Pulmonology

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

In 2019, more than five times as many high school students were using tobacco electronically than smoking actual cigarettes, according to the Centers for Disease Control and Prevention.

From 2015 to 2019, current use of electronic vapor products among students in grades 9-12 rose from 24.1% to 32.7%, while the same level of cigarette use – on 1 or more days in the previous 30 – dropped from 10.8% to 6.0%, based on data from the Youth Risk Behavior Survey.

Among the survey respondents, 50.1% had at least tried an electronic vapor product by 2019, up from 44.9% in 2015. Cigarettes again showed a decline, as ever use fell from 32.3% to 24.1%, or less than half of the e-product prevalence. Everyday use of vaping products was 7.2% in 2019 (up from 2.0% in 2015), compared with 1.1% for cigarettes (down from 2.3%), the YRBS data show.

“The dramatic increase in electronic vapor product use among high school students has led to increases in overall tobacco product use among U.S. youths, erasing gains made in previous years and leading the U.S. Surgeon General to declare youth e-cigarette use an epidemic in the United States,” MeLisa R. Creamer, PhD, and associates at the CDC wrote in the MMWR.

Electronic vapor products, as defined by the survey, “include e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, and mods.”

Current use of cigarettes among high school students, as measured by the YRBS, has been declining since reaching a high of 36.4% in 1997; the prevalence of everyday use peaked at 12.8% in 1999. Current use of cigars declined as well, falling from 17.7% in 1999 to 5.7% in 2019, according to YRBS data.

“In 2019, a total of 36.5% of high school students currently used any tobacco product, with electronic vapor products being the most commonly used product,” Dr. Creamer and associates wrote in their recent analysis of the YRBS data (MMWR Supp. 2020 Aug 21;69[1]:56-63).

For the first time since the use of electronic vapor products was included in the every-other-year survey in 2015, females were more likely than males to be current users of vaping products last year, 33.5% to 32.0%. Males were heavier users of cigarettes by a margin of 6.9% to 4.9%, the CDC reported.

Geographically speaking, use of both electronic vapor products and cigarettes varied considerably among the 43 states with available data. Current use of electronic products ranged from a low of 9.7% in Utah to a high of 35.7% in West Virginia, with the two states in the same positions regarding current cigarette use: Utah (2.2%) lowest and West Virginia (13.5%) highest, based on the 2019 YRBS data.

“Tobacco product usage has evolved, and the increasing prevalence of electronic vapor product use among youths during recent years is concerning,” Dr. Creamer and associates wrote.

rfranki@mdedge.com

In 2019, more than five times as many high school students were using tobacco electronically than smoking actual cigarettes, according to the Centers for Disease Control and Prevention.

From 2015 to 2019, current use of electronic vapor products among students in grades 9-12 rose from 24.1% to 32.7%, while the same level of cigarette use – on 1 or more days in the previous 30 – dropped from 10.8% to 6.0%, based on data from the Youth Risk Behavior Survey.

Among the survey respondents, 50.1% had at least tried an electronic vapor product by 2019, up from 44.9% in 2015. Cigarettes again showed a decline, as ever use fell from 32.3% to 24.1%, or less than half of the e-product prevalence. Everyday use of vaping products was 7.2% in 2019 (up from 2.0% in 2015), compared with 1.1% for cigarettes (down from 2.3%), the YRBS data show.

“The dramatic increase in electronic vapor product use among high school students has led to increases in overall tobacco product use among U.S. youths, erasing gains made in previous years and leading the U.S. Surgeon General to declare youth e-cigarette use an epidemic in the United States,” MeLisa R. Creamer, PhD, and associates at the CDC wrote in the MMWR.

Electronic vapor products, as defined by the survey, “include e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, and mods.”

Current use of cigarettes among high school students, as measured by the YRBS, has been declining since reaching a high of 36.4% in 1997; the prevalence of everyday use peaked at 12.8% in 1999. Current use of cigars declined as well, falling from 17.7% in 1999 to 5.7% in 2019, according to YRBS data.

“In 2019, a total of 36.5% of high school students currently used any tobacco product, with electronic vapor products being the most commonly used product,” Dr. Creamer and associates wrote in their recent analysis of the YRBS data (MMWR Supp. 2020 Aug 21;69[1]:56-63).

For the first time since the use of electronic vapor products was included in the every-other-year survey in 2015, females were more likely than males to be current users of vaping products last year, 33.5% to 32.0%. Males were heavier users of cigarettes by a margin of 6.9% to 4.9%, the CDC reported.

Geographically speaking, use of both electronic vapor products and cigarettes varied considerably among the 43 states with available data. Current use of electronic products ranged from a low of 9.7% in Utah to a high of 35.7% in West Virginia, with the two states in the same positions regarding current cigarette use: Utah (2.2%) lowest and West Virginia (13.5%) highest, based on the 2019 YRBS data.

“Tobacco product usage has evolved, and the increasing prevalence of electronic vapor product use among youths during recent years is concerning,” Dr. Creamer and associates wrote.

rfranki@mdedge.com

In 2019, more than five times as many high school students were using tobacco electronically than smoking actual cigarettes, according to the Centers for Disease Control and Prevention.

From 2015 to 2019, current use of electronic vapor products among students in grades 9-12 rose from 24.1% to 32.7%, while the same level of cigarette use – on 1 or more days in the previous 30 – dropped from 10.8% to 6.0%, based on data from the Youth Risk Behavior Survey.

Among the survey respondents, 50.1% had at least tried an electronic vapor product by 2019, up from 44.9% in 2015. Cigarettes again showed a decline, as ever use fell from 32.3% to 24.1%, or less than half of the e-product prevalence. Everyday use of vaping products was 7.2% in 2019 (up from 2.0% in 2015), compared with 1.1% for cigarettes (down from 2.3%), the YRBS data show.

“The dramatic increase in electronic vapor product use among high school students has led to increases in overall tobacco product use among U.S. youths, erasing gains made in previous years and leading the U.S. Surgeon General to declare youth e-cigarette use an epidemic in the United States,” MeLisa R. Creamer, PhD, and associates at the CDC wrote in the MMWR.

Electronic vapor products, as defined by the survey, “include e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, and mods.”

Current use of cigarettes among high school students, as measured by the YRBS, has been declining since reaching a high of 36.4% in 1997; the prevalence of everyday use peaked at 12.8% in 1999. Current use of cigars declined as well, falling from 17.7% in 1999 to 5.7% in 2019, according to YRBS data.

“In 2019, a total of 36.5% of high school students currently used any tobacco product, with electronic vapor products being the most commonly used product,” Dr. Creamer and associates wrote in their recent analysis of the YRBS data (MMWR Supp. 2020 Aug 21;69[1]:56-63).

For the first time since the use of electronic vapor products was included in the every-other-year survey in 2015, females were more likely than males to be current users of vaping products last year, 33.5% to 32.0%. Males were heavier users of cigarettes by a margin of 6.9% to 4.9%, the CDC reported.

Geographically speaking, use of both electronic vapor products and cigarettes varied considerably among the 43 states with available data. Current use of electronic products ranged from a low of 9.7% in Utah to a high of 35.7% in West Virginia, with the two states in the same positions regarding current cigarette use: Utah (2.2%) lowest and West Virginia (13.5%) highest, based on the 2019 YRBS data.

“Tobacco product usage has evolved, and the increasing prevalence of electronic vapor product use among youths during recent years is concerning,” Dr. Creamer and associates wrote.

rfranki@mdedge.com

Patients with chronic obstructive pulmonary disease who also had certain interstitial lung abnormalities experienced more exacerbations and reduced lung function than those without such abnormalities, findings from a retrospective study has shown.

Interstitial lung abnormalities (ILA) are considered precursor lesions of interstitial lung disease and previous studies suggested an association with poor outcomes among chronic obstructive pulmonary disease (COPD) patients, but data on long-term clinical relevance are limited, wrote Tae Seung Lee, MD, of Seoul (South Korea) National University Hospital, and colleagues.

In a study published in Chest, the researchers reviewed data from 363 COPD patients including 44 with equivocal ILA and 103 with definite ILA. Overall, the ILA patients were older and had poorer lung function than non-ILA patients. Patients received chest CT scan and longitudinal pulmonary function tests between January 2013 and December 2018.

Over an average follow-up period of 5.4 years, patients with ILA experienced significantly more acute COPD exacerbations than did those without ILA (adjusted odds ratio, 2.03). The percentages of frequent exacerbators among patients with no ILA, equivocal ILA, and definite ILA were 8.3%, 15.9%, and 20.4%, respectively.

“Acute exacerbation is an important event during the clinical course of COPD, because it is associated with temporary or persistent reductions in lung function, lower quality of life, hospitalization, and mortality,” the researchers noted.

In a multivariate analysis, the annual decline in lung function (FEV₁) was –35.7 in patients with equivocal ILA, compared with –28.0 in patients with no ILA and –15.9 in those with definite ILA.

“This may be due to the distribution of the spirometric stages in each group, and to the resulting changes in lung function,” the researchers wrote. In this study, “the equivocal ILA group had a significantly lower baseline FEV₁ than the other groups. In our study population, the lower the spirometric stage, the faster the annual decline in FEV₁, consistent with the results of a prior prospective study of a COPD cohort.”

The findings were limited by several factors including the retrospective design and relatively small number of ILA patients, as well as the limited evaluation of ILA and potential for selection bias, the researchers noted. However, the result support the impact of ILA on exacerbations and accelerated decline in lung function in COPD patients.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Lee TS et al. Chest. 2020 Aug 13. doi: 10.1016/j.chest.2020.08.017.

Patients with chronic obstructive pulmonary disease who also had certain interstitial lung abnormalities experienced more exacerbations and reduced lung function than those without such abnormalities, findings from a retrospective study has shown.

Interstitial lung abnormalities (ILA) are considered precursor lesions of interstitial lung disease and previous studies suggested an association with poor outcomes among chronic obstructive pulmonary disease (COPD) patients, but data on long-term clinical relevance are limited, wrote Tae Seung Lee, MD, of Seoul (South Korea) National University Hospital, and colleagues.

In a study published in Chest, the researchers reviewed data from 363 COPD patients including 44 with equivocal ILA and 103 with definite ILA. Overall, the ILA patients were older and had poorer lung function than non-ILA patients. Patients received chest CT scan and longitudinal pulmonary function tests between January 2013 and December 2018.

Over an average follow-up period of 5.4 years, patients with ILA experienced significantly more acute COPD exacerbations than did those without ILA (adjusted odds ratio, 2.03). The percentages of frequent exacerbators among patients with no ILA, equivocal ILA, and definite ILA were 8.3%, 15.9%, and 20.4%, respectively.

“Acute exacerbation is an important event during the clinical course of COPD, because it is associated with temporary or persistent reductions in lung function, lower quality of life, hospitalization, and mortality,” the researchers noted.

In a multivariate analysis, the annual decline in lung function (FEV₁) was –35.7 in patients with equivocal ILA, compared with –28.0 in patients with no ILA and –15.9 in those with definite ILA.

“This may be due to the distribution of the spirometric stages in each group, and to the resulting changes in lung function,” the researchers wrote. In this study, “the equivocal ILA group had a significantly lower baseline FEV₁ than the other groups. In our study population, the lower the spirometric stage, the faster the annual decline in FEV₁, consistent with the results of a prior prospective study of a COPD cohort.”

The findings were limited by several factors including the retrospective design and relatively small number of ILA patients, as well as the limited evaluation of ILA and potential for selection bias, the researchers noted. However, the result support the impact of ILA on exacerbations and accelerated decline in lung function in COPD patients.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Lee TS et al. Chest. 2020 Aug 13. doi: 10.1016/j.chest.2020.08.017.

Patients with chronic obstructive pulmonary disease who also had certain interstitial lung abnormalities experienced more exacerbations and reduced lung function than those without such abnormalities, findings from a retrospective study has shown.

Interstitial lung abnormalities (ILA) are considered precursor lesions of interstitial lung disease and previous studies suggested an association with poor outcomes among chronic obstructive pulmonary disease (COPD) patients, but data on long-term clinical relevance are limited, wrote Tae Seung Lee, MD, of Seoul (South Korea) National University Hospital, and colleagues.

In a study published in Chest, the researchers reviewed data from 363 COPD patients including 44 with equivocal ILA and 103 with definite ILA. Overall, the ILA patients were older and had poorer lung function than non-ILA patients. Patients received chest CT scan and longitudinal pulmonary function tests between January 2013 and December 2018.

Over an average follow-up period of 5.4 years, patients with ILA experienced significantly more acute COPD exacerbations than did those without ILA (adjusted odds ratio, 2.03). The percentages of frequent exacerbators among patients with no ILA, equivocal ILA, and definite ILA were 8.3%, 15.9%, and 20.4%, respectively.

“Acute exacerbation is an important event during the clinical course of COPD, because it is associated with temporary or persistent reductions in lung function, lower quality of life, hospitalization, and mortality,” the researchers noted.

In a multivariate analysis, the annual decline in lung function (FEV₁) was –35.7 in patients with equivocal ILA, compared with –28.0 in patients with no ILA and –15.9 in those with definite ILA.

“This may be due to the distribution of the spirometric stages in each group, and to the resulting changes in lung function,” the researchers wrote. In this study, “the equivocal ILA group had a significantly lower baseline FEV₁ than the other groups. In our study population, the lower the spirometric stage, the faster the annual decline in FEV₁, consistent with the results of a prior prospective study of a COPD cohort.”

The findings were limited by several factors including the retrospective design and relatively small number of ILA patients, as well as the limited evaluation of ILA and potential for selection bias, the researchers noted. However, the result support the impact of ILA on exacerbations and accelerated decline in lung function in COPD patients.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Lee TS et al. Chest. 2020 Aug 13. doi: 10.1016/j.chest.2020.08.017.

The pragmatic Hestia criteria proved as safe as the more structured, points-based simplified Pulmonary Embolism Severity Index (sPESI) score for selection of patients with acute pulmonary embolism for outpatient care in the large, randomized HOME-PE trial presented at the virtual annual congress of the European Society of Cardiology.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License

“These results support outpatient management of acute pulmonary embolism patients using either the Hestia method or the sPESI score with the option for the physician-in-charge to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications,” Pierre-Marie Roy, MD, said in presenting the HOME-PE findings.

The study clarifies a transatlantic controversy regarding how best to triage patients with acute pulmonary embolism (PE) for outpatient care. The answer? It’s basically a tie between the points-based sPESI score recommended in the current ESC guidelines (Eur Respir J. 2019 Oct 9;54[3]:1901647) and the Hestia method endorsed in the American College of Chest Physician guidelines (Chest. 2016 Feb;149[2]:315-52).

The sPESI is a validated tool that grants 1 point each for age over 80 years, background cardiopulmonary disease, a systolic blood pressure below 100 mm Hg, cancer, a heart rate of 110 bpm or more, and an oxygen saturation level below 90%. A patient needs a score of zero to be eligible for outpatient management. In contrast, the Hestia method relies upon 11 simple bedside criteria rather than a points system, explained Dr. Roy of University Hospital of Angers, France (J Thromb Haemost. 2011 Aug;9[8]:1500-7).

HOME-PE was a randomized, open-label, noninferiority trial conducted at 26 hospitals in France, Belgium, Switzerland, and the Netherlands. The study included 1,974 patients presenting to the emergency department with non–high-risk acute PE as defined by hemodynamic stability. About 39% of patients in the Hestia group were eligible for outpatient care on the basis of ‘no’ answers regarding all 11 criteria, while 48% of patients had an sPESI score of 0 and were thus initially considered appropriate for outpatient management.

However, the investigators recognized that no scoring system for acute PE is perfect, and that the judgment of a physician with extensive experience in managing this life-threatening condition counts for a lot. So they stipulated that a patient’s physician-in-charge could overrule a decision for early discharge. This happened 29% of the time in patients with a sPESI score of 0, as compared with a 3% overrule rate with the Hestia rule. The physician-in-charge also moved small numbers of patients who were Hestia or sPESI positive into the outpatient care group. As a result, a similar proportion of patients in both groups were discharged home within 24 hours for outpatient treatment: 38% of the total Hestia group and 37% in the sPESI arm.

Major adverse event rates were reassuringly low in both groups managed on an outpatient basis. The composite of recurrent venous thromboembolism, bleeding, or death within 30 days occurred in 1.3% of Hestia outpatients and 1.1% of sPESI outpatients. Among patients managed in the hospital, these rates were 5.6% in the Hestia group and 4.7% in the sPESI group.

Discussant Stavros V. Konstantinides, MD, who chaired the ESC guideline committee, asked rhetorically, “who’s happy with the HOME-PE trial? I think everybody.”

“The Hestia criteria integrate the feasibility of family support of the individual patient. This is a good thing. And eligibility based on the Hestia criteria, unlike sPESI, does not require age younger than 80 years or no cancer, and it appears from the HOME-PE study that this is okay,” observed Dr. Konstantinides of the Center for Thrombosis and Hemostasis at the University of Mainz (Germany).

In an interview, Hadley Wilson, MD, called the HOME-PE trial “transformative” and predicted it will change clinical practice. He was particularly impressed with the high quality of the trial, noting that 87% of participants managed as outpatients received a direct oral anticoagulant.

The Hestia rule is simpler and more user-friendly. And greater use of this triaging strategy might have advantages in terms of economics and health care utilization by potentially encouraging movement of decision-making regarding outpatient management of acute PE out of the hospital wards and into emergency departments, said Dr. Wilson, executive vice chair of the Sanger Heart and Vascular Institute and a cardiologist at the University of North Carolina at Chapel Hill.

Dr. Roy reported receiving research grants to conduct HOME-PE from the French Ministry of Health, the study sponsor. In addition, he is on scientific advisory boards and/or speakers’ panels for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Aspen, Daiichi Sankyo, and Sanofi Aventis.
 

bjancin@mdedge.com

The pragmatic Hestia criteria proved as safe as the more structured, points-based simplified Pulmonary Embolism Severity Index (sPESI) score for selection of patients with acute pulmonary embolism for outpatient care in the large, randomized HOME-PE trial presented at the virtual annual congress of the European Society of Cardiology.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License

“These results support outpatient management of acute pulmonary embolism patients using either the Hestia method or the sPESI score with the option for the physician-in-charge to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications,” Pierre-Marie Roy, MD, said in presenting the HOME-PE findings.

The study clarifies a transatlantic controversy regarding how best to triage patients with acute pulmonary embolism (PE) for outpatient care. The answer? It’s basically a tie between the points-based sPESI score recommended in the current ESC guidelines (Eur Respir J. 2019 Oct 9;54[3]:1901647) and the Hestia method endorsed in the American College of Chest Physician guidelines (Chest. 2016 Feb;149[2]:315-52).

The sPESI is a validated tool that grants 1 point each for age over 80 years, background cardiopulmonary disease, a systolic blood pressure below 100 mm Hg, cancer, a heart rate of 110 bpm or more, and an oxygen saturation level below 90%. A patient needs a score of zero to be eligible for outpatient management. In contrast, the Hestia method relies upon 11 simple bedside criteria rather than a points system, explained Dr. Roy of University Hospital of Angers, France (J Thromb Haemost. 2011 Aug;9[8]:1500-7).

HOME-PE was a randomized, open-label, noninferiority trial conducted at 26 hospitals in France, Belgium, Switzerland, and the Netherlands. The study included 1,974 patients presenting to the emergency department with non–high-risk acute PE as defined by hemodynamic stability. About 39% of patients in the Hestia group were eligible for outpatient care on the basis of ‘no’ answers regarding all 11 criteria, while 48% of patients had an sPESI score of 0 and were thus initially considered appropriate for outpatient management.

However, the investigators recognized that no scoring system for acute PE is perfect, and that the judgment of a physician with extensive experience in managing this life-threatening condition counts for a lot. So they stipulated that a patient’s physician-in-charge could overrule a decision for early discharge. This happened 29% of the time in patients with a sPESI score of 0, as compared with a 3% overrule rate with the Hestia rule. The physician-in-charge also moved small numbers of patients who were Hestia or sPESI positive into the outpatient care group. As a result, a similar proportion of patients in both groups were discharged home within 24 hours for outpatient treatment: 38% of the total Hestia group and 37% in the sPESI arm.

Major adverse event rates were reassuringly low in both groups managed on an outpatient basis. The composite of recurrent venous thromboembolism, bleeding, or death within 30 days occurred in 1.3% of Hestia outpatients and 1.1% of sPESI outpatients. Among patients managed in the hospital, these rates were 5.6% in the Hestia group and 4.7% in the sPESI group.

Discussant Stavros V. Konstantinides, MD, who chaired the ESC guideline committee, asked rhetorically, “who’s happy with the HOME-PE trial? I think everybody.”

“The Hestia criteria integrate the feasibility of family support of the individual patient. This is a good thing. And eligibility based on the Hestia criteria, unlike sPESI, does not require age younger than 80 years or no cancer, and it appears from the HOME-PE study that this is okay,” observed Dr. Konstantinides of the Center for Thrombosis and Hemostasis at the University of Mainz (Germany).

In an interview, Hadley Wilson, MD, called the HOME-PE trial “transformative” and predicted it will change clinical practice. He was particularly impressed with the high quality of the trial, noting that 87% of participants managed as outpatients received a direct oral anticoagulant.

The Hestia rule is simpler and more user-friendly. And greater use of this triaging strategy might have advantages in terms of economics and health care utilization by potentially encouraging movement of decision-making regarding outpatient management of acute PE out of the hospital wards and into emergency departments, said Dr. Wilson, executive vice chair of the Sanger Heart and Vascular Institute and a cardiologist at the University of North Carolina at Chapel Hill.

Dr. Roy reported receiving research grants to conduct HOME-PE from the French Ministry of Health, the study sponsor. In addition, he is on scientific advisory boards and/or speakers’ panels for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Aspen, Daiichi Sankyo, and Sanofi Aventis.
 

bjancin@mdedge.com

The pragmatic Hestia criteria proved as safe as the more structured, points-based simplified Pulmonary Embolism Severity Index (sPESI) score for selection of patients with acute pulmonary embolism for outpatient care in the large, randomized HOME-PE trial presented at the virtual annual congress of the European Society of Cardiology.

Courtesy Wikimedia Commons/Walter Serra, Giuseppe De Iaco, Claudio Reverberi, and Tiziano Gherli/Creative Commons License

“These results support outpatient management of acute pulmonary embolism patients using either the Hestia method or the sPESI score with the option for the physician-in-charge to override the decision. In hospitals organized for outpatient management, both triaging strategies enable more than a third of pulmonary embolism patients to be managed at home with a low rate of complications,” Pierre-Marie Roy, MD, said in presenting the HOME-PE findings.

The study clarifies a transatlantic controversy regarding how best to triage patients with acute pulmonary embolism (PE) for outpatient care. The answer? It’s basically a tie between the points-based sPESI score recommended in the current ESC guidelines (Eur Respir J. 2019 Oct 9;54[3]:1901647) and the Hestia method endorsed in the American College of Chest Physician guidelines (Chest. 2016 Feb;149[2]:315-52).

The sPESI is a validated tool that grants 1 point each for age over 80 years, background cardiopulmonary disease, a systolic blood pressure below 100 mm Hg, cancer, a heart rate of 110 bpm or more, and an oxygen saturation level below 90%. A patient needs a score of zero to be eligible for outpatient management. In contrast, the Hestia method relies upon 11 simple bedside criteria rather than a points system, explained Dr. Roy of University Hospital of Angers, France (J Thromb Haemost. 2011 Aug;9[8]:1500-7).

HOME-PE was a randomized, open-label, noninferiority trial conducted at 26 hospitals in France, Belgium, Switzerland, and the Netherlands. The study included 1,974 patients presenting to the emergency department with non–high-risk acute PE as defined by hemodynamic stability. About 39% of patients in the Hestia group were eligible for outpatient care on the basis of ‘no’ answers regarding all 11 criteria, while 48% of patients had an sPESI score of 0 and were thus initially considered appropriate for outpatient management.

However, the investigators recognized that no scoring system for acute PE is perfect, and that the judgment of a physician with extensive experience in managing this life-threatening condition counts for a lot. So they stipulated that a patient’s physician-in-charge could overrule a decision for early discharge. This happened 29% of the time in patients with a sPESI score of 0, as compared with a 3% overrule rate with the Hestia rule. The physician-in-charge also moved small numbers of patients who were Hestia or sPESI positive into the outpatient care group. As a result, a similar proportion of patients in both groups were discharged home within 24 hours for outpatient treatment: 38% of the total Hestia group and 37% in the sPESI arm.

Major adverse event rates were reassuringly low in both groups managed on an outpatient basis. The composite of recurrent venous thromboembolism, bleeding, or death within 30 days occurred in 1.3% of Hestia outpatients and 1.1% of sPESI outpatients. Among patients managed in the hospital, these rates were 5.6% in the Hestia group and 4.7% in the sPESI group.

Discussant Stavros V. Konstantinides, MD, who chaired the ESC guideline committee, asked rhetorically, “who’s happy with the HOME-PE trial? I think everybody.”

“The Hestia criteria integrate the feasibility of family support of the individual patient. This is a good thing. And eligibility based on the Hestia criteria, unlike sPESI, does not require age younger than 80 years or no cancer, and it appears from the HOME-PE study that this is okay,” observed Dr. Konstantinides of the Center for Thrombosis and Hemostasis at the University of Mainz (Germany).

In an interview, Hadley Wilson, MD, called the HOME-PE trial “transformative” and predicted it will change clinical practice. He was particularly impressed with the high quality of the trial, noting that 87% of participants managed as outpatients received a direct oral anticoagulant.

The Hestia rule is simpler and more user-friendly. And greater use of this triaging strategy might have advantages in terms of economics and health care utilization by potentially encouraging movement of decision-making regarding outpatient management of acute PE out of the hospital wards and into emergency departments, said Dr. Wilson, executive vice chair of the Sanger Heart and Vascular Institute and a cardiologist at the University of North Carolina at Chapel Hill.

Dr. Roy reported receiving research grants to conduct HOME-PE from the French Ministry of Health, the study sponsor. In addition, he is on scientific advisory boards and/or speakers’ panels for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, Aspen, Daiichi Sankyo, and Sanofi Aventis.
 

bjancin@mdedge.com

Marilyn Stebbins, PharmD, fell ill at the end of February 2020. Initially diagnosed with multifocal pneumonia and treated with antibiotics, she later developed severe gastrointestinal symptoms, fatigue, and shortness of breath. She was hospitalized in early March and was diagnosed with COVID-19.

It was still early in the pandemic, and testing was not available for her husband. After she was discharged, her husband isolated himself as much as possible. But that limited the amount of care he could offer.

“When I came home after 8 days in the ICU, I felt completely alone and terrified of not being able to care for myself and not knowing how much care my husband could provide,” said Dr. Stebbins, professor of clinical pharmacy at the University of California, San Francisco.

“I can’t even imagine what it would have been like if I had been home alone without my husband in the house,” she said. “I think about the people who died at home and understand how that might happen.”

Dr. Stebbins is one of tens of thousands of people who, whether hospitalized and discharged or never admitted for inpatient care, needed to find ways to convalesce at home. Data from the Centers for Medicare & Medicaid Services show that, of 326,674 beneficiaries who tested positive for COVID-19 between May 16 and June 11, 2020, 109,607 were hospitalized, suggesting that two-thirds were outpatients.

Most attention has focused on the sickest patients, leaving less severe cases to fall through the cracks. Despite fever, cough, difficulty breathing, and a surfeit of other symptoms, there are few available resources and all too little support to help patients navigate the physical and emotional struggles of contending with COVID-19 at home.
 

No ‘cookie-cutter’ approach

The speed with which the pandemic progressed caught public health systems off guard, but now, “it is essential to put into place the infrastructure to care for the physical and mental health needs of patients at home because most are in the community and many, if not most, still aren’t receiving sufficient support at home,” said Dr. Stebbins.

Caring for COVID-19 patients at home begins with determining their individual needs, said Gary LeRoy, MD, a family physician in Dayton, Ohio. He emphasized that there is “no cookie-cutter formula” for home care, because every patient’s situation is different.

“I begin by having a detailed conversation with each patient to ascertain whether their home environment is safe and to paint a picture of their circumstances,” Dr. LeRoy, who is the president of the American Academy of Family Physicians, said in an interview.

Dr. LeRoy suggested questions that constitute “not just a ‘medical’ checklist but a ‘whole life’ checklist.”

• Do you have access to food, water, medications, sanitation/cleaning supplies, a thermometer, and other necessities? If not, who might assist in providing those?
• Do you need help with activities of daily living and self-care?
• Who else lives in your household? Do they have signs and symptoms of the virus? Have they been tested?
• Do you have enough physical space between you and other household members?
• Do you have children? How are they being cared for?
• What type of work do you do? What are the implications for your employment if you are unable to work for an extended period?
• Do you have an emotional, social, and spiritual support system (e.g., family, friends, community, church)?
• Do you have concerns I haven’t mentioned?

Patients’ responses will inform the management plan and determine what medical and social resources are needed, he said.
 

Daily check-in

Dr. Stebbins said the nurse case manager from her insurance company called her daily after she came home from the hospital. She was told that a public health nurse would also call, but no one from the health department called for days – a situation she hopes has improved.

One way or another, she said, “health care providers [or their staff] should check in with patients daily, either telephonically or via video.” She noted that video is superior, because “someone who isn’t a family member needs to put eyes on a patient and might be able to detect warning signs that a family member without healthcare training might not notice.”

Dr. LeRoy, who is also an associate professor of medicine at Wright State University, Dayton, Ohio, said that, given his time constraints, a nurse or medical assistant in his practice conducts the daily check-ins and notifies him if the patient has fever or other symptoms.

“Under ordinary circumstances, when a patient comes to see me for some type of medical condition, I get to meet the patient, consider what might be going on, then order a test, wait for the results, and suggest a treatment plan. But these are anything but ordinary circumstances,” said Matthew Exline, MD, a pulmonary and critical care specialist at the Ohio State University Wexner Medical Center, Columbus.

“That traditional structure broke down with COVID-19, when we may have test results without even seeing the patient. And without this interaction, it is harder to know as a physician what course of action to take,” he said in an interview.

Once a diagnosis has been made, the physician has at least some data to help guide next steps, even if there has been no prior meeting with the patient.

For example, a positive test raises a host of issues, not the least of which is the risk of spreading the infection to other household members and questions about whether to go the hospital. Moreover, for patients, positive tests can have serious ramifications.

“Severe shortness of breath at rest is not typical of the flu, nor is loss of taste or smell,” said Dr. Exline. Practitioners must educate patients and families about specific symptoms of COVID-19, including shortness of breath, loss of taste or smell, and gastrointestinal or neurologic symptoms, and when to seek emergency care.

Dr. LeRoy suggests buying a pulse oximeter to gauge blood oxygen levels and pulse rate. Together with a thermometer, a portable blood pressure monitor, and, if indicated, a blood glucose monitor, these devices provide a comprehensive and accurate assessment of vital signs.

Dr. LeRoy also educates patients and their families about when to seek medical attention.

Dr. Stebbins takes a similar approach. “Family members are part of, not apart from, the care of patients with COVID-19, and it’s our responsibility as healthcare providers to consider them in the patient’s care plan.”
 

Keeping family safe

Beyond care, family members need a plan to keep themselves healthy, too.

“A patient with COVID-19 at home should self-quarantine as much as possible to keep other family members safe, if they continue to live in the same house,” Dr. Exline said.

Ideally, uninfected family members should stay with relatives or friends. When that’s not possible, everyone in the household should wear a mask, be vigilant about hand washing, and wipe down all surfaces – including doorknobs, light switches, faucet handles, cellphones, and utensils – regularly with bleach or an alcohol solution.

Caregivers should also minimize the amount of time they are exposed to the patient.

“Set food, water, and medication on the night table and leave the room rather than spending hours at the bedside, since limiting exposure to viral load reduces the chances of contagion,” said Dr. Exline.

The Centers for Disease Control and Prevention offers guidance for household members caring for COVID-19 patients at home. It provides tips on how to help patients follow the doctor’s instructions and ways to ensure adequate hydration and rest, among others.

Patients with COVID-19 who live alone face more formidable challenges.

Dr. LeRoy says physicians can help patients by educating themselves about available social services in their community so they can provide appropriate referrals and connections. Such initiatives can include meal programs, friendly visit and financial assistance programs, as well as childcare and home health agencies.

He noted that Aunt Bertha, a social care network, provides a guide to social services throughout the United States. Additional resources are available on USA.gov.
 

Comfort and support

Patients with COVID-19 need to be as comfortable and as supported as possible, both physically and emotionally.

“While I was sick, my dogs curled up next to me and didn’t leave my side, and they were my saving grace. There’s not enough to be said about emotional support,” Dr. Stebbins said.

Although important, emotional support is not enough. For patients with respiratory disorders, such as chronic obstructive pulmonary disease, asthma, heart failure, or pneumonia, their subjective symptoms of shortness of breath, air hunger, or cough may improve with supplemental oxygen at home. Other measures include repositioning of the patient to lessen the body weight over the lungs or the use of lung percussion, Leroy said.

He added that improvement may also come from drainage of sputum from the airway passages, the use of agents to liquefy thick sputum (mucolytics), or aerosolized bronchodilator medications.

However, Dr. LeRoy cautioned, “one remedy does not work for everyone – an individual can improve gradually by using these home support interventions, or their respiratory status can deteriorate rapidly despite all these interventions.”

For this reason, he says patients should consult their personal physician to determine which, if any, of these home treatments would be best for their particular situation.

Patients who need emotional support, psychotherapy, or psychotropic medications may find teletherapy helpful. Guidance for psychiatrists, psychologists, and social workers regarding the treatment of COVID-19 patients via teletherapy can be found on the American Psychiatric Association, the American Psychological Association, and the National Association of Social Workers websites.

Pharmacists can also help ensure patient safety, Dr. Stebbins said.

If a patient has not picked up their usual medications, Dr. Stebbins said, “they may need a check-in call. Some may be ill and alone and may need encouragement to seek medical attention, and some may have no means of getting to the pharmacy and may need medications delivered.”

A home healthcare agency may also be helpful for homebound patients. David Bersson, director of operations at Synergy Home Care of Bergen County, N.J., has arranged in-home caregivers for patients with COVID-19.

The amount of care that professional caregivers provide can range from several hours per week to full-time, depending on the patient’s needs and budget, and can include companionship, Mr. Bersson said in an interview.

Because patient and caregiver safety are paramount, caregivers are thoroughly trained in protection and decontamination procedures and are regularly tested for COVID-19 prior to being sent into a client’s home.

Health insurance companies do not cover this service, Mr. Bersson noted, but the VetAssist program covers home care for veterans and their spouses who meet income requirements.

Caregiving and companionship are both vital pieces of the at-home care puzzle. “It was the virtual emotional support I got from friends, family, coworkers, and healthcare professionals that meant so much to me, and I know they played an important part in my recovery,” Dr. Stebbins said.

Dr. LeRoy agreed, noting that he calls patients, even if they only have mild symptoms and his nurse has already spoken to them. “The call doesn’t take much time – maybe just a 5-minute conversation – but it makes patients aware that I care.”

Dr. Stebbins, Dr. Exline, and Dr. LeRoy report no relevant financial relationships. Mr. Bersson is the director of operations at Synergy Home Care of Bergen County, New Jersey.

This story first appeared on Medscape.com.

Marilyn Stebbins, PharmD, fell ill at the end of February 2020. Initially diagnosed with multifocal pneumonia and treated with antibiotics, she later developed severe gastrointestinal symptoms, fatigue, and shortness of breath. She was hospitalized in early March and was diagnosed with COVID-19.

It was still early in the pandemic, and testing was not available for her husband. After she was discharged, her husband isolated himself as much as possible. But that limited the amount of care he could offer.

“When I came home after 8 days in the ICU, I felt completely alone and terrified of not being able to care for myself and not knowing how much care my husband could provide,” said Dr. Stebbins, professor of clinical pharmacy at the University of California, San Francisco.

“I can’t even imagine what it would have been like if I had been home alone without my husband in the house,” she said. “I think about the people who died at home and understand how that might happen.”

Dr. Stebbins is one of tens of thousands of people who, whether hospitalized and discharged or never admitted for inpatient care, needed to find ways to convalesce at home. Data from the Centers for Medicare & Medicaid Services show that, of 326,674 beneficiaries who tested positive for COVID-19 between May 16 and June 11, 2020, 109,607 were hospitalized, suggesting that two-thirds were outpatients.

Most attention has focused on the sickest patients, leaving less severe cases to fall through the cracks. Despite fever, cough, difficulty breathing, and a surfeit of other symptoms, there are few available resources and all too little support to help patients navigate the physical and emotional struggles of contending with COVID-19 at home.
 

No ‘cookie-cutter’ approach

The speed with which the pandemic progressed caught public health systems off guard, but now, “it is essential to put into place the infrastructure to care for the physical and mental health needs of patients at home because most are in the community and many, if not most, still aren’t receiving sufficient support at home,” said Dr. Stebbins.

Caring for COVID-19 patients at home begins with determining their individual needs, said Gary LeRoy, MD, a family physician in Dayton, Ohio. He emphasized that there is “no cookie-cutter formula” for home care, because every patient’s situation is different.

“I begin by having a detailed conversation with each patient to ascertain whether their home environment is safe and to paint a picture of their circumstances,” Dr. LeRoy, who is the president of the American Academy of Family Physicians, said in an interview.

Dr. LeRoy suggested questions that constitute “not just a ‘medical’ checklist but a ‘whole life’ checklist.”

• Do you have access to food, water, medications, sanitation/cleaning supplies, a thermometer, and other necessities? If not, who might assist in providing those?
• Do you need help with activities of daily living and self-care?
• Who else lives in your household? Do they have signs and symptoms of the virus? Have they been tested?
• Do you have enough physical space between you and other household members?
• Do you have children? How are they being cared for?
• What type of work do you do? What are the implications for your employment if you are unable to work for an extended period?
• Do you have an emotional, social, and spiritual support system (e.g., family, friends, community, church)?
• Do you have concerns I haven’t mentioned?

Patients’ responses will inform the management plan and determine what medical and social resources are needed, he said.
 

Daily check-in

Dr. Stebbins said the nurse case manager from her insurance company called her daily after she came home from the hospital. She was told that a public health nurse would also call, but no one from the health department called for days – a situation she hopes has improved.

One way or another, she said, “health care providers [or their staff] should check in with patients daily, either telephonically or via video.” She noted that video is superior, because “someone who isn’t a family member needs to put eyes on a patient and might be able to detect warning signs that a family member without healthcare training might not notice.”

Dr. LeRoy, who is also an associate professor of medicine at Wright State University, Dayton, Ohio, said that, given his time constraints, a nurse or medical assistant in his practice conducts the daily check-ins and notifies him if the patient has fever or other symptoms.

“Under ordinary circumstances, when a patient comes to see me for some type of medical condition, I get to meet the patient, consider what might be going on, then order a test, wait for the results, and suggest a treatment plan. But these are anything but ordinary circumstances,” said Matthew Exline, MD, a pulmonary and critical care specialist at the Ohio State University Wexner Medical Center, Columbus.

“That traditional structure broke down with COVID-19, when we may have test results without even seeing the patient. And without this interaction, it is harder to know as a physician what course of action to take,” he said in an interview.

Once a diagnosis has been made, the physician has at least some data to help guide next steps, even if there has been no prior meeting with the patient.

For example, a positive test raises a host of issues, not the least of which is the risk of spreading the infection to other household members and questions about whether to go the hospital. Moreover, for patients, positive tests can have serious ramifications.

“Severe shortness of breath at rest is not typical of the flu, nor is loss of taste or smell,” said Dr. Exline. Practitioners must educate patients and families about specific symptoms of COVID-19, including shortness of breath, loss of taste or smell, and gastrointestinal or neurologic symptoms, and when to seek emergency care.

Dr. LeRoy suggests buying a pulse oximeter to gauge blood oxygen levels and pulse rate. Together with a thermometer, a portable blood pressure monitor, and, if indicated, a blood glucose monitor, these devices provide a comprehensive and accurate assessment of vital signs.

Dr. LeRoy also educates patients and their families about when to seek medical attention.

Dr. Stebbins takes a similar approach. “Family members are part of, not apart from, the care of patients with COVID-19, and it’s our responsibility as healthcare providers to consider them in the patient’s care plan.”
 

Keeping family safe

Beyond care, family members need a plan to keep themselves healthy, too.

“A patient with COVID-19 at home should self-quarantine as much as possible to keep other family members safe, if they continue to live in the same house,” Dr. Exline said.

Ideally, uninfected family members should stay with relatives or friends. When that’s not possible, everyone in the household should wear a mask, be vigilant about hand washing, and wipe down all surfaces – including doorknobs, light switches, faucet handles, cellphones, and utensils – regularly with bleach or an alcohol solution.

Caregivers should also minimize the amount of time they are exposed to the patient.

“Set food, water, and medication on the night table and leave the room rather than spending hours at the bedside, since limiting exposure to viral load reduces the chances of contagion,” said Dr. Exline.

The Centers for Disease Control and Prevention offers guidance for household members caring for COVID-19 patients at home. It provides tips on how to help patients follow the doctor’s instructions and ways to ensure adequate hydration and rest, among others.

Patients with COVID-19 who live alone face more formidable challenges.

Dr. LeRoy says physicians can help patients by educating themselves about available social services in their community so they can provide appropriate referrals and connections. Such initiatives can include meal programs, friendly visit and financial assistance programs, as well as childcare and home health agencies.

He noted that Aunt Bertha, a social care network, provides a guide to social services throughout the United States. Additional resources are available on USA.gov.
 

Comfort and support

Patients with COVID-19 need to be as comfortable and as supported as possible, both physically and emotionally.

“While I was sick, my dogs curled up next to me and didn’t leave my side, and they were my saving grace. There’s not enough to be said about emotional support,” Dr. Stebbins said.

Although important, emotional support is not enough. For patients with respiratory disorders, such as chronic obstructive pulmonary disease, asthma, heart failure, or pneumonia, their subjective symptoms of shortness of breath, air hunger, or cough may improve with supplemental oxygen at home. Other measures include repositioning of the patient to lessen the body weight over the lungs or the use of lung percussion, Leroy said.

He added that improvement may also come from drainage of sputum from the airway passages, the use of agents to liquefy thick sputum (mucolytics), or aerosolized bronchodilator medications.

However, Dr. LeRoy cautioned, “one remedy does not work for everyone – an individual can improve gradually by using these home support interventions, or their respiratory status can deteriorate rapidly despite all these interventions.”

For this reason, he says patients should consult their personal physician to determine which, if any, of these home treatments would be best for their particular situation.

Patients who need emotional support, psychotherapy, or psychotropic medications may find teletherapy helpful. Guidance for psychiatrists, psychologists, and social workers regarding the treatment of COVID-19 patients via teletherapy can be found on the American Psychiatric Association, the American Psychological Association, and the National Association of Social Workers websites.

Pharmacists can also help ensure patient safety, Dr. Stebbins said.

If a patient has not picked up their usual medications, Dr. Stebbins said, “they may need a check-in call. Some may be ill and alone and may need encouragement to seek medical attention, and some may have no means of getting to the pharmacy and may need medications delivered.”

A home healthcare agency may also be helpful for homebound patients. David Bersson, director of operations at Synergy Home Care of Bergen County, N.J., has arranged in-home caregivers for patients with COVID-19.

The amount of care that professional caregivers provide can range from several hours per week to full-time, depending on the patient’s needs and budget, and can include companionship, Mr. Bersson said in an interview.

Because patient and caregiver safety are paramount, caregivers are thoroughly trained in protection and decontamination procedures and are regularly tested for COVID-19 prior to being sent into a client’s home.

Health insurance companies do not cover this service, Mr. Bersson noted, but the VetAssist program covers home care for veterans and their spouses who meet income requirements.

Caregiving and companionship are both vital pieces of the at-home care puzzle. “It was the virtual emotional support I got from friends, family, coworkers, and healthcare professionals that meant so much to me, and I know they played an important part in my recovery,” Dr. Stebbins said.

Dr. LeRoy agreed, noting that he calls patients, even if they only have mild symptoms and his nurse has already spoken to them. “The call doesn’t take much time – maybe just a 5-minute conversation – but it makes patients aware that I care.”

Dr. Stebbins, Dr. Exline, and Dr. LeRoy report no relevant financial relationships. Mr. Bersson is the director of operations at Synergy Home Care of Bergen County, New Jersey.

This story first appeared on Medscape.com.

Marilyn Stebbins, PharmD, fell ill at the end of February 2020. Initially diagnosed with multifocal pneumonia and treated with antibiotics, she later developed severe gastrointestinal symptoms, fatigue, and shortness of breath. She was hospitalized in early March and was diagnosed with COVID-19.

It was still early in the pandemic, and testing was not available for her husband. After she was discharged, her husband isolated himself as much as possible. But that limited the amount of care he could offer.

“When I came home after 8 days in the ICU, I felt completely alone and terrified of not being able to care for myself and not knowing how much care my husband could provide,” said Dr. Stebbins, professor of clinical pharmacy at the University of California, San Francisco.

“I can’t even imagine what it would have been like if I had been home alone without my husband in the house,” she said. “I think about the people who died at home and understand how that might happen.”

Dr. Stebbins is one of tens of thousands of people who, whether hospitalized and discharged or never admitted for inpatient care, needed to find ways to convalesce at home. Data from the Centers for Medicare & Medicaid Services show that, of 326,674 beneficiaries who tested positive for COVID-19 between May 16 and June 11, 2020, 109,607 were hospitalized, suggesting that two-thirds were outpatients.

Most attention has focused on the sickest patients, leaving less severe cases to fall through the cracks. Despite fever, cough, difficulty breathing, and a surfeit of other symptoms, there are few available resources and all too little support to help patients navigate the physical and emotional struggles of contending with COVID-19 at home.
 

No ‘cookie-cutter’ approach

The speed with which the pandemic progressed caught public health systems off guard, but now, “it is essential to put into place the infrastructure to care for the physical and mental health needs of patients at home because most are in the community and many, if not most, still aren’t receiving sufficient support at home,” said Dr. Stebbins.

Caring for COVID-19 patients at home begins with determining their individual needs, said Gary LeRoy, MD, a family physician in Dayton, Ohio. He emphasized that there is “no cookie-cutter formula” for home care, because every patient’s situation is different.

“I begin by having a detailed conversation with each patient to ascertain whether their home environment is safe and to paint a picture of their circumstances,” Dr. LeRoy, who is the president of the American Academy of Family Physicians, said in an interview.

Dr. LeRoy suggested questions that constitute “not just a ‘medical’ checklist but a ‘whole life’ checklist.”

• Do you have access to food, water, medications, sanitation/cleaning supplies, a thermometer, and other necessities? If not, who might assist in providing those?
• Do you need help with activities of daily living and self-care?
• Who else lives in your household? Do they have signs and symptoms of the virus? Have they been tested?
• Do you have enough physical space between you and other household members?
• Do you have children? How are they being cared for?
• What type of work do you do? What are the implications for your employment if you are unable to work for an extended period?
• Do you have an emotional, social, and spiritual support system (e.g., family, friends, community, church)?
• Do you have concerns I haven’t mentioned?

Patients’ responses will inform the management plan and determine what medical and social resources are needed, he said.
 

Daily check-in

Dr. Stebbins said the nurse case manager from her insurance company called her daily after she came home from the hospital. She was told that a public health nurse would also call, but no one from the health department called for days – a situation she hopes has improved.

One way or another, she said, “health care providers [or their staff] should check in with patients daily, either telephonically or via video.” She noted that video is superior, because “someone who isn’t a family member needs to put eyes on a patient and might be able to detect warning signs that a family member without healthcare training might not notice.”

Dr. LeRoy, who is also an associate professor of medicine at Wright State University, Dayton, Ohio, said that, given his time constraints, a nurse or medical assistant in his practice conducts the daily check-ins and notifies him if the patient has fever or other symptoms.

“Under ordinary circumstances, when a patient comes to see me for some type of medical condition, I get to meet the patient, consider what might be going on, then order a test, wait for the results, and suggest a treatment plan. But these are anything but ordinary circumstances,” said Matthew Exline, MD, a pulmonary and critical care specialist at the Ohio State University Wexner Medical Center, Columbus.

“That traditional structure broke down with COVID-19, when we may have test results without even seeing the patient. And without this interaction, it is harder to know as a physician what course of action to take,” he said in an interview.

Once a diagnosis has been made, the physician has at least some data to help guide next steps, even if there has been no prior meeting with the patient.

For example, a positive test raises a host of issues, not the least of which is the risk of spreading the infection to other household members and questions about whether to go the hospital. Moreover, for patients, positive tests can have serious ramifications.

“Severe shortness of breath at rest is not typical of the flu, nor is loss of taste or smell,” said Dr. Exline. Practitioners must educate patients and families about specific symptoms of COVID-19, including shortness of breath, loss of taste or smell, and gastrointestinal or neurologic symptoms, and when to seek emergency care.

Dr. LeRoy suggests buying a pulse oximeter to gauge blood oxygen levels and pulse rate. Together with a thermometer, a portable blood pressure monitor, and, if indicated, a blood glucose monitor, these devices provide a comprehensive and accurate assessment of vital signs.

Dr. LeRoy also educates patients and their families about when to seek medical attention.

Dr. Stebbins takes a similar approach. “Family members are part of, not apart from, the care of patients with COVID-19, and it’s our responsibility as healthcare providers to consider them in the patient’s care plan.”
 

Keeping family safe

Beyond care, family members need a plan to keep themselves healthy, too.

“A patient with COVID-19 at home should self-quarantine as much as possible to keep other family members safe, if they continue to live in the same house,” Dr. Exline said.

Ideally, uninfected family members should stay with relatives or friends. When that’s not possible, everyone in the household should wear a mask, be vigilant about hand washing, and wipe down all surfaces – including doorknobs, light switches, faucet handles, cellphones, and utensils – regularly with bleach or an alcohol solution.

Caregivers should also minimize the amount of time they are exposed to the patient.

“Set food, water, and medication on the night table and leave the room rather than spending hours at the bedside, since limiting exposure to viral load reduces the chances of contagion,” said Dr. Exline.

The Centers for Disease Control and Prevention offers guidance for household members caring for COVID-19 patients at home. It provides tips on how to help patients follow the doctor’s instructions and ways to ensure adequate hydration and rest, among others.

Patients with COVID-19 who live alone face more formidable challenges.

Dr. LeRoy says physicians can help patients by educating themselves about available social services in their community so they can provide appropriate referrals and connections. Such initiatives can include meal programs, friendly visit and financial assistance programs, as well as childcare and home health agencies.

He noted that Aunt Bertha, a social care network, provides a guide to social services throughout the United States. Additional resources are available on USA.gov.
 

Comfort and support

Patients with COVID-19 need to be as comfortable and as supported as possible, both physically and emotionally.

“While I was sick, my dogs curled up next to me and didn’t leave my side, and they were my saving grace. There’s not enough to be said about emotional support,” Dr. Stebbins said.

Although important, emotional support is not enough. For patients with respiratory disorders, such as chronic obstructive pulmonary disease, asthma, heart failure, or pneumonia, their subjective symptoms of shortness of breath, air hunger, or cough may improve with supplemental oxygen at home. Other measures include repositioning of the patient to lessen the body weight over the lungs or the use of lung percussion, Leroy said.

He added that improvement may also come from drainage of sputum from the airway passages, the use of agents to liquefy thick sputum (mucolytics), or aerosolized bronchodilator medications.

However, Dr. LeRoy cautioned, “one remedy does not work for everyone – an individual can improve gradually by using these home support interventions, or their respiratory status can deteriorate rapidly despite all these interventions.”

For this reason, he says patients should consult their personal physician to determine which, if any, of these home treatments would be best for their particular situation.

Patients who need emotional support, psychotherapy, or psychotropic medications may find teletherapy helpful. Guidance for psychiatrists, psychologists, and social workers regarding the treatment of COVID-19 patients via teletherapy can be found on the American Psychiatric Association, the American Psychological Association, and the National Association of Social Workers websites.

Pharmacists can also help ensure patient safety, Dr. Stebbins said.

If a patient has not picked up their usual medications, Dr. Stebbins said, “they may need a check-in call. Some may be ill and alone and may need encouragement to seek medical attention, and some may have no means of getting to the pharmacy and may need medications delivered.”

A home healthcare agency may also be helpful for homebound patients. David Bersson, director of operations at Synergy Home Care of Bergen County, N.J., has arranged in-home caregivers for patients with COVID-19.

The amount of care that professional caregivers provide can range from several hours per week to full-time, depending on the patient’s needs and budget, and can include companionship, Mr. Bersson said in an interview.

Because patient and caregiver safety are paramount, caregivers are thoroughly trained in protection and decontamination procedures and are regularly tested for COVID-19 prior to being sent into a client’s home.

Health insurance companies do not cover this service, Mr. Bersson noted, but the VetAssist program covers home care for veterans and their spouses who meet income requirements.

Caregiving and companionship are both vital pieces of the at-home care puzzle. “It was the virtual emotional support I got from friends, family, coworkers, and healthcare professionals that meant so much to me, and I know they played an important part in my recovery,” Dr. Stebbins said.

Dr. LeRoy agreed, noting that he calls patients, even if they only have mild symptoms and his nurse has already spoken to them. “The call doesn’t take much time – maybe just a 5-minute conversation – but it makes patients aware that I care.”

Dr. Stebbins, Dr. Exline, and Dr. LeRoy report no relevant financial relationships. Mr. Bersson is the director of operations at Synergy Home Care of Bergen County, New Jersey.

This story first appeared on Medscape.com.

Among hospitalized COVID-19 patients, the use of famotidine was significantly associated with a reduction in death and either death or intubation. It also demonstrated lower levels of serum markers for severe disease.

The findings come from an observational study of 83 hospitalized patients that was published in the American Journal of Gastroenterology.

“The mechanism of exactly how famotidine works has yet to be proven,” lead study author Jeffrey F. Mather, MS, said in an interview. “There’s thought that it works directly on the virus, and there is thought that it works through inactivating certain proteases that are required for the virus infection, but I think the most interesting [hypothesis] is by Malone et al. “They’re looking at the blocking of the histamine-2 receptor causing a decrease in the amount of histamine. It’s all speculative, but it will be interesting if that gets worked out.”

In a study that largely mimicked that of an earlier, larger published observational study on the topic (doi: 10.1053/j.gastro.2020.05.053), Mr. Mather and colleagues retrospectively evaluated 878 patients who tested positive for SARS-CoV-2 and who required admission to Hartford (Conn.) Hospital between Feb. 24, 2020, and May 14, 2020. Patients were classified as receiving famotidine if they were treated with either oral or intravenous drug within 1 week of COVID-19 screening and/or hospital admission. Primary outcomes of interest were in-hospital death as recorded in the discharge of the patients, requirement for mechanical ventilation, and the composite of death or requirement for ventilation. Secondary outcomes of interest were several serum markers of disease activity including white blood cell count, lymphocyte count, and eosinophil count.

Famotidine was administered orally in 83% of the patients and intravenously in the remaining 17%. Mr. Mather, director of data management in the division of research management at Hartford Hospital, and his colleagues reported that 83 of the 878 patients studied (9.5%) received famotidine. Compared with patients not treated with famotidine, those who received the drug were slightly younger (a mean of 64 vs. 68 years, respectively; P = .021); otherwise, there were no differences between the two groups in baseline demographics or in preexisting comorbidities.

The use of famotidine was associated with a decreased risk of in-hospital mortality (odds ratio, 0.37; P = .021) as well as combined death or intubation (OR, 0.47; P = .040). The outcomes were similar when the researchers performed propensity score matching to adjust for age differences between groups.

In addition, the use of famotidine was associated with lower levels of serum markers for severe disease including lower median peak C-reactive protein levels (9.4 vs. 12.7 mg/dL; P =. 002), lower median procalcitonin levels (0.16 vs. 0.30 ng/mL; P = .004), and a nonsignificant trend to lower median mean ferritin levels (797.5 vs. 964 ng/mL; P = .076).

Logistic regression analysis revealed that use of famotidine was an independent predictor of both lower mortality and combined death/intubation. In addition, predictors of both adverse outcomes included older age, a body mass index of greater than 30 kg/m², chronic kidney disease, the national early warning score, and a higher neutrophil-lymphocyte ratio.

“This is an important stepping stone, but until we have a randomized, controlled trial, we really can’t speak about causation; we can only speak about association, and that’s okay,” Brennan Spiegel, MD, MSHS, director of health services research at Cedars-Sinai, Los Angeles, who was not affiliated with the study, said in an interview. “There’s nothing wrong with association because finding associations can raise important hypotheses that can then be tested in prospective randomized trials, for example.”

In July 2020, Dr. Spiegel and his colleagues published a separate paper looking at proton pump inhibitors and the risk of COVID-19. “In that study we did look at H₂ blockers, and we did find that they were slightly associated with a reduction in COVID-19,” he said. “It was a small effect, but it was a benefit. When we see consistency among studies, it’s a signal in the noise we can try and follow and see if there is something more to it.”

Mr. Mather acknowledged certain limitations of the study, including the fact that patients who did and did not receive famotidine were propensity-matched for age. “The risk factors that others have shown for adverse events are equivalent in the groups, but anytime you do a retrospective study like this there is the potential for underlying factors that may play a role in the outcomes that you’re not considering,” Mr. Mather said. “That’s why the gold standard is the randomized trial, to wash those effects out. There’s only an association here, and it supports the need for a randomized trial.”

Famotidine is currently being tested in a double-blind randomized clinical trial in combination with either hydroxychloroquine or remdesivir (NCT 04370262).

“It’s fascinating because famotidine is a safe medicine,” added Dr. Spiegel, who is also co–editor in chief of the American Journal of Gastroenterology. “There are very few side effects; it’s something we’ve been using for decades.”

Mr. Mather and his colleagues reported having no financial disclosures. Dr. Spiegel disclosed that he has served on advisory boards for Allergan, Alnylam Pharmaceuticals, Arena Pharmaceuticals, Ironwood Pharmaceuticals, Salix Pharmaceuticals, Synergy Pharmaceuticals, and Takeda Pharmaceuticals.

dbrunk@mdedge.com

SOURCE: Mather J et al. 2020 Aug 14. Am J Gastroenterol.

Among hospitalized COVID-19 patients, the use of famotidine was significantly associated with a reduction in death and either death or intubation. It also demonstrated lower levels of serum markers for severe disease.

The findings come from an observational study of 83 hospitalized patients that was published in the American Journal of Gastroenterology.

“The mechanism of exactly how famotidine works has yet to be proven,” lead study author Jeffrey F. Mather, MS, said in an interview. “There’s thought that it works directly on the virus, and there is thought that it works through inactivating certain proteases that are required for the virus infection, but I think the most interesting [hypothesis] is by Malone et al. “They’re looking at the blocking of the histamine-2 receptor causing a decrease in the amount of histamine. It’s all speculative, but it will be interesting if that gets worked out.”

In a study that largely mimicked that of an earlier, larger published observational study on the topic (doi: 10.1053/j.gastro.2020.05.053), Mr. Mather and colleagues retrospectively evaluated 878 patients who tested positive for SARS-CoV-2 and who required admission to Hartford (Conn.) Hospital between Feb. 24, 2020, and May 14, 2020. Patients were classified as receiving famotidine if they were treated with either oral or intravenous drug within 1 week of COVID-19 screening and/or hospital admission. Primary outcomes of interest were in-hospital death as recorded in the discharge of the patients, requirement for mechanical ventilation, and the composite of death or requirement for ventilation. Secondary outcomes of interest were several serum markers of disease activity including white blood cell count, lymphocyte count, and eosinophil count.

Famotidine was administered orally in 83% of the patients and intravenously in the remaining 17%. Mr. Mather, director of data management in the division of research management at Hartford Hospital, and his colleagues reported that 83 of the 878 patients studied (9.5%) received famotidine. Compared with patients not treated with famotidine, those who received the drug were slightly younger (a mean of 64 vs. 68 years, respectively; P = .021); otherwise, there were no differences between the two groups in baseline demographics or in preexisting comorbidities.

The use of famotidine was associated with a decreased risk of in-hospital mortality (odds ratio, 0.37; P = .021) as well as combined death or intubation (OR, 0.47; P = .040). The outcomes were similar when the researchers performed propensity score matching to adjust for age differences between groups.

In addition, the use of famotidine was associated with lower levels of serum markers for severe disease including lower median peak C-reactive protein levels (9.4 vs. 12.7 mg/dL; P =. 002), lower median procalcitonin levels (0.16 vs. 0.30 ng/mL; P = .004), and a nonsignificant trend to lower median mean ferritin levels (797.5 vs. 964 ng/mL; P = .076).

Logistic regression analysis revealed that use of famotidine was an independent predictor of both lower mortality and combined death/intubation. In addition, predictors of both adverse outcomes included older age, a body mass index of greater than 30 kg/m², chronic kidney disease, the national early warning score, and a higher neutrophil-lymphocyte ratio.

“This is an important stepping stone, but until we have a randomized, controlled trial, we really can’t speak about causation; we can only speak about association, and that’s okay,” Brennan Spiegel, MD, MSHS, director of health services research at Cedars-Sinai, Los Angeles, who was not affiliated with the study, said in an interview. “There’s nothing wrong with association because finding associations can raise important hypotheses that can then be tested in prospective randomized trials, for example.”

In July 2020, Dr. Spiegel and his colleagues published a separate paper looking at proton pump inhibitors and the risk of COVID-19. “In that study we did look at H₂ blockers, and we did find that they were slightly associated with a reduction in COVID-19,” he said. “It was a small effect, but it was a benefit. When we see consistency among studies, it’s a signal in the noise we can try and follow and see if there is something more to it.”

Mr. Mather acknowledged certain limitations of the study, including the fact that patients who did and did not receive famotidine were propensity-matched for age. “The risk factors that others have shown for adverse events are equivalent in the groups, but anytime you do a retrospective study like this there is the potential for underlying factors that may play a role in the outcomes that you’re not considering,” Mr. Mather said. “That’s why the gold standard is the randomized trial, to wash those effects out. There’s only an association here, and it supports the need for a randomized trial.”

Famotidine is currently being tested in a double-blind randomized clinical trial in combination with either hydroxychloroquine or remdesivir (NCT 04370262).

“It’s fascinating because famotidine is a safe medicine,” added Dr. Spiegel, who is also co–editor in chief of the American Journal of Gastroenterology. “There are very few side effects; it’s something we’ve been using for decades.”

Mr. Mather and his colleagues reported having no financial disclosures. Dr. Spiegel disclosed that he has served on advisory boards for Allergan, Alnylam Pharmaceuticals, Arena Pharmaceuticals, Ironwood Pharmaceuticals, Salix Pharmaceuticals, Synergy Pharmaceuticals, and Takeda Pharmaceuticals.

dbrunk@mdedge.com

SOURCE: Mather J et al. 2020 Aug 14. Am J Gastroenterol.

Among hospitalized COVID-19 patients, the use of famotidine was significantly associated with a reduction in death and either death or intubation. It also demonstrated lower levels of serum markers for severe disease.

The findings come from an observational study of 83 hospitalized patients that was published in the American Journal of Gastroenterology.

“The mechanism of exactly how famotidine works has yet to be proven,” lead study author Jeffrey F. Mather, MS, said in an interview. “There’s thought that it works directly on the virus, and there is thought that it works through inactivating certain proteases that are required for the virus infection, but I think the most interesting [hypothesis] is by Malone et al. “They’re looking at the blocking of the histamine-2 receptor causing a decrease in the amount of histamine. It’s all speculative, but it will be interesting if that gets worked out.”

In a study that largely mimicked that of an earlier, larger published observational study on the topic (doi: 10.1053/j.gastro.2020.05.053), Mr. Mather and colleagues retrospectively evaluated 878 patients who tested positive for SARS-CoV-2 and who required admission to Hartford (Conn.) Hospital between Feb. 24, 2020, and May 14, 2020. Patients were classified as receiving famotidine if they were treated with either oral or intravenous drug within 1 week of COVID-19 screening and/or hospital admission. Primary outcomes of interest were in-hospital death as recorded in the discharge of the patients, requirement for mechanical ventilation, and the composite of death or requirement for ventilation. Secondary outcomes of interest were several serum markers of disease activity including white blood cell count, lymphocyte count, and eosinophil count.

Famotidine was administered orally in 83% of the patients and intravenously in the remaining 17%. Mr. Mather, director of data management in the division of research management at Hartford Hospital, and his colleagues reported that 83 of the 878 patients studied (9.5%) received famotidine. Compared with patients not treated with famotidine, those who received the drug were slightly younger (a mean of 64 vs. 68 years, respectively; P = .021); otherwise, there were no differences between the two groups in baseline demographics or in preexisting comorbidities.

The use of famotidine was associated with a decreased risk of in-hospital mortality (odds ratio, 0.37; P = .021) as well as combined death or intubation (OR, 0.47; P = .040). The outcomes were similar when the researchers performed propensity score matching to adjust for age differences between groups.

In addition, the use of famotidine was associated with lower levels of serum markers for severe disease including lower median peak C-reactive protein levels (9.4 vs. 12.7 mg/dL; P =. 002), lower median procalcitonin levels (0.16 vs. 0.30 ng/mL; P = .004), and a nonsignificant trend to lower median mean ferritin levels (797.5 vs. 964 ng/mL; P = .076).

Logistic regression analysis revealed that use of famotidine was an independent predictor of both lower mortality and combined death/intubation. In addition, predictors of both adverse outcomes included older age, a body mass index of greater than 30 kg/m², chronic kidney disease, the national early warning score, and a higher neutrophil-lymphocyte ratio.

“This is an important stepping stone, but until we have a randomized, controlled trial, we really can’t speak about causation; we can only speak about association, and that’s okay,” Brennan Spiegel, MD, MSHS, director of health services research at Cedars-Sinai, Los Angeles, who was not affiliated with the study, said in an interview. “There’s nothing wrong with association because finding associations can raise important hypotheses that can then be tested in prospective randomized trials, for example.”

In July 2020, Dr. Spiegel and his colleagues published a separate paper looking at proton pump inhibitors and the risk of COVID-19. “In that study we did look at H₂ blockers, and we did find that they were slightly associated with a reduction in COVID-19,” he said. “It was a small effect, but it was a benefit. When we see consistency among studies, it’s a signal in the noise we can try and follow and see if there is something more to it.”

Mr. Mather acknowledged certain limitations of the study, including the fact that patients who did and did not receive famotidine were propensity-matched for age. “The risk factors that others have shown for adverse events are equivalent in the groups, but anytime you do a retrospective study like this there is the potential for underlying factors that may play a role in the outcomes that you’re not considering,” Mr. Mather said. “That’s why the gold standard is the randomized trial, to wash those effects out. There’s only an association here, and it supports the need for a randomized trial.”

Famotidine is currently being tested in a double-blind randomized clinical trial in combination with either hydroxychloroquine or remdesivir (NCT 04370262).

“It’s fascinating because famotidine is a safe medicine,” added Dr. Spiegel, who is also co–editor in chief of the American Journal of Gastroenterology. “There are very few side effects; it’s something we’ve been using for decades.”

Mr. Mather and his colleagues reported having no financial disclosures. Dr. Spiegel disclosed that he has served on advisory boards for Allergan, Alnylam Pharmaceuticals, Arena Pharmaceuticals, Ironwood Pharmaceuticals, Salix Pharmaceuticals, Synergy Pharmaceuticals, and Takeda Pharmaceuticals.

dbrunk@mdedge.com

SOURCE: Mather J et al. 2020 Aug 14. Am J Gastroenterol.

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.¹ For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.²

A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.³ The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.² Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.⁴

Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.

Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.¹ For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.²

A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.³ The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.² Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.⁴

Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.

Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

Complications from tobacco use are the most common preventable cause of death, disability, and disease in the United States. Tobacco use causes 480,000 premature deaths every year. In pregnancy, tobacco use causes complications such as premature birth, intrauterine growth restriction, and placental abruption. In the perinatal period, it is associated with sudden infant death syndrome. While cigarette smoking is decreasing in adolescents, e-cigarette use in on the rise. Approximately 1,600 children aged 12-17 smoke their first cigarette every day and it is estimated that 5.6 million children and adolescents will die of a tobacco use–related death.¹ For these reasons it is important to address tobacco use and cessation with patients whenever it is possible. Below is a case and recommendations related to a new American Thoracic Society guideline on initiating pharmacologic treatment in tobacco-dependent adults.

A forty-five-year-old male who rarely comes to the office is here today for a physical exam at the urging of his partner. He has been smoking a pack a day since age 17. You have tried at past visits to discuss quitting, but he had been in the precontemplative stage and had been unwilling to consider any change. This visit, however, he is ready to try to quit. What can you offer him?

Core recommendations from ATS guidelines

This patient can be offered varenicline plus nicotine replacement therapy rather than nicotine replacement therapy, bupropion, e-cigarettes, or varenicline alone. His course of therapy should extend beyond 12 weeks instead of the standard 6- to 12-week therapy. Alternatively, he could be offered varenicline alone, rather than nicotine replacement.²

A change from previous guidelines

What makes this recommendation so interesting and new is the emphasis it places on varenicline. The United States Preventive Services Task Force released a recommendation statement in 2015 that stressed a combination of pharmacological and behavioral interventions. It discussed nicotine replacement therapy, bupropion, and varenicline, but did not recommend any one over any of the others.³ The new recommendation from the American Thoracic Society favors varenicline over other pharmacologic interventions. It is based on an independent systematic review of the literature that showed higher rates of tobacco use abstinence at the 6-month follow-up with varenicline alone versus nicotine replacement therapy alone, bupropion alone, or e-cigarette use only.

A review of 14 randomized controlled trials showed that varenicline improves abstinence rates during treatment by approximately 40% compared with nicotine replacement, and by 20% at the end of 6 months of treatment. The review found that varenicline plus nicotine replacement therapy is more effective than varenicline alone. In this comparison, based on three trials, there was a 36% higher abstinence rate at 6 months using varenicline plus nicotine replacement. When varenicline use was compared with use of a nicotine patch, bupropion, or e-cigarettes, there was a reduction in serious adverse events – changes in mood, suicidal ideation, and neurological side effects such as seizures.² Clinicians may remember a black box warning on the varenicline label citing neuropsychiatric effects and it is important to note that the Food and Drug Administration removed this boxed warning in 2016.⁴

Opinion

This recommendation represents an important, evidence-based change from previous guidelines. It presents the opportunity for better outcomes, but will likely take a while to filter into practice, as clinicians need to become more comfortable with the use of varenicline and insurance supports the cost of varenicline.

The average cost of varenicline for 12 weeks is between $1,220 and $1,584. For comparison, nicotine replacement therapy costs $170 to $240 for the same number of weeks. To put those costs in perspective, the 12-week cost of cigarettes for a two-pack-a-day smoker is approximately $1,000.

For some patients, the motivation to quit smoking comes from the realization of how much they are spending on cigarettes each month. That said, if a patient does not have insurance or their insurance does not cover the cost of varenicline, nicotine replacement therapy might be more appealing. It should be noted that better abstinence rates have been seen in patients taking varenicline plus nicotine replacement therapy versus varenicline alone.

Suggested treatment

Based on a systematic review of randomized controlled trials, the American Thoracic Society’s guideline on pharmacological treatment in tobacco-dependent adults concludes that varenicline plus nicotine patch is the preferred pharmacological treatment for tobacco cessation when compared with varenicline alone, bupropion alone, nicotine replacement therapy alone, and e-cigarettes alone. If the patient does not want to start two medicines at once, then varenicline alone would be the preferred choice.

Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. Dr. Sprogell is a third-year resident in the family medicine residency program at Abington Jefferson Health. They have no conflicts related to the content of this piece. For questions or comments, feel free to contact Dr. Skolnik on Twitter @NeilSkolnik.

References

1. U.S. Preventive Services Task Force. Primary care interventions for prevention and cessation of tobacco use in children and adolescents: U.S. Preventive Services Task Force Recommendation Statement. JAMA.2020;323(16):1590-8. doi: 10.1001/jama.2020.4679.

2. Leone FT et al. Initiating pharmacologic treatment in tobacco-dependent adults: An official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020;202(2):e5–e31.

3. Tobacco smoking cessation in adults, including pregnant women: Behavioral and pharmacotherapy interventions. U.S. Preventive Services Task Force 2015 Sep 21.

4. FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings. 2016 Dec. 16.

Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.

“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.

The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm^–5 for those randomized to PADN versus 149 dyn/sec per cm^–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.

For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.

Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).

A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm^–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.

Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.

Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.

At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.

About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm^–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.

Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).

There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.

Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.

In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.

“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”

The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.

“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.

In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.

“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”

Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”

If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.

“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.

Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.

In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”

Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.

SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.

Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.

“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.

The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm^–5 for those randomized to PADN versus 149 dyn/sec per cm^–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.

For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.

Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).

A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm^–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.

Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.

Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.

At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.

About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm^–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.

Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).

There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.

Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.

In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.

“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”

The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.

“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.

In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.

“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”

Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”

If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.

“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.

Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.

In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”

Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.

SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.

Pulmonary artery denervation (PADN) provides persistent and clinically significant hemodynamic improvements in patients with persistent chronic thromboembolic hypertension (CTEPH) after pulmonary endarterectomy (PEA), according to a randomized, sham-controlled trial.

“PADN in patients with CTEPH after PEA was safe and effective,” according to an investigating team led by Alexander Romanov, MD, PhD.

The mean reduction in pulmonary vascular resistance (PVR) was 258 dyn/sec per cm^–5 for those randomized to PADN versus 149 dyn/sec per cm^–5 (P = .001) for those randomized to the sham procedure, according to the newly published findings.

For the 6-minute walk test (6MWT), the mean distance was 470 m for the experimental group versus 399 m (P = .03) for the controls.

Several secondary endpoints measuring hemodynamics also favored PADN relative to the sham procedure at 12 months. This included the relative increase in tricuspid annular systolic excursion (P = .03) and the increase in the right ventricular fraction area (P < .001).

A total of 50 patients with residual CTEPH for at least 6 months after PEA despite medical therapy were enrolled and randomized. Entry criteria included a mean pulmonary artery pressure (PAP) of 25 mm Hg or greater or PVR greater than 400 dyn/sec per cm^–5 on right heart catheterization. Patients with comorbidities associated with a life expectancy of less than 1 year were excluded.

Those randomized to the sham group were treated with riociguat over the course of follow-up. This therapy was not offered to patients in the PADN group, but all patients were blinded to the procedure and told that riociguat might or might not be administered.

Following the procedure, participating clinicians, who were also blinded to the procedure, were instructed to provide standard therapies for heart failure, such beta-blockers, diuretics, or digoxin, as needed. All patients were placed on an oral anticoagulant.

At 12 months the mean PAP (26 vs. 35 mm Hg; P < .001) and the mean systolic PAP (46 vs. 54 mm Hg; P = .01) were significantly lower in the PADN group versus those who underwent a sham procedure.

About 52% of the PADN group versus 12% of the sham group were classified as responders by the definition of a PVR reduction of at least 150 dyn/sec per cm^–5 and 6MWT improvement of at least 20%, compared with baseline, reported Dr. Romanov, of the E. Meshalkin National Medical Research Center, ministry of health, Novosibirsk, Russia, and coinvestigators.

Of the three deaths caused by heart failure over the course of follow-up, two occurred in the sham group. Of the eight hospitalizations for heart failure, seven (29% of the sham group) occurred among controls versus one in those treated with PADN (4% of this group; P = .049).

There was one groin hematoma at the puncture site in each group. Both resolved without any consequences prior to hospital discharge. There were no other significant procedure-related complications in either group.

Larger multicenter trials are needed to confirm these findings, according to both the trial investigators and Marius M. Hoeper, MD, who is charge of the pulmonary hypertension program at the Hannover (Germany) Medical School.

In an editorial that accompanied publication of these findings, Dr. Hoeper identified the small sample size of this study as one of its limitations, but he said the results are consistent with several other small studies associating pulmonary artery denervation with benefit in pulmonary hypertension.

“It appears as if we are currently witnessing the emergence of a new treatment option for various forms of pulmonary hypertension,” Dr. Hoeper wrote. In his critique of the study, he suggested that it would have been “more informative” if both groups were on background riociguat, but the data from this and other studies so far indicates that ablation to achieve denervation “is safe and feasible.”

The PADN technique used in this study might be relevant to the results. Dr. Hoeper noted that the investigators employed catheter tip–based electroanatomic mapping with a novel remote navigation system with three-dimensional imaging of the right ventricle and central pulmonary arteries.

“Apparently, this approach minimizes radiation exposure and provides precise location of ablation sites,” Dr. Hoeper observed. However, he called for direct comparisons of this tool to the guidance systems used in other studies.

In an interview, Dr. Hoeper acknowledged that it is not yet clear that a large-scale trial of pulmonary artery denervation for the indication evaluated in this study is coming. He noted several strategies in CTEPH are widely used without trials confirming a reduction in clinical events.

“Balloon pulmonary angioplasty for CTEPH has become an established treatment around the world without any randomized, controlled trial and without demonstration of improved outcomes. A couple of well-conducted observational trials might be sufficient to convince physicians to introduce PADN as well,” he said. If such studies associated PADN with “improvements in hemodynamics, exercise capacity, and patient-reported outcomes, it might be sufficient.”

Currently, Dr. Hoeper is most concerned about obtaining further evidence of safety, which he characterized as a “major issue.”

If a multicenter trial is conducted “the primary endpoint should be focused on clinical events,” according to Dr. Romanov, who was asked to comment on the next steps in validating PADN for the treatment of CTEPH-associated pulmonary hypertension persisting after endarterectomy.

“The mortality rate during 1-year long-term follow-up is not so high, but heart failure progression is a problem. So in my view, the primary endpoint should be a composite of death and heart failure hospitalization,” he said. He called for follow-up duration of 2-3 years.

Jonathan Steinberg, MD, director of cardiac clinical trials and education, Summit Medical Group, Montclair, N.J., also called a trial with hard endpoints, such as death, the ideal.

In the meantime, hemodynamic and functional measures “are still quite valuable and move the ball forward for this intervention,” he said in an interview. Senior author of this trial and principle investigator of the recent ERADICATE-AF trial, which evaluated renal denervation in preventing recurrence of atrial fibrillation (JAMA. 2020;323:248-55), Dr. Steinberg predicted, “I do indeed suspect we will see trials that are more accomplishable [than a large-scale, randomized, controlled trial] in the not too distant future.”

Dr. Romanov received funding from Biosense Webster. Dr. Hoeper has received fees for lectures and/or consultations from Acceleron, Actelion, Bayer, Janssen, Merck Sharp & Dohme, and Pfizer.

SOURCE: Romanov A et al. J Am Coll Cardiol. 2020 Aug 17;76:916-26.

Pulmonary rehabilitation reduces the likelihood that patients with chronic obstructive pulmonary disease (COPD) will be readmitted to the hospital in the year after discharge by 33%, new research shows, but few patients participate in those programs.

In fact, in a retrospective cohort of 197,376 patients from 4446 hospitals, only 1.5% of patients initiated pulmonary rehabilitation in the 90 days after hospital discharge.

“This is a striking finding,” said Mihaela Stefan, PhD, from the University of Massachusetts Medical School–Baystate in Springfield. “Our study demonstrates that we need to increase access to rehabilitation to reduce the risk of readmissions.”

Not enough patients are initiating rehabilitation, but the onus is not only on them; the system is failing them. “We wanted to understand how much pulmonary rehabilitation lowers the readmission rate,” Stefan told Medscape Medical News.

So she and her colleagues examined the records of patients who were hospitalized for COPD in 2014 to see whether they had begun rehabilitation in the 90 days after discharge and whether they were readmitted to the hospital in the subsequent 12 months.

Patients who were unlikely to initiate pulmonary rehabilitation — such as those with dementia or metastatic cancer and those discharged to hospice care or a nursing home — were excluded from the analysis, Stefan said during her presentation at the study results at the virtual American Thoracic Society (ATS) 2020 International Conference.

The risk analysis was complex because many patients died before the year was out, and “a patient who dies has no risk of being readmitted,” she explained. Selection bias was also a factor because patients who do pulmonary rehab tend to be in better shape.

The researchers used propensity score matching and Anderson–Gill models of cumulative rehospitalizations or death at 1 year with time-varying exposure to pulmonary rehabilitation to account for clustering of individual events and adjust for covariates. “It was a complicated risk analysis,” she said.

In the year after discharge, 130,660 patients (66%) were readmitted to the hospital. The rate of rehospitalization was lower for those who initiated rehabilitation than for those who did not (59% vs 66%), as was the mean number of readmissions per patient (1.4 vs 1.8).

Rehabilitation was associated with a lower risk for readmission or death (hazard ratio, 0.67; 95% CI, 0.66 - 0.69).

“We know the referral rates are low and that pulmonary rehabilitation is effective in clinical trials,” said Stefan, and now “we see that pulmonary rehabilitation is effective when you look at patients in real life.”

From a provider perspective, “we need to make sure that hospitals get more money for pulmonary rehabilitation. Cardiac rehabilitation is paid for,” she explained. "But pulmonary rehab is not a lucrative business. I don›t know why the CMS pays more for cardiac."

A rehabilitation program generally consists of 36 sessions, held two or three times a week, and many patients can’t afford that on their own, she noted. Transportation is another huge issue.

A recent study in which semi-structured interviews were conducted with 15 COPD patients showed that the main barriers to enrollment in a pulmonary rehabilitation program are lack of awareness, family obligations, transportation, and lack of motivation, said Stefan, who was involved in that research.

Telehealth rehabilitation programs might become more available in the near future, given the COVID pandemic. But “currently, Medicare doesn’t pay for telerehab,” she said. Virtual sessions might attract more patients, but lack of computer access and training could present another barrier for some.

PAH rehab

Uptake for pulmonary rehabilitation is as low for patients with pulmonary arterial hypertension (PAH) as it is for those with COPD, according to another study presented at the virtual ATS meeting.

An examination of the electronic health records of 111,356 veterans who experienced incident PAH from 2010 to 2016 showed that only 1,737 (1.6%) followed through on pulmonary rehabilitation.

“Exercise therapy is safe and effective at improving outcomes,” lead author Thomas Cascino, MD, from the University of Michigan in Ann Arbor, said in an ATS press release. “Recognizing that it is being underutilized is a necessary first step in working toward increasing patient access to rehab.

His group is currently working on a trial for home-based rehabilitation “using wearable technology as a means to expand access for people unable to come to center-based rehab for a variety of reasons,” he explained.

“The goal of all our treatments is to help people feel better and live longer,” Cascino added.

Stefan and Cascino have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Pulmonary rehabilitation reduces the likelihood that patients with chronic obstructive pulmonary disease (COPD) will be readmitted to the hospital in the year after discharge by 33%, new research shows, but few patients participate in those programs.

In fact, in a retrospective cohort of 197,376 patients from 4446 hospitals, only 1.5% of patients initiated pulmonary rehabilitation in the 90 days after hospital discharge.

“This is a striking finding,” said Mihaela Stefan, PhD, from the University of Massachusetts Medical School–Baystate in Springfield. “Our study demonstrates that we need to increase access to rehabilitation to reduce the risk of readmissions.”

Not enough patients are initiating rehabilitation, but the onus is not only on them; the system is failing them. “We wanted to understand how much pulmonary rehabilitation lowers the readmission rate,” Stefan told Medscape Medical News.

So she and her colleagues examined the records of patients who were hospitalized for COPD in 2014 to see whether they had begun rehabilitation in the 90 days after discharge and whether they were readmitted to the hospital in the subsequent 12 months.

Patients who were unlikely to initiate pulmonary rehabilitation — such as those with dementia or metastatic cancer and those discharged to hospice care or a nursing home — were excluded from the analysis, Stefan said during her presentation at the study results at the virtual American Thoracic Society (ATS) 2020 International Conference.

The risk analysis was complex because many patients died before the year was out, and “a patient who dies has no risk of being readmitted,” she explained. Selection bias was also a factor because patients who do pulmonary rehab tend to be in better shape.

The researchers used propensity score matching and Anderson–Gill models of cumulative rehospitalizations or death at 1 year with time-varying exposure to pulmonary rehabilitation to account for clustering of individual events and adjust for covariates. “It was a complicated risk analysis,” she said.

In the year after discharge, 130,660 patients (66%) were readmitted to the hospital. The rate of rehospitalization was lower for those who initiated rehabilitation than for those who did not (59% vs 66%), as was the mean number of readmissions per patient (1.4 vs 1.8).

Rehabilitation was associated with a lower risk for readmission or death (hazard ratio, 0.67; 95% CI, 0.66 - 0.69).

“We know the referral rates are low and that pulmonary rehabilitation is effective in clinical trials,” said Stefan, and now “we see that pulmonary rehabilitation is effective when you look at patients in real life.”

From a provider perspective, “we need to make sure that hospitals get more money for pulmonary rehabilitation. Cardiac rehabilitation is paid for,” she explained. "But pulmonary rehab is not a lucrative business. I don›t know why the CMS pays more for cardiac."

A rehabilitation program generally consists of 36 sessions, held two or three times a week, and many patients can’t afford that on their own, she noted. Transportation is another huge issue.

A recent study in which semi-structured interviews were conducted with 15 COPD patients showed that the main barriers to enrollment in a pulmonary rehabilitation program are lack of awareness, family obligations, transportation, and lack of motivation, said Stefan, who was involved in that research.

Telehealth rehabilitation programs might become more available in the near future, given the COVID pandemic. But “currently, Medicare doesn’t pay for telerehab,” she said. Virtual sessions might attract more patients, but lack of computer access and training could present another barrier for some.

PAH rehab

Uptake for pulmonary rehabilitation is as low for patients with pulmonary arterial hypertension (PAH) as it is for those with COPD, according to another study presented at the virtual ATS meeting.

An examination of the electronic health records of 111,356 veterans who experienced incident PAH from 2010 to 2016 showed that only 1,737 (1.6%) followed through on pulmonary rehabilitation.

“Exercise therapy is safe and effective at improving outcomes,” lead author Thomas Cascino, MD, from the University of Michigan in Ann Arbor, said in an ATS press release. “Recognizing that it is being underutilized is a necessary first step in working toward increasing patient access to rehab.

His group is currently working on a trial for home-based rehabilitation “using wearable technology as a means to expand access for people unable to come to center-based rehab for a variety of reasons,” he explained.

“The goal of all our treatments is to help people feel better and live longer,” Cascino added.

Stefan and Cascino have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Pulmonary rehabilitation reduces the likelihood that patients with chronic obstructive pulmonary disease (COPD) will be readmitted to the hospital in the year after discharge by 33%, new research shows, but few patients participate in those programs.

In fact, in a retrospective cohort of 197,376 patients from 4446 hospitals, only 1.5% of patients initiated pulmonary rehabilitation in the 90 days after hospital discharge.

“This is a striking finding,” said Mihaela Stefan, PhD, from the University of Massachusetts Medical School–Baystate in Springfield. “Our study demonstrates that we need to increase access to rehabilitation to reduce the risk of readmissions.”

Not enough patients are initiating rehabilitation, but the onus is not only on them; the system is failing them. “We wanted to understand how much pulmonary rehabilitation lowers the readmission rate,” Stefan told Medscape Medical News.

So she and her colleagues examined the records of patients who were hospitalized for COPD in 2014 to see whether they had begun rehabilitation in the 90 days after discharge and whether they were readmitted to the hospital in the subsequent 12 months.

Patients who were unlikely to initiate pulmonary rehabilitation — such as those with dementia or metastatic cancer and those discharged to hospice care or a nursing home — were excluded from the analysis, Stefan said during her presentation at the study results at the virtual American Thoracic Society (ATS) 2020 International Conference.

The risk analysis was complex because many patients died before the year was out, and “a patient who dies has no risk of being readmitted,” she explained. Selection bias was also a factor because patients who do pulmonary rehab tend to be in better shape.

The researchers used propensity score matching and Anderson–Gill models of cumulative rehospitalizations or death at 1 year with time-varying exposure to pulmonary rehabilitation to account for clustering of individual events and adjust for covariates. “It was a complicated risk analysis,” she said.

In the year after discharge, 130,660 patients (66%) were readmitted to the hospital. The rate of rehospitalization was lower for those who initiated rehabilitation than for those who did not (59% vs 66%), as was the mean number of readmissions per patient (1.4 vs 1.8).

Rehabilitation was associated with a lower risk for readmission or death (hazard ratio, 0.67; 95% CI, 0.66 - 0.69).

“We know the referral rates are low and that pulmonary rehabilitation is effective in clinical trials,” said Stefan, and now “we see that pulmonary rehabilitation is effective when you look at patients in real life.”

From a provider perspective, “we need to make sure that hospitals get more money for pulmonary rehabilitation. Cardiac rehabilitation is paid for,” she explained. "But pulmonary rehab is not a lucrative business. I don›t know why the CMS pays more for cardiac."

A rehabilitation program generally consists of 36 sessions, held two or three times a week, and many patients can’t afford that on their own, she noted. Transportation is another huge issue.

A recent study in which semi-structured interviews were conducted with 15 COPD patients showed that the main barriers to enrollment in a pulmonary rehabilitation program are lack of awareness, family obligations, transportation, and lack of motivation, said Stefan, who was involved in that research.

Telehealth rehabilitation programs might become more available in the near future, given the COVID pandemic. But “currently, Medicare doesn’t pay for telerehab,” she said. Virtual sessions might attract more patients, but lack of computer access and training could present another barrier for some.

PAH rehab

Uptake for pulmonary rehabilitation is as low for patients with pulmonary arterial hypertension (PAH) as it is for those with COPD, according to another study presented at the virtual ATS meeting.

An examination of the electronic health records of 111,356 veterans who experienced incident PAH from 2010 to 2016 showed that only 1,737 (1.6%) followed through on pulmonary rehabilitation.

“Exercise therapy is safe and effective at improving outcomes,” lead author Thomas Cascino, MD, from the University of Michigan in Ann Arbor, said in an ATS press release. “Recognizing that it is being underutilized is a necessary first step in working toward increasing patient access to rehab.

His group is currently working on a trial for home-based rehabilitation “using wearable technology as a means to expand access for people unable to come to center-based rehab for a variety of reasons,” he explained.

“The goal of all our treatments is to help people feel better and live longer,” Cascino added.

Stefan and Cascino have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Following invasive ventilation for severe hypercapnic respiratory failure, patients with chronic obstructive pulmonary disease had similar levels of treatment failure if they received high-flow nasal cannula oxygen therapy or noninvasive ventilation, recent research in Critical Care has suggested.

However, for patients with COPD weaned off invasive ventilation, high-flow nasal cannula (HFNC) oxygen therapy was “more comfortable and better tolerated,” compared with noninvasive ventilation (NIV). In addition, “airway care interventions and the incidence of nasofacial skin breakdown associated with HFNC were significantly lower than in NIV,” according to Dingyu Tan of the Clinical Medical College of Yangzhou (China) University, Northern Jiangsu People’s Hospital, and colleagues. “HFNC appears to be an effective means of respiratory support for COPD patients extubated after severe hypercapnic respiratory failure,” they said.

The investigators screened patients with COPD and hypercapnic respiratory failure for enrollment, including those who met Global Initiative for Obstructive Lung Disease (GOLD) criteria, were 85 years old or younger and caring for themselves, had bronchopulmonary infection–induced respiratory failure, and had achieved pulmonary infection control criteria. Exclusion criteria were:

• Patients under age 18 years.
• Presence of oral or facial trauma.
• Poor sputum excretion ability.
• Hemodynamic instability that would contraindicate use of NIV.
• Poor cough during PIC window.
• Poor short-term prognosis.
• Failure of the heart, brain, liver or kidney.
• Patients who could not consent to treatment.

Patients were determined to have failed treatment if they returned to invasive mechanical ventilation or switched from one treatment to another (HFNC to NIV or NIV to HFNC). Investigators also performed an arterial blood gas analysis, recorded the number of duration of airway care interventions, and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation as secondary analyses.

Overall, 44 patients randomized to receive HFNC and 42 patients randomized for NIV were available for analysis. The investigators found 22.7% of patients in the HFNC group and 28.6% in the NIV group experienced treatment failure (risk difference, –5.8%; 95% confidence interval, −23.8 to 12.4%; P = .535), with patients in the HFNC group experiencing a significantly lower level of treatment intolerance, compared with patients in the NIV group (risk difference, ­–50.0%; 95% CI, −74.6 to −12.9%; P = .015). There were no significant differences between either group regarding intubation (−0.65%; 95% CI, −16.01 to 14.46%), while rate of switching treatments was lower in the HFNC group but not significant (−5.2%; 95% CI, −19.82 to 9.05%).

Patients in both the HFNC and NIV groups had faster mean respiratory rates 1 hour after extubation (P < .050). After 24 hours, the NIV group had higher-than-baseline respiratory rates, compared with the HFNC group, which had returned to normal (20 vs. 24.5 breaths per minute; P < .050). Both groups had returned to baseline by 48 hours after extubation. At 1 hour after extubation, patients in the HFNC group had lower PaO₂/FiO₂ (P < .050) and pH values (P < .050), and higher PaCO₂ values (P less than .050), compared with baseline. There were no statistically significant differences in PaO₂/FiO₂, pH, and PaCO₂ values in either group at 24 hours or 48 hours after extubation.

Daily airway care interventions were significantly higher on average in the NIV group, compared with the HFNC group (7 vs. 6; P = .0006), and the HFNC group also had significantly better comfort scores (7 vs. 5; P < .001) as measured by a modified visual analog scale, as well as incidence of nasal and facial skin breakdown (0 vs. 9.6%; P = .027), compared with the NIV group.
 

Results difficult to apply to North American patients

David L. Bowton, MD, FCCP, a professor specializing in critical care at Wake Forest University, Winston-Salem, N.C., said in an interview the results of this trial may not be applicable for patients with infection-related respiratory failure and COPD in North America “due to the differences in common weaning practices between North America and China.”

For example, the trial used the pulmonary infection control (PIC) window criteria for extubation, which requires a significant decrease in radiographic infiltrates, improvement in quality and quantity of sputum, normalizing of leukocyte count, a synchronized intermittent mandatory ventilation (SIMV) rate of 10-12 breaths per minute, and pressure support less than 10-12 cm/H₂O (Int J Chron Obstruct Pulmon Dis. 2017;12:1255-67).

“The process used to achieve these measures is not standardized. In North America, daily awakening and screening for spontaneous breathing trials would be usual, but this was not reported in the current trial,” he explained.

Differences in patient population also make the application of the results difficult, Dr. Bowton said. “Only 60% of the patients had spirometrically confirmed COPD and fewer than half were on at least dual inhaled therapy prior to hospitalization with only one-third taking beta agonists or anticholinergic agents,” he noted. “The cause of respiratory failure was infectious, requiring an infiltrate on chest radiograph; thus, patients with hypercarbic respiratory failure without a new infiltrate were excluded from the study. On average, patients were hypercarbic, yet alkalemic at the time of extubation; the PaCO₂ and pH at the time of intubation were not reported.

“This study suggests that in some patients with COPD and respiratory failure requiring invasive mechanical ventilation, HFO [high-flow oxygen] may be better tolerated and equally effective as NIPPV [noninvasive positive-pressure ventilation] at mitigating the need for reintubation following extubation. In this patient population where hypoxemia prior to extubation was not severe, the mechanisms by which HFO is beneficial remain speculative,” he said.

This study was funded by the Rui E special fund for emergency medicine research and the Yangzhou Science and Technology Development Plan. The authors report no relevant conflicts of interest. Dr. Bowton reports no relevant conflicts of interest.

SOURCE: Tan D et al. Crit Care. 2020 Aug 6. doi: 10.1186/s13054-020-03214-9.

Following invasive ventilation for severe hypercapnic respiratory failure, patients with chronic obstructive pulmonary disease had similar levels of treatment failure if they received high-flow nasal cannula oxygen therapy or noninvasive ventilation, recent research in Critical Care has suggested.

However, for patients with COPD weaned off invasive ventilation, high-flow nasal cannula (HFNC) oxygen therapy was “more comfortable and better tolerated,” compared with noninvasive ventilation (NIV). In addition, “airway care interventions and the incidence of nasofacial skin breakdown associated with HFNC were significantly lower than in NIV,” according to Dingyu Tan of the Clinical Medical College of Yangzhou (China) University, Northern Jiangsu People’s Hospital, and colleagues. “HFNC appears to be an effective means of respiratory support for COPD patients extubated after severe hypercapnic respiratory failure,” they said.

The investigators screened patients with COPD and hypercapnic respiratory failure for enrollment, including those who met Global Initiative for Obstructive Lung Disease (GOLD) criteria, were 85 years old or younger and caring for themselves, had bronchopulmonary infection–induced respiratory failure, and had achieved pulmonary infection control criteria. Exclusion criteria were:

• Patients under age 18 years.
• Presence of oral or facial trauma.
• Poor sputum excretion ability.
• Hemodynamic instability that would contraindicate use of NIV.
• Poor cough during PIC window.
• Poor short-term prognosis.
• Failure of the heart, brain, liver or kidney.
• Patients who could not consent to treatment.

Patients were determined to have failed treatment if they returned to invasive mechanical ventilation or switched from one treatment to another (HFNC to NIV or NIV to HFNC). Investigators also performed an arterial blood gas analysis, recorded the number of duration of airway care interventions, and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation as secondary analyses.

Overall, 44 patients randomized to receive HFNC and 42 patients randomized for NIV were available for analysis. The investigators found 22.7% of patients in the HFNC group and 28.6% in the NIV group experienced treatment failure (risk difference, –5.8%; 95% confidence interval, −23.8 to 12.4%; P = .535), with patients in the HFNC group experiencing a significantly lower level of treatment intolerance, compared with patients in the NIV group (risk difference, ­–50.0%; 95% CI, −74.6 to −12.9%; P = .015). There were no significant differences between either group regarding intubation (−0.65%; 95% CI, −16.01 to 14.46%), while rate of switching treatments was lower in the HFNC group but not significant (−5.2%; 95% CI, −19.82 to 9.05%).

Patients in both the HFNC and NIV groups had faster mean respiratory rates 1 hour after extubation (P < .050). After 24 hours, the NIV group had higher-than-baseline respiratory rates, compared with the HFNC group, which had returned to normal (20 vs. 24.5 breaths per minute; P < .050). Both groups had returned to baseline by 48 hours after extubation. At 1 hour after extubation, patients in the HFNC group had lower PaO₂/FiO₂ (P < .050) and pH values (P < .050), and higher PaCO₂ values (P less than .050), compared with baseline. There were no statistically significant differences in PaO₂/FiO₂, pH, and PaCO₂ values in either group at 24 hours or 48 hours after extubation.

Daily airway care interventions were significantly higher on average in the NIV group, compared with the HFNC group (7 vs. 6; P = .0006), and the HFNC group also had significantly better comfort scores (7 vs. 5; P < .001) as measured by a modified visual analog scale, as well as incidence of nasal and facial skin breakdown (0 vs. 9.6%; P = .027), compared with the NIV group.
 

Results difficult to apply to North American patients

David L. Bowton, MD, FCCP, a professor specializing in critical care at Wake Forest University, Winston-Salem, N.C., said in an interview the results of this trial may not be applicable for patients with infection-related respiratory failure and COPD in North America “due to the differences in common weaning practices between North America and China.”

For example, the trial used the pulmonary infection control (PIC) window criteria for extubation, which requires a significant decrease in radiographic infiltrates, improvement in quality and quantity of sputum, normalizing of leukocyte count, a synchronized intermittent mandatory ventilation (SIMV) rate of 10-12 breaths per minute, and pressure support less than 10-12 cm/H₂O (Int J Chron Obstruct Pulmon Dis. 2017;12:1255-67).

“The process used to achieve these measures is not standardized. In North America, daily awakening and screening for spontaneous breathing trials would be usual, but this was not reported in the current trial,” he explained.

Differences in patient population also make the application of the results difficult, Dr. Bowton said. “Only 60% of the patients had spirometrically confirmed COPD and fewer than half were on at least dual inhaled therapy prior to hospitalization with only one-third taking beta agonists or anticholinergic agents,” he noted. “The cause of respiratory failure was infectious, requiring an infiltrate on chest radiograph; thus, patients with hypercarbic respiratory failure without a new infiltrate were excluded from the study. On average, patients were hypercarbic, yet alkalemic at the time of extubation; the PaCO₂ and pH at the time of intubation were not reported.

“This study suggests that in some patients with COPD and respiratory failure requiring invasive mechanical ventilation, HFO [high-flow oxygen] may be better tolerated and equally effective as NIPPV [noninvasive positive-pressure ventilation] at mitigating the need for reintubation following extubation. In this patient population where hypoxemia prior to extubation was not severe, the mechanisms by which HFO is beneficial remain speculative,” he said.

This study was funded by the Rui E special fund for emergency medicine research and the Yangzhou Science and Technology Development Plan. The authors report no relevant conflicts of interest. Dr. Bowton reports no relevant conflicts of interest.

SOURCE: Tan D et al. Crit Care. 2020 Aug 6. doi: 10.1186/s13054-020-03214-9.

Following invasive ventilation for severe hypercapnic respiratory failure, patients with chronic obstructive pulmonary disease had similar levels of treatment failure if they received high-flow nasal cannula oxygen therapy or noninvasive ventilation, recent research in Critical Care has suggested.

However, for patients with COPD weaned off invasive ventilation, high-flow nasal cannula (HFNC) oxygen therapy was “more comfortable and better tolerated,” compared with noninvasive ventilation (NIV). In addition, “airway care interventions and the incidence of nasofacial skin breakdown associated with HFNC were significantly lower than in NIV,” according to Dingyu Tan of the Clinical Medical College of Yangzhou (China) University, Northern Jiangsu People’s Hospital, and colleagues. “HFNC appears to be an effective means of respiratory support for COPD patients extubated after severe hypercapnic respiratory failure,” they said.

The investigators screened patients with COPD and hypercapnic respiratory failure for enrollment, including those who met Global Initiative for Obstructive Lung Disease (GOLD) criteria, were 85 years old or younger and caring for themselves, had bronchopulmonary infection–induced respiratory failure, and had achieved pulmonary infection control criteria. Exclusion criteria were:

• Patients under age 18 years.
• Presence of oral or facial trauma.
• Poor sputum excretion ability.
• Hemodynamic instability that would contraindicate use of NIV.
• Poor cough during PIC window.
• Poor short-term prognosis.
• Failure of the heart, brain, liver or kidney.
• Patients who could not consent to treatment.

Patients were determined to have failed treatment if they returned to invasive mechanical ventilation or switched from one treatment to another (HFNC to NIV or NIV to HFNC). Investigators also performed an arterial blood gas analysis, recorded the number of duration of airway care interventions, and monitored vital signs at 1 hour, 24 hours, and 48 hours after extubation as secondary analyses.

Overall, 44 patients randomized to receive HFNC and 42 patients randomized for NIV were available for analysis. The investigators found 22.7% of patients in the HFNC group and 28.6% in the NIV group experienced treatment failure (risk difference, –5.8%; 95% confidence interval, −23.8 to 12.4%; P = .535), with patients in the HFNC group experiencing a significantly lower level of treatment intolerance, compared with patients in the NIV group (risk difference, ­–50.0%; 95% CI, −74.6 to −12.9%; P = .015). There were no significant differences between either group regarding intubation (−0.65%; 95% CI, −16.01 to 14.46%), while rate of switching treatments was lower in the HFNC group but not significant (−5.2%; 95% CI, −19.82 to 9.05%).

Patients in both the HFNC and NIV groups had faster mean respiratory rates 1 hour after extubation (P < .050). After 24 hours, the NIV group had higher-than-baseline respiratory rates, compared with the HFNC group, which had returned to normal (20 vs. 24.5 breaths per minute; P < .050). Both groups had returned to baseline by 48 hours after extubation. At 1 hour after extubation, patients in the HFNC group had lower PaO₂/FiO₂ (P < .050) and pH values (P < .050), and higher PaCO₂ values (P less than .050), compared with baseline. There were no statistically significant differences in PaO₂/FiO₂, pH, and PaCO₂ values in either group at 24 hours or 48 hours after extubation.

Daily airway care interventions were significantly higher on average in the NIV group, compared with the HFNC group (7 vs. 6; P = .0006), and the HFNC group also had significantly better comfort scores (7 vs. 5; P < .001) as measured by a modified visual analog scale, as well as incidence of nasal and facial skin breakdown (0 vs. 9.6%; P = .027), compared with the NIV group.
 

Results difficult to apply to North American patients

David L. Bowton, MD, FCCP, a professor specializing in critical care at Wake Forest University, Winston-Salem, N.C., said in an interview the results of this trial may not be applicable for patients with infection-related respiratory failure and COPD in North America “due to the differences in common weaning practices between North America and China.”

For example, the trial used the pulmonary infection control (PIC) window criteria for extubation, which requires a significant decrease in radiographic infiltrates, improvement in quality and quantity of sputum, normalizing of leukocyte count, a synchronized intermittent mandatory ventilation (SIMV) rate of 10-12 breaths per minute, and pressure support less than 10-12 cm/H₂O (Int J Chron Obstruct Pulmon Dis. 2017;12:1255-67).

“The process used to achieve these measures is not standardized. In North America, daily awakening and screening for spontaneous breathing trials would be usual, but this was not reported in the current trial,” he explained.

Differences in patient population also make the application of the results difficult, Dr. Bowton said. “Only 60% of the patients had spirometrically confirmed COPD and fewer than half were on at least dual inhaled therapy prior to hospitalization with only one-third taking beta agonists or anticholinergic agents,” he noted. “The cause of respiratory failure was infectious, requiring an infiltrate on chest radiograph; thus, patients with hypercarbic respiratory failure without a new infiltrate were excluded from the study. On average, patients were hypercarbic, yet alkalemic at the time of extubation; the PaCO₂ and pH at the time of intubation were not reported.

“This study suggests that in some patients with COPD and respiratory failure requiring invasive mechanical ventilation, HFO [high-flow oxygen] may be better tolerated and equally effective as NIPPV [noninvasive positive-pressure ventilation] at mitigating the need for reintubation following extubation. In this patient population where hypoxemia prior to extubation was not severe, the mechanisms by which HFO is beneficial remain speculative,” he said.

This study was funded by the Rui E special fund for emergency medicine research and the Yangzhou Science and Technology Development Plan. The authors report no relevant conflicts of interest. Dr. Bowton reports no relevant conflicts of interest.

SOURCE: Tan D et al. Crit Care. 2020 Aug 6. doi: 10.1186/s13054-020-03214-9.