Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure (BP) control, researchers concluded based on their randomized multicenter trial.

Deprescription of one of at least two antihypertensive meds in such patients was found noninferior to usual care in keeping systolic BP below 150 mm Hg at 12 weeks, in the study that randomly assigned only patients who were considered appropriate for BP-med reduction by their primary care physicians.

Major trials that have shaped some contemporary hypertension guidelines, notably SPRINT, in general have not included such older patients with hypertension along with other chronic conditions, such as diabetes or a history of stroke. So “it’s difficult to know whether their data are relevant for frail, multimorbid patients. In fact, the guidelines say you should use some clinical judgment when applying the results of SPRINT to the kind of patients seen in clinical practice,” James P. Sheppard, PhD, of University of Oxford (England) said in an interview.

The current study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” Dr. Sheppard said.

The trial is meant to provide something of an otherwise-scant evidence base for how to deprescribe antihypertensive medications, said Dr. Sheppard, who is lead author on the report published May 25 in JAMA.

Of the trial’s 282 patients randomly assigned to the drug-reduction group, 86.4% reached the primary endpoint goal of systolic BP less than 150 mm Hg, compared with 87.7% of the 287 patients on usual care, a difference which in adjusted analysis met the predetermined standard for noninferiority.

The intervention group reduced its number of antihypertensive agents by a mean of 0.6 per patient, which the authors described as “a modest reduction.” However, they noted, drugs that were taken away could be reintroduced as judged necessary by the physicians, yet most of the group sustained their reductions until the end of the 12 weeks.

Had the primary endpoint instead specified a threshold of 130 mm Hg for BP control, which is more consistent with SPRINT and some guidelines in the United States, “the deprescribing strategy would have failed to be considered noninferior to usual care” as calculated by the OPTIMISE authors themselves, observed an accompanying editorial.

The 150 mm Hg threshold chosen by the trialists for the primary endpoint, therefore, “was somewhat of a low bar,” wrote Eric D. Peterson, MD, MPH, of Duke University, Durham, N.C., and Michael W. Rich, MD, of Washington University School of Medicine, St. Louis, Mo.

“Here in the UK it wouldn’t be considered a low bar,” Dr. Sheppard said in an interview. The National Institute for Health and Care Excellence guidelines in Britain “recommends that you treat people over the age of 18 regardless of whether they have any other conditions and to 150 mm Hg systolic.”

The study’s general practitioners, he said, “did what we told them to do, and as a result, two-thirds of the patients were able to reduce their medications. If we had a lower threshold for treatment, it’s possible that more patients might have had medications reintroduced. I think you still could have potentially ended up with a noninferior result.”

Participating physicians were instructed to enroll only “patients who, in their opinion, might potentially benefit from medication reduction due to one or more of the following existing characteristics: polypharmacy, comorbidity, nonadherence or dislike of medicines, or frailty,” the report notes.

They chose which antihypertensives would be dropped for each patient and “were given a medication reduction algorithm to assist with this decision.” Physicians also followed a guide for monitoring for safety issues and were told to reintroduce medications if systolic BP exceeded 150 mm Hg or diastolic BP rose above 90 mm Hg for more than 1 week or in the event of adverse events or signs of accelerated hypertension, the group wrote.

In the deprescription group, the mean systolic BP rose 4.3 points from baseline to 12 weeks, from 129.4 to 133.7 mm Hg. For those given usual care, mean systolic BP went from 130.5 to 130.8 mm Hg. Adjusted, the mean change in systolic BP was 3.4 mm Hg greater (P = .005) in the intervention group. The corresponding adjusted mean change in diastolic BP was a 2.2 mm Hg increase in the intervention group (P = .001).

Although the difference seems minimal, wrote Dr. Peterson and Dr. Rich, “such differences in BP can potentially lead to long-term differences in outcomes at the population level.”

Also, they pointed out, only about 10% of patients screened for enrollment actually entered the study, which brings into question the study’s generalizability, and “patients in the trial had relatively well-controlled BP at baseline.”

Dr. Sheppard said patients in the original screened population, taken from a national database, were directly invited to participate en masse by conventional mail, based on broad inclusion criteria. Far more than the number needed were invited, and nearly all of those excluded from the study had simply not responded to the invitation.

As for greater increases in systolic and diastolic pressures in the deprescribing group, the OPTIMISE authors acknowledged that “caution should be exercised when adopting this approach in routine clinical practice.”

His own view, Dr. Sheppard said, “is that there are some patients who will definitely benefit from intensive blood pressure lowering like you saw in the SPRINT trial. And there’s other patients who will benefit from deprescribing and having a slightly higher target. Those sorts of things very much need to be individualized at the patient level.”

And ideally, he added, clinicians in practice should probably be even more selective in choosing patients for a deprescribing strategy, “and focus on people who are at the highest risk of adverse events.”

Dr. Sheppard has disclosed no relevant financial relationships; disclosures for the other authors are in the report. Dr. Peterson disclosed receiving personal fees from Cerner and Livongo and grants and personal fees from AstraZeneca, Janssen, and Amgen; Dr. Rick has disclosed no relevant financial relationships.

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

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure (BP) control, researchers concluded based on their randomized multicenter trial.

Deprescription of one of at least two antihypertensive meds in such patients was found noninferior to usual care in keeping systolic BP below 150 mm Hg at 12 weeks, in the study that randomly assigned only patients who were considered appropriate for BP-med reduction by their primary care physicians.

Major trials that have shaped some contemporary hypertension guidelines, notably SPRINT, in general have not included such older patients with hypertension along with other chronic conditions, such as diabetes or a history of stroke. So “it’s difficult to know whether their data are relevant for frail, multimorbid patients. In fact, the guidelines say you should use some clinical judgment when applying the results of SPRINT to the kind of patients seen in clinical practice,” James P. Sheppard, PhD, of University of Oxford (England) said in an interview.

The current study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” Dr. Sheppard said.

The trial is meant to provide something of an otherwise-scant evidence base for how to deprescribe antihypertensive medications, said Dr. Sheppard, who is lead author on the report published May 25 in JAMA.

Of the trial’s 282 patients randomly assigned to the drug-reduction group, 86.4% reached the primary endpoint goal of systolic BP less than 150 mm Hg, compared with 87.7% of the 287 patients on usual care, a difference which in adjusted analysis met the predetermined standard for noninferiority.

The intervention group reduced its number of antihypertensive agents by a mean of 0.6 per patient, which the authors described as “a modest reduction.” However, they noted, drugs that were taken away could be reintroduced as judged necessary by the physicians, yet most of the group sustained their reductions until the end of the 12 weeks.

Had the primary endpoint instead specified a threshold of 130 mm Hg for BP control, which is more consistent with SPRINT and some guidelines in the United States, “the deprescribing strategy would have failed to be considered noninferior to usual care” as calculated by the OPTIMISE authors themselves, observed an accompanying editorial.

The 150 mm Hg threshold chosen by the trialists for the primary endpoint, therefore, “was somewhat of a low bar,” wrote Eric D. Peterson, MD, MPH, of Duke University, Durham, N.C., and Michael W. Rich, MD, of Washington University School of Medicine, St. Louis, Mo.

“Here in the UK it wouldn’t be considered a low bar,” Dr. Sheppard said in an interview. The National Institute for Health and Care Excellence guidelines in Britain “recommends that you treat people over the age of 18 regardless of whether they have any other conditions and to 150 mm Hg systolic.”

The study’s general practitioners, he said, “did what we told them to do, and as a result, two-thirds of the patients were able to reduce their medications. If we had a lower threshold for treatment, it’s possible that more patients might have had medications reintroduced. I think you still could have potentially ended up with a noninferior result.”

Participating physicians were instructed to enroll only “patients who, in their opinion, might potentially benefit from medication reduction due to one or more of the following existing characteristics: polypharmacy, comorbidity, nonadherence or dislike of medicines, or frailty,” the report notes.

They chose which antihypertensives would be dropped for each patient and “were given a medication reduction algorithm to assist with this decision.” Physicians also followed a guide for monitoring for safety issues and were told to reintroduce medications if systolic BP exceeded 150 mm Hg or diastolic BP rose above 90 mm Hg for more than 1 week or in the event of adverse events or signs of accelerated hypertension, the group wrote.

In the deprescription group, the mean systolic BP rose 4.3 points from baseline to 12 weeks, from 129.4 to 133.7 mm Hg. For those given usual care, mean systolic BP went from 130.5 to 130.8 mm Hg. Adjusted, the mean change in systolic BP was 3.4 mm Hg greater (P = .005) in the intervention group. The corresponding adjusted mean change in diastolic BP was a 2.2 mm Hg increase in the intervention group (P = .001).

Although the difference seems minimal, wrote Dr. Peterson and Dr. Rich, “such differences in BP can potentially lead to long-term differences in outcomes at the population level.”

Also, they pointed out, only about 10% of patients screened for enrollment actually entered the study, which brings into question the study’s generalizability, and “patients in the trial had relatively well-controlled BP at baseline.”

Dr. Sheppard said patients in the original screened population, taken from a national database, were directly invited to participate en masse by conventional mail, based on broad inclusion criteria. Far more than the number needed were invited, and nearly all of those excluded from the study had simply not responded to the invitation.

As for greater increases in systolic and diastolic pressures in the deprescribing group, the OPTIMISE authors acknowledged that “caution should be exercised when adopting this approach in routine clinical practice.”

His own view, Dr. Sheppard said, “is that there are some patients who will definitely benefit from intensive blood pressure lowering like you saw in the SPRINT trial. And there’s other patients who will benefit from deprescribing and having a slightly higher target. Those sorts of things very much need to be individualized at the patient level.”

And ideally, he added, clinicians in practice should probably be even more selective in choosing patients for a deprescribing strategy, “and focus on people who are at the highest risk of adverse events.”

Dr. Sheppard has disclosed no relevant financial relationships; disclosures for the other authors are in the report. Dr. Peterson disclosed receiving personal fees from Cerner and Livongo and grants and personal fees from AstraZeneca, Janssen, and Amgen; Dr. Rick has disclosed no relevant financial relationships.

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

Some patients aged 80 years or older can potentially cut back on their number of antihypertensive meds, under physician guidance, without an important loss of blood pressure (BP) control, researchers concluded based on their randomized multicenter trial.

Deprescription of one of at least two antihypertensive meds in such patients was found noninferior to usual care in keeping systolic BP below 150 mm Hg at 12 weeks, in the study that randomly assigned only patients who were considered appropriate for BP-med reduction by their primary care physicians.

Major trials that have shaped some contemporary hypertension guidelines, notably SPRINT, in general have not included such older patients with hypertension along with other chronic conditions, such as diabetes or a history of stroke. So “it’s difficult to know whether their data are relevant for frail, multimorbid patients. In fact, the guidelines say you should use some clinical judgment when applying the results of SPRINT to the kind of patients seen in clinical practice,” James P. Sheppard, PhD, of University of Oxford (England) said in an interview.

The current study, called Optimising Treatment for Mild Systolic Hypertension in the Elderly (OPTIMISE), entered “patients in whom the benefits of taking blood pressure-lowering treatments might start to be outweighed by the potential harms,” Dr. Sheppard said.

The trial is meant to provide something of an otherwise-scant evidence base for how to deprescribe antihypertensive medications, said Dr. Sheppard, who is lead author on the report published May 25 in JAMA.

Of the trial’s 282 patients randomly assigned to the drug-reduction group, 86.4% reached the primary endpoint goal of systolic BP less than 150 mm Hg, compared with 87.7% of the 287 patients on usual care, a difference which in adjusted analysis met the predetermined standard for noninferiority.

The intervention group reduced its number of antihypertensive agents by a mean of 0.6 per patient, which the authors described as “a modest reduction.” However, they noted, drugs that were taken away could be reintroduced as judged necessary by the physicians, yet most of the group sustained their reductions until the end of the 12 weeks.

Had the primary endpoint instead specified a threshold of 130 mm Hg for BP control, which is more consistent with SPRINT and some guidelines in the United States, “the deprescribing strategy would have failed to be considered noninferior to usual care” as calculated by the OPTIMISE authors themselves, observed an accompanying editorial.

The 150 mm Hg threshold chosen by the trialists for the primary endpoint, therefore, “was somewhat of a low bar,” wrote Eric D. Peterson, MD, MPH, of Duke University, Durham, N.C., and Michael W. Rich, MD, of Washington University School of Medicine, St. Louis, Mo.

“Here in the UK it wouldn’t be considered a low bar,” Dr. Sheppard said in an interview. The National Institute for Health and Care Excellence guidelines in Britain “recommends that you treat people over the age of 18 regardless of whether they have any other conditions and to 150 mm Hg systolic.”

The study’s general practitioners, he said, “did what we told them to do, and as a result, two-thirds of the patients were able to reduce their medications. If we had a lower threshold for treatment, it’s possible that more patients might have had medications reintroduced. I think you still could have potentially ended up with a noninferior result.”

Participating physicians were instructed to enroll only “patients who, in their opinion, might potentially benefit from medication reduction due to one or more of the following existing characteristics: polypharmacy, comorbidity, nonadherence or dislike of medicines, or frailty,” the report notes.

They chose which antihypertensives would be dropped for each patient and “were given a medication reduction algorithm to assist with this decision.” Physicians also followed a guide for monitoring for safety issues and were told to reintroduce medications if systolic BP exceeded 150 mm Hg or diastolic BP rose above 90 mm Hg for more than 1 week or in the event of adverse events or signs of accelerated hypertension, the group wrote.

In the deprescription group, the mean systolic BP rose 4.3 points from baseline to 12 weeks, from 129.4 to 133.7 mm Hg. For those given usual care, mean systolic BP went from 130.5 to 130.8 mm Hg. Adjusted, the mean change in systolic BP was 3.4 mm Hg greater (P = .005) in the intervention group. The corresponding adjusted mean change in diastolic BP was a 2.2 mm Hg increase in the intervention group (P = .001).

Although the difference seems minimal, wrote Dr. Peterson and Dr. Rich, “such differences in BP can potentially lead to long-term differences in outcomes at the population level.”

Also, they pointed out, only about 10% of patients screened for enrollment actually entered the study, which brings into question the study’s generalizability, and “patients in the trial had relatively well-controlled BP at baseline.”

Dr. Sheppard said patients in the original screened population, taken from a national database, were directly invited to participate en masse by conventional mail, based on broad inclusion criteria. Far more than the number needed were invited, and nearly all of those excluded from the study had simply not responded to the invitation.

As for greater increases in systolic and diastolic pressures in the deprescribing group, the OPTIMISE authors acknowledged that “caution should be exercised when adopting this approach in routine clinical practice.”

His own view, Dr. Sheppard said, “is that there are some patients who will definitely benefit from intensive blood pressure lowering like you saw in the SPRINT trial. And there’s other patients who will benefit from deprescribing and having a slightly higher target. Those sorts of things very much need to be individualized at the patient level.”

And ideally, he added, clinicians in practice should probably be even more selective in choosing patients for a deprescribing strategy, “and focus on people who are at the highest risk of adverse events.”

Dr. Sheppard has disclosed no relevant financial relationships; disclosures for the other authors are in the report. Dr. Peterson disclosed receiving personal fees from Cerner and Livongo and grants and personal fees from AstraZeneca, Janssen, and Amgen; Dr. Rick has disclosed no relevant financial relationships.

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

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.

Courtesy Dr. Sejal Hathi

Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.

“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”

The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.

In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.

Courtesy John Paul Schnapper-Casteras

“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
 

Letter highlights hospitals’ obligations

As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.

Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”

“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”

Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.

“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”

Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.

Workplace rights, legal options

Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.

“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”

In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.

Courtesy Sheel Tyle

“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.

Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.

“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”

While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.

Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.

“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”

agallegos@mdedge.com

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.

Courtesy Dr. Sejal Hathi

Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.

“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”

The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.

In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.

Courtesy John Paul Schnapper-Casteras

“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
 

Letter highlights hospitals’ obligations

As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.

Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”

“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”

Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.

“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”

Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.

Workplace rights, legal options

Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.

“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”

In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.

Courtesy Sheel Tyle

“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.

Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.

“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”

While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.

Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.

“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”

agallegos@mdedge.com

Sejal Hathi, MD, and two colleagues had long kicked around the idea of starting a nonprofit group that would center on civic and legal advocacy.

Courtesy Dr. Sejal Hathi

Once the COVID-19 pandemic hit, the three friends – who have a mix of legal, medical, and advocacy backgrounds – began chatting by email and through Zoom video meetings about how to make the plan a reality.

“When COVID came around, we began talking about where we could make a difference and help people where help was needed most,” said Dr. Hathi, an internal medicine resident at Massachusetts General Hospital in Boston. “We decided the PPE issue makes a good first focus.”

The new organization – named Beacon – quickly mobilized, assembled their team, and launched a website. Beacon’s first project now aims to highlight and protect the legal rights of medical professionals who speak out about personal protection equipment (PPE) supply and other matters of public concern related to coronavirus.

In recent months, health care professionals have reported being reprimanded or even terminated for publicly discussing PPE shortages or sharing safety concerns. Other clinicians say they can’t share their experiences for fear of reprisal by their hospitals.

Courtesy John Paul Schnapper-Casteras

“The centrality of adequate PPE is pretty undeniable at this point,” said John Paul Schnapper-Casteras, JD, an attorney and cofounder of the organization. “In terms of speaking up about matters of workplace safety and public concern, when health care workers share knowledge, correct problems – and in some cases, blow the whistle – it affirmatively benefits medical science, disease control, and the public interest,” he said in an interview. “We have seen in other countries, the disastrous consequences that can stem from silencing medical professionals who try to speak out.”
 

Letter highlights hospitals’ obligations

As part of their efforts, Beacon leaders drafted a strongly worded letter on behalf of health care workers outlining the legal obligations of hospitals to ensure workplace safety, underscoring the federal protections that bar retaliation against employees who exercise their workplace rights. Whistleblower protections under the Occupational Safety and Health Act, the False Claims Act, and the National Labor Relations Act, for instance, prohibit retaliation against employees for blowing the whistle on unsafe or unlawful conditions.

Beacon’s letter urges hospitals to adopt a uniform policy that recognizes “the importance and legitimacy of doctors, nurses, and medical professionals who research, write, and speak about the use and supply of PPE in addressing coronavirus.”

“We are deeply troubled by reports that medical professionals are being fired, retaliated against, disciplined, or threatened for speaking (or potentially speaking) about PPE shortages and related safety conditions that directly place their and their patients’ lives in danger,” the letter states. “As a matter of law, medical personnel have a wide range of rights that protect their employment status and ability to comment on matters of public concern (and provide a cause of action in court if these rights are violated).”

Dr. Hathi, who over the last decade has founded two social enterprises advancing women’s rights, said organizers have sent the letter to hospitals and health systems that were publicly reported or otherwise known to have threatened, terminated, or retaliated against employees for protesting PPE shortages or speaking up about unsafe working conditions during this crisis. The letter is available on the Beacon website.

“Many letters have been written [recently] criticizing hospitals for retaliating against their workers,” Dr. Hathi said. “Ours amplifies this voice. But it also serves as a tool for self-empowerment, a stark warning to health systems that their actions bear consequences, and an assurance to health workers across the country that we’re listening and we’re here to help them safeguard their rights and their dignity at work.”

Dr. Hathi and her colleagues have also circulated the letter on social media and other platforms as a petition that health care professionals and others can sign in support of fair and safe treatment of employees with respect to PPE. So far, the group has collected signatures from individuals, communities, and organizations representing about 35,000 people, Dr. Hathi said.

Workplace rights, legal options

Beacon leaders have also begun counseling and advising health care workers who have experienced retaliation or discipline associated with PPE issues. Educating medical professionals about their workplace rights and legal options is another key focus of the group, according to its founders.

“There are a flurry of reports coming our way about physicians and nurses, as well as other health care workers, who are for whatever reason being disciplined or retaliated against for simply seeking appropriate safety policies at their workplaces,” Dr. Hathi said. “What we’ve found is that many of them don’t even know what their options look like. Doctors, nurses, health care workers are not the typical type to engage politically, to speak out, [or to] advocate for themselves.”

In one instance, they heard from a physician who wanted to protect nurses at his hospital because they did not have masks and were being coughed on by COVID-19 patients. The doctor requested that his hospital supply masks to the nurses. After making the request, the physician was disciplined by hospital leadership, Dr. Hathi said. In another case, a physician assistant told the group she was terminated because she wanted to wear her own mask in a hospital that was treating COVID patients.

Courtesy Sheel Tyle

“She was not allowed to, and she was fired for even bringing it up,” said Sheel Tyle, JD, an attorney and Beacon cofounder.

Beacon intends to assist health care workers who face such retaliation and discipline in a number of ways, Mr. Tyle said. For instance, by helping an individual get compensation for what happened, aiding the professional in getting their job back, or helping the worker retain a severance package of some kind, he said.

“And then there is the larger public policy issue of preventing the hospital from being a bad actor,” Mr. Tyle said. “That can be done through state or federal complaints, largely under different statutes related to workplace protection or OSHA. Our group [has] lawyers that could represent clients individually as well as a number of friends who are attorneys in various states who we could partner with, depending on the situation.”

While the organization is positioned to represent health professionals in lawsuits if necessary, Mr. Tyle emphasized that litigation is not the intended goal of the group. Rather, they are seeking to deter hospitals and others from being “bad actors,” through any number of methods, including communication, advocacy, or complaints.

Ultimately, Dr. Hathi said she hopes the organization’s efforts activate health care workers as an organizing body and in the process, spark policy change at the federal level to better protect health care workers.

“The challenges we’re facing now – protecting workplace safety, employee voice, a living wage, adequate sick and family leave – long predate this pandemic,” Dr. Hathi said. “But they’ve deepened and acquired existential significance as, battered by policy failures and the unsparing virus itself, physicians shed their political indifference and join a growing nationwide chorus to restore workers’ rights and to fundamentally reimagine our broken healthcare system. Now, more than ever before, organizations like Beacon are vital for arming health workers in this fight.”

agallegos@mdedge.com

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The Food and Drug Administration issued an emergency use authorization for use of the Impella RP heart pump system in COVID-19 patients with right heart failure or decompensation, Abiomed announced June 1.

“Based on extrapolation of data from the approved indication and reported clinical experience, FDA has concluded that the Impella RP may be effective at providing temporary right ventricular support for the treatment of acute right heart failure or decompensation caused by COVID-19 complications, including PE [pulmonary embolism],” the letter noted.

It cited, for example, use of the temporary heart pump in a 59-year-old woman suffering from COVID-19 who went into right ventricular failure and became hypotensive after an acute PE was removed. After placement of the device, the patient experienced a “dramatic and immediate” improvement in arterial pressure and the device was removed on the fifth day, according to Amir Kaki, MD, and Ted Schreiber, MD, of Ascension St. John Hospital, Detroit, whose review of the case has been posted online.

“Acute pulmonary embolism is clearly being recognized as a life-threatening manifestation of COVID-19. Impella RP is an important tool to help cardiologists save lives during this pandemic,” Dr. Kaki said in the letter. “As we have demonstrated in our series of patients, early recognition of right ventricular dysfunction and early placement of the Impella RP for patients who are hypotensive can be lifesaving.”

Other data cited in support of the Impella RP emergency use authorization (EUA) include a 2019 series of hemodynamically unstable patients with PE in Japan and a 2017 case report of a 47-year-old man with right ventricular failure, profound shock, and a massive PE.

The FDA granted premarket approval of the Impella RP system in 2017 to provide temporary right ventricular support for up to 14 days in patients with a body surface area of at least 1.5 m² who develop acute right heart failure or decompensation following left ventricular assist device implantation, MI, heart transplant, or open-heart surgery.

The EUA indication for the Impella RP system is to provide temporary right ventricular support for up to 14 days in critical care patients with a body surface area of at least 1.5 m2 for the treatment of acute right heart failure or decompensation caused by complications related to COVID-19, including PE.

The Impella RP is authorized only for emergency use under the EUA and only for the duration of the circumstances justifying use of EUAs, the letter noted.

Last year, concerns were raised about off-indication use after interim results from a postapproval study suggested a higher risk for death than seen in premarket studies treated with the temporary heart pump.

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

The US Department of Defense (DoD) has unveiled a plan for returning to normal operations. The plan is tied to “local conditions” and does not have specific dates for opening. Instead, the plan provides phase-by-phase guidance to commanders, supervisors, and employees to safely and effectively return to Pentagon Reservation offices. Along with guidelines for in-office and telework targets; vulnerable populations; entrance screening; and the status and cleaning of common areas, food courts, gyms and other facilities, the plan includes mandatory requirements regarding face coverings, social distancing, and symptomatic personnel throughout each phase.

Building on the 3-phase White House “Opening Up America Again” plan, the Joint Staff, military services, and the DoD COVID Task Force have developed a 5-phase plan. Currently, the department is at Phase Zero. The Pentagon Reservation Plan for Resilience and ‘Aligning with National Guidelines for Opening Up America Again’ “places the health and safety of our workforce first,” is “nested” within the White House, Office of Management and Budget, and Office of Personnel Management guidelines and plans. The goal is to allow the workforce to return to the Pentagon Reservation “in a controlled and steady manner.”

The DoD reported nearly 10,000 COVID-19 cases as of June 1, 2020, including 6,596 active-duty service members, 1,124 dependents, 1,516 civilians, and 649 DoD contractors. To date, 3 service members and 5 dependents have died of COVID-19, including Capt. Douglas Linn Hickok, a physician assistant and member of the New Jersey National Guard, who died March 28, 2020.

Since mid-March the DoD says it has taken “aggressive steps” to stop the spread of COVID-19, implementing health protection measures that resulted in a sustained transmission rate below that of the region at large. Teams have deep cleaned and sanitized more than 1 million square feet of office space on the Pentagon Reservation to US Centers for Disease Control and Prevention standards. And for the first time ever, according to the DoD, maximized telework options have enabled more than two-thirds of the Pentagon Reservation workforce to continue to work at alternate locations.

The criteria to enter Phase 1 require a downward trajectory of influenza-like illnesses reported with a 14-day period and a downward trajectory of COVID-like symptoms reported within a 14-day period. There must also be a downward trajectory of documented COVID-19 cases within a 14-day period or a downward trajectory of positive COVID-19 tests as a percentage of total tests within a 14-day period (flat or increasing volume of tests).

Finally, hospitals must treat all patients without crisis care and have a “robust” testing program in place for at-risk health care workers, including emerging antibody testing.

Those same criteria must be met between each phase of the plan. The “gates” for controlling moves from phase to phase are not tied to dates but are based on state, regional, and local public health conditions, availability of hospitals and testing capacity, and monitoring through the DoD’s Electronic Surveillance System for Early Notification of Community-based Epidemics (ESSENCE).

If the monitors detect a resurgence in the spread of COVID-19, the department will reassess its protection measures and workforce phase and respond appropriately. DoD service members and civilian employees are advised to talk with their commanders or supervisors to determine when it’s all right to return.

The US Department of Defense (DoD) has unveiled a plan for returning to normal operations. The plan is tied to “local conditions” and does not have specific dates for opening. Instead, the plan provides phase-by-phase guidance to commanders, supervisors, and employees to safely and effectively return to Pentagon Reservation offices. Along with guidelines for in-office and telework targets; vulnerable populations; entrance screening; and the status and cleaning of common areas, food courts, gyms and other facilities, the plan includes mandatory requirements regarding face coverings, social distancing, and symptomatic personnel throughout each phase.

Building on the 3-phase White House “Opening Up America Again” plan, the Joint Staff, military services, and the DoD COVID Task Force have developed a 5-phase plan. Currently, the department is at Phase Zero. The Pentagon Reservation Plan for Resilience and ‘Aligning with National Guidelines for Opening Up America Again’ “places the health and safety of our workforce first,” is “nested” within the White House, Office of Management and Budget, and Office of Personnel Management guidelines and plans. The goal is to allow the workforce to return to the Pentagon Reservation “in a controlled and steady manner.”

The DoD reported nearly 10,000 COVID-19 cases as of June 1, 2020, including 6,596 active-duty service members, 1,124 dependents, 1,516 civilians, and 649 DoD contractors. To date, 3 service members and 5 dependents have died of COVID-19, including Capt. Douglas Linn Hickok, a physician assistant and member of the New Jersey National Guard, who died March 28, 2020.

Since mid-March the DoD says it has taken “aggressive steps” to stop the spread of COVID-19, implementing health protection measures that resulted in a sustained transmission rate below that of the region at large. Teams have deep cleaned and sanitized more than 1 million square feet of office space on the Pentagon Reservation to US Centers for Disease Control and Prevention standards. And for the first time ever, according to the DoD, maximized telework options have enabled more than two-thirds of the Pentagon Reservation workforce to continue to work at alternate locations.

The criteria to enter Phase 1 require a downward trajectory of influenza-like illnesses reported with a 14-day period and a downward trajectory of COVID-like symptoms reported within a 14-day period. There must also be a downward trajectory of documented COVID-19 cases within a 14-day period or a downward trajectory of positive COVID-19 tests as a percentage of total tests within a 14-day period (flat or increasing volume of tests).

Finally, hospitals must treat all patients without crisis care and have a “robust” testing program in place for at-risk health care workers, including emerging antibody testing.

Those same criteria must be met between each phase of the plan. The “gates” for controlling moves from phase to phase are not tied to dates but are based on state, regional, and local public health conditions, availability of hospitals and testing capacity, and monitoring through the DoD’s Electronic Surveillance System for Early Notification of Community-based Epidemics (ESSENCE).

If the monitors detect a resurgence in the spread of COVID-19, the department will reassess its protection measures and workforce phase and respond appropriately. DoD service members and civilian employees are advised to talk with their commanders or supervisors to determine when it’s all right to return.

The US Department of Defense (DoD) has unveiled a plan for returning to normal operations. The plan is tied to “local conditions” and does not have specific dates for opening. Instead, the plan provides phase-by-phase guidance to commanders, supervisors, and employees to safely and effectively return to Pentagon Reservation offices. Along with guidelines for in-office and telework targets; vulnerable populations; entrance screening; and the status and cleaning of common areas, food courts, gyms and other facilities, the plan includes mandatory requirements regarding face coverings, social distancing, and symptomatic personnel throughout each phase.

Building on the 3-phase White House “Opening Up America Again” plan, the Joint Staff, military services, and the DoD COVID Task Force have developed a 5-phase plan. Currently, the department is at Phase Zero. The Pentagon Reservation Plan for Resilience and ‘Aligning with National Guidelines for Opening Up America Again’ “places the health and safety of our workforce first,” is “nested” within the White House, Office of Management and Budget, and Office of Personnel Management guidelines and plans. The goal is to allow the workforce to return to the Pentagon Reservation “in a controlled and steady manner.”

The DoD reported nearly 10,000 COVID-19 cases as of June 1, 2020, including 6,596 active-duty service members, 1,124 dependents, 1,516 civilians, and 649 DoD contractors. To date, 3 service members and 5 dependents have died of COVID-19, including Capt. Douglas Linn Hickok, a physician assistant and member of the New Jersey National Guard, who died March 28, 2020.

Since mid-March the DoD says it has taken “aggressive steps” to stop the spread of COVID-19, implementing health protection measures that resulted in a sustained transmission rate below that of the region at large. Teams have deep cleaned and sanitized more than 1 million square feet of office space on the Pentagon Reservation to US Centers for Disease Control and Prevention standards. And for the first time ever, according to the DoD, maximized telework options have enabled more than two-thirds of the Pentagon Reservation workforce to continue to work at alternate locations.

The criteria to enter Phase 1 require a downward trajectory of influenza-like illnesses reported with a 14-day period and a downward trajectory of COVID-like symptoms reported within a 14-day period. There must also be a downward trajectory of documented COVID-19 cases within a 14-day period or a downward trajectory of positive COVID-19 tests as a percentage of total tests within a 14-day period (flat or increasing volume of tests).

Finally, hospitals must treat all patients without crisis care and have a “robust” testing program in place for at-risk health care workers, including emerging antibody testing.

Those same criteria must be met between each phase of the plan. The “gates” for controlling moves from phase to phase are not tied to dates but are based on state, regional, and local public health conditions, availability of hospitals and testing capacity, and monitoring through the DoD’s Electronic Surveillance System for Early Notification of Community-based Epidemics (ESSENCE).

If the monitors detect a resurgence in the spread of COVID-19, the department will reassess its protection measures and workforce phase and respond appropriately. DoD service members and civilian employees are advised to talk with their commanders or supervisors to determine when it’s all right to return.

Hidradenitis suppurativa (HS) was associated with a significantly increased risk of any cancer as well as for several specific cancers in a population-based study of approximately 200,000 individuals in Korea.

HS is associated with severe comorbidities, and previous studies have suggested a link between HS and cancer development, wrote Joon Min Jung, MD, of the University of Ulsan College of Medicine, Seoul, Korea, and colleagues.

“The aberrant immune response and chronic inflammation in HS and genetic and environmental factors associated with the disease may all be factors in the development of cancer,” but large, population-based studies of cancer in HS patients are limited, they noted.

In a study published in JAMA Dermatology, the researchers reviewed data from 22,468 adults with HS and 179,734 matched controls, in the Korean National Health Insurance System, seen by physicians between January 2009 and December 2017. The average age of the participants was 34 years, and 64% were male.

Overall, HS patients had a significantly higher risk of cancer compared with controls, with an adjusted hazard ratio (aHR) of 1.28.

As for specific cancers, HS patients had a significantly higher risk for Hodgkin lymphoma (aHR 5.08), oral cavity and pharyngeal cancer (aHR 3.10), central nervous system cancer (aHR 2.40), nonmelanoma skin cancer (aHR 2.06), prostate cancer (aHR 2.05), and colorectal cancer (aHR 1.45).

The risk of any cancer was not significantly different between women with HS and female controls (after adjustment for comorbidities), but was significantly higher among men with HS compared with male controls, also after adjustment for comorbidities (aHR, 1.37). In addition, HS patients in both younger (less than 40 years) and older (aged 40 years and older) age groups had increased cancer risk compared with age-matched controls. Overall cancer risk and the risk of most cancer types were higher among HS patients with moderate to severe disease than in those with mild disease, with the exception of nonmelanoma skin cancer, prostate cancer, lymphoma, and leukemia.

“Overall cancer risk showed a tendency to increase with worsening HS severity, reinforcing the possibility of an association between HS and cancer development,” the researchers noted. “However, we could not identify tendencies in some specific cancers, such as nonmelanoma skin cancer, CNS cancer, and prostate cancer, because the number of occurrences of those cancers was too small in the group with moderate to severe HS.”

The study findings were limited by several factors including the potential underestimate of HS cases in the population and the inability of the study design to adjust for factors including smoking status, alcohol use, and obesity, the researchers noted. However, the results support an increased cancer risk in HS patients and suggest the need to promote lifestyle modifications to reduce risk, and to increase cancer surveillance in these patients, they said. “For early detection of skin cancer, more aggressive histologic examination and a high level of suspicion are required,” they added.

The study was supported by the National Research Foundation of Korea and the Korea Health Technology R&D Project. The researchers had no financial conflicts to disclose.

SOURCE: Jung JM et al. JAMA Dermatol. 2020 May 27. doi: 10.1001/jamadermatol.2020.1422.

Hidradenitis suppurativa (HS) was associated with a significantly increased risk of any cancer as well as for several specific cancers in a population-based study of approximately 200,000 individuals in Korea.

HS is associated with severe comorbidities, and previous studies have suggested a link between HS and cancer development, wrote Joon Min Jung, MD, of the University of Ulsan College of Medicine, Seoul, Korea, and colleagues.

“The aberrant immune response and chronic inflammation in HS and genetic and environmental factors associated with the disease may all be factors in the development of cancer,” but large, population-based studies of cancer in HS patients are limited, they noted.

In a study published in JAMA Dermatology, the researchers reviewed data from 22,468 adults with HS and 179,734 matched controls, in the Korean National Health Insurance System, seen by physicians between January 2009 and December 2017. The average age of the participants was 34 years, and 64% were male.

Overall, HS patients had a significantly higher risk of cancer compared with controls, with an adjusted hazard ratio (aHR) of 1.28.

As for specific cancers, HS patients had a significantly higher risk for Hodgkin lymphoma (aHR 5.08), oral cavity and pharyngeal cancer (aHR 3.10), central nervous system cancer (aHR 2.40), nonmelanoma skin cancer (aHR 2.06), prostate cancer (aHR 2.05), and colorectal cancer (aHR 1.45).

The risk of any cancer was not significantly different between women with HS and female controls (after adjustment for comorbidities), but was significantly higher among men with HS compared with male controls, also after adjustment for comorbidities (aHR, 1.37). In addition, HS patients in both younger (less than 40 years) and older (aged 40 years and older) age groups had increased cancer risk compared with age-matched controls. Overall cancer risk and the risk of most cancer types were higher among HS patients with moderate to severe disease than in those with mild disease, with the exception of nonmelanoma skin cancer, prostate cancer, lymphoma, and leukemia.

“Overall cancer risk showed a tendency to increase with worsening HS severity, reinforcing the possibility of an association between HS and cancer development,” the researchers noted. “However, we could not identify tendencies in some specific cancers, such as nonmelanoma skin cancer, CNS cancer, and prostate cancer, because the number of occurrences of those cancers was too small in the group with moderate to severe HS.”

The study findings were limited by several factors including the potential underestimate of HS cases in the population and the inability of the study design to adjust for factors including smoking status, alcohol use, and obesity, the researchers noted. However, the results support an increased cancer risk in HS patients and suggest the need to promote lifestyle modifications to reduce risk, and to increase cancer surveillance in these patients, they said. “For early detection of skin cancer, more aggressive histologic examination and a high level of suspicion are required,” they added.

The study was supported by the National Research Foundation of Korea and the Korea Health Technology R&D Project. The researchers had no financial conflicts to disclose.

SOURCE: Jung JM et al. JAMA Dermatol. 2020 May 27. doi: 10.1001/jamadermatol.2020.1422.

Hidradenitis suppurativa (HS) was associated with a significantly increased risk of any cancer as well as for several specific cancers in a population-based study of approximately 200,000 individuals in Korea.

HS is associated with severe comorbidities, and previous studies have suggested a link between HS and cancer development, wrote Joon Min Jung, MD, of the University of Ulsan College of Medicine, Seoul, Korea, and colleagues.

“The aberrant immune response and chronic inflammation in HS and genetic and environmental factors associated with the disease may all be factors in the development of cancer,” but large, population-based studies of cancer in HS patients are limited, they noted.

In a study published in JAMA Dermatology, the researchers reviewed data from 22,468 adults with HS and 179,734 matched controls, in the Korean National Health Insurance System, seen by physicians between January 2009 and December 2017. The average age of the participants was 34 years, and 64% were male.

Overall, HS patients had a significantly higher risk of cancer compared with controls, with an adjusted hazard ratio (aHR) of 1.28.

As for specific cancers, HS patients had a significantly higher risk for Hodgkin lymphoma (aHR 5.08), oral cavity and pharyngeal cancer (aHR 3.10), central nervous system cancer (aHR 2.40), nonmelanoma skin cancer (aHR 2.06), prostate cancer (aHR 2.05), and colorectal cancer (aHR 1.45).

The risk of any cancer was not significantly different between women with HS and female controls (after adjustment for comorbidities), but was significantly higher among men with HS compared with male controls, also after adjustment for comorbidities (aHR, 1.37). In addition, HS patients in both younger (less than 40 years) and older (aged 40 years and older) age groups had increased cancer risk compared with age-matched controls. Overall cancer risk and the risk of most cancer types were higher among HS patients with moderate to severe disease than in those with mild disease, with the exception of nonmelanoma skin cancer, prostate cancer, lymphoma, and leukemia.

“Overall cancer risk showed a tendency to increase with worsening HS severity, reinforcing the possibility of an association between HS and cancer development,” the researchers noted. “However, we could not identify tendencies in some specific cancers, such as nonmelanoma skin cancer, CNS cancer, and prostate cancer, because the number of occurrences of those cancers was too small in the group with moderate to severe HS.”

The study findings were limited by several factors including the potential underestimate of HS cases in the population and the inability of the study design to adjust for factors including smoking status, alcohol use, and obesity, the researchers noted. However, the results support an increased cancer risk in HS patients and suggest the need to promote lifestyle modifications to reduce risk, and to increase cancer surveillance in these patients, they said. “For early detection of skin cancer, more aggressive histologic examination and a high level of suspicion are required,” they added.

The study was supported by the National Research Foundation of Korea and the Korea Health Technology R&D Project. The researchers had no financial conflicts to disclose.

SOURCE: Jung JM et al. JAMA Dermatol. 2020 May 27. doi: 10.1001/jamadermatol.2020.1422.

Coronaviruses (CoVs) are among the most common causes of the common cold but also can lead to severe respiratory disease.¹ In recent years, CoVs have been responsible for outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), caused by SARS-CoV and MERS-CoV, respectively. Severe acute respiratory syndrome emerged from China in 2002, and MERS started in Saudi Arabia in 2012. In December 2019, several cases of unexplained pneumonia were reported in Wuhan, China.¹ A novel CoV--SARS-CoV-2--was isolated in these patients and is now known to cause coronavirus disease 19 (COVID-19).¹ Coronavirus disease 19 can cause acute respiratory distress and multiorgan failure.^1,2 It spread quickly throughout the world and was declared a pandemic by the World Health Organization on March 11, 2020. According to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html), there were approximately 14,500 COVID-19 cases diagnosed worldwide on February 1, 2020; by May 22, 2020, there were more than 5,159,600 cases. Thus, heightened measures for infection prevention and control were put in place around the globe in an attempt to slow the spread of disease.¹  

In this article, we describe the dermatologic implications of COVID-19, including the clinical manifestations of the disease, risk reduction techniques for patients and providers, personal protective equipment-associated adverse reactions, and the financial impact on dermatologists.  

Clinical Manifestations 

At the start of the COVID-19 outbreak, little was known about the skin manifestations of the disease. Providers speculated that COVID-19 could have nonspecific skin findings similar to many other viral illnesses.^3,4 Research throughout the pandemic has found many cutaneous manifestations of the disease.^3-6 A case report from Thailand described a patient who presented with petechiae in addition to fever and thrombocytopenia, which led to an initial misdiagnosis of Dengue fever; however, when the patient began having respiratory symptoms, the diagnosis of COVID-19 was discovered.⁵ Furthermore, a study from Italy (N=88) showed dermatologic findings in 20.4% (18/88) of patients, including erythematous rash (77.8% [14/18]), widespread urticaria (16.7% [3/18]), and chickenpoxlike vesicles (5.6% [1/18]). A recent study from Spain (N=375) found 5 cutaneous patterns associated with COVID-19: pseudochilblain--acral areas of erythema with vesicles and/or pustules--lesions (19%), vesicular eruptions (9%), urticarial lesions (19%), maculopapular eruptions (47%), and livedoid/necrotic lesions (6%).⁶ Pseudochilblain lesions appeared in younger patients, occurred later in the disease course, and were associated with less severe disease. Vesicular lesions often were found in middle-aged patients prior to the onset of other COVID-19 symptoms, and they were associated with intermediate disease severity. Urticarial and maculopapular lesions typically paralleled other COVID-19 symptoms in timing and were associated with more severe disease. Likewise, livedoid and necrotic lesions were associated with more severe disease; they occurred more frequently in older patients.⁶ Clinicians at Cleveland Clinic found similar cutaneous lesions in COVID-19 patients, including morbilliform rashes, acral purpura resembling perniosis, and livedoid lesions.³ Initial biopsies of these lesions pointed to viral exanthema and thrombotic vasculopathy as potential etiologies of morbilliform and livedoid lesions, respectively. Interestingly, patients may present with multiple cutaneous morphologies of the disease at the same time.³ The acral lesions ("COVID toes") have been popularized throughout the media and thus may be the best-known cutaneous manifestation of the disease at this time. New findings continuously arise, and further research is warranted as lesions that develop in hospitalized COVID-19 patients could be virus related or secondary to hospital-induced skin irritation, stressors, or medications.³ Importantly, clinicians should be aware of these cutaneous signs of COVID-19, especially when triaging patients.

Risk Reduction

The current health crisis could have a drastic impact on dermatology patients and providers. One factor that may increase COVID-19 risk in dermatology patients is immunosuppression. Many patients are on immunomodulators and biologics for skin conditions, which can cause immunosuppression directly and indirectly. Immunosuppression is a risk factor for severe disease in patients with COVID-19, so this population is at higher risk for serious infection.⁷ Telemedicine for nonemergent cases and follow-ups should be considered to decrease traffic in high-risk hospitals; to limit the number of people in waiting rooms; and to protect staff, providers, and patients alike.¹ Recommendations for teledermatology consultation during this time include the following: First, have patients take photographs of their skin lesions and send them remotely to the consulting physician. If the lesion is easily recognizable, treatment recommendations can be made remotely; if the diagnosis is ambiguous, the dermatologist can set up an in-person appointment.¹  

Personal Protective Equipment

Moreover, the current need to wear personal protective equipment (PPE) and wash hands frequently may lead to skin disease among health care providers. Facial rashes may arise from wearing masks and goggles, and repeated handwashing and wearing gloves may lead to hand dermatitis.⁸ One study examined adverse skin reactions among health care workers (N=322) during the SARS outbreak in 2003. More than one-third (35.5%) of staff members who wore masks regularly during the outbreak reported adverse skin reactions, including acne (59.6%), facial itching (51.4%), and rash (35.8%).⁸ The acne etiology likely is multifactorial. Masks increase heat and humidity in the covered facial region, which can cause acne flare-ups due to increased sebum production and Cutibacterium acnes growth.⁸ Additionally, tight N95 masks may occlude the pilosebaceous glands, causing acne to flare. In the SARS study, facial itchiness and rashes likely were due to irritant contact dermatitis to the N95 masks. All of the respondents with adverse skin reactions from masks developed them after using N95 masks; those who wore surgical masks did not report reactions.⁸ Because N95 masks are recommended for health care workers caring for patients with highly transmissible respiratory infections such as SARS and COVID-19, it will be difficult to avoid wearing them during the current crisis. For this reason, topical retinoids and topical benzoyl peroxide should be the first-line treatment of mask-induced acne, and moisturization and topical corticosteroids should be used for facial erythema. Additionally, 21.4% of respondents reported adverse skin reactions from latex gloves during the SARS outbreak, including dry skin, itchiness, rash, and wheals.⁸ These skin reactions may have been type I IgE-mediated hypersensitivity reactions or irritant contact dermatitis due to latex sensitization and frequent handwashing. No respondents reported skin reactions to plastic gloves.⁸ For this reason, health care providers should consider wearing plastic gloves in lieu of or under latex gloves to prevent hand dermatitis during this time. Moisturization, barrier creams, and topical corticosteroids also can help treat hand dermatitis. Frequently changing PPE may help prevent skin disease among the frontline health care workers,⁸ which posed a problem at the beginning of the COVID-19 outbreak as there was a PPE shortage. With industry and individuals coming together to make and donate PPE, it is now more widely available for our frontline providers.  

Financial Impact

Finally, the pandemic is having an immense financial impact on dermatology.⁹ At the onset of the outbreak, our role as health care providers was to help slow the spread of COVID-19; for this reason, most elective procedures were cancelled, and many outpatient clinics closed. Both elective procedures and outpatient visits are central to dermatology, so many dermatologists worked less or not at all during this time, leading to a loss of revenue. The goals of these measures were to reduce transmissibility of the disease, to prevent the health care system from being overwhelmed with critical COVID-19 cases, and to allocate resources to the frontline providers.⁹ Although these measures were beneficial for slowing the spread of disease, they were detrimental to some providers' and practices' financial stability. Many dermatology practices have begun to reopen with COVID-19 precautions in place. For example, practices are limiting the number of patients that can be in the office at one time, mandating temperature readings upon check-in, and requiring masks be worn throughout the entire visit. With continued recommendations for individuals to stay at home as much as possible, the number of patients being seen in dermatology clinics on a daily basis remains less than normal. One potential solution is telemedicine, which would allow patients' concerns to be addressed while keeping providers practicing with a normal patient volume during this time.⁹ Keeping providers financially afloat is vital for private practices to continue operating after the pandemic. Dermatology appointments are in high demand with long waiting lists during nonpandemic times; without dermatologists practicing at full capacity, there will be an accumulation of patients with dermatologic conditions with even longer waiting times after the pandemic. Telemedicine may help reduce this potential accumulation of patients and allow patients to be treated in a more timely manner while alleviating financial pressures for providers.

Final Thoughts

The COVID-19 pandemic has spread across the world, infecting millions of people. Although the trends have slowed, more than 106,100 cases are still being diagnosed daily according to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html). Patients with COVID-19 may present with a variety of cutaneous lesions. Wearing PPE to take care of COVID-19 patients may lead to skin irritation, so care should be taken to address these adverse skin reactions to maintain the safety of providers. Finally, dermatologists should consider telemedicine during this time to protect high-risk patients, prevent a postpandemic surge of patients, and alleviate financial stressors caused by COVID-19.

Coronaviruses (CoVs) are among the most common causes of the common cold but also can lead to severe respiratory disease.¹ In recent years, CoVs have been responsible for outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), caused by SARS-CoV and MERS-CoV, respectively. Severe acute respiratory syndrome emerged from China in 2002, and MERS started in Saudi Arabia in 2012. In December 2019, several cases of unexplained pneumonia were reported in Wuhan, China.¹ A novel CoV--SARS-CoV-2--was isolated in these patients and is now known to cause coronavirus disease 19 (COVID-19).¹ Coronavirus disease 19 can cause acute respiratory distress and multiorgan failure.^1,2 It spread quickly throughout the world and was declared a pandemic by the World Health Organization on March 11, 2020. According to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html), there were approximately 14,500 COVID-19 cases diagnosed worldwide on February 1, 2020; by May 22, 2020, there were more than 5,159,600 cases. Thus, heightened measures for infection prevention and control were put in place around the globe in an attempt to slow the spread of disease.¹  

In this article, we describe the dermatologic implications of COVID-19, including the clinical manifestations of the disease, risk reduction techniques for patients and providers, personal protective equipment-associated adverse reactions, and the financial impact on dermatologists.  

Clinical Manifestations 

At the start of the COVID-19 outbreak, little was known about the skin manifestations of the disease. Providers speculated that COVID-19 could have nonspecific skin findings similar to many other viral illnesses.^3,4 Research throughout the pandemic has found many cutaneous manifestations of the disease.^3-6 A case report from Thailand described a patient who presented with petechiae in addition to fever and thrombocytopenia, which led to an initial misdiagnosis of Dengue fever; however, when the patient began having respiratory symptoms, the diagnosis of COVID-19 was discovered.⁵ Furthermore, a study from Italy (N=88) showed dermatologic findings in 20.4% (18/88) of patients, including erythematous rash (77.8% [14/18]), widespread urticaria (16.7% [3/18]), and chickenpoxlike vesicles (5.6% [1/18]). A recent study from Spain (N=375) found 5 cutaneous patterns associated with COVID-19: pseudochilblain--acral areas of erythema with vesicles and/or pustules--lesions (19%), vesicular eruptions (9%), urticarial lesions (19%), maculopapular eruptions (47%), and livedoid/necrotic lesions (6%).⁶ Pseudochilblain lesions appeared in younger patients, occurred later in the disease course, and were associated with less severe disease. Vesicular lesions often were found in middle-aged patients prior to the onset of other COVID-19 symptoms, and they were associated with intermediate disease severity. Urticarial and maculopapular lesions typically paralleled other COVID-19 symptoms in timing and were associated with more severe disease. Likewise, livedoid and necrotic lesions were associated with more severe disease; they occurred more frequently in older patients.⁶ Clinicians at Cleveland Clinic found similar cutaneous lesions in COVID-19 patients, including morbilliform rashes, acral purpura resembling perniosis, and livedoid lesions.³ Initial biopsies of these lesions pointed to viral exanthema and thrombotic vasculopathy as potential etiologies of morbilliform and livedoid lesions, respectively. Interestingly, patients may present with multiple cutaneous morphologies of the disease at the same time.³ The acral lesions ("COVID toes") have been popularized throughout the media and thus may be the best-known cutaneous manifestation of the disease at this time. New findings continuously arise, and further research is warranted as lesions that develop in hospitalized COVID-19 patients could be virus related or secondary to hospital-induced skin irritation, stressors, or medications.³ Importantly, clinicians should be aware of these cutaneous signs of COVID-19, especially when triaging patients.

Risk Reduction

The current health crisis could have a drastic impact on dermatology patients and providers. One factor that may increase COVID-19 risk in dermatology patients is immunosuppression. Many patients are on immunomodulators and biologics for skin conditions, which can cause immunosuppression directly and indirectly. Immunosuppression is a risk factor for severe disease in patients with COVID-19, so this population is at higher risk for serious infection.⁷ Telemedicine for nonemergent cases and follow-ups should be considered to decrease traffic in high-risk hospitals; to limit the number of people in waiting rooms; and to protect staff, providers, and patients alike.¹ Recommendations for teledermatology consultation during this time include the following: First, have patients take photographs of their skin lesions and send them remotely to the consulting physician. If the lesion is easily recognizable, treatment recommendations can be made remotely; if the diagnosis is ambiguous, the dermatologist can set up an in-person appointment.¹  

Personal Protective Equipment

Moreover, the current need to wear personal protective equipment (PPE) and wash hands frequently may lead to skin disease among health care providers. Facial rashes may arise from wearing masks and goggles, and repeated handwashing and wearing gloves may lead to hand dermatitis.⁸ One study examined adverse skin reactions among health care workers (N=322) during the SARS outbreak in 2003. More than one-third (35.5%) of staff members who wore masks regularly during the outbreak reported adverse skin reactions, including acne (59.6%), facial itching (51.4%), and rash (35.8%).⁸ The acne etiology likely is multifactorial. Masks increase heat and humidity in the covered facial region, which can cause acne flare-ups due to increased sebum production and Cutibacterium acnes growth.⁸ Additionally, tight N95 masks may occlude the pilosebaceous glands, causing acne to flare. In the SARS study, facial itchiness and rashes likely were due to irritant contact dermatitis to the N95 masks. All of the respondents with adverse skin reactions from masks developed them after using N95 masks; those who wore surgical masks did not report reactions.⁸ Because N95 masks are recommended for health care workers caring for patients with highly transmissible respiratory infections such as SARS and COVID-19, it will be difficult to avoid wearing them during the current crisis. For this reason, topical retinoids and topical benzoyl peroxide should be the first-line treatment of mask-induced acne, and moisturization and topical corticosteroids should be used for facial erythema. Additionally, 21.4% of respondents reported adverse skin reactions from latex gloves during the SARS outbreak, including dry skin, itchiness, rash, and wheals.⁸ These skin reactions may have been type I IgE-mediated hypersensitivity reactions or irritant contact dermatitis due to latex sensitization and frequent handwashing. No respondents reported skin reactions to plastic gloves.⁸ For this reason, health care providers should consider wearing plastic gloves in lieu of or under latex gloves to prevent hand dermatitis during this time. Moisturization, barrier creams, and topical corticosteroids also can help treat hand dermatitis. Frequently changing PPE may help prevent skin disease among the frontline health care workers,⁸ which posed a problem at the beginning of the COVID-19 outbreak as there was a PPE shortage. With industry and individuals coming together to make and donate PPE, it is now more widely available for our frontline providers.  

Financial Impact

Finally, the pandemic is having an immense financial impact on dermatology.⁹ At the onset of the outbreak, our role as health care providers was to help slow the spread of COVID-19; for this reason, most elective procedures were cancelled, and many outpatient clinics closed. Both elective procedures and outpatient visits are central to dermatology, so many dermatologists worked less or not at all during this time, leading to a loss of revenue. The goals of these measures were to reduce transmissibility of the disease, to prevent the health care system from being overwhelmed with critical COVID-19 cases, and to allocate resources to the frontline providers.⁹ Although these measures were beneficial for slowing the spread of disease, they were detrimental to some providers' and practices' financial stability. Many dermatology practices have begun to reopen with COVID-19 precautions in place. For example, practices are limiting the number of patients that can be in the office at one time, mandating temperature readings upon check-in, and requiring masks be worn throughout the entire visit. With continued recommendations for individuals to stay at home as much as possible, the number of patients being seen in dermatology clinics on a daily basis remains less than normal. One potential solution is telemedicine, which would allow patients' concerns to be addressed while keeping providers practicing with a normal patient volume during this time.⁹ Keeping providers financially afloat is vital for private practices to continue operating after the pandemic. Dermatology appointments are in high demand with long waiting lists during nonpandemic times; without dermatologists practicing at full capacity, there will be an accumulation of patients with dermatologic conditions with even longer waiting times after the pandemic. Telemedicine may help reduce this potential accumulation of patients and allow patients to be treated in a more timely manner while alleviating financial pressures for providers.

Final Thoughts

The COVID-19 pandemic has spread across the world, infecting millions of people. Although the trends have slowed, more than 106,100 cases are still being diagnosed daily according to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html). Patients with COVID-19 may present with a variety of cutaneous lesions. Wearing PPE to take care of COVID-19 patients may lead to skin irritation, so care should be taken to address these adverse skin reactions to maintain the safety of providers. Finally, dermatologists should consider telemedicine during this time to protect high-risk patients, prevent a postpandemic surge of patients, and alleviate financial stressors caused by COVID-19.

Coronaviruses (CoVs) are among the most common causes of the common cold but also can lead to severe respiratory disease.¹ In recent years, CoVs have been responsible for outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), caused by SARS-CoV and MERS-CoV, respectively. Severe acute respiratory syndrome emerged from China in 2002, and MERS started in Saudi Arabia in 2012. In December 2019, several cases of unexplained pneumonia were reported in Wuhan, China.¹ A novel CoV--SARS-CoV-2--was isolated in these patients and is now known to cause coronavirus disease 19 (COVID-19).¹ Coronavirus disease 19 can cause acute respiratory distress and multiorgan failure.^1,2 It spread quickly throughout the world and was declared a pandemic by the World Health Organization on March 11, 2020. According to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html), there were approximately 14,500 COVID-19 cases diagnosed worldwide on February 1, 2020; by May 22, 2020, there were more than 5,159,600 cases. Thus, heightened measures for infection prevention and control were put in place around the globe in an attempt to slow the spread of disease.¹  

In this article, we describe the dermatologic implications of COVID-19, including the clinical manifestations of the disease, risk reduction techniques for patients and providers, personal protective equipment-associated adverse reactions, and the financial impact on dermatologists.  

Clinical Manifestations 

At the start of the COVID-19 outbreak, little was known about the skin manifestations of the disease. Providers speculated that COVID-19 could have nonspecific skin findings similar to many other viral illnesses.^3,4 Research throughout the pandemic has found many cutaneous manifestations of the disease.^3-6 A case report from Thailand described a patient who presented with petechiae in addition to fever and thrombocytopenia, which led to an initial misdiagnosis of Dengue fever; however, when the patient began having respiratory symptoms, the diagnosis of COVID-19 was discovered.⁵ Furthermore, a study from Italy (N=88) showed dermatologic findings in 20.4% (18/88) of patients, including erythematous rash (77.8% [14/18]), widespread urticaria (16.7% [3/18]), and chickenpoxlike vesicles (5.6% [1/18]). A recent study from Spain (N=375) found 5 cutaneous patterns associated with COVID-19: pseudochilblain--acral areas of erythema with vesicles and/or pustules--lesions (19%), vesicular eruptions (9%), urticarial lesions (19%), maculopapular eruptions (47%), and livedoid/necrotic lesions (6%).⁶ Pseudochilblain lesions appeared in younger patients, occurred later in the disease course, and were associated with less severe disease. Vesicular lesions often were found in middle-aged patients prior to the onset of other COVID-19 symptoms, and they were associated with intermediate disease severity. Urticarial and maculopapular lesions typically paralleled other COVID-19 symptoms in timing and were associated with more severe disease. Likewise, livedoid and necrotic lesions were associated with more severe disease; they occurred more frequently in older patients.⁶ Clinicians at Cleveland Clinic found similar cutaneous lesions in COVID-19 patients, including morbilliform rashes, acral purpura resembling perniosis, and livedoid lesions.³ Initial biopsies of these lesions pointed to viral exanthema and thrombotic vasculopathy as potential etiologies of morbilliform and livedoid lesions, respectively. Interestingly, patients may present with multiple cutaneous morphologies of the disease at the same time.³ The acral lesions ("COVID toes") have been popularized throughout the media and thus may be the best-known cutaneous manifestation of the disease at this time. New findings continuously arise, and further research is warranted as lesions that develop in hospitalized COVID-19 patients could be virus related or secondary to hospital-induced skin irritation, stressors, or medications.³ Importantly, clinicians should be aware of these cutaneous signs of COVID-19, especially when triaging patients.

Risk Reduction

The current health crisis could have a drastic impact on dermatology patients and providers. One factor that may increase COVID-19 risk in dermatology patients is immunosuppression. Many patients are on immunomodulators and biologics for skin conditions, which can cause immunosuppression directly and indirectly. Immunosuppression is a risk factor for severe disease in patients with COVID-19, so this population is at higher risk for serious infection.⁷ Telemedicine for nonemergent cases and follow-ups should be considered to decrease traffic in high-risk hospitals; to limit the number of people in waiting rooms; and to protect staff, providers, and patients alike.¹ Recommendations for teledermatology consultation during this time include the following: First, have patients take photographs of their skin lesions and send them remotely to the consulting physician. If the lesion is easily recognizable, treatment recommendations can be made remotely; if the diagnosis is ambiguous, the dermatologist can set up an in-person appointment.¹  

Personal Protective Equipment

Moreover, the current need to wear personal protective equipment (PPE) and wash hands frequently may lead to skin disease among health care providers. Facial rashes may arise from wearing masks and goggles, and repeated handwashing and wearing gloves may lead to hand dermatitis.⁸ One study examined adverse skin reactions among health care workers (N=322) during the SARS outbreak in 2003. More than one-third (35.5%) of staff members who wore masks regularly during the outbreak reported adverse skin reactions, including acne (59.6%), facial itching (51.4%), and rash (35.8%).⁸ The acne etiology likely is multifactorial. Masks increase heat and humidity in the covered facial region, which can cause acne flare-ups due to increased sebum production and Cutibacterium acnes growth.⁸ Additionally, tight N95 masks may occlude the pilosebaceous glands, causing acne to flare. In the SARS study, facial itchiness and rashes likely were due to irritant contact dermatitis to the N95 masks. All of the respondents with adverse skin reactions from masks developed them after using N95 masks; those who wore surgical masks did not report reactions.⁸ Because N95 masks are recommended for health care workers caring for patients with highly transmissible respiratory infections such as SARS and COVID-19, it will be difficult to avoid wearing them during the current crisis. For this reason, topical retinoids and topical benzoyl peroxide should be the first-line treatment of mask-induced acne, and moisturization and topical corticosteroids should be used for facial erythema. Additionally, 21.4% of respondents reported adverse skin reactions from latex gloves during the SARS outbreak, including dry skin, itchiness, rash, and wheals.⁸ These skin reactions may have been type I IgE-mediated hypersensitivity reactions or irritant contact dermatitis due to latex sensitization and frequent handwashing. No respondents reported skin reactions to plastic gloves.⁸ For this reason, health care providers should consider wearing plastic gloves in lieu of or under latex gloves to prevent hand dermatitis during this time. Moisturization, barrier creams, and topical corticosteroids also can help treat hand dermatitis. Frequently changing PPE may help prevent skin disease among the frontline health care workers,⁸ which posed a problem at the beginning of the COVID-19 outbreak as there was a PPE shortage. With industry and individuals coming together to make and donate PPE, it is now more widely available for our frontline providers.  

Financial Impact

Finally, the pandemic is having an immense financial impact on dermatology.⁹ At the onset of the outbreak, our role as health care providers was to help slow the spread of COVID-19; for this reason, most elective procedures were cancelled, and many outpatient clinics closed. Both elective procedures and outpatient visits are central to dermatology, so many dermatologists worked less or not at all during this time, leading to a loss of revenue. The goals of these measures were to reduce transmissibility of the disease, to prevent the health care system from being overwhelmed with critical COVID-19 cases, and to allocate resources to the frontline providers.⁹ Although these measures were beneficial for slowing the spread of disease, they were detrimental to some providers' and practices' financial stability. Many dermatology practices have begun to reopen with COVID-19 precautions in place. For example, practices are limiting the number of patients that can be in the office at one time, mandating temperature readings upon check-in, and requiring masks be worn throughout the entire visit. With continued recommendations for individuals to stay at home as much as possible, the number of patients being seen in dermatology clinics on a daily basis remains less than normal. One potential solution is telemedicine, which would allow patients' concerns to be addressed while keeping providers practicing with a normal patient volume during this time.⁹ Keeping providers financially afloat is vital for private practices to continue operating after the pandemic. Dermatology appointments are in high demand with long waiting lists during nonpandemic times; without dermatologists practicing at full capacity, there will be an accumulation of patients with dermatologic conditions with even longer waiting times after the pandemic. Telemedicine may help reduce this potential accumulation of patients and allow patients to be treated in a more timely manner while alleviating financial pressures for providers.

Final Thoughts

The COVID-19 pandemic has spread across the world, infecting millions of people. Although the trends have slowed, more than 106,100 cases are still being diagnosed daily according to the Johns Hopkins University Coronavirus Resource Center (https://coronavirus.jhu.edu/map.html). Patients with COVID-19 may present with a variety of cutaneous lesions. Wearing PPE to take care of COVID-19 patients may lead to skin irritation, so care should be taken to address these adverse skin reactions to maintain the safety of providers. Finally, dermatologists should consider telemedicine during this time to protect high-risk patients, prevent a postpandemic surge of patients, and alleviate financial stressors caused by COVID-19.

Testing for HER2 in patients with colorectal cancer (CRC) should become a new standard of care, say experts discussing new results from a phase 2 trial showing benefit with trastuzumab deruxtecan (T-DXd, marketed as Enhertu, AstraZeneca/Daiichi Sankyo).

This drug is approved in the United States for use in the treatment of unresectable or metastatic HER2-positive breast cancer in patients who have already received two or more prior anti–HER2-based regimens in the metastatic setting.

Results come from a phase 2 study, dubbed DESTINY-CRC01, in patients with previously treated HER2+ advanced CRC.

The results show that, in patients with the highest degree of HER2 positivity, T-DXd was associated with an objective response rate of over 45% and a median progression-free survival (PFS) of almost 7 months.

They “demonstrate, in our opinion, the potential of T-DXd as a treatment option” for patients with advanced HER2-positive colorectal cancer that is refractory to standard therapies, said lead investigator Salvatore Siena, MD, from Niguarda Cancer Center, in Milan, Italy.

He presented the results at the 2020 annual meeting of the American Society of Clinical Oncology, held virtually because of the coronavirus pandemic.

At the same time, results from another study, this time in gastric cancer patients, were published online in the New England Journal of Medicine.
 

Interstitial lung disease as adverse event

The safety profile of T-DXd seen in the colorectal trial “is consistent with what has been previously reported,” said Siena, adding that most of the adverse events were low grade. But he noted there was also a serious adverse effect – interstitial lung disease (ILD). This occurred in 6% of patients, two of whom died. This is “an important risk and requires careful monitoring and proper intervention,” he emphasized.

The ILD adverse effect in this study is “a concern…and something to consider,” commented discussant for the study Michael S. Lee, MD, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill. But he added that these are the “the best data so far for subsequent anti-HER2 therapy in colorectal cancer”.

Also, the dose of drug used in this trial was higher than that approved for breast cancer, and the incidence of ILD “begs the question of whether we should be using a lower dose in this patient population,” said Autumn J. McRee, MD, also from Lineberger, in a highlights session at the meeting.

“The question here really is whether an HER2-specific approach is superior to what we would offer to these patients in the standard of care setting,” McRee said.

She noted that the patients in DESTINY-CRC01 were “heavily pretreated…and if you think about what our options are in the refractory setting, we do have two approved treatments: regorafenib [Stivarga, Bayer] and TAS-102 [Lonsurf, Taiho Oncology].”

The current data suggest, however, that T-DXd is associated with a trend toward higher response rates and improved survival outcomes, as well as lower monthly costs.

“Without a doubt, this trial is clinically relevant,” she said, adding that it’s “important not to miss these patients.”

“They are rare…but I would argue that testing for HER2 amplification in colorectal cancer should be considered standard of care,” she said.

She added that, based on the current evidence, the trial “may be” practice changing, although it is “still to be determined how to sequence HER2 targeted therapies.”
 

Study details

The trial was conducted in 78 patients with previously treated unresectable and/or metastatic CRC that was HER2 expressing, RAS/BRAF wild type, and patients had to have received at least two prior regimens, including prior anti-HER2 treatment. Patients with current or suspected ILD were excluded.

Patients were divided into three cohorts based on the degree of HER2 positivity:

• HER2+ with immunohistochemistry (IHC) scoring 3+ or IHC2+/in-situ-hybridization (ISH)+ (cohort A, n = 53)
• HER2 IHC2+/ISH– (cohort B, n = 7)
• HER2 IHC1+ (cohort C, n = 18)

All patients received T-DXd at 6.4 mg/kg intravenously every 3 weeks until progression or intolerable toxicity.

Across the three cohorts, the median age was 58.5 years, and nearly half (47.4%) of patients were female. The vast majority (98.7%) of patents had ECOG performance status 0 or 1, and the primary tumor site was the left colon or rectum in 89.7%.

Siena noted that “the median number of prior lines of standard therapies was four, ranging from two to 11.” All patients had previously received irinotecan and oxaliplatin, and 20.5% had received an anti-HER2 drug.

At the data cutoff on August 9, 2019, 38.5% of patients remained on treatment. The reason for discontinuation was progressive disease in 41%, and clinical progression in 9%.

Siena reported that the overall response rate, as confirmed by independent central review, was 45.3% in cohort A, with all but one of the 24 responders having a partial response. No responses were recorded in cohorts B and C.

Stable disease was seen in 37.7% of cohort A patients, giving a disease control rate of 83%. The median duration of response was not reached.

Median PFS was 6.9 months in cohort A, and the medial overall survival was not reached.

In terms of safety, 50.9% of patients in cohort A and 48.7% patients overall experienced drug-related treatment emergent adverse events, with 22.6% and 17.9%, respectively, having serious drug-related events.

The most common treatment-emergent adverse events were nausea, anemia, reduced neutrophil count, fatigue, and decreased appetite.

There were two deaths related to the study drug, as determined by investigator assessment: one from pneumonitis and one as a result of ILD, with both occurring in cohort A.

Looking specifically at ILD, Siena said there were five events – two grade 2, one grade 3, and two grade 5 – at a median time to reported onset of 80 days. All patients received corticosteroids, as per the study protocol, and two recovered.

Study discussant Lee commented that biomarker testing, such as for HER2, “is part of our standard of care for colorectal cancer,” although studies such as the current one are providing new data to “better refine” treatment approaches.

Lee said that, overall, T-DXd had a response rate and PFS survival “that looked similar to prior data from previous single arm phase 2 studies,” with response rates generally ranging from 30% to 50%, “and this compares favorably with other standard of care options” for chemotherapy-refractory patients.

Nevertheless, there are several ongoing questions related to the treatment of HER2 amplified metastatic CRC patients, some of which are being addressed in the ongoing SWOG S1613 study.

Lee said that, for now, he would recommend that patients with HER2 amplification enroll in a clinical trial, if possible. “However, if that’s not feasible, there are a range of options to consider,” including trastuzumab plus lapatinib (Tykerb, Novartis), or trastuzumab plus pembrolizumab (Keytruda, Merck).

However, “none of these options are FDA approved so there will be issues potentially with financial toxicity and other regulatory issues,” he said.

The study was funded by Daiichi Sankyo Co, Ltd.

Siena reports stock and other ownership interests with Guardant Health and Myriad Genetics; a consulting or advisory role with Amgen, Bayer, Bristol-Myers Squibb, CheckmAb, Clovis Oncology, Daiichi Sankyo, Incyte, Merck, Novartis, Roche/Genentech, Seattle Genetics; research funding from MSD Oncology (Inst); patents, royalties, and other intellectual property from Amgen; and travel, accommodations, expenses from Amgen, Bayer, and Roche. Other coauthors report potential conflicts of interest. The full list can be found with the original article.

Lee reports: Research Funding – Amgen (Inst); Bristol-Myers Squibb (Inst); EMD Serono (Inst); Exelixis (Inst); Genentech/Roche (Inst); Pfizer (Inst); Travel, Accommodations, Expenses – Genentech/Roche.

McRee reports honoraria from Cor2Ed and Onc Live; research funding from AstraZeneca (Inst), BioMed Valley Discoveries (Inst), Boston Biomedical (Inst), Inovio Pharmaceuticals (Inst), Merck (Inst), Novartis (Inst), Rgenix (Inst), and Takeda (Inst); and travel, accommodations, expenses from Cor2Ed.

This article first appeared on Medscape.com.

Testing for HER2 in patients with colorectal cancer (CRC) should become a new standard of care, say experts discussing new results from a phase 2 trial showing benefit with trastuzumab deruxtecan (T-DXd, marketed as Enhertu, AstraZeneca/Daiichi Sankyo).

This drug is approved in the United States for use in the treatment of unresectable or metastatic HER2-positive breast cancer in patients who have already received two or more prior anti–HER2-based regimens in the metastatic setting.

Results come from a phase 2 study, dubbed DESTINY-CRC01, in patients with previously treated HER2+ advanced CRC.

The results show that, in patients with the highest degree of HER2 positivity, T-DXd was associated with an objective response rate of over 45% and a median progression-free survival (PFS) of almost 7 months.

They “demonstrate, in our opinion, the potential of T-DXd as a treatment option” for patients with advanced HER2-positive colorectal cancer that is refractory to standard therapies, said lead investigator Salvatore Siena, MD, from Niguarda Cancer Center, in Milan, Italy.

He presented the results at the 2020 annual meeting of the American Society of Clinical Oncology, held virtually because of the coronavirus pandemic.

At the same time, results from another study, this time in gastric cancer patients, were published online in the New England Journal of Medicine.
 

Interstitial lung disease as adverse event

The safety profile of T-DXd seen in the colorectal trial “is consistent with what has been previously reported,” said Siena, adding that most of the adverse events were low grade. But he noted there was also a serious adverse effect – interstitial lung disease (ILD). This occurred in 6% of patients, two of whom died. This is “an important risk and requires careful monitoring and proper intervention,” he emphasized.

The ILD adverse effect in this study is “a concern…and something to consider,” commented discussant for the study Michael S. Lee, MD, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill. But he added that these are the “the best data so far for subsequent anti-HER2 therapy in colorectal cancer”.

Also, the dose of drug used in this trial was higher than that approved for breast cancer, and the incidence of ILD “begs the question of whether we should be using a lower dose in this patient population,” said Autumn J. McRee, MD, also from Lineberger, in a highlights session at the meeting.

“The question here really is whether an HER2-specific approach is superior to what we would offer to these patients in the standard of care setting,” McRee said.

She noted that the patients in DESTINY-CRC01 were “heavily pretreated…and if you think about what our options are in the refractory setting, we do have two approved treatments: regorafenib [Stivarga, Bayer] and TAS-102 [Lonsurf, Taiho Oncology].”

The current data suggest, however, that T-DXd is associated with a trend toward higher response rates and improved survival outcomes, as well as lower monthly costs.

“Without a doubt, this trial is clinically relevant,” she said, adding that it’s “important not to miss these patients.”

“They are rare…but I would argue that testing for HER2 amplification in colorectal cancer should be considered standard of care,” she said.

She added that, based on the current evidence, the trial “may be” practice changing, although it is “still to be determined how to sequence HER2 targeted therapies.”
 

Study details

The trial was conducted in 78 patients with previously treated unresectable and/or metastatic CRC that was HER2 expressing, RAS/BRAF wild type, and patients had to have received at least two prior regimens, including prior anti-HER2 treatment. Patients with current or suspected ILD were excluded.

Patients were divided into three cohorts based on the degree of HER2 positivity:

• HER2+ with immunohistochemistry (IHC) scoring 3+ or IHC2+/in-situ-hybridization (ISH)+ (cohort A, n = 53)
• HER2 IHC2+/ISH– (cohort B, n = 7)
• HER2 IHC1+ (cohort C, n = 18)

All patients received T-DXd at 6.4 mg/kg intravenously every 3 weeks until progression or intolerable toxicity.

Across the three cohorts, the median age was 58.5 years, and nearly half (47.4%) of patients were female. The vast majority (98.7%) of patents had ECOG performance status 0 or 1, and the primary tumor site was the left colon or rectum in 89.7%.

Siena noted that “the median number of prior lines of standard therapies was four, ranging from two to 11.” All patients had previously received irinotecan and oxaliplatin, and 20.5% had received an anti-HER2 drug.

At the data cutoff on August 9, 2019, 38.5% of patients remained on treatment. The reason for discontinuation was progressive disease in 41%, and clinical progression in 9%.

Siena reported that the overall response rate, as confirmed by independent central review, was 45.3% in cohort A, with all but one of the 24 responders having a partial response. No responses were recorded in cohorts B and C.

Stable disease was seen in 37.7% of cohort A patients, giving a disease control rate of 83%. The median duration of response was not reached.

Median PFS was 6.9 months in cohort A, and the medial overall survival was not reached.

In terms of safety, 50.9% of patients in cohort A and 48.7% patients overall experienced drug-related treatment emergent adverse events, with 22.6% and 17.9%, respectively, having serious drug-related events.

The most common treatment-emergent adverse events were nausea, anemia, reduced neutrophil count, fatigue, and decreased appetite.

There were two deaths related to the study drug, as determined by investigator assessment: one from pneumonitis and one as a result of ILD, with both occurring in cohort A.

Looking specifically at ILD, Siena said there were five events – two grade 2, one grade 3, and two grade 5 – at a median time to reported onset of 80 days. All patients received corticosteroids, as per the study protocol, and two recovered.

Study discussant Lee commented that biomarker testing, such as for HER2, “is part of our standard of care for colorectal cancer,” although studies such as the current one are providing new data to “better refine” treatment approaches.

Lee said that, overall, T-DXd had a response rate and PFS survival “that looked similar to prior data from previous single arm phase 2 studies,” with response rates generally ranging from 30% to 50%, “and this compares favorably with other standard of care options” for chemotherapy-refractory patients.

Nevertheless, there are several ongoing questions related to the treatment of HER2 amplified metastatic CRC patients, some of which are being addressed in the ongoing SWOG S1613 study.

Lee said that, for now, he would recommend that patients with HER2 amplification enroll in a clinical trial, if possible. “However, if that’s not feasible, there are a range of options to consider,” including trastuzumab plus lapatinib (Tykerb, Novartis), or trastuzumab plus pembrolizumab (Keytruda, Merck).

However, “none of these options are FDA approved so there will be issues potentially with financial toxicity and other regulatory issues,” he said.

The study was funded by Daiichi Sankyo Co, Ltd.

Siena reports stock and other ownership interests with Guardant Health and Myriad Genetics; a consulting or advisory role with Amgen, Bayer, Bristol-Myers Squibb, CheckmAb, Clovis Oncology, Daiichi Sankyo, Incyte, Merck, Novartis, Roche/Genentech, Seattle Genetics; research funding from MSD Oncology (Inst); patents, royalties, and other intellectual property from Amgen; and travel, accommodations, expenses from Amgen, Bayer, and Roche. Other coauthors report potential conflicts of interest. The full list can be found with the original article.

Lee reports: Research Funding – Amgen (Inst); Bristol-Myers Squibb (Inst); EMD Serono (Inst); Exelixis (Inst); Genentech/Roche (Inst); Pfizer (Inst); Travel, Accommodations, Expenses – Genentech/Roche.

McRee reports honoraria from Cor2Ed and Onc Live; research funding from AstraZeneca (Inst), BioMed Valley Discoveries (Inst), Boston Biomedical (Inst), Inovio Pharmaceuticals (Inst), Merck (Inst), Novartis (Inst), Rgenix (Inst), and Takeda (Inst); and travel, accommodations, expenses from Cor2Ed.

This article first appeared on Medscape.com.

Testing for HER2 in patients with colorectal cancer (CRC) should become a new standard of care, say experts discussing new results from a phase 2 trial showing benefit with trastuzumab deruxtecan (T-DXd, marketed as Enhertu, AstraZeneca/Daiichi Sankyo).

This drug is approved in the United States for use in the treatment of unresectable or metastatic HER2-positive breast cancer in patients who have already received two or more prior anti–HER2-based regimens in the metastatic setting.

Results come from a phase 2 study, dubbed DESTINY-CRC01, in patients with previously treated HER2+ advanced CRC.

The results show that, in patients with the highest degree of HER2 positivity, T-DXd was associated with an objective response rate of over 45% and a median progression-free survival (PFS) of almost 7 months.

They “demonstrate, in our opinion, the potential of T-DXd as a treatment option” for patients with advanced HER2-positive colorectal cancer that is refractory to standard therapies, said lead investigator Salvatore Siena, MD, from Niguarda Cancer Center, in Milan, Italy.

He presented the results at the 2020 annual meeting of the American Society of Clinical Oncology, held virtually because of the coronavirus pandemic.

At the same time, results from another study, this time in gastric cancer patients, were published online in the New England Journal of Medicine.
 

Interstitial lung disease as adverse event

The safety profile of T-DXd seen in the colorectal trial “is consistent with what has been previously reported,” said Siena, adding that most of the adverse events were low grade. But he noted there was also a serious adverse effect – interstitial lung disease (ILD). This occurred in 6% of patients, two of whom died. This is “an important risk and requires careful monitoring and proper intervention,” he emphasized.

The ILD adverse effect in this study is “a concern…and something to consider,” commented discussant for the study Michael S. Lee, MD, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill. But he added that these are the “the best data so far for subsequent anti-HER2 therapy in colorectal cancer”.

Also, the dose of drug used in this trial was higher than that approved for breast cancer, and the incidence of ILD “begs the question of whether we should be using a lower dose in this patient population,” said Autumn J. McRee, MD, also from Lineberger, in a highlights session at the meeting.

“The question here really is whether an HER2-specific approach is superior to what we would offer to these patients in the standard of care setting,” McRee said.

She noted that the patients in DESTINY-CRC01 were “heavily pretreated…and if you think about what our options are in the refractory setting, we do have two approved treatments: regorafenib [Stivarga, Bayer] and TAS-102 [Lonsurf, Taiho Oncology].”

The current data suggest, however, that T-DXd is associated with a trend toward higher response rates and improved survival outcomes, as well as lower monthly costs.

“Without a doubt, this trial is clinically relevant,” she said, adding that it’s “important not to miss these patients.”

“They are rare…but I would argue that testing for HER2 amplification in colorectal cancer should be considered standard of care,” she said.

She added that, based on the current evidence, the trial “may be” practice changing, although it is “still to be determined how to sequence HER2 targeted therapies.”
 

Study details

The trial was conducted in 78 patients with previously treated unresectable and/or metastatic CRC that was HER2 expressing, RAS/BRAF wild type, and patients had to have received at least two prior regimens, including prior anti-HER2 treatment. Patients with current or suspected ILD were excluded.

Patients were divided into three cohorts based on the degree of HER2 positivity:

• HER2+ with immunohistochemistry (IHC) scoring 3+ or IHC2+/in-situ-hybridization (ISH)+ (cohort A, n = 53)
• HER2 IHC2+/ISH– (cohort B, n = 7)
• HER2 IHC1+ (cohort C, n = 18)

All patients received T-DXd at 6.4 mg/kg intravenously every 3 weeks until progression or intolerable toxicity.

Across the three cohorts, the median age was 58.5 years, and nearly half (47.4%) of patients were female. The vast majority (98.7%) of patents had ECOG performance status 0 or 1, and the primary tumor site was the left colon or rectum in 89.7%.

Siena noted that “the median number of prior lines of standard therapies was four, ranging from two to 11.” All patients had previously received irinotecan and oxaliplatin, and 20.5% had received an anti-HER2 drug.

At the data cutoff on August 9, 2019, 38.5% of patients remained on treatment. The reason for discontinuation was progressive disease in 41%, and clinical progression in 9%.

Siena reported that the overall response rate, as confirmed by independent central review, was 45.3% in cohort A, with all but one of the 24 responders having a partial response. No responses were recorded in cohorts B and C.

Stable disease was seen in 37.7% of cohort A patients, giving a disease control rate of 83%. The median duration of response was not reached.

Median PFS was 6.9 months in cohort A, and the medial overall survival was not reached.

In terms of safety, 50.9% of patients in cohort A and 48.7% patients overall experienced drug-related treatment emergent adverse events, with 22.6% and 17.9%, respectively, having serious drug-related events.

The most common treatment-emergent adverse events were nausea, anemia, reduced neutrophil count, fatigue, and decreased appetite.

There were two deaths related to the study drug, as determined by investigator assessment: one from pneumonitis and one as a result of ILD, with both occurring in cohort A.

Looking specifically at ILD, Siena said there were five events – two grade 2, one grade 3, and two grade 5 – at a median time to reported onset of 80 days. All patients received corticosteroids, as per the study protocol, and two recovered.

Study discussant Lee commented that biomarker testing, such as for HER2, “is part of our standard of care for colorectal cancer,” although studies such as the current one are providing new data to “better refine” treatment approaches.

Lee said that, overall, T-DXd had a response rate and PFS survival “that looked similar to prior data from previous single arm phase 2 studies,” with response rates generally ranging from 30% to 50%, “and this compares favorably with other standard of care options” for chemotherapy-refractory patients.

Nevertheless, there are several ongoing questions related to the treatment of HER2 amplified metastatic CRC patients, some of which are being addressed in the ongoing SWOG S1613 study.

Lee said that, for now, he would recommend that patients with HER2 amplification enroll in a clinical trial, if possible. “However, if that’s not feasible, there are a range of options to consider,” including trastuzumab plus lapatinib (Tykerb, Novartis), or trastuzumab plus pembrolizumab (Keytruda, Merck).

However, “none of these options are FDA approved so there will be issues potentially with financial toxicity and other regulatory issues,” he said.

The study was funded by Daiichi Sankyo Co, Ltd.

Siena reports stock and other ownership interests with Guardant Health and Myriad Genetics; a consulting or advisory role with Amgen, Bayer, Bristol-Myers Squibb, CheckmAb, Clovis Oncology, Daiichi Sankyo, Incyte, Merck, Novartis, Roche/Genentech, Seattle Genetics; research funding from MSD Oncology (Inst); patents, royalties, and other intellectual property from Amgen; and travel, accommodations, expenses from Amgen, Bayer, and Roche. Other coauthors report potential conflicts of interest. The full list can be found with the original article.

Lee reports: Research Funding – Amgen (Inst); Bristol-Myers Squibb (Inst); EMD Serono (Inst); Exelixis (Inst); Genentech/Roche (Inst); Pfizer (Inst); Travel, Accommodations, Expenses – Genentech/Roche.

McRee reports honoraria from Cor2Ed and Onc Live; research funding from AstraZeneca (Inst), BioMed Valley Discoveries (Inst), Boston Biomedical (Inst), Inovio Pharmaceuticals (Inst), Merck (Inst), Novartis (Inst), Rgenix (Inst), and Takeda (Inst); and travel, accommodations, expenses from Cor2Ed.

This article first appeared on Medscape.com.

Patients with Merkel cell carcinoma and chronic immunosuppression may fare better or worse on immunotherapy based on the reason for immunosuppression, according to recent research at the annual meeting of the Society for Investigative Dermatology, held virtually.

About 10% of patients with Merkel cell carcinoma (MCC) are immunosuppressed at diagnosis, and these patients tend to have a more aggressive disease course and worse disease-specific survival compared with immunocompetent patients, Lauren Zawacki, a research assistant in the Nghiem Lab at the University of Washington, Seattle, said in her presentation. Although patients are receiving immune checkpoint inhibitors such as anti-PD-1 and anti-PD-L1 as treatments, the efficacy and side effects on immunosuppressed patients have not been well studied because many of these patients are not eligible for clinical trials.

Ms. Zawacki and colleagues analyzed data from a prospective Seattle registry of 1,442 patients with MCC, identifying 179 patients with MCC who had chronic immunosuppression due to chronic lymphocytic leukemia (CLL), solid organ transplants, autoimmune disorders, other hematological malignancies, and HIV and AIDS. Non-Hodgkin lymphoma comprised 7 of 8 patients in the group with other hematological malignancies, and Crohn’s disease made up 5 of 6 patients in the autoimmune disorder group. Of the 179 patients with MCC and immunosuppression, 31 patients were treated with either anti-PD-1 or anti-PD-L1 therapy.

There was an objective response rate of 52%, with 14 patients having a complete response, 2 patients having a partial response, and 15 patients experiencing disease progression. Of the patients with disease progression, 11 died of MCC. The response rate in immunocompromised patients is similar to results seen by her group in immunocompetent patients (Nghiem P et al. N Engl J Med 2016; 374:2542-52), said Ms. Zawacki. “While the overall objective response rate is comparable between immunocompetent and immunosuppressed patients, the response rates vary greatly between the different types of immunosuppression,” she said.

When grouping response rates by immunosuppression type, they found 2 of 11 patients with CLL (18%) and 2 of 6 patients with autoimmune disease (33%) had an objective response, while 2 of 3 patients with HIV/AIDS (66%) and 7 of 7 patients with other hematologic malignancies (100%) had an objective response.

“While the numbers of the cohort are small, there still seems to be a considerable difference in the response rate between the different types of immune suppression, which is critical when we’re treating patients who typically have a more aggressive disease course,” said Ms. Zawacki.

In particular, the finding of no patients with MCC and CLL achieving a complete response interested Ms. Zawacki and her colleagues, since about one-fourth of patients in the Seattle registry have this combination of disease. “Not only did none of the CLL patients have a complete response, but 7 out of the 11 patients with CLL died from MCC,” she explained. When examining further, the researchers found 45% of patients in this group discontinued because of side effects of immunotherapy and had a median time to recurrence of 1.5 months. “This finding suggests that CLL in particular plays a large role in impairing the function of the immune system, leading to not only a more aggressive disease course, but a poorer response to immunotherapy,” she said.

“There is a significant need for improved interventions for patients with CLL and autoimmune disorders,” she added. “Research for immunosuppressed patients is critical given the associated aggressive disease course and their lack of inclusion in clinical trials.”

Ms. Zawacki acknowledged the small number of patients in the study as a limitation, and patients who received follow-up at outside facilities may have received slightly different care, which could impact adverse event reporting or reasons for study discontinuation.

“A multi-institutional study would be beneficial to expand the number of patients in that cohort and to help confirm the trend observed in this study. In addition, future studies should assess the role of combination systemic therapy, such as neutron radiation and immunotherapy together in order to see if the objective response can be approved among immunosuppressed patients,” she said.

This study was supported by funding from the MCC Patient Gift Fund, the National Cancer Institute, and a grant from NIH. Ms. Zawacki reports no relevant conflicts of interest.

SOURCE: Zawacki L. SID 2020, Abstract 497.

Patients with Merkel cell carcinoma and chronic immunosuppression may fare better or worse on immunotherapy based on the reason for immunosuppression, according to recent research at the annual meeting of the Society for Investigative Dermatology, held virtually.

About 10% of patients with Merkel cell carcinoma (MCC) are immunosuppressed at diagnosis, and these patients tend to have a more aggressive disease course and worse disease-specific survival compared with immunocompetent patients, Lauren Zawacki, a research assistant in the Nghiem Lab at the University of Washington, Seattle, said in her presentation. Although patients are receiving immune checkpoint inhibitors such as anti-PD-1 and anti-PD-L1 as treatments, the efficacy and side effects on immunosuppressed patients have not been well studied because many of these patients are not eligible for clinical trials.

Ms. Zawacki and colleagues analyzed data from a prospective Seattle registry of 1,442 patients with MCC, identifying 179 patients with MCC who had chronic immunosuppression due to chronic lymphocytic leukemia (CLL), solid organ transplants, autoimmune disorders, other hematological malignancies, and HIV and AIDS. Non-Hodgkin lymphoma comprised 7 of 8 patients in the group with other hematological malignancies, and Crohn’s disease made up 5 of 6 patients in the autoimmune disorder group. Of the 179 patients with MCC and immunosuppression, 31 patients were treated with either anti-PD-1 or anti-PD-L1 therapy.

There was an objective response rate of 52%, with 14 patients having a complete response, 2 patients having a partial response, and 15 patients experiencing disease progression. Of the patients with disease progression, 11 died of MCC. The response rate in immunocompromised patients is similar to results seen by her group in immunocompetent patients (Nghiem P et al. N Engl J Med 2016; 374:2542-52), said Ms. Zawacki. “While the overall objective response rate is comparable between immunocompetent and immunosuppressed patients, the response rates vary greatly between the different types of immunosuppression,” she said.

When grouping response rates by immunosuppression type, they found 2 of 11 patients with CLL (18%) and 2 of 6 patients with autoimmune disease (33%) had an objective response, while 2 of 3 patients with HIV/AIDS (66%) and 7 of 7 patients with other hematologic malignancies (100%) had an objective response.

“While the numbers of the cohort are small, there still seems to be a considerable difference in the response rate between the different types of immune suppression, which is critical when we’re treating patients who typically have a more aggressive disease course,” said Ms. Zawacki.

In particular, the finding of no patients with MCC and CLL achieving a complete response interested Ms. Zawacki and her colleagues, since about one-fourth of patients in the Seattle registry have this combination of disease. “Not only did none of the CLL patients have a complete response, but 7 out of the 11 patients with CLL died from MCC,” she explained. When examining further, the researchers found 45% of patients in this group discontinued because of side effects of immunotherapy and had a median time to recurrence of 1.5 months. “This finding suggests that CLL in particular plays a large role in impairing the function of the immune system, leading to not only a more aggressive disease course, but a poorer response to immunotherapy,” she said.

“There is a significant need for improved interventions for patients with CLL and autoimmune disorders,” she added. “Research for immunosuppressed patients is critical given the associated aggressive disease course and their lack of inclusion in clinical trials.”

Ms. Zawacki acknowledged the small number of patients in the study as a limitation, and patients who received follow-up at outside facilities may have received slightly different care, which could impact adverse event reporting or reasons for study discontinuation.

“A multi-institutional study would be beneficial to expand the number of patients in that cohort and to help confirm the trend observed in this study. In addition, future studies should assess the role of combination systemic therapy, such as neutron radiation and immunotherapy together in order to see if the objective response can be approved among immunosuppressed patients,” she said.

This study was supported by funding from the MCC Patient Gift Fund, the National Cancer Institute, and a grant from NIH. Ms. Zawacki reports no relevant conflicts of interest.

SOURCE: Zawacki L. SID 2020, Abstract 497.

Patients with Merkel cell carcinoma and chronic immunosuppression may fare better or worse on immunotherapy based on the reason for immunosuppression, according to recent research at the annual meeting of the Society for Investigative Dermatology, held virtually.

About 10% of patients with Merkel cell carcinoma (MCC) are immunosuppressed at diagnosis, and these patients tend to have a more aggressive disease course and worse disease-specific survival compared with immunocompetent patients, Lauren Zawacki, a research assistant in the Nghiem Lab at the University of Washington, Seattle, said in her presentation. Although patients are receiving immune checkpoint inhibitors such as anti-PD-1 and anti-PD-L1 as treatments, the efficacy and side effects on immunosuppressed patients have not been well studied because many of these patients are not eligible for clinical trials.

Ms. Zawacki and colleagues analyzed data from a prospective Seattle registry of 1,442 patients with MCC, identifying 179 patients with MCC who had chronic immunosuppression due to chronic lymphocytic leukemia (CLL), solid organ transplants, autoimmune disorders, other hematological malignancies, and HIV and AIDS. Non-Hodgkin lymphoma comprised 7 of 8 patients in the group with other hematological malignancies, and Crohn’s disease made up 5 of 6 patients in the autoimmune disorder group. Of the 179 patients with MCC and immunosuppression, 31 patients were treated with either anti-PD-1 or anti-PD-L1 therapy.

There was an objective response rate of 52%, with 14 patients having a complete response, 2 patients having a partial response, and 15 patients experiencing disease progression. Of the patients with disease progression, 11 died of MCC. The response rate in immunocompromised patients is similar to results seen by her group in immunocompetent patients (Nghiem P et al. N Engl J Med 2016; 374:2542-52), said Ms. Zawacki. “While the overall objective response rate is comparable between immunocompetent and immunosuppressed patients, the response rates vary greatly between the different types of immunosuppression,” she said.

When grouping response rates by immunosuppression type, they found 2 of 11 patients with CLL (18%) and 2 of 6 patients with autoimmune disease (33%) had an objective response, while 2 of 3 patients with HIV/AIDS (66%) and 7 of 7 patients with other hematologic malignancies (100%) had an objective response.

“While the numbers of the cohort are small, there still seems to be a considerable difference in the response rate between the different types of immune suppression, which is critical when we’re treating patients who typically have a more aggressive disease course,” said Ms. Zawacki.

In particular, the finding of no patients with MCC and CLL achieving a complete response interested Ms. Zawacki and her colleagues, since about one-fourth of patients in the Seattle registry have this combination of disease. “Not only did none of the CLL patients have a complete response, but 7 out of the 11 patients with CLL died from MCC,” she explained. When examining further, the researchers found 45% of patients in this group discontinued because of side effects of immunotherapy and had a median time to recurrence of 1.5 months. “This finding suggests that CLL in particular plays a large role in impairing the function of the immune system, leading to not only a more aggressive disease course, but a poorer response to immunotherapy,” she said.

“There is a significant need for improved interventions for patients with CLL and autoimmune disorders,” she added. “Research for immunosuppressed patients is critical given the associated aggressive disease course and their lack of inclusion in clinical trials.”

Ms. Zawacki acknowledged the small number of patients in the study as a limitation, and patients who received follow-up at outside facilities may have received slightly different care, which could impact adverse event reporting or reasons for study discontinuation.

“A multi-institutional study would be beneficial to expand the number of patients in that cohort and to help confirm the trend observed in this study. In addition, future studies should assess the role of combination systemic therapy, such as neutron radiation and immunotherapy together in order to see if the objective response can be approved among immunosuppressed patients,” she said.

This study was supported by funding from the MCC Patient Gift Fund, the National Cancer Institute, and a grant from NIH. Ms. Zawacki reports no relevant conflicts of interest.

SOURCE: Zawacki L. SID 2020, Abstract 497.

This is the second of a two-part article on the role of racism and bias in the U.S. maternal mortality crisis and part of an ongoing Ob.Gyn. News feature series on the crisis. Part one of the story explored existing data, societal factors, and patient experiences related to structural racism, overt racism, and implicit bias as factors contributing to racial disparities in maternal outcomes. Here we explore potential solutions for addressing the inequities as proposed by thought leaders and key stakeholders.



The emerging racial disparities in COVID-19 incidence and outcomes in the United States are on a collision course with long-standing racial disparities in U.S. maternal care and mortality.

Maternal health advocates are bracing for the impact, but in the spotlight that the pandemic is training on the inequities and the health system changes taking shape in its wake, some also see hope for a shift in at least one important driver of the racial health disparities: access to care.

Non-Hispanic black women are at least three times more likely than Hispanic women and non-Hispanic white women to experience pregnancy-related death, and indigenous women are more than twice as likely, according to the latest data from the Centers for Disease Control and Prevention’s National Center for Health Statistics. The added strain COVID-19 is putting on the system stands to further limit the access to care that many pregnant women of color experience and to exacerbate racial disparities, panelists agreed during a recent National Maternal Health Patient Centered Outcomes Research Network webinar entitled “The Impact of COVID-19 on Black, Brown, and Native Pregnant People.”

“The saying is that ‘the virus doesn’t discriminate,’ but it understands our biases, right? So, the virus takes advantage of the weaknesses in our system,” said panelist Joia A. Crear-Perry, MD, an ob.gyn. and founder and president of the National Birth Equity Collaborative (NBEC), a New Orleans–based research, training, and advocacy organization working to optimize black maternal and infant health.
 

Hope for solutions from the ashes of a pandemic

The weaknesses in the system that Dr. Crear-Perry spoke of are in many ways a product of structural racism as described in a conceptual report in The Lancet, titled “America: Equity and Equality in Health,” which dug into the entrenched and tangled historical roots of racist sociological and political factors that formed a foundation for health inequity over time.

Today, people of color remain more likely to be excluded from access to health insurance and adequate health care. The authors defined structural racism as “the totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care, and criminal justice.” Today, largely as a result of these “reinforcing systems,” people of color remain more likely to be excluded from access to health insurance and adequate health care. At the same time, and for the same reasons, they are more likely to work in the service industry, be essential workers, and use mass transit, each of which increases the risk of exposure to COVID-19, Dr. Crear-Perry explained.

“It’s important for us to know that, for maternal mortality, it’s the same thing that happens,” she said. That means the focus on COVID-19–related disparities helps magnify and elevate the conversation regarding similar disparities in maternal outcomes.

It also means that some of the care delivery solutions embraced and facilitated amid the pandemic, such as extension of Medicaid coverage for up to a year after giving birth and broader use and insurance coverage of telemedicine, could finally gain traction; those are solutions long-sought by advocates like Dr. Crear-Perry and others as a means for alleviating racial disparities in maternal outcomes and addressing the maternal mortality crisis.

Therein lies the hope, she explained in an interview. “Some of the policies that we know would have been helpful prior to COVID-19 now are being seen as really important.”
 

Solution: Extending coverage

During a May 7 virtual Congressional hearing on “America’s Two Public Health Crises: The Impact of COVID-19 on Racial Inequities and Maternal Mortality in the U.S.,” cosponsored by the American College of Obstetricians and Gynecologists, the March of Dimes, and the NBEC, Dr. Crear-Perry further explained the importance of extended coverage and care access.

Asked what Congress could do immediately to “ensure that the pandemic does not compound the nation’s maternal mortality crisis, including unacceptable rates among black women,” she didn’t hesitate.

“Well, it would be amazing if we could get Medicaid extended for 12 months post delivery,” she said. “As you can imagine right now, we have moms who are birthing in hospitals where they have to worry about, 2 months later, not having coverage for themselves.”

If that mom is exposed to COVID-19 and has no insurance coverage and a newborn at home, the likelihood that she will call a provider if she develops symptoms is low, Dr. Crear-Perry said. “This is a great opportunity for us to really rethink some of those policies that we know are barriers, that we have created for people to be able to thrive after they have a baby and during child birth.”

Current policies are centered around an arbitrary cutoff of about 6 weeks for postpartum care, but the CDC reports that a third of all postpartum deaths occur between 1 week and 12 months after birth.

“We need our policies to reflect the current knowledge and the science,” she said. “Just like babies have automatic insurance coverage for a year later, mothers should have the same.”

Medicaid finances nearly half of all births in the United States, according to a 2019 Kaiser Family Foundation brief, which explained that federal law requires Medicaid coverage for only 60 days post partum for women who are eligible. Decisions regarding coverage after 60 days are determined by individual states; those that expanded Medicaid under the Affordable Care Act typically allow extended coverage – but only with reapplication at 60 days.

Many women in nonexpansion states become uninsured after pregnancy-related coverage ends, as do some in expansion states for whom reapplying is a hurdle too high to clear with a newborn baby to care for at home, Dr. Crear-Perry said.

Addressing these coverage gaps is key to improving access, and it is a core component of the Black Maternal Health Momnibus Act of 2020, a nine-bill package introduced in March by Rep. Lauren Underwood (D-Ill.), Rep. Alma Adams (D-N.C.), Sen. Kamala Harris (D-Calif.), and members of the Black Maternal Health Caucus to “fill gaps in existing legislation to comprehensively address every dimension of the Black maternal health crisis in America.”

One bill in the package addresses extended coverage with a goal to “promote innovative payment models to incentivize high-quality maternity care and continuity of health insurance coverage from pregnancy through labor and delivery and up to 1 year post partum.” Another focuses on promoting alternative ways to access care, such as through telemedicine.

Solution: Expanding care access

“There is a need for the democratization of care,” Dr. Crear-Perry said. “There is a need for people to have more ways to get care. This idea that the only way you can get prenatal care is you have to come to me at my office, has been a burden for working people for a long, long time.”

The COVID-19 pandemic necessitates increased use of telemedicine, but building blocks to allow patients to use it effectively must be put in place, she said. That means expanding broadband access, providing patients with blood pressure cuffs and other tools for use remotely, and expanding reimbursement to include not just video, but also phone calls.

Heart Safe Motherhood, a University of Pennsylvania text-based intervention developed to address postpartum hypertension – a leading cause of maternal morbidity and mortality, and at the start of the program, the leading cause of 7-day readmissions among obstetric patients, demonstrated the value of such approaches to care.

The program involves remote blood pressure monitoring using a digital monitor provided to at-risk patients at discharge. Text-based monitoring reminders encourage patients to check their blood pressure twice daily for the first 7 days.

“In our randomized, controlled trial, we saw our ability to meet ACOG guidelines on postpartum blood monitoring leap from 0% to 82%, compared to in-person office visits and 7-day readmissions from hypertension drop from 3% to 0%,” an update at the program website states.

ACOG

Rebekah Gee, MD, an ob.gyn. and director of the Louisiana State University Health System in New Orleans, also noted the importance of finding ways to deliver care “that are outside the traditional norm.

“Telemedicine, home visiting ... I think there are a wide variety of ways,” she said, noting that these kind of approaches not only help circumvent roadblocks to care, such as lack of transportation, but also can feel more personal and approachable for some women.
 

Solution: Measuring, investing, diversifying, respecting

The aims of other bills in the Momnibus Act also mirror several solutions proposed by maternal health advocates interviewed for this article. Among them are:

• Development of improved data collection processes and quality measures to better understand the factors that contribute to the crisis overall and among special populations, and to inform solutions for addressing them.
• Investments in social determinants of health that influence maternal health outcomes, like housing, transportation, and nutrition.
• Commitment to the growth and diversification of the perinatal workforce to ensure that every mom receives maternity care and support from people she can trust to provide quality care and treat her with respect.

The latter is one that Dr. Gee, Dr. Crear-Perry, and others particularly emphasized.

“We need patient advocates like doulas, midwives and others who are better listeners and better able to advocate for patients,” Dr. Gee said. This would better allow for women’s desires in the childbirth experience to be addressed appropriately, she said, adding that this is something that “frankly, a lot of doctors do not have the time to do.”

That’s why the efforts to address maternal mortality have to focus on the health care system, not just on doctors’ behavior with respect to bias, she said.

Dr. Gee also said there is a need for culturally appropriate literacy and numeracy communications “that respect how people seek and understand information.” This varies by population, which is why it’s important to provide the same approach to care “no matter what the patient looks like,” while also understanding that different patients communicate in different ways.

A 2019 study published in Social Science & Medicine underscored how communication differences can affect outcomes; using a national sample of women who gave birth in U.S. hospitals, the authors found that those who had declined care for themselves or their infant during their childbirth hospitalization were more likely to report receiving poor treatment based on race or ethnicity. They concluded that, in the context of childbirth care, women – particularly black women – pay a penalty for what is perceived as uncooperative behavior.

This is another area where doulas and other patient advocates can help, Dr. Gee said.

Doulas have long been an integral part of the birthing process for many women, particularly women of color, and evidence suggests the supportive care they provide helps to improve outcomes. In fact, several states – including Oregon, Minnesota, and New York, among others – have expanded or have proposed expanding Medicaid coverage to include doula services for pregnant beneficiaries, a move cheered by doula associations and other maternal health advocates.

In many ways, it’s about “respectful maternity care,” which is something Dr. Crear-Perry has been working to promote through the NBEC in partnership with ACOG and the Robert Wood Johnson Foundation. It’s also something the World Health Organization has promoted by establishing global standards for such care.

“We’re hoping to socialize that as a norm in United States ... to really see what it would look like to value what birthing people want and to see them as partners in their birth,” she said.

However, the 2019 Giving Voice to Mothers study demonstrating consistently higher rates of mistreatment during obstetrical care for women of color than for comparable white women shows that the United States is falling short of those standards. The national study of 2,700 women examined how race, ethnicity, and place of birth interact with the experience of receiving maternity care in the United States, and showed that 1 in 6 experienced one or more types of mistreatment – with consistently higher rates among women of color, even after adjusting for interactions between race and other maternal characteristics, Saraswathi Veda, MD, of the Birth Place Lab and professor of midwifery at the University of British Columbia, Vancouver, and colleagues reported in Reproductive Health.
 

Solution: Listening, learning, reflecting, partnering

Timoria McQueen Saba, birth trauma survivor and maternal health advocate, has described experiencing instances of mistreatment throughout her obstetric care, and like Dr. Crear-Perry, she said trust and collaboration in care is imperative for improving outcomes.

“I think the most important thing you can do is really consider a patient a partner in the care you give them,” she said during a panel discussion at the 2019 ACOG annual meeting. “You’re not experts in their lived experience ... center a patient’s voice or the voice of a patient’s family. Incorporate that into your learning.”

During a virtual workshop held May 19-20 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Judette Louis, MD, chair of the department of obstetrics and gynecology at the University of South Florida, Tampa, and president of the Society of Maternal-Fetal Medicine, provided practical guidance for addressing racism and implicit bias in practice and in research to reduce disparities in outcomes.

In an interview, she summarized her key points, reiterating solutions proposed by Dr. Gee and Dr. Crear-Perry and addressed in the Momnibus Act, and also offering a few others:

First, put aside the notion that disparities are genetically driven. For a variety of reasons, that just doesn’t make sense. For one thing, not all blacks are African American.

“My family is from the Caribbean,” she said. “Is it really conceivable that we’re all so similar?”

Look also at the disparities among Native Americans, she said. “How can you take 500 distinct tribes that live across a wide geographic area and lump them into one group and assume that they are similar?”

The problem is racism, not race. “When you keep saying ‘it’s about race, it’s about race, it’s about race’ – that sends a message to the person who is of that race that there is something inherently broken about [them],” she said.

Recognize that the roots of the problem run deep. Learn about and support efforts to address the underlying structural factors that contribute to the problem, Dr. Louis emphasized, and recognize your own bias. “We all have it. The key is to recognize [biases] and mitigate them when taking care of patients.”

That’s easier said than done, at least judging by one survey of maternal-fetal medicine specialists in which 84% of respondents agreed that disparities impact practice, but only 29% agreed their own personal biases affect how they care for patients, she noted.

Tools are available to help individuals identify implicit bias, and training programs for health care providers can help, as well, she said. Implicit bias tests and training programs that help to identify and address bias and racism on individual and organizational levels are increasingly available through academic centers, health systems, and advocacy organizations.

Hope for solutions: Progress and promise

Like Dr. Crear-Perry, Dr. Louis sees hope for reducing disparities and improving maternal outcomes.

In another survey of SMFM members to identify the practice issues most important to them, racial disparities ranked in the top three.

“It says a lot that our [maternal-fetal medicine specialists] really see this as a problem and they want it fixed,” she said. “And I think it says that a lot of people need to work on this, not just us.”

Indeed, many are engaged in that work. Veronica Gillispie, MD, medical director of the Louisiana Perinatal Quality Collaborative and Pregnancy-Associated Mortality Review, has been instrumental in recent initiatives to improve maternal outcomes in Louisiana, and she too said she feels optimistic.

“I am hopeful and I do see signs of hope,” she said in an interview.

Teams that she works with and trains seem invested, institutions are increasingly implementing faculty training on racism and bias, and Oschner Health, where Dr. Gillispie practices as an ob.gyn., appointed its first chief diversity officer in February.

Medical students she works with are attuned to the issues of racism, bias, and disparities, and they show a desire to enact change, she said. “They already get it, and they are working to make it better.”

Dr. Crear-Perry also predicts practice-changing results from studies looking at the delivery of obstetrical care and the role of supportive care, and she pointed out another aspect of the COVID-19 crisis that provides an important lesson for health care providers who care for birthing people: the scarcity of personal protective equipment amid the pandemic.

“My friends who are ob.gyns., who are now not getting access to the things they need to stay safe to practice medicine and who are feeling very marginalized at this moment, feeling not valued – that’s how birthing people [of color] feel,” she said. “I’m hoping that builds a sense of empathy.

”I’m hoping at the end of this crisis, that those ob.gyns. will think of patients as allies in fighting for more access to health for everybody and for more resources to do their work,” Dr. Crear-Perry said. “We’re all in this together.”

sworcester@mdedge.com

This is the second of a two-part article on the role of racism and bias in the U.S. maternal mortality crisis and part of an ongoing Ob.Gyn. News feature series on the crisis. Part one of the story explored existing data, societal factors, and patient experiences related to structural racism, overt racism, and implicit bias as factors contributing to racial disparities in maternal outcomes. Here we explore potential solutions for addressing the inequities as proposed by thought leaders and key stakeholders.



The emerging racial disparities in COVID-19 incidence and outcomes in the United States are on a collision course with long-standing racial disparities in U.S. maternal care and mortality.

Maternal health advocates are bracing for the impact, but in the spotlight that the pandemic is training on the inequities and the health system changes taking shape in its wake, some also see hope for a shift in at least one important driver of the racial health disparities: access to care.

Non-Hispanic black women are at least three times more likely than Hispanic women and non-Hispanic white women to experience pregnancy-related death, and indigenous women are more than twice as likely, according to the latest data from the Centers for Disease Control and Prevention’s National Center for Health Statistics. The added strain COVID-19 is putting on the system stands to further limit the access to care that many pregnant women of color experience and to exacerbate racial disparities, panelists agreed during a recent National Maternal Health Patient Centered Outcomes Research Network webinar entitled “The Impact of COVID-19 on Black, Brown, and Native Pregnant People.”

“The saying is that ‘the virus doesn’t discriminate,’ but it understands our biases, right? So, the virus takes advantage of the weaknesses in our system,” said panelist Joia A. Crear-Perry, MD, an ob.gyn. and founder and president of the National Birth Equity Collaborative (NBEC), a New Orleans–based research, training, and advocacy organization working to optimize black maternal and infant health.
 

Hope for solutions from the ashes of a pandemic

The weaknesses in the system that Dr. Crear-Perry spoke of are in many ways a product of structural racism as described in a conceptual report in The Lancet, titled “America: Equity and Equality in Health,” which dug into the entrenched and tangled historical roots of racist sociological and political factors that formed a foundation for health inequity over time.

Today, people of color remain more likely to be excluded from access to health insurance and adequate health care. The authors defined structural racism as “the totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care, and criminal justice.” Today, largely as a result of these “reinforcing systems,” people of color remain more likely to be excluded from access to health insurance and adequate health care. At the same time, and for the same reasons, they are more likely to work in the service industry, be essential workers, and use mass transit, each of which increases the risk of exposure to COVID-19, Dr. Crear-Perry explained.

“It’s important for us to know that, for maternal mortality, it’s the same thing that happens,” she said. That means the focus on COVID-19–related disparities helps magnify and elevate the conversation regarding similar disparities in maternal outcomes.

It also means that some of the care delivery solutions embraced and facilitated amid the pandemic, such as extension of Medicaid coverage for up to a year after giving birth and broader use and insurance coverage of telemedicine, could finally gain traction; those are solutions long-sought by advocates like Dr. Crear-Perry and others as a means for alleviating racial disparities in maternal outcomes and addressing the maternal mortality crisis.

Therein lies the hope, she explained in an interview. “Some of the policies that we know would have been helpful prior to COVID-19 now are being seen as really important.”
 

Solution: Extending coverage

During a May 7 virtual Congressional hearing on “America’s Two Public Health Crises: The Impact of COVID-19 on Racial Inequities and Maternal Mortality in the U.S.,” cosponsored by the American College of Obstetricians and Gynecologists, the March of Dimes, and the NBEC, Dr. Crear-Perry further explained the importance of extended coverage and care access.

Asked what Congress could do immediately to “ensure that the pandemic does not compound the nation’s maternal mortality crisis, including unacceptable rates among black women,” she didn’t hesitate.

“Well, it would be amazing if we could get Medicaid extended for 12 months post delivery,” she said. “As you can imagine right now, we have moms who are birthing in hospitals where they have to worry about, 2 months later, not having coverage for themselves.”

If that mom is exposed to COVID-19 and has no insurance coverage and a newborn at home, the likelihood that she will call a provider if she develops symptoms is low, Dr. Crear-Perry said. “This is a great opportunity for us to really rethink some of those policies that we know are barriers, that we have created for people to be able to thrive after they have a baby and during child birth.”

Current policies are centered around an arbitrary cutoff of about 6 weeks for postpartum care, but the CDC reports that a third of all postpartum deaths occur between 1 week and 12 months after birth.

“We need our policies to reflect the current knowledge and the science,” she said. “Just like babies have automatic insurance coverage for a year later, mothers should have the same.”

Medicaid finances nearly half of all births in the United States, according to a 2019 Kaiser Family Foundation brief, which explained that federal law requires Medicaid coverage for only 60 days post partum for women who are eligible. Decisions regarding coverage after 60 days are determined by individual states; those that expanded Medicaid under the Affordable Care Act typically allow extended coverage – but only with reapplication at 60 days.

Many women in nonexpansion states become uninsured after pregnancy-related coverage ends, as do some in expansion states for whom reapplying is a hurdle too high to clear with a newborn baby to care for at home, Dr. Crear-Perry said.

Addressing these coverage gaps is key to improving access, and it is a core component of the Black Maternal Health Momnibus Act of 2020, a nine-bill package introduced in March by Rep. Lauren Underwood (D-Ill.), Rep. Alma Adams (D-N.C.), Sen. Kamala Harris (D-Calif.), and members of the Black Maternal Health Caucus to “fill gaps in existing legislation to comprehensively address every dimension of the Black maternal health crisis in America.”

One bill in the package addresses extended coverage with a goal to “promote innovative payment models to incentivize high-quality maternity care and continuity of health insurance coverage from pregnancy through labor and delivery and up to 1 year post partum.” Another focuses on promoting alternative ways to access care, such as through telemedicine.

Solution: Expanding care access

“There is a need for the democratization of care,” Dr. Crear-Perry said. “There is a need for people to have more ways to get care. This idea that the only way you can get prenatal care is you have to come to me at my office, has been a burden for working people for a long, long time.”

The COVID-19 pandemic necessitates increased use of telemedicine, but building blocks to allow patients to use it effectively must be put in place, she said. That means expanding broadband access, providing patients with blood pressure cuffs and other tools for use remotely, and expanding reimbursement to include not just video, but also phone calls.

Heart Safe Motherhood, a University of Pennsylvania text-based intervention developed to address postpartum hypertension – a leading cause of maternal morbidity and mortality, and at the start of the program, the leading cause of 7-day readmissions among obstetric patients, demonstrated the value of such approaches to care.

The program involves remote blood pressure monitoring using a digital monitor provided to at-risk patients at discharge. Text-based monitoring reminders encourage patients to check their blood pressure twice daily for the first 7 days.

“In our randomized, controlled trial, we saw our ability to meet ACOG guidelines on postpartum blood monitoring leap from 0% to 82%, compared to in-person office visits and 7-day readmissions from hypertension drop from 3% to 0%,” an update at the program website states.

ACOG

Rebekah Gee, MD, an ob.gyn. and director of the Louisiana State University Health System in New Orleans, also noted the importance of finding ways to deliver care “that are outside the traditional norm.

“Telemedicine, home visiting ... I think there are a wide variety of ways,” she said, noting that these kind of approaches not only help circumvent roadblocks to care, such as lack of transportation, but also can feel more personal and approachable for some women.
 

Solution: Measuring, investing, diversifying, respecting

The aims of other bills in the Momnibus Act also mirror several solutions proposed by maternal health advocates interviewed for this article. Among them are:

• Development of improved data collection processes and quality measures to better understand the factors that contribute to the crisis overall and among special populations, and to inform solutions for addressing them.
• Investments in social determinants of health that influence maternal health outcomes, like housing, transportation, and nutrition.
• Commitment to the growth and diversification of the perinatal workforce to ensure that every mom receives maternity care and support from people she can trust to provide quality care and treat her with respect.

The latter is one that Dr. Gee, Dr. Crear-Perry, and others particularly emphasized.

“We need patient advocates like doulas, midwives and others who are better listeners and better able to advocate for patients,” Dr. Gee said. This would better allow for women’s desires in the childbirth experience to be addressed appropriately, she said, adding that this is something that “frankly, a lot of doctors do not have the time to do.”

That’s why the efforts to address maternal mortality have to focus on the health care system, not just on doctors’ behavior with respect to bias, she said.

Dr. Gee also said there is a need for culturally appropriate literacy and numeracy communications “that respect how people seek and understand information.” This varies by population, which is why it’s important to provide the same approach to care “no matter what the patient looks like,” while also understanding that different patients communicate in different ways.

A 2019 study published in Social Science & Medicine underscored how communication differences can affect outcomes; using a national sample of women who gave birth in U.S. hospitals, the authors found that those who had declined care for themselves or their infant during their childbirth hospitalization were more likely to report receiving poor treatment based on race or ethnicity. They concluded that, in the context of childbirth care, women – particularly black women – pay a penalty for what is perceived as uncooperative behavior.

This is another area where doulas and other patient advocates can help, Dr. Gee said.

Doulas have long been an integral part of the birthing process for many women, particularly women of color, and evidence suggests the supportive care they provide helps to improve outcomes. In fact, several states – including Oregon, Minnesota, and New York, among others – have expanded or have proposed expanding Medicaid coverage to include doula services for pregnant beneficiaries, a move cheered by doula associations and other maternal health advocates.

In many ways, it’s about “respectful maternity care,” which is something Dr. Crear-Perry has been working to promote through the NBEC in partnership with ACOG and the Robert Wood Johnson Foundation. It’s also something the World Health Organization has promoted by establishing global standards for such care.

“We’re hoping to socialize that as a norm in United States ... to really see what it would look like to value what birthing people want and to see them as partners in their birth,” she said.

However, the 2019 Giving Voice to Mothers study demonstrating consistently higher rates of mistreatment during obstetrical care for women of color than for comparable white women shows that the United States is falling short of those standards. The national study of 2,700 women examined how race, ethnicity, and place of birth interact with the experience of receiving maternity care in the United States, and showed that 1 in 6 experienced one or more types of mistreatment – with consistently higher rates among women of color, even after adjusting for interactions between race and other maternal characteristics, Saraswathi Veda, MD, of the Birth Place Lab and professor of midwifery at the University of British Columbia, Vancouver, and colleagues reported in Reproductive Health.
 

Solution: Listening, learning, reflecting, partnering

Timoria McQueen Saba, birth trauma survivor and maternal health advocate, has described experiencing instances of mistreatment throughout her obstetric care, and like Dr. Crear-Perry, she said trust and collaboration in care is imperative for improving outcomes.

“I think the most important thing you can do is really consider a patient a partner in the care you give them,” she said during a panel discussion at the 2019 ACOG annual meeting. “You’re not experts in their lived experience ... center a patient’s voice or the voice of a patient’s family. Incorporate that into your learning.”

During a virtual workshop held May 19-20 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Judette Louis, MD, chair of the department of obstetrics and gynecology at the University of South Florida, Tampa, and president of the Society of Maternal-Fetal Medicine, provided practical guidance for addressing racism and implicit bias in practice and in research to reduce disparities in outcomes.

In an interview, she summarized her key points, reiterating solutions proposed by Dr. Gee and Dr. Crear-Perry and addressed in the Momnibus Act, and also offering a few others:

First, put aside the notion that disparities are genetically driven. For a variety of reasons, that just doesn’t make sense. For one thing, not all blacks are African American.

“My family is from the Caribbean,” she said. “Is it really conceivable that we’re all so similar?”

Look also at the disparities among Native Americans, she said. “How can you take 500 distinct tribes that live across a wide geographic area and lump them into one group and assume that they are similar?”

The problem is racism, not race. “When you keep saying ‘it’s about race, it’s about race, it’s about race’ – that sends a message to the person who is of that race that there is something inherently broken about [them],” she said.

Recognize that the roots of the problem run deep. Learn about and support efforts to address the underlying structural factors that contribute to the problem, Dr. Louis emphasized, and recognize your own bias. “We all have it. The key is to recognize [biases] and mitigate them when taking care of patients.”

That’s easier said than done, at least judging by one survey of maternal-fetal medicine specialists in which 84% of respondents agreed that disparities impact practice, but only 29% agreed their own personal biases affect how they care for patients, she noted.

Tools are available to help individuals identify implicit bias, and training programs for health care providers can help, as well, she said. Implicit bias tests and training programs that help to identify and address bias and racism on individual and organizational levels are increasingly available through academic centers, health systems, and advocacy organizations.

Hope for solutions: Progress and promise

Like Dr. Crear-Perry, Dr. Louis sees hope for reducing disparities and improving maternal outcomes.

In another survey of SMFM members to identify the practice issues most important to them, racial disparities ranked in the top three.

“It says a lot that our [maternal-fetal medicine specialists] really see this as a problem and they want it fixed,” she said. “And I think it says that a lot of people need to work on this, not just us.”

Indeed, many are engaged in that work. Veronica Gillispie, MD, medical director of the Louisiana Perinatal Quality Collaborative and Pregnancy-Associated Mortality Review, has been instrumental in recent initiatives to improve maternal outcomes in Louisiana, and she too said she feels optimistic.

“I am hopeful and I do see signs of hope,” she said in an interview.

Teams that she works with and trains seem invested, institutions are increasingly implementing faculty training on racism and bias, and Oschner Health, where Dr. Gillispie practices as an ob.gyn., appointed its first chief diversity officer in February.

Medical students she works with are attuned to the issues of racism, bias, and disparities, and they show a desire to enact change, she said. “They already get it, and they are working to make it better.”

Dr. Crear-Perry also predicts practice-changing results from studies looking at the delivery of obstetrical care and the role of supportive care, and she pointed out another aspect of the COVID-19 crisis that provides an important lesson for health care providers who care for birthing people: the scarcity of personal protective equipment amid the pandemic.

“My friends who are ob.gyns., who are now not getting access to the things they need to stay safe to practice medicine and who are feeling very marginalized at this moment, feeling not valued – that’s how birthing people [of color] feel,” she said. “I’m hoping that builds a sense of empathy.

”I’m hoping at the end of this crisis, that those ob.gyns. will think of patients as allies in fighting for more access to health for everybody and for more resources to do their work,” Dr. Crear-Perry said. “We’re all in this together.”

sworcester@mdedge.com

This is the second of a two-part article on the role of racism and bias in the U.S. maternal mortality crisis and part of an ongoing Ob.Gyn. News feature series on the crisis. Part one of the story explored existing data, societal factors, and patient experiences related to structural racism, overt racism, and implicit bias as factors contributing to racial disparities in maternal outcomes. Here we explore potential solutions for addressing the inequities as proposed by thought leaders and key stakeholders.



The emerging racial disparities in COVID-19 incidence and outcomes in the United States are on a collision course with long-standing racial disparities in U.S. maternal care and mortality.

Maternal health advocates are bracing for the impact, but in the spotlight that the pandemic is training on the inequities and the health system changes taking shape in its wake, some also see hope for a shift in at least one important driver of the racial health disparities: access to care.

Non-Hispanic black women are at least three times more likely than Hispanic women and non-Hispanic white women to experience pregnancy-related death, and indigenous women are more than twice as likely, according to the latest data from the Centers for Disease Control and Prevention’s National Center for Health Statistics. The added strain COVID-19 is putting on the system stands to further limit the access to care that many pregnant women of color experience and to exacerbate racial disparities, panelists agreed during a recent National Maternal Health Patient Centered Outcomes Research Network webinar entitled “The Impact of COVID-19 on Black, Brown, and Native Pregnant People.”

“The saying is that ‘the virus doesn’t discriminate,’ but it understands our biases, right? So, the virus takes advantage of the weaknesses in our system,” said panelist Joia A. Crear-Perry, MD, an ob.gyn. and founder and president of the National Birth Equity Collaborative (NBEC), a New Orleans–based research, training, and advocacy organization working to optimize black maternal and infant health.
 

Hope for solutions from the ashes of a pandemic

The weaknesses in the system that Dr. Crear-Perry spoke of are in many ways a product of structural racism as described in a conceptual report in The Lancet, titled “America: Equity and Equality in Health,” which dug into the entrenched and tangled historical roots of racist sociological and political factors that formed a foundation for health inequity over time.

Today, people of color remain more likely to be excluded from access to health insurance and adequate health care. The authors defined structural racism as “the totality of ways in which societies foster racial discrimination through mutually reinforcing systems of housing, education, employment, earnings, benefits, credit, media, health care, and criminal justice.” Today, largely as a result of these “reinforcing systems,” people of color remain more likely to be excluded from access to health insurance and adequate health care. At the same time, and for the same reasons, they are more likely to work in the service industry, be essential workers, and use mass transit, each of which increases the risk of exposure to COVID-19, Dr. Crear-Perry explained.

“It’s important for us to know that, for maternal mortality, it’s the same thing that happens,” she said. That means the focus on COVID-19–related disparities helps magnify and elevate the conversation regarding similar disparities in maternal outcomes.

It also means that some of the care delivery solutions embraced and facilitated amid the pandemic, such as extension of Medicaid coverage for up to a year after giving birth and broader use and insurance coverage of telemedicine, could finally gain traction; those are solutions long-sought by advocates like Dr. Crear-Perry and others as a means for alleviating racial disparities in maternal outcomes and addressing the maternal mortality crisis.

Therein lies the hope, she explained in an interview. “Some of the policies that we know would have been helpful prior to COVID-19 now are being seen as really important.”
 

Solution: Extending coverage

During a May 7 virtual Congressional hearing on “America’s Two Public Health Crises: The Impact of COVID-19 on Racial Inequities and Maternal Mortality in the U.S.,” cosponsored by the American College of Obstetricians and Gynecologists, the March of Dimes, and the NBEC, Dr. Crear-Perry further explained the importance of extended coverage and care access.

Asked what Congress could do immediately to “ensure that the pandemic does not compound the nation’s maternal mortality crisis, including unacceptable rates among black women,” she didn’t hesitate.

“Well, it would be amazing if we could get Medicaid extended for 12 months post delivery,” she said. “As you can imagine right now, we have moms who are birthing in hospitals where they have to worry about, 2 months later, not having coverage for themselves.”

If that mom is exposed to COVID-19 and has no insurance coverage and a newborn at home, the likelihood that she will call a provider if she develops symptoms is low, Dr. Crear-Perry said. “This is a great opportunity for us to really rethink some of those policies that we know are barriers, that we have created for people to be able to thrive after they have a baby and during child birth.”

Current policies are centered around an arbitrary cutoff of about 6 weeks for postpartum care, but the CDC reports that a third of all postpartum deaths occur between 1 week and 12 months after birth.

“We need our policies to reflect the current knowledge and the science,” she said. “Just like babies have automatic insurance coverage for a year later, mothers should have the same.”

Medicaid finances nearly half of all births in the United States, according to a 2019 Kaiser Family Foundation brief, which explained that federal law requires Medicaid coverage for only 60 days post partum for women who are eligible. Decisions regarding coverage after 60 days are determined by individual states; those that expanded Medicaid under the Affordable Care Act typically allow extended coverage – but only with reapplication at 60 days.

Many women in nonexpansion states become uninsured after pregnancy-related coverage ends, as do some in expansion states for whom reapplying is a hurdle too high to clear with a newborn baby to care for at home, Dr. Crear-Perry said.

Addressing these coverage gaps is key to improving access, and it is a core component of the Black Maternal Health Momnibus Act of 2020, a nine-bill package introduced in March by Rep. Lauren Underwood (D-Ill.), Rep. Alma Adams (D-N.C.), Sen. Kamala Harris (D-Calif.), and members of the Black Maternal Health Caucus to “fill gaps in existing legislation to comprehensively address every dimension of the Black maternal health crisis in America.”

One bill in the package addresses extended coverage with a goal to “promote innovative payment models to incentivize high-quality maternity care and continuity of health insurance coverage from pregnancy through labor and delivery and up to 1 year post partum.” Another focuses on promoting alternative ways to access care, such as through telemedicine.

Solution: Expanding care access

“There is a need for the democratization of care,” Dr. Crear-Perry said. “There is a need for people to have more ways to get care. This idea that the only way you can get prenatal care is you have to come to me at my office, has been a burden for working people for a long, long time.”

The COVID-19 pandemic necessitates increased use of telemedicine, but building blocks to allow patients to use it effectively must be put in place, she said. That means expanding broadband access, providing patients with blood pressure cuffs and other tools for use remotely, and expanding reimbursement to include not just video, but also phone calls.

Heart Safe Motherhood, a University of Pennsylvania text-based intervention developed to address postpartum hypertension – a leading cause of maternal morbidity and mortality, and at the start of the program, the leading cause of 7-day readmissions among obstetric patients, demonstrated the value of such approaches to care.

The program involves remote blood pressure monitoring using a digital monitor provided to at-risk patients at discharge. Text-based monitoring reminders encourage patients to check their blood pressure twice daily for the first 7 days.

“In our randomized, controlled trial, we saw our ability to meet ACOG guidelines on postpartum blood monitoring leap from 0% to 82%, compared to in-person office visits and 7-day readmissions from hypertension drop from 3% to 0%,” an update at the program website states.

ACOG

Rebekah Gee, MD, an ob.gyn. and director of the Louisiana State University Health System in New Orleans, also noted the importance of finding ways to deliver care “that are outside the traditional norm.

“Telemedicine, home visiting ... I think there are a wide variety of ways,” she said, noting that these kind of approaches not only help circumvent roadblocks to care, such as lack of transportation, but also can feel more personal and approachable for some women.
 

Solution: Measuring, investing, diversifying, respecting

The aims of other bills in the Momnibus Act also mirror several solutions proposed by maternal health advocates interviewed for this article. Among them are:

• Development of improved data collection processes and quality measures to better understand the factors that contribute to the crisis overall and among special populations, and to inform solutions for addressing them.
• Investments in social determinants of health that influence maternal health outcomes, like housing, transportation, and nutrition.
• Commitment to the growth and diversification of the perinatal workforce to ensure that every mom receives maternity care and support from people she can trust to provide quality care and treat her with respect.

The latter is one that Dr. Gee, Dr. Crear-Perry, and others particularly emphasized.

“We need patient advocates like doulas, midwives and others who are better listeners and better able to advocate for patients,” Dr. Gee said. This would better allow for women’s desires in the childbirth experience to be addressed appropriately, she said, adding that this is something that “frankly, a lot of doctors do not have the time to do.”

That’s why the efforts to address maternal mortality have to focus on the health care system, not just on doctors’ behavior with respect to bias, she said.

Dr. Gee also said there is a need for culturally appropriate literacy and numeracy communications “that respect how people seek and understand information.” This varies by population, which is why it’s important to provide the same approach to care “no matter what the patient looks like,” while also understanding that different patients communicate in different ways.

A 2019 study published in Social Science & Medicine underscored how communication differences can affect outcomes; using a national sample of women who gave birth in U.S. hospitals, the authors found that those who had declined care for themselves or their infant during their childbirth hospitalization were more likely to report receiving poor treatment based on race or ethnicity. They concluded that, in the context of childbirth care, women – particularly black women – pay a penalty for what is perceived as uncooperative behavior.

This is another area where doulas and other patient advocates can help, Dr. Gee said.

Doulas have long been an integral part of the birthing process for many women, particularly women of color, and evidence suggests the supportive care they provide helps to improve outcomes. In fact, several states – including Oregon, Minnesota, and New York, among others – have expanded or have proposed expanding Medicaid coverage to include doula services for pregnant beneficiaries, a move cheered by doula associations and other maternal health advocates.

In many ways, it’s about “respectful maternity care,” which is something Dr. Crear-Perry has been working to promote through the NBEC in partnership with ACOG and the Robert Wood Johnson Foundation. It’s also something the World Health Organization has promoted by establishing global standards for such care.

“We’re hoping to socialize that as a norm in United States ... to really see what it would look like to value what birthing people want and to see them as partners in their birth,” she said.

However, the 2019 Giving Voice to Mothers study demonstrating consistently higher rates of mistreatment during obstetrical care for women of color than for comparable white women shows that the United States is falling short of those standards. The national study of 2,700 women examined how race, ethnicity, and place of birth interact with the experience of receiving maternity care in the United States, and showed that 1 in 6 experienced one or more types of mistreatment – with consistently higher rates among women of color, even after adjusting for interactions between race and other maternal characteristics, Saraswathi Veda, MD, of the Birth Place Lab and professor of midwifery at the University of British Columbia, Vancouver, and colleagues reported in Reproductive Health.
 

Solution: Listening, learning, reflecting, partnering

Timoria McQueen Saba, birth trauma survivor and maternal health advocate, has described experiencing instances of mistreatment throughout her obstetric care, and like Dr. Crear-Perry, she said trust and collaboration in care is imperative for improving outcomes.

“I think the most important thing you can do is really consider a patient a partner in the care you give them,” she said during a panel discussion at the 2019 ACOG annual meeting. “You’re not experts in their lived experience ... center a patient’s voice or the voice of a patient’s family. Incorporate that into your learning.”

During a virtual workshop held May 19-20 by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Judette Louis, MD, chair of the department of obstetrics and gynecology at the University of South Florida, Tampa, and president of the Society of Maternal-Fetal Medicine, provided practical guidance for addressing racism and implicit bias in practice and in research to reduce disparities in outcomes.

In an interview, she summarized her key points, reiterating solutions proposed by Dr. Gee and Dr. Crear-Perry and addressed in the Momnibus Act, and also offering a few others:

First, put aside the notion that disparities are genetically driven. For a variety of reasons, that just doesn’t make sense. For one thing, not all blacks are African American.

“My family is from the Caribbean,” she said. “Is it really conceivable that we’re all so similar?”

Look also at the disparities among Native Americans, she said. “How can you take 500 distinct tribes that live across a wide geographic area and lump them into one group and assume that they are similar?”

The problem is racism, not race. “When you keep saying ‘it’s about race, it’s about race, it’s about race’ – that sends a message to the person who is of that race that there is something inherently broken about [them],” she said.

Recognize that the roots of the problem run deep. Learn about and support efforts to address the underlying structural factors that contribute to the problem, Dr. Louis emphasized, and recognize your own bias. “We all have it. The key is to recognize [biases] and mitigate them when taking care of patients.”

That’s easier said than done, at least judging by one survey of maternal-fetal medicine specialists in which 84% of respondents agreed that disparities impact practice, but only 29% agreed their own personal biases affect how they care for patients, she noted.

Tools are available to help individuals identify implicit bias, and training programs for health care providers can help, as well, she said. Implicit bias tests and training programs that help to identify and address bias and racism on individual and organizational levels are increasingly available through academic centers, health systems, and advocacy organizations.

Hope for solutions: Progress and promise

Like Dr. Crear-Perry, Dr. Louis sees hope for reducing disparities and improving maternal outcomes.

In another survey of SMFM members to identify the practice issues most important to them, racial disparities ranked in the top three.

“It says a lot that our [maternal-fetal medicine specialists] really see this as a problem and they want it fixed,” she said. “And I think it says that a lot of people need to work on this, not just us.”

Indeed, many are engaged in that work. Veronica Gillispie, MD, medical director of the Louisiana Perinatal Quality Collaborative and Pregnancy-Associated Mortality Review, has been instrumental in recent initiatives to improve maternal outcomes in Louisiana, and she too said she feels optimistic.

“I am hopeful and I do see signs of hope,” she said in an interview.

Teams that she works with and trains seem invested, institutions are increasingly implementing faculty training on racism and bias, and Oschner Health, where Dr. Gillispie practices as an ob.gyn., appointed its first chief diversity officer in February.

Medical students she works with are attuned to the issues of racism, bias, and disparities, and they show a desire to enact change, she said. “They already get it, and they are working to make it better.”

Dr. Crear-Perry also predicts practice-changing results from studies looking at the delivery of obstetrical care and the role of supportive care, and she pointed out another aspect of the COVID-19 crisis that provides an important lesson for health care providers who care for birthing people: the scarcity of personal protective equipment amid the pandemic.

“My friends who are ob.gyns., who are now not getting access to the things they need to stay safe to practice medicine and who are feeling very marginalized at this moment, feeling not valued – that’s how birthing people [of color] feel,” she said. “I’m hoping that builds a sense of empathy.

”I’m hoping at the end of this crisis, that those ob.gyns. will think of patients as allies in fighting for more access to health for everybody and for more resources to do their work,” Dr. Crear-Perry said. “We’re all in this together.”

sworcester@mdedge.com

Erythema associated with chronic graft-versus-host disease (GVHD) after allogenic stem cell transplantation is likely to resolve regardless of when it appears, while sclerosis that develops more than 3 months after a chronic GVHD diagnosis is less likely to resolve, according to research presented during a plenary session at the annual meeting of the Society for Investigative Dermatology, held virtually.

In addition, greater improvement in erythema, as measured by body surface area (BSA) in the study was significantly associated with higher patient survival, Laura X. Baker, BS, a medical student at Vanderbilt University, and coinvestigators at Vanderbilt Dermatology Translational Research Clinic in Nashville, Tenn., said in her presentation.

This new significant association between erythema response and survival could inform future studies,” she said. “Our findings highlight the importance of thorough skin exams in chronic GVHD patients.”

Ms. Baker and colleagues performed a prospective, observational study of 242 patients with chronic GVHD and cutaneous manifestations, enrolled in the Chronic GVHD Consortium across nine centers between 2007 and 2012.

Patients had either erythema or sclerosis at the time of enrollment, which was considered incident if erythema or sclerosis appeared less than 3 months after diagnosis of chronic GVHD, or prevalent if erythema or sclerosis appeared 3 months or later after a chronic GVHD diagnosis. All patients were enrolled in the Chronic GVHD Consortium within 3 years of a transplant and were receiving systemic immunosuppressive therapy.

Transplant clinicians examined patients every 6 months, assessing clinical parameters such as skin involvement. Ms. Baker and colleagues used the 2005 National Institutes of Health (NIH) criteria to assess a complete response, a partial response, or no cutaneous response using measurements made by the transplant clinicians. The NIH criteria recommend calculating the change in BSA at the first follow-up visit to determine these changes (Pavletic S et al. Biol Blood Marrow Transplant. 2006 Mar;12[3]:252-66). Researchers also developed a Cox regression model to evaluate overall survival and non-relapse mortality.

Among those with erythema, 133 patients had incident cases and 52 had prevalent cases of cutaneous chronic GVHD. At first follow-up after a finding of cutaneous involvement, the mean BSA was 4.5%, but the median BSA was zero, “meaning that more than half of the patients had complete disappearance of any erythema by the first follow-up,” Ms. Baker said. By the second follow-up visit, 74% of patients with erythema had complete responses, 9% achieved a partial response, and 18% had no response. A similar complete response rate was seen among patients with prevalent cases.

Among patients with sclerosis, there were 43 incident and 47 prevalent cases. Among patients with incident sclerosis, 68% achieved a clear response, 2% a partial response, and 30% no response. But only 28% of those with prevalent sclerosis had a complete response, 4% had a partial response, and 68% had no response.

Most erythema showed a complete response by the first follow-up, and it was not dependent on time from cGVHD diagnosis, Ms. Baker said. However, while most sclerosis within 3 months of cGVHD diagnosis showed a response, sclerosis present beyond the initial 3 months did not generally respond by the first follow-up.

“These findings could inform clinical care and expectations in addition to guiding the selection of outcome measures and endpoint definitions in clinical trials,” she added.

The researchers also looked at overall survival and nonrelapse mortality among patients with incident and prevalent erythema. After adjustment for age and BSA at enrollment, patients with incident cases of erythema with a complete response had significantly better odds of overall survival compared with patients who had no clinical response (hazard ratio, 0.50; 95% confidence interval; 0.25-1.00; P = .05).

Overall survival was greater in patients with prevalent cases of erythema (HR, 0.29; 95% CI, 0.09-0.87; P = .03). Nonrelapse mortality was also significantly lower among prevalent cases with complete or partial clinical response for erythema (HR, 0.19; 95% CI, 0.06-0.64; P = .01).

In a subgroup analysis, 113 patients with incident cases of erythema that had other organ cGVHD had significantly greater overall survival than did patients without a clinical response (HR, 0.20; 95% CI, 0.08-0.46; P < .005). Median survival distance after the first follow-up between patients with and without a clinical response was 28.9 months among incident cases, and 33.7 months among prevalent erythema cases.

“We knew that erythema is not a direct cause of mortality,” Ms. Baker said. Our results suggest the association between erythema response and survival is important and could inform future study.”

The researchers noted their study was limited by transplant clinicians measuring BSA rather than dermatologists, patients being treated at top transplant centers, and their GVHD diagnosis being within 3 years of a transplant, which could limit generalizability of the findings.

This study was funded by a career development award from the U.S. Department of Veterans Affairs and grants from the National Institutes of Health/National Cancer Institute.

SOURCE: Baker L. SID 2020, Abstract 434.

Erythema associated with chronic graft-versus-host disease (GVHD) after allogenic stem cell transplantation is likely to resolve regardless of when it appears, while sclerosis that develops more than 3 months after a chronic GVHD diagnosis is less likely to resolve, according to research presented during a plenary session at the annual meeting of the Society for Investigative Dermatology, held virtually.

In addition, greater improvement in erythema, as measured by body surface area (BSA) in the study was significantly associated with higher patient survival, Laura X. Baker, BS, a medical student at Vanderbilt University, and coinvestigators at Vanderbilt Dermatology Translational Research Clinic in Nashville, Tenn., said in her presentation.

This new significant association between erythema response and survival could inform future studies,” she said. “Our findings highlight the importance of thorough skin exams in chronic GVHD patients.”

Ms. Baker and colleagues performed a prospective, observational study of 242 patients with chronic GVHD and cutaneous manifestations, enrolled in the Chronic GVHD Consortium across nine centers between 2007 and 2012.

Patients had either erythema or sclerosis at the time of enrollment, which was considered incident if erythema or sclerosis appeared less than 3 months after diagnosis of chronic GVHD, or prevalent if erythema or sclerosis appeared 3 months or later after a chronic GVHD diagnosis. All patients were enrolled in the Chronic GVHD Consortium within 3 years of a transplant and were receiving systemic immunosuppressive therapy.

Transplant clinicians examined patients every 6 months, assessing clinical parameters such as skin involvement. Ms. Baker and colleagues used the 2005 National Institutes of Health (NIH) criteria to assess a complete response, a partial response, or no cutaneous response using measurements made by the transplant clinicians. The NIH criteria recommend calculating the change in BSA at the first follow-up visit to determine these changes (Pavletic S et al. Biol Blood Marrow Transplant. 2006 Mar;12[3]:252-66). Researchers also developed a Cox regression model to evaluate overall survival and non-relapse mortality.

Among those with erythema, 133 patients had incident cases and 52 had prevalent cases of cutaneous chronic GVHD. At first follow-up after a finding of cutaneous involvement, the mean BSA was 4.5%, but the median BSA was zero, “meaning that more than half of the patients had complete disappearance of any erythema by the first follow-up,” Ms. Baker said. By the second follow-up visit, 74% of patients with erythema had complete responses, 9% achieved a partial response, and 18% had no response. A similar complete response rate was seen among patients with prevalent cases.

Among patients with sclerosis, there were 43 incident and 47 prevalent cases. Among patients with incident sclerosis, 68% achieved a clear response, 2% a partial response, and 30% no response. But only 28% of those with prevalent sclerosis had a complete response, 4% had a partial response, and 68% had no response.

Most erythema showed a complete response by the first follow-up, and it was not dependent on time from cGVHD diagnosis, Ms. Baker said. However, while most sclerosis within 3 months of cGVHD diagnosis showed a response, sclerosis present beyond the initial 3 months did not generally respond by the first follow-up.

“These findings could inform clinical care and expectations in addition to guiding the selection of outcome measures and endpoint definitions in clinical trials,” she added.

The researchers also looked at overall survival and nonrelapse mortality among patients with incident and prevalent erythema. After adjustment for age and BSA at enrollment, patients with incident cases of erythema with a complete response had significantly better odds of overall survival compared with patients who had no clinical response (hazard ratio, 0.50; 95% confidence interval; 0.25-1.00; P = .05).

Overall survival was greater in patients with prevalent cases of erythema (HR, 0.29; 95% CI, 0.09-0.87; P = .03). Nonrelapse mortality was also significantly lower among prevalent cases with complete or partial clinical response for erythema (HR, 0.19; 95% CI, 0.06-0.64; P = .01).

In a subgroup analysis, 113 patients with incident cases of erythema that had other organ cGVHD had significantly greater overall survival than did patients without a clinical response (HR, 0.20; 95% CI, 0.08-0.46; P < .005). Median survival distance after the first follow-up between patients with and without a clinical response was 28.9 months among incident cases, and 33.7 months among prevalent erythema cases.

“We knew that erythema is not a direct cause of mortality,” Ms. Baker said. Our results suggest the association between erythema response and survival is important and could inform future study.”

The researchers noted their study was limited by transplant clinicians measuring BSA rather than dermatologists, patients being treated at top transplant centers, and their GVHD diagnosis being within 3 years of a transplant, which could limit generalizability of the findings.

This study was funded by a career development award from the U.S. Department of Veterans Affairs and grants from the National Institutes of Health/National Cancer Institute.

SOURCE: Baker L. SID 2020, Abstract 434.

Erythema associated with chronic graft-versus-host disease (GVHD) after allogenic stem cell transplantation is likely to resolve regardless of when it appears, while sclerosis that develops more than 3 months after a chronic GVHD diagnosis is less likely to resolve, according to research presented during a plenary session at the annual meeting of the Society for Investigative Dermatology, held virtually.

In addition, greater improvement in erythema, as measured by body surface area (BSA) in the study was significantly associated with higher patient survival, Laura X. Baker, BS, a medical student at Vanderbilt University, and coinvestigators at Vanderbilt Dermatology Translational Research Clinic in Nashville, Tenn., said in her presentation.

This new significant association between erythema response and survival could inform future studies,” she said. “Our findings highlight the importance of thorough skin exams in chronic GVHD patients.”

Ms. Baker and colleagues performed a prospective, observational study of 242 patients with chronic GVHD and cutaneous manifestations, enrolled in the Chronic GVHD Consortium across nine centers between 2007 and 2012.

Patients had either erythema or sclerosis at the time of enrollment, which was considered incident if erythema or sclerosis appeared less than 3 months after diagnosis of chronic GVHD, or prevalent if erythema or sclerosis appeared 3 months or later after a chronic GVHD diagnosis. All patients were enrolled in the Chronic GVHD Consortium within 3 years of a transplant and were receiving systemic immunosuppressive therapy.

Transplant clinicians examined patients every 6 months, assessing clinical parameters such as skin involvement. Ms. Baker and colleagues used the 2005 National Institutes of Health (NIH) criteria to assess a complete response, a partial response, or no cutaneous response using measurements made by the transplant clinicians. The NIH criteria recommend calculating the change in BSA at the first follow-up visit to determine these changes (Pavletic S et al. Biol Blood Marrow Transplant. 2006 Mar;12[3]:252-66). Researchers also developed a Cox regression model to evaluate overall survival and non-relapse mortality.

Among those with erythema, 133 patients had incident cases and 52 had prevalent cases of cutaneous chronic GVHD. At first follow-up after a finding of cutaneous involvement, the mean BSA was 4.5%, but the median BSA was zero, “meaning that more than half of the patients had complete disappearance of any erythema by the first follow-up,” Ms. Baker said. By the second follow-up visit, 74% of patients with erythema had complete responses, 9% achieved a partial response, and 18% had no response. A similar complete response rate was seen among patients with prevalent cases.

Among patients with sclerosis, there were 43 incident and 47 prevalent cases. Among patients with incident sclerosis, 68% achieved a clear response, 2% a partial response, and 30% no response. But only 28% of those with prevalent sclerosis had a complete response, 4% had a partial response, and 68% had no response.

Most erythema showed a complete response by the first follow-up, and it was not dependent on time from cGVHD diagnosis, Ms. Baker said. However, while most sclerosis within 3 months of cGVHD diagnosis showed a response, sclerosis present beyond the initial 3 months did not generally respond by the first follow-up.

“These findings could inform clinical care and expectations in addition to guiding the selection of outcome measures and endpoint definitions in clinical trials,” she added.

The researchers also looked at overall survival and nonrelapse mortality among patients with incident and prevalent erythema. After adjustment for age and BSA at enrollment, patients with incident cases of erythema with a complete response had significantly better odds of overall survival compared with patients who had no clinical response (hazard ratio, 0.50; 95% confidence interval; 0.25-1.00; P = .05).

Overall survival was greater in patients with prevalent cases of erythema (HR, 0.29; 95% CI, 0.09-0.87; P = .03). Nonrelapse mortality was also significantly lower among prevalent cases with complete or partial clinical response for erythema (HR, 0.19; 95% CI, 0.06-0.64; P = .01).

In a subgroup analysis, 113 patients with incident cases of erythema that had other organ cGVHD had significantly greater overall survival than did patients without a clinical response (HR, 0.20; 95% CI, 0.08-0.46; P < .005). Median survival distance after the first follow-up between patients with and without a clinical response was 28.9 months among incident cases, and 33.7 months among prevalent erythema cases.

“We knew that erythema is not a direct cause of mortality,” Ms. Baker said. Our results suggest the association between erythema response and survival is important and could inform future study.”

The researchers noted their study was limited by transplant clinicians measuring BSA rather than dermatologists, patients being treated at top transplant centers, and their GVHD diagnosis being within 3 years of a transplant, which could limit generalizability of the findings.

This study was funded by a career development award from the U.S. Department of Veterans Affairs and grants from the National Institutes of Health/National Cancer Institute.

SOURCE: Baker L. SID 2020, Abstract 434.