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Specialists Are ‘Underwater’ With Some Insurance-Preferred Biosimilars
Editor’s note: This article is adapted from an explanatory statement that Dr. Feldman wrote for the Coalition of State Rheumatology Organizations (CSRO).
According to the Guinness Book of World records, the longest time someone has held their breath underwater voluntarily is 24 minutes and 37.36 seconds. While certainly an amazing feat, UnitedHealthcare, many of the Blues, and other national “payers” are expecting rheumatologists and other specialists to live “underwater” in order to take care of their patients. In other words, these insurance companies are mandating that specialists use certain provider-administered biosimilars whose acquisition cost is higher than what the insurance company is willing to reimburse them. Essentially, the insurance companies expect the rheumatologists to pay them to take care of their patients. Because of the substantial and destabilizing financial losses incurred, many practices and free-standing infusion centers have been forced to cease offering these biosimilars. Most rheumatologists will provide patients with appropriate alternatives when available and permitted by the insurer; otherwise, they must refer patients to hospital-based infusion centers. That results in delayed care and increased costs for patients and the system, because hospital-based infusion typically costs more than twice what office-based infusion costs.
Quantifying the Problem
To help quantify the magnitude of this issue, the Coalition of State Rheumatology Organizations (CSRO) recently conducted a survey of its membership. A shocking 97% of respondents reported that their practice had been affected by reimbursement rates for some biosimilars being lower than acquisition costs, with 91% of respondents stating that this issue is more pronounced for certain biosimilars than others. Across the board, respondents most frequently identified Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as being especially affected: Over 88% and over 85% of respondents identified these two products, respectively, as being underwater. These results support the ongoing anecdotal reports CSRO continues to receive from rheumatology practices.
However, the survey results indicated that this issue is by no means confined to those two biosimilars. Truxima (rituximab-abbs) — a biosimilar for Rituxan — was frequently mentioned as well. Notably, respondents almost uniformly identified biosimilars in the infliximab and rituximab families, which illustrates that this issue is no longer confined to one or two early-to-market biosimilars but has almost become a hallmark of this particular biosimilars market. Remarkably, one respondent commented that the brand products are now cheaper to acquire than the biosimilars. Furthermore, the survey included respondents from across the country, indicating that this issue is not confined to a particular region.
How Did This Happen?
Biosimilars held promise for increasing availability and decreasing biologic costs for patients but, thus far, no patients have seen their cost go down. It appears that the only biosimilars that have made it to “preferred” status on the formulary are the ones that have made more money for the middlemen in the drug supply chain, particularly those that construct formularies. Now, we have provider-administered biosimilars whose acquisition cost exceeds the reimbursement for these drugs. This disparity was ultimately created by biosimilar manufacturers “over-rebating” their drugs to health insurance companies to gain “fail-first” status on the formulary.
For example, the manufacturer of Inflectra offered substantial rebates to health insurers for preferred formulary placement. These rebates are factored into the sales price of the medication, which then results in a rapidly declining average sales price (ASP) for the biosimilar. Unfortunately, the acquisition cost for the drug does not experience commensurate reductions, resulting in physicians being reimbursed far less for the drug than it costs to acquire. The financial losses for physicians put them underwater as a result of the acquisition costs for the preferred drugs far surpassing the reimbursement from the health insurance company that constructed the formulary.
While various factors affect ASPs and acquisition costs, this particular consequence of formulary placement based on price concessions is a major driver of the underwater situation in which physicians have found themselves with many biosimilars. Not only does that lead to a lower uptake of biosimilars, but it also results in patients being referred to the hospital outpatient infusion sites to receive this care, as freestanding infusion centers cannot treat these patients either. Hospitals incur higher costs because of facility fees and elevated rates, and this makes private rheumatology in-office infusion centers a much lower-cost option. Similarly, home infusion services, while convenient, are marginally more expensive than private practices and, in cases of biologic infusions, it is important to note that physicians’ offices have a greater safety profile than home infusion of biologics. The overall result of these “fail-first underwater drugs” is delayed and more costly care for the patient and the “system,” particularly self-insured employers.
What Is Being Done to Correct This?
Since ASPs are updated quarterly, it is possible that acquisition costs and reimbursements might stabilize over time, making the drugs affordable again to practices. However, that does not appear to be happening in the near future, so that possibility does not offer immediate relief to struggling practices. It doesn’t promise a favorable outlook for future biosimilar entries of provider-administered medications if formularies continue to prefer the highest-rebated medication.
This dynamic between ASP and acquisition cost does not happen on the pharmacy side because the price concessions on specific drug rebates and fees are proprietary. There appears to be no equivalent to a publicly known ASP on the pharmacy side, which has led to myriad pricing definitions and manipulation on the pharmacy benefit side of medications. In any event, the savings from rebates and other manufacturer price concessions on pharmacy drugs do not influence ASPs of medical benefit drugs.
The Inflation Reduction Act provided a temporary increase in the add-on payment for biosimilars from ASP+6% to ASP+8%, but as long as the biosimilar’s ASP is lower than the reference brand’s ASP, that temporary increase does not appear to make up for the large differential between ASP and acquisition cost. It should be noted that any federal attempt to artificially lower the ASP of a provider-administered drug without a pathway assuring that the acquisition cost for the provider is less than the reimbursement is going to result in loss of access for patients to those medications and/or higher hospital site of care costs.
A Few Partial Fixes, But Most Complaints Go Ignored
Considering the higher costs of hospital-based infusion, insurers should be motivated to keep patients within private practices. Perhaps through insurers’ recognition of that fact, some practices have successfully negotiated exceptions for specific patients by discussing this situation with insurers. From the feedback that CSRO has received from rheumatology practices, it appears that most insurers have been ignoring the complaints from physicians. The few who have responded have resulted in only partial fixes, with some of the biosimilars still left underwater.
Ultimate Solution?
This issue is a direct result of the “rebate game,” whereby price concessions from drug manufacturers drive formulary placement. For provider-administered medications, this results in an artificially lowered ASP, not as a consequence of free-market incentives that benefit the patient, but as a result of misaligned incentives created by Safe Harbor–protected “kickbacks,” distorting the free market and paradoxically reducing access to these medications, delaying care, and increasing prices for patients and the healthcare system.
While federal and state governments are not likely to address this particular situation in the biosimilars market, CSRO is highlighting this issue as a prime example of why the current formulary construction system urgently requires federal reform. At this time, the biosimilars most affected are Inflectra and Avsola, but if nothing changes, more and more biosimilars will fall victim to the short-sighted pricing strategy of aggressive rebating to gain formulary position, with physician purchasers and patients left to navigate the aftermath. The existing system, which necessitates drug companies purchasing formulary access from pharmacy benefit managers, has led to delayed and even denied patient access to certain provider-administered drugs. Moreover, it now appears to be hindering the adoption of biosimilars.
To address this, a multifaceted approach is required. It not only involves reevaluating the rebate system and its impact on formulary construction and ASP, but also ensuring that acquisition costs for providers are aligned with reimbursement rates. Insurers must recognize the economic and clinical value of maintaining infusions within private practices and immediately update their policies to ensure that physician in-office infusion is financially feasible for these “fail-first” biosimilars.
Ultimately, the goal should be to create a sustainable model that promotes the use of affordable biosimilars, enhances patient access to affordable care, and supports the financial viability of medical practices. Concerted efforts to reform the current formulary construction system are required to achieve a healthcare environment that is both cost effective and patient centric.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Editor’s note: This article is adapted from an explanatory statement that Dr. Feldman wrote for the Coalition of State Rheumatology Organizations (CSRO).
According to the Guinness Book of World records, the longest time someone has held their breath underwater voluntarily is 24 minutes and 37.36 seconds. While certainly an amazing feat, UnitedHealthcare, many of the Blues, and other national “payers” are expecting rheumatologists and other specialists to live “underwater” in order to take care of their patients. In other words, these insurance companies are mandating that specialists use certain provider-administered biosimilars whose acquisition cost is higher than what the insurance company is willing to reimburse them. Essentially, the insurance companies expect the rheumatologists to pay them to take care of their patients. Because of the substantial and destabilizing financial losses incurred, many practices and free-standing infusion centers have been forced to cease offering these biosimilars. Most rheumatologists will provide patients with appropriate alternatives when available and permitted by the insurer; otherwise, they must refer patients to hospital-based infusion centers. That results in delayed care and increased costs for patients and the system, because hospital-based infusion typically costs more than twice what office-based infusion costs.
Quantifying the Problem
To help quantify the magnitude of this issue, the Coalition of State Rheumatology Organizations (CSRO) recently conducted a survey of its membership. A shocking 97% of respondents reported that their practice had been affected by reimbursement rates for some biosimilars being lower than acquisition costs, with 91% of respondents stating that this issue is more pronounced for certain biosimilars than others. Across the board, respondents most frequently identified Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as being especially affected: Over 88% and over 85% of respondents identified these two products, respectively, as being underwater. These results support the ongoing anecdotal reports CSRO continues to receive from rheumatology practices.
However, the survey results indicated that this issue is by no means confined to those two biosimilars. Truxima (rituximab-abbs) — a biosimilar for Rituxan — was frequently mentioned as well. Notably, respondents almost uniformly identified biosimilars in the infliximab and rituximab families, which illustrates that this issue is no longer confined to one or two early-to-market biosimilars but has almost become a hallmark of this particular biosimilars market. Remarkably, one respondent commented that the brand products are now cheaper to acquire than the biosimilars. Furthermore, the survey included respondents from across the country, indicating that this issue is not confined to a particular region.
How Did This Happen?
Biosimilars held promise for increasing availability and decreasing biologic costs for patients but, thus far, no patients have seen their cost go down. It appears that the only biosimilars that have made it to “preferred” status on the formulary are the ones that have made more money for the middlemen in the drug supply chain, particularly those that construct formularies. Now, we have provider-administered biosimilars whose acquisition cost exceeds the reimbursement for these drugs. This disparity was ultimately created by biosimilar manufacturers “over-rebating” their drugs to health insurance companies to gain “fail-first” status on the formulary.
For example, the manufacturer of Inflectra offered substantial rebates to health insurers for preferred formulary placement. These rebates are factored into the sales price of the medication, which then results in a rapidly declining average sales price (ASP) for the biosimilar. Unfortunately, the acquisition cost for the drug does not experience commensurate reductions, resulting in physicians being reimbursed far less for the drug than it costs to acquire. The financial losses for physicians put them underwater as a result of the acquisition costs for the preferred drugs far surpassing the reimbursement from the health insurance company that constructed the formulary.
While various factors affect ASPs and acquisition costs, this particular consequence of formulary placement based on price concessions is a major driver of the underwater situation in which physicians have found themselves with many biosimilars. Not only does that lead to a lower uptake of biosimilars, but it also results in patients being referred to the hospital outpatient infusion sites to receive this care, as freestanding infusion centers cannot treat these patients either. Hospitals incur higher costs because of facility fees and elevated rates, and this makes private rheumatology in-office infusion centers a much lower-cost option. Similarly, home infusion services, while convenient, are marginally more expensive than private practices and, in cases of biologic infusions, it is important to note that physicians’ offices have a greater safety profile than home infusion of biologics. The overall result of these “fail-first underwater drugs” is delayed and more costly care for the patient and the “system,” particularly self-insured employers.
What Is Being Done to Correct This?
Since ASPs are updated quarterly, it is possible that acquisition costs and reimbursements might stabilize over time, making the drugs affordable again to practices. However, that does not appear to be happening in the near future, so that possibility does not offer immediate relief to struggling practices. It doesn’t promise a favorable outlook for future biosimilar entries of provider-administered medications if formularies continue to prefer the highest-rebated medication.
This dynamic between ASP and acquisition cost does not happen on the pharmacy side because the price concessions on specific drug rebates and fees are proprietary. There appears to be no equivalent to a publicly known ASP on the pharmacy side, which has led to myriad pricing definitions and manipulation on the pharmacy benefit side of medications. In any event, the savings from rebates and other manufacturer price concessions on pharmacy drugs do not influence ASPs of medical benefit drugs.
The Inflation Reduction Act provided a temporary increase in the add-on payment for biosimilars from ASP+6% to ASP+8%, but as long as the biosimilar’s ASP is lower than the reference brand’s ASP, that temporary increase does not appear to make up for the large differential between ASP and acquisition cost. It should be noted that any federal attempt to artificially lower the ASP of a provider-administered drug without a pathway assuring that the acquisition cost for the provider is less than the reimbursement is going to result in loss of access for patients to those medications and/or higher hospital site of care costs.
A Few Partial Fixes, But Most Complaints Go Ignored
Considering the higher costs of hospital-based infusion, insurers should be motivated to keep patients within private practices. Perhaps through insurers’ recognition of that fact, some practices have successfully negotiated exceptions for specific patients by discussing this situation with insurers. From the feedback that CSRO has received from rheumatology practices, it appears that most insurers have been ignoring the complaints from physicians. The few who have responded have resulted in only partial fixes, with some of the biosimilars still left underwater.
Ultimate Solution?
This issue is a direct result of the “rebate game,” whereby price concessions from drug manufacturers drive formulary placement. For provider-administered medications, this results in an artificially lowered ASP, not as a consequence of free-market incentives that benefit the patient, but as a result of misaligned incentives created by Safe Harbor–protected “kickbacks,” distorting the free market and paradoxically reducing access to these medications, delaying care, and increasing prices for patients and the healthcare system.
While federal and state governments are not likely to address this particular situation in the biosimilars market, CSRO is highlighting this issue as a prime example of why the current formulary construction system urgently requires federal reform. At this time, the biosimilars most affected are Inflectra and Avsola, but if nothing changes, more and more biosimilars will fall victim to the short-sighted pricing strategy of aggressive rebating to gain formulary position, with physician purchasers and patients left to navigate the aftermath. The existing system, which necessitates drug companies purchasing formulary access from pharmacy benefit managers, has led to delayed and even denied patient access to certain provider-administered drugs. Moreover, it now appears to be hindering the adoption of biosimilars.
To address this, a multifaceted approach is required. It not only involves reevaluating the rebate system and its impact on formulary construction and ASP, but also ensuring that acquisition costs for providers are aligned with reimbursement rates. Insurers must recognize the economic and clinical value of maintaining infusions within private practices and immediately update their policies to ensure that physician in-office infusion is financially feasible for these “fail-first” biosimilars.
Ultimately, the goal should be to create a sustainable model that promotes the use of affordable biosimilars, enhances patient access to affordable care, and supports the financial viability of medical practices. Concerted efforts to reform the current formulary construction system are required to achieve a healthcare environment that is both cost effective and patient centric.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Editor’s note: This article is adapted from an explanatory statement that Dr. Feldman wrote for the Coalition of State Rheumatology Organizations (CSRO).
According to the Guinness Book of World records, the longest time someone has held their breath underwater voluntarily is 24 minutes and 37.36 seconds. While certainly an amazing feat, UnitedHealthcare, many of the Blues, and other national “payers” are expecting rheumatologists and other specialists to live “underwater” in order to take care of their patients. In other words, these insurance companies are mandating that specialists use certain provider-administered biosimilars whose acquisition cost is higher than what the insurance company is willing to reimburse them. Essentially, the insurance companies expect the rheumatologists to pay them to take care of their patients. Because of the substantial and destabilizing financial losses incurred, many practices and free-standing infusion centers have been forced to cease offering these biosimilars. Most rheumatologists will provide patients with appropriate alternatives when available and permitted by the insurer; otherwise, they must refer patients to hospital-based infusion centers. That results in delayed care and increased costs for patients and the system, because hospital-based infusion typically costs more than twice what office-based infusion costs.
Quantifying the Problem
To help quantify the magnitude of this issue, the Coalition of State Rheumatology Organizations (CSRO) recently conducted a survey of its membership. A shocking 97% of respondents reported that their practice had been affected by reimbursement rates for some biosimilars being lower than acquisition costs, with 91% of respondents stating that this issue is more pronounced for certain biosimilars than others. Across the board, respondents most frequently identified Inflectra (infliximab-dyyb) and Avsola (infliximab-axxq) as being especially affected: Over 88% and over 85% of respondents identified these two products, respectively, as being underwater. These results support the ongoing anecdotal reports CSRO continues to receive from rheumatology practices.
However, the survey results indicated that this issue is by no means confined to those two biosimilars. Truxima (rituximab-abbs) — a biosimilar for Rituxan — was frequently mentioned as well. Notably, respondents almost uniformly identified biosimilars in the infliximab and rituximab families, which illustrates that this issue is no longer confined to one or two early-to-market biosimilars but has almost become a hallmark of this particular biosimilars market. Remarkably, one respondent commented that the brand products are now cheaper to acquire than the biosimilars. Furthermore, the survey included respondents from across the country, indicating that this issue is not confined to a particular region.
How Did This Happen?
Biosimilars held promise for increasing availability and decreasing biologic costs for patients but, thus far, no patients have seen their cost go down. It appears that the only biosimilars that have made it to “preferred” status on the formulary are the ones that have made more money for the middlemen in the drug supply chain, particularly those that construct formularies. Now, we have provider-administered biosimilars whose acquisition cost exceeds the reimbursement for these drugs. This disparity was ultimately created by biosimilar manufacturers “over-rebating” their drugs to health insurance companies to gain “fail-first” status on the formulary.
For example, the manufacturer of Inflectra offered substantial rebates to health insurers for preferred formulary placement. These rebates are factored into the sales price of the medication, which then results in a rapidly declining average sales price (ASP) for the biosimilar. Unfortunately, the acquisition cost for the drug does not experience commensurate reductions, resulting in physicians being reimbursed far less for the drug than it costs to acquire. The financial losses for physicians put them underwater as a result of the acquisition costs for the preferred drugs far surpassing the reimbursement from the health insurance company that constructed the formulary.
While various factors affect ASPs and acquisition costs, this particular consequence of formulary placement based on price concessions is a major driver of the underwater situation in which physicians have found themselves with many biosimilars. Not only does that lead to a lower uptake of biosimilars, but it also results in patients being referred to the hospital outpatient infusion sites to receive this care, as freestanding infusion centers cannot treat these patients either. Hospitals incur higher costs because of facility fees and elevated rates, and this makes private rheumatology in-office infusion centers a much lower-cost option. Similarly, home infusion services, while convenient, are marginally more expensive than private practices and, in cases of biologic infusions, it is important to note that physicians’ offices have a greater safety profile than home infusion of biologics. The overall result of these “fail-first underwater drugs” is delayed and more costly care for the patient and the “system,” particularly self-insured employers.
What Is Being Done to Correct This?
Since ASPs are updated quarterly, it is possible that acquisition costs and reimbursements might stabilize over time, making the drugs affordable again to practices. However, that does not appear to be happening in the near future, so that possibility does not offer immediate relief to struggling practices. It doesn’t promise a favorable outlook for future biosimilar entries of provider-administered medications if formularies continue to prefer the highest-rebated medication.
This dynamic between ASP and acquisition cost does not happen on the pharmacy side because the price concessions on specific drug rebates and fees are proprietary. There appears to be no equivalent to a publicly known ASP on the pharmacy side, which has led to myriad pricing definitions and manipulation on the pharmacy benefit side of medications. In any event, the savings from rebates and other manufacturer price concessions on pharmacy drugs do not influence ASPs of medical benefit drugs.
The Inflation Reduction Act provided a temporary increase in the add-on payment for biosimilars from ASP+6% to ASP+8%, but as long as the biosimilar’s ASP is lower than the reference brand’s ASP, that temporary increase does not appear to make up for the large differential between ASP and acquisition cost. It should be noted that any federal attempt to artificially lower the ASP of a provider-administered drug without a pathway assuring that the acquisition cost for the provider is less than the reimbursement is going to result in loss of access for patients to those medications and/or higher hospital site of care costs.
A Few Partial Fixes, But Most Complaints Go Ignored
Considering the higher costs of hospital-based infusion, insurers should be motivated to keep patients within private practices. Perhaps through insurers’ recognition of that fact, some practices have successfully negotiated exceptions for specific patients by discussing this situation with insurers. From the feedback that CSRO has received from rheumatology practices, it appears that most insurers have been ignoring the complaints from physicians. The few who have responded have resulted in only partial fixes, with some of the biosimilars still left underwater.
Ultimate Solution?
This issue is a direct result of the “rebate game,” whereby price concessions from drug manufacturers drive formulary placement. For provider-administered medications, this results in an artificially lowered ASP, not as a consequence of free-market incentives that benefit the patient, but as a result of misaligned incentives created by Safe Harbor–protected “kickbacks,” distorting the free market and paradoxically reducing access to these medications, delaying care, and increasing prices for patients and the healthcare system.
While federal and state governments are not likely to address this particular situation in the biosimilars market, CSRO is highlighting this issue as a prime example of why the current formulary construction system urgently requires federal reform. At this time, the biosimilars most affected are Inflectra and Avsola, but if nothing changes, more and more biosimilars will fall victim to the short-sighted pricing strategy of aggressive rebating to gain formulary position, with physician purchasers and patients left to navigate the aftermath. The existing system, which necessitates drug companies purchasing formulary access from pharmacy benefit managers, has led to delayed and even denied patient access to certain provider-administered drugs. Moreover, it now appears to be hindering the adoption of biosimilars.
To address this, a multifaceted approach is required. It not only involves reevaluating the rebate system and its impact on formulary construction and ASP, but also ensuring that acquisition costs for providers are aligned with reimbursement rates. Insurers must recognize the economic and clinical value of maintaining infusions within private practices and immediately update their policies to ensure that physician in-office infusion is financially feasible for these “fail-first” biosimilars.
Ultimately, the goal should be to create a sustainable model that promotes the use of affordable biosimilars, enhances patient access to affordable care, and supports the financial viability of medical practices. Concerted efforts to reform the current formulary construction system are required to achieve a healthcare environment that is both cost effective and patient centric.
Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is the CSRO’s vice president of advocacy and government affairs and its immediate past president, as well as past chair of the Alliance for Safe Biologic Medicines and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].
Pediatric Dermatologists Beat ChatGPT on Board Questions
In an experiment that pitted the wits of
results from a small single-center study showed.“We were relieved to find that the pediatric dermatologists in our study performed better than ChatGPT on both multiple choice and case-based questions; however, the latest iteration of ChatGPT (4.0) was very close,” one of the study’s first authors Charles Huang, a fourth-year medical student at Thomas Jefferson University, Philadelphia, said in an interview. “Something else that was interesting in our data was that the pediatric dermatologists performed much better than ChatGPT on questions related to procedural dermatology/surgical techniques, perhaps indicating that knowledge/reasoning gained through practical experience isn’t easily replicated in AI tools such as ChatGPT.”
For the study, which was published on May 9 in Pediatric Dermatology, Mr. Huang, and co-first author Esther Zhang, BS, a medical student at the University of Pennsylvania, Philadelphia, and coauthors from the Department of Dermatology, Children’s Hospital of Philadelphia, asked five pediatric dermatologists to answer 24 text-based questions including 16 single-answer, multiple-choice questions and two multiple answer questions drawn from the American Board of Dermatology 2021 Certification Sample Test and six free-response case-based questions drawn from the “Photoquiz” section of Pediatric Dermatology between July 2022 and July 2023. The researchers then processed the same set of questions through ChatGPT versions 3.5 and 4.0 and used statistical analysis to compare responses between the pediatric dermatologists and ChatGPT. A 5-point scale adapted from current AI tools was used to score replies to case-based questions.
On average, study participants had 5.6 years of clinical experience. Pediatric dermatologists performed significantly better than ChatGPT version 3.5 on multiple-choice and multiple answer questions (91.4% vs 76.2%, respectively; P = .021) but not significantly better than ChatGPT version 4.0 (90.5%; P = .44). As for replies to case-based questions, the average performance based on the 5-point scale was 3.81 for pediatric dermatologists and 3.53 for ChatGPT overall. The mean scores were significantly greater for pediatric dermatologists than for ChatGPT version 3.5 (P = .039) but not ChatGPT version 4.0 (P = .43).
The researchers acknowledged certain limitations of the analysis, including the evolving nature of AI tools, which may affect the reproducibility of results with subsequent model updates. And, while participating pediatric dermatologists said they were unfamiliar with the questions and cases used in the study, “there is potential for prior exposure through other dermatology board examination review processes,” they wrote.
“AI tools such as ChatGPT and similar large language models can be a valuable tool in your clinical practice, but be aware of potential pitfalls such as patient privacy, medical inaccuracies, [and] intrinsic biases in the tools,” Mr. Huang told this news organization. “As these technologies continue to advance, it is essential for all of us as medical clinicians to gain familiarity and stay abreast of new developments, just as we adapted to electronic health records and the use of the Internet.”
Maria Buethe, MD, PhD, a pediatric dermatology fellow at Rady Children’s Hospital–San Diego, who was asked to comment on the study, said she found it “interesting” that ChatGPT’s version 4.0 started to produce comparable results to clinician responses in some of the tested scenarios.
“The authors propose a set of best practices for pediatric dermatology clinicians using ChatGPT and other AI tools,” said Dr. Buethe, who was senior author of a recent literature review on AI and its application to pediatric dermatology. It was published in SKIN The Journal of Cutaneous Medicine. “One interesting recommended use for AI tools is to utilize it to generate differential diagnosis, which can broaden the list of pathologies previously considered.”
Asked to comment on the study, Erum Ilyas, MD, who practices dermatology in King of Prussia, Pennsylvania, and is a member of the Society for Pediatric Dermatology, said she was not surprised that ChatGPT “can perform fairly well on multiple-choice questions as we find available in testing circumstances,” as presented in the study. “Just as board questions only support testing a base of medical knowledge and facts for clinicians to master, they do not necessarily provide real-life circumstances that apply to caring for patients, which is inherently nuanced.”
In addition, the study “highlights that ChatGPT can be an aid to support thinking through differentials based on data entered by a clinician who understands how to phrase queries, especially if provided with enough data while respecting patient privacy, in the context of fact checking responses,” Dr. Ilyas said. “This underscores the fact that AI tools can be helpful to clinicians in assimilating various data points entered. However, ultimately, the tool is only able to support an output based on the information it has access to.” She added, “ChatGPT cannot be relied on to provide a single diagnosis with the clinician still responsible for making a final diagnosis. The tool is not definitive and cannot assimilate data that is not entered correctly.”
The study was not funded, and the study authors reported having no disclosures. Dr. Buethe and Dr. Ilyas, who were not involved with the study, had no disclosures.
A version of this article appeared on Medscape.com .
In an experiment that pitted the wits of
results from a small single-center study showed.“We were relieved to find that the pediatric dermatologists in our study performed better than ChatGPT on both multiple choice and case-based questions; however, the latest iteration of ChatGPT (4.0) was very close,” one of the study’s first authors Charles Huang, a fourth-year medical student at Thomas Jefferson University, Philadelphia, said in an interview. “Something else that was interesting in our data was that the pediatric dermatologists performed much better than ChatGPT on questions related to procedural dermatology/surgical techniques, perhaps indicating that knowledge/reasoning gained through practical experience isn’t easily replicated in AI tools such as ChatGPT.”
For the study, which was published on May 9 in Pediatric Dermatology, Mr. Huang, and co-first author Esther Zhang, BS, a medical student at the University of Pennsylvania, Philadelphia, and coauthors from the Department of Dermatology, Children’s Hospital of Philadelphia, asked five pediatric dermatologists to answer 24 text-based questions including 16 single-answer, multiple-choice questions and two multiple answer questions drawn from the American Board of Dermatology 2021 Certification Sample Test and six free-response case-based questions drawn from the “Photoquiz” section of Pediatric Dermatology between July 2022 and July 2023. The researchers then processed the same set of questions through ChatGPT versions 3.5 and 4.0 and used statistical analysis to compare responses between the pediatric dermatologists and ChatGPT. A 5-point scale adapted from current AI tools was used to score replies to case-based questions.
On average, study participants had 5.6 years of clinical experience. Pediatric dermatologists performed significantly better than ChatGPT version 3.5 on multiple-choice and multiple answer questions (91.4% vs 76.2%, respectively; P = .021) but not significantly better than ChatGPT version 4.0 (90.5%; P = .44). As for replies to case-based questions, the average performance based on the 5-point scale was 3.81 for pediatric dermatologists and 3.53 for ChatGPT overall. The mean scores were significantly greater for pediatric dermatologists than for ChatGPT version 3.5 (P = .039) but not ChatGPT version 4.0 (P = .43).
The researchers acknowledged certain limitations of the analysis, including the evolving nature of AI tools, which may affect the reproducibility of results with subsequent model updates. And, while participating pediatric dermatologists said they were unfamiliar with the questions and cases used in the study, “there is potential for prior exposure through other dermatology board examination review processes,” they wrote.
“AI tools such as ChatGPT and similar large language models can be a valuable tool in your clinical practice, but be aware of potential pitfalls such as patient privacy, medical inaccuracies, [and] intrinsic biases in the tools,” Mr. Huang told this news organization. “As these technologies continue to advance, it is essential for all of us as medical clinicians to gain familiarity and stay abreast of new developments, just as we adapted to electronic health records and the use of the Internet.”
Maria Buethe, MD, PhD, a pediatric dermatology fellow at Rady Children’s Hospital–San Diego, who was asked to comment on the study, said she found it “interesting” that ChatGPT’s version 4.0 started to produce comparable results to clinician responses in some of the tested scenarios.
“The authors propose a set of best practices for pediatric dermatology clinicians using ChatGPT and other AI tools,” said Dr. Buethe, who was senior author of a recent literature review on AI and its application to pediatric dermatology. It was published in SKIN The Journal of Cutaneous Medicine. “One interesting recommended use for AI tools is to utilize it to generate differential diagnosis, which can broaden the list of pathologies previously considered.”
Asked to comment on the study, Erum Ilyas, MD, who practices dermatology in King of Prussia, Pennsylvania, and is a member of the Society for Pediatric Dermatology, said she was not surprised that ChatGPT “can perform fairly well on multiple-choice questions as we find available in testing circumstances,” as presented in the study. “Just as board questions only support testing a base of medical knowledge and facts for clinicians to master, they do not necessarily provide real-life circumstances that apply to caring for patients, which is inherently nuanced.”
In addition, the study “highlights that ChatGPT can be an aid to support thinking through differentials based on data entered by a clinician who understands how to phrase queries, especially if provided with enough data while respecting patient privacy, in the context of fact checking responses,” Dr. Ilyas said. “This underscores the fact that AI tools can be helpful to clinicians in assimilating various data points entered. However, ultimately, the tool is only able to support an output based on the information it has access to.” She added, “ChatGPT cannot be relied on to provide a single diagnosis with the clinician still responsible for making a final diagnosis. The tool is not definitive and cannot assimilate data that is not entered correctly.”
The study was not funded, and the study authors reported having no disclosures. Dr. Buethe and Dr. Ilyas, who were not involved with the study, had no disclosures.
A version of this article appeared on Medscape.com .
In an experiment that pitted the wits of
results from a small single-center study showed.“We were relieved to find that the pediatric dermatologists in our study performed better than ChatGPT on both multiple choice and case-based questions; however, the latest iteration of ChatGPT (4.0) was very close,” one of the study’s first authors Charles Huang, a fourth-year medical student at Thomas Jefferson University, Philadelphia, said in an interview. “Something else that was interesting in our data was that the pediatric dermatologists performed much better than ChatGPT on questions related to procedural dermatology/surgical techniques, perhaps indicating that knowledge/reasoning gained through practical experience isn’t easily replicated in AI tools such as ChatGPT.”
For the study, which was published on May 9 in Pediatric Dermatology, Mr. Huang, and co-first author Esther Zhang, BS, a medical student at the University of Pennsylvania, Philadelphia, and coauthors from the Department of Dermatology, Children’s Hospital of Philadelphia, asked five pediatric dermatologists to answer 24 text-based questions including 16 single-answer, multiple-choice questions and two multiple answer questions drawn from the American Board of Dermatology 2021 Certification Sample Test and six free-response case-based questions drawn from the “Photoquiz” section of Pediatric Dermatology between July 2022 and July 2023. The researchers then processed the same set of questions through ChatGPT versions 3.5 and 4.0 and used statistical analysis to compare responses between the pediatric dermatologists and ChatGPT. A 5-point scale adapted from current AI tools was used to score replies to case-based questions.
On average, study participants had 5.6 years of clinical experience. Pediatric dermatologists performed significantly better than ChatGPT version 3.5 on multiple-choice and multiple answer questions (91.4% vs 76.2%, respectively; P = .021) but not significantly better than ChatGPT version 4.0 (90.5%; P = .44). As for replies to case-based questions, the average performance based on the 5-point scale was 3.81 for pediatric dermatologists and 3.53 for ChatGPT overall. The mean scores were significantly greater for pediatric dermatologists than for ChatGPT version 3.5 (P = .039) but not ChatGPT version 4.0 (P = .43).
The researchers acknowledged certain limitations of the analysis, including the evolving nature of AI tools, which may affect the reproducibility of results with subsequent model updates. And, while participating pediatric dermatologists said they were unfamiliar with the questions and cases used in the study, “there is potential for prior exposure through other dermatology board examination review processes,” they wrote.
“AI tools such as ChatGPT and similar large language models can be a valuable tool in your clinical practice, but be aware of potential pitfalls such as patient privacy, medical inaccuracies, [and] intrinsic biases in the tools,” Mr. Huang told this news organization. “As these technologies continue to advance, it is essential for all of us as medical clinicians to gain familiarity and stay abreast of new developments, just as we adapted to electronic health records and the use of the Internet.”
Maria Buethe, MD, PhD, a pediatric dermatology fellow at Rady Children’s Hospital–San Diego, who was asked to comment on the study, said she found it “interesting” that ChatGPT’s version 4.0 started to produce comparable results to clinician responses in some of the tested scenarios.
“The authors propose a set of best practices for pediatric dermatology clinicians using ChatGPT and other AI tools,” said Dr. Buethe, who was senior author of a recent literature review on AI and its application to pediatric dermatology. It was published in SKIN The Journal of Cutaneous Medicine. “One interesting recommended use for AI tools is to utilize it to generate differential diagnosis, which can broaden the list of pathologies previously considered.”
Asked to comment on the study, Erum Ilyas, MD, who practices dermatology in King of Prussia, Pennsylvania, and is a member of the Society for Pediatric Dermatology, said she was not surprised that ChatGPT “can perform fairly well on multiple-choice questions as we find available in testing circumstances,” as presented in the study. “Just as board questions only support testing a base of medical knowledge and facts for clinicians to master, they do not necessarily provide real-life circumstances that apply to caring for patients, which is inherently nuanced.”
In addition, the study “highlights that ChatGPT can be an aid to support thinking through differentials based on data entered by a clinician who understands how to phrase queries, especially if provided with enough data while respecting patient privacy, in the context of fact checking responses,” Dr. Ilyas said. “This underscores the fact that AI tools can be helpful to clinicians in assimilating various data points entered. However, ultimately, the tool is only able to support an output based on the information it has access to.” She added, “ChatGPT cannot be relied on to provide a single diagnosis with the clinician still responsible for making a final diagnosis. The tool is not definitive and cannot assimilate data that is not entered correctly.”
The study was not funded, and the study authors reported having no disclosures. Dr. Buethe and Dr. Ilyas, who were not involved with the study, had no disclosures.
A version of this article appeared on Medscape.com .
Global Analysis Identifies Drugs Associated With SJS-TEN in Children
TOPLINE:
METHODOLOGY:
- SJS and TEN are rare, life-threatening mucocutaneous reactions mainly associated with medications, but large pharmacovigilance studies of drugs associated with SJS-TEN in the pediatric population are still lacking.
- Using the WHO’s pharmacovigilance database (VigiBase) containing individual case safety reports from January 1967 to July 2022, researchers identified 7342 adverse drug reaction reports of SJS-TEN in children (younger than 18 years; median age, 9 years) in all six continents. Median onset was 5 days, and 3.2% were fatal.
- They analyzed drugs reported as suspected treatments, and for each molecule, they performed a case–non-case study to assess a potential pharmacovigilance signal by computing the information component (IC).
- A positive IC value suggested more frequent reporting of a specific drug-adverse reaction pair. A positive IC025, a traditional threshold for statistical signal detection, is suggestive of a potential pharmacovigilance signal.
TAKEAWAY:
- Overall, 165 drugs were associated with a diagnosis of SJS-TEN; antiepileptic and anti-infectious drugs were the most common drug classes represented.
- The five most frequently reported drugs were carbamazepine (11.7%), lamotrigine (10.6%), sulfamethoxazole-trimethoprim (9%), acetaminophen (8.4%), and phenytoin (6.6%). The five drugs with the highest IC025 were lamotrigine, carbamazepine, phenobarbital, phenytoin, and nimesulide.
- All antiepileptics, many antibiotic families, dapsone, antiretroviral drugs, some antifungal drugs, and nonsteroidal anti-inflammatory drugs were identified in reports, with penicillins the most frequently reported antibiotic family and sulfonamides having the strongest pharmacovigilance signal.
- Vaccines were not associated with significant signals.
IN PRACTICE:
The study provides an update on “the spectrum of drugs potentially associated with SJS-TEN in the pediatric population,” the authors concluded, and “underlines the importance of reporting to pharmacovigilance the suspicion of this severe side effect of drugs with the most precise and detailed clinical description possible.”
SOURCE:
The study, led by Pauline Bataille, MD, of the Department of Pediatric Dermatology, Hôpital Necker-Enfants Malades, Paris City University, France, was published online in the Journal of the European Academy of Dermatology and Venereology.
LIMITATIONS:
Limitations include the possibility that some cases could have had an infectious or idiopathic cause not related to a drug and the lack of detailed clinical data in the database.
DISCLOSURES:
This study did not receive any funding. The authors declared no conflict of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- SJS and TEN are rare, life-threatening mucocutaneous reactions mainly associated with medications, but large pharmacovigilance studies of drugs associated with SJS-TEN in the pediatric population are still lacking.
- Using the WHO’s pharmacovigilance database (VigiBase) containing individual case safety reports from January 1967 to July 2022, researchers identified 7342 adverse drug reaction reports of SJS-TEN in children (younger than 18 years; median age, 9 years) in all six continents. Median onset was 5 days, and 3.2% were fatal.
- They analyzed drugs reported as suspected treatments, and for each molecule, they performed a case–non-case study to assess a potential pharmacovigilance signal by computing the information component (IC).
- A positive IC value suggested more frequent reporting of a specific drug-adverse reaction pair. A positive IC025, a traditional threshold for statistical signal detection, is suggestive of a potential pharmacovigilance signal.
TAKEAWAY:
- Overall, 165 drugs were associated with a diagnosis of SJS-TEN; antiepileptic and anti-infectious drugs were the most common drug classes represented.
- The five most frequently reported drugs were carbamazepine (11.7%), lamotrigine (10.6%), sulfamethoxazole-trimethoprim (9%), acetaminophen (8.4%), and phenytoin (6.6%). The five drugs with the highest IC025 were lamotrigine, carbamazepine, phenobarbital, phenytoin, and nimesulide.
- All antiepileptics, many antibiotic families, dapsone, antiretroviral drugs, some antifungal drugs, and nonsteroidal anti-inflammatory drugs were identified in reports, with penicillins the most frequently reported antibiotic family and sulfonamides having the strongest pharmacovigilance signal.
- Vaccines were not associated with significant signals.
IN PRACTICE:
The study provides an update on “the spectrum of drugs potentially associated with SJS-TEN in the pediatric population,” the authors concluded, and “underlines the importance of reporting to pharmacovigilance the suspicion of this severe side effect of drugs with the most precise and detailed clinical description possible.”
SOURCE:
The study, led by Pauline Bataille, MD, of the Department of Pediatric Dermatology, Hôpital Necker-Enfants Malades, Paris City University, France, was published online in the Journal of the European Academy of Dermatology and Venereology.
LIMITATIONS:
Limitations include the possibility that some cases could have had an infectious or idiopathic cause not related to a drug and the lack of detailed clinical data in the database.
DISCLOSURES:
This study did not receive any funding. The authors declared no conflict of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- SJS and TEN are rare, life-threatening mucocutaneous reactions mainly associated with medications, but large pharmacovigilance studies of drugs associated with SJS-TEN in the pediatric population are still lacking.
- Using the WHO’s pharmacovigilance database (VigiBase) containing individual case safety reports from January 1967 to July 2022, researchers identified 7342 adverse drug reaction reports of SJS-TEN in children (younger than 18 years; median age, 9 years) in all six continents. Median onset was 5 days, and 3.2% were fatal.
- They analyzed drugs reported as suspected treatments, and for each molecule, they performed a case–non-case study to assess a potential pharmacovigilance signal by computing the information component (IC).
- A positive IC value suggested more frequent reporting of a specific drug-adverse reaction pair. A positive IC025, a traditional threshold for statistical signal detection, is suggestive of a potential pharmacovigilance signal.
TAKEAWAY:
- Overall, 165 drugs were associated with a diagnosis of SJS-TEN; antiepileptic and anti-infectious drugs were the most common drug classes represented.
- The five most frequently reported drugs were carbamazepine (11.7%), lamotrigine (10.6%), sulfamethoxazole-trimethoprim (9%), acetaminophen (8.4%), and phenytoin (6.6%). The five drugs with the highest IC025 were lamotrigine, carbamazepine, phenobarbital, phenytoin, and nimesulide.
- All antiepileptics, many antibiotic families, dapsone, antiretroviral drugs, some antifungal drugs, and nonsteroidal anti-inflammatory drugs were identified in reports, with penicillins the most frequently reported antibiotic family and sulfonamides having the strongest pharmacovigilance signal.
- Vaccines were not associated with significant signals.
IN PRACTICE:
The study provides an update on “the spectrum of drugs potentially associated with SJS-TEN in the pediatric population,” the authors concluded, and “underlines the importance of reporting to pharmacovigilance the suspicion of this severe side effect of drugs with the most precise and detailed clinical description possible.”
SOURCE:
The study, led by Pauline Bataille, MD, of the Department of Pediatric Dermatology, Hôpital Necker-Enfants Malades, Paris City University, France, was published online in the Journal of the European Academy of Dermatology and Venereology.
LIMITATIONS:
Limitations include the possibility that some cases could have had an infectious or idiopathic cause not related to a drug and the lack of detailed clinical data in the database.
DISCLOSURES:
This study did not receive any funding. The authors declared no conflict of interest.
A version of this article first appeared on Medscape.com.
Aquagenic Wrinkling Among Skin-Related Signs of Cystic Fibrosis
TOPLINE:
METHODOLOGY:
- Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
- Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
- They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.
TAKEAWAY:
- Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
- CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
- CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
- CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.
IN PRACTICE:
“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”
SOURCE:
Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The authors did not make a comment about the limitations of their review.
DISCLOSURES:
No funding was received for the review. The authors had no disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
- Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
- They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.
TAKEAWAY:
- Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
- CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
- CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
- CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.
IN PRACTICE:
“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”
SOURCE:
Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The authors did not make a comment about the limitations of their review.
DISCLOSURES:
No funding was received for the review. The authors had no disclosures.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Patients with CF, caused by a mutation in the CF Transmembrane Conductance Regulator (CFTR) gene, can develop diverse dermatologic manifestations.
- Researchers reviewed the literature and provided their own clinical experience regarding dermatologic manifestations of CF.
- They also reviewed the cutaneous side effects of CFTR modulators and antibiotics used to treat CF.
TAKEAWAY:
- Aquagenic wrinkling of the palm is common in individuals with CF, affecting up to 80% of patients (and 25% of CF gene carriers), and can be an early manifestation of CF. Treatments include topical medications (such as aluminum chloride, corticosteroids, and salicylic acid), botulinum toxin injections, and recently, CFTR-modulating treatments.
- CF nutrient deficiency dermatitis, often in a diaper distribution, usually appears in infancy and, before newborn screening was available, was sometimes the first sign of CF in some cases. It usually resolves with an adequate diet, pancreatic enzymes, and/or nutritional supplements. Zinc and essential fatty acid deficiencies can lead to acrodermatitis enteropathica–like symptoms and psoriasiform rashes, respectively.
- CF is also associated with vascular disorders, including cutaneous and, rarely, systemic vasculitis. Treatment includes topical and oral steroids and immune-modulating therapies.
- CFTR modulators, now the most common and highly effective treatment for CF, are associated with several skin reactions, which can be managed with treatments that include topical steroids and oral antihistamines. Frequent antibiotic treatment can also trigger skin reactions.
IN PRACTICE:
“Recognition and familiarity with dermatologic clinical manifestations of CF are important for multidisciplinary care” for patients with CF, the authors wrote, adding that “dermatology providers may play a significant role in the diagnosis and management of CF cutaneous comorbidities.”
SOURCE:
Aaron D. Smith, BS, from the University of Virginia (UVA) School of Medicine, Charlottesville, and coauthors were from the departments of dermatology and pulmonology/critical care medicine at UVA. The study was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
The authors did not make a comment about the limitations of their review.
DISCLOSURES:
No funding was received for the review. The authors had no disclosures.
A version of this article first appeared on Medscape.com.
Survey Spotlights Identification of Dermatologic Adverse Events From Cancer Therapies
“New cancer therapies have brought a diversity of treatment-related dermatologic adverse events (dAEs) beyond those experienced with conventional chemotherapy, which has demanded an evolving assessment of toxicities,” researchers led by Nicole R. LeBoeuf, MD, MPH, of the Department of Dermatology at Brigham and Women’s Hospital and the Center for Cutaneous Oncology at the Dana-Farber Brigham Cancer Center, Boston, wrote in a poster presented at the American Academy of Dermatology annual meeting.
The authors noted that “Version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE v5.0)” serves as the current, broadly accepted criteria for classification and grading during routine medical care and clinical trials. But despite extensive utilization of CTCAE, there is little data regarding its application.”
To evaluate how CTCAE is being used in clinical practice, they sent a four-case survey of dAEs to 81 dermatologists and 182 medical oncologists at six US-based academic institutions. For three of the cases, respondents were asked to classify and grade morbilliform, psoriasiform, and papulopustular rashes based on a review of photographs and text descriptions. For the fourth case, respondents were asked to grade a dAE using only a clinic note text description. The researchers used chi-square tests in R software to compare survey responses.
Compared with medical oncologists, dermatologists were significantly more likely to provide correct responses in characterizing morbilliform and psoriasiform eruptions. “As low as 12%” of medical oncologists were correct, and “as low as 87%” of dermatologists were correct (P < .001). Similarly, dermatologists were significantly more likely to grade the psoriasiform, papulopustular, and written cases correctly compared with medical oncologists (P < .001 for all associations).
“These cases demonstrated poor concordance of classification and grading between specialties and across medical oncology,” the authors concluded in their poster, noting that 87% of medical oncologists were interested in additional educational tools on dAEs. “With correct classification as low as 12%, medical oncologists may have more difficulty delivering appropriate, toxicity-specific therapy and may consider banal eruptions dangerous.”
Poor concordance of grading among the two groups of clinicians “raises the question of whether CTCAE v5.0 is an appropriate determinant for patient continuation on therapy or in trials,” they added. “As anticancer therapy becomes more complex — with new toxicities from novel agents and combinations — we must ensure we have a grading system that is valid across investigators and does not harm patients by instituting unnecessary treatment stops.”
Future studies, they said, “can explore what interventions beyond involvement of dermatologists improve classification and grading in practice.”
Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, noted that with the continued expansion and introduction of new targeted and immunotherapies in the oncology space, “you can be sure we will continue to appreciate the importance and value of the field of supportive oncodermatology, as hair, skin, and nails are almost guaranteed collateral damage in this story.
“Ensuring early identification and consistent grading severity is not only important for the plethora of patients who are currently developing the litany of cutaneous adverse events but to evaluate potential mitigation strategies and even push along countermeasures down the FDA approval pathway,” Dr. Friedman said. In this study, the investigators demonstrated that work “is sorely needed, not just in dermatology but even more so for our colleagues across the aisle. A central tenet of supportive oncodermatology must also be education for all stakeholders, and the good news is our oncology partners will welcome it.”
Dr. LeBoeuf disclosed that she is a consultant to and has received honoraria from Bayer, Seattle Genetics, Sanofi, Silverback, Fortress Biotech, and Synox Therapeutics outside the submitted work. No other authors reported having financial disclosures. Dr. Friedman directs the supportive oncodermatology program at GW that received independent funding from La Roche-Posay.
A version of this article first appeared on Medscape.com.
“New cancer therapies have brought a diversity of treatment-related dermatologic adverse events (dAEs) beyond those experienced with conventional chemotherapy, which has demanded an evolving assessment of toxicities,” researchers led by Nicole R. LeBoeuf, MD, MPH, of the Department of Dermatology at Brigham and Women’s Hospital and the Center for Cutaneous Oncology at the Dana-Farber Brigham Cancer Center, Boston, wrote in a poster presented at the American Academy of Dermatology annual meeting.
The authors noted that “Version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE v5.0)” serves as the current, broadly accepted criteria for classification and grading during routine medical care and clinical trials. But despite extensive utilization of CTCAE, there is little data regarding its application.”
To evaluate how CTCAE is being used in clinical practice, they sent a four-case survey of dAEs to 81 dermatologists and 182 medical oncologists at six US-based academic institutions. For three of the cases, respondents were asked to classify and grade morbilliform, psoriasiform, and papulopustular rashes based on a review of photographs and text descriptions. For the fourth case, respondents were asked to grade a dAE using only a clinic note text description. The researchers used chi-square tests in R software to compare survey responses.
Compared with medical oncologists, dermatologists were significantly more likely to provide correct responses in characterizing morbilliform and psoriasiform eruptions. “As low as 12%” of medical oncologists were correct, and “as low as 87%” of dermatologists were correct (P < .001). Similarly, dermatologists were significantly more likely to grade the psoriasiform, papulopustular, and written cases correctly compared with medical oncologists (P < .001 for all associations).
“These cases demonstrated poor concordance of classification and grading between specialties and across medical oncology,” the authors concluded in their poster, noting that 87% of medical oncologists were interested in additional educational tools on dAEs. “With correct classification as low as 12%, medical oncologists may have more difficulty delivering appropriate, toxicity-specific therapy and may consider banal eruptions dangerous.”
Poor concordance of grading among the two groups of clinicians “raises the question of whether CTCAE v5.0 is an appropriate determinant for patient continuation on therapy or in trials,” they added. “As anticancer therapy becomes more complex — with new toxicities from novel agents and combinations — we must ensure we have a grading system that is valid across investigators and does not harm patients by instituting unnecessary treatment stops.”
Future studies, they said, “can explore what interventions beyond involvement of dermatologists improve classification and grading in practice.”
Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, noted that with the continued expansion and introduction of new targeted and immunotherapies in the oncology space, “you can be sure we will continue to appreciate the importance and value of the field of supportive oncodermatology, as hair, skin, and nails are almost guaranteed collateral damage in this story.
“Ensuring early identification and consistent grading severity is not only important for the plethora of patients who are currently developing the litany of cutaneous adverse events but to evaluate potential mitigation strategies and even push along countermeasures down the FDA approval pathway,” Dr. Friedman said. In this study, the investigators demonstrated that work “is sorely needed, not just in dermatology but even more so for our colleagues across the aisle. A central tenet of supportive oncodermatology must also be education for all stakeholders, and the good news is our oncology partners will welcome it.”
Dr. LeBoeuf disclosed that she is a consultant to and has received honoraria from Bayer, Seattle Genetics, Sanofi, Silverback, Fortress Biotech, and Synox Therapeutics outside the submitted work. No other authors reported having financial disclosures. Dr. Friedman directs the supportive oncodermatology program at GW that received independent funding from La Roche-Posay.
A version of this article first appeared on Medscape.com.
“New cancer therapies have brought a diversity of treatment-related dermatologic adverse events (dAEs) beyond those experienced with conventional chemotherapy, which has demanded an evolving assessment of toxicities,” researchers led by Nicole R. LeBoeuf, MD, MPH, of the Department of Dermatology at Brigham and Women’s Hospital and the Center for Cutaneous Oncology at the Dana-Farber Brigham Cancer Center, Boston, wrote in a poster presented at the American Academy of Dermatology annual meeting.
The authors noted that “Version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE v5.0)” serves as the current, broadly accepted criteria for classification and grading during routine medical care and clinical trials. But despite extensive utilization of CTCAE, there is little data regarding its application.”
To evaluate how CTCAE is being used in clinical practice, they sent a four-case survey of dAEs to 81 dermatologists and 182 medical oncologists at six US-based academic institutions. For three of the cases, respondents were asked to classify and grade morbilliform, psoriasiform, and papulopustular rashes based on a review of photographs and text descriptions. For the fourth case, respondents were asked to grade a dAE using only a clinic note text description. The researchers used chi-square tests in R software to compare survey responses.
Compared with medical oncologists, dermatologists were significantly more likely to provide correct responses in characterizing morbilliform and psoriasiform eruptions. “As low as 12%” of medical oncologists were correct, and “as low as 87%” of dermatologists were correct (P < .001). Similarly, dermatologists were significantly more likely to grade the psoriasiform, papulopustular, and written cases correctly compared with medical oncologists (P < .001 for all associations).
“These cases demonstrated poor concordance of classification and grading between specialties and across medical oncology,” the authors concluded in their poster, noting that 87% of medical oncologists were interested in additional educational tools on dAEs. “With correct classification as low as 12%, medical oncologists may have more difficulty delivering appropriate, toxicity-specific therapy and may consider banal eruptions dangerous.”
Poor concordance of grading among the two groups of clinicians “raises the question of whether CTCAE v5.0 is an appropriate determinant for patient continuation on therapy or in trials,” they added. “As anticancer therapy becomes more complex — with new toxicities from novel agents and combinations — we must ensure we have a grading system that is valid across investigators and does not harm patients by instituting unnecessary treatment stops.”
Future studies, they said, “can explore what interventions beyond involvement of dermatologists improve classification and grading in practice.”
Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who was asked to comment on the study, noted that with the continued expansion and introduction of new targeted and immunotherapies in the oncology space, “you can be sure we will continue to appreciate the importance and value of the field of supportive oncodermatology, as hair, skin, and nails are almost guaranteed collateral damage in this story.
“Ensuring early identification and consistent grading severity is not only important for the plethora of patients who are currently developing the litany of cutaneous adverse events but to evaluate potential mitigation strategies and even push along countermeasures down the FDA approval pathway,” Dr. Friedman said. In this study, the investigators demonstrated that work “is sorely needed, not just in dermatology but even more so for our colleagues across the aisle. A central tenet of supportive oncodermatology must also be education for all stakeholders, and the good news is our oncology partners will welcome it.”
Dr. LeBoeuf disclosed that she is a consultant to and has received honoraria from Bayer, Seattle Genetics, Sanofi, Silverback, Fortress Biotech, and Synox Therapeutics outside the submitted work. No other authors reported having financial disclosures. Dr. Friedman directs the supportive oncodermatology program at GW that received independent funding from La Roche-Posay.
A version of this article first appeared on Medscape.com.
FROM AAD 2024
A 6-Year-Old Female Presents With a Bruise-Like Lesion on the Lip, Tongue, and Chin Area Present Since Birth
Diagnosis: Venous Malformation
Although present at birth, they are not always clinically evident early in life. They also tend to grow with the child without spontaneous regression, causing potential cosmetic concerns or complications from impingement on surrounding tissue.
Venous malformations appear with a bluish color appearing beneath the skin and can vary significantly in size and severity. Venous malformations are compressible and characterized by low to stagnant blood flow, which can spontaneously thrombose. Clinically, this may cause pain, swelling, skin changes, tissue and limb overgrowth, or functional impairment depending on location and size.
Venous malformations result from disorganized angiogenesis secondary to sporadic mutations in somatic cells. The most common implicated gene is TEK, a receptor tyrosine kinase. PIK3CA has also been involved. Both genes are involved in the PI3K/AKT/mTOR pathway, which regulates cell growth, proliferation, and angiogenesis. In venous endothelial cells, abnormal angiogenesis and vessel maturation may lead to venous malformation formation. Dysplastic vessels frequently separate from normal veins but may be contiguous with the deep venous system.
Diagnosis involves clinical history and physical examination. Imaging with ultrasound and magnetic resonance imaging (MRI) may be utilized. While ultrasound may be preferred for superficial venous malformations, MRI or MRI with MR angiography (MRA) is the preferred method for venous malformation assessment. Genetic testing may be appropriate for complex malformations, as classification of lesions by underlying mutation may allow targeted therapy.
This patient’s past MRI and MRA findings were consistent with a venous malformation.
Treatment
Venous malformations rarely regress spontaneously. Treatment is required if venous malformations are symptomatic, which may include pain, swelling, deformity, thrombosis, or interference with daily activities of living. Treatment plans require consideration of patient goals of care. The main categories of therapy are embolization/sclerotherapy, surgical resection, and molecular targeted therapy.
Sclerotherapy is a well-tolerated and efficacious first-line therapy. It can be used as either nonsurgical curative therapy or preoperative adjunct therapy to minimize blood loss before surgical resection. While surgical resection may cause scarring, multimodal approaches with sclerotherapy or laser therapy can decrease complications. Molecular therapies aim to reduce vascular proliferation and symptoms. Referral to hematology/oncology for evaluation and consideration of chemotherapeutic agents may be required. Sirolimus has been shown in mice models to inhibit an endothelial cell tyrosine kinase receptor that plays a role in venous malformation growth. Multiple studies have proved its efficacy in managing complicated vascular anomalies, including venous malformations. Alpelisib is an inhibitor of PI3KCA, which is part of the pathway that contributes to venous malformation formation. Dactolisib, a dual inhibitor of the PI3KA and mTOR pathways, and rebastinib, a TEK inhibitor, are being investigated.
Differential Diagnoses
The differential diagnosis includes dermal melanocytosis, nevus of Ota, hemangioma of infancy, and ashy dermatosis. In addition, venous malformations can be part of more complex vascular malformations.
Dermal melanocytosis, also known as Mongolian spots, are blue-gray patches of discoloration on the skin that appear at birth or shortly after. They result from the arrest of dermal melanocytes in the dermis during fetal life and tissue modeling. They are commonly observed in those of Asian or African descent with darker skin types. Most often, they are located in the lumbar or sacral-gluteal region. Unlike venous malformations, they are benign and do not involve vascular abnormalities. They typically fade over time.
Nevus of Ota is a benign congenital condition that presents with blue-gray or brown patches of pigmentation on the skin around the eyes, cheeks, and forehead. They are dermal melanocytes with a speckled instead of uniform appearance. Nevus of Ota primarily affects individuals of Asian descent and typically presents in the trigeminal nerve distribution region. Treatment can be done to minimize deformity, generally with pigmented laser surgery.
Hemangiomas of infancy are common benign tumors of infancy caused by endothelial cell proliferation. They are characterized by rapid growth followed by spontaneous involution within the first year of life and for several years. Hemangiomas can be superficial, deep, or mixed with features of both superficial and deep. Superficial hemangiomas present as raised, lobulated, and bright red while deep hemangiomas present as a bluish-hued nodule, plaque, or tumor. They are diagnosed clinically but skin biopsies and imaging can confirm the suspected diagnosis. While hemangiomas may self-resolve, complicated hemangiomas can be treated with topical timolol, oral propranolol, topical and intralesional corticosteroids, pulsed-dye laser, and surgical resection.
Ashy dermatosis is a term for asymptomatic, gray-blue or ashy patches distributed symmetrically on the trunk, head, neck, and upper extremities. It primarily affects individuals with darker skin types (Fitzpatrick III-V), and is more common in patients with Hispanic, Asian, or African backgrounds. The direct cause of ashy dermatosis is unknown but it is thought to be linked to drug ingestion, genetics, infection, and immune-mediated mechanisms. The general treatment includes topical corticosteroids, clofazimine, topical calcineurin inhibitors, oral dapsone, phototherapy, topical retinoids, or isotretinoin to reduce inflammation and pigmentation.
Danny Lee and Samuel Le serve as research fellows and Jolina Bui as research associate in the Pediatric Dermatology Division of the Department of Dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is Distinguished Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. The authors have no relevant financial disclosures.
Suggested Reading
Agarwal P, Patel BC. Nevus of Ota and Ito. [Updated 2023 Jul 10]. In: StatPearls [Internet]. StatPearls Publishing; 2024.
Dompmartin A et al. The VASCERN-VASCA Working Group Diagnostic and Management Pathways for Venous Malformations. J Vasc Anom (Phila). 2023 Mar 23;4(2):e064.
Dompmartin A et al. Venous malformation: Update on aetiopathogenesis, diagnosis and management. Phlebology. 2010 Oct;25(5):224-235.
Gupta D, Thappa DM. Mongolian spots. Indian J Dermatol Venereol Leprol. 2013 Jul-Aug;79(4):469-478.
Krowchuk DP et al. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475.
Nguyen K, Khachemoune A. Ashy dermatosis: A review. Dermatol Online J. 2019 May 15;25(5):13030/qt44f462s8.
Patel ND, Chong AT et al. Venous Malformations. Semin Intervent Radiol. 2022 Dec 20;39(5):498-507.
Diagnosis: Venous Malformation
Although present at birth, they are not always clinically evident early in life. They also tend to grow with the child without spontaneous regression, causing potential cosmetic concerns or complications from impingement on surrounding tissue.
Venous malformations appear with a bluish color appearing beneath the skin and can vary significantly in size and severity. Venous malformations are compressible and characterized by low to stagnant blood flow, which can spontaneously thrombose. Clinically, this may cause pain, swelling, skin changes, tissue and limb overgrowth, or functional impairment depending on location and size.
Venous malformations result from disorganized angiogenesis secondary to sporadic mutations in somatic cells. The most common implicated gene is TEK, a receptor tyrosine kinase. PIK3CA has also been involved. Both genes are involved in the PI3K/AKT/mTOR pathway, which regulates cell growth, proliferation, and angiogenesis. In venous endothelial cells, abnormal angiogenesis and vessel maturation may lead to venous malformation formation. Dysplastic vessels frequently separate from normal veins but may be contiguous with the deep venous system.
Diagnosis involves clinical history and physical examination. Imaging with ultrasound and magnetic resonance imaging (MRI) may be utilized. While ultrasound may be preferred for superficial venous malformations, MRI or MRI with MR angiography (MRA) is the preferred method for venous malformation assessment. Genetic testing may be appropriate for complex malformations, as classification of lesions by underlying mutation may allow targeted therapy.
This patient’s past MRI and MRA findings were consistent with a venous malformation.
Treatment
Venous malformations rarely regress spontaneously. Treatment is required if venous malformations are symptomatic, which may include pain, swelling, deformity, thrombosis, or interference with daily activities of living. Treatment plans require consideration of patient goals of care. The main categories of therapy are embolization/sclerotherapy, surgical resection, and molecular targeted therapy.
Sclerotherapy is a well-tolerated and efficacious first-line therapy. It can be used as either nonsurgical curative therapy or preoperative adjunct therapy to minimize blood loss before surgical resection. While surgical resection may cause scarring, multimodal approaches with sclerotherapy or laser therapy can decrease complications. Molecular therapies aim to reduce vascular proliferation and symptoms. Referral to hematology/oncology for evaluation and consideration of chemotherapeutic agents may be required. Sirolimus has been shown in mice models to inhibit an endothelial cell tyrosine kinase receptor that plays a role in venous malformation growth. Multiple studies have proved its efficacy in managing complicated vascular anomalies, including venous malformations. Alpelisib is an inhibitor of PI3KCA, which is part of the pathway that contributes to venous malformation formation. Dactolisib, a dual inhibitor of the PI3KA and mTOR pathways, and rebastinib, a TEK inhibitor, are being investigated.
Differential Diagnoses
The differential diagnosis includes dermal melanocytosis, nevus of Ota, hemangioma of infancy, and ashy dermatosis. In addition, venous malformations can be part of more complex vascular malformations.
Dermal melanocytosis, also known as Mongolian spots, are blue-gray patches of discoloration on the skin that appear at birth or shortly after. They result from the arrest of dermal melanocytes in the dermis during fetal life and tissue modeling. They are commonly observed in those of Asian or African descent with darker skin types. Most often, they are located in the lumbar or sacral-gluteal region. Unlike venous malformations, they are benign and do not involve vascular abnormalities. They typically fade over time.
Nevus of Ota is a benign congenital condition that presents with blue-gray or brown patches of pigmentation on the skin around the eyes, cheeks, and forehead. They are dermal melanocytes with a speckled instead of uniform appearance. Nevus of Ota primarily affects individuals of Asian descent and typically presents in the trigeminal nerve distribution region. Treatment can be done to minimize deformity, generally with pigmented laser surgery.
Hemangiomas of infancy are common benign tumors of infancy caused by endothelial cell proliferation. They are characterized by rapid growth followed by spontaneous involution within the first year of life and for several years. Hemangiomas can be superficial, deep, or mixed with features of both superficial and deep. Superficial hemangiomas present as raised, lobulated, and bright red while deep hemangiomas present as a bluish-hued nodule, plaque, or tumor. They are diagnosed clinically but skin biopsies and imaging can confirm the suspected diagnosis. While hemangiomas may self-resolve, complicated hemangiomas can be treated with topical timolol, oral propranolol, topical and intralesional corticosteroids, pulsed-dye laser, and surgical resection.
Ashy dermatosis is a term for asymptomatic, gray-blue or ashy patches distributed symmetrically on the trunk, head, neck, and upper extremities. It primarily affects individuals with darker skin types (Fitzpatrick III-V), and is more common in patients with Hispanic, Asian, or African backgrounds. The direct cause of ashy dermatosis is unknown but it is thought to be linked to drug ingestion, genetics, infection, and immune-mediated mechanisms. The general treatment includes topical corticosteroids, clofazimine, topical calcineurin inhibitors, oral dapsone, phototherapy, topical retinoids, or isotretinoin to reduce inflammation and pigmentation.
Danny Lee and Samuel Le serve as research fellows and Jolina Bui as research associate in the Pediatric Dermatology Division of the Department of Dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is Distinguished Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. The authors have no relevant financial disclosures.
Suggested Reading
Agarwal P, Patel BC. Nevus of Ota and Ito. [Updated 2023 Jul 10]. In: StatPearls [Internet]. StatPearls Publishing; 2024.
Dompmartin A et al. The VASCERN-VASCA Working Group Diagnostic and Management Pathways for Venous Malformations. J Vasc Anom (Phila). 2023 Mar 23;4(2):e064.
Dompmartin A et al. Venous malformation: Update on aetiopathogenesis, diagnosis and management. Phlebology. 2010 Oct;25(5):224-235.
Gupta D, Thappa DM. Mongolian spots. Indian J Dermatol Venereol Leprol. 2013 Jul-Aug;79(4):469-478.
Krowchuk DP et al. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475.
Nguyen K, Khachemoune A. Ashy dermatosis: A review. Dermatol Online J. 2019 May 15;25(5):13030/qt44f462s8.
Patel ND, Chong AT et al. Venous Malformations. Semin Intervent Radiol. 2022 Dec 20;39(5):498-507.
Diagnosis: Venous Malformation
Although present at birth, they are not always clinically evident early in life. They also tend to grow with the child without spontaneous regression, causing potential cosmetic concerns or complications from impingement on surrounding tissue.
Venous malformations appear with a bluish color appearing beneath the skin and can vary significantly in size and severity. Venous malformations are compressible and characterized by low to stagnant blood flow, which can spontaneously thrombose. Clinically, this may cause pain, swelling, skin changes, tissue and limb overgrowth, or functional impairment depending on location and size.
Venous malformations result from disorganized angiogenesis secondary to sporadic mutations in somatic cells. The most common implicated gene is TEK, a receptor tyrosine kinase. PIK3CA has also been involved. Both genes are involved in the PI3K/AKT/mTOR pathway, which regulates cell growth, proliferation, and angiogenesis. In venous endothelial cells, abnormal angiogenesis and vessel maturation may lead to venous malformation formation. Dysplastic vessels frequently separate from normal veins but may be contiguous with the deep venous system.
Diagnosis involves clinical history and physical examination. Imaging with ultrasound and magnetic resonance imaging (MRI) may be utilized. While ultrasound may be preferred for superficial venous malformations, MRI or MRI with MR angiography (MRA) is the preferred method for venous malformation assessment. Genetic testing may be appropriate for complex malformations, as classification of lesions by underlying mutation may allow targeted therapy.
This patient’s past MRI and MRA findings were consistent with a venous malformation.
Treatment
Venous malformations rarely regress spontaneously. Treatment is required if venous malformations are symptomatic, which may include pain, swelling, deformity, thrombosis, or interference with daily activities of living. Treatment plans require consideration of patient goals of care. The main categories of therapy are embolization/sclerotherapy, surgical resection, and molecular targeted therapy.
Sclerotherapy is a well-tolerated and efficacious first-line therapy. It can be used as either nonsurgical curative therapy or preoperative adjunct therapy to minimize blood loss before surgical resection. While surgical resection may cause scarring, multimodal approaches with sclerotherapy or laser therapy can decrease complications. Molecular therapies aim to reduce vascular proliferation and symptoms. Referral to hematology/oncology for evaluation and consideration of chemotherapeutic agents may be required. Sirolimus has been shown in mice models to inhibit an endothelial cell tyrosine kinase receptor that plays a role in venous malformation growth. Multiple studies have proved its efficacy in managing complicated vascular anomalies, including venous malformations. Alpelisib is an inhibitor of PI3KCA, which is part of the pathway that contributes to venous malformation formation. Dactolisib, a dual inhibitor of the PI3KA and mTOR pathways, and rebastinib, a TEK inhibitor, are being investigated.
Differential Diagnoses
The differential diagnosis includes dermal melanocytosis, nevus of Ota, hemangioma of infancy, and ashy dermatosis. In addition, venous malformations can be part of more complex vascular malformations.
Dermal melanocytosis, also known as Mongolian spots, are blue-gray patches of discoloration on the skin that appear at birth or shortly after. They result from the arrest of dermal melanocytes in the dermis during fetal life and tissue modeling. They are commonly observed in those of Asian or African descent with darker skin types. Most often, they are located in the lumbar or sacral-gluteal region. Unlike venous malformations, they are benign and do not involve vascular abnormalities. They typically fade over time.
Nevus of Ota is a benign congenital condition that presents with blue-gray or brown patches of pigmentation on the skin around the eyes, cheeks, and forehead. They are dermal melanocytes with a speckled instead of uniform appearance. Nevus of Ota primarily affects individuals of Asian descent and typically presents in the trigeminal nerve distribution region. Treatment can be done to minimize deformity, generally with pigmented laser surgery.
Hemangiomas of infancy are common benign tumors of infancy caused by endothelial cell proliferation. They are characterized by rapid growth followed by spontaneous involution within the first year of life and for several years. Hemangiomas can be superficial, deep, or mixed with features of both superficial and deep. Superficial hemangiomas present as raised, lobulated, and bright red while deep hemangiomas present as a bluish-hued nodule, plaque, or tumor. They are diagnosed clinically but skin biopsies and imaging can confirm the suspected diagnosis. While hemangiomas may self-resolve, complicated hemangiomas can be treated with topical timolol, oral propranolol, topical and intralesional corticosteroids, pulsed-dye laser, and surgical resection.
Ashy dermatosis is a term for asymptomatic, gray-blue or ashy patches distributed symmetrically on the trunk, head, neck, and upper extremities. It primarily affects individuals with darker skin types (Fitzpatrick III-V), and is more common in patients with Hispanic, Asian, or African backgrounds. The direct cause of ashy dermatosis is unknown but it is thought to be linked to drug ingestion, genetics, infection, and immune-mediated mechanisms. The general treatment includes topical corticosteroids, clofazimine, topical calcineurin inhibitors, oral dapsone, phototherapy, topical retinoids, or isotretinoin to reduce inflammation and pigmentation.
Danny Lee and Samuel Le serve as research fellows and Jolina Bui as research associate in the Pediatric Dermatology Division of the Department of Dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Dr. Eichenfield is Distinguished Professor of Dermatology and Pediatrics and Vice-Chair of the Department of Dermatology at the University of California, San Diego, and Rady Children’s Hospital, San Diego. The authors have no relevant financial disclosures.
Suggested Reading
Agarwal P, Patel BC. Nevus of Ota and Ito. [Updated 2023 Jul 10]. In: StatPearls [Internet]. StatPearls Publishing; 2024.
Dompmartin A et al. The VASCERN-VASCA Working Group Diagnostic and Management Pathways for Venous Malformations. J Vasc Anom (Phila). 2023 Mar 23;4(2):e064.
Dompmartin A et al. Venous malformation: Update on aetiopathogenesis, diagnosis and management. Phlebology. 2010 Oct;25(5):224-235.
Gupta D, Thappa DM. Mongolian spots. Indian J Dermatol Venereol Leprol. 2013 Jul-Aug;79(4):469-478.
Krowchuk DP et al. Clinical Practice Guideline for the Management of Infantile Hemangiomas. Pediatrics. 2019 Jan;143(1):e20183475.
Nguyen K, Khachemoune A. Ashy dermatosis: A review. Dermatol Online J. 2019 May 15;25(5):13030/qt44f462s8.
Patel ND, Chong AT et al. Venous Malformations. Semin Intervent Radiol. 2022 Dec 20;39(5):498-507.
A 6-year-old girl presents with a bruise-like lesion on the lip, tongue, and chin area present since birth. The family states that her tongue has been increasing in size and is painful. On physical exam, she presents with left lower mucosal lip fullness and an overlying violaceous hue extending into the oral mucosa and onto the left tongue. The left portion of the dorsal tongue displays an increased thickness and bluish discoloration and there is a pink, smooth papule on the left anterolateral tongue.
Study Evaluates CVD, Mortality Risks In Patients With Prurigo Nodularis
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
TOPLINE:
, particularly among women and White patients.
METHODOLOGY:
- Studies have shown increased risks for cardiovascular diseases in patients with PN, but limited sample sizes have hindered further subgroup analysis. Given PN’s pronounced sex and ethnicity skew, it is important to examine underrepresented groups to accurately assess their cardiovascular risk.
- In this propensity-score matched analysis, researchers identified 64,801 patients (59.44% women) with PN using electronic health reports from the Global Collaborative Network of TriNetX and matched to individuals without PN.
- Researchers calculated risks for 15 cardiovascular endpoints and all-cause mortality within 10 years of diagnosis. Major adverse cardiovascular events (MACE) included acute cerebral and myocardial infarction (MI), heart failure, ventricular arrhythmia, and sudden cardiac death.
TAKEAWAY:
- Patients with PN showed a higher risk for death (hazard ratio [HR], 1.1243) and MACE (HR, 1.117) (P < .0001 for both).
- PN was also associated with a higher risk for heart failure (HR, 1.062), thrombotic venous disease (HR, 1.26), angina pectoris (HR, 1.096), and peripheral arterial diseases (HR, 1.082) (P < .0001 for all) and for acute MI (HR, 1.11; P = .0015) and valve disorders (HR, 1.08; P = .0018).
- White patients with PN had a significantly increased risk for MACE, death, heart failure, cardiac arrest, vascular diseases, and acute MI, but this was not observed in people of color.
- Women exhibited a higher risk for MACE, heart failure, peripheral artery disease, acute MI, conduction disease, and valve disorders, while men did not have an increased risk for major or acute cardiovascular events. Both men and women had a higher risk for death, chronic ischemic heart disease, and venous disease.
IN PRACTICE:
“Although no novel PN-specific treatment rationale can be derived from the presented data, the potential risk of subsequent cardiovascular disease should be considered in the care of patients with PN, which includes screening and optimal management of other additional cardiovascular risk factors,” the authors wrote.
LIMITATIONS:
Retrospective observational design introduced inherent biases. Misdiagnosis or false coding in electronic health records could affect the data accuracy and ethnicity-specific analyses.
SOURCE:
This work, led by Henning Olbrich, from the Department of Dermatology, University of Lübeck, Germany, was published online in eBioMedicine.
DISCLOSURES:
The study was supported by the University of Lübeck, the Deutsche Forschungsgemeinschaft, and the State of Schleswig-Holstein. One author declared financial ties outside this work, and one author is an employee of TriNetX.
A version of this article appeared on Medscape.com.
Consider a Four-Step Approach to Shared Decision-Making in Pediatric Dermatology
SAN DIEGO — In the clinical experience of Kelly M. Cordoro, MD, .
“SDM is a cornerstone of person-centered care,” Dr. Cordoro, professor of dermatology and pediatrics at the University of California, San Francisco, said at the Society for Pediatric Dermatology meeting, held in advance of the annual meeting of the American Academy of Dermatology. “We do it all the time. It can be patient-led, clinician-led, or a patient/family dyad approach. If we do it well, it can improve outcomes. Patients report more satisfying interactions with their care team. It brings adolescent patients especially a sense of independence and they adapt faster to their illness.”
First described in 1982, SDM is now recognized as being a measure of high-quality decision-making. In fact, some reimbursement models include SDM in assessments of complex medical decision-making. “SDM is ideally used for complex, preference-sensitive decisions when there are several reasonable alternatives,” she said. “It makes sense that these are heavily used by oncology, cardiology, surgery, and palliative care. Certainly, there is room for SDM in dermatology. Though we are behind other specialties in terms of the research, there are some patient decision aids available for some skin diseases.”
Conditions such as acne, psoriasis, and atopic dermatitis have multiple treatment options, often without a single best choice. The ideal treatment depends on disease characteristics (extent, sites affected, symptoms, and natural history), the patient (age, comorbidities, overall disease burden), therapies (safety, efficacy, duration, and adverse events), and preferences (logistics, time, shots vs. pills, etc.). “These factors vary between patients and within the same patient over time, and at each step along the course of the condition, SDM approaches are relevant,” she said.
AHRQ’s Five-Step Approach
The Agency for Healthcare Research and Quality developed a five-step approach to SDM known as SHARE: Seek your patient’s participation; Help your patient explore and compare treatment options; Assess your patient’s values and preferences; Reach a decision with your patient, and Evaluate your patient’s decision. “We do this all the time in practice with adult patients, but may not label it as SDM,” said Dr. Cordoro, chief and fellowship director of pediatric dermatology at UCSF.
“Where it gets a little murkier is in pediatric decision-making, which is a complex type of surrogate decision-making.” In this situation the patient — a minor — does not have full autonomy. The challenge for caregivers is that giving or withholding permission for interventions is a difficult role. “Their job is to protect the patient’s well-being while empowering them toward independence,” she said. “It can be hard for caregivers to understand complex information.” The challenge for clinicians, she continued, is to know when to invite SDM. This requires relational and sharp communication skills. “We must consider our patient’s/family’s health literacy and be sure the information we share is understood,” she said. “What are the social and structural determinants of health that are going to influence decision-making? You want to move into a relationship like this with cultural humility so you can understand what their preferences are and how they’re seeing the problem. Because there’s no universal agreement on the age at which minors should be deemed decision-making competent in health care, the approach is nuanced and depends on each individual patient and family.”
Dr. Cordoro proposed the following four-step approach to SDM to use in pediatric dermatology:
Step 1: Share relevant information about the condition and treatment options in a clear and understandable manner. The average US resident is at the seventh-to eighth-grade level, “so we have to avoid medical jargon and use plain language,” Dr. Cordoro said. Then, use the teach-back approach to assess their understanding. “Ask, ‘What is your understanding of the most important points that we talked about?’ Or, ‘Please share with me what you heard so I’m sure we all understand the plan.’ Using these techniques will reduce the barriers to care such as health literacy.”
Step 2: Solicit and understand patient/patient family perspectives, preferences and priorities. The goal here is to uncover their beliefs, concerns, and assumptions that may influence their decisions. “Be mindful of power asymmetry,” she noted. “Many families still believe the doctor is the boss and they are there to be told what to do. Be clear that the patient has a say. Talk directly to the patient about their interests if developmentally appropriate.”
Step 3: Invite patients/family into a shared decision-making conversation. Consider statements like, “There are many reasonable options here. Let’s work together to come up with the decision that’s right for you.” Or, “Let’s start by exploring your specific goals and concerns. As you think about the options I just talked to you about, what’s important to you?” Or, “Do you want to think about this decision with anyone else?”
Step 4: Check back in frequently. Pause between significant points and check in. “See how they’re doing during the conversation,” she said. “At future appointments, remember to solicit their input on additional decisions.”
In Dr. Cordoro’s opinion, one potential pitfall of SDM is an over-reliance on patient decision aids. “Very few are available in dermatology,” she said. “Some are relevant but none specifically to pediatric dermatology. They are often complex and require a high reading comprehension level. This disadvantages patients and families with low health literacy. Keep it clear and simple. Your patients will appreciate it.”
Dr. Cordoro reported having no relevant disclosures.
SAN DIEGO — In the clinical experience of Kelly M. Cordoro, MD, .
“SDM is a cornerstone of person-centered care,” Dr. Cordoro, professor of dermatology and pediatrics at the University of California, San Francisco, said at the Society for Pediatric Dermatology meeting, held in advance of the annual meeting of the American Academy of Dermatology. “We do it all the time. It can be patient-led, clinician-led, or a patient/family dyad approach. If we do it well, it can improve outcomes. Patients report more satisfying interactions with their care team. It brings adolescent patients especially a sense of independence and they adapt faster to their illness.”
First described in 1982, SDM is now recognized as being a measure of high-quality decision-making. In fact, some reimbursement models include SDM in assessments of complex medical decision-making. “SDM is ideally used for complex, preference-sensitive decisions when there are several reasonable alternatives,” she said. “It makes sense that these are heavily used by oncology, cardiology, surgery, and palliative care. Certainly, there is room for SDM in dermatology. Though we are behind other specialties in terms of the research, there are some patient decision aids available for some skin diseases.”
Conditions such as acne, psoriasis, and atopic dermatitis have multiple treatment options, often without a single best choice. The ideal treatment depends on disease characteristics (extent, sites affected, symptoms, and natural history), the patient (age, comorbidities, overall disease burden), therapies (safety, efficacy, duration, and adverse events), and preferences (logistics, time, shots vs. pills, etc.). “These factors vary between patients and within the same patient over time, and at each step along the course of the condition, SDM approaches are relevant,” she said.
AHRQ’s Five-Step Approach
The Agency for Healthcare Research and Quality developed a five-step approach to SDM known as SHARE: Seek your patient’s participation; Help your patient explore and compare treatment options; Assess your patient’s values and preferences; Reach a decision with your patient, and Evaluate your patient’s decision. “We do this all the time in practice with adult patients, but may not label it as SDM,” said Dr. Cordoro, chief and fellowship director of pediatric dermatology at UCSF.
“Where it gets a little murkier is in pediatric decision-making, which is a complex type of surrogate decision-making.” In this situation the patient — a minor — does not have full autonomy. The challenge for caregivers is that giving or withholding permission for interventions is a difficult role. “Their job is to protect the patient’s well-being while empowering them toward independence,” she said. “It can be hard for caregivers to understand complex information.” The challenge for clinicians, she continued, is to know when to invite SDM. This requires relational and sharp communication skills. “We must consider our patient’s/family’s health literacy and be sure the information we share is understood,” she said. “What are the social and structural determinants of health that are going to influence decision-making? You want to move into a relationship like this with cultural humility so you can understand what their preferences are and how they’re seeing the problem. Because there’s no universal agreement on the age at which minors should be deemed decision-making competent in health care, the approach is nuanced and depends on each individual patient and family.”
Dr. Cordoro proposed the following four-step approach to SDM to use in pediatric dermatology:
Step 1: Share relevant information about the condition and treatment options in a clear and understandable manner. The average US resident is at the seventh-to eighth-grade level, “so we have to avoid medical jargon and use plain language,” Dr. Cordoro said. Then, use the teach-back approach to assess their understanding. “Ask, ‘What is your understanding of the most important points that we talked about?’ Or, ‘Please share with me what you heard so I’m sure we all understand the plan.’ Using these techniques will reduce the barriers to care such as health literacy.”
Step 2: Solicit and understand patient/patient family perspectives, preferences and priorities. The goal here is to uncover their beliefs, concerns, and assumptions that may influence their decisions. “Be mindful of power asymmetry,” she noted. “Many families still believe the doctor is the boss and they are there to be told what to do. Be clear that the patient has a say. Talk directly to the patient about their interests if developmentally appropriate.”
Step 3: Invite patients/family into a shared decision-making conversation. Consider statements like, “There are many reasonable options here. Let’s work together to come up with the decision that’s right for you.” Or, “Let’s start by exploring your specific goals and concerns. As you think about the options I just talked to you about, what’s important to you?” Or, “Do you want to think about this decision with anyone else?”
Step 4: Check back in frequently. Pause between significant points and check in. “See how they’re doing during the conversation,” she said. “At future appointments, remember to solicit their input on additional decisions.”
In Dr. Cordoro’s opinion, one potential pitfall of SDM is an over-reliance on patient decision aids. “Very few are available in dermatology,” she said. “Some are relevant but none specifically to pediatric dermatology. They are often complex and require a high reading comprehension level. This disadvantages patients and families with low health literacy. Keep it clear and simple. Your patients will appreciate it.”
Dr. Cordoro reported having no relevant disclosures.
SAN DIEGO — In the clinical experience of Kelly M. Cordoro, MD, .
“SDM is a cornerstone of person-centered care,” Dr. Cordoro, professor of dermatology and pediatrics at the University of California, San Francisco, said at the Society for Pediatric Dermatology meeting, held in advance of the annual meeting of the American Academy of Dermatology. “We do it all the time. It can be patient-led, clinician-led, or a patient/family dyad approach. If we do it well, it can improve outcomes. Patients report more satisfying interactions with their care team. It brings adolescent patients especially a sense of independence and they adapt faster to their illness.”
First described in 1982, SDM is now recognized as being a measure of high-quality decision-making. In fact, some reimbursement models include SDM in assessments of complex medical decision-making. “SDM is ideally used for complex, preference-sensitive decisions when there are several reasonable alternatives,” she said. “It makes sense that these are heavily used by oncology, cardiology, surgery, and palliative care. Certainly, there is room for SDM in dermatology. Though we are behind other specialties in terms of the research, there are some patient decision aids available for some skin diseases.”
Conditions such as acne, psoriasis, and atopic dermatitis have multiple treatment options, often without a single best choice. The ideal treatment depends on disease characteristics (extent, sites affected, symptoms, and natural history), the patient (age, comorbidities, overall disease burden), therapies (safety, efficacy, duration, and adverse events), and preferences (logistics, time, shots vs. pills, etc.). “These factors vary between patients and within the same patient over time, and at each step along the course of the condition, SDM approaches are relevant,” she said.
AHRQ’s Five-Step Approach
The Agency for Healthcare Research and Quality developed a five-step approach to SDM known as SHARE: Seek your patient’s participation; Help your patient explore and compare treatment options; Assess your patient’s values and preferences; Reach a decision with your patient, and Evaluate your patient’s decision. “We do this all the time in practice with adult patients, but may not label it as SDM,” said Dr. Cordoro, chief and fellowship director of pediatric dermatology at UCSF.
“Where it gets a little murkier is in pediatric decision-making, which is a complex type of surrogate decision-making.” In this situation the patient — a minor — does not have full autonomy. The challenge for caregivers is that giving or withholding permission for interventions is a difficult role. “Their job is to protect the patient’s well-being while empowering them toward independence,” she said. “It can be hard for caregivers to understand complex information.” The challenge for clinicians, she continued, is to know when to invite SDM. This requires relational and sharp communication skills. “We must consider our patient’s/family’s health literacy and be sure the information we share is understood,” she said. “What are the social and structural determinants of health that are going to influence decision-making? You want to move into a relationship like this with cultural humility so you can understand what their preferences are and how they’re seeing the problem. Because there’s no universal agreement on the age at which minors should be deemed decision-making competent in health care, the approach is nuanced and depends on each individual patient and family.”
Dr. Cordoro proposed the following four-step approach to SDM to use in pediatric dermatology:
Step 1: Share relevant information about the condition and treatment options in a clear and understandable manner. The average US resident is at the seventh-to eighth-grade level, “so we have to avoid medical jargon and use plain language,” Dr. Cordoro said. Then, use the teach-back approach to assess their understanding. “Ask, ‘What is your understanding of the most important points that we talked about?’ Or, ‘Please share with me what you heard so I’m sure we all understand the plan.’ Using these techniques will reduce the barriers to care such as health literacy.”
Step 2: Solicit and understand patient/patient family perspectives, preferences and priorities. The goal here is to uncover their beliefs, concerns, and assumptions that may influence their decisions. “Be mindful of power asymmetry,” she noted. “Many families still believe the doctor is the boss and they are there to be told what to do. Be clear that the patient has a say. Talk directly to the patient about their interests if developmentally appropriate.”
Step 3: Invite patients/family into a shared decision-making conversation. Consider statements like, “There are many reasonable options here. Let’s work together to come up with the decision that’s right for you.” Or, “Let’s start by exploring your specific goals and concerns. As you think about the options I just talked to you about, what’s important to you?” Or, “Do you want to think about this decision with anyone else?”
Step 4: Check back in frequently. Pause between significant points and check in. “See how they’re doing during the conversation,” she said. “At future appointments, remember to solicit their input on additional decisions.”
In Dr. Cordoro’s opinion, one potential pitfall of SDM is an over-reliance on patient decision aids. “Very few are available in dermatology,” she said. “Some are relevant but none specifically to pediatric dermatology. They are often complex and require a high reading comprehension level. This disadvantages patients and families with low health literacy. Keep it clear and simple. Your patients will appreciate it.”
Dr. Cordoro reported having no relevant disclosures.
FROM AAD 2024
New HIV Infections After Vampire Facials at Unlicensed Spa
At least three clients of an unlicensed spa in New Mexico contracted HIV after receiving platelet-rich plasma (PRP) microneedling facials, according to an investigation by the US Centers for Disease Control and Prevention (CDC).
The investigation, spanning 5 years with parts of it still ongoing, has resulted in the closure of the spa and is raising questions about public safety in cosmetic clinics.
Though transmission of HIV by unsterile injection practices is a known risk, this is the first time it has been linked to cosmetic injection services, said Anna Stadelman-Behar, PhD, MPH, of the CDC’s Epidemic Intelligence Service.
Sometimes called a vampire facial, the PRP treatment involves taking a patient’s own blood and separating it in a centrifuge. The portion containing a high concentration of platelets is then reinjected with a syringe or microneedling device.
“The idea is that when you inject this concentrated amount of platelets, the growth factors that the platelets release help to stimulate the regenerative nature of that area,” said Anthony Rossi, MD, professor of dermatology at Weill Cornell Medical College in New York, and attending dermatologist at Memorial Sloan Kettering Cancer Center.
The infections under investigation first came to light when a woman was diagnosed with HIV with no known risk factors for the disease other than exposure to microneedling facials at a cosmetic spa.
The New Mexico Department of Health and the CDC launched an investigation of the spa and discovered a litany of “gross violations of infection control practices,” said Dr. Stadelman-Behar.
Infection-Control Violations
At the spa in New Mexico, investigators found:
- On a kitchen counter, a centrifuge, a heating dry bath, and a rack of unlabeled tubes containing blood
- In a refrigerator, unlabeled tubes of blood and medical injectables including botox and lidocaine stored along with food
- Unwrapped syringes in drawers, on counters, and discarded in regular trash cans
- No autoclave for steam sterilization on the premises
- Only surface cleaning for procedure equipment with ammonium chloride disinfecting spray and benzalkonium chloride disinfecting wipes after each client visit
- Disposable electric desiccator tips cleaned only by alcohol immersion to be reused
The spa’s owner operated without appropriate licenses at multiple locations and did not have an appointment scheduling system that stored client contact information.
Investigators contacted as many people as they could find and launched a large-scale community outreach effort to find more.
In total, four clients and one intimate partner of a client were diagnosed with HIV during the investigation, but one client and her partner were determined to likely have been infected before the spa visit.
It is not clear whether the infections were due to unlabeled contaminated blood products being given to the wrong client or contamination on shared needles. Investigators did not have the authority to collect specimens during their site visit that would have allowed them to study that.
“We can’t definitively say what the route of contamination was,” noted Dr. Stadelman-Behar.
Anne Chapas, MD, a board-certified dermatologist, and instructor at Mount Sinai Hospital in New York, added that just because a procedure is cosmetic, that doesn’t mean it is not medical. “Personally, I feel it should only be done by medical practitioners who understand the risks.”
A Medical Procedure
PRP microneedling has been used extensively in orthopedic surgery to promote joint regeneration. For the past 10 years, it has also been used in dermatology to treat hair loss from alopecia, to augment wound healing, and cosmetically to reduce facial wrinkles.
It is generally done in a doctor’s office or medical spa, and the procedure takes about half an hour.
Dr. Stadelman-Behar said that this ongoing investigation highlights the importance of front-line healthcare workers using their clinical expertise to help identify potential new routes of transmission for infections. “It was provider-led intuition that sparked this investigation, so it’s important to let the department of health know if there is something amiss with any of the exposures that the patient might have had,” she said.
A version of this article appeared on Medscape.com.
At least three clients of an unlicensed spa in New Mexico contracted HIV after receiving platelet-rich plasma (PRP) microneedling facials, according to an investigation by the US Centers for Disease Control and Prevention (CDC).
The investigation, spanning 5 years with parts of it still ongoing, has resulted in the closure of the spa and is raising questions about public safety in cosmetic clinics.
Though transmission of HIV by unsterile injection practices is a known risk, this is the first time it has been linked to cosmetic injection services, said Anna Stadelman-Behar, PhD, MPH, of the CDC’s Epidemic Intelligence Service.
Sometimes called a vampire facial, the PRP treatment involves taking a patient’s own blood and separating it in a centrifuge. The portion containing a high concentration of platelets is then reinjected with a syringe or microneedling device.
“The idea is that when you inject this concentrated amount of platelets, the growth factors that the platelets release help to stimulate the regenerative nature of that area,” said Anthony Rossi, MD, professor of dermatology at Weill Cornell Medical College in New York, and attending dermatologist at Memorial Sloan Kettering Cancer Center.
The infections under investigation first came to light when a woman was diagnosed with HIV with no known risk factors for the disease other than exposure to microneedling facials at a cosmetic spa.
The New Mexico Department of Health and the CDC launched an investigation of the spa and discovered a litany of “gross violations of infection control practices,” said Dr. Stadelman-Behar.
Infection-Control Violations
At the spa in New Mexico, investigators found:
- On a kitchen counter, a centrifuge, a heating dry bath, and a rack of unlabeled tubes containing blood
- In a refrigerator, unlabeled tubes of blood and medical injectables including botox and lidocaine stored along with food
- Unwrapped syringes in drawers, on counters, and discarded in regular trash cans
- No autoclave for steam sterilization on the premises
- Only surface cleaning for procedure equipment with ammonium chloride disinfecting spray and benzalkonium chloride disinfecting wipes after each client visit
- Disposable electric desiccator tips cleaned only by alcohol immersion to be reused
The spa’s owner operated without appropriate licenses at multiple locations and did not have an appointment scheduling system that stored client contact information.
Investigators contacted as many people as they could find and launched a large-scale community outreach effort to find more.
In total, four clients and one intimate partner of a client were diagnosed with HIV during the investigation, but one client and her partner were determined to likely have been infected before the spa visit.
It is not clear whether the infections were due to unlabeled contaminated blood products being given to the wrong client or contamination on shared needles. Investigators did not have the authority to collect specimens during their site visit that would have allowed them to study that.
“We can’t definitively say what the route of contamination was,” noted Dr. Stadelman-Behar.
Anne Chapas, MD, a board-certified dermatologist, and instructor at Mount Sinai Hospital in New York, added that just because a procedure is cosmetic, that doesn’t mean it is not medical. “Personally, I feel it should only be done by medical practitioners who understand the risks.”
A Medical Procedure
PRP microneedling has been used extensively in orthopedic surgery to promote joint regeneration. For the past 10 years, it has also been used in dermatology to treat hair loss from alopecia, to augment wound healing, and cosmetically to reduce facial wrinkles.
It is generally done in a doctor’s office or medical spa, and the procedure takes about half an hour.
Dr. Stadelman-Behar said that this ongoing investigation highlights the importance of front-line healthcare workers using their clinical expertise to help identify potential new routes of transmission for infections. “It was provider-led intuition that sparked this investigation, so it’s important to let the department of health know if there is something amiss with any of the exposures that the patient might have had,” she said.
A version of this article appeared on Medscape.com.
At least three clients of an unlicensed spa in New Mexico contracted HIV after receiving platelet-rich plasma (PRP) microneedling facials, according to an investigation by the US Centers for Disease Control and Prevention (CDC).
The investigation, spanning 5 years with parts of it still ongoing, has resulted in the closure of the spa and is raising questions about public safety in cosmetic clinics.
Though transmission of HIV by unsterile injection practices is a known risk, this is the first time it has been linked to cosmetic injection services, said Anna Stadelman-Behar, PhD, MPH, of the CDC’s Epidemic Intelligence Service.
Sometimes called a vampire facial, the PRP treatment involves taking a patient’s own blood and separating it in a centrifuge. The portion containing a high concentration of platelets is then reinjected with a syringe or microneedling device.
“The idea is that when you inject this concentrated amount of platelets, the growth factors that the platelets release help to stimulate the regenerative nature of that area,” said Anthony Rossi, MD, professor of dermatology at Weill Cornell Medical College in New York, and attending dermatologist at Memorial Sloan Kettering Cancer Center.
The infections under investigation first came to light when a woman was diagnosed with HIV with no known risk factors for the disease other than exposure to microneedling facials at a cosmetic spa.
The New Mexico Department of Health and the CDC launched an investigation of the spa and discovered a litany of “gross violations of infection control practices,” said Dr. Stadelman-Behar.
Infection-Control Violations
At the spa in New Mexico, investigators found:
- On a kitchen counter, a centrifuge, a heating dry bath, and a rack of unlabeled tubes containing blood
- In a refrigerator, unlabeled tubes of blood and medical injectables including botox and lidocaine stored along with food
- Unwrapped syringes in drawers, on counters, and discarded in regular trash cans
- No autoclave for steam sterilization on the premises
- Only surface cleaning for procedure equipment with ammonium chloride disinfecting spray and benzalkonium chloride disinfecting wipes after each client visit
- Disposable electric desiccator tips cleaned only by alcohol immersion to be reused
The spa’s owner operated without appropriate licenses at multiple locations and did not have an appointment scheduling system that stored client contact information.
Investigators contacted as many people as they could find and launched a large-scale community outreach effort to find more.
In total, four clients and one intimate partner of a client were diagnosed with HIV during the investigation, but one client and her partner were determined to likely have been infected before the spa visit.
It is not clear whether the infections were due to unlabeled contaminated blood products being given to the wrong client or contamination on shared needles. Investigators did not have the authority to collect specimens during their site visit that would have allowed them to study that.
“We can’t definitively say what the route of contamination was,” noted Dr. Stadelman-Behar.
Anne Chapas, MD, a board-certified dermatologist, and instructor at Mount Sinai Hospital in New York, added that just because a procedure is cosmetic, that doesn’t mean it is not medical. “Personally, I feel it should only be done by medical practitioners who understand the risks.”
A Medical Procedure
PRP microneedling has been used extensively in orthopedic surgery to promote joint regeneration. For the past 10 years, it has also been used in dermatology to treat hair loss from alopecia, to augment wound healing, and cosmetically to reduce facial wrinkles.
It is generally done in a doctor’s office or medical spa, and the procedure takes about half an hour.
Dr. Stadelman-Behar said that this ongoing investigation highlights the importance of front-line healthcare workers using their clinical expertise to help identify potential new routes of transmission for infections. “It was provider-led intuition that sparked this investigation, so it’s important to let the department of health know if there is something amiss with any of the exposures that the patient might have had,” she said.
A version of this article appeared on Medscape.com.
Mpox Presentation Compared in Different Racial, Ethnic Groups
TOPLINE:
.
METHODOLOGY:
- There is limited information on the populations disproportionately affected by the recent global mpox outbreak, particularly in individuals with HIV and racial and ethnic minorities.
- To investigate morphologic and clinical presentations of mpox in diverse populations, researchers conducted a review of the records of 54 individuals (mean age, 42.4 years) diagnosed with mpox at a San Francisco clinic for patients with HIV or at high risk for HIV, between June and October 2022.
- All patients were assigned male at birth, and three identified themselves as transgender women.
- Morphologic descriptions were documented through either photographic evidence or physical examination notes.
TAKEAWAY:
- Pustules or pseudopustules were the most common morphologic finding in 57.1% of the White non-Hispanic patients and 62.5% of the patients of color (P = .72).
- White non-Hispanic patients were more likely to have no prodromal symptoms (50.0% vs 17.5%; P = .02) and were more likely to have genital lesions (78.6% vs 40.0%; P = .01) than patients of color. These differences were significant or nearly significant when White non-Hispanic patients were compared with Hispanic patients but not in other ethnic or racial groups.
- There were no differences in HIV viral loads or CD4 counts between racial and ethnic groups, and no variations in clinical presentations were observed based on CD4 counts.
- Patients with higher HIV viral loads were more likely to have concurrent sexually transmitted infections (57.1% vs 25%; P = .03).
- Symptoms resolved in all patients, regardless of medical intervention, within weeks of initial presentation, and there were no hospitalizations or deaths.
IN PRACTICE:
Considering that HIV viral burden was not significantly different between White non-Hispanic patients and patients of color, the difference in presentation of the prodrome “may indicate disparities in vulnerable populations,” the authors wrote, noting that more research in large groups is needed to confirm their results.
SOURCE:
The study, led by Richard W. Kim, BS, from the University of California San Francisco, was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
Inclusion of “other” racial category in the records highlighted potential inaccuracies in data representation.
DISCLOSURES:
The study received no external funding. The authors did not declare any competing interests.
A version of this article first appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- There is limited information on the populations disproportionately affected by the recent global mpox outbreak, particularly in individuals with HIV and racial and ethnic minorities.
- To investigate morphologic and clinical presentations of mpox in diverse populations, researchers conducted a review of the records of 54 individuals (mean age, 42.4 years) diagnosed with mpox at a San Francisco clinic for patients with HIV or at high risk for HIV, between June and October 2022.
- All patients were assigned male at birth, and three identified themselves as transgender women.
- Morphologic descriptions were documented through either photographic evidence or physical examination notes.
TAKEAWAY:
- Pustules or pseudopustules were the most common morphologic finding in 57.1% of the White non-Hispanic patients and 62.5% of the patients of color (P = .72).
- White non-Hispanic patients were more likely to have no prodromal symptoms (50.0% vs 17.5%; P = .02) and were more likely to have genital lesions (78.6% vs 40.0%; P = .01) than patients of color. These differences were significant or nearly significant when White non-Hispanic patients were compared with Hispanic patients but not in other ethnic or racial groups.
- There were no differences in HIV viral loads or CD4 counts between racial and ethnic groups, and no variations in clinical presentations were observed based on CD4 counts.
- Patients with higher HIV viral loads were more likely to have concurrent sexually transmitted infections (57.1% vs 25%; P = .03).
- Symptoms resolved in all patients, regardless of medical intervention, within weeks of initial presentation, and there were no hospitalizations or deaths.
IN PRACTICE:
Considering that HIV viral burden was not significantly different between White non-Hispanic patients and patients of color, the difference in presentation of the prodrome “may indicate disparities in vulnerable populations,” the authors wrote, noting that more research in large groups is needed to confirm their results.
SOURCE:
The study, led by Richard W. Kim, BS, from the University of California San Francisco, was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
Inclusion of “other” racial category in the records highlighted potential inaccuracies in data representation.
DISCLOSURES:
The study received no external funding. The authors did not declare any competing interests.
A version of this article first appeared on Medscape.com.
TOPLINE:
.
METHODOLOGY:
- There is limited information on the populations disproportionately affected by the recent global mpox outbreak, particularly in individuals with HIV and racial and ethnic minorities.
- To investigate morphologic and clinical presentations of mpox in diverse populations, researchers conducted a review of the records of 54 individuals (mean age, 42.4 years) diagnosed with mpox at a San Francisco clinic for patients with HIV or at high risk for HIV, between June and October 2022.
- All patients were assigned male at birth, and three identified themselves as transgender women.
- Morphologic descriptions were documented through either photographic evidence or physical examination notes.
TAKEAWAY:
- Pustules or pseudopustules were the most common morphologic finding in 57.1% of the White non-Hispanic patients and 62.5% of the patients of color (P = .72).
- White non-Hispanic patients were more likely to have no prodromal symptoms (50.0% vs 17.5%; P = .02) and were more likely to have genital lesions (78.6% vs 40.0%; P = .01) than patients of color. These differences were significant or nearly significant when White non-Hispanic patients were compared with Hispanic patients but not in other ethnic or racial groups.
- There were no differences in HIV viral loads or CD4 counts between racial and ethnic groups, and no variations in clinical presentations were observed based on CD4 counts.
- Patients with higher HIV viral loads were more likely to have concurrent sexually transmitted infections (57.1% vs 25%; P = .03).
- Symptoms resolved in all patients, regardless of medical intervention, within weeks of initial presentation, and there were no hospitalizations or deaths.
IN PRACTICE:
Considering that HIV viral burden was not significantly different between White non-Hispanic patients and patients of color, the difference in presentation of the prodrome “may indicate disparities in vulnerable populations,” the authors wrote, noting that more research in large groups is needed to confirm their results.
SOURCE:
The study, led by Richard W. Kim, BS, from the University of California San Francisco, was published online in the Journal of the American Academy of Dermatology.
LIMITATIONS:
Inclusion of “other” racial category in the records highlighted potential inaccuracies in data representation.
DISCLOSURES:
The study received no external funding. The authors did not declare any competing interests.
A version of this article first appeared on Medscape.com.