis, which could allow the condition to worsen before treatment. Timing Setting Technical Reliability Clinically Valid Most published studies to date on MSDSLA have been industry-sponsored and/or coauthored by employees of or consultants for MELA Sciences (manufacturer of MelaFind). A study published by Monheit et al. (2011) contained the data submitted to the FDA for approval of the MelaFind device.12 This prospective study included patients with at least 1 pigmented lesion scheduled for first-time biopsy. Lesions were between 2 mm and 22 mm in diameter. The following were exclusion criteria: anatomic site was not accessible to the device; lesion was not intact (eg, open sores, ulcers, bleeding); lesion was on a palmar, plantar, or mucosal surface or under nails; lesion was in an area of visible scarring; and the lesion contained tattoo ink, splinter, or other foreign matter. In addition, lesions with a prebiopsy diagnosis of melanoma were excluded from analysis. Histologic diagnosis was used as the reference standard. A total of 1,393 patients with 1,831 lesions were enrolled at major academic centers. Of the 1,831 lesions, 1,632 (90%) were eligible and evaluable. There were 165 lesions not evaluable for various reasons, including operator error, camera malfunction, and ineligibility after enrollment related to scarring. Histologic analysis determined that 127 (7.8%) of 1,632 lesions were melanoma. The sensitivity of MSDSLA for recommending biopsy of the melanoma lesions was 98.2% (125/127 melanomas), with a 95% lower CI bound of 95.6%. The average specificity (averaged over clinicians) of MSDSLA for melanoma was 9.5%. The accuracy of clinician diagnosis was determined by randomly selecting 25 melanoma cases and matching them with 25 nonmelanoma lesions. Clinicians were asked to classify lesions into 2 categories of melanoma: cannot rule out melanoma or not melanoma. The specificity of clinician diagnosis, as determined by the proportion of melanomas among the total number of lesions recommended for biopsy, was 3.7%, which was significantly lower than the specificity for MSDSLA (p=0.02). The Monheit study only included lesions previously examined clinically and determined to be sufficiently suspicious to warrant biopsy. The study did not include patients initially presenting with pigmented lesions to see whether MelaFind could enhance the accuracy of diagnosis based on clinical examination findings alone. In 2016, Winkelmann et al. reported on further analysis of the same 1,632 lesions; the reviewers sought to correlate MSDSLA classifier scores with histopathologic severity and clinical features of melanoma.13 Mean classifier scores were higher for melanomas (3.5) than for high-grade lesions (2.7; p=0.002), low-grade dysplastic nevi (7.1; p<0.001), nondysplastic nevi (1.6; p<0.001), and benign non-melanocytic lesions (2.0; p<0.001). In 2015, Winkelmann et al. also reported on the diagnostic accuracy of MelaFind for evaluating suspicious lesions obtained from patients undergoing routine skin examination in a community practice.14 Dermatologists identified suspicious lesions and selected them for biopsy. Prior to biopsy, the lesions were imaged with MelaFind (all met the FDA-approved indication for use of the device). (The study protocol did not involve reevaluation of images using MSDSLA findings.) Lesions were then biopsied and the diagnostic accuracy of MSDSLA for these lesions was determined and compared with histopathologic analysis of samples. A total of 137 consecutive lesions scheduled for biopsy were included in the study. MSDSLA categorized 21 of these lesions as having “low disorganization” (negative MSDSLA finding). All 21 lesions were histologically benign (11 mildly dysplastic nevi, 9 seborrheic keratosis, 1 compound nevus). The remaining 116 lesions were categorized by MSDSLA as having high disorganization (positive MSDSLA finding). Ninety-nine (85%) of these lesions were considered to be “true positives” (ie, malignant melanoma, lesions with atypical melanocytic proliferation, moderately and severely dysplastic nevi). The study population included only 1 true melanoma, and this was categorized by MSDSLA as having high disorganization. Advantages of this study were its prospective design and practice setting; however, as with the Monheit study, it did not evaluate the ability of MSDSLA to enhance the accuracy of biopsy decisions. In 2016, Song et al. reported on a smaller study comparing the diagnostic accuracy of MSDSLA with reflectance confocal microscopy in the prebiopsy detection of melanoma in 55 atypical-appearing lesions from 36 patients undergoing biopsy.15 MSDSLA was performed with MelaFind and reflectance confocal microscopy was performed with VivaScope (MAVIG GmbH, Munich, Germany), by separate evaluators who were blinded to others’ evaluations; reflectance confocal microscopy was more sensitive than MSDSLA (p=0.001). For the diagnosis of melanoma, MSDSLA had a sensitivity of 71.4%. Fink et al. (2017) reported the performance of MelaFind in a clinical setting.16 The study included retrospective analysis of 360 pigmented lesions with one or more clinical or historical characteristics of melanoma but for which there were not unequivocal features of melanoma (i.e., “atypical pigmented skin lesion”). The lesions were from 111 patients evaluated by office-based dermatologists. Surgical excision decisions were made by the examining dermatologists using MelaFind results and other clinical information; a description of the other information used was not provided. Of the 360 pigmented skin lesions, 147 (41%) were graded as a MelaFind score of 2 or more (ie, suspicious for malignancy); 14 of these were excluded because they were biopsied elsewhere, and 26 were not excised at the physician’s discretion; 107 lesions with MelaFind score of 2 or more were excised (86 patients), and an additional six with a MelaFind score less than 2 were excised. Among excised lesions, the sensitivity and specificity of a MelaFind score of 2 or more were 100% and 5.5%, respectively, and the positive and negative predictive values were 2.8% and 100%, respectively; CIs were not given. Assuming the lesions with a MelaFind score less than 2 that were not biopsied were negative, the specificity would be 68.5%, although the follow-up was insufficient to confirm that the lesions were actually benign. Other studies have reported on the clinical performance of image-based classifiers other than MelaFind. In 2015, Ferris et al. reported on the training and validation of a novel classifier.17 The classifier was trained on a malignant test set (105 melanomas, 29 high-grade dysplastic nevi, 23 basal cell carcinomas, 3 squamous cell carcinomas) and a benign training set (93 benign melanocytic lesions, 20 other benign lesions). In receiver operating characteristic curve analysis, with a threshold severity score of 0.4, the area under the curve was 0.818. The classifier’s performance was evaluated in a test set containing 39 melanomas, 11 basal cell carcinomas, 3 squamous cell carcinomas, and 120 benign lesions, all with available biopsy results, and 27 lesions considered not appropriate for biopsy by 2 dermatologists. The classifier’s sensitivity for melanoma was 97.4% (95% CI, 86.5% to 99.9%). Among the 120 benign lesions, 53 were correctly classified as benign (specificity, 44.2%; 95% CI, 35.1% to 53.5%); among the 27 unbiopsied lesions, 20 were classified as benign (specificity, 74.1%; 95% CI, 53.7% to 88.9%). Section Summary: Clinically Valid Clinically Useful Indirect evidence of clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility. One randomized controlled trial has been published; however, it was conducted over the Internet rather than in a clinical setting and involved retrospective analysis of lesions. The trial was published by Hauschild et al. (2014) in Germany.18 It included 215 board-certified dermatologists selected on a first-come basis after receiving invitations to participate. Each participant was presented with information on 130 pigmented lesions; 93% had been biopsied in a prior study. Half the lesions were melanomas and half were nonmelanomas. (The lesions were a subset of evaluable lesions from the Monheit trial (previously described).12 All lesions met the FDA’s indications for MelaFind. Study participants were randomized to review clinical examination information and high-quality digital images only (n=108) or clinical information, high-quality digital images, and the MSDSLA results (n=107). After reviewing each case, participants completed a survey about their lesion management decision (e.g., recommendation for biopsy). A decision was considered correct if melanoma lesions were recommended for biopsy or if non- melanoma lesions were not recommended for biopsy. Before examining the cases, participants were shown an online slide presentation about MelaFind, including the devices performance data. Among dermatologists in the arm without MSDSLA findings, the sensitivity and specificity of biopsy were 69.5% (95% CI, 64.3% to 76.0%) and 55.9% (47.3% to 60.5%), respectively. In the arm with MSDSLA findings, the sensitivity and specificity were 78.0% (95% CI, 73.9% to 83.5%) and 45.8% (38.1 to 50.8%), respectively. Differences in sensitivity and specificity between arms were statistically significant (p<0.001). Some nonrandomized studies have evaluated whether the use of MSDSLA would hypothetically lead to management changes.19,20 These studies were not conducted in clinical settings, and it is unclear whether the selection of lesion types and study participants (dermatologists) were representative of actual practice. Several industry-sponsored simulation exercises have also been conducted at professional conferences. For example, Winkelman et al. (2015) reported on 60 health care providers, 30 of whom were dermatologists, who participated in an exercise at a national dermoscopy conference.21 Participants were shown images of 12 lesions previously analyzed by MSDSLA using the MelaFind device. They were asked 3 times whether they would biopsy the lesion: (1) based on clinical images alone; (2) with the addition of high-resolution dermoscopic images; and (3) with the addition of MSDSLA classifier scores. The 12 lesions consisted of 2 melanomas in situ, 3 invasive melanomas, and 7 low-grade dysplastic nevi. Diagnostic accuracy did not increase after being shown dermatoscopic images, but it did increase after getting MSDSLA scores. The proportion of dermatologists responding that they would biopsy all 5 malignant melanomas was 4% with clinical images alone, 10% after dermatoscopy, and 72% after MSDSLA. Proportions among nondermatologists were 13%, 6%, and 78%, respectively. Conversely, among dermatologists, the proportion of low-grade dysplastic nevi recommended for biopsy was 53% with clinical images alone, 60% after dermatoscopy, and 42% after MSDSLA. Among dermatologists, proportions were 53%, 66%, and 45%, respectively. The changes in biopsy recommendations after MSDSLA were statistically significant in all cases. Other studies conducted at conferences that used similar methodology had comparable results; biopsy decision accuracy increased significantly after clinicians were provided with MSDSLA findings.22-24 Without health outcome data, studies of how physicians use medical tests, or how they may change behavior based on medical tests, do not provide significant additional data to inform clinical utility. Section Summary: Clinically Useful SUMMARY OF EVIDENCE PRACTICE GUIDELINES AND POSITION STATEMENTS National Institute for Health and Care Excellence U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS ONGOING AND UNPUBLISHED CLINICAL
TRIALS Table 1. Summary of Key Trials
NCT: national clinical trial. References
Coding Section
Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines. "Current Procedural Terminology© American Medical Association. All Rights Reserved." History From 2016 Forward
What are the primary lesions of the skin?Primary lesions, which are associated with specific causes on previously unaltered skin, occur as initial reactions to the internal or external environment. Vesicles, bullae, and pustules are formed by fluid within skin layers. Nodules, tumors, papules, wheals, and plaques are palpable, elevated, solid masses.
What are the 10 primary lesions?Learn the 10 primary skin lesions, which include macule, papule, nodule, plaque, tumor, vesicle, pustule, bulla, wheal, and burrow. Skin lesions are relatively common and frequently arise due to localized skin injury. Primary skin lesions are color or texture alterations that occur at birth or develop over time.
What are the 5 types of skin lesions?What are the different types of primary skin lesions?. Blisters. Blisters are skin lesions filled with a clear fluid. ... . Macules. Macules are small spots that are typically brown, red, or white. ... . Nodules. ... . Papules. ... . Pustules. ... . Rashes. ... . Wheals.. What are the 3 types of skin lesions?Primary skin lesions tend to be divided into three groups: Lesions formed by fluid within the skin layers: Examples include vesicles and pustules. Lesions that are solid masses: Examples include nodules and tumors. Flat lesions: Examples include patches and macules.
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