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COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

A version of this article first appeared on Medscape.com.

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

A version of this article first appeared on Medscape.com.

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

A version of this article first appeared on Medscape.com.

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

A version of this article first appeared on Medscape.com.

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

A version of this article first appeared on Medscape.com.

The American Medical Association estimates that physician burnout costs the country $4.6 billion annually, and that doesn’t include the cost for nurses and other clinicians. In addition, physicians note too many bureaucratic tasks as a main contributor to their daily stress.

Such revelations have prompted many in the health care industry to focus on clinician burnout, including a panel at the recent American Telemedicine Association annual conference in Boston.

Not surprisingly, the discussion quickly turned to the COVID-19 pandemic, commonly cited as an event that has exacerbated existing clinician burnout and caused what has become known as the “great resignation.”

Peter Yellowlees, MBBS, MD, professor of psychiatry and chief wellness officer at the University of California, Davis, said his health system has experienced a lot of its nursing staff resigning or moving to other employment, particularly from intensive care units and the emergency department.

“We actually haven’t had too many physicians go, but I have a funny feeling we’re going to see that over the next year or so because I think a lot of people have just put their head down during the pandemic and they’ve worked themselves hard,” he said. “They’re now sort of putting their heads up above the wall,” and could realize that they want a change.

In his role as the wellness officer at the academic medical center, Dr. Yellowlees is proactively addressing burnout among the organization’s 14,000 employees. For example, during the pandemic, he developed a peer responder program. Under this initiative, 600 staff members received training in “psychological first aid,” essentially utilizing staff to become therapists for peers.

For example, if a clinician is struggling emotionally while dealing with a patient who has had significant trauma, a peer responder could talk with the clinician, helping him or her to better deal with the situation.

Marlene McDermott, senior director of therapy services at Array Behavioral Care, a national telepsychiatry provider with offices in New Jersey and Illinois, noted that her organization also addresses burnout by creating opportunities for peer-to-peer support.

“We’ve got hundreds of clinicians and we’ll take 10 to 15 of them, put them in small treatment teams and they have a live chat, a one-off virtual meeting with each other to vent and to ask clinical questions. It’s all clinicians, there’s no administrative staff in there,” Ms. McDermott said. The clinicians have found value in these meetings, as they can share their concerns as well as “silly images or quotes, just to keep things light at times. That’s made a big difference.”
 

Retraining, technology can help curb administrative burdens

In addition to providing peer support, both Dr. Yellowlees and Ms. McDermott are addressing the significant administrative burden that plagues physicians.

This burden is especially onerous for physicians in the United States, according to a study that compared the number of keystrokes required to produce clinical notes among physicians in several countries.

“What [the study] discovered was that the American notes were three to five times longer than the notes of the Australian or U.K. physicians. I’ve worked in all three countries and I can promise you there’s no difference in the quality of the doctors across those places,” Dr. Yellowlees said.

To address this issue, Dr. Yellowlees is training physicians to reduce the length of their clinical documentation.

“I am trying to retrain physicians who for many years have been trained to be defensive in their documentation – to write absurd amounts just to justify billing,” Dr. Yellowlees said. “We are trying to go back in some respects to the way that we used to write notes 20 years ago ... so much shorter. This is a huge retraining exercise but it’s an exercise that is essential.”

Ms. McDermott also is tackling the administrative burden at her organization.

“We are trying to make the workflow as efficient as possible, doing some asynchronous work where consumers are completing information before a session ... so clinicians are essentially reconciling information instead of gathering all nonpertinent information. They can just work at the top of the license and not be burdened by some of the questions that don’t directly affect treatment,” Ms. McDermott noted.

Encouraging and training physicians in concurrent documentation also can help reduce administrative burden.

“Being proficient at remaining in session and documenting as much as you can during a session can help. So that at the end, you’re pressing the button, closing the encounter and you’ve finished documenting,” Ms. McDermott said. “It’s definitely possible to do that without losing the connection with the patient.”

To accomplish this, physicians need to leverage touch-typing – the practice of typing without looking at the keyboard. Fortunately, telehealth makes this mode of documentation easily achievable. Consider the following: During an online session, clinicians can place the patient’s picture “right underneath the camera and make it small. And then you type with the note floating behind it. So you’re actually staring at the note and the person all at the same time,” Ms. McDermott said.

The continued uptake of telehealth in general could also reduce stress for physicians, added Dr. Yellowlees.

“One of the interesting things about that is just how much time we save the physicians because it actually takes quite a lot of time to room patients,” Dr. Yellowlees concluded. “We are now doing about 20% of all our outpatient visits in all disciplines by video. We were higher than that midway through COVID. I’m hoping we’ll go back to being higher than that.”

A version of this article first appeared on Medscape.com.

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

A version of this article first appeared on Medscape.com.

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

A version of this article first appeared on Medscape.com.

MI. HTN. hx. Although these abbreviations might make it easier for physicians and other health care professionals to create and consume clinical documentation, the shorthand confuses patients, according to a study published in JAMA Network Open.

Researchers, who conducted clinical trials at three hospitals, found that expansion of 10 common medical abbreviations and acronyms in patient health records significantly increased overall comprehension.

Corresponding author Lisa Grossman Liu, PhD, MD, of Columbia University, New York, told this news organization that “comprehension of abbreviations was much lower than we expected and much lower than the clinicians who participated in this study expected.”

This discovery is particularly relevant in this era of digital care, where providers are now communicating with patients electronically more than ever before – and are required by rules emanating from the 21st Century Cures Act to provide online access to electronic health records.
 

Using elongated terms

Although the study found that expansion of medical abbreviations and acronyms can improve patient understanding, identifying all of the medical abbreviations that exist is difficult because the terms vary by specialty and geography. The fact that many abbreviations and acronyms have multiple meanings complicates matters even more. For example, the abbreviation PA has 128 possible meanings, Dr. Grossman Liu pointed out.

Technology, fortunately, has advanced in the last few years and is on the cusp of providing a solution. Artificial intelligence systems could help to develop large compendiums of abbreviations and acronyms and then machine learning could elongate the words.

“We’re almost to the point where we have these automated systems that can actually expand abbreviations pretty well and with a great degree of accuracy and ... where those can actually be used in medicine to help with patient communication,” Dr. Grossman Liu said.

Such intervention, however, is not a cure-all.

“There are abbreviations that are really hard to understand even after you expand them, such as MI for myocardial infarction, which is really a tough term all around. It means heart attack. So even if you tell patients, MI means myocardial infarction, they’re still not going to understand it,” Dr. Grossman Liu said.

On the flip side, patients are likely to understand some abbreviations such as hrs, which stands for hours, without elongating the words.
 

Moving from in-person to online communication

A look at the evolution of clinical documentation explains how this abbreviation problem came to fruition. Prior to this digital age where providers communicate with patients through portals, secure messaging, and other electronic methods, patients and providers would talk face to face. Now, however, electronic written communication is becoming the norm.

“We are not only seeing direct written communication through things like messaging systems or email, but also patients are now reading their medical records online and you can consider that as a form of communication,” Dr. Grossman Liu said. “It’s really interesting that the electronic health record itself has essentially become a medium for communication between patients and providers when previously it was only a way for providers to communicate with themselves and document patient care. So, clinicians use abbreviations because they aren’t intending for patients to see the records.”

Requiring physicians to use complete words in clinical documentation now that electronic records are relied on for patient communication, however, is not a practical solution.

“Abbreviations are so commonly used because they are more efficient to read and more efficient to write. We really shouldn’t be putting the onus on providers to spell out all the abbreviations in their notes. That’s realistically not going to work, because it compromises clinical efficiency,” Dr. Grossman Liu said.

While physicians should not be forced to use complete words in documentation, they should be wary of patients’ unfamiliarity with abbreviations as they communicate in person.

“I use terms like ED constantly when I talk to patients, and it turns out that only 67% of patients understand what you’re talking about when you say ED in reference to the emergency department. So it’s important to be mindful of that,” Dr. Grossman Liu concluded.

A version of this article first appeared on Medscape.com.

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The continuing changes in medicine have led to a significant erosion of physician autonomy, and to ever-increasing administrative burdens that affect small practices far more severely than larger ones. While there are some smaller offices offering unique services that may be able to remain small, most small general practices will be forced to at least consider a larger alternative. Recently, I discussed one option – merging individual practices into a larger one – but others are available.

One alternate strategy is to form a cooperative group. If you look around your area of practice, you will likely find other small practices in similar situations that might be willing to collaborate with you for the purpose of pooling your billing and purchasing resources. This allows each participant to maintain independence, yet share office overhead expenses and employee salaries for mutual benefit. If that arrangement works, and remains satisfactory for all participants, you can consider expanding your sharing of expenditures, such as collective purchasing of supplies and equipment, and centralizing appointment scheduling. Such an arrangement might be particularly attractive to physicians in later stages of their careers who need to alleviate financial burdens but don’t wish to close up shop just yet.

After more time has passed, if everyone remains happy with the arrangement, an outright merger can be considered, allowing the group to negotiate higher insurance remunerations and even lower overhead costs. Obviously, projects of this size and scope require careful planning and implementation, and should not be undertaken without the help of competent legal counsel and an experienced business consultant.

Another option is to join an independent practice association (IPA), if one is operating in your area. IPAs are physician-directed legal entities, formed to provide the same advantages enjoyed by large group practices while allowing individual members to remain independent. IPAs have greater purchasing power, allowing members to cut costs on medical and office supplies. They can also negotiate more favorable contracts with insurance companies and other payers.

Before joining such an organization, examine its legal status carefully. Some IPAs have been charged with antitrust violations because their member practices are, in reality, competitors. Make certain that any IPA you consider joining abides by antitrust and price fixing laws. Look carefully at its financial solvency as well, as IPAs have also been known to fail, leaving former members to pick up the tab.

An alternative to the IPA is the accountable care organization (ACO), a relatively new entity created as part of the Affordable Care Act. Like an IPA, an ACO’s basic purpose is to limit unnecessary spending; but ACOs are typically limited to Medicare and Medicaid recipients, and involve a larger network of doctors and hospitals sharing financial and medical responsibility for patient care. Criteria for limits on spending are established by the Centers for Medicare & Medicaid Services (CMS).

ACOs offer financial incentives to cooperate, and to save money by avoiding unnecessary tests and procedures. A key component is the sharing of information. Providers who save money while also meeting quality targets are theoretically entitled to a portion of the savings. According to federal data, ACOs saved Medicare $4.1 billion in 2020). As of January 2022, 483 ACOs were participating in the Medicare Shared Savings Program. A similar entity designed for private-sector patients is the clinically integrated network (CIN), created by the Federal Trade Commission to serve the commercial or self-insured market, while ACOs treat Medicare and Medicaid patients. Like ACOs, the idea is to work together to improve care and reduce costs by sharing records and tracking data.

When joining any group, read the agreement carefully for any clauses that might infringe on your clinical judgment. In particular, be sure that there are no restrictions on patient treatment or physician referral options for your patients. You should also negotiate an escape clause, allowing you to opt out if you become unhappy with the arrangement.

Clearly, the price of remaining autonomous is significant, and many private practitioners are unwilling to pay it. In 2019, the American Medical Association reported that for the first time, there were fewer physician owners (45.9%) than employees (47.4%).

But as I have written many times, those of us who remain committed to independence will find ways to preserve it. In medicine, as in life, those most responsive to change will survive and flourish.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

A version of this article first appeared on Medscape.com.

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

A version of this article first appeared on Medscape.com.

Before the pandemic hit in 2019, Pooja Aysola, MD, considered herself lucky because she could tap into telehealth for neurology consults in her work as an emergency department physician.  

“We would wheel in a computer screen with a neurologist on board every time we had a suspected stroke patient. And I was able to talk directly to the neurologist about my patient’s symptoms. And it was great,” Dr. Aysola said.

The pandemic, however, prompted the need for telehealth in many situations beyond specialty care. As such, investment exploded over the past few years.

“We’re seeing telehealth across all specialties ... more than half of clinicians are now saying that they do believe that virtual visits will surpass in-person visits for primary care needs,” said Dr. Aysola, who also serves as senior director, clinical operations at Wheel, a Texas-based telehealth company.

Dr. Aysola spoke during an American Telemedicine Association conference panel addressing how COVID prompted an uptick in telehealth investment and utilization and how such virtual care is likely to evolve moving forward.

Nathaniel Lacktman, a partner at law firm Foley & Lardner, agreed with Dr. Aysola’s assessment of the market.

“The appetite for virtual care has become voracious,” said Mr. Lacktman, who chairs the firm’s telemedicine and digital health team. “It reminds me in some ways of taking my kids out to dinner and saying, ‘Try this new food.’ They’re like, ‘No, I won’t like it.’ They finally get a little taste and they’re like, ‘This is amazing.’”

While there is no doubt that stakeholders – from innovators to investors to providers to patients – will want more than just a taste of telehealth in the future, panelists addressed if this undeniable demand for virtual care was simply a short-term response to the pandemic or if there is a long-term desire to fundamentally change how care is delivered.
 

Expanding on the pandemic-driven ‘sandbox’

While the uptick in telehealth investment and utilization is not expected to continue at such jarring rates in the future, the panelists pointed out that innovation will proceed but perhaps at a different pace.

“The last 3 years have been a sandbox during which the industry was able to experiment,” said Mr. Lacktman. “What we’re going to see more of even post pandemic is building upon that experimental sandbox and creating models that aren’t just high growth and really quick but that are sustainable and meaningful.”

As such, patients and providers won’t be looking for telehealth to simply provide access to care but to provide a full scope of services while also improving quality.   

Rachel Stillman, vice president of 7wireVentures, a Chicago-based venture capital firm, also expects interest in telehealth to continue but at a less frenetic pace. In 2021, the industry witnessed nearly $31 billion of venture financing directed towards digital health companies, she said.

“Now, Q1 2022 has had a little bit of a slower start. But with that said, we still have invested $6 billion in early stage companies. So ... we’re seeing some initial signs perhaps of – I don’t want to call it a slowdown – but increased discipline,” Ms. Stillman said.

Start-up companies will need to carefully position themselves for success in this post pandemic environment. “Ultimately, it really goes down to making sure your fundamentals are strong ... and having a really compelling [return on investment] case for your health plan, your self-insured employer, your health system, or your ultimate buyer,” Ms. Stillman said.

Two models are coming into play as innovation continues, she added. One is a traditional care delivery model whereby a start-up organization is building their own provider network specialized for the conditions or patient populations they are serving.

“Conversely, there are new entrants that are thinking about how they can leverage their insightful and strong technology foundations and platforms for existing provider networks that could benefit from a telemedicine partner,” Ms. Stillman pointed out.

Dr. Aysola added that companies are moving forward strategically to achieve post pandemic success. Some telehealth start-ups, for instance, are “capturing some of the low-hanging fruit, the simple UTIs, the really easy things to treat,” Dr. Aysola said. 

Others are addressing the clinician’s experience. “Over 50% of clinicians have thought about leaving their jobs at some point during the pandemic. And so it’s becoming really clear that focusing on the clinician and the clinician’s needs are just imperative to [creating a] winning model post-pandemic,” Dr. Aysola said.
 

Adapting to the new normal

Health care provider organizations also need to adjust to post pandemic realities. “We work with a number of hospital systems, and it’s astounding how slow they are compared to the start-ups because there’s a lot more constituents; there’s bureaucracy,” Mr. Lacktman said. As a result, “the hospitals are in a more uncomfortable position post pandemic than the start-ups.”

To move forward successfully, these organizations, which are typically risk averse, need to create alignment among legal, compliance, and clinical leaders, Mr. Lacktman advised. 

One of the first decisions that these teams need to make is whether they should proceed on their own or enter into a partnership with a start-up or pursue a merger and acquisition. In addition, some health systems, hospitals, and health plans are even opting to establish their own venture funds.

“Building your own venture fund or even investing ... in companies directly or in other venture funds [are strategies] that health systems might be able to leverage both to accelerate partnerships and also really be on top of key trends,” Ms. Stillman said.

No matter how health care systems invest in and implement telemedicine technologies, though, the need to move quickly is paramount.

Traditional health care systems “don’t always have the luxury of time. Things have to be done pretty quickly in order to remain competitive,” Dr. Aysola concluded. “We’ve found that companies can launch a virtual care offering in a matter of weeks. When in reality, if a traditional health care system were to try to launch it on their own, it could take upwards of 15 months.”

A version of this article first appeared on Medscape.com.

An investigative synthetic cannabinoid receptor type 2 (CB2) agonist, lenabasum, was associated with greater improvements than placebo in patients with skin-predominant dermatomyositis – some of it statistically significant – in a phase 2, double-blind, randomized, controlled study.

Patients taking lenabasum experienced greater reductions in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) – a validated outcome designed to assess inflammatory skin involvement in the rare autoimmune disease – and improvements in patient-reported and biomarker outcomes, compared with those on placebo, dermatologist Victoria P. Werth, MD, and coinvestigators reported.

Courtesy RegionalDerm.com

And in a recently completed phase 3 trial, reported by the manufacturer, a subpopulation of patients with active skin disease and no active muscle disease again showed greater reductions in CDASI activity scores – a secondary outcome in the trial.

However, the phase 3 DETERMINE trial produced negative findings overall. It enrolled a more heterogeneous group of patients – including those with both muscle weakness and skin involvement – and its primary outcome measure was a broader composite measure, the Total Improvement Score. The trial failed to meet this primary endpoint, Corbus Pharmaceuticals, the developer of lenabasum, announced in a press release in June 2021.

The phase 3 results are “frustrating” for patients with symptomatic and refractory skin manifestations of dermatomyositis (DM), given the promising findings from the phase 2 trial and from an open-label extension study, said Dr. Werth, professor of dermatology and medicine, University of Pennsylvania, Philadelphia, and principal investigator and coprincipal investigator of the phase 2 and phase 3 studies, respectively.

Dr. Werth is scheduled to present the results from the phase 3 trial at the annual European Alliance of Associations for Rheumatology meeting in June.

“With lenabasum, we have a therapy that doesn’t work for every patient, but does work for quite a number of them,” Dr. Werth said in an interview. “It’s oral, it’s not really that immunosuppressing, and there aren’t many side effects. Right now, patients are often being managed with steroids ... we really need treatments that are not as toxic.”

Robert Spiera, MD, a rheumatologist who led trials of lenabasum for treatment of diffuse cutaneous systemic sclerosis (dcSSc), agreed. “The CB2 agonist strategy is appealing because it’s nonimmunosuppressing and has both anti-inflammatory and antifibrotic properties,” he said in an interview. “I wouldn’t want to give up on it ... especially [for patients] with scleroderma and dermatomyositis who are treated with substantial drugs that are associated with morbidity.”

Lenabasum, he said, has proven to be “incredibly safe, and incredibly safe in the long term.”

While the phase 2 trial of the drug for dcSSc showed clear benefit over placebo, the phase 3 trial did not meet its primary endpoint using the American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis.

It allowed background immunosuppressant therapy to reflect real-world clinical practice, and “there was such a high response rate to [that therapy, largely mycophenolate] that there was little room to show benefit beyond that,” said Dr. Spiera, director of the vasculitis and scleroderma program, Hospital for Special Surgery, New York.

The drug led to more improvement in the small subset of participants who were not receiving background immunotherapy during the trial, he noted.

Corbus is currently “seeking a partnership to further explore the drug” for treatment in different subpopulations, according to a company spokesperson. Results of a phase 2 trial of lenabasum for the treatment of systemic lupus erythematosus – with a pain rating as the primary outcome measure – are expected soon.
 

Phase 2 findings

The single-center phase 2 trial of lenabasum for DM enrolled 22 adults with minimal muscle involvement as evidenced by normal maximal resistance on muscle testing at entry and throughout the study. Most were taking immunosuppressant medication, and all had CDASI scores of at least 20, with mean scores in the severe range (> 26). Symptoms registered on patient-reported outcome measures were moderate to severe.

Patients received a half-dose of lenabasum (20 mg daily) for 1 month and a full dose (20 mg twice daily) for 2 months, or placebo, and were followed for an additional month without dosing.

Starting at day 43 – approximately 2 weeks after the dose was increased – there was “a trend for the change from baseline CDASI to be greater” in the lenabasum group, compared with those on placebo, Dr. Werth and colleagues reported. The differences reached statistical significance on day 113 (P = .038), a month after patients discontinued lenabasum, “suggesting that the modulation of the inflammatory response by lenabasum continued beyond its last dose.”

Five of the 11 patients treated with lenabasum (45%), and none of those on placebo, achieved at least a 40% reduction in the CDASI activity score by the end of the study.

Patients in the lenabasum group also had greater improvement in the Skindex-29 Symptoms scores – an objective measure of itch – and improvements in other secondary efficacy outcomes, including pain, though these did not reach statistical significance.

Skin biopsies before and after treatment showed significant reductions in inflammatory cytokines relevant to DM pathogenesis. Patients treated with the CB2 agonist had a downward trend in the CD4+ T cell population, which correlated with decreased CDASI activity scores, for instance, and a decrease in IL-31 protein expression, which correlated with decreased Skindex-29 Symptoms scores, the investigators reported.

There were no serious adverse events related to the CB2 agonist, and no treatment discontinuations.

The main part of the phase 2 trial, conducted from 2015 to 2017, was followed by a 3-year, open-label extension, in which 20 of the 22 patients took lenabasum 20 mg twice a day. The drug continued to be safe and well tolerated, and the CDASI activity score and other outcomes improved through year 1 and remained stable thereafter, according to a poster presented by Dr. Werth at the 2021 EULAR meeting.

After 1 year in the open-label extension, 60%-70% of patients had achieved mild skin disease, and 75% had achieved at least a 40% reduction in CDASI activity.

“A lot of patients, even if they weren’t completely cleared, were much happier in terms of their itch,” said Dr. Werth, also chief of dermatology, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia. “It’s been difficult for a lot of them now that they’re off the long-term extension ... a lot of them are flaring.”

The future

In the lab, with funding from the National Institutes of Health, Dr. Werth is continuing to investigate how lenabasum may be working in DM. A paper just published in the open access journal Arthritis Research & Therapy describes CB2 receptor distribution and up-regulation on key immune cells in the skin and blood, and how, in DM skin, its highest expression is on dendritic cells.

Through both mechanistic and more clinical research, “it’s important to understand the characteristics of the people [lenabasum] worked in or didn’t work in,” she said. 

And in clinical trials, it’s important to capture meaningful improvement from the patient perspective. “It may be,” she noted, “that more global, systemic assessments are not the way to go for autoimmune skin disease.”

For dcSSc, Dr. Spiera said, it’s possible that a CB2 agonist may be helpful for patients who have been on immunosuppressants, particularly mycophenolate, for more than 6 months “and are still struggling.”

The phase 2 trial in DM was funded by the National Institutes of Health, the Department of Veterans Affairs, and Corbus Pharmaceuticals. The phase 3 trials in DM and in dcSSc were funded by Corbus. Dr. Werth disclosed grant support from Corbus and several other pharmaceutical companies. Dr. Spiera disclosed that he has received grant support or consulting fees from Roche-Genentech, GlaxoSmithKline, and several other pharmaceutical companies.

A version of this article first appeared on Medscape.com.

An investigative synthetic cannabinoid receptor type 2 (CB2) agonist, lenabasum, was associated with greater improvements than placebo in patients with skin-predominant dermatomyositis – some of it statistically significant – in a phase 2, double-blind, randomized, controlled study.

Patients taking lenabasum experienced greater reductions in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) – a validated outcome designed to assess inflammatory skin involvement in the rare autoimmune disease – and improvements in patient-reported and biomarker outcomes, compared with those on placebo, dermatologist Victoria P. Werth, MD, and coinvestigators reported.

Courtesy RegionalDerm.com

And in a recently completed phase 3 trial, reported by the manufacturer, a subpopulation of patients with active skin disease and no active muscle disease again showed greater reductions in CDASI activity scores – a secondary outcome in the trial.

However, the phase 3 DETERMINE trial produced negative findings overall. It enrolled a more heterogeneous group of patients – including those with both muscle weakness and skin involvement – and its primary outcome measure was a broader composite measure, the Total Improvement Score. The trial failed to meet this primary endpoint, Corbus Pharmaceuticals, the developer of lenabasum, announced in a press release in June 2021.

The phase 3 results are “frustrating” for patients with symptomatic and refractory skin manifestations of dermatomyositis (DM), given the promising findings from the phase 2 trial and from an open-label extension study, said Dr. Werth, professor of dermatology and medicine, University of Pennsylvania, Philadelphia, and principal investigator and coprincipal investigator of the phase 2 and phase 3 studies, respectively.

Dr. Werth is scheduled to present the results from the phase 3 trial at the annual European Alliance of Associations for Rheumatology meeting in June.

“With lenabasum, we have a therapy that doesn’t work for every patient, but does work for quite a number of them,” Dr. Werth said in an interview. “It’s oral, it’s not really that immunosuppressing, and there aren’t many side effects. Right now, patients are often being managed with steroids ... we really need treatments that are not as toxic.”

Robert Spiera, MD, a rheumatologist who led trials of lenabasum for treatment of diffuse cutaneous systemic sclerosis (dcSSc), agreed. “The CB2 agonist strategy is appealing because it’s nonimmunosuppressing and has both anti-inflammatory and antifibrotic properties,” he said in an interview. “I wouldn’t want to give up on it ... especially [for patients] with scleroderma and dermatomyositis who are treated with substantial drugs that are associated with morbidity.”

Lenabasum, he said, has proven to be “incredibly safe, and incredibly safe in the long term.”

While the phase 2 trial of the drug for dcSSc showed clear benefit over placebo, the phase 3 trial did not meet its primary endpoint using the American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis.

It allowed background immunosuppressant therapy to reflect real-world clinical practice, and “there was such a high response rate to [that therapy, largely mycophenolate] that there was little room to show benefit beyond that,” said Dr. Spiera, director of the vasculitis and scleroderma program, Hospital for Special Surgery, New York.

The drug led to more improvement in the small subset of participants who were not receiving background immunotherapy during the trial, he noted.

Corbus is currently “seeking a partnership to further explore the drug” for treatment in different subpopulations, according to a company spokesperson. Results of a phase 2 trial of lenabasum for the treatment of systemic lupus erythematosus – with a pain rating as the primary outcome measure – are expected soon.
 

Phase 2 findings

The single-center phase 2 trial of lenabasum for DM enrolled 22 adults with minimal muscle involvement as evidenced by normal maximal resistance on muscle testing at entry and throughout the study. Most were taking immunosuppressant medication, and all had CDASI scores of at least 20, with mean scores in the severe range (> 26). Symptoms registered on patient-reported outcome measures were moderate to severe.

Patients received a half-dose of lenabasum (20 mg daily) for 1 month and a full dose (20 mg twice daily) for 2 months, or placebo, and were followed for an additional month without dosing.

Starting at day 43 – approximately 2 weeks after the dose was increased – there was “a trend for the change from baseline CDASI to be greater” in the lenabasum group, compared with those on placebo, Dr. Werth and colleagues reported. The differences reached statistical significance on day 113 (P = .038), a month after patients discontinued lenabasum, “suggesting that the modulation of the inflammatory response by lenabasum continued beyond its last dose.”

Five of the 11 patients treated with lenabasum (45%), and none of those on placebo, achieved at least a 40% reduction in the CDASI activity score by the end of the study.

Patients in the lenabasum group also had greater improvement in the Skindex-29 Symptoms scores – an objective measure of itch – and improvements in other secondary efficacy outcomes, including pain, though these did not reach statistical significance.

Skin biopsies before and after treatment showed significant reductions in inflammatory cytokines relevant to DM pathogenesis. Patients treated with the CB2 agonist had a downward trend in the CD4+ T cell population, which correlated with decreased CDASI activity scores, for instance, and a decrease in IL-31 protein expression, which correlated with decreased Skindex-29 Symptoms scores, the investigators reported.

There were no serious adverse events related to the CB2 agonist, and no treatment discontinuations.

The main part of the phase 2 trial, conducted from 2015 to 2017, was followed by a 3-year, open-label extension, in which 20 of the 22 patients took lenabasum 20 mg twice a day. The drug continued to be safe and well tolerated, and the CDASI activity score and other outcomes improved through year 1 and remained stable thereafter, according to a poster presented by Dr. Werth at the 2021 EULAR meeting.

After 1 year in the open-label extension, 60%-70% of patients had achieved mild skin disease, and 75% had achieved at least a 40% reduction in CDASI activity.

“A lot of patients, even if they weren’t completely cleared, were much happier in terms of their itch,” said Dr. Werth, also chief of dermatology, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia. “It’s been difficult for a lot of them now that they’re off the long-term extension ... a lot of them are flaring.”

The future

In the lab, with funding from the National Institutes of Health, Dr. Werth is continuing to investigate how lenabasum may be working in DM. A paper just published in the open access journal Arthritis Research & Therapy describes CB2 receptor distribution and up-regulation on key immune cells in the skin and blood, and how, in DM skin, its highest expression is on dendritic cells.

Through both mechanistic and more clinical research, “it’s important to understand the characteristics of the people [lenabasum] worked in or didn’t work in,” she said. 

And in clinical trials, it’s important to capture meaningful improvement from the patient perspective. “It may be,” she noted, “that more global, systemic assessments are not the way to go for autoimmune skin disease.”

For dcSSc, Dr. Spiera said, it’s possible that a CB2 agonist may be helpful for patients who have been on immunosuppressants, particularly mycophenolate, for more than 6 months “and are still struggling.”

The phase 2 trial in DM was funded by the National Institutes of Health, the Department of Veterans Affairs, and Corbus Pharmaceuticals. The phase 3 trials in DM and in dcSSc were funded by Corbus. Dr. Werth disclosed grant support from Corbus and several other pharmaceutical companies. Dr. Spiera disclosed that he has received grant support or consulting fees from Roche-Genentech, GlaxoSmithKline, and several other pharmaceutical companies.

A version of this article first appeared on Medscape.com.

An investigative synthetic cannabinoid receptor type 2 (CB2) agonist, lenabasum, was associated with greater improvements than placebo in patients with skin-predominant dermatomyositis – some of it statistically significant – in a phase 2, double-blind, randomized, controlled study.

Patients taking lenabasum experienced greater reductions in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) – a validated outcome designed to assess inflammatory skin involvement in the rare autoimmune disease – and improvements in patient-reported and biomarker outcomes, compared with those on placebo, dermatologist Victoria P. Werth, MD, and coinvestigators reported.

Courtesy RegionalDerm.com

And in a recently completed phase 3 trial, reported by the manufacturer, a subpopulation of patients with active skin disease and no active muscle disease again showed greater reductions in CDASI activity scores – a secondary outcome in the trial.

However, the phase 3 DETERMINE trial produced negative findings overall. It enrolled a more heterogeneous group of patients – including those with both muscle weakness and skin involvement – and its primary outcome measure was a broader composite measure, the Total Improvement Score. The trial failed to meet this primary endpoint, Corbus Pharmaceuticals, the developer of lenabasum, announced in a press release in June 2021.

The phase 3 results are “frustrating” for patients with symptomatic and refractory skin manifestations of dermatomyositis (DM), given the promising findings from the phase 2 trial and from an open-label extension study, said Dr. Werth, professor of dermatology and medicine, University of Pennsylvania, Philadelphia, and principal investigator and coprincipal investigator of the phase 2 and phase 3 studies, respectively.

Dr. Werth is scheduled to present the results from the phase 3 trial at the annual European Alliance of Associations for Rheumatology meeting in June.

“With lenabasum, we have a therapy that doesn’t work for every patient, but does work for quite a number of them,” Dr. Werth said in an interview. “It’s oral, it’s not really that immunosuppressing, and there aren’t many side effects. Right now, patients are often being managed with steroids ... we really need treatments that are not as toxic.”

Robert Spiera, MD, a rheumatologist who led trials of lenabasum for treatment of diffuse cutaneous systemic sclerosis (dcSSc), agreed. “The CB2 agonist strategy is appealing because it’s nonimmunosuppressing and has both anti-inflammatory and antifibrotic properties,” he said in an interview. “I wouldn’t want to give up on it ... especially [for patients] with scleroderma and dermatomyositis who are treated with substantial drugs that are associated with morbidity.”

Lenabasum, he said, has proven to be “incredibly safe, and incredibly safe in the long term.”

While the phase 2 trial of the drug for dcSSc showed clear benefit over placebo, the phase 3 trial did not meet its primary endpoint using the American College of Rheumatology Combined Response Index in Diffuse Cutaneous Systemic Sclerosis.

It allowed background immunosuppressant therapy to reflect real-world clinical practice, and “there was such a high response rate to [that therapy, largely mycophenolate] that there was little room to show benefit beyond that,” said Dr. Spiera, director of the vasculitis and scleroderma program, Hospital for Special Surgery, New York.

The drug led to more improvement in the small subset of participants who were not receiving background immunotherapy during the trial, he noted.

Corbus is currently “seeking a partnership to further explore the drug” for treatment in different subpopulations, according to a company spokesperson. Results of a phase 2 trial of lenabasum for the treatment of systemic lupus erythematosus – with a pain rating as the primary outcome measure – are expected soon.
 

Phase 2 findings

The single-center phase 2 trial of lenabasum for DM enrolled 22 adults with minimal muscle involvement as evidenced by normal maximal resistance on muscle testing at entry and throughout the study. Most were taking immunosuppressant medication, and all had CDASI scores of at least 20, with mean scores in the severe range (> 26). Symptoms registered on patient-reported outcome measures were moderate to severe.

Patients received a half-dose of lenabasum (20 mg daily) for 1 month and a full dose (20 mg twice daily) for 2 months, or placebo, and were followed for an additional month without dosing.

Starting at day 43 – approximately 2 weeks after the dose was increased – there was “a trend for the change from baseline CDASI to be greater” in the lenabasum group, compared with those on placebo, Dr. Werth and colleagues reported. The differences reached statistical significance on day 113 (P = .038), a month after patients discontinued lenabasum, “suggesting that the modulation of the inflammatory response by lenabasum continued beyond its last dose.”

Five of the 11 patients treated with lenabasum (45%), and none of those on placebo, achieved at least a 40% reduction in the CDASI activity score by the end of the study.

Patients in the lenabasum group also had greater improvement in the Skindex-29 Symptoms scores – an objective measure of itch – and improvements in other secondary efficacy outcomes, including pain, though these did not reach statistical significance.

Skin biopsies before and after treatment showed significant reductions in inflammatory cytokines relevant to DM pathogenesis. Patients treated with the CB2 agonist had a downward trend in the CD4+ T cell population, which correlated with decreased CDASI activity scores, for instance, and a decrease in IL-31 protein expression, which correlated with decreased Skindex-29 Symptoms scores, the investigators reported.

There were no serious adverse events related to the CB2 agonist, and no treatment discontinuations.

The main part of the phase 2 trial, conducted from 2015 to 2017, was followed by a 3-year, open-label extension, in which 20 of the 22 patients took lenabasum 20 mg twice a day. The drug continued to be safe and well tolerated, and the CDASI activity score and other outcomes improved through year 1 and remained stable thereafter, according to a poster presented by Dr. Werth at the 2021 EULAR meeting.

After 1 year in the open-label extension, 60%-70% of patients had achieved mild skin disease, and 75% had achieved at least a 40% reduction in CDASI activity.

“A lot of patients, even if they weren’t completely cleared, were much happier in terms of their itch,” said Dr. Werth, also chief of dermatology, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia. “It’s been difficult for a lot of them now that they’re off the long-term extension ... a lot of them are flaring.”

The future

In the lab, with funding from the National Institutes of Health, Dr. Werth is continuing to investigate how lenabasum may be working in DM. A paper just published in the open access journal Arthritis Research & Therapy describes CB2 receptor distribution and up-regulation on key immune cells in the skin and blood, and how, in DM skin, its highest expression is on dendritic cells.

Through both mechanistic and more clinical research, “it’s important to understand the characteristics of the people [lenabasum] worked in or didn’t work in,” she said. 

And in clinical trials, it’s important to capture meaningful improvement from the patient perspective. “It may be,” she noted, “that more global, systemic assessments are not the way to go for autoimmune skin disease.”

For dcSSc, Dr. Spiera said, it’s possible that a CB2 agonist may be helpful for patients who have been on immunosuppressants, particularly mycophenolate, for more than 6 months “and are still struggling.”

The phase 2 trial in DM was funded by the National Institutes of Health, the Department of Veterans Affairs, and Corbus Pharmaceuticals. The phase 3 trials in DM and in dcSSc were funded by Corbus. Dr. Werth disclosed grant support from Corbus and several other pharmaceutical companies. Dr. Spiera disclosed that he has received grant support or consulting fees from Roche-Genentech, GlaxoSmithKline, and several other pharmaceutical companies.

A version of this article first appeared on Medscape.com.

Dupilumab is a humanized monoclonal antibody approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe atopic dermatitis. Through inhibition of the IL-4R α subunit, it prevents activation of the IL-4/IL-13 signaling cascade. This dampens the T _H 2 inflammatory response, thereby improving the symptoms associated with atopic dermatitis. ^1,2 Recent literature suggests that dupilumab may be useful in the treatment of other chronic dermatologic conditions, including allergic contact dermatitis (ACD) refractory to allergen avoidance and other treatments. Herein, we provide an overview of ACD, the role that dupilumab may play in its management, and its impact on patch testing results.

Pathogenesis of ACD

Allergic contact dermatitis is a cell-mediated type IV hypersensitivity reaction that develops through 2 distinct stages. In the sensitization phase, an allergen penetrates the skin and subsequently is engulfed by a cutaneous antigen-presenting cell. The allergen is then combined with a peptide to form a complex that is presented to naïve T lymphocytes in regional lymph nodes. The result is clonal expansion of a T-cell population that recognizes the allergen. In the elicitation phase, repeat exposure to the allergen leads to the recruitment of primed T cells to the skin, followed by cytokine release, inflammation, and resultant dermatitis.³

Historically, ACD was thought to be primarily driven by the T_H1 inflammatory response; however, it is now known that T_H2, T_H9, T_H17, and T_H22 also may play a role in its pathogenesis.^4,5 Another key finding is that the immune response in ACD appears to be at least partially allergen specific. Molecular profiling has revealed that nickel primarily induces a T_H1/T_H17 response, while allergens such as fragrance and rubber primarily induce a T_H2 response.⁴

Management of ACD

Allergen avoidance is the mainstay of ACD treatment; however, in some patients, this approach does not always improve symptoms. In addition, eliminating the source of the allergen may not be possible in those with certain occupational, environmental, or medical exposures.

There are no FDA-approved treatments for ACD. When allergen avoidance alone is insufficient, first-line pharmacologic therapy typically includes topical or oral corticosteroids, the choice of which depends on the extent and severity of the dermatitis; however, a steroid-sparing agent often is preferred to avoid the unfavorable effects of long-term steroid use. Other systemic treatments for ACD include methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine.⁶ These agents are used for severe ACD and typically are chosen as a last resort due to their immunosuppressive activity.

Phototherapy is another option, often as an adjunct to other therapies. Narrowband UVB and psoralen plus UVA have both been used. Psoralen plus UVA tends to have more side effects; therefore, narrowband UVB often is preferred.^7,8

Use of Dupilumab in ACD

Biologics are unique, as they can target a single step in the immune response to improve a wide variety of symptoms. Research investigating their role as a treatment modality for ACD is still evolving alongside our increasing knowledge of its pathophysiology.⁹ Of note, studies examining the anti–IL-17 biologic secukinumab revealed it to be ineffective against ACD,^10,11 which suggests that targeting specific immune components may not always result in improvement of ACD symptoms, likely because its pathophysiology involves several pathways.

There have been multiple reports demonstrating the effectiveness of dupilumab in the treatment of ACD (eTable).^12-20 The findings from these studies show that dupilumab can improve recalcitrant dermatitis caused by a broad range of contact allergens, including nickel. This highlights its ability to improve ACD caused by allergens with a T_H1 bias, despite its primarily T_H2-dampening effects. Notably, several studies have reported successful use of dupilumab for systemic ACD.^12,18 In addition, dupilumab may be able to improve symptoms of ACD in as little as 1 to 4 weeks. Unlike some systemic therapies for ACD, dupilumab also benefits from its lack of notable immunosuppressive effects.⁹ A phase 4 clinical trial at Brigham and Women’s Hospital (Boston, Massachusetts) is recruiting participants, with a primary goal of investigating dupilumab’s impact on ACD in patients who have not improved despite allergen avoidance (ClinicalTrials.gov identifier NCT03935971).

There are a few potential disadvantages to dupilumab. Because it is not yet FDA approved for the treatment of ACD, insurance companies may deny coverage, making it likely to be unaffordable for most patients. Furthermore, the side-effect profile has not been fully characterized. In addition to ocular adverse effects, a growing number of studies have reported face and neck erythema after starting dupilumab. Although the cause is unclear, one theory is that the inhibition of IL-4/IL-13 leads to T_H1/T_H17 polarization, thereby worsening ACD caused by allergens that activate a T_H1-predominant response.²¹ Finally, not all cases of ACD respond to dupilumab.²²

Patch Testing While on Dupilumab

Diagnosing ACD is a challenging process. An accurate history and physical examination are critical, and patch testing remains the gold standard when it comes to identifying the source of the contact allergen(s).

There is ongoing debate among contact dermatitis experts regarding the diagnostic accuracy of patch testing for those on immunomodulators or immunosuppressants, as these medications can dampen positive results and increase the risk for false-negative readings.²³ Consequently, some have questioned whether patch testing on dupilumab is accurate or feasible.²⁴ Contact dermatitis experts have examined patch testing results before and after initiation of dupilumab to further investigate. Puza and Atwater²⁵ established that patients are able to mount a positive patch test reaction while on dupilumab. Moreover, a retrospective review by Raffi et al²⁶ found that out of 125 before therapy/on therapy patch test pairs, only 13 were lost after administration of dupilumab. Although this would suggest that dupilumab has little impact on patch testing, Jo et al²⁷ found in a systematic review that patch test reactions may remain positive, change to negative, or become newly positive after dupilumab initiation.

This inconsistency in results may relate to the allergen-specific pathogenesis of ACD—one allergen may have a different response to the mechanism of dupilumab than another.^28,29 More recently, de Wijs et al³⁰ reported a series of 20 patients in whom more than two-thirds of prior positive patch test reactions were lost after retesting on dupilumab; there were no clear trends according to the immune polarity of the allergens. This finding suggests that patient-specific factors also should be considered, as this too could have an impact on the reliability of patch test findings after starting dupilumab.²⁹

Final Interpretation

Given its overall excellent safety profile, dupilumab may be a feasible off-label option for patients with ACD that does not respond to allergen avoidance or for those who experience adverse effects from traditional therapies; however, it remains difficult to obtain through insurance because it is not yet FDA approved for ACD. Likewise, its impact on the accuracy of patch testing is not yet well defined. Further investigations are needed to elucidate the pathophysiology of ACD and to guide further use of dupilumab in its treatment.

Dupilumab is a humanized monoclonal antibody approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe atopic dermatitis. Through inhibition of the IL-4R α subunit, it prevents activation of the IL-4/IL-13 signaling cascade. This dampens the T _H 2 inflammatory response, thereby improving the symptoms associated with atopic dermatitis. ^1,2 Recent literature suggests that dupilumab may be useful in the treatment of other chronic dermatologic conditions, including allergic contact dermatitis (ACD) refractory to allergen avoidance and other treatments. Herein, we provide an overview of ACD, the role that dupilumab may play in its management, and its impact on patch testing results.

Pathogenesis of ACD

Allergic contact dermatitis is a cell-mediated type IV hypersensitivity reaction that develops through 2 distinct stages. In the sensitization phase, an allergen penetrates the skin and subsequently is engulfed by a cutaneous antigen-presenting cell. The allergen is then combined with a peptide to form a complex that is presented to naïve T lymphocytes in regional lymph nodes. The result is clonal expansion of a T-cell population that recognizes the allergen. In the elicitation phase, repeat exposure to the allergen leads to the recruitment of primed T cells to the skin, followed by cytokine release, inflammation, and resultant dermatitis.³

Historically, ACD was thought to be primarily driven by the T_H1 inflammatory response; however, it is now known that T_H2, T_H9, T_H17, and T_H22 also may play a role in its pathogenesis.^4,5 Another key finding is that the immune response in ACD appears to be at least partially allergen specific. Molecular profiling has revealed that nickel primarily induces a T_H1/T_H17 response, while allergens such as fragrance and rubber primarily induce a T_H2 response.⁴

Management of ACD

Allergen avoidance is the mainstay of ACD treatment; however, in some patients, this approach does not always improve symptoms. In addition, eliminating the source of the allergen may not be possible in those with certain occupational, environmental, or medical exposures.

There are no FDA-approved treatments for ACD. When allergen avoidance alone is insufficient, first-line pharmacologic therapy typically includes topical or oral corticosteroids, the choice of which depends on the extent and severity of the dermatitis; however, a steroid-sparing agent often is preferred to avoid the unfavorable effects of long-term steroid use. Other systemic treatments for ACD include methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine.⁶ These agents are used for severe ACD and typically are chosen as a last resort due to their immunosuppressive activity.

Phototherapy is another option, often as an adjunct to other therapies. Narrowband UVB and psoralen plus UVA have both been used. Psoralen plus UVA tends to have more side effects; therefore, narrowband UVB often is preferred.^7,8

Use of Dupilumab in ACD

Biologics are unique, as they can target a single step in the immune response to improve a wide variety of symptoms. Research investigating their role as a treatment modality for ACD is still evolving alongside our increasing knowledge of its pathophysiology.⁹ Of note, studies examining the anti–IL-17 biologic secukinumab revealed it to be ineffective against ACD,^10,11 which suggests that targeting specific immune components may not always result in improvement of ACD symptoms, likely because its pathophysiology involves several pathways.

There have been multiple reports demonstrating the effectiveness of dupilumab in the treatment of ACD (eTable).^12-20 The findings from these studies show that dupilumab can improve recalcitrant dermatitis caused by a broad range of contact allergens, including nickel. This highlights its ability to improve ACD caused by allergens with a T_H1 bias, despite its primarily T_H2-dampening effects. Notably, several studies have reported successful use of dupilumab for systemic ACD.^12,18 In addition, dupilumab may be able to improve symptoms of ACD in as little as 1 to 4 weeks. Unlike some systemic therapies for ACD, dupilumab also benefits from its lack of notable immunosuppressive effects.⁹ A phase 4 clinical trial at Brigham and Women’s Hospital (Boston, Massachusetts) is recruiting participants, with a primary goal of investigating dupilumab’s impact on ACD in patients who have not improved despite allergen avoidance (ClinicalTrials.gov identifier NCT03935971).

There are a few potential disadvantages to dupilumab. Because it is not yet FDA approved for the treatment of ACD, insurance companies may deny coverage, making it likely to be unaffordable for most patients. Furthermore, the side-effect profile has not been fully characterized. In addition to ocular adverse effects, a growing number of studies have reported face and neck erythema after starting dupilumab. Although the cause is unclear, one theory is that the inhibition of IL-4/IL-13 leads to T_H1/T_H17 polarization, thereby worsening ACD caused by allergens that activate a T_H1-predominant response.²¹ Finally, not all cases of ACD respond to dupilumab.²²

Patch Testing While on Dupilumab

Diagnosing ACD is a challenging process. An accurate history and physical examination are critical, and patch testing remains the gold standard when it comes to identifying the source of the contact allergen(s).

There is ongoing debate among contact dermatitis experts regarding the diagnostic accuracy of patch testing for those on immunomodulators or immunosuppressants, as these medications can dampen positive results and increase the risk for false-negative readings.²³ Consequently, some have questioned whether patch testing on dupilumab is accurate or feasible.²⁴ Contact dermatitis experts have examined patch testing results before and after initiation of dupilumab to further investigate. Puza and Atwater²⁵ established that patients are able to mount a positive patch test reaction while on dupilumab. Moreover, a retrospective review by Raffi et al²⁶ found that out of 125 before therapy/on therapy patch test pairs, only 13 were lost after administration of dupilumab. Although this would suggest that dupilumab has little impact on patch testing, Jo et al²⁷ found in a systematic review that patch test reactions may remain positive, change to negative, or become newly positive after dupilumab initiation.

This inconsistency in results may relate to the allergen-specific pathogenesis of ACD—one allergen may have a different response to the mechanism of dupilumab than another.^28,29 More recently, de Wijs et al³⁰ reported a series of 20 patients in whom more than two-thirds of prior positive patch test reactions were lost after retesting on dupilumab; there were no clear trends according to the immune polarity of the allergens. This finding suggests that patient-specific factors also should be considered, as this too could have an impact on the reliability of patch test findings after starting dupilumab.²⁹

Final Interpretation

Given its overall excellent safety profile, dupilumab may be a feasible off-label option for patients with ACD that does not respond to allergen avoidance or for those who experience adverse effects from traditional therapies; however, it remains difficult to obtain through insurance because it is not yet FDA approved for ACD. Likewise, its impact on the accuracy of patch testing is not yet well defined. Further investigations are needed to elucidate the pathophysiology of ACD and to guide further use of dupilumab in its treatment.

Dupilumab is a humanized monoclonal antibody approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe atopic dermatitis. Through inhibition of the IL-4R α subunit, it prevents activation of the IL-4/IL-13 signaling cascade. This dampens the T _H 2 inflammatory response, thereby improving the symptoms associated with atopic dermatitis. ^1,2 Recent literature suggests that dupilumab may be useful in the treatment of other chronic dermatologic conditions, including allergic contact dermatitis (ACD) refractory to allergen avoidance and other treatments. Herein, we provide an overview of ACD, the role that dupilumab may play in its management, and its impact on patch testing results.

Pathogenesis of ACD

Allergic contact dermatitis is a cell-mediated type IV hypersensitivity reaction that develops through 2 distinct stages. In the sensitization phase, an allergen penetrates the skin and subsequently is engulfed by a cutaneous antigen-presenting cell. The allergen is then combined with a peptide to form a complex that is presented to naïve T lymphocytes in regional lymph nodes. The result is clonal expansion of a T-cell population that recognizes the allergen. In the elicitation phase, repeat exposure to the allergen leads to the recruitment of primed T cells to the skin, followed by cytokine release, inflammation, and resultant dermatitis.³

Historically, ACD was thought to be primarily driven by the T_H1 inflammatory response; however, it is now known that T_H2, T_H9, T_H17, and T_H22 also may play a role in its pathogenesis.^4,5 Another key finding is that the immune response in ACD appears to be at least partially allergen specific. Molecular profiling has revealed that nickel primarily induces a T_H1/T_H17 response, while allergens such as fragrance and rubber primarily induce a T_H2 response.⁴

Management of ACD

Allergen avoidance is the mainstay of ACD treatment; however, in some patients, this approach does not always improve symptoms. In addition, eliminating the source of the allergen may not be possible in those with certain occupational, environmental, or medical exposures.

There are no FDA-approved treatments for ACD. When allergen avoidance alone is insufficient, first-line pharmacologic therapy typically includes topical or oral corticosteroids, the choice of which depends on the extent and severity of the dermatitis; however, a steroid-sparing agent often is preferred to avoid the unfavorable effects of long-term steroid use. Other systemic treatments for ACD include methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine.⁶ These agents are used for severe ACD and typically are chosen as a last resort due to their immunosuppressive activity.

Phototherapy is another option, often as an adjunct to other therapies. Narrowband UVB and psoralen plus UVA have both been used. Psoralen plus UVA tends to have more side effects; therefore, narrowband UVB often is preferred.^7,8

Use of Dupilumab in ACD

Biologics are unique, as they can target a single step in the immune response to improve a wide variety of symptoms. Research investigating their role as a treatment modality for ACD is still evolving alongside our increasing knowledge of its pathophysiology.⁹ Of note, studies examining the anti–IL-17 biologic secukinumab revealed it to be ineffective against ACD,^10,11 which suggests that targeting specific immune components may not always result in improvement of ACD symptoms, likely because its pathophysiology involves several pathways.

There have been multiple reports demonstrating the effectiveness of dupilumab in the treatment of ACD (eTable).^12-20 The findings from these studies show that dupilumab can improve recalcitrant dermatitis caused by a broad range of contact allergens, including nickel. This highlights its ability to improve ACD caused by allergens with a T_H1 bias, despite its primarily T_H2-dampening effects. Notably, several studies have reported successful use of dupilumab for systemic ACD.^12,18 In addition, dupilumab may be able to improve symptoms of ACD in as little as 1 to 4 weeks. Unlike some systemic therapies for ACD, dupilumab also benefits from its lack of notable immunosuppressive effects.⁹ A phase 4 clinical trial at Brigham and Women’s Hospital (Boston, Massachusetts) is recruiting participants, with a primary goal of investigating dupilumab’s impact on ACD in patients who have not improved despite allergen avoidance (ClinicalTrials.gov identifier NCT03935971).

There are a few potential disadvantages to dupilumab. Because it is not yet FDA approved for the treatment of ACD, insurance companies may deny coverage, making it likely to be unaffordable for most patients. Furthermore, the side-effect profile has not been fully characterized. In addition to ocular adverse effects, a growing number of studies have reported face and neck erythema after starting dupilumab. Although the cause is unclear, one theory is that the inhibition of IL-4/IL-13 leads to T_H1/T_H17 polarization, thereby worsening ACD caused by allergens that activate a T_H1-predominant response.²¹ Finally, not all cases of ACD respond to dupilumab.²²

Patch Testing While on Dupilumab

Diagnosing ACD is a challenging process. An accurate history and physical examination are critical, and patch testing remains the gold standard when it comes to identifying the source of the contact allergen(s).

There is ongoing debate among contact dermatitis experts regarding the diagnostic accuracy of patch testing for those on immunomodulators or immunosuppressants, as these medications can dampen positive results and increase the risk for false-negative readings.²³ Consequently, some have questioned whether patch testing on dupilumab is accurate or feasible.²⁴ Contact dermatitis experts have examined patch testing results before and after initiation of dupilumab to further investigate. Puza and Atwater²⁵ established that patients are able to mount a positive patch test reaction while on dupilumab. Moreover, a retrospective review by Raffi et al²⁶ found that out of 125 before therapy/on therapy patch test pairs, only 13 were lost after administration of dupilumab. Although this would suggest that dupilumab has little impact on patch testing, Jo et al²⁷ found in a systematic review that patch test reactions may remain positive, change to negative, or become newly positive after dupilumab initiation.

This inconsistency in results may relate to the allergen-specific pathogenesis of ACD—one allergen may have a different response to the mechanism of dupilumab than another.^28,29 More recently, de Wijs et al³⁰ reported a series of 20 patients in whom more than two-thirds of prior positive patch test reactions were lost after retesting on dupilumab; there were no clear trends according to the immune polarity of the allergens. This finding suggests that patient-specific factors also should be considered, as this too could have an impact on the reliability of patch test findings after starting dupilumab.²⁹

Final Interpretation

Given its overall excellent safety profile, dupilumab may be a feasible off-label option for patients with ACD that does not respond to allergen avoidance or for those who experience adverse effects from traditional therapies; however, it remains difficult to obtain through insurance because it is not yet FDA approved for ACD. Likewise, its impact on the accuracy of patch testing is not yet well defined. Further investigations are needed to elucidate the pathophysiology of ACD and to guide further use of dupilumab in its treatment.

To the Editor:

Skin cancer represents a notable health care burden of rising incidence.^1-3 Nondermatologist health care providers play a key role in skin cancer screening through the use of skin cancer examination (SCE)^1,4; however, several factors including poor diagnostic accuracy, low confidence, and lack of training have contributed to limited use of the SCE by these providers.^4,5 Therefore, it is important to identify and implement changes in the medical school curriculum that can facilitate improved use of SCE in clinical practice. We sought to examine factors in the medical school curriculum that influence skin cancer education.

A voluntary electronic survey was distributed through class email and social media to all medical student classes at 4 medical schools (Figure). Responses were collected between March 2 and April 20, 2020. Survey items assessed demographics and curricular factors that influence skin cancer education. Our study was approved by the Institutional Review Board for Human Research of the Medical University of South Carolina (Charleston, South Carolina).

Knowledge of the clinical features of melanoma was assessed by asking participants to correctly identify at least 5 of 6 pigmented lesions as concerning or not concerning for melanoma. Confidence in performing the SCE—the primary outcome—was measured by dichotomizing a 4-point Likert-type scale (“very confident” and “moderately confident” against “slightly confident” and “not at all confident”).

Logistic regression was used to examine curricular factors associated with confidence; descriptive statistics were used for remaining analyses. Analyses were performed using SAS 9.4 statistical software. Prior to analysis, responses from the University of South Carolina School of Medicine Greenville were excluded because the response rate was less than 20%.

The survey was distributed to 1524 students; 619 (40.6%) answered at least 1 question, with a variable response rate to each item (eTable 1). Most respondents were female (351 [56.7%]); 438 (70.8%) were White.

Most respondents said that they received 3 hours or less of general skin cancer (74.9%) or SCE-specific (93.0%) education by the end of their fourth year of medical training. Lecture was the most common method of instruction. Education was provided most often by dermatologists (48.6%), followed by general practice physicians (21.2%). Numerous (26.9%) fourth-year respondents reported that they had never observed SCE; even more (47.6%) had never performed SCE. Almost half of second- and third-year students (43.2% and 44.8%, respectively) considered themselves knowledgeable about the clinical features of melanoma, but only 31.9% of fourth-year students considered themselves knowledgeable.

Only 24.1% of fourth-year students reported confidence performing SCE (eTable 1). Students who received most of their instruction through real clinical encounters were 4.14 times more likely to be confident performing SCE than students who had been given lecture-based learning. Students who performed 1 to 3 SCE or 4 or more SCE were 3.02 and 32.25 times, respectively, more likely to be confident than students who had never performed SCE (eTable 2).

Consistent with a recent study,⁶ our results reflect the discrepancy between the burden and education of skin cancer. This is especially demonstrated by our cohort’s low confidence in performing SCE, a metric associated with both intention to perform and actual performance of SCE in practice.^4,5 We also observed a downward trend in knowledge among students who were about to enter residency, potentially indicating the need for longitudinal training.

Given curricular time constraints, it is essential that medical schools implement changes in learning that will have the greatest impact. Although our results strongly support the efficacy of hands-on clinical training, exposure to dermatology in the second half of medical school training is limited nationwide.⁶ Concentrated efforts to increase clinical exposure might help prepare future physicians in all specialties to combat the burden of this disease.

Limitations of our study include the potential for selection and recall biases. Although our survey spanned multiple institutions in different regions of the United States, results might not be universally representative.

Acknowledgments—We thank Dirk Elston, MD, and Amy Wahlquist, MS (both from Charleston, South Carolina), who helped facilitate the survey on which our research is based. We also acknowledge the assistance of Philip Carmon, MD (Columbia, South Carolina); Julie Flugel (Columbia, South Carolina); Algimantas Simpson, MD (Columbia, South Carolina); Nathan Jasperse, MD (Irvine, California); Jeremy Teruel, MD (Charleston, South Carolina); Alan Snyder, MD, MSCR (Charleston, South Carolina); John Bosland (Charleston, South Carolina); and Daniel Spangler (Greenville, South Carolina).

To the Editor:

Skin cancer represents a notable health care burden of rising incidence.^1-3 Nondermatologist health care providers play a key role in skin cancer screening through the use of skin cancer examination (SCE)^1,4; however, several factors including poor diagnostic accuracy, low confidence, and lack of training have contributed to limited use of the SCE by these providers.^4,5 Therefore, it is important to identify and implement changes in the medical school curriculum that can facilitate improved use of SCE in clinical practice. We sought to examine factors in the medical school curriculum that influence skin cancer education.

A voluntary electronic survey was distributed through class email and social media to all medical student classes at 4 medical schools (Figure). Responses were collected between March 2 and April 20, 2020. Survey items assessed demographics and curricular factors that influence skin cancer education. Our study was approved by the Institutional Review Board for Human Research of the Medical University of South Carolina (Charleston, South Carolina).

Knowledge of the clinical features of melanoma was assessed by asking participants to correctly identify at least 5 of 6 pigmented lesions as concerning or not concerning for melanoma. Confidence in performing the SCE—the primary outcome—was measured by dichotomizing a 4-point Likert-type scale (“very confident” and “moderately confident” against “slightly confident” and “not at all confident”).

Logistic regression was used to examine curricular factors associated with confidence; descriptive statistics were used for remaining analyses. Analyses were performed using SAS 9.4 statistical software. Prior to analysis, responses from the University of South Carolina School of Medicine Greenville were excluded because the response rate was less than 20%.

The survey was distributed to 1524 students; 619 (40.6%) answered at least 1 question, with a variable response rate to each item (eTable 1). Most respondents were female (351 [56.7%]); 438 (70.8%) were White.

Most respondents said that they received 3 hours or less of general skin cancer (74.9%) or SCE-specific (93.0%) education by the end of their fourth year of medical training. Lecture was the most common method of instruction. Education was provided most often by dermatologists (48.6%), followed by general practice physicians (21.2%). Numerous (26.9%) fourth-year respondents reported that they had never observed SCE; even more (47.6%) had never performed SCE. Almost half of second- and third-year students (43.2% and 44.8%, respectively) considered themselves knowledgeable about the clinical features of melanoma, but only 31.9% of fourth-year students considered themselves knowledgeable.

Only 24.1% of fourth-year students reported confidence performing SCE (eTable 1). Students who received most of their instruction through real clinical encounters were 4.14 times more likely to be confident performing SCE than students who had been given lecture-based learning. Students who performed 1 to 3 SCE or 4 or more SCE were 3.02 and 32.25 times, respectively, more likely to be confident than students who had never performed SCE (eTable 2).

Consistent with a recent study,⁶ our results reflect the discrepancy between the burden and education of skin cancer. This is especially demonstrated by our cohort’s low confidence in performing SCE, a metric associated with both intention to perform and actual performance of SCE in practice.^4,5 We also observed a downward trend in knowledge among students who were about to enter residency, potentially indicating the need for longitudinal training.

Given curricular time constraints, it is essential that medical schools implement changes in learning that will have the greatest impact. Although our results strongly support the efficacy of hands-on clinical training, exposure to dermatology in the second half of medical school training is limited nationwide.⁶ Concentrated efforts to increase clinical exposure might help prepare future physicians in all specialties to combat the burden of this disease.

Limitations of our study include the potential for selection and recall biases. Although our survey spanned multiple institutions in different regions of the United States, results might not be universally representative.

Acknowledgments—We thank Dirk Elston, MD, and Amy Wahlquist, MS (both from Charleston, South Carolina), who helped facilitate the survey on which our research is based. We also acknowledge the assistance of Philip Carmon, MD (Columbia, South Carolina); Julie Flugel (Columbia, South Carolina); Algimantas Simpson, MD (Columbia, South Carolina); Nathan Jasperse, MD (Irvine, California); Jeremy Teruel, MD (Charleston, South Carolina); Alan Snyder, MD, MSCR (Charleston, South Carolina); John Bosland (Charleston, South Carolina); and Daniel Spangler (Greenville, South Carolina).

To the Editor:

Skin cancer represents a notable health care burden of rising incidence.^1-3 Nondermatologist health care providers play a key role in skin cancer screening through the use of skin cancer examination (SCE)^1,4; however, several factors including poor diagnostic accuracy, low confidence, and lack of training have contributed to limited use of the SCE by these providers.^4,5 Therefore, it is important to identify and implement changes in the medical school curriculum that can facilitate improved use of SCE in clinical practice. We sought to examine factors in the medical school curriculum that influence skin cancer education.

A voluntary electronic survey was distributed through class email and social media to all medical student classes at 4 medical schools (Figure). Responses were collected between March 2 and April 20, 2020. Survey items assessed demographics and curricular factors that influence skin cancer education. Our study was approved by the Institutional Review Board for Human Research of the Medical University of South Carolina (Charleston, South Carolina).

Knowledge of the clinical features of melanoma was assessed by asking participants to correctly identify at least 5 of 6 pigmented lesions as concerning or not concerning for melanoma. Confidence in performing the SCE—the primary outcome—was measured by dichotomizing a 4-point Likert-type scale (“very confident” and “moderately confident” against “slightly confident” and “not at all confident”).

Logistic regression was used to examine curricular factors associated with confidence; descriptive statistics were used for remaining analyses. Analyses were performed using SAS 9.4 statistical software. Prior to analysis, responses from the University of South Carolina School of Medicine Greenville were excluded because the response rate was less than 20%.

The survey was distributed to 1524 students; 619 (40.6%) answered at least 1 question, with a variable response rate to each item (eTable 1). Most respondents were female (351 [56.7%]); 438 (70.8%) were White.

Most respondents said that they received 3 hours or less of general skin cancer (74.9%) or SCE-specific (93.0%) education by the end of their fourth year of medical training. Lecture was the most common method of instruction. Education was provided most often by dermatologists (48.6%), followed by general practice physicians (21.2%). Numerous (26.9%) fourth-year respondents reported that they had never observed SCE; even more (47.6%) had never performed SCE. Almost half of second- and third-year students (43.2% and 44.8%, respectively) considered themselves knowledgeable about the clinical features of melanoma, but only 31.9% of fourth-year students considered themselves knowledgeable.

Only 24.1% of fourth-year students reported confidence performing SCE (eTable 1). Students who received most of their instruction through real clinical encounters were 4.14 times more likely to be confident performing SCE than students who had been given lecture-based learning. Students who performed 1 to 3 SCE or 4 or more SCE were 3.02 and 32.25 times, respectively, more likely to be confident than students who had never performed SCE (eTable 2).

Consistent with a recent study,⁶ our results reflect the discrepancy between the burden and education of skin cancer. This is especially demonstrated by our cohort’s low confidence in performing SCE, a metric associated with both intention to perform and actual performance of SCE in practice.^4,5 We also observed a downward trend in knowledge among students who were about to enter residency, potentially indicating the need for longitudinal training.

Given curricular time constraints, it is essential that medical schools implement changes in learning that will have the greatest impact. Although our results strongly support the efficacy of hands-on clinical training, exposure to dermatology in the second half of medical school training is limited nationwide.⁶ Concentrated efforts to increase clinical exposure might help prepare future physicians in all specialties to combat the burden of this disease.

Limitations of our study include the potential for selection and recall biases. Although our survey spanned multiple institutions in different regions of the United States, results might not be universally representative.

Acknowledgments—We thank Dirk Elston, MD, and Amy Wahlquist, MS (both from Charleston, South Carolina), who helped facilitate the survey on which our research is based. We also acknowledge the assistance of Philip Carmon, MD (Columbia, South Carolina); Julie Flugel (Columbia, South Carolina); Algimantas Simpson, MD (Columbia, South Carolina); Nathan Jasperse, MD (Irvine, California); Jeremy Teruel, MD (Charleston, South Carolina); Alan Snyder, MD, MSCR (Charleston, South Carolina); John Bosland (Charleston, South Carolina); and Daniel Spangler (Greenville, South Carolina).

Background and Clinical Presentation

Seabather’s Eruption—Seabather’s eruption is a type I and IV hypersensitivity reaction caused by nematocysts of larval-stage thimble jellyfish (Linuche unguiculata), sea anemones (eg, Edwardsiella lineata), and larval cnidarians.¹Linuche unguiculata commonly is found along the southeast coast of the United States and in the Caribbean, the Gulf of Mexico, and the coasts of Florida; less commonly, it has been reported along the coasts of Brazil and Papua New Guinea. Edwardsiella lineata more commonly is seen along the East Coast of the United States.² Seabather’s eruption presents as numerous scattered, pruritic, red macules and papules (measuring 1 mm to 1.5 cm in size) distributed in areas covered by skin folds, wet clothing, or hair following exposure to marine water (Figure 1). This maculopapular rash generally appears shortly after exiting the water and can last up to several weeks in some cases.³ The cause for this delayed presentation is that the marine organisms become entrapped between the skin of the human contact and another object (eg, swimwear) but do not release their preformed antivenom until they are exposed to air after removal from the water, at which point the organisms die and cell lysis results in injection of the venom.

Diver’s Dermatitis—Diver’s dermatitis (also referred to as “swimmer’s itch”) is a type I and IV hypersensitivity reaction caused by schistosome cercariae released by aquatic snails.⁴ There are several different cercarial species known to be capable of causing diver dermatitis, but the most commonly implicated genera are Trichobilharzia and Gigantobilharzia. These parasites most commonly are found in freshwater lakes but also occur in oceans, particularly in brackish areas adjacent to freshwater access. Factors associated with increased concentrations of these parasites include shallow, slow-moving water and prolonged onshore wind causing accumulation near the shoreline. It also is thought that the snail host will shed greater concentrations of the parasitic worm in the morning hours and after prolonged exposure to sunlight.⁴ These flatworm trematodes have a 2-host life cycle. The snails function as intermediate hosts for the parasites before they enter their final host, which are birds. Humans only function as incidental and nonviable hosts for these worms. The parasites gain access to the human body by burrowing into exposed skin. Because the parasite is unable to survive on human hosts, it dies shortly after penetrating the skin, which leads to an intense inflammatory response causing symptoms of pruritus within hours of exposure (Figure 2). The initial eruption progresses over a few days into a diffuse, maculopapular, pruritic rash, similar to that seen in seabather’s eruption. This rash then regresses completely in 1 to 3 weeks. Subsequent exposure to the same parasite is associated with increased severity of future rashes, likely due to antibody-mediated sensitization.⁴

Photograph courtesy of Tomas Machacek, PhD (Prague, Czechia).

Diagnosis—Marine-derived dermatoses from various sources can present very similarly; thus, it is difficult to discern the specific etiology behind the clinical presentation. No commonly utilized imaging modalities can differentiate between seabather’s eruption and diver’s dermatitis, but eliciting a thorough patient history often can aid in differentiation of the cause of the eruption. For example, lesions located only on nonexposed areas of the skin increases the likelihood of seabather’s eruption due to nematocysts being trapped between clothing and the skin. In contrast, diver’s dermatitis generally appears on areas of the skin that were directly exposed to water and uncovered by clothing.⁵ Patient reports of a lack of symptoms until shortly after exiting the water further support a diagnosis of seabather’s eruption, as this delayed presentation of symptoms is caused by lysis of the culprit organisms following removal from the marine environment. The cell lysis is responsible for the widespread injection of preformed venom via the numerous nematocysts trapped between clothing and the patient’s body.¹

Treatment

For both conditions, the symptoms are treated with hydrocortisone or other topical steroid solutions in conjunction with oral hydroxyzine. Alternative treatments include calamine lotion with 1% menthol and nonsteroidal anti-inflammatory drugs. Taking baths with oatmeal, Epsom salts, or baking soda also may alleviate some of the pruritic symptoms.²

Prevention

The ability to diagnose the precise cause of these similar marine rashes can bring peace of mind to both patients and physicians regardless of their similar management strategies. Severe contact dermatitis of unknown etiology can be disconcerting for patients. Additionally, documenting the causes of marine rashes in particular geographic locations can be beneficial for establishing which organisms are most likely to affect visitors to those areas. This type of data collection can be utilized to develop preventative recommendations, such as deciding when to avoid the water. Education of the public can be done with the use of informational posters located near popular swimming areas and online public service announcements. Informing the general public about the dangers of entering the ocean, especially during certain times of the year when nematocyst-equipped sea creatures are in abundance, could serve to prevent numerous cases of seabather’s eruption. Likewise, advising against immersion in shallow, slow-moving water during the morning hours or after prolonged sun exposure in trematode-endemic areas could prevent numerous cases of diver’s dermatitis. Basic information on what to expect if afflicted by a marine rash also may reduce the number of emergency department visits for these conditions, thus providing economic benefit for patients and for hospitals since patients would better know how to acutely treat these rashes and lessen the patient load at hospital emergency departments. If individuals can assure themselves of the self-limited nature of these types of dermatoses, they may be less inclined to seek medical consultation.

Final Thoughts

As the climate continues to change, the incidence of marine rashes such as seabather’s eruption and diver’s dermatitis is expected to increase due to warmer surface temperatures causing more frequent and earlier blooms of L unguiculata and E lineata. Cases of diver’s dermatitis also could increase due to a longer season of more frequent human exposure from an increase in warmer temperatures. The projected uptick in incidences of these marine rashes makes understanding these pathologies even more pertinent for physicians.⁶ Increasing our understanding of the different types of marine rashes and their causes will help guide future recommendations for the general public when visiting the ocean.

Future research may wish to investigate unique ways in which to prevent contact between these organisms and humans. Past research on mice indicated that topical application of DEET (N,N-diethyl-meta-toluamide) prior to trematode exposure prevented penetration of the skin by parasitic worms.⁷ Future studies are needed to examine the effectiveness of this preventative technique on humans. For now, dermatologists may counsel our ocean-going patients on preventative behaviors as well as provide reassurance and symptomatic relief when they present to our clinics with marine rashes.

Background and Clinical Presentation

Seabather’s Eruption—Seabather’s eruption is a type I and IV hypersensitivity reaction caused by nematocysts of larval-stage thimble jellyfish (Linuche unguiculata), sea anemones (eg, Edwardsiella lineata), and larval cnidarians.¹Linuche unguiculata commonly is found along the southeast coast of the United States and in the Caribbean, the Gulf of Mexico, and the coasts of Florida; less commonly, it has been reported along the coasts of Brazil and Papua New Guinea. Edwardsiella lineata more commonly is seen along the East Coast of the United States.² Seabather’s eruption presents as numerous scattered, pruritic, red macules and papules (measuring 1 mm to 1.5 cm in size) distributed in areas covered by skin folds, wet clothing, or hair following exposure to marine water (Figure 1). This maculopapular rash generally appears shortly after exiting the water and can last up to several weeks in some cases.³ The cause for this delayed presentation is that the marine organisms become entrapped between the skin of the human contact and another object (eg, swimwear) but do not release their preformed antivenom until they are exposed to air after removal from the water, at which point the organisms die and cell lysis results in injection of the venom.

Diver’s Dermatitis—Diver’s dermatitis (also referred to as “swimmer’s itch”) is a type I and IV hypersensitivity reaction caused by schistosome cercariae released by aquatic snails.⁴ There are several different cercarial species known to be capable of causing diver dermatitis, but the most commonly implicated genera are Trichobilharzia and Gigantobilharzia. These parasites most commonly are found in freshwater lakes but also occur in oceans, particularly in brackish areas adjacent to freshwater access. Factors associated with increased concentrations of these parasites include shallow, slow-moving water and prolonged onshore wind causing accumulation near the shoreline. It also is thought that the snail host will shed greater concentrations of the parasitic worm in the morning hours and after prolonged exposure to sunlight.⁴ These flatworm trematodes have a 2-host life cycle. The snails function as intermediate hosts for the parasites before they enter their final host, which are birds. Humans only function as incidental and nonviable hosts for these worms. The parasites gain access to the human body by burrowing into exposed skin. Because the parasite is unable to survive on human hosts, it dies shortly after penetrating the skin, which leads to an intense inflammatory response causing symptoms of pruritus within hours of exposure (Figure 2). The initial eruption progresses over a few days into a diffuse, maculopapular, pruritic rash, similar to that seen in seabather’s eruption. This rash then regresses completely in 1 to 3 weeks. Subsequent exposure to the same parasite is associated with increased severity of future rashes, likely due to antibody-mediated sensitization.⁴

Photograph courtesy of Tomas Machacek, PhD (Prague, Czechia).

Diagnosis—Marine-derived dermatoses from various sources can present very similarly; thus, it is difficult to discern the specific etiology behind the clinical presentation. No commonly utilized imaging modalities can differentiate between seabather’s eruption and diver’s dermatitis, but eliciting a thorough patient history often can aid in differentiation of the cause of the eruption. For example, lesions located only on nonexposed areas of the skin increases the likelihood of seabather’s eruption due to nematocysts being trapped between clothing and the skin. In contrast, diver’s dermatitis generally appears on areas of the skin that were directly exposed to water and uncovered by clothing.⁵ Patient reports of a lack of symptoms until shortly after exiting the water further support a diagnosis of seabather’s eruption, as this delayed presentation of symptoms is caused by lysis of the culprit organisms following removal from the marine environment. The cell lysis is responsible for the widespread injection of preformed venom via the numerous nematocysts trapped between clothing and the patient’s body.¹

Treatment

For both conditions, the symptoms are treated with hydrocortisone or other topical steroid solutions in conjunction with oral hydroxyzine. Alternative treatments include calamine lotion with 1% menthol and nonsteroidal anti-inflammatory drugs. Taking baths with oatmeal, Epsom salts, or baking soda also may alleviate some of the pruritic symptoms.²

Prevention

The ability to diagnose the precise cause of these similar marine rashes can bring peace of mind to both patients and physicians regardless of their similar management strategies. Severe contact dermatitis of unknown etiology can be disconcerting for patients. Additionally, documenting the causes of marine rashes in particular geographic locations can be beneficial for establishing which organisms are most likely to affect visitors to those areas. This type of data collection can be utilized to develop preventative recommendations, such as deciding when to avoid the water. Education of the public can be done with the use of informational posters located near popular swimming areas and online public service announcements. Informing the general public about the dangers of entering the ocean, especially during certain times of the year when nematocyst-equipped sea creatures are in abundance, could serve to prevent numerous cases of seabather’s eruption. Likewise, advising against immersion in shallow, slow-moving water during the morning hours or after prolonged sun exposure in trematode-endemic areas could prevent numerous cases of diver’s dermatitis. Basic information on what to expect if afflicted by a marine rash also may reduce the number of emergency department visits for these conditions, thus providing economic benefit for patients and for hospitals since patients would better know how to acutely treat these rashes and lessen the patient load at hospital emergency departments. If individuals can assure themselves of the self-limited nature of these types of dermatoses, they may be less inclined to seek medical consultation.

Final Thoughts

As the climate continues to change, the incidence of marine rashes such as seabather’s eruption and diver’s dermatitis is expected to increase due to warmer surface temperatures causing more frequent and earlier blooms of L unguiculata and E lineata. Cases of diver’s dermatitis also could increase due to a longer season of more frequent human exposure from an increase in warmer temperatures. The projected uptick in incidences of these marine rashes makes understanding these pathologies even more pertinent for physicians.⁶ Increasing our understanding of the different types of marine rashes and their causes will help guide future recommendations for the general public when visiting the ocean.

Future research may wish to investigate unique ways in which to prevent contact between these organisms and humans. Past research on mice indicated that topical application of DEET (N,N-diethyl-meta-toluamide) prior to trematode exposure prevented penetration of the skin by parasitic worms.⁷ Future studies are needed to examine the effectiveness of this preventative technique on humans. For now, dermatologists may counsel our ocean-going patients on preventative behaviors as well as provide reassurance and symptomatic relief when they present to our clinics with marine rashes.

Background and Clinical Presentation

Seabather’s Eruption—Seabather’s eruption is a type I and IV hypersensitivity reaction caused by nematocysts of larval-stage thimble jellyfish (Linuche unguiculata), sea anemones (eg, Edwardsiella lineata), and larval cnidarians.¹Linuche unguiculata commonly is found along the southeast coast of the United States and in the Caribbean, the Gulf of Mexico, and the coasts of Florida; less commonly, it has been reported along the coasts of Brazil and Papua New Guinea. Edwardsiella lineata more commonly is seen along the East Coast of the United States.² Seabather’s eruption presents as numerous scattered, pruritic, red macules and papules (measuring 1 mm to 1.5 cm in size) distributed in areas covered by skin folds, wet clothing, or hair following exposure to marine water (Figure 1). This maculopapular rash generally appears shortly after exiting the water and can last up to several weeks in some cases.³ The cause for this delayed presentation is that the marine organisms become entrapped between the skin of the human contact and another object (eg, swimwear) but do not release their preformed antivenom until they are exposed to air after removal from the water, at which point the organisms die and cell lysis results in injection of the venom.

Diver’s Dermatitis—Diver’s dermatitis (also referred to as “swimmer’s itch”) is a type I and IV hypersensitivity reaction caused by schistosome cercariae released by aquatic snails.⁴ There are several different cercarial species known to be capable of causing diver dermatitis, but the most commonly implicated genera are Trichobilharzia and Gigantobilharzia. These parasites most commonly are found in freshwater lakes but also occur in oceans, particularly in brackish areas adjacent to freshwater access. Factors associated with increased concentrations of these parasites include shallow, slow-moving water and prolonged onshore wind causing accumulation near the shoreline. It also is thought that the snail host will shed greater concentrations of the parasitic worm in the morning hours and after prolonged exposure to sunlight.⁴ These flatworm trematodes have a 2-host life cycle. The snails function as intermediate hosts for the parasites before they enter their final host, which are birds. Humans only function as incidental and nonviable hosts for these worms. The parasites gain access to the human body by burrowing into exposed skin. Because the parasite is unable to survive on human hosts, it dies shortly after penetrating the skin, which leads to an intense inflammatory response causing symptoms of pruritus within hours of exposure (Figure 2). The initial eruption progresses over a few days into a diffuse, maculopapular, pruritic rash, similar to that seen in seabather’s eruption. This rash then regresses completely in 1 to 3 weeks. Subsequent exposure to the same parasite is associated with increased severity of future rashes, likely due to antibody-mediated sensitization.⁴

Photograph courtesy of Tomas Machacek, PhD (Prague, Czechia).

Diagnosis—Marine-derived dermatoses from various sources can present very similarly; thus, it is difficult to discern the specific etiology behind the clinical presentation. No commonly utilized imaging modalities can differentiate between seabather’s eruption and diver’s dermatitis, but eliciting a thorough patient history often can aid in differentiation of the cause of the eruption. For example, lesions located only on nonexposed areas of the skin increases the likelihood of seabather’s eruption due to nematocysts being trapped between clothing and the skin. In contrast, diver’s dermatitis generally appears on areas of the skin that were directly exposed to water and uncovered by clothing.⁵ Patient reports of a lack of symptoms until shortly after exiting the water further support a diagnosis of seabather’s eruption, as this delayed presentation of symptoms is caused by lysis of the culprit organisms following removal from the marine environment. The cell lysis is responsible for the widespread injection of preformed venom via the numerous nematocysts trapped between clothing and the patient’s body.¹

Treatment

For both conditions, the symptoms are treated with hydrocortisone or other topical steroid solutions in conjunction with oral hydroxyzine. Alternative treatments include calamine lotion with 1% menthol and nonsteroidal anti-inflammatory drugs. Taking baths with oatmeal, Epsom salts, or baking soda also may alleviate some of the pruritic symptoms.²

Prevention

The ability to diagnose the precise cause of these similar marine rashes can bring peace of mind to both patients and physicians regardless of their similar management strategies. Severe contact dermatitis of unknown etiology can be disconcerting for patients. Additionally, documenting the causes of marine rashes in particular geographic locations can be beneficial for establishing which organisms are most likely to affect visitors to those areas. This type of data collection can be utilized to develop preventative recommendations, such as deciding when to avoid the water. Education of the public can be done with the use of informational posters located near popular swimming areas and online public service announcements. Informing the general public about the dangers of entering the ocean, especially during certain times of the year when nematocyst-equipped sea creatures are in abundance, could serve to prevent numerous cases of seabather’s eruption. Likewise, advising against immersion in shallow, slow-moving water during the morning hours or after prolonged sun exposure in trematode-endemic areas could prevent numerous cases of diver’s dermatitis. Basic information on what to expect if afflicted by a marine rash also may reduce the number of emergency department visits for these conditions, thus providing economic benefit for patients and for hospitals since patients would better know how to acutely treat these rashes and lessen the patient load at hospital emergency departments. If individuals can assure themselves of the self-limited nature of these types of dermatoses, they may be less inclined to seek medical consultation.

Final Thoughts

As the climate continues to change, the incidence of marine rashes such as seabather’s eruption and diver’s dermatitis is expected to increase due to warmer surface temperatures causing more frequent and earlier blooms of L unguiculata and E lineata. Cases of diver’s dermatitis also could increase due to a longer season of more frequent human exposure from an increase in warmer temperatures. The projected uptick in incidences of these marine rashes makes understanding these pathologies even more pertinent for physicians.⁶ Increasing our understanding of the different types of marine rashes and their causes will help guide future recommendations for the general public when visiting the ocean.

Future research may wish to investigate unique ways in which to prevent contact between these organisms and humans. Past research on mice indicated that topical application of DEET (N,N-diethyl-meta-toluamide) prior to trematode exposure prevented penetration of the skin by parasitic worms.⁷ Future studies are needed to examine the effectiveness of this preventative technique on humans. For now, dermatologists may counsel our ocean-going patients on preventative behaviors as well as provide reassurance and symptomatic relief when they present to our clinics with marine rashes.

The Diagnosis: Metastatic Clear Cell Renal Cell Carcinoma

Renal cell carcinoma (RCC) is a common genitourinary system malignancy with incidence peaking between 50 and 70 years of age and a male predominance.¹ The clear cell variant is the most common subtype of RCC, accounting for 70% to 75% of all cases. It is known to be a highly aggressive malignancy that frequently metastasizes to the lungs, lymphatics, bones, liver, and brain.^2,3 Approximately 20% to 50% of patients with RCC eventually will develop metastasis after nephrectomy.⁴ Survival with metastatic RCC to any site typically is in the range of 10 to 22 months.^5,6 Cutaneous metastases of RCC rarely have been reported in the literature (3%–6% of cases⁷) and most commonly are found on the scalp, followed by the chest or abdomen. ⁸ Cutaneous metastases generally are regarded as a late manifestation of the disease with a very poor prognosis. ⁹ It is unusual to identify cutaneous RCC metastasis without known RCC or other symptoms consistent with advanced RCC, such as hematuria or abdominal/flank pain. Renal cell carcinoma accounts for an estimated 6% to 7% of all cutaneous metastatic lesions.¹⁰ Cutaneous metastatic lesions of RCC often are solitary and grow rapidly, with the clinical appearance of an erythematous or violaceous, nodular, highly vascular, and often hemorrhagic growth.^9,11,12

Following the histologic diagnosis of metastatic clear cell RCC, our patient was referred to medical oncology for further workup. Magnetic resonance imaging and a positron emission tomography scan demonstrated widespread disease with a 7-cm left renal mass, liver and lung metastases, and bilateral mediastinal lymphadenopathy. The patient was started on combination immunotherapy as a palliative treatment given the widespread disease.

Histologically, clear cell RCC is characterized by lipid and glycogen-rich cells with ample cytoplasm and a well-developed vascular network, which often is thin walled with a chicken wire–like architecture. Metastatic clear cell RCC tumor cells may form glandular, acinar, or papillary structures with variable lymphocytic inflammatory infiltrates and abundant capillary formation. Immunohistochemically, the tumor cells should demonstrate positivity for paired box gene 8, PAX8, and RCC marker antigen.¹³ Vimentin and carcinoembryonic antigen may be utilized to distinguish from hidradenoma as carcinoembryonic antigen will be positive in hidradenoma and vimentin will be negative.¹⁴ Renal cell carcinoma also has a common molecular signature of von Hippel-Lindau tumor suppressor gene inactivation as well as upregulation of hypoxia inducible factor and vascular endothelial growth factor.¹⁵

Balloon cell nevi often clinically present in young patients as bicolored nevi that sometimes are polypoid or verrucous in appearance with central yellow globules surrounded by a peripheral reticular pattern on dermoscopy. Histologically, balloon cell nevi are characterized by large cells with small, round, centrally located basophilic nuclei and clear foamy cytoplasm (Figure 1), which are thought to be formed by progressive vacuolization of melanocytes due to the enlargement and disintegration of melanosomes. This ballooning change reflects an seen in malignant melanoma, in which case nuclear pleomorphism, atypia, and increased mitotic activity also are observed. The prominent vascular network characteristic of RCC typically is not present.¹⁶

Clear cell hidradenomas are benign skin appendage tumors that often present as small, firm, solitary dermal nodules that may extend into the subcutaneous fat. They have a predilection for the head, face, and arms and demonstrate 2 predominant cell types, including a polyhedral cell with a rounded nucleus and slightly basophilic cytoplasm as well as a round cell with clear cytoplasm and bland nuclei (Figure 2). The latter cell type is less common, representing the predominant cell type in less than one-third of hidradenomas, and can present a diagnostic quandary based on histologic similarity to other clear cell neoplasms. The clear cells contain glycogen but no lipid. Ductlike structures often are present, and the intervening stroma varies from delicate vascularized cords of fibrous tissue to dense hyalinized collagen. Immunohistochemistry may be required for definitive diagnosis, and clear cell hidradenomas should react with monoclonal antibodies that label both eccrine and apocrine secretory elements, such as cytokeratins 6/18, 7, and 8/18.¹⁷

Pyogenic granulomas (also referred to as lobular capillary hemangiomas) are common and present clinically as rapidly growing, polypoid, red masses surrounded by a thickened epidermis that often are found on the fingers or lips. This entity is benign and often regresses spontaneously. Histologically, pyogenic granulomas are characterized by a lobular pattern of vascular proliferation associated with edema and inflammation resembling granulation tissue, with acanthosis and hyperkeratosis at the edges of the lesion (Figure 3).¹⁸

Sebaceous carcinoma is a locally aggressive malignant neoplasm arising from the cells of the sebaceous glands and occurring most commonly in the periorbital area. This neoplasm most often affects older adults, with a mean age at diagnosis of 63 to 77 years. It commonly presents as a solitary nodule with yellowish discoloration and madarosis, which is a key distinguishing feature to differentiate this entity from a chalazion or hordeolum. Histologically, sebaceous carcinoma is a dermal-based infiltrative, nodular tumor with varying degrees of clear cell changes—well-differentiated tumors show more clear cell change as compared to more poorly differentiated variants—along with basaloid or squamous features and abundant mitotic activity (Figure 4), which may be useful in distinguishing it from the other entities in the clear cell neoplasm differential.^19-22

The Diagnosis: Metastatic Clear Cell Renal Cell Carcinoma

Renal cell carcinoma (RCC) is a common genitourinary system malignancy with incidence peaking between 50 and 70 years of age and a male predominance.¹ The clear cell variant is the most common subtype of RCC, accounting for 70% to 75% of all cases. It is known to be a highly aggressive malignancy that frequently metastasizes to the lungs, lymphatics, bones, liver, and brain.^2,3 Approximately 20% to 50% of patients with RCC eventually will develop metastasis after nephrectomy.⁴ Survival with metastatic RCC to any site typically is in the range of 10 to 22 months.^5,6 Cutaneous metastases of RCC rarely have been reported in the literature (3%–6% of cases⁷) and most commonly are found on the scalp, followed by the chest or abdomen. ⁸ Cutaneous metastases generally are regarded as a late manifestation of the disease with a very poor prognosis. ⁹ It is unusual to identify cutaneous RCC metastasis without known RCC or other symptoms consistent with advanced RCC, such as hematuria or abdominal/flank pain. Renal cell carcinoma accounts for an estimated 6% to 7% of all cutaneous metastatic lesions.¹⁰ Cutaneous metastatic lesions of RCC often are solitary and grow rapidly, with the clinical appearance of an erythematous or violaceous, nodular, highly vascular, and often hemorrhagic growth.^9,11,12

Following the histologic diagnosis of metastatic clear cell RCC, our patient was referred to medical oncology for further workup. Magnetic resonance imaging and a positron emission tomography scan demonstrated widespread disease with a 7-cm left renal mass, liver and lung metastases, and bilateral mediastinal lymphadenopathy. The patient was started on combination immunotherapy as a palliative treatment given the widespread disease.

Histologically, clear cell RCC is characterized by lipid and glycogen-rich cells with ample cytoplasm and a well-developed vascular network, which often is thin walled with a chicken wire–like architecture. Metastatic clear cell RCC tumor cells may form glandular, acinar, or papillary structures with variable lymphocytic inflammatory infiltrates and abundant capillary formation. Immunohistochemically, the tumor cells should demonstrate positivity for paired box gene 8, PAX8, and RCC marker antigen.¹³ Vimentin and carcinoembryonic antigen may be utilized to distinguish from hidradenoma as carcinoembryonic antigen will be positive in hidradenoma and vimentin will be negative.¹⁴ Renal cell carcinoma also has a common molecular signature of von Hippel-Lindau tumor suppressor gene inactivation as well as upregulation of hypoxia inducible factor and vascular endothelial growth factor.¹⁵

Balloon cell nevi often clinically present in young patients as bicolored nevi that sometimes are polypoid or verrucous in appearance with central yellow globules surrounded by a peripheral reticular pattern on dermoscopy. Histologically, balloon cell nevi are characterized by large cells with small, round, centrally located basophilic nuclei and clear foamy cytoplasm (Figure 1), which are thought to be formed by progressive vacuolization of melanocytes due to the enlargement and disintegration of melanosomes. This ballooning change reflects an seen in malignant melanoma, in which case nuclear pleomorphism, atypia, and increased mitotic activity also are observed. The prominent vascular network characteristic of RCC typically is not present.¹⁶

Clear cell hidradenomas are benign skin appendage tumors that often present as small, firm, solitary dermal nodules that may extend into the subcutaneous fat. They have a predilection for the head, face, and arms and demonstrate 2 predominant cell types, including a polyhedral cell with a rounded nucleus and slightly basophilic cytoplasm as well as a round cell with clear cytoplasm and bland nuclei (Figure 2). The latter cell type is less common, representing the predominant cell type in less than one-third of hidradenomas, and can present a diagnostic quandary based on histologic similarity to other clear cell neoplasms. The clear cells contain glycogen but no lipid. Ductlike structures often are present, and the intervening stroma varies from delicate vascularized cords of fibrous tissue to dense hyalinized collagen. Immunohistochemistry may be required for definitive diagnosis, and clear cell hidradenomas should react with monoclonal antibodies that label both eccrine and apocrine secretory elements, such as cytokeratins 6/18, 7, and 8/18.¹⁷

Pyogenic granulomas (also referred to as lobular capillary hemangiomas) are common and present clinically as rapidly growing, polypoid, red masses surrounded by a thickened epidermis that often are found on the fingers or lips. This entity is benign and often regresses spontaneously. Histologically, pyogenic granulomas are characterized by a lobular pattern of vascular proliferation associated with edema and inflammation resembling granulation tissue, with acanthosis and hyperkeratosis at the edges of the lesion (Figure 3).¹⁸

Sebaceous carcinoma is a locally aggressive malignant neoplasm arising from the cells of the sebaceous glands and occurring most commonly in the periorbital area. This neoplasm most often affects older adults, with a mean age at diagnosis of 63 to 77 years. It commonly presents as a solitary nodule with yellowish discoloration and madarosis, which is a key distinguishing feature to differentiate this entity from a chalazion or hordeolum. Histologically, sebaceous carcinoma is a dermal-based infiltrative, nodular tumor with varying degrees of clear cell changes—well-differentiated tumors show more clear cell change as compared to more poorly differentiated variants—along with basaloid or squamous features and abundant mitotic activity (Figure 4), which may be useful in distinguishing it from the other entities in the clear cell neoplasm differential.^19-22

The Diagnosis: Metastatic Clear Cell Renal Cell Carcinoma

Renal cell carcinoma (RCC) is a common genitourinary system malignancy with incidence peaking between 50 and 70 years of age and a male predominance.¹ The clear cell variant is the most common subtype of RCC, accounting for 70% to 75% of all cases. It is known to be a highly aggressive malignancy that frequently metastasizes to the lungs, lymphatics, bones, liver, and brain.^2,3 Approximately 20% to 50% of patients with RCC eventually will develop metastasis after nephrectomy.⁴ Survival with metastatic RCC to any site typically is in the range of 10 to 22 months.^5,6 Cutaneous metastases of RCC rarely have been reported in the literature (3%–6% of cases⁷) and most commonly are found on the scalp, followed by the chest or abdomen. ⁸ Cutaneous metastases generally are regarded as a late manifestation of the disease with a very poor prognosis. ⁹ It is unusual to identify cutaneous RCC metastasis without known RCC or other symptoms consistent with advanced RCC, such as hematuria or abdominal/flank pain. Renal cell carcinoma accounts for an estimated 6% to 7% of all cutaneous metastatic lesions.¹⁰ Cutaneous metastatic lesions of RCC often are solitary and grow rapidly, with the clinical appearance of an erythematous or violaceous, nodular, highly vascular, and often hemorrhagic growth.^9,11,12

Following the histologic diagnosis of metastatic clear cell RCC, our patient was referred to medical oncology for further workup. Magnetic resonance imaging and a positron emission tomography scan demonstrated widespread disease with a 7-cm left renal mass, liver and lung metastases, and bilateral mediastinal lymphadenopathy. The patient was started on combination immunotherapy as a palliative treatment given the widespread disease.

Histologically, clear cell RCC is characterized by lipid and glycogen-rich cells with ample cytoplasm and a well-developed vascular network, which often is thin walled with a chicken wire–like architecture. Metastatic clear cell RCC tumor cells may form glandular, acinar, or papillary structures with variable lymphocytic inflammatory infiltrates and abundant capillary formation. Immunohistochemically, the tumor cells should demonstrate positivity for paired box gene 8, PAX8, and RCC marker antigen.¹³ Vimentin and carcinoembryonic antigen may be utilized to distinguish from hidradenoma as carcinoembryonic antigen will be positive in hidradenoma and vimentin will be negative.¹⁴ Renal cell carcinoma also has a common molecular signature of von Hippel-Lindau tumor suppressor gene inactivation as well as upregulation of hypoxia inducible factor and vascular endothelial growth factor.¹⁵

Balloon cell nevi often clinically present in young patients as bicolored nevi that sometimes are polypoid or verrucous in appearance with central yellow globules surrounded by a peripheral reticular pattern on dermoscopy. Histologically, balloon cell nevi are characterized by large cells with small, round, centrally located basophilic nuclei and clear foamy cytoplasm (Figure 1), which are thought to be formed by progressive vacuolization of melanocytes due to the enlargement and disintegration of melanosomes. This ballooning change reflects an seen in malignant melanoma, in which case nuclear pleomorphism, atypia, and increased mitotic activity also are observed. The prominent vascular network characteristic of RCC typically is not present.¹⁶

Clear cell hidradenomas are benign skin appendage tumors that often present as small, firm, solitary dermal nodules that may extend into the subcutaneous fat. They have a predilection for the head, face, and arms and demonstrate 2 predominant cell types, including a polyhedral cell with a rounded nucleus and slightly basophilic cytoplasm as well as a round cell with clear cytoplasm and bland nuclei (Figure 2). The latter cell type is less common, representing the predominant cell type in less than one-third of hidradenomas, and can present a diagnostic quandary based on histologic similarity to other clear cell neoplasms. The clear cells contain glycogen but no lipid. Ductlike structures often are present, and the intervening stroma varies from delicate vascularized cords of fibrous tissue to dense hyalinized collagen. Immunohistochemistry may be required for definitive diagnosis, and clear cell hidradenomas should react with monoclonal antibodies that label both eccrine and apocrine secretory elements, such as cytokeratins 6/18, 7, and 8/18.¹⁷

Pyogenic granulomas (also referred to as lobular capillary hemangiomas) are common and present clinically as rapidly growing, polypoid, red masses surrounded by a thickened epidermis that often are found on the fingers or lips. This entity is benign and often regresses spontaneously. Histologically, pyogenic granulomas are characterized by a lobular pattern of vascular proliferation associated with edema and inflammation resembling granulation tissue, with acanthosis and hyperkeratosis at the edges of the lesion (Figure 3).¹⁸

Sebaceous carcinoma is a locally aggressive malignant neoplasm arising from the cells of the sebaceous glands and occurring most commonly in the periorbital area. This neoplasm most often affects older adults, with a mean age at diagnosis of 63 to 77 years. It commonly presents as a solitary nodule with yellowish discoloration and madarosis, which is a key distinguishing feature to differentiate this entity from a chalazion or hordeolum. Histologically, sebaceous carcinoma is a dermal-based infiltrative, nodular tumor with varying degrees of clear cell changes—well-differentiated tumors show more clear cell change as compared to more poorly differentiated variants—along with basaloid or squamous features and abundant mitotic activity (Figure 4), which may be useful in distinguishing it from the other entities in the clear cell neoplasm differential.^19-22