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Sticker Shock
A recent online study by Gerami et al in the Journal of the American Academy of Dermatology highlighted a new genomic method using messenger RNA to classify pigmented lesions as benign or malignant using a noninvasive adhesive patch developed by DermTech International. Patches were applied to the surface of pigmented lesions (42 melanomas; 22 nevi), vigorously rubbed, removed, frozen, and sent to the proprietary laboratory for RNA extraction and gene expression analysis. Then each lesion was excised for pathologic review. A 2-gene signature was discovered, including CMIP and LINC00518, differentiating melanoma from nevi with sensitivity of 97.6% and specificity of 72.7%.
What’s the issue?
Along with our evolving understanding and case-specific use of noninvasive modalities to diagnose difficult pigmented lesions, we add this test to the number of other tests and imaging approaches that seem perhaps too good to be true. A test that strips epithelial cells and involves no wound care but explores true gene differences likely sits better with us than surface microscopy, dermoscopy, and other imaging because, in this case, it provides a signature. A result. Similar to a pregnancy test, right? We wish. The diversity of pigmented lesions, especially the ones that stump us even on pathologic review, will likely prove too cryptic for 1 test to decode, but as these modalities evolve, their signatures will hopefully merge between researchers and industry to create a pigmented lesion map that we can all read. What noninvasive modalities do you use in your practices for pigmented lesions? How do you think this test will fit in?
A recent online study by Gerami et al in the Journal of the American Academy of Dermatology highlighted a new genomic method using messenger RNA to classify pigmented lesions as benign or malignant using a noninvasive adhesive patch developed by DermTech International. Patches were applied to the surface of pigmented lesions (42 melanomas; 22 nevi), vigorously rubbed, removed, frozen, and sent to the proprietary laboratory for RNA extraction and gene expression analysis. Then each lesion was excised for pathologic review. A 2-gene signature was discovered, including CMIP and LINC00518, differentiating melanoma from nevi with sensitivity of 97.6% and specificity of 72.7%.
What’s the issue?
Along with our evolving understanding and case-specific use of noninvasive modalities to diagnose difficult pigmented lesions, we add this test to the number of other tests and imaging approaches that seem perhaps too good to be true. A test that strips epithelial cells and involves no wound care but explores true gene differences likely sits better with us than surface microscopy, dermoscopy, and other imaging because, in this case, it provides a signature. A result. Similar to a pregnancy test, right? We wish. The diversity of pigmented lesions, especially the ones that stump us even on pathologic review, will likely prove too cryptic for 1 test to decode, but as these modalities evolve, their signatures will hopefully merge between researchers and industry to create a pigmented lesion map that we can all read. What noninvasive modalities do you use in your practices for pigmented lesions? How do you think this test will fit in?
A recent online study by Gerami et al in the Journal of the American Academy of Dermatology highlighted a new genomic method using messenger RNA to classify pigmented lesions as benign or malignant using a noninvasive adhesive patch developed by DermTech International. Patches were applied to the surface of pigmented lesions (42 melanomas; 22 nevi), vigorously rubbed, removed, frozen, and sent to the proprietary laboratory for RNA extraction and gene expression analysis. Then each lesion was excised for pathologic review. A 2-gene signature was discovered, including CMIP and LINC00518, differentiating melanoma from nevi with sensitivity of 97.6% and specificity of 72.7%.
What’s the issue?
Along with our evolving understanding and case-specific use of noninvasive modalities to diagnose difficult pigmented lesions, we add this test to the number of other tests and imaging approaches that seem perhaps too good to be true. A test that strips epithelial cells and involves no wound care but explores true gene differences likely sits better with us than surface microscopy, dermoscopy, and other imaging because, in this case, it provides a signature. A result. Similar to a pregnancy test, right? We wish. The diversity of pigmented lesions, especially the ones that stump us even on pathologic review, will likely prove too cryptic for 1 test to decode, but as these modalities evolve, their signatures will hopefully merge between researchers and industry to create a pigmented lesion map that we can all read. What noninvasive modalities do you use in your practices for pigmented lesions? How do you think this test will fit in?
Red Is Wrong; In the Red Also Is Wrong
A recent study in the Journal of Drugs in Dermatology (2014;13:56-61) featured long-term data regarding use of brimonidine gel, which was approved by the US Food and Drug Administration last year as the only topical agent on the market to treat erythema associated with rosacea. Compared to the initial safety and efficacy in phase 2 and 3 trials with 4-week use, this study spanned 12 months and assessed the erythema and adverse events associated with the drug. The decrease in erythema with once-daily application was observed after first use and was durable until the end of the study with no tachyphylaxis. The side-effect profile was mild and included flushing and irritancy events that typically improved over time.
What’s the issue?
The manufacturers of this new product tout that “Red is Wrong” (http://www.rediswrong.com). Although this strong statement virtually forces people to sprint to the Web site to see how they could improve their facial erythema and my patients have reported quite favorably on its efficacy and tolerability, obtaining the medication has been problematic. Similar to many of the coupon cards and assistance provided by pharmaceutical companies, the true segment of the population for which they serve is more limited than it appears, as health insurance plans with prescription deductibles, Medicare, Medicaid (and any spin-offs of the sort in the last few months involving US health care cost-management gymnastics) typically are excluded from discounts, and the out-of-pocket cost can be well over $200 per month. In an era when we have heroically developed a new and effective drug for a common and problematic indication, how will we practically provide it to the masses?
A recent study in the Journal of Drugs in Dermatology (2014;13:56-61) featured long-term data regarding use of brimonidine gel, which was approved by the US Food and Drug Administration last year as the only topical agent on the market to treat erythema associated with rosacea. Compared to the initial safety and efficacy in phase 2 and 3 trials with 4-week use, this study spanned 12 months and assessed the erythema and adverse events associated with the drug. The decrease in erythema with once-daily application was observed after first use and was durable until the end of the study with no tachyphylaxis. The side-effect profile was mild and included flushing and irritancy events that typically improved over time.
What’s the issue?
The manufacturers of this new product tout that “Red is Wrong” (http://www.rediswrong.com). Although this strong statement virtually forces people to sprint to the Web site to see how they could improve their facial erythema and my patients have reported quite favorably on its efficacy and tolerability, obtaining the medication has been problematic. Similar to many of the coupon cards and assistance provided by pharmaceutical companies, the true segment of the population for which they serve is more limited than it appears, as health insurance plans with prescription deductibles, Medicare, Medicaid (and any spin-offs of the sort in the last few months involving US health care cost-management gymnastics) typically are excluded from discounts, and the out-of-pocket cost can be well over $200 per month. In an era when we have heroically developed a new and effective drug for a common and problematic indication, how will we practically provide it to the masses?
A recent study in the Journal of Drugs in Dermatology (2014;13:56-61) featured long-term data regarding use of brimonidine gel, which was approved by the US Food and Drug Administration last year as the only topical agent on the market to treat erythema associated with rosacea. Compared to the initial safety and efficacy in phase 2 and 3 trials with 4-week use, this study spanned 12 months and assessed the erythema and adverse events associated with the drug. The decrease in erythema with once-daily application was observed after first use and was durable until the end of the study with no tachyphylaxis. The side-effect profile was mild and included flushing and irritancy events that typically improved over time.
What’s the issue?
The manufacturers of this new product tout that “Red is Wrong” (http://www.rediswrong.com). Although this strong statement virtually forces people to sprint to the Web site to see how they could improve their facial erythema and my patients have reported quite favorably on its efficacy and tolerability, obtaining the medication has been problematic. Similar to many of the coupon cards and assistance provided by pharmaceutical companies, the true segment of the population for which they serve is more limited than it appears, as health insurance plans with prescription deductibles, Medicare, Medicaid (and any spin-offs of the sort in the last few months involving US health care cost-management gymnastics) typically are excluded from discounts, and the out-of-pocket cost can be well over $200 per month. In an era when we have heroically developed a new and effective drug for a common and problematic indication, how will we practically provide it to the masses?
Sorting Out Supplements
In December 2013, the Annals of Internal Medicine amassed 2 original research articles, 1 review, and 1 editorial analyzing and supporting the hypothesis that vitamin and mineral supplementation may not be beneficial for many facets of total health. One study assessed daily multivitamin efficacy in older adults for prevention of cognitive decline (Ann Intern Med. 2013;159:806-814); one evaluated high-dosage daily multivitamin in myocardial infarction patients for prevention of repeated cardiovascular events (Ann Intern Med. 2013;159:797-805); and the systematic review reported all-cause mortality, cardiovascular disease, and cancer in multivitamin users (Ann Intern Med. 2013;159:824-834). All 3 concluded that there was no significant benefit, and the editorial asked that we close the book on this question (Ann Intern Med. 2013;159:850-851).
What’s the issue?
In dermatology, patients often inquire about supplements, dietary changes, and natural methods for aiding in their recovery and for preventing disease. This set of publications attempts to steer us to summarily discourage widespread multivitamin and supplement use. However, there are certainly instances in which dogma from medical school training, smaller patient cohorts, and anecdotal cases compel us to continue them. The first things to come to mind in dermatology (and beyond) are biotin for hair and nail growth, folic acid for preconception and pregnancy prevention of fetal neural defects, and vitamin D for bone health.
Should everyone be on a multivitamin? For which diagnoses do you routinely recommend vitamin or mineral supplementation? In fact, in which instances do you take supplementation yourself? Do you feel comfortable with the evidence that supports it? Which references do you trust in this facet?
In December 2013, the Annals of Internal Medicine amassed 2 original research articles, 1 review, and 1 editorial analyzing and supporting the hypothesis that vitamin and mineral supplementation may not be beneficial for many facets of total health. One study assessed daily multivitamin efficacy in older adults for prevention of cognitive decline (Ann Intern Med. 2013;159:806-814); one evaluated high-dosage daily multivitamin in myocardial infarction patients for prevention of repeated cardiovascular events (Ann Intern Med. 2013;159:797-805); and the systematic review reported all-cause mortality, cardiovascular disease, and cancer in multivitamin users (Ann Intern Med. 2013;159:824-834). All 3 concluded that there was no significant benefit, and the editorial asked that we close the book on this question (Ann Intern Med. 2013;159:850-851).
What’s the issue?
In dermatology, patients often inquire about supplements, dietary changes, and natural methods for aiding in their recovery and for preventing disease. This set of publications attempts to steer us to summarily discourage widespread multivitamin and supplement use. However, there are certainly instances in which dogma from medical school training, smaller patient cohorts, and anecdotal cases compel us to continue them. The first things to come to mind in dermatology (and beyond) are biotin for hair and nail growth, folic acid for preconception and pregnancy prevention of fetal neural defects, and vitamin D for bone health.
Should everyone be on a multivitamin? For which diagnoses do you routinely recommend vitamin or mineral supplementation? In fact, in which instances do you take supplementation yourself? Do you feel comfortable with the evidence that supports it? Which references do you trust in this facet?
In December 2013, the Annals of Internal Medicine amassed 2 original research articles, 1 review, and 1 editorial analyzing and supporting the hypothesis that vitamin and mineral supplementation may not be beneficial for many facets of total health. One study assessed daily multivitamin efficacy in older adults for prevention of cognitive decline (Ann Intern Med. 2013;159:806-814); one evaluated high-dosage daily multivitamin in myocardial infarction patients for prevention of repeated cardiovascular events (Ann Intern Med. 2013;159:797-805); and the systematic review reported all-cause mortality, cardiovascular disease, and cancer in multivitamin users (Ann Intern Med. 2013;159:824-834). All 3 concluded that there was no significant benefit, and the editorial asked that we close the book on this question (Ann Intern Med. 2013;159:850-851).
What’s the issue?
In dermatology, patients often inquire about supplements, dietary changes, and natural methods for aiding in their recovery and for preventing disease. This set of publications attempts to steer us to summarily discourage widespread multivitamin and supplement use. However, there are certainly instances in which dogma from medical school training, smaller patient cohorts, and anecdotal cases compel us to continue them. The first things to come to mind in dermatology (and beyond) are biotin for hair and nail growth, folic acid for preconception and pregnancy prevention of fetal neural defects, and vitamin D for bone health.
Should everyone be on a multivitamin? For which diagnoses do you routinely recommend vitamin or mineral supplementation? In fact, in which instances do you take supplementation yourself? Do you feel comfortable with the evidence that supports it? Which references do you trust in this facet?
Choosing Wisely
Along with 80 other medical societies, the American Academy of Dermatology (AAD) recently published a list of unnecessary medical tests and procedures as part of a stewardship effort called Choosing Wisely, orchestrated by the American Board of Internal Medicine (ABIM) Foundation to conserve health care resources. For dermatologists, the list includes:
- Don’t prescribe oral antifungal therapy for suspected nail fungus without confirmation of fungal infection.
- Don’t perform sentinel lymph node biopsy or other diagnostic tests for the evaluation of early, thin melanoma because they do not improve survival.
- Don’t treat uncomplicated, nonmelanoma skin cancer less than 1 centimeter in size on the trunk and extremities with Mohs micrographic surgery.
- Don’t use oral antibiotics for treatment of atopic dermatitis unless there is clinical evidence of infection.
- Don’t routinely use topical antibiotics on a surgical wound.
What’s the issue?
Read the list. Assess your current clinical practices. Note where health care waste exists. A November 2013 ABC News investigation noted that hospital charges are the largest source of medical inflation, and I thought to myself, “Yes, think of all the emergency department and inpatients who are reflexively on expensive broad-spectrum antibiotics, or think of the number of patients admitted for stable conditions.” However, from a different standpoint, some might say that dermatology costs are extravagant based on the items on this list, particularly the surgical inconsistencies. Therefore, we should try not to cast the first stone unless our own specialty’s waste is managed. What are examples of regional sources of excess that you can identify?
Along with 80 other medical societies, the American Academy of Dermatology (AAD) recently published a list of unnecessary medical tests and procedures as part of a stewardship effort called Choosing Wisely, orchestrated by the American Board of Internal Medicine (ABIM) Foundation to conserve health care resources. For dermatologists, the list includes:
- Don’t prescribe oral antifungal therapy for suspected nail fungus without confirmation of fungal infection.
- Don’t perform sentinel lymph node biopsy or other diagnostic tests for the evaluation of early, thin melanoma because they do not improve survival.
- Don’t treat uncomplicated, nonmelanoma skin cancer less than 1 centimeter in size on the trunk and extremities with Mohs micrographic surgery.
- Don’t use oral antibiotics for treatment of atopic dermatitis unless there is clinical evidence of infection.
- Don’t routinely use topical antibiotics on a surgical wound.
What’s the issue?
Read the list. Assess your current clinical practices. Note where health care waste exists. A November 2013 ABC News investigation noted that hospital charges are the largest source of medical inflation, and I thought to myself, “Yes, think of all the emergency department and inpatients who are reflexively on expensive broad-spectrum antibiotics, or think of the number of patients admitted for stable conditions.” However, from a different standpoint, some might say that dermatology costs are extravagant based on the items on this list, particularly the surgical inconsistencies. Therefore, we should try not to cast the first stone unless our own specialty’s waste is managed. What are examples of regional sources of excess that you can identify?
Along with 80 other medical societies, the American Academy of Dermatology (AAD) recently published a list of unnecessary medical tests and procedures as part of a stewardship effort called Choosing Wisely, orchestrated by the American Board of Internal Medicine (ABIM) Foundation to conserve health care resources. For dermatologists, the list includes:
- Don’t prescribe oral antifungal therapy for suspected nail fungus without confirmation of fungal infection.
- Don’t perform sentinel lymph node biopsy or other diagnostic tests for the evaluation of early, thin melanoma because they do not improve survival.
- Don’t treat uncomplicated, nonmelanoma skin cancer less than 1 centimeter in size on the trunk and extremities with Mohs micrographic surgery.
- Don’t use oral antibiotics for treatment of atopic dermatitis unless there is clinical evidence of infection.
- Don’t routinely use topical antibiotics on a surgical wound.
What’s the issue?
Read the list. Assess your current clinical practices. Note where health care waste exists. A November 2013 ABC News investigation noted that hospital charges are the largest source of medical inflation, and I thought to myself, “Yes, think of all the emergency department and inpatients who are reflexively on expensive broad-spectrum antibiotics, or think of the number of patients admitted for stable conditions.” However, from a different standpoint, some might say that dermatology costs are extravagant based on the items on this list, particularly the surgical inconsistencies. Therefore, we should try not to cast the first stone unless our own specialty’s waste is managed. What are examples of regional sources of excess that you can identify?
Open Notes, Open Risk?
The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.
What’s the issue?
From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?
The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.
What’s the issue?
From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?
The Journal of Medical Internet Research recently outlined a study addressing online patient access to personal medical records (OpenNotes intervention). It is the latest in a series of publications regarding this initiative’s utilization, risks, benefits, and perspectives from physicians as well as from patients. This cohort study surveyed attitudes about privacy in approximately 4000 primary care patients at baseline and 1 year after access to their own medical records via online secure portals. One-third of patients voiced concern about privacy both before and after the study period; however, it did not deter use of the portal, as nearly all participants viewed their records during the study.
What’s the issue?
From the standpoint of a patient, OpenNotes provides timely information gathering and transparency in reporting. From the standpoint of physicians and institutions, the same is true. And in a perfect world, all would be well. Currently, at any office, patients can access their records via telephone, fax, or mail, but OpenNotes creates a ubiquitous and rapid portal. The word portal, however, may breed thoughts of hackers, viruses, and worms to laypeople, and thoughts of lawsuits and bureaucracy to providers. This study did not prove that patients consciously trust the system after 1 year, but perhaps they do subconsciously, as they used the portal anyway. What do your patients think of this evolution in information technology, what do providers think, and where might the glitches, if any, emerge?
Melanoma Regression: A Quandary of Progression, Progress, and Prognosis
The British Journal of Dermatology recently described prognostic data regarding 1693 consecutive melanoma patients (American Joint Committee on Cancer stage I to II). Based on disease-free and overall survival and sentinel lymph node biopsy (SLNB) characteristics, the study found that the majority of regional lymph node metastases were in patients who did not undergo SLNB and that histologic regression was considered protective. The authors concluded that regression should not be an indication for SLNB in thin melanomas; in fact, it may be a favorable prognostic factor.
What’s the issue?
The art of medicine and its gray areas are respected and in full effect for melanoma, as clinicians always have to take into account the patient’s clinical history, comorbidities, and a fair amount of “gut instinct” in addition to the pathology specimen characteristics when deciding on surgical margins, imaging/laboratory tests, and particularly SLNB. How do you approach cases with regression? Although not an official upstaging factor anymore and now with evidence presented in the above study, how much do we worry and account for the mysterious route a particular melanoma took clinically and molecularly before the patient presented to us?
The British Journal of Dermatology recently described prognostic data regarding 1693 consecutive melanoma patients (American Joint Committee on Cancer stage I to II). Based on disease-free and overall survival and sentinel lymph node biopsy (SLNB) characteristics, the study found that the majority of regional lymph node metastases were in patients who did not undergo SLNB and that histologic regression was considered protective. The authors concluded that regression should not be an indication for SLNB in thin melanomas; in fact, it may be a favorable prognostic factor.
What’s the issue?
The art of medicine and its gray areas are respected and in full effect for melanoma, as clinicians always have to take into account the patient’s clinical history, comorbidities, and a fair amount of “gut instinct” in addition to the pathology specimen characteristics when deciding on surgical margins, imaging/laboratory tests, and particularly SLNB. How do you approach cases with regression? Although not an official upstaging factor anymore and now with evidence presented in the above study, how much do we worry and account for the mysterious route a particular melanoma took clinically and molecularly before the patient presented to us?
The British Journal of Dermatology recently described prognostic data regarding 1693 consecutive melanoma patients (American Joint Committee on Cancer stage I to II). Based on disease-free and overall survival and sentinel lymph node biopsy (SLNB) characteristics, the study found that the majority of regional lymph node metastases were in patients who did not undergo SLNB and that histologic regression was considered protective. The authors concluded that regression should not be an indication for SLNB in thin melanomas; in fact, it may be a favorable prognostic factor.
What’s the issue?
The art of medicine and its gray areas are respected and in full effect for melanoma, as clinicians always have to take into account the patient’s clinical history, comorbidities, and a fair amount of “gut instinct” in addition to the pathology specimen characteristics when deciding on surgical margins, imaging/laboratory tests, and particularly SLNB. How do you approach cases with regression? Although not an official upstaging factor anymore and now with evidence presented in the above study, how much do we worry and account for the mysterious route a particular melanoma took clinically and molecularly before the patient presented to us?
MelaFind: Invaluable or Inane?
JAMA Dermatology (formerly Archives of Dermatology) reported a study (Arch Dermatol. 2012;148:1083-1084) on the diagnosis of pigmented lesions by dermatologists compared with the MelaFind device (Mela Sciences), a handheld light unit that produces a 3-dimensional computer image of a pigmented lesion with subsequent recommendation of “high disorganization” versus “low disorganization.” Of 47 pigmented lesions (23 melanoma; 24 nonmelanoma), MelaFind recommended biopsy in 44 cases and no biopsy in 3 cases, with 1 lesion that was truly melanoma (96% sensitivity; 8% specificity), compared with a range of 48% to 100% (mean, 80%) sensitivity and 4% to 71% (mean, 43%) specificity among the study dermatologists. The authors quote in their conclusion paragraph that MelaFind is a “very sensitive tool to guide dermatologists.”
What’s the issue?
A recent patient forcefully suggested to me that our department should “keep up with the times” and invest in MelaFind. MelaFind’s Web site states that it is “not a screening device.” The physician fact sheet says that it is “the world’s first and only multi-spectral, non-invasive, painless, and 100% objective and automated computer vision technology that evaluates clinically atypical pigmented skin lesions and classifies them unambiguously and clearly based upon their level of 3-dimensional morphological disorganization.” Given these claims and its US Food and Drug Administration approval, how can we not own one? The word unambiguous has never been used to describe the clinical decision making and diagnosis of pigmented lesions, but we all hope for it. Quite well-known leaders in our field have spoken highly of this technology, though I await better-powered studies and more poignant data, or perhaps just a better grasp of how it works. Can someone aid us in understanding its true niche in clinical practice?
JAMA Dermatology (formerly Archives of Dermatology) reported a study (Arch Dermatol. 2012;148:1083-1084) on the diagnosis of pigmented lesions by dermatologists compared with the MelaFind device (Mela Sciences), a handheld light unit that produces a 3-dimensional computer image of a pigmented lesion with subsequent recommendation of “high disorganization” versus “low disorganization.” Of 47 pigmented lesions (23 melanoma; 24 nonmelanoma), MelaFind recommended biopsy in 44 cases and no biopsy in 3 cases, with 1 lesion that was truly melanoma (96% sensitivity; 8% specificity), compared with a range of 48% to 100% (mean, 80%) sensitivity and 4% to 71% (mean, 43%) specificity among the study dermatologists. The authors quote in their conclusion paragraph that MelaFind is a “very sensitive tool to guide dermatologists.”
What’s the issue?
A recent patient forcefully suggested to me that our department should “keep up with the times” and invest in MelaFind. MelaFind’s Web site states that it is “not a screening device.” The physician fact sheet says that it is “the world’s first and only multi-spectral, non-invasive, painless, and 100% objective and automated computer vision technology that evaluates clinically atypical pigmented skin lesions and classifies them unambiguously and clearly based upon their level of 3-dimensional morphological disorganization.” Given these claims and its US Food and Drug Administration approval, how can we not own one? The word unambiguous has never been used to describe the clinical decision making and diagnosis of pigmented lesions, but we all hope for it. Quite well-known leaders in our field have spoken highly of this technology, though I await better-powered studies and more poignant data, or perhaps just a better grasp of how it works. Can someone aid us in understanding its true niche in clinical practice?
JAMA Dermatology (formerly Archives of Dermatology) reported a study (Arch Dermatol. 2012;148:1083-1084) on the diagnosis of pigmented lesions by dermatologists compared with the MelaFind device (Mela Sciences), a handheld light unit that produces a 3-dimensional computer image of a pigmented lesion with subsequent recommendation of “high disorganization” versus “low disorganization.” Of 47 pigmented lesions (23 melanoma; 24 nonmelanoma), MelaFind recommended biopsy in 44 cases and no biopsy in 3 cases, with 1 lesion that was truly melanoma (96% sensitivity; 8% specificity), compared with a range of 48% to 100% (mean, 80%) sensitivity and 4% to 71% (mean, 43%) specificity among the study dermatologists. The authors quote in their conclusion paragraph that MelaFind is a “very sensitive tool to guide dermatologists.”
What’s the issue?
A recent patient forcefully suggested to me that our department should “keep up with the times” and invest in MelaFind. MelaFind’s Web site states that it is “not a screening device.” The physician fact sheet says that it is “the world’s first and only multi-spectral, non-invasive, painless, and 100% objective and automated computer vision technology that evaluates clinically atypical pigmented skin lesions and classifies them unambiguously and clearly based upon their level of 3-dimensional morphological disorganization.” Given these claims and its US Food and Drug Administration approval, how can we not own one? The word unambiguous has never been used to describe the clinical decision making and diagnosis of pigmented lesions, but we all hope for it. Quite well-known leaders in our field have spoken highly of this technology, though I await better-powered studies and more poignant data, or perhaps just a better grasp of how it works. Can someone aid us in understanding its true niche in clinical practice?