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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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Evidence suggests that use of dermatoscopy for diagnosis of melanoma is superior to the current standard of care of unaided-eye examination alone for both primary care physicians and dermatologists who received appropriate training and who are experienced in using the technique. A review of available evidence demonstrates that diagnostic sensitivity and specificity increase when dermatoscopy is added to the examination for melanoma in both specialist dermatology and primary care practices. This leads to a reduction in the numbers of unnecessary biopsies/excisions performed and benefits patients, particularly those with multiple lesions.(Hayes 2007)

Total body or single lesion photography is unproven for detection of melanoma.

There is insufficient evidence from the available studies to conclude that either total body photography (also referred to as whole body photography) or photography of individual melanocytic skin lesions reduces the incidence of benign biopsies or improves the detection rate for melanoma. Although the data suggest that photography may prove to be a useful adjunct tool for surveillance of high-risk patients with multiple melanocytic nevi or for evaluation of individual lesions, these benefits remain to be established in large-scale, randomized controlled trials. In addition, appropriate patient selection criteria and protocols for reliable standardized image collection must be defined. Clinical evidence does not support the use of photography in place of excisional biopsy for lesions where there is suspicion of malignancy.

Additional Information:

Current literature states that physicians who are trained and experienced in the use of dermatoscopy along with unaided eye-examination for the detection of melanoma have superior outcomes over those that do not have this training. The training involves the use of an algorithm during examination. There are several currently accepted algorithms supported by recent literature.

Examples of algorithms that are used most often in clinical studies of dermoscopy would be The ABCD rule of dermoscopy, The Menzies Method, The Seven-Point Checklist, The Three-Point Checklist, Pattern Analysis and Seven features for melanoma (7FFM). (Hayes 2007).

Regulatory Requirements

U.S. Food and Drug Administration (FDA):

U.S. Food and Drug Administration (FDA): Dermatoscopy is a procedure and, as such, is not regulated by the FDA.

However, the devices used to perform the procedure are regulated by the FDA premarket approval process.

Visiomed AG received FDA 510(k) approval (K040171) for the MicroDERM® device on June 8, 2004. It is a digital dermoscope and software system that captures skin surface images for physician diagnostic and referral purposes. It consists of a camera, proprietary software, and a frame grabber card. The software runs on Microsoft's Windows 2000 operating system. (Accessed December 9, 2008. Last updated December 9, 2008) A listing of all devices in the same product classification as the MicroDERM (Product Code FSS) is available on the FDA Web site indicated below.

Dermatoscopy and Surveillance Photography for Detection of Melanoma - Commercial Medical Management Guideline FDA Approvals: Enter 510(k) number or Product Code FSS, KZF or KYT into the form at this site:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.

To date, the cameras used for photographic surveillance of melanoma have not been considered medical devices, and therefore are not subject to FDA regulation.

Research Evidence

Background:

Skin cancer is the most common of all cancers. Melanoma, which involves the pigment-producing melanocytes, is the most aggressive and lethal form of skin cancer. Melanoma can be cured if it is diagnosed and treated when the tumor is thin and has not invaded the skin deeply. However, if a melanoma is not excised at its early stages, cancer cells may infiltrate the skin surface, invading healthy tissue below. Surgery to remove a melanoma is the standard treatment for this disease.

The major clinical criteria used for diagnosing a cutaneous malignant melanoma are defined by the ABCDE rule, which evaluates asymmetry, irregular borders, multiple colors, diameter greater than 6 mm, and enlarging lesion. While the majority of pigmented skin lesions can be diagnosed on the basis of these clinical criteria, there remain a considerably high number of small lesions in which the distinction between benign and malignant is difficult with the unaided eye. The early phase of malignant melanoma can be particularly difficult to identify because cutaneous malignant melanomas can share many clinical features with an atypical nevus. Several studies have described diagnostic accuracy rates for visual inspection ranging from 50% to 75%, suggesting that more accurate diagnostic tools are needed. (Lorentzen et al., 1999;

Kittler et al., 2000; Binder et al., 1999) Dermatoscopy, or epiluminescence microscopy (ELM), has been introduced as an aid in the visual examination of pigmented skin lesions. A dermatoscope is a hand-held skin-surface microscope providing approximately 10 times magnification for in vivo examination of pigmented skin lesions. When immersion oil is applied to the skin and the lesion is illuminated with visible light, the corneal layer of the epidermis becomes translucent, making the different layers of the epidermis and the upper dermis visible. This allows detailed evaluation of the color and microstructures of the epidermis, the dermo-epidermal junction, and the papillary dermis, features that are not visible to the naked eye. An electric camera can be used to capture a color image and to separate it into red, green, and blue gray-level images, which can then be analyzed with a computer. It has been proposed that the identification of specific color and morphologic changes can aid in differentiating malignant from benign pigmented skin lesions, and therefore may improve the detection rate for malignant lesions and reduce the number of unnecessary biopsies. In addition, the newly developed digital dermatoscope uses an electronic camera to acquire images of lesions and therefore can store images in digital form. This may allow more accurate serial evaluation of lesions over time to identify impending or incipient malignancy. (Elbaum et al., 2001) Photographic surveillance of single lesions or the entire body has been employed to limit the number of unnecessary skin surgeries and to enhance the early detection of melanoma. The theory behind this technique is that images recorded digitally or on photographic film can facilitate detection of adverse changes in skin lesions, such as inflammation, growth, increased pigmentation, or development of satellites. Lesions showing evidence of malignancy can be further examined with skin surface microscopy before a final decision is made about the need for surgical excision and histological analysis.





Standardized protocols for photographic surveillance for melanoma lesions have not been established. Several photographic systems have been used, including single-lesion photography with a Polaroid instant camera and total-body photography with 17, 24, 36, or 85 35-mm photographs. More recently, digital cameras have been used to take 36 images that are stored on a compact disc. Regardless of the photographic method used, the appearance of suspicious new lesions or development of adverse changes in preexisting lesions can be detected by comparing the current state of the lesion with the stored images. This comparison is usually performed by a dermatologist using visual inspection, although recently Dermatoscopy and Surveillance Photography for Detection of Melanoma - Commercial Medical Management Guideline developed software utilizes specific algorithms to allow computerized detection of new lesions or changes in existing lesions. Lesions are likely to be excised or biopsied if they have grown, developed satellites, or become inflamed or more pigmented.

Research:

Dermatoscopy:

Vestergaard et al. (2008) conducted a meta-analysis on prospective studies of consecutive patients, conducted in a clinical setting to evaluate the evidence for improved diagnostic accuracy when using dermoscopy in addition to naked eye examination for accurate clinical diagnosis of melanoma. Nine studies met the criteria and were included in the review.

According to the authors, the diagnostic odds ratio (DOR) was estimated to be 15.6 times higher for dermoscopy than for naked eye examination (95% confidence interval [CI] 2.9-83.7, p = 0.016. When two studies with extreme values of sensitivity and specificity were removed from the analysis, the DOR lowered to 9.0 (95% CI 1.5-54.6, p = 0.03). This meta-analysis suggests that dermoscopy may be more accurate that naked eye examination for the diagnosis of cutaneous melanoma in suspicious skin lesions when performed in a clinical setting.

A randomized controlled trial was performed to determine whether the use of dermatoscopy with standard clinical examination improves the accuracy of primary care physicians to triage lesions suggestive of skin cancer. Seventy-three providers were given a day training course in dermatoscopic evaluation and skin cancer detection and were randomly assigned to the dermatoscopy group or naked-eye examination group. The physicians evaluated 2,522 patients with skin lesions and the lesions were scored as benign or suggestive of skin cancer. The patients were then evaluated and scored by two expert dermatologists who were blinded as to which arm of the study the patients were part of. All lesions that the dermatologists thought were suggestive of skin cancer were excised and diagnosed histopathologically. Referral sensitivity, specificity, and positive and negative predictive values were 54.1%, 71.3%, 11.3%, and 95.8% respectively in the naked-eye group, and 79.2%, 71.8%, 16.1%, and 98.1% respectively in the dermatoscopy group. Histopathologic examination of equivocal lesions demonstrated 23 malignant lesions missed by naked-eye examination and 6 by dermatoscopy. The investigators concluded that dermatoscopy improves the ability of primary care physicians to triage lesions suggestive of skin cancer. (Argenziano et al., 2006) Carli et al. (2004a) conducted a randomized controlled trial of 913 patients with pigmented lesions who were randomized to combined examination (naked-eye and dermatoscopy) with mandatory excision of equivocal lesions or to conventional naked-eye examination for melanoma with mandatory excision of equivocal lesions. Combined examination demonstrated a significant reduction in the number of patients referred for operation (9.0% versus 15.6%).

A case series of 3053 melanocytic lesions was conducted to evaluate the impact of routine dermoscopy use on the malignant/benign ratio in excised melanocytic lesions. The investigators found that the adoption of dermatoscopy in routine melanoma screening is followed by improvement in terms of malignant/benign ratio. Dermatoscopy users were more likely to diagnose melanoma within a series of excised lesions than nonusers. (Carli et al., 2004b) A large case series of 27,885 pigmented skin lesions from 10,974 patients was conducted to evaluate the sensitivity, specificity, and accuracy of epiluminescence microscopy (ELM) in identifying melanocytic from non-melanocytic lesions and in diagnosing melanomas. The lesions were considered suspicious based on the patient's history and clinical parameters. Of these lesions, 2.64% were surgically removed and follow-up examinations were scheduled for the other lesions. ELM showed an accuracy of 98.76% in distinguishing melanocytic from non-melanocytic lesions and demonstrated a sensitivity of 92.6%, a specificity of 98.1%, and an accuracy of 84.8% in identifying melanomas from other non-melanoma lesions. The investigators concluded that it is possible to reduce the risk of false-negative diagnoses by combining the clinical and dermatoscopic examinations. (Broganelli et al., 2005).

Barzegari et al. (2005) conducted a study in which 122 pigmented skin lesions were examined by the naked eye and computer-aided dermatoscopy. All lesions were excised and histologically examined. The investigators determined that Dermatoscopy and Surveillance Photography for Detection of Melanoma - Commercial Medical Management Guideline the diagnostic accuracy of the dermatoscopy system was similar to clinical examination by dermatologists with naked eyes.

A total of 520 pigmented skin lesions were evaluated in a study using a video microscope. Clinical diagnosis and dermatoscopy performance in identifying histologic features were compared on 79 surgically excised lesions. Overall agreement for dermatoscopy was 82.3%, and overall agreement for the clinical examination was 58.2%. Dermatoscopy sensitivity in detecting melanoma was 91.6% and specificity was 98.2%. The sensitivity and specificity for clinical examination was 66.6% and 94.5%, respectively. The investigators concluded that dermatoscopy is beneficial for diagnosing melanoma and determining which lesions need surgical excision. (Viglizzo and Rongioletti, 2004) A retrospective study evaluated 325 cases of melanoma that were initially missed by dermatoscopy. All lesions were excised because of changes over time. The investigators concluded the dermatoscopy is limited in the diagnosis of early and featureless melanomas. (Skvara et al., 2005) Bono et al. (2006) conducted a study of 206 pigmented skin lesions with a maximum diameter of 3 mm. Lesions were examined clinically and by dermatoscopic evaluation prior to surgery. Diagnostic sensitivity was 43% and specificity was 91% for clinical evaluation. Dermatoscopy produced a sensitivity of 83% and a specificity of 69%.



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