MDedge Dermatology

Reducing the frequency of routine blood monitoring for methotrexate in patients with rheumatoid arthritis during the COVID-19 pandemic was associated with no adverse outcomes for patients, British researchers have found.

Similar laboratory results were recorded in patients who were switched from testing once per month to once every 3 or 5 months, Natasha Wood, a general practice trainee at North Devon District Hospital in Barnstaple, England, reported at the annual meeting of the British Society for Rheumatology.

sshepard/iStock

“Less frequent monitoring did not result in patient harm,” she said.

“There’s an increasing evidence base; we wonder whether now’s the time to reconsider our DMARD-monitoring strategy,” Ms. Wood said.
 

Changes in monitoring because of pandemic

Methotrexate monitoring is important to minimize the risk of harm to patients, and it is recommended that standard laboratory tests, such as a complete blood count, creatinine, and liver enzymes are measured regularly. Indeed, both the BSR and the American College of Rheumatology have specific recommendations on the monitoring of methotrexate and other conventional synthetic disease-modifying antirheumatic drugs (csDMARDS).

“The BSR used to advise for monthly blood tests in patients taking methotrexate,” Ms. Wood said, but the BSR moved to recommend testing patients on a stable dose every 3 months in 2017.

“Things of course changed again rapidly with COVID, with the BSR quickly updating their guidelines advising for less frequent monitoring in this patient group,” Ms. Wood said.

As a result, the North Devon Clinical Commissioning Group, which covers the hospital where Ms. Wood works, agreed to allow testing every 6 months for patients on a stable methotrexate dose. “This was across specialties, so not just rheumatology, but dermatology and gastroenterology as well,” she said.

“This provided us with a really exciting and unique opportunity to look at this patient group and see what happened,” Ms. Wood explained.

Effect of less frequent monitoring

At the meeting, Ms. Wood presented the results of an audit of 854 patients found via a search of hospital pathology records who were stable on methotrexate monotherapy for at least 12 months.

Two subanalyses were performed: One looked at patients who had changed from blood testing once every month to once every 3 months (n = 229) and the other looking at a group of 120 patients who had gone from testing once every 3 months to approximately every 5 months.

The mean age of patients was 67 for monthly testing, 69 for testing every 3 months, and 66 for testing about every 5 months, with around two-thirds of patients being of female sex.

A comparison of the number of blood tests performed to the end of April 2020 with the number performed to the end of April 2021 showed that there had mainly been a shift from testing once per month to once every 3 months, with some patients being tested in line with the revised BSR guidelines at around 5 months.

“Interestingly, a third of this group had no changed monitoring frequency despite the change in guidelines,” Ms. Wood said.

“Prepandemic, most patients [were] having monthly bloods despite BSR advice from 2017, and despite the pandemic with the updated shared care guidelines,” patients were still having blood drawn every 3 months, Ms. Wood noted. This perhaps needs further investigation and consideration to understand why recommended changes to the frequency of testing are not being adhered to.

The overall distribution of laboratory findings was similar among those who went from testing once per month to once every 3 months and from every 3 months to every 5 months. This included the distribution of neutrophils, whole blood counts, and alanine aminotransferase. There were some changes for platelets, mean cell volume, and the estimated glomerular filtration rate, but these were not clinically significant.

“Abnormal blood results aren’t common in stable methotrexate monotherapy patients,” Ms. Wood reported. “Where abnormalities did occur, it was in the context of patients being concurrently unwell and symptomatic.”
 

Time for patient-initiated testing?

There are several advantages of less frequent methotrexate monitoring, Ms. Wood said. One is the practicalities of getting to and from appointments, particularly in remote locations, such as where she works.

In addition to reducing workloads and pressure on already busy hospitals and primary care, this could have a huge environmental impact, she suggested.

Moreover, “moderate-quality evidence” supports the current monitoring frequency recommendation.

“We know that our numbers are small – we’re a small center – but our findings are consistent with much larger studies across the U.K.,” Ms. Wood said.

“We wonder whether there’s the possibility of moving towards annual monitoring with good safety netting and patient education for additional blood tests if they are unwell,” she said, adding that “now may be the time for patient-initiated methotrexate monitoring.”

Ms. Wood disclosed Janssen sponsorship for attending the BSR 2022 annual meeting.

Reducing the frequency of routine blood monitoring for methotrexate in patients with rheumatoid arthritis during the COVID-19 pandemic was associated with no adverse outcomes for patients, British researchers have found.

Similar laboratory results were recorded in patients who were switched from testing once per month to once every 3 or 5 months, Natasha Wood, a general practice trainee at North Devon District Hospital in Barnstaple, England, reported at the annual meeting of the British Society for Rheumatology.

sshepard/iStock

“Less frequent monitoring did not result in patient harm,” she said.

“There’s an increasing evidence base; we wonder whether now’s the time to reconsider our DMARD-monitoring strategy,” Ms. Wood said.
 

Changes in monitoring because of pandemic

Methotrexate monitoring is important to minimize the risk of harm to patients, and it is recommended that standard laboratory tests, such as a complete blood count, creatinine, and liver enzymes are measured regularly. Indeed, both the BSR and the American College of Rheumatology have specific recommendations on the monitoring of methotrexate and other conventional synthetic disease-modifying antirheumatic drugs (csDMARDS).

“The BSR used to advise for monthly blood tests in patients taking methotrexate,” Ms. Wood said, but the BSR moved to recommend testing patients on a stable dose every 3 months in 2017.

“Things of course changed again rapidly with COVID, with the BSR quickly updating their guidelines advising for less frequent monitoring in this patient group,” Ms. Wood said.

As a result, the North Devon Clinical Commissioning Group, which covers the hospital where Ms. Wood works, agreed to allow testing every 6 months for patients on a stable methotrexate dose. “This was across specialties, so not just rheumatology, but dermatology and gastroenterology as well,” she said.

“This provided us with a really exciting and unique opportunity to look at this patient group and see what happened,” Ms. Wood explained.

Effect of less frequent monitoring

At the meeting, Ms. Wood presented the results of an audit of 854 patients found via a search of hospital pathology records who were stable on methotrexate monotherapy for at least 12 months.

Two subanalyses were performed: One looked at patients who had changed from blood testing once every month to once every 3 months (n = 229) and the other looking at a group of 120 patients who had gone from testing once every 3 months to approximately every 5 months.

The mean age of patients was 67 for monthly testing, 69 for testing every 3 months, and 66 for testing about every 5 months, with around two-thirds of patients being of female sex.

A comparison of the number of blood tests performed to the end of April 2020 with the number performed to the end of April 2021 showed that there had mainly been a shift from testing once per month to once every 3 months, with some patients being tested in line with the revised BSR guidelines at around 5 months.

“Interestingly, a third of this group had no changed monitoring frequency despite the change in guidelines,” Ms. Wood said.

“Prepandemic, most patients [were] having monthly bloods despite BSR advice from 2017, and despite the pandemic with the updated shared care guidelines,” patients were still having blood drawn every 3 months, Ms. Wood noted. This perhaps needs further investigation and consideration to understand why recommended changes to the frequency of testing are not being adhered to.

The overall distribution of laboratory findings was similar among those who went from testing once per month to once every 3 months and from every 3 months to every 5 months. This included the distribution of neutrophils, whole blood counts, and alanine aminotransferase. There were some changes for platelets, mean cell volume, and the estimated glomerular filtration rate, but these were not clinically significant.

“Abnormal blood results aren’t common in stable methotrexate monotherapy patients,” Ms. Wood reported. “Where abnormalities did occur, it was in the context of patients being concurrently unwell and symptomatic.”
 

Time for patient-initiated testing?

There are several advantages of less frequent methotrexate monitoring, Ms. Wood said. One is the practicalities of getting to and from appointments, particularly in remote locations, such as where she works.

In addition to reducing workloads and pressure on already busy hospitals and primary care, this could have a huge environmental impact, she suggested.

Moreover, “moderate-quality evidence” supports the current monitoring frequency recommendation.

“We know that our numbers are small – we’re a small center – but our findings are consistent with much larger studies across the U.K.,” Ms. Wood said.

“We wonder whether there’s the possibility of moving towards annual monitoring with good safety netting and patient education for additional blood tests if they are unwell,” she said, adding that “now may be the time for patient-initiated methotrexate monitoring.”

Ms. Wood disclosed Janssen sponsorship for attending the BSR 2022 annual meeting.

Reducing the frequency of routine blood monitoring for methotrexate in patients with rheumatoid arthritis during the COVID-19 pandemic was associated with no adverse outcomes for patients, British researchers have found.

Similar laboratory results were recorded in patients who were switched from testing once per month to once every 3 or 5 months, Natasha Wood, a general practice trainee at North Devon District Hospital in Barnstaple, England, reported at the annual meeting of the British Society for Rheumatology.

sshepard/iStock

“Less frequent monitoring did not result in patient harm,” she said.

“There’s an increasing evidence base; we wonder whether now’s the time to reconsider our DMARD-monitoring strategy,” Ms. Wood said.
 

Changes in monitoring because of pandemic

Methotrexate monitoring is important to minimize the risk of harm to patients, and it is recommended that standard laboratory tests, such as a complete blood count, creatinine, and liver enzymes are measured regularly. Indeed, both the BSR and the American College of Rheumatology have specific recommendations on the monitoring of methotrexate and other conventional synthetic disease-modifying antirheumatic drugs (csDMARDS).

“The BSR used to advise for monthly blood tests in patients taking methotrexate,” Ms. Wood said, but the BSR moved to recommend testing patients on a stable dose every 3 months in 2017.

“Things of course changed again rapidly with COVID, with the BSR quickly updating their guidelines advising for less frequent monitoring in this patient group,” Ms. Wood said.

As a result, the North Devon Clinical Commissioning Group, which covers the hospital where Ms. Wood works, agreed to allow testing every 6 months for patients on a stable methotrexate dose. “This was across specialties, so not just rheumatology, but dermatology and gastroenterology as well,” she said.

“This provided us with a really exciting and unique opportunity to look at this patient group and see what happened,” Ms. Wood explained.

Effect of less frequent monitoring

At the meeting, Ms. Wood presented the results of an audit of 854 patients found via a search of hospital pathology records who were stable on methotrexate monotherapy for at least 12 months.

Two subanalyses were performed: One looked at patients who had changed from blood testing once every month to once every 3 months (n = 229) and the other looking at a group of 120 patients who had gone from testing once every 3 months to approximately every 5 months.

The mean age of patients was 67 for monthly testing, 69 for testing every 3 months, and 66 for testing about every 5 months, with around two-thirds of patients being of female sex.

A comparison of the number of blood tests performed to the end of April 2020 with the number performed to the end of April 2021 showed that there had mainly been a shift from testing once per month to once every 3 months, with some patients being tested in line with the revised BSR guidelines at around 5 months.

“Interestingly, a third of this group had no changed monitoring frequency despite the change in guidelines,” Ms. Wood said.

“Prepandemic, most patients [were] having monthly bloods despite BSR advice from 2017, and despite the pandemic with the updated shared care guidelines,” patients were still having blood drawn every 3 months, Ms. Wood noted. This perhaps needs further investigation and consideration to understand why recommended changes to the frequency of testing are not being adhered to.

The overall distribution of laboratory findings was similar among those who went from testing once per month to once every 3 months and from every 3 months to every 5 months. This included the distribution of neutrophils, whole blood counts, and alanine aminotransferase. There were some changes for platelets, mean cell volume, and the estimated glomerular filtration rate, but these were not clinically significant.

“Abnormal blood results aren’t common in stable methotrexate monotherapy patients,” Ms. Wood reported. “Where abnormalities did occur, it was in the context of patients being concurrently unwell and symptomatic.”
 

Time for patient-initiated testing?

There are several advantages of less frequent methotrexate monitoring, Ms. Wood said. One is the practicalities of getting to and from appointments, particularly in remote locations, such as where she works.

In addition to reducing workloads and pressure on already busy hospitals and primary care, this could have a huge environmental impact, she suggested.

Moreover, “moderate-quality evidence” supports the current monitoring frequency recommendation.

“We know that our numbers are small – we’re a small center – but our findings are consistent with much larger studies across the U.K.,” Ms. Wood said.

“We wonder whether there’s the possibility of moving towards annual monitoring with good safety netting and patient education for additional blood tests if they are unwell,” she said, adding that “now may be the time for patient-initiated methotrexate monitoring.”

Ms. Wood disclosed Janssen sponsorship for attending the BSR 2022 annual meeting.

People who are not vaccinated against a respiratory virus such as SARS-CoV-2 present a disproportionate infectious risk to those who are vaccinated, according to a mathematical modeling study.

The study, which simulated patterns of infection among vaccinated and unvaccinated populations, showed that, as the populations mixed less, attack rates decreased among vaccinated people (from 15% to 10%) and increased among unvaccinated people (from 62% to 79%). The unvaccinated increasingly became the source of infection, however.

“When the vaccinated and unvaccinated mix, indirect protection is conferred upon the unvaccinated by the buffering effect of vaccinated individuals, and by contrast, risk in the vaccinated goes up,” lead author David Fisman, MD, professor of epidemiology at the University of Toronto, told this news organization.

As the groups mix less and less, the size of the epidemic increases among the unvaccinated and decreases among the vaccinated. “But the impact of the unvaccinated on risk in the vaccinated is disproportionate to the numbers of contacts between the two groups,” said Dr. Fisman.

The study was published online in the Canadian Medical Association Journal.


 

Relative contributions to risk

The researchers used a model of a respiratory viral disease “similar to SARS-CoV-2 infection with Delta variant.” They included reproduction values to capture the dynamics of the Omicron variant, which was emerging at the time. In the study, vaccines ranged in effectiveness from 40% to 80%. The study incorporated various levels of mixing between a partially vaccinated and an unvaccinated population. The mixing ranged from random mixing to like-with-like mixing (“assortativity”). There were three possible “compartments” of people in the model: those considered susceptible to infection, those considered infected and infectious, and those considered immune because of recovery.

The model showed that, as mixing between the vaccinated and the unvaccinated populations increased, case numbers rose, “with cases in the unvaccinated subpopulation accounting for a substantial proportion of infections.” However, as mixing between the populations decreased, the final attack rate decreased among vaccinated people, but the relative “contribution of risk to vaccinated people caused by infection acquired from contact with unvaccinated people ... increased.”

When the vaccination rate was increased in the model, case numbers among the vaccinated declined “as expected, owing to indirect protective effects,” the researchers noted. But this also “further increased the relative contribution to risk in vaccinated people by those who were unvaccinated.”
 

Self-regarding risk?

The findings show that “choices made by people who forgo vaccination contribute disproportionately to risk among those who do get vaccinated,” the researchers wrote. “Although risk associated with avoiding vaccination during a virulent pandemic accrues chiefly to those who are unvaccinated, the choice of some individuals to refuse vaccination is likely to affect the health and safety of vaccinated people in a manner disproportionate to the fraction of unvaccinated people in the population.”

The fact that like-with-like mixing cannot mitigate the risk to vaccinated people “undermines the assertion that vaccine choice is best left to the individual and supports strong public actions aimed at enhancing vaccine uptake and limiting access to public spaces for unvaccinated people,” they wrote.
 

Mandates and passports

“Our model provides support for vaccine mandates and passports during epidemics, such that vaccination is required for people to take part in nonessential activities,” said Dr. Fisman. The choice to not be vaccinated against COVID-19 should not be considered “self-regarding,” he added. “Risk is self-regarding when it only impacts the person engaging in the activity. Something like smoking cigarettes (alone, without others around) creates a lot of risk over time, but if nobody is breathing your secondhand smoke, you’re only creating risk for yourself. By contrast, we regulate, in Ontario, your right to smoke in public indoor spaces such as restaurants, because once other people are around, the risk isn’t self-regarding anymore. You’re creating risk for others.”

The authors also noted that the risks created by the unvaccinated extend beyond those of infection by “creating a risk that those around them may not be able to obtain the care they need.” They recommended that considerations of equity and justice for people who do choose to be vaccinated, as well as those who choose not to be, need to be included in formulating vaccination policy.
 

Illuminating the discussion

Asked to comment on the study, Matthew Oughton, MD, assistant professor of medicine at McGill University, Montreal, said: “It is easy to dismiss a mathematical model as a series of assumptions that leads to an implausible conclusion. ... However, they can serve to illustrate and, to an extent, quantify the results of complex interactions, and this study does just that.” Dr. Oughton was not involved in the research.

During the past 2 years, the scientific press and the general press have often discussed the individual and collective effects of disease-prevention methods, including nonpharmaceutical interventions. “Models like this can help illuminate those discussions by highlighting important consequences of preventive measures,” said Dr. Oughton, who also works in the division of infectious diseases at the Jewish General Hospital, Montreal.

It’s worth noting that the authors modeled vaccine effectiveness against all infection, “rather than the generally greater and more durable effects we have seen for vaccines in prevention of severe infection,” said Dr. Oughton. He added that the authors did not include the effect of vaccination in reducing forward transmission. “Inclusion of this effect would presumably have reduced overall infectious burden in mixed populations and increased the difference between groups at lower levels of mixing between populations.”

The research was supported by a grant from the Canadian Institutes of Health Research. Dr. Fisman has served on advisory boards related to influenza and SARS-CoV-2 vaccines for Seqirus, Pfizer, AstraZeneca, and Sanofi-Pasteur Vaccines and has served as a legal expert on issues related to COVID-19 epidemiology for the Elementary Teachers Federation of Ontario and the Registered Nurses Association of Ontario. Dr. Oughton disclosed no relevant financial relationships.

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

People who are not vaccinated against a respiratory virus such as SARS-CoV-2 present a disproportionate infectious risk to those who are vaccinated, according to a mathematical modeling study.

The study, which simulated patterns of infection among vaccinated and unvaccinated populations, showed that, as the populations mixed less, attack rates decreased among vaccinated people (from 15% to 10%) and increased among unvaccinated people (from 62% to 79%). The unvaccinated increasingly became the source of infection, however.

“When the vaccinated and unvaccinated mix, indirect protection is conferred upon the unvaccinated by the buffering effect of vaccinated individuals, and by contrast, risk in the vaccinated goes up,” lead author David Fisman, MD, professor of epidemiology at the University of Toronto, told this news organization.

As the groups mix less and less, the size of the epidemic increases among the unvaccinated and decreases among the vaccinated. “But the impact of the unvaccinated on risk in the vaccinated is disproportionate to the numbers of contacts between the two groups,” said Dr. Fisman.

The study was published online in the Canadian Medical Association Journal.


 

Relative contributions to risk

The researchers used a model of a respiratory viral disease “similar to SARS-CoV-2 infection with Delta variant.” They included reproduction values to capture the dynamics of the Omicron variant, which was emerging at the time. In the study, vaccines ranged in effectiveness from 40% to 80%. The study incorporated various levels of mixing between a partially vaccinated and an unvaccinated population. The mixing ranged from random mixing to like-with-like mixing (“assortativity”). There were three possible “compartments” of people in the model: those considered susceptible to infection, those considered infected and infectious, and those considered immune because of recovery.

The model showed that, as mixing between the vaccinated and the unvaccinated populations increased, case numbers rose, “with cases in the unvaccinated subpopulation accounting for a substantial proportion of infections.” However, as mixing between the populations decreased, the final attack rate decreased among vaccinated people, but the relative “contribution of risk to vaccinated people caused by infection acquired from contact with unvaccinated people ... increased.”

When the vaccination rate was increased in the model, case numbers among the vaccinated declined “as expected, owing to indirect protective effects,” the researchers noted. But this also “further increased the relative contribution to risk in vaccinated people by those who were unvaccinated.”
 

Self-regarding risk?

The findings show that “choices made by people who forgo vaccination contribute disproportionately to risk among those who do get vaccinated,” the researchers wrote. “Although risk associated with avoiding vaccination during a virulent pandemic accrues chiefly to those who are unvaccinated, the choice of some individuals to refuse vaccination is likely to affect the health and safety of vaccinated people in a manner disproportionate to the fraction of unvaccinated people in the population.”

The fact that like-with-like mixing cannot mitigate the risk to vaccinated people “undermines the assertion that vaccine choice is best left to the individual and supports strong public actions aimed at enhancing vaccine uptake and limiting access to public spaces for unvaccinated people,” they wrote.
 

Mandates and passports

“Our model provides support for vaccine mandates and passports during epidemics, such that vaccination is required for people to take part in nonessential activities,” said Dr. Fisman. The choice to not be vaccinated against COVID-19 should not be considered “self-regarding,” he added. “Risk is self-regarding when it only impacts the person engaging in the activity. Something like smoking cigarettes (alone, without others around) creates a lot of risk over time, but if nobody is breathing your secondhand smoke, you’re only creating risk for yourself. By contrast, we regulate, in Ontario, your right to smoke in public indoor spaces such as restaurants, because once other people are around, the risk isn’t self-regarding anymore. You’re creating risk for others.”

The authors also noted that the risks created by the unvaccinated extend beyond those of infection by “creating a risk that those around them may not be able to obtain the care they need.” They recommended that considerations of equity and justice for people who do choose to be vaccinated, as well as those who choose not to be, need to be included in formulating vaccination policy.
 

Illuminating the discussion

Asked to comment on the study, Matthew Oughton, MD, assistant professor of medicine at McGill University, Montreal, said: “It is easy to dismiss a mathematical model as a series of assumptions that leads to an implausible conclusion. ... However, they can serve to illustrate and, to an extent, quantify the results of complex interactions, and this study does just that.” Dr. Oughton was not involved in the research.

During the past 2 years, the scientific press and the general press have often discussed the individual and collective effects of disease-prevention methods, including nonpharmaceutical interventions. “Models like this can help illuminate those discussions by highlighting important consequences of preventive measures,” said Dr. Oughton, who also works in the division of infectious diseases at the Jewish General Hospital, Montreal.

It’s worth noting that the authors modeled vaccine effectiveness against all infection, “rather than the generally greater and more durable effects we have seen for vaccines in prevention of severe infection,” said Dr. Oughton. He added that the authors did not include the effect of vaccination in reducing forward transmission. “Inclusion of this effect would presumably have reduced overall infectious burden in mixed populations and increased the difference between groups at lower levels of mixing between populations.”

The research was supported by a grant from the Canadian Institutes of Health Research. Dr. Fisman has served on advisory boards related to influenza and SARS-CoV-2 vaccines for Seqirus, Pfizer, AstraZeneca, and Sanofi-Pasteur Vaccines and has served as a legal expert on issues related to COVID-19 epidemiology for the Elementary Teachers Federation of Ontario and the Registered Nurses Association of Ontario. Dr. Oughton disclosed no relevant financial relationships.

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

People who are not vaccinated against a respiratory virus such as SARS-CoV-2 present a disproportionate infectious risk to those who are vaccinated, according to a mathematical modeling study.

The study, which simulated patterns of infection among vaccinated and unvaccinated populations, showed that, as the populations mixed less, attack rates decreased among vaccinated people (from 15% to 10%) and increased among unvaccinated people (from 62% to 79%). The unvaccinated increasingly became the source of infection, however.

“When the vaccinated and unvaccinated mix, indirect protection is conferred upon the unvaccinated by the buffering effect of vaccinated individuals, and by contrast, risk in the vaccinated goes up,” lead author David Fisman, MD, professor of epidemiology at the University of Toronto, told this news organization.

As the groups mix less and less, the size of the epidemic increases among the unvaccinated and decreases among the vaccinated. “But the impact of the unvaccinated on risk in the vaccinated is disproportionate to the numbers of contacts between the two groups,” said Dr. Fisman.

The study was published online in the Canadian Medical Association Journal.


 

Relative contributions to risk

The researchers used a model of a respiratory viral disease “similar to SARS-CoV-2 infection with Delta variant.” They included reproduction values to capture the dynamics of the Omicron variant, which was emerging at the time. In the study, vaccines ranged in effectiveness from 40% to 80%. The study incorporated various levels of mixing between a partially vaccinated and an unvaccinated population. The mixing ranged from random mixing to like-with-like mixing (“assortativity”). There were three possible “compartments” of people in the model: those considered susceptible to infection, those considered infected and infectious, and those considered immune because of recovery.

The model showed that, as mixing between the vaccinated and the unvaccinated populations increased, case numbers rose, “with cases in the unvaccinated subpopulation accounting for a substantial proportion of infections.” However, as mixing between the populations decreased, the final attack rate decreased among vaccinated people, but the relative “contribution of risk to vaccinated people caused by infection acquired from contact with unvaccinated people ... increased.”

When the vaccination rate was increased in the model, case numbers among the vaccinated declined “as expected, owing to indirect protective effects,” the researchers noted. But this also “further increased the relative contribution to risk in vaccinated people by those who were unvaccinated.”
 

Self-regarding risk?

The findings show that “choices made by people who forgo vaccination contribute disproportionately to risk among those who do get vaccinated,” the researchers wrote. “Although risk associated with avoiding vaccination during a virulent pandemic accrues chiefly to those who are unvaccinated, the choice of some individuals to refuse vaccination is likely to affect the health and safety of vaccinated people in a manner disproportionate to the fraction of unvaccinated people in the population.”

The fact that like-with-like mixing cannot mitigate the risk to vaccinated people “undermines the assertion that vaccine choice is best left to the individual and supports strong public actions aimed at enhancing vaccine uptake and limiting access to public spaces for unvaccinated people,” they wrote.
 

Mandates and passports

“Our model provides support for vaccine mandates and passports during epidemics, such that vaccination is required for people to take part in nonessential activities,” said Dr. Fisman. The choice to not be vaccinated against COVID-19 should not be considered “self-regarding,” he added. “Risk is self-regarding when it only impacts the person engaging in the activity. Something like smoking cigarettes (alone, without others around) creates a lot of risk over time, but if nobody is breathing your secondhand smoke, you’re only creating risk for yourself. By contrast, we regulate, in Ontario, your right to smoke in public indoor spaces such as restaurants, because once other people are around, the risk isn’t self-regarding anymore. You’re creating risk for others.”

The authors also noted that the risks created by the unvaccinated extend beyond those of infection by “creating a risk that those around them may not be able to obtain the care they need.” They recommended that considerations of equity and justice for people who do choose to be vaccinated, as well as those who choose not to be, need to be included in formulating vaccination policy.
 

Illuminating the discussion

Asked to comment on the study, Matthew Oughton, MD, assistant professor of medicine at McGill University, Montreal, said: “It is easy to dismiss a mathematical model as a series of assumptions that leads to an implausible conclusion. ... However, they can serve to illustrate and, to an extent, quantify the results of complex interactions, and this study does just that.” Dr. Oughton was not involved in the research.

During the past 2 years, the scientific press and the general press have often discussed the individual and collective effects of disease-prevention methods, including nonpharmaceutical interventions. “Models like this can help illuminate those discussions by highlighting important consequences of preventive measures,” said Dr. Oughton, who also works in the division of infectious diseases at the Jewish General Hospital, Montreal.

It’s worth noting that the authors modeled vaccine effectiveness against all infection, “rather than the generally greater and more durable effects we have seen for vaccines in prevention of severe infection,” said Dr. Oughton. He added that the authors did not include the effect of vaccination in reducing forward transmission. “Inclusion of this effect would presumably have reduced overall infectious burden in mixed populations and increased the difference between groups at lower levels of mixing between populations.”

The research was supported by a grant from the Canadian Institutes of Health Research. Dr. Fisman has served on advisory boards related to influenza and SARS-CoV-2 vaccines for Seqirus, Pfizer, AstraZeneca, and Sanofi-Pasteur Vaccines and has served as a legal expert on issues related to COVID-19 epidemiology for the Elementary Teachers Federation of Ontario and the Registered Nurses Association of Ontario. Dr. Oughton disclosed no relevant financial relationships.

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

Coronavirus-related hospital admissions and deaths in the United States are projected to increase over the next four weeks, according to a national forecast used by the Centers for Disease Control and Prevention.

The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.

The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.

In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.

Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.

The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.

On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.

Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.

The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.

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

Coronavirus-related hospital admissions and deaths in the United States are projected to increase over the next four weeks, according to a national forecast used by the Centers for Disease Control and Prevention.

The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.

The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.

In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.

Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.

The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.

On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.

Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.

The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.

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

Coronavirus-related hospital admissions and deaths in the United States are projected to increase over the next four weeks, according to a national forecast used by the Centers for Disease Control and Prevention.

The national model also predicts that about 5,000 deaths will occur over the next two weeks, with Ohio, New Jersey, and New York projected to see the largest totals of daily deaths in upcoming weeks.

The numbers follow several weeks of steady increases in infections across the country. More than 67,000 new cases are being reported daily, according to the data tracker from The New York Times, marking a 59% increase in the past two weeks.

In the Northeast, infection rates have risen by nearly 65%. In the New York and New Jersey region, infection rates are up about 55% in the past two weeks.

Hospitalizations have already begun to climb as well, with about 19,000 COVID-19 patients hospitalized nationwide and 1,725 in intensive care, according to the latest data from the Department of Health and Human Services. In the last week, hospital admissions have jumped by 20%, and emergency department visits are up by 18%.

The CDC forecast shows that 42 states and territories will see increases in hospital admissions during the next two weeks. Florida, Minnesota, New York, and Wisconsin will see some of the largest increases.

On average, more than 2,200 COVID-19 patients are entering the hospital each day, which has increased about 20% in the last week, according to ABC News. This also marks the highest number of COVID-19 patients needing hospital care since mid-March.

Public health officials have cited several factors for the increase in cases, such as states lifting mask mandates and other safety restrictions, ABC News reported. Highly contagious Omicron subvariants, such as BA.2 and BA.2.12.1, continue to spread in the United States and escape immunity from previous infections.

The BA.2 subvariant accounts for 62% of new national cases, according to the latest CDC data. The BA.2.12.1 subvariant makes up about 36% of new cases across the United States but 62% in the New York area.

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

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; [email protected]

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; [email protected]

Normal blood pressure (BP) is defined as systolic BP (SBP) < 120 mm Hg and diastolic BP (DBP) < 80 mm Hg.¹ The thresholds for hypertension (HTN) are shown in TABLE 1.¹ These thresholds must be met on at least 2 separate occasions to merit a diagnosis of HTN.¹

Given the high prevalence of HTN and its associated comorbidities, the US Preventive Services Task Force (USPSTF) recently reaffirmed its recommendation that every adult be screened for HTN, regardless of risk factors.² Patients 40 years of age and older and those with risk factors (obesity, family history of HTN, diabetes) should have their BP checked at least annually. Individuals ages 18 to 39 years without risk factors who are initially normotensive should be rescreened within 3 to 5 years.²

Patients are most commonly screened for HTN in the outpatient setting. However, office BP measurements may be inaccurate and are of limited diagnostic utility when taken as a single reading.^1,3,4 As will be described later, office BP measurements are subject to multiple sources of error that can result in a mean underestimation of 24  mm Hg to a mean overestimation of 33 mm Hg for SBP, and a mean underestimation of 14  mm Hg to a mean overestimation of 23 mm Hg for DBP.⁴

Differences to this degree between true BP and measured BP can have important implications for the diagnosis, surveillance, and management of HTN. To diminish this potential for error, the American Heart Association HTN guideline and USPSTF recommendation advise clinicians to obtain out-of-office BP measurements to confirm a diagnosis of HTN before initiating treatment.^1,2 The preferred methods for out-of-office BP assessment are home BP monitoring (HBPM) and 24-hour ambulatory BP monitoring (ABPM).

Limitations of office BP measurement

Multiple sources of error can lead to wide variability in the measurement of office BP, whether taken via the traditional sphygmomanometer auscultatory approach or with an oscillometric monitor.^1,4 Measurement error can be patient related (eg, talking during the reading, or eating or using tobacco prior to measurement), device related (eg, device has not been calibrated or validated), or procedure related (eg, miscuffing, improper patient positioning).

Although use of validated oscillometric monitors eliminates some sources of error such as terminal digit bias, rapid cuff deflation, and missed Korotkoff sounds, their use does not eliminate other sources of error. For example, a patient’s use of tobacco 30 to 60 minutes prior to measurement can raise SBP by 2.8 to 25 mm Hg and DBP 2 to 18 mm Hg.⁴ Having a full bladder can elevate SBP by 4.2 to 33 mm Hg and DBP by 2.8 to 18.5 mm Hg.⁴ If the patient is talking during measurement, is crossing one leg over the opposite knee, or has an unsupported arm below the level of the heart, SBP and DBP can rise, respectively, by an estimated mean 2 to 23 mm Hg and 2 to 14 mm Hg.⁴

Although many sources of BP measurement error can be reduced or eliminated through standardization of technique across office staff, some sources of inaccuracy will persist. Even if all variables are optimized, relying solely on office BP monitoring will still misclassify BP phenotypes, which require out-of-office BP assessments.^1,3FIGURE 1 reviews key tips for maximizing the accuracy of BP measurement, regardless of where the measurement is done.

Continue to: Automated office BP

Automated office BP (AOBP) lessens some of the limitations inherent with the traditional sphygmomanometer auscultatory and single-measurement oscillometric devices. AOBP combines oscillometric technology with the capacity to record multiple BP readings within a single activation, thereby providing an average of these readings.¹ The total time required for AOBP is 4 to 6 minutes, including a brief rest period before the measurement starts. Studies have reported comparable readings between staff-attended and unattended AOBP, which is an encouraging way to eliminate some measurement error (eg, talking with the patient) and to improve efficiency.^5,6

Waiting several minutes per patient to record BP may not be practical in a busy office setting and may require an alteration of workflow. There is a paucity of literature evaluating practice realities, which makes it difficult to know how many patients are getting their BP checked in this manner. Several studies have shown that BP measured with AOBP is closer to awake out-of-office BP as measured with ABPM (discussed in a bit),^5-8 largely through mitigation of white-coat effect. Canada now recommends AOBP as the preferred method for diagnosing HTN and monitoring BP.⁹

Home blood pressure monitoring

HBPM refers to individuals measuring their own BP at home. It is important to remember this definition, as the term is sometimes applied to a patient’s BP measured at home by an observer or to an individual taking their own BP outside of the home (kiosk, pharmacy, at work). The short-term reproducibility of mean BP with HBPM is high. The test-retest correlations of HBPM range from 0.70 to 0.84 mm Hg for mean SBP, and from 0.57 to 0.83 mm Hg for mean DBP.^10-13 In contrast to 24-hour ABPM, HBPM is better tolerated, cheaper, and more widely available.^14,15

There is strong evidence that HBPM adds value over and above office measurements in predicting end-organ damage and cardiovascular disease (CVD) outcomes, and it has a stronger relationship with CVD risk than office BP.¹ Compared with office BP measurement, HBPM is a better predictor of echocardiographic left ventricular mass index, urinary albumin-to-creatinine ratio, proteinuria, silent cerebrovascular disease, nonfatal cardiovascular outcomes, cardiovascular mortality, and all-cause mortality.^15,16 There is no strong evidence demonstrating the superiority of HBPM over ABPM, or vice versa, for predicting CVD events or mortality.¹⁷ Both ABPM and HBPM have important roles in out-of-office monitoring (FIGURE 2³).

Clinical indications for HBPM

HBPM can facilitate diagnosis of white-coat HTN or effect (if already on BP-lowering medication) as well as masked uncontrolled HTN and masked HTN. Importantly, masked HTN is associated with nearly the same risk of target organ damage and cardiovascular events as sustained HTN. In one meta-analysis the overall adjusted hazard ratio for CVD events was 2.00 (95% CI, 1.58-2.52) for masked HTN and 2.28 (95% CI, 1.87-2.78) for sustained HTN, compared with normotensive individuals.¹⁸ Other studies support these results, demonstrating that masked HTN confers risk similar to sustained HTN.^19,20

Even treated subjects with masked uncontrolled HTN (normal office and high home BP) have higher CVD risk, likely due to undertreatment given lower BP in the office setting. Among 1451 treated patients in a large cohort study who were followed for a median of 8.3 years, CVD was higher in those with masked uncontrolled HTN (adjusted hazard ratio = 1.76; 95% CI, 1.23-2.53) compared to treated controlled patients (normal office and home BP).²¹

Home BP monitoring can reveal masked hypertension, which confers risk for endorgan damage similar to that of sustained hypertension.

HBPM also can be used to monitor BP levels over time, to increase patient involvement in chronic disease management, and to improve adherence with medications. Since 2008, several meta-analyses have been published showing improved BP control when HBPM is combined with other interventions and patient education.^22-25 Particularly relevant in the age of increased telehealth, several meta-analyses demonstrate improvement in BP control when HBPM is combined with web- or phone-based support, systematic medication titration, patient education, and provider counseling.^22-25 A comprehensive systematic review found HBPM with this kind of ongoing support (compared with usual care) led to clinic SBP reductions of 3.2 mm Hg (95% CI, 1.6-4.9) at 12 months.²²

Continue to: HBPM nuts and bolts

When using HBPM to obtain a BP average either for confirming a diagnosis or assessing HTN control, patients should be instructed to record their BP measurements twice in the morning and twice at night for a minimum of 3 days (ie, 12 readings).^26,27 For each monitoring period, both SBP and DBP readings should be recorded, although protocols differ as to whether to discard the initial reading of each day, or the entire first day of readings.^26-29 Consecutive days of monitoring are preferred, although nonconsecutive days also are likely to provide valid data. Once BP stabilizes, monitoring 1 to 3 days a week is likely sufficient.

Most guidelines cite a mean BP of ≥ 135/85 mm Hg as the indication of high BP on HBPM.^1,28,29 This value corresponds to an office BP average of 140/90 mm Hg. TABLE 2¹ shows the comparison of home, ambulatory, and office BP thresholds.

Device selection and validation

As with any BP device, validation and proper technique are important. Recommend only upper-arm cuff devices that have passed validation protocols.³⁰ To eliminate the burden on patients to accurately record and store their BP readings, and to eliminate this step as a source of bias, additionally recommend devices with built-in memory. Although easy-to-use wrist and finger monitors have become popular, there are important limitations in terms of accurate positioning and a lack of validated protocols.^31,32

The brachial artery is still the recommended measurement location, unless otherwise precluded due to arm size (the largest size for most validated upper-arm cuffs is 42 cm), patient discomfort, medical contraindication (eg, lymphedema), or immobility (eg, due to injury). Arm size limitation is particularly important as obesity rates continue to rise. Data from the National Health and Nutrition Examination Survey indicate that 52% of men and 38% of women with HTN need a different cuff size than the US standard.³³ If the brachial artery is not an option, there are no definitive data to recommend finger over wrist devices, as both are limited by lack of validated protocols.

The website www.stridebp.org maintains a current list of validated and preferred BP devices, and is supported by the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. There are more than 4000 devices on the global market, but only 8% have been validated according to StrideBP.

Advances in HBPM that offset previous limitations

The usefulness of HBPM depends on patient factors such as a commitment to monitoring, applying standardized technique, and accurately recording measurements. Discuss these matters with patients before recommending HBPM. Until recently, HBPM devices could not measure BP during sleep. However, a device that assesses BP during sleep has now come on the US market, with preliminary data suggesting the BP measurements are similar to those obtained with ABPM.³⁴ Advances in device memory and data storage and increased availability of electronic health record connection continue to improve the standardization and reliability of HBPM. In fact, there is a growing list of electronic health portals that can be synced with apps for direct transfer of HBPM data.

Ambulatory blood pressure monitoring

ABPM involves wearing a small device connected to an arm BP cuff that measures BP at pre-programmed intervals over a 24-hour period, during sleep and wakefulness. ABPM is the standard against which HBPM and office BP are compared.^1-3

Continue to: Clinical indications for ABPM

Compared with office-based BP measurements, ABPM has a stronger positive correlation with clinical CVD outcomes and HTN-related organ damage.¹ ABPM has the advantage of being able to provide a large number of measurements over the course of a patient’s daily activities, including sleep. It is useful to evaluate for a wide spectrum of hypertensive or hypotensive patterns, including nocturnal, postprandial, and drug-related patterns. ABPM also is used to assess for white-coat HTN and masked HTN.¹

Among these BP phenotypes, an estimated 15% to 30% of adults in the United States exhibit white-coat HTN.¹ Most evidence suggests that white-coat HTN confers similar cardiovascular risk as normotension, and it therefore does not require treatment.³⁵ Confirming this diagnosis saves the individual and the health care system the cost of unnecessary diagnosis and treatment.

A home monitor that assesses sleep BP is available in some US markets, with data showing its sleep measurements are similar to those obtained with ambulatory BP monitoring.

One cost-effectiveness study using ABPM for annual screening with subsequent treatment for those confirmed to be hypertensive found that ABPM reduced treatment-years by correctly identifying white-coat HTN, and also delayed treatment for those who would eventually develop HTN with advancing age.³⁶ The estimates in savings were 3% to 14% for total cost of care for hypertension and 10% to 23% reduction in treatment days.³⁶ An Australian study showed similar cost reductions.³⁷ A more recent analysis demonstrated that compared with clinic BP measurement alone, incorporation of ABPM is associated with lifetime cost-savings ranging from $77 to $5013, depending on the age and sex of the patients modeled.³⁸

ABPM can also be used to rule out white-coat effect in patients being evaluated for resistant HTN. Several studies demonstrate that among patients with apparent resistant HTN, approximately one-third have controlled BP when assessed by ABPM.^39-41 Thus, it is recommended to conduct an out-of-office BP assessment in patients with apparent resistant HTN prior to adding another medication.⁴¹Twelve percent of US adults have masked HTN.⁴² As described earlier, these patients, unrecognized without out-of-office BP assessment, are twice as likely to experience a CVD event compared with normotensive patients.^1,42,43

ABPM nuts and bolts

ABPM devices are typically worn for 24 hours and with little interruption to daily routines. Prior to BP capture, the device will alert the patient to ensure the patient’s arm can be held still while the BP measurement is being captured.⁴⁴ At the completion of 24 hours, specific software uses the stored data to calculate the BP and heart rate averages, as well as minimums and maximums throughout the monitoring period. Clinical decision-making should be driven by the average BP measurements during times of sleep and wakefulness.^1,14,44FIGURE 3 is an example of output from an ABPM session. TABLE 3^1,44 offers a comparison of HBPM and ABPM.

Limitations of ABPM

While ABPM has been designed to be almost effortless to use, some may find it inconvenient to wear. The repeated cuff inflations can cause discomfort or bruising, and the device can interfere with sleep.⁴⁵ Inconsistent or incorrect wear of ABPM can diminish the quality of BP measurements, which can potentially affect interpretation and subsequent clinical decision-making. Therefore, consider the likelihood of correct and complete usage before ordering ABPM for your patient. Such deliberation is particularly relevant when there is concern for BP phenotypes such as nocturnal nondipping (failure of BP to fall appropriately during sleep) and postprandial HTN and hypotension.

Conduct out-of-office BP assessment of apparent resistant hypertension before adding another medication.

Trained personnel are needed to oversee coordination of the ABPM service within the clinic and to educate patients about proper wear. Additionally, ABPM has not been widely used in US clinical practices to date, in part because this diagnostic strategy is not favorably reimbursed. Based on geographic region, Medicare currently pays between $56 and $122 per 24-hour ABPM session, and only for suspected white-coat HTN.³⁸ Discrepancies remain between commercial and Medicaid/Medicare coverage.⁴⁴

Continue to: Other modes of monitoring BP

Other modes of monitoring BP

The COVID pandemic has changed health care in many ways, including the frequency of in-person visits. As clinics come to rely more on virtual visits and telehealth, accurate monitoring of out-of-office BP has become more important. Kiosks and smart technology offer the opportunity to supplement traditional in-office BP readings. Kiosks are commonly found in pharmacies and grocery stores. These stations facilitate BP monitoring, as long as the device is appropriately validated and calibrated. Unfortunately, most kiosks have only one cuff size that is too small for many US adults, and some do not have a back support.^46,47 Additionally, despite US Food and Drug Administration clearance, many kiosks do not have validated protocols, and the reproducibility of kiosk-measured BP is questionable.^46,47

Mobile health technology is increasingly being examined as an effective means of providing health information, support, and management in chronic disease. Smartphone technology, wearable sensors, and cuffless BP monitors offer promise for providing BP data in more convenient ways. However, as with kiosk devices, very few of these have been validated, and several have been shown to have poor accuracy compared with oscillometric devices.^48-50 For these reasons, kiosk and smart technology for BP monitoring are not recommended at this time, unless no alternatives are available to the patient.

CORRESPONDENCE
Anthony J. Viera, MD, Department of Family Medicine and Community Health, Duke University School of Medicine, 2200 West Main Street, Suite 400, Durham, NC 27705; [email protected]

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

The Diagnosis: Calciphylaxis

Histopathology revealed epidermal and dermal necrosis, a perivascular neutrophilic infiltrate, and scattered microcalcifications within small- and medium-sized subcutaneous vessels, consistent with a diagnosis of calciphylaxis (Figure). Calciphylaxis (also known as calcific uremic arteriolopathy) is a rare, severe, and often fatal vasculopathy that predominately occurs in patients with end-stage renal failure.¹ The pathogenesis of calciphylaxis remains poorly understood; however, it generally is thought that an imbalance in calcium homeostasis in susceptible hosts results in the precipitation of calcium phosphate within vessel walls leading to endothelial damage with subsequent thrombotic vasculopathy and ischemic tissue damage. Acquired and congenital hypercoagulable states have been implicated in the pathogenesis of calciphylaxis.²

Treatment of calciphylaxis is directed at normalizing abnormal calcium metabolism; removing possible exacerbating agents, such as warfarin, systemic corticosteroids, calcium, and iron; and transitioning patients with end-stage renal disease to hemodialysis, if not already initiated. The treatment approach is multifaceted, and numerous therapies usually are attempted simultaneously. Vitamin K supplementation, low-calcium dialysate, non–calcium carbonate phosphate binders, cinacalcet, becaplermin, bisphosphonates, hyperbaric oxygen, and intravenous sodium thiosulfate all have been utilized with some success. Currently, intravenous sodium thiosulfate is the mainstay therapy for the treatment of calciphylaxis.² Although the mechanism of sodium thiosulfate is not entirely understood, it is known to have anticalcification, vasodilatory, and antioxidant properties.

Retiform purpura clinically is characterized by reticulated, branching, purpuric skin lesions. It occurs following vascular insult by way of vessel lumen occlusion (thrombotic vasculopathy) and less frequently by vessel wall inflammation (vasculitis). The differential diagnosis for retiform purpura includes various causes of microvascular occlusion, including hypercoagulable states and type I cryoglobulinemia, calciphylaxis, infections, autoimmune vasculitic conditions, and embolic causes.³

Cutaneous disease in individuals with antiphospholipid antibodies may present similarly with retiform purpura in the form of necrotizing livedo reticularis, leg ulcers, or widespread cutaneous necrosis. Histopathologic findings include vascular thrombi with partial or complete obstruction of the small- to medium-sized arteries at the dermoepidermal junction, often in the absence of an inflammatory infiltrate.⁴ True vasculitis is not typical of antiphospholipid syndrome.

Medium vessel vasculitides, such as polyarteritis nodosa, clinically present with livedo reticularis, subcutaneous nodules, and tissue necrosis. Dermatopathologic evaluation of a medium-sized vessel vasculitis would demonstrate a neutrophilic vasculitis involving vessels within the deep dermis and septa of subcutaneous fat.⁵ Tissue sampling should be deep and wide enough to visualize the pathology, as shallow biopsies may show intraluminal thrombi of the superficial dermal plexus only, while a narrow specimen may result in falsenegative findings due to the focal nature of vessel involvement in conditions such as polyarteritis nodosa.

Type I cryoglobulinemia often is a manifestation of plasma cell dyscrasia and commonly presents with Raynaud phenomenon, livedo reticularis, and acrocyanosis of helices⁶ ; pathology demonstrates vessel occlusion and erythrocyte extravasation. In contrast, types II and III, also known as mixed cryoglobulinemia, are associated with hepatitis C and autoimmune connective tissue disease. They clinically present as purpuric plaques and nodules that have a propensity to vesiculate and ulcerate.⁷ Histopathologically, features of leukocytoclastic vasculitis are seen, and direct immunofluorescence demonstrates perivascular granular deposits consisting predominantly of IgM and C3 in the papillary dermis.⁸

Warfarin therapy, particularly in high initial doses, can induce lesions of cutaneous necrosis, which clinically may resemble the appearance of calciphylaxis. Warfarininduced skin necrosis typically occurs 3 to 5 days after the initiation of therapy and is the result of a temporary prothrombotic state.9 The half-life of antithrombotic protein C is shorter than vitamin K–dependent prothrombotic factors II, X, and IX. Early in warfarin treatment, an acquired state of reduced protein C level exists, which can lead to vessel thrombosis and subsequent cutaneous necrosis. Treatment of warfarin-induced skin necrosis involves cessation of warfarin, supplementation with vitamin K to reverse the effects of warfarin, and the initiation of heparin or low-molecular-weight heparin.⁹

Physician assistants (PAs) entered dermatology at a higher rate than all other specialties combined from 2013 to 2018, based on national certification data.

Dermatology added PAs at a mean rate of 11.6% annually over that 6-year period, compared with a mean of 7.8% for all other specialties (P <.001), as the National Commission on Certification of Physician Assistants (NCCPA) tallied 2,324 working in dermatology and 64,490 in all other specialties in 2013 and 3,938/94,616, respectively, in 2018, Justin D. Arnold, MD, of the University of California, Irvine, and associates reported in JAMA Dermatology.

“There is, however, a lack of racial and ethnic diversity within the dermatology PA workforce,” they noted. A detailed comparison using the 2018 data showed that only 1.6% of dermatology PAs identified as Black, compared with 3.7% of those in all other specialties (P <.001), although “similar rates of Hispanic ethnicity were observed” in dermatology PAs (6.0%) and PAs in other fields (6.5%), the investigators added.

That was not the case for women in the profession, as 82% of PAs in dermatology were female in 2018, compared with 67% in the other specialties. Dermatology PAs also were significantly more likely to work in office-based practices than their nondermatology peers (93% vs. 37%, P < .001) and to reside in metropolitan areas (95% vs. 92%, P < .001), Dr. Arnold and associates said in the research letter.

The dermatology PAs also were more likely to work part time (30 or fewer hours per week) than those outside dermatology, 19.1% vs. 12.9% (P < .001). Despite that, the dermatology PAs reported seeing more patients per week (a mean of 119) than those in all of the other specialties (a mean of 71), the investigators said.

The total number of certified PAs was over 131,000 in 2018, but about 25% had not selected a principal specialty in their PA Professional Profiles and were not included in the study, they explained.

“Although this study did not assess the reasons for the substantial increase of dermatology PAs, numerous factors, such as a potential physician shortage or the expansion of private equity–owned practices, may contribute to the accelerating use of PAs within the field,” they wrote.

Physician assistants (PAs) entered dermatology at a higher rate than all other specialties combined from 2013 to 2018, based on national certification data.

Dermatology added PAs at a mean rate of 11.6% annually over that 6-year period, compared with a mean of 7.8% for all other specialties (P <.001), as the National Commission on Certification of Physician Assistants (NCCPA) tallied 2,324 working in dermatology and 64,490 in all other specialties in 2013 and 3,938/94,616, respectively, in 2018, Justin D. Arnold, MD, of the University of California, Irvine, and associates reported in JAMA Dermatology.

“There is, however, a lack of racial and ethnic diversity within the dermatology PA workforce,” they noted. A detailed comparison using the 2018 data showed that only 1.6% of dermatology PAs identified as Black, compared with 3.7% of those in all other specialties (P <.001), although “similar rates of Hispanic ethnicity were observed” in dermatology PAs (6.0%) and PAs in other fields (6.5%), the investigators added.

That was not the case for women in the profession, as 82% of PAs in dermatology were female in 2018, compared with 67% in the other specialties. Dermatology PAs also were significantly more likely to work in office-based practices than their nondermatology peers (93% vs. 37%, P < .001) and to reside in metropolitan areas (95% vs. 92%, P < .001), Dr. Arnold and associates said in the research letter.

The dermatology PAs also were more likely to work part time (30 or fewer hours per week) than those outside dermatology, 19.1% vs. 12.9% (P < .001). Despite that, the dermatology PAs reported seeing more patients per week (a mean of 119) than those in all of the other specialties (a mean of 71), the investigators said.

The total number of certified PAs was over 131,000 in 2018, but about 25% had not selected a principal specialty in their PA Professional Profiles and were not included in the study, they explained.

“Although this study did not assess the reasons for the substantial increase of dermatology PAs, numerous factors, such as a potential physician shortage or the expansion of private equity–owned practices, may contribute to the accelerating use of PAs within the field,” they wrote.

Physician assistants (PAs) entered dermatology at a higher rate than all other specialties combined from 2013 to 2018, based on national certification data.

Dermatology added PAs at a mean rate of 11.6% annually over that 6-year period, compared with a mean of 7.8% for all other specialties (P <.001), as the National Commission on Certification of Physician Assistants (NCCPA) tallied 2,324 working in dermatology and 64,490 in all other specialties in 2013 and 3,938/94,616, respectively, in 2018, Justin D. Arnold, MD, of the University of California, Irvine, and associates reported in JAMA Dermatology.

“There is, however, a lack of racial and ethnic diversity within the dermatology PA workforce,” they noted. A detailed comparison using the 2018 data showed that only 1.6% of dermatology PAs identified as Black, compared with 3.7% of those in all other specialties (P <.001), although “similar rates of Hispanic ethnicity were observed” in dermatology PAs (6.0%) and PAs in other fields (6.5%), the investigators added.

That was not the case for women in the profession, as 82% of PAs in dermatology were female in 2018, compared with 67% in the other specialties. Dermatology PAs also were significantly more likely to work in office-based practices than their nondermatology peers (93% vs. 37%, P < .001) and to reside in metropolitan areas (95% vs. 92%, P < .001), Dr. Arnold and associates said in the research letter.

The dermatology PAs also were more likely to work part time (30 or fewer hours per week) than those outside dermatology, 19.1% vs. 12.9% (P < .001). Despite that, the dermatology PAs reported seeing more patients per week (a mean of 119) than those in all of the other specialties (a mean of 71), the investigators said.

The total number of certified PAs was over 131,000 in 2018, but about 25% had not selected a principal specialty in their PA Professional Profiles and were not included in the study, they explained.

“Although this study did not assess the reasons for the substantial increase of dermatology PAs, numerous factors, such as a potential physician shortage or the expansion of private equity–owned practices, may contribute to the accelerating use of PAs within the field,” they wrote.

A mutation in a gene involved in chromatin remodeling is associated with aggressive melanoma, according to a new study that combined in vitro and animal model data.

The gene, ARID2, is a part of the switch/sucrose nonfermentable (SWI/SNF) complex, which maneuvers cellular structures called nucleosomes to make cellular DNA accessible. About 20% of human cancers have a mutation within the SWI/SNF complex.

In the new study, published in Cell Reports, researchers reported that the ARID2 subunit was mutated in about 13% of melanoma patients identified through the Cancer Genome Atlas.

ARID2 mutations have been found in early melanoma lesions, which the authors suggested may play a role in early cancer cell dissemination. Other studies have shown SWI/SNF mutations, including ARID2 mutations, in melanoma metastases, especially the brain.

The researchers also found an up-regulation of synaptic pathways in melanoma cells as well as the Cancer Genome Atlas, which also suggests a potential role of ARID2 loss in metastasis or targeting the brain, since synaptic activation in cancer cells has been shown elsewhere to influence cell migration and survival in the brain.

“We look forward to future studies that investigate the role of the PBAF complex ... in order to better tailor treatments for melanoma patients,” wrote the study authors, who were led by Emily Bernstein, PhD, a professor in oncological sciences with the Icahn School of Medicine at Mount Sinai, New York.

The SWI/SNF complex includes a subcomplex that targets specific DNA sequences or chromatin reader domains. There are multiple versions of the targeting subcomplex, but two of the most frequently occurring are BAF and PBAF. The most commonly mutated subunit in melanoma is ARID2, which is part of PBAF, and contains an AT-rich region responsible for non–sequence-specific DNA interactions. There is evidence that it plays a role in tumor suppression. In mouse tumors, depletion of ARID2 is associated with increased sensitivity to immune checkpoint inhibition and destruction by T cells.

To better understand the role of ARID2 in tumor suppression, the researchers used CRISPR-Cas9 to create ARID2 deficiency in a known human metastatic melanoma cell line. They found there was reduced chromatin accessibility and accompanying gene expression among some PBAF and shared BAF-PBAF–occupied regions. There was also increased chromatin accessibility and gene expression in BAF-occupied regions, and these changes were associated with tumor aggression. In mice, they led to metastasis of distal organs.

This mechanism appears to be conserved between different melanoma cell lines, but deregulated transcriptional targets were different depending on the dominant transcription factors in the cell line. That suggests that the effect of ARID2 mutation or loss may be different depending on the stage of melanoma progression or level of invasiveness. “As melanoma comprises transcriptionally distinct, heterogeneous cell populations, we envision future studies utilizing single-cell methodologies to better understand the nuanced effects of ARID2 loss within subpopulations of cells in human melanoma tumors,” the authors wrote.

The study is limited by the fact that not all ARID2 mutations lead to complete loss of protein, and may lead instead to aberrant complexes.

The study was funded by the National Institutes of Health.

A mutation in a gene involved in chromatin remodeling is associated with aggressive melanoma, according to a new study that combined in vitro and animal model data.

The gene, ARID2, is a part of the switch/sucrose nonfermentable (SWI/SNF) complex, which maneuvers cellular structures called nucleosomes to make cellular DNA accessible. About 20% of human cancers have a mutation within the SWI/SNF complex.

In the new study, published in Cell Reports, researchers reported that the ARID2 subunit was mutated in about 13% of melanoma patients identified through the Cancer Genome Atlas.

ARID2 mutations have been found in early melanoma lesions, which the authors suggested may play a role in early cancer cell dissemination. Other studies have shown SWI/SNF mutations, including ARID2 mutations, in melanoma metastases, especially the brain.

The researchers also found an up-regulation of synaptic pathways in melanoma cells as well as the Cancer Genome Atlas, which also suggests a potential role of ARID2 loss in metastasis or targeting the brain, since synaptic activation in cancer cells has been shown elsewhere to influence cell migration and survival in the brain.

“We look forward to future studies that investigate the role of the PBAF complex ... in order to better tailor treatments for melanoma patients,” wrote the study authors, who were led by Emily Bernstein, PhD, a professor in oncological sciences with the Icahn School of Medicine at Mount Sinai, New York.

The SWI/SNF complex includes a subcomplex that targets specific DNA sequences or chromatin reader domains. There are multiple versions of the targeting subcomplex, but two of the most frequently occurring are BAF and PBAF. The most commonly mutated subunit in melanoma is ARID2, which is part of PBAF, and contains an AT-rich region responsible for non–sequence-specific DNA interactions. There is evidence that it plays a role in tumor suppression. In mouse tumors, depletion of ARID2 is associated with increased sensitivity to immune checkpoint inhibition and destruction by T cells.

To better understand the role of ARID2 in tumor suppression, the researchers used CRISPR-Cas9 to create ARID2 deficiency in a known human metastatic melanoma cell line. They found there was reduced chromatin accessibility and accompanying gene expression among some PBAF and shared BAF-PBAF–occupied regions. There was also increased chromatin accessibility and gene expression in BAF-occupied regions, and these changes were associated with tumor aggression. In mice, they led to metastasis of distal organs.

This mechanism appears to be conserved between different melanoma cell lines, but deregulated transcriptional targets were different depending on the dominant transcription factors in the cell line. That suggests that the effect of ARID2 mutation or loss may be different depending on the stage of melanoma progression or level of invasiveness. “As melanoma comprises transcriptionally distinct, heterogeneous cell populations, we envision future studies utilizing single-cell methodologies to better understand the nuanced effects of ARID2 loss within subpopulations of cells in human melanoma tumors,” the authors wrote.

The study is limited by the fact that not all ARID2 mutations lead to complete loss of protein, and may lead instead to aberrant complexes.

The study was funded by the National Institutes of Health.

A mutation in a gene involved in chromatin remodeling is associated with aggressive melanoma, according to a new study that combined in vitro and animal model data.

The gene, ARID2, is a part of the switch/sucrose nonfermentable (SWI/SNF) complex, which maneuvers cellular structures called nucleosomes to make cellular DNA accessible. About 20% of human cancers have a mutation within the SWI/SNF complex.

In the new study, published in Cell Reports, researchers reported that the ARID2 subunit was mutated in about 13% of melanoma patients identified through the Cancer Genome Atlas.

ARID2 mutations have been found in early melanoma lesions, which the authors suggested may play a role in early cancer cell dissemination. Other studies have shown SWI/SNF mutations, including ARID2 mutations, in melanoma metastases, especially the brain.

The researchers also found an up-regulation of synaptic pathways in melanoma cells as well as the Cancer Genome Atlas, which also suggests a potential role of ARID2 loss in metastasis or targeting the brain, since synaptic activation in cancer cells has been shown elsewhere to influence cell migration and survival in the brain.

“We look forward to future studies that investigate the role of the PBAF complex ... in order to better tailor treatments for melanoma patients,” wrote the study authors, who were led by Emily Bernstein, PhD, a professor in oncological sciences with the Icahn School of Medicine at Mount Sinai, New York.

The SWI/SNF complex includes a subcomplex that targets specific DNA sequences or chromatin reader domains. There are multiple versions of the targeting subcomplex, but two of the most frequently occurring are BAF and PBAF. The most commonly mutated subunit in melanoma is ARID2, which is part of PBAF, and contains an AT-rich region responsible for non–sequence-specific DNA interactions. There is evidence that it plays a role in tumor suppression. In mouse tumors, depletion of ARID2 is associated with increased sensitivity to immune checkpoint inhibition and destruction by T cells.

To better understand the role of ARID2 in tumor suppression, the researchers used CRISPR-Cas9 to create ARID2 deficiency in a known human metastatic melanoma cell line. They found there was reduced chromatin accessibility and accompanying gene expression among some PBAF and shared BAF-PBAF–occupied regions. There was also increased chromatin accessibility and gene expression in BAF-occupied regions, and these changes were associated with tumor aggression. In mice, they led to metastasis of distal organs.

This mechanism appears to be conserved between different melanoma cell lines, but deregulated transcriptional targets were different depending on the dominant transcription factors in the cell line. That suggests that the effect of ARID2 mutation or loss may be different depending on the stage of melanoma progression or level of invasiveness. “As melanoma comprises transcriptionally distinct, heterogeneous cell populations, we envision future studies utilizing single-cell methodologies to better understand the nuanced effects of ARID2 loss within subpopulations of cells in human melanoma tumors,” the authors wrote.

The study is limited by the fact that not all ARID2 mutations lead to complete loss of protein, and may lead instead to aberrant complexes.

The study was funded by the National Institutes of Health.

Concerns about the side effects of topical corticosteroids continue to be a source of anxiety for parents of children with atopic dermatitis (AD), leading some medical providers to prescribe weaker products, Nanette B. Silverberg, MD, said at the Revolutionizing Atopic Dermatitis meeting.

Up to 40% of parents of children with chronic AD cite anxiety surrounding corticosteroids, according to Dr. Silverberg, chief of pediatric dermatology at the Mount Sinai Health System, New York.

When the potential for adverse events are explained to parents who are anxious about a drug, “they take it in a different way than other individuals,” noted Dr. Silverberg, clinical professor of pediatrics and dermatology at Icahn School of Medicine at Mount Sinai.

In a systematic review of 16 studies examining topical corticosteroid phobia in AD, published between 1946 and 2016, the prevalence of corticosteroid phobia among patients with AD or their caregivers ranged from 21% to 83.7%, with definitions of phobia that ranged from “concern” to “irrational fear.” In two studies where adherence was evaluated, patients with corticosteroid phobia had a higher rate of partial adherence (49.4%) or nonadherence (14.1%) when compared with patients who didn’t have a phobia of corticosteroids (29.3 % and 9.8%, respectively)..

The source of these fears can be information from friends, relatives, media, the Internet, as well as doctors, Dr. Silverberg noted. “We have to be responsible for providing proper data to these individuals,” she said.

Primary care providers also treat young children with AD differently from older children, when compared with other specialties, according to the results of one study that involved a survey and a retrospective chart review, published in 2020. In the survey, 88% of primary care providers in Chicago said they managed AD differently in children under aged 2 years than in older children, with 65% reporting they were more likely to refer a child under 2 years to a specialist, and 64% said they were less likely to prescribe high-potency topical corticosteroids to children in this age group. The retrospective review found that at PCP visits, significantly more children with AD between aged 2 and 5 years were more likely to be prescribed medium-potency topical corticosteroids (0.66% vs. 0.37%, P < .01) and high-potency topical corticosteroids (0.15% vs. 0.05%; P < .01) than children under 2 years old, respectively.

Of the children who had seen a specialist, more dermatologists (57%) prescribed medium-potency and high-potency topical corticosteroids for children under aged 2 years than did allergists (30%) and pediatricians (15%) (P < .01), according to the study.

“These are our colleagues who are often very strong prescribers using systemic agents, and only 15% of pediatricians will do this,” Dr. Silverberg said. “We’re really looking at a big divide between us and other subspecialties and primary care, and [topical corticosteroids] are frequently underutilized because of these fears.”

In another study looking at the use of topical corticosteroids for AD in the pediatric emergency department (mean age of patients, 6.3 years), from 2012 to 2017, patients at 46 of 167 visits were prescribed over-the-counter topical hydrocortisone, while at 63 of 167 visits, patients were not prescribed or recommended any corticosteroid.

The mean class of the topical corticosteroid prescribed was 5.5, and the most commonly recommended corticosteroid was class 7 (the least potent available) in 61 of 104 patients (P < .001). A dermatologist was consulted in 14 of 167 visits (8.6%), and in those cases, topical corticosteroids were often prescribed (P = .018), as was a higher class of corticosteroids (a mean of 3.1 vs. 5.9; P < .001).

Topical corticosteroids also tend to be prescribed less by internal medicine physicians than by family medicine physicians or dermatologists. A 2020 study of ambulatory care data in the United States from 2006 to 2016 found that internists were 22 times less likely to prescribe topical corticosteroids for AD compared with dermatologists (5.1% vs. 52.2%; P = .001). But there was no significant difference in prescribing between family medicine physicians and dermatologists (39.1% vs. 52.2%, P = .27).

“We know they [corticosteroids] work, but so many people are fearful of them ... even with a low, low side effect profile,” Dr. Silverberg said.

For children with AD, corticosteroid use is “suboptimal” across the United States, with evidence that Medicaid-insured pediatric patients with AD are less likely to see a specialist and less likely to be prescribed high-potency topical corticosteroids compared with commercially-insured patients.

 

Discussing efficacy and safety
 

Dr. Silverberg said providers who care for children with AD should talk about the fear surrounding these medications and educate parents with anxiety surrounding corticosteroids. “Side effects are usually short term and limited, so we really can assure parents that there is a long safety profile,” she said.

Asked to comment on this topic, Adelaide Hebert, MD, professor of dermatology and director of pediatric dermatology at the University of Texas, Houston, said that she often sees concerns surrounding the use of topical corticosteroids, both in her practice with parents and when teaching residents in other disciplines, such as pediatrics, family medicine, and emergency medicine.

“We don’t do a good job in medical school educating the students about the safety, applicability, and proper use of topical steroids, and I think that leads to some of the confusion when it comes to properly using this class of medications in treating atopic dermatitis,” she said in an interview.

The use of a high-potency topical steroid is important, she noted, as lower doses may not adequately control AD. “If the patient has very mild disease, this may be just fine,” she noted. Those patients often do not see a pediatric dermatologist, “but the ones with moderate or severe atopic dermatitis often do, and I would say [the problem of] undertreatment is all too common.”

Like Dr. Silverberg, Dr. Hebert said that in her clinical experience, side effects from topical corticosteroids have been rare. “I could count on one hand the number of patients in a 38-year pediatric dermatology practice where they had an adverse effect from a topical steroid,” she said.

Dr. Silverberg reports receiving consulting fees from Amryt Pharma, Galderma, Incyte, and Vyne; non-CME related fees from Pfizer and Regeneron; and contracted research fees from Incyte and the Vitiligo Research Foundation. Dr. Hebert reports receiving research funds from GSK, Leo, Ortho Dermatologics, Galderma, Dermavant, Pfizer, and Arcutis Biotherapeutics paid to her institution; honoraria from Pfizer, Arcutis, Incyte; and having served on the data safety monitoring board for Regeneron-Sanofi, GSK, and Ortho Dermatologics.

Concerns about the side effects of topical corticosteroids continue to be a source of anxiety for parents of children with atopic dermatitis (AD), leading some medical providers to prescribe weaker products, Nanette B. Silverberg, MD, said at the Revolutionizing Atopic Dermatitis meeting.

Up to 40% of parents of children with chronic AD cite anxiety surrounding corticosteroids, according to Dr. Silverberg, chief of pediatric dermatology at the Mount Sinai Health System, New York.

When the potential for adverse events are explained to parents who are anxious about a drug, “they take it in a different way than other individuals,” noted Dr. Silverberg, clinical professor of pediatrics and dermatology at Icahn School of Medicine at Mount Sinai.

In a systematic review of 16 studies examining topical corticosteroid phobia in AD, published between 1946 and 2016, the prevalence of corticosteroid phobia among patients with AD or their caregivers ranged from 21% to 83.7%, with definitions of phobia that ranged from “concern” to “irrational fear.” In two studies where adherence was evaluated, patients with corticosteroid phobia had a higher rate of partial adherence (49.4%) or nonadherence (14.1%) when compared with patients who didn’t have a phobia of corticosteroids (29.3 % and 9.8%, respectively)..

The source of these fears can be information from friends, relatives, media, the Internet, as well as doctors, Dr. Silverberg noted. “We have to be responsible for providing proper data to these individuals,” she said.

Primary care providers also treat young children with AD differently from older children, when compared with other specialties, according to the results of one study that involved a survey and a retrospective chart review, published in 2020. In the survey, 88% of primary care providers in Chicago said they managed AD differently in children under aged 2 years than in older children, with 65% reporting they were more likely to refer a child under 2 years to a specialist, and 64% said they were less likely to prescribe high-potency topical corticosteroids to children in this age group. The retrospective review found that at PCP visits, significantly more children with AD between aged 2 and 5 years were more likely to be prescribed medium-potency topical corticosteroids (0.66% vs. 0.37%, P < .01) and high-potency topical corticosteroids (0.15% vs. 0.05%; P < .01) than children under 2 years old, respectively.

Of the children who had seen a specialist, more dermatologists (57%) prescribed medium-potency and high-potency topical corticosteroids for children under aged 2 years than did allergists (30%) and pediatricians (15%) (P < .01), according to the study.

“These are our colleagues who are often very strong prescribers using systemic agents, and only 15% of pediatricians will do this,” Dr. Silverberg said. “We’re really looking at a big divide between us and other subspecialties and primary care, and [topical corticosteroids] are frequently underutilized because of these fears.”

In another study looking at the use of topical corticosteroids for AD in the pediatric emergency department (mean age of patients, 6.3 years), from 2012 to 2017, patients at 46 of 167 visits were prescribed over-the-counter topical hydrocortisone, while at 63 of 167 visits, patients were not prescribed or recommended any corticosteroid.

The mean class of the topical corticosteroid prescribed was 5.5, and the most commonly recommended corticosteroid was class 7 (the least potent available) in 61 of 104 patients (P < .001). A dermatologist was consulted in 14 of 167 visits (8.6%), and in those cases, topical corticosteroids were often prescribed (P = .018), as was a higher class of corticosteroids (a mean of 3.1 vs. 5.9; P < .001).

Topical corticosteroids also tend to be prescribed less by internal medicine physicians than by family medicine physicians or dermatologists. A 2020 study of ambulatory care data in the United States from 2006 to 2016 found that internists were 22 times less likely to prescribe topical corticosteroids for AD compared with dermatologists (5.1% vs. 52.2%; P = .001). But there was no significant difference in prescribing between family medicine physicians and dermatologists (39.1% vs. 52.2%, P = .27).

“We know they [corticosteroids] work, but so many people are fearful of them ... even with a low, low side effect profile,” Dr. Silverberg said.

For children with AD, corticosteroid use is “suboptimal” across the United States, with evidence that Medicaid-insured pediatric patients with AD are less likely to see a specialist and less likely to be prescribed high-potency topical corticosteroids compared with commercially-insured patients.

 

Discussing efficacy and safety
 

Dr. Silverberg said providers who care for children with AD should talk about the fear surrounding these medications and educate parents with anxiety surrounding corticosteroids. “Side effects are usually short term and limited, so we really can assure parents that there is a long safety profile,” she said.

Asked to comment on this topic, Adelaide Hebert, MD, professor of dermatology and director of pediatric dermatology at the University of Texas, Houston, said that she often sees concerns surrounding the use of topical corticosteroids, both in her practice with parents and when teaching residents in other disciplines, such as pediatrics, family medicine, and emergency medicine.

“We don’t do a good job in medical school educating the students about the safety, applicability, and proper use of topical steroids, and I think that leads to some of the confusion when it comes to properly using this class of medications in treating atopic dermatitis,” she said in an interview.

The use of a high-potency topical steroid is important, she noted, as lower doses may not adequately control AD. “If the patient has very mild disease, this may be just fine,” she noted. Those patients often do not see a pediatric dermatologist, “but the ones with moderate or severe atopic dermatitis often do, and I would say [the problem of] undertreatment is all too common.”

Like Dr. Silverberg, Dr. Hebert said that in her clinical experience, side effects from topical corticosteroids have been rare. “I could count on one hand the number of patients in a 38-year pediatric dermatology practice where they had an adverse effect from a topical steroid,” she said.

Dr. Silverberg reports receiving consulting fees from Amryt Pharma, Galderma, Incyte, and Vyne; non-CME related fees from Pfizer and Regeneron; and contracted research fees from Incyte and the Vitiligo Research Foundation. Dr. Hebert reports receiving research funds from GSK, Leo, Ortho Dermatologics, Galderma, Dermavant, Pfizer, and Arcutis Biotherapeutics paid to her institution; honoraria from Pfizer, Arcutis, Incyte; and having served on the data safety monitoring board for Regeneron-Sanofi, GSK, and Ortho Dermatologics.

Concerns about the side effects of topical corticosteroids continue to be a source of anxiety for parents of children with atopic dermatitis (AD), leading some medical providers to prescribe weaker products, Nanette B. Silverberg, MD, said at the Revolutionizing Atopic Dermatitis meeting.

Up to 40% of parents of children with chronic AD cite anxiety surrounding corticosteroids, according to Dr. Silverberg, chief of pediatric dermatology at the Mount Sinai Health System, New York.

When the potential for adverse events are explained to parents who are anxious about a drug, “they take it in a different way than other individuals,” noted Dr. Silverberg, clinical professor of pediatrics and dermatology at Icahn School of Medicine at Mount Sinai.

In a systematic review of 16 studies examining topical corticosteroid phobia in AD, published between 1946 and 2016, the prevalence of corticosteroid phobia among patients with AD or their caregivers ranged from 21% to 83.7%, with definitions of phobia that ranged from “concern” to “irrational fear.” In two studies where adherence was evaluated, patients with corticosteroid phobia had a higher rate of partial adherence (49.4%) or nonadherence (14.1%) when compared with patients who didn’t have a phobia of corticosteroids (29.3 % and 9.8%, respectively)..

The source of these fears can be information from friends, relatives, media, the Internet, as well as doctors, Dr. Silverberg noted. “We have to be responsible for providing proper data to these individuals,” she said.

Primary care providers also treat young children with AD differently from older children, when compared with other specialties, according to the results of one study that involved a survey and a retrospective chart review, published in 2020. In the survey, 88% of primary care providers in Chicago said they managed AD differently in children under aged 2 years than in older children, with 65% reporting they were more likely to refer a child under 2 years to a specialist, and 64% said they were less likely to prescribe high-potency topical corticosteroids to children in this age group. The retrospective review found that at PCP visits, significantly more children with AD between aged 2 and 5 years were more likely to be prescribed medium-potency topical corticosteroids (0.66% vs. 0.37%, P < .01) and high-potency topical corticosteroids (0.15% vs. 0.05%; P < .01) than children under 2 years old, respectively.

Of the children who had seen a specialist, more dermatologists (57%) prescribed medium-potency and high-potency topical corticosteroids for children under aged 2 years than did allergists (30%) and pediatricians (15%) (P < .01), according to the study.

“These are our colleagues who are often very strong prescribers using systemic agents, and only 15% of pediatricians will do this,” Dr. Silverberg said. “We’re really looking at a big divide between us and other subspecialties and primary care, and [topical corticosteroids] are frequently underutilized because of these fears.”

In another study looking at the use of topical corticosteroids for AD in the pediatric emergency department (mean age of patients, 6.3 years), from 2012 to 2017, patients at 46 of 167 visits were prescribed over-the-counter topical hydrocortisone, while at 63 of 167 visits, patients were not prescribed or recommended any corticosteroid.

The mean class of the topical corticosteroid prescribed was 5.5, and the most commonly recommended corticosteroid was class 7 (the least potent available) in 61 of 104 patients (P < .001). A dermatologist was consulted in 14 of 167 visits (8.6%), and in those cases, topical corticosteroids were often prescribed (P = .018), as was a higher class of corticosteroids (a mean of 3.1 vs. 5.9; P < .001).

Topical corticosteroids also tend to be prescribed less by internal medicine physicians than by family medicine physicians or dermatologists. A 2020 study of ambulatory care data in the United States from 2006 to 2016 found that internists were 22 times less likely to prescribe topical corticosteroids for AD compared with dermatologists (5.1% vs. 52.2%; P = .001). But there was no significant difference in prescribing between family medicine physicians and dermatologists (39.1% vs. 52.2%, P = .27).

“We know they [corticosteroids] work, but so many people are fearful of them ... even with a low, low side effect profile,” Dr. Silverberg said.

For children with AD, corticosteroid use is “suboptimal” across the United States, with evidence that Medicaid-insured pediatric patients with AD are less likely to see a specialist and less likely to be prescribed high-potency topical corticosteroids compared with commercially-insured patients.

 

Discussing efficacy and safety
 

Dr. Silverberg said providers who care for children with AD should talk about the fear surrounding these medications and educate parents with anxiety surrounding corticosteroids. “Side effects are usually short term and limited, so we really can assure parents that there is a long safety profile,” she said.

Asked to comment on this topic, Adelaide Hebert, MD, professor of dermatology and director of pediatric dermatology at the University of Texas, Houston, said that she often sees concerns surrounding the use of topical corticosteroids, both in her practice with parents and when teaching residents in other disciplines, such as pediatrics, family medicine, and emergency medicine.

“We don’t do a good job in medical school educating the students about the safety, applicability, and proper use of topical steroids, and I think that leads to some of the confusion when it comes to properly using this class of medications in treating atopic dermatitis,” she said in an interview.

The use of a high-potency topical steroid is important, she noted, as lower doses may not adequately control AD. “If the patient has very mild disease, this may be just fine,” she noted. Those patients often do not see a pediatric dermatologist, “but the ones with moderate or severe atopic dermatitis often do, and I would say [the problem of] undertreatment is all too common.”

Like Dr. Silverberg, Dr. Hebert said that in her clinical experience, side effects from topical corticosteroids have been rare. “I could count on one hand the number of patients in a 38-year pediatric dermatology practice where they had an adverse effect from a topical steroid,” she said.

Dr. Silverberg reports receiving consulting fees from Amryt Pharma, Galderma, Incyte, and Vyne; non-CME related fees from Pfizer and Regeneron; and contracted research fees from Incyte and the Vitiligo Research Foundation. Dr. Hebert reports receiving research funds from GSK, Leo, Ortho Dermatologics, Galderma, Dermavant, Pfizer, and Arcutis Biotherapeutics paid to her institution; honoraria from Pfizer, Arcutis, Incyte; and having served on the data safety monitoring board for Regeneron-Sanofi, GSK, and Ortho Dermatologics.

There has been increasing awareness of field cancerization in dermatology and how it relates to actinic damage, actinic keratoses (AKs), and the development of cutaneous squamous cell carcinomas (SCCs). The concept of field cancerization, which was first described in the context of oropharyngeal SCCs, attempted to explain the repeated observation of local recurrences that were instead multiple primary oropharyngeal SCCs occurring within a specific region of tissue. It was hypothesized that the tissue surrounding a malignancy also harbors irreversible oncogenic damage and therefore predisposes the surrounding tissue to developing further malignancy.¹ The development of additional malignant lesions would be considered distinct from a true recurrence of the original malignancy.

Field cancerization may be partially explained by a genetic basis, as mutations in the tumor suppressor gene, TP53—the most frequently observed mutation in cutaneous SCCs—also is found in sun-exposed but clinically normal skin.^2,3 The finding of oncogenic mutations in nonlesional skin supports the theory of field cancerization, in which a region contains multiple genetically altered populations, some of which may progress to cancer. Because there currently is no widely accepted clinical definition or validated clinical measurement of field cancerization in dermatology, it may be difficult for dermatologists to recognize which patients may be at risk for developing further malignancy in a potential area of field cancerization. Willenbrink et al⁴ updated the definition of field cancerization in dermatology as “multifocal clinical atypia characterized by AKs or SCCs in situ with or without invasive disease occurring in a field exposed to chronic UV radiation.” Managing patients with field cancerization can be challenging. Herein, we discuss updates to nonsurgical field-directed and lesion-directed therapies as well as other emerging therapies.

Field-Directed Therapies

Topical 5-fluorouracil (5-FU) and imiquimod cream 5% used as field-directed therapies help reduce the extent of AKs and actinic damage in areas of possible field cancerization.⁵ The addition of calcipotriol to topical 5-FU, which theoretically augments the skin’s T-cell antitumor response via the cytokine thymic stromal lymphopoietin, recently has been studied using short treatment courses resulting in an 87.8% reduction in AKs compared to a 26.3% reduction with topical 5-FU alone (when used twice daily for 4 days) and conferred a reduced risk of cutaneous SCCs 3 years after treatment (hazard ratio, 0.215 [95% CI, 0.048-0.972]; P=.032).^6,7 Chemowraps using topical 5-FU may be considered in more difficult-to-treat areas of field cancerization with multiple AKs or keratinocyte carcinomas of the lower extremities.⁸ The routine use of chemowraps—weekly application of 5-FU covered with an occlusive dressing—may be limited by the inability to control the extent of epidermal damage and subsequent systemic absorption. Ingenol mebutate, which was approved for treatment of AKs in 2012, was removed from both the European and US markets in 2020 because the medication may paradoxically increase the long-term incidence of skin cancer.⁹

Meta-analysis has shown that photodynamic therapy (PDT) with aminolevulinic acid demonstrated complete AK clearance in 75.8% of patients (N=156)(95% CI, 55.4%-96.2%).¹⁰ A more recent method of PDT using natural sunlight as the activation source demonstrated AK clearance of 95.5%, and it appeared to be a less painful alternative to traditional PDT.¹¹ Tacalcitol, another form of vitamin D, also has been shown to enhance the efficacy of PDT for AKs.¹²

Field-directed treatment with erbium:YAG and CO₂ lasers, which physically remove the actinically damaged epidermis, have been shown to possibly be as efficacious as topical 5-FU and 30% trichloroacetic acid (TCA) but possibly inferior to PDT.¹³ There has been growing interest in laser-assisted therapy, in which an ablative fractional laser is used to generate microscopic channels to theoretically enhance the absorption of a topical medication. A meta-analysis of the use of laser-assisted therapy for photosensitizing agents in PDT demonstrated a 33% increased chance of AK clearance compared to PDT alone (P<.01).¹⁴

Lesion-Directed Therapies

Multiple KAs or cutaneous SCCs may develop in an area of field cancerization, and surgically treating these multiple lesions in a concentrated area may be challenging. Intralesional agents, including methotrexate, 5-FU, bleomycin, and interferon, are known treatments for KAs.¹⁵ Intralesional 5-FU (25 mg once weekly for 3–4 weeks) in particular produced complete resolution in 92% of cutaneous SCCs and may be optimal for multiple or rapidly growing lesions, especially on the extremities.¹⁶

Oral Therapies

Oral therapies are considered in high-risk patients with multiple or recurrent cutaneous SCCs or in those who are immunosuppressed. Two trials demonstrated that nicotinamide 500 mg twice daily for 4 and 12 months decreased AKs by 29% to 35% and 13% (average of 3–5 fewer AKs as compared to baseline), respectively.^17,18 A meta-analysis found a reduction of cutaneous SCCs (rate ratio, 0.48 [95% CI, 0.26-0.88]; I²=67%; 552 patients, 5 trials), and given the favorable safety profile, nicotinamide can be considered for chemoprevention.¹⁹

Acitretin, shown to reduce AKs by 13.4% to 50%, is the primary oral chemoprevention recommended in transplant recipients.²⁰ Interestingly, a recent meta-analysis failed to find significant differences between the efficacy of acitretin and nicotinamide.²¹ The tolerability of acitretin requires serious consideration, as 52.2% of patients withdrew due to adverse effects in one trial.²²

Capecitabine (250–1150 mg twice daily), the oral form of 5-FU, decreased the incidence of AKs and cutaneous SCCs in 53% and 72% of transplant recipients, respectively.²³ Although several reports observed paradoxical eruptions of AKs following capecitabine for other malignancies, this actually underscores the efficacy of capecitabine, as the newly emerged AKs resolved thereafter.²⁴ Still, the evidence supporting capecitabine does not include any controlled studies.

Novel Therapies

In 2021, tirbanibulin ointment 1%, a Src tyrosine kinase inhibitor of tubulin polymerization that induces p53 expression and subsequent cell death, was approved by the US Food and Drug Administration for the treatment of AKs.²⁵ Two trials reported AK clearance rates of 44% and 54% with application of tirbanibulin once daily for 5 days (vs 5% and 13%, respectively, with placebo, each with P<.001) at 2 months and a sustained clearance rate of 27% at 1 year. The predominant adverse effects were local skin reactions, including application-site pain, pruritus, mild erythema, or scaling. Unlike in other treatments such as 5-FU or cryotherapy, erosions, dyspigmentation, or scarring were not notably observed.

Intralesional talimogene laherparepvec (T-VEC), an oncolytic, genetically modified herpes simplex virus type 1 that incites antitumor immune responses, received US Food and Drug Administration approval in 2015 for the treatment of cutaneous and lymph node metastases of melanoma that are unable to be surgically resected. More recently, T-VEC has been investigated for oropharyngeal SCC. A phase 1 and phase 2 trial of 17 stage III/IV SCC patients receiving T-VEC and cisplatin demonstrated pathologic remission in 14 of 15 (93%) patients, with 82.4% survival at 29 months.²⁶ A multicenter phase 1b trial of 36 patients with recurrent or metastatic head and neck SCCs treated with T-VEC and pembrolizumab exhibited a tolerable safety profile, and 5 cases had a partial response.²⁷ However, phase 3 trials of T-VEC have yet to be pursued. Regarding its potential use for cutaneous SCCs, it has been reportedly used in a liver transplant recipient with metastatic cutaneous SCCs who received 2 doses of T-VEC (1 month apart) and attained remission of disease.²⁸ There currently is a phase 2 trial examining the effectiveness of T-VEC in patients with cutaneous SCCs (ClinicalTrials.gov identifier NCT03714828).

Final Thoughts

It is important for dermatologists to bear in mind the possible role of field cancerization in their comprehensive care of patients at risk for multiple skin cancers. Management of areas of field cancerization can be challenging, particularly in patients who develop multiple KAs or cutaneous SCCs in a concentrated area and may need to involve different levels of treatment options, including field-directed therapies and lesion-directed therapies, as well as systemic chemoprevention.

There has been increasing awareness of field cancerization in dermatology and how it relates to actinic damage, actinic keratoses (AKs), and the development of cutaneous squamous cell carcinomas (SCCs). The concept of field cancerization, which was first described in the context of oropharyngeal SCCs, attempted to explain the repeated observation of local recurrences that were instead multiple primary oropharyngeal SCCs occurring within a specific region of tissue. It was hypothesized that the tissue surrounding a malignancy also harbors irreversible oncogenic damage and therefore predisposes the surrounding tissue to developing further malignancy.¹ The development of additional malignant lesions would be considered distinct from a true recurrence of the original malignancy.

Field cancerization may be partially explained by a genetic basis, as mutations in the tumor suppressor gene, TP53—the most frequently observed mutation in cutaneous SCCs—also is found in sun-exposed but clinically normal skin.^2,3 The finding of oncogenic mutations in nonlesional skin supports the theory of field cancerization, in which a region contains multiple genetically altered populations, some of which may progress to cancer. Because there currently is no widely accepted clinical definition or validated clinical measurement of field cancerization in dermatology, it may be difficult for dermatologists to recognize which patients may be at risk for developing further malignancy in a potential area of field cancerization. Willenbrink et al⁴ updated the definition of field cancerization in dermatology as “multifocal clinical atypia characterized by AKs or SCCs in situ with or without invasive disease occurring in a field exposed to chronic UV radiation.” Managing patients with field cancerization can be challenging. Herein, we discuss updates to nonsurgical field-directed and lesion-directed therapies as well as other emerging therapies.

Field-Directed Therapies

Topical 5-fluorouracil (5-FU) and imiquimod cream 5% used as field-directed therapies help reduce the extent of AKs and actinic damage in areas of possible field cancerization.⁵ The addition of calcipotriol to topical 5-FU, which theoretically augments the skin’s T-cell antitumor response via the cytokine thymic stromal lymphopoietin, recently has been studied using short treatment courses resulting in an 87.8% reduction in AKs compared to a 26.3% reduction with topical 5-FU alone (when used twice daily for 4 days) and conferred a reduced risk of cutaneous SCCs 3 years after treatment (hazard ratio, 0.215 [95% CI, 0.048-0.972]; P=.032).^6,7 Chemowraps using topical 5-FU may be considered in more difficult-to-treat areas of field cancerization with multiple AKs or keratinocyte carcinomas of the lower extremities.⁸ The routine use of chemowraps—weekly application of 5-FU covered with an occlusive dressing—may be limited by the inability to control the extent of epidermal damage and subsequent systemic absorption. Ingenol mebutate, which was approved for treatment of AKs in 2012, was removed from both the European and US markets in 2020 because the medication may paradoxically increase the long-term incidence of skin cancer.⁹

Meta-analysis has shown that photodynamic therapy (PDT) with aminolevulinic acid demonstrated complete AK clearance in 75.8% of patients (N=156)(95% CI, 55.4%-96.2%).¹⁰ A more recent method of PDT using natural sunlight as the activation source demonstrated AK clearance of 95.5%, and it appeared to be a less painful alternative to traditional PDT.¹¹ Tacalcitol, another form of vitamin D, also has been shown to enhance the efficacy of PDT for AKs.¹²

Field-directed treatment with erbium:YAG and CO₂ lasers, which physically remove the actinically damaged epidermis, have been shown to possibly be as efficacious as topical 5-FU and 30% trichloroacetic acid (TCA) but possibly inferior to PDT.¹³ There has been growing interest in laser-assisted therapy, in which an ablative fractional laser is used to generate microscopic channels to theoretically enhance the absorption of a topical medication. A meta-analysis of the use of laser-assisted therapy for photosensitizing agents in PDT demonstrated a 33% increased chance of AK clearance compared to PDT alone (P<.01).¹⁴

Lesion-Directed Therapies

Multiple KAs or cutaneous SCCs may develop in an area of field cancerization, and surgically treating these multiple lesions in a concentrated area may be challenging. Intralesional agents, including methotrexate, 5-FU, bleomycin, and interferon, are known treatments for KAs.¹⁵ Intralesional 5-FU (25 mg once weekly for 3–4 weeks) in particular produced complete resolution in 92% of cutaneous SCCs and may be optimal for multiple or rapidly growing lesions, especially on the extremities.¹⁶

Oral Therapies

Oral therapies are considered in high-risk patients with multiple or recurrent cutaneous SCCs or in those who are immunosuppressed. Two trials demonstrated that nicotinamide 500 mg twice daily for 4 and 12 months decreased AKs by 29% to 35% and 13% (average of 3–5 fewer AKs as compared to baseline), respectively.^17,18 A meta-analysis found a reduction of cutaneous SCCs (rate ratio, 0.48 [95% CI, 0.26-0.88]; I²=67%; 552 patients, 5 trials), and given the favorable safety profile, nicotinamide can be considered for chemoprevention.¹⁹

Acitretin, shown to reduce AKs by 13.4% to 50%, is the primary oral chemoprevention recommended in transplant recipients.²⁰ Interestingly, a recent meta-analysis failed to find significant differences between the efficacy of acitretin and nicotinamide.²¹ The tolerability of acitretin requires serious consideration, as 52.2% of patients withdrew due to adverse effects in one trial.²²

Capecitabine (250–1150 mg twice daily), the oral form of 5-FU, decreased the incidence of AKs and cutaneous SCCs in 53% and 72% of transplant recipients, respectively.²³ Although several reports observed paradoxical eruptions of AKs following capecitabine for other malignancies, this actually underscores the efficacy of capecitabine, as the newly emerged AKs resolved thereafter.²⁴ Still, the evidence supporting capecitabine does not include any controlled studies.

Novel Therapies

In 2021, tirbanibulin ointment 1%, a Src tyrosine kinase inhibitor of tubulin polymerization that induces p53 expression and subsequent cell death, was approved by the US Food and Drug Administration for the treatment of AKs.²⁵ Two trials reported AK clearance rates of 44% and 54% with application of tirbanibulin once daily for 5 days (vs 5% and 13%, respectively, with placebo, each with P<.001) at 2 months and a sustained clearance rate of 27% at 1 year. The predominant adverse effects were local skin reactions, including application-site pain, pruritus, mild erythema, or scaling. Unlike in other treatments such as 5-FU or cryotherapy, erosions, dyspigmentation, or scarring were not notably observed.

Intralesional talimogene laherparepvec (T-VEC), an oncolytic, genetically modified herpes simplex virus type 1 that incites antitumor immune responses, received US Food and Drug Administration approval in 2015 for the treatment of cutaneous and lymph node metastases of melanoma that are unable to be surgically resected. More recently, T-VEC has been investigated for oropharyngeal SCC. A phase 1 and phase 2 trial of 17 stage III/IV SCC patients receiving T-VEC and cisplatin demonstrated pathologic remission in 14 of 15 (93%) patients, with 82.4% survival at 29 months.²⁶ A multicenter phase 1b trial of 36 patients with recurrent or metastatic head and neck SCCs treated with T-VEC and pembrolizumab exhibited a tolerable safety profile, and 5 cases had a partial response.²⁷ However, phase 3 trials of T-VEC have yet to be pursued. Regarding its potential use for cutaneous SCCs, it has been reportedly used in a liver transplant recipient with metastatic cutaneous SCCs who received 2 doses of T-VEC (1 month apart) and attained remission of disease.²⁸ There currently is a phase 2 trial examining the effectiveness of T-VEC in patients with cutaneous SCCs (ClinicalTrials.gov identifier NCT03714828).

Final Thoughts

It is important for dermatologists to bear in mind the possible role of field cancerization in their comprehensive care of patients at risk for multiple skin cancers. Management of areas of field cancerization can be challenging, particularly in patients who develop multiple KAs or cutaneous SCCs in a concentrated area and may need to involve different levels of treatment options, including field-directed therapies and lesion-directed therapies, as well as systemic chemoprevention.

There has been increasing awareness of field cancerization in dermatology and how it relates to actinic damage, actinic keratoses (AKs), and the development of cutaneous squamous cell carcinomas (SCCs). The concept of field cancerization, which was first described in the context of oropharyngeal SCCs, attempted to explain the repeated observation of local recurrences that were instead multiple primary oropharyngeal SCCs occurring within a specific region of tissue. It was hypothesized that the tissue surrounding a malignancy also harbors irreversible oncogenic damage and therefore predisposes the surrounding tissue to developing further malignancy.¹ The development of additional malignant lesions would be considered distinct from a true recurrence of the original malignancy.

Field cancerization may be partially explained by a genetic basis, as mutations in the tumor suppressor gene, TP53—the most frequently observed mutation in cutaneous SCCs—also is found in sun-exposed but clinically normal skin.^2,3 The finding of oncogenic mutations in nonlesional skin supports the theory of field cancerization, in which a region contains multiple genetically altered populations, some of which may progress to cancer. Because there currently is no widely accepted clinical definition or validated clinical measurement of field cancerization in dermatology, it may be difficult for dermatologists to recognize which patients may be at risk for developing further malignancy in a potential area of field cancerization. Willenbrink et al⁴ updated the definition of field cancerization in dermatology as “multifocal clinical atypia characterized by AKs or SCCs in situ with or without invasive disease occurring in a field exposed to chronic UV radiation.” Managing patients with field cancerization can be challenging. Herein, we discuss updates to nonsurgical field-directed and lesion-directed therapies as well as other emerging therapies.

Field-Directed Therapies

Topical 5-fluorouracil (5-FU) and imiquimod cream 5% used as field-directed therapies help reduce the extent of AKs and actinic damage in areas of possible field cancerization.⁵ The addition of calcipotriol to topical 5-FU, which theoretically augments the skin’s T-cell antitumor response via the cytokine thymic stromal lymphopoietin, recently has been studied using short treatment courses resulting in an 87.8% reduction in AKs compared to a 26.3% reduction with topical 5-FU alone (when used twice daily for 4 days) and conferred a reduced risk of cutaneous SCCs 3 years after treatment (hazard ratio, 0.215 [95% CI, 0.048-0.972]; P=.032).^6,7 Chemowraps using topical 5-FU may be considered in more difficult-to-treat areas of field cancerization with multiple AKs or keratinocyte carcinomas of the lower extremities.⁸ The routine use of chemowraps—weekly application of 5-FU covered with an occlusive dressing—may be limited by the inability to control the extent of epidermal damage and subsequent systemic absorption. Ingenol mebutate, which was approved for treatment of AKs in 2012, was removed from both the European and US markets in 2020 because the medication may paradoxically increase the long-term incidence of skin cancer.⁹

Meta-analysis has shown that photodynamic therapy (PDT) with aminolevulinic acid demonstrated complete AK clearance in 75.8% of patients (N=156)(95% CI, 55.4%-96.2%).¹⁰ A more recent method of PDT using natural sunlight as the activation source demonstrated AK clearance of 95.5%, and it appeared to be a less painful alternative to traditional PDT.¹¹ Tacalcitol, another form of vitamin D, also has been shown to enhance the efficacy of PDT for AKs.¹²

Field-directed treatment with erbium:YAG and CO₂ lasers, which physically remove the actinically damaged epidermis, have been shown to possibly be as efficacious as topical 5-FU and 30% trichloroacetic acid (TCA) but possibly inferior to PDT.¹³ There has been growing interest in laser-assisted therapy, in which an ablative fractional laser is used to generate microscopic channels to theoretically enhance the absorption of a topical medication. A meta-analysis of the use of laser-assisted therapy for photosensitizing agents in PDT demonstrated a 33% increased chance of AK clearance compared to PDT alone (P<.01).¹⁴

Lesion-Directed Therapies

Multiple KAs or cutaneous SCCs may develop in an area of field cancerization, and surgically treating these multiple lesions in a concentrated area may be challenging. Intralesional agents, including methotrexate, 5-FU, bleomycin, and interferon, are known treatments for KAs.¹⁵ Intralesional 5-FU (25 mg once weekly for 3–4 weeks) in particular produced complete resolution in 92% of cutaneous SCCs and may be optimal for multiple or rapidly growing lesions, especially on the extremities.¹⁶

Oral Therapies

Oral therapies are considered in high-risk patients with multiple or recurrent cutaneous SCCs or in those who are immunosuppressed. Two trials demonstrated that nicotinamide 500 mg twice daily for 4 and 12 months decreased AKs by 29% to 35% and 13% (average of 3–5 fewer AKs as compared to baseline), respectively.^17,18 A meta-analysis found a reduction of cutaneous SCCs (rate ratio, 0.48 [95% CI, 0.26-0.88]; I²=67%; 552 patients, 5 trials), and given the favorable safety profile, nicotinamide can be considered for chemoprevention.¹⁹

Acitretin, shown to reduce AKs by 13.4% to 50%, is the primary oral chemoprevention recommended in transplant recipients.²⁰ Interestingly, a recent meta-analysis failed to find significant differences between the efficacy of acitretin and nicotinamide.²¹ The tolerability of acitretin requires serious consideration, as 52.2% of patients withdrew due to adverse effects in one trial.²²

Capecitabine (250–1150 mg twice daily), the oral form of 5-FU, decreased the incidence of AKs and cutaneous SCCs in 53% and 72% of transplant recipients, respectively.²³ Although several reports observed paradoxical eruptions of AKs following capecitabine for other malignancies, this actually underscores the efficacy of capecitabine, as the newly emerged AKs resolved thereafter.²⁴ Still, the evidence supporting capecitabine does not include any controlled studies.

Novel Therapies

In 2021, tirbanibulin ointment 1%, a Src tyrosine kinase inhibitor of tubulin polymerization that induces p53 expression and subsequent cell death, was approved by the US Food and Drug Administration for the treatment of AKs.²⁵ Two trials reported AK clearance rates of 44% and 54% with application of tirbanibulin once daily for 5 days (vs 5% and 13%, respectively, with placebo, each with P<.001) at 2 months and a sustained clearance rate of 27% at 1 year. The predominant adverse effects were local skin reactions, including application-site pain, pruritus, mild erythema, or scaling. Unlike in other treatments such as 5-FU or cryotherapy, erosions, dyspigmentation, or scarring were not notably observed.

Intralesional talimogene laherparepvec (T-VEC), an oncolytic, genetically modified herpes simplex virus type 1 that incites antitumor immune responses, received US Food and Drug Administration approval in 2015 for the treatment of cutaneous and lymph node metastases of melanoma that are unable to be surgically resected. More recently, T-VEC has been investigated for oropharyngeal SCC. A phase 1 and phase 2 trial of 17 stage III/IV SCC patients receiving T-VEC and cisplatin demonstrated pathologic remission in 14 of 15 (93%) patients, with 82.4% survival at 29 months.²⁶ A multicenter phase 1b trial of 36 patients with recurrent or metastatic head and neck SCCs treated with T-VEC and pembrolizumab exhibited a tolerable safety profile, and 5 cases had a partial response.²⁷ However, phase 3 trials of T-VEC have yet to be pursued. Regarding its potential use for cutaneous SCCs, it has been reportedly used in a liver transplant recipient with metastatic cutaneous SCCs who received 2 doses of T-VEC (1 month apart) and attained remission of disease.²⁸ There currently is a phase 2 trial examining the effectiveness of T-VEC in patients with cutaneous SCCs (ClinicalTrials.gov identifier NCT03714828).

Final Thoughts

It is important for dermatologists to bear in mind the possible role of field cancerization in their comprehensive care of patients at risk for multiple skin cancers. Management of areas of field cancerization can be challenging, particularly in patients who develop multiple KAs or cutaneous SCCs in a concentrated area and may need to involve different levels of treatment options, including field-directed therapies and lesion-directed therapies, as well as systemic chemoprevention.

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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

When the hospital’s trauma team could not get an IV inserted into an accident victim, they called Illinois emergency physician William Sullivan, DO, JD, for help. Dr. Sullivan, who is based in the Chicago suburb of Frankfort, inserted a central line into the patient’s leg on his first attempt – a task that took about 20 minutes.

A year later, Dr. Sullivan was shocked and angry to learn he was being sued by the trauma patient’s family. Inserting the line was his only interaction with the woman, and he had no role in her care management, he said. Yet, the suit claimed he was negligent for failing to diagnose the patient with internal bleeding and for not performing surgery. 

“The lawsuit put a lot of stress on our family,” Dr. Sullivan recalled. “At the time my wife was pregnant. I was in law school, and I was also working full time in the ER to support our family. I remember my wife crying on the couch after reading the complaint and asking how the plaintiff’s attorney could get away with making the allegations he made.”

Dr. Sullivan soon learned that 15 medical providers in the patient’s medical record were named as defendants. This included the director of the radiology department, whose name was on a radiology report as “director” but who was actually out of the country when the incident occurred.

Despite some of the accusations being impossible, a medical expert had claimed there was a “meritorious claim” against every health professional named in the suit. Illinois is among the 28 states that require plaintiffs’ attorneys to file an affidavit of merit for medical malpractice claims to move forward.

Dr. Sullivan wondered who would endorse such outlandish accusations, but the expert’s identity was a mystery. According to Illinois law, plaintiffs’ attorneys can withhold the identity of medical experts with whom they consult for affidavits of merit. About one-third of states with merit requirements permit anonymous experts, according to research and attorneys familiar with the issue.

Because the expert’s identity remains hidden, physicians have no way of knowing whether they were qualified to render an opinion, Dr. Sullivan said. The loopholes can drag out frivolous claims and waste significant time and expense, say legal experts. Frequently, it takes a year or more before innocent physicians are dismissed from unfounded lawsuits by the court or dropped when plaintiffs can’t support the claim.

“It’s hugely frustrating,” said Bruce Montoya, JD, a Colorado medical liability defense attorney. “You have an expert who is not disclosed. Further down the road, when experts are being deposed, the plaintiff does not have to reveal whether any of those testifying experts is the same one who certified the case. You never get to determine whether they, in fact, had a certificate reviewer who was legitimate.”

The laws have led to a recent outcry among physicians and fueled a revised resolution by the American College of Emergency Physicians (ACEP) denouncing anonymous affidavits of merit. (The revision has not yet been published online.)

“The minute experts are identified, they can be vetted,” said Rade B. Vukmir, MD, JD, chair of ACEP’s Medical Legal Committee. “There are reasons that you want to clarify the qualification and veracity of the witness. [Anonymous affidavits of merit] don’t allow that, and there’s something inherently wrong with that.”

Because the identities of consulting experts are unknown, it’s hard to know how many are unqualified. Expert witnesses who testify during trials, on the other hand, have long come under scrutiny for questionable qualifications. Some have come under fire for allegedly lying under oath about their experience, misrepresenting their credentials, and falsely representing their knowledge.

“Considering the known problem of potentially unethical expert witness testimony at trial, there’s is the potential likelihood that experts in anonymous affidavits of merit may sometimes lack the qualifications to give opinions,” said Dr. Vukmir, an emergency care physician in Pittsburgh.
 

Attorneys: Hidden experts increase costs, waste time

In Colorado, Mr. Montoya has seen firsthand how anonymous experts can prolong questionable claims and burden defendants.

Like Illinois, Colorado does not require attorneys to identify the medical experts used to fulfill its certificate of review statute. The expert consulted must have expertise in the same area of the alleged negligence, but does not have to practice in the same specialty, and the statute allows one expert to certify a lawsuit against multiple doctors.

In a recent case, Mr. Montoya represented a Denver neurosurgeon who was sued along with multiple other health care professionals. From the outset, Mr. Montoya argued the claim had no merit against the neurosurgeon, but the plaintiff’s attorney refused to dismiss the physician. Mr. Montoya asked whether the expert consulted for the certificate of merit was a neurosurgeon, but the attorney declined to disclose that information, he said.

The case progressed and Mr. Montoya eventually asked the judge to review the certificate of merit. By law, a judge can confidentially review the certificate of merit and decide whether it aligns with the state statute, but without disclosing the expert’s identity to the defense. The judge ruled the certificate appeared to conform with state law, and the case continued.

A year later, as both sides were getting ready to disclose their experts who would testify, Mr. Montoya again argued the neurosurgeon should be dropped from the suit. This time, he warned if the claim continued against the neurosurgeon, the defense would be filing a motion for summary judgment and pursuing attorney fees and costs. Colorado law allows for such fees if the filing or pursuit of an action is frivolous.

“Boom, my client was dismissed,” Mr. Montoya said. “This is a year later, after multiple conferences among the attorneys, multiple pleadings filed, expert witnesses retained to review the care, discovery exchanged, and records obtained. If we had [a stronger] certificate of review statute, it would have been a different ballgame. It’s never going to get a year down the road.”

In New York, physician defendants have experienced similar woes. The state’s law requires plaintiffs’ attorneys to certify that they consulted with a physician prior to filing the claim, and that they believe based on that discussion, there’s a reasonable basis for the claim to move forward. Attorneys are not required to disclose the expert’s identity.

The law also allows “an out,” explained Morris Auster, JD, senior vice president and chief legislative counsel for the Medical Society of the State of New York. If the attorney made three separate attempts to obtain a consultation, and all three experts would not agree to the consultation, the lawsuit can be filed anyway, he said.

“From our standpoint, it’s important to have an affidavit of merit requirement; it’s better than not having it,” Mr. Auster said. “But its effectiveness in providing control over the filing of lawsuits in New York has never been as strong as it could’ve been.”

Mr. Auster notes that New York has some of the highest liability costs in the country in addition to doctors paying some of the steepest medical liability insurance premiums.

“This really affects a lot of physicians and it’s driving physicians into employment arrangements, so they don’t have to deal with it on their own,” he said. “We support a number of measures to address these significantly high costs, and stronger certificate of merit requirements would certainly be one of those advocacy goals.”
 

Why are anonymous experts allowed?

Certificates of merit that shield the identity of consultants encourage a greater pool of physicians willing to review cases, said J. Matthew Dudley, JD, president of the Illinois Trial Lawyers Association. When the requirements first went into effect in Illinois, there was significant animosity among physicians toward doctors who testified in medical malpractice cases for patients, Mr. Dudley explained.

“Sometimes they would be ostracized from their professional societies, or it would hurt a referral relationship.” he said. “Over time, that animosity has lessened, but there was a concern that if the identity of physicians in certificates of merit weren’t protected, then doctors would not look at cases for patients.”

This would result in additional barriers for patients and their attorneys in pursuing their legal rights, Mr. Dudley said. He said Illinois’ certificate of merit statute is successful in fulfilling its intended purpose, and he has not seen any statistical evidence to suggest otherwise.

“It has proven effective at decreasing filings in medical malpractice and effectively screening medical malpractice cases,” he said. “Certificates of merit help to decrease filings by firms that aren’t that experienced in dealing with those kinds of cases.”

Kentucky is another state that does not require attorneys to identity the experts consulted for certificates of merit. Malpractice defense attorney Andrew DeSimone, JD, who practices in Kentucky, said this isn’t a problem since attorneys eventually must disclose the expert witnesses who will testify at trial.

“Knowing the name behind the certificate of merit is not that pertinent,” Mr. DeSimone said. “Physicians and their attorneys will ultimately have the chance to question and evaluate the expert witnesses used at trial. The certificate of merit is designed to weed out totally frivolous cases that do not have expert support. It’s not designed to be a trial on the merits.” 

The belief that plaintiffs’ attorneys frequently bring weak cases and use unqualified experts to certify claims is not realistic or logical, added Sean Domnick, JD, a Florida medical malpractice attorney and vice president for the American Association for Justice. Medical malpractice cases are extremely challenging for plaintiffs – and they’re expensive, Mr. Domnick said.  

“We can’t afford to take bad cases,” he said. “For me to take on a medical malpractice case, it’s not unusual for me to spend well over $100,000. Remember, if we lose, I don’t get that money back and I don’t get paid. Why in the world would a plaintiff take on that type of a burden for a case they didn’t believe in? The logic escapes me.”

In Florida, where Mr. Domnick practices, plaintiffs’ attorneys must send their certificates of merit to the defense with the expert identified. Domnick believes the requirement is a hindrance.

“It creates a delay that is unnecessary in a system that is already designed to wear our clients down,” he said. “It’s just another component that makes it harder on them.”
 

Hidden experts may insulate plaintiffs’ attorneys from liability

Dr. Sullivan, the Illinois emergency physician, was ultimately dismissed from the multiparty lawsuit, but not for roughly 18 months. After the dismissal, he fought back. He sued the plaintiff’s law firm for malicious prosecution, negligence in hiring, and relying on the opinion of an expert who was unqualified to render an opinion against an emergency physician.

The law firm, however, argued that it was immune from liability because it reasonably relied on the expert’s opinion as required by Illinois law. A trial court agreed with the plaintiffs’ firm. The judge denied Dr. Sullivan’s request to identify the expert, ruling there was no finding that the affidavit was untrue or made without reasonable cause. Dr. Sullivan appealed, and the appellate court upheld the trial’s court decision.

“As happened with my case, law firms can use the affidavit as a defense against countersuits or motions for sanctions,” Dr. Sullivan said. “Although the certificate of merit is intended to prevent attorneys from filing frivolous cases, it can also have the opposite effect of helping to insulate plaintiff attorneys from liability for filing a frivolous lawsuit.”

In Colorado, complaints about the state’s certificate of merit statute have gone before the Colorado Supreme Court. In one case, a lower court ruled that a certificate of merit was deficient because the consultants were not chiropractors. In another case, a nurse defendant argued the claim’s certificate of review was insufficient because the consulting expert was a physician.

In both instances, Colorado judges held the state’s statute does not require consultants to be in the same profession or the same specialty as the health professional defendant. 

In New York, meanwhile, Mr. Auster said several bills to strengthen the state’s certificate of merit requirements have failed in recent years.

“It’s hard to say whether it will improve anytime soon,” he said. “The trial lawyers are a very powerful advocacy force in the state, and they tend to oppose even the slightest of changes in civil liability. [In addition], some of these issues have been put on a lower tier because of trying to manage the pandemic.”

Ultimately, Dr. Sullivan said that courts and legislatures need to strongly consider the ethics of allowing anonymous experts to provide testimony against defendant physicians.

“I also think we need to consider how the notion of a secret expert comports with a defendant physician’s due process,” he said. “If an expert’s opinion is appropriate, why would there be a need to shroud one’s identity in a veil of secrecy?” 

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