Pulmonology

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Conventional chest x-rays combined with artificial intelligence (AI) can identify lung damage from COVID-19 and differentiate coronavirus patients from other patients, improving triage efforts, new research suggests.

The AI tool – developed by Jason Fleischer, PhD, and graduate student Mohammad Tariqul Islam, both from Princeton (N.J.) University – can distinguish COVID-19 patients from those with pneumonia or normal lung tissue with an accuracy of more than 95%.

“We were able to separate the COVID-19 patients with very high fidelity,” Dr. Fleischer said in an interview. “If you give me an x-ray now, I can say with very high confidence whether a patient has COVID-19.”

The diagnostic tool pinpoints patterns on x-ray images that are too subtle for even trained experts to notice. The precision of CT scanning is similar to that of the AI tool, but CT costs much more and has other disadvantages, said Dr. Fleischer, who presented his findings at the virtual European Respiratory Society International Congress 2020.

“CT is more expensive and uses higher doses of radiation,” he said. “Another big thing is that not everyone has tomography facilities – including a lot of rural places and developing countries – so you need something that’s on the spot.”

With machine learning, Dr. Fleischer analyzed 2,300 x-ray images: 1,018 “normal” images from patients who had neither pneumonia nor COVID-19, 1,011 from patients with pneumonia, and 271 from patients with COVID-19.

The AI tool uses a neural network to refine the number and type of lung features being tracked. A UMAP (Uniform Manifold Approximation and Projection) clustering algorithm then looks for similarities and differences in those images, he explained.

“We, as users, knew which type each x-ray was – normal, pneumonia positive, or COVID-19 positive – but the network did not,” he added.

Clinicians have observed two basic types of lung problems in COVID-19 patients: pneumonia that fills lung air sacs with fluid and dangerously low blood-oxygen levels despite nearly normal breathing patterns. Because treatment can vary according to type, it would be beneficial to quickly distinguish between them, Dr. Fleischer said.

The AI tool showed that there is a distinct difference in chest x-rays from pneumonia-positive patients and healthy people, he said. It also demonstrated two distinct clusters of COVID-19–positive chest x-rays: those that looked like pneumonia and those with a more normal presentation.

The fact that “the AI system recognizes something unique in chest x-rays from COVID-19–positive patients” indicates that the computer is able to identify visual markers for coronavirus, he explained. “We currently do not know what these markers are.”

Dr. Fleischer said his goal is not to replace physician decision-making, but to supplement it.

“I’m uncomfortable with having computers make the final decision,” he said. “They often have a narrow focus, whereas doctors have the big picture in mind.”

This AI tool is “very interesting,” especially in the context of expanding AI applications in various specialties, said Thierry Fumeaux, MD, from Nyon (Switzerland) Hospital. Some physicians currently disagree on whether a chest x-ray or CT scan is the better tool to help diagnose COVID-19.

“It seems better than the human eye and brain” to pinpoint COVID-19 lung damage, “so it’s very attractive as a technology,” Dr. Fumeaux said in an interview.

And AI can be used to supplement the efforts of busy and fatigued clinicians who might be stretched thin by large caseloads. “I cannot read 200 chest x-rays in a day, but a computer can do that in 2 minutes,” he said.

But Dr. Fumeaux offered a caveat: “Pattern recognition is promising, but at the moment I’m not aware of papers showing that, by using AI, you’re changing anything in the outcome of a patient.”

Ideally, Dr. Fleischer said he hopes that AI will soon be able to accurately indicate which treatments are most effective for individual COVID-19 patients. And the technology might eventually be used to help with treatment decisions for patients with asthma or chronic obstructive pulmonary disease, he noted.

But he needs more data before results indicate whether a COVID-19 patient would benefit from ventilator support, for example, and the tool can be used more widely. To contribute data or collaborate with Dr. Fleischer’s efforts, contact him.

“Machine learning is all about data, so you can find these correlations,” he said. “It would be nice to be able to use it to reassure a worried patient that their prognosis is good; to say that most of the people with symptoms like yours will be just fine.”

Dr. Fleischer and Dr. Fumeaux have declared no relevant financial relationships.

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

Diagnoses of 12 common pediatric infectious diseases in a large pediatric primary care network declined significantly in the weeks after COVID-19 social distancing (SD) was enacted in Massachusetts, compared with the same time period in 2019, an analysis of EHR data has shown.

ArtMarie/E+

While declines in infectious disease transmission with SD are not surprising, “these data demonstrate the extent to which transmission of common pediatric infections can be altered when close contact with other children is eliminated,” Jonathan Hatoun, MD, MPH of the Pediatric Physicians’ Organization at Children’s in Brookline, Mass., and coauthors wrote in Pediatrics . “Notably, three of the studied diseases, namely, influenza, croup, and bronchiolitis, essentially disappeared with [social distancing].”

The researchers analyzed the weekly incidence of each diagnosis for similar calendar periods in 2019 and 2020. A pre-SD period was defined as week 1-9, starting on Jan. 1, and a post-SD period was defined as week 13-18. (The several-week gap represented an implementation period as social distancing was enacted in the state earlier in 2020, from a declared statewide state of emergency through school closures and stay-at-home advisories.)

To isolate the effect of widespread SD, they performed a “difference-in-differences regression analysis, with diagnosis count as a function of calendar year, time period (pre-SD versus post-SD) and the interaction between the two.” The Massachusetts pediatric network provides care for approximately 375,000 children in 100 locations around the state.

In their research brief, Dr. Hatoun and coauthors presented weekly rates expressed as diagnoses per 100,000 patients per day. The rate of bronchiolitis, for instance, was 18 and 8 in the pre- and post-SD–equivalent weeks of 2019, respectively, and 20 and 0.6 in the pre- and post-SD weeks of 2020. Their analysis showed the rate in the 2020 post-SD period to be 10 diagnoses per 100,000 patients per day lower than they would have expected based on the 2019 trend.

Rates of pneumonia, acute otitis media, and streptococcal pharyngitis were similarly 14, 85, and 31 diagnoses per 100,000 patients per day lower, respectively. The prevalence of each of the other conditions analyzed – the common cold, croup, gastroenteritis, nonstreptococcal pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infection (UTI) – also was significantly lower in the 2020 post-SD period than would be expected based on 2019 data (P < .001 for all diagnoses).
 

Putting things in perspective

“This study puts numbers to the sense that we have all had in pediatrics – that social distancing appears to have had a dramatic impact on the transmission of common childhood infectious diseases, especially other respiratory viral pathogens,” Audrey R. John, MD, PhD, chief of the division of pediatric infectious disease at Children’s Hospital of Philadelphia, said in an interview.

The authors acknowledged the possible role of families not seeking care, but said that a smaller decrease in diagnoses of UTI – generally not a contagious disease – “suggests that changes in care-seeking behavior had a relatively modest effect on the other observed declines.” (The rate of UTI for the pre- and post-SD periods was 3.3 and 3.7 per 100,000 patients per day in 2019, and 3.4 and 2.4 in 2020, for a difference in differences of –1.5).

In an accompanying editorial, David W. Kimberlin, MD and Erica C. Bjornstad, MD, PhD, MPH, of the University of Alabama at Birmingham, called the report “provocative” and wrote that similar observations of infections dropping during periods of isolation – namely, dramatic declines in influenza and other respiratory viruses in Seattle after a record snowstorm in 2019 – combined with findings from other modeling studies “suggest that the decline [reported in Boston] is indeed real” (Pediatrics 2020. doi: 10.1542/peds.2020-019232).

However, “we also now know that immunization rates for American children have plummeted since the onset of the SARS-CoV-2 pandemic [because of a] ... dramatic decrease in the use of health care during the first months of the pandemic,” they wrote. “Viewed through this lens,” the declines reported in Boston may reflect inflections going “undiagnosed and untreated.”

Ultimately, Dr. Kimberlin and Dr. Bjornstad said, “the verdict remains out.”

Dr. John said that she and others are “concerned about children not seeking care in a timely manner, and [concerned] that reductions in reported infections might be due to a lack of recognition rather than a lack of transmission.”

In Philadelphia, however, declines in admissions for asthma exacerbations, “which are often caused by respiratory viral infections, suggests that this may not be the case,” said Dr. John, who was asked to comment on the study.

In addition, she said, the Massachusetts data showing that UTI diagnoses “are nearly as common this year as in 2019” are “reassuring.”
 

Are there lessons for the future?

Coauthor Louis Vernacchio, MD, MSc, chief medical officer of the Pediatric Physicians’ Organization at Children’s network, said in an interview that beyond the pandemic, it’s likely that “more careful attention to proven infection control practices in daycares and schools could reduce the burden of common infectious diseases in children.”

Dr. John similarly sees a long-term value of quantifying the impact of social distancing. “We’ve always known [for instance] that bronchiolitis is the result of viral infection.” Findings like the Massachusetts data “will help us advise families who might be trying to protect their premature infants (at risk for severe bronchiolitis) through social distancing.”

The analysis covered both in-person and telemedicine encounters occurring on weekdays.

The authors of the research brief indicated they have no relevant financial disclosures and there was no external funding. The authors of the commentary also reported they have no relevant financial disclosures, and Dr. John said she had no relevant financial disclosures.

SOURCE: Hatoun J et al. Pediatrics. 2020. doi: 10.1542/peds.2020-006460.

Diagnoses of 12 common pediatric infectious diseases in a large pediatric primary care network declined significantly in the weeks after COVID-19 social distancing (SD) was enacted in Massachusetts, compared with the same time period in 2019, an analysis of EHR data has shown.

ArtMarie/E+

While declines in infectious disease transmission with SD are not surprising, “these data demonstrate the extent to which transmission of common pediatric infections can be altered when close contact with other children is eliminated,” Jonathan Hatoun, MD, MPH of the Pediatric Physicians’ Organization at Children’s in Brookline, Mass., and coauthors wrote in Pediatrics . “Notably, three of the studied diseases, namely, influenza, croup, and bronchiolitis, essentially disappeared with [social distancing].”

The researchers analyzed the weekly incidence of each diagnosis for similar calendar periods in 2019 and 2020. A pre-SD period was defined as week 1-9, starting on Jan. 1, and a post-SD period was defined as week 13-18. (The several-week gap represented an implementation period as social distancing was enacted in the state earlier in 2020, from a declared statewide state of emergency through school closures and stay-at-home advisories.)

To isolate the effect of widespread SD, they performed a “difference-in-differences regression analysis, with diagnosis count as a function of calendar year, time period (pre-SD versus post-SD) and the interaction between the two.” The Massachusetts pediatric network provides care for approximately 375,000 children in 100 locations around the state.

In their research brief, Dr. Hatoun and coauthors presented weekly rates expressed as diagnoses per 100,000 patients per day. The rate of bronchiolitis, for instance, was 18 and 8 in the pre- and post-SD–equivalent weeks of 2019, respectively, and 20 and 0.6 in the pre- and post-SD weeks of 2020. Their analysis showed the rate in the 2020 post-SD period to be 10 diagnoses per 100,000 patients per day lower than they would have expected based on the 2019 trend.

Rates of pneumonia, acute otitis media, and streptococcal pharyngitis were similarly 14, 85, and 31 diagnoses per 100,000 patients per day lower, respectively. The prevalence of each of the other conditions analyzed – the common cold, croup, gastroenteritis, nonstreptococcal pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infection (UTI) – also was significantly lower in the 2020 post-SD period than would be expected based on 2019 data (P < .001 for all diagnoses).
 

Putting things in perspective

“This study puts numbers to the sense that we have all had in pediatrics – that social distancing appears to have had a dramatic impact on the transmission of common childhood infectious diseases, especially other respiratory viral pathogens,” Audrey R. John, MD, PhD, chief of the division of pediatric infectious disease at Children’s Hospital of Philadelphia, said in an interview.

The authors acknowledged the possible role of families not seeking care, but said that a smaller decrease in diagnoses of UTI – generally not a contagious disease – “suggests that changes in care-seeking behavior had a relatively modest effect on the other observed declines.” (The rate of UTI for the pre- and post-SD periods was 3.3 and 3.7 per 100,000 patients per day in 2019, and 3.4 and 2.4 in 2020, for a difference in differences of –1.5).

In an accompanying editorial, David W. Kimberlin, MD and Erica C. Bjornstad, MD, PhD, MPH, of the University of Alabama at Birmingham, called the report “provocative” and wrote that similar observations of infections dropping during periods of isolation – namely, dramatic declines in influenza and other respiratory viruses in Seattle after a record snowstorm in 2019 – combined with findings from other modeling studies “suggest that the decline [reported in Boston] is indeed real” (Pediatrics 2020. doi: 10.1542/peds.2020-019232).

However, “we also now know that immunization rates for American children have plummeted since the onset of the SARS-CoV-2 pandemic [because of a] ... dramatic decrease in the use of health care during the first months of the pandemic,” they wrote. “Viewed through this lens,” the declines reported in Boston may reflect inflections going “undiagnosed and untreated.”

Ultimately, Dr. Kimberlin and Dr. Bjornstad said, “the verdict remains out.”

Dr. John said that she and others are “concerned about children not seeking care in a timely manner, and [concerned] that reductions in reported infections might be due to a lack of recognition rather than a lack of transmission.”

In Philadelphia, however, declines in admissions for asthma exacerbations, “which are often caused by respiratory viral infections, suggests that this may not be the case,” said Dr. John, who was asked to comment on the study.

In addition, she said, the Massachusetts data showing that UTI diagnoses “are nearly as common this year as in 2019” are “reassuring.”
 

Are there lessons for the future?

Coauthor Louis Vernacchio, MD, MSc, chief medical officer of the Pediatric Physicians’ Organization at Children’s network, said in an interview that beyond the pandemic, it’s likely that “more careful attention to proven infection control practices in daycares and schools could reduce the burden of common infectious diseases in children.”

Dr. John similarly sees a long-term value of quantifying the impact of social distancing. “We’ve always known [for instance] that bronchiolitis is the result of viral infection.” Findings like the Massachusetts data “will help us advise families who might be trying to protect their premature infants (at risk for severe bronchiolitis) through social distancing.”

The analysis covered both in-person and telemedicine encounters occurring on weekdays.

The authors of the research brief indicated they have no relevant financial disclosures and there was no external funding. The authors of the commentary also reported they have no relevant financial disclosures, and Dr. John said she had no relevant financial disclosures.

SOURCE: Hatoun J et al. Pediatrics. 2020. doi: 10.1542/peds.2020-006460.

Diagnoses of 12 common pediatric infectious diseases in a large pediatric primary care network declined significantly in the weeks after COVID-19 social distancing (SD) was enacted in Massachusetts, compared with the same time period in 2019, an analysis of EHR data has shown.

ArtMarie/E+

While declines in infectious disease transmission with SD are not surprising, “these data demonstrate the extent to which transmission of common pediatric infections can be altered when close contact with other children is eliminated,” Jonathan Hatoun, MD, MPH of the Pediatric Physicians’ Organization at Children’s in Brookline, Mass., and coauthors wrote in Pediatrics . “Notably, three of the studied diseases, namely, influenza, croup, and bronchiolitis, essentially disappeared with [social distancing].”

The researchers analyzed the weekly incidence of each diagnosis for similar calendar periods in 2019 and 2020. A pre-SD period was defined as week 1-9, starting on Jan. 1, and a post-SD period was defined as week 13-18. (The several-week gap represented an implementation period as social distancing was enacted in the state earlier in 2020, from a declared statewide state of emergency through school closures and stay-at-home advisories.)

To isolate the effect of widespread SD, they performed a “difference-in-differences regression analysis, with diagnosis count as a function of calendar year, time period (pre-SD versus post-SD) and the interaction between the two.” The Massachusetts pediatric network provides care for approximately 375,000 children in 100 locations around the state.

In their research brief, Dr. Hatoun and coauthors presented weekly rates expressed as diagnoses per 100,000 patients per day. The rate of bronchiolitis, for instance, was 18 and 8 in the pre- and post-SD–equivalent weeks of 2019, respectively, and 20 and 0.6 in the pre- and post-SD weeks of 2020. Their analysis showed the rate in the 2020 post-SD period to be 10 diagnoses per 100,000 patients per day lower than they would have expected based on the 2019 trend.

Rates of pneumonia, acute otitis media, and streptococcal pharyngitis were similarly 14, 85, and 31 diagnoses per 100,000 patients per day lower, respectively. The prevalence of each of the other conditions analyzed – the common cold, croup, gastroenteritis, nonstreptococcal pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infection (UTI) – also was significantly lower in the 2020 post-SD period than would be expected based on 2019 data (P < .001 for all diagnoses).
 

Putting things in perspective

“This study puts numbers to the sense that we have all had in pediatrics – that social distancing appears to have had a dramatic impact on the transmission of common childhood infectious diseases, especially other respiratory viral pathogens,” Audrey R. John, MD, PhD, chief of the division of pediatric infectious disease at Children’s Hospital of Philadelphia, said in an interview.

The authors acknowledged the possible role of families not seeking care, but said that a smaller decrease in diagnoses of UTI – generally not a contagious disease – “suggests that changes in care-seeking behavior had a relatively modest effect on the other observed declines.” (The rate of UTI for the pre- and post-SD periods was 3.3 and 3.7 per 100,000 patients per day in 2019, and 3.4 and 2.4 in 2020, for a difference in differences of –1.5).

In an accompanying editorial, David W. Kimberlin, MD and Erica C. Bjornstad, MD, PhD, MPH, of the University of Alabama at Birmingham, called the report “provocative” and wrote that similar observations of infections dropping during periods of isolation – namely, dramatic declines in influenza and other respiratory viruses in Seattle after a record snowstorm in 2019 – combined with findings from other modeling studies “suggest that the decline [reported in Boston] is indeed real” (Pediatrics 2020. doi: 10.1542/peds.2020-019232).

However, “we also now know that immunization rates for American children have plummeted since the onset of the SARS-CoV-2 pandemic [because of a] ... dramatic decrease in the use of health care during the first months of the pandemic,” they wrote. “Viewed through this lens,” the declines reported in Boston may reflect inflections going “undiagnosed and untreated.”

Ultimately, Dr. Kimberlin and Dr. Bjornstad said, “the verdict remains out.”

Dr. John said that she and others are “concerned about children not seeking care in a timely manner, and [concerned] that reductions in reported infections might be due to a lack of recognition rather than a lack of transmission.”

In Philadelphia, however, declines in admissions for asthma exacerbations, “which are often caused by respiratory viral infections, suggests that this may not be the case,” said Dr. John, who was asked to comment on the study.

In addition, she said, the Massachusetts data showing that UTI diagnoses “are nearly as common this year as in 2019” are “reassuring.”
 

Are there lessons for the future?

Coauthor Louis Vernacchio, MD, MSc, chief medical officer of the Pediatric Physicians’ Organization at Children’s network, said in an interview that beyond the pandemic, it’s likely that “more careful attention to proven infection control practices in daycares and schools could reduce the burden of common infectious diseases in children.”

Dr. John similarly sees a long-term value of quantifying the impact of social distancing. “We’ve always known [for instance] that bronchiolitis is the result of viral infection.” Findings like the Massachusetts data “will help us advise families who might be trying to protect their premature infants (at risk for severe bronchiolitis) through social distancing.”

The analysis covered both in-person and telemedicine encounters occurring on weekdays.

The authors of the research brief indicated they have no relevant financial disclosures and there was no external funding. The authors of the commentary also reported they have no relevant financial disclosures, and Dr. John said she had no relevant financial disclosures.

SOURCE: Hatoun J et al. Pediatrics. 2020. doi: 10.1542/peds.2020-006460.

Insomnia is “highly prevalent” in veterans with chronic pulmonary obstructive disease and is significantly associated with greater COPD-related health care utilization, according to an analysis of national Veterans Health Administration data.

“The study highlights the importance of exploring potential sleep disturbances and disorders in this population and suggests that a targeted treatment for insomnia may help to improve COPD outcomes in veterans with COPD and insomnia,” said Faith Luyster, PhD, assistant professor at the University of Pittsburgh, in an interview after the virtual annual meeting of the Associated Professional Sleep Societies, where she presented the findings.

Dr. Luyster and coinvestigators used an administrative database from the Veterans Affairs Corporate Data Warehouse to identify more than 1.5 million patients with COPD who used VHA services over a 6-year period (fiscal years 2011-2017). Insomnia was defined by ICD-9/10 diagnostic codes and/or a sedative-hypnotic prescription for at least 30 doses during any of these years.

Insomnia with COPD was prevalent in this sample of veterans at 37.3%. Compared with veterans without comorbid insomnia, those who had both COPD and insomnia (575,539 of the total 1,542,642) were older (69 vs. 64 years), more likely to be female (6.3% vs. 3.7%), more likely to be Black (14% vs. 11%) and more likely to be a current smoker (46.1% vs. 35.5%).

Those with both COPD and insomnia were also more likely to have a service-connected disability rating of 50% of greater; use supplemental oxygen; be divorced, widowed, or separated; have a higher body mass index; or have other medical or psychiatric conditions – in particular obstructive sleep apnea (39% vs. 7%), depression (21% vs. 5%), and PTSD (33% vs. 3%).

P values were < .001 for all of these demographic and clinical variables, Dr. Luyster reported at the meeting.

Comorbid insomnia clearly impacted health care utilization, she said. Veterans with insomnia in addition to COPD had more outpatient and ED visits (10.5 vs 6.9, and 1.6 vs. 1.4, respectively) and more hospitalizations (2.2 vs. 1.8) with a primary diagnostic code for COPD or COPD exacerbation (P < .001).

A negative binomial regression analysis (P < .001) showed that “even after controlling for demographic and other medical conditions, COPD patients with insomnia had greater rates of health care utilization relative to COPD patients without insomnia,” Dr. Luyster said in the interview.

Prior studies have suggested that disturbed sleep is a predictor of poorer longitudinal outcomes in COPD, even after controlling for COPD severity, but have not looked specifically at insomnia, she said.

Commenting on the study Octavian C. Ioachimescu, MD, PhD, of Emory University, Atlanta, and the Atlanta VA Medical Center in Decatur, said the criteria used to define insomnia – unadjudicated ICD diagnoses as well as sedative-hypnotic prescriptions – may explain part of the reported prevalence of insomnia. Even so, the findings add to existing literature demonstrating that COPD and insomnia are both common disorders among VHA patients, and that their frequent coexistence “could have adverse consequences on the overall health, functional status, long-term outcomes, and quality of life of these patients.”

Questions of causation are yet to be answered, he said. “Is it that uncontrolled or severe airflow obstruction causing frequent nocturnal arousals, dyspnea, orthopnea, overuse of inhaled sympathomimetics and heightened anxiety leads to insomnia? Or is it that insomnia – possibly in a cluster with other affective disorders such as depression, anxiety disorders, or PTSD – elicits more frequent or more severe symptoms of shortness of breath in those with smoking-induced airway and parenchymal lung disease, making the latter diagnosis more overt than in others?

“My bet is on a bidirectional causal relationship,” said Dr. Ioachimescu, an editorial board advisor of CHEST Physician.

“Regardless of the etiology [of insomnia in veterans with COPD],” Dr. Luyster said, “it’s important that [insomnia] be addressed and treated appropriately, whether that be through pharmacological treatment, or probably more ideally through [cognitive behavioral therapy] for insomnia.”

The study did not control for COPD severity, she said, because of the difficulty of extracting this data from the VA Corporate Data Warehouse. The study was funded by the VA Competitive Career Development Fund.Dr. Luyster reported that she had no disclosures. Dr. Ioachimescu also said he had no relevant disclosures.
 

Insomnia is “highly prevalent” in veterans with chronic pulmonary obstructive disease and is significantly associated with greater COPD-related health care utilization, according to an analysis of national Veterans Health Administration data.

“The study highlights the importance of exploring potential sleep disturbances and disorders in this population and suggests that a targeted treatment for insomnia may help to improve COPD outcomes in veterans with COPD and insomnia,” said Faith Luyster, PhD, assistant professor at the University of Pittsburgh, in an interview after the virtual annual meeting of the Associated Professional Sleep Societies, where she presented the findings.

Dr. Luyster and coinvestigators used an administrative database from the Veterans Affairs Corporate Data Warehouse to identify more than 1.5 million patients with COPD who used VHA services over a 6-year period (fiscal years 2011-2017). Insomnia was defined by ICD-9/10 diagnostic codes and/or a sedative-hypnotic prescription for at least 30 doses during any of these years.

Insomnia with COPD was prevalent in this sample of veterans at 37.3%. Compared with veterans without comorbid insomnia, those who had both COPD and insomnia (575,539 of the total 1,542,642) were older (69 vs. 64 years), more likely to be female (6.3% vs. 3.7%), more likely to be Black (14% vs. 11%) and more likely to be a current smoker (46.1% vs. 35.5%).

Those with both COPD and insomnia were also more likely to have a service-connected disability rating of 50% of greater; use supplemental oxygen; be divorced, widowed, or separated; have a higher body mass index; or have other medical or psychiatric conditions – in particular obstructive sleep apnea (39% vs. 7%), depression (21% vs. 5%), and PTSD (33% vs. 3%).

P values were < .001 for all of these demographic and clinical variables, Dr. Luyster reported at the meeting.

Comorbid insomnia clearly impacted health care utilization, she said. Veterans with insomnia in addition to COPD had more outpatient and ED visits (10.5 vs 6.9, and 1.6 vs. 1.4, respectively) and more hospitalizations (2.2 vs. 1.8) with a primary diagnostic code for COPD or COPD exacerbation (P < .001).

A negative binomial regression analysis (P < .001) showed that “even after controlling for demographic and other medical conditions, COPD patients with insomnia had greater rates of health care utilization relative to COPD patients without insomnia,” Dr. Luyster said in the interview.

Prior studies have suggested that disturbed sleep is a predictor of poorer longitudinal outcomes in COPD, even after controlling for COPD severity, but have not looked specifically at insomnia, she said.

Commenting on the study Octavian C. Ioachimescu, MD, PhD, of Emory University, Atlanta, and the Atlanta VA Medical Center in Decatur, said the criteria used to define insomnia – unadjudicated ICD diagnoses as well as sedative-hypnotic prescriptions – may explain part of the reported prevalence of insomnia. Even so, the findings add to existing literature demonstrating that COPD and insomnia are both common disorders among VHA patients, and that their frequent coexistence “could have adverse consequences on the overall health, functional status, long-term outcomes, and quality of life of these patients.”

Questions of causation are yet to be answered, he said. “Is it that uncontrolled or severe airflow obstruction causing frequent nocturnal arousals, dyspnea, orthopnea, overuse of inhaled sympathomimetics and heightened anxiety leads to insomnia? Or is it that insomnia – possibly in a cluster with other affective disorders such as depression, anxiety disorders, or PTSD – elicits more frequent or more severe symptoms of shortness of breath in those with smoking-induced airway and parenchymal lung disease, making the latter diagnosis more overt than in others?

“My bet is on a bidirectional causal relationship,” said Dr. Ioachimescu, an editorial board advisor of CHEST Physician.

“Regardless of the etiology [of insomnia in veterans with COPD],” Dr. Luyster said, “it’s important that [insomnia] be addressed and treated appropriately, whether that be through pharmacological treatment, or probably more ideally through [cognitive behavioral therapy] for insomnia.”

The study did not control for COPD severity, she said, because of the difficulty of extracting this data from the VA Corporate Data Warehouse. The study was funded by the VA Competitive Career Development Fund.Dr. Luyster reported that she had no disclosures. Dr. Ioachimescu also said he had no relevant disclosures.
 

Insomnia is “highly prevalent” in veterans with chronic pulmonary obstructive disease and is significantly associated with greater COPD-related health care utilization, according to an analysis of national Veterans Health Administration data.

“The study highlights the importance of exploring potential sleep disturbances and disorders in this population and suggests that a targeted treatment for insomnia may help to improve COPD outcomes in veterans with COPD and insomnia,” said Faith Luyster, PhD, assistant professor at the University of Pittsburgh, in an interview after the virtual annual meeting of the Associated Professional Sleep Societies, where she presented the findings.

Dr. Luyster and coinvestigators used an administrative database from the Veterans Affairs Corporate Data Warehouse to identify more than 1.5 million patients with COPD who used VHA services over a 6-year period (fiscal years 2011-2017). Insomnia was defined by ICD-9/10 diagnostic codes and/or a sedative-hypnotic prescription for at least 30 doses during any of these years.

Insomnia with COPD was prevalent in this sample of veterans at 37.3%. Compared with veterans without comorbid insomnia, those who had both COPD and insomnia (575,539 of the total 1,542,642) were older (69 vs. 64 years), more likely to be female (6.3% vs. 3.7%), more likely to be Black (14% vs. 11%) and more likely to be a current smoker (46.1% vs. 35.5%).

Those with both COPD and insomnia were also more likely to have a service-connected disability rating of 50% of greater; use supplemental oxygen; be divorced, widowed, or separated; have a higher body mass index; or have other medical or psychiatric conditions – in particular obstructive sleep apnea (39% vs. 7%), depression (21% vs. 5%), and PTSD (33% vs. 3%).

P values were < .001 for all of these demographic and clinical variables, Dr. Luyster reported at the meeting.

Comorbid insomnia clearly impacted health care utilization, she said. Veterans with insomnia in addition to COPD had more outpatient and ED visits (10.5 vs 6.9, and 1.6 vs. 1.4, respectively) and more hospitalizations (2.2 vs. 1.8) with a primary diagnostic code for COPD or COPD exacerbation (P < .001).

A negative binomial regression analysis (P < .001) showed that “even after controlling for demographic and other medical conditions, COPD patients with insomnia had greater rates of health care utilization relative to COPD patients without insomnia,” Dr. Luyster said in the interview.

Prior studies have suggested that disturbed sleep is a predictor of poorer longitudinal outcomes in COPD, even after controlling for COPD severity, but have not looked specifically at insomnia, she said.

Commenting on the study Octavian C. Ioachimescu, MD, PhD, of Emory University, Atlanta, and the Atlanta VA Medical Center in Decatur, said the criteria used to define insomnia – unadjudicated ICD diagnoses as well as sedative-hypnotic prescriptions – may explain part of the reported prevalence of insomnia. Even so, the findings add to existing literature demonstrating that COPD and insomnia are both common disorders among VHA patients, and that their frequent coexistence “could have adverse consequences on the overall health, functional status, long-term outcomes, and quality of life of these patients.”

Questions of causation are yet to be answered, he said. “Is it that uncontrolled or severe airflow obstruction causing frequent nocturnal arousals, dyspnea, orthopnea, overuse of inhaled sympathomimetics and heightened anxiety leads to insomnia? Or is it that insomnia – possibly in a cluster with other affective disorders such as depression, anxiety disorders, or PTSD – elicits more frequent or more severe symptoms of shortness of breath in those with smoking-induced airway and parenchymal lung disease, making the latter diagnosis more overt than in others?

“My bet is on a bidirectional causal relationship,” said Dr. Ioachimescu, an editorial board advisor of CHEST Physician.

“Regardless of the etiology [of insomnia in veterans with COPD],” Dr. Luyster said, “it’s important that [insomnia] be addressed and treated appropriately, whether that be through pharmacological treatment, or probably more ideally through [cognitive behavioral therapy] for insomnia.”

The study did not control for COPD severity, she said, because of the difficulty of extracting this data from the VA Corporate Data Warehouse. The study was funded by the VA Competitive Career Development Fund.Dr. Luyster reported that she had no disclosures. Dr. Ioachimescu also said he had no relevant disclosures.
 

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.
 

[email protected]

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.
 

[email protected]

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.
 

[email protected]

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.

[email protected]

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.

[email protected]

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.

[email protected]

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.