Conference Coverage

Americans are not feeling more suicidal even in the depths of the COVID-19 pandemic of spring 2020, according to analysis of real-time national data accrued through the Crisis Text Line.

But that’s not to say Americans are feeling less distressed. Quite the contrary, Nancy Lublin, CEO and cofounder of Crisis Text Line, noted at the virtual annual meeting of the American Association of Suicidology.

“We’ve seen a 40% increase in volume since early March. Seventy-eight percent of our conversations are now including words like ‘freaked out,’ ‘panicked,’ ‘scared.’ People are worried about COVID-19. They’re nervous about symptoms; they’re concerned for family on the front lines,” she said.

And yet, from mid-March through mid-April, only 22% of texters to the crisis line expressed suicidal ideation, down from a usual background rate of 28%. Moreover, just 13% of texters who mentioned ‘COVID,’ ‘quarantine,’ or ‘virus’ expressed suicidal ideation, compared with 25% of other texters.

Ms. Lublin and her data crunchers are tracking not only the impact of the disease, but they’re also monitoring the mental health effects of the quarantine and social distancing.

“People are away from their routines, and perhaps [are] quarantined with abusive people. We’ve seen a 48% increase in texts involving sexual abuse and a 74% increase in domestic violence,” she said.

Texts focused on eating disorders or body image issues have jumped by 45%. And roughly two-thirds of texters now describe feelings of depression.

One of the biggest mental health impacts she and colleagues have seen stem from the economic recession triggered by the pandemic.

“We’ve seen more people reach out with fears of bankruptcy, fears of homelessness, fears of financial ruin. Thirty-two percent of our texters now report household incomes under $20,000 per year. That’s up from 19% before,” according to Ms. Lublin.

The Crisis Text Line (text HOME to 741741) uses machine-learning algorithms that sift through incoming text messages from people in crisis for key words, then ranks the messages by severity. Since its launch in 2013, this service, available 24/7, has processed roughly 150 million text messages. The high-risk texters – for example, someone who’s swallowed a bottle of pills or is texting from the San Francisco’s Golden Gate Bridge, as has occurred some 500 times – are connected in an average of 24 seconds with a thoroughly trained volunteer crisis counselor. And there is a third party in these texting conversations: a paid staff supervisor with a master’s degree in a relevant discipline who follows the encounter in real time and can step in if needed.

“Active rescues are involved in less than 1% of our conversations, but still we do them on average 26 times per day. Over the years, we’ve completed more than 32,000 active rescues,” she said.

The Crisis Text Line is not exclusively a suicide prevention hotline. The top five issues people text about involve relationship concerns, depression, anxiety, self-harm, and suicidal ideation. Roughly 45% of the texters are under age 17, 17% are Hispanic, 5.5% Native American, and 44% are LGBTQ. Over time, Ms. Lublin and staff have used Big Data to tweak the screening algorithm as they’ve identified even higher red flag texting words than “suicide.”

“The word ‘military’ makes it twice as likely that we’ll have to call 9-1-1 than the word ‘suicide.’ ‘Gun,’ ‘rope’ – four times as likely. In the [United KIngdom], where we’re also operating, we see the word ‘cliff’ is a more lethal word than the word ‘suicide.’ But the most dangerous words that we see are any named pill,” she said.

The Crisis Text Line was recently awarded a 2020 TED Audacious Project grant to expand their services from English to also be offered in Spanish, French, Portuguese, and Arabic worldwide within the next two and a half years. This will provide coverage to one-third of the world’s population, including people with cell phones living in countries with very limited mental health services.
 

Will COVID-19 trigger a spike in deaths by suicide?

Whether the COVID-19 pandemic will result in a bump in suicide rates is unclear and will remain so for quite a while, according to David Gunnell, MD, PhD, a suicidologist and professor of epidemiology at the University of Bristol (England).

In the United Kingdom, investigation of a suspicious death typically takes more than 6 months before an official declaration of suicide is recorded by the medical examiner. The lag time is even longer in the United States: The latest national suicide rate data are for 2018 because state-by-state reporting practices vary widely, he noted at a National Press Foundation briefing on COVID-19 and mental health.

Although suicide is consistently the 10th-leading cause of death in the United States, it’s important to put it in perspective, he added. In 2018, there were an average of 4,000 deaths by suicide per month nationally, whereas in March and April of 2020, there were 28,400 deaths per month attributable to COVID-19.

A classic study of the Spanish influenza pandemic in the United States during 1918-1919 concluded that there was “a slight upturn” in the rate of suicide in the months following the pandemic’s peak. More recently, a study of the 2003 SARS (severe acute respiratory syndrome) epidemic in Hong Kong found roughly a 30% increase in the rate of suicide among the elderly during that time frame, Dr. Gunnell noted.

“What limited evidence there is provides an indication of a small rise in suicides, but the number of deaths is far outweighed by the number of deaths associated with these big pandemics,” according to the epidemiologist.

Pandemics aside, there is far more compelling evidence that periods of economic recession are associated with an increase in the suicide rate, he added.

Another speaker, Holly C. Wilcox, PhD, a psychiatric epidemiologist at Johns Hopkins University, Baltimore, commented: “It’s not surprising that, during times of disaster the suicide rates decrease a bit. It could be because of people coming toghether. It could be one silver lining of COVID-19. But if there’s prolonged stress economically and socially and we can’t work towards reducing stress for people, we could see an increase. I don’t know if we will.”

In a recent article, Dr. Gunnell and coauthors offered a series of recommendations aimed at blunting the mental health consequences of COVID-19 and the related economic fallout (Lancet Psychiatry. 2020 Apr 21. doi: 10.1016/S2215-0366[20]30171-1).

The authors highlighted the need for interventions aimed at defusing the adverse impact of self-isolation, social distancing, fear, an anticipated rise in alcohol misuse, joblessness, interrupted education, bereavement, and complicated grief. Governments can blunt the well-established effect of financial distress as a risk factor for suicide by providing safety nets in the form of supports for housing, food, and unemployment benefits. And it will be important that those mental health services that develop expertise in performing psychiatric assessments and interventions remotely via telemedicine share their insights, Dr. Gunnell said.

bjancin@mdedge.com

Americans are not feeling more suicidal even in the depths of the COVID-19 pandemic of spring 2020, according to analysis of real-time national data accrued through the Crisis Text Line.

But that’s not to say Americans are feeling less distressed. Quite the contrary, Nancy Lublin, CEO and cofounder of Crisis Text Line, noted at the virtual annual meeting of the American Association of Suicidology.

“We’ve seen a 40% increase in volume since early March. Seventy-eight percent of our conversations are now including words like ‘freaked out,’ ‘panicked,’ ‘scared.’ People are worried about COVID-19. They’re nervous about symptoms; they’re concerned for family on the front lines,” she said.

And yet, from mid-March through mid-April, only 22% of texters to the crisis line expressed suicidal ideation, down from a usual background rate of 28%. Moreover, just 13% of texters who mentioned ‘COVID,’ ‘quarantine,’ or ‘virus’ expressed suicidal ideation, compared with 25% of other texters.

Ms. Lublin and her data crunchers are tracking not only the impact of the disease, but they’re also monitoring the mental health effects of the quarantine and social distancing.

“People are away from their routines, and perhaps [are] quarantined with abusive people. We’ve seen a 48% increase in texts involving sexual abuse and a 74% increase in domestic violence,” she said.

Texts focused on eating disorders or body image issues have jumped by 45%. And roughly two-thirds of texters now describe feelings of depression.

One of the biggest mental health impacts she and colleagues have seen stem from the economic recession triggered by the pandemic.

“We’ve seen more people reach out with fears of bankruptcy, fears of homelessness, fears of financial ruin. Thirty-two percent of our texters now report household incomes under $20,000 per year. That’s up from 19% before,” according to Ms. Lublin.

The Crisis Text Line (text HOME to 741741) uses machine-learning algorithms that sift through incoming text messages from people in crisis for key words, then ranks the messages by severity. Since its launch in 2013, this service, available 24/7, has processed roughly 150 million text messages. The high-risk texters – for example, someone who’s swallowed a bottle of pills or is texting from the San Francisco’s Golden Gate Bridge, as has occurred some 500 times – are connected in an average of 24 seconds with a thoroughly trained volunteer crisis counselor. And there is a third party in these texting conversations: a paid staff supervisor with a master’s degree in a relevant discipline who follows the encounter in real time and can step in if needed.

“Active rescues are involved in less than 1% of our conversations, but still we do them on average 26 times per day. Over the years, we’ve completed more than 32,000 active rescues,” she said.

The Crisis Text Line is not exclusively a suicide prevention hotline. The top five issues people text about involve relationship concerns, depression, anxiety, self-harm, and suicidal ideation. Roughly 45% of the texters are under age 17, 17% are Hispanic, 5.5% Native American, and 44% are LGBTQ. Over time, Ms. Lublin and staff have used Big Data to tweak the screening algorithm as they’ve identified even higher red flag texting words than “suicide.”

“The word ‘military’ makes it twice as likely that we’ll have to call 9-1-1 than the word ‘suicide.’ ‘Gun,’ ‘rope’ – four times as likely. In the [United KIngdom], where we’re also operating, we see the word ‘cliff’ is a more lethal word than the word ‘suicide.’ But the most dangerous words that we see are any named pill,” she said.

The Crisis Text Line was recently awarded a 2020 TED Audacious Project grant to expand their services from English to also be offered in Spanish, French, Portuguese, and Arabic worldwide within the next two and a half years. This will provide coverage to one-third of the world’s population, including people with cell phones living in countries with very limited mental health services.
 

Will COVID-19 trigger a spike in deaths by suicide?

Whether the COVID-19 pandemic will result in a bump in suicide rates is unclear and will remain so for quite a while, according to David Gunnell, MD, PhD, a suicidologist and professor of epidemiology at the University of Bristol (England).

In the United Kingdom, investigation of a suspicious death typically takes more than 6 months before an official declaration of suicide is recorded by the medical examiner. The lag time is even longer in the United States: The latest national suicide rate data are for 2018 because state-by-state reporting practices vary widely, he noted at a National Press Foundation briefing on COVID-19 and mental health.

Although suicide is consistently the 10th-leading cause of death in the United States, it’s important to put it in perspective, he added. In 2018, there were an average of 4,000 deaths by suicide per month nationally, whereas in March and April of 2020, there were 28,400 deaths per month attributable to COVID-19.

A classic study of the Spanish influenza pandemic in the United States during 1918-1919 concluded that there was “a slight upturn” in the rate of suicide in the months following the pandemic’s peak. More recently, a study of the 2003 SARS (severe acute respiratory syndrome) epidemic in Hong Kong found roughly a 30% increase in the rate of suicide among the elderly during that time frame, Dr. Gunnell noted.

“What limited evidence there is provides an indication of a small rise in suicides, but the number of deaths is far outweighed by the number of deaths associated with these big pandemics,” according to the epidemiologist.

Pandemics aside, there is far more compelling evidence that periods of economic recession are associated with an increase in the suicide rate, he added.

Another speaker, Holly C. Wilcox, PhD, a psychiatric epidemiologist at Johns Hopkins University, Baltimore, commented: “It’s not surprising that, during times of disaster the suicide rates decrease a bit. It could be because of people coming toghether. It could be one silver lining of COVID-19. But if there’s prolonged stress economically and socially and we can’t work towards reducing stress for people, we could see an increase. I don’t know if we will.”

In a recent article, Dr. Gunnell and coauthors offered a series of recommendations aimed at blunting the mental health consequences of COVID-19 and the related economic fallout (Lancet Psychiatry. 2020 Apr 21. doi: 10.1016/S2215-0366[20]30171-1).

The authors highlighted the need for interventions aimed at defusing the adverse impact of self-isolation, social distancing, fear, an anticipated rise in alcohol misuse, joblessness, interrupted education, bereavement, and complicated grief. Governments can blunt the well-established effect of financial distress as a risk factor for suicide by providing safety nets in the form of supports for housing, food, and unemployment benefits. And it will be important that those mental health services that develop expertise in performing psychiatric assessments and interventions remotely via telemedicine share their insights, Dr. Gunnell said.

bjancin@mdedge.com

Americans are not feeling more suicidal even in the depths of the COVID-19 pandemic of spring 2020, according to analysis of real-time national data accrued through the Crisis Text Line.

But that’s not to say Americans are feeling less distressed. Quite the contrary, Nancy Lublin, CEO and cofounder of Crisis Text Line, noted at the virtual annual meeting of the American Association of Suicidology.

“We’ve seen a 40% increase in volume since early March. Seventy-eight percent of our conversations are now including words like ‘freaked out,’ ‘panicked,’ ‘scared.’ People are worried about COVID-19. They’re nervous about symptoms; they’re concerned for family on the front lines,” she said.

And yet, from mid-March through mid-April, only 22% of texters to the crisis line expressed suicidal ideation, down from a usual background rate of 28%. Moreover, just 13% of texters who mentioned ‘COVID,’ ‘quarantine,’ or ‘virus’ expressed suicidal ideation, compared with 25% of other texters.

Ms. Lublin and her data crunchers are tracking not only the impact of the disease, but they’re also monitoring the mental health effects of the quarantine and social distancing.

“People are away from their routines, and perhaps [are] quarantined with abusive people. We’ve seen a 48% increase in texts involving sexual abuse and a 74% increase in domestic violence,” she said.

Texts focused on eating disorders or body image issues have jumped by 45%. And roughly two-thirds of texters now describe feelings of depression.

One of the biggest mental health impacts she and colleagues have seen stem from the economic recession triggered by the pandemic.

“We’ve seen more people reach out with fears of bankruptcy, fears of homelessness, fears of financial ruin. Thirty-two percent of our texters now report household incomes under $20,000 per year. That’s up from 19% before,” according to Ms. Lublin.

The Crisis Text Line (text HOME to 741741) uses machine-learning algorithms that sift through incoming text messages from people in crisis for key words, then ranks the messages by severity. Since its launch in 2013, this service, available 24/7, has processed roughly 150 million text messages. The high-risk texters – for example, someone who’s swallowed a bottle of pills or is texting from the San Francisco’s Golden Gate Bridge, as has occurred some 500 times – are connected in an average of 24 seconds with a thoroughly trained volunteer crisis counselor. And there is a third party in these texting conversations: a paid staff supervisor with a master’s degree in a relevant discipline who follows the encounter in real time and can step in if needed.

“Active rescues are involved in less than 1% of our conversations, but still we do them on average 26 times per day. Over the years, we’ve completed more than 32,000 active rescues,” she said.

The Crisis Text Line is not exclusively a suicide prevention hotline. The top five issues people text about involve relationship concerns, depression, anxiety, self-harm, and suicidal ideation. Roughly 45% of the texters are under age 17, 17% are Hispanic, 5.5% Native American, and 44% are LGBTQ. Over time, Ms. Lublin and staff have used Big Data to tweak the screening algorithm as they’ve identified even higher red flag texting words than “suicide.”

“The word ‘military’ makes it twice as likely that we’ll have to call 9-1-1 than the word ‘suicide.’ ‘Gun,’ ‘rope’ – four times as likely. In the [United KIngdom], where we’re also operating, we see the word ‘cliff’ is a more lethal word than the word ‘suicide.’ But the most dangerous words that we see are any named pill,” she said.

The Crisis Text Line was recently awarded a 2020 TED Audacious Project grant to expand their services from English to also be offered in Spanish, French, Portuguese, and Arabic worldwide within the next two and a half years. This will provide coverage to one-third of the world’s population, including people with cell phones living in countries with very limited mental health services.
 

Will COVID-19 trigger a spike in deaths by suicide?

Whether the COVID-19 pandemic will result in a bump in suicide rates is unclear and will remain so for quite a while, according to David Gunnell, MD, PhD, a suicidologist and professor of epidemiology at the University of Bristol (England).

In the United Kingdom, investigation of a suspicious death typically takes more than 6 months before an official declaration of suicide is recorded by the medical examiner. The lag time is even longer in the United States: The latest national suicide rate data are for 2018 because state-by-state reporting practices vary widely, he noted at a National Press Foundation briefing on COVID-19 and mental health.

Although suicide is consistently the 10th-leading cause of death in the United States, it’s important to put it in perspective, he added. In 2018, there were an average of 4,000 deaths by suicide per month nationally, whereas in March and April of 2020, there were 28,400 deaths per month attributable to COVID-19.

A classic study of the Spanish influenza pandemic in the United States during 1918-1919 concluded that there was “a slight upturn” in the rate of suicide in the months following the pandemic’s peak. More recently, a study of the 2003 SARS (severe acute respiratory syndrome) epidemic in Hong Kong found roughly a 30% increase in the rate of suicide among the elderly during that time frame, Dr. Gunnell noted.

“What limited evidence there is provides an indication of a small rise in suicides, but the number of deaths is far outweighed by the number of deaths associated with these big pandemics,” according to the epidemiologist.

Pandemics aside, there is far more compelling evidence that periods of economic recession are associated with an increase in the suicide rate, he added.

Another speaker, Holly C. Wilcox, PhD, a psychiatric epidemiologist at Johns Hopkins University, Baltimore, commented: “It’s not surprising that, during times of disaster the suicide rates decrease a bit. It could be because of people coming toghether. It could be one silver lining of COVID-19. But if there’s prolonged stress economically and socially and we can’t work towards reducing stress for people, we could see an increase. I don’t know if we will.”

In a recent article, Dr. Gunnell and coauthors offered a series of recommendations aimed at blunting the mental health consequences of COVID-19 and the related economic fallout (Lancet Psychiatry. 2020 Apr 21. doi: 10.1016/S2215-0366[20]30171-1).

The authors highlighted the need for interventions aimed at defusing the adverse impact of self-isolation, social distancing, fear, an anticipated rise in alcohol misuse, joblessness, interrupted education, bereavement, and complicated grief. Governments can blunt the well-established effect of financial distress as a risk factor for suicide by providing safety nets in the form of supports for housing, food, and unemployment benefits. And it will be important that those mental health services that develop expertise in performing psychiatric assessments and interventions remotely via telemedicine share their insights, Dr. Gunnell said.

bjancin@mdedge.com

Calls to a mental health crisis hotline in New York City have soared during the COVID-19 pandemic, which has closed schools and businesses, put millions out of work, and ushered in stay-at-home orders.

“Crisis hotlines are a core part of our nation’s mental health safety net, ensuring that care is available when and where needed during a crisis, whether that be an individual crisis, a local community crisis, or a national mental health crisis like we are facing right now,” said Kimberly Williams, president and CEO of Vibrant Emotional Health.

Vibrant Emotional Health, formerly the Mental Health Association of New York City, provides crisis line services across the United States in partnership with local and federal governments and corporations. NYC Well is one of them.

Ms. Williams and two of her colleagues spoke about crisis hotlines April 25 during the American Psychiatric Association’s Virtual Spring Highlights Meeting.
 

Rapid crisis intervention

Crisis hotlines provide “rapid crisis intervention, delivering help immediately from trained crisis counselors who respond to unique needs, actively engage in collaborative problem solving, and assess risk for suicide,” Ms. Williams said.

They have a proven track record, she noted. Research shows that they are able to decrease emotional distress and reduce suicidality in crisis situations.

Kelly Clarke, program director of NYC Well, noted that inbound call volume has increased roughly 50% since the COVID-19 pandemic hit.

Callers to NYC Well most commonly report mood/anxiety concerns, stressful life events, and interpersonal problems. “Many people are reaching out to seek support in how to manage their own emotional well-being in light of the pandemic and the restrictions put in place,” said Ms. Clarke.

Multilingual peer support specialists and counselors with NYC Well provide free, confidential support by talk, text, or chat 24 hours per day, 7 days per week, 365 days a year. The service also provides mobile crisis teams and follow-up services. NYC Well has set up a landing page of resources specifically geared toward COVID-19.

How to cope with the rapid growth and at the same time ensure high quality of services are two key challenges for NYC Well, Ms. Clarke said.
 

“Absolutely essential” service

For John Draper, PhD, the experience early in his career of working on a mobile mental health crisis team in Brooklyn “changed his life.”

First, it showed him that, for people who are severely psychiatrically ill, “care has to come to them,” said Dr. Draper, executive vice president of national networks for Vibrant Emotional Health.

“So many of the people we were seeing were too depressed to get out of bed, much less get to a clinic, and I realized our system was not set up to serve its customers. It was like putting a spinal cord injury clinic at the top of a stairs,” he said.

Crisis hotlines are “absolutely essential.” Their value for communities and individuals “can’t be overestimated,” said Dr. Draper.

This was revealed after the terrorist attacks of 9/11 and now with COVID-19, said Dr. Draper. He noted, that following the attacks of 9/11, a federal report referred to crisis hotlines as “the single most important asset in the response.”

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

Calls to a mental health crisis hotline in New York City have soared during the COVID-19 pandemic, which has closed schools and businesses, put millions out of work, and ushered in stay-at-home orders.

“Crisis hotlines are a core part of our nation’s mental health safety net, ensuring that care is available when and where needed during a crisis, whether that be an individual crisis, a local community crisis, or a national mental health crisis like we are facing right now,” said Kimberly Williams, president and CEO of Vibrant Emotional Health.

Vibrant Emotional Health, formerly the Mental Health Association of New York City, provides crisis line services across the United States in partnership with local and federal governments and corporations. NYC Well is one of them.

Ms. Williams and two of her colleagues spoke about crisis hotlines April 25 during the American Psychiatric Association’s Virtual Spring Highlights Meeting.
 

Rapid crisis intervention

Crisis hotlines provide “rapid crisis intervention, delivering help immediately from trained crisis counselors who respond to unique needs, actively engage in collaborative problem solving, and assess risk for suicide,” Ms. Williams said.

They have a proven track record, she noted. Research shows that they are able to decrease emotional distress and reduce suicidality in crisis situations.

Kelly Clarke, program director of NYC Well, noted that inbound call volume has increased roughly 50% since the COVID-19 pandemic hit.

Callers to NYC Well most commonly report mood/anxiety concerns, stressful life events, and interpersonal problems. “Many people are reaching out to seek support in how to manage their own emotional well-being in light of the pandemic and the restrictions put in place,” said Ms. Clarke.

Multilingual peer support specialists and counselors with NYC Well provide free, confidential support by talk, text, or chat 24 hours per day, 7 days per week, 365 days a year. The service also provides mobile crisis teams and follow-up services. NYC Well has set up a landing page of resources specifically geared toward COVID-19.

How to cope with the rapid growth and at the same time ensure high quality of services are two key challenges for NYC Well, Ms. Clarke said.
 

“Absolutely essential” service

For John Draper, PhD, the experience early in his career of working on a mobile mental health crisis team in Brooklyn “changed his life.”

First, it showed him that, for people who are severely psychiatrically ill, “care has to come to them,” said Dr. Draper, executive vice president of national networks for Vibrant Emotional Health.

“So many of the people we were seeing were too depressed to get out of bed, much less get to a clinic, and I realized our system was not set up to serve its customers. It was like putting a spinal cord injury clinic at the top of a stairs,” he said.

Crisis hotlines are “absolutely essential.” Their value for communities and individuals “can’t be overestimated,” said Dr. Draper.

This was revealed after the terrorist attacks of 9/11 and now with COVID-19, said Dr. Draper. He noted, that following the attacks of 9/11, a federal report referred to crisis hotlines as “the single most important asset in the response.”

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

Calls to a mental health crisis hotline in New York City have soared during the COVID-19 pandemic, which has closed schools and businesses, put millions out of work, and ushered in stay-at-home orders.

“Crisis hotlines are a core part of our nation’s mental health safety net, ensuring that care is available when and where needed during a crisis, whether that be an individual crisis, a local community crisis, or a national mental health crisis like we are facing right now,” said Kimberly Williams, president and CEO of Vibrant Emotional Health.

Vibrant Emotional Health, formerly the Mental Health Association of New York City, provides crisis line services across the United States in partnership with local and federal governments and corporations. NYC Well is one of them.

Ms. Williams and two of her colleagues spoke about crisis hotlines April 25 during the American Psychiatric Association’s Virtual Spring Highlights Meeting.
 

Rapid crisis intervention

Crisis hotlines provide “rapid crisis intervention, delivering help immediately from trained crisis counselors who respond to unique needs, actively engage in collaborative problem solving, and assess risk for suicide,” Ms. Williams said.

They have a proven track record, she noted. Research shows that they are able to decrease emotional distress and reduce suicidality in crisis situations.

Kelly Clarke, program director of NYC Well, noted that inbound call volume has increased roughly 50% since the COVID-19 pandemic hit.

Callers to NYC Well most commonly report mood/anxiety concerns, stressful life events, and interpersonal problems. “Many people are reaching out to seek support in how to manage their own emotional well-being in light of the pandemic and the restrictions put in place,” said Ms. Clarke.

Multilingual peer support specialists and counselors with NYC Well provide free, confidential support by talk, text, or chat 24 hours per day, 7 days per week, 365 days a year. The service also provides mobile crisis teams and follow-up services. NYC Well has set up a landing page of resources specifically geared toward COVID-19.

How to cope with the rapid growth and at the same time ensure high quality of services are two key challenges for NYC Well, Ms. Clarke said.
 

“Absolutely essential” service

For John Draper, PhD, the experience early in his career of working on a mobile mental health crisis team in Brooklyn “changed his life.”

First, it showed him that, for people who are severely psychiatrically ill, “care has to come to them,” said Dr. Draper, executive vice president of national networks for Vibrant Emotional Health.

“So many of the people we were seeing were too depressed to get out of bed, much less get to a clinic, and I realized our system was not set up to serve its customers. It was like putting a spinal cord injury clinic at the top of a stairs,” he said.

Crisis hotlines are “absolutely essential.” Their value for communities and individuals “can’t be overestimated,” said Dr. Draper.

This was revealed after the terrorist attacks of 9/11 and now with COVID-19, said Dr. Draper. He noted, that following the attacks of 9/11, a federal report referred to crisis hotlines as “the single most important asset in the response.”

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

Cancer type, stage, and recent treatment may affect outcomes of COVID-19 in cancer patients, according to a study of patients from China.

The data showed that patients with hematologic malignancies and those with metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying.

On the other hand, patients with nonmetastatic cancer had outcomes comparable to those of noncancer patients with COVID-19.

Similarly, cancer patients who had recently undergone surgery or received immunotherapy were more likely to have poor outcomes, whereas cancer patients treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

Hongbing Cai, MD, of Zhongnan Hospital of Wuhan University in China, presented these results at the AACR virtual meeting I. The results also were published in Cancer Discovery.
 

Cancer vs. noncancer patients

The study included 105 cancer patients with COVID-19 who were treated from Jan. 1 to Feb. 24, 2020, at 14 hospitals in Wuhan, China. Patients had lung (20.95%), gastrointestinal (12.38%), breast (10.48%), and thyroid cancers (10.48%) as well as hematologic malignancies (8.57%). Dr. Cai and colleagues matched the COVID-19 cancer patients to 536 COVID-19 patients without cancer. Patients were matched by hospital, duration of hospitalization, and age.

“COVID-19 patients with cancer had higher risks of all severe outcomes,” Dr. Cai noted.

Compared with noncancer patients, the cancer patients had a higher risk of:

• Severe or critical COVID-19 symptoms – odds ratio, 2.79 (P < .01).
• Being admitted to the ICU – OR, 2.84 (P < .01).
• Requiring invasive mechanical ventilation – OR, 14 (P < .01).
• Death – OR, 2.34 (P = .03).

Cancer type and stage

Dr. Cai noted that outcomes were the worst among patients with hematologic malignancies and those with metastatic cancer (stage IV).

Compared with patients without cancer, those with hematologic malignancies had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• ICU admission – OR, 9.66 (P < .01).
• Invasive mechanical ventilation – OR, 38 (P < .01).
• Death – OR, 9.07 (P = .01).

Compared with patients without cancer, those with metastatic cancer had a higher risk of:

• Severe/critical symptoms – OR, 5.97 (P < .01).
• ICU admission – OR, 6.59 (P < 0.01).
• Invasive mechanical ventilation – OR, 55.42 (P < .01).
• Death – OR, 5.58 (P = .01).

On the other hand, outcomes in patients with nonmetastatic cancer were not significantly different from outcomes in patients without cancer (P > .05 for all outcomes).
 

Cancer treatment

The treatments cancer patients received within 40 days before the onset of COVID-19 symptoms were radiotherapy (12.26%), chemotherapy (14.15%), surgery (7.62%), targeted therapies (3.81%), and immunotherapy (5.71%).

Compared with patients without cancer, those who received immunotherapy had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• Death – OR, 9.07 (P = .04).

Patients who underwent surgery had a higher risk of:

• Severe/critical symptoms – OR, 8.84 (P < .01).
• ICU admission – OR, 7.24 (P = .02).
• Invasive mechanical ventilation – OR, 44.33 (P < .01).

Conversely, outcomes in cancer patients who received radiotherapy were not significantly different from outcomes in patients without cancer (P > .10 for all).

These results suggest that “postponing surgery should be considered in outbreak areas,” Dr. Cai said, adding that scheduled radiotherapy can go ahead but with “intensive protection and surveillance.”

Dr. Cai said it remains to be seen whether patients with early-stage cancer need to postpone their treatments during the COVID-19 pandemic or whether immunotherapy aggravates severe outcomes in cancer patients with COVID-19. For now, she said, cancer patients should have individualized treatment plans based on their tumor type and stage.

Dr. Cai disclosed no conflicts of interest. This study was supported by the National Natural Science Foundation of China, the Singapore Ministry of Health’s National Medical Research Council, the National Institutes of Health/National Heart, Lung, and Blood Institute, and the Xiu Research Fund.

jensmith@mdedge.com

SOURCE: Cai H. AACR 2020. Patients with cancer appear more vulnerable to SARS-COV-2: A multicenter study during the COVID-19 outbreak; Dai M et al. Cancer Discov. 2020 Apr 28. doi: 10.1158/2159-8290.CD-20-0422.

Cancer type, stage, and recent treatment may affect outcomes of COVID-19 in cancer patients, according to a study of patients from China.

The data showed that patients with hematologic malignancies and those with metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying.

On the other hand, patients with nonmetastatic cancer had outcomes comparable to those of noncancer patients with COVID-19.

Similarly, cancer patients who had recently undergone surgery or received immunotherapy were more likely to have poor outcomes, whereas cancer patients treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

Hongbing Cai, MD, of Zhongnan Hospital of Wuhan University in China, presented these results at the AACR virtual meeting I. The results also were published in Cancer Discovery.
 

Cancer vs. noncancer patients

The study included 105 cancer patients with COVID-19 who were treated from Jan. 1 to Feb. 24, 2020, at 14 hospitals in Wuhan, China. Patients had lung (20.95%), gastrointestinal (12.38%), breast (10.48%), and thyroid cancers (10.48%) as well as hematologic malignancies (8.57%). Dr. Cai and colleagues matched the COVID-19 cancer patients to 536 COVID-19 patients without cancer. Patients were matched by hospital, duration of hospitalization, and age.

“COVID-19 patients with cancer had higher risks of all severe outcomes,” Dr. Cai noted.

Compared with noncancer patients, the cancer patients had a higher risk of:

• Severe or critical COVID-19 symptoms – odds ratio, 2.79 (P < .01).
• Being admitted to the ICU – OR, 2.84 (P < .01).
• Requiring invasive mechanical ventilation – OR, 14 (P < .01).
• Death – OR, 2.34 (P = .03).

Cancer type and stage

Dr. Cai noted that outcomes were the worst among patients with hematologic malignancies and those with metastatic cancer (stage IV).

Compared with patients without cancer, those with hematologic malignancies had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• ICU admission – OR, 9.66 (P < .01).
• Invasive mechanical ventilation – OR, 38 (P < .01).
• Death – OR, 9.07 (P = .01).

Compared with patients without cancer, those with metastatic cancer had a higher risk of:

• Severe/critical symptoms – OR, 5.97 (P < .01).
• ICU admission – OR, 6.59 (P < 0.01).
• Invasive mechanical ventilation – OR, 55.42 (P < .01).
• Death – OR, 5.58 (P = .01).

On the other hand, outcomes in patients with nonmetastatic cancer were not significantly different from outcomes in patients without cancer (P > .05 for all outcomes).
 

Cancer treatment

The treatments cancer patients received within 40 days before the onset of COVID-19 symptoms were radiotherapy (12.26%), chemotherapy (14.15%), surgery (7.62%), targeted therapies (3.81%), and immunotherapy (5.71%).

Compared with patients without cancer, those who received immunotherapy had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• Death – OR, 9.07 (P = .04).

Patients who underwent surgery had a higher risk of:

• Severe/critical symptoms – OR, 8.84 (P < .01).
• ICU admission – OR, 7.24 (P = .02).
• Invasive mechanical ventilation – OR, 44.33 (P < .01).

Conversely, outcomes in cancer patients who received radiotherapy were not significantly different from outcomes in patients without cancer (P > .10 for all).

These results suggest that “postponing surgery should be considered in outbreak areas,” Dr. Cai said, adding that scheduled radiotherapy can go ahead but with “intensive protection and surveillance.”

Dr. Cai said it remains to be seen whether patients with early-stage cancer need to postpone their treatments during the COVID-19 pandemic or whether immunotherapy aggravates severe outcomes in cancer patients with COVID-19. For now, she said, cancer patients should have individualized treatment plans based on their tumor type and stage.

Dr. Cai disclosed no conflicts of interest. This study was supported by the National Natural Science Foundation of China, the Singapore Ministry of Health’s National Medical Research Council, the National Institutes of Health/National Heart, Lung, and Blood Institute, and the Xiu Research Fund.

jensmith@mdedge.com

SOURCE: Cai H. AACR 2020. Patients with cancer appear more vulnerable to SARS-COV-2: A multicenter study during the COVID-19 outbreak; Dai M et al. Cancer Discov. 2020 Apr 28. doi: 10.1158/2159-8290.CD-20-0422.

Cancer type, stage, and recent treatment may affect outcomes of COVID-19 in cancer patients, according to a study of patients from China.

The data showed that patients with hematologic malignancies and those with metastatic cancers had higher risks of developing severe or critical COVID-19 symptoms, being admitted to the ICU, requiring ventilation, and dying.

On the other hand, patients with nonmetastatic cancer had outcomes comparable to those of noncancer patients with COVID-19.

Similarly, cancer patients who had recently undergone surgery or received immunotherapy were more likely to have poor outcomes, whereas cancer patients treated with radiotherapy had outcomes similar to those of noncancer COVID-19 patients.

Hongbing Cai, MD, of Zhongnan Hospital of Wuhan University in China, presented these results at the AACR virtual meeting I. The results also were published in Cancer Discovery.
 

Cancer vs. noncancer patients

The study included 105 cancer patients with COVID-19 who were treated from Jan. 1 to Feb. 24, 2020, at 14 hospitals in Wuhan, China. Patients had lung (20.95%), gastrointestinal (12.38%), breast (10.48%), and thyroid cancers (10.48%) as well as hematologic malignancies (8.57%). Dr. Cai and colleagues matched the COVID-19 cancer patients to 536 COVID-19 patients without cancer. Patients were matched by hospital, duration of hospitalization, and age.

“COVID-19 patients with cancer had higher risks of all severe outcomes,” Dr. Cai noted.

Compared with noncancer patients, the cancer patients had a higher risk of:

• Severe or critical COVID-19 symptoms – odds ratio, 2.79 (P < .01).
• Being admitted to the ICU – OR, 2.84 (P < .01).
• Requiring invasive mechanical ventilation – OR, 14 (P < .01).
• Death – OR, 2.34 (P = .03).

Cancer type and stage

Dr. Cai noted that outcomes were the worst among patients with hematologic malignancies and those with metastatic cancer (stage IV).

Compared with patients without cancer, those with hematologic malignancies had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• ICU admission – OR, 9.66 (P < .01).
• Invasive mechanical ventilation – OR, 38 (P < .01).
• Death – OR, 9.07 (P = .01).

Compared with patients without cancer, those with metastatic cancer had a higher risk of:

• Severe/critical symptoms – OR, 5.97 (P < .01).
• ICU admission – OR, 6.59 (P < 0.01).
• Invasive mechanical ventilation – OR, 55.42 (P < .01).
• Death – OR, 5.58 (P = .01).

On the other hand, outcomes in patients with nonmetastatic cancer were not significantly different from outcomes in patients without cancer (P > .05 for all outcomes).
 

Cancer treatment

The treatments cancer patients received within 40 days before the onset of COVID-19 symptoms were radiotherapy (12.26%), chemotherapy (14.15%), surgery (7.62%), targeted therapies (3.81%), and immunotherapy (5.71%).

Compared with patients without cancer, those who received immunotherapy had a higher risk of:

• Severe/critical symptoms – OR, 10.61 (P < .01).
• Death – OR, 9.07 (P = .04).

Patients who underwent surgery had a higher risk of:

• Severe/critical symptoms – OR, 8.84 (P < .01).
• ICU admission – OR, 7.24 (P = .02).
• Invasive mechanical ventilation – OR, 44.33 (P < .01).

Conversely, outcomes in cancer patients who received radiotherapy were not significantly different from outcomes in patients without cancer (P > .10 for all).

These results suggest that “postponing surgery should be considered in outbreak areas,” Dr. Cai said, adding that scheduled radiotherapy can go ahead but with “intensive protection and surveillance.”

Dr. Cai said it remains to be seen whether patients with early-stage cancer need to postpone their treatments during the COVID-19 pandemic or whether immunotherapy aggravates severe outcomes in cancer patients with COVID-19. For now, she said, cancer patients should have individualized treatment plans based on their tumor type and stage.

Dr. Cai disclosed no conflicts of interest. This study was supported by the National Natural Science Foundation of China, the Singapore Ministry of Health’s National Medical Research Council, the National Institutes of Health/National Heart, Lung, and Blood Institute, and the Xiu Research Fund.

jensmith@mdedge.com

SOURCE: Cai H. AACR 2020. Patients with cancer appear more vulnerable to SARS-COV-2: A multicenter study during the COVID-19 outbreak; Dai M et al. Cancer Discov. 2020 Apr 28. doi: 10.1158/2159-8290.CD-20-0422.

No clinical benefit was seen from adding the immune checkpoint inhibitor atezolizumab (Tecentriq, Genentech) to standard treatment with the androgen receptor inhibitor enzalutamide (Xtandi; Astellas Pharma) for men with metastatic castration-resistant prostate cancer (mCRPC).

Median overall survival, the trial’s primary endpoint, was numerically but not statistically longer among patients with mCRPC who were randomly assigned to receive treatment with enzalutamide alone, reported lead investigator Christopher J. Sweeney, MBBS, from the Dana-Farber Cancer Institute in Boston.

The finding comes from the phase 3 IMbassador250 trial.

This was “the first phase 3 trial to investigate a checkpoint inhibitor therapy combination in metastatic CRPC. It revealed no evidence of a difference in cancer control between arms, whether it be measured by radiographic progression-free survival or time to PSA [prostate-specific antigen] progression,” he said.

Adding insult to injury, the investigators could not identify, on the basis of expression of programmed death–ligand 1 (PD-L1), a subpopulation of patients who might have benefited from the combination therapy, and adverse events were more frequent than with enzalutamide alone, Sweeney said.

Sweeney presented the results online during the American Association for Cancer Research (AACR) 2020 virtual meeting.
 

What happened?

It sounded good on paper: the clinical rationale for combining an immune checkpoint inhibitor with enzalutamide was that there was evidence that immunotherapy with sipuleucel-T (Provenge, Dendreon Pharmaceuticals) had efficacy in CRPC, and initial investigations with ipilimumab (Yervoy, Bristol-Myers Squibb) that showed an increase in antigen-specific T cells following treatment with sipuleucel-T, Sweeney said.

In addition, there has been evidence that programmed death–1 (PD-1) blockade may have activity following the development of resistance to enzalutamide and that monotherapy with atezolizumab, an inhibitor of PD-1 and PD-L1, was associated with long-term disease control in mCRPC, he added.

However, these new results “indicate that neither anti-PD-1/PD-L1 monotherapy or the anti-PD-1/PD-L1 combination therapy with enzalutamide are likely to provide improved clinical benefit over standard-of-care agents for patients with mCRPC whose disease progressed on prior hormonal therapy and prior chemotherapy,” commented Padmanee Sharma, MD, PhD, from the University of Texas MD Anderson Cancer Center in Houston, who was the invited discussant.

Discussing why the IMbassador250 trial may have failed, she noted that prostate cancer has few T cells, and therefore targeting PD-1 or PD-L1 would not have much of an effect.

“There are multiple immunosuppressive pathways within the prostate tumor microenvironment, and the PD-1/PD-L1-targeting agents may not sufficiently target all these immunosuppressive pathways,” she said.

In addition, “there are few mutations in prostate cancer, and as a result, the effector T cells may not be able to recognize an adequate number of antigens to lead to an antitumor response,” Sharma said.
 

Study details

The IMbassador250 study was a phase 3, multicenter, randomized, open-label study involving 759 men with metastatic, locally advanced, or incurable CRPC who had experienced disease progression with abiraterone (Zytiga, Janssen), were ineligible or refused a taxane-based regimen, or for whom a taxane regimen had failed.

After stratification on the basis of prior taxane therapy, presence of liver metastases, lactate dehydrogenase levels, and pain severity in the past 24 hours, the patients were randomly assigned to receive either enzalutamide 160 mg daily or the same regimen plus atezolizumab 1200 mg intravenously every 3 weeks. Treatment continued until loss of clinical benefit or unacceptable toxicity.

Median overall survival (OS) was 15.2 months with the combination, compared with 16.6 months for enzalutamide alone, which translated into a hazard ratio for death with the combination of 1.12 (P = .28).

The 12-month OS rates were 60.6% for enzalutamide alone versus 64.7% for the combination.

An analysis of OS by clinical subgroup found no advantage from the combination over enzalutamide alone for prior docetaxel exposure, prior local therapy, measurable disease status, the presence of visceral or nonvisceral metastases, or PD-L1 expression.

Radiographic progression-free survival was 4.2 months with atezolizumab/enzalutamide versus 4.1 months with enzalutamide alone (P = ns). Time to PSA progression was 2.8 months in each arm.

Among patients with measurable disease at baseline, the overall response rates were 14% in the combination group and 7% in the group that received enzalutamide alone. Two patients in the combination group and one in the enzalutamide-only group had complete responses.

Grade 3 or 4 treatment-related adverse events (AEs) occurred in 28% of patients who received the combination, versus 10% who received enzalutamide alone. Seven patients in the combination arm and one in the enzalutamide arm died from treatment-related causes. Treatment-related serious AEs were also more frequent with the combination (14% vs. 3%), and AEs that led to discontinuation of any treatment component occurred in 14% of patients in the combination arm, versus 6% in the enzalutamide-alone arm.

The study was sponsored by F. Hoffman–La Roche. Enzalutamide was provided by Astellas and Pfizer. Sweeny has advisory or consulting roles and/or has received research funding from the companies. Sharma has consulting roles, has engaged in advisory board activities, or owns stock in for various companies, not including the sponsors.

This article first appeared on Medscape.com.

No clinical benefit was seen from adding the immune checkpoint inhibitor atezolizumab (Tecentriq, Genentech) to standard treatment with the androgen receptor inhibitor enzalutamide (Xtandi; Astellas Pharma) for men with metastatic castration-resistant prostate cancer (mCRPC).

Median overall survival, the trial’s primary endpoint, was numerically but not statistically longer among patients with mCRPC who were randomly assigned to receive treatment with enzalutamide alone, reported lead investigator Christopher J. Sweeney, MBBS, from the Dana-Farber Cancer Institute in Boston.

The finding comes from the phase 3 IMbassador250 trial.

This was “the first phase 3 trial to investigate a checkpoint inhibitor therapy combination in metastatic CRPC. It revealed no evidence of a difference in cancer control between arms, whether it be measured by radiographic progression-free survival or time to PSA [prostate-specific antigen] progression,” he said.

Adding insult to injury, the investigators could not identify, on the basis of expression of programmed death–ligand 1 (PD-L1), a subpopulation of patients who might have benefited from the combination therapy, and adverse events were more frequent than with enzalutamide alone, Sweeney said.

Sweeney presented the results online during the American Association for Cancer Research (AACR) 2020 virtual meeting.
 

What happened?

It sounded good on paper: the clinical rationale for combining an immune checkpoint inhibitor with enzalutamide was that there was evidence that immunotherapy with sipuleucel-T (Provenge, Dendreon Pharmaceuticals) had efficacy in CRPC, and initial investigations with ipilimumab (Yervoy, Bristol-Myers Squibb) that showed an increase in antigen-specific T cells following treatment with sipuleucel-T, Sweeney said.

In addition, there has been evidence that programmed death–1 (PD-1) blockade may have activity following the development of resistance to enzalutamide and that monotherapy with atezolizumab, an inhibitor of PD-1 and PD-L1, was associated with long-term disease control in mCRPC, he added.

However, these new results “indicate that neither anti-PD-1/PD-L1 monotherapy or the anti-PD-1/PD-L1 combination therapy with enzalutamide are likely to provide improved clinical benefit over standard-of-care agents for patients with mCRPC whose disease progressed on prior hormonal therapy and prior chemotherapy,” commented Padmanee Sharma, MD, PhD, from the University of Texas MD Anderson Cancer Center in Houston, who was the invited discussant.

Discussing why the IMbassador250 trial may have failed, she noted that prostate cancer has few T cells, and therefore targeting PD-1 or PD-L1 would not have much of an effect.

“There are multiple immunosuppressive pathways within the prostate tumor microenvironment, and the PD-1/PD-L1-targeting agents may not sufficiently target all these immunosuppressive pathways,” she said.

In addition, “there are few mutations in prostate cancer, and as a result, the effector T cells may not be able to recognize an adequate number of antigens to lead to an antitumor response,” Sharma said.
 

Study details

The IMbassador250 study was a phase 3, multicenter, randomized, open-label study involving 759 men with metastatic, locally advanced, or incurable CRPC who had experienced disease progression with abiraterone (Zytiga, Janssen), were ineligible or refused a taxane-based regimen, or for whom a taxane regimen had failed.

After stratification on the basis of prior taxane therapy, presence of liver metastases, lactate dehydrogenase levels, and pain severity in the past 24 hours, the patients were randomly assigned to receive either enzalutamide 160 mg daily or the same regimen plus atezolizumab 1200 mg intravenously every 3 weeks. Treatment continued until loss of clinical benefit or unacceptable toxicity.

Median overall survival (OS) was 15.2 months with the combination, compared with 16.6 months for enzalutamide alone, which translated into a hazard ratio for death with the combination of 1.12 (P = .28).

The 12-month OS rates were 60.6% for enzalutamide alone versus 64.7% for the combination.

An analysis of OS by clinical subgroup found no advantage from the combination over enzalutamide alone for prior docetaxel exposure, prior local therapy, measurable disease status, the presence of visceral or nonvisceral metastases, or PD-L1 expression.

Radiographic progression-free survival was 4.2 months with atezolizumab/enzalutamide versus 4.1 months with enzalutamide alone (P = ns). Time to PSA progression was 2.8 months in each arm.

Among patients with measurable disease at baseline, the overall response rates were 14% in the combination group and 7% in the group that received enzalutamide alone. Two patients in the combination group and one in the enzalutamide-only group had complete responses.

Grade 3 or 4 treatment-related adverse events (AEs) occurred in 28% of patients who received the combination, versus 10% who received enzalutamide alone. Seven patients in the combination arm and one in the enzalutamide arm died from treatment-related causes. Treatment-related serious AEs were also more frequent with the combination (14% vs. 3%), and AEs that led to discontinuation of any treatment component occurred in 14% of patients in the combination arm, versus 6% in the enzalutamide-alone arm.

The study was sponsored by F. Hoffman–La Roche. Enzalutamide was provided by Astellas and Pfizer. Sweeny has advisory or consulting roles and/or has received research funding from the companies. Sharma has consulting roles, has engaged in advisory board activities, or owns stock in for various companies, not including the sponsors.

This article first appeared on Medscape.com.

No clinical benefit was seen from adding the immune checkpoint inhibitor atezolizumab (Tecentriq, Genentech) to standard treatment with the androgen receptor inhibitor enzalutamide (Xtandi; Astellas Pharma) for men with metastatic castration-resistant prostate cancer (mCRPC).

Median overall survival, the trial’s primary endpoint, was numerically but not statistically longer among patients with mCRPC who were randomly assigned to receive treatment with enzalutamide alone, reported lead investigator Christopher J. Sweeney, MBBS, from the Dana-Farber Cancer Institute in Boston.

The finding comes from the phase 3 IMbassador250 trial.

This was “the first phase 3 trial to investigate a checkpoint inhibitor therapy combination in metastatic CRPC. It revealed no evidence of a difference in cancer control between arms, whether it be measured by radiographic progression-free survival or time to PSA [prostate-specific antigen] progression,” he said.

Adding insult to injury, the investigators could not identify, on the basis of expression of programmed death–ligand 1 (PD-L1), a subpopulation of patients who might have benefited from the combination therapy, and adverse events were more frequent than with enzalutamide alone, Sweeney said.

Sweeney presented the results online during the American Association for Cancer Research (AACR) 2020 virtual meeting.
 

What happened?

It sounded good on paper: the clinical rationale for combining an immune checkpoint inhibitor with enzalutamide was that there was evidence that immunotherapy with sipuleucel-T (Provenge, Dendreon Pharmaceuticals) had efficacy in CRPC, and initial investigations with ipilimumab (Yervoy, Bristol-Myers Squibb) that showed an increase in antigen-specific T cells following treatment with sipuleucel-T, Sweeney said.

In addition, there has been evidence that programmed death–1 (PD-1) blockade may have activity following the development of resistance to enzalutamide and that monotherapy with atezolizumab, an inhibitor of PD-1 and PD-L1, was associated with long-term disease control in mCRPC, he added.

However, these new results “indicate that neither anti-PD-1/PD-L1 monotherapy or the anti-PD-1/PD-L1 combination therapy with enzalutamide are likely to provide improved clinical benefit over standard-of-care agents for patients with mCRPC whose disease progressed on prior hormonal therapy and prior chemotherapy,” commented Padmanee Sharma, MD, PhD, from the University of Texas MD Anderson Cancer Center in Houston, who was the invited discussant.

Discussing why the IMbassador250 trial may have failed, she noted that prostate cancer has few T cells, and therefore targeting PD-1 or PD-L1 would not have much of an effect.

“There are multiple immunosuppressive pathways within the prostate tumor microenvironment, and the PD-1/PD-L1-targeting agents may not sufficiently target all these immunosuppressive pathways,” she said.

In addition, “there are few mutations in prostate cancer, and as a result, the effector T cells may not be able to recognize an adequate number of antigens to lead to an antitumor response,” Sharma said.
 

Study details

The IMbassador250 study was a phase 3, multicenter, randomized, open-label study involving 759 men with metastatic, locally advanced, or incurable CRPC who had experienced disease progression with abiraterone (Zytiga, Janssen), were ineligible or refused a taxane-based regimen, or for whom a taxane regimen had failed.

After stratification on the basis of prior taxane therapy, presence of liver metastases, lactate dehydrogenase levels, and pain severity in the past 24 hours, the patients were randomly assigned to receive either enzalutamide 160 mg daily or the same regimen plus atezolizumab 1200 mg intravenously every 3 weeks. Treatment continued until loss of clinical benefit or unacceptable toxicity.

Median overall survival (OS) was 15.2 months with the combination, compared with 16.6 months for enzalutamide alone, which translated into a hazard ratio for death with the combination of 1.12 (P = .28).

The 12-month OS rates were 60.6% for enzalutamide alone versus 64.7% for the combination.

An analysis of OS by clinical subgroup found no advantage from the combination over enzalutamide alone for prior docetaxel exposure, prior local therapy, measurable disease status, the presence of visceral or nonvisceral metastases, or PD-L1 expression.

Radiographic progression-free survival was 4.2 months with atezolizumab/enzalutamide versus 4.1 months with enzalutamide alone (P = ns). Time to PSA progression was 2.8 months in each arm.

Among patients with measurable disease at baseline, the overall response rates were 14% in the combination group and 7% in the group that received enzalutamide alone. Two patients in the combination group and one in the enzalutamide-only group had complete responses.

Grade 3 or 4 treatment-related adverse events (AEs) occurred in 28% of patients who received the combination, versus 10% who received enzalutamide alone. Seven patients in the combination arm and one in the enzalutamide arm died from treatment-related causes. Treatment-related serious AEs were also more frequent with the combination (14% vs. 3%), and AEs that led to discontinuation of any treatment component occurred in 14% of patients in the combination arm, versus 6% in the enzalutamide-alone arm.

The study was sponsored by F. Hoffman–La Roche. Enzalutamide was provided by Astellas and Pfizer. Sweeny has advisory or consulting roles and/or has received research funding from the companies. Sharma has consulting roles, has engaged in advisory board activities, or owns stock in for various companies, not including the sponsors.

This article first appeared on Medscape.com.

A novel combination has boosted responses in women with high-risk, HER2-negative breast cancer.

The new combo comprises the immune checkpoint inhibitor durvalumab (Imfinzi, AstraZeneca) and the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza, AstraZeneca).

When this combo was added to standard neoadjuvant chemotherapy, it yielded a significantly higher pathologic complete response (pCR) rate at the time of surgery than was seen with chemotherapy alone.

The superior pCR rate was seen across all HER2-negative breast cancer subtypes, including HER2-negative, estrogen receptor–positive tumors (Mammaprint high risk), and in women with triple-negative breast cancer (TNBC), reported lead investigator Lajos Pusztai, MD, DPhil, from Yale Cancer Center in New Haven, Connecticut.

“These results provide further evidence for the clinical value of immunotherapy in early-stage breast cancer and suggest new avenues for how to exploit these drugs in hormone receptor [HR]–positive breast cancers,” said Pusztai.

He presented the results at the American Association for Cancer Research (AACR) virtual annual meeting, which took place online, owing to the COVID-19 pandemic.
 

Toxicities, including financial

“The benefits from immunotherapy are clearly emerging in early and metastatic triple-negative breast cancer, likely with PD-L1 expression. However, there’s much more uncertainty in patients with hormone-sensitive tumors whether there is benefit and who will benefit from immunotherapy,” commented Pamela N. Munster, MD, from the University of California, San Francisco, who was the invited discussant.

“The signal of a better pCR rate among patients in the ultra-high Mammaprint group may allow selection of patients with HR-positive disease who may benefit from immunotherapeutic agents and/or PARP inhibitors,” she said.

Munster noted that the approximately 10% higher rate of immune-related adverse events of grade 3 or greater that was seen with the combination appears similar to that seen in other studies, but anemia and fatigue appeared to be less frequent with durvalumab/olaparaib and paclitaxel in comparison with paclitaxel alone.

“In the absence of a clear delineation of the contribution of olaparib, some weight should be given to the financial burden of adding both durvalumab and olaparib to a preoperative regimen,” she said.

The additional cost of durvalumab is approximately $34,000, and adding olaparib boosts that by about $22,000 more, Munster said.
 

Ongoing platform trial

The new results come from one arm of the ongoing Investigation of Serial Studies to Predict Your Therapeutic Response Through Imaging and Molecular Analysis 2 (I-SPY-2) trial. This is an ongoing platform trial that is exploring the use of new drugs in combination with a standard neoadjuvant therapy backbone for the treatment of high-risk cancers.

In this trial, women with stage II or III breast cancer with tumors 2.5 cm or larger are assessed for one of eight biomarker subtypes according to HER2 status, HR status, and genetic risk factors, as determined on the basis of a 70-gene assay. The patients within each biomarker subtype are randomly assigned to receive standard therapy either with or without an investigational agent.

For each subtrial, a primary endpoint is an improvement in pCR in comparison with the standard of care.

Changes in tumor volume on MRI are used to predict whether patients will achieve a pCR. Those who are considered to have a high Bayesian predictive probability of success are eligible for moving on to phase 3 trials.

The I-SPY-2 trial was described in detail by principal investigator Laura J. Esserman, MD, MBA, from the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco, in a 2017 interview from the annual meeting of the American Society of Clinical Oncology.

As previously reported, the first drugs to “graduate” from the trial were the HER2/HER4 inhibitor neratinib (Nerlynx, Puma Biotechnology) and the investigational PARP inhibitor veliparib (AbbVie).
 

Study details

The I-SPY-2 results that Pusztai reported at the AACR meeting were based on an analysis of 73 HER2-negative patients, including 21 patients with TNBC and 52 with HR-positive tumors with Mammaprint high-risk features. These patients underwent treatment with durvalumab 1500 mg every 4 weeks for three cycles, olaparib 100 mg twice daily for weeks 1 through 11, and paclitaxel 80 mg/m2 weekly for 12 weeks, followed by AC chemotherapy (doxorubicin and cyclophosphamide) for four cycles.

The 299 patients in the control arm received paclitaxel and chemotherapy only.

In all three biomarker subsets studied, durvalumab and olaparib increased pCR rates compared with controls, as shown in the table.

The probability that the combination was superior to control in each subgroup approached 100%, Pusztai noted.

Adverse events with the combination were consistent with known side effects of the drugs, he commented. Immune-related grade 3 adverse events occurred in 19% of patients in the combination therapy arm, compared with 1.6% in the control arm.

Higher pCR rates were seen in the subset of immune-rich tumors among all cancer subtypes and in both study arms.

“Exploratory analysis suggests several potential predictive markers of durvalumab/olaparib benefit over chemotherapy alone,” Pusztai reported.

These markers included Mammaprint MP2 (ultra high) versus MP1 in HR+/HER2– tumors, and low CD3/CD8 gene signature ratio, high macrophage/Tc-class 2 gene signature ratio, and high proliferation signature, all of which were associated with higher pCR rates in the experimental arm among patients with TNBC.

The trial was supported by the William K. Bowes Jr Foundation, Foundation for the NIH, Give Breast Cancer the Boot, UCSF, the Biomarkers Consortium, IQVIA, the Breast Cancer Research Foundation, Safeway, California Breast Cancer Research Program, Breast Cancer Research–Atwater Trust, and Stand Up to Cancer. Pusztai has received honoraria and consulting fees from AstraZeneca and other companies. Munster has received research and travel support from and has served on the scientific advisory boards of AstraZeneca and other companies.

This article first appeared on Medscape.com.

A novel combination has boosted responses in women with high-risk, HER2-negative breast cancer.

The new combo comprises the immune checkpoint inhibitor durvalumab (Imfinzi, AstraZeneca) and the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza, AstraZeneca).

When this combo was added to standard neoadjuvant chemotherapy, it yielded a significantly higher pathologic complete response (pCR) rate at the time of surgery than was seen with chemotherapy alone.

The superior pCR rate was seen across all HER2-negative breast cancer subtypes, including HER2-negative, estrogen receptor–positive tumors (Mammaprint high risk), and in women with triple-negative breast cancer (TNBC), reported lead investigator Lajos Pusztai, MD, DPhil, from Yale Cancer Center in New Haven, Connecticut.

“These results provide further evidence for the clinical value of immunotherapy in early-stage breast cancer and suggest new avenues for how to exploit these drugs in hormone receptor [HR]–positive breast cancers,” said Pusztai.

He presented the results at the American Association for Cancer Research (AACR) virtual annual meeting, which took place online, owing to the COVID-19 pandemic.
 

Toxicities, including financial

“The benefits from immunotherapy are clearly emerging in early and metastatic triple-negative breast cancer, likely with PD-L1 expression. However, there’s much more uncertainty in patients with hormone-sensitive tumors whether there is benefit and who will benefit from immunotherapy,” commented Pamela N. Munster, MD, from the University of California, San Francisco, who was the invited discussant.

“The signal of a better pCR rate among patients in the ultra-high Mammaprint group may allow selection of patients with HR-positive disease who may benefit from immunotherapeutic agents and/or PARP inhibitors,” she said.

Munster noted that the approximately 10% higher rate of immune-related adverse events of grade 3 or greater that was seen with the combination appears similar to that seen in other studies, but anemia and fatigue appeared to be less frequent with durvalumab/olaparaib and paclitaxel in comparison with paclitaxel alone.

“In the absence of a clear delineation of the contribution of olaparib, some weight should be given to the financial burden of adding both durvalumab and olaparib to a preoperative regimen,” she said.

The additional cost of durvalumab is approximately $34,000, and adding olaparib boosts that by about $22,000 more, Munster said.
 

Ongoing platform trial

The new results come from one arm of the ongoing Investigation of Serial Studies to Predict Your Therapeutic Response Through Imaging and Molecular Analysis 2 (I-SPY-2) trial. This is an ongoing platform trial that is exploring the use of new drugs in combination with a standard neoadjuvant therapy backbone for the treatment of high-risk cancers.

In this trial, women with stage II or III breast cancer with tumors 2.5 cm or larger are assessed for one of eight biomarker subtypes according to HER2 status, HR status, and genetic risk factors, as determined on the basis of a 70-gene assay. The patients within each biomarker subtype are randomly assigned to receive standard therapy either with or without an investigational agent.

For each subtrial, a primary endpoint is an improvement in pCR in comparison with the standard of care.

Changes in tumor volume on MRI are used to predict whether patients will achieve a pCR. Those who are considered to have a high Bayesian predictive probability of success are eligible for moving on to phase 3 trials.

The I-SPY-2 trial was described in detail by principal investigator Laura J. Esserman, MD, MBA, from the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco, in a 2017 interview from the annual meeting of the American Society of Clinical Oncology.

As previously reported, the first drugs to “graduate” from the trial were the HER2/HER4 inhibitor neratinib (Nerlynx, Puma Biotechnology) and the investigational PARP inhibitor veliparib (AbbVie).
 

Study details

The I-SPY-2 results that Pusztai reported at the AACR meeting were based on an analysis of 73 HER2-negative patients, including 21 patients with TNBC and 52 with HR-positive tumors with Mammaprint high-risk features. These patients underwent treatment with durvalumab 1500 mg every 4 weeks for three cycles, olaparib 100 mg twice daily for weeks 1 through 11, and paclitaxel 80 mg/m2 weekly for 12 weeks, followed by AC chemotherapy (doxorubicin and cyclophosphamide) for four cycles.

The 299 patients in the control arm received paclitaxel and chemotherapy only.

In all three biomarker subsets studied, durvalumab and olaparib increased pCR rates compared with controls, as shown in the table.

The probability that the combination was superior to control in each subgroup approached 100%, Pusztai noted.

Adverse events with the combination were consistent with known side effects of the drugs, he commented. Immune-related grade 3 adverse events occurred in 19% of patients in the combination therapy arm, compared with 1.6% in the control arm.

Higher pCR rates were seen in the subset of immune-rich tumors among all cancer subtypes and in both study arms.

“Exploratory analysis suggests several potential predictive markers of durvalumab/olaparib benefit over chemotherapy alone,” Pusztai reported.

These markers included Mammaprint MP2 (ultra high) versus MP1 in HR+/HER2– tumors, and low CD3/CD8 gene signature ratio, high macrophage/Tc-class 2 gene signature ratio, and high proliferation signature, all of which were associated with higher pCR rates in the experimental arm among patients with TNBC.

The trial was supported by the William K. Bowes Jr Foundation, Foundation for the NIH, Give Breast Cancer the Boot, UCSF, the Biomarkers Consortium, IQVIA, the Breast Cancer Research Foundation, Safeway, California Breast Cancer Research Program, Breast Cancer Research–Atwater Trust, and Stand Up to Cancer. Pusztai has received honoraria and consulting fees from AstraZeneca and other companies. Munster has received research and travel support from and has served on the scientific advisory boards of AstraZeneca and other companies.

This article first appeared on Medscape.com.

A novel combination has boosted responses in women with high-risk, HER2-negative breast cancer.

The new combo comprises the immune checkpoint inhibitor durvalumab (Imfinzi, AstraZeneca) and the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza, AstraZeneca).

When this combo was added to standard neoadjuvant chemotherapy, it yielded a significantly higher pathologic complete response (pCR) rate at the time of surgery than was seen with chemotherapy alone.

The superior pCR rate was seen across all HER2-negative breast cancer subtypes, including HER2-negative, estrogen receptor–positive tumors (Mammaprint high risk), and in women with triple-negative breast cancer (TNBC), reported lead investigator Lajos Pusztai, MD, DPhil, from Yale Cancer Center in New Haven, Connecticut.

“These results provide further evidence for the clinical value of immunotherapy in early-stage breast cancer and suggest new avenues for how to exploit these drugs in hormone receptor [HR]–positive breast cancers,” said Pusztai.

He presented the results at the American Association for Cancer Research (AACR) virtual annual meeting, which took place online, owing to the COVID-19 pandemic.
 

Toxicities, including financial

“The benefits from immunotherapy are clearly emerging in early and metastatic triple-negative breast cancer, likely with PD-L1 expression. However, there’s much more uncertainty in patients with hormone-sensitive tumors whether there is benefit and who will benefit from immunotherapy,” commented Pamela N. Munster, MD, from the University of California, San Francisco, who was the invited discussant.

“The signal of a better pCR rate among patients in the ultra-high Mammaprint group may allow selection of patients with HR-positive disease who may benefit from immunotherapeutic agents and/or PARP inhibitors,” she said.

Munster noted that the approximately 10% higher rate of immune-related adverse events of grade 3 or greater that was seen with the combination appears similar to that seen in other studies, but anemia and fatigue appeared to be less frequent with durvalumab/olaparaib and paclitaxel in comparison with paclitaxel alone.

“In the absence of a clear delineation of the contribution of olaparib, some weight should be given to the financial burden of adding both durvalumab and olaparib to a preoperative regimen,” she said.

The additional cost of durvalumab is approximately $34,000, and adding olaparib boosts that by about $22,000 more, Munster said.
 

Ongoing platform trial

The new results come from one arm of the ongoing Investigation of Serial Studies to Predict Your Therapeutic Response Through Imaging and Molecular Analysis 2 (I-SPY-2) trial. This is an ongoing platform trial that is exploring the use of new drugs in combination with a standard neoadjuvant therapy backbone for the treatment of high-risk cancers.

In this trial, women with stage II or III breast cancer with tumors 2.5 cm or larger are assessed for one of eight biomarker subtypes according to HER2 status, HR status, and genetic risk factors, as determined on the basis of a 70-gene assay. The patients within each biomarker subtype are randomly assigned to receive standard therapy either with or without an investigational agent.

For each subtrial, a primary endpoint is an improvement in pCR in comparison with the standard of care.

Changes in tumor volume on MRI are used to predict whether patients will achieve a pCR. Those who are considered to have a high Bayesian predictive probability of success are eligible for moving on to phase 3 trials.

The I-SPY-2 trial was described in detail by principal investigator Laura J. Esserman, MD, MBA, from the Helen Diller Comprehensive Cancer Center at the University of California, San Francisco, in a 2017 interview from the annual meeting of the American Society of Clinical Oncology.

As previously reported, the first drugs to “graduate” from the trial were the HER2/HER4 inhibitor neratinib (Nerlynx, Puma Biotechnology) and the investigational PARP inhibitor veliparib (AbbVie).
 

Study details

The I-SPY-2 results that Pusztai reported at the AACR meeting were based on an analysis of 73 HER2-negative patients, including 21 patients with TNBC and 52 with HR-positive tumors with Mammaprint high-risk features. These patients underwent treatment with durvalumab 1500 mg every 4 weeks for three cycles, olaparib 100 mg twice daily for weeks 1 through 11, and paclitaxel 80 mg/m2 weekly for 12 weeks, followed by AC chemotherapy (doxorubicin and cyclophosphamide) for four cycles.

The 299 patients in the control arm received paclitaxel and chemotherapy only.

In all three biomarker subsets studied, durvalumab and olaparib increased pCR rates compared with controls, as shown in the table.

The probability that the combination was superior to control in each subgroup approached 100%, Pusztai noted.

Adverse events with the combination were consistent with known side effects of the drugs, he commented. Immune-related grade 3 adverse events occurred in 19% of patients in the combination therapy arm, compared with 1.6% in the control arm.

Higher pCR rates were seen in the subset of immune-rich tumors among all cancer subtypes and in both study arms.

“Exploratory analysis suggests several potential predictive markers of durvalumab/olaparib benefit over chemotherapy alone,” Pusztai reported.

These markers included Mammaprint MP2 (ultra high) versus MP1 in HR+/HER2– tumors, and low CD3/CD8 gene signature ratio, high macrophage/Tc-class 2 gene signature ratio, and high proliferation signature, all of which were associated with higher pCR rates in the experimental arm among patients with TNBC.

The trial was supported by the William K. Bowes Jr Foundation, Foundation for the NIH, Give Breast Cancer the Boot, UCSF, the Biomarkers Consortium, IQVIA, the Breast Cancer Research Foundation, Safeway, California Breast Cancer Research Program, Breast Cancer Research–Atwater Trust, and Stand Up to Cancer. Pusztai has received honoraria and consulting fees from AstraZeneca and other companies. Munster has received research and travel support from and has served on the scientific advisory boards of AstraZeneca and other companies.

This article first appeared on Medscape.com.

Menopausal women with an intact uterus treated for a year with a daily, oral, single-pill formulation of estradiol and progesterone for the primary goal of reducing moderate to severe vasomotor symptoms showed evidence of reduced bone turnover in a post hoc, subgroup analysis of 157 women enrolled in the REPLENISH trial.

Ingram Publishing/Thinkstock

These findings “provide support for a potential skeletal benefit” when menopausal women with an intact uterus regularly used the tested estradiol plus progesterone formulation to treat moderate to severe vasomotor symptoms (VMS), Risa Kagan, MD, and associates wrote in an abstract released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting, and released abstracts for press coverage.

The reductions reported for three different markers of bone turnover compared with placebo control after 6 and 12 months on treatment with a U.S.-marketed estradiol plus progesterone formulation were ”reassuring and in line with expectations” said Lubna Pal, MBBS, professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., who was not involved with the study. But the findings fell short of addressing the more clinically relevant issue of whether the tested regimen reduces the rate of bone fractures.

The analysis included 56 women treated with 1.0 mg estradiol and 100 mg progesterone daily, 56 who received 0.5 mg estradiol and 100 mg progesterone daily, and 45 women in the placebo arm. It assessed changes from baseline in the on-treatment compared with placebo groups using immunoassays for bone-specific alkaline phosphatase (BSAP), C-terminal telopeptide of type 1 collagen (CTX-1), and N-terminal propeptide of type 1 procollagen (PINP). For this analysis, the researchers combined the two active-treatment arms, and found that all three markers showed statistically significant drops from baseline with treatment, compared with placebo at both 6- and 12-month follow-up. For all three markers, the declines on active treatment grew larger with time, and after 12 months the mean drops from baseline compared with placebo were an 18% relative reduction in BSAP, a 41% relative reduction in CTX-1, and a 29% relative reduction in PINP, reported Dr. Kagan, a gynecologist based in Berkeley, Calif., who is affiliated with the University of California San Francisco.

In addition to not yet providing more clinically meaningful results on bone fracture rates, Dr. Pal cited additional issues that limit interpretation of both these findings and the broader REPLENISH results. First, the new analysis of bone-turnover markers as reported in the abstract does not allow assessment of a possible dose-dependent effect on bone turnover. More importantly, while the full REPLENISH trial provided reassuring data on endometrial protection, it has not yet reported data on the other major safety concern of hormone replacement: the effects of treatment on breast cancer rates. “They need to show no harm” in breast tissue, Dr. Pal said in an interview. In addition, the positive effect reported on markers of bone turnover is not unique to this formulation. Other formulations with estrogen at similar dosages would have similar effects, she said.

Other considerations when using an oral formulation include the reduced risk for prothrombotic effects from estradiol when delivered transdermally instead of orally, although some women have trouble getting insurance coverage for transdermal formulations, Dr. Pal said. Oral estrogen is appropriate only for women without an elevated clotting risk. Daily progesterone treatment also is more problematic than a cyclical dosage regimen, but noncontinuous progesterone results in monthly bleeding, something that some women prefer to avoid. “I’m not convinced that continuous progesterone is a physiologic approach,” said Dr. Pal, a member of the Ob.Gyn. News editorial advisory board. In addition, some women may find the formulation attractive because both the estradiol and progesterone are bioidentical and not synthetic molecules.

In short, the oral estradiol plus progesterone formulation tested in REPLENISH “is another tool” that’s an option for selected menopausal women with a uterus. “The bone findings are in line with expectations and are reassuring. Long-term data are keenly awaited to understand whether the bone marker changes lead to fewer fractures. The impact of the treatment on breast safety will be especially important.” For women who want a bioidentical, oral option and to not have bleeding, the tested formulation can be an effective option providing both symptom benefit and endometrial protection, Dr. Pal said.

REPLENISH was funded by TherapeuticsMD, the company that markets the tested estradiol plus progesterone formulation (Bijuva). Dr. Kagan has been a consultant and adviser to and speaker on behalf of Therapeutics MD, and she has also been a consultant or adviser to or has spoken on behalf of AMAG, Amgen, Astellas, Lupin, Radius, and Warner Chilcott/Allergan, and she has received research funding from Endoceutics. Dr. Pal has been a consultant to Flow Health.

mzoler@mdedge.com

SOURCE: Kagan R et al. Obstet Gynecol. 2020 May;135:62S. doi: 10.1097/01.AOG.0000665076.20231.a8.

Menopausal women with an intact uterus treated for a year with a daily, oral, single-pill formulation of estradiol and progesterone for the primary goal of reducing moderate to severe vasomotor symptoms showed evidence of reduced bone turnover in a post hoc, subgroup analysis of 157 women enrolled in the REPLENISH trial.

Ingram Publishing/Thinkstock

These findings “provide support for a potential skeletal benefit” when menopausal women with an intact uterus regularly used the tested estradiol plus progesterone formulation to treat moderate to severe vasomotor symptoms (VMS), Risa Kagan, MD, and associates wrote in an abstract released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting, and released abstracts for press coverage.

The reductions reported for three different markers of bone turnover compared with placebo control after 6 and 12 months on treatment with a U.S.-marketed estradiol plus progesterone formulation were ”reassuring and in line with expectations” said Lubna Pal, MBBS, professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., who was not involved with the study. But the findings fell short of addressing the more clinically relevant issue of whether the tested regimen reduces the rate of bone fractures.

The analysis included 56 women treated with 1.0 mg estradiol and 100 mg progesterone daily, 56 who received 0.5 mg estradiol and 100 mg progesterone daily, and 45 women in the placebo arm. It assessed changes from baseline in the on-treatment compared with placebo groups using immunoassays for bone-specific alkaline phosphatase (BSAP), C-terminal telopeptide of type 1 collagen (CTX-1), and N-terminal propeptide of type 1 procollagen (PINP). For this analysis, the researchers combined the two active-treatment arms, and found that all three markers showed statistically significant drops from baseline with treatment, compared with placebo at both 6- and 12-month follow-up. For all three markers, the declines on active treatment grew larger with time, and after 12 months the mean drops from baseline compared with placebo were an 18% relative reduction in BSAP, a 41% relative reduction in CTX-1, and a 29% relative reduction in PINP, reported Dr. Kagan, a gynecologist based in Berkeley, Calif., who is affiliated with the University of California San Francisco.

In addition to not yet providing more clinically meaningful results on bone fracture rates, Dr. Pal cited additional issues that limit interpretation of both these findings and the broader REPLENISH results. First, the new analysis of bone-turnover markers as reported in the abstract does not allow assessment of a possible dose-dependent effect on bone turnover. More importantly, while the full REPLENISH trial provided reassuring data on endometrial protection, it has not yet reported data on the other major safety concern of hormone replacement: the effects of treatment on breast cancer rates. “They need to show no harm” in breast tissue, Dr. Pal said in an interview. In addition, the positive effect reported on markers of bone turnover is not unique to this formulation. Other formulations with estrogen at similar dosages would have similar effects, she said.

Other considerations when using an oral formulation include the reduced risk for prothrombotic effects from estradiol when delivered transdermally instead of orally, although some women have trouble getting insurance coverage for transdermal formulations, Dr. Pal said. Oral estrogen is appropriate only for women without an elevated clotting risk. Daily progesterone treatment also is more problematic than a cyclical dosage regimen, but noncontinuous progesterone results in monthly bleeding, something that some women prefer to avoid. “I’m not convinced that continuous progesterone is a physiologic approach,” said Dr. Pal, a member of the Ob.Gyn. News editorial advisory board. In addition, some women may find the formulation attractive because both the estradiol and progesterone are bioidentical and not synthetic molecules.

In short, the oral estradiol plus progesterone formulation tested in REPLENISH “is another tool” that’s an option for selected menopausal women with a uterus. “The bone findings are in line with expectations and are reassuring. Long-term data are keenly awaited to understand whether the bone marker changes lead to fewer fractures. The impact of the treatment on breast safety will be especially important.” For women who want a bioidentical, oral option and to not have bleeding, the tested formulation can be an effective option providing both symptom benefit and endometrial protection, Dr. Pal said.

REPLENISH was funded by TherapeuticsMD, the company that markets the tested estradiol plus progesterone formulation (Bijuva). Dr. Kagan has been a consultant and adviser to and speaker on behalf of Therapeutics MD, and she has also been a consultant or adviser to or has spoken on behalf of AMAG, Amgen, Astellas, Lupin, Radius, and Warner Chilcott/Allergan, and she has received research funding from Endoceutics. Dr. Pal has been a consultant to Flow Health.

mzoler@mdedge.com

SOURCE: Kagan R et al. Obstet Gynecol. 2020 May;135:62S. doi: 10.1097/01.AOG.0000665076.20231.a8.

Menopausal women with an intact uterus treated for a year with a daily, oral, single-pill formulation of estradiol and progesterone for the primary goal of reducing moderate to severe vasomotor symptoms showed evidence of reduced bone turnover in a post hoc, subgroup analysis of 157 women enrolled in the REPLENISH trial.

Ingram Publishing/Thinkstock

These findings “provide support for a potential skeletal benefit” when menopausal women with an intact uterus regularly used the tested estradiol plus progesterone formulation to treat moderate to severe vasomotor symptoms (VMS), Risa Kagan, MD, and associates wrote in an abstract released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting, and released abstracts for press coverage.

The reductions reported for three different markers of bone turnover compared with placebo control after 6 and 12 months on treatment with a U.S.-marketed estradiol plus progesterone formulation were ”reassuring and in line with expectations” said Lubna Pal, MBBS, professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., who was not involved with the study. But the findings fell short of addressing the more clinically relevant issue of whether the tested regimen reduces the rate of bone fractures.

The analysis included 56 women treated with 1.0 mg estradiol and 100 mg progesterone daily, 56 who received 0.5 mg estradiol and 100 mg progesterone daily, and 45 women in the placebo arm. It assessed changes from baseline in the on-treatment compared with placebo groups using immunoassays for bone-specific alkaline phosphatase (BSAP), C-terminal telopeptide of type 1 collagen (CTX-1), and N-terminal propeptide of type 1 procollagen (PINP). For this analysis, the researchers combined the two active-treatment arms, and found that all three markers showed statistically significant drops from baseline with treatment, compared with placebo at both 6- and 12-month follow-up. For all three markers, the declines on active treatment grew larger with time, and after 12 months the mean drops from baseline compared with placebo were an 18% relative reduction in BSAP, a 41% relative reduction in CTX-1, and a 29% relative reduction in PINP, reported Dr. Kagan, a gynecologist based in Berkeley, Calif., who is affiliated with the University of California San Francisco.

In addition to not yet providing more clinically meaningful results on bone fracture rates, Dr. Pal cited additional issues that limit interpretation of both these findings and the broader REPLENISH results. First, the new analysis of bone-turnover markers as reported in the abstract does not allow assessment of a possible dose-dependent effect on bone turnover. More importantly, while the full REPLENISH trial provided reassuring data on endometrial protection, it has not yet reported data on the other major safety concern of hormone replacement: the effects of treatment on breast cancer rates. “They need to show no harm” in breast tissue, Dr. Pal said in an interview. In addition, the positive effect reported on markers of bone turnover is not unique to this formulation. Other formulations with estrogen at similar dosages would have similar effects, she said.

Other considerations when using an oral formulation include the reduced risk for prothrombotic effects from estradiol when delivered transdermally instead of orally, although some women have trouble getting insurance coverage for transdermal formulations, Dr. Pal said. Oral estrogen is appropriate only for women without an elevated clotting risk. Daily progesterone treatment also is more problematic than a cyclical dosage regimen, but noncontinuous progesterone results in monthly bleeding, something that some women prefer to avoid. “I’m not convinced that continuous progesterone is a physiologic approach,” said Dr. Pal, a member of the Ob.Gyn. News editorial advisory board. In addition, some women may find the formulation attractive because both the estradiol and progesterone are bioidentical and not synthetic molecules.

In short, the oral estradiol plus progesterone formulation tested in REPLENISH “is another tool” that’s an option for selected menopausal women with a uterus. “The bone findings are in line with expectations and are reassuring. Long-term data are keenly awaited to understand whether the bone marker changes lead to fewer fractures. The impact of the treatment on breast safety will be especially important.” For women who want a bioidentical, oral option and to not have bleeding, the tested formulation can be an effective option providing both symptom benefit and endometrial protection, Dr. Pal said.

REPLENISH was funded by TherapeuticsMD, the company that markets the tested estradiol plus progesterone formulation (Bijuva). Dr. Kagan has been a consultant and adviser to and speaker on behalf of Therapeutics MD, and she has also been a consultant or adviser to or has spoken on behalf of AMAG, Amgen, Astellas, Lupin, Radius, and Warner Chilcott/Allergan, and she has received research funding from Endoceutics. Dr. Pal has been a consultant to Flow Health.

mzoler@mdedge.com

SOURCE: Kagan R et al. Obstet Gynecol. 2020 May;135:62S. doi: 10.1097/01.AOG.0000665076.20231.a8.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Application of enhanced recovery after surgery (ERAS) protocols significantly reduced the use of opioids, as well as hospital stays and hospital costs, based on data from cohorts of women before and after the introduction of the protocols.

selimaksan/E+

The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

ERAS protocols have been introduced in surgical specialties including colorectal, urologic, gynecologic, and hepatobiliary – with noted benefits to patients and the health care system, wrote Nnamdi I. Gwacham, DO, of Saint Barnabas Medical Center, Livingston, N.J., and colleagues.

The researchers explored the impact of ERAS on reduction in opioid use after cesarean sections at a community teaching hospital in a retrospective study also published in Obstetrics & Gynecology.

The study population included a historical cohort of 2,109 patients from 2018 before the establishment of the ERAS pathway and 1,463 patients since the ERAS pathway was established in 2019.*

Significantly fewer patients in the ERAS group required opioids, compared with the historical group (1,766 vs. 341). A total of 8,082 opioid units were used before the introduction of the ERAS pathway, compared with 803 units used since its introduction, Dr. Gwacham and associates reported. The study was a Donald F. Richardson Prize Paper.

The ERAS pathway consisted of received transversus abdominis plane blocks in the immediate postoperative period (given to 98% of the patients), and all patients were started on “a scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge,” the researchers wrote. Patients received opioids only if their pain was not well controlled with the ERAS protocol.

In addition, patients who received ERAS had significantly shorter hospital stays than the historical group (3.19 days vs. 2.63 days) and incurred a significantly lower average direct cost ($4,290 vs. $3,957).

The groups were not significantly different in age, race, or body mass index.

“Given the current opioid epidemic in America, researching ways to reduce their use is an urgent matter,” Angela Martin, MD, of the University of Kansas, Kansas City, said in an interview.

She thought the study findings were to be expected based on research in other areas. “Given the trends and ability to reduced opioid use with ERAS in other specialties, it does not surprise me that women recovering from cesarean sections are similar.”

The take-home message for clinicians: “Begin thinking outside of the box when it comes to pain control,” emphasized Dr. Martin, who was not a part of this study. “Opioids don’t have to be the first line medications for postoperative pain management.”

She added that additional directions for research could include the patient perspective on postoperative pain management after a cesarean delivery. “Alternative options to opioids would be even more enticing if the inpatient experience was also improved,” said Dr. Martin, who is a member of the Ob.Gyn News editorial advisory board.

The researchers had no financial conflicts to disclose. Dr. Martin had no relevant financial disclosures.

SOURCE: Gwacham NI et al. Obstet Gynecol. 2020 May;135:2S. doi: 10.1097/01.AOG.0000662880.08512.6b.

*This article was updated on 4/29/2020.

Vaginal cleansing before cesarean delivery was successfully implemented – and significantly decreased the rate of surgical site infections (SSI) – in a quality improvement study done at Thomas Jefferson University Hospital in Philadelphia.

“Our goal was not to prove that vaginal preparation [before cesarean section] works, because that’s already been shown in large randomized, controlled trials, but to show that we can implement it and that we can see the same results in real life,” lead investigator Johanna Quist-Nelson, MD, said in an interview.

Dr. Quist-Nelson, a third-year fellow at the hospital and the department of obstetrics and gynecology at Sidney Kimmel Medical College, Philadelphia, was scheduled to present the findings at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

Resident and staff physicians as well as nursing and operating room staff were educated/reminded through a multipronged intervention about the benefits of vaginal cleansing with a sponge stick preparation of 10% povidone-iodine solution (Betadine) – and later about the potential benefits of intravenous azithromycin – immediately before cesarean delivery for women in labor and women with ruptured membranes.

Dr. Quist-Nelson and coinvestigators compared three periods of time: 12 months preintervention, 14 months with vaginal cleansing promoted for infection prophylaxis, and 16 months of instructions for both vaginal cleansing and intravenous azithromycin. The three periods captured 1,033 patients. The researchers used control charts – a tool “often used in implementation science,” she said – to analyze monthly data and assess trends for SSI rates and for compliance.

The rate of SSI – as defined by the Centers for Disease Control and Prevention – decreased by 33%, they found, from 23% to 15%. The drop occurred mainly 4 months into the vaginal cleansing portion of the study and was sustained during the following 26 months. The addition of intravenous azithromycin education did not result in any further change in the SSI rate, Dr. Quist-Nelson and associates reported in the study – the abstract for which was published in Obstetrics & Gynecology. It won a third-place prize among the papers on current clinical and basic investigation.

Compliance with the vaginal cleansing protocol increased from 60% at the start of the vaginal cleansing phase to 85% 1 year later. Azithromycin compliance rose to 75% over the third phase of the intervention.

Vaginal cleansing has received attention at Thomas Jefferson for several years. In 2017, researchers there collaborated with investigators in Italy on a systemic review and meta-analysis which concluded that women who received vaginal cleansing before cesarean delivery – most commonly with 10% povidine-iodine – had a significantly lower incidence of endometritis (Obstet Gynecol. 2017 Sep;130[3]:527-38).

A subgroup analysis showed that the benefit of vaginal cleansing was limited to “those women who have a cesarean section after their water breaks or when they’re in labor,” Dr. Quist-Nelson said.

Azithromycin similarly was found to reduce the risk of postoperative infection in women undergoing nonelective cesarean deliveries in a randomized trial published in 2016 (N Engl J Med. 2016 Sep 29;375[13]:1231-41). While the new quality improvement study did not suggest any additional benefit to intravenous azithromycin, “we continue to offer it [at our hospital] because it has been shown [in prior research] to be beneficial and because our study wasn’t [designed] to show benefit,” Dr. Quist-Nelson said.

The quality improvement intervention included hands-on training on vaginal cleansing for resident physicians and e-mail reminders for physician staff, and daily reviews for 1 week on intravenous azithromycin for resident physicians and EMR “best practice advisory” reminders for physician staff. “We also wrote a protocol available online, and put reminders in our OR notes, as well as trained the nursing staff and OR staff,” she said.

Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview that SSI rates are “problematic [in obstetrics], not only because of morbidity but also potential cost because of rehospitalization.” The study shows that vaginal cleansing “is absolutely a good target for quality improvement,” she said. “It’s promising, and very exciting to see something like this have such a dramatic positive result.” Dr. Cansino, who is a member of the Ob.Gyn News editorial advisory board, was not involved in this study.

Thomas Jefferson Hospital has had relatively high SSI rates, Dr. Quist-Nelson noted.

Dr. Quist-Nelson and coinvestigators did not report any potential conflicts of interest. Dr. Cansino also did not report any potential conflicts of interest.
 

SOURCE: Quist-Nelson J et al. Obstet. Gynecol. 2020 May;135:1S. doi: 10.1097/01.AOG.0000662876.23603.13.

Vaginal cleansing before cesarean delivery was successfully implemented – and significantly decreased the rate of surgical site infections (SSI) – in a quality improvement study done at Thomas Jefferson University Hospital in Philadelphia.

“Our goal was not to prove that vaginal preparation [before cesarean section] works, because that’s already been shown in large randomized, controlled trials, but to show that we can implement it and that we can see the same results in real life,” lead investigator Johanna Quist-Nelson, MD, said in an interview.

Dr. Quist-Nelson, a third-year fellow at the hospital and the department of obstetrics and gynecology at Sidney Kimmel Medical College, Philadelphia, was scheduled to present the findings at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

Resident and staff physicians as well as nursing and operating room staff were educated/reminded through a multipronged intervention about the benefits of vaginal cleansing with a sponge stick preparation of 10% povidone-iodine solution (Betadine) – and later about the potential benefits of intravenous azithromycin – immediately before cesarean delivery for women in labor and women with ruptured membranes.

Dr. Quist-Nelson and coinvestigators compared three periods of time: 12 months preintervention, 14 months with vaginal cleansing promoted for infection prophylaxis, and 16 months of instructions for both vaginal cleansing and intravenous azithromycin. The three periods captured 1,033 patients. The researchers used control charts – a tool “often used in implementation science,” she said – to analyze monthly data and assess trends for SSI rates and for compliance.

The rate of SSI – as defined by the Centers for Disease Control and Prevention – decreased by 33%, they found, from 23% to 15%. The drop occurred mainly 4 months into the vaginal cleansing portion of the study and was sustained during the following 26 months. The addition of intravenous azithromycin education did not result in any further change in the SSI rate, Dr. Quist-Nelson and associates reported in the study – the abstract for which was published in Obstetrics & Gynecology. It won a third-place prize among the papers on current clinical and basic investigation.

Compliance with the vaginal cleansing protocol increased from 60% at the start of the vaginal cleansing phase to 85% 1 year later. Azithromycin compliance rose to 75% over the third phase of the intervention.

Vaginal cleansing has received attention at Thomas Jefferson for several years. In 2017, researchers there collaborated with investigators in Italy on a systemic review and meta-analysis which concluded that women who received vaginal cleansing before cesarean delivery – most commonly with 10% povidine-iodine – had a significantly lower incidence of endometritis (Obstet Gynecol. 2017 Sep;130[3]:527-38).

A subgroup analysis showed that the benefit of vaginal cleansing was limited to “those women who have a cesarean section after their water breaks or when they’re in labor,” Dr. Quist-Nelson said.

Azithromycin similarly was found to reduce the risk of postoperative infection in women undergoing nonelective cesarean deliveries in a randomized trial published in 2016 (N Engl J Med. 2016 Sep 29;375[13]:1231-41). While the new quality improvement study did not suggest any additional benefit to intravenous azithromycin, “we continue to offer it [at our hospital] because it has been shown [in prior research] to be beneficial and because our study wasn’t [designed] to show benefit,” Dr. Quist-Nelson said.

The quality improvement intervention included hands-on training on vaginal cleansing for resident physicians and e-mail reminders for physician staff, and daily reviews for 1 week on intravenous azithromycin for resident physicians and EMR “best practice advisory” reminders for physician staff. “We also wrote a protocol available online, and put reminders in our OR notes, as well as trained the nursing staff and OR staff,” she said.

Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview that SSI rates are “problematic [in obstetrics], not only because of morbidity but also potential cost because of rehospitalization.” The study shows that vaginal cleansing “is absolutely a good target for quality improvement,” she said. “It’s promising, and very exciting to see something like this have such a dramatic positive result.” Dr. Cansino, who is a member of the Ob.Gyn News editorial advisory board, was not involved in this study.

Thomas Jefferson Hospital has had relatively high SSI rates, Dr. Quist-Nelson noted.

Dr. Quist-Nelson and coinvestigators did not report any potential conflicts of interest. Dr. Cansino also did not report any potential conflicts of interest.
 

SOURCE: Quist-Nelson J et al. Obstet. Gynecol. 2020 May;135:1S. doi: 10.1097/01.AOG.0000662876.23603.13.

Vaginal cleansing before cesarean delivery was successfully implemented – and significantly decreased the rate of surgical site infections (SSI) – in a quality improvement study done at Thomas Jefferson University Hospital in Philadelphia.

“Our goal was not to prove that vaginal preparation [before cesarean section] works, because that’s already been shown in large randomized, controlled trials, but to show that we can implement it and that we can see the same results in real life,” lead investigator Johanna Quist-Nelson, MD, said in an interview.

Dr. Quist-Nelson, a third-year fellow at the hospital and the department of obstetrics and gynecology at Sidney Kimmel Medical College, Philadelphia, was scheduled to present the findings at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

Resident and staff physicians as well as nursing and operating room staff were educated/reminded through a multipronged intervention about the benefits of vaginal cleansing with a sponge stick preparation of 10% povidone-iodine solution (Betadine) – and later about the potential benefits of intravenous azithromycin – immediately before cesarean delivery for women in labor and women with ruptured membranes.

Dr. Quist-Nelson and coinvestigators compared three periods of time: 12 months preintervention, 14 months with vaginal cleansing promoted for infection prophylaxis, and 16 months of instructions for both vaginal cleansing and intravenous azithromycin. The three periods captured 1,033 patients. The researchers used control charts – a tool “often used in implementation science,” she said – to analyze monthly data and assess trends for SSI rates and for compliance.

The rate of SSI – as defined by the Centers for Disease Control and Prevention – decreased by 33%, they found, from 23% to 15%. The drop occurred mainly 4 months into the vaginal cleansing portion of the study and was sustained during the following 26 months. The addition of intravenous azithromycin education did not result in any further change in the SSI rate, Dr. Quist-Nelson and associates reported in the study – the abstract for which was published in Obstetrics & Gynecology. It won a third-place prize among the papers on current clinical and basic investigation.

Compliance with the vaginal cleansing protocol increased from 60% at the start of the vaginal cleansing phase to 85% 1 year later. Azithromycin compliance rose to 75% over the third phase of the intervention.

Vaginal cleansing has received attention at Thomas Jefferson for several years. In 2017, researchers there collaborated with investigators in Italy on a systemic review and meta-analysis which concluded that women who received vaginal cleansing before cesarean delivery – most commonly with 10% povidine-iodine – had a significantly lower incidence of endometritis (Obstet Gynecol. 2017 Sep;130[3]:527-38).

A subgroup analysis showed that the benefit of vaginal cleansing was limited to “those women who have a cesarean section after their water breaks or when they’re in labor,” Dr. Quist-Nelson said.

Azithromycin similarly was found to reduce the risk of postoperative infection in women undergoing nonelective cesarean deliveries in a randomized trial published in 2016 (N Engl J Med. 2016 Sep 29;375[13]:1231-41). While the new quality improvement study did not suggest any additional benefit to intravenous azithromycin, “we continue to offer it [at our hospital] because it has been shown [in prior research] to be beneficial and because our study wasn’t [designed] to show benefit,” Dr. Quist-Nelson said.

The quality improvement intervention included hands-on training on vaginal cleansing for resident physicians and e-mail reminders for physician staff, and daily reviews for 1 week on intravenous azithromycin for resident physicians and EMR “best practice advisory” reminders for physician staff. “We also wrote a protocol available online, and put reminders in our OR notes, as well as trained the nursing staff and OR staff,” she said.

Catherine Cansino, MD, MPH, of the University of California, Davis, said in an interview that SSI rates are “problematic [in obstetrics], not only because of morbidity but also potential cost because of rehospitalization.” The study shows that vaginal cleansing “is absolutely a good target for quality improvement,” she said. “It’s promising, and very exciting to see something like this have such a dramatic positive result.” Dr. Cansino, who is a member of the Ob.Gyn News editorial advisory board, was not involved in this study.

Thomas Jefferson Hospital has had relatively high SSI rates, Dr. Quist-Nelson noted.

Dr. Quist-Nelson and coinvestigators did not report any potential conflicts of interest. Dr. Cansino also did not report any potential conflicts of interest.
 

SOURCE: Quist-Nelson J et al. Obstet. Gynecol. 2020 May;135:1S. doi: 10.1097/01.AOG.0000662876.23603.13.

Women who use copper IUDs and concurrently use menstrual cups face a higher than expected rate of IUD expulsion, results from a prospective study showed.

Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.

Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.

“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.

According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.

“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”

Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.

SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.

*The article was updated on 4/28/2020.
 

Women who use copper IUDs and concurrently use menstrual cups face a higher than expected rate of IUD expulsion, results from a prospective study showed.

Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.

Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.

“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.

According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.

“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”

Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.

SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.

*The article was updated on 4/28/2020.
 

Women who use copper IUDs and concurrently use menstrual cups face a higher than expected rate of IUD expulsion, results from a prospective study showed.

Citing menstrual cup use for menstrual hygiene as “increasingly popular,” researchers led by Jill Long, MD, MPH, studied women participating in a prospective contraceptive efficacy trial of two copper IUDs to evaluate the relationship between menstrual cup use and IUD expulsion over a period of 24 months. The findings were released ahead of the study’s scheduled presentation at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. ACOG canceled the meeting and released abstracts for press coverage.

In the ongoing 3-year trial, which also was published in Obstetrics & Gynecology, 1,092 women were randomized to one of two copper IUDs. Dr. Long, project officer for the Contraceptive Clinical Trials Network, a project of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Md. and colleagues conducted follow-up visits at 6 weeks after insertion in the first year, and then 3, 6, and 12 months after insertion. At the 9-month mark, the study counseling was amended to advise patients against concurrent use of the menstrual cup because of a higher risk of IUD expulsions noted in women using the cup.

Among the 1,092 women studied, 266 (24%) reported menstrual cup use. At 24 months after initiating enrollment, 43 cup users (17%) and 43 nonusers (5%) experienced expulsion (odds ratio, 3.81). Fourteen menstrual cup users with expulsion (30%) reported that the event occurred during menstrual cup removal. Dr. Long and colleagues found that, at year 1 of the study, expulsion rates among menstrual cup users and nonusers were 14% and 5%, respectively (P < .001). At the end of year 2, these rates rose to 23% and 7% (P < .001). The study won second place among abstracts in the category of current clinical and basic investigation.

“This outstanding abstract reflects an important study with results that should lead to changes in the way providers counsel patients about IUDs, namely that the risk of IUD expulsion is significantly higher in women who use menstrual cups than in those who use other menstrual hygiene products,” Eve Espey, MD, MPH, who was not affiliated with the study, said in an interview.

According to Dr. Espey, who chairs the department of obstetrics and gynecology at the University of New Mexico, Albuquerque, key strengths of the study include its prospective methodology and the relatively large number of patients with concurrent IUD and menstrual cup use.

“A limitation is the nonrandomized design for the current study’s aim, which would require randomizing women using the IUD to menstrual cup use versus nonuse,” said Dr. Espey, who is a member of the Ob.Gyn News editorial advisory board.* “Another limitation is that only copper IUDs were used, but it is plausible that this result would apply to other IUDs as well. The study is innovative and important in being the first prospective study to evaluate the association between menstrual cup use and IUD expulsion.”

Dr. Long and two coauthors reported having no financial disclosures, but the remaining three authors reported having numerous potential conflicts of interest. Dr. Espey reported having no financial disclosures.

SOURCE: Long J et al. Obstet Gynecol. 2020 May;135.1S. doi: 10.1097/01.AOG.0000662872.89062.83.

*The article was updated on 4/28/2020.
 

Physicians and their sponsoring health care facilities shouldn’t have to worry about visa technicalities as they work on the front lines during the COVID-19 pandemic, said health care leaders and immigration reform advocates.

In a press call hosted by the National Immigration Forum, speakers highlighted the need for fast and flexible solutions to enable health care workers, including physicians, to contribute to efforts to combat the pandemic.

Nationwide, over one in five physicians are immigrants, according to data from the Forum. That figure is over one in three in New York, New Jersey, and California, three states hard-hit by COVID-19 cases.

Many physicians stand willing and able to serve where they’re needed, but visa restrictions often block the ability of immigrant physicians to meet COVID-19 surges across the country, said Amit Vashist, MD, senior vice president and chief clinical officer for Ballad Health, Johnson City, Tenn., and a member of the public policy committee of the Society of Hospital Medicine. Ballad Health is an integrated health care system that serves 29 counties in the rural Southeast.

“This pandemic is a war with an invisible enemy, and immigrant physicians have been absolutely critical to providing quality care, especially on the front lines – but current visa restrictions have limited the ability to deploy these physicians in communities with the greatest need,” said Dr. Vashist during the press conference.

Visa requirements currently tie a non-US citizen resident physician to a particular institution and facility, limiting the ability to meet demand flexibly. “Federal agencies and Congress should provide additional flexibility in visa processing to allow for automatic renewals and expediting processing so immigrant medical workers can focus on treating the sick and not on their visa requirements,” said Dr. Vashist.

Dr. Vashist noted that, when he speaks with the many Ballad Health hospitalists who are waiting on permanent residency or citizenship, many of them also cite worries about the fate of their families should they themselves fall ill. Depending on the physician’s visa status, the family may face deportation without recourse if the physician should die.

“Tens of thousands of our physicians continue to endure years, even decades of waiting to obtain a permanent residency in the United States and at the same time, relentlessly and fearlessly serve their communities including in this COVID-19 pandemic,” said Dr. Vashist. “It’s time we take care of them and their long-term immigration needs, and give them the peace of mind that they so desperately deserve,” he added.

Frank Trinity, chief legal officer for the Association of American Medical Colleges, also participated in the call. “For decades,” he said, the United States “has relied on physicians from other countries, especially in rural and underserved areas.”

One of these physicians, Mihir Patel, MD, FHM, a hospitalist at Ballad Health, came to the United States in 2005, but 15 years later is still waiting for the green card that signifies U.S. permanent residency status. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the health system’s COVID-10 Strike Team.

“During the COVID crisis, these restrictions can cause significant negative impact for small rural hospitals,” Dr. Patel said. “There are physicians on a visa who cannot legally work outside their primary facilities – even though they are willing to do so.”

Regarding the pandemic, Mr. Trinity expressed concerns about whether the surge of patients would “outstrip our workforce.” He noted that, with an unprecedented number of desperately ill patients needing emergency care all across the country, “now is the time for our government to take every possible action to ensure that these highly qualified and courageous health professionals are available in the fight against the coronavirus.”

Mr. Trinity outlined five governmental actions AAMC is proposing to allow immigrant physicians to participate fully in the battle against COVID-19. The first would be to approve a blanket extension of visa deadlines. The second would be to expedite processing of visa extension applications, including reinstating expedited processing of physicians currently holding H-1B visa status.

The third action proposed by AAMC is to provide flexibility to visa sponsors during the emergency so that an individual whose visa is currently limited to a particular program can provide care at another location or by means of telehealth.

Fourth, AAMC proposes streamlined entry for the 4,200 physicians who are matched into residency programs so that they may begin their residencies on time or early.

Finally, Mr. Trinity said that AAMC is proposing that work authorizations be maintained for the 29,000 physicians who are currently not U.S. citizens and actively participating in the health care workforce.

Jacinta Ma, the Forum’s vice president of policy and advocacy, said immigrants are a critical component of the U.S. health care workforce as a whole.

“With immigrants accounting for 17% of health care workers amid the COVID-19 pandemic, it’s clear that they are vital to our communities,” she said. “Congress and the Trump administration both have an opportunity to advance solutions that protect immigrants, and remove immigration-related barriers for immigrant medical professionals by ensuring that immigrant doctors, nurses, home health care workers, researchers, and others can continue their vital work during this pandemic while being afforded adequate protection from COVID-19.”
 

Physicians and their sponsoring health care facilities shouldn’t have to worry about visa technicalities as they work on the front lines during the COVID-19 pandemic, said health care leaders and immigration reform advocates.

In a press call hosted by the National Immigration Forum, speakers highlighted the need for fast and flexible solutions to enable health care workers, including physicians, to contribute to efforts to combat the pandemic.

Nationwide, over one in five physicians are immigrants, according to data from the Forum. That figure is over one in three in New York, New Jersey, and California, three states hard-hit by COVID-19 cases.

Many physicians stand willing and able to serve where they’re needed, but visa restrictions often block the ability of immigrant physicians to meet COVID-19 surges across the country, said Amit Vashist, MD, senior vice president and chief clinical officer for Ballad Health, Johnson City, Tenn., and a member of the public policy committee of the Society of Hospital Medicine. Ballad Health is an integrated health care system that serves 29 counties in the rural Southeast.

“This pandemic is a war with an invisible enemy, and immigrant physicians have been absolutely critical to providing quality care, especially on the front lines – but current visa restrictions have limited the ability to deploy these physicians in communities with the greatest need,” said Dr. Vashist during the press conference.

Visa requirements currently tie a non-US citizen resident physician to a particular institution and facility, limiting the ability to meet demand flexibly. “Federal agencies and Congress should provide additional flexibility in visa processing to allow for automatic renewals and expediting processing so immigrant medical workers can focus on treating the sick and not on their visa requirements,” said Dr. Vashist.

Dr. Vashist noted that, when he speaks with the many Ballad Health hospitalists who are waiting on permanent residency or citizenship, many of them also cite worries about the fate of their families should they themselves fall ill. Depending on the physician’s visa status, the family may face deportation without recourse if the physician should die.

“Tens of thousands of our physicians continue to endure years, even decades of waiting to obtain a permanent residency in the United States and at the same time, relentlessly and fearlessly serve their communities including in this COVID-19 pandemic,” said Dr. Vashist. “It’s time we take care of them and their long-term immigration needs, and give them the peace of mind that they so desperately deserve,” he added.

Frank Trinity, chief legal officer for the Association of American Medical Colleges, also participated in the call. “For decades,” he said, the United States “has relied on physicians from other countries, especially in rural and underserved areas.”

One of these physicians, Mihir Patel, MD, FHM, a hospitalist at Ballad Health, came to the United States in 2005, but 15 years later is still waiting for the green card that signifies U.S. permanent residency status. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the health system’s COVID-10 Strike Team.

“During the COVID crisis, these restrictions can cause significant negative impact for small rural hospitals,” Dr. Patel said. “There are physicians on a visa who cannot legally work outside their primary facilities – even though they are willing to do so.”

Regarding the pandemic, Mr. Trinity expressed concerns about whether the surge of patients would “outstrip our workforce.” He noted that, with an unprecedented number of desperately ill patients needing emergency care all across the country, “now is the time for our government to take every possible action to ensure that these highly qualified and courageous health professionals are available in the fight against the coronavirus.”

Mr. Trinity outlined five governmental actions AAMC is proposing to allow immigrant physicians to participate fully in the battle against COVID-19. The first would be to approve a blanket extension of visa deadlines. The second would be to expedite processing of visa extension applications, including reinstating expedited processing of physicians currently holding H-1B visa status.

The third action proposed by AAMC is to provide flexibility to visa sponsors during the emergency so that an individual whose visa is currently limited to a particular program can provide care at another location or by means of telehealth.

Fourth, AAMC proposes streamlined entry for the 4,200 physicians who are matched into residency programs so that they may begin their residencies on time or early.

Finally, Mr. Trinity said that AAMC is proposing that work authorizations be maintained for the 29,000 physicians who are currently not U.S. citizens and actively participating in the health care workforce.

Jacinta Ma, the Forum’s vice president of policy and advocacy, said immigrants are a critical component of the U.S. health care workforce as a whole.

“With immigrants accounting for 17% of health care workers amid the COVID-19 pandemic, it’s clear that they are vital to our communities,” she said. “Congress and the Trump administration both have an opportunity to advance solutions that protect immigrants, and remove immigration-related barriers for immigrant medical professionals by ensuring that immigrant doctors, nurses, home health care workers, researchers, and others can continue their vital work during this pandemic while being afforded adequate protection from COVID-19.”
 

Physicians and their sponsoring health care facilities shouldn’t have to worry about visa technicalities as they work on the front lines during the COVID-19 pandemic, said health care leaders and immigration reform advocates.

In a press call hosted by the National Immigration Forum, speakers highlighted the need for fast and flexible solutions to enable health care workers, including physicians, to contribute to efforts to combat the pandemic.

Nationwide, over one in five physicians are immigrants, according to data from the Forum. That figure is over one in three in New York, New Jersey, and California, three states hard-hit by COVID-19 cases.

Many physicians stand willing and able to serve where they’re needed, but visa restrictions often block the ability of immigrant physicians to meet COVID-19 surges across the country, said Amit Vashist, MD, senior vice president and chief clinical officer for Ballad Health, Johnson City, Tenn., and a member of the public policy committee of the Society of Hospital Medicine. Ballad Health is an integrated health care system that serves 29 counties in the rural Southeast.

“This pandemic is a war with an invisible enemy, and immigrant physicians have been absolutely critical to providing quality care, especially on the front lines – but current visa restrictions have limited the ability to deploy these physicians in communities with the greatest need,” said Dr. Vashist during the press conference.

Visa requirements currently tie a non-US citizen resident physician to a particular institution and facility, limiting the ability to meet demand flexibly. “Federal agencies and Congress should provide additional flexibility in visa processing to allow for automatic renewals and expediting processing so immigrant medical workers can focus on treating the sick and not on their visa requirements,” said Dr. Vashist.

Dr. Vashist noted that, when he speaks with the many Ballad Health hospitalists who are waiting on permanent residency or citizenship, many of them also cite worries about the fate of their families should they themselves fall ill. Depending on the physician’s visa status, the family may face deportation without recourse if the physician should die.

“Tens of thousands of our physicians continue to endure years, even decades of waiting to obtain a permanent residency in the United States and at the same time, relentlessly and fearlessly serve their communities including in this COVID-19 pandemic,” said Dr. Vashist. “It’s time we take care of them and their long-term immigration needs, and give them the peace of mind that they so desperately deserve,” he added.

Frank Trinity, chief legal officer for the Association of American Medical Colleges, also participated in the call. “For decades,” he said, the United States “has relied on physicians from other countries, especially in rural and underserved areas.”

One of these physicians, Mihir Patel, MD, FHM, a hospitalist at Ballad Health, came to the United States in 2005, but 15 years later is still waiting for the green card that signifies U.S. permanent residency status. He is the corporate director of Ballad’s telemedicine program and is now also the medical director of the health system’s COVID-10 Strike Team.

“During the COVID crisis, these restrictions can cause significant negative impact for small rural hospitals,” Dr. Patel said. “There are physicians on a visa who cannot legally work outside their primary facilities – even though they are willing to do so.”

Regarding the pandemic, Mr. Trinity expressed concerns about whether the surge of patients would “outstrip our workforce.” He noted that, with an unprecedented number of desperately ill patients needing emergency care all across the country, “now is the time for our government to take every possible action to ensure that these highly qualified and courageous health professionals are available in the fight against the coronavirus.”

Mr. Trinity outlined five governmental actions AAMC is proposing to allow immigrant physicians to participate fully in the battle against COVID-19. The first would be to approve a blanket extension of visa deadlines. The second would be to expedite processing of visa extension applications, including reinstating expedited processing of physicians currently holding H-1B visa status.

The third action proposed by AAMC is to provide flexibility to visa sponsors during the emergency so that an individual whose visa is currently limited to a particular program can provide care at another location or by means of telehealth.

Fourth, AAMC proposes streamlined entry for the 4,200 physicians who are matched into residency programs so that they may begin their residencies on time or early.

Finally, Mr. Trinity said that AAMC is proposing that work authorizations be maintained for the 29,000 physicians who are currently not U.S. citizens and actively participating in the health care workforce.

Jacinta Ma, the Forum’s vice president of policy and advocacy, said immigrants are a critical component of the U.S. health care workforce as a whole.

“With immigrants accounting for 17% of health care workers amid the COVID-19 pandemic, it’s clear that they are vital to our communities,” she said. “Congress and the Trump administration both have an opportunity to advance solutions that protect immigrants, and remove immigration-related barriers for immigrant medical professionals by ensuring that immigrant doctors, nurses, home health care workers, researchers, and others can continue their vital work during this pandemic while being afforded adequate protection from COVID-19.”