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Consider the ‘long game’ in tumor management following Mohs surgery
PORTLAND, ORE. – In his nearly 2 decades of dermatology practice, Keith L. Duffy, MD, has seen his share of cases where Mohs surgery was misused or misappropriated.
, Salt Lake City, said at the annual meeting of the Pacific Dermatologic Association. “I want to protect our specialty. I see patients who have dozens of skin cancers. I want to emphasize the long game of management in those patients. You have to think about the tumors in terms of decades.”
In 2012, an ad hoc task force from the American Academy of Dermatology (AAD), the American College of Mohs Surgery, the American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery developed appropriate use criteria (AUC) for 270 scenarios for which Mohs micrographic surgery (MMS) is frequently considered. The task force used a 9-point scale to rate each indication, as follows:
- A score of 7 to 9: The use of MMS is appropriate for the specific indication and is generally considered acceptable.
- A score of 4 to 6: The use of MMS is uncertain for the specific indication, although its use may be appropriate and acceptable.
- A score of 1 to 3: The use of MMS is inappropriate for the specific indication and is generally not considered acceptable.
These ratings were translated into a free Mohs Surgery Appropriate Use Criteria App developed by the AAD.
Subsequently, Dr. Duffy and colleagues retrospectively examined the University of Utah’s adherence to the Mohs AUC over the course of 3 months. Their analysis, published in 2015, included 1,026 nonmelanoma skin cancers in 724 patients. Of the 1,026 cancers, 350 (34.1%) were treated with MMS. Of these, 339 (96.9%) were deemed appropriate based on the AUC guidelines, 4 (1.1%) were deemed uncertain, and 7 (2%) were deemed inappropriate.
There were also 611 skin cancers that were not treated with Mohs but met criteria for treatment with Mohs. “Most of these were AUC 7 tumors,” Dr. Duffy said. “When I see an AUC 7 tumor, I give high consideration for certain anatomic locations, especially the lower leg, scalp, eyelid, genitalia, ear, hands, and feet. I also think about the patient’s age, the number of skin cancers, and histological characteristics. Consider the long game in management and remember that skin cancer patients can make a near infinite amount of skin cancers, so be conservative when excising skin cancers to preserve precious skin.”
In his opinion, full thickness wounds requiring sutures should be avoided on the scalp and lower leg, if possible. “Most carcinomas in these locations are superficial and not aggressive in immunocompetent patients,” said Dr. Duffy, who said he has had one patient in 12 years who was not a transplant patient who had a metastatic squamous cell carcinoma on the lower leg. “Postop complications can be totally avoided. I don’t worry about these patients bleeding or [about] dehiscence. They can go back and play golf the next day, so you save valuable skin where the real estate is precious. This underscores a practice pearl: Incorporate the Mohs AUC and consideration of anatomic location when considering the most appropriate treatment of skin cancers.”
He also advises dermatologists to consider the histopathologic characteristics of the tumor when treating skin cancers to reduce complications and save tissue, so that patients can resume their lifestyle. “When you read the pathology report, really think about what the dermatopathologist saw under the microscope,” said Dr. Duffy, who is an investigator at the University of Utah’s Huntsman Cancer Institute. He said that he is able to review the slides for 90% of his own cases before surgery. “I’m lucky that way, but if you have any questions, your dermatopathologist should be on speed dial.”
Ultimately, he concluded, proper selection of a treatment modality for a specific tumor and patient rules the day. “Tumors should be thought about in the context of the patient and not as a single or isolated cancer,” he said.
Dr. Duffy reported having no relevant disclosures.
PORTLAND, ORE. – In his nearly 2 decades of dermatology practice, Keith L. Duffy, MD, has seen his share of cases where Mohs surgery was misused or misappropriated.
, Salt Lake City, said at the annual meeting of the Pacific Dermatologic Association. “I want to protect our specialty. I see patients who have dozens of skin cancers. I want to emphasize the long game of management in those patients. You have to think about the tumors in terms of decades.”
In 2012, an ad hoc task force from the American Academy of Dermatology (AAD), the American College of Mohs Surgery, the American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery developed appropriate use criteria (AUC) for 270 scenarios for which Mohs micrographic surgery (MMS) is frequently considered. The task force used a 9-point scale to rate each indication, as follows:
- A score of 7 to 9: The use of MMS is appropriate for the specific indication and is generally considered acceptable.
- A score of 4 to 6: The use of MMS is uncertain for the specific indication, although its use may be appropriate and acceptable.
- A score of 1 to 3: The use of MMS is inappropriate for the specific indication and is generally not considered acceptable.
These ratings were translated into a free Mohs Surgery Appropriate Use Criteria App developed by the AAD.
Subsequently, Dr. Duffy and colleagues retrospectively examined the University of Utah’s adherence to the Mohs AUC over the course of 3 months. Their analysis, published in 2015, included 1,026 nonmelanoma skin cancers in 724 patients. Of the 1,026 cancers, 350 (34.1%) were treated with MMS. Of these, 339 (96.9%) were deemed appropriate based on the AUC guidelines, 4 (1.1%) were deemed uncertain, and 7 (2%) were deemed inappropriate.
There were also 611 skin cancers that were not treated with Mohs but met criteria for treatment with Mohs. “Most of these were AUC 7 tumors,” Dr. Duffy said. “When I see an AUC 7 tumor, I give high consideration for certain anatomic locations, especially the lower leg, scalp, eyelid, genitalia, ear, hands, and feet. I also think about the patient’s age, the number of skin cancers, and histological characteristics. Consider the long game in management and remember that skin cancer patients can make a near infinite amount of skin cancers, so be conservative when excising skin cancers to preserve precious skin.”
In his opinion, full thickness wounds requiring sutures should be avoided on the scalp and lower leg, if possible. “Most carcinomas in these locations are superficial and not aggressive in immunocompetent patients,” said Dr. Duffy, who said he has had one patient in 12 years who was not a transplant patient who had a metastatic squamous cell carcinoma on the lower leg. “Postop complications can be totally avoided. I don’t worry about these patients bleeding or [about] dehiscence. They can go back and play golf the next day, so you save valuable skin where the real estate is precious. This underscores a practice pearl: Incorporate the Mohs AUC and consideration of anatomic location when considering the most appropriate treatment of skin cancers.”
He also advises dermatologists to consider the histopathologic characteristics of the tumor when treating skin cancers to reduce complications and save tissue, so that patients can resume their lifestyle. “When you read the pathology report, really think about what the dermatopathologist saw under the microscope,” said Dr. Duffy, who is an investigator at the University of Utah’s Huntsman Cancer Institute. He said that he is able to review the slides for 90% of his own cases before surgery. “I’m lucky that way, but if you have any questions, your dermatopathologist should be on speed dial.”
Ultimately, he concluded, proper selection of a treatment modality for a specific tumor and patient rules the day. “Tumors should be thought about in the context of the patient and not as a single or isolated cancer,” he said.
Dr. Duffy reported having no relevant disclosures.
PORTLAND, ORE. – In his nearly 2 decades of dermatology practice, Keith L. Duffy, MD, has seen his share of cases where Mohs surgery was misused or misappropriated.
, Salt Lake City, said at the annual meeting of the Pacific Dermatologic Association. “I want to protect our specialty. I see patients who have dozens of skin cancers. I want to emphasize the long game of management in those patients. You have to think about the tumors in terms of decades.”
In 2012, an ad hoc task force from the American Academy of Dermatology (AAD), the American College of Mohs Surgery, the American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery developed appropriate use criteria (AUC) for 270 scenarios for which Mohs micrographic surgery (MMS) is frequently considered. The task force used a 9-point scale to rate each indication, as follows:
- A score of 7 to 9: The use of MMS is appropriate for the specific indication and is generally considered acceptable.
- A score of 4 to 6: The use of MMS is uncertain for the specific indication, although its use may be appropriate and acceptable.
- A score of 1 to 3: The use of MMS is inappropriate for the specific indication and is generally not considered acceptable.
These ratings were translated into a free Mohs Surgery Appropriate Use Criteria App developed by the AAD.
Subsequently, Dr. Duffy and colleagues retrospectively examined the University of Utah’s adherence to the Mohs AUC over the course of 3 months. Their analysis, published in 2015, included 1,026 nonmelanoma skin cancers in 724 patients. Of the 1,026 cancers, 350 (34.1%) were treated with MMS. Of these, 339 (96.9%) were deemed appropriate based on the AUC guidelines, 4 (1.1%) were deemed uncertain, and 7 (2%) were deemed inappropriate.
There were also 611 skin cancers that were not treated with Mohs but met criteria for treatment with Mohs. “Most of these were AUC 7 tumors,” Dr. Duffy said. “When I see an AUC 7 tumor, I give high consideration for certain anatomic locations, especially the lower leg, scalp, eyelid, genitalia, ear, hands, and feet. I also think about the patient’s age, the number of skin cancers, and histological characteristics. Consider the long game in management and remember that skin cancer patients can make a near infinite amount of skin cancers, so be conservative when excising skin cancers to preserve precious skin.”
In his opinion, full thickness wounds requiring sutures should be avoided on the scalp and lower leg, if possible. “Most carcinomas in these locations are superficial and not aggressive in immunocompetent patients,” said Dr. Duffy, who said he has had one patient in 12 years who was not a transplant patient who had a metastatic squamous cell carcinoma on the lower leg. “Postop complications can be totally avoided. I don’t worry about these patients bleeding or [about] dehiscence. They can go back and play golf the next day, so you save valuable skin where the real estate is precious. This underscores a practice pearl: Incorporate the Mohs AUC and consideration of anatomic location when considering the most appropriate treatment of skin cancers.”
He also advises dermatologists to consider the histopathologic characteristics of the tumor when treating skin cancers to reduce complications and save tissue, so that patients can resume their lifestyle. “When you read the pathology report, really think about what the dermatopathologist saw under the microscope,” said Dr. Duffy, who is an investigator at the University of Utah’s Huntsman Cancer Institute. He said that he is able to review the slides for 90% of his own cases before surgery. “I’m lucky that way, but if you have any questions, your dermatopathologist should be on speed dial.”
Ultimately, he concluded, proper selection of a treatment modality for a specific tumor and patient rules the day. “Tumors should be thought about in the context of the patient and not as a single or isolated cancer,” he said.
Dr. Duffy reported having no relevant disclosures.
AT PDA 2022
Second opinions on melanocytic lesions swayed when first opinion is known
, diminishing the value and accuracy of an independent analysis.
In a novel effort to determine whether previous interpretations sway second opinions, 149 dermatopathologists were asked to read melanocytic skin biopsy specimens without access to the initial pathology report. A year or more later they read them again but now with access to the initial reading.
The study showed that the participants, independent of many variables, such as years of experience or frequency with which they offered second options, were more likely to upgrade or downgrade the severity of the specimens in accordance with the initial report even if their original reading was correct.
If the goal of a second dermatopathologist opinion is to obtain an independent diagnostic opinion, the message from this study is that they “should be blinded to first opinions,” according to the authors of this study, led by Joann G. Elmore, MD, professor of medicine, University of California, Los Angeles. The study was published online in JAMA Dermatology.
Two-phase study has 1-year washout
The study was conducted in two phases. In phase 1, a nationally representative sample of volunteer dermatopathologists performed 878 interpretations. In phase 2, conducted after a washout period of 12 months or more, the dermatopathologists read a random subset of the same cases evaluated in phase 1, but this time, unlike the first, they were first exposed to prior pathology reports.
Ultimately, “the dermatologists provided more than 5,000 interpretations of study cases, which was a big contribution of time,” Dr. Elmore said in an interview. Grateful for their critical contribution, she speculated that they were driven by the importance of the question being asked.
When categorized by the Melanocytic Pathology Assessment Tool (MPAT), which rates specimens from benign (class 1) to pT1b invasive melanoma (class 4), the influence of the prior report went in both directions, so that the likelihood of upgrading or downgrading went in accordance with the grading in the original dermatopathology report.
As a result, the risk of a less severe interpretation on the second relative to the first reading was 38% greater if the initial dermatopathology report had a lower grade (relative risk, 1.38; 95% confidence interval [CI], 1.19-1.59). The risk of upgrading the second report if the initial pathology report had a higher grade was increased by more than 50% (RR, 1.52; 95% CI, 1.34-1.73).
The greater likelihood of upgrading than downgrading is “understandable,” Dr. Elmore said. “I think this is consistent with the concern about missing something,” she explained.
According to Dr. Elmore, one of the greatest concerns regarding the bias imposed by the original pathology report is that the switch of opinions often went from one that was accurate to one that was inaccurate.
If the phase 1 diagnosis was accurate but upgraded in the phase 2 diagnosis, the risk of inaccuracy was almost doubled (RR, 1.96; 95% CI, 1.31-2.93). If the phase 1 report was inaccurate, the relative risk of changing the phase 2 diagnosis was still high but lower than if it was accurate (RR, 1.46; 95% CI, 1.27-1.68).
“That is, even when the phase 1 diagnoses agreed with the consensus reference diagnosis, they were swayed away from the correct diagnosis in phase 2 [when the initial pathology report characterized the specimen as higher grade],” Dr. Elmore reported.
Conversely, the risk of downgrading was about the same whether the phase 1 evaluation was accurate (RR, 1.37; 95% CI, 1.14-1.64) or inaccurate (RR 1.32; 95% CI, 1.07-1.64).
Downward and upward shifts in severity from an accurate diagnosis are concerning because of the likelihood they will lead to overtreatment or undertreatment. The problem, according to data from this study, is that dermatologists making a second opinion cannot judge their own susceptibility to being swayed by the original report.
Pathologists might be unaware of bias
At baseline, the participants were asked whether they thought they were influenced by the first interpretation when providing a second opinion. Although 69% acknowledged that they might be “somewhat influenced,” 31% maintained that they do not take initial reports into consideration. When the two groups were compared, the risk of downgrading was nearly identical. The risk of upgrading was lower in those claiming to disregard initial reports (RR, 1.29) relative to those who said they were “somewhat influenced” by a previous diagnosis (RR, 1.64), but the difference was not significant.
The actual risk of bias incurred by prior pathology reports might be greater than that captured in this study for several reasons, according to the investigators. They pointed out that all participants were experienced and board-certified and might therefore be expected to be more confident in their interpretations than an unselected group of dermatopathologists. In addition, participants might have been more careful in their interpretations knowing they were participating in a study.
“There are a lot of data to support the value of second opinions [in dermatopathology and other areas], but we need to consider the process of how they are being obtained,” Dr. Elmore said. “There needs to be a greater emphasis on providing an independent analysis.”
More than 60% of the dermatologists participating in this study reported that they agreed or strongly agreed with the premise that they prefer to have the original dermatopathology report when they offer a second opinion. Dr. Elmore said that the desire of those offering a second opinion to have as much information in front of them as possible is understandable, but the bias imposed by the original report weakens the value of the second opinion.
Blind reading of pathology reports needed
“These data suggest that seeing the original report sways opinions and that includes swaying opinions away from an accurate reading,” Dr. Elmore said. She thinks that for dermatopathologists to render a valuable and independent second opinion, the specimens should be examined “at least initially” without access to the first report.
The results of this study were not surprising to Vishal Anil Patel, MD, director of the Cutaneous Oncology Program, George Washington University Cancer Center, Washington. He made the point that physicians “are human first and foremost and not perfect machines.” As a result, he suggested bias and error are inevitable.
Although strategies to avoid bias are likely to offer some protection against inaccuracy, he said that diagnostic support tools such as artificial intelligence might be the right direction for improving inter- and intra-rater reliability.
Ruifeng Guo, MD, PhD, a consultant in the division of anatomic pathology at the Mayo Clinic, Rochester, Minn., agreed with the basic premise of the study, but he cautioned that restricting access to the initial pathology report might not always be the right approach.
It is true that “dermatopathologists providing a second opinion in diagnosing cutaneous melanoma are mostly unaware of the risk of bias if they read the initial pathology report,” said Dr. Guo, but restricting access comes with risks.
“There are also times critical information may be contained in the initial pathology report that needs to be considered when providing a second opinion consultation,” he noted. Ultimately, the decision to read or not read the initial report should be decided “on an individual basis.”
The study was funded by grants from the National Cancer Institute. Dr. Elmore, Dr. Patel, and Dr. Guo reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, diminishing the value and accuracy of an independent analysis.
In a novel effort to determine whether previous interpretations sway second opinions, 149 dermatopathologists were asked to read melanocytic skin biopsy specimens without access to the initial pathology report. A year or more later they read them again but now with access to the initial reading.
The study showed that the participants, independent of many variables, such as years of experience or frequency with which they offered second options, were more likely to upgrade or downgrade the severity of the specimens in accordance with the initial report even if their original reading was correct.
If the goal of a second dermatopathologist opinion is to obtain an independent diagnostic opinion, the message from this study is that they “should be blinded to first opinions,” according to the authors of this study, led by Joann G. Elmore, MD, professor of medicine, University of California, Los Angeles. The study was published online in JAMA Dermatology.
Two-phase study has 1-year washout
The study was conducted in two phases. In phase 1, a nationally representative sample of volunteer dermatopathologists performed 878 interpretations. In phase 2, conducted after a washout period of 12 months or more, the dermatopathologists read a random subset of the same cases evaluated in phase 1, but this time, unlike the first, they were first exposed to prior pathology reports.
Ultimately, “the dermatologists provided more than 5,000 interpretations of study cases, which was a big contribution of time,” Dr. Elmore said in an interview. Grateful for their critical contribution, she speculated that they were driven by the importance of the question being asked.
When categorized by the Melanocytic Pathology Assessment Tool (MPAT), which rates specimens from benign (class 1) to pT1b invasive melanoma (class 4), the influence of the prior report went in both directions, so that the likelihood of upgrading or downgrading went in accordance with the grading in the original dermatopathology report.
As a result, the risk of a less severe interpretation on the second relative to the first reading was 38% greater if the initial dermatopathology report had a lower grade (relative risk, 1.38; 95% confidence interval [CI], 1.19-1.59). The risk of upgrading the second report if the initial pathology report had a higher grade was increased by more than 50% (RR, 1.52; 95% CI, 1.34-1.73).
The greater likelihood of upgrading than downgrading is “understandable,” Dr. Elmore said. “I think this is consistent with the concern about missing something,” she explained.
According to Dr. Elmore, one of the greatest concerns regarding the bias imposed by the original pathology report is that the switch of opinions often went from one that was accurate to one that was inaccurate.
If the phase 1 diagnosis was accurate but upgraded in the phase 2 diagnosis, the risk of inaccuracy was almost doubled (RR, 1.96; 95% CI, 1.31-2.93). If the phase 1 report was inaccurate, the relative risk of changing the phase 2 diagnosis was still high but lower than if it was accurate (RR, 1.46; 95% CI, 1.27-1.68).
“That is, even when the phase 1 diagnoses agreed with the consensus reference diagnosis, they were swayed away from the correct diagnosis in phase 2 [when the initial pathology report characterized the specimen as higher grade],” Dr. Elmore reported.
Conversely, the risk of downgrading was about the same whether the phase 1 evaluation was accurate (RR, 1.37; 95% CI, 1.14-1.64) or inaccurate (RR 1.32; 95% CI, 1.07-1.64).
Downward and upward shifts in severity from an accurate diagnosis are concerning because of the likelihood they will lead to overtreatment or undertreatment. The problem, according to data from this study, is that dermatologists making a second opinion cannot judge their own susceptibility to being swayed by the original report.
Pathologists might be unaware of bias
At baseline, the participants were asked whether they thought they were influenced by the first interpretation when providing a second opinion. Although 69% acknowledged that they might be “somewhat influenced,” 31% maintained that they do not take initial reports into consideration. When the two groups were compared, the risk of downgrading was nearly identical. The risk of upgrading was lower in those claiming to disregard initial reports (RR, 1.29) relative to those who said they were “somewhat influenced” by a previous diagnosis (RR, 1.64), but the difference was not significant.
The actual risk of bias incurred by prior pathology reports might be greater than that captured in this study for several reasons, according to the investigators. They pointed out that all participants were experienced and board-certified and might therefore be expected to be more confident in their interpretations than an unselected group of dermatopathologists. In addition, participants might have been more careful in their interpretations knowing they were participating in a study.
“There are a lot of data to support the value of second opinions [in dermatopathology and other areas], but we need to consider the process of how they are being obtained,” Dr. Elmore said. “There needs to be a greater emphasis on providing an independent analysis.”
More than 60% of the dermatologists participating in this study reported that they agreed or strongly agreed with the premise that they prefer to have the original dermatopathology report when they offer a second opinion. Dr. Elmore said that the desire of those offering a second opinion to have as much information in front of them as possible is understandable, but the bias imposed by the original report weakens the value of the second opinion.
Blind reading of pathology reports needed
“These data suggest that seeing the original report sways opinions and that includes swaying opinions away from an accurate reading,” Dr. Elmore said. She thinks that for dermatopathologists to render a valuable and independent second opinion, the specimens should be examined “at least initially” without access to the first report.
The results of this study were not surprising to Vishal Anil Patel, MD, director of the Cutaneous Oncology Program, George Washington University Cancer Center, Washington. He made the point that physicians “are human first and foremost and not perfect machines.” As a result, he suggested bias and error are inevitable.
Although strategies to avoid bias are likely to offer some protection against inaccuracy, he said that diagnostic support tools such as artificial intelligence might be the right direction for improving inter- and intra-rater reliability.
Ruifeng Guo, MD, PhD, a consultant in the division of anatomic pathology at the Mayo Clinic, Rochester, Minn., agreed with the basic premise of the study, but he cautioned that restricting access to the initial pathology report might not always be the right approach.
It is true that “dermatopathologists providing a second opinion in diagnosing cutaneous melanoma are mostly unaware of the risk of bias if they read the initial pathology report,” said Dr. Guo, but restricting access comes with risks.
“There are also times critical information may be contained in the initial pathology report that needs to be considered when providing a second opinion consultation,” he noted. Ultimately, the decision to read or not read the initial report should be decided “on an individual basis.”
The study was funded by grants from the National Cancer Institute. Dr. Elmore, Dr. Patel, and Dr. Guo reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, diminishing the value and accuracy of an independent analysis.
In a novel effort to determine whether previous interpretations sway second opinions, 149 dermatopathologists were asked to read melanocytic skin biopsy specimens without access to the initial pathology report. A year or more later they read them again but now with access to the initial reading.
The study showed that the participants, independent of many variables, such as years of experience or frequency with which they offered second options, were more likely to upgrade or downgrade the severity of the specimens in accordance with the initial report even if their original reading was correct.
If the goal of a second dermatopathologist opinion is to obtain an independent diagnostic opinion, the message from this study is that they “should be blinded to first opinions,” according to the authors of this study, led by Joann G. Elmore, MD, professor of medicine, University of California, Los Angeles. The study was published online in JAMA Dermatology.
Two-phase study has 1-year washout
The study was conducted in two phases. In phase 1, a nationally representative sample of volunteer dermatopathologists performed 878 interpretations. In phase 2, conducted after a washout period of 12 months or more, the dermatopathologists read a random subset of the same cases evaluated in phase 1, but this time, unlike the first, they were first exposed to prior pathology reports.
Ultimately, “the dermatologists provided more than 5,000 interpretations of study cases, which was a big contribution of time,” Dr. Elmore said in an interview. Grateful for their critical contribution, she speculated that they were driven by the importance of the question being asked.
When categorized by the Melanocytic Pathology Assessment Tool (MPAT), which rates specimens from benign (class 1) to pT1b invasive melanoma (class 4), the influence of the prior report went in both directions, so that the likelihood of upgrading or downgrading went in accordance with the grading in the original dermatopathology report.
As a result, the risk of a less severe interpretation on the second relative to the first reading was 38% greater if the initial dermatopathology report had a lower grade (relative risk, 1.38; 95% confidence interval [CI], 1.19-1.59). The risk of upgrading the second report if the initial pathology report had a higher grade was increased by more than 50% (RR, 1.52; 95% CI, 1.34-1.73).
The greater likelihood of upgrading than downgrading is “understandable,” Dr. Elmore said. “I think this is consistent with the concern about missing something,” she explained.
According to Dr. Elmore, one of the greatest concerns regarding the bias imposed by the original pathology report is that the switch of opinions often went from one that was accurate to one that was inaccurate.
If the phase 1 diagnosis was accurate but upgraded in the phase 2 diagnosis, the risk of inaccuracy was almost doubled (RR, 1.96; 95% CI, 1.31-2.93). If the phase 1 report was inaccurate, the relative risk of changing the phase 2 diagnosis was still high but lower than if it was accurate (RR, 1.46; 95% CI, 1.27-1.68).
“That is, even when the phase 1 diagnoses agreed with the consensus reference diagnosis, they were swayed away from the correct diagnosis in phase 2 [when the initial pathology report characterized the specimen as higher grade],” Dr. Elmore reported.
Conversely, the risk of downgrading was about the same whether the phase 1 evaluation was accurate (RR, 1.37; 95% CI, 1.14-1.64) or inaccurate (RR 1.32; 95% CI, 1.07-1.64).
Downward and upward shifts in severity from an accurate diagnosis are concerning because of the likelihood they will lead to overtreatment or undertreatment. The problem, according to data from this study, is that dermatologists making a second opinion cannot judge their own susceptibility to being swayed by the original report.
Pathologists might be unaware of bias
At baseline, the participants were asked whether they thought they were influenced by the first interpretation when providing a second opinion. Although 69% acknowledged that they might be “somewhat influenced,” 31% maintained that they do not take initial reports into consideration. When the two groups were compared, the risk of downgrading was nearly identical. The risk of upgrading was lower in those claiming to disregard initial reports (RR, 1.29) relative to those who said they were “somewhat influenced” by a previous diagnosis (RR, 1.64), but the difference was not significant.
The actual risk of bias incurred by prior pathology reports might be greater than that captured in this study for several reasons, according to the investigators. They pointed out that all participants were experienced and board-certified and might therefore be expected to be more confident in their interpretations than an unselected group of dermatopathologists. In addition, participants might have been more careful in their interpretations knowing they were participating in a study.
“There are a lot of data to support the value of second opinions [in dermatopathology and other areas], but we need to consider the process of how they are being obtained,” Dr. Elmore said. “There needs to be a greater emphasis on providing an independent analysis.”
More than 60% of the dermatologists participating in this study reported that they agreed or strongly agreed with the premise that they prefer to have the original dermatopathology report when they offer a second opinion. Dr. Elmore said that the desire of those offering a second opinion to have as much information in front of them as possible is understandable, but the bias imposed by the original report weakens the value of the second opinion.
Blind reading of pathology reports needed
“These data suggest that seeing the original report sways opinions and that includes swaying opinions away from an accurate reading,” Dr. Elmore said. She thinks that for dermatopathologists to render a valuable and independent second opinion, the specimens should be examined “at least initially” without access to the first report.
The results of this study were not surprising to Vishal Anil Patel, MD, director of the Cutaneous Oncology Program, George Washington University Cancer Center, Washington. He made the point that physicians “are human first and foremost and not perfect machines.” As a result, he suggested bias and error are inevitable.
Although strategies to avoid bias are likely to offer some protection against inaccuracy, he said that diagnostic support tools such as artificial intelligence might be the right direction for improving inter- and intra-rater reliability.
Ruifeng Guo, MD, PhD, a consultant in the division of anatomic pathology at the Mayo Clinic, Rochester, Minn., agreed with the basic premise of the study, but he cautioned that restricting access to the initial pathology report might not always be the right approach.
It is true that “dermatopathologists providing a second opinion in diagnosing cutaneous melanoma are mostly unaware of the risk of bias if they read the initial pathology report,” said Dr. Guo, but restricting access comes with risks.
“There are also times critical information may be contained in the initial pathology report that needs to be considered when providing a second opinion consultation,” he noted. Ultimately, the decision to read or not read the initial report should be decided “on an individual basis.”
The study was funded by grants from the National Cancer Institute. Dr. Elmore, Dr. Patel, and Dr. Guo reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Getting cancer research on track again may require a ‘behemoth’ effort
In 2016, as vice president, Joe Biden launched the Cancer Moonshot program just 1 year after his son Beau died from glioblastoma multiforme. His objective, he said, was to “cure” cancer, but to get close to that goal, to get cancer research just back up to pre-COVID-19 pandemic levels.
There has been a significant decrease in the launch of new clinical trials for cancer and biologic therapies since 2020. “That can affect every aspect of our research operation. It really affected our capacity to continue to move forward at a fast pace. It will require a behemoth effort to get back to pre-COVID times,” said Tanios S. Bekaii-Saab, MD, leader of the gastrointestinal cancer program at Mayo Clinic in Phoenix.
Congress passed the 21st Century Cures Act in 2016 authorizing $1.8 billion for Cancer Moonshot over 7 years. More recently, the program received $194 million from the $6.9 billion National Cancer Institute budget in FY 2022.
Joseph Alvarnas, MD, a hematologist oncologist and vice president of government affairs at City of Hope, Duarte, Calif., sees the Moonshot budget as a potential shortcoming.
“The priorities are well founded and based on what we would think are the most important things to cover, but, if we’re going to achieve these extraordinarily ambitious goals of halving cancer mortality and serving communities more equitably, it’s going to need more funding positioned at making these things real,” he said.
Moonshot is being positioned as an opportunity to double down on efforts started in 2016, but treating cancer is complex and goes well beyond funding new research.
“We know that we have amazing research and progress around innovations that will drive us toward the goal of reducing the death rate from cancer. But we also know that we have tools that aren’t reaching all parts of the country, so we have a great opportunity to make sure that we’re doing all we can to prevent, detect and treat cancer,” Dr. Carnival said.
Can cancer be cured?
The Biden administration relaunched Moonshot in 2022 with newly defined goals: Cut the rate of cancer-related deaths in half within 25 years; improve the experience of people with cancer, cancer survivors, and their families; and “end cancer as we know it,” President Biden said in a press conference in February.
Cancer is the second leading cause of death in the United States after heart disease, but it may indeed be possible to cut the total number of cancer-related deaths in half over the next 25 years.
“As a hematologist who’s been involved in both research and clinical care, I think it’s important to realize this is actually doable. Between 1990 and 2020 cancer mortality rates decreased by 31%, and in the last American Cancer Society’s annual report, mortality rates dropped by the largest percentages for 2 consecutive years in a row. The question shifts now from ‘Is this possible? to ‘How do we ensure that it’s possible?’ The spirit of Cancer Moonshot 2.0 is identifying the multiple paths to move this effort forward,” Dr. Alvarnas said.
But without a significant infusion of cash for research, it’s doubtful cancer-related deaths will drop by 50% over the next 25 years.
“There are a lot of big and lofty goals in Cancer Moonshot, and the words ‘ending cancer,’ well those are big words,” Dr. Bekaii-Saab said. “The reality is how do we measure in 25 years the impact of this today? I think it will require significantly more funding over the next few years to achieve the goals set by the Moonshot. Otherwise it will be a 7-year done deal that will accrue a lot of great numbers but won’t make a dent in those goals for the next 25 years. To stop it at some point and not invest more into it, we will probably lose most of the benefit.”
Closing the loop on data sharing
Moonshot has been instrumental in fostering research collaborations by encouraging data sharing among scientists.
“It also brought together a new way for the National Cancer Institute and Department of Energy to drive progress on some of the big data initiatives. The initial Cancer Moonshot infused a sense of urgency and hope into this effort,” said Danielle Carnival, PhD, coordinator of Cancer Moonshot.
Between 2017 and 2022, Cancer Moonshot created more than 70 consortiums or programs, and funded about 240 research projects. Its fundamental goals of improving data sharing and encouraging collaboration are very important, Dr. Bekaii-Saab said.
“Because, historically, what happens with cancer is that researchers compete for resources...and they become very protective of their data. Sharing gets more difficult, collaborations become more onerous, and it becomes counterproductive,” he said.
Dr. Bekaii-Saab highlighted two networks created specifically for data sharing. They include the Human Tumor Atlas for cellular, morphological, and molecular tumor data, and PDXNet, a patient derived xenograft research network.
A shift in funding priorities?
Cancer funding has been stagnant for years. When adjusted for growth, it hasn’t had a significant infusion of funding since at least 2003—at least in relative terms, Dr. Bekaii-Saab said. “This affects a lot of the things we do, including NCI-funded clinical trials. It pushes us to work with the private sector, which is not necessarily a detriment, but it doesn’t advance the academic mission at the same level. So, overall, I wouldn’t call it tragic, but I do think we’re falling behind,” he said.
“I think when we do the process for the budget for FY24 and after we’ve had time to really explore the best ideas and build the foundation for some of these new aspects of the Cancer Moonshot, we hope to have something more concrete going toward these efforts,” Dr. Carnival said.
But in addition to funding, Dr. Alvarnas says, it is equally important to address gaps in care. Not all patients have access to existing cancer treatments.
“The great challenge to us in the 2020s is not only about developing new and more effective technologies, but also in doing a better job of getting existing life-saving treatments into the hands of underserved populations. One of the really positive challenges set forth by the Biden administration is the idea that financing care equity is as important, if not more so, than advancing technologies. If there’s been stagnation, it’s because from a government and resourcing point of view, that priority has been ineffectively supported financially.”
The pandemic stymies cancer research
The pandemic has had a significant impact on cancer research. As in other fields, it disrupted ongoing research, but it may have also contributed to the loss of employees who resigned in what’s been called the “Great Resignation.” “A lot of employees just decided to change jobs in the middle of the pandemic, which led to a cancer research staffing crisis,” Dr. Bekaii-Saab said.
“We all recognized that turning so much of the attention of the entire biomedical research engine and health system to the COVID-19 pandemic would have an impact across cancer research, screenings and care,” Dr. Carnival said. “There is work to do to get us back to whole, but from a research perspective, we’ve seen a reorientation of the trial networks we were using for COVID-19 research, back to their initial purpose. Some of those are cancer and oncology networks, so we’re excited about that and fully believe that we can catch up.”
But then there’s also the impact the pandemic has had on cancer patients who delayed their care at the primary level. This, Dr. Bekaii-Saab fears, will lead to more patients presenting with more advanced disease in years to come. “One of the biggest problems was that a lot of patients delayed their care at the primary level. My biggest concern is that in the years to come we will see a lot more patients presenting with more advanced cancer.”
In 2016, as vice president, Joe Biden launched the Cancer Moonshot program just 1 year after his son Beau died from glioblastoma multiforme. His objective, he said, was to “cure” cancer, but to get close to that goal, to get cancer research just back up to pre-COVID-19 pandemic levels.
There has been a significant decrease in the launch of new clinical trials for cancer and biologic therapies since 2020. “That can affect every aspect of our research operation. It really affected our capacity to continue to move forward at a fast pace. It will require a behemoth effort to get back to pre-COVID times,” said Tanios S. Bekaii-Saab, MD, leader of the gastrointestinal cancer program at Mayo Clinic in Phoenix.
Congress passed the 21st Century Cures Act in 2016 authorizing $1.8 billion for Cancer Moonshot over 7 years. More recently, the program received $194 million from the $6.9 billion National Cancer Institute budget in FY 2022.
Joseph Alvarnas, MD, a hematologist oncologist and vice president of government affairs at City of Hope, Duarte, Calif., sees the Moonshot budget as a potential shortcoming.
“The priorities are well founded and based on what we would think are the most important things to cover, but, if we’re going to achieve these extraordinarily ambitious goals of halving cancer mortality and serving communities more equitably, it’s going to need more funding positioned at making these things real,” he said.
Moonshot is being positioned as an opportunity to double down on efforts started in 2016, but treating cancer is complex and goes well beyond funding new research.
“We know that we have amazing research and progress around innovations that will drive us toward the goal of reducing the death rate from cancer. But we also know that we have tools that aren’t reaching all parts of the country, so we have a great opportunity to make sure that we’re doing all we can to prevent, detect and treat cancer,” Dr. Carnival said.
Can cancer be cured?
The Biden administration relaunched Moonshot in 2022 with newly defined goals: Cut the rate of cancer-related deaths in half within 25 years; improve the experience of people with cancer, cancer survivors, and their families; and “end cancer as we know it,” President Biden said in a press conference in February.
Cancer is the second leading cause of death in the United States after heart disease, but it may indeed be possible to cut the total number of cancer-related deaths in half over the next 25 years.
“As a hematologist who’s been involved in both research and clinical care, I think it’s important to realize this is actually doable. Between 1990 and 2020 cancer mortality rates decreased by 31%, and in the last American Cancer Society’s annual report, mortality rates dropped by the largest percentages for 2 consecutive years in a row. The question shifts now from ‘Is this possible? to ‘How do we ensure that it’s possible?’ The spirit of Cancer Moonshot 2.0 is identifying the multiple paths to move this effort forward,” Dr. Alvarnas said.
But without a significant infusion of cash for research, it’s doubtful cancer-related deaths will drop by 50% over the next 25 years.
“There are a lot of big and lofty goals in Cancer Moonshot, and the words ‘ending cancer,’ well those are big words,” Dr. Bekaii-Saab said. “The reality is how do we measure in 25 years the impact of this today? I think it will require significantly more funding over the next few years to achieve the goals set by the Moonshot. Otherwise it will be a 7-year done deal that will accrue a lot of great numbers but won’t make a dent in those goals for the next 25 years. To stop it at some point and not invest more into it, we will probably lose most of the benefit.”
Closing the loop on data sharing
Moonshot has been instrumental in fostering research collaborations by encouraging data sharing among scientists.
“It also brought together a new way for the National Cancer Institute and Department of Energy to drive progress on some of the big data initiatives. The initial Cancer Moonshot infused a sense of urgency and hope into this effort,” said Danielle Carnival, PhD, coordinator of Cancer Moonshot.
Between 2017 and 2022, Cancer Moonshot created more than 70 consortiums or programs, and funded about 240 research projects. Its fundamental goals of improving data sharing and encouraging collaboration are very important, Dr. Bekaii-Saab said.
“Because, historically, what happens with cancer is that researchers compete for resources...and they become very protective of their data. Sharing gets more difficult, collaborations become more onerous, and it becomes counterproductive,” he said.
Dr. Bekaii-Saab highlighted two networks created specifically for data sharing. They include the Human Tumor Atlas for cellular, morphological, and molecular tumor data, and PDXNet, a patient derived xenograft research network.
A shift in funding priorities?
Cancer funding has been stagnant for years. When adjusted for growth, it hasn’t had a significant infusion of funding since at least 2003—at least in relative terms, Dr. Bekaii-Saab said. “This affects a lot of the things we do, including NCI-funded clinical trials. It pushes us to work with the private sector, which is not necessarily a detriment, but it doesn’t advance the academic mission at the same level. So, overall, I wouldn’t call it tragic, but I do think we’re falling behind,” he said.
“I think when we do the process for the budget for FY24 and after we’ve had time to really explore the best ideas and build the foundation for some of these new aspects of the Cancer Moonshot, we hope to have something more concrete going toward these efforts,” Dr. Carnival said.
But in addition to funding, Dr. Alvarnas says, it is equally important to address gaps in care. Not all patients have access to existing cancer treatments.
“The great challenge to us in the 2020s is not only about developing new and more effective technologies, but also in doing a better job of getting existing life-saving treatments into the hands of underserved populations. One of the really positive challenges set forth by the Biden administration is the idea that financing care equity is as important, if not more so, than advancing technologies. If there’s been stagnation, it’s because from a government and resourcing point of view, that priority has been ineffectively supported financially.”
The pandemic stymies cancer research
The pandemic has had a significant impact on cancer research. As in other fields, it disrupted ongoing research, but it may have also contributed to the loss of employees who resigned in what’s been called the “Great Resignation.” “A lot of employees just decided to change jobs in the middle of the pandemic, which led to a cancer research staffing crisis,” Dr. Bekaii-Saab said.
“We all recognized that turning so much of the attention of the entire biomedical research engine and health system to the COVID-19 pandemic would have an impact across cancer research, screenings and care,” Dr. Carnival said. “There is work to do to get us back to whole, but from a research perspective, we’ve seen a reorientation of the trial networks we were using for COVID-19 research, back to their initial purpose. Some of those are cancer and oncology networks, so we’re excited about that and fully believe that we can catch up.”
But then there’s also the impact the pandemic has had on cancer patients who delayed their care at the primary level. This, Dr. Bekaii-Saab fears, will lead to more patients presenting with more advanced disease in years to come. “One of the biggest problems was that a lot of patients delayed their care at the primary level. My biggest concern is that in the years to come we will see a lot more patients presenting with more advanced cancer.”
In 2016, as vice president, Joe Biden launched the Cancer Moonshot program just 1 year after his son Beau died from glioblastoma multiforme. His objective, he said, was to “cure” cancer, but to get close to that goal, to get cancer research just back up to pre-COVID-19 pandemic levels.
There has been a significant decrease in the launch of new clinical trials for cancer and biologic therapies since 2020. “That can affect every aspect of our research operation. It really affected our capacity to continue to move forward at a fast pace. It will require a behemoth effort to get back to pre-COVID times,” said Tanios S. Bekaii-Saab, MD, leader of the gastrointestinal cancer program at Mayo Clinic in Phoenix.
Congress passed the 21st Century Cures Act in 2016 authorizing $1.8 billion for Cancer Moonshot over 7 years. More recently, the program received $194 million from the $6.9 billion National Cancer Institute budget in FY 2022.
Joseph Alvarnas, MD, a hematologist oncologist and vice president of government affairs at City of Hope, Duarte, Calif., sees the Moonshot budget as a potential shortcoming.
“The priorities are well founded and based on what we would think are the most important things to cover, but, if we’re going to achieve these extraordinarily ambitious goals of halving cancer mortality and serving communities more equitably, it’s going to need more funding positioned at making these things real,” he said.
Moonshot is being positioned as an opportunity to double down on efforts started in 2016, but treating cancer is complex and goes well beyond funding new research.
“We know that we have amazing research and progress around innovations that will drive us toward the goal of reducing the death rate from cancer. But we also know that we have tools that aren’t reaching all parts of the country, so we have a great opportunity to make sure that we’re doing all we can to prevent, detect and treat cancer,” Dr. Carnival said.
Can cancer be cured?
The Biden administration relaunched Moonshot in 2022 with newly defined goals: Cut the rate of cancer-related deaths in half within 25 years; improve the experience of people with cancer, cancer survivors, and their families; and “end cancer as we know it,” President Biden said in a press conference in February.
Cancer is the second leading cause of death in the United States after heart disease, but it may indeed be possible to cut the total number of cancer-related deaths in half over the next 25 years.
“As a hematologist who’s been involved in both research and clinical care, I think it’s important to realize this is actually doable. Between 1990 and 2020 cancer mortality rates decreased by 31%, and in the last American Cancer Society’s annual report, mortality rates dropped by the largest percentages for 2 consecutive years in a row. The question shifts now from ‘Is this possible? to ‘How do we ensure that it’s possible?’ The spirit of Cancer Moonshot 2.0 is identifying the multiple paths to move this effort forward,” Dr. Alvarnas said.
But without a significant infusion of cash for research, it’s doubtful cancer-related deaths will drop by 50% over the next 25 years.
“There are a lot of big and lofty goals in Cancer Moonshot, and the words ‘ending cancer,’ well those are big words,” Dr. Bekaii-Saab said. “The reality is how do we measure in 25 years the impact of this today? I think it will require significantly more funding over the next few years to achieve the goals set by the Moonshot. Otherwise it will be a 7-year done deal that will accrue a lot of great numbers but won’t make a dent in those goals for the next 25 years. To stop it at some point and not invest more into it, we will probably lose most of the benefit.”
Closing the loop on data sharing
Moonshot has been instrumental in fostering research collaborations by encouraging data sharing among scientists.
“It also brought together a new way for the National Cancer Institute and Department of Energy to drive progress on some of the big data initiatives. The initial Cancer Moonshot infused a sense of urgency and hope into this effort,” said Danielle Carnival, PhD, coordinator of Cancer Moonshot.
Between 2017 and 2022, Cancer Moonshot created more than 70 consortiums or programs, and funded about 240 research projects. Its fundamental goals of improving data sharing and encouraging collaboration are very important, Dr. Bekaii-Saab said.
“Because, historically, what happens with cancer is that researchers compete for resources...and they become very protective of their data. Sharing gets more difficult, collaborations become more onerous, and it becomes counterproductive,” he said.
Dr. Bekaii-Saab highlighted two networks created specifically for data sharing. They include the Human Tumor Atlas for cellular, morphological, and molecular tumor data, and PDXNet, a patient derived xenograft research network.
A shift in funding priorities?
Cancer funding has been stagnant for years. When adjusted for growth, it hasn’t had a significant infusion of funding since at least 2003—at least in relative terms, Dr. Bekaii-Saab said. “This affects a lot of the things we do, including NCI-funded clinical trials. It pushes us to work with the private sector, which is not necessarily a detriment, but it doesn’t advance the academic mission at the same level. So, overall, I wouldn’t call it tragic, but I do think we’re falling behind,” he said.
“I think when we do the process for the budget for FY24 and after we’ve had time to really explore the best ideas and build the foundation for some of these new aspects of the Cancer Moonshot, we hope to have something more concrete going toward these efforts,” Dr. Carnival said.
But in addition to funding, Dr. Alvarnas says, it is equally important to address gaps in care. Not all patients have access to existing cancer treatments.
“The great challenge to us in the 2020s is not only about developing new and more effective technologies, but also in doing a better job of getting existing life-saving treatments into the hands of underserved populations. One of the really positive challenges set forth by the Biden administration is the idea that financing care equity is as important, if not more so, than advancing technologies. If there’s been stagnation, it’s because from a government and resourcing point of view, that priority has been ineffectively supported financially.”
The pandemic stymies cancer research
The pandemic has had a significant impact on cancer research. As in other fields, it disrupted ongoing research, but it may have also contributed to the loss of employees who resigned in what’s been called the “Great Resignation.” “A lot of employees just decided to change jobs in the middle of the pandemic, which led to a cancer research staffing crisis,” Dr. Bekaii-Saab said.
“We all recognized that turning so much of the attention of the entire biomedical research engine and health system to the COVID-19 pandemic would have an impact across cancer research, screenings and care,” Dr. Carnival said. “There is work to do to get us back to whole, but from a research perspective, we’ve seen a reorientation of the trial networks we were using for COVID-19 research, back to their initial purpose. Some of those are cancer and oncology networks, so we’re excited about that and fully believe that we can catch up.”
But then there’s also the impact the pandemic has had on cancer patients who delayed their care at the primary level. This, Dr. Bekaii-Saab fears, will lead to more patients presenting with more advanced disease in years to come. “One of the biggest problems was that a lot of patients delayed their care at the primary level. My biggest concern is that in the years to come we will see a lot more patients presenting with more advanced cancer.”
Experts: EPA should assess risk of sunscreens’ UV filters
The , an expert panel of the National Academies of Sciences, Engineering, and Medicine (NAS) said on Aug. 9.
The assessment is urgently needed, the experts said, and the results should be shared with the Food and Drug Administration, which oversees sunscreens.
In its 400-page report, titled the Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health, the panel does not make recommendations but suggests that such an EPA risk assessment should highlight gaps in knowledge.
“We are teeing up the critical information that will be used to take on the challenge of risk assessment,” Charles A. Menzie, PhD, chair of the committee that wrote the report, said at a media briefing Aug. 9 when the report was released. Dr. Menzie is a principal at Exponent, Inc., an engineering and scientific consulting firm. He is former executive director of the Society of Environmental Toxicology and Chemistry.
The EPA sponsored the study, which was conducted by a committee of the National Academy of Sciences, a nonprofit, nongovernmental organization authorized by Congress that studies issues related to science, technology, and medicine.
Balancing aquatic, human health concerns
Such an EPA assessment, Dr. Menzie said in a statement, will help inform efforts to understand the environmental effects of UV filters as well as clarify a path forward for managing sunscreens. For years, concerns have been raised about the potential toxicity of sunscreens regarding many marine and freshwater aquatic organisms, especially coral. That concern, however, must be balanced against the benefits of sunscreens, which are known to protect against skin cancer. A low percentage of people use sunscreen regularly, Dr. Menzie and other panel members said.
“Only about a third of the U.S. population regularly uses sunscreen,” Mark Cullen, MD, vice chair of the NAS committee and former director of the Center for Population Health Sciences, Stanford (Calif.) University, said at the briefing. About 70% or 80% of people use it at the beach or outdoors, he said.
Report background, details
UV filters are the active ingredients in physical as well as chemical sunscreen products. They decrease the amount of UV radiation that reaches the skin. They have been found in water, sediments, and marine organisms, both saltwater and freshwater.
Currently, 17 UV filters are used in U.S. sunscreens; 15 of those are organic, such as oxybenzone and avobenzone, and are used in chemical sunscreens. They work by absorbing the rays before they damage the skin. In addition, two inorganic filters, which are used in physical sunscreens, sit on the skin and as a shield to block the rays.
UV filters enter bodies of water by direct release, as when sunscreens rinse off people while swimming or while engaging in other water activities. They also enter bodies of water in storm water runoff and wastewater.
Lab toxicity tests, which are the most widely used, provide effects data for ecologic risk assessment. The tests are more often used in the study of short-term, not long-term exposure. Test results have shown that in high enough concentrations, some UV filters can be toxic to algal, invertebrate, and fish species.
But much information is lacking, the experts said. Toxicity data for many species, for instance, are limited. There are few studies on the longer-term environmental effects of UV filter exposure. Not enough is known about the rate at which the filters degrade in the environment. The filters accumulate in higher amounts in different areas. Recreational water areas have higher concentrations.
The recommendations
The panel is urging the EPA to complete a formal risk assessment of the UV filters “with some urgency,” Dr. Cullen said. That will enable decisions to be made about the use of the products. The risks to aquatic life must be balanced against the need for sun protection to reduce skin cancer risk.
The experts made two recommendations:
- The EPA should conduct ecologic risk assessments for all the UV filters now marketed and for all new ones. The assessment should evaluate the filters individually as well as the risk from co-occurring filters. The assessments should take into account the different exposure scenarios.
- The EPA, along with partner agencies, and sunscreen and UV filter manufacturers should fund, support, and conduct research and share data. Research should include study of human health outcomes if usage and availability of sunscreens change.
Dermatologists should “continue to emphasize the importance of protection from UV radiation in every way that can be done,” Dr. Cullen said, including the use of sunscreen as well as other protective practices, such as wearing long sleeves and hats, seeking shade, and avoiding the sun during peak hours.
A dermatologist’s perspective
“I applaud their scientific curiosity to know one way or the other whether this is an issue,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC. “I welcome this investigation.”
The multitude of studies, Dr. Friedman said, don’t always agree about whether the filters pose dangers. He noted that the concentration of UV filters detected in water is often lower than the concentrations found to be harmful in a lab setting to marine life, specifically coral.
However, he said, “these studies are snapshots.” For that reason, calling for more assessment of risk is desirable, Dr. Friedman said, but “I want to be sure the call to do more research is not an admission of guilt. It’s very easy to vilify sunscreens – but the facts we know are that UV light causes skin cancer and aging, and sunscreen protects us against this.”
Dr. Friedman has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The , an expert panel of the National Academies of Sciences, Engineering, and Medicine (NAS) said on Aug. 9.
The assessment is urgently needed, the experts said, and the results should be shared with the Food and Drug Administration, which oversees sunscreens.
In its 400-page report, titled the Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health, the panel does not make recommendations but suggests that such an EPA risk assessment should highlight gaps in knowledge.
“We are teeing up the critical information that will be used to take on the challenge of risk assessment,” Charles A. Menzie, PhD, chair of the committee that wrote the report, said at a media briefing Aug. 9 when the report was released. Dr. Menzie is a principal at Exponent, Inc., an engineering and scientific consulting firm. He is former executive director of the Society of Environmental Toxicology and Chemistry.
The EPA sponsored the study, which was conducted by a committee of the National Academy of Sciences, a nonprofit, nongovernmental organization authorized by Congress that studies issues related to science, technology, and medicine.
Balancing aquatic, human health concerns
Such an EPA assessment, Dr. Menzie said in a statement, will help inform efforts to understand the environmental effects of UV filters as well as clarify a path forward for managing sunscreens. For years, concerns have been raised about the potential toxicity of sunscreens regarding many marine and freshwater aquatic organisms, especially coral. That concern, however, must be balanced against the benefits of sunscreens, which are known to protect against skin cancer. A low percentage of people use sunscreen regularly, Dr. Menzie and other panel members said.
“Only about a third of the U.S. population regularly uses sunscreen,” Mark Cullen, MD, vice chair of the NAS committee and former director of the Center for Population Health Sciences, Stanford (Calif.) University, said at the briefing. About 70% or 80% of people use it at the beach or outdoors, he said.
Report background, details
UV filters are the active ingredients in physical as well as chemical sunscreen products. They decrease the amount of UV radiation that reaches the skin. They have been found in water, sediments, and marine organisms, both saltwater and freshwater.
Currently, 17 UV filters are used in U.S. sunscreens; 15 of those are organic, such as oxybenzone and avobenzone, and are used in chemical sunscreens. They work by absorbing the rays before they damage the skin. In addition, two inorganic filters, which are used in physical sunscreens, sit on the skin and as a shield to block the rays.
UV filters enter bodies of water by direct release, as when sunscreens rinse off people while swimming or while engaging in other water activities. They also enter bodies of water in storm water runoff and wastewater.
Lab toxicity tests, which are the most widely used, provide effects data for ecologic risk assessment. The tests are more often used in the study of short-term, not long-term exposure. Test results have shown that in high enough concentrations, some UV filters can be toxic to algal, invertebrate, and fish species.
But much information is lacking, the experts said. Toxicity data for many species, for instance, are limited. There are few studies on the longer-term environmental effects of UV filter exposure. Not enough is known about the rate at which the filters degrade in the environment. The filters accumulate in higher amounts in different areas. Recreational water areas have higher concentrations.
The recommendations
The panel is urging the EPA to complete a formal risk assessment of the UV filters “with some urgency,” Dr. Cullen said. That will enable decisions to be made about the use of the products. The risks to aquatic life must be balanced against the need for sun protection to reduce skin cancer risk.
The experts made two recommendations:
- The EPA should conduct ecologic risk assessments for all the UV filters now marketed and for all new ones. The assessment should evaluate the filters individually as well as the risk from co-occurring filters. The assessments should take into account the different exposure scenarios.
- The EPA, along with partner agencies, and sunscreen and UV filter manufacturers should fund, support, and conduct research and share data. Research should include study of human health outcomes if usage and availability of sunscreens change.
Dermatologists should “continue to emphasize the importance of protection from UV radiation in every way that can be done,” Dr. Cullen said, including the use of sunscreen as well as other protective practices, such as wearing long sleeves and hats, seeking shade, and avoiding the sun during peak hours.
A dermatologist’s perspective
“I applaud their scientific curiosity to know one way or the other whether this is an issue,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC. “I welcome this investigation.”
The multitude of studies, Dr. Friedman said, don’t always agree about whether the filters pose dangers. He noted that the concentration of UV filters detected in water is often lower than the concentrations found to be harmful in a lab setting to marine life, specifically coral.
However, he said, “these studies are snapshots.” For that reason, calling for more assessment of risk is desirable, Dr. Friedman said, but “I want to be sure the call to do more research is not an admission of guilt. It’s very easy to vilify sunscreens – but the facts we know are that UV light causes skin cancer and aging, and sunscreen protects us against this.”
Dr. Friedman has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The , an expert panel of the National Academies of Sciences, Engineering, and Medicine (NAS) said on Aug. 9.
The assessment is urgently needed, the experts said, and the results should be shared with the Food and Drug Administration, which oversees sunscreens.
In its 400-page report, titled the Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health, the panel does not make recommendations but suggests that such an EPA risk assessment should highlight gaps in knowledge.
“We are teeing up the critical information that will be used to take on the challenge of risk assessment,” Charles A. Menzie, PhD, chair of the committee that wrote the report, said at a media briefing Aug. 9 when the report was released. Dr. Menzie is a principal at Exponent, Inc., an engineering and scientific consulting firm. He is former executive director of the Society of Environmental Toxicology and Chemistry.
The EPA sponsored the study, which was conducted by a committee of the National Academy of Sciences, a nonprofit, nongovernmental organization authorized by Congress that studies issues related to science, technology, and medicine.
Balancing aquatic, human health concerns
Such an EPA assessment, Dr. Menzie said in a statement, will help inform efforts to understand the environmental effects of UV filters as well as clarify a path forward for managing sunscreens. For years, concerns have been raised about the potential toxicity of sunscreens regarding many marine and freshwater aquatic organisms, especially coral. That concern, however, must be balanced against the benefits of sunscreens, which are known to protect against skin cancer. A low percentage of people use sunscreen regularly, Dr. Menzie and other panel members said.
“Only about a third of the U.S. population regularly uses sunscreen,” Mark Cullen, MD, vice chair of the NAS committee and former director of the Center for Population Health Sciences, Stanford (Calif.) University, said at the briefing. About 70% or 80% of people use it at the beach or outdoors, he said.
Report background, details
UV filters are the active ingredients in physical as well as chemical sunscreen products. They decrease the amount of UV radiation that reaches the skin. They have been found in water, sediments, and marine organisms, both saltwater and freshwater.
Currently, 17 UV filters are used in U.S. sunscreens; 15 of those are organic, such as oxybenzone and avobenzone, and are used in chemical sunscreens. They work by absorbing the rays before they damage the skin. In addition, two inorganic filters, which are used in physical sunscreens, sit on the skin and as a shield to block the rays.
UV filters enter bodies of water by direct release, as when sunscreens rinse off people while swimming or while engaging in other water activities. They also enter bodies of water in storm water runoff and wastewater.
Lab toxicity tests, which are the most widely used, provide effects data for ecologic risk assessment. The tests are more often used in the study of short-term, not long-term exposure. Test results have shown that in high enough concentrations, some UV filters can be toxic to algal, invertebrate, and fish species.
But much information is lacking, the experts said. Toxicity data for many species, for instance, are limited. There are few studies on the longer-term environmental effects of UV filter exposure. Not enough is known about the rate at which the filters degrade in the environment. The filters accumulate in higher amounts in different areas. Recreational water areas have higher concentrations.
The recommendations
The panel is urging the EPA to complete a formal risk assessment of the UV filters “with some urgency,” Dr. Cullen said. That will enable decisions to be made about the use of the products. The risks to aquatic life must be balanced against the need for sun protection to reduce skin cancer risk.
The experts made two recommendations:
- The EPA should conduct ecologic risk assessments for all the UV filters now marketed and for all new ones. The assessment should evaluate the filters individually as well as the risk from co-occurring filters. The assessments should take into account the different exposure scenarios.
- The EPA, along with partner agencies, and sunscreen and UV filter manufacturers should fund, support, and conduct research and share data. Research should include study of human health outcomes if usage and availability of sunscreens change.
Dermatologists should “continue to emphasize the importance of protection from UV radiation in every way that can be done,” Dr. Cullen said, including the use of sunscreen as well as other protective practices, such as wearing long sleeves and hats, seeking shade, and avoiding the sun during peak hours.
A dermatologist’s perspective
“I applaud their scientific curiosity to know one way or the other whether this is an issue,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, DC. “I welcome this investigation.”
The multitude of studies, Dr. Friedman said, don’t always agree about whether the filters pose dangers. He noted that the concentration of UV filters detected in water is often lower than the concentrations found to be harmful in a lab setting to marine life, specifically coral.
However, he said, “these studies are snapshots.” For that reason, calling for more assessment of risk is desirable, Dr. Friedman said, but “I want to be sure the call to do more research is not an admission of guilt. It’s very easy to vilify sunscreens – but the facts we know are that UV light causes skin cancer and aging, and sunscreen protects us against this.”
Dr. Friedman has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Firm Exophytic Tumor on the Shin
The Diagnosis: Leiomyosarcoma
Cutaneous leiomyosarcomas are relatively rare neoplasms that favor the head, neck, and extremities of older adults.1 Dermal leiomyosarcomas originate from arrector pili and are locally aggressive, whereas subcutaneous leiomyosarcomas arise from vascular smooth muscle and metastasize in 30% to 60% of cases.2 Clinically, leiomyosarcomas present as solitary, firm, well-circumscribed nodules with possible ulceration and crusting.3 Histopathology of leiomyosarcoma shows fascicles of atypical spindle cells with blunt-ended nuclei and perinuclear glycogen vacuoles, variable atypia, and mitotic figures (quiz images). Definitive diagnosis is based on positive immunohistochemical staining for desmin and smooth muscle actin.4 Treatment entails complete removal via wide local excision or Mohs micrographic surgery.5
Atypical fibroxanthoma (AFX) is a malignant fibrohistiocytic neoplasm that arises in the dermis and preferentially affects the head and neck in older individuals.3 Atypical fibroxanthoma presents as a nonspecific, pinkred, sometimes ulcerated papule on sun-damaged skin that may clinically resemble a squamous cell carcinoma (SCC) or basal cell carcinoma.6 Histopathology shows pleomorphic spindle cells with hyperchromatic nuclei and abundant cytoplasm mixed with multinucleated giant cells and scattered mitotic figures (Figure 1). Immunohistochemistry is essential for distinguishing AFX from other spindle cell neoplasms. Atypical fibroxanthoma stains positively for vimentin, procollagen-1, CD10, and CD68 but is negative for S-100, human melanoma black 45, Melan-A, desmin, cytokeratin, p40, and p63.6 Treatment includes wide local excision or Mohs micrographic surgery.
Melanoma is an aggressive cancer with the propensity to metastasize. Both desmoplastic and spindle cell variants demonstrate atypical spindled melanocytes on histology, and desmoplasia is seen in the desmoplastic variant (Figure 2). In some cases, evaluation of the epidermis for melanoma in situ may aid in diagnosis.7 Clinical and prognostic features differ between the 2 variants. Desmoplastic melanomas usually present on the head and neck as scarlike nodules with a low rate of nodal involvement, while spindle cell melanomas can occur anywhere on the body, often are amelanotic, and are associated with widespread metastatic disease at the time of presentation.8 SOX10 (SRY-box transcription factor 10) and S-100 may be the only markers that are positive in desmoplastic melanoma.9,10 Treatment depends on the thickness of the lesion.11
Spindle cell SCC is a histologic variant of SCC characterized by spindled epithelial cells. Spindle cell SCC typically presents as an ulcerated or exophytic mass in sun-exposed areas or areas exposed to ionizing radiation, or in immunocompromised individuals. Histopathology shows spindled pleomorphic keratinocytes with elongated nuclei infiltrating the dermis and minimal keratinization (Figure 3).12 Immunohistochemistry is necessary to distinguish spindle cell SCC from other spindle cell tumors such as spindle cell melanoma, AFX, and leiomyosarcoma. Spindle cell SCC is positive for high-molecular-weight cytokeratin, p40, and p63. Mohs micrographic surgery provides the highest cure rate, and radiation therapy may be considered when clear surgical margins cannot be obtained.6
Undifferentiated pleomorphic sarcoma (UPS) (formerly known as malignant fibrous histiocytoma) describes tumors that resemble AFX but are more invasive. They commonly involve the soft tissue with a higher risk for both recurrence and metastasis than AFX.13 Histopathology shows marked cytologic pleomorphism, bizarre cellular forms, atypical mitoses, and ulceration (Figure 4).14 Diagnosis of UPS is by exclusion and is dependent on immunohistochemical studies. In contrast to AFX, UPS is more likely to be positive for LN-2 (CD74).6 Undifferentiated pleomorphic sarcoma has been treated with surgical excision in combination with chemical and radiation therapy, but due to limited data, optimal management is less clear compared to AFX.15 There is a substantial risk for local recurrence and metastasis, and the lungs are the most common sites of distant metastasis.13 In a study of 23 individuals with high-grade UPS, 5-year metastasis-free survival and local recurrence-free survival were 26% and 16%, respectively.10
- Massi D, Franchi A, Alos L, et al. Primary cutaneous leiomyosarcoma: clinicopathological analysis of 36 cases. Histopathology. 2010;56: 251-262. doi:10.1111/j.1365-2559.2009.03471.x
- Ciurea ME, Georgescu CV, Radu CC, et al. Cutaneous leiomyosarcoma—case report [published online June 25, 2014]. J Med Life. 2014;7:270-273.
- Fleury LFF, Sanches JA. Primary cutaneous sarcomas. An Bras Dermatol. 2006;81:207-221. doi:10.1590/s0365-05962006000300002
- Murback NDN, de Castro BC, Takita LC, et al. Cutaneous leiomyosarcoma on the face. An Bras Dermatol. 2018;93:262-264. doi:10.1590 /abd1806-4841.20186715
- Winchester DS, Hocker TL, Brewer JD, et al. Leiomyosarcoma of the skin: clinical, histopathologic, and prognostic factors that influence outcomes. J Am Acad Dermatol. 2014;71:919-925. doi:10.1016/j .jaad.2014.07.020
- Hollmig ST, Sachdev R, Cockerell CJ, et al. Spindle cell neoplasms encountered in dermatologic surgery: a review. Dermatol Surg. 2012;38:825-850. doi:10.1111/j.1524-4725.2012.02296.x
- De Almeida LS, Requena L, Rütten A, et al. Desmoplastic malignant melanoma: a clinicopathologic analysis of 113 cases. Am J Dermatopathol. 2008;30:207-215. doi:10.1097/DAD.0B013E3181716E6B
- Weissinger SE, Keil P, Silvers DN, et al. A diagnostic algorithm to distinguish desmoplastic from spindle cell melanoma. Mod Pathol. 2014;27:524-534. doi:10.1038/modpathol.2013.162
- Ohsie SJ, Sarantopoulos GP, Cochran AJ, et al. Immunohistochemical characteristics of melanoma. J Cutan Pathol. 2008;35:433-444. doi:10.1111/j.1600-0560.2007.00891.x
- Delisca GO, Mesko NW, Alamanda VK, et al. MFH and highgrade undifferentiated pleomorphic sarcoma—what’s in a name? [published online September 12, 2014]. J Surg Oncol. 2015;111:173-177. doi:10.1002/jso.23787
- Baron PL, Nguyen CL. Malignant of melanoma. In: Holzheimer RG, Mannick JA, eds. Surgical Treatment: Evidence-Based and Problem- Oriented. Zuckschwerdt; 2001. https://www.ncbi.nlm.nih.gov/books /NBK6877
- Wernheden E, Trøstrup H, Pedersen Pilt A. Unusual presentation of cutaneous spindle cell squamous cell carcinoma: a case report. Case Rep Dermatol. 2020;12:70-75. doi:10.1159/000507358
- Ramsey JK, Chen JL, Schoenfield L, et al. Undifferentiated pleomorphic sarcoma metastatic to the orbit. Ophthal Plast Reconstr Surg. 2018;34:E193-E195. doi:10.1097/IOP.0000000000001240
- Winchester D, Lehman J, Tello T, et al. Undifferentiated pleomorphic sarcoma: factors predictive of adverse outcomes. J Am Acad Dermatol. 2018;79:853-859. doi:10.1016/j.jaad.2018.05.022
- Soleymani T, Tyler Hollmig S. Conception and management of a poorly understood spectrum of dermatologic neoplasms: atypical fibroxanthoma, pleomorphic dermal sarcoma, and undifferentiated pleomorphic sarcoma. Curr Treat Options Oncol. 2017;18:50. doi:10.1007 /s11864-017-0489-6
The Diagnosis: Leiomyosarcoma
Cutaneous leiomyosarcomas are relatively rare neoplasms that favor the head, neck, and extremities of older adults.1 Dermal leiomyosarcomas originate from arrector pili and are locally aggressive, whereas subcutaneous leiomyosarcomas arise from vascular smooth muscle and metastasize in 30% to 60% of cases.2 Clinically, leiomyosarcomas present as solitary, firm, well-circumscribed nodules with possible ulceration and crusting.3 Histopathology of leiomyosarcoma shows fascicles of atypical spindle cells with blunt-ended nuclei and perinuclear glycogen vacuoles, variable atypia, and mitotic figures (quiz images). Definitive diagnosis is based on positive immunohistochemical staining for desmin and smooth muscle actin.4 Treatment entails complete removal via wide local excision or Mohs micrographic surgery.5
Atypical fibroxanthoma (AFX) is a malignant fibrohistiocytic neoplasm that arises in the dermis and preferentially affects the head and neck in older individuals.3 Atypical fibroxanthoma presents as a nonspecific, pinkred, sometimes ulcerated papule on sun-damaged skin that may clinically resemble a squamous cell carcinoma (SCC) or basal cell carcinoma.6 Histopathology shows pleomorphic spindle cells with hyperchromatic nuclei and abundant cytoplasm mixed with multinucleated giant cells and scattered mitotic figures (Figure 1). Immunohistochemistry is essential for distinguishing AFX from other spindle cell neoplasms. Atypical fibroxanthoma stains positively for vimentin, procollagen-1, CD10, and CD68 but is negative for S-100, human melanoma black 45, Melan-A, desmin, cytokeratin, p40, and p63.6 Treatment includes wide local excision or Mohs micrographic surgery.
Melanoma is an aggressive cancer with the propensity to metastasize. Both desmoplastic and spindle cell variants demonstrate atypical spindled melanocytes on histology, and desmoplasia is seen in the desmoplastic variant (Figure 2). In some cases, evaluation of the epidermis for melanoma in situ may aid in diagnosis.7 Clinical and prognostic features differ between the 2 variants. Desmoplastic melanomas usually present on the head and neck as scarlike nodules with a low rate of nodal involvement, while spindle cell melanomas can occur anywhere on the body, often are amelanotic, and are associated with widespread metastatic disease at the time of presentation.8 SOX10 (SRY-box transcription factor 10) and S-100 may be the only markers that are positive in desmoplastic melanoma.9,10 Treatment depends on the thickness of the lesion.11
Spindle cell SCC is a histologic variant of SCC characterized by spindled epithelial cells. Spindle cell SCC typically presents as an ulcerated or exophytic mass in sun-exposed areas or areas exposed to ionizing radiation, or in immunocompromised individuals. Histopathology shows spindled pleomorphic keratinocytes with elongated nuclei infiltrating the dermis and minimal keratinization (Figure 3).12 Immunohistochemistry is necessary to distinguish spindle cell SCC from other spindle cell tumors such as spindle cell melanoma, AFX, and leiomyosarcoma. Spindle cell SCC is positive for high-molecular-weight cytokeratin, p40, and p63. Mohs micrographic surgery provides the highest cure rate, and radiation therapy may be considered when clear surgical margins cannot be obtained.6
Undifferentiated pleomorphic sarcoma (UPS) (formerly known as malignant fibrous histiocytoma) describes tumors that resemble AFX but are more invasive. They commonly involve the soft tissue with a higher risk for both recurrence and metastasis than AFX.13 Histopathology shows marked cytologic pleomorphism, bizarre cellular forms, atypical mitoses, and ulceration (Figure 4).14 Diagnosis of UPS is by exclusion and is dependent on immunohistochemical studies. In contrast to AFX, UPS is more likely to be positive for LN-2 (CD74).6 Undifferentiated pleomorphic sarcoma has been treated with surgical excision in combination with chemical and radiation therapy, but due to limited data, optimal management is less clear compared to AFX.15 There is a substantial risk for local recurrence and metastasis, and the lungs are the most common sites of distant metastasis.13 In a study of 23 individuals with high-grade UPS, 5-year metastasis-free survival and local recurrence-free survival were 26% and 16%, respectively.10
The Diagnosis: Leiomyosarcoma
Cutaneous leiomyosarcomas are relatively rare neoplasms that favor the head, neck, and extremities of older adults.1 Dermal leiomyosarcomas originate from arrector pili and are locally aggressive, whereas subcutaneous leiomyosarcomas arise from vascular smooth muscle and metastasize in 30% to 60% of cases.2 Clinically, leiomyosarcomas present as solitary, firm, well-circumscribed nodules with possible ulceration and crusting.3 Histopathology of leiomyosarcoma shows fascicles of atypical spindle cells with blunt-ended nuclei and perinuclear glycogen vacuoles, variable atypia, and mitotic figures (quiz images). Definitive diagnosis is based on positive immunohistochemical staining for desmin and smooth muscle actin.4 Treatment entails complete removal via wide local excision or Mohs micrographic surgery.5
Atypical fibroxanthoma (AFX) is a malignant fibrohistiocytic neoplasm that arises in the dermis and preferentially affects the head and neck in older individuals.3 Atypical fibroxanthoma presents as a nonspecific, pinkred, sometimes ulcerated papule on sun-damaged skin that may clinically resemble a squamous cell carcinoma (SCC) or basal cell carcinoma.6 Histopathology shows pleomorphic spindle cells with hyperchromatic nuclei and abundant cytoplasm mixed with multinucleated giant cells and scattered mitotic figures (Figure 1). Immunohistochemistry is essential for distinguishing AFX from other spindle cell neoplasms. Atypical fibroxanthoma stains positively for vimentin, procollagen-1, CD10, and CD68 but is negative for S-100, human melanoma black 45, Melan-A, desmin, cytokeratin, p40, and p63.6 Treatment includes wide local excision or Mohs micrographic surgery.
Melanoma is an aggressive cancer with the propensity to metastasize. Both desmoplastic and spindle cell variants demonstrate atypical spindled melanocytes on histology, and desmoplasia is seen in the desmoplastic variant (Figure 2). In some cases, evaluation of the epidermis for melanoma in situ may aid in diagnosis.7 Clinical and prognostic features differ between the 2 variants. Desmoplastic melanomas usually present on the head and neck as scarlike nodules with a low rate of nodal involvement, while spindle cell melanomas can occur anywhere on the body, often are amelanotic, and are associated with widespread metastatic disease at the time of presentation.8 SOX10 (SRY-box transcription factor 10) and S-100 may be the only markers that are positive in desmoplastic melanoma.9,10 Treatment depends on the thickness of the lesion.11
Spindle cell SCC is a histologic variant of SCC characterized by spindled epithelial cells. Spindle cell SCC typically presents as an ulcerated or exophytic mass in sun-exposed areas or areas exposed to ionizing radiation, or in immunocompromised individuals. Histopathology shows spindled pleomorphic keratinocytes with elongated nuclei infiltrating the dermis and minimal keratinization (Figure 3).12 Immunohistochemistry is necessary to distinguish spindle cell SCC from other spindle cell tumors such as spindle cell melanoma, AFX, and leiomyosarcoma. Spindle cell SCC is positive for high-molecular-weight cytokeratin, p40, and p63. Mohs micrographic surgery provides the highest cure rate, and radiation therapy may be considered when clear surgical margins cannot be obtained.6
Undifferentiated pleomorphic sarcoma (UPS) (formerly known as malignant fibrous histiocytoma) describes tumors that resemble AFX but are more invasive. They commonly involve the soft tissue with a higher risk for both recurrence and metastasis than AFX.13 Histopathology shows marked cytologic pleomorphism, bizarre cellular forms, atypical mitoses, and ulceration (Figure 4).14 Diagnosis of UPS is by exclusion and is dependent on immunohistochemical studies. In contrast to AFX, UPS is more likely to be positive for LN-2 (CD74).6 Undifferentiated pleomorphic sarcoma has been treated with surgical excision in combination with chemical and radiation therapy, but due to limited data, optimal management is less clear compared to AFX.15 There is a substantial risk for local recurrence and metastasis, and the lungs are the most common sites of distant metastasis.13 In a study of 23 individuals with high-grade UPS, 5-year metastasis-free survival and local recurrence-free survival were 26% and 16%, respectively.10
- Massi D, Franchi A, Alos L, et al. Primary cutaneous leiomyosarcoma: clinicopathological analysis of 36 cases. Histopathology. 2010;56: 251-262. doi:10.1111/j.1365-2559.2009.03471.x
- Ciurea ME, Georgescu CV, Radu CC, et al. Cutaneous leiomyosarcoma—case report [published online June 25, 2014]. J Med Life. 2014;7:270-273.
- Fleury LFF, Sanches JA. Primary cutaneous sarcomas. An Bras Dermatol. 2006;81:207-221. doi:10.1590/s0365-05962006000300002
- Murback NDN, de Castro BC, Takita LC, et al. Cutaneous leiomyosarcoma on the face. An Bras Dermatol. 2018;93:262-264. doi:10.1590 /abd1806-4841.20186715
- Winchester DS, Hocker TL, Brewer JD, et al. Leiomyosarcoma of the skin: clinical, histopathologic, and prognostic factors that influence outcomes. J Am Acad Dermatol. 2014;71:919-925. doi:10.1016/j .jaad.2014.07.020
- Hollmig ST, Sachdev R, Cockerell CJ, et al. Spindle cell neoplasms encountered in dermatologic surgery: a review. Dermatol Surg. 2012;38:825-850. doi:10.1111/j.1524-4725.2012.02296.x
- De Almeida LS, Requena L, Rütten A, et al. Desmoplastic malignant melanoma: a clinicopathologic analysis of 113 cases. Am J Dermatopathol. 2008;30:207-215. doi:10.1097/DAD.0B013E3181716E6B
- Weissinger SE, Keil P, Silvers DN, et al. A diagnostic algorithm to distinguish desmoplastic from spindle cell melanoma. Mod Pathol. 2014;27:524-534. doi:10.1038/modpathol.2013.162
- Ohsie SJ, Sarantopoulos GP, Cochran AJ, et al. Immunohistochemical characteristics of melanoma. J Cutan Pathol. 2008;35:433-444. doi:10.1111/j.1600-0560.2007.00891.x
- Delisca GO, Mesko NW, Alamanda VK, et al. MFH and highgrade undifferentiated pleomorphic sarcoma—what’s in a name? [published online September 12, 2014]. J Surg Oncol. 2015;111:173-177. doi:10.1002/jso.23787
- Baron PL, Nguyen CL. Malignant of melanoma. In: Holzheimer RG, Mannick JA, eds. Surgical Treatment: Evidence-Based and Problem- Oriented. Zuckschwerdt; 2001. https://www.ncbi.nlm.nih.gov/books /NBK6877
- Wernheden E, Trøstrup H, Pedersen Pilt A. Unusual presentation of cutaneous spindle cell squamous cell carcinoma: a case report. Case Rep Dermatol. 2020;12:70-75. doi:10.1159/000507358
- Ramsey JK, Chen JL, Schoenfield L, et al. Undifferentiated pleomorphic sarcoma metastatic to the orbit. Ophthal Plast Reconstr Surg. 2018;34:E193-E195. doi:10.1097/IOP.0000000000001240
- Winchester D, Lehman J, Tello T, et al. Undifferentiated pleomorphic sarcoma: factors predictive of adverse outcomes. J Am Acad Dermatol. 2018;79:853-859. doi:10.1016/j.jaad.2018.05.022
- Soleymani T, Tyler Hollmig S. Conception and management of a poorly understood spectrum of dermatologic neoplasms: atypical fibroxanthoma, pleomorphic dermal sarcoma, and undifferentiated pleomorphic sarcoma. Curr Treat Options Oncol. 2017;18:50. doi:10.1007 /s11864-017-0489-6
- Massi D, Franchi A, Alos L, et al. Primary cutaneous leiomyosarcoma: clinicopathological analysis of 36 cases. Histopathology. 2010;56: 251-262. doi:10.1111/j.1365-2559.2009.03471.x
- Ciurea ME, Georgescu CV, Radu CC, et al. Cutaneous leiomyosarcoma—case report [published online June 25, 2014]. J Med Life. 2014;7:270-273.
- Fleury LFF, Sanches JA. Primary cutaneous sarcomas. An Bras Dermatol. 2006;81:207-221. doi:10.1590/s0365-05962006000300002
- Murback NDN, de Castro BC, Takita LC, et al. Cutaneous leiomyosarcoma on the face. An Bras Dermatol. 2018;93:262-264. doi:10.1590 /abd1806-4841.20186715
- Winchester DS, Hocker TL, Brewer JD, et al. Leiomyosarcoma of the skin: clinical, histopathologic, and prognostic factors that influence outcomes. J Am Acad Dermatol. 2014;71:919-925. doi:10.1016/j .jaad.2014.07.020
- Hollmig ST, Sachdev R, Cockerell CJ, et al. Spindle cell neoplasms encountered in dermatologic surgery: a review. Dermatol Surg. 2012;38:825-850. doi:10.1111/j.1524-4725.2012.02296.x
- De Almeida LS, Requena L, Rütten A, et al. Desmoplastic malignant melanoma: a clinicopathologic analysis of 113 cases. Am J Dermatopathol. 2008;30:207-215. doi:10.1097/DAD.0B013E3181716E6B
- Weissinger SE, Keil P, Silvers DN, et al. A diagnostic algorithm to distinguish desmoplastic from spindle cell melanoma. Mod Pathol. 2014;27:524-534. doi:10.1038/modpathol.2013.162
- Ohsie SJ, Sarantopoulos GP, Cochran AJ, et al. Immunohistochemical characteristics of melanoma. J Cutan Pathol. 2008;35:433-444. doi:10.1111/j.1600-0560.2007.00891.x
- Delisca GO, Mesko NW, Alamanda VK, et al. MFH and highgrade undifferentiated pleomorphic sarcoma—what’s in a name? [published online September 12, 2014]. J Surg Oncol. 2015;111:173-177. doi:10.1002/jso.23787
- Baron PL, Nguyen CL. Malignant of melanoma. In: Holzheimer RG, Mannick JA, eds. Surgical Treatment: Evidence-Based and Problem- Oriented. Zuckschwerdt; 2001. https://www.ncbi.nlm.nih.gov/books /NBK6877
- Wernheden E, Trøstrup H, Pedersen Pilt A. Unusual presentation of cutaneous spindle cell squamous cell carcinoma: a case report. Case Rep Dermatol. 2020;12:70-75. doi:10.1159/000507358
- Ramsey JK, Chen JL, Schoenfield L, et al. Undifferentiated pleomorphic sarcoma metastatic to the orbit. Ophthal Plast Reconstr Surg. 2018;34:E193-E195. doi:10.1097/IOP.0000000000001240
- Winchester D, Lehman J, Tello T, et al. Undifferentiated pleomorphic sarcoma: factors predictive of adverse outcomes. J Am Acad Dermatol. 2018;79:853-859. doi:10.1016/j.jaad.2018.05.022
- Soleymani T, Tyler Hollmig S. Conception and management of a poorly understood spectrum of dermatologic neoplasms: atypical fibroxanthoma, pleomorphic dermal sarcoma, and undifferentiated pleomorphic sarcoma. Curr Treat Options Oncol. 2017;18:50. doi:10.1007 /s11864-017-0489-6
A 62-year-old man presented with a firm, exophytic, 2.8×1.5-cm tumor on the left shin of 6 to 7 years’ duration. An excisional biopsy was obtained for histopathologic evaluation.
FDA acts against sales of unapproved mole and skin tag products on Amazon, other sites
according to a press release issued on Aug. 9.
In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.
Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.
Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.
The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.
“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.
The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.
Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.
Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.
The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.
according to a press release issued on Aug. 9.
In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.
Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.
Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.
The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.
“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.
The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.
Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.
Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.
The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.
according to a press release issued on Aug. 9.
In addition to Amazon.com, the other two companies are Ariella Naturals, and Justified Laboratories.
Currently, no over-the-counter products are FDA-approved for the at-home removal of moles and skin tags, and use of unapproved products could be dangerous to consumers, according to the statement. These products may be sold as ointments, gels, sticks, or liquids, and may contain high concentrations of salicylic acid or other harmful ingredients. Introducing unapproved products in to interstate commerce violates the Federal Food, Drug, and Cosmetic Act.
Two products sold on Amazon are the “Deisana Skin Tag Remover, Mole Remover and Repair Gel Set” and “Skincell Mole Skin Tag Corrector Serum,” according to the letter sent to Amazon.
The warning letters alert the three companies that they have 15 days from receipt to address any violations. However, warning letters are not a final FDA action, according to the statement.
“The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law,” he added.
The statement emphasized that moles should be evaluated by a health care professional, as attempts at self-diagnosis and at-home treatment could lead to a delayed cancer diagnosis, and potentially to cancer progression.
Products marketed to consumers for at-home removal of moles, skin tags, and other skin lesions could cause injuries, infections, and scarring, according to a related consumer update first posted by the FDA in June, which was updated after the warning letters were sent out.
Consumers and health care professionals are encouraged to report any adverse events related to mole removal or skin tag removal products to the agency’s MedWatch Adverse Event Reporting program.
The FDA also offers an online guide, BeSafeRx, with advice for consumers about potential risks of using online pharmacies and how to do so safely.
Audit Proof Your Mohs Note
In October 2020, Medicare released an updated guidance to reduce Mohs micrographic surgery (MMS) reimbursement issues,1 which initially was released in 2013. This guidance defines the latest performance and documentation requirements that Medicare requires for MMS. Understanding these requirements and making sure that your Mohs surgical reports have all the needed documentation details are critical because auditors from not only Medicare Administrative Contractors (MACs) but also private insurers and Medicare Advantage plans have adopted these standards and will deny payment for Mohs surgical codes if they are not met. This article provides a review of the updated Medicare requirements to make sure your MMS procedure notes are audit proof.
Notes Must Indicate Mohs Is the Most Appropriate Treatment
I review many of my colleagues’ Mohs notes and can tell you that some of the requirements laid out in the updated guidance typically are already reported by Mohs surgeons in their notes, including the location, number, and size of the lesion or lesions treated and the number of stages performed. However, there are some new requirements that often are not reported by Mohs surgeons that now need to be included. The guidance indicates the following:
The majority of skin cancers can be managed by simple excision or destruction techniques. The medical record of a patient undergoing MMS should clearly show that this procedure was chosen because of the complexity (eg, poorly defined clinical borders, possible deep invasion, prior irradiation), size or location (eg, maximum conservation of tumor-free tissue is important). Medicare will consider reimbursement for MMS for accepted diagnoses and indications, which you must document in the patient’s medical record as being appropriate for MMS and that MMS is the most appropriate choice for the treatment of a particular lesion.1
In my experience, most Mohs notes include some statement that the skin cancer treated is appropriate based on the Mohs appropriate use criteria (AUC) or the AUC score. However, notes should make clear not just that the lesion treated is “appropriate” for MMS but also that it is the most appropriate treatment (eg, why the lesion was not managed by standard excision or destruction technique).
Mohs Surgeon Must Perform the Surgery and Interpret Slides
The updated guidance clearly indicates that MMS may only be performed by a physician who is specifically trained and highly skilled in Mohs techniques and pathologic identification: “Medicare will only reimburse for MMS services when the Mohs surgeon acts as both surgeon and pathologist.”1 Mohs micrographic surgery codes may not be billed if preparation or interpretation of the pathology slides is performed by a physician other than the Mohs surgeon. Operative notes and pathology documentation in the patient’s medical record should clearly show that MMS was performed using an accepted MMS technique in which the physician acts in 2 integrated and distinct capacities—surgeon and pathologist—thereby confirming that the procedure meets the definition of the Current Procedural Terminology code(s).
Furthermore, the Mohs operative report should detail “the number of specimens per stage.”1 I interpret this statement to indicate that the Mohs surgeon should document the number of tissue blocks examined in each stage of Mohs surgery. For example, a statement in the notes such as “the specimen from the first Mohs stage was oriented, mapped, and divided into 4 blocks” should suffice to meet this requirement.
Histologic Description Must Be Included in Mohs Notes
Medicare will require the Mohs surgeon to document “the histology of the specimens taken. That description should include depth of invasion, pathological pattern, cell morphology, and, if present, perineural invasion or presence of scar tissue.”1 Although this histologic description requirement appears daunting, it is common for Mohs surgeons to indicate their pathologic findings on their Mohs map such as “NBCC” next to a red area to indicate “nodular basal cell carcinoma visualized.” A template-based system to translate typical pathologic findings can be employed to rapidly and accurately populate a Mohs note with histologic description such as “NBBC=nodular aggregates of palisaded basaloid epithelial tumor arising from the epidermis forming a palisade with a cleft forming from the adjacent mucinous stroma extending to the mid dermis. Centrally the nuclei become crowded with scattered mitotic figures and necrotic bodies evident.”
Recent Improvement for 1-Stage Mohs Surgeries
The most notable improvement in the
Final Thoughts
Overall, the updated Medicare guidance provides important details in the requirements for performance and documentation of Mohs surgery cases. However, additional critical information will be found in Mohs coverage policies and local coverage determinations (LCDs) from MACs and private insurers.2-4 Each LCD and insurer Mohs payment policy has unique wording and requirements. Coverage of MMS for specific malignant diagnoses, histologic subtypes, locations, and clinical scenarios varies between LCDs; most are based directly on the Mohs AUC, while others have a less specific coverage criteria. To understand the specific documentation and coverage requirements of the MAC for a particular region or private insurer, Mohs surgeons are encouraged to familiarize themselves with the Mohs surgery LCD of their local MAC and coverage policies of their insurers and to ensure their documentation substantiates these requirements. Making sure that your MMS documentation is accurate and complies with Medicare and insurer requirements will keep you out of hot water with auditors and allow reimbursement for this critical skin cancer procedure.
- Centers for Disease Control and Prevention. Guidance to reduce Mohs surgery reimbursement issues. MLN Matters. Published October 27, 2020. Accessed July 18, 2022. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1318.pdf
- Mohs micrographic surgery policy, professional. United Healthcare website. Accessed July 12, 2022. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/COMM-Mohs-Micrographic-Surgery-Policy.pdf#:~:text=This%20policy%20describes%20reimbursement%20guidelines%20for%20reporting%20Mohs,CCI%20Editing%20Policy%20and%20the%20Laboratory%20Services%20Policy.
- Clinical UM guideline—Mohs micrographic surgery. Anthem Insurance Companies website. Published October 6, 2021. Accessed July 27, 2022. https://www.anthem.com/dam/medpolicies/abcbs/active/guidelines/gl_pw_d085074.html
- Local coverage determinations. Centers for Medicare and Medicaid Services website. Updated July 12, 2022. Accessed July 12, 2022. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/LCDs
In October 2020, Medicare released an updated guidance to reduce Mohs micrographic surgery (MMS) reimbursement issues,1 which initially was released in 2013. This guidance defines the latest performance and documentation requirements that Medicare requires for MMS. Understanding these requirements and making sure that your Mohs surgical reports have all the needed documentation details are critical because auditors from not only Medicare Administrative Contractors (MACs) but also private insurers and Medicare Advantage plans have adopted these standards and will deny payment for Mohs surgical codes if they are not met. This article provides a review of the updated Medicare requirements to make sure your MMS procedure notes are audit proof.
Notes Must Indicate Mohs Is the Most Appropriate Treatment
I review many of my colleagues’ Mohs notes and can tell you that some of the requirements laid out in the updated guidance typically are already reported by Mohs surgeons in their notes, including the location, number, and size of the lesion or lesions treated and the number of stages performed. However, there are some new requirements that often are not reported by Mohs surgeons that now need to be included. The guidance indicates the following:
The majority of skin cancers can be managed by simple excision or destruction techniques. The medical record of a patient undergoing MMS should clearly show that this procedure was chosen because of the complexity (eg, poorly defined clinical borders, possible deep invasion, prior irradiation), size or location (eg, maximum conservation of tumor-free tissue is important). Medicare will consider reimbursement for MMS for accepted diagnoses and indications, which you must document in the patient’s medical record as being appropriate for MMS and that MMS is the most appropriate choice for the treatment of a particular lesion.1
In my experience, most Mohs notes include some statement that the skin cancer treated is appropriate based on the Mohs appropriate use criteria (AUC) or the AUC score. However, notes should make clear not just that the lesion treated is “appropriate” for MMS but also that it is the most appropriate treatment (eg, why the lesion was not managed by standard excision or destruction technique).
Mohs Surgeon Must Perform the Surgery and Interpret Slides
The updated guidance clearly indicates that MMS may only be performed by a physician who is specifically trained and highly skilled in Mohs techniques and pathologic identification: “Medicare will only reimburse for MMS services when the Mohs surgeon acts as both surgeon and pathologist.”1 Mohs micrographic surgery codes may not be billed if preparation or interpretation of the pathology slides is performed by a physician other than the Mohs surgeon. Operative notes and pathology documentation in the patient’s medical record should clearly show that MMS was performed using an accepted MMS technique in which the physician acts in 2 integrated and distinct capacities—surgeon and pathologist—thereby confirming that the procedure meets the definition of the Current Procedural Terminology code(s).
Furthermore, the Mohs operative report should detail “the number of specimens per stage.”1 I interpret this statement to indicate that the Mohs surgeon should document the number of tissue blocks examined in each stage of Mohs surgery. For example, a statement in the notes such as “the specimen from the first Mohs stage was oriented, mapped, and divided into 4 blocks” should suffice to meet this requirement.
Histologic Description Must Be Included in Mohs Notes
Medicare will require the Mohs surgeon to document “the histology of the specimens taken. That description should include depth of invasion, pathological pattern, cell morphology, and, if present, perineural invasion or presence of scar tissue.”1 Although this histologic description requirement appears daunting, it is common for Mohs surgeons to indicate their pathologic findings on their Mohs map such as “NBCC” next to a red area to indicate “nodular basal cell carcinoma visualized.” A template-based system to translate typical pathologic findings can be employed to rapidly and accurately populate a Mohs note with histologic description such as “NBBC=nodular aggregates of palisaded basaloid epithelial tumor arising from the epidermis forming a palisade with a cleft forming from the adjacent mucinous stroma extending to the mid dermis. Centrally the nuclei become crowded with scattered mitotic figures and necrotic bodies evident.”
Recent Improvement for 1-Stage Mohs Surgeries
The most notable improvement in the
Final Thoughts
Overall, the updated Medicare guidance provides important details in the requirements for performance and documentation of Mohs surgery cases. However, additional critical information will be found in Mohs coverage policies and local coverage determinations (LCDs) from MACs and private insurers.2-4 Each LCD and insurer Mohs payment policy has unique wording and requirements. Coverage of MMS for specific malignant diagnoses, histologic subtypes, locations, and clinical scenarios varies between LCDs; most are based directly on the Mohs AUC, while others have a less specific coverage criteria. To understand the specific documentation and coverage requirements of the MAC for a particular region or private insurer, Mohs surgeons are encouraged to familiarize themselves with the Mohs surgery LCD of their local MAC and coverage policies of their insurers and to ensure their documentation substantiates these requirements. Making sure that your MMS documentation is accurate and complies with Medicare and insurer requirements will keep you out of hot water with auditors and allow reimbursement for this critical skin cancer procedure.
In October 2020, Medicare released an updated guidance to reduce Mohs micrographic surgery (MMS) reimbursement issues,1 which initially was released in 2013. This guidance defines the latest performance and documentation requirements that Medicare requires for MMS. Understanding these requirements and making sure that your Mohs surgical reports have all the needed documentation details are critical because auditors from not only Medicare Administrative Contractors (MACs) but also private insurers and Medicare Advantage plans have adopted these standards and will deny payment for Mohs surgical codes if they are not met. This article provides a review of the updated Medicare requirements to make sure your MMS procedure notes are audit proof.
Notes Must Indicate Mohs Is the Most Appropriate Treatment
I review many of my colleagues’ Mohs notes and can tell you that some of the requirements laid out in the updated guidance typically are already reported by Mohs surgeons in their notes, including the location, number, and size of the lesion or lesions treated and the number of stages performed. However, there are some new requirements that often are not reported by Mohs surgeons that now need to be included. The guidance indicates the following:
The majority of skin cancers can be managed by simple excision or destruction techniques. The medical record of a patient undergoing MMS should clearly show that this procedure was chosen because of the complexity (eg, poorly defined clinical borders, possible deep invasion, prior irradiation), size or location (eg, maximum conservation of tumor-free tissue is important). Medicare will consider reimbursement for MMS for accepted diagnoses and indications, which you must document in the patient’s medical record as being appropriate for MMS and that MMS is the most appropriate choice for the treatment of a particular lesion.1
In my experience, most Mohs notes include some statement that the skin cancer treated is appropriate based on the Mohs appropriate use criteria (AUC) or the AUC score. However, notes should make clear not just that the lesion treated is “appropriate” for MMS but also that it is the most appropriate treatment (eg, why the lesion was not managed by standard excision or destruction technique).
Mohs Surgeon Must Perform the Surgery and Interpret Slides
The updated guidance clearly indicates that MMS may only be performed by a physician who is specifically trained and highly skilled in Mohs techniques and pathologic identification: “Medicare will only reimburse for MMS services when the Mohs surgeon acts as both surgeon and pathologist.”1 Mohs micrographic surgery codes may not be billed if preparation or interpretation of the pathology slides is performed by a physician other than the Mohs surgeon. Operative notes and pathology documentation in the patient’s medical record should clearly show that MMS was performed using an accepted MMS technique in which the physician acts in 2 integrated and distinct capacities—surgeon and pathologist—thereby confirming that the procedure meets the definition of the Current Procedural Terminology code(s).
Furthermore, the Mohs operative report should detail “the number of specimens per stage.”1 I interpret this statement to indicate that the Mohs surgeon should document the number of tissue blocks examined in each stage of Mohs surgery. For example, a statement in the notes such as “the specimen from the first Mohs stage was oriented, mapped, and divided into 4 blocks” should suffice to meet this requirement.
Histologic Description Must Be Included in Mohs Notes
Medicare will require the Mohs surgeon to document “the histology of the specimens taken. That description should include depth of invasion, pathological pattern, cell morphology, and, if present, perineural invasion or presence of scar tissue.”1 Although this histologic description requirement appears daunting, it is common for Mohs surgeons to indicate their pathologic findings on their Mohs map such as “NBCC” next to a red area to indicate “nodular basal cell carcinoma visualized.” A template-based system to translate typical pathologic findings can be employed to rapidly and accurately populate a Mohs note with histologic description such as “NBBC=nodular aggregates of palisaded basaloid epithelial tumor arising from the epidermis forming a palisade with a cleft forming from the adjacent mucinous stroma extending to the mid dermis. Centrally the nuclei become crowded with scattered mitotic figures and necrotic bodies evident.”
Recent Improvement for 1-Stage Mohs Surgeries
The most notable improvement in the
Final Thoughts
Overall, the updated Medicare guidance provides important details in the requirements for performance and documentation of Mohs surgery cases. However, additional critical information will be found in Mohs coverage policies and local coverage determinations (LCDs) from MACs and private insurers.2-4 Each LCD and insurer Mohs payment policy has unique wording and requirements. Coverage of MMS for specific malignant diagnoses, histologic subtypes, locations, and clinical scenarios varies between LCDs; most are based directly on the Mohs AUC, while others have a less specific coverage criteria. To understand the specific documentation and coverage requirements of the MAC for a particular region or private insurer, Mohs surgeons are encouraged to familiarize themselves with the Mohs surgery LCD of their local MAC and coverage policies of their insurers and to ensure their documentation substantiates these requirements. Making sure that your MMS documentation is accurate and complies with Medicare and insurer requirements will keep you out of hot water with auditors and allow reimbursement for this critical skin cancer procedure.
- Centers for Disease Control and Prevention. Guidance to reduce Mohs surgery reimbursement issues. MLN Matters. Published October 27, 2020. Accessed July 18, 2022. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1318.pdf
- Mohs micrographic surgery policy, professional. United Healthcare website. Accessed July 12, 2022. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/COMM-Mohs-Micrographic-Surgery-Policy.pdf#:~:text=This%20policy%20describes%20reimbursement%20guidelines%20for%20reporting%20Mohs,CCI%20Editing%20Policy%20and%20the%20Laboratory%20Services%20Policy.
- Clinical UM guideline—Mohs micrographic surgery. Anthem Insurance Companies website. Published October 6, 2021. Accessed July 27, 2022. https://www.anthem.com/dam/medpolicies/abcbs/active/guidelines/gl_pw_d085074.html
- Local coverage determinations. Centers for Medicare and Medicaid Services website. Updated July 12, 2022. Accessed July 12, 2022. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/LCDs
- Centers for Disease Control and Prevention. Guidance to reduce Mohs surgery reimbursement issues. MLN Matters. Published October 27, 2020. Accessed July 18, 2022. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1318.pdf
- Mohs micrographic surgery policy, professional. United Healthcare website. Accessed July 12, 2022. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-reimbursement/COMM-Mohs-Micrographic-Surgery-Policy.pdf#:~:text=This%20policy%20describes%20reimbursement%20guidelines%20for%20reporting%20Mohs,CCI%20Editing%20Policy%20and%20the%20Laboratory%20Services%20Policy.
- Clinical UM guideline—Mohs micrographic surgery. Anthem Insurance Companies website. Published October 6, 2021. Accessed July 27, 2022. https://www.anthem.com/dam/medpolicies/abcbs/active/guidelines/gl_pw_d085074.html
- Local coverage determinations. Centers for Medicare and Medicaid Services website. Updated July 12, 2022. Accessed July 12, 2022. https://www.cms.gov/Medicare/Coverage/DeterminationProcess/LCDs
Practice Points
- Medicare’s updated guidance for documentation of Mohs micrographic surgery (MMS) includes some new requirements that Mohs surgeons should ensure are implemented in their Mohs records.
- Per Medicare guidance, MMS records should include a justification of why MMS was the most appropriate treatment and a description of the histologic findings from the Mohs slides.
- One major improvement with the updated documentation requirements is that if no tumor is visualized in the first stage of MMS, then no histology description of the tumor is required.
Discrepancies in Skin Cancer Screening Reporting Among Patients, Primary Care Physicians, and Patient Medical Records
Keratinocyte carcinoma (KC), or nonmelanoma skin cancer, is the most commonly diagnosed cancer in the United States.1 Basal cell carcinoma comprises the majority of all KCs.2,3 Squamous cell carcinoma is the second most common skin cancer, representing approximately 20% of KCs and accounting for the majority of KC-related deaths.4-7 Malignant melanoma represents the majority of all skin cancer–related deaths.8 The incidence of basal cell carcinoma, squamous cell carcinoma, and malignant melanoma in the United States is on the rise and carries substantial morbidity and mortality with notable social and economic burdens.1,8-10
Prevention is necessary to reduce skin cancer morbidity and mortality as well as rising treatment costs. The most commonly used skin cancer screening method among dermatologists is the visual full-body skin examination (FBSE), which is a noninvasive, safe, quick, and cost-effective method of early detection and prevention.11 To effectively confront the growing incidence and health care burden of skin cancer, primary care providers (PCPs) must join dermatologists in conducting FBSEs.12,13
Despite being the predominant means of secondary skin cancer prevention, the US Preventive Services Task Force (USPSTF) issued an I rating for insufficient evidence to assess the benefits vs harms of screening the adult general population by PCPs.14,15 A major barrier to studying screening is the lack of a standardized method for conducting and reporting FBSEs.13 Systematic thorough skin examination generally is not performed in the primary care setting.16-18
We aimed to investigate what occurs during an FBSE in the primary care setting and how often they are performed. We examined whether there was potential variation in the execution of the examination, what was perceived by the patient vs reported by the physician, and what was ultimately included in the medical record. Miscommunication between patient and provider regarding performance of FBSEs has previously been noted,17-19 and we sought to characterize and quantify that miscommunication. We hypothesized that there would be lower patient-reported FBSEs compared to physicians and patient medical records. We also hypothesized that there would be variability in how physicians screened for skin cancer.
METHODS
This study was cross-sectional and was conducted based on interviews and a review of medical records at secondary- and tertiary-level units (clinics and hospitals) across the United States. We examined baseline data from a randomized controlled trial of a Web-based skin cancer early detection continuing education course—the Basic Skin Cancer Triage curriculum. Complete details have been described elsewhere.12 This study was approved by the institutional review boards of the Providence Veterans Affairs Medical Center, Rhode Island Hospital, and Brown University (all in Providence, Rhode Island), as well as those of all recruitment sites.
Data were collected from 2005 to 2008 and included physician online surveys, patient telephone interviews, and patient medical record data abstracted by research assistants. Primary care providers included in the study were general internists, family physicians, or medicine-pediatrics practitioners who were recruited from 4 collaborating centers across the United States in the mid-Atlantic region, Ohio, Kansas, and southern California, and who had been in practice for at least a year. Patients were recruited from participating physician practices and selected by research assistants who traveled to each clinic for coordination, recruitment, and performance of medical record reviews. Patients were selected as having minimal risk of melanoma (eg, no signs of severe photodamage to the skin). Patients completed structured telephone surveys within 1 to 2 weeks of the office visit regarding the practices observed and clinical questions asked during their recent clinical encounter with their PCP.
Measures
Demographics—Demographic variables asked of physicians included age, sex, ethnicity, academic degree (MD vs DO), years in practice, training, and prior dermatology training. Demographic information asked of patients included age, sex, ethnicity, education, and household income.
Physician-Reported Examination and Counseling Variables—Physicians were asked to characterize their clinical practices, prompted by questions regarding performance of FBSEs: “Please think of a typical month and using the scale below, indicate how frequently you perform a total body skin exam during an annual exam (eg, periodic follow-up exam).” Physicians responded to 3 questions on a 5-point scale (1=never, 2=sometimes, 3=about half, 4=often, 5=almost always).
Patient-Reported Examination Variables—Patients also were asked to characterize the skin examination experienced in their clinical encounter with their PCP, including: “During your last visit, as far as you could tell, did your physician: (1) look at the skin on your back? (2) look at the skin on your belly area? (3) look at the skin on the back of your legs?” Patient responses were coded as yes, no, don’t know, or refused. Participants who refused were excluded from analysis; participants who responded are detailed in Table 1. In addition, patients also reported the level of undress with their physician by answering the following question: “During your last medical exam, did you: 1=keep your clothes on; 2=partially undress; 3=totally undress except for undergarments; 4=totally undress, including all undergarments?”
Patient Medical Record–Extracted Data—Research assistants used a structured abstract form to extract the information from the patient’s medical record and graded it as 0 (absence) or 1 (presence) from the medical record.
Statistical Analysis
Descriptive statistics included mean and standard deviation (SD) for continuous variables as well as frequency and percentage for categorical variables. Logit/logistic regression analysis was used to predict the odds of patient-reported outcomes that were binary with physician-reported variables as the predictor. Linear regression analysis was used to assess the association between 2 continuous variables. All analyses were conducted using SPSS version 24 (IBM).20 Significance criterion was set at α of .05.
RESULTS Demographics
The final sample included data from 53 physicians and 3343 patients. The study sample mean age (SD) was 50.3 (9.9) years for PCPs (n=53) and 59.8 (16.9) years for patients (n=3343). The physician sample was 36% female and predominantly White (83%). Ninety-one percent of the PCPs had an MD (the remaining had a DO degree), and the mean (SD) years practicing was 21.8 (10.6) years. Seventeen percent of PCPs were trained in internal medicine, 4% in internal medicine and pediatrics, and 79% family medicine; 79% of PCPs had received prior training in dermatology. The patient sample was 58% female, predominantly White (84%), non-Hispanic/Latinx (95%), had completed high school (94%), and earned more than $40,000 annually (66%).
Physician- and Patient-Reported FBSEs
Physicians reported performing FBSEs with variable frequency. Among PCPs who conducted FBSEs with greater frequency, there was a modest increase in the odds that patients reported a particular body part was examined (back: odds ratio [OR], 24.5% [95% CI, 1.18-1.31; P<.001]; abdomen: OR, 23.3% [95% CI, 1.17-1.30; P<.001]; backs of legs: OR, 20.4% [95% CI, 1.13-1.28; P<.001])(Table 1). The patient-reported level of undress during examination was significantly associated with physician-reported FBSE (β=0.16 [95% CI, 0.13-0.18; P<.001])(Table 2).
Because of the bimodal distribution of scores in the physician-reported frequency of FBSEs, particularly pertaining to the extreme points of the scale, we further repeated analysis with only the never and almost always groups (Table 1). Primary care providers who reported almost always for FBSE had 29.6% increased odds of patient-reported back examination (95% CI, 1.00-1.68; P=.048) and 59.3% increased odds of patient-reported abdomen examination (95% CI, 1.23-2.06; P<.001). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having never conducted an FBSE were 56%, 40%, and 26%, respectively. The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having almost always conducted an FBSE were 52%, 51%, and 30%, respectively. Raw percentages were calculated by dividing the number of "yes" responses by participants for each body part examined by thetotal number of participant responses (“yes” and “no”) for each respective body part. There was no significant change in odds of patient-reported backs of legs examined with PCP-reported never vs almost always conducting an FBSE. In addition, a greater patient-reported level of undress was associated with 20.2% increased odds of PCPs reporting almost always conducting an FBSE (95% CI, 1.08-1.34; P=.001).
FBSEs in Patient Medical Records
When comparing PCP-reported FBSE and report of FBSE in patient medical records, there was a 39.0% increased odds of the patient medical record indicating FBSE when physicians reported conducting an FBSE with greater frequency (95% CI, 1.30-1.48; P<.001)(eTable 1). When examining PCP-reported never vs almost always conducting an FBSE, a report of almost always was associated with 79.0% increased odds of the patient medical record indicating that an FBSE was conducted (95% CI, 1.28-2.49; P=.001). The raw percentage of the patient medical record indicating an FBSE was conducted when the PCP reported having never conducted an FBSE was 17% and 26% when the PCP reported having almost always conducted an FBSE.
When comparing the patient-reported body part examined with patient FBSE medical record documentation, an indication of yes for FBSE on the patient medical record was associated with a considerable increase in odds that patients reported a particular body part was examined (back: 91.4% [95% CI, 1.59-2.31; P<.001]; abdomen: 75.0% [95% CI, 1.45-2.11; P<.001]; backs of legs: 91.6% [95% CI, 1.56-2.36; P<.001])(eTable 2). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined vs not examined when the patient medical record indicated an FBSE was completed were 24% vs 14%, 23% vs 15%, and 26% vs 16%, respectively. An increase in patient-reported level of undress was associated with a 57.0% increased odds of their medical record indicating an FBSE was conducted (95% CI, 1.45-1.70; P<.001).
COMMENT How PCPs Perform FBSEs Varies
We found that PCPs performed FBSEs with variable frequency, and among those who did, the patient report of their examination varied considerably (Table 1). There appears to be considerable ambiguity in each of these means of determining the extent to which the skin was inspected for skin cancer, which may render the task of improving such inspection more difficult. We asked patients whether their back, abdomen, and backs of legs were examined as an assessment of some of the variety of areas inspected during an FBSE. During a general well-visit appointment, a patient’s back and abdomen may be examined for multiple reasons. Patients may have misinterpreted elements of the pulmonary, cardiac, abdominal, or musculoskeletal examinations as being part of the FBSE. The back and abdomen—the least specific features of the FBSE—were reported by patients to be the most often examined. Conversely, the backs of the legs—the most specific feature of the FBSE—had the lowest odds of being examined (Table 1).
In addition to the potential limitations of patient awareness of physician activity, our results also could be explained by differences among PCPs in how they performed FBSEs. There is no standardized method of conducting an FBSE. Furthermore, not all medical students and residents are exposed to dermatology training. In our sample of 53 physicians, 79% had reported receiving dermatology training; however, we did not assess the extent to which they had been trained in conducting an FBSE and/or identifying malignant lesions. In an American survey of 659 medical students, more than two-thirds of students had never been trained or never examined a patient for skin cancer.21 In another American survey of 342 internal medicine, family medicine, pediatrics, and obstetrics/gynecology residents across 7 medical schools and 4 residency programs, more than three-quarters of residents had never been trained in skin cancer screening.22 Our findings reflect insufficient and inconsistent training in skin cancer screening and underscore the need for mandatory education to ensure quality FBSEs are performed in the primary care setting.
Frequency of PCPs Performing FBSEs
Similar to prior studies analyzing the frequency of FBSE performance in the primary care setting,16,19,23,24 more than half of our PCP sample reported sometimes to never conducting FBSEs. The percentage of physicians who reported conducting FBSEs in our sample was greater than the proportion reported by the National Health Interview Survey, in which only 8% of patients received an FBSE in the prior year by a PCP or obstetrician/gynecologist,16 but similar to a smaller patient study.19 In that study, 87% of patients, regardless of their skin cancer history, also reported that they would like their PCP to perform an FBSE regularly.19 Although some of our patient participants may have declined an FBSE, it is unlikely that that would have entirely accounted for the relatively low number of PCPs who reported frequently performing FBSEs.
Documentation in Medical Records of FBSEs
Compared to PCP self-reported performance of FBSEs, considerably fewer PCPs marked the patient medical record as having completed an FBSE. Among patients with medical records that indicated an FBSE had been conducted, they reported higher odds of all 3 body parts being examined, the highest being the backs of the legs. Also, when the patient medical record indicated an FBSE had been completed, the odds that the PCP reported an FBSE also were higher. The relatively low medical record documentation of FBSEs highlights the need for more rigorous enforcement of accurate documentation. However, among the cases that were recorded, it appeared that the content of the examinations was more consistent.
Benefits of PCP-Led FBSEs
Although the USPSTF issued an I rating for PCP-led FBSEs,14 multiple national medical societies, including the American Cancer Society,25 American Academy of Dermatology,26 and Skin Cancer Foundation,27 as well as international guidelines in Germany,28 Australia,29,30 and New Zealand,31 recommend regular FBSEs among the general or at-risk population; New Zealand and Australia have the highest incidence and prevalence of melanoma in the world.8 The benefits of physician-led FBSEs on detection of early-stage skin cancer, and in particular, melanoma detection, have been documented in numerous studies.30,32-38 However, the variability and often poor quality of skin screening may contribute in part to the just as numerous null results from prior skin screening studies,15 perpetuating the insufficient status of skin examinations by USPSTF standards.14 Our study underscores both the variability in frequency and content of PCP-administered FBSEs. It also highlights the need for standardization of screening examinations at the medical student, trainee, and physician level.
Study Limitations
The present study has several limitations. First, there was an unknown time lag between the FBSEs and physician self-reported surveys. Similarly, there was a variable time lag between the patient examination encounter and subsequent telephone survey. Both the physician and patient survey data may have been affected by recall bias. Second, patients were not asked directly whether an FBSE had been conducted. Furthermore, patients may not have appreciated whether the body part examined was part of the FBSE or another examination. Also, screenings often were not recorded in the medical record, assuming that the patient report and/or physician report was more accurate than the medical record.
Our study also was limited by demographics; our patient sample was largely comprised of White, educated, US adults, potentially limiting the generalizability of our findings. Conversely, a notable strength of our study was that our participants were recruited from 4 geographically diverse centers. Furthermore, we had a comparatively large sample size of patients and physicians. Also, the independent assessment of provider-reported examinations, objective assessment of medical records, and patient reports of their encounters provides a strong foundation for assessing the independent contributions of each data source.
CONCLUSION
Our study highlights the challenges future studies face in promoting skin cancer screening in the primary care setting. Our findings underscore the need for a standardized FBSE as well as clear clinical expectations regarding skin cancer screening that is expected of PCPs.
As long as skin cancer screening rates remain low in the United States, patients will be subject to potential delays and missed diagnoses, impacting morbidity and mortality.8 There are burgeoning resources and efforts in place to increase skin cancer screening. For example, free validated online training is available for early detection of melanoma and other skin cancers (https://www.visualdx.com/skin-cancer-education/).39-42 Future directions for bolstering screening numbers must focus on educating PCPs about skin cancer prevention and perhaps narrowing the screening population by age-appropriate risk assessments.
- Rogers HW, Weinstock MA, Feldman SR, et al. Incidence estimate of nonmelanoma skin cancer (keratinocyte carcinomas) in the U.S. population, 2012. JAMA Dermatol. 2015;151:1081-1086.
- Marzuka AG, Book SE. Basal cell carcinoma: pathogenesis, epidemiology, clinical features, diagnosis, histopathology, and management. Yale J Biol Med. 2015;88:167-179.
- Dourmishev LA, Rusinova D, Botev I. Clinical variants, stages, and management of basal cell carcinoma. Indian Dermatol Online J. 2013;4:12-17.
- Thompson AK, Kelley BF, Prokop LJ, et al. Risk factors for cutaneous squamous cell carcinoma outcomes: a systematic review and meta-analysis. JAMA Dermatol. 2016;152:419-428.
- Motaparthi K, Kapil JP, Velazquez EF. Cutaneous squamous cell carcinoma: review of the eighth edition of the American Joint Committee on Cancer Staging Guidelines, Prognostic Factors, and Histopathologic Variants. Adv Anat Pathol. 2017;24:171-194.
- Barton V, Armeson K, Hampras S, et al. Nonmelanoma skin cancer and risk of all-cause and cancer-related mortality: a systematic review. Arch Dermatol Res. 2017;309:243-251.
- Weinstock MA, Bogaars HA, Ashley M, et al. Nonmelanoma skin cancer mortality. a population-based study. Arch Dermatol. 1991;127:1194-1197.
- Matthews NH, Li W-Q, Qureshi AA, et al. Epidemiology of melanoma. In: Ward WH, Farma JM, eds. Cutaneous Melanoma: Etiology and Therapy. Codon Publications; 2017:3-22.
- Cakir BO, Adamson P, Cingi C. Epidemiology and economic burden of nonmelanoma skin cancer. Facial Plast Surg Clin North Am. 2012;20:419-422.
- Guy GP, Machlin SR, Ekwueme DU, et al. Prevalence and costs of skin cancer treatment in the U.S., 2002-2006 and 2007-2011. Am J Prev Med. 2015;48:183-187.
- Losina E, Walensky RP, Geller A, et al. Visual screening for malignant melanoma: a cost-effectiveness analysis. Arch Dermatol. 2007;143:21-28.
- Markova A, Weinstock MA, Risica P, et al. Effect of a web-based curriculum on primary care practice: basic skin cancer triage trial. Fam Med. 2013;45:558-568.
- Johnson MM, Leachman SA, Aspinwall LG, et al. Skin cancer screening: recommendations for data-driven screening guidelines and a review of the US Preventive Services Task Force controversy. Melanoma Manag. 2017;4:13-37.
- Agency for Healthcare Research and Quality. Screening for skin cancer in adults: an updated systematic evidence review for the U.S. Preventive Services Task Force. November 30, 2015. Accessed July 25, 2022. http://uspreventiveservicestaskforce.org/Page/Document/draft-evidence-review159/skin-cancer-screening2
- Wernli KJ, Henrikson NB, Morrison CC, et al. Screening for skin cancer in adults: updated evidence report and systematic review forthe US Preventive Services Task Force. JAMA. 2016;316:436-447.
- LeBlanc WG, Vidal L, Kirsner RS, et al. Reported skin cancer screening of US adult workers. J Am Acad Dermatol. 2008;59:55-63.
- Federman DG, Concato J, Caralis PV, et al. Screening for skin cancer in primary care settings. Arch Dermatol. 1997;133:1423-1425.
- Kirsner RS, Muhkerjee S, Federman DG. Skin cancer screening in primary care: prevalence and barriers. J Am Acad Dermatol. 1999;41:564-566.
- Federman DG, Kravetz JD, Tobin DG, et al. Full-body skin examinations: the patient’s perspective. Arch Dermatol. 2004;140:530-534.
- IBM. IBM SPSS Statistics for Windows. IBM Corp; 2015.
- Moore MM, Geller AC, Zhang Z, et al. Skin cancer examination teaching in US medical education. Arch Dermatol. 2006;142:439-444.
- Wise E, Singh D, Moore M, et al. Rates of skin cancer screening and prevention counseling by US medical residents. Arch Dermatol. 2009;145:1131-1136.
- Lakhani NA, Saraiya M, Thompson TD, et al. Total body skin examination for skin cancer screening among U.S. adults from 2000 to 2010. Prev Med. 2014;61:75-80.
- Coups EJ, Geller AC, Weinstock MA, et al. Prevalence and correlates of skin cancer screening among middle-aged and older white adults in the United States. Am J Med. 2010;123:439-445.
- American Cancer Society. Cancer facts & figures 2016. Accessed March 13, 2022. https://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/
- American Academy of Dermatology. Skin cancer incidence rates. Updated April 22, 2022. Accessed August 1, 2022. https://www.aad.org/media/stats-skin-cancer
- Skin Cancer Foundation. Skin cancer prevention. Accessed July 25, 2022. http://skincancer.org/prevention/sun-protection/prevention-guidelines
- Katalinic A, Eisemann N, Waldmann A. Skin cancer screening in Germany. documenting melanoma incidence and mortality from 2008 to 2013. Dtsch Arztebl Int. 2015;112:629-634.
- Cancer Council Australia. Position statement: screening and early detection of skin cancer. Published July 2014. Accessed July 25, 2022. https://dermcoll.edu.au/wp-content/uploads/2014/05/PosStatEarlyDetectSkinCa.pdf
- Royal Australian College of General Practitioners. Guidelines for Preventive Activities in General Practice. 9th ed. The Royal Australian College of General Practitioners; 2016. Accessed July 27, 2022. https://www.racgp.org.au/download/Documents/Guidelines/Redbook9/17048-Red-Book-9th-Edition.pdf
- Cancer Council Australia and Australian Cancer Network and New Zealand Guidelines Group. Clinical Practice Guidelines for the Management of Melanoma in Australia and New Zealand. The Cancer Council Australia and Australian Cancer Network, Sydney and New Zealand Guidelines Group, Wellington; 2008. Accessed July 27, 2022. https://www.health.govt.nz/system/files/documents/publications/melanoma-guideline-nov08-v2.pdf
- Swetter SM, Pollitt RA, Johnson TM, et al. Behavioral determinants of successful early melanoma detection: role of self and physician skin examination. Cancer. 2012;118:3725-3734.
- Terushkin V, Halpern AC. Melanoma early detection. Hematol Oncol Clin North Am. 2009;23:481-500, viii.
- Aitken JF, Elwood M, Baade PD, et al. Clinical whole-body skin examination reduces the incidence of thick melanomas. Int J Cancer. 2010;126:450-458.
- Aitken JF, Elwood JM, Lowe JB, et al. A randomised trial of population screening for melanoma. J Med Screen. 2002;9:33-37.
- Breitbart EW, Waldmann A, Nolte S, et al. Systematic skin cancer screening in Northern Germany. J Am Acad Dermatol. 2012;66:201-211.
- Janda M, Lowe JB, Elwood M, et al. Do centralised skin screening clinics increase participation in melanoma screening (Australia)? Cancer Causes Control. 2006;17:161-168.
- Aitken JF, Janda M, Elwood M, et al. Clinical outcomes from skin screening clinics within a community-based melanoma screening program. J Am Acad Dermatol. 2006;54:105-114.
- Eide MJ, Asgari MM, Fletcher SW, et al. Effects on skills and practice from a web-based skin cancer course for primary care providers. J Am Board Fam Med. 2013;26:648-657.
- Weinstock MA, Ferris LK, Saul MI, et al. Downstream consequences of melanoma screening in a community practice setting: first results. Cancer. 2016;122:3152-3156.
- Matthews NH, Risica PM, Ferris LK, et al. Psychosocial impact of skin biopsies in the setting of melanoma screening: a cross-sectional survey. Br J Dermatol. 2019;180:664-665.
- Risica PM, Matthews NH, Dionne L, et al. Psychosocial consequences of skin cancer screening. Prev Med Rep. 2018;10:310-316.
Keratinocyte carcinoma (KC), or nonmelanoma skin cancer, is the most commonly diagnosed cancer in the United States.1 Basal cell carcinoma comprises the majority of all KCs.2,3 Squamous cell carcinoma is the second most common skin cancer, representing approximately 20% of KCs and accounting for the majority of KC-related deaths.4-7 Malignant melanoma represents the majority of all skin cancer–related deaths.8 The incidence of basal cell carcinoma, squamous cell carcinoma, and malignant melanoma in the United States is on the rise and carries substantial morbidity and mortality with notable social and economic burdens.1,8-10
Prevention is necessary to reduce skin cancer morbidity and mortality as well as rising treatment costs. The most commonly used skin cancer screening method among dermatologists is the visual full-body skin examination (FBSE), which is a noninvasive, safe, quick, and cost-effective method of early detection and prevention.11 To effectively confront the growing incidence and health care burden of skin cancer, primary care providers (PCPs) must join dermatologists in conducting FBSEs.12,13
Despite being the predominant means of secondary skin cancer prevention, the US Preventive Services Task Force (USPSTF) issued an I rating for insufficient evidence to assess the benefits vs harms of screening the adult general population by PCPs.14,15 A major barrier to studying screening is the lack of a standardized method for conducting and reporting FBSEs.13 Systematic thorough skin examination generally is not performed in the primary care setting.16-18
We aimed to investigate what occurs during an FBSE in the primary care setting and how often they are performed. We examined whether there was potential variation in the execution of the examination, what was perceived by the patient vs reported by the physician, and what was ultimately included in the medical record. Miscommunication between patient and provider regarding performance of FBSEs has previously been noted,17-19 and we sought to characterize and quantify that miscommunication. We hypothesized that there would be lower patient-reported FBSEs compared to physicians and patient medical records. We also hypothesized that there would be variability in how physicians screened for skin cancer.
METHODS
This study was cross-sectional and was conducted based on interviews and a review of medical records at secondary- and tertiary-level units (clinics and hospitals) across the United States. We examined baseline data from a randomized controlled trial of a Web-based skin cancer early detection continuing education course—the Basic Skin Cancer Triage curriculum. Complete details have been described elsewhere.12 This study was approved by the institutional review boards of the Providence Veterans Affairs Medical Center, Rhode Island Hospital, and Brown University (all in Providence, Rhode Island), as well as those of all recruitment sites.
Data were collected from 2005 to 2008 and included physician online surveys, patient telephone interviews, and patient medical record data abstracted by research assistants. Primary care providers included in the study were general internists, family physicians, or medicine-pediatrics practitioners who were recruited from 4 collaborating centers across the United States in the mid-Atlantic region, Ohio, Kansas, and southern California, and who had been in practice for at least a year. Patients were recruited from participating physician practices and selected by research assistants who traveled to each clinic for coordination, recruitment, and performance of medical record reviews. Patients were selected as having minimal risk of melanoma (eg, no signs of severe photodamage to the skin). Patients completed structured telephone surveys within 1 to 2 weeks of the office visit regarding the practices observed and clinical questions asked during their recent clinical encounter with their PCP.
Measures
Demographics—Demographic variables asked of physicians included age, sex, ethnicity, academic degree (MD vs DO), years in practice, training, and prior dermatology training. Demographic information asked of patients included age, sex, ethnicity, education, and household income.
Physician-Reported Examination and Counseling Variables—Physicians were asked to characterize their clinical practices, prompted by questions regarding performance of FBSEs: “Please think of a typical month and using the scale below, indicate how frequently you perform a total body skin exam during an annual exam (eg, periodic follow-up exam).” Physicians responded to 3 questions on a 5-point scale (1=never, 2=sometimes, 3=about half, 4=often, 5=almost always).
Patient-Reported Examination Variables—Patients also were asked to characterize the skin examination experienced in their clinical encounter with their PCP, including: “During your last visit, as far as you could tell, did your physician: (1) look at the skin on your back? (2) look at the skin on your belly area? (3) look at the skin on the back of your legs?” Patient responses were coded as yes, no, don’t know, or refused. Participants who refused were excluded from analysis; participants who responded are detailed in Table 1. In addition, patients also reported the level of undress with their physician by answering the following question: “During your last medical exam, did you: 1=keep your clothes on; 2=partially undress; 3=totally undress except for undergarments; 4=totally undress, including all undergarments?”
Patient Medical Record–Extracted Data—Research assistants used a structured abstract form to extract the information from the patient’s medical record and graded it as 0 (absence) or 1 (presence) from the medical record.
Statistical Analysis
Descriptive statistics included mean and standard deviation (SD) for continuous variables as well as frequency and percentage for categorical variables. Logit/logistic regression analysis was used to predict the odds of patient-reported outcomes that were binary with physician-reported variables as the predictor. Linear regression analysis was used to assess the association between 2 continuous variables. All analyses were conducted using SPSS version 24 (IBM).20 Significance criterion was set at α of .05.
RESULTS Demographics
The final sample included data from 53 physicians and 3343 patients. The study sample mean age (SD) was 50.3 (9.9) years for PCPs (n=53) and 59.8 (16.9) years for patients (n=3343). The physician sample was 36% female and predominantly White (83%). Ninety-one percent of the PCPs had an MD (the remaining had a DO degree), and the mean (SD) years practicing was 21.8 (10.6) years. Seventeen percent of PCPs were trained in internal medicine, 4% in internal medicine and pediatrics, and 79% family medicine; 79% of PCPs had received prior training in dermatology. The patient sample was 58% female, predominantly White (84%), non-Hispanic/Latinx (95%), had completed high school (94%), and earned more than $40,000 annually (66%).
Physician- and Patient-Reported FBSEs
Physicians reported performing FBSEs with variable frequency. Among PCPs who conducted FBSEs with greater frequency, there was a modest increase in the odds that patients reported a particular body part was examined (back: odds ratio [OR], 24.5% [95% CI, 1.18-1.31; P<.001]; abdomen: OR, 23.3% [95% CI, 1.17-1.30; P<.001]; backs of legs: OR, 20.4% [95% CI, 1.13-1.28; P<.001])(Table 1). The patient-reported level of undress during examination was significantly associated with physician-reported FBSE (β=0.16 [95% CI, 0.13-0.18; P<.001])(Table 2).
Because of the bimodal distribution of scores in the physician-reported frequency of FBSEs, particularly pertaining to the extreme points of the scale, we further repeated analysis with only the never and almost always groups (Table 1). Primary care providers who reported almost always for FBSE had 29.6% increased odds of patient-reported back examination (95% CI, 1.00-1.68; P=.048) and 59.3% increased odds of patient-reported abdomen examination (95% CI, 1.23-2.06; P<.001). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having never conducted an FBSE were 56%, 40%, and 26%, respectively. The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having almost always conducted an FBSE were 52%, 51%, and 30%, respectively. Raw percentages were calculated by dividing the number of "yes" responses by participants for each body part examined by thetotal number of participant responses (“yes” and “no”) for each respective body part. There was no significant change in odds of patient-reported backs of legs examined with PCP-reported never vs almost always conducting an FBSE. In addition, a greater patient-reported level of undress was associated with 20.2% increased odds of PCPs reporting almost always conducting an FBSE (95% CI, 1.08-1.34; P=.001).
FBSEs in Patient Medical Records
When comparing PCP-reported FBSE and report of FBSE in patient medical records, there was a 39.0% increased odds of the patient medical record indicating FBSE when physicians reported conducting an FBSE with greater frequency (95% CI, 1.30-1.48; P<.001)(eTable 1). When examining PCP-reported never vs almost always conducting an FBSE, a report of almost always was associated with 79.0% increased odds of the patient medical record indicating that an FBSE was conducted (95% CI, 1.28-2.49; P=.001). The raw percentage of the patient medical record indicating an FBSE was conducted when the PCP reported having never conducted an FBSE was 17% and 26% when the PCP reported having almost always conducted an FBSE.
When comparing the patient-reported body part examined with patient FBSE medical record documentation, an indication of yes for FBSE on the patient medical record was associated with a considerable increase in odds that patients reported a particular body part was examined (back: 91.4% [95% CI, 1.59-2.31; P<.001]; abdomen: 75.0% [95% CI, 1.45-2.11; P<.001]; backs of legs: 91.6% [95% CI, 1.56-2.36; P<.001])(eTable 2). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined vs not examined when the patient medical record indicated an FBSE was completed were 24% vs 14%, 23% vs 15%, and 26% vs 16%, respectively. An increase in patient-reported level of undress was associated with a 57.0% increased odds of their medical record indicating an FBSE was conducted (95% CI, 1.45-1.70; P<.001).
COMMENT How PCPs Perform FBSEs Varies
We found that PCPs performed FBSEs with variable frequency, and among those who did, the patient report of their examination varied considerably (Table 1). There appears to be considerable ambiguity in each of these means of determining the extent to which the skin was inspected for skin cancer, which may render the task of improving such inspection more difficult. We asked patients whether their back, abdomen, and backs of legs were examined as an assessment of some of the variety of areas inspected during an FBSE. During a general well-visit appointment, a patient’s back and abdomen may be examined for multiple reasons. Patients may have misinterpreted elements of the pulmonary, cardiac, abdominal, or musculoskeletal examinations as being part of the FBSE. The back and abdomen—the least specific features of the FBSE—were reported by patients to be the most often examined. Conversely, the backs of the legs—the most specific feature of the FBSE—had the lowest odds of being examined (Table 1).
In addition to the potential limitations of patient awareness of physician activity, our results also could be explained by differences among PCPs in how they performed FBSEs. There is no standardized method of conducting an FBSE. Furthermore, not all medical students and residents are exposed to dermatology training. In our sample of 53 physicians, 79% had reported receiving dermatology training; however, we did not assess the extent to which they had been trained in conducting an FBSE and/or identifying malignant lesions. In an American survey of 659 medical students, more than two-thirds of students had never been trained or never examined a patient for skin cancer.21 In another American survey of 342 internal medicine, family medicine, pediatrics, and obstetrics/gynecology residents across 7 medical schools and 4 residency programs, more than three-quarters of residents had never been trained in skin cancer screening.22 Our findings reflect insufficient and inconsistent training in skin cancer screening and underscore the need for mandatory education to ensure quality FBSEs are performed in the primary care setting.
Frequency of PCPs Performing FBSEs
Similar to prior studies analyzing the frequency of FBSE performance in the primary care setting,16,19,23,24 more than half of our PCP sample reported sometimes to never conducting FBSEs. The percentage of physicians who reported conducting FBSEs in our sample was greater than the proportion reported by the National Health Interview Survey, in which only 8% of patients received an FBSE in the prior year by a PCP or obstetrician/gynecologist,16 but similar to a smaller patient study.19 In that study, 87% of patients, regardless of their skin cancer history, also reported that they would like their PCP to perform an FBSE regularly.19 Although some of our patient participants may have declined an FBSE, it is unlikely that that would have entirely accounted for the relatively low number of PCPs who reported frequently performing FBSEs.
Documentation in Medical Records of FBSEs
Compared to PCP self-reported performance of FBSEs, considerably fewer PCPs marked the patient medical record as having completed an FBSE. Among patients with medical records that indicated an FBSE had been conducted, they reported higher odds of all 3 body parts being examined, the highest being the backs of the legs. Also, when the patient medical record indicated an FBSE had been completed, the odds that the PCP reported an FBSE also were higher. The relatively low medical record documentation of FBSEs highlights the need for more rigorous enforcement of accurate documentation. However, among the cases that were recorded, it appeared that the content of the examinations was more consistent.
Benefits of PCP-Led FBSEs
Although the USPSTF issued an I rating for PCP-led FBSEs,14 multiple national medical societies, including the American Cancer Society,25 American Academy of Dermatology,26 and Skin Cancer Foundation,27 as well as international guidelines in Germany,28 Australia,29,30 and New Zealand,31 recommend regular FBSEs among the general or at-risk population; New Zealand and Australia have the highest incidence and prevalence of melanoma in the world.8 The benefits of physician-led FBSEs on detection of early-stage skin cancer, and in particular, melanoma detection, have been documented in numerous studies.30,32-38 However, the variability and often poor quality of skin screening may contribute in part to the just as numerous null results from prior skin screening studies,15 perpetuating the insufficient status of skin examinations by USPSTF standards.14 Our study underscores both the variability in frequency and content of PCP-administered FBSEs. It also highlights the need for standardization of screening examinations at the medical student, trainee, and physician level.
Study Limitations
The present study has several limitations. First, there was an unknown time lag between the FBSEs and physician self-reported surveys. Similarly, there was a variable time lag between the patient examination encounter and subsequent telephone survey. Both the physician and patient survey data may have been affected by recall bias. Second, patients were not asked directly whether an FBSE had been conducted. Furthermore, patients may not have appreciated whether the body part examined was part of the FBSE or another examination. Also, screenings often were not recorded in the medical record, assuming that the patient report and/or physician report was more accurate than the medical record.
Our study also was limited by demographics; our patient sample was largely comprised of White, educated, US adults, potentially limiting the generalizability of our findings. Conversely, a notable strength of our study was that our participants were recruited from 4 geographically diverse centers. Furthermore, we had a comparatively large sample size of patients and physicians. Also, the independent assessment of provider-reported examinations, objective assessment of medical records, and patient reports of their encounters provides a strong foundation for assessing the independent contributions of each data source.
CONCLUSION
Our study highlights the challenges future studies face in promoting skin cancer screening in the primary care setting. Our findings underscore the need for a standardized FBSE as well as clear clinical expectations regarding skin cancer screening that is expected of PCPs.
As long as skin cancer screening rates remain low in the United States, patients will be subject to potential delays and missed diagnoses, impacting morbidity and mortality.8 There are burgeoning resources and efforts in place to increase skin cancer screening. For example, free validated online training is available for early detection of melanoma and other skin cancers (https://www.visualdx.com/skin-cancer-education/).39-42 Future directions for bolstering screening numbers must focus on educating PCPs about skin cancer prevention and perhaps narrowing the screening population by age-appropriate risk assessments.
Keratinocyte carcinoma (KC), or nonmelanoma skin cancer, is the most commonly diagnosed cancer in the United States.1 Basal cell carcinoma comprises the majority of all KCs.2,3 Squamous cell carcinoma is the second most common skin cancer, representing approximately 20% of KCs and accounting for the majority of KC-related deaths.4-7 Malignant melanoma represents the majority of all skin cancer–related deaths.8 The incidence of basal cell carcinoma, squamous cell carcinoma, and malignant melanoma in the United States is on the rise and carries substantial morbidity and mortality with notable social and economic burdens.1,8-10
Prevention is necessary to reduce skin cancer morbidity and mortality as well as rising treatment costs. The most commonly used skin cancer screening method among dermatologists is the visual full-body skin examination (FBSE), which is a noninvasive, safe, quick, and cost-effective method of early detection and prevention.11 To effectively confront the growing incidence and health care burden of skin cancer, primary care providers (PCPs) must join dermatologists in conducting FBSEs.12,13
Despite being the predominant means of secondary skin cancer prevention, the US Preventive Services Task Force (USPSTF) issued an I rating for insufficient evidence to assess the benefits vs harms of screening the adult general population by PCPs.14,15 A major barrier to studying screening is the lack of a standardized method for conducting and reporting FBSEs.13 Systematic thorough skin examination generally is not performed in the primary care setting.16-18
We aimed to investigate what occurs during an FBSE in the primary care setting and how often they are performed. We examined whether there was potential variation in the execution of the examination, what was perceived by the patient vs reported by the physician, and what was ultimately included in the medical record. Miscommunication between patient and provider regarding performance of FBSEs has previously been noted,17-19 and we sought to characterize and quantify that miscommunication. We hypothesized that there would be lower patient-reported FBSEs compared to physicians and patient medical records. We also hypothesized that there would be variability in how physicians screened for skin cancer.
METHODS
This study was cross-sectional and was conducted based on interviews and a review of medical records at secondary- and tertiary-level units (clinics and hospitals) across the United States. We examined baseline data from a randomized controlled trial of a Web-based skin cancer early detection continuing education course—the Basic Skin Cancer Triage curriculum. Complete details have been described elsewhere.12 This study was approved by the institutional review boards of the Providence Veterans Affairs Medical Center, Rhode Island Hospital, and Brown University (all in Providence, Rhode Island), as well as those of all recruitment sites.
Data were collected from 2005 to 2008 and included physician online surveys, patient telephone interviews, and patient medical record data abstracted by research assistants. Primary care providers included in the study were general internists, family physicians, or medicine-pediatrics practitioners who were recruited from 4 collaborating centers across the United States in the mid-Atlantic region, Ohio, Kansas, and southern California, and who had been in practice for at least a year. Patients were recruited from participating physician practices and selected by research assistants who traveled to each clinic for coordination, recruitment, and performance of medical record reviews. Patients were selected as having minimal risk of melanoma (eg, no signs of severe photodamage to the skin). Patients completed structured telephone surveys within 1 to 2 weeks of the office visit regarding the practices observed and clinical questions asked during their recent clinical encounter with their PCP.
Measures
Demographics—Demographic variables asked of physicians included age, sex, ethnicity, academic degree (MD vs DO), years in practice, training, and prior dermatology training. Demographic information asked of patients included age, sex, ethnicity, education, and household income.
Physician-Reported Examination and Counseling Variables—Physicians were asked to characterize their clinical practices, prompted by questions regarding performance of FBSEs: “Please think of a typical month and using the scale below, indicate how frequently you perform a total body skin exam during an annual exam (eg, periodic follow-up exam).” Physicians responded to 3 questions on a 5-point scale (1=never, 2=sometimes, 3=about half, 4=often, 5=almost always).
Patient-Reported Examination Variables—Patients also were asked to characterize the skin examination experienced in their clinical encounter with their PCP, including: “During your last visit, as far as you could tell, did your physician: (1) look at the skin on your back? (2) look at the skin on your belly area? (3) look at the skin on the back of your legs?” Patient responses were coded as yes, no, don’t know, or refused. Participants who refused were excluded from analysis; participants who responded are detailed in Table 1. In addition, patients also reported the level of undress with their physician by answering the following question: “During your last medical exam, did you: 1=keep your clothes on; 2=partially undress; 3=totally undress except for undergarments; 4=totally undress, including all undergarments?”
Patient Medical Record–Extracted Data—Research assistants used a structured abstract form to extract the information from the patient’s medical record and graded it as 0 (absence) or 1 (presence) from the medical record.
Statistical Analysis
Descriptive statistics included mean and standard deviation (SD) for continuous variables as well as frequency and percentage for categorical variables. Logit/logistic regression analysis was used to predict the odds of patient-reported outcomes that were binary with physician-reported variables as the predictor. Linear regression analysis was used to assess the association between 2 continuous variables. All analyses were conducted using SPSS version 24 (IBM).20 Significance criterion was set at α of .05.
RESULTS Demographics
The final sample included data from 53 physicians and 3343 patients. The study sample mean age (SD) was 50.3 (9.9) years for PCPs (n=53) and 59.8 (16.9) years for patients (n=3343). The physician sample was 36% female and predominantly White (83%). Ninety-one percent of the PCPs had an MD (the remaining had a DO degree), and the mean (SD) years practicing was 21.8 (10.6) years. Seventeen percent of PCPs were trained in internal medicine, 4% in internal medicine and pediatrics, and 79% family medicine; 79% of PCPs had received prior training in dermatology. The patient sample was 58% female, predominantly White (84%), non-Hispanic/Latinx (95%), had completed high school (94%), and earned more than $40,000 annually (66%).
Physician- and Patient-Reported FBSEs
Physicians reported performing FBSEs with variable frequency. Among PCPs who conducted FBSEs with greater frequency, there was a modest increase in the odds that patients reported a particular body part was examined (back: odds ratio [OR], 24.5% [95% CI, 1.18-1.31; P<.001]; abdomen: OR, 23.3% [95% CI, 1.17-1.30; P<.001]; backs of legs: OR, 20.4% [95% CI, 1.13-1.28; P<.001])(Table 1). The patient-reported level of undress during examination was significantly associated with physician-reported FBSE (β=0.16 [95% CI, 0.13-0.18; P<.001])(Table 2).
Because of the bimodal distribution of scores in the physician-reported frequency of FBSEs, particularly pertaining to the extreme points of the scale, we further repeated analysis with only the never and almost always groups (Table 1). Primary care providers who reported almost always for FBSE had 29.6% increased odds of patient-reported back examination (95% CI, 1.00-1.68; P=.048) and 59.3% increased odds of patient-reported abdomen examination (95% CI, 1.23-2.06; P<.001). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having never conducted an FBSE were 56%, 40%, and 26%, respectively. The raw percentages of patients who reported having their back, abdomen, and backs of legs examined when the PCP reported having almost always conducted an FBSE were 52%, 51%, and 30%, respectively. Raw percentages were calculated by dividing the number of "yes" responses by participants for each body part examined by thetotal number of participant responses (“yes” and “no”) for each respective body part. There was no significant change in odds of patient-reported backs of legs examined with PCP-reported never vs almost always conducting an FBSE. In addition, a greater patient-reported level of undress was associated with 20.2% increased odds of PCPs reporting almost always conducting an FBSE (95% CI, 1.08-1.34; P=.001).
FBSEs in Patient Medical Records
When comparing PCP-reported FBSE and report of FBSE in patient medical records, there was a 39.0% increased odds of the patient medical record indicating FBSE when physicians reported conducting an FBSE with greater frequency (95% CI, 1.30-1.48; P<.001)(eTable 1). When examining PCP-reported never vs almost always conducting an FBSE, a report of almost always was associated with 79.0% increased odds of the patient medical record indicating that an FBSE was conducted (95% CI, 1.28-2.49; P=.001). The raw percentage of the patient medical record indicating an FBSE was conducted when the PCP reported having never conducted an FBSE was 17% and 26% when the PCP reported having almost always conducted an FBSE.
When comparing the patient-reported body part examined with patient FBSE medical record documentation, an indication of yes for FBSE on the patient medical record was associated with a considerable increase in odds that patients reported a particular body part was examined (back: 91.4% [95% CI, 1.59-2.31; P<.001]; abdomen: 75.0% [95% CI, 1.45-2.11; P<.001]; backs of legs: 91.6% [95% CI, 1.56-2.36; P<.001])(eTable 2). The raw percentages of patients who reported having their back, abdomen, and backs of legs examined vs not examined when the patient medical record indicated an FBSE was completed were 24% vs 14%, 23% vs 15%, and 26% vs 16%, respectively. An increase in patient-reported level of undress was associated with a 57.0% increased odds of their medical record indicating an FBSE was conducted (95% CI, 1.45-1.70; P<.001).
COMMENT How PCPs Perform FBSEs Varies
We found that PCPs performed FBSEs with variable frequency, and among those who did, the patient report of their examination varied considerably (Table 1). There appears to be considerable ambiguity in each of these means of determining the extent to which the skin was inspected for skin cancer, which may render the task of improving such inspection more difficult. We asked patients whether their back, abdomen, and backs of legs were examined as an assessment of some of the variety of areas inspected during an FBSE. During a general well-visit appointment, a patient’s back and abdomen may be examined for multiple reasons. Patients may have misinterpreted elements of the pulmonary, cardiac, abdominal, or musculoskeletal examinations as being part of the FBSE. The back and abdomen—the least specific features of the FBSE—were reported by patients to be the most often examined. Conversely, the backs of the legs—the most specific feature of the FBSE—had the lowest odds of being examined (Table 1).
In addition to the potential limitations of patient awareness of physician activity, our results also could be explained by differences among PCPs in how they performed FBSEs. There is no standardized method of conducting an FBSE. Furthermore, not all medical students and residents are exposed to dermatology training. In our sample of 53 physicians, 79% had reported receiving dermatology training; however, we did not assess the extent to which they had been trained in conducting an FBSE and/or identifying malignant lesions. In an American survey of 659 medical students, more than two-thirds of students had never been trained or never examined a patient for skin cancer.21 In another American survey of 342 internal medicine, family medicine, pediatrics, and obstetrics/gynecology residents across 7 medical schools and 4 residency programs, more than three-quarters of residents had never been trained in skin cancer screening.22 Our findings reflect insufficient and inconsistent training in skin cancer screening and underscore the need for mandatory education to ensure quality FBSEs are performed in the primary care setting.
Frequency of PCPs Performing FBSEs
Similar to prior studies analyzing the frequency of FBSE performance in the primary care setting,16,19,23,24 more than half of our PCP sample reported sometimes to never conducting FBSEs. The percentage of physicians who reported conducting FBSEs in our sample was greater than the proportion reported by the National Health Interview Survey, in which only 8% of patients received an FBSE in the prior year by a PCP or obstetrician/gynecologist,16 but similar to a smaller patient study.19 In that study, 87% of patients, regardless of their skin cancer history, also reported that they would like their PCP to perform an FBSE regularly.19 Although some of our patient participants may have declined an FBSE, it is unlikely that that would have entirely accounted for the relatively low number of PCPs who reported frequently performing FBSEs.
Documentation in Medical Records of FBSEs
Compared to PCP self-reported performance of FBSEs, considerably fewer PCPs marked the patient medical record as having completed an FBSE. Among patients with medical records that indicated an FBSE had been conducted, they reported higher odds of all 3 body parts being examined, the highest being the backs of the legs. Also, when the patient medical record indicated an FBSE had been completed, the odds that the PCP reported an FBSE also were higher. The relatively low medical record documentation of FBSEs highlights the need for more rigorous enforcement of accurate documentation. However, among the cases that were recorded, it appeared that the content of the examinations was more consistent.
Benefits of PCP-Led FBSEs
Although the USPSTF issued an I rating for PCP-led FBSEs,14 multiple national medical societies, including the American Cancer Society,25 American Academy of Dermatology,26 and Skin Cancer Foundation,27 as well as international guidelines in Germany,28 Australia,29,30 and New Zealand,31 recommend regular FBSEs among the general or at-risk population; New Zealand and Australia have the highest incidence and prevalence of melanoma in the world.8 The benefits of physician-led FBSEs on detection of early-stage skin cancer, and in particular, melanoma detection, have been documented in numerous studies.30,32-38 However, the variability and often poor quality of skin screening may contribute in part to the just as numerous null results from prior skin screening studies,15 perpetuating the insufficient status of skin examinations by USPSTF standards.14 Our study underscores both the variability in frequency and content of PCP-administered FBSEs. It also highlights the need for standardization of screening examinations at the medical student, trainee, and physician level.
Study Limitations
The present study has several limitations. First, there was an unknown time lag between the FBSEs and physician self-reported surveys. Similarly, there was a variable time lag between the patient examination encounter and subsequent telephone survey. Both the physician and patient survey data may have been affected by recall bias. Second, patients were not asked directly whether an FBSE had been conducted. Furthermore, patients may not have appreciated whether the body part examined was part of the FBSE or another examination. Also, screenings often were not recorded in the medical record, assuming that the patient report and/or physician report was more accurate than the medical record.
Our study also was limited by demographics; our patient sample was largely comprised of White, educated, US adults, potentially limiting the generalizability of our findings. Conversely, a notable strength of our study was that our participants were recruited from 4 geographically diverse centers. Furthermore, we had a comparatively large sample size of patients and physicians. Also, the independent assessment of provider-reported examinations, objective assessment of medical records, and patient reports of their encounters provides a strong foundation for assessing the independent contributions of each data source.
CONCLUSION
Our study highlights the challenges future studies face in promoting skin cancer screening in the primary care setting. Our findings underscore the need for a standardized FBSE as well as clear clinical expectations regarding skin cancer screening that is expected of PCPs.
As long as skin cancer screening rates remain low in the United States, patients will be subject to potential delays and missed diagnoses, impacting morbidity and mortality.8 There are burgeoning resources and efforts in place to increase skin cancer screening. For example, free validated online training is available for early detection of melanoma and other skin cancers (https://www.visualdx.com/skin-cancer-education/).39-42 Future directions for bolstering screening numbers must focus on educating PCPs about skin cancer prevention and perhaps narrowing the screening population by age-appropriate risk assessments.
- Rogers HW, Weinstock MA, Feldman SR, et al. Incidence estimate of nonmelanoma skin cancer (keratinocyte carcinomas) in the U.S. population, 2012. JAMA Dermatol. 2015;151:1081-1086.
- Marzuka AG, Book SE. Basal cell carcinoma: pathogenesis, epidemiology, clinical features, diagnosis, histopathology, and management. Yale J Biol Med. 2015;88:167-179.
- Dourmishev LA, Rusinova D, Botev I. Clinical variants, stages, and management of basal cell carcinoma. Indian Dermatol Online J. 2013;4:12-17.
- Thompson AK, Kelley BF, Prokop LJ, et al. Risk factors for cutaneous squamous cell carcinoma outcomes: a systematic review and meta-analysis. JAMA Dermatol. 2016;152:419-428.
- Motaparthi K, Kapil JP, Velazquez EF. Cutaneous squamous cell carcinoma: review of the eighth edition of the American Joint Committee on Cancer Staging Guidelines, Prognostic Factors, and Histopathologic Variants. Adv Anat Pathol. 2017;24:171-194.
- Barton V, Armeson K, Hampras S, et al. Nonmelanoma skin cancer and risk of all-cause and cancer-related mortality: a systematic review. Arch Dermatol Res. 2017;309:243-251.
- Weinstock MA, Bogaars HA, Ashley M, et al. Nonmelanoma skin cancer mortality. a population-based study. Arch Dermatol. 1991;127:1194-1197.
- Matthews NH, Li W-Q, Qureshi AA, et al. Epidemiology of melanoma. In: Ward WH, Farma JM, eds. Cutaneous Melanoma: Etiology and Therapy. Codon Publications; 2017:3-22.
- Cakir BO, Adamson P, Cingi C. Epidemiology and economic burden of nonmelanoma skin cancer. Facial Plast Surg Clin North Am. 2012;20:419-422.
- Guy GP, Machlin SR, Ekwueme DU, et al. Prevalence and costs of skin cancer treatment in the U.S., 2002-2006 and 2007-2011. Am J Prev Med. 2015;48:183-187.
- Losina E, Walensky RP, Geller A, et al. Visual screening for malignant melanoma: a cost-effectiveness analysis. Arch Dermatol. 2007;143:21-28.
- Markova A, Weinstock MA, Risica P, et al. Effect of a web-based curriculum on primary care practice: basic skin cancer triage trial. Fam Med. 2013;45:558-568.
- Johnson MM, Leachman SA, Aspinwall LG, et al. Skin cancer screening: recommendations for data-driven screening guidelines and a review of the US Preventive Services Task Force controversy. Melanoma Manag. 2017;4:13-37.
- Agency for Healthcare Research and Quality. Screening for skin cancer in adults: an updated systematic evidence review for the U.S. Preventive Services Task Force. November 30, 2015. Accessed July 25, 2022. http://uspreventiveservicestaskforce.org/Page/Document/draft-evidence-review159/skin-cancer-screening2
- Wernli KJ, Henrikson NB, Morrison CC, et al. Screening for skin cancer in adults: updated evidence report and systematic review forthe US Preventive Services Task Force. JAMA. 2016;316:436-447.
- LeBlanc WG, Vidal L, Kirsner RS, et al. Reported skin cancer screening of US adult workers. J Am Acad Dermatol. 2008;59:55-63.
- Federman DG, Concato J, Caralis PV, et al. Screening for skin cancer in primary care settings. Arch Dermatol. 1997;133:1423-1425.
- Kirsner RS, Muhkerjee S, Federman DG. Skin cancer screening in primary care: prevalence and barriers. J Am Acad Dermatol. 1999;41:564-566.
- Federman DG, Kravetz JD, Tobin DG, et al. Full-body skin examinations: the patient’s perspective. Arch Dermatol. 2004;140:530-534.
- IBM. IBM SPSS Statistics for Windows. IBM Corp; 2015.
- Moore MM, Geller AC, Zhang Z, et al. Skin cancer examination teaching in US medical education. Arch Dermatol. 2006;142:439-444.
- Wise E, Singh D, Moore M, et al. Rates of skin cancer screening and prevention counseling by US medical residents. Arch Dermatol. 2009;145:1131-1136.
- Lakhani NA, Saraiya M, Thompson TD, et al. Total body skin examination for skin cancer screening among U.S. adults from 2000 to 2010. Prev Med. 2014;61:75-80.
- Coups EJ, Geller AC, Weinstock MA, et al. Prevalence and correlates of skin cancer screening among middle-aged and older white adults in the United States. Am J Med. 2010;123:439-445.
- American Cancer Society. Cancer facts & figures 2016. Accessed March 13, 2022. https://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/
- American Academy of Dermatology. Skin cancer incidence rates. Updated April 22, 2022. Accessed August 1, 2022. https://www.aad.org/media/stats-skin-cancer
- Skin Cancer Foundation. Skin cancer prevention. Accessed July 25, 2022. http://skincancer.org/prevention/sun-protection/prevention-guidelines
- Katalinic A, Eisemann N, Waldmann A. Skin cancer screening in Germany. documenting melanoma incidence and mortality from 2008 to 2013. Dtsch Arztebl Int. 2015;112:629-634.
- Cancer Council Australia. Position statement: screening and early detection of skin cancer. Published July 2014. Accessed July 25, 2022. https://dermcoll.edu.au/wp-content/uploads/2014/05/PosStatEarlyDetectSkinCa.pdf
- Royal Australian College of General Practitioners. Guidelines for Preventive Activities in General Practice. 9th ed. The Royal Australian College of General Practitioners; 2016. Accessed July 27, 2022. https://www.racgp.org.au/download/Documents/Guidelines/Redbook9/17048-Red-Book-9th-Edition.pdf
- Cancer Council Australia and Australian Cancer Network and New Zealand Guidelines Group. Clinical Practice Guidelines for the Management of Melanoma in Australia and New Zealand. The Cancer Council Australia and Australian Cancer Network, Sydney and New Zealand Guidelines Group, Wellington; 2008. Accessed July 27, 2022. https://www.health.govt.nz/system/files/documents/publications/melanoma-guideline-nov08-v2.pdf
- Swetter SM, Pollitt RA, Johnson TM, et al. Behavioral determinants of successful early melanoma detection: role of self and physician skin examination. Cancer. 2012;118:3725-3734.
- Terushkin V, Halpern AC. Melanoma early detection. Hematol Oncol Clin North Am. 2009;23:481-500, viii.
- Aitken JF, Elwood M, Baade PD, et al. Clinical whole-body skin examination reduces the incidence of thick melanomas. Int J Cancer. 2010;126:450-458.
- Aitken JF, Elwood JM, Lowe JB, et al. A randomised trial of population screening for melanoma. J Med Screen. 2002;9:33-37.
- Breitbart EW, Waldmann A, Nolte S, et al. Systematic skin cancer screening in Northern Germany. J Am Acad Dermatol. 2012;66:201-211.
- Janda M, Lowe JB, Elwood M, et al. Do centralised skin screening clinics increase participation in melanoma screening (Australia)? Cancer Causes Control. 2006;17:161-168.
- Aitken JF, Janda M, Elwood M, et al. Clinical outcomes from skin screening clinics within a community-based melanoma screening program. J Am Acad Dermatol. 2006;54:105-114.
- Eide MJ, Asgari MM, Fletcher SW, et al. Effects on skills and practice from a web-based skin cancer course for primary care providers. J Am Board Fam Med. 2013;26:648-657.
- Weinstock MA, Ferris LK, Saul MI, et al. Downstream consequences of melanoma screening in a community practice setting: first results. Cancer. 2016;122:3152-3156.
- Matthews NH, Risica PM, Ferris LK, et al. Psychosocial impact of skin biopsies in the setting of melanoma screening: a cross-sectional survey. Br J Dermatol. 2019;180:664-665.
- Risica PM, Matthews NH, Dionne L, et al. Psychosocial consequences of skin cancer screening. Prev Med Rep. 2018;10:310-316.
- Rogers HW, Weinstock MA, Feldman SR, et al. Incidence estimate of nonmelanoma skin cancer (keratinocyte carcinomas) in the U.S. population, 2012. JAMA Dermatol. 2015;151:1081-1086.
- Marzuka AG, Book SE. Basal cell carcinoma: pathogenesis, epidemiology, clinical features, diagnosis, histopathology, and management. Yale J Biol Med. 2015;88:167-179.
- Dourmishev LA, Rusinova D, Botev I. Clinical variants, stages, and management of basal cell carcinoma. Indian Dermatol Online J. 2013;4:12-17.
- Thompson AK, Kelley BF, Prokop LJ, et al. Risk factors for cutaneous squamous cell carcinoma outcomes: a systematic review and meta-analysis. JAMA Dermatol. 2016;152:419-428.
- Motaparthi K, Kapil JP, Velazquez EF. Cutaneous squamous cell carcinoma: review of the eighth edition of the American Joint Committee on Cancer Staging Guidelines, Prognostic Factors, and Histopathologic Variants. Adv Anat Pathol. 2017;24:171-194.
- Barton V, Armeson K, Hampras S, et al. Nonmelanoma skin cancer and risk of all-cause and cancer-related mortality: a systematic review. Arch Dermatol Res. 2017;309:243-251.
- Weinstock MA, Bogaars HA, Ashley M, et al. Nonmelanoma skin cancer mortality. a population-based study. Arch Dermatol. 1991;127:1194-1197.
- Matthews NH, Li W-Q, Qureshi AA, et al. Epidemiology of melanoma. In: Ward WH, Farma JM, eds. Cutaneous Melanoma: Etiology and Therapy. Codon Publications; 2017:3-22.
- Cakir BO, Adamson P, Cingi C. Epidemiology and economic burden of nonmelanoma skin cancer. Facial Plast Surg Clin North Am. 2012;20:419-422.
- Guy GP, Machlin SR, Ekwueme DU, et al. Prevalence and costs of skin cancer treatment in the U.S., 2002-2006 and 2007-2011. Am J Prev Med. 2015;48:183-187.
- Losina E, Walensky RP, Geller A, et al. Visual screening for malignant melanoma: a cost-effectiveness analysis. Arch Dermatol. 2007;143:21-28.
- Markova A, Weinstock MA, Risica P, et al. Effect of a web-based curriculum on primary care practice: basic skin cancer triage trial. Fam Med. 2013;45:558-568.
- Johnson MM, Leachman SA, Aspinwall LG, et al. Skin cancer screening: recommendations for data-driven screening guidelines and a review of the US Preventive Services Task Force controversy. Melanoma Manag. 2017;4:13-37.
- Agency for Healthcare Research and Quality. Screening for skin cancer in adults: an updated systematic evidence review for the U.S. Preventive Services Task Force. November 30, 2015. Accessed July 25, 2022. http://uspreventiveservicestaskforce.org/Page/Document/draft-evidence-review159/skin-cancer-screening2
- Wernli KJ, Henrikson NB, Morrison CC, et al. Screening for skin cancer in adults: updated evidence report and systematic review forthe US Preventive Services Task Force. JAMA. 2016;316:436-447.
- LeBlanc WG, Vidal L, Kirsner RS, et al. Reported skin cancer screening of US adult workers. J Am Acad Dermatol. 2008;59:55-63.
- Federman DG, Concato J, Caralis PV, et al. Screening for skin cancer in primary care settings. Arch Dermatol. 1997;133:1423-1425.
- Kirsner RS, Muhkerjee S, Federman DG. Skin cancer screening in primary care: prevalence and barriers. J Am Acad Dermatol. 1999;41:564-566.
- Federman DG, Kravetz JD, Tobin DG, et al. Full-body skin examinations: the patient’s perspective. Arch Dermatol. 2004;140:530-534.
- IBM. IBM SPSS Statistics for Windows. IBM Corp; 2015.
- Moore MM, Geller AC, Zhang Z, et al. Skin cancer examination teaching in US medical education. Arch Dermatol. 2006;142:439-444.
- Wise E, Singh D, Moore M, et al. Rates of skin cancer screening and prevention counseling by US medical residents. Arch Dermatol. 2009;145:1131-1136.
- Lakhani NA, Saraiya M, Thompson TD, et al. Total body skin examination for skin cancer screening among U.S. adults from 2000 to 2010. Prev Med. 2014;61:75-80.
- Coups EJ, Geller AC, Weinstock MA, et al. Prevalence and correlates of skin cancer screening among middle-aged and older white adults in the United States. Am J Med. 2010;123:439-445.
- American Cancer Society. Cancer facts & figures 2016. Accessed March 13, 2022. https://cancer.org/research/cancerfactsstatistics/cancerfactsfigures2016/
- American Academy of Dermatology. Skin cancer incidence rates. Updated April 22, 2022. Accessed August 1, 2022. https://www.aad.org/media/stats-skin-cancer
- Skin Cancer Foundation. Skin cancer prevention. Accessed July 25, 2022. http://skincancer.org/prevention/sun-protection/prevention-guidelines
- Katalinic A, Eisemann N, Waldmann A. Skin cancer screening in Germany. documenting melanoma incidence and mortality from 2008 to 2013. Dtsch Arztebl Int. 2015;112:629-634.
- Cancer Council Australia. Position statement: screening and early detection of skin cancer. Published July 2014. Accessed July 25, 2022. https://dermcoll.edu.au/wp-content/uploads/2014/05/PosStatEarlyDetectSkinCa.pdf
- Royal Australian College of General Practitioners. Guidelines for Preventive Activities in General Practice. 9th ed. The Royal Australian College of General Practitioners; 2016. Accessed July 27, 2022. https://www.racgp.org.au/download/Documents/Guidelines/Redbook9/17048-Red-Book-9th-Edition.pdf
- Cancer Council Australia and Australian Cancer Network and New Zealand Guidelines Group. Clinical Practice Guidelines for the Management of Melanoma in Australia and New Zealand. The Cancer Council Australia and Australian Cancer Network, Sydney and New Zealand Guidelines Group, Wellington; 2008. Accessed July 27, 2022. https://www.health.govt.nz/system/files/documents/publications/melanoma-guideline-nov08-v2.pdf
- Swetter SM, Pollitt RA, Johnson TM, et al. Behavioral determinants of successful early melanoma detection: role of self and physician skin examination. Cancer. 2012;118:3725-3734.
- Terushkin V, Halpern AC. Melanoma early detection. Hematol Oncol Clin North Am. 2009;23:481-500, viii.
- Aitken JF, Elwood M, Baade PD, et al. Clinical whole-body skin examination reduces the incidence of thick melanomas. Int J Cancer. 2010;126:450-458.
- Aitken JF, Elwood JM, Lowe JB, et al. A randomised trial of population screening for melanoma. J Med Screen. 2002;9:33-37.
- Breitbart EW, Waldmann A, Nolte S, et al. Systematic skin cancer screening in Northern Germany. J Am Acad Dermatol. 2012;66:201-211.
- Janda M, Lowe JB, Elwood M, et al. Do centralised skin screening clinics increase participation in melanoma screening (Australia)? Cancer Causes Control. 2006;17:161-168.
- Aitken JF, Janda M, Elwood M, et al. Clinical outcomes from skin screening clinics within a community-based melanoma screening program. J Am Acad Dermatol. 2006;54:105-114.
- Eide MJ, Asgari MM, Fletcher SW, et al. Effects on skills and practice from a web-based skin cancer course for primary care providers. J Am Board Fam Med. 2013;26:648-657.
- Weinstock MA, Ferris LK, Saul MI, et al. Downstream consequences of melanoma screening in a community practice setting: first results. Cancer. 2016;122:3152-3156.
- Matthews NH, Risica PM, Ferris LK, et al. Psychosocial impact of skin biopsies in the setting of melanoma screening: a cross-sectional survey. Br J Dermatol. 2019;180:664-665.
- Risica PM, Matthews NH, Dionne L, et al. Psychosocial consequences of skin cancer screening. Prev Med Rep. 2018;10:310-316.
PRACTICE POINTS
- Dermatologists should be aware of the variability in practice and execution of full-body skin examinations (FBSEs) among primary care providers and offer comprehensive examinations for every patient.
- Variability in reporting and execution of FBSEs may impact the continued US Preventive Services Task Force I rating in their guidelines and promotion of skin cancer screening in the primary care setting.
Devices to detect skin cancer: FDA advisers offer mixed views
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So far, the U.S. Food and Drug Administration has cleared two devices. Both are computer-aided skin lesion classification devices meant to help clinicians assess cases of suspected melanoma.
Both were given a class III designation. That classification is intended for products that are considered to have a high risk of harm because of flawed design or implementation. Many such devices are under development, and there has been a proposal to include these devices in class II, which is less restrictive.
The FDA turned to one of its expert panels for advice. At a meeting held on Aug. 29, experts on the panel offered differing views and expressed concerns about the accuracy of these devices.
This was the second day of meetings of the general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee. On the previous day, the panel held a wide-ranging discussion about expanding use of skin lesion analyzer devices.
The FDA sought the expert panel’s advice concerning a field that appears to be heating up quickly after relatively quiet times.
Two devices have been approved by the FDA so far, but only one is still being promoted – SciBase AB’s Nevisense. The Swedish company announced in May 2020 that it had received FDA approval for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection, an AI-based point-of-care system for the noninvasive evaluation of irregular moles.
The other device, known as MelaFind, was acquired by Strata Skin Sciences, but the company said in 2017 that it discontinued research and development, sales, and support activity related to the device, according to a filing with the Securities and Exchange Commission.
But there’s been a swell in recent years in the number of publications related to the use of AI and machine learning, which could give rise to new tools for aiding in the diagnosis of skin conditions, including cancer. Google is among the companies that are involved in these efforts.
So, the FDA asked the expert panel to discuss a series of questions related to how the agency should weigh the risks of computer-aided devices for melanoma diagnosis. The agency also asked the panel to provide feedback about how well risks associated with such devices and tools might be managed and to offer suggestions.
The discussion at the July 29 meeting spun beyond narrow questions about reclassification of the current class III devices to topics involving emerging technology, such as efforts to apply AI to dermatology.
“Innovation continues. Medical device developers are anxious to plan how they might be able to develop the level of evidence that would meet your expectations” for future products, Binita Ashar, MD, a senior official in FDA’s Center for Devices and Radiological Health, told the panel.
Company CEO backs tougher regulation
Simon Grant, the chief executive of SciBase, which markets Nevisense, the first and only skin cancer–detecting device currently on the U.S. market, sought to make a case for sticking with the tougher class III regulations.
Speaking during the public comment session, Mr. Grant said switching to class II designations would weaken the standards used in clearing products that analyze skin lesions so as to put patients at risk.
Under the FDA’s rules, the agency designates as class III devices that present potential unreasonable risk of illness or injury. Only about 10% of devices fall into this category. Such devices include implantable pacemakers and breast implants, as well as SciBase’s Nevisense.
About 43% of medical devices fall into the class II category, which includes powered wheelchairs and some pregnancy test kits, the FDA website says.
Class I medical devices pose minimal potential for harm and tend to be simpler in design. These include enema kits and elastic bandages, the FDA says.
Mr. Grant told the meeting that in his career he has worked on two class III products and about 20 class II products. (He had previously worked at medical startups Synectics Medical and Neoventa, as well as established multinationals such as Medtronic.)
“I can tell you that – practically – the FDA has many fewer sticks and much less control when it comes to class II devices,” he said. He offered an example of a manufacturer of a class II device having more latitude in making small changes to products without notifying the FDA.
In his hypothetical example, such a change could have unintended consequences, and “with AI systems, small changes can result in large and nonlinear or even random effects,” Mr. Grant said. “But it’s too late if the product is on the market and the harm has already occurred,” he said.
The American Society for Dermatologic Surgery Association also protested the reclassifying of approved computer-aided melanoma detection class III devices.
In a statement posted on the FDA website as part of the materials for the meeting, the ASDSA raised a series of concerns about the prospects of expanded U.S. use of tools for assisting in diagnosing melanoma, including ones that would be marketed to consumers.
“To the extent that algorithms and devices for patient self-diagnosis of skin lesions are already widely available, they should be required to include detailed disclaimers that include that they are for entertainment and educational purposes and not a diagnostic device, that they are not approved by dermatologists or a recognized medical regulatory authority for self-diagnosis,” the ASDSA said.
Devices and algorithms in screening tools “are not highly regulated and remain unproven. They may result in wrong diagnoses, missed diagnoses, or over- or underdiagnosis,” the ASDSA added. “Both patients at low risk and those at high risk are better served by scheduling an in-person examination with a board-certified dermatologist, who can also help them determine the appropriate future skin screening schedule that is most appropriate for them.”
‘Stepping stone’
However, there is strong consumer demand for better information about skin conditions, and many patients face hurdles in going to dermatologists.
Google research has shown that consumers are seeking “a stepping stone” between the information they can easily find online and what they could get from a medical professional, said Lily Peng, MD, PhD, a director of product management for the health AI team at Google. Dr. Peng was a scheduled presenter at the July 29 meeting.
Consumers often are looking for more information on common conditions such as acne and poison ivy, and they sometimes face challenges in getting access to clinicians, she said.
“There are many unmet needs for consumers experiencing skin issues, many of which are lower-acuity conditions. There’s a big opportunity to increase accessibility and relevance of health journeys for consumers,” Dr. Peng said. “We have heard from consumers that they would like to have a self-help tool for nonserious conditions so they can decide when to seek medical attention.”
Dr. Peng’s presentation was not directly related to the question of class II or class III designation for existing products. Instead, her talk served as a glimpse into the work already underway in creating apps and tools for consumers.
Google researchers have published a number of studies in recent years about the use of AI to improve dermatology diagnosis.
A 2020 article reported on Google’s test of a form of AI known as deep learning system (DLS) to provide a differential diagnosis of skin conditions. On 963 validation cases, where a rotating panel of three board-certified dermatologists defined the reference standard, the DLS was noninferior to six other dermatologists and was superior to six primary care physicians (PCPs) and six nurse practitioners (NPs), according to a summary of the article.
A 2021 report published in JAMA Network Open said that use of an AI tool was associated with a higher agreement rate with dermatologists’ reference diagnoses for both PCPs and NPs.
In a 2021 blog post, Google scientists wrote that their AI model that powers a tool for checking skin conditions had earned European clearance, known as a CE mark, as a class I medical device.
SkinVision has an app that the company says “is available worldwide (with the exception of the USA and Canada).” The firm’s website includes a link where people in the United States and Canada can sign up for notifications about when SkinVision will be available in these nations.
‘Not ready for prime time’
The FDA panel did not cast formal votes at the July 29 meeting. Rather, the members engaged in broad discussions about risks and potential benefits of new tools for aiding in the detection of skin cancer.
Among the key issues discussed was a question of whether the FDA could impose requirements and restrictions, known as special controls, to provide “reasonable assurance of safety and effectiveness” for computer-aided devices that provide adjunctive diagnostic information to dermatologists about lesions suspicious for melanoma.
Among the potential special controls would be clinical performance testing in regards to rates of the sensitivity (true-positive rate) and specificity (true-negative rate).
The FDA could also look at requirements on software validation and verification and cybersecurity testing, as well as directions on labeling so as to mitigate risk.
Dermatologists serving on the panel called for caution in proceeding with steps that would make it easier for companies to market tools for aiding in melanoma diagnosis than it would be within the class III framework used for MelaFind and Nevisense.
Many expressed concerns about the need to design studies that would answer questions about how well new tools could accurately identify concerning lesions.
The phrase “not ready for prime time” was used at least three times during the discussion.
FDA panelist Maral Skelsey, MD, a skin cancer specialist from Chevy Chase, Maryland, said that over the years, she had used both Nevisense and MelaFind.
She said she had found MelaFind “unusable,” owing in large part to the high number of false positives it generated. The device also was limited as to where on patients’ bodies it could be used.
However, she spoke with enthusiasm about the prospects for better devices to aid in diagnosis of skin lesions. “It’s an area where we’re on the verge, and we really need these devices. There’s a need for patients to be able to examine themselves, for nondermatologists to be able to assess lesions,” Dr. Skelsey said.
But this field is “just not ready for prime time” yet, even with special controls, Dr. Skelsey said. To loosen approval standards too quickly could be a “detriment to what’s coming down the pipeline,” she said.
“It’s harmful to things that are likely to be around the corner,” she said.
FDA panelist Renata Block, PA-C, who works in a Chicago dermatology practice, pressed for maintaining a class III designation. “We are not ready for prime time yet, though the data that is coming down the pipeline on what we have is quite exciting,” Ms. Block said.
FDA panelist Karla V. Ballman, PhD, a statistician from Weill Cornell Medicine, New York, said there would need to be a clear standard for clinical performance before proceeding toward reclassification of devices for aid in detecting melanoma. “I just don’t think it’s ready for prime time at this point and should remain in class III,” she said.
But there was support from some panelists for the idea of a lower bar for clearance, combined with special controls to ensure patient safety.
In expressing her view, FDA panelist Katalin Roth, MD, JD, professor of medicine, George Washington University, Washington, said she was an outlier in her support for the agency’s view that these risks could be managed and that future tools could allow more patients to take a step on the pathway toward critical diagnoses.
“I deal with a lot of people with cancer as a palliative care physician,” Dr. Roth said. “I think what we’re missing here is the issue of time. Melanoma is a terrible disease, and missing the diagnosis is a terrible thing, but I think special controls would be sufficient to counter the concerns of my colleagues on the committee.”
The FDA’s Dr. Ashar ended the meeting with questions posed to one panelist, Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center in New York.
Dr. Rotemberg has for years been working in the field of research on developing AI and other computer-based tools for detecting and diagnosing melanoma, the deadliest form of skin cancer.
She has been publicly skeptical of the performance of commercial apps that scan moles and other lesions and that claim to identify which are cancerous. A May blog post on the Memorial Sloan Kettering website highlighted a recent British Journal of Dermatology article in which Dr. Rotemberg and coauthors reported on their evaluations of commercial apps. They judged them to be on average only 59% accurate, the blog post said.
However, during an earlier discussion at the meeting, she had spoken more positively about the prospects for using special controls in the near term to mitigate risk, although she said she would have a “very long list” of these requirements.
In the closing exchange with Dr. Ashar, Dr. Rotemberg outlined steps that could potentially ensure the safe use of tools to aid in melanoma screening. These included a need for postmarketing surveillance, which would require evaluation over time of algorithms used in tools meant to detect skin cancer.
“We need to have a mechanism for sampling,” Dr. Rotemberg said. “Most of our data is electronic now anyway, so comparing an algorithm and performance with biopsy results should not be that challenging.”
A version of this article first appeared on Medscape.com.
.
So far, the U.S. Food and Drug Administration has cleared two devices. Both are computer-aided skin lesion classification devices meant to help clinicians assess cases of suspected melanoma.
Both were given a class III designation. That classification is intended for products that are considered to have a high risk of harm because of flawed design or implementation. Many such devices are under development, and there has been a proposal to include these devices in class II, which is less restrictive.
The FDA turned to one of its expert panels for advice. At a meeting held on Aug. 29, experts on the panel offered differing views and expressed concerns about the accuracy of these devices.
This was the second day of meetings of the general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee. On the previous day, the panel held a wide-ranging discussion about expanding use of skin lesion analyzer devices.
The FDA sought the expert panel’s advice concerning a field that appears to be heating up quickly after relatively quiet times.
Two devices have been approved by the FDA so far, but only one is still being promoted – SciBase AB’s Nevisense. The Swedish company announced in May 2020 that it had received FDA approval for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection, an AI-based point-of-care system for the noninvasive evaluation of irregular moles.
The other device, known as MelaFind, was acquired by Strata Skin Sciences, but the company said in 2017 that it discontinued research and development, sales, and support activity related to the device, according to a filing with the Securities and Exchange Commission.
But there’s been a swell in recent years in the number of publications related to the use of AI and machine learning, which could give rise to new tools for aiding in the diagnosis of skin conditions, including cancer. Google is among the companies that are involved in these efforts.
So, the FDA asked the expert panel to discuss a series of questions related to how the agency should weigh the risks of computer-aided devices for melanoma diagnosis. The agency also asked the panel to provide feedback about how well risks associated with such devices and tools might be managed and to offer suggestions.
The discussion at the July 29 meeting spun beyond narrow questions about reclassification of the current class III devices to topics involving emerging technology, such as efforts to apply AI to dermatology.
“Innovation continues. Medical device developers are anxious to plan how they might be able to develop the level of evidence that would meet your expectations” for future products, Binita Ashar, MD, a senior official in FDA’s Center for Devices and Radiological Health, told the panel.
Company CEO backs tougher regulation
Simon Grant, the chief executive of SciBase, which markets Nevisense, the first and only skin cancer–detecting device currently on the U.S. market, sought to make a case for sticking with the tougher class III regulations.
Speaking during the public comment session, Mr. Grant said switching to class II designations would weaken the standards used in clearing products that analyze skin lesions so as to put patients at risk.
Under the FDA’s rules, the agency designates as class III devices that present potential unreasonable risk of illness or injury. Only about 10% of devices fall into this category. Such devices include implantable pacemakers and breast implants, as well as SciBase’s Nevisense.
About 43% of medical devices fall into the class II category, which includes powered wheelchairs and some pregnancy test kits, the FDA website says.
Class I medical devices pose minimal potential for harm and tend to be simpler in design. These include enema kits and elastic bandages, the FDA says.
Mr. Grant told the meeting that in his career he has worked on two class III products and about 20 class II products. (He had previously worked at medical startups Synectics Medical and Neoventa, as well as established multinationals such as Medtronic.)
“I can tell you that – practically – the FDA has many fewer sticks and much less control when it comes to class II devices,” he said. He offered an example of a manufacturer of a class II device having more latitude in making small changes to products without notifying the FDA.
In his hypothetical example, such a change could have unintended consequences, and “with AI systems, small changes can result in large and nonlinear or even random effects,” Mr. Grant said. “But it’s too late if the product is on the market and the harm has already occurred,” he said.
The American Society for Dermatologic Surgery Association also protested the reclassifying of approved computer-aided melanoma detection class III devices.
In a statement posted on the FDA website as part of the materials for the meeting, the ASDSA raised a series of concerns about the prospects of expanded U.S. use of tools for assisting in diagnosing melanoma, including ones that would be marketed to consumers.
“To the extent that algorithms and devices for patient self-diagnosis of skin lesions are already widely available, they should be required to include detailed disclaimers that include that they are for entertainment and educational purposes and not a diagnostic device, that they are not approved by dermatologists or a recognized medical regulatory authority for self-diagnosis,” the ASDSA said.
Devices and algorithms in screening tools “are not highly regulated and remain unproven. They may result in wrong diagnoses, missed diagnoses, or over- or underdiagnosis,” the ASDSA added. “Both patients at low risk and those at high risk are better served by scheduling an in-person examination with a board-certified dermatologist, who can also help them determine the appropriate future skin screening schedule that is most appropriate for them.”
‘Stepping stone’
However, there is strong consumer demand for better information about skin conditions, and many patients face hurdles in going to dermatologists.
Google research has shown that consumers are seeking “a stepping stone” between the information they can easily find online and what they could get from a medical professional, said Lily Peng, MD, PhD, a director of product management for the health AI team at Google. Dr. Peng was a scheduled presenter at the July 29 meeting.
Consumers often are looking for more information on common conditions such as acne and poison ivy, and they sometimes face challenges in getting access to clinicians, she said.
“There are many unmet needs for consumers experiencing skin issues, many of which are lower-acuity conditions. There’s a big opportunity to increase accessibility and relevance of health journeys for consumers,” Dr. Peng said. “We have heard from consumers that they would like to have a self-help tool for nonserious conditions so they can decide when to seek medical attention.”
Dr. Peng’s presentation was not directly related to the question of class II or class III designation for existing products. Instead, her talk served as a glimpse into the work already underway in creating apps and tools for consumers.
Google researchers have published a number of studies in recent years about the use of AI to improve dermatology diagnosis.
A 2020 article reported on Google’s test of a form of AI known as deep learning system (DLS) to provide a differential diagnosis of skin conditions. On 963 validation cases, where a rotating panel of three board-certified dermatologists defined the reference standard, the DLS was noninferior to six other dermatologists and was superior to six primary care physicians (PCPs) and six nurse practitioners (NPs), according to a summary of the article.
A 2021 report published in JAMA Network Open said that use of an AI tool was associated with a higher agreement rate with dermatologists’ reference diagnoses for both PCPs and NPs.
In a 2021 blog post, Google scientists wrote that their AI model that powers a tool for checking skin conditions had earned European clearance, known as a CE mark, as a class I medical device.
SkinVision has an app that the company says “is available worldwide (with the exception of the USA and Canada).” The firm’s website includes a link where people in the United States and Canada can sign up for notifications about when SkinVision will be available in these nations.
‘Not ready for prime time’
The FDA panel did not cast formal votes at the July 29 meeting. Rather, the members engaged in broad discussions about risks and potential benefits of new tools for aiding in the detection of skin cancer.
Among the key issues discussed was a question of whether the FDA could impose requirements and restrictions, known as special controls, to provide “reasonable assurance of safety and effectiveness” for computer-aided devices that provide adjunctive diagnostic information to dermatologists about lesions suspicious for melanoma.
Among the potential special controls would be clinical performance testing in regards to rates of the sensitivity (true-positive rate) and specificity (true-negative rate).
The FDA could also look at requirements on software validation and verification and cybersecurity testing, as well as directions on labeling so as to mitigate risk.
Dermatologists serving on the panel called for caution in proceeding with steps that would make it easier for companies to market tools for aiding in melanoma diagnosis than it would be within the class III framework used for MelaFind and Nevisense.
Many expressed concerns about the need to design studies that would answer questions about how well new tools could accurately identify concerning lesions.
The phrase “not ready for prime time” was used at least three times during the discussion.
FDA panelist Maral Skelsey, MD, a skin cancer specialist from Chevy Chase, Maryland, said that over the years, she had used both Nevisense and MelaFind.
She said she had found MelaFind “unusable,” owing in large part to the high number of false positives it generated. The device also was limited as to where on patients’ bodies it could be used.
However, she spoke with enthusiasm about the prospects for better devices to aid in diagnosis of skin lesions. “It’s an area where we’re on the verge, and we really need these devices. There’s a need for patients to be able to examine themselves, for nondermatologists to be able to assess lesions,” Dr. Skelsey said.
But this field is “just not ready for prime time” yet, even with special controls, Dr. Skelsey said. To loosen approval standards too quickly could be a “detriment to what’s coming down the pipeline,” she said.
“It’s harmful to things that are likely to be around the corner,” she said.
FDA panelist Renata Block, PA-C, who works in a Chicago dermatology practice, pressed for maintaining a class III designation. “We are not ready for prime time yet, though the data that is coming down the pipeline on what we have is quite exciting,” Ms. Block said.
FDA panelist Karla V. Ballman, PhD, a statistician from Weill Cornell Medicine, New York, said there would need to be a clear standard for clinical performance before proceeding toward reclassification of devices for aid in detecting melanoma. “I just don’t think it’s ready for prime time at this point and should remain in class III,” she said.
But there was support from some panelists for the idea of a lower bar for clearance, combined with special controls to ensure patient safety.
In expressing her view, FDA panelist Katalin Roth, MD, JD, professor of medicine, George Washington University, Washington, said she was an outlier in her support for the agency’s view that these risks could be managed and that future tools could allow more patients to take a step on the pathway toward critical diagnoses.
“I deal with a lot of people with cancer as a palliative care physician,” Dr. Roth said. “I think what we’re missing here is the issue of time. Melanoma is a terrible disease, and missing the diagnosis is a terrible thing, but I think special controls would be sufficient to counter the concerns of my colleagues on the committee.”
The FDA’s Dr. Ashar ended the meeting with questions posed to one panelist, Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center in New York.
Dr. Rotemberg has for years been working in the field of research on developing AI and other computer-based tools for detecting and diagnosing melanoma, the deadliest form of skin cancer.
She has been publicly skeptical of the performance of commercial apps that scan moles and other lesions and that claim to identify which are cancerous. A May blog post on the Memorial Sloan Kettering website highlighted a recent British Journal of Dermatology article in which Dr. Rotemberg and coauthors reported on their evaluations of commercial apps. They judged them to be on average only 59% accurate, the blog post said.
However, during an earlier discussion at the meeting, she had spoken more positively about the prospects for using special controls in the near term to mitigate risk, although she said she would have a “very long list” of these requirements.
In the closing exchange with Dr. Ashar, Dr. Rotemberg outlined steps that could potentially ensure the safe use of tools to aid in melanoma screening. These included a need for postmarketing surveillance, which would require evaluation over time of algorithms used in tools meant to detect skin cancer.
“We need to have a mechanism for sampling,” Dr. Rotemberg said. “Most of our data is electronic now anyway, so comparing an algorithm and performance with biopsy results should not be that challenging.”
A version of this article first appeared on Medscape.com.
.
So far, the U.S. Food and Drug Administration has cleared two devices. Both are computer-aided skin lesion classification devices meant to help clinicians assess cases of suspected melanoma.
Both were given a class III designation. That classification is intended for products that are considered to have a high risk of harm because of flawed design or implementation. Many such devices are under development, and there has been a proposal to include these devices in class II, which is less restrictive.
The FDA turned to one of its expert panels for advice. At a meeting held on Aug. 29, experts on the panel offered differing views and expressed concerns about the accuracy of these devices.
This was the second day of meetings of the general and plastic surgery devices panel of the FDA’s Medical Devices Advisory Committee. On the previous day, the panel held a wide-ranging discussion about expanding use of skin lesion analyzer devices.
The FDA sought the expert panel’s advice concerning a field that appears to be heating up quickly after relatively quiet times.
Two devices have been approved by the FDA so far, but only one is still being promoted – SciBase AB’s Nevisense. The Swedish company announced in May 2020 that it had received FDA approval for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection, an AI-based point-of-care system for the noninvasive evaluation of irregular moles.
The other device, known as MelaFind, was acquired by Strata Skin Sciences, but the company said in 2017 that it discontinued research and development, sales, and support activity related to the device, according to a filing with the Securities and Exchange Commission.
But there’s been a swell in recent years in the number of publications related to the use of AI and machine learning, which could give rise to new tools for aiding in the diagnosis of skin conditions, including cancer. Google is among the companies that are involved in these efforts.
So, the FDA asked the expert panel to discuss a series of questions related to how the agency should weigh the risks of computer-aided devices for melanoma diagnosis. The agency also asked the panel to provide feedback about how well risks associated with such devices and tools might be managed and to offer suggestions.
The discussion at the July 29 meeting spun beyond narrow questions about reclassification of the current class III devices to topics involving emerging technology, such as efforts to apply AI to dermatology.
“Innovation continues. Medical device developers are anxious to plan how they might be able to develop the level of evidence that would meet your expectations” for future products, Binita Ashar, MD, a senior official in FDA’s Center for Devices and Radiological Health, told the panel.
Company CEO backs tougher regulation
Simon Grant, the chief executive of SciBase, which markets Nevisense, the first and only skin cancer–detecting device currently on the U.S. market, sought to make a case for sticking with the tougher class III regulations.
Speaking during the public comment session, Mr. Grant said switching to class II designations would weaken the standards used in clearing products that analyze skin lesions so as to put patients at risk.
Under the FDA’s rules, the agency designates as class III devices that present potential unreasonable risk of illness or injury. Only about 10% of devices fall into this category. Such devices include implantable pacemakers and breast implants, as well as SciBase’s Nevisense.
About 43% of medical devices fall into the class II category, which includes powered wheelchairs and some pregnancy test kits, the FDA website says.
Class I medical devices pose minimal potential for harm and tend to be simpler in design. These include enema kits and elastic bandages, the FDA says.
Mr. Grant told the meeting that in his career he has worked on two class III products and about 20 class II products. (He had previously worked at medical startups Synectics Medical and Neoventa, as well as established multinationals such as Medtronic.)
“I can tell you that – practically – the FDA has many fewer sticks and much less control when it comes to class II devices,” he said. He offered an example of a manufacturer of a class II device having more latitude in making small changes to products without notifying the FDA.
In his hypothetical example, such a change could have unintended consequences, and “with AI systems, small changes can result in large and nonlinear or even random effects,” Mr. Grant said. “But it’s too late if the product is on the market and the harm has already occurred,” he said.
The American Society for Dermatologic Surgery Association also protested the reclassifying of approved computer-aided melanoma detection class III devices.
In a statement posted on the FDA website as part of the materials for the meeting, the ASDSA raised a series of concerns about the prospects of expanded U.S. use of tools for assisting in diagnosing melanoma, including ones that would be marketed to consumers.
“To the extent that algorithms and devices for patient self-diagnosis of skin lesions are already widely available, they should be required to include detailed disclaimers that include that they are for entertainment and educational purposes and not a diagnostic device, that they are not approved by dermatologists or a recognized medical regulatory authority for self-diagnosis,” the ASDSA said.
Devices and algorithms in screening tools “are not highly regulated and remain unproven. They may result in wrong diagnoses, missed diagnoses, or over- or underdiagnosis,” the ASDSA added. “Both patients at low risk and those at high risk are better served by scheduling an in-person examination with a board-certified dermatologist, who can also help them determine the appropriate future skin screening schedule that is most appropriate for them.”
‘Stepping stone’
However, there is strong consumer demand for better information about skin conditions, and many patients face hurdles in going to dermatologists.
Google research has shown that consumers are seeking “a stepping stone” between the information they can easily find online and what they could get from a medical professional, said Lily Peng, MD, PhD, a director of product management for the health AI team at Google. Dr. Peng was a scheduled presenter at the July 29 meeting.
Consumers often are looking for more information on common conditions such as acne and poison ivy, and they sometimes face challenges in getting access to clinicians, she said.
“There are many unmet needs for consumers experiencing skin issues, many of which are lower-acuity conditions. There’s a big opportunity to increase accessibility and relevance of health journeys for consumers,” Dr. Peng said. “We have heard from consumers that they would like to have a self-help tool for nonserious conditions so they can decide when to seek medical attention.”
Dr. Peng’s presentation was not directly related to the question of class II or class III designation for existing products. Instead, her talk served as a glimpse into the work already underway in creating apps and tools for consumers.
Google researchers have published a number of studies in recent years about the use of AI to improve dermatology diagnosis.
A 2020 article reported on Google’s test of a form of AI known as deep learning system (DLS) to provide a differential diagnosis of skin conditions. On 963 validation cases, where a rotating panel of three board-certified dermatologists defined the reference standard, the DLS was noninferior to six other dermatologists and was superior to six primary care physicians (PCPs) and six nurse practitioners (NPs), according to a summary of the article.
A 2021 report published in JAMA Network Open said that use of an AI tool was associated with a higher agreement rate with dermatologists’ reference diagnoses for both PCPs and NPs.
In a 2021 blog post, Google scientists wrote that their AI model that powers a tool for checking skin conditions had earned European clearance, known as a CE mark, as a class I medical device.
SkinVision has an app that the company says “is available worldwide (with the exception of the USA and Canada).” The firm’s website includes a link where people in the United States and Canada can sign up for notifications about when SkinVision will be available in these nations.
‘Not ready for prime time’
The FDA panel did not cast formal votes at the July 29 meeting. Rather, the members engaged in broad discussions about risks and potential benefits of new tools for aiding in the detection of skin cancer.
Among the key issues discussed was a question of whether the FDA could impose requirements and restrictions, known as special controls, to provide “reasonable assurance of safety and effectiveness” for computer-aided devices that provide adjunctive diagnostic information to dermatologists about lesions suspicious for melanoma.
Among the potential special controls would be clinical performance testing in regards to rates of the sensitivity (true-positive rate) and specificity (true-negative rate).
The FDA could also look at requirements on software validation and verification and cybersecurity testing, as well as directions on labeling so as to mitigate risk.
Dermatologists serving on the panel called for caution in proceeding with steps that would make it easier for companies to market tools for aiding in melanoma diagnosis than it would be within the class III framework used for MelaFind and Nevisense.
Many expressed concerns about the need to design studies that would answer questions about how well new tools could accurately identify concerning lesions.
The phrase “not ready for prime time” was used at least three times during the discussion.
FDA panelist Maral Skelsey, MD, a skin cancer specialist from Chevy Chase, Maryland, said that over the years, she had used both Nevisense and MelaFind.
She said she had found MelaFind “unusable,” owing in large part to the high number of false positives it generated. The device also was limited as to where on patients’ bodies it could be used.
However, she spoke with enthusiasm about the prospects for better devices to aid in diagnosis of skin lesions. “It’s an area where we’re on the verge, and we really need these devices. There’s a need for patients to be able to examine themselves, for nondermatologists to be able to assess lesions,” Dr. Skelsey said.
But this field is “just not ready for prime time” yet, even with special controls, Dr. Skelsey said. To loosen approval standards too quickly could be a “detriment to what’s coming down the pipeline,” she said.
“It’s harmful to things that are likely to be around the corner,” she said.
FDA panelist Renata Block, PA-C, who works in a Chicago dermatology practice, pressed for maintaining a class III designation. “We are not ready for prime time yet, though the data that is coming down the pipeline on what we have is quite exciting,” Ms. Block said.
FDA panelist Karla V. Ballman, PhD, a statistician from Weill Cornell Medicine, New York, said there would need to be a clear standard for clinical performance before proceeding toward reclassification of devices for aid in detecting melanoma. “I just don’t think it’s ready for prime time at this point and should remain in class III,” she said.
But there was support from some panelists for the idea of a lower bar for clearance, combined with special controls to ensure patient safety.
In expressing her view, FDA panelist Katalin Roth, MD, JD, professor of medicine, George Washington University, Washington, said she was an outlier in her support for the agency’s view that these risks could be managed and that future tools could allow more patients to take a step on the pathway toward critical diagnoses.
“I deal with a lot of people with cancer as a palliative care physician,” Dr. Roth said. “I think what we’re missing here is the issue of time. Melanoma is a terrible disease, and missing the diagnosis is a terrible thing, but I think special controls would be sufficient to counter the concerns of my colleagues on the committee.”
The FDA’s Dr. Ashar ended the meeting with questions posed to one panelist, Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center in New York.
Dr. Rotemberg has for years been working in the field of research on developing AI and other computer-based tools for detecting and diagnosing melanoma, the deadliest form of skin cancer.
She has been publicly skeptical of the performance of commercial apps that scan moles and other lesions and that claim to identify which are cancerous. A May blog post on the Memorial Sloan Kettering website highlighted a recent British Journal of Dermatology article in which Dr. Rotemberg and coauthors reported on their evaluations of commercial apps. They judged them to be on average only 59% accurate, the blog post said.
However, during an earlier discussion at the meeting, she had spoken more positively about the prospects for using special controls in the near term to mitigate risk, although she said she would have a “very long list” of these requirements.
In the closing exchange with Dr. Ashar, Dr. Rotemberg outlined steps that could potentially ensure the safe use of tools to aid in melanoma screening. These included a need for postmarketing surveillance, which would require evaluation over time of algorithms used in tools meant to detect skin cancer.
“We need to have a mechanism for sampling,” Dr. Rotemberg said. “Most of our data is electronic now anyway, so comparing an algorithm and performance with biopsy results should not be that challenging.”
A version of this article first appeared on Medscape.com.
Banana Boat recalls scalp sunscreen spray
.
The company announced a voluntary recall for three batches of the Banana Boat Hair & Scalp Spray SPF 30, which came in 6-ounce bottles and was sold across the U.S. through various retailers and online, according to a recall alert by the Food and Drug Administration.
The three batches have a UPC label of 0-79656-04041-8 and fall under the lot codes 20016AF, 20084BF, and 21139AF, with the expiration dates of December 2022, February 2023, and April 2024, respectively.
“An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed the unexpected levels of benzene came from the propellant that sprays the product out of the can,” according to the recall notice.
“Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended,” the company wrote.
Benzene is classified as a human carcinogen, the FDA wrote. Exposure to benzene can occur through the nose, mouth, and skin, and it can result in serious conditions such as leukemia, bone marrow cancer, and blood disorders.
“Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources,” the company said. “Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.”
Edgewell said it hasn’t received any reports of bad events related to the recall. The company has told retailers to remove the affected batches from shelves.
Banana Boat will reimburse consumers who purchased a product with one of the affected lot codes, which are on the bottom of the can. In the meantime, consumers should stop using the affected product right away and discard it.
The recall comes a little over a year after Johnson & Johnson recalled five sunscreens due to low levels of benzene, according to The Associated Press. That recall included Aveeno and Neutrogena products in spray cans.
Consumers with questions about the recall can contact Edgewell Personal Care at 888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. ET. People can also read more at the Banana Boat FAQ page or file for a refund directly on the Banana Boat Recall page.
A version of this article first appeared on WebMD.com.
.
The company announced a voluntary recall for three batches of the Banana Boat Hair & Scalp Spray SPF 30, which came in 6-ounce bottles and was sold across the U.S. through various retailers and online, according to a recall alert by the Food and Drug Administration.
The three batches have a UPC label of 0-79656-04041-8 and fall under the lot codes 20016AF, 20084BF, and 21139AF, with the expiration dates of December 2022, February 2023, and April 2024, respectively.
“An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed the unexpected levels of benzene came from the propellant that sprays the product out of the can,” according to the recall notice.
“Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended,” the company wrote.
Benzene is classified as a human carcinogen, the FDA wrote. Exposure to benzene can occur through the nose, mouth, and skin, and it can result in serious conditions such as leukemia, bone marrow cancer, and blood disorders.
“Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources,” the company said. “Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.”
Edgewell said it hasn’t received any reports of bad events related to the recall. The company has told retailers to remove the affected batches from shelves.
Banana Boat will reimburse consumers who purchased a product with one of the affected lot codes, which are on the bottom of the can. In the meantime, consumers should stop using the affected product right away and discard it.
The recall comes a little over a year after Johnson & Johnson recalled five sunscreens due to low levels of benzene, according to The Associated Press. That recall included Aveeno and Neutrogena products in spray cans.
Consumers with questions about the recall can contact Edgewell Personal Care at 888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. ET. People can also read more at the Banana Boat FAQ page or file for a refund directly on the Banana Boat Recall page.
A version of this article first appeared on WebMD.com.
.
The company announced a voluntary recall for three batches of the Banana Boat Hair & Scalp Spray SPF 30, which came in 6-ounce bottles and was sold across the U.S. through various retailers and online, according to a recall alert by the Food and Drug Administration.
The three batches have a UPC label of 0-79656-04041-8 and fall under the lot codes 20016AF, 20084BF, and 21139AF, with the expiration dates of December 2022, February 2023, and April 2024, respectively.
“An internal review found that some samples of the product contained trace levels of benzene. While benzene is not an ingredient in any Banana Boat products, the review showed the unexpected levels of benzene came from the propellant that sprays the product out of the can,” according to the recall notice.
“Importantly, no other batches of Hair & Scalp (either before or after these batch codes) and no other Banana Boat products are in the scope of this recall and may continue to be used by consumers safely and as intended,” the company wrote.
Benzene is classified as a human carcinogen, the FDA wrote. Exposure to benzene can occur through the nose, mouth, and skin, and it can result in serious conditions such as leukemia, bone marrow cancer, and blood disorders.
“Benzene is ubiquitous in the environment. Humans around the world have daily exposures to it indoors and outdoors from multiple sources,” the company said. “Daily exposure to benzene in the recalled products would not be expected to cause adverse health consequences according to an independent health assessment using established exposure modeling guidelines.”
Edgewell said it hasn’t received any reports of bad events related to the recall. The company has told retailers to remove the affected batches from shelves.
Banana Boat will reimburse consumers who purchased a product with one of the affected lot codes, which are on the bottom of the can. In the meantime, consumers should stop using the affected product right away and discard it.
The recall comes a little over a year after Johnson & Johnson recalled five sunscreens due to low levels of benzene, according to The Associated Press. That recall included Aveeno and Neutrogena products in spray cans.
Consumers with questions about the recall can contact Edgewell Personal Care at 888-686-3988 Monday through Friday, 9 a.m. to 6 p.m. ET. People can also read more at the Banana Boat FAQ page or file for a refund directly on the Banana Boat Recall page.
A version of this article first appeared on WebMD.com.