Neil Osterweil

The words “you have colorectal cancer” can concentrate a patient’s mind, but certainly not in the way that the clinician delivering the bad news intends.

“A lot of my patients, frankly, have told me that on the first visit the only thing they really hear is the diagnosis of cancer, confirming a malignancy, and everything else that follows is what I call the ‘2 minutes of terror.’ Everything else gets drowned out, and they don’t hear my comments on diseases and sometimes my hopefully reassuring comments on prognosis,” said Mark A. Lewis, MD, director of the gastrointestinal oncology program at Intermountain Healthcare in Murray, Utah, who is himself a survivor of a rare cancer.

An estimated 150,000 people hear something like “you have colorectal cancer” in the United States each year, according to American Cancer Society estimates.

Even before the diagnosis, the patient, still groggy from sedation after a colonoscopy, may wake up and be told “we’ve found something; I’ll call you in a few days when we get the pathology results.”

You don’t have to be a psychiatrist to understand that times of great emotional upheaval, stress, or uncertainty are not ideal for decision-making, especially when the person who is asked to decide is facing a challenge that may seem overwhelmingly complex.

Many patients’ first thoughts are to go online for information, but that too can be overwhelming. For example, a Google search for the words “colorectal cancer” turns up roughly 134 million results, in six-tenths of a second, no less.

There are of course solid, reliable sources for information out there, and reliable information is a very good place to start, as noted by the staff at the Mayo Clinic in Rochester, Minn.

The Mayo website offers 11 tips with for coping with a cancer diagnosis. First among the recommendations is “get the facts about your cancer diagnosis,” and that’s the inspiration behind CRC POP.

Text COLON to 484848

“There are 13,000 of us gastroenterologists in the country, and we diagnosis colorectal cancer 150,000 times a year,” said CRC POP program creator Brian Dooreck, MD, from Memorial Healthcare System in Pembroke Pines, Fla.

When the doctor tells patients the results “their world is turned upside down, they’re shocked, and they don’t pick up much after the word ‘cancer’,” Dr. Dooreck said in an interview.

Both Dr. Dooreck and Dr. Lewis noted that, after going home with a diagnosis of colorectal cancer, a large majority of patients will go online to find information about their diagnosis.

“We know from studies and anecdotal experience that the odds that someone will try to research their own diagnosis are in the 97% range, and then they’re going to run into the pluses and minuses of search engine optimization,” Dr. Lewis said.

As even the most casual Internet user can attest, available medical information can range from the practical to the preposterous, from the National Cancer Institute’s Cancer.gov to a Facebook post on Aunt Tillie’s miracle mayonnaise cure. Helping patients to quickly identify which resources are valuable and trustworthy is the overarching goal of CRC POP, Dr. Dooreck explained.

“What we created with the Colorectal Cancer Provider Outreach Program is that it now allows gastroenterologists to have a conversation with a patient – I can say ‘Now listen, take out your phone, and text the world COLON and send it to 484848.”

Doing so returns a text in a few seconds with the words “You are not alone. You have our support. Here. Now,” and a blue heart emoji, followed by a link that takes the user to a web page with a document containing contact information for the ACS, Colorectal Cancer Alliance, Fight Colorectal Cancer, Colon Cancer Coalition, and Colon Cancer Foundation. Free resources offered by the various organizations include a helpline staffed 24 hours a day (ACS), peer support online or one-to-one and financial assistance (Colorectal Cancer Alliance), access to screening for the under- and uninsured in select areas (Colon Cancer Coalition), and links to a colorectal cancer patient registry (Colon Cancer Foundation).

“I can tell patients ‘Hey listen, go home, call these groups, get on their websites. I’ll call you in a week; call me if you need me. We’re gonna figure this thing out together,’ ” Dr. Dooreck said. “This is a great place to get resources here and now. It’s a very different shift from going home without anything other than a treatment plan.”

No gain – except helping patients

After Dr. Dooreck conceived of CRC POP, in September 2020, he described his plan for consolidating links to free resources in a video conference with the organizations he aimed to include. The organizations immediately agreed, and the text-based service, with technology provided free of charge by the marketing company EZ Texting, went live the following month.

“There’s no hook, there’s no cost, there’s no sale, it’s not monetized. There’s no gain except helping people,” Dr. Dooreck emphasized.

Dr. Lewis agreed: “I think it’s a great initiative, and it helps unify some of the guidance we give these folks.”

Dr. Lewis has the rare perspective of seeing the issue from standpoint of both an oncologist and a patient: Early in his hematology-oncology fellowship at the Mayo Clinic in 2009, he was diagnosed with multiple endocrine neoplasia type 1, and he subsequently underwent surgery to resect pancreatic neuroendocrine tumors.

He says that the buy-in for CRC POP from major support organizations and from gastroenterologists alike is important because most colonoscopies are performed and diagnoses are made in community settings by gastroenterologists who may or may not have formal connections with a cancer center, rather than in large urban or suburban networks affiliated with medical schools.

In most cases, he said, the gastroenterologist makes the CRC diagnosis, and hands the patient off to a surgeon, who may connect with a medical oncologist and/or radiation oncologist depending on the individual patient’s circumstance. This process can take weeks, and in the meantime, patients are left in limbo.

Offering patients multiple trustworthy resources through a simple text message is a particularly appealing part of the CRC POP initiative, and can help patients feel that they are more in control of their care, Dr. Lewis said.

Useful resources, multidisciplinary care

The connection to resources offered by CRC POP is valuable and may be especially helpful for community-based or small gastroenterology practices; on the other hand, large academic medical centers may be able to provide more resources on their own.

“We have home-grown support services that we make available to patients if they either ask for them or if we ascertain that those services would be important components of their care,” Caroline Kuhlman, a nurse practitioner from The Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Cancer Center in Boston, explained in an interview. “Our approach to a newly diagnosed patient happens in the context of a multidisciplinary visit.”

“Newly diagnosed patients meet with a surgeon, a medical oncologist, sometimes a radiation oncologist if that’s going to be a part their care, and whenever possible during the same outpatient visit. Patients are also provided with written information about colon cancer, and we have a patient resource center that has even more information about support from various organizations,” she said.

Patients can also be referred as needed to other resources within the hospital system, including nutritionists, social workers who can help to determine whether patients could benefit from additional social and financial support, and educational resources such as information sessions on what to expect if they receive chemotherapy.

Similarly, Dr. Lewis said that, at Intermountain Health Care, patients newly diagnosed with cancer are contacted within 24 hours by patient navigators who help them manage concerns and expectations about their care and connect them to resources both in the hospital and the community.

Although their own practices differ in size and scope and in the resources they can offer patients, the clinicians interviewed for this article agreed with the central message and purpose of CRC POP: “You are not alone. You have our support.”

Dr. Lewis, Dr. Dooreck, and Ms. Kuhlman reported having no conflicts of interest relevant to the subjects discussed in this article.

The words “you have colorectal cancer” can concentrate a patient’s mind, but certainly not in the way that the clinician delivering the bad news intends.

“A lot of my patients, frankly, have told me that on the first visit the only thing they really hear is the diagnosis of cancer, confirming a malignancy, and everything else that follows is what I call the ‘2 minutes of terror.’ Everything else gets drowned out, and they don’t hear my comments on diseases and sometimes my hopefully reassuring comments on prognosis,” said Mark A. Lewis, MD, director of the gastrointestinal oncology program at Intermountain Healthcare in Murray, Utah, who is himself a survivor of a rare cancer.

An estimated 150,000 people hear something like “you have colorectal cancer” in the United States each year, according to American Cancer Society estimates.

Even before the diagnosis, the patient, still groggy from sedation after a colonoscopy, may wake up and be told “we’ve found something; I’ll call you in a few days when we get the pathology results.”

You don’t have to be a psychiatrist to understand that times of great emotional upheaval, stress, or uncertainty are not ideal for decision-making, especially when the person who is asked to decide is facing a challenge that may seem overwhelmingly complex.

Many patients’ first thoughts are to go online for information, but that too can be overwhelming. For example, a Google search for the words “colorectal cancer” turns up roughly 134 million results, in six-tenths of a second, no less.

There are of course solid, reliable sources for information out there, and reliable information is a very good place to start, as noted by the staff at the Mayo Clinic in Rochester, Minn.

The Mayo website offers 11 tips with for coping with a cancer diagnosis. First among the recommendations is “get the facts about your cancer diagnosis,” and that’s the inspiration behind CRC POP.

Text COLON to 484848

“There are 13,000 of us gastroenterologists in the country, and we diagnosis colorectal cancer 150,000 times a year,” said CRC POP program creator Brian Dooreck, MD, from Memorial Healthcare System in Pembroke Pines, Fla.

When the doctor tells patients the results “their world is turned upside down, they’re shocked, and they don’t pick up much after the word ‘cancer’,” Dr. Dooreck said in an interview.

Both Dr. Dooreck and Dr. Lewis noted that, after going home with a diagnosis of colorectal cancer, a large majority of patients will go online to find information about their diagnosis.

“We know from studies and anecdotal experience that the odds that someone will try to research their own diagnosis are in the 97% range, and then they’re going to run into the pluses and minuses of search engine optimization,” Dr. Lewis said.

As even the most casual Internet user can attest, available medical information can range from the practical to the preposterous, from the National Cancer Institute’s Cancer.gov to a Facebook post on Aunt Tillie’s miracle mayonnaise cure. Helping patients to quickly identify which resources are valuable and trustworthy is the overarching goal of CRC POP, Dr. Dooreck explained.

“What we created with the Colorectal Cancer Provider Outreach Program is that it now allows gastroenterologists to have a conversation with a patient – I can say ‘Now listen, take out your phone, and text the world COLON and send it to 484848.”

Doing so returns a text in a few seconds with the words “You are not alone. You have our support. Here. Now,” and a blue heart emoji, followed by a link that takes the user to a web page with a document containing contact information for the ACS, Colorectal Cancer Alliance, Fight Colorectal Cancer, Colon Cancer Coalition, and Colon Cancer Foundation. Free resources offered by the various organizations include a helpline staffed 24 hours a day (ACS), peer support online or one-to-one and financial assistance (Colorectal Cancer Alliance), access to screening for the under- and uninsured in select areas (Colon Cancer Coalition), and links to a colorectal cancer patient registry (Colon Cancer Foundation).

“I can tell patients ‘Hey listen, go home, call these groups, get on their websites. I’ll call you in a week; call me if you need me. We’re gonna figure this thing out together,’ ” Dr. Dooreck said. “This is a great place to get resources here and now. It’s a very different shift from going home without anything other than a treatment plan.”

No gain – except helping patients

After Dr. Dooreck conceived of CRC POP, in September 2020, he described his plan for consolidating links to free resources in a video conference with the organizations he aimed to include. The organizations immediately agreed, and the text-based service, with technology provided free of charge by the marketing company EZ Texting, went live the following month.

“There’s no hook, there’s no cost, there’s no sale, it’s not monetized. There’s no gain except helping people,” Dr. Dooreck emphasized.

Dr. Lewis agreed: “I think it’s a great initiative, and it helps unify some of the guidance we give these folks.”

Dr. Lewis has the rare perspective of seeing the issue from standpoint of both an oncologist and a patient: Early in his hematology-oncology fellowship at the Mayo Clinic in 2009, he was diagnosed with multiple endocrine neoplasia type 1, and he subsequently underwent surgery to resect pancreatic neuroendocrine tumors.

He says that the buy-in for CRC POP from major support organizations and from gastroenterologists alike is important because most colonoscopies are performed and diagnoses are made in community settings by gastroenterologists who may or may not have formal connections with a cancer center, rather than in large urban or suburban networks affiliated with medical schools.

In most cases, he said, the gastroenterologist makes the CRC diagnosis, and hands the patient off to a surgeon, who may connect with a medical oncologist and/or radiation oncologist depending on the individual patient’s circumstance. This process can take weeks, and in the meantime, patients are left in limbo.

Offering patients multiple trustworthy resources through a simple text message is a particularly appealing part of the CRC POP initiative, and can help patients feel that they are more in control of their care, Dr. Lewis said.

Useful resources, multidisciplinary care

The connection to resources offered by CRC POP is valuable and may be especially helpful for community-based or small gastroenterology practices; on the other hand, large academic medical centers may be able to provide more resources on their own.

“We have home-grown support services that we make available to patients if they either ask for them or if we ascertain that those services would be important components of their care,” Caroline Kuhlman, a nurse practitioner from The Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Cancer Center in Boston, explained in an interview. “Our approach to a newly diagnosed patient happens in the context of a multidisciplinary visit.”

“Newly diagnosed patients meet with a surgeon, a medical oncologist, sometimes a radiation oncologist if that’s going to be a part their care, and whenever possible during the same outpatient visit. Patients are also provided with written information about colon cancer, and we have a patient resource center that has even more information about support from various organizations,” she said.

Patients can also be referred as needed to other resources within the hospital system, including nutritionists, social workers who can help to determine whether patients could benefit from additional social and financial support, and educational resources such as information sessions on what to expect if they receive chemotherapy.

Similarly, Dr. Lewis said that, at Intermountain Health Care, patients newly diagnosed with cancer are contacted within 24 hours by patient navigators who help them manage concerns and expectations about their care and connect them to resources both in the hospital and the community.

Although their own practices differ in size and scope and in the resources they can offer patients, the clinicians interviewed for this article agreed with the central message and purpose of CRC POP: “You are not alone. You have our support.”

Dr. Lewis, Dr. Dooreck, and Ms. Kuhlman reported having no conflicts of interest relevant to the subjects discussed in this article.

The words “you have colorectal cancer” can concentrate a patient’s mind, but certainly not in the way that the clinician delivering the bad news intends.

“A lot of my patients, frankly, have told me that on the first visit the only thing they really hear is the diagnosis of cancer, confirming a malignancy, and everything else that follows is what I call the ‘2 minutes of terror.’ Everything else gets drowned out, and they don’t hear my comments on diseases and sometimes my hopefully reassuring comments on prognosis,” said Mark A. Lewis, MD, director of the gastrointestinal oncology program at Intermountain Healthcare in Murray, Utah, who is himself a survivor of a rare cancer.

An estimated 150,000 people hear something like “you have colorectal cancer” in the United States each year, according to American Cancer Society estimates.

Even before the diagnosis, the patient, still groggy from sedation after a colonoscopy, may wake up and be told “we’ve found something; I’ll call you in a few days when we get the pathology results.”

You don’t have to be a psychiatrist to understand that times of great emotional upheaval, stress, or uncertainty are not ideal for decision-making, especially when the person who is asked to decide is facing a challenge that may seem overwhelmingly complex.

Many patients’ first thoughts are to go online for information, but that too can be overwhelming. For example, a Google search for the words “colorectal cancer” turns up roughly 134 million results, in six-tenths of a second, no less.

There are of course solid, reliable sources for information out there, and reliable information is a very good place to start, as noted by the staff at the Mayo Clinic in Rochester, Minn.

The Mayo website offers 11 tips with for coping with a cancer diagnosis. First among the recommendations is “get the facts about your cancer diagnosis,” and that’s the inspiration behind CRC POP.

Text COLON to 484848

“There are 13,000 of us gastroenterologists in the country, and we diagnosis colorectal cancer 150,000 times a year,” said CRC POP program creator Brian Dooreck, MD, from Memorial Healthcare System in Pembroke Pines, Fla.

When the doctor tells patients the results “their world is turned upside down, they’re shocked, and they don’t pick up much after the word ‘cancer’,” Dr. Dooreck said in an interview.

Both Dr. Dooreck and Dr. Lewis noted that, after going home with a diagnosis of colorectal cancer, a large majority of patients will go online to find information about their diagnosis.

“We know from studies and anecdotal experience that the odds that someone will try to research their own diagnosis are in the 97% range, and then they’re going to run into the pluses and minuses of search engine optimization,” Dr. Lewis said.

As even the most casual Internet user can attest, available medical information can range from the practical to the preposterous, from the National Cancer Institute’s Cancer.gov to a Facebook post on Aunt Tillie’s miracle mayonnaise cure. Helping patients to quickly identify which resources are valuable and trustworthy is the overarching goal of CRC POP, Dr. Dooreck explained.

“What we created with the Colorectal Cancer Provider Outreach Program is that it now allows gastroenterologists to have a conversation with a patient – I can say ‘Now listen, take out your phone, and text the world COLON and send it to 484848.”

Doing so returns a text in a few seconds with the words “You are not alone. You have our support. Here. Now,” and a blue heart emoji, followed by a link that takes the user to a web page with a document containing contact information for the ACS, Colorectal Cancer Alliance, Fight Colorectal Cancer, Colon Cancer Coalition, and Colon Cancer Foundation. Free resources offered by the various organizations include a helpline staffed 24 hours a day (ACS), peer support online or one-to-one and financial assistance (Colorectal Cancer Alliance), access to screening for the under- and uninsured in select areas (Colon Cancer Coalition), and links to a colorectal cancer patient registry (Colon Cancer Foundation).

“I can tell patients ‘Hey listen, go home, call these groups, get on their websites. I’ll call you in a week; call me if you need me. We’re gonna figure this thing out together,’ ” Dr. Dooreck said. “This is a great place to get resources here and now. It’s a very different shift from going home without anything other than a treatment plan.”

No gain – except helping patients

After Dr. Dooreck conceived of CRC POP, in September 2020, he described his plan for consolidating links to free resources in a video conference with the organizations he aimed to include. The organizations immediately agreed, and the text-based service, with technology provided free of charge by the marketing company EZ Texting, went live the following month.

“There’s no hook, there’s no cost, there’s no sale, it’s not monetized. There’s no gain except helping people,” Dr. Dooreck emphasized.

Dr. Lewis agreed: “I think it’s a great initiative, and it helps unify some of the guidance we give these folks.”

Dr. Lewis has the rare perspective of seeing the issue from standpoint of both an oncologist and a patient: Early in his hematology-oncology fellowship at the Mayo Clinic in 2009, he was diagnosed with multiple endocrine neoplasia type 1, and he subsequently underwent surgery to resect pancreatic neuroendocrine tumors.

He says that the buy-in for CRC POP from major support organizations and from gastroenterologists alike is important because most colonoscopies are performed and diagnoses are made in community settings by gastroenterologists who may or may not have formal connections with a cancer center, rather than in large urban or suburban networks affiliated with medical schools.

In most cases, he said, the gastroenterologist makes the CRC diagnosis, and hands the patient off to a surgeon, who may connect with a medical oncologist and/or radiation oncologist depending on the individual patient’s circumstance. This process can take weeks, and in the meantime, patients are left in limbo.

Offering patients multiple trustworthy resources through a simple text message is a particularly appealing part of the CRC POP initiative, and can help patients feel that they are more in control of their care, Dr. Lewis said.

Useful resources, multidisciplinary care

The connection to resources offered by CRC POP is valuable and may be especially helpful for community-based or small gastroenterology practices; on the other hand, large academic medical centers may be able to provide more resources on their own.

“We have home-grown support services that we make available to patients if they either ask for them or if we ascertain that those services would be important components of their care,” Caroline Kuhlman, a nurse practitioner from The Tucker Gosnell Center for Gastrointestinal Cancers at Massachusetts General Cancer Center in Boston, explained in an interview. “Our approach to a newly diagnosed patient happens in the context of a multidisciplinary visit.”

“Newly diagnosed patients meet with a surgeon, a medical oncologist, sometimes a radiation oncologist if that’s going to be a part their care, and whenever possible during the same outpatient visit. Patients are also provided with written information about colon cancer, and we have a patient resource center that has even more information about support from various organizations,” she said.

Patients can also be referred as needed to other resources within the hospital system, including nutritionists, social workers who can help to determine whether patients could benefit from additional social and financial support, and educational resources such as information sessions on what to expect if they receive chemotherapy.

Similarly, Dr. Lewis said that, at Intermountain Health Care, patients newly diagnosed with cancer are contacted within 24 hours by patient navigators who help them manage concerns and expectations about their care and connect them to resources both in the hospital and the community.

Although their own practices differ in size and scope and in the resources they can offer patients, the clinicians interviewed for this article agreed with the central message and purpose of CRC POP: “You are not alone. You have our support.”

Dr. Lewis, Dr. Dooreck, and Ms. Kuhlman reported having no conflicts of interest relevant to the subjects discussed in this article.

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

Racial/ethnic disparities in COVID-19 mortality rates may be related more to comorbidities than to demographics, suggest authors of a new study.

Researchers compared the length of stay in intensive care units in two suburban hospitals for patients with severe SARS-CoV-2 infections. Their study shows that although the incidence of comorbidities and rates of use of mechanical ventilation and death were higher among Black patients than among patients of other races, length of stay in the ICU was generally similar for patients of all races. The study was conducted by Tripti Kumar, DO, from Lankenau Medical Center, Wynnewood, Pennsylvania, and colleagues.

“Racial disparities are observed in the United States concerning COVID-19, and studies have discovered that minority populations are at ongoing risk for health inequity,” Dr. Kumar said in a narrated e-poster presented during the American College of Chest Physicians (CHEST) 2021 Annual Meeting.

“Primary prevention initiatives should take precedence in mitigating the effect that comorbidities have on these vulnerable populations to help reduce necessity for mechanical ventilation, hospital length of stay, and overall mortality,” she said.
 

Higher death rates for Black patients

At the time the study was conducted, the COVID-19 death rate in the United States had topped 500,000 (as of this writing, it stands at 726,000). Of those who died, 22.4% were Black, 18.1% were Hispanic, and 3.6% were of Asian descent. The numbers of COVID-19 diagnoses and deaths were significantly higher in U.S. counties where the proportions of Black residents were higher, the authors note.

To see whether differences in COVID-19 outcomes were reflected in ICU length of stay, the researchers conducted a retrospective chart review of data on 162 patients admitted to ICUs at Paoli Hospital and Lankenau Medical Center, both in the suburban Philadelphia town of Wynnewood.

All patients were diagnosed with COVID-19 from March through June 2020.

In all, 60% of the study population were Black, 35% were White, 3% were Asian, and 2% were Hispanic. Women composed 46% of the sample.

The average length of ICU stay, which was the primary endpoint, was similar among Black patients (15.4 days), White patients (15.5 days), and Asians (16 days). The shortest average hospital stay was among Hispanic patients, at 11.3 days.

The investigators determined that among all races, the prevalence of type 2 diabetes, obesity, hypertension, and smoking was highest among Black patients.

Overall, nearly 85% of patients required mechanical ventilation. Among the patients who required it, 86% were Black, 84% were White, 66% were Hispanic, and 75% were Asian.

Overall mortality was 62%. It was higher among Black patients, at 60%, than among White patients, at 33%. The investigators did not report mortality rates for Hispanic or Asian patients.
 

Missing data

Demondes Haynes, MD, FCCP, professor of medicine in the Division of Pulmonary and Critical Care and associate dean for admissions at the University of Mississippi Medical Center and School of Medicine, Jackson, who was not involved in the study, told this news organization that there are some gaps in the study that make it difficult to draw strong conclusions about the findings.

“For sure, comorbidities contribute a great deal to mortality, but is there something else going on? I think this poster is incomplete in that it cannot answer that question,” he said in an interview.

He noted that the use of retrospective rather than prospective data makes it hard to account for potential confounders.

“I agree that these findings show the potential contribution of comorbidities, but to me, this is a little incomplete to make that a definitive statement,” he said.

“I can’t argue with their recommendation for primary prevention – we definitely want to do primary prevention to decrease comorbidities. Would it decrease overall mortality? It might, it sure might, for just COVID-19 I’d say no, we need more information.”

No funding source for the study was reported. Dr. Kumar and colleagues and Dr. Haynes reported no relevant financial relationships.

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

Racial/ethnic disparities in COVID-19 mortality rates may be related more to comorbidities than to demographics, suggest authors of a new study.

Researchers compared the length of stay in intensive care units in two suburban hospitals for patients with severe SARS-CoV-2 infections. Their study shows that although the incidence of comorbidities and rates of use of mechanical ventilation and death were higher among Black patients than among patients of other races, length of stay in the ICU was generally similar for patients of all races. The study was conducted by Tripti Kumar, DO, from Lankenau Medical Center, Wynnewood, Pennsylvania, and colleagues.

“Racial disparities are observed in the United States concerning COVID-19, and studies have discovered that minority populations are at ongoing risk for health inequity,” Dr. Kumar said in a narrated e-poster presented during the American College of Chest Physicians (CHEST) 2021 Annual Meeting.

“Primary prevention initiatives should take precedence in mitigating the effect that comorbidities have on these vulnerable populations to help reduce necessity for mechanical ventilation, hospital length of stay, and overall mortality,” she said.
 

Higher death rates for Black patients

At the time the study was conducted, the COVID-19 death rate in the United States had topped 500,000 (as of this writing, it stands at 726,000). Of those who died, 22.4% were Black, 18.1% were Hispanic, and 3.6% were of Asian descent. The numbers of COVID-19 diagnoses and deaths were significantly higher in U.S. counties where the proportions of Black residents were higher, the authors note.

To see whether differences in COVID-19 outcomes were reflected in ICU length of stay, the researchers conducted a retrospective chart review of data on 162 patients admitted to ICUs at Paoli Hospital and Lankenau Medical Center, both in the suburban Philadelphia town of Wynnewood.

All patients were diagnosed with COVID-19 from March through June 2020.

In all, 60% of the study population were Black, 35% were White, 3% were Asian, and 2% were Hispanic. Women composed 46% of the sample.

The average length of ICU stay, which was the primary endpoint, was similar among Black patients (15.4 days), White patients (15.5 days), and Asians (16 days). The shortest average hospital stay was among Hispanic patients, at 11.3 days.

The investigators determined that among all races, the prevalence of type 2 diabetes, obesity, hypertension, and smoking was highest among Black patients.

Overall, nearly 85% of patients required mechanical ventilation. Among the patients who required it, 86% were Black, 84% were White, 66% were Hispanic, and 75% were Asian.

Overall mortality was 62%. It was higher among Black patients, at 60%, than among White patients, at 33%. The investigators did not report mortality rates for Hispanic or Asian patients.
 

Missing data

Demondes Haynes, MD, FCCP, professor of medicine in the Division of Pulmonary and Critical Care and associate dean for admissions at the University of Mississippi Medical Center and School of Medicine, Jackson, who was not involved in the study, told this news organization that there are some gaps in the study that make it difficult to draw strong conclusions about the findings.

“For sure, comorbidities contribute a great deal to mortality, but is there something else going on? I think this poster is incomplete in that it cannot answer that question,” he said in an interview.

He noted that the use of retrospective rather than prospective data makes it hard to account for potential confounders.

“I agree that these findings show the potential contribution of comorbidities, but to me, this is a little incomplete to make that a definitive statement,” he said.

“I can’t argue with their recommendation for primary prevention – we definitely want to do primary prevention to decrease comorbidities. Would it decrease overall mortality? It might, it sure might, for just COVID-19 I’d say no, we need more information.”

No funding source for the study was reported. Dr. Kumar and colleagues and Dr. Haynes reported no relevant financial relationships.

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

Racial/ethnic disparities in COVID-19 mortality rates may be related more to comorbidities than to demographics, suggest authors of a new study.

Researchers compared the length of stay in intensive care units in two suburban hospitals for patients with severe SARS-CoV-2 infections. Their study shows that although the incidence of comorbidities and rates of use of mechanical ventilation and death were higher among Black patients than among patients of other races, length of stay in the ICU was generally similar for patients of all races. The study was conducted by Tripti Kumar, DO, from Lankenau Medical Center, Wynnewood, Pennsylvania, and colleagues.

“Racial disparities are observed in the United States concerning COVID-19, and studies have discovered that minority populations are at ongoing risk for health inequity,” Dr. Kumar said in a narrated e-poster presented during the American College of Chest Physicians (CHEST) 2021 Annual Meeting.

“Primary prevention initiatives should take precedence in mitigating the effect that comorbidities have on these vulnerable populations to help reduce necessity for mechanical ventilation, hospital length of stay, and overall mortality,” she said.
 

Higher death rates for Black patients

At the time the study was conducted, the COVID-19 death rate in the United States had topped 500,000 (as of this writing, it stands at 726,000). Of those who died, 22.4% were Black, 18.1% were Hispanic, and 3.6% were of Asian descent. The numbers of COVID-19 diagnoses and deaths were significantly higher in U.S. counties where the proportions of Black residents were higher, the authors note.

To see whether differences in COVID-19 outcomes were reflected in ICU length of stay, the researchers conducted a retrospective chart review of data on 162 patients admitted to ICUs at Paoli Hospital and Lankenau Medical Center, both in the suburban Philadelphia town of Wynnewood.

All patients were diagnosed with COVID-19 from March through June 2020.

In all, 60% of the study population were Black, 35% were White, 3% were Asian, and 2% were Hispanic. Women composed 46% of the sample.

The average length of ICU stay, which was the primary endpoint, was similar among Black patients (15.4 days), White patients (15.5 days), and Asians (16 days). The shortest average hospital stay was among Hispanic patients, at 11.3 days.

The investigators determined that among all races, the prevalence of type 2 diabetes, obesity, hypertension, and smoking was highest among Black patients.

Overall, nearly 85% of patients required mechanical ventilation. Among the patients who required it, 86% were Black, 84% were White, 66% were Hispanic, and 75% were Asian.

Overall mortality was 62%. It was higher among Black patients, at 60%, than among White patients, at 33%. The investigators did not report mortality rates for Hispanic or Asian patients.
 

Missing data

Demondes Haynes, MD, FCCP, professor of medicine in the Division of Pulmonary and Critical Care and associate dean for admissions at the University of Mississippi Medical Center and School of Medicine, Jackson, who was not involved in the study, told this news organization that there are some gaps in the study that make it difficult to draw strong conclusions about the findings.

“For sure, comorbidities contribute a great deal to mortality, but is there something else going on? I think this poster is incomplete in that it cannot answer that question,” he said in an interview.

He noted that the use of retrospective rather than prospective data makes it hard to account for potential confounders.

“I agree that these findings show the potential contribution of comorbidities, but to me, this is a little incomplete to make that a definitive statement,” he said.

“I can’t argue with their recommendation for primary prevention – we definitely want to do primary prevention to decrease comorbidities. Would it decrease overall mortality? It might, it sure might, for just COVID-19 I’d say no, we need more information.”

No funding source for the study was reported. Dr. Kumar and colleagues and Dr. Haynes reported no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

For patients with refractory acute respiratory distress syndrome (ARDS) caused by COVID-19 infections, extracorporeal membrane oxygenation (ECMO) may be the treatment of last resort.

But for reasons that aren’t clear, in the second wave of the COVID-19 pandemic at a major teaching hospital, the mortality rate of patients on ECMO for COVID-induced ARDS was significantly higher than it was during the first wave, despite changes in drug therapy and clinical management, reported Rohit Reddy, BS, a second-year medical student, and colleagues at Thomas Jefferson University Hospital in Philadelphia.

During the first wave, from April to September 2020, the survival rate of patients while on ECMO in their ICUs was 67%. In contrast, for patients treated during the second wave, from November 2020 to March 2021, the ECMO survival rate was 31% (P = .003).

The 30-day survival rates were also higher in the first wave compared with the second, at 54% versus 31%, but this difference was not statistically significant.

“More research is required to develop stricter inclusion/exclusion criteria and to improve pre-ECMO management in order to improve outcomes,” Mr. Reddy said in a narrated poster presented at the annual meeting of the American College of Chest Physicians, held virtually this year.
 

ARDS severity higher

ARDS is a major complication of COVID-19 infections, and there is evidence to suggest that COVID-associated ARDS is more severe than ARDS caused by other causes, the investigators noted.

“ECMO, which has been used as a rescue therapy in prior viral outbreaks, has been used to support certain patients with refractory ARDS due to COVID-19, but evidence for its efficacy is limited. Respiratory failure remained a highly concerning complication in the second wave of the COVID-19 pandemic, but it is unclear how the evolution of the disease and pharmacologic utility has affected the clinical utility of ECMO,” Mr. Reddy said.

To see whether changes in disease course or in treatment could explain changes in outcomes for patients with COVID-related ARDS, the investigators compared characteristics and outcomes for patients treated in the first versus second waves of the pandemic. Their study did not include data from patients infected with the Delta variant of the SARS-CoV-2 virus, which became the predominant viral strain later in 2021.

The study included data on 28 patients treated during the first wave, and 13 during the second. The sample included 28 men and 13 women with a mean age of 51 years.

All patients had venovenous ECMO, with cannulation in the femoral or internal jugular veins; some patients received ECMO via a single double-lumen cannula.

There were no significant differences between the two time periods in patient comorbidities prior to initiation of ECMO.

Patients in the second wave were significantly more likely to receive steroids (54% vs. 100%; P = .003) and remdesivir (39% vs. 85%; P = .007). Prone positioning before ECMO was also significantly more frequent in the second wave (11% vs. 85%; P < .001).

Patients in the second wave stayed on ECMO longer – median 20 days versus 14 days for first-wave patients – but as noted before, ECMO mortality rates were significantly higher during the second wave. During the first wave, 33% of patients died while on ECMO, compared with 69% in the second wave (P = .03). Respective 30-day mortality rates were 46% versus 69% (ns).

Rates of complications during ECMO were generally comparable between the groups, including acute renal failure (39% in the first wave vs 38% in the second), sepsis (32% vs. 23%), bacterial pneumonia (11% vs. 8%), and gastrointestinal bleeding (21% vs. 15%). However, significantly more patients in the second wave had cerebral vascular accidents (4% vs. 23%; P = .050).

Senior author Hitoshi Hirose, MD, PhD, professor of surgery at Thomas Jefferson University, said in an interview that the difference in outcomes was likely caused by changes in pre-ECMO therapy between the first and second waves.

“Our study showed the incidence of sepsis had a large impact on the patient outcomes,” he wrote. “We speculate that sepsis was attributed to use of immune modulation therapy. The prevention of the sepsis would be key to improve survival of ECMO for COVID 19.”

“It’s possible that the explanation for this is that patients in the second wave were sicker in a way that wasn’t adequately measured in the first wave,” CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center in Hartford, said in an interview.

The differences may also have been attributable to changes in virulence, or to clinical decisions to put sicker patients on ECMO, he said.

Casey Cable, MD, MSc, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center in Richmond, also speculated in an interview that second-wave patients may have been sicker.

“One interesting piece of this story is that we now know a lot more – we know about the use of steroids plus or minus remdesivir and proning, and patients received a large majority of those treatments but still got put on ECMO,” she said. “I wonder if there is a subset of really sick patients, and no matter what we treat with – steroids, proning – whatever we do they’re just not going to do well.”

Both Dr. Carroll and Dr. Cable emphasized the importance of ECMO as a rescue therapy for patients with severe, refractory ARDS associated with COVID-19 or other diseases.

Neither Dr. Carroll nor Dr. Cable were involved in the study.

No study funding was reported. Mr. Reddy, Dr. Hirose, Dr. Carroll, and Dr. Cable disclosed no relevant financial relationships.

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

Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.

“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.

“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.

Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.

Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.

Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.

Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
 

Empathy and diversity

Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.

“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.

The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”

Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
 

Beyond COVID-19

CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.

“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.

“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”

The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.

Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.

There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
 

Fun and games

In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.

Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
 

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

Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.

“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.

“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.

Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.

Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.

Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.

Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
 

Empathy and diversity

Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.

“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.

The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”

Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
 

Beyond COVID-19

CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.

“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.

“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”

The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.

Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.

There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
 

Fun and games

In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.

Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
 

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

Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.

“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.

“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.

Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.

Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.

Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.

Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
 

Empathy and diversity

Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.

“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.

The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”

Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
 

Beyond COVID-19

CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.

“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.

“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”

The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.

Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.

There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
 

Fun and games

In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.

Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
 

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

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

When 23 frail elderly patients in Norway died in early 2021 shortly after they had received an mRNA-based vaccine against COVID-19, Norwegian health authorities cautioned physicians to conduct more thorough assessments of patients prior to immunization, and launched an investigation into the safety of the BNT162b2 vaccine (Comirnaty; Pfizer-BioNTech).

Now, the results of that investigation and of a subsequent larger study of nursing home residents in Norway have shown no increased risk for short-term mortality following COVID-19 vaccination in the overall population of elderly patients. The new research also showed clear evidence of a survival benefit compared with the unvaccinated population, Anette Hylen Ranhoff, MD, PhD, said at the annual meeting of the European Geriatric Medicine Society, held in a hybrid format in Athens, Greece, and online.

“We found no evidence of increased short-term mortality among vaccinated older individuals, and particularly not among the nursing home patients,” said Dr. Ranhoff, a senior researcher at the Norwegian Institute of Public Health and professor at University of Bergen, Norway. “But we think that this [lower] mortality risk was most likely a sort of ‘healthy-vaccinee’ effect, which means that people who were a bit more healthy were vaccinated, and not those who were the very, very most frail.”

“We have more or less the same data in France about events, with very high rates of vaccination,” said session moderator Athanase Benetos MD, PhD, professor and chairman of geriatric medicine at the University Hospital of Nancy in France, who was not involved in the study.

“In my department, a month after the end of the vaccination and at the same time while the pandemic in the city was going up, we had a 90% decrease in mortality from COVID in the nursing homes,” he told Dr. Ranhoff.
 

Potential risks

Frail elderly patients were not included in clinical trials of COVID-19 vaccines, and although previous studies have shown a low incidence of local or systemic reactions to vaccination among older people, “we think that quite mild adverse events following vaccination could trigger and destabilize a frail person,” Dr. Ranhoff said.

As reported Jan. 15, 2021, in BMJ, investigation by the Norwegian Medicines Agency (NOMA) into 13 of the 23 reported cases concluded that common adverse reactions associated with mRNA vaccines could have contributed to the deaths of some of the frail elderly patients

Steinar Madsen, MD, NOMA medical director, told BMJ “we are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease.”
 

Health authorities investigate

In response to the report and at the request of the Norwegian Public Health Institute and NOMA, Dr. Ranhoff and colleagues investigated the first 100 deaths among nursing-home residents who received the vaccine. The team consisted of three geriatricians and an infectious disease specialist who sees patients in nursing homes.

They looked at each patient’s clinical course before and after vaccination, their health trajectory and life expectancy at the time of vaccination, new symptoms following vaccination, and the time from vaccination to new symptoms and to death.

In addition, the investigators evaluated Clinical Frailty Scale (CFS) scores for each patient. CFS scores range from 1 (very fit) to 9 (terminally ill, with a life expectancy of less than 6 months who are otherwise evidently frail).

The initial investigation found that among 95 evaluable patients, the association between vaccination and death was “probable” in 10, “possible” in 26, and “unlikely” in 59.

The mean time from vaccination to symptoms was 1.4 days in the probable cases, 2.5 days in the possible cases, and 4.7 days in the unlikely cases.

The mean time from vaccination to death was 3.1, 8.3, and 8.2 days, respectively.

In all three categories, the patients had mean CFS scores ranging from 7.6 to 7.9, putting them in the “severely frail” category, defined as people who are completely dependent for personal care but seem stable and not at high risk for dying.

“We have quite many nursing home residents in Norway, 35,000; more than 80% have dementia, and the mean age is 85 years. We know that approximately 45 people die every day in these nursing homes, and their mean age of death is 87.5 years,” Dr. Ranhoff said.
 

Population-wide study

Dr. Ranhoff and colleagues also looked more broadly into the question of potential vaccine-related mortality in the total population of older people in Norway from the day of vaccination to follow-up at 3 weeks.

They conducted a matched cohort study to investigate the relationship between the mRNA SARS-CoV-2 vaccine and overall death among persons aged 65 and older in the general population, and across four groups: patients receiving home-based care, long-term nursing home patients, short-term nursing home patients, and those not receiving health services.

The researchers identified a total of 967,786 residents of Norway aged 65 and over at the start of the country’s vaccination campaign at the end of December, 2020, and they matched vaccinated individuals with unvaccinated persons based on demographic, geographic, and clinical risk group factors.

Dr. Ranhoff showed Kaplan-Meier survival curves for the total population and for each of the health-service states. In all cases there was a clear survival benefit for vaccinated vs. unvaccinated patients. She did not, however, provide specific numbers or hazard ratios for the differences between vaccinated and unvaccinated individuals in each of the comparisons.

The study was supported by the Norwegian Institute of Public Health. Dr. Ranhoff and Dr. Benetos reported no conflicts of interest.

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

In frail elderly adults with COVID-19 infections, treatment with omega-3 fatty acids may improve lipid responses and decrease levels of proinflammatory lipid mediators, results of a small randomized controlled trial suggest.

Results of the study, which included 22 patients with multiple comorbidities, were presented at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

The patients, who had a median age of 81 years, were randomized to receive an intravenous infusion of an omega-3 polyunsaturated fatty acid (PUFA) emulsion containing 10 g of fish oil per 100 mL or a saline placebo.

Those who received the intravenous infusion had significant decreases from baseline to end of treatment in the neutrophil-to-lymphocyte ratio (NLR), indicating marked reductions in systemic inflammation.

In contrast, patients randomized to a saline placebo had no significant improvements in NLR, Magnus Bäck, MD, PhD, from the Karolinska Institute in Stockholm reported at the meeting.

“Our lipidomic analysis also showed that omega-3 treatment skewed the lipid response, with reduced levels of proinflammatory lipid mediators, and increased levels of proresolving mediators,” according to a late-breaking abstract, which Dr. Bäck presented during the session.

Omega-3 treatment was not significantly associated with reduction in either C-reactive protein (CRP) or the proinflammatory cytokine interleukin-6, however.
 

‘Eicosanoid storm’

In a review article published in January 2021 in the open-access journal Frontiers in Physiology, Dr. Bäck and colleagues outlined the rationale for their randomized trial.

“Excessive inflammation has been reported in severe cases with respiratory failure and cardiovascular complications,” they wrote. “In addition to the release of cytokines, referred to as cytokine release syndrome or ‘cytokine storm,’ increased proinflammatory lipid mediators derived from the omega-6 polyunsaturated fatty acid (PUFA) arachidonic acid may cause an ‘eicosanoid storm,’ which contributes to the uncontrolled systemic inflammation.”

Omega-3 PUFA contains proresolving mediators that can limit inflammatory reactions, suggesting the possibility of an inflammation-resolving benefit in patients with COVID-19 without concerns about immunosuppression, the authors hypothesized.
 

Trial details

In the trial, COVID-Omega-F, they enrolled patients with a COVID-19 diagnosis requiring hospitalization. Patients with an allergy to fish oil or who had contraindications to intravenous PUFA administration (for example, risk for bleeding, shock, or emboli) were excluded.

Ten patients were randomly assigned to receive infusions of the omega-3 PUFA and 12 were assigned to receive infusions of the placebo, once daily for 5 days. The primary outcome measure was change in inflammatory biomarkers, including white blood cell counts, CRP, cytokines, and lipid mediators.

Baseline demographic and clinical characteristics were similar between the two study arms, with a median of about 7 days since the onset of symptoms, and 3.5 days since a diagnosis of COVID-19.

All patients had low lymphocyte responses reflected by a high NLR, a prognostic measure for worse outcomes in patients with COVID-19 infections, Dr. Bäck said.

Inflammation was moderate, with a CRP of 65 mg/L in the placebo group and 62 mg/L in the omega-3 group.

Seven patients in each study arm received concomitant corticoid treatment. Two patients in each arm died in hospital, but there were no serious treatment-related adverse events.
 

Inflammatory markers improve

As noted before, there was a significant decline in NLR from baseline among patients randomized to omega-3 (P = .02) but no corresponding decrease in patients assigned to placebo infusions.

“The significant decrease was largely driven by an increase in the lymphocyte count in the omega-3 treated group (P = .004), whereas lymphocytes did not significantly change,” Dr. Bäck said.

As expected, patients in the omega-3 group had pronounced increases in omega-3 fatty acids, including eicosapentaenoic acid and docosahexaenoic acid.

The metabolism of fatty acids also differed markedly between the groups, with a significant decrease in the omega-3 group but not the placebo group in proinflammatory mediators, and an increase in precursors to proresolving mediators, Dr. Bäck noted.
 

AFib concerns

In a question-and-answer part of the session, a physician who identified herself as “Senya from Russia” questioned the safety of omega-3 treatment in this population, “because recently there was a meta-analysis which showed that omega-3 fatty acids will increase the risk of atrial fibrillation in older adults especially.”

The systematic review and meta-analysis she referred to, published in Circulation and reported on by this news organization, showed that, among 81,210 patients with a mean age of 65 enrolled in seven randomized controlled trials, omega-3 fatty acid supplementation was associated with a 25% increase in risk for atrial fibrillation. This risk appeared to be higher in trials testing doses greater than 1 g/day, according to the paper.

“This was not monitored in this study,” Dr. Bäck replied. “It is true that the meta-analysis showed an increased incidence of atrial fibrillation, so it would be something to monitor in case this trial would be expanded to a larger population.”

The study was supported by the Karolinska Institute. Dr. Bäck disclosed no relevant financial relationships.

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

A simple caregiver education intervention reduced the use of psychotropic medications and associated drugs costs in long-term care facilities for the elderly in a new study.

The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.

The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.

“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.

Heavy drug use

Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.

To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.

Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).

Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.

The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.

Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
 

Short-term benefit

As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.

By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.

Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.

In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.

Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).

“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.

The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
 

Randomized design

In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”

“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.

Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.

Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.

Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”

Dr. Aalto and Dr. Ryg had no disclosures.

A simple caregiver education intervention reduced the use of psychotropic medications and associated drugs costs in long-term care facilities for the elderly in a new study.

The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.

The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.

“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.

Heavy drug use

Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.

To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.

Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).

Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.

The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.

Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
 

Short-term benefit

As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.

By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.

Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.

In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.

Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).

“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.

The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
 

Randomized design

In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”

“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.

Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.

Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.

Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”

Dr. Aalto and Dr. Ryg had no disclosures.

A simple caregiver education intervention reduced the use of psychotropic medications and associated drugs costs in long-term care facilities for the elderly in a new study.

The effect of the intervention was transient, possibly because of high staff turnover, according to the investigators in the new randomized, controlled trial.

The findings were presented by Ulla Aalto, MD, PhD, during a session at the European Geriatric Medicine Society annual congress, a hybrid live and online meeting.

There was a significant reduction in the use of psychotropic agents at 6 months in long-term care wards where the nursing staff had undergone a short training session on drug therapy for older patients, but there was no improvement in wards that were randomly assigned to serve as controls, Dr. Aalto, from Helsinki Hospital, reported during the session.

“Future research would be investigating how we could maintain the positive effects that were gained at 6 months but not seen any more at 1 year, and how to implement the good practice in nursing homes by this kind of staff training,” she said.

Heavy drug use

Psychotropic medications are widely used in long-term care settings, but their indiscriminate use or use of the wrong drug for the wrong patient can be harmful. Inappropriate drug use in long-term care settings is also associated with higher costs, Dr. Aalto said.

To see whether a staff-training intervention could reduce drugs use and lower costs, the investigators conducted a randomized clinical trial in assisted living facilities in Helsinki in 2011, with a total of 227 patients 65 years and older.

Long-term care wards were randomly assigned to either an intervention for nursing staff consisting of two 4-hour sessions on good drug-therapy practice for older adults, or to serve as controls (10 wards in each group).

Drug use and costs were monitored at both 6 and 12 months after randomization. Psychotropic drugs included antipsychotics, antidepressants, anxiolytics, and hypnotics as classified by the World Health Organization. For the purposes of comparison, actual doses were counted and converted into relative proportions of defined daily doses.

The baseline characteristics of patients in each group were generally similar, with a mean age of around 83 years. In each study arm, nearly two-thirds of patients were on at least one psychotropic drug, and of this group, a third had been prescribed 2 or more psychotropic agents.

Nearly half of the patients were on at least one antipsychotic agent and/or antidepressant.
 

Short-term benefit

As noted before, in the wards randomized to staff training, there was a significant reduction in use of all psychotropics from baseline at 6 months after randomization (P = .045), but there was no change among the control wards.

By 12 months, however, the differences between the intervention and control arms narrowed, and drug use in the intervention arm was no longer significantly lower over baseline.

Drugs costs significantly decreased in the intervention group at 6 months (P = .027) and were numerically but not statistically lower over baseline at 12 months.

In contrast, drug costs in the control arm were numerically (but not statistically) higher at both 6 and 12 months of follow-up.

Annual drug costs in the intervention group decreased by mean of 12.3 euros ($14.22) whereas costs in the control group increased by a mean of 20.6 euros ($23.81).

“This quite light and feasible intervention succeeded in reducing overall defined daily doses of psychotropics in the short term,” Dr. Aalto said.

The waning of the intervention’s effect on drug use and costs may be caused partly by the high employee turnover rate in long-term care facilities and to the dilution effect, she said, referring to a form of judgment bias in which people tend to devalue diagnostic information when other, nondiagnostic information is also available.
 

Randomized design

In the question-and-answer session following her presentation, audience member Jesper Ryg, MD, PhD from Odense (Denmark) University Hospital and the University of Southern Denmark, also in Odense, commented: “It’s a great study, doing a [randomized, controlled trial] on deprescribing, we need more of those.”

“But what we know now is that a lot of studies show it is possible to deprescribe and get less drugs, but do we have any clinical data? Does this deprescribing lead to less falls, did it lead to lower mortality?” he asked.

Dr. Aalto replied that, in an earlier report from this study, investigators showed that harmful medication use was reduced and negative outcomes were reduced.

Another audience member asked why nursing staff were the target of the intervention, given that physicians do the actual drug prescribing.

Dr. Aalto responded: “It is the physician of course who prescribes, but in nursing homes and long-term care, nursing staff is there all the time, and the physicians are kind of consultants who just come there once in a while, so it’s important that the nurses also know about these harmful medications and can bring them to the doctor when he or she arrives there.”

Dr. Aalto and Dr. Ryg had no disclosures.

Approximately one-third of the patients treated in the ASCENT clinical trial comparing the antibody-drug conjugate sacituzumab govitecan (Trodelvy, Gilead) with single-agent chemotherapy in patients with triple-negative breast cancer (TNBC) did not have an initial diagnosis of TNBC.

But as a subanalysis of data from the randomized, phase 3 study showed, sacituzumab govitecan was associated with significantly better progression-free survival (PFS) and overall survival among patients without an initial TNBC diagnosis, with efficacy similar to that seen in the overall study population and in patients without known brain metastases, reported Joyce O’Shaughnessy, MD, at the 2021 European Society for Medical Oncology Congress. In her presentation (abstract 258P), Dr. O’Shaughnessy, who is an oncologist with the Texas Oncology–Baylor Charles A. Sammons Cancer Center in Dallas, said that it’s not uncommon to see acquired triple-negative breast cancer in patients who have hormone receptor–positive disease initially and then later on, develop triple-negative breast cancer.

“That is why at the time of metastatic diagnosis we always say that patients should have repeat receptor [testing], because it’s been well described that a subset of hormone receptor–positive breast can become triple negative under pressure from endocrine therapy,” said ASCENT coinvestigator Aditya Bardia, MD, MPH, Massachusetts General Hospital, Boston, in an interview

Coinvestigator Kevine Punie, MD, from University Hospitals Leuven (Belgium), said that “triple-negative breast cancer is a diagnosis of exclusion. This is a heterogenous disease where several biological subsets are merged.”

“It was important to perform this subgroup analysis to reassure us that the treatment effect we see from [sacituzumab govitecan] in the overall population is also observed in this specific subgroup of patients where biologically we’re treating a different disease,” he said in an interview.
 

Antibody-drug conjugate

Sacituzumab govitecan consists of an antibody targeted to the trophoblast antigen 2 cell surface receptor found on most breast cancer cells, plus the topoisomerase-1 inhibitor SN-38 as its toxic payload.

In the primary intent-to-treat (ITT) analysis of ASCENT, sacituzumab significantly prolonged PFS with a median of 4.8 versus 1.7 months for patients treated with the physician’s choice of either capecitabine, eribulin, vinorelbine, or gemcitabine. The difference translated into an HR for progression with the antibody-drug conjugate of 0.41 (P < .00001).

The subgroup analysis looked at outcomes for 70 patients randomized to sacituzumab govitecan and 78 randomized to single-agent chemotherapy who did not have an initial diagnosis of TNBC.

In all, 27% of patients in this subgroup in the sacituzumab arm and 29% in the chemotherapy arm had received a prior line of treatment with a CDK4/6 inhibitor.

At the time of data cutoff in March 2020, four patients (6%) in the sacituzumab arm remained on treatment versus no patient in the chemotherapy arm. The most common reason for treatment discontinuation was disease progression, which occurred in 84% and 72% of patients, respectively.

The median treatment duration was 5.1 months in the sacituzumab and 1.2 months in the chemotherapy arm. The median duration of follow-up was 10.6 and 6.1 months, respectively.
 

Progression-free survival, overall survival results

For all patients without an initial TNBC diagnosis, the median PFS was 4.6 months with sacituzumab versus 2.3 months with chemotherapy, which translated into a hazard ratio for progression of 0.48 (95% confidence interval, 0.32-0.72). The progression-free benefit with the antibody-drug conjugate was similar to that seen in the intent-to-treat population, as noted before, and among the overall population of patients in the study with no known brain metastases (HR, 5.6 vs. 1.7, respectively; P < .001).

The objective response rates were 21% in the sacituzumab and 5% in the chemotherapy arm. Objective responses were not affected by the prior use of CDK 4/6 inhibitors.

Median overall survival in this subgroup was 12.4 months with the antibody-drug conjugate versus 6.7 months with chemotherapy (95% CI, 0.30-0.64).

The investigators reported that the safety profile was manageable in this subgroup of patients, with a low rate of treatment discontinuations because of adverse events (5%) and no treatment-related deaths with sacituzumab govitecan.
 

Health-related quality of life

In a separate poster (abstract 257P) presented at the meeting, the ASCENT investigators reported health-related quality of life results in the overall population.

The mean European Organization for the Research and Treatment of Cancer quality of life questionnaire subscale scores at baseline were similar between treatment arms.

For the major domains of global health status, physical and emotional functioning as well as lower symptomatic impact of fatigue, pain, dyspnea, and insomnia, sacituzumab govitecan showed “significantly and meaningfully greater improvement” than the physician’s choice of chemotherapy, the investigators found.

Of individual symptoms, only diarrhea was worse with the antibody-drug conjugate.

“These were important improvements,” Dr. Punie said, “because we saw improvements in the primary health-related quality of life domains such as global health status. We also saw that the time to clinically meaningful deterioration of quality of life domains were significantly longer for patients treated with [sacituzumab govitecan].”

“Patients who received sacituzumab govitecan had better health-related quality of life as compared to the control arm, and that’s a very important result, because in the metastatic setting our goal is twofold: We want to prolong survival, and we want patients to have improved quality of life,” Dr. Bardia said.

The Ascent trial is sponsored by Gilead Sciences. Dr. Punie disclosed relationships with multiple companies/organizations, not including Gilead. Dr. Bardia disclosed contracted research for Gilead and others, as well as other relationships.

Approximately one-third of the patients treated in the ASCENT clinical trial comparing the antibody-drug conjugate sacituzumab govitecan (Trodelvy, Gilead) with single-agent chemotherapy in patients with triple-negative breast cancer (TNBC) did not have an initial diagnosis of TNBC.

But as a subanalysis of data from the randomized, phase 3 study showed, sacituzumab govitecan was associated with significantly better progression-free survival (PFS) and overall survival among patients without an initial TNBC diagnosis, with efficacy similar to that seen in the overall study population and in patients without known brain metastases, reported Joyce O’Shaughnessy, MD, at the 2021 European Society for Medical Oncology Congress. In her presentation (abstract 258P), Dr. O’Shaughnessy, who is an oncologist with the Texas Oncology–Baylor Charles A. Sammons Cancer Center in Dallas, said that it’s not uncommon to see acquired triple-negative breast cancer in patients who have hormone receptor–positive disease initially and then later on, develop triple-negative breast cancer.

“That is why at the time of metastatic diagnosis we always say that patients should have repeat receptor [testing], because it’s been well described that a subset of hormone receptor–positive breast can become triple negative under pressure from endocrine therapy,” said ASCENT coinvestigator Aditya Bardia, MD, MPH, Massachusetts General Hospital, Boston, in an interview

Coinvestigator Kevine Punie, MD, from University Hospitals Leuven (Belgium), said that “triple-negative breast cancer is a diagnosis of exclusion. This is a heterogenous disease where several biological subsets are merged.”

“It was important to perform this subgroup analysis to reassure us that the treatment effect we see from [sacituzumab govitecan] in the overall population is also observed in this specific subgroup of patients where biologically we’re treating a different disease,” he said in an interview.
 

Antibody-drug conjugate

Sacituzumab govitecan consists of an antibody targeted to the trophoblast antigen 2 cell surface receptor found on most breast cancer cells, plus the topoisomerase-1 inhibitor SN-38 as its toxic payload.

In the primary intent-to-treat (ITT) analysis of ASCENT, sacituzumab significantly prolonged PFS with a median of 4.8 versus 1.7 months for patients treated with the physician’s choice of either capecitabine, eribulin, vinorelbine, or gemcitabine. The difference translated into an HR for progression with the antibody-drug conjugate of 0.41 (P < .00001).

The subgroup analysis looked at outcomes for 70 patients randomized to sacituzumab govitecan and 78 randomized to single-agent chemotherapy who did not have an initial diagnosis of TNBC.

In all, 27% of patients in this subgroup in the sacituzumab arm and 29% in the chemotherapy arm had received a prior line of treatment with a CDK4/6 inhibitor.

At the time of data cutoff in March 2020, four patients (6%) in the sacituzumab arm remained on treatment versus no patient in the chemotherapy arm. The most common reason for treatment discontinuation was disease progression, which occurred in 84% and 72% of patients, respectively.

The median treatment duration was 5.1 months in the sacituzumab and 1.2 months in the chemotherapy arm. The median duration of follow-up was 10.6 and 6.1 months, respectively.
 

Progression-free survival, overall survival results

For all patients without an initial TNBC diagnosis, the median PFS was 4.6 months with sacituzumab versus 2.3 months with chemotherapy, which translated into a hazard ratio for progression of 0.48 (95% confidence interval, 0.32-0.72). The progression-free benefit with the antibody-drug conjugate was similar to that seen in the intent-to-treat population, as noted before, and among the overall population of patients in the study with no known brain metastases (HR, 5.6 vs. 1.7, respectively; P < .001).

The objective response rates were 21% in the sacituzumab and 5% in the chemotherapy arm. Objective responses were not affected by the prior use of CDK 4/6 inhibitors.

Median overall survival in this subgroup was 12.4 months with the antibody-drug conjugate versus 6.7 months with chemotherapy (95% CI, 0.30-0.64).

The investigators reported that the safety profile was manageable in this subgroup of patients, with a low rate of treatment discontinuations because of adverse events (5%) and no treatment-related deaths with sacituzumab govitecan.
 

Health-related quality of life

In a separate poster (abstract 257P) presented at the meeting, the ASCENT investigators reported health-related quality of life results in the overall population.

The mean European Organization for the Research and Treatment of Cancer quality of life questionnaire subscale scores at baseline were similar between treatment arms.

For the major domains of global health status, physical and emotional functioning as well as lower symptomatic impact of fatigue, pain, dyspnea, and insomnia, sacituzumab govitecan showed “significantly and meaningfully greater improvement” than the physician’s choice of chemotherapy, the investigators found.

Of individual symptoms, only diarrhea was worse with the antibody-drug conjugate.

“These were important improvements,” Dr. Punie said, “because we saw improvements in the primary health-related quality of life domains such as global health status. We also saw that the time to clinically meaningful deterioration of quality of life domains were significantly longer for patients treated with [sacituzumab govitecan].”

“Patients who received sacituzumab govitecan had better health-related quality of life as compared to the control arm, and that’s a very important result, because in the metastatic setting our goal is twofold: We want to prolong survival, and we want patients to have improved quality of life,” Dr. Bardia said.

The Ascent trial is sponsored by Gilead Sciences. Dr. Punie disclosed relationships with multiple companies/organizations, not including Gilead. Dr. Bardia disclosed contracted research for Gilead and others, as well as other relationships.

Approximately one-third of the patients treated in the ASCENT clinical trial comparing the antibody-drug conjugate sacituzumab govitecan (Trodelvy, Gilead) with single-agent chemotherapy in patients with triple-negative breast cancer (TNBC) did not have an initial diagnosis of TNBC.

But as a subanalysis of data from the randomized, phase 3 study showed, sacituzumab govitecan was associated with significantly better progression-free survival (PFS) and overall survival among patients without an initial TNBC diagnosis, with efficacy similar to that seen in the overall study population and in patients without known brain metastases, reported Joyce O’Shaughnessy, MD, at the 2021 European Society for Medical Oncology Congress. In her presentation (abstract 258P), Dr. O’Shaughnessy, who is an oncologist with the Texas Oncology–Baylor Charles A. Sammons Cancer Center in Dallas, said that it’s not uncommon to see acquired triple-negative breast cancer in patients who have hormone receptor–positive disease initially and then later on, develop triple-negative breast cancer.

“That is why at the time of metastatic diagnosis we always say that patients should have repeat receptor [testing], because it’s been well described that a subset of hormone receptor–positive breast can become triple negative under pressure from endocrine therapy,” said ASCENT coinvestigator Aditya Bardia, MD, MPH, Massachusetts General Hospital, Boston, in an interview

Coinvestigator Kevine Punie, MD, from University Hospitals Leuven (Belgium), said that “triple-negative breast cancer is a diagnosis of exclusion. This is a heterogenous disease where several biological subsets are merged.”

“It was important to perform this subgroup analysis to reassure us that the treatment effect we see from [sacituzumab govitecan] in the overall population is also observed in this specific subgroup of patients where biologically we’re treating a different disease,” he said in an interview.
 

Antibody-drug conjugate

Sacituzumab govitecan consists of an antibody targeted to the trophoblast antigen 2 cell surface receptor found on most breast cancer cells, plus the topoisomerase-1 inhibitor SN-38 as its toxic payload.

In the primary intent-to-treat (ITT) analysis of ASCENT, sacituzumab significantly prolonged PFS with a median of 4.8 versus 1.7 months for patients treated with the physician’s choice of either capecitabine, eribulin, vinorelbine, or gemcitabine. The difference translated into an HR for progression with the antibody-drug conjugate of 0.41 (P < .00001).

The subgroup analysis looked at outcomes for 70 patients randomized to sacituzumab govitecan and 78 randomized to single-agent chemotherapy who did not have an initial diagnosis of TNBC.

In all, 27% of patients in this subgroup in the sacituzumab arm and 29% in the chemotherapy arm had received a prior line of treatment with a CDK4/6 inhibitor.

At the time of data cutoff in March 2020, four patients (6%) in the sacituzumab arm remained on treatment versus no patient in the chemotherapy arm. The most common reason for treatment discontinuation was disease progression, which occurred in 84% and 72% of patients, respectively.

The median treatment duration was 5.1 months in the sacituzumab and 1.2 months in the chemotherapy arm. The median duration of follow-up was 10.6 and 6.1 months, respectively.
 

Progression-free survival, overall survival results

For all patients without an initial TNBC diagnosis, the median PFS was 4.6 months with sacituzumab versus 2.3 months with chemotherapy, which translated into a hazard ratio for progression of 0.48 (95% confidence interval, 0.32-0.72). The progression-free benefit with the antibody-drug conjugate was similar to that seen in the intent-to-treat population, as noted before, and among the overall population of patients in the study with no known brain metastases (HR, 5.6 vs. 1.7, respectively; P < .001).

The objective response rates were 21% in the sacituzumab and 5% in the chemotherapy arm. Objective responses were not affected by the prior use of CDK 4/6 inhibitors.

Median overall survival in this subgroup was 12.4 months with the antibody-drug conjugate versus 6.7 months with chemotherapy (95% CI, 0.30-0.64).

The investigators reported that the safety profile was manageable in this subgroup of patients, with a low rate of treatment discontinuations because of adverse events (5%) and no treatment-related deaths with sacituzumab govitecan.
 

Health-related quality of life

In a separate poster (abstract 257P) presented at the meeting, the ASCENT investigators reported health-related quality of life results in the overall population.

The mean European Organization for the Research and Treatment of Cancer quality of life questionnaire subscale scores at baseline were similar between treatment arms.

For the major domains of global health status, physical and emotional functioning as well as lower symptomatic impact of fatigue, pain, dyspnea, and insomnia, sacituzumab govitecan showed “significantly and meaningfully greater improvement” than the physician’s choice of chemotherapy, the investigators found.

Of individual symptoms, only diarrhea was worse with the antibody-drug conjugate.

“These were important improvements,” Dr. Punie said, “because we saw improvements in the primary health-related quality of life domains such as global health status. We also saw that the time to clinically meaningful deterioration of quality of life domains were significantly longer for patients treated with [sacituzumab govitecan].”

“Patients who received sacituzumab govitecan had better health-related quality of life as compared to the control arm, and that’s a very important result, because in the metastatic setting our goal is twofold: We want to prolong survival, and we want patients to have improved quality of life,” Dr. Bardia said.

The Ascent trial is sponsored by Gilead Sciences. Dr. Punie disclosed relationships with multiple companies/organizations, not including Gilead. Dr. Bardia disclosed contracted research for Gilead and others, as well as other relationships.