Journal of Clinical Outcomes Management

The US Food and Drug Administration has approved fostemsavir (Rukobia, ViiV Healthcare), a first-in-class attachment inhibitor for the treatment of HIV-1 infection in adults.

Fostemsavir is indicated for use in combination with other antiretroviral (ARV) agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who fail to achieve viral suppression on other regimens due to resistance, intolerance, or safety considerations.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications to potentially live longer, healthier lives,” he said.

Fostemsavir 600 mg extended-release tablets are taken twice daily.

In the phase 3 BRIGHTE study, 60% of adults who added fostemsavir to optimized background ARV therapy achieved and maintained viral suppression through 96 weeks and saw clinically meaningful improvements in CD4+ T cells.

Most of the 371 participants in the study had been on anti-HIV therapy for more than 15 years (71%), had been exposed to five or more different HIV treatment regimens (85%), and/or had a history of AIDS (86%).

The most common adverse reactions with fostemsavir are nausea, fatigue, and diarrhea. Serious drug reactions included liver enzyme elevations in patients co-infected with hepatitis B or C virus and three cases of severe immune reconstitution inflammatory syndrome. 

“Exciting” Advance

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” Deborah Waterhouse, CEO of ViiV Healthcare, said in a news release.

“The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,” she said.

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV,” Jacob P. Lalezari, MD, chief executive officer and director of Quest Clinical Research, commented in the release.

Fostemsavir is an “exciting” advance for the heavily treatment-experienced population and “an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV,” he added.

Fostemsavir was reviewed and approved under the FDA’s fast track and breakthrough therapy designations, which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Full prescribing information is available online.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved fostemsavir (Rukobia, ViiV Healthcare), a first-in-class attachment inhibitor for the treatment of HIV-1 infection in adults.

Fostemsavir is indicated for use in combination with other antiretroviral (ARV) agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who fail to achieve viral suppression on other regimens due to resistance, intolerance, or safety considerations.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications to potentially live longer, healthier lives,” he said.

Fostemsavir 600 mg extended-release tablets are taken twice daily.

In the phase 3 BRIGHTE study, 60% of adults who added fostemsavir to optimized background ARV therapy achieved and maintained viral suppression through 96 weeks and saw clinically meaningful improvements in CD4+ T cells.

Most of the 371 participants in the study had been on anti-HIV therapy for more than 15 years (71%), had been exposed to five or more different HIV treatment regimens (85%), and/or had a history of AIDS (86%).

The most common adverse reactions with fostemsavir are nausea, fatigue, and diarrhea. Serious drug reactions included liver enzyme elevations in patients co-infected with hepatitis B or C virus and three cases of severe immune reconstitution inflammatory syndrome. 

“Exciting” Advance

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” Deborah Waterhouse, CEO of ViiV Healthcare, said in a news release.

“The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,” she said.

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV,” Jacob P. Lalezari, MD, chief executive officer and director of Quest Clinical Research, commented in the release.

Fostemsavir is an “exciting” advance for the heavily treatment-experienced population and “an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV,” he added.

Fostemsavir was reviewed and approved under the FDA’s fast track and breakthrough therapy designations, which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Full prescribing information is available online.
 

This article first appeared on Medscape.com.

The US Food and Drug Administration has approved fostemsavir (Rukobia, ViiV Healthcare), a first-in-class attachment inhibitor for the treatment of HIV-1 infection in adults.

Fostemsavir is indicated for use in combination with other antiretroviral (ARV) agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who fail to achieve viral suppression on other regimens due to resistance, intolerance, or safety considerations.

“This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV treatment options,” Jeff Murray, MD, deputy director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“The availability of new classes of antiretroviral drugs is critical for heavily treatment-experienced patients living with multidrug resistant HIV infection — helping people living with hard-to-treat HIV who are at greater risk for HIV-related complications to potentially live longer, healthier lives,” he said.

Fostemsavir 600 mg extended-release tablets are taken twice daily.

In the phase 3 BRIGHTE study, 60% of adults who added fostemsavir to optimized background ARV therapy achieved and maintained viral suppression through 96 weeks and saw clinically meaningful improvements in CD4+ T cells.

Most of the 371 participants in the study had been on anti-HIV therapy for more than 15 years (71%), had been exposed to five or more different HIV treatment regimens (85%), and/or had a history of AIDS (86%).

The most common adverse reactions with fostemsavir are nausea, fatigue, and diarrhea. Serious drug reactions included liver enzyme elevations in patients co-infected with hepatitis B or C virus and three cases of severe immune reconstitution inflammatory syndrome. 

“Exciting” Advance

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS,” Deborah Waterhouse, CEO of ViiV Healthcare, said in a news release.

“The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,” she said.

“As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV,” Jacob P. Lalezari, MD, chief executive officer and director of Quest Clinical Research, commented in the release.

Fostemsavir is an “exciting” advance for the heavily treatment-experienced population and “an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV,” he added.

Fostemsavir was reviewed and approved under the FDA’s fast track and breakthrough therapy designations, which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

Full prescribing information is available online.
 

This article first appeared on Medscape.com.

The care transition period between inpatient psychiatric hospitalization and initiation of outpatient mental health services is a time of extraordinarily heightened suicide risk that has been woefully neglected, according to speakers from the National Action Alliance for Suicide Prevention at the virtual annual meeting of the American Association of Suicidology.

This transition period traditionally has been a time when nobody really takes responsibility for patient care. In an effort to close this potentially deadly gap in services, the alliance recently has issued a report entitled, “Best Practices in Care Transitions for Individuals with Suicide Risk: Inpatient Care to Outpatient Care.” The recommendations focus on specific, innovative, evidence-based strategies that health care systems can use to prevent patients from falling through the cracks in care, mainly by implementing protocols aimed at fostering interorganizational teamwork between inpatient and outpatient behavioral health services.

“I believe that improving care transitions in the United States is the area where we can likely save the most lives. It’s within our grasp if we can just do this better,” declared Richard McKeon, PhD, MPH, chief of the Suicide Prevention Branch at the Center for Mental Health Services within SAMHSA, the Substance Abuse and Mental Health Services Administration.

He cited a recent meta-analysis that concluded that the risk of suicide during the first week post discharge after psychiatric hospitalization is a staggering 300 times greater than in the general population, while in the first month, the risk is increased 200-fold. The meta-analysis included 29 studies encompassing 3,551 suicides during the first month and 24 studies reporting 1,928 suicides during the first week post discharge (BMJ Open. 2019 Mar 23;9[3]:e023883. doi: 10.1136/bmjopen-2018-023883).

Everyone in the mental health field as well as patients and their families should know those statistics, but they don’t.

“I think it’s natural for people to think someone who’s been discharged from an inpatient unit or the emergency department is not at risk, when in reality it’s still a high-risk time. Suicide risk is not like a light switch that you can just switch off,” the clinical psychologist observed.

He cited other harrowing statistics that underscore the vast problem of poor care transitions. Nationally, fully one-third of patients don’t complete a single outpatient visit within the first 30 days after discharge from inpatient behavioral health care. And one in seven people who die by suicide have had contact with inpatient mental health services in the year before they died.

“That doesn’t mean that inpatient care did not do everything that they could do. What it does reflect is the need to make sure that there’s follow-up care after inpatient discharge. Too often, people don’t get the follow-up care that they need. And the research literature is clear that intervention can save lives,” Dr. McKeon said.

Panelist Becky Stoll, LCSW, vice president for crisis and disaster management at Centerstone Health in Nashville, Tenn., noted, “We see a lot of no-shows on the outpatient side, because nobody ever asked the patients if they can actually get to the outpatient appointment that’s been made.

“We have got to figure out this care transition and do better. The road to mental health is paved with Swiss cheese. There are so many holes to fall into, even if you know how to navigate the system – and most of the people we’re serving don’t know how,” observed Ms. Stoll, who, like Dr. McKeon, was among the coauthors of the alliance’s guidelines on best practices in care transitions. Ms. Stoll also serves on the AAS board as crisis services division chair.* 

The National Action Alliance for Suicide Prevention is a public/private partnership whose goal is to advance the National Strategy for Suicide Prevention, which was developed by the alliance and the U.S. Surgeon General. The alliance includes mental health professionals as well as influential leaders from the military, journalism, entertainment, railroad, health insurance, law enforcement, defense, education, technology, and other industries.

Dr. McKeon and Ms. Stall were joined by Karen Johnson, MSW, another coauthor of the guidelines. They shared highlights of the report.

Inpatient provider strategies

Discharge and crisis safety planning should begin upon admission, according to Ms. Johnson, senior vice president for clinical services and division compliance at Universal Health Services, which owns and operates more than 200 behavioral health facilities across the United States.

Inpatient and outpatient care providers need to sit down and develop collaborative protocols and negotiate a memorandum of understanding regarding expectations, which absolutely must include procedures to ensure timely electronic delivery of medical records and other key documents to the outpatient care providers. The inpatient providers need to work collaboratively with the patient, family, and community support resources to develop a safety plan – including reduced access to lethal mean – as part of predischarge planning.

Among the strategies routinely employed on the inpatient side at Universal Health Services are advance scheduling of an initial outpatient appointment within 24-72 hours post discharge. Also, someone on the inpatient team is tasked with connecting with the outpatient provider prior to discharge to develop rapport.

“If our outpatient providers are located in our facility, as many of them are, we ask them to come in and attend inpatient team meetings to identify and meet with patients who are appropriate for continuing care in outpatient settings,” she explained. “A soft, warm handoff is critical.”

At these team meetings, the appropriateness of step-down care in the form of partial hospitalization or intensive outpatient care is weighed. Someone from the inpatient side is charged with maintaining contact with the patient until after the first outpatient appointment. Ongoing caring contact in the form of brief, encouraging postcards, emails, or texts that do not require a response from the patient should be maintained for several months.
 

Strategies for outpatient providers

Ms. Stoll is a big believer in the guideline-recommended practice of notifying the inpatient provider that the patient kept the outpatient appointment, along with having a system for red-flagging no-shows for prompt follow-up by a crisis management team.

She and her colleagues at Centerstone Health have conducted two studies of an intensive patient outreach program designed for the first 30 days of the care transition. The program included many elements of the alliance’s best practices guidelines. The yearlong first study, funded by Blue Cross/Blue Shield of Tennessee, documented zero suicides and 92% freedom from emergency department visits during the care transition period, along with greater than $400,000 savings in health care costs, compared with usual care. The second study, funded by SAMHSA, showed much the same over a 2-year period.

She emphasized that this was not a high-tech, intensive intervention. She characterized it, instead as “high-touch follow-up.

“It’s some staff and a phone and a laptop, nothing fancy, just a person who’s competent and confident and skilled with a laptop. With that, you can do some pretty amazing stuff: Get people what they need, keep them alive, and oh, guess what? You can also save a lot of health care dollars that can be put back into the system,” Ms. Stoll said.

She recognizes that it’s a lot to ask busy outpatient providers to leave their practice during the workday to participate in inpatient team meetings addressing discharge planning, as recommended in the alliance guidelines. But in this regard, she sees a silver lining to the COVID-19 pandemic, in that it forces health professionals to rely upon newly opened channels of telemedicine.

“COVID-19 is giving us an opportunity to do things in a different way. Things don’t just have to be done in person. Now that we’ve opened up new channels of telehealth, I’m really excited that we’re almost in a beta test that we’ve dreamed about for decades, where we can do things in a more innovative way,” she said.

Dr. McKeon agreed that reimbursement issues have long impeded efforts to improve the inpatient to outpatient care transition. He added that it will be really important that adequate reimbursement of remote forms of care remain in place after COVID-19 fades.

“This is exactly the kind of thing that’s needed to improve care transitions,” according to Dr. McKeon.

*This story was updated 7/9/2020.

[email protected]

The care transition period between inpatient psychiatric hospitalization and initiation of outpatient mental health services is a time of extraordinarily heightened suicide risk that has been woefully neglected, according to speakers from the National Action Alliance for Suicide Prevention at the virtual annual meeting of the American Association of Suicidology.

This transition period traditionally has been a time when nobody really takes responsibility for patient care. In an effort to close this potentially deadly gap in services, the alliance recently has issued a report entitled, “Best Practices in Care Transitions for Individuals with Suicide Risk: Inpatient Care to Outpatient Care.” The recommendations focus on specific, innovative, evidence-based strategies that health care systems can use to prevent patients from falling through the cracks in care, mainly by implementing protocols aimed at fostering interorganizational teamwork between inpatient and outpatient behavioral health services.

“I believe that improving care transitions in the United States is the area where we can likely save the most lives. It’s within our grasp if we can just do this better,” declared Richard McKeon, PhD, MPH, chief of the Suicide Prevention Branch at the Center for Mental Health Services within SAMHSA, the Substance Abuse and Mental Health Services Administration.

He cited a recent meta-analysis that concluded that the risk of suicide during the first week post discharge after psychiatric hospitalization is a staggering 300 times greater than in the general population, while in the first month, the risk is increased 200-fold. The meta-analysis included 29 studies encompassing 3,551 suicides during the first month and 24 studies reporting 1,928 suicides during the first week post discharge (BMJ Open. 2019 Mar 23;9[3]:e023883. doi: 10.1136/bmjopen-2018-023883).

Everyone in the mental health field as well as patients and their families should know those statistics, but they don’t.

“I think it’s natural for people to think someone who’s been discharged from an inpatient unit or the emergency department is not at risk, when in reality it’s still a high-risk time. Suicide risk is not like a light switch that you can just switch off,” the clinical psychologist observed.

He cited other harrowing statistics that underscore the vast problem of poor care transitions. Nationally, fully one-third of patients don’t complete a single outpatient visit within the first 30 days after discharge from inpatient behavioral health care. And one in seven people who die by suicide have had contact with inpatient mental health services in the year before they died.

“That doesn’t mean that inpatient care did not do everything that they could do. What it does reflect is the need to make sure that there’s follow-up care after inpatient discharge. Too often, people don’t get the follow-up care that they need. And the research literature is clear that intervention can save lives,” Dr. McKeon said.

Panelist Becky Stoll, LCSW, vice president for crisis and disaster management at Centerstone Health in Nashville, Tenn., noted, “We see a lot of no-shows on the outpatient side, because nobody ever asked the patients if they can actually get to the outpatient appointment that’s been made.

“We have got to figure out this care transition and do better. The road to mental health is paved with Swiss cheese. There are so many holes to fall into, even if you know how to navigate the system – and most of the people we’re serving don’t know how,” observed Ms. Stoll, who, like Dr. McKeon, was among the coauthors of the alliance’s guidelines on best practices in care transitions. Ms. Stoll also serves on the AAS board as crisis services division chair.* 

The National Action Alliance for Suicide Prevention is a public/private partnership whose goal is to advance the National Strategy for Suicide Prevention, which was developed by the alliance and the U.S. Surgeon General. The alliance includes mental health professionals as well as influential leaders from the military, journalism, entertainment, railroad, health insurance, law enforcement, defense, education, technology, and other industries.

Dr. McKeon and Ms. Stall were joined by Karen Johnson, MSW, another coauthor of the guidelines. They shared highlights of the report.

Inpatient provider strategies

Discharge and crisis safety planning should begin upon admission, according to Ms. Johnson, senior vice president for clinical services and division compliance at Universal Health Services, which owns and operates more than 200 behavioral health facilities across the United States.

Inpatient and outpatient care providers need to sit down and develop collaborative protocols and negotiate a memorandum of understanding regarding expectations, which absolutely must include procedures to ensure timely electronic delivery of medical records and other key documents to the outpatient care providers. The inpatient providers need to work collaboratively with the patient, family, and community support resources to develop a safety plan – including reduced access to lethal mean – as part of predischarge planning.

Among the strategies routinely employed on the inpatient side at Universal Health Services are advance scheduling of an initial outpatient appointment within 24-72 hours post discharge. Also, someone on the inpatient team is tasked with connecting with the outpatient provider prior to discharge to develop rapport.

“If our outpatient providers are located in our facility, as many of them are, we ask them to come in and attend inpatient team meetings to identify and meet with patients who are appropriate for continuing care in outpatient settings,” she explained. “A soft, warm handoff is critical.”

At these team meetings, the appropriateness of step-down care in the form of partial hospitalization or intensive outpatient care is weighed. Someone from the inpatient side is charged with maintaining contact with the patient until after the first outpatient appointment. Ongoing caring contact in the form of brief, encouraging postcards, emails, or texts that do not require a response from the patient should be maintained for several months.
 

Strategies for outpatient providers

Ms. Stoll is a big believer in the guideline-recommended practice of notifying the inpatient provider that the patient kept the outpatient appointment, along with having a system for red-flagging no-shows for prompt follow-up by a crisis management team.

She and her colleagues at Centerstone Health have conducted two studies of an intensive patient outreach program designed for the first 30 days of the care transition. The program included many elements of the alliance’s best practices guidelines. The yearlong first study, funded by Blue Cross/Blue Shield of Tennessee, documented zero suicides and 92% freedom from emergency department visits during the care transition period, along with greater than $400,000 savings in health care costs, compared with usual care. The second study, funded by SAMHSA, showed much the same over a 2-year period.

She emphasized that this was not a high-tech, intensive intervention. She characterized it, instead as “high-touch follow-up.

“It’s some staff and a phone and a laptop, nothing fancy, just a person who’s competent and confident and skilled with a laptop. With that, you can do some pretty amazing stuff: Get people what they need, keep them alive, and oh, guess what? You can also save a lot of health care dollars that can be put back into the system,” Ms. Stoll said.

She recognizes that it’s a lot to ask busy outpatient providers to leave their practice during the workday to participate in inpatient team meetings addressing discharge planning, as recommended in the alliance guidelines. But in this regard, she sees a silver lining to the COVID-19 pandemic, in that it forces health professionals to rely upon newly opened channels of telemedicine.

“COVID-19 is giving us an opportunity to do things in a different way. Things don’t just have to be done in person. Now that we’ve opened up new channels of telehealth, I’m really excited that we’re almost in a beta test that we’ve dreamed about for decades, where we can do things in a more innovative way,” she said.

Dr. McKeon agreed that reimbursement issues have long impeded efforts to improve the inpatient to outpatient care transition. He added that it will be really important that adequate reimbursement of remote forms of care remain in place after COVID-19 fades.

“This is exactly the kind of thing that’s needed to improve care transitions,” according to Dr. McKeon.

*This story was updated 7/9/2020.

[email protected]

The care transition period between inpatient psychiatric hospitalization and initiation of outpatient mental health services is a time of extraordinarily heightened suicide risk that has been woefully neglected, according to speakers from the National Action Alliance for Suicide Prevention at the virtual annual meeting of the American Association of Suicidology.

This transition period traditionally has been a time when nobody really takes responsibility for patient care. In an effort to close this potentially deadly gap in services, the alliance recently has issued a report entitled, “Best Practices in Care Transitions for Individuals with Suicide Risk: Inpatient Care to Outpatient Care.” The recommendations focus on specific, innovative, evidence-based strategies that health care systems can use to prevent patients from falling through the cracks in care, mainly by implementing protocols aimed at fostering interorganizational teamwork between inpatient and outpatient behavioral health services.

“I believe that improving care transitions in the United States is the area where we can likely save the most lives. It’s within our grasp if we can just do this better,” declared Richard McKeon, PhD, MPH, chief of the Suicide Prevention Branch at the Center for Mental Health Services within SAMHSA, the Substance Abuse and Mental Health Services Administration.

He cited a recent meta-analysis that concluded that the risk of suicide during the first week post discharge after psychiatric hospitalization is a staggering 300 times greater than in the general population, while in the first month, the risk is increased 200-fold. The meta-analysis included 29 studies encompassing 3,551 suicides during the first month and 24 studies reporting 1,928 suicides during the first week post discharge (BMJ Open. 2019 Mar 23;9[3]:e023883. doi: 10.1136/bmjopen-2018-023883).

Everyone in the mental health field as well as patients and their families should know those statistics, but they don’t.

“I think it’s natural for people to think someone who’s been discharged from an inpatient unit or the emergency department is not at risk, when in reality it’s still a high-risk time. Suicide risk is not like a light switch that you can just switch off,” the clinical psychologist observed.

He cited other harrowing statistics that underscore the vast problem of poor care transitions. Nationally, fully one-third of patients don’t complete a single outpatient visit within the first 30 days after discharge from inpatient behavioral health care. And one in seven people who die by suicide have had contact with inpatient mental health services in the year before they died.

“That doesn’t mean that inpatient care did not do everything that they could do. What it does reflect is the need to make sure that there’s follow-up care after inpatient discharge. Too often, people don’t get the follow-up care that they need. And the research literature is clear that intervention can save lives,” Dr. McKeon said.

Panelist Becky Stoll, LCSW, vice president for crisis and disaster management at Centerstone Health in Nashville, Tenn., noted, “We see a lot of no-shows on the outpatient side, because nobody ever asked the patients if they can actually get to the outpatient appointment that’s been made.

“We have got to figure out this care transition and do better. The road to mental health is paved with Swiss cheese. There are so many holes to fall into, even if you know how to navigate the system – and most of the people we’re serving don’t know how,” observed Ms. Stoll, who, like Dr. McKeon, was among the coauthors of the alliance’s guidelines on best practices in care transitions. Ms. Stoll also serves on the AAS board as crisis services division chair.* 

The National Action Alliance for Suicide Prevention is a public/private partnership whose goal is to advance the National Strategy for Suicide Prevention, which was developed by the alliance and the U.S. Surgeon General. The alliance includes mental health professionals as well as influential leaders from the military, journalism, entertainment, railroad, health insurance, law enforcement, defense, education, technology, and other industries.

Dr. McKeon and Ms. Stall were joined by Karen Johnson, MSW, another coauthor of the guidelines. They shared highlights of the report.

Inpatient provider strategies

Discharge and crisis safety planning should begin upon admission, according to Ms. Johnson, senior vice president for clinical services and division compliance at Universal Health Services, which owns and operates more than 200 behavioral health facilities across the United States.

Inpatient and outpatient care providers need to sit down and develop collaborative protocols and negotiate a memorandum of understanding regarding expectations, which absolutely must include procedures to ensure timely electronic delivery of medical records and other key documents to the outpatient care providers. The inpatient providers need to work collaboratively with the patient, family, and community support resources to develop a safety plan – including reduced access to lethal mean – as part of predischarge planning.

Among the strategies routinely employed on the inpatient side at Universal Health Services are advance scheduling of an initial outpatient appointment within 24-72 hours post discharge. Also, someone on the inpatient team is tasked with connecting with the outpatient provider prior to discharge to develop rapport.

“If our outpatient providers are located in our facility, as many of them are, we ask them to come in and attend inpatient team meetings to identify and meet with patients who are appropriate for continuing care in outpatient settings,” she explained. “A soft, warm handoff is critical.”

At these team meetings, the appropriateness of step-down care in the form of partial hospitalization or intensive outpatient care is weighed. Someone from the inpatient side is charged with maintaining contact with the patient until after the first outpatient appointment. Ongoing caring contact in the form of brief, encouraging postcards, emails, or texts that do not require a response from the patient should be maintained for several months.
 

Strategies for outpatient providers

Ms. Stoll is a big believer in the guideline-recommended practice of notifying the inpatient provider that the patient kept the outpatient appointment, along with having a system for red-flagging no-shows for prompt follow-up by a crisis management team.

She and her colleagues at Centerstone Health have conducted two studies of an intensive patient outreach program designed for the first 30 days of the care transition. The program included many elements of the alliance’s best practices guidelines. The yearlong first study, funded by Blue Cross/Blue Shield of Tennessee, documented zero suicides and 92% freedom from emergency department visits during the care transition period, along with greater than $400,000 savings in health care costs, compared with usual care. The second study, funded by SAMHSA, showed much the same over a 2-year period.

She emphasized that this was not a high-tech, intensive intervention. She characterized it, instead as “high-touch follow-up.

“It’s some staff and a phone and a laptop, nothing fancy, just a person who’s competent and confident and skilled with a laptop. With that, you can do some pretty amazing stuff: Get people what they need, keep them alive, and oh, guess what? You can also save a lot of health care dollars that can be put back into the system,” Ms. Stoll said.

She recognizes that it’s a lot to ask busy outpatient providers to leave their practice during the workday to participate in inpatient team meetings addressing discharge planning, as recommended in the alliance guidelines. But in this regard, she sees a silver lining to the COVID-19 pandemic, in that it forces health professionals to rely upon newly opened channels of telemedicine.

“COVID-19 is giving us an opportunity to do things in a different way. Things don’t just have to be done in person. Now that we’ve opened up new channels of telehealth, I’m really excited that we’re almost in a beta test that we’ve dreamed about for decades, where we can do things in a more innovative way,” she said.

Dr. McKeon agreed that reimbursement issues have long impeded efforts to improve the inpatient to outpatient care transition. He added that it will be really important that adequate reimbursement of remote forms of care remain in place after COVID-19 fades.

“This is exactly the kind of thing that’s needed to improve care transitions,” according to Dr. McKeon.

*This story was updated 7/9/2020.

[email protected]

Opioid overdoses have shot up by almost 10-fold at a Virginia ED since March, a new report finds. The report provides more evidence that the coronavirus pandemic is sparking a severe medical crisis among illicit drug users.

“Health care providers should closely monitor the number of overdoses coming into their hospitals and in the surrounding community during this time,” study lead author and postdoctoral research fellow Taylor Ochalek, PhD, said in an interview. “If they do notice an increasing trend of overdoses, they should spread awareness in the community to the general public, and offer resources and information for those that may be seeking help and/or may be at a high risk of overdosing.”

Dr. Ochalek presented the study findings at the virtual annual meeting of the College on Problems of Drug Dependence.

According to the report, opioid overdoses at the VCU Medical Center in Richmond, Va., grew from an average of six a month from February to December 2019 to 50, 57, and 63 in March, April, and May 2020. Of the 171 cases in the later time frame, the average age was 44 years, 72% were male, and 82% were African American.

“The steep increase in overdoses began primarily in March,” said Dr. Ochalek, of Virginia Commonwealth University in Richmond. “This timing coincides with the Virginia governor’s state of emergency declaration, stay-at-home order, and closure of nonessential businesses order.”

The researchers did not provide details about the types of opioids used, the patient outcomes, or whether the patients tested positive for COVID-19. It’s unclear whether the pandemic directly spawned a higher number of overdoses, but there are growing signs of a stark nationwide trend.

“Nationwide, federal and local officials are reporting alarming spikes in drug overdoses – a hidden epidemic within the coronavirus pandemic,” the Washington Post reported on July 1, pointing to increases in Kentucky, Virginia, and the Chicago area.

Meanwhile, the federal Overdose Detection Mapping Application Program, which tracks overdoses nationwide, issued 191% more “spike alerts” in January to April 2020 than in the same time period in 2019. However, the spike alerts began to increase in January, weeks before the pandemic began to take hold.

The findings are consistent with trends in Houston, where overdose calls were up 31% in the first 3 months of 2020, compared with 2019, said psychologist James Bray, PhD, of the University of Texas, San Antonio, in an interview. More recent data suggest that the numbers are rising even higher, said Dr. Bray, who works with Houston first responders and has analyzed data.

Possible causes include “stress due to economic problems, increased anxiety over COVID infection, and more relational stress due to social distancing and quarantining,” Dr. Bray said.

Another potential factor is the disruption in the illicit drug supply chain because of limits on crossings at the southern border, said ED physician Scott Weiner, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston. “As a result, opioids of extremely variable potency have infiltrated markets, and people using drugs may not be used to the new doses, especially if they are high-potency fentanyl analogues.”

Moving forward, Dr. Bray said, “people need continued access to treatment. Telehealth and other virtual services need to be provided so that people can continue to have access to treatment even during the pandemic.”

Dr. Weiner also emphasized the importance of treatment for patients who overdose on opioids. “In my previous work, we discovered that about 1 in 20 patients who are treated in an emergency department and survive would die within 1 year. That number will likely increase drastically during COVID,” he said. “When a patient presents after overdose, we must intervene aggressively with buprenorphine and other harm-reduction techniques to save these lives.”

The study was funded by the National Institutes of Health. Dr. Ochalek, Dr. Weiner, and Dr. Bray reported no relevant disclosures.

Opioid overdoses have shot up by almost 10-fold at a Virginia ED since March, a new report finds. The report provides more evidence that the coronavirus pandemic is sparking a severe medical crisis among illicit drug users.

“Health care providers should closely monitor the number of overdoses coming into their hospitals and in the surrounding community during this time,” study lead author and postdoctoral research fellow Taylor Ochalek, PhD, said in an interview. “If they do notice an increasing trend of overdoses, they should spread awareness in the community to the general public, and offer resources and information for those that may be seeking help and/or may be at a high risk of overdosing.”

Dr. Ochalek presented the study findings at the virtual annual meeting of the College on Problems of Drug Dependence.

According to the report, opioid overdoses at the VCU Medical Center in Richmond, Va., grew from an average of six a month from February to December 2019 to 50, 57, and 63 in March, April, and May 2020. Of the 171 cases in the later time frame, the average age was 44 years, 72% were male, and 82% were African American.

“The steep increase in overdoses began primarily in March,” said Dr. Ochalek, of Virginia Commonwealth University in Richmond. “This timing coincides with the Virginia governor’s state of emergency declaration, stay-at-home order, and closure of nonessential businesses order.”

The researchers did not provide details about the types of opioids used, the patient outcomes, or whether the patients tested positive for COVID-19. It’s unclear whether the pandemic directly spawned a higher number of overdoses, but there are growing signs of a stark nationwide trend.

“Nationwide, federal and local officials are reporting alarming spikes in drug overdoses – a hidden epidemic within the coronavirus pandemic,” the Washington Post reported on July 1, pointing to increases in Kentucky, Virginia, and the Chicago area.

Meanwhile, the federal Overdose Detection Mapping Application Program, which tracks overdoses nationwide, issued 191% more “spike alerts” in January to April 2020 than in the same time period in 2019. However, the spike alerts began to increase in January, weeks before the pandemic began to take hold.

The findings are consistent with trends in Houston, where overdose calls were up 31% in the first 3 months of 2020, compared with 2019, said psychologist James Bray, PhD, of the University of Texas, San Antonio, in an interview. More recent data suggest that the numbers are rising even higher, said Dr. Bray, who works with Houston first responders and has analyzed data.

Possible causes include “stress due to economic problems, increased anxiety over COVID infection, and more relational stress due to social distancing and quarantining,” Dr. Bray said.

Another potential factor is the disruption in the illicit drug supply chain because of limits on crossings at the southern border, said ED physician Scott Weiner, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston. “As a result, opioids of extremely variable potency have infiltrated markets, and people using drugs may not be used to the new doses, especially if they are high-potency fentanyl analogues.”

Moving forward, Dr. Bray said, “people need continued access to treatment. Telehealth and other virtual services need to be provided so that people can continue to have access to treatment even during the pandemic.”

Dr. Weiner also emphasized the importance of treatment for patients who overdose on opioids. “In my previous work, we discovered that about 1 in 20 patients who are treated in an emergency department and survive would die within 1 year. That number will likely increase drastically during COVID,” he said. “When a patient presents after overdose, we must intervene aggressively with buprenorphine and other harm-reduction techniques to save these lives.”

The study was funded by the National Institutes of Health. Dr. Ochalek, Dr. Weiner, and Dr. Bray reported no relevant disclosures.

Opioid overdoses have shot up by almost 10-fold at a Virginia ED since March, a new report finds. The report provides more evidence that the coronavirus pandemic is sparking a severe medical crisis among illicit drug users.

“Health care providers should closely monitor the number of overdoses coming into their hospitals and in the surrounding community during this time,” study lead author and postdoctoral research fellow Taylor Ochalek, PhD, said in an interview. “If they do notice an increasing trend of overdoses, they should spread awareness in the community to the general public, and offer resources and information for those that may be seeking help and/or may be at a high risk of overdosing.”

Dr. Ochalek presented the study findings at the virtual annual meeting of the College on Problems of Drug Dependence.

According to the report, opioid overdoses at the VCU Medical Center in Richmond, Va., grew from an average of six a month from February to December 2019 to 50, 57, and 63 in March, April, and May 2020. Of the 171 cases in the later time frame, the average age was 44 years, 72% were male, and 82% were African American.

“The steep increase in overdoses began primarily in March,” said Dr. Ochalek, of Virginia Commonwealth University in Richmond. “This timing coincides with the Virginia governor’s state of emergency declaration, stay-at-home order, and closure of nonessential businesses order.”

The researchers did not provide details about the types of opioids used, the patient outcomes, or whether the patients tested positive for COVID-19. It’s unclear whether the pandemic directly spawned a higher number of overdoses, but there are growing signs of a stark nationwide trend.

“Nationwide, federal and local officials are reporting alarming spikes in drug overdoses – a hidden epidemic within the coronavirus pandemic,” the Washington Post reported on July 1, pointing to increases in Kentucky, Virginia, and the Chicago area.

Meanwhile, the federal Overdose Detection Mapping Application Program, which tracks overdoses nationwide, issued 191% more “spike alerts” in January to April 2020 than in the same time period in 2019. However, the spike alerts began to increase in January, weeks before the pandemic began to take hold.

The findings are consistent with trends in Houston, where overdose calls were up 31% in the first 3 months of 2020, compared with 2019, said psychologist James Bray, PhD, of the University of Texas, San Antonio, in an interview. More recent data suggest that the numbers are rising even higher, said Dr. Bray, who works with Houston first responders and has analyzed data.

Possible causes include “stress due to economic problems, increased anxiety over COVID infection, and more relational stress due to social distancing and quarantining,” Dr. Bray said.

Another potential factor is the disruption in the illicit drug supply chain because of limits on crossings at the southern border, said ED physician Scott Weiner, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School, both in Boston. “As a result, opioids of extremely variable potency have infiltrated markets, and people using drugs may not be used to the new doses, especially if they are high-potency fentanyl analogues.”

Moving forward, Dr. Bray said, “people need continued access to treatment. Telehealth and other virtual services need to be provided so that people can continue to have access to treatment even during the pandemic.”

Dr. Weiner also emphasized the importance of treatment for patients who overdose on opioids. “In my previous work, we discovered that about 1 in 20 patients who are treated in an emergency department and survive would die within 1 year. That number will likely increase drastically during COVID,” he said. “When a patient presents after overdose, we must intervene aggressively with buprenorphine and other harm-reduction techniques to save these lives.”

The study was funded by the National Institutes of Health. Dr. Ochalek, Dr. Weiner, and Dr. Bray reported no relevant disclosures.

Opioid and nonopioid prescription pain medications have taken different journeys since 2009, but they ended up in the same place in 2018, according to a recent report from the National Center for Health Statistics.

At least by one measure, anyway. Survey data from 2009 to 2010 show that 6.2% of adults aged 20 years and older had taken at least one prescription opioid in the last 30 days and 4.3% had used a prescription nonopioid without an opioid. By 2017-2018, past 30-day use of both drug groups was 5.7%, Craig M. Hales, MD, and associates said in an NCHS data brief.

“Opioids may be prescribed together with nonopioid pain medications, [but] nonpharmacologic and nonopioid-containing pharmacologic therapies are preferred for management of chronic pain,” the NCHS researchers noted.

The increase in prescription nonopioid use over the entire 10-year period managed to reach statistical significance, as did the short-term increase in nonopioids from 2015-2016 to 2017-2018, but the 10-year trend for opioids was not significant, based on data from the National Health and Nutrition Examination Survey.

Much of the analysis focused on 2015-2018, when 30-day use of any prescription pain medication was reported by 10.7% of adults aged 20 years and older, with use of opioids at 5.7% and nonopioids at 5.0%. For women, use of any pain drug was 12.6% (6.4% opioid, 6.2% nonopioid) from 2015 to 2018, compared with 8.7% for men (4.9%, 3.8%), Dr. Hales and associates reported.

Past 30-day use of both opioids and nonopioids over those 4 years was highest for non-Hispanic whites and lowest, by a significant margin for both drug groups, among non-Hispanic Asian adults, a pattern that held for both men and women, they said.

[email protected]

Opioid and nonopioid prescription pain medications have taken different journeys since 2009, but they ended up in the same place in 2018, according to a recent report from the National Center for Health Statistics.

At least by one measure, anyway. Survey data from 2009 to 2010 show that 6.2% of adults aged 20 years and older had taken at least one prescription opioid in the last 30 days and 4.3% had used a prescription nonopioid without an opioid. By 2017-2018, past 30-day use of both drug groups was 5.7%, Craig M. Hales, MD, and associates said in an NCHS data brief.

“Opioids may be prescribed together with nonopioid pain medications, [but] nonpharmacologic and nonopioid-containing pharmacologic therapies are preferred for management of chronic pain,” the NCHS researchers noted.

The increase in prescription nonopioid use over the entire 10-year period managed to reach statistical significance, as did the short-term increase in nonopioids from 2015-2016 to 2017-2018, but the 10-year trend for opioids was not significant, based on data from the National Health and Nutrition Examination Survey.

Much of the analysis focused on 2015-2018, when 30-day use of any prescription pain medication was reported by 10.7% of adults aged 20 years and older, with use of opioids at 5.7% and nonopioids at 5.0%. For women, use of any pain drug was 12.6% (6.4% opioid, 6.2% nonopioid) from 2015 to 2018, compared with 8.7% for men (4.9%, 3.8%), Dr. Hales and associates reported.

Past 30-day use of both opioids and nonopioids over those 4 years was highest for non-Hispanic whites and lowest, by a significant margin for both drug groups, among non-Hispanic Asian adults, a pattern that held for both men and women, they said.

[email protected]

Opioid and nonopioid prescription pain medications have taken different journeys since 2009, but they ended up in the same place in 2018, according to a recent report from the National Center for Health Statistics.

At least by one measure, anyway. Survey data from 2009 to 2010 show that 6.2% of adults aged 20 years and older had taken at least one prescription opioid in the last 30 days and 4.3% had used a prescription nonopioid without an opioid. By 2017-2018, past 30-day use of both drug groups was 5.7%, Craig M. Hales, MD, and associates said in an NCHS data brief.

“Opioids may be prescribed together with nonopioid pain medications, [but] nonpharmacologic and nonopioid-containing pharmacologic therapies are preferred for management of chronic pain,” the NCHS researchers noted.

The increase in prescription nonopioid use over the entire 10-year period managed to reach statistical significance, as did the short-term increase in nonopioids from 2015-2016 to 2017-2018, but the 10-year trend for opioids was not significant, based on data from the National Health and Nutrition Examination Survey.

Much of the analysis focused on 2015-2018, when 30-day use of any prescription pain medication was reported by 10.7% of adults aged 20 years and older, with use of opioids at 5.7% and nonopioids at 5.0%. For women, use of any pain drug was 12.6% (6.4% opioid, 6.2% nonopioid) from 2015 to 2018, compared with 8.7% for men (4.9%, 3.8%), Dr. Hales and associates reported.

Past 30-day use of both opioids and nonopioids over those 4 years was highest for non-Hispanic whites and lowest, by a significant margin for both drug groups, among non-Hispanic Asian adults, a pattern that held for both men and women, they said.

[email protected]

People living with HIV who are admitted to the hospital with COVID-19 are no more likely to die than those without HIV, an analysis conducted in New York City shows. This is despite the fact that comorbidities associated with worse COVID-19 outcomes were more common in the HIV group.

“We don’t see any signs that people with HIV should take extra precautions” to protect themselves from COVID-19, said Keith Sigel, MD, associate professor of medicine and infectious diseases at the Icahn School of Medicine at Mount Sinai, New York, and the lead researcher on the study, published online June 28 in Clinical Infectious Diseases.

“We still don’t have a great explanation for why we’re seeing what we’re seeing,” he added. “But we’re glad we’re seeing it.”

The findings have changed how Dr. Sigel talks to his patients with HIV about protecting themselves from COVID-19. Some patients have so curtailed their behavior for fear of acquiring COVID-19 that they aren’t buying groceries or attending needed medical appointments. With these data, Dr. Sigel said he’s comfortable telling his patients, “COVID-19 is bad all by itself, but you don’t need to go crazy. Wear a mask, practice appropriate social distancing and hygiene, but your risk doesn’t appear to be greater.”

The findings conform with those on the lack of association between HIV and COVID-19 severity seen in a cohort study from Spain, a case study from China, and case series from New Jersey, New York City, and Spain.

One of the only regions reporting something different so far is South Africa. There, HIV is the third most common comorbidity associated with death from COVID-19, according to a cohort analysis conducted in the province of Western Cape.

The intersection of HIV and COVID-19 will be a major theme at the virtual meeting of the International AIDS conference. Along with data from HIV prevention and treatment trials, the conference will feature updates on where the world stands in the control of HIV during the COVID-19 pandemic. And for an even more focused look, the IAS COVID-19 Conference will immediately follow that meeting.

The New York City cohort

For their study, Dr. Sigel and colleagues examined the 4402 COVID-19 cases at the Mount Sinai Health System’s five hospitals between March 12 and April 23.

They found 88 people with COVID-19 whose charts showed codes indicating they were living with HIV. All 88 were receiving treatment, and 81% of them had undetectable viral loads documented at COVID admission or in the 12 months prior to admission.

The median age was 61 years, and 40% of the cohort was black and 30% was Hispanic.

Patients in the comparison group – 405 people without HIV from the Veterans Aging Cohort Study who had been admitted to the hospital for COVID-19 – were matched in terms of age, race, and stage of COVID-19.

The study had an 80% power to detect a 15% increase in the absolute risk for death in people with COVID-19, with or without HIV.

Patients with HIV were almost three times as likely to have smoked and were more likely to have chronic obstructive pulmonary disease, cirrhosis, and a history of cancer.

“This was a group of patients that one might suspect would do worse,” Dr. Sigel said. And yet, “we didn’t see any difference in deaths. We didn’t see any difference in respiratory failure.”

In fact, people with HIV required mechanical ventilation less often than those without HIV (18% vs. 23%). And when it came to mortality, one in five people died from COVID-19 during follow-up whether they had HIV or not (21% vs. 20%).

The only factor associated with significantly worse outcomes was a history of organ transplantation, “suggesting that non-HIV causes of immunodeficiency may be more prominent risks for severe outcomes,” Dr. Sigel and colleagues explained.

A surprise association

What’s more, the researchers found a slight association between the use of nucleoside reverse-transcriptase inhibitors (NRTI) by people with HIV and better outcomes in COVID-19. That echoes findings published June 26 in Annals of Internal Medicine, which showed that people with HIV taking the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) were less likely to be diagnosed with COVID-19, less likely to be hospitalized, and less likely to die.

This has led some to wonder whether NRTIs have some effect on SARS-CoV-2, the virus that causes COVID-19. Dr. Sigel said he wonders that too, but right now, it’s just musings.

“These studies are not even remotely designed” to show that NRTIs are protective against COVID-19, he explained. “Ours was extremely underpowered to detect that and there was a high potential for confounding.”

“I’d be wary of any study in a subpopulation – which is what we’re dealing with here – that is looking for signals of protection with certain medications,” he added.

A “modest” increase

Using the South African data, released on June 22, public health officials estimate that people with HIV are 2.75 times more likely to die from COVID-19 than those without HIV, making it the third most common comorbidity in people who died from COVID-19, behind diabetes and hypertension. This held true regardless of whether the people with HIV were on treatment.

But when they looked at COVID-19 deaths in the sickest of the sick – those hospitalized with COVID-19 symptoms – HIV was associated with just a 28% increase in the risk for death. The South African researchers called this risk “modest.”

“While these findings may overestimate the effect of HIV on COVID-19 death due to the presence of residual confounding, people living with HIV should be considered a high-risk group for COVID-19 management, with modestly elevated risk of poor outcomes, irrespective of viral suppression,” they wrote.

Epidemiologist Gregorio Millett, MPH, has been tracking the effect of HIV on COVID-19 outcomes since the start of the pandemic in his role as vice president and head of policy at the American Foundation for AIDS Research (amFAR).

Back in April, he and his colleagues looked at rates of COVID-19 deaths and hospitalizations in counties with disproportionate levels of black residents. These areas often overlapped with the communities selected for the Ending the HIV Epidemic plan to control HIV by 2030. What they found was that there was more HIV and COVID-19 in those communities.

What they didn’t find was that people with HIV in those communities had worse outcomes with COVID-19. This remained true even when they reran the analysis after the number of cases of COVID-19 in the United States surpassed 100,000. Those data have yet to be published, Mr. Millett reported.

“HIV does not pop out,” he said. “It’s still social determinants of health. It’s still underlying conditions. It’s still age as a primary factor.”

“People living with HIV are mainly dying of underlying conditions – so all the things associated with COVID-19 – rather than the association being with HIV itself,” he added.

Although he’s not ruling out the possibility that an association like the one in South Africa could emerge, Mr. Millett, who will present a plenary on the context of the HIV epidemic at the IAS conference, said he suspects we won’t see one.

“If we didn’t see an association with the counties that are disproportionately African American, in the black belt where we see high rates of HIV, particularly where we see the social determinants of health that definitely make a difference – if we’re not seeing that association there, where we have a high proportion of African Americans who are at risk both for HIV and COVID-19 – I just don’t think it’s going to emerge,” he said.

This article first appeared on Medscape.com.

People living with HIV who are admitted to the hospital with COVID-19 are no more likely to die than those without HIV, an analysis conducted in New York City shows. This is despite the fact that comorbidities associated with worse COVID-19 outcomes were more common in the HIV group.

“We don’t see any signs that people with HIV should take extra precautions” to protect themselves from COVID-19, said Keith Sigel, MD, associate professor of medicine and infectious diseases at the Icahn School of Medicine at Mount Sinai, New York, and the lead researcher on the study, published online June 28 in Clinical Infectious Diseases.

“We still don’t have a great explanation for why we’re seeing what we’re seeing,” he added. “But we’re glad we’re seeing it.”

The findings have changed how Dr. Sigel talks to his patients with HIV about protecting themselves from COVID-19. Some patients have so curtailed their behavior for fear of acquiring COVID-19 that they aren’t buying groceries or attending needed medical appointments. With these data, Dr. Sigel said he’s comfortable telling his patients, “COVID-19 is bad all by itself, but you don’t need to go crazy. Wear a mask, practice appropriate social distancing and hygiene, but your risk doesn’t appear to be greater.”

The findings conform with those on the lack of association between HIV and COVID-19 severity seen in a cohort study from Spain, a case study from China, and case series from New Jersey, New York City, and Spain.

One of the only regions reporting something different so far is South Africa. There, HIV is the third most common comorbidity associated with death from COVID-19, according to a cohort analysis conducted in the province of Western Cape.

The intersection of HIV and COVID-19 will be a major theme at the virtual meeting of the International AIDS conference. Along with data from HIV prevention and treatment trials, the conference will feature updates on where the world stands in the control of HIV during the COVID-19 pandemic. And for an even more focused look, the IAS COVID-19 Conference will immediately follow that meeting.

The New York City cohort

For their study, Dr. Sigel and colleagues examined the 4402 COVID-19 cases at the Mount Sinai Health System’s five hospitals between March 12 and April 23.

They found 88 people with COVID-19 whose charts showed codes indicating they were living with HIV. All 88 were receiving treatment, and 81% of them had undetectable viral loads documented at COVID admission or in the 12 months prior to admission.

The median age was 61 years, and 40% of the cohort was black and 30% was Hispanic.

Patients in the comparison group – 405 people without HIV from the Veterans Aging Cohort Study who had been admitted to the hospital for COVID-19 – were matched in terms of age, race, and stage of COVID-19.

The study had an 80% power to detect a 15% increase in the absolute risk for death in people with COVID-19, with or without HIV.

Patients with HIV were almost three times as likely to have smoked and were more likely to have chronic obstructive pulmonary disease, cirrhosis, and a history of cancer.

“This was a group of patients that one might suspect would do worse,” Dr. Sigel said. And yet, “we didn’t see any difference in deaths. We didn’t see any difference in respiratory failure.”

In fact, people with HIV required mechanical ventilation less often than those without HIV (18% vs. 23%). And when it came to mortality, one in five people died from COVID-19 during follow-up whether they had HIV or not (21% vs. 20%).

The only factor associated with significantly worse outcomes was a history of organ transplantation, “suggesting that non-HIV causes of immunodeficiency may be more prominent risks for severe outcomes,” Dr. Sigel and colleagues explained.

A surprise association

What’s more, the researchers found a slight association between the use of nucleoside reverse-transcriptase inhibitors (NRTI) by people with HIV and better outcomes in COVID-19. That echoes findings published June 26 in Annals of Internal Medicine, which showed that people with HIV taking the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) were less likely to be diagnosed with COVID-19, less likely to be hospitalized, and less likely to die.

This has led some to wonder whether NRTIs have some effect on SARS-CoV-2, the virus that causes COVID-19. Dr. Sigel said he wonders that too, but right now, it’s just musings.

“These studies are not even remotely designed” to show that NRTIs are protective against COVID-19, he explained. “Ours was extremely underpowered to detect that and there was a high potential for confounding.”

“I’d be wary of any study in a subpopulation – which is what we’re dealing with here – that is looking for signals of protection with certain medications,” he added.

A “modest” increase

Using the South African data, released on June 22, public health officials estimate that people with HIV are 2.75 times more likely to die from COVID-19 than those without HIV, making it the third most common comorbidity in people who died from COVID-19, behind diabetes and hypertension. This held true regardless of whether the people with HIV were on treatment.

But when they looked at COVID-19 deaths in the sickest of the sick – those hospitalized with COVID-19 symptoms – HIV was associated with just a 28% increase in the risk for death. The South African researchers called this risk “modest.”

“While these findings may overestimate the effect of HIV on COVID-19 death due to the presence of residual confounding, people living with HIV should be considered a high-risk group for COVID-19 management, with modestly elevated risk of poor outcomes, irrespective of viral suppression,” they wrote.

Epidemiologist Gregorio Millett, MPH, has been tracking the effect of HIV on COVID-19 outcomes since the start of the pandemic in his role as vice president and head of policy at the American Foundation for AIDS Research (amFAR).

Back in April, he and his colleagues looked at rates of COVID-19 deaths and hospitalizations in counties with disproportionate levels of black residents. These areas often overlapped with the communities selected for the Ending the HIV Epidemic plan to control HIV by 2030. What they found was that there was more HIV and COVID-19 in those communities.

What they didn’t find was that people with HIV in those communities had worse outcomes with COVID-19. This remained true even when they reran the analysis after the number of cases of COVID-19 in the United States surpassed 100,000. Those data have yet to be published, Mr. Millett reported.

“HIV does not pop out,” he said. “It’s still social determinants of health. It’s still underlying conditions. It’s still age as a primary factor.”

“People living with HIV are mainly dying of underlying conditions – so all the things associated with COVID-19 – rather than the association being with HIV itself,” he added.

Although he’s not ruling out the possibility that an association like the one in South Africa could emerge, Mr. Millett, who will present a plenary on the context of the HIV epidemic at the IAS conference, said he suspects we won’t see one.

“If we didn’t see an association with the counties that are disproportionately African American, in the black belt where we see high rates of HIV, particularly where we see the social determinants of health that definitely make a difference – if we’re not seeing that association there, where we have a high proportion of African Americans who are at risk both for HIV and COVID-19 – I just don’t think it’s going to emerge,” he said.

This article first appeared on Medscape.com.

People living with HIV who are admitted to the hospital with COVID-19 are no more likely to die than those without HIV, an analysis conducted in New York City shows. This is despite the fact that comorbidities associated with worse COVID-19 outcomes were more common in the HIV group.

“We don’t see any signs that people with HIV should take extra precautions” to protect themselves from COVID-19, said Keith Sigel, MD, associate professor of medicine and infectious diseases at the Icahn School of Medicine at Mount Sinai, New York, and the lead researcher on the study, published online June 28 in Clinical Infectious Diseases.

“We still don’t have a great explanation for why we’re seeing what we’re seeing,” he added. “But we’re glad we’re seeing it.”

The findings have changed how Dr. Sigel talks to his patients with HIV about protecting themselves from COVID-19. Some patients have so curtailed their behavior for fear of acquiring COVID-19 that they aren’t buying groceries or attending needed medical appointments. With these data, Dr. Sigel said he’s comfortable telling his patients, “COVID-19 is bad all by itself, but you don’t need to go crazy. Wear a mask, practice appropriate social distancing and hygiene, but your risk doesn’t appear to be greater.”

The findings conform with those on the lack of association between HIV and COVID-19 severity seen in a cohort study from Spain, a case study from China, and case series from New Jersey, New York City, and Spain.

One of the only regions reporting something different so far is South Africa. There, HIV is the third most common comorbidity associated with death from COVID-19, according to a cohort analysis conducted in the province of Western Cape.

The intersection of HIV and COVID-19 will be a major theme at the virtual meeting of the International AIDS conference. Along with data from HIV prevention and treatment trials, the conference will feature updates on where the world stands in the control of HIV during the COVID-19 pandemic. And for an even more focused look, the IAS COVID-19 Conference will immediately follow that meeting.

The New York City cohort

For their study, Dr. Sigel and colleagues examined the 4402 COVID-19 cases at the Mount Sinai Health System’s five hospitals between March 12 and April 23.

They found 88 people with COVID-19 whose charts showed codes indicating they were living with HIV. All 88 were receiving treatment, and 81% of them had undetectable viral loads documented at COVID admission or in the 12 months prior to admission.

The median age was 61 years, and 40% of the cohort was black and 30% was Hispanic.

Patients in the comparison group – 405 people without HIV from the Veterans Aging Cohort Study who had been admitted to the hospital for COVID-19 – were matched in terms of age, race, and stage of COVID-19.

The study had an 80% power to detect a 15% increase in the absolute risk for death in people with COVID-19, with or without HIV.

Patients with HIV were almost three times as likely to have smoked and were more likely to have chronic obstructive pulmonary disease, cirrhosis, and a history of cancer.

“This was a group of patients that one might suspect would do worse,” Dr. Sigel said. And yet, “we didn’t see any difference in deaths. We didn’t see any difference in respiratory failure.”

In fact, people with HIV required mechanical ventilation less often than those without HIV (18% vs. 23%). And when it came to mortality, one in five people died from COVID-19 during follow-up whether they had HIV or not (21% vs. 20%).

The only factor associated with significantly worse outcomes was a history of organ transplantation, “suggesting that non-HIV causes of immunodeficiency may be more prominent risks for severe outcomes,” Dr. Sigel and colleagues explained.

A surprise association

What’s more, the researchers found a slight association between the use of nucleoside reverse-transcriptase inhibitors (NRTI) by people with HIV and better outcomes in COVID-19. That echoes findings published June 26 in Annals of Internal Medicine, which showed that people with HIV taking the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) were less likely to be diagnosed with COVID-19, less likely to be hospitalized, and less likely to die.

This has led some to wonder whether NRTIs have some effect on SARS-CoV-2, the virus that causes COVID-19. Dr. Sigel said he wonders that too, but right now, it’s just musings.

“These studies are not even remotely designed” to show that NRTIs are protective against COVID-19, he explained. “Ours was extremely underpowered to detect that and there was a high potential for confounding.”

“I’d be wary of any study in a subpopulation – which is what we’re dealing with here – that is looking for signals of protection with certain medications,” he added.

A “modest” increase

Using the South African data, released on June 22, public health officials estimate that people with HIV are 2.75 times more likely to die from COVID-19 than those without HIV, making it the third most common comorbidity in people who died from COVID-19, behind diabetes and hypertension. This held true regardless of whether the people with HIV were on treatment.

But when they looked at COVID-19 deaths in the sickest of the sick – those hospitalized with COVID-19 symptoms – HIV was associated with just a 28% increase in the risk for death. The South African researchers called this risk “modest.”

“While these findings may overestimate the effect of HIV on COVID-19 death due to the presence of residual confounding, people living with HIV should be considered a high-risk group for COVID-19 management, with modestly elevated risk of poor outcomes, irrespective of viral suppression,” they wrote.

Epidemiologist Gregorio Millett, MPH, has been tracking the effect of HIV on COVID-19 outcomes since the start of the pandemic in his role as vice president and head of policy at the American Foundation for AIDS Research (amFAR).

Back in April, he and his colleagues looked at rates of COVID-19 deaths and hospitalizations in counties with disproportionate levels of black residents. These areas often overlapped with the communities selected for the Ending the HIV Epidemic plan to control HIV by 2030. What they found was that there was more HIV and COVID-19 in those communities.

What they didn’t find was that people with HIV in those communities had worse outcomes with COVID-19. This remained true even when they reran the analysis after the number of cases of COVID-19 in the United States surpassed 100,000. Those data have yet to be published, Mr. Millett reported.

“HIV does not pop out,” he said. “It’s still social determinants of health. It’s still underlying conditions. It’s still age as a primary factor.”

“People living with HIV are mainly dying of underlying conditions – so all the things associated with COVID-19 – rather than the association being with HIV itself,” he added.

Although he’s not ruling out the possibility that an association like the one in South Africa could emerge, Mr. Millett, who will present a plenary on the context of the HIV epidemic at the IAS conference, said he suspects we won’t see one.

“If we didn’t see an association with the counties that are disproportionately African American, in the black belt where we see high rates of HIV, particularly where we see the social determinants of health that definitely make a difference – if we’re not seeing that association there, where we have a high proportion of African Americans who are at risk both for HIV and COVID-19 – I just don’t think it’s going to emerge,” he said.

This article first appeared on Medscape.com.

Patients with COVID-19 may be at increased risk of acute ischemic stroke compared with patients with influenza, according to a retrospective cohort study conducted at New York–Presbyterian Hospital and Weill Cornell Medicine, New York. “These findings suggest that clinicians should be vigilant for symptoms and signs of acute ischemic stroke in patients with COVID-19 so that time-sensitive interventions, such as thrombolysis and thrombectomy, can be instituted if possible to reduce the burden of long-term disability,” wrote Alexander E. Merkler and colleagues. Their report is in JAMA Neurology.

While several recent publications have “raised the possibility” of this link, none have had an appropriate control group, noted Dr. Merkler of the department of neurology, Weill Cornell Medicine. “Further elucidation of thrombotic mechanisms in patients with COVID-19 may yield better strategies to prevent disabling thrombotic complications like ischemic stroke,” he added.
 

An increased risk of stroke

The study included 1,916 adults with confirmed COVID-19 (median age 64 years) who were either hospitalized or visited an emergency department between March 4 and May 2, 2020. These cases were compared with a historical cohort of 1,486 patients (median age 62 years) who were hospitalized with laboratory-confirmed influenza A or B between January 1, 2016, and May 31, 2018.

Among the patients with COVID-19, a diagnosis of cerebrovascular disease during hospitalization, a brain computed tomography (CT), or brain magnetic resonance imaging (MRI) was an indication of possible ischemic stroke. These records were then independently reviewed by two board-certified attending neurologists (with a third resolving any disagreement) to adjudicate a final stroke diagnosis. In the influenza cohort, the Cornell Acute Stroke Academic Registry (CAESAR) was used to ascertain ischemic strokes.

The study identified 31 patients with stroke among the COVID-19 cohort (1.6%; 95% confidence interval, 1.1%-2.3%) and 3 in the influenza cohort (0.2%; 95% CI, 0.0%-0.6%). After adjustment for age, sex, and race, stroke risk was almost 8 times higher in the COVID-19 cohort (OR, 7.6; 95% CI, 2.3-25.2).

This association “persisted across multiple sensitivity analyses, with the magnitude of relative associations ranging from 4.0 to 9,” wrote the authors. “This included a sensitivity analysis that adjusted for the number of vascular risk factors and ICU admissions (OR, 4.6; 95% CI, 1.4-15.7).”

The median age of patients with COVID-19 and stroke was 69 years, and the median duration of COVID-19 symptom onset to stroke diagnosis was 16 days. Stroke symptoms were the presenting complaint in only 26% of the patients, while the remainder developing stroke while hospitalized, and more than a third (35%) of all strokes occurred in patients who were mechanically ventilated with severe COVID-19. Inpatient mortality was considerably higher among patients with COVID-19 with stroke versus without (32% vs. 14%; P = .003).

In patients with COVID-19 “most ischemic strokes occurred in older age groups, those with traditional stroke risk factors, and people of color,” wrote the authors. “We also noted that initial plasma D-dimer levels were nearly 3-fold higher in those who received a diagnosis of ischemic stroke than in those who did not” (1.930 mcg/mL vs. 0.682 mcg/mL).

The authors suggested several possible explanations for the elevated risk of stroke in COVID-19. Acute viral illnesses are known to trigger inflammation, and COVID-19 in particular is associated with “a vigorous inflammatory response accompanied by coagulopathy, with elevated D-dimer levels and the frequent presence of antiphospholipid antibodies,” they wrote. The infection is also associated with more severe respiratory syndrome compared with influenza, as well as a heightened risk for complications such as atrial arrhythmias, myocardial infarction, heart failure, myocarditis, and venous thromboses, all of which likely contribute to the risk of ischemic stroke.”
 

COVID or conventional risk factors?

Asked to comment on the study, Benedict Michael, MBChB (Hons), MRCP (Neurol), PhD, from the United Kingdom’s Coronerve Studies Group, a collaborative initiative to study the neurological features of COVID-19, said in an interview that “this study suggests many cases of stroke are occurring in older patients with multiple existing conventional and well recognized risks for stroke, and may simply represent decompensation during sepsis.”

Dr. Michael, a senior clinician scientist fellow at the University of Liverpool and an honorary consultant neurologist at the Walton Centre, was the senior author on a recently published UK-wide surveillance study on the neurological and neuropsychiatric complications of COVID-19 (Lancet Psychiatry. 2020 Jun 25. doi: 10.1016/S2215-0366[20]30287-X).

He said among patients in the New York study, “those with COVID and a stroke appeared to have many conventional risk factors for stroke (and often at higher percentages than COVID patients without a stroke), e.g. hypertension, overweight, diabetes, hyperlipidemia, existing vascular disease affecting the coronary arteries and atrial fibrillation. To establish evidence-based treatment pathways, clearly further studies are needed to determine the biological mechanisms underlying the seemingly higher rate of stroke with COVID-19 than influenza; but this must especially focus on those younger patients without conventional risk factors for stroke (which are largely not included in this study).”

SOURCE: Merkler AE et al. JAMA Neurol. doi: 10.1001/jamaneurol.2020.2730.

Patients with COVID-19 may be at increased risk of acute ischemic stroke compared with patients with influenza, according to a retrospective cohort study conducted at New York–Presbyterian Hospital and Weill Cornell Medicine, New York. “These findings suggest that clinicians should be vigilant for symptoms and signs of acute ischemic stroke in patients with COVID-19 so that time-sensitive interventions, such as thrombolysis and thrombectomy, can be instituted if possible to reduce the burden of long-term disability,” wrote Alexander E. Merkler and colleagues. Their report is in JAMA Neurology.

While several recent publications have “raised the possibility” of this link, none have had an appropriate control group, noted Dr. Merkler of the department of neurology, Weill Cornell Medicine. “Further elucidation of thrombotic mechanisms in patients with COVID-19 may yield better strategies to prevent disabling thrombotic complications like ischemic stroke,” he added.
 

An increased risk of stroke

The study included 1,916 adults with confirmed COVID-19 (median age 64 years) who were either hospitalized or visited an emergency department between March 4 and May 2, 2020. These cases were compared with a historical cohort of 1,486 patients (median age 62 years) who were hospitalized with laboratory-confirmed influenza A or B between January 1, 2016, and May 31, 2018.

Among the patients with COVID-19, a diagnosis of cerebrovascular disease during hospitalization, a brain computed tomography (CT), or brain magnetic resonance imaging (MRI) was an indication of possible ischemic stroke. These records were then independently reviewed by two board-certified attending neurologists (with a third resolving any disagreement) to adjudicate a final stroke diagnosis. In the influenza cohort, the Cornell Acute Stroke Academic Registry (CAESAR) was used to ascertain ischemic strokes.

The study identified 31 patients with stroke among the COVID-19 cohort (1.6%; 95% confidence interval, 1.1%-2.3%) and 3 in the influenza cohort (0.2%; 95% CI, 0.0%-0.6%). After adjustment for age, sex, and race, stroke risk was almost 8 times higher in the COVID-19 cohort (OR, 7.6; 95% CI, 2.3-25.2).

This association “persisted across multiple sensitivity analyses, with the magnitude of relative associations ranging from 4.0 to 9,” wrote the authors. “This included a sensitivity analysis that adjusted for the number of vascular risk factors and ICU admissions (OR, 4.6; 95% CI, 1.4-15.7).”

The median age of patients with COVID-19 and stroke was 69 years, and the median duration of COVID-19 symptom onset to stroke diagnosis was 16 days. Stroke symptoms were the presenting complaint in only 26% of the patients, while the remainder developing stroke while hospitalized, and more than a third (35%) of all strokes occurred in patients who were mechanically ventilated with severe COVID-19. Inpatient mortality was considerably higher among patients with COVID-19 with stroke versus without (32% vs. 14%; P = .003).

In patients with COVID-19 “most ischemic strokes occurred in older age groups, those with traditional stroke risk factors, and people of color,” wrote the authors. “We also noted that initial plasma D-dimer levels were nearly 3-fold higher in those who received a diagnosis of ischemic stroke than in those who did not” (1.930 mcg/mL vs. 0.682 mcg/mL).

The authors suggested several possible explanations for the elevated risk of stroke in COVID-19. Acute viral illnesses are known to trigger inflammation, and COVID-19 in particular is associated with “a vigorous inflammatory response accompanied by coagulopathy, with elevated D-dimer levels and the frequent presence of antiphospholipid antibodies,” they wrote. The infection is also associated with more severe respiratory syndrome compared with influenza, as well as a heightened risk for complications such as atrial arrhythmias, myocardial infarction, heart failure, myocarditis, and venous thromboses, all of which likely contribute to the risk of ischemic stroke.”
 

COVID or conventional risk factors?

Asked to comment on the study, Benedict Michael, MBChB (Hons), MRCP (Neurol), PhD, from the United Kingdom’s Coronerve Studies Group, a collaborative initiative to study the neurological features of COVID-19, said in an interview that “this study suggests many cases of stroke are occurring in older patients with multiple existing conventional and well recognized risks for stroke, and may simply represent decompensation during sepsis.”

Dr. Michael, a senior clinician scientist fellow at the University of Liverpool and an honorary consultant neurologist at the Walton Centre, was the senior author on a recently published UK-wide surveillance study on the neurological and neuropsychiatric complications of COVID-19 (Lancet Psychiatry. 2020 Jun 25. doi: 10.1016/S2215-0366[20]30287-X).

He said among patients in the New York study, “those with COVID and a stroke appeared to have many conventional risk factors for stroke (and often at higher percentages than COVID patients without a stroke), e.g. hypertension, overweight, diabetes, hyperlipidemia, existing vascular disease affecting the coronary arteries and atrial fibrillation. To establish evidence-based treatment pathways, clearly further studies are needed to determine the biological mechanisms underlying the seemingly higher rate of stroke with COVID-19 than influenza; but this must especially focus on those younger patients without conventional risk factors for stroke (which are largely not included in this study).”

SOURCE: Merkler AE et al. JAMA Neurol. doi: 10.1001/jamaneurol.2020.2730.

Patients with COVID-19 may be at increased risk of acute ischemic stroke compared with patients with influenza, according to a retrospective cohort study conducted at New York–Presbyterian Hospital and Weill Cornell Medicine, New York. “These findings suggest that clinicians should be vigilant for symptoms and signs of acute ischemic stroke in patients with COVID-19 so that time-sensitive interventions, such as thrombolysis and thrombectomy, can be instituted if possible to reduce the burden of long-term disability,” wrote Alexander E. Merkler and colleagues. Their report is in JAMA Neurology.

While several recent publications have “raised the possibility” of this link, none have had an appropriate control group, noted Dr. Merkler of the department of neurology, Weill Cornell Medicine. “Further elucidation of thrombotic mechanisms in patients with COVID-19 may yield better strategies to prevent disabling thrombotic complications like ischemic stroke,” he added.
 

An increased risk of stroke

The study included 1,916 adults with confirmed COVID-19 (median age 64 years) who were either hospitalized or visited an emergency department between March 4 and May 2, 2020. These cases were compared with a historical cohort of 1,486 patients (median age 62 years) who were hospitalized with laboratory-confirmed influenza A or B between January 1, 2016, and May 31, 2018.

Among the patients with COVID-19, a diagnosis of cerebrovascular disease during hospitalization, a brain computed tomography (CT), or brain magnetic resonance imaging (MRI) was an indication of possible ischemic stroke. These records were then independently reviewed by two board-certified attending neurologists (with a third resolving any disagreement) to adjudicate a final stroke diagnosis. In the influenza cohort, the Cornell Acute Stroke Academic Registry (CAESAR) was used to ascertain ischemic strokes.

The study identified 31 patients with stroke among the COVID-19 cohort (1.6%; 95% confidence interval, 1.1%-2.3%) and 3 in the influenza cohort (0.2%; 95% CI, 0.0%-0.6%). After adjustment for age, sex, and race, stroke risk was almost 8 times higher in the COVID-19 cohort (OR, 7.6; 95% CI, 2.3-25.2).

This association “persisted across multiple sensitivity analyses, with the magnitude of relative associations ranging from 4.0 to 9,” wrote the authors. “This included a sensitivity analysis that adjusted for the number of vascular risk factors and ICU admissions (OR, 4.6; 95% CI, 1.4-15.7).”

The median age of patients with COVID-19 and stroke was 69 years, and the median duration of COVID-19 symptom onset to stroke diagnosis was 16 days. Stroke symptoms were the presenting complaint in only 26% of the patients, while the remainder developing stroke while hospitalized, and more than a third (35%) of all strokes occurred in patients who were mechanically ventilated with severe COVID-19. Inpatient mortality was considerably higher among patients with COVID-19 with stroke versus without (32% vs. 14%; P = .003).

In patients with COVID-19 “most ischemic strokes occurred in older age groups, those with traditional stroke risk factors, and people of color,” wrote the authors. “We also noted that initial plasma D-dimer levels were nearly 3-fold higher in those who received a diagnosis of ischemic stroke than in those who did not” (1.930 mcg/mL vs. 0.682 mcg/mL).

The authors suggested several possible explanations for the elevated risk of stroke in COVID-19. Acute viral illnesses are known to trigger inflammation, and COVID-19 in particular is associated with “a vigorous inflammatory response accompanied by coagulopathy, with elevated D-dimer levels and the frequent presence of antiphospholipid antibodies,” they wrote. The infection is also associated with more severe respiratory syndrome compared with influenza, as well as a heightened risk for complications such as atrial arrhythmias, myocardial infarction, heart failure, myocarditis, and venous thromboses, all of which likely contribute to the risk of ischemic stroke.”
 

COVID or conventional risk factors?

Asked to comment on the study, Benedict Michael, MBChB (Hons), MRCP (Neurol), PhD, from the United Kingdom’s Coronerve Studies Group, a collaborative initiative to study the neurological features of COVID-19, said in an interview that “this study suggests many cases of stroke are occurring in older patients with multiple existing conventional and well recognized risks for stroke, and may simply represent decompensation during sepsis.”

Dr. Michael, a senior clinician scientist fellow at the University of Liverpool and an honorary consultant neurologist at the Walton Centre, was the senior author on a recently published UK-wide surveillance study on the neurological and neuropsychiatric complications of COVID-19 (Lancet Psychiatry. 2020 Jun 25. doi: 10.1016/S2215-0366[20]30287-X).

He said among patients in the New York study, “those with COVID and a stroke appeared to have many conventional risk factors for stroke (and often at higher percentages than COVID patients without a stroke), e.g. hypertension, overweight, diabetes, hyperlipidemia, existing vascular disease affecting the coronary arteries and atrial fibrillation. To establish evidence-based treatment pathways, clearly further studies are needed to determine the biological mechanisms underlying the seemingly higher rate of stroke with COVID-19 than influenza; but this must especially focus on those younger patients without conventional risk factors for stroke (which are largely not included in this study).”

SOURCE: Merkler AE et al. JAMA Neurol. doi: 10.1001/jamaneurol.2020.2730.

Lipophilic statin use is associated with reduced mortality risk in women with ovarian cancer, findings from a large observational study suggest.

The study included 10,062 patients with epithelial ovarian cancer enrolled in the Finnish national cancer registry. There were 2,621 patients who were prescribed statins between 1995 and 2015, and 80% of them used lipophilic statins.

When compared with no statin use, any statin use was associated with a 40% reduction in ovarian cancer mortality (weighted hazard ratio, 0.60), and any use of lipophilic statins was associated with a 43% reduction in ovarian cancer mortality (wHR, 0.57).

Kala Visvanathan, MD, of Johns Hopkins University in Baltimore, and colleagues reported these findings in a poster at the AACR virtual meeting II.

Reductions in ovarian cancer mortality were observed in women who took simvastatin or atorvastatin (wHRs 0.24 and 0.20, respectively), the researchers found.

Lipophilic statin use also was associated with a reduction in ovarian cancer mortality across disease subtypes, although the magnitude of reduction varied. The hazard ratios were 0.60 for high-grade serous ovarian cancer, 0.50 for endometrioid ovarian cancer, 0.20 for clear cell ovarian cancer, 0.30 for mucinous ovarian cancer, and 0.27 for borderline disease.

Survival benefits were evident both in patients who started statins prior to their ovarian cancer diagnosis and in those who started statins after diagnosis.

Never-statin users had a median age of 62 years at baseline, and ever-statin users had a median age of 67 years. The median follow-up was 3.6 years and 5.5 years, respectively.

Data from the registry were linked to prescription claims, and a series of analyses were conducted to examine the association between pre- and postdiagnostic statin use and mortality. The findings were adjusted for age at diagnosis, stage, ovarian cancer subtype, treatments, year of diagnosis, and chronic disease medications. Adherence to statins was greater than 90%.
 

Implications and next steps

The idea of using statins for the treatment of ovarian cancer is appealing because of the promising survival data as well as the broad access, low cost, and tolerability of statins, Dr. Visvanathan said in a statement. About 28% of U.S. adults over age 40 routinely take statins for cholesterol control, and statins are widely used in other countries, she said.

“Our results support research to evaluate the repurposing of therapies that are well tolerated and inexpensive in order to help reduce the global cancer burden,” Dr. Visvanathan and colleagues wrote in their poster.

“Our results provide evidence in support of the evaluation of lipophilic statins, particularly atorvastatin and/or simvastatin, for the treatment of [epithelial ovarian cancer] in conjunction with existing therapies,” the researchers wrote. They added that these statins should be “evaluated in randomized clinical trials that include correlative endpoints.”

Further, the researchers argued that “the results are biologically plausible based on known mechanisms associated with statin use and highlight the fact that statins may be effective to treat more than one disease/outcome (i.e., high cholesterol, EOC [epithelial ovarian cancer], breast cancer).”

The results of this study are intriguing, according to James Yarmolinsky, MSc, of the University of Bristol, England. Mr. Yarmolinsky is the lead author of a case-control study that showed an association between genetically proxied 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibition and lower odds of developing epithelial ovarian cancer (JAMA. 2020;323[7]:646-655).

Mr. Yarmolinsky and colleagues found that HMG-CoA reductase inhibition equivalent to a 38.7-mg/dL reduction in low-density lipoprotein cholesterol was significantly associated with lower odds of epithelial ovarian cancer in the general population (odds ratio, 0.60) and among BRCA1/2 mutation carriers (hazard ratio, 0.69). The findings raised questions about whether a similar association would be seen with medications such as statins that inhibit HMG-CoA reductase.

“These findings linking statin use to lower ovarian cancer mortality are really interesting given our own research suggesting that these drugs may also lower women’s risk of developing this disease in the first place,” Mr. Yarmolinsky said.

“The survival rate for ovarian cancer remains the lowest among all gynecological cancers in the United States, so use of these medications in either a preventive or therapeutic context could offer an important approach for reducing disease burden,” he added. “If the findings reported by Visvanathan and colleagues can be shown to replicate in other large population-based studies, testing the efficacy of statins in a randomized clinical trial could provide definitive evidence of whether these medications lower ovarian cancer mortality.”

The Department of Defense and the Breast Cancer Research Foundation funded the current study. Dr. Visvanathan and Mr. Yarmolinsky reported no disclosures.

[email protected]

SOURCE: Visvanathan K et al. AACR 2020, Abstract 5782.

Lipophilic statin use is associated with reduced mortality risk in women with ovarian cancer, findings from a large observational study suggest.

The study included 10,062 patients with epithelial ovarian cancer enrolled in the Finnish national cancer registry. There were 2,621 patients who were prescribed statins between 1995 and 2015, and 80% of them used lipophilic statins.

When compared with no statin use, any statin use was associated with a 40% reduction in ovarian cancer mortality (weighted hazard ratio, 0.60), and any use of lipophilic statins was associated with a 43% reduction in ovarian cancer mortality (wHR, 0.57).

Kala Visvanathan, MD, of Johns Hopkins University in Baltimore, and colleagues reported these findings in a poster at the AACR virtual meeting II.

Reductions in ovarian cancer mortality were observed in women who took simvastatin or atorvastatin (wHRs 0.24 and 0.20, respectively), the researchers found.

Lipophilic statin use also was associated with a reduction in ovarian cancer mortality across disease subtypes, although the magnitude of reduction varied. The hazard ratios were 0.60 for high-grade serous ovarian cancer, 0.50 for endometrioid ovarian cancer, 0.20 for clear cell ovarian cancer, 0.30 for mucinous ovarian cancer, and 0.27 for borderline disease.

Survival benefits were evident both in patients who started statins prior to their ovarian cancer diagnosis and in those who started statins after diagnosis.

Never-statin users had a median age of 62 years at baseline, and ever-statin users had a median age of 67 years. The median follow-up was 3.6 years and 5.5 years, respectively.

Data from the registry were linked to prescription claims, and a series of analyses were conducted to examine the association between pre- and postdiagnostic statin use and mortality. The findings were adjusted for age at diagnosis, stage, ovarian cancer subtype, treatments, year of diagnosis, and chronic disease medications. Adherence to statins was greater than 90%.
 

Implications and next steps

The idea of using statins for the treatment of ovarian cancer is appealing because of the promising survival data as well as the broad access, low cost, and tolerability of statins, Dr. Visvanathan said in a statement. About 28% of U.S. adults over age 40 routinely take statins for cholesterol control, and statins are widely used in other countries, she said.

“Our results support research to evaluate the repurposing of therapies that are well tolerated and inexpensive in order to help reduce the global cancer burden,” Dr. Visvanathan and colleagues wrote in their poster.

“Our results provide evidence in support of the evaluation of lipophilic statins, particularly atorvastatin and/or simvastatin, for the treatment of [epithelial ovarian cancer] in conjunction with existing therapies,” the researchers wrote. They added that these statins should be “evaluated in randomized clinical trials that include correlative endpoints.”

Further, the researchers argued that “the results are biologically plausible based on known mechanisms associated with statin use and highlight the fact that statins may be effective to treat more than one disease/outcome (i.e., high cholesterol, EOC [epithelial ovarian cancer], breast cancer).”

The results of this study are intriguing, according to James Yarmolinsky, MSc, of the University of Bristol, England. Mr. Yarmolinsky is the lead author of a case-control study that showed an association between genetically proxied 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibition and lower odds of developing epithelial ovarian cancer (JAMA. 2020;323[7]:646-655).

Mr. Yarmolinsky and colleagues found that HMG-CoA reductase inhibition equivalent to a 38.7-mg/dL reduction in low-density lipoprotein cholesterol was significantly associated with lower odds of epithelial ovarian cancer in the general population (odds ratio, 0.60) and among BRCA1/2 mutation carriers (hazard ratio, 0.69). The findings raised questions about whether a similar association would be seen with medications such as statins that inhibit HMG-CoA reductase.

“These findings linking statin use to lower ovarian cancer mortality are really interesting given our own research suggesting that these drugs may also lower women’s risk of developing this disease in the first place,” Mr. Yarmolinsky said.

“The survival rate for ovarian cancer remains the lowest among all gynecological cancers in the United States, so use of these medications in either a preventive or therapeutic context could offer an important approach for reducing disease burden,” he added. “If the findings reported by Visvanathan and colleagues can be shown to replicate in other large population-based studies, testing the efficacy of statins in a randomized clinical trial could provide definitive evidence of whether these medications lower ovarian cancer mortality.”

The Department of Defense and the Breast Cancer Research Foundation funded the current study. Dr. Visvanathan and Mr. Yarmolinsky reported no disclosures.

[email protected]

SOURCE: Visvanathan K et al. AACR 2020, Abstract 5782.

Lipophilic statin use is associated with reduced mortality risk in women with ovarian cancer, findings from a large observational study suggest.

The study included 10,062 patients with epithelial ovarian cancer enrolled in the Finnish national cancer registry. There were 2,621 patients who were prescribed statins between 1995 and 2015, and 80% of them used lipophilic statins.

When compared with no statin use, any statin use was associated with a 40% reduction in ovarian cancer mortality (weighted hazard ratio, 0.60), and any use of lipophilic statins was associated with a 43% reduction in ovarian cancer mortality (wHR, 0.57).

Kala Visvanathan, MD, of Johns Hopkins University in Baltimore, and colleagues reported these findings in a poster at the AACR virtual meeting II.

Reductions in ovarian cancer mortality were observed in women who took simvastatin or atorvastatin (wHRs 0.24 and 0.20, respectively), the researchers found.

Lipophilic statin use also was associated with a reduction in ovarian cancer mortality across disease subtypes, although the magnitude of reduction varied. The hazard ratios were 0.60 for high-grade serous ovarian cancer, 0.50 for endometrioid ovarian cancer, 0.20 for clear cell ovarian cancer, 0.30 for mucinous ovarian cancer, and 0.27 for borderline disease.

Survival benefits were evident both in patients who started statins prior to their ovarian cancer diagnosis and in those who started statins after diagnosis.

Never-statin users had a median age of 62 years at baseline, and ever-statin users had a median age of 67 years. The median follow-up was 3.6 years and 5.5 years, respectively.

Data from the registry were linked to prescription claims, and a series of analyses were conducted to examine the association between pre- and postdiagnostic statin use and mortality. The findings were adjusted for age at diagnosis, stage, ovarian cancer subtype, treatments, year of diagnosis, and chronic disease medications. Adherence to statins was greater than 90%.
 

Implications and next steps

The idea of using statins for the treatment of ovarian cancer is appealing because of the promising survival data as well as the broad access, low cost, and tolerability of statins, Dr. Visvanathan said in a statement. About 28% of U.S. adults over age 40 routinely take statins for cholesterol control, and statins are widely used in other countries, she said.

“Our results support research to evaluate the repurposing of therapies that are well tolerated and inexpensive in order to help reduce the global cancer burden,” Dr. Visvanathan and colleagues wrote in their poster.

“Our results provide evidence in support of the evaluation of lipophilic statins, particularly atorvastatin and/or simvastatin, for the treatment of [epithelial ovarian cancer] in conjunction with existing therapies,” the researchers wrote. They added that these statins should be “evaluated in randomized clinical trials that include correlative endpoints.”

Further, the researchers argued that “the results are biologically plausible based on known mechanisms associated with statin use and highlight the fact that statins may be effective to treat more than one disease/outcome (i.e., high cholesterol, EOC [epithelial ovarian cancer], breast cancer).”

The results of this study are intriguing, according to James Yarmolinsky, MSc, of the University of Bristol, England. Mr. Yarmolinsky is the lead author of a case-control study that showed an association between genetically proxied 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibition and lower odds of developing epithelial ovarian cancer (JAMA. 2020;323[7]:646-655).

Mr. Yarmolinsky and colleagues found that HMG-CoA reductase inhibition equivalent to a 38.7-mg/dL reduction in low-density lipoprotein cholesterol was significantly associated with lower odds of epithelial ovarian cancer in the general population (odds ratio, 0.60) and among BRCA1/2 mutation carriers (hazard ratio, 0.69). The findings raised questions about whether a similar association would be seen with medications such as statins that inhibit HMG-CoA reductase.

“These findings linking statin use to lower ovarian cancer mortality are really interesting given our own research suggesting that these drugs may also lower women’s risk of developing this disease in the first place,” Mr. Yarmolinsky said.

“The survival rate for ovarian cancer remains the lowest among all gynecological cancers in the United States, so use of these medications in either a preventive or therapeutic context could offer an important approach for reducing disease burden,” he added. “If the findings reported by Visvanathan and colleagues can be shown to replicate in other large population-based studies, testing the efficacy of statins in a randomized clinical trial could provide definitive evidence of whether these medications lower ovarian cancer mortality.”

The Department of Defense and the Breast Cancer Research Foundation funded the current study. Dr. Visvanathan and Mr. Yarmolinsky reported no disclosures.

[email protected]

SOURCE: Visvanathan K et al. AACR 2020, Abstract 5782.

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.

That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.

When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.

Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.

“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.

When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
 

Much depends on the future of telehealth

Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.

COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.

Several things need to happen to change the outlook for outpatient care, he said.

A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.

If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.

“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.

In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.

However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.

Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
 

Visit trends still down

Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.

Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”

They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.

Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.

“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.

It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
 

Telemedicine rates dropping

Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.

He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”

Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.

He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”

Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.

Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”

For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”

Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.

A version of this article originally on Medscape.com.

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.

That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.

When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.

Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.

“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.

When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
 

Much depends on the future of telehealth

Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.

COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.

Several things need to happen to change the outlook for outpatient care, he said.

A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.

If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.

“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.

In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.

However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.

Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
 

Visit trends still down

Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.

Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”

They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.

Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.

“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.

It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
 

Telemedicine rates dropping

Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.

He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”

Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.

He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”

Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.

Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”

For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”

Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.

A version of this article originally on Medscape.com.

Primary care practices stand to lose almost $68,000 per full-time physician this year as COVID-19 causes care delays and cancellations, researchers estimate. And while some outpatient care has started to rebound to near baseline appointment levels, other ambulatory specialties remain dramatically down from prepandemic rates.

For primary care practices, Sanjay Basu, MD, and colleagues calculated the losses at $67,774 in gross revenue per physician (interquartile range, $80,577-$54,990), with a national toll of $15.1 billion this year.

That’s without a potential second wave of COVID-19, noted Dr. Basu, director of research and population health at Collective Health in San Francisco, and colleagues.

When they added a theoretical stay-at-home order for November and December, the estimated loss climbed to $85,666 in gross revenue per full-time physician, with a loss of $19.1 billion nationally. The findings were published online in Health Affairs.

Meanwhile, clinical losses from canceled outpatient care are piling up as well, according to a study by Ateev Mehrotra, MD, associate professor of health care policy and medicine at Harvard Medical School in Boston, and colleagues, which calculated the clinical losses in outpatient care.

“The ‘cumulative deficit’ in visits over the last 3 months (March 15 to June 20) is nearly 40%,” the authors wrote. They reported their findings in an article published online June 25 by the Commonwealth Fund.

When examined by specialty, Dr. Mehrotra and colleagues found that appointment rebound rates have been uneven. Whereas dermatology and rheumatology visits have already recovered, a couple of specialties have cumulative deficits that are particularly concerning. For example, pediatric visits were down by 47% in the 3 months since March 15 and pulmonology visits were down 45% in that time.
 

Much depends on the future of telehealth

Closing the financial and care gaps will depend largely on changing payment models for outpatient care and assuring adequate and enduring reimbursement for telehealth, according to experts.

COVID-19 has put a spotlight on the fragility of a fee-for-service system that depends on in-person visits for stability, Daniel Horn, MD, director of population health and quality at Massachusetts General Hospital in Boston, said in an interview.

Several things need to happen to change the outlook for outpatient care, he said.

A need mentioned in both studies is that the COVID-19 waivers that make it possible for telehealth visits to be reimbursed like other visits must continue after the pandemic. Those assurances are critical as practices decide whether to invest in telemedicine.

If U.S. practices revert as of Oct. 1, 2020, to the pre–COVID-19 payment system for telehealth, national losses for the year would be more than double the current estimates.

“Given the number of active primary care physicians (n = 223,125), we estimated that the cost would be $38.7 billion (IQR, $31.1 billion-$48.3 billion) at a national level to neutralize the gross revenue losses caused by COVID-19 among primary care practices, without subjecting staff to furloughs,” Dr. Basu and colleagues wrote.

In addition to stabilizing telehealth payment models, another need to improve the outlook for outpatient care is more effective communication that in-person care is safe again in regions with protocols in place, Dr. Horn said.

However, the most important change, Dr. Horn said, is a switch to prospective lump-sum payments – payments made in advance to physicians to treat each patient in the way they and the patient deem best with the most appropriate appointment type – whether by in-person visit, phone call, text reminders, or video session.

Prospective payments would take multipayer coalitions working in conjunction with leadership on the federal level from the Centers for Medicare & Medicaid Services, Dr. Horn said. Commercial payers and states (through Medicaid funds) should already have that money available with the cancellations of nonessential procedures, he said.

“We expect ongoing turbulent times, so having a prospective payment could unleash the capacity for primary care practices to be creative in the way they care for their patients,” Dr. Horn said.
 

Visit trends still down

Calculations by Dr. Basu, who is also on the faculty at Harvard Medical School’s Center for Primary Care, and colleagues were partially informed by Dr. Mehrotra’s data on how many visits have been lost because of COVID-19.

Dr. Mehrotra said a clear message in their study is that “visit trends are not back to baseline.”

They found that the number of visits to ambulatory practices had dropped nearly 60% by early April. Since then, numbers have rebounded substantially. As of the week of June 14, overall visits, compared with baseline were down 11%. But the drops varied widely across specialties.

Dr. Mehrotra said he found particularly disturbing the drop in pediatric visits and the sharp contrast between those rates and the higher number of visits for adults. While visits for patients aged 75 and older had climbed back to just 3% below baseline, the drop seen among kids aged 3-5 years remains 43% below baseline.

“Even kids 0-2 years old are still down 30% from baseline,” he pointed out.

It’s possible that kids are getting care from other sources or perhaps are not sick as often because they are not in school. However, he added, “I do think there’s a concern that some kids are not getting the care they need for chronic illnesses such as attention deficit hyperactivity disorder, asthma, eczema, and psoriasis, and vaccination rates have fallen.”
 

Telemedicine rates dropping

Telemedicine was “supposed to have its shining moment,” Dr. Mehrotra said, but trends show it cannot make up the gaps of in-person care. His team’s data show a decline in telemedicine as a percentage of all visits from a high of 13.8% in mid-April to 7.4% the week of June 14.

He attributes that partially to physicians’ mixed success in getting reimbursed. “While Medicare has done a good job reimbursing, commercial payers and Medicaid plans have been mixed in their coverage.”

Some physicians who don’t get reimbursed or receive delayed or reduced payments are going back to in-person visits, Dr. Mehrotra said.

He said it’s important to remember that, before the pandemic, “telemedicine was making up 0.1% of all visits. Even if now it declines (from the April high of 13.8%) to 5% or 3%, that’s still a 30-fold increase within the course of a couple of months.”

Prospective payments would help expand the possibilities for telemedicine, he said, and could include apps and wearables and texts in addition to or instead of traditional video sessions.

Dr. Mehrotra said change won’t come fast enough for some and many practices won’t survive. “People are worried about their livelihood. This is nothing we’ve ever – at least in my career as a physician – had to focus on. Now we’re really having practices ask whether they can financially sustain themselves.”

For many, he said, the damage will be long term. “That cumulative deficit in visits – I’m not sure if it’s ever coming back. If you’re a primary care practice, you can only work so hard.”

Dr. Basu reported receiving a salary for clinical duties from HealthRIGHT360, a Federally Qualified Health Center, and Collective Health, a care management organization. Dr. Horn and Dr. Mehrotra reported no relevant financial relationships.

A version of this article originally on Medscape.com.

Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.

Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.

The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.

This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.

In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.

“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.

The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”

Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.

Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.

The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.

Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.

The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.

According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).

“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.

However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.

The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
 

Stemming the shortages

The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.

“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.

He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.

However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.

Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.

Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”

The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.

Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.

She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.

Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.

Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.

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

Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.

Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.

The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.

This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.

In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.

“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.

The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”

Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.

Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.

The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.

Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.

The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.

According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).

“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.

However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.

The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
 

Stemming the shortages

The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.

“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.

He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.

However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.

Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.

Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”

The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.

Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.

She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.

Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.

Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.

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

Fifteen-year projections for the shortage of primary care and specialty physicians in the United States grew to between 54,000 and 139,000 in the latest annual report by the Association of American Medical Colleges.

Those estimates are up from last year’s projections of a shortfall of 46,900-121,900 by 2032.

The Complexities of Physician Supply and Demand: Projections from 2018 to 2033, was the sixth annual study conducted for the AAMC by the Life Science division of global analytics firm IHS Markit.

This analysis, conducted in 2019, includes supply and demand scenarios but predates the COVID-19 pandemic.

In a telephone press briefing this morning, David J. Skorton, MD, AAMC’s president and CEO, told reporters that the pandemic has highlighted the acute effects of physician shortages.

“We’ve seen in stark detail how fragile and quickly overwhelmed America’s health care system truly is, and we’re nowhere near out of the woods with this public health emergency yet,” he said.

The persistent shortages mean people “will have ongoing difficulty accessing the care that they need, especially as we all age.”

Some of the biggest shortages will be seen in non–primary care specialists. Dr. Skorton notes that, during the pandemic, shortages of specialists in hospital settings, including critical care, emergency medicine, pulmonology, and infectious disease, are an urgent concern.

Population trends continue to be the biggest drivers of the shortage. Report authors found that by 2033, the U.S. population is expected to grow by 10.4% from 327 million to 361 million, with wide differences by age.

The under-18 population is expected to grow by 3.9%, whereas the numbers of those aged 65 and older is expected to balloon by 45.1% in that time, thus stoking demand for specialties focused on care for older Americans.

Physician age is also a large factor in the projections. More than two in five currently active physicians will be 65 or older in the next 10 years, according to the report. A wave of retirements will have a large impact on the supply of physicians.

The report explains that the projected shortages remain under predictable scenarios: an increase in the use of advanced practice nurses (APRNs) and physician assistants (PAs), more care in alternate settings such as retail clinics, and changes in payment and delivery.

According to the report, the supply of APRNs and PAs is on track to double over the next 15 years (with growth rates varying by APRN and PA specialty).

“At current rates of production, by 2033 APRN supply will grow by 276,000 [full-time equivalents (FTEs)] and PA supply by nearly 138,000 FTEs,” the report states.

However, authors acknowledge there is scant evidence on what effect these numbers will have on demand for physicians.

The report points out that if underserved communities were able to access health care in numbers similar to those without barriers imposed by where they live or what insurance they have, demand could rise beyond the projections in this report by an additional 74,000 to 145,000 physicians.
 

Stemming the shortages

The first step in addressing the shortage, Dr. Skorton said, is assuring a healthy physician pipeline to meet the demand for generations.

“One essential step that we believe Congress must take is to end the freeze that has been in place since 1997 that limits federal support for residency training of new physicians,” Skorton said.

He noted that AAMC supports the bipartisan Resident Physician Shortage Reduction Act, introduced to Congress in 2019, which calls for an increase in Medicare support for 3000 new residency positions each year over the next 5 years.

However, additional steps are needed, including enabling advanced practice providers to play a greater role in increasing the health care workforce, Dr. Skorton said.

Pointing out some of the effects of physician shortages, Janis M. Orlowski, MD, chief health care officer for the AAMC, noted that high rates of maternal morbidity are partially linked to lack of adequate numbers of physicians in the United States, and a lack of behavioral health specialists has exacerbated effects of the opioid epidemic.

Shortages are already evident in the current pandemic, she added, saying, “Today we see governors calling for retired physicians or physicians from other states to come and help battle the pandemic within their states.”

The report explains that long-term effects on physician numbers from the pandemic likely will include workforce exits because of COVID-19 deaths, early retirements from burnout, or a shift in interest in certain specialties.

Karen Fisher, JD, chief public policy officer for AAMC, said telehealth will also play an important role in bridging gaps in access to care, and its importance has already been seen in this first wave of the pandemic.

She noted that temporary federal waivers have made it easier for those enrolled in Medicare, Medicaid, and the Children’s Health Insurance Program to receive telehealth services during the pandemic.

Expanding the access to telehealth permanently will be important in helping to fill gaps, Ms. Fisher said.

Dr. Skorton, Dr. Orlowski, and Ms. Fisher have disclosed no relevant financial relationships.

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

New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.

In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.

For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.

The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.

“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.

All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.

Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.

The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.

“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.

The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”

Important Differences From Kawasaki Disease

In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).

Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.

The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.

In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.

Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.

Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”

As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.

Questions Remain

With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.

“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.

“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”

Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.

“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”

Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:

• Why do some children get MIS-C and not others?
• What is the long-term outcome of children with MIS-C?
• How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
• Does MIS-C occur in young adults?

Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.

On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”

Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.

This article first appeared on Medscape.com.

New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.

In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.

For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.

The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.

“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.

All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.

Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.

The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.

“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.

The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”

Important Differences From Kawasaki Disease

In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).

Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.

The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.

In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.

Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.

Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”

As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.

Questions Remain

With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.

“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.

“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”

Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.

“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”

Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:

• Why do some children get MIS-C and not others?
• What is the long-term outcome of children with MIS-C?
• How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
• Does MIS-C occur in young adults?

Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.

On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”

Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.

This article first appeared on Medscape.com.

New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.

In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.

For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.

The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.

“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.

All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.

Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.

The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.

“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.

The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”

Important Differences From Kawasaki Disease

In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).

Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.

The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.

In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.

Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.

Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”

As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.

Questions Remain

With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.

“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.

“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”

Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.

“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”

Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:

• Why do some children get MIS-C and not others?
• What is the long-term outcome of children with MIS-C?
• How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
• Does MIS-C occur in young adults?

Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.

On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”

Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.

This article first appeared on Medscape.com.