Clinical Endocrinology News

The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.

The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.

The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.

The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.

The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.

“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.

“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.

As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.

The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.

The FDA emphasizes that an EUA is not a full FDA approval.

In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.

“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.

The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.

The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.

The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.

The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.

“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.

“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.

As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.

The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.

The FDA emphasizes that an EUA is not a full FDA approval.

In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.

“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
 

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) Nov. 19 issued an emergency use authorization (EUA) for the Janus kinase inhibitor baricitinib (Olumiant, Eli Lilly) in combination with remdesivir (Veklury, Gilead) for treating hospitalized adults and children at least 2 years old with suspected or confirmed COVID-19.

The combination treatment is meant for patients who need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Baricitinib/remdesivir was shown in a clinical trial to reduce time to recovery within 29 days of starting the treatment compared with a control group who received placebo/remdesivir, according to the FDA press release.

The median time to recovery from COVID-19 was 7 days for the combination group vs. 8 days for those in the placebo/remdesivir group. Recovery was defined as either discharge from the hospital or “being hospitalized but not requiring supplemental oxygen and no longer requiring ongoing medical care,” the agency explained in the press release.

The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo/remdesivir, the press release said without providing specific data. “For all of these endpoints, the effects were statistically significant,” the agency stated.

The safety and efficacy continues to be evaluated. Baricitinib alone is not approved as a treatment for COVID-19.

“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research.

“Despite advances in the management of COVID-19 infection since the onset of the pandemic, we need more therapies to accelerate recovery and additional clinical research will be essential to identifying therapies that slow disease progression and lower mortality in the sicker patients,” she said.

As a JAK inhibitor, baricitinib interferes with a pathway that leads to inflammation. Baricitinib is already prescribed as an oral medication and is FDA-approved for treating moderate to severe rheumatoid arthritis.

The data supporting the EUA for the combination treatment are based on a randomized, double-blind, placebo-controlled clinical trial (ACTT-2), conducted by the National Institute of Allergy and Infectious Diseases (NIAID).

The trial followed patients for 29 days and included 1,033 patients with moderate to severe COVID-19; 515 patients received baricitinib/remdesivir, and 518 patients received placebo/remdesivir.

The FDA emphasizes that an EUA is not a full FDA approval.

In reviewing the combination, the FDA “determined that it is reasonable to believe that baricitinib, in combination with remdesivir, may be effective in treating COVID-19 for the authorized population” and the known benefits outweigh the known and potential risks. Additionally, there are no adequate, approved, and available alternatives for the treatment population.

“Today’s action demonstrates the FDA’s steadfast efforts to make potential COVID-19 treatments available in a timely manner, where appropriate, while continuing to support research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, MD. “As part of our Coronavirus Treatment Acceleration Program, the FDA continues to use every possible avenue to facilitate new treatments for patients as quickly as possible to combat COVID-19.”
 

This article first appeared on Medscape.com.

Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.

Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.

Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.

The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.

InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.

Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”

Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”

Smart pens: How large is the market?

Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.

She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.

Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”

But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”

Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.

Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”

As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”

In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
 

Emerging field: “I think they’re here to stay”

The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.

The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.

Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.

Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.

For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.

Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.

Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.

“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”

Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
 

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

Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.

Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.

Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.

The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.

InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.

Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”

Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”

Smart pens: How large is the market?

Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.

She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.

Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”

But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”

Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.

Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”

As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”

In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
 

Emerging field: “I think they’re here to stay”

The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.

The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.

Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.

Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.

For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.

Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.

Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.

“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”

Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
 

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

Medtronic’s launch of a new version of its smart insulin pen with integrated continuous glucose monitoring (CGM) is the first such device for use by people with diabetes who use multiple daily injections (MDI) of insulin.

Initially launched by Companion Medical in 2017, the InPen system is a reusable insulin injector pen combined with a smartphone app that provides insulin dose calculation information and tracking.

Medtronic acquired Companion in September 2020 and now the new version, the InPen with Real-Time Guardian Connect CGM Data, allows users to view glucose readings and insulin dose information in the same app.

The InPen, a so-called “connected delivery device,” also provides reports that aggregate insulin, glucose, and carbohydrate information into graphical displays. As with other current CGM systems, the information can be sent wirelessly to a clinician. And as with insulin pumps, the pens are programmed with target blood glucose levels, insulin-to-carb ratios, and insulin sensitivity parameters. The device tracks “insulin on board” and delivers reminders for basal and bolus doses.

InPen delivers only short-acting insulin from cartridges, all the three major brands. Patients who need long-acting insulin still need to inject that separately.

Barry H. Ginsberg, MD, PhD, of Diabetes Technology Consultants, Arlington, Va., said in an interview, “People using pumps have had data integration for a while now. This is an excellent first step in data integration for people doing MDI and I am sure it will improve blood glucose control.”

Asked about comparative costs, Medtronic spokeswoman Pamela Reese said in an interview, “While insurance costs will vary, the smart pen is less expensive than the insulin pump.”

Smart pens: How large is the market?

Speaking on Nov. 14 at the Diabetes Technology Society conference, diabetes care and education specialist Hope Warshaw, RD, gave an overview of the current smart pen/connected delivery device landscape.

She noted that the patient population who might benefit from smart pens, those using MDI, which is defined as injecting both long-acting insulin and short-acting insulin before meals, may be larger than appreciated. There are about 1.6 million U.S. patients with type 1 diabetes, of whom just 30%-40% currently use insulin pumps. In addition, of the 5.8 million with type 2 diabetes who take insulin, about 29%, or 1.7 million, use MDI.

Among those with type 1 diabetes, she said that smart pens might be a good option for “people who don’t want to wear the physical pump. They can deal with the sensor, but for psychological reasons or they have dermatologic issues, they just can’t wear a pump.”

But, Ms. Warshaw stressed, the type 2 diabetes population shouldn’t be overlooked. “More and more people with type 2 diabetes are on MDI. ... In fact, there are more who use MDI than the entire population with type 1 diabetes. ... This is happening because people with type 2 are getting it earlier and living longer.”

Dr. Ginsberg views smart pens as a bridge between simple pen injectors to automated insulin delivery (AID) systems, those that link insulin pumps with CGMs.

Regarding patients with type 1 diabetes, he said, “I see pen users on MDI slowly moving to integrated systems and then, when comfortable with the technology, moving to AID, finances allowing.”

As for those with type 2 diabetes, he said that they “are less computer literate and less likely to move to integrated systems, but they will, over time.”

In all, Dr. Ginsberg said, “I see integrated pens as increasing, not decreasing, the AID market.”
 

Emerging field: “I think they’re here to stay”

The new Medtronic InPen system can still display information from other compatible CGM systems, but on a 3-hour delay. This is important since the Guardian is not currently approved for determining insulin doses. In order to do that, users must still either use readings from another CGM system on a separate app or perform fingerstick blood glucose measurements.

The InPen is the first CGM-integrated pen device but is not likely to be the last. Similar technologies are being pursued by all three of the major insulin manufacturers and some other companies.

Eli Lilly’s Humalog Tempo Pen, a modified version of KwikPen, is integrated with the Dexcom CGM. The pen itself has been cleared by the U.S. Food and Drug Administration, but some of the component parts await authorization.

Novo Nordisk is expected to file with the FDA in 2021 for its NovoPen Echo Plus.

For its part, in December 2019, Sanofi teamed up with Bioport to fit its SoloStar insulin pens with their technology called Mallya, which had received CE Mark in June 2019. That device, which clips onto the top and the button of most major pens, adds smart pen capacity via Bluetooth. BioCorp also has teamed up with other manufacturers including Roche and AgaMatrix.

Another major player, Bigfoot Biomedical, has filed with the FDA for its connected pen that works with the Abbott FreeStyle Libre 2 CGM.

Ms. Warshaw advised, “We need to start talking more about the ways that peoples’ wants, needs, and desires change and evolve over the person’s life as their diabetes evolves and as all this technology evolves.

“Time will tell how many people will be on the very expensive [AID] systems. ... Pens are cheaper. The main cost is insulin. I think they’re here to stay. The big insulin makers wouldn’t be doing it otherwise.”

Dr. Ginsberg has no disclosures. Ms. Warshaw is a consultant and writer for Companion Medical/Medtronic and a faculty member of LifeScan Diabetes Institute.
 

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

The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes.

The Lucira COVID-19 All-In-One Test-Kit is a single-use test that has a nasal swab to collect samples for people ages 14 and older. It’s available only by prescription, which can be given by a doctor who suspects a patient may have contracted the coronavirus.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn, MD, said in the statement.

The test kit can also be used in doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.

After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA. Within 30 minutes, the results appear on the unit’s light-up display. People who receive a positive result should self-isolate and seek care from their doctor. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn’t necessarily mean they don’t have the coronavirus.

Testing is still a key part of controlling the spread of the coronavirus, Reuters reports. The United States surpassed 11 million infections Sunday, only 8 days after passing 10 million cases.

With the at-home testing kit, public health officials still need to track and monitor results. As part of the emergency use authorization, the FDA requires doctors who prescribe the tests to report all results to public health authorities based on local, state, and federal requirements. Lucira Health, the test maker, also created box labeling and instructions to help doctors to report results.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

This article first appeared on WebMD.com.

The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes.

The Lucira COVID-19 All-In-One Test-Kit is a single-use test that has a nasal swab to collect samples for people ages 14 and older. It’s available only by prescription, which can be given by a doctor who suspects a patient may have contracted the coronavirus.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn, MD, said in the statement.

The test kit can also be used in doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.

After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA. Within 30 minutes, the results appear on the unit’s light-up display. People who receive a positive result should self-isolate and seek care from their doctor. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn’t necessarily mean they don’t have the coronavirus.

Testing is still a key part of controlling the spread of the coronavirus, Reuters reports. The United States surpassed 11 million infections Sunday, only 8 days after passing 10 million cases.

With the at-home testing kit, public health officials still need to track and monitor results. As part of the emergency use authorization, the FDA requires doctors who prescribe the tests to report all results to public health authorities based on local, state, and federal requirements. Lucira Health, the test maker, also created box labeling and instructions to help doctors to report results.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

This article first appeared on WebMD.com.

The FDA issued an emergency use authorization Tuesday for the first self-testing COVID-19 kit to use at home, which provides results in about 30 minutes.

The Lucira COVID-19 All-In-One Test-Kit is a single-use test that has a nasal swab to collect samples for people ages 14 and older. It’s available only by prescription, which can be given by a doctor who suspects a patient may have contracted the coronavirus.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn, MD, said in the statement.

The test kit can also be used in doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages, but samples must be collected by a health care professional if the patient is under age 14.

After using the nasal swab, the test works by swirling the sample in a vial and then placing it in the provided test unit, according to the FDA. Within 30 minutes, the results appear on the unit’s light-up display. People who receive a positive result should self-isolate and seek care from their doctor. Those who test negative but have COVID-like symptoms should follow up with their doctor, since a negative result doesn’t necessarily mean they don’t have the coronavirus.

Testing is still a key part of controlling the spread of the coronavirus, Reuters reports. The United States surpassed 11 million infections Sunday, only 8 days after passing 10 million cases.

With the at-home testing kit, public health officials still need to track and monitor results. As part of the emergency use authorization, the FDA requires doctors who prescribe the tests to report all results to public health authorities based on local, state, and federal requirements. Lucira Health, the test maker, also created box labeling and instructions to help doctors to report results.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in the statement.

This article first appeared on WebMD.com.

Researchers are testing whether a probiotic called Lactobacillus rhamnosus GG can prevent COVID-19 in household contacts of COVID patients.

On the Nov. 12 episode of the Blood & Cancer podcast, Anthony D. Sung, MD, of Duke University, Durham, N.C., joined host David H. Henry, MD, of Penn Medicine in Philadelphia, to discuss the trial of LGG as well as other research. The following transcript of that discussion has been edited for length and clarity.
 

David Henry, MD: Here we are in COVID. We’re recording this the first week in November. Sadly, cases are spiking in the country. And I understand you’ve got some information that you might share about how manipulating ... the microbiome that we all exist with inside our gut might somehow play into doing better or worse with COVID.

Anthony Sung, MD: Absolutely. So, as associate director of the Duke Microbiome Center, I was approached by one of my colleagues, Paul Wischmeyer, who is a professor of anesthesiology and critical care medicine at Duke. Paul had previously done some very nice murine studies with the probiotic Lactobacillus rhamnosus GG, or LGG.

He showed, in a murine model of pseudomonas pneumonia, that giving LGG to mice would help modulate their microbiome and, in turn, their immune system, leading to decreased inflammation, decreased TNF-alpha, IL [interleukin]-2, and IL-6, [and] increased Treg cells [Clin Nutr. 2017;36[6]:1549-57]. This also helped prevent lung injury, and it actually significantly improved survival in mice receiving LGG [Shock. 2013;40[6]:496-503].

In addition, there has been a randomized clinical trial of LGG showing that its administration would help prevent ventilator-associated pneumonia, or VAP [Am J Respir Crit Care Med. 2010 Oct 15;182[8]:1058-64].

And a few years ago, there was another RCT [randomized, controlled trial], published in Nature, showing that another Lactobacillus product significantly decreased the combined endpoint of sepsis and mortality, primarily by reducing lower respiratory tract infection [Nature. 2017 Aug 24;548[7668]:407-12].
 

Dr. Henry: And how is that working? What is the bacillus doing to help us?

Dr. Sung: We think it’s through modulating the immune system. As mentioned in Paul’s studies, we saw significantly decreased amounts of TNF-alpha, IL-2, and IL-6, which are the same cytokines that have been implicated in COVID-19 and associated with increased lung injury in patients during this pandemic.

And we believe that by giving individuals this probiotic, LGG, we may help modulate the immune system, decrease lung injury and symptoms, and maybe even prevent COVID-19.

So with support from the Duke Microbiome Center, as well as private donations and philanthropy, we are conducting a randomized clinical trial of LGG to prevent COVID-19 in household contacts who’ve been exposed to the disease. In other words, if someone in the house gets COVID-19, we want to try to prophylax everybody else living in that house and prevent them from coming down with the same infection.
 

Dr. Henry: And this is an oral administration?

Dr. Sung: Correct. This is an oral pill, two pills once a day.

Dr. Henry: And it’s an ongoing study, of course, in COVID right now?

Dr. Sung: Correct. So we have an IND [investigational new drug application] from the FDA [Food and Drug Administration], and we are actively recruiting subjects both at Duke University, but also due to the unique study design, we can enroll patients anywhere across the country. Because of the importance of social distancing, everything is done remotely.

So a household contact can hear about us, either through your podcast or one of our Facebook ads or through other media. They can reach out to our study website, which is https://sites.duke.edu/protectehc, or reach out to us at our study email, protect-ehc@duke.edu.

And we can go ahead and screen them for eligibility in our trial. And if they are eligible and they consent to participate, we will mail them a package basically overnight, FedEx, containing either LGG or placebo, as well as kits so that they can self-collect their stool and nasal swabs so we can test it for SARS-CoV-2 by PCR [polymerase chain reaction] and look at the microbiome.

Dr. Sung and Dr. Henry have no relevant disclosures. Funding for the trial is provided by the Duke Microbiome Center and philanthropic giving. The LGG and placebo used in the trial are provided by DSM.

Researchers are testing whether a probiotic called Lactobacillus rhamnosus GG can prevent COVID-19 in household contacts of COVID patients.

On the Nov. 12 episode of the Blood & Cancer podcast, Anthony D. Sung, MD, of Duke University, Durham, N.C., joined host David H. Henry, MD, of Penn Medicine in Philadelphia, to discuss the trial of LGG as well as other research. The following transcript of that discussion has been edited for length and clarity.
 

David Henry, MD: Here we are in COVID. We’re recording this the first week in November. Sadly, cases are spiking in the country. And I understand you’ve got some information that you might share about how manipulating ... the microbiome that we all exist with inside our gut might somehow play into doing better or worse with COVID.

Anthony Sung, MD: Absolutely. So, as associate director of the Duke Microbiome Center, I was approached by one of my colleagues, Paul Wischmeyer, who is a professor of anesthesiology and critical care medicine at Duke. Paul had previously done some very nice murine studies with the probiotic Lactobacillus rhamnosus GG, or LGG.

He showed, in a murine model of pseudomonas pneumonia, that giving LGG to mice would help modulate their microbiome and, in turn, their immune system, leading to decreased inflammation, decreased TNF-alpha, IL [interleukin]-2, and IL-6, [and] increased Treg cells [Clin Nutr. 2017;36[6]:1549-57]. This also helped prevent lung injury, and it actually significantly improved survival in mice receiving LGG [Shock. 2013;40[6]:496-503].

In addition, there has been a randomized clinical trial of LGG showing that its administration would help prevent ventilator-associated pneumonia, or VAP [Am J Respir Crit Care Med. 2010 Oct 15;182[8]:1058-64].

And a few years ago, there was another RCT [randomized, controlled trial], published in Nature, showing that another Lactobacillus product significantly decreased the combined endpoint of sepsis and mortality, primarily by reducing lower respiratory tract infection [Nature. 2017 Aug 24;548[7668]:407-12].
 

Dr. Henry: And how is that working? What is the bacillus doing to help us?

Dr. Sung: We think it’s through modulating the immune system. As mentioned in Paul’s studies, we saw significantly decreased amounts of TNF-alpha, IL-2, and IL-6, which are the same cytokines that have been implicated in COVID-19 and associated with increased lung injury in patients during this pandemic.

And we believe that by giving individuals this probiotic, LGG, we may help modulate the immune system, decrease lung injury and symptoms, and maybe even prevent COVID-19.

So with support from the Duke Microbiome Center, as well as private donations and philanthropy, we are conducting a randomized clinical trial of LGG to prevent COVID-19 in household contacts who’ve been exposed to the disease. In other words, if someone in the house gets COVID-19, we want to try to prophylax everybody else living in that house and prevent them from coming down with the same infection.
 

Dr. Henry: And this is an oral administration?

Dr. Sung: Correct. This is an oral pill, two pills once a day.

Dr. Henry: And it’s an ongoing study, of course, in COVID right now?

Dr. Sung: Correct. So we have an IND [investigational new drug application] from the FDA [Food and Drug Administration], and we are actively recruiting subjects both at Duke University, but also due to the unique study design, we can enroll patients anywhere across the country. Because of the importance of social distancing, everything is done remotely.

So a household contact can hear about us, either through your podcast or one of our Facebook ads or through other media. They can reach out to our study website, which is https://sites.duke.edu/protectehc, or reach out to us at our study email, protect-ehc@duke.edu.

And we can go ahead and screen them for eligibility in our trial. And if they are eligible and they consent to participate, we will mail them a package basically overnight, FedEx, containing either LGG or placebo, as well as kits so that they can self-collect their stool and nasal swabs so we can test it for SARS-CoV-2 by PCR [polymerase chain reaction] and look at the microbiome.

Dr. Sung and Dr. Henry have no relevant disclosures. Funding for the trial is provided by the Duke Microbiome Center and philanthropic giving. The LGG and placebo used in the trial are provided by DSM.

Researchers are testing whether a probiotic called Lactobacillus rhamnosus GG can prevent COVID-19 in household contacts of COVID patients.

On the Nov. 12 episode of the Blood & Cancer podcast, Anthony D. Sung, MD, of Duke University, Durham, N.C., joined host David H. Henry, MD, of Penn Medicine in Philadelphia, to discuss the trial of LGG as well as other research. The following transcript of that discussion has been edited for length and clarity.
 

David Henry, MD: Here we are in COVID. We’re recording this the first week in November. Sadly, cases are spiking in the country. And I understand you’ve got some information that you might share about how manipulating ... the microbiome that we all exist with inside our gut might somehow play into doing better or worse with COVID.

Anthony Sung, MD: Absolutely. So, as associate director of the Duke Microbiome Center, I was approached by one of my colleagues, Paul Wischmeyer, who is a professor of anesthesiology and critical care medicine at Duke. Paul had previously done some very nice murine studies with the probiotic Lactobacillus rhamnosus GG, or LGG.

He showed, in a murine model of pseudomonas pneumonia, that giving LGG to mice would help modulate their microbiome and, in turn, their immune system, leading to decreased inflammation, decreased TNF-alpha, IL [interleukin]-2, and IL-6, [and] increased Treg cells [Clin Nutr. 2017;36[6]:1549-57]. This also helped prevent lung injury, and it actually significantly improved survival in mice receiving LGG [Shock. 2013;40[6]:496-503].

In addition, there has been a randomized clinical trial of LGG showing that its administration would help prevent ventilator-associated pneumonia, or VAP [Am J Respir Crit Care Med. 2010 Oct 15;182[8]:1058-64].

And a few years ago, there was another RCT [randomized, controlled trial], published in Nature, showing that another Lactobacillus product significantly decreased the combined endpoint of sepsis and mortality, primarily by reducing lower respiratory tract infection [Nature. 2017 Aug 24;548[7668]:407-12].
 

Dr. Henry: And how is that working? What is the bacillus doing to help us?

Dr. Sung: We think it’s through modulating the immune system. As mentioned in Paul’s studies, we saw significantly decreased amounts of TNF-alpha, IL-2, and IL-6, which are the same cytokines that have been implicated in COVID-19 and associated with increased lung injury in patients during this pandemic.

And we believe that by giving individuals this probiotic, LGG, we may help modulate the immune system, decrease lung injury and symptoms, and maybe even prevent COVID-19.

So with support from the Duke Microbiome Center, as well as private donations and philanthropy, we are conducting a randomized clinical trial of LGG to prevent COVID-19 in household contacts who’ve been exposed to the disease. In other words, if someone in the house gets COVID-19, we want to try to prophylax everybody else living in that house and prevent them from coming down with the same infection.
 

Dr. Henry: And this is an oral administration?

Dr. Sung: Correct. This is an oral pill, two pills once a day.

Dr. Henry: And it’s an ongoing study, of course, in COVID right now?

Dr. Sung: Correct. So we have an IND [investigational new drug application] from the FDA [Food and Drug Administration], and we are actively recruiting subjects both at Duke University, but also due to the unique study design, we can enroll patients anywhere across the country. Because of the importance of social distancing, everything is done remotely.

So a household contact can hear about us, either through your podcast or one of our Facebook ads or through other media. They can reach out to our study website, which is https://sites.duke.edu/protectehc, or reach out to us at our study email, protect-ehc@duke.edu.

And we can go ahead and screen them for eligibility in our trial. And if they are eligible and they consent to participate, we will mail them a package basically overnight, FedEx, containing either LGG or placebo, as well as kits so that they can self-collect their stool and nasal swabs so we can test it for SARS-CoV-2 by PCR [polymerase chain reaction] and look at the microbiome.

Dr. Sung and Dr. Henry have no relevant disclosures. Funding for the trial is provided by the Duke Microbiome Center and philanthropic giving. The LGG and placebo used in the trial are provided by DSM.

After initial promising interim results on Nov. 9, Pfizer and BioNTech today announced that their mRNA vaccine, in development to prevent COVID-19, is 95% effective.

Final analysis of the randomized, phase 3 study of more than 43,000 people yielded 170 confirmed cases of COVID-19 – with 162 positive cases in the placebo group versus 8 in the BNT162b2 vaccine group.

Researchers reported 10 severe cases of COVID-19 in the trial, 9 of which occurred in the placebo group.

The study was ethnically diverse, and results were consistent across gender and age groups, with a 94% efficacy reported among participants aged older than 65 years.

Pfizer plans to file for an emergency-use authorization with the Food and Drug Administration “within days,” having now met all the FDA data endpoints, according to a news release from the two companies.

The vaccine was well tolerated with no serious safety concerns, the company stated. Two grade 3 adverse events were reported – fatigue in 3.8% of participants and headache in 2%.

The 95% efficacy places the Pfizer vaccine in the same neighborhood as the interim results of the Moderna vaccine, reported at 94.5%. Both products are two-dose mRNA vaccines.

As of Nov. 13, of 43,661 total participants in the Pfizer vaccine phase 3 trial, 41,135 received a second dose. The final results are based on two outcomes measured 7 days after the second dose: vaccine efficacy in people without prior SARS-CoV-2 infection as well as a secondary outcome in people both with and without prior SARS-CoV-2 infection.

The 95% vaccine efficacy was statistically significant, compared with placebo (P < .0001).
 

‘Historic 8-month journey’

The BNT162b2 vaccine candidate is a joint effort between Pfizer and BioNTech. “The study results mark an important step in this historic 8-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, DVM, PhD, Pfizer chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

Ugur Sahin, MD, PhD, cofounder and CEO of BioNTech, added, “we are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30-mcg dose, underscoring the power of BNT162 in providing early protection.”

The two companies expect to produce up to 50 million vaccine doses in 2020 for global distribution. Projections for 2021 include up to 1.3 billion doses.

The companies also designed temperature-controlled thermal shipping containers with dry ice to maintain the required, approximate –70° C (–94° F) conditions. Clinicians can use the containers as temporary storage units for up to 15 days by replacing the dry ice.

This article first appeared on Medscape.com.

After initial promising interim results on Nov. 9, Pfizer and BioNTech today announced that their mRNA vaccine, in development to prevent COVID-19, is 95% effective.

Final analysis of the randomized, phase 3 study of more than 43,000 people yielded 170 confirmed cases of COVID-19 – with 162 positive cases in the placebo group versus 8 in the BNT162b2 vaccine group.

Researchers reported 10 severe cases of COVID-19 in the trial, 9 of which occurred in the placebo group.

The study was ethnically diverse, and results were consistent across gender and age groups, with a 94% efficacy reported among participants aged older than 65 years.

Pfizer plans to file for an emergency-use authorization with the Food and Drug Administration “within days,” having now met all the FDA data endpoints, according to a news release from the two companies.

The vaccine was well tolerated with no serious safety concerns, the company stated. Two grade 3 adverse events were reported – fatigue in 3.8% of participants and headache in 2%.

The 95% efficacy places the Pfizer vaccine in the same neighborhood as the interim results of the Moderna vaccine, reported at 94.5%. Both products are two-dose mRNA vaccines.

As of Nov. 13, of 43,661 total participants in the Pfizer vaccine phase 3 trial, 41,135 received a second dose. The final results are based on two outcomes measured 7 days after the second dose: vaccine efficacy in people without prior SARS-CoV-2 infection as well as a secondary outcome in people both with and without prior SARS-CoV-2 infection.

The 95% vaccine efficacy was statistically significant, compared with placebo (P < .0001).
 

‘Historic 8-month journey’

The BNT162b2 vaccine candidate is a joint effort between Pfizer and BioNTech. “The study results mark an important step in this historic 8-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, DVM, PhD, Pfizer chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

Ugur Sahin, MD, PhD, cofounder and CEO of BioNTech, added, “we are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30-mcg dose, underscoring the power of BNT162 in providing early protection.”

The two companies expect to produce up to 50 million vaccine doses in 2020 for global distribution. Projections for 2021 include up to 1.3 billion doses.

The companies also designed temperature-controlled thermal shipping containers with dry ice to maintain the required, approximate –70° C (–94° F) conditions. Clinicians can use the containers as temporary storage units for up to 15 days by replacing the dry ice.

This article first appeared on Medscape.com.

After initial promising interim results on Nov. 9, Pfizer and BioNTech today announced that their mRNA vaccine, in development to prevent COVID-19, is 95% effective.

Final analysis of the randomized, phase 3 study of more than 43,000 people yielded 170 confirmed cases of COVID-19 – with 162 positive cases in the placebo group versus 8 in the BNT162b2 vaccine group.

Researchers reported 10 severe cases of COVID-19 in the trial, 9 of which occurred in the placebo group.

The study was ethnically diverse, and results were consistent across gender and age groups, with a 94% efficacy reported among participants aged older than 65 years.

Pfizer plans to file for an emergency-use authorization with the Food and Drug Administration “within days,” having now met all the FDA data endpoints, according to a news release from the two companies.

The vaccine was well tolerated with no serious safety concerns, the company stated. Two grade 3 adverse events were reported – fatigue in 3.8% of participants and headache in 2%.

The 95% efficacy places the Pfizer vaccine in the same neighborhood as the interim results of the Moderna vaccine, reported at 94.5%. Both products are two-dose mRNA vaccines.

As of Nov. 13, of 43,661 total participants in the Pfizer vaccine phase 3 trial, 41,135 received a second dose. The final results are based on two outcomes measured 7 days after the second dose: vaccine efficacy in people without prior SARS-CoV-2 infection as well as a secondary outcome in people both with and without prior SARS-CoV-2 infection.

The 95% vaccine efficacy was statistically significant, compared with placebo (P < .0001).
 

‘Historic 8-month journey’

The BNT162b2 vaccine candidate is a joint effort between Pfizer and BioNTech. “The study results mark an important step in this historic 8-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, DVM, PhD, Pfizer chairman and CEO, said in a statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”

Ugur Sahin, MD, PhD, cofounder and CEO of BioNTech, added, “we are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30-mcg dose, underscoring the power of BNT162 in providing early protection.”

The two companies expect to produce up to 50 million vaccine doses in 2020 for global distribution. Projections for 2021 include up to 1.3 billion doses.

The companies also designed temperature-controlled thermal shipping containers with dry ice to maintain the required, approximate –70° C (–94° F) conditions. Clinicians can use the containers as temporary storage units for up to 15 days by replacing the dry ice.

This article first appeared on Medscape.com.

A “hospital at home” (HaH) program at Atrium Health, a large integrated delivery system in the Southeast, expanded its hospital capacity during the early phase of the COVID-19 pandemic by providing hospital-level acute care to COVID-19 patients at home, according to a new study in Annals of Internal Medicine.

“Virtual hospital programs have the potential to provide health systems with additional inpatient capacity during the COVID-19 pandemic and beyond,” wrote Kranthi Sitammagari, MD, from the Atrium Health Hospitalist Group, Monroe, N.C., and colleagues.

Whereas most previous HaH programs have relied on visiting nurses and physicians, the new study uses telemedicine to connect with patients. Advocate Health Care researchers published the only other study using the telemedicine-powered model in 2015.

The new Atrium Health study evaluated 1,477 patients who received care in the HaH program between March 23 and May 7 of this year after having been diagnosed with COVID-19. The program provided home monitoring and hospital-level care in a home-based virtual observation unit (VOU) and a virtual acute care unit (VACU).

Patients were tested for the virus in Atrium emergency departments, primary care clinics, urgent care centers, and external testing sites. Those who tested positive were invited to be cared for either in the VOU, if they had mild to moderate symptoms, or in the VACU, if they were sick enough to be admitted to the hospital.
 

Patients hop onboard

Nearly all COVID-positive patients tested in these sites agreed to be admitted to the hospital at home, coauthor Stephanie Murphy, DO, medical director of the Atrium Health HaH program, said in an interview.

Patients with moderate symptoms were glad to be monitored at home, she said. When they got to the point where the nurse supervising their care felt they needed escalation to acute care, they were asked whether they wanted to continue to be cared for at home. Most opted to stay home rather than be admitted to the hospital, where their loved ones couldn’t visit them.

Low-acuity patients in the VOU received daily telemonitoring by a nurse to identify disease progression and escalate care as needed. For those who required more care and were admitted to the VACU, a team of paramedics and registered nurses (RNs; mobile clinicians) visited the patient’s home within 24 hours, setting up a hospital bed, other necessary medical equipment, videoconferencing gear, and a remote-monitoring kit that included a blood pressure cuff, a pulse oximeter, and a thermometer.

Dedicated hospitalists and nurses managed patients with 24/7 coverage and monitoring, bringing in other specialties as needed for virtual consults. Mobile clinician and virtual provider visits continued daily until a patient’s condition improved to the point where they could be deescalated back to the VOU. After that, patients received mobile app-driven symptom monitoring and telephone follow-up with a nurse until they got better.
 

Few patients go to hospital

Overall, patients had a median length of stay of 11 days in the VOU or the VACU or both. The vast majority, 1,293 patients (88%), received care in the VOU only. In that cohort, just 40 patients (3%) required hospitalization in an Atrium facility. Sixteen of those patients spent time in an ICU, seven required ventilator support, and two died in the hospital.

A total of 184 patients (12%) were admitted to the VACU. Twenty-one (11%) required intravenous fluids, 16 (9%) received antibiotics, 40 (22%) required inhaler or nebulizer treatments, 41 (22%) used supplemental oxygen, and 24 (13%) were admitted to a conventional hospital. Of the latter patients, 10 were admitted to an ICU, one required a ventilator, and none died in the hospital.

Dr. Sitammagari, a hospitalist and comedical director for quality at Atrium Health, told this news organization that, overall, the outcomes for patients in the system’s HaH were comparable to those seen in the literature among other COVID-19 cohorts.
 

Augmenting hospital capacity

The authors note that treating the 160 VACU patients within the HaH saved hospital beds for other patients. The HaH maintained a consistent census of between 20 and 30 patients for the first 6 weeks as COVID-19 cases spread.

Since last spring, Dr. Murphy said, the Atrium HaH’s daily census has grown to between 30 and 45 patients. “We could absorb 50 patients if our hospitals required it.”

How much capacity does that add to Atrium Health? While there are 50 hospitals in the health system, the HaH was set up mainly to care for COVID-19 patients who would otherwise have been admitted to the 10 acute-care hospitals in the Charlotte, N.C., area. In the 4 weeks ending Nov. 16, these facilities carried an average daily census of around 160 COVID-19 patients, Dr. Murphy noted. “During that time, the Atrium Health HaH has carried, on average, about 20%-25% of that census.”

If the pandemic were to overwhelm area hospitals, she added, “the structure would support flexing up our staffing and supplies to expand to crisis capacity,” which could be up to 200 patients a day.

For the nurses who make most of the phone calls to patients, patients average about 12 to 15 per RN, Dr. Murphy said, and there’s one mobile clinician for every six to nine patients. That’s pretty consistent with the staffing on med-surg floors in hospitals, she said.

The physicians in the program include hospitalists dedicated to telemedicine and some doctors who can’t work in the regular hospital because they’re immunocompromised. The physicians round virtually, covering 12-17 HaH patients per day, according to Dr. Murphy.
 

Prior planning paid off

Unlike some other health care systems that have launched HaH programs with the aid of outside vendors, Atrium Health developed its own HaH and brought it online just 2 weeks after deciding to launch the program. Atrium was able to do this, Dr. Sitammagari explained, because before the pandemic its hospitalist program was already developing an HaH model to improve the care of high-risk patients after hospital discharge to prevent readmission.

While Atrium’s electronic health record system wasn’t designed for hospital at home, its health information technology department and clinicians collaborated in rewriting some of the workflows and order sets in the EHR. For example, they set up a nursing questionnaire to administer after VACU admission, and they created another form for automatic admission to the HaH after a patient tested positive for COVID-19. Atrium staff also modified a patient-doctor communications app to help clinicians monitor HaH patients, Dr. Murphy noted.

Other hospital systems have gotten up to speed on HaH pretty quickly by using platforms supplied by outside vendors. Adventist Health in Los Angeles, for example, started admitting patients to its hospital at home just a month after approaching a vendor called Medically Home.
 

COVID vs. non-COVID patients

Atrium’s decision to focus its HaH effort on COVID-19 patients is unusual among the small but growing number of health systems that have adopted the HaH model to increase their capacity. (Atrium is now transferring some hospitalized patients with other conditions to its HaH, but is still focusing mainly on COVID-19 in its HaH program.)

Bruce Leff, MD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, Baltimore, a leading expert on the HaH model, agrees that it can increase hospital capacity significantly.

Dr. Leff praised the Atrium Health study. “It proves that within an integrated delivery system you can quickly deploy and implement a virtual hospital in the specific-use case of COVID, and help patients and help the system at scale,” he said. “They took a bunch of people into the virtual observation unit and thereby kept people from overwhelming their [emergency department] and treated those people safely at home.”

Dr. Leff had no problem with Atrium’s focus on patients with COVID-19 rather than other conditions. “My guess is that they have the ability to take what they developed and apply it to other conditions. Once you have the ability to do acute care at home, you can do a lot at home.”

The biggest barrier to the spread of hospital at home remains the lack of insurer coverage. Dr. Murphy said that health plans are covering virtual physician consultations with patients in the HaH, as well as some other bits and pieces, but not the entire episode of acute care.

Dr. Leff believes that this will start changing soon. COVID-19 has altered the attitudes of physicians and hospitals toward telehealth, he noted, “and it has moved policy makers and payers to start thinking about the new models – home-based care in general and hospital at home in particular. For the first time in 25 years, payers are starting to get interested.”

Most of the authors are employees of Atrium Health. In addition, one coauthor reports being the cofounder of a digital health company, iEnroll, and receiving grants from The Heineman Foundation. Dr. Leff is an advisor to Medically Home, which provides support to hospital at home programs.

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

A “hospital at home” (HaH) program at Atrium Health, a large integrated delivery system in the Southeast, expanded its hospital capacity during the early phase of the COVID-19 pandemic by providing hospital-level acute care to COVID-19 patients at home, according to a new study in Annals of Internal Medicine.

“Virtual hospital programs have the potential to provide health systems with additional inpatient capacity during the COVID-19 pandemic and beyond,” wrote Kranthi Sitammagari, MD, from the Atrium Health Hospitalist Group, Monroe, N.C., and colleagues.

Whereas most previous HaH programs have relied on visiting nurses and physicians, the new study uses telemedicine to connect with patients. Advocate Health Care researchers published the only other study using the telemedicine-powered model in 2015.

The new Atrium Health study evaluated 1,477 patients who received care in the HaH program between March 23 and May 7 of this year after having been diagnosed with COVID-19. The program provided home monitoring and hospital-level care in a home-based virtual observation unit (VOU) and a virtual acute care unit (VACU).

Patients were tested for the virus in Atrium emergency departments, primary care clinics, urgent care centers, and external testing sites. Those who tested positive were invited to be cared for either in the VOU, if they had mild to moderate symptoms, or in the VACU, if they were sick enough to be admitted to the hospital.
 

Patients hop onboard

Nearly all COVID-positive patients tested in these sites agreed to be admitted to the hospital at home, coauthor Stephanie Murphy, DO, medical director of the Atrium Health HaH program, said in an interview.

Patients with moderate symptoms were glad to be monitored at home, she said. When they got to the point where the nurse supervising their care felt they needed escalation to acute care, they were asked whether they wanted to continue to be cared for at home. Most opted to stay home rather than be admitted to the hospital, where their loved ones couldn’t visit them.

Low-acuity patients in the VOU received daily telemonitoring by a nurse to identify disease progression and escalate care as needed. For those who required more care and were admitted to the VACU, a team of paramedics and registered nurses (RNs; mobile clinicians) visited the patient’s home within 24 hours, setting up a hospital bed, other necessary medical equipment, videoconferencing gear, and a remote-monitoring kit that included a blood pressure cuff, a pulse oximeter, and a thermometer.

Dedicated hospitalists and nurses managed patients with 24/7 coverage and monitoring, bringing in other specialties as needed for virtual consults. Mobile clinician and virtual provider visits continued daily until a patient’s condition improved to the point where they could be deescalated back to the VOU. After that, patients received mobile app-driven symptom monitoring and telephone follow-up with a nurse until they got better.
 

Few patients go to hospital

Overall, patients had a median length of stay of 11 days in the VOU or the VACU or both. The vast majority, 1,293 patients (88%), received care in the VOU only. In that cohort, just 40 patients (3%) required hospitalization in an Atrium facility. Sixteen of those patients spent time in an ICU, seven required ventilator support, and two died in the hospital.

A total of 184 patients (12%) were admitted to the VACU. Twenty-one (11%) required intravenous fluids, 16 (9%) received antibiotics, 40 (22%) required inhaler or nebulizer treatments, 41 (22%) used supplemental oxygen, and 24 (13%) were admitted to a conventional hospital. Of the latter patients, 10 were admitted to an ICU, one required a ventilator, and none died in the hospital.

Dr. Sitammagari, a hospitalist and comedical director for quality at Atrium Health, told this news organization that, overall, the outcomes for patients in the system’s HaH were comparable to those seen in the literature among other COVID-19 cohorts.
 

Augmenting hospital capacity

The authors note that treating the 160 VACU patients within the HaH saved hospital beds for other patients. The HaH maintained a consistent census of between 20 and 30 patients for the first 6 weeks as COVID-19 cases spread.

Since last spring, Dr. Murphy said, the Atrium HaH’s daily census has grown to between 30 and 45 patients. “We could absorb 50 patients if our hospitals required it.”

How much capacity does that add to Atrium Health? While there are 50 hospitals in the health system, the HaH was set up mainly to care for COVID-19 patients who would otherwise have been admitted to the 10 acute-care hospitals in the Charlotte, N.C., area. In the 4 weeks ending Nov. 16, these facilities carried an average daily census of around 160 COVID-19 patients, Dr. Murphy noted. “During that time, the Atrium Health HaH has carried, on average, about 20%-25% of that census.”

If the pandemic were to overwhelm area hospitals, she added, “the structure would support flexing up our staffing and supplies to expand to crisis capacity,” which could be up to 200 patients a day.

For the nurses who make most of the phone calls to patients, patients average about 12 to 15 per RN, Dr. Murphy said, and there’s one mobile clinician for every six to nine patients. That’s pretty consistent with the staffing on med-surg floors in hospitals, she said.

The physicians in the program include hospitalists dedicated to telemedicine and some doctors who can’t work in the regular hospital because they’re immunocompromised. The physicians round virtually, covering 12-17 HaH patients per day, according to Dr. Murphy.
 

Prior planning paid off

Unlike some other health care systems that have launched HaH programs with the aid of outside vendors, Atrium Health developed its own HaH and brought it online just 2 weeks after deciding to launch the program. Atrium was able to do this, Dr. Sitammagari explained, because before the pandemic its hospitalist program was already developing an HaH model to improve the care of high-risk patients after hospital discharge to prevent readmission.

While Atrium’s electronic health record system wasn’t designed for hospital at home, its health information technology department and clinicians collaborated in rewriting some of the workflows and order sets in the EHR. For example, they set up a nursing questionnaire to administer after VACU admission, and they created another form for automatic admission to the HaH after a patient tested positive for COVID-19. Atrium staff also modified a patient-doctor communications app to help clinicians monitor HaH patients, Dr. Murphy noted.

Other hospital systems have gotten up to speed on HaH pretty quickly by using platforms supplied by outside vendors. Adventist Health in Los Angeles, for example, started admitting patients to its hospital at home just a month after approaching a vendor called Medically Home.
 

COVID vs. non-COVID patients

Atrium’s decision to focus its HaH effort on COVID-19 patients is unusual among the small but growing number of health systems that have adopted the HaH model to increase their capacity. (Atrium is now transferring some hospitalized patients with other conditions to its HaH, but is still focusing mainly on COVID-19 in its HaH program.)

Bruce Leff, MD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, Baltimore, a leading expert on the HaH model, agrees that it can increase hospital capacity significantly.

Dr. Leff praised the Atrium Health study. “It proves that within an integrated delivery system you can quickly deploy and implement a virtual hospital in the specific-use case of COVID, and help patients and help the system at scale,” he said. “They took a bunch of people into the virtual observation unit and thereby kept people from overwhelming their [emergency department] and treated those people safely at home.”

Dr. Leff had no problem with Atrium’s focus on patients with COVID-19 rather than other conditions. “My guess is that they have the ability to take what they developed and apply it to other conditions. Once you have the ability to do acute care at home, you can do a lot at home.”

The biggest barrier to the spread of hospital at home remains the lack of insurer coverage. Dr. Murphy said that health plans are covering virtual physician consultations with patients in the HaH, as well as some other bits and pieces, but not the entire episode of acute care.

Dr. Leff believes that this will start changing soon. COVID-19 has altered the attitudes of physicians and hospitals toward telehealth, he noted, “and it has moved policy makers and payers to start thinking about the new models – home-based care in general and hospital at home in particular. For the first time in 25 years, payers are starting to get interested.”

Most of the authors are employees of Atrium Health. In addition, one coauthor reports being the cofounder of a digital health company, iEnroll, and receiving grants from The Heineman Foundation. Dr. Leff is an advisor to Medically Home, which provides support to hospital at home programs.

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

A “hospital at home” (HaH) program at Atrium Health, a large integrated delivery system in the Southeast, expanded its hospital capacity during the early phase of the COVID-19 pandemic by providing hospital-level acute care to COVID-19 patients at home, according to a new study in Annals of Internal Medicine.

“Virtual hospital programs have the potential to provide health systems with additional inpatient capacity during the COVID-19 pandemic and beyond,” wrote Kranthi Sitammagari, MD, from the Atrium Health Hospitalist Group, Monroe, N.C., and colleagues.

Whereas most previous HaH programs have relied on visiting nurses and physicians, the new study uses telemedicine to connect with patients. Advocate Health Care researchers published the only other study using the telemedicine-powered model in 2015.

The new Atrium Health study evaluated 1,477 patients who received care in the HaH program between March 23 and May 7 of this year after having been diagnosed with COVID-19. The program provided home monitoring and hospital-level care in a home-based virtual observation unit (VOU) and a virtual acute care unit (VACU).

Patients were tested for the virus in Atrium emergency departments, primary care clinics, urgent care centers, and external testing sites. Those who tested positive were invited to be cared for either in the VOU, if they had mild to moderate symptoms, or in the VACU, if they were sick enough to be admitted to the hospital.
 

Patients hop onboard

Nearly all COVID-positive patients tested in these sites agreed to be admitted to the hospital at home, coauthor Stephanie Murphy, DO, medical director of the Atrium Health HaH program, said in an interview.

Patients with moderate symptoms were glad to be monitored at home, she said. When they got to the point where the nurse supervising their care felt they needed escalation to acute care, they were asked whether they wanted to continue to be cared for at home. Most opted to stay home rather than be admitted to the hospital, where their loved ones couldn’t visit them.

Low-acuity patients in the VOU received daily telemonitoring by a nurse to identify disease progression and escalate care as needed. For those who required more care and were admitted to the VACU, a team of paramedics and registered nurses (RNs; mobile clinicians) visited the patient’s home within 24 hours, setting up a hospital bed, other necessary medical equipment, videoconferencing gear, and a remote-monitoring kit that included a blood pressure cuff, a pulse oximeter, and a thermometer.

Dedicated hospitalists and nurses managed patients with 24/7 coverage and monitoring, bringing in other specialties as needed for virtual consults. Mobile clinician and virtual provider visits continued daily until a patient’s condition improved to the point where they could be deescalated back to the VOU. After that, patients received mobile app-driven symptom monitoring and telephone follow-up with a nurse until they got better.
 

Few patients go to hospital

Overall, patients had a median length of stay of 11 days in the VOU or the VACU or both. The vast majority, 1,293 patients (88%), received care in the VOU only. In that cohort, just 40 patients (3%) required hospitalization in an Atrium facility. Sixteen of those patients spent time in an ICU, seven required ventilator support, and two died in the hospital.

A total of 184 patients (12%) were admitted to the VACU. Twenty-one (11%) required intravenous fluids, 16 (9%) received antibiotics, 40 (22%) required inhaler or nebulizer treatments, 41 (22%) used supplemental oxygen, and 24 (13%) were admitted to a conventional hospital. Of the latter patients, 10 were admitted to an ICU, one required a ventilator, and none died in the hospital.

Dr. Sitammagari, a hospitalist and comedical director for quality at Atrium Health, told this news organization that, overall, the outcomes for patients in the system’s HaH were comparable to those seen in the literature among other COVID-19 cohorts.
 

Augmenting hospital capacity

The authors note that treating the 160 VACU patients within the HaH saved hospital beds for other patients. The HaH maintained a consistent census of between 20 and 30 patients for the first 6 weeks as COVID-19 cases spread.

Since last spring, Dr. Murphy said, the Atrium HaH’s daily census has grown to between 30 and 45 patients. “We could absorb 50 patients if our hospitals required it.”

How much capacity does that add to Atrium Health? While there are 50 hospitals in the health system, the HaH was set up mainly to care for COVID-19 patients who would otherwise have been admitted to the 10 acute-care hospitals in the Charlotte, N.C., area. In the 4 weeks ending Nov. 16, these facilities carried an average daily census of around 160 COVID-19 patients, Dr. Murphy noted. “During that time, the Atrium Health HaH has carried, on average, about 20%-25% of that census.”

If the pandemic were to overwhelm area hospitals, she added, “the structure would support flexing up our staffing and supplies to expand to crisis capacity,” which could be up to 200 patients a day.

For the nurses who make most of the phone calls to patients, patients average about 12 to 15 per RN, Dr. Murphy said, and there’s one mobile clinician for every six to nine patients. That’s pretty consistent with the staffing on med-surg floors in hospitals, she said.

The physicians in the program include hospitalists dedicated to telemedicine and some doctors who can’t work in the regular hospital because they’re immunocompromised. The physicians round virtually, covering 12-17 HaH patients per day, according to Dr. Murphy.
 

Prior planning paid off

Unlike some other health care systems that have launched HaH programs with the aid of outside vendors, Atrium Health developed its own HaH and brought it online just 2 weeks after deciding to launch the program. Atrium was able to do this, Dr. Sitammagari explained, because before the pandemic its hospitalist program was already developing an HaH model to improve the care of high-risk patients after hospital discharge to prevent readmission.

While Atrium’s electronic health record system wasn’t designed for hospital at home, its health information technology department and clinicians collaborated in rewriting some of the workflows and order sets in the EHR. For example, they set up a nursing questionnaire to administer after VACU admission, and they created another form for automatic admission to the HaH after a patient tested positive for COVID-19. Atrium staff also modified a patient-doctor communications app to help clinicians monitor HaH patients, Dr. Murphy noted.

Other hospital systems have gotten up to speed on HaH pretty quickly by using platforms supplied by outside vendors. Adventist Health in Los Angeles, for example, started admitting patients to its hospital at home just a month after approaching a vendor called Medically Home.
 

COVID vs. non-COVID patients

Atrium’s decision to focus its HaH effort on COVID-19 patients is unusual among the small but growing number of health systems that have adopted the HaH model to increase their capacity. (Atrium is now transferring some hospitalized patients with other conditions to its HaH, but is still focusing mainly on COVID-19 in its HaH program.)

Bruce Leff, MD, a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health, Baltimore, a leading expert on the HaH model, agrees that it can increase hospital capacity significantly.

Dr. Leff praised the Atrium Health study. “It proves that within an integrated delivery system you can quickly deploy and implement a virtual hospital in the specific-use case of COVID, and help patients and help the system at scale,” he said. “They took a bunch of people into the virtual observation unit and thereby kept people from overwhelming their [emergency department] and treated those people safely at home.”

Dr. Leff had no problem with Atrium’s focus on patients with COVID-19 rather than other conditions. “My guess is that they have the ability to take what they developed and apply it to other conditions. Once you have the ability to do acute care at home, you can do a lot at home.”

The biggest barrier to the spread of hospital at home remains the lack of insurer coverage. Dr. Murphy said that health plans are covering virtual physician consultations with patients in the HaH, as well as some other bits and pieces, but not the entire episode of acute care.

Dr. Leff believes that this will start changing soon. COVID-19 has altered the attitudes of physicians and hospitals toward telehealth, he noted, “and it has moved policy makers and payers to start thinking about the new models – home-based care in general and hospital at home in particular. For the first time in 25 years, payers are starting to get interested.”

Most of the authors are employees of Atrium Health. In addition, one coauthor reports being the cofounder of a digital health company, iEnroll, and receiving grants from The Heineman Foundation. Dr. Leff is an advisor to Medically Home, which provides support to hospital at home programs.

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

An international autopsy study of 21 patients who died from COVID-19 has shown the presence of multifocal lymphocytic myocarditis in three patients (14%). In an additional six patients, focally increased interstitial T-lymphocytes within the myocardium were noted, with only focal or no myocyte injury.

However, increased interstitial macrophage infiltration, possibly related to cytokine infiltration, was seen in 86% of patients.

“One way to think about this is that, if these patients were having biopsies and not autopsies, there would be myocardial injury in the patients with myocarditis, even after they recovered. But with interstitial macrophages, there may or may not be any injury,” said cardiovascular pathologist James R. Stone, MD, PhD, Massachusetts General Hospital, Boston.

Dr. Stone and colleagues from Mass General, two hospitals in Italy, the University of Amsterdam, and the Mayo Clinic in Rochester, Minn., conducted the autopsies in March and April. The results were published in the October 14 issue of the European Heart Journal.

Their technique was rigorous: a median of 20 full-thickness blocks of myocardium were examined histologically (range, 5-29 blocks).

The presence of myocarditis, defined by the presence of multiple foci of inflammation with associated myocyte injury, was determined, and the inflammatory cell composition analyzed by immunohistochemistry.

“I think one of the take-homes from this study is that you have to do a thorough sampling of the heart in order to exclude myocardial injury. You cannot exclude myocarditis with just a biopsy or two,” said Dr. Stone in an interview.

“We looked at multiple different sections of tissue preserved in paraffin for every case and found only 14% had myocarditis. The vast majority of autopsies done on patients dying from COVID-19 have short-changed the autopsy and not been done in a way to exclude myocarditis,” he added.

For all patients, COVID-19 was the underlying cause of death, but the mechanisms of death were acute respiratory distress syndrome in 15, viral pneumonia in 4, cardiogenic shock in 1, and cardiac arrest in 1. Seven patients had a history of cardiovascular disease, including atrial fibrillation in four, coronary artery disease in three, left ventricular hypertrophy in one, and previous valve replacement in one. A total of 16 had hypertension, 7 had diabetes mellitus, and 1 had chronic obstructive pulmonary disease. In four cases, mild pericarditis was present. Acute myocyte injury in the right ventricle, most probably from strain or overload, was also present in four cases.

A nonsignificant trend was seen toward higher serum troponin levels in the patients with myocarditis compared with those without myocarditis. There were no reports of disrupted coronary artery plaques, coronary artery aneurysms, or large pulmonary emboli.

Macrophage infiltration rather than myocarditis, myocardial injury?

The study sheds more light on previous cardiac magnetic resonance (CMR) imaging findings that have suggested that many patients who recover from COVID-19 show signs suggestive of myocarditis. These earlier studies include a recent one in competitive athletes and the earlier Puntmann and colleagues study of relatively young COVID-19 patients, which showed ongoing myocardial involvement in a majority of patients.

“It would not surprise me if some or all of the cardiac MR changes seen in some of these recent imaging studies are due to the macrophages,” said Dr. Stone.

“What we saw was not a routine pathology by any means. It was a huge amount of macrophages, higher that what we saw in SARS and more similar to a study published in 2007 that looked at patients with bacterial sepsis,” said Dr. Stone.

In an older study of SARS patients, 35% had the virus detected in myocardial tissue by polymerase chain reaction. In that subset, the degree of myocardial macrophage infiltrate was comparable to that seen in 86% of the COVID-19 cases described in this series.

Another possibility is that the macrophage infiltration reflects underlying disease rather than COVID-19. All but one of the patients had known underlying medical conditions associated with cardiac remodeling, said Nikolaos G. Frangogiannis, MD, a cardiologist who studies the mechanisms of cardiac injury, repair, and remodeling.

Frangogiannis, from Albert Einstein College of Medicine, New York, wrote an editorial that accompanied the autopsy study.

“The problem with this finding of increased macrophage infiltration is that it’s very hard to interpret because as we age, and especially in a less healthy population, the numbers and the density of macrophages in the heart increase, so it’s impossible to interpret as an effect of the infection itself unless you have an appropriate control population that matches the same characteristics, which is almost impossible to ask for,” he said.

“I’ve observed since the beginning of the pandemic that there seemed to be some people who wanted every single case to be myocarditis and others who had a bias toward not wanting COVID-19 to be a cause of myocarditis. I think what we’re seeing is it’s not either/or for anything with this virus, it’s a bit of everything,” said Dr. Stone.

Dr. Stone and Dr. Frangogiannis reported no conflict of interest.
 

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

An international autopsy study of 21 patients who died from COVID-19 has shown the presence of multifocal lymphocytic myocarditis in three patients (14%). In an additional six patients, focally increased interstitial T-lymphocytes within the myocardium were noted, with only focal or no myocyte injury.

However, increased interstitial macrophage infiltration, possibly related to cytokine infiltration, was seen in 86% of patients.

“One way to think about this is that, if these patients were having biopsies and not autopsies, there would be myocardial injury in the patients with myocarditis, even after they recovered. But with interstitial macrophages, there may or may not be any injury,” said cardiovascular pathologist James R. Stone, MD, PhD, Massachusetts General Hospital, Boston.

Dr. Stone and colleagues from Mass General, two hospitals in Italy, the University of Amsterdam, and the Mayo Clinic in Rochester, Minn., conducted the autopsies in March and April. The results were published in the October 14 issue of the European Heart Journal.

Their technique was rigorous: a median of 20 full-thickness blocks of myocardium were examined histologically (range, 5-29 blocks).

The presence of myocarditis, defined by the presence of multiple foci of inflammation with associated myocyte injury, was determined, and the inflammatory cell composition analyzed by immunohistochemistry.

“I think one of the take-homes from this study is that you have to do a thorough sampling of the heart in order to exclude myocardial injury. You cannot exclude myocarditis with just a biopsy or two,” said Dr. Stone in an interview.

“We looked at multiple different sections of tissue preserved in paraffin for every case and found only 14% had myocarditis. The vast majority of autopsies done on patients dying from COVID-19 have short-changed the autopsy and not been done in a way to exclude myocarditis,” he added.

For all patients, COVID-19 was the underlying cause of death, but the mechanisms of death were acute respiratory distress syndrome in 15, viral pneumonia in 4, cardiogenic shock in 1, and cardiac arrest in 1. Seven patients had a history of cardiovascular disease, including atrial fibrillation in four, coronary artery disease in three, left ventricular hypertrophy in one, and previous valve replacement in one. A total of 16 had hypertension, 7 had diabetes mellitus, and 1 had chronic obstructive pulmonary disease. In four cases, mild pericarditis was present. Acute myocyte injury in the right ventricle, most probably from strain or overload, was also present in four cases.

A nonsignificant trend was seen toward higher serum troponin levels in the patients with myocarditis compared with those without myocarditis. There were no reports of disrupted coronary artery plaques, coronary artery aneurysms, or large pulmonary emboli.

Macrophage infiltration rather than myocarditis, myocardial injury?

The study sheds more light on previous cardiac magnetic resonance (CMR) imaging findings that have suggested that many patients who recover from COVID-19 show signs suggestive of myocarditis. These earlier studies include a recent one in competitive athletes and the earlier Puntmann and colleagues study of relatively young COVID-19 patients, which showed ongoing myocardial involvement in a majority of patients.

“It would not surprise me if some or all of the cardiac MR changes seen in some of these recent imaging studies are due to the macrophages,” said Dr. Stone.

“What we saw was not a routine pathology by any means. It was a huge amount of macrophages, higher that what we saw in SARS and more similar to a study published in 2007 that looked at patients with bacterial sepsis,” said Dr. Stone.

In an older study of SARS patients, 35% had the virus detected in myocardial tissue by polymerase chain reaction. In that subset, the degree of myocardial macrophage infiltrate was comparable to that seen in 86% of the COVID-19 cases described in this series.

Another possibility is that the macrophage infiltration reflects underlying disease rather than COVID-19. All but one of the patients had known underlying medical conditions associated with cardiac remodeling, said Nikolaos G. Frangogiannis, MD, a cardiologist who studies the mechanisms of cardiac injury, repair, and remodeling.

Frangogiannis, from Albert Einstein College of Medicine, New York, wrote an editorial that accompanied the autopsy study.

“The problem with this finding of increased macrophage infiltration is that it’s very hard to interpret because as we age, and especially in a less healthy population, the numbers and the density of macrophages in the heart increase, so it’s impossible to interpret as an effect of the infection itself unless you have an appropriate control population that matches the same characteristics, which is almost impossible to ask for,” he said.

“I’ve observed since the beginning of the pandemic that there seemed to be some people who wanted every single case to be myocarditis and others who had a bias toward not wanting COVID-19 to be a cause of myocarditis. I think what we’re seeing is it’s not either/or for anything with this virus, it’s a bit of everything,” said Dr. Stone.

Dr. Stone and Dr. Frangogiannis reported no conflict of interest.
 

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

An international autopsy study of 21 patients who died from COVID-19 has shown the presence of multifocal lymphocytic myocarditis in three patients (14%). In an additional six patients, focally increased interstitial T-lymphocytes within the myocardium were noted, with only focal or no myocyte injury.

However, increased interstitial macrophage infiltration, possibly related to cytokine infiltration, was seen in 86% of patients.

“One way to think about this is that, if these patients were having biopsies and not autopsies, there would be myocardial injury in the patients with myocarditis, even after they recovered. But with interstitial macrophages, there may or may not be any injury,” said cardiovascular pathologist James R. Stone, MD, PhD, Massachusetts General Hospital, Boston.

Dr. Stone and colleagues from Mass General, two hospitals in Italy, the University of Amsterdam, and the Mayo Clinic in Rochester, Minn., conducted the autopsies in March and April. The results were published in the October 14 issue of the European Heart Journal.

Their technique was rigorous: a median of 20 full-thickness blocks of myocardium were examined histologically (range, 5-29 blocks).

The presence of myocarditis, defined by the presence of multiple foci of inflammation with associated myocyte injury, was determined, and the inflammatory cell composition analyzed by immunohistochemistry.

“I think one of the take-homes from this study is that you have to do a thorough sampling of the heart in order to exclude myocardial injury. You cannot exclude myocarditis with just a biopsy or two,” said Dr. Stone in an interview.

“We looked at multiple different sections of tissue preserved in paraffin for every case and found only 14% had myocarditis. The vast majority of autopsies done on patients dying from COVID-19 have short-changed the autopsy and not been done in a way to exclude myocarditis,” he added.

For all patients, COVID-19 was the underlying cause of death, but the mechanisms of death were acute respiratory distress syndrome in 15, viral pneumonia in 4, cardiogenic shock in 1, and cardiac arrest in 1. Seven patients had a history of cardiovascular disease, including atrial fibrillation in four, coronary artery disease in three, left ventricular hypertrophy in one, and previous valve replacement in one. A total of 16 had hypertension, 7 had diabetes mellitus, and 1 had chronic obstructive pulmonary disease. In four cases, mild pericarditis was present. Acute myocyte injury in the right ventricle, most probably from strain or overload, was also present in four cases.

A nonsignificant trend was seen toward higher serum troponin levels in the patients with myocarditis compared with those without myocarditis. There were no reports of disrupted coronary artery plaques, coronary artery aneurysms, or large pulmonary emboli.

Macrophage infiltration rather than myocarditis, myocardial injury?

The study sheds more light on previous cardiac magnetic resonance (CMR) imaging findings that have suggested that many patients who recover from COVID-19 show signs suggestive of myocarditis. These earlier studies include a recent one in competitive athletes and the earlier Puntmann and colleagues study of relatively young COVID-19 patients, which showed ongoing myocardial involvement in a majority of patients.

“It would not surprise me if some or all of the cardiac MR changes seen in some of these recent imaging studies are due to the macrophages,” said Dr. Stone.

“What we saw was not a routine pathology by any means. It was a huge amount of macrophages, higher that what we saw in SARS and more similar to a study published in 2007 that looked at patients with bacterial sepsis,” said Dr. Stone.

In an older study of SARS patients, 35% had the virus detected in myocardial tissue by polymerase chain reaction. In that subset, the degree of myocardial macrophage infiltrate was comparable to that seen in 86% of the COVID-19 cases described in this series.

Another possibility is that the macrophage infiltration reflects underlying disease rather than COVID-19. All but one of the patients had known underlying medical conditions associated with cardiac remodeling, said Nikolaos G. Frangogiannis, MD, a cardiologist who studies the mechanisms of cardiac injury, repair, and remodeling.

Frangogiannis, from Albert Einstein College of Medicine, New York, wrote an editorial that accompanied the autopsy study.

“The problem with this finding of increased macrophage infiltration is that it’s very hard to interpret because as we age, and especially in a less healthy population, the numbers and the density of macrophages in the heart increase, so it’s impossible to interpret as an effect of the infection itself unless you have an appropriate control population that matches the same characteristics, which is almost impossible to ask for,” he said.

“I’ve observed since the beginning of the pandemic that there seemed to be some people who wanted every single case to be myocarditis and others who had a bias toward not wanting COVID-19 to be a cause of myocarditis. I think what we’re seeing is it’s not either/or for anything with this virus, it’s a bit of everything,” said Dr. Stone.

Dr. Stone and Dr. Frangogiannis reported no conflict of interest.
 

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

Much has changed in the 10 years since Medscape’s first survey on what physicians would do when faced with painful choices in patient care.

A new report, Ethics 2020: Life, Death, and Painful Dilemmas, shows that physicians’ value judgments have shifted in many respects, sometimes as a result of increased regulations and fears of litigation.
 

 End-of-life decisions

Several of the questions in the survey revolved around end-of-life decisions, and in some cases, the differences seen in just a decade were striking. One example concerned life support decisions in the context of a family’s choices.

Age also seemed to play a role in the 2020 answers to that question: Physicians younger than 45 were more likely (28%) to answer “yes” (that they would withdraw life support in that instance) than were those 45 and older (16%).

A critical care physician said, “If the family appears to have an underlying motivation that may not be in the patient’s best interest, I might be inclined to pursue a legal decision prior to withdrawing support.”

A cardiologist had a more pointed response to the question: “To me, that would be murder.”

Another example of how perspectives have changed over the past 10 years concerns whether physician-aided dying should be legal for terminally ill patients. The practice is now mandated by law in eight states and the District of Columbia, and it is mandated by court ruling in two additional states.

In 2010, 41% said “no.” That number dropped to 28% in 2020.

On legalization, a psychiatrist said, “Yes, when there is truly no hope and the quality of remaining life is too poor. We show more compassion to our sick animals than we do to our human population.”

Conversely, a neurologist answered, “No, I see younger physicians already becoming comfortable with the idea of deciding ASAP whether there is a reasonable chance of survival and then pressing for the right code status. This change would make things worse.”
 

Assisted death and incurable suffering

Far fewer physicians supported physician-assisted death for those who had years to live but faced incurable suffering: Thirty-seven percent said “yes,” 34% said “no,” and 29% said “it depends.”

However, support was significantly higher than it was just 2 years ago, in 2018, when only 27% supported the concept, the report authors noted.

“The shift reflects movements by many states to legalize assisted dying for the terminally ill,” Arthur Caplan, PhD, director of the division of medical ethics, New York University, said in the report. “Legalization has not been abused, so some doctors are more willing to press further beyond terminal illness as a trigger to suffering.”

Conversely, many more physicians (44% vs. 24% a decade ago) said they would provide life-sustaining therapy if the family requested it, even if the physician thought it was futile.

“Concerns over a malpractice lawsuit and potential negative patient/family online reviews are factors that play into this change,” the survey authors wrote.

Shared decision making also increased in the past decade.
 

Would you undertreat pain?

Primary care physicians fear the consequences of what they consider adequate pain management more than specialists do (24% vs. 17%), the survey authors noted.

Ten years ago, Medscape asked physicians whether they would undertreat a patient’s pain because of fear of repercussions or the patient’s becoming addicted: Eighty-four percent said “no,” and 6% said “yes.” The rest said “it depends.”

In 2020, the question was asked slightly differently: “Would you undertreat a patient’s pain for fear of addiction or Drug Enforcement Administration or medical board scrutiny?” This year, three times as many said “yes” (18%); 63% said “no.”

“Respondents this year talked about investigations and reprimands by medical boards, and how much they wanted to avoid that,” the survey authors wrote.
 

Should physicians be required to treat COVID-19 patients?

Some questions were new this year, including one on whether physicians should be required to treat COVID-19 patients. Fewer than half (47%) answered “yes,” 24% said “no,” and 29% answered “it depends.”

Doctors’ answers to this question differed slightly by gender: Fifty percent of men and 43% of women said “yes.” In their responses, many physicians said consideration should be given to risk factors, such as age, underlying conditions, risk of family members, and availability of personal protective equipment (PPE).

Another pandemic-related question asked whether physicians felt they should correct physicians who post misinformation about the pandemic on social media. Half (50%) said “yes,” 19% said “no,” and 31% said “it depends.”
 

Speaking out against the workplace

This year, many physicians have felt betrayed when they didn’t have adequate PPE during the pandemic.

Asked, “Is it right to speak out against your hospital or workplace when they don’t give you what you need?” 53% of physicians said “yes,” 8% said “no,” and 40% said “it depends.”

A cardiologist made the value judgment this way: “Speaking out just because you had an argument with your boss is inappropriate. Bringing to the public repeated failures to correct situations that have been brought through the proper channels is necessary to incite change.”
 

Random drug testing for physicians?

Another question in the survey asked whether physicians should be subjected to random drug testing for alcohol and drug abuse. About one-third (34%) said yes, 43% said no, and 23% said “it depends.” A study found that between 10% and 15% of physicians have abused a substance at some point in their careers.

The subject continues to hit a nerve in medicine.

A family physician wrote, “This should not be done unless a particular physician had a problem with drug or alcohol abuse and shows signs of impairment.”

An internist took a different view, saying, “Military service men and women, police, firefighters, airline pilots, and other professions that have responsibilities affecting people’s lives are subject to testing; why not physicians?”
 

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

Much has changed in the 10 years since Medscape’s first survey on what physicians would do when faced with painful choices in patient care.

A new report, Ethics 2020: Life, Death, and Painful Dilemmas, shows that physicians’ value judgments have shifted in many respects, sometimes as a result of increased regulations and fears of litigation.
 

 End-of-life decisions

Several of the questions in the survey revolved around end-of-life decisions, and in some cases, the differences seen in just a decade were striking. One example concerned life support decisions in the context of a family’s choices.

Age also seemed to play a role in the 2020 answers to that question: Physicians younger than 45 were more likely (28%) to answer “yes” (that they would withdraw life support in that instance) than were those 45 and older (16%).

A critical care physician said, “If the family appears to have an underlying motivation that may not be in the patient’s best interest, I might be inclined to pursue a legal decision prior to withdrawing support.”

A cardiologist had a more pointed response to the question: “To me, that would be murder.”

Another example of how perspectives have changed over the past 10 years concerns whether physician-aided dying should be legal for terminally ill patients. The practice is now mandated by law in eight states and the District of Columbia, and it is mandated by court ruling in two additional states.

In 2010, 41% said “no.” That number dropped to 28% in 2020.

On legalization, a psychiatrist said, “Yes, when there is truly no hope and the quality of remaining life is too poor. We show more compassion to our sick animals than we do to our human population.”

Conversely, a neurologist answered, “No, I see younger physicians already becoming comfortable with the idea of deciding ASAP whether there is a reasonable chance of survival and then pressing for the right code status. This change would make things worse.”
 

Assisted death and incurable suffering

Far fewer physicians supported physician-assisted death for those who had years to live but faced incurable suffering: Thirty-seven percent said “yes,” 34% said “no,” and 29% said “it depends.”

However, support was significantly higher than it was just 2 years ago, in 2018, when only 27% supported the concept, the report authors noted.

“The shift reflects movements by many states to legalize assisted dying for the terminally ill,” Arthur Caplan, PhD, director of the division of medical ethics, New York University, said in the report. “Legalization has not been abused, so some doctors are more willing to press further beyond terminal illness as a trigger to suffering.”

Conversely, many more physicians (44% vs. 24% a decade ago) said they would provide life-sustaining therapy if the family requested it, even if the physician thought it was futile.

“Concerns over a malpractice lawsuit and potential negative patient/family online reviews are factors that play into this change,” the survey authors wrote.

Shared decision making also increased in the past decade.
 

Would you undertreat pain?

Primary care physicians fear the consequences of what they consider adequate pain management more than specialists do (24% vs. 17%), the survey authors noted.

Ten years ago, Medscape asked physicians whether they would undertreat a patient’s pain because of fear of repercussions or the patient’s becoming addicted: Eighty-four percent said “no,” and 6% said “yes.” The rest said “it depends.”

In 2020, the question was asked slightly differently: “Would you undertreat a patient’s pain for fear of addiction or Drug Enforcement Administration or medical board scrutiny?” This year, three times as many said “yes” (18%); 63% said “no.”

“Respondents this year talked about investigations and reprimands by medical boards, and how much they wanted to avoid that,” the survey authors wrote.
 

Should physicians be required to treat COVID-19 patients?

Some questions were new this year, including one on whether physicians should be required to treat COVID-19 patients. Fewer than half (47%) answered “yes,” 24% said “no,” and 29% answered “it depends.”

Doctors’ answers to this question differed slightly by gender: Fifty percent of men and 43% of women said “yes.” In their responses, many physicians said consideration should be given to risk factors, such as age, underlying conditions, risk of family members, and availability of personal protective equipment (PPE).

Another pandemic-related question asked whether physicians felt they should correct physicians who post misinformation about the pandemic on social media. Half (50%) said “yes,” 19% said “no,” and 31% said “it depends.”
 

Speaking out against the workplace

This year, many physicians have felt betrayed when they didn’t have adequate PPE during the pandemic.

Asked, “Is it right to speak out against your hospital or workplace when they don’t give you what you need?” 53% of physicians said “yes,” 8% said “no,” and 40% said “it depends.”

A cardiologist made the value judgment this way: “Speaking out just because you had an argument with your boss is inappropriate. Bringing to the public repeated failures to correct situations that have been brought through the proper channels is necessary to incite change.”
 

Random drug testing for physicians?

Another question in the survey asked whether physicians should be subjected to random drug testing for alcohol and drug abuse. About one-third (34%) said yes, 43% said no, and 23% said “it depends.” A study found that between 10% and 15% of physicians have abused a substance at some point in their careers.

The subject continues to hit a nerve in medicine.

A family physician wrote, “This should not be done unless a particular physician had a problem with drug or alcohol abuse and shows signs of impairment.”

An internist took a different view, saying, “Military service men and women, police, firefighters, airline pilots, and other professions that have responsibilities affecting people’s lives are subject to testing; why not physicians?”
 

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

Much has changed in the 10 years since Medscape’s first survey on what physicians would do when faced with painful choices in patient care.

A new report, Ethics 2020: Life, Death, and Painful Dilemmas, shows that physicians’ value judgments have shifted in many respects, sometimes as a result of increased regulations and fears of litigation.
 

 End-of-life decisions

Several of the questions in the survey revolved around end-of-life decisions, and in some cases, the differences seen in just a decade were striking. One example concerned life support decisions in the context of a family’s choices.

Age also seemed to play a role in the 2020 answers to that question: Physicians younger than 45 were more likely (28%) to answer “yes” (that they would withdraw life support in that instance) than were those 45 and older (16%).

A critical care physician said, “If the family appears to have an underlying motivation that may not be in the patient’s best interest, I might be inclined to pursue a legal decision prior to withdrawing support.”

A cardiologist had a more pointed response to the question: “To me, that would be murder.”

Another example of how perspectives have changed over the past 10 years concerns whether physician-aided dying should be legal for terminally ill patients. The practice is now mandated by law in eight states and the District of Columbia, and it is mandated by court ruling in two additional states.

In 2010, 41% said “no.” That number dropped to 28% in 2020.

On legalization, a psychiatrist said, “Yes, when there is truly no hope and the quality of remaining life is too poor. We show more compassion to our sick animals than we do to our human population.”

Conversely, a neurologist answered, “No, I see younger physicians already becoming comfortable with the idea of deciding ASAP whether there is a reasonable chance of survival and then pressing for the right code status. This change would make things worse.”
 

Assisted death and incurable suffering

Far fewer physicians supported physician-assisted death for those who had years to live but faced incurable suffering: Thirty-seven percent said “yes,” 34% said “no,” and 29% said “it depends.”

However, support was significantly higher than it was just 2 years ago, in 2018, when only 27% supported the concept, the report authors noted.

“The shift reflects movements by many states to legalize assisted dying for the terminally ill,” Arthur Caplan, PhD, director of the division of medical ethics, New York University, said in the report. “Legalization has not been abused, so some doctors are more willing to press further beyond terminal illness as a trigger to suffering.”

Conversely, many more physicians (44% vs. 24% a decade ago) said they would provide life-sustaining therapy if the family requested it, even if the physician thought it was futile.

“Concerns over a malpractice lawsuit and potential negative patient/family online reviews are factors that play into this change,” the survey authors wrote.

Shared decision making also increased in the past decade.
 

Would you undertreat pain?

Primary care physicians fear the consequences of what they consider adequate pain management more than specialists do (24% vs. 17%), the survey authors noted.

Ten years ago, Medscape asked physicians whether they would undertreat a patient’s pain because of fear of repercussions or the patient’s becoming addicted: Eighty-four percent said “no,” and 6% said “yes.” The rest said “it depends.”

In 2020, the question was asked slightly differently: “Would you undertreat a patient’s pain for fear of addiction or Drug Enforcement Administration or medical board scrutiny?” This year, three times as many said “yes” (18%); 63% said “no.”

“Respondents this year talked about investigations and reprimands by medical boards, and how much they wanted to avoid that,” the survey authors wrote.
 

Should physicians be required to treat COVID-19 patients?

Some questions were new this year, including one on whether physicians should be required to treat COVID-19 patients. Fewer than half (47%) answered “yes,” 24% said “no,” and 29% answered “it depends.”

Doctors’ answers to this question differed slightly by gender: Fifty percent of men and 43% of women said “yes.” In their responses, many physicians said consideration should be given to risk factors, such as age, underlying conditions, risk of family members, and availability of personal protective equipment (PPE).

Another pandemic-related question asked whether physicians felt they should correct physicians who post misinformation about the pandemic on social media. Half (50%) said “yes,” 19% said “no,” and 31% said “it depends.”
 

Speaking out against the workplace

This year, many physicians have felt betrayed when they didn’t have adequate PPE during the pandemic.

Asked, “Is it right to speak out against your hospital or workplace when they don’t give you what you need?” 53% of physicians said “yes,” 8% said “no,” and 40% said “it depends.”

A cardiologist made the value judgment this way: “Speaking out just because you had an argument with your boss is inappropriate. Bringing to the public repeated failures to correct situations that have been brought through the proper channels is necessary to incite change.”
 

Random drug testing for physicians?

Another question in the survey asked whether physicians should be subjected to random drug testing for alcohol and drug abuse. About one-third (34%) said yes, 43% said no, and 23% said “it depends.” A study found that between 10% and 15% of physicians have abused a substance at some point in their careers.

The subject continues to hit a nerve in medicine.

A family physician wrote, “This should not be done unless a particular physician had a problem with drug or alcohol abuse and shows signs of impairment.”

An internist took a different view, saying, “Military service men and women, police, firefighters, airline pilots, and other professions that have responsibilities affecting people’s lives are subject to testing; why not physicians?”
 

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

More patients are surviving critical illnesses requiring ICU care but many emerge with physical debility that may or may not eventually resolve.

Over the past decade, functional status deterioration after critical illness has become more common and of greater magnitude, despite concurrent efforts to reduce post–intensive care syndrome, based on a retrospective analysis of more than 100,000 patients.

Almost one-third of patients who survived nonsurgical ICU admission had evidence of functional status decline, reported lead author Nicholas E. Ingraham, MD, of the University of Minnesota, Minneapolis, and colleagues.

“Increasing capacity and decreasing mortality have created an evolving and diverse population of ICU survivors,” the investigators wrote in Critical Care Medicine. “Today’s survivors of critical illness are increasingly burdened by extensive physical and psychological comorbidities, often resulting in reduced quality of life.”

To determine trends in post–intensive care syndrome from 2008 to 2016, Dr. Ingraham and colleagues analyzed data from the Cerner Acute Physiology and Chronic Health Evaluation outcomes database, a national prospective cohort. Out of 202,786 adult patients admitted to the ICU, 129,917 were eligible for the study. Patients were excluded because of surgical admission, death, lack of functional status documentation, or inadequate hospital size or duration of participation. The final dataset had a median age of 63 years, with a slight predominance of male patients (54.0%). Most patients (80.9%) were White.

The primary outcome was defined as presence or absence of functional status deterioration, based on functional status at admission versus time of discharge. The secondary outcome was magnitude of deterioration over time.

The analysis, which controlled for age and severity of illness, revealed concerning trends for both outcomes.

Across the entire cohort 38,116 patients (29.3%) had functional status deterioration, with a 15% increase in prevalence over the course of the decade that spanned all disease categories (prevalence rate ratio, 1.15; 95% confidence interval, 1.13-1.17; P < .001). The magnitude of functional status decline also increased by 4% (odds ratio, 1.04; P < .001), with all but nonsurgical trauma patients showing greater deterioration over time.

“However, despite the decreasing magnitude of functional status deterioration in nonsurgical trauma, many admission diagnoses in this category remain in the top quartile of higher risk for functional status deterioration,” the investigators noted.

Functional status decline was most common among patients with head and polytrauma (OR, 3.39), followed closely by chest and spine trauma (OR, 3.38), and spine trauma (OR, 3.19). The top quartile of categories for prevalence of deterioration included nonsurgical trauma, neurologic, pulmonary, and gastrointestinal diseases.

Functional status decline was least common among patients diagnosed with diabetic ketoacidosis (OR, 0.27) or asthma (OR, 0.35).

“We believe our study provides important information that can be used in beginning to identify patients at high risk of functional status decline,” the investigators concluded. “Improving the identification of these patients and targeting appropriate interventions to mitigate this decline will be important directions for future studies in this area.”

According to David L. Bowton, MD, FCCP, professor emeritus, section on critical care, Wake Forest Baptist Health, Winston-Salem, N.C., the findings show just how common functional decline is after critical illness, and may actually underestimate prevalence.

“Because the authors employed a course evaluation tool employing only three categories of ability/disability and abstracted the level of disability from the medical record, they likely underestimated the frequency of clinically important, though not detected, disability at the time of hospital discharge,” Dr. Bowton said. “The study did not address cognitive impairment which can be detected in half of patients at 3 months following critical illness, and which significantly affects patients’ quality of life (Am J Respir Crit Care Med. 2020;202[2]:193-201).”

Dr. Bowton suggested that evidence-based methods of preventing post–intensive care syndrome are limited.

“Current efforts to improve post-ICU functional and cognitive outcomes suffer from the lack of proven effective interventions (Crit Care Med. 2019;47[11]:1607-18),” he said. “Observational data indicates that compliance with the ABCDEF bundle decreases the duration and incidence of delirium, ICU length of stay, duration of mechanical ventilation, and mortality (Crit Care Med. 2019;47[1]:3-14). However, the implications of these improvements on postdischarge functional outcomes are unknown as area the relative importance of individual elements of the bundle. Early mobility and patient and family diaries appear to improve functional status at discharge and postdischarge anxiety and depression, though the evidence supporting this is thin.”

Appropriate intervention may be especially challenging during the COVID-19 pandemic, he added.

“The impact of COVID on ICU staffing adequacy and stress is significant and the impact on quality bundle compliance and the availability of support services is currently not clear, but likely to be detrimental, especially to support services such as physical therapy that are already commonly understaffed,” Dr. Bowton said.

The study was supported by grants from the University of Minnesota’s Critical Care Research and Programmatic Development Program; the National Heart, Lung, and Blood Institute; and the University of Minnesota Clinical and Translational Science via the National Center for Advancing Translational Sciences. The investigators reported financial relationships with no other relevant organizations. Dr. Bowton reported no conflicts of interest.

SOURCE: Ingraham NE et al. Crit Care Med. 2020 Nov. doi: 10.1097/CCM.0000000000004524.

More patients are surviving critical illnesses requiring ICU care but many emerge with physical debility that may or may not eventually resolve.

Over the past decade, functional status deterioration after critical illness has become more common and of greater magnitude, despite concurrent efforts to reduce post–intensive care syndrome, based on a retrospective analysis of more than 100,000 patients.

Almost one-third of patients who survived nonsurgical ICU admission had evidence of functional status decline, reported lead author Nicholas E. Ingraham, MD, of the University of Minnesota, Minneapolis, and colleagues.

“Increasing capacity and decreasing mortality have created an evolving and diverse population of ICU survivors,” the investigators wrote in Critical Care Medicine. “Today’s survivors of critical illness are increasingly burdened by extensive physical and psychological comorbidities, often resulting in reduced quality of life.”

To determine trends in post–intensive care syndrome from 2008 to 2016, Dr. Ingraham and colleagues analyzed data from the Cerner Acute Physiology and Chronic Health Evaluation outcomes database, a national prospective cohort. Out of 202,786 adult patients admitted to the ICU, 129,917 were eligible for the study. Patients were excluded because of surgical admission, death, lack of functional status documentation, or inadequate hospital size or duration of participation. The final dataset had a median age of 63 years, with a slight predominance of male patients (54.0%). Most patients (80.9%) were White.

The primary outcome was defined as presence or absence of functional status deterioration, based on functional status at admission versus time of discharge. The secondary outcome was magnitude of deterioration over time.

The analysis, which controlled for age and severity of illness, revealed concerning trends for both outcomes.

Across the entire cohort 38,116 patients (29.3%) had functional status deterioration, with a 15% increase in prevalence over the course of the decade that spanned all disease categories (prevalence rate ratio, 1.15; 95% confidence interval, 1.13-1.17; P < .001). The magnitude of functional status decline also increased by 4% (odds ratio, 1.04; P < .001), with all but nonsurgical trauma patients showing greater deterioration over time.

“However, despite the decreasing magnitude of functional status deterioration in nonsurgical trauma, many admission diagnoses in this category remain in the top quartile of higher risk for functional status deterioration,” the investigators noted.

Functional status decline was most common among patients with head and polytrauma (OR, 3.39), followed closely by chest and spine trauma (OR, 3.38), and spine trauma (OR, 3.19). The top quartile of categories for prevalence of deterioration included nonsurgical trauma, neurologic, pulmonary, and gastrointestinal diseases.

Functional status decline was least common among patients diagnosed with diabetic ketoacidosis (OR, 0.27) or asthma (OR, 0.35).

“We believe our study provides important information that can be used in beginning to identify patients at high risk of functional status decline,” the investigators concluded. “Improving the identification of these patients and targeting appropriate interventions to mitigate this decline will be important directions for future studies in this area.”

According to David L. Bowton, MD, FCCP, professor emeritus, section on critical care, Wake Forest Baptist Health, Winston-Salem, N.C., the findings show just how common functional decline is after critical illness, and may actually underestimate prevalence.

“Because the authors employed a course evaluation tool employing only three categories of ability/disability and abstracted the level of disability from the medical record, they likely underestimated the frequency of clinically important, though not detected, disability at the time of hospital discharge,” Dr. Bowton said. “The study did not address cognitive impairment which can be detected in half of patients at 3 months following critical illness, and which significantly affects patients’ quality of life (Am J Respir Crit Care Med. 2020;202[2]:193-201).”

Dr. Bowton suggested that evidence-based methods of preventing post–intensive care syndrome are limited.

“Current efforts to improve post-ICU functional and cognitive outcomes suffer from the lack of proven effective interventions (Crit Care Med. 2019;47[11]:1607-18),” he said. “Observational data indicates that compliance with the ABCDEF bundle decreases the duration and incidence of delirium, ICU length of stay, duration of mechanical ventilation, and mortality (Crit Care Med. 2019;47[1]:3-14). However, the implications of these improvements on postdischarge functional outcomes are unknown as area the relative importance of individual elements of the bundle. Early mobility and patient and family diaries appear to improve functional status at discharge and postdischarge anxiety and depression, though the evidence supporting this is thin.”

Appropriate intervention may be especially challenging during the COVID-19 pandemic, he added.

“The impact of COVID on ICU staffing adequacy and stress is significant and the impact on quality bundle compliance and the availability of support services is currently not clear, but likely to be detrimental, especially to support services such as physical therapy that are already commonly understaffed,” Dr. Bowton said.

The study was supported by grants from the University of Minnesota’s Critical Care Research and Programmatic Development Program; the National Heart, Lung, and Blood Institute; and the University of Minnesota Clinical and Translational Science via the National Center for Advancing Translational Sciences. The investigators reported financial relationships with no other relevant organizations. Dr. Bowton reported no conflicts of interest.

SOURCE: Ingraham NE et al. Crit Care Med. 2020 Nov. doi: 10.1097/CCM.0000000000004524.

More patients are surviving critical illnesses requiring ICU care but many emerge with physical debility that may or may not eventually resolve.

Over the past decade, functional status deterioration after critical illness has become more common and of greater magnitude, despite concurrent efforts to reduce post–intensive care syndrome, based on a retrospective analysis of more than 100,000 patients.

Almost one-third of patients who survived nonsurgical ICU admission had evidence of functional status decline, reported lead author Nicholas E. Ingraham, MD, of the University of Minnesota, Minneapolis, and colleagues.

“Increasing capacity and decreasing mortality have created an evolving and diverse population of ICU survivors,” the investigators wrote in Critical Care Medicine. “Today’s survivors of critical illness are increasingly burdened by extensive physical and psychological comorbidities, often resulting in reduced quality of life.”

To determine trends in post–intensive care syndrome from 2008 to 2016, Dr. Ingraham and colleagues analyzed data from the Cerner Acute Physiology and Chronic Health Evaluation outcomes database, a national prospective cohort. Out of 202,786 adult patients admitted to the ICU, 129,917 were eligible for the study. Patients were excluded because of surgical admission, death, lack of functional status documentation, or inadequate hospital size or duration of participation. The final dataset had a median age of 63 years, with a slight predominance of male patients (54.0%). Most patients (80.9%) were White.

The primary outcome was defined as presence or absence of functional status deterioration, based on functional status at admission versus time of discharge. The secondary outcome was magnitude of deterioration over time.

The analysis, which controlled for age and severity of illness, revealed concerning trends for both outcomes.

Across the entire cohort 38,116 patients (29.3%) had functional status deterioration, with a 15% increase in prevalence over the course of the decade that spanned all disease categories (prevalence rate ratio, 1.15; 95% confidence interval, 1.13-1.17; P < .001). The magnitude of functional status decline also increased by 4% (odds ratio, 1.04; P < .001), with all but nonsurgical trauma patients showing greater deterioration over time.

“However, despite the decreasing magnitude of functional status deterioration in nonsurgical trauma, many admission diagnoses in this category remain in the top quartile of higher risk for functional status deterioration,” the investigators noted.

Functional status decline was most common among patients with head and polytrauma (OR, 3.39), followed closely by chest and spine trauma (OR, 3.38), and spine trauma (OR, 3.19). The top quartile of categories for prevalence of deterioration included nonsurgical trauma, neurologic, pulmonary, and gastrointestinal diseases.

Functional status decline was least common among patients diagnosed with diabetic ketoacidosis (OR, 0.27) or asthma (OR, 0.35).

“We believe our study provides important information that can be used in beginning to identify patients at high risk of functional status decline,” the investigators concluded. “Improving the identification of these patients and targeting appropriate interventions to mitigate this decline will be important directions for future studies in this area.”

According to David L. Bowton, MD, FCCP, professor emeritus, section on critical care, Wake Forest Baptist Health, Winston-Salem, N.C., the findings show just how common functional decline is after critical illness, and may actually underestimate prevalence.

“Because the authors employed a course evaluation tool employing only three categories of ability/disability and abstracted the level of disability from the medical record, they likely underestimated the frequency of clinically important, though not detected, disability at the time of hospital discharge,” Dr. Bowton said. “The study did not address cognitive impairment which can be detected in half of patients at 3 months following critical illness, and which significantly affects patients’ quality of life (Am J Respir Crit Care Med. 2020;202[2]:193-201).”

Dr. Bowton suggested that evidence-based methods of preventing post–intensive care syndrome are limited.

“Current efforts to improve post-ICU functional and cognitive outcomes suffer from the lack of proven effective interventions (Crit Care Med. 2019;47[11]:1607-18),” he said. “Observational data indicates that compliance with the ABCDEF bundle decreases the duration and incidence of delirium, ICU length of stay, duration of mechanical ventilation, and mortality (Crit Care Med. 2019;47[1]:3-14). However, the implications of these improvements on postdischarge functional outcomes are unknown as area the relative importance of individual elements of the bundle. Early mobility and patient and family diaries appear to improve functional status at discharge and postdischarge anxiety and depression, though the evidence supporting this is thin.”

Appropriate intervention may be especially challenging during the COVID-19 pandemic, he added.

“The impact of COVID on ICU staffing adequacy and stress is significant and the impact on quality bundle compliance and the availability of support services is currently not clear, but likely to be detrimental, especially to support services such as physical therapy that are already commonly understaffed,” Dr. Bowton said.

The study was supported by grants from the University of Minnesota’s Critical Care Research and Programmatic Development Program; the National Heart, Lung, and Blood Institute; and the University of Minnesota Clinical and Translational Science via the National Center for Advancing Translational Sciences. The investigators reported financial relationships with no other relevant organizations. Dr. Bowton reported no conflicts of interest.

SOURCE: Ingraham NE et al. Crit Care Med. 2020 Nov. doi: 10.1097/CCM.0000000000004524.

COVID-19 patients who survive their hospitalization don’t leave the disease behind upon discharge, as a significant percentage died within 60 days of discharge, with an ICU admission heightening the risk, according to an observational study of 38 Michigan hospitals. What’s more, many of them were burdened with health and emotional challenges ranging from hospital readmission to job loss and financial problems.

“These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses,” wrote lead author Vineet Chopra, MBBS, of the University of Michigan, Ann Arbor, and colleagues (Ann Intern Med. 2020 Nov 11: doi: 10.7326/M20-5661)

The researchers found that 29.2% of all patients hospitalized for COVID-19 from March 16 to July 1 died. The observational cohort study included 1,648 COVID-19 patients hospitalized at 38 Michigan hospitals participating in a statewide collaborative.

The bulk of those deaths occurred during hospitalization: 24.2% of patients (n = 398). Of the 1,250 patients discharged, 78% (n = 975) went home and 12.6% (n = 158) went to a skilled nursing facility, with the remainder unaccounted for. Within 60 days of discharge, 6.7% (n = 84) of hospitalized survivors had died and 15.2% (n = 189) were readmitted. The researchers gathered 60-day postdischarge data via a telephone survey, contacting 41.8% (n = 488) of discharged patients.

Outcomes were even worse for discharged patients who spent time in the ICU. The death rate among this group was 10.4% (17 of 165) after discharge. That resulted in an overall study death rate of 63.5% (n = 257) for the 405 patients who were in the ICU.

While the study data were in the first wave of the novel coronavirus, the findings have relevance today, said Mary Jo Farmer, MD, PhD, FCCP, directory of pulmonary hypertension services at Baystate Health in Springfield, Mass.

“This is the best information we have to date,” she said. “We have to continue to have an open mind and expect that this information may change as the virus possibly mutates as it spreads, and we should continue doing these types of outcomes studies at 90 days, 120 days, etc.”

The median age of study patients was 62, with a range of 50-72. The three leading comorbidities among discharged patients were hypertension (n = 800, 64%), diabetes (34.9%, n = 436), and cardiovascular disease (24.1%, n = 301).

Poor postdischarge outcomes weren’t limited to mortality and readmission. Almost 19% (n = 92) reported new or worsening cardiopulmonary symptoms such as cough and dyspnea, 13.3% had a persistent loss of taste or smell, and 12% (n = 58) reported more difficulty with daily living tasks.

The after-effects were not only physical. Nearly half of discharged patients (48.7%, n = 238) reported emotional effects and almost 6% (n = 28) sought mental health care. Among the 40% (n = 195) employed before they were hospitalized, 36% (n = 78) couldn’t return to work because of health issues or layoffs. Sixty percent (n = 117) of the pre-employed discharged patients did return to work, but 25% (n = 30) did so with reduced hours or modified job duties because of health problems.

Financial problems were also a burden. More than a third, 36.7% (n = 179), reported some financial impact from their hospitalization. About 10% (n = 47) said they used most or all of their savings, and 7% (n = 35) said they resorted to rationing necessities such as food or medications.

The researchers noted that one in five patients had no primary care follow-up at 2 months post discharge. “Collectively, these findings suggest that better models to support COVID-19 survivors are necessary,” said Dr. Chopra and colleagues.

The postdischarge course for patients involves two humps, said Sachin Gupta, MD, FCCP a pulmonary and critical care specialist at Alameda Health System in Oakland, Calif.: Getting over the hospitalization itself and the recovery phase. “As you look at the median age of the survivors, elderly patients who survive a hospital stay are still going to have a period of recovery, and like any viral illness that leads to someone being hospitalized, when you have an elderly patient with comorbidities, not all of them can make it over that final hump.”

SOURCE: Chopra V et al. Ann Intern Med. 2020 Nov 11. doi: 10.7326/M20-5661.

COVID-19 patients who survive their hospitalization don’t leave the disease behind upon discharge, as a significant percentage died within 60 days of discharge, with an ICU admission heightening the risk, according to an observational study of 38 Michigan hospitals. What’s more, many of them were burdened with health and emotional challenges ranging from hospital readmission to job loss and financial problems.

“These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses,” wrote lead author Vineet Chopra, MBBS, of the University of Michigan, Ann Arbor, and colleagues (Ann Intern Med. 2020 Nov 11: doi: 10.7326/M20-5661)

The researchers found that 29.2% of all patients hospitalized for COVID-19 from March 16 to July 1 died. The observational cohort study included 1,648 COVID-19 patients hospitalized at 38 Michigan hospitals participating in a statewide collaborative.

The bulk of those deaths occurred during hospitalization: 24.2% of patients (n = 398). Of the 1,250 patients discharged, 78% (n = 975) went home and 12.6% (n = 158) went to a skilled nursing facility, with the remainder unaccounted for. Within 60 days of discharge, 6.7% (n = 84) of hospitalized survivors had died and 15.2% (n = 189) were readmitted. The researchers gathered 60-day postdischarge data via a telephone survey, contacting 41.8% (n = 488) of discharged patients.

Outcomes were even worse for discharged patients who spent time in the ICU. The death rate among this group was 10.4% (17 of 165) after discharge. That resulted in an overall study death rate of 63.5% (n = 257) for the 405 patients who were in the ICU.

While the study data were in the first wave of the novel coronavirus, the findings have relevance today, said Mary Jo Farmer, MD, PhD, FCCP, directory of pulmonary hypertension services at Baystate Health in Springfield, Mass.

“This is the best information we have to date,” she said. “We have to continue to have an open mind and expect that this information may change as the virus possibly mutates as it spreads, and we should continue doing these types of outcomes studies at 90 days, 120 days, etc.”

The median age of study patients was 62, with a range of 50-72. The three leading comorbidities among discharged patients were hypertension (n = 800, 64%), diabetes (34.9%, n = 436), and cardiovascular disease (24.1%, n = 301).

Poor postdischarge outcomes weren’t limited to mortality and readmission. Almost 19% (n = 92) reported new or worsening cardiopulmonary symptoms such as cough and dyspnea, 13.3% had a persistent loss of taste or smell, and 12% (n = 58) reported more difficulty with daily living tasks.

The after-effects were not only physical. Nearly half of discharged patients (48.7%, n = 238) reported emotional effects and almost 6% (n = 28) sought mental health care. Among the 40% (n = 195) employed before they were hospitalized, 36% (n = 78) couldn’t return to work because of health issues or layoffs. Sixty percent (n = 117) of the pre-employed discharged patients did return to work, but 25% (n = 30) did so with reduced hours or modified job duties because of health problems.

Financial problems were also a burden. More than a third, 36.7% (n = 179), reported some financial impact from their hospitalization. About 10% (n = 47) said they used most or all of their savings, and 7% (n = 35) said they resorted to rationing necessities such as food or medications.

The researchers noted that one in five patients had no primary care follow-up at 2 months post discharge. “Collectively, these findings suggest that better models to support COVID-19 survivors are necessary,” said Dr. Chopra and colleagues.

The postdischarge course for patients involves two humps, said Sachin Gupta, MD, FCCP a pulmonary and critical care specialist at Alameda Health System in Oakland, Calif.: Getting over the hospitalization itself and the recovery phase. “As you look at the median age of the survivors, elderly patients who survive a hospital stay are still going to have a period of recovery, and like any viral illness that leads to someone being hospitalized, when you have an elderly patient with comorbidities, not all of them can make it over that final hump.”

SOURCE: Chopra V et al. Ann Intern Med. 2020 Nov 11. doi: 10.7326/M20-5661.

COVID-19 patients who survive their hospitalization don’t leave the disease behind upon discharge, as a significant percentage died within 60 days of discharge, with an ICU admission heightening the risk, according to an observational study of 38 Michigan hospitals. What’s more, many of them were burdened with health and emotional challenges ranging from hospital readmission to job loss and financial problems.

“These data confirm that the toll of COVID-19 extends well beyond hospitalization, a finding consistent with long-term sequelae from sepsis and other severe respiratory viral illnesses,” wrote lead author Vineet Chopra, MBBS, of the University of Michigan, Ann Arbor, and colleagues (Ann Intern Med. 2020 Nov 11: doi: 10.7326/M20-5661)

The researchers found that 29.2% of all patients hospitalized for COVID-19 from March 16 to July 1 died. The observational cohort study included 1,648 COVID-19 patients hospitalized at 38 Michigan hospitals participating in a statewide collaborative.

The bulk of those deaths occurred during hospitalization: 24.2% of patients (n = 398). Of the 1,250 patients discharged, 78% (n = 975) went home and 12.6% (n = 158) went to a skilled nursing facility, with the remainder unaccounted for. Within 60 days of discharge, 6.7% (n = 84) of hospitalized survivors had died and 15.2% (n = 189) were readmitted. The researchers gathered 60-day postdischarge data via a telephone survey, contacting 41.8% (n = 488) of discharged patients.

Outcomes were even worse for discharged patients who spent time in the ICU. The death rate among this group was 10.4% (17 of 165) after discharge. That resulted in an overall study death rate of 63.5% (n = 257) for the 405 patients who were in the ICU.

While the study data were in the first wave of the novel coronavirus, the findings have relevance today, said Mary Jo Farmer, MD, PhD, FCCP, directory of pulmonary hypertension services at Baystate Health in Springfield, Mass.

“This is the best information we have to date,” she said. “We have to continue to have an open mind and expect that this information may change as the virus possibly mutates as it spreads, and we should continue doing these types of outcomes studies at 90 days, 120 days, etc.”

The median age of study patients was 62, with a range of 50-72. The three leading comorbidities among discharged patients were hypertension (n = 800, 64%), diabetes (34.9%, n = 436), and cardiovascular disease (24.1%, n = 301).

Poor postdischarge outcomes weren’t limited to mortality and readmission. Almost 19% (n = 92) reported new or worsening cardiopulmonary symptoms such as cough and dyspnea, 13.3% had a persistent loss of taste or smell, and 12% (n = 58) reported more difficulty with daily living tasks.

The after-effects were not only physical. Nearly half of discharged patients (48.7%, n = 238) reported emotional effects and almost 6% (n = 28) sought mental health care. Among the 40% (n = 195) employed before they were hospitalized, 36% (n = 78) couldn’t return to work because of health issues or layoffs. Sixty percent (n = 117) of the pre-employed discharged patients did return to work, but 25% (n = 30) did so with reduced hours or modified job duties because of health problems.

Financial problems were also a burden. More than a third, 36.7% (n = 179), reported some financial impact from their hospitalization. About 10% (n = 47) said they used most or all of their savings, and 7% (n = 35) said they resorted to rationing necessities such as food or medications.

The researchers noted that one in five patients had no primary care follow-up at 2 months post discharge. “Collectively, these findings suggest that better models to support COVID-19 survivors are necessary,” said Dr. Chopra and colleagues.

The postdischarge course for patients involves two humps, said Sachin Gupta, MD, FCCP a pulmonary and critical care specialist at Alameda Health System in Oakland, Calif.: Getting over the hospitalization itself and the recovery phase. “As you look at the median age of the survivors, elderly patients who survive a hospital stay are still going to have a period of recovery, and like any viral illness that leads to someone being hospitalized, when you have an elderly patient with comorbidities, not all of them can make it over that final hump.”

SOURCE: Chopra V et al. Ann Intern Med. 2020 Nov 11. doi: 10.7326/M20-5661.