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Know the 15% rule in scleroderma
MAUI, HAWAII – The 15% rule in scleroderma is a handy tool that raises awareness of the disease’s associated prevalence of various severe organ complications so clinicians can screen appropriately, Janet Pope, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Dr. Pope and colleagues in the Canadian Scleroderma Research Group developed the 15% rule because they recognized that scleroderma is rare enough that most physicians practicing outside of a few specialized centers don’t see many affected patients. The systemic autoimmune disease is marked by numerous possible expressions of vascular inflammation and malfunction, fibrosis, and autoimmunity in different organ systems.
“A lot of clinicians do not know how common this stuff is,” according to Dr. Pope, professor of medicine at the University of Western Ontario and head of the division of rheumatology at St. Joseph’s Health Center in London, Ont.
Basically, the 15% rule holds that, at any given time, a patient with scleroderma has roughly a 15% chance – or one in six – of having any of an extensive array of severe organ complications. That means a 15% chance of having prevalent clinically significant pulmonary hypertension as defined by a systolic pulmonary artery pressure of 45 mm Hg or more on Doppler echocardiography, a 15% likelihood of interstitial lung disease or clinically significant pulmonary fibrosis as suggested by a forced vital capacity less than 70% of predicted, a 15% prevalence of Sjögren’s syndrome, a 15% likelihood of having pulmonary artery hypertension upon right heart catheterization, a 15% chance of inflammatory arthritis, and a one-in-six chance of having a myopathy or myositis. Also, diastolic dysfunction, 15%. Ditto symptomatic arrhythmias.
“It’s a good little rule of thumb,” Dr. Pope commented.
The odds of having a current digital ulcer on any given day? Again, about 15%. In addition, scleroderma patients have a 15% lifetime risk of developing a complicated digital ulcer requiring hospitalization and/or amputation, she continued.
And while the prevalence of scleroderma renal crisis in the overall population with scleroderma is low, at 3%, in the subgroup with diffuse cutaneous systemic sclerosis, it climbs to 12%-15%.
Every rule has its exceptions. The 15% rule doesn’t apply to Raynaud’s phenomenon, which is present in nearly all patients with scleroderma, nor to gastroesophageal reflux disease or dysphagia, present in roughly 80% of patients.
Dr. Pope and coinvestigators developed the 15% rule pertaining to the prevalence of serious organ complications in scleroderma by conducting a systematic review of 69 published studies, each including a minimum of 50 scleroderma patients. The detailed results of the systematic review have been published.
Dr. Pope reported receiving research grants from and/or serving as a consultant to more than a dozen pharmaceutical companies.
MAUI, HAWAII – The 15% rule in scleroderma is a handy tool that raises awareness of the disease’s associated prevalence of various severe organ complications so clinicians can screen appropriately, Janet Pope, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Dr. Pope and colleagues in the Canadian Scleroderma Research Group developed the 15% rule because they recognized that scleroderma is rare enough that most physicians practicing outside of a few specialized centers don’t see many affected patients. The systemic autoimmune disease is marked by numerous possible expressions of vascular inflammation and malfunction, fibrosis, and autoimmunity in different organ systems.
“A lot of clinicians do not know how common this stuff is,” according to Dr. Pope, professor of medicine at the University of Western Ontario and head of the division of rheumatology at St. Joseph’s Health Center in London, Ont.
Basically, the 15% rule holds that, at any given time, a patient with scleroderma has roughly a 15% chance – or one in six – of having any of an extensive array of severe organ complications. That means a 15% chance of having prevalent clinically significant pulmonary hypertension as defined by a systolic pulmonary artery pressure of 45 mm Hg or more on Doppler echocardiography, a 15% likelihood of interstitial lung disease or clinically significant pulmonary fibrosis as suggested by a forced vital capacity less than 70% of predicted, a 15% prevalence of Sjögren’s syndrome, a 15% likelihood of having pulmonary artery hypertension upon right heart catheterization, a 15% chance of inflammatory arthritis, and a one-in-six chance of having a myopathy or myositis. Also, diastolic dysfunction, 15%. Ditto symptomatic arrhythmias.
“It’s a good little rule of thumb,” Dr. Pope commented.
The odds of having a current digital ulcer on any given day? Again, about 15%. In addition, scleroderma patients have a 15% lifetime risk of developing a complicated digital ulcer requiring hospitalization and/or amputation, she continued.
And while the prevalence of scleroderma renal crisis in the overall population with scleroderma is low, at 3%, in the subgroup with diffuse cutaneous systemic sclerosis, it climbs to 12%-15%.
Every rule has its exceptions. The 15% rule doesn’t apply to Raynaud’s phenomenon, which is present in nearly all patients with scleroderma, nor to gastroesophageal reflux disease or dysphagia, present in roughly 80% of patients.
Dr. Pope and coinvestigators developed the 15% rule pertaining to the prevalence of serious organ complications in scleroderma by conducting a systematic review of 69 published studies, each including a minimum of 50 scleroderma patients. The detailed results of the systematic review have been published.
Dr. Pope reported receiving research grants from and/or serving as a consultant to more than a dozen pharmaceutical companies.
MAUI, HAWAII – The 15% rule in scleroderma is a handy tool that raises awareness of the disease’s associated prevalence of various severe organ complications so clinicians can screen appropriately, Janet Pope, MD, said at the 2020 Rheumatology Winter Clinical Symposium.
Dr. Pope and colleagues in the Canadian Scleroderma Research Group developed the 15% rule because they recognized that scleroderma is rare enough that most physicians practicing outside of a few specialized centers don’t see many affected patients. The systemic autoimmune disease is marked by numerous possible expressions of vascular inflammation and malfunction, fibrosis, and autoimmunity in different organ systems.
“A lot of clinicians do not know how common this stuff is,” according to Dr. Pope, professor of medicine at the University of Western Ontario and head of the division of rheumatology at St. Joseph’s Health Center in London, Ont.
Basically, the 15% rule holds that, at any given time, a patient with scleroderma has roughly a 15% chance – or one in six – of having any of an extensive array of severe organ complications. That means a 15% chance of having prevalent clinically significant pulmonary hypertension as defined by a systolic pulmonary artery pressure of 45 mm Hg or more on Doppler echocardiography, a 15% likelihood of interstitial lung disease or clinically significant pulmonary fibrosis as suggested by a forced vital capacity less than 70% of predicted, a 15% prevalence of Sjögren’s syndrome, a 15% likelihood of having pulmonary artery hypertension upon right heart catheterization, a 15% chance of inflammatory arthritis, and a one-in-six chance of having a myopathy or myositis. Also, diastolic dysfunction, 15%. Ditto symptomatic arrhythmias.
“It’s a good little rule of thumb,” Dr. Pope commented.
The odds of having a current digital ulcer on any given day? Again, about 15%. In addition, scleroderma patients have a 15% lifetime risk of developing a complicated digital ulcer requiring hospitalization and/or amputation, she continued.
And while the prevalence of scleroderma renal crisis in the overall population with scleroderma is low, at 3%, in the subgroup with diffuse cutaneous systemic sclerosis, it climbs to 12%-15%.
Every rule has its exceptions. The 15% rule doesn’t apply to Raynaud’s phenomenon, which is present in nearly all patients with scleroderma, nor to gastroesophageal reflux disease or dysphagia, present in roughly 80% of patients.
Dr. Pope and coinvestigators developed the 15% rule pertaining to the prevalence of serious organ complications in scleroderma by conducting a systematic review of 69 published studies, each including a minimum of 50 scleroderma patients. The detailed results of the systematic review have been published.
Dr. Pope reported receiving research grants from and/or serving as a consultant to more than a dozen pharmaceutical companies.
REPORTING FROM RWCS 2020
Some infected patients could show COVID-19 symptoms after quarantine
Although a 14-day quarantine after exposure to novel coronavirus is “well supported” by evidence, some infected individuals will not become symptomatic until after that period, according to authors of a recent analysis published in Annals of Internal Medicine.
Most individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will develop symptoms by day 12 of the infection, which is within the 14-day period of active monitoring currently recommended by the Centers for Disease Control and Prevention, the authors wrote.
However, an estimated 101 out of 10,000 cases could become symptomatic after the end of that 14-day monitoring period, they cautioned.
“Our analyses do not preclude that estimate from being higher,” said the investigators, led by Stephen A. Lauer, PhD, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore.
The analysis, based on 181 confirmed cases of coronavirus disease 2019 (COVID-19) that were documented outside of the outbreak epicenter, Wuhan, China, makes “more conservative assumptions” about the window of symptom onset and potential for continued exposure, compared with analyses in previous studies, the researchers wrote.
The estimated incubation period for SARS-CoV-2 in the 181-patient study was a median of 5.1 days, which is comparable with previous estimates based on COVID-19 cases outside of Wuhan and consistent with other known human coronavirus diseases, such as SARS, which had a reported mean incubation period of 5 days, Dr. Lauer and colleagues noted.
Symptoms developed within 11.5 days for 97.5% of patients in the study.
Whether it’s acceptable to have 101 out of 10,000 cases becoming symptomatic beyond the recommended quarantine window depends on two factors, according to the authors. The first is the expected infection risk in the population that is being monitored, and the second is “judgment about the cost of missing cases,” wrote the authors.
In an interview, Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau, Oceanside, N.Y., said that in practical terms, the results suggest that the majority of patients with COVID-19 will be identified within 14 days, with an “outside chance” of an infected individual leaving quarantine and transmitting virus for a short period of time before becoming symptomatic.
“I think the proper message to give those patients [who are asymptomatic upon leaving quarantine] is, ‘after 14 days, we’re pretty sure you’re out of the woods, but should you get any symptoms, immediately requarantine yourself and seek medical care,” he said.
Study coauthor Kyra H. Grantz, a doctoral graduate student at the Johns Hopkins Bloomberg School of Public Health, said that extending a quarantine beyond 14 days might be considered in the highest-risk scenarios, though the benefits of doing so would have to be weighed against the costs to public health and to the individuals under quarantine.
“Our estimate of the incubation period definitely supports the 14-day recommendation that the CDC has been using,” she said in an interview.
Dr. Grantz emphasized that the estimate of 101 out of 10,000 cases developing symptoms after day 14 of active monitoring – representing the 99th percentile of cases – assumes the “most conservative, worst-case scenario” in a population that is fully infected.
“If you’re looking at a following a cohort of 1,000 people whom you think may have been exposed, only a certain percentage will be infected, and only a certain percentage of those will even develop symptoms – before we get to this idea of how many people would we miss,” she said.
The study was supported by the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the National Institute of General Medical Sciences, and the Alexander von Humboldt Foundation. Four authors reported disclosures related to those entities, and the remaining five reported no conflicts of interest.
SOURCE: Lauer SA et al. Ann Intern Med. 2020 Mar 9. doi:10.1101/2020.02.02.20020016.
Although a 14-day quarantine after exposure to novel coronavirus is “well supported” by evidence, some infected individuals will not become symptomatic until after that period, according to authors of a recent analysis published in Annals of Internal Medicine.
Most individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will develop symptoms by day 12 of the infection, which is within the 14-day period of active monitoring currently recommended by the Centers for Disease Control and Prevention, the authors wrote.
However, an estimated 101 out of 10,000 cases could become symptomatic after the end of that 14-day monitoring period, they cautioned.
“Our analyses do not preclude that estimate from being higher,” said the investigators, led by Stephen A. Lauer, PhD, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore.
The analysis, based on 181 confirmed cases of coronavirus disease 2019 (COVID-19) that were documented outside of the outbreak epicenter, Wuhan, China, makes “more conservative assumptions” about the window of symptom onset and potential for continued exposure, compared with analyses in previous studies, the researchers wrote.
The estimated incubation period for SARS-CoV-2 in the 181-patient study was a median of 5.1 days, which is comparable with previous estimates based on COVID-19 cases outside of Wuhan and consistent with other known human coronavirus diseases, such as SARS, which had a reported mean incubation period of 5 days, Dr. Lauer and colleagues noted.
Symptoms developed within 11.5 days for 97.5% of patients in the study.
Whether it’s acceptable to have 101 out of 10,000 cases becoming symptomatic beyond the recommended quarantine window depends on two factors, according to the authors. The first is the expected infection risk in the population that is being monitored, and the second is “judgment about the cost of missing cases,” wrote the authors.
In an interview, Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau, Oceanside, N.Y., said that in practical terms, the results suggest that the majority of patients with COVID-19 will be identified within 14 days, with an “outside chance” of an infected individual leaving quarantine and transmitting virus for a short period of time before becoming symptomatic.
“I think the proper message to give those patients [who are asymptomatic upon leaving quarantine] is, ‘after 14 days, we’re pretty sure you’re out of the woods, but should you get any symptoms, immediately requarantine yourself and seek medical care,” he said.
Study coauthor Kyra H. Grantz, a doctoral graduate student at the Johns Hopkins Bloomberg School of Public Health, said that extending a quarantine beyond 14 days might be considered in the highest-risk scenarios, though the benefits of doing so would have to be weighed against the costs to public health and to the individuals under quarantine.
“Our estimate of the incubation period definitely supports the 14-day recommendation that the CDC has been using,” she said in an interview.
Dr. Grantz emphasized that the estimate of 101 out of 10,000 cases developing symptoms after day 14 of active monitoring – representing the 99th percentile of cases – assumes the “most conservative, worst-case scenario” in a population that is fully infected.
“If you’re looking at a following a cohort of 1,000 people whom you think may have been exposed, only a certain percentage will be infected, and only a certain percentage of those will even develop symptoms – before we get to this idea of how many people would we miss,” she said.
The study was supported by the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the National Institute of General Medical Sciences, and the Alexander von Humboldt Foundation. Four authors reported disclosures related to those entities, and the remaining five reported no conflicts of interest.
SOURCE: Lauer SA et al. Ann Intern Med. 2020 Mar 9. doi:10.1101/2020.02.02.20020016.
Although a 14-day quarantine after exposure to novel coronavirus is “well supported” by evidence, some infected individuals will not become symptomatic until after that period, according to authors of a recent analysis published in Annals of Internal Medicine.
Most individuals infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will develop symptoms by day 12 of the infection, which is within the 14-day period of active monitoring currently recommended by the Centers for Disease Control and Prevention, the authors wrote.
However, an estimated 101 out of 10,000 cases could become symptomatic after the end of that 14-day monitoring period, they cautioned.
“Our analyses do not preclude that estimate from being higher,” said the investigators, led by Stephen A. Lauer, PhD, MD, of Johns Hopkins Bloomberg School of Public Health, Baltimore.
The analysis, based on 181 confirmed cases of coronavirus disease 2019 (COVID-19) that were documented outside of the outbreak epicenter, Wuhan, China, makes “more conservative assumptions” about the window of symptom onset and potential for continued exposure, compared with analyses in previous studies, the researchers wrote.
The estimated incubation period for SARS-CoV-2 in the 181-patient study was a median of 5.1 days, which is comparable with previous estimates based on COVID-19 cases outside of Wuhan and consistent with other known human coronavirus diseases, such as SARS, which had a reported mean incubation period of 5 days, Dr. Lauer and colleagues noted.
Symptoms developed within 11.5 days for 97.5% of patients in the study.
Whether it’s acceptable to have 101 out of 10,000 cases becoming symptomatic beyond the recommended quarantine window depends on two factors, according to the authors. The first is the expected infection risk in the population that is being monitored, and the second is “judgment about the cost of missing cases,” wrote the authors.
In an interview, Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau, Oceanside, N.Y., said that in practical terms, the results suggest that the majority of patients with COVID-19 will be identified within 14 days, with an “outside chance” of an infected individual leaving quarantine and transmitting virus for a short period of time before becoming symptomatic.
“I think the proper message to give those patients [who are asymptomatic upon leaving quarantine] is, ‘after 14 days, we’re pretty sure you’re out of the woods, but should you get any symptoms, immediately requarantine yourself and seek medical care,” he said.
Study coauthor Kyra H. Grantz, a doctoral graduate student at the Johns Hopkins Bloomberg School of Public Health, said that extending a quarantine beyond 14 days might be considered in the highest-risk scenarios, though the benefits of doing so would have to be weighed against the costs to public health and to the individuals under quarantine.
“Our estimate of the incubation period definitely supports the 14-day recommendation that the CDC has been using,” she said in an interview.
Dr. Grantz emphasized that the estimate of 101 out of 10,000 cases developing symptoms after day 14 of active monitoring – representing the 99th percentile of cases – assumes the “most conservative, worst-case scenario” in a population that is fully infected.
“If you’re looking at a following a cohort of 1,000 people whom you think may have been exposed, only a certain percentage will be infected, and only a certain percentage of those will even develop symptoms – before we get to this idea of how many people would we miss,” she said.
The study was supported by the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the National Institute of General Medical Sciences, and the Alexander von Humboldt Foundation. Four authors reported disclosures related to those entities, and the remaining five reported no conflicts of interest.
SOURCE: Lauer SA et al. Ann Intern Med. 2020 Mar 9. doi:10.1101/2020.02.02.20020016.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Some individuals who are infected with the novel coronavirus could become symptomatic after the active 14-day quarantine period.
Major finding: The median incubation period was 5.1 days, with 97.5% of patients developing symptoms within 11.5 days, implying that 101 of every 10,000 cases (99th percentile) would develop symptoms beyond the quarantine period.
Study details: Analysis of 181 confirmed COVID-19 cases identified outside of the outbreak epicenter, Wuhan, China.
Disclosures: The study was supported by the U.S. Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Diseases, the National Institute of General Medical Sciences, and the Alexander von Humboldt Foundation. Four authors reported disclosures related to those entities, and the remaining five reported no conflicts of interest.
Source: Lauer SA et al. Ann Intern Med. 2020 Mar 9. doi: 10.1101/2020.02.02.20020016.
New RA diagnosis prompts patients to quit smoking
Health care factors, such as type of health system and being newly diagnosed, rather than patient socioeconomic factors, were significant predictors of smoking cessation in patients with RA, according to findings published in Arthritis Care & Research.
Smoking is a known risk factor for poor outcomes in RA, but data on factors that predict smoking cessation in these patients are limited, wrote Maria Schletzbaum, a student in the MD-PhD program at the University of Wisconsin–Madison, and colleagues. “Further, most patients with RA are not aware of the associations between smoking and RA development and complications, although such knowledge could influence cessation attempts.”
To identify predictors of smoking cessation, the investigators reviewed the 2005-2016 electronic medical records for 3,577 adults aged 18 years or older and with at least two RA diagnosis codes. The records were from two health systems, one urban and one rural.
Overall, patients who were baseline smokers and who were new to rheumatology care were 60% more likely to quit smoking (adjusted odds ratio, 1.60). However, patients who were seropositive and baseline smokers were 43% less likely to quit (aOR, 0.57). Demographic factors, including age, race, and sex, were not significantly associated with smoking cessation.
“The observed increased likelihood of quitting in patients new to rheumatology care may partially be due to cessation following a new RA diagnosis, a phenomenon previously reported in RA and other chronic diseases,” the researchers noted. Notably, the significance of being new to rheumatology disappeared in an analysis controlling for health system, “potentially suggesting greater importance of system-level factors versus individual patient factors.”
In addition, patients in the rural community health system were 66% more likely to quit smoking, possibly because about half of the patients in that system were covered by the systems’ insurance, and therefore qualified for various smoking cessation interventions, they wrote.
The study population included 915 former smokers and 507 current smokers. Seropositivity was most common in current smokers (71%), followed by former smokers (64%) and never smokers (59%). The disinclination of seropositive patients to quit smoking may reflect greater smoking intensity, and these patients may need greater support, the researchers wrote.
The study findings were limited by several factors; for example, some differences in patient populations, such as education and income levels, were not measured, and there was a lack of complete information on cumulative smoking exposure. However, the results were strengthened by the large sample size and use of data from two centers and support national guidelines for health system interventions in smoking cessation for RA patients, they noted.
The study was funded in part by the Rheumatology Research Foundation, the University of Wisconsin Medical Scientist Training Program, and the University of Wisconsin Clinical and Translational Science Award. The authors did not report any financial conflicts of interest.
SOURCE: Schletzbaum M et al. Arthritis Car Res. 2020 Mar 3. doi: 10.1002/ACR.24154.
Health care factors, such as type of health system and being newly diagnosed, rather than patient socioeconomic factors, were significant predictors of smoking cessation in patients with RA, according to findings published in Arthritis Care & Research.
Smoking is a known risk factor for poor outcomes in RA, but data on factors that predict smoking cessation in these patients are limited, wrote Maria Schletzbaum, a student in the MD-PhD program at the University of Wisconsin–Madison, and colleagues. “Further, most patients with RA are not aware of the associations between smoking and RA development and complications, although such knowledge could influence cessation attempts.”
To identify predictors of smoking cessation, the investigators reviewed the 2005-2016 electronic medical records for 3,577 adults aged 18 years or older and with at least two RA diagnosis codes. The records were from two health systems, one urban and one rural.
Overall, patients who were baseline smokers and who were new to rheumatology care were 60% more likely to quit smoking (adjusted odds ratio, 1.60). However, patients who were seropositive and baseline smokers were 43% less likely to quit (aOR, 0.57). Demographic factors, including age, race, and sex, were not significantly associated with smoking cessation.
“The observed increased likelihood of quitting in patients new to rheumatology care may partially be due to cessation following a new RA diagnosis, a phenomenon previously reported in RA and other chronic diseases,” the researchers noted. Notably, the significance of being new to rheumatology disappeared in an analysis controlling for health system, “potentially suggesting greater importance of system-level factors versus individual patient factors.”
In addition, patients in the rural community health system were 66% more likely to quit smoking, possibly because about half of the patients in that system were covered by the systems’ insurance, and therefore qualified for various smoking cessation interventions, they wrote.
The study population included 915 former smokers and 507 current smokers. Seropositivity was most common in current smokers (71%), followed by former smokers (64%) and never smokers (59%). The disinclination of seropositive patients to quit smoking may reflect greater smoking intensity, and these patients may need greater support, the researchers wrote.
The study findings were limited by several factors; for example, some differences in patient populations, such as education and income levels, were not measured, and there was a lack of complete information on cumulative smoking exposure. However, the results were strengthened by the large sample size and use of data from two centers and support national guidelines for health system interventions in smoking cessation for RA patients, they noted.
The study was funded in part by the Rheumatology Research Foundation, the University of Wisconsin Medical Scientist Training Program, and the University of Wisconsin Clinical and Translational Science Award. The authors did not report any financial conflicts of interest.
SOURCE: Schletzbaum M et al. Arthritis Car Res. 2020 Mar 3. doi: 10.1002/ACR.24154.
Health care factors, such as type of health system and being newly diagnosed, rather than patient socioeconomic factors, were significant predictors of smoking cessation in patients with RA, according to findings published in Arthritis Care & Research.
Smoking is a known risk factor for poor outcomes in RA, but data on factors that predict smoking cessation in these patients are limited, wrote Maria Schletzbaum, a student in the MD-PhD program at the University of Wisconsin–Madison, and colleagues. “Further, most patients with RA are not aware of the associations between smoking and RA development and complications, although such knowledge could influence cessation attempts.”
To identify predictors of smoking cessation, the investigators reviewed the 2005-2016 electronic medical records for 3,577 adults aged 18 years or older and with at least two RA diagnosis codes. The records were from two health systems, one urban and one rural.
Overall, patients who were baseline smokers and who were new to rheumatology care were 60% more likely to quit smoking (adjusted odds ratio, 1.60). However, patients who were seropositive and baseline smokers were 43% less likely to quit (aOR, 0.57). Demographic factors, including age, race, and sex, were not significantly associated with smoking cessation.
“The observed increased likelihood of quitting in patients new to rheumatology care may partially be due to cessation following a new RA diagnosis, a phenomenon previously reported in RA and other chronic diseases,” the researchers noted. Notably, the significance of being new to rheumatology disappeared in an analysis controlling for health system, “potentially suggesting greater importance of system-level factors versus individual patient factors.”
In addition, patients in the rural community health system were 66% more likely to quit smoking, possibly because about half of the patients in that system were covered by the systems’ insurance, and therefore qualified for various smoking cessation interventions, they wrote.
The study population included 915 former smokers and 507 current smokers. Seropositivity was most common in current smokers (71%), followed by former smokers (64%) and never smokers (59%). The disinclination of seropositive patients to quit smoking may reflect greater smoking intensity, and these patients may need greater support, the researchers wrote.
The study findings were limited by several factors; for example, some differences in patient populations, such as education and income levels, were not measured, and there was a lack of complete information on cumulative smoking exposure. However, the results were strengthened by the large sample size and use of data from two centers and support national guidelines for health system interventions in smoking cessation for RA patients, they noted.
The study was funded in part by the Rheumatology Research Foundation, the University of Wisconsin Medical Scientist Training Program, and the University of Wisconsin Clinical and Translational Science Award. The authors did not report any financial conflicts of interest.
SOURCE: Schletzbaum M et al. Arthritis Car Res. 2020 Mar 3. doi: 10.1002/ACR.24154.
FROM ARTHRITIS CARE & RESEARCH
Flu activity declines again but remains high
Outpatient visits to health care providers for influenza-like illness dropped from 5.5% the previous week to 5.3% of all visits for the week ending Feb. 29, the Centers for Disease Control and Prevention said on March 6.
The national baseline rate of 2.4% was first reached during the week of Nov. 9, 2019 – marking the start of flu season – and has remained at or above that level for 17 consecutive weeks. Last year’s season, which also was the longest in a decade, lasted 21 consecutive weeks but started 2 weeks later than the current season and had a lower outpatient-visit rate (4.5%) for the last week of February, CDC data show.
This season’s earlier start could mean that even a somewhat steep decline in visits to below the baseline rate – marking the end of the season – might take 5 or 6 weeks and would make 2019-2020 even longer than 2018-2019.
The activity situation on the state level reflects the small national decline. For the week ending Feb. 29, there were 33 states at level 10 on the CDC’s 1-10 activity scale, compared with 37 the week before, and a total of 40 in the “high” range of 8-10, compared with 43 the week before, the CDC’s influenza division reported.
The other main measure of influenza activity, percentage of respiratory specimens testing positive, also declined for the third week in a row and is now at 24.3% after reaching a high of 30.3% during the week of Feb. 2-8, the influenza division said.
The overall cumulative hospitalization rate continues to remain at a fairly typical 57.9 per 100,000 population, but rates for school-aged children (84.9 per 100,000) and young adults (31.2 per 100,000) are among the highest ever recorded at this point in the season. Mortality among children – now at 136 for 2019-2020 – is higher than for any season since reporting began in 2004, with the exception of the 2009 pandemic, the CDC said.
Outpatient visits to health care providers for influenza-like illness dropped from 5.5% the previous week to 5.3% of all visits for the week ending Feb. 29, the Centers for Disease Control and Prevention said on March 6.
The national baseline rate of 2.4% was first reached during the week of Nov. 9, 2019 – marking the start of flu season – and has remained at or above that level for 17 consecutive weeks. Last year’s season, which also was the longest in a decade, lasted 21 consecutive weeks but started 2 weeks later than the current season and had a lower outpatient-visit rate (4.5%) for the last week of February, CDC data show.
This season’s earlier start could mean that even a somewhat steep decline in visits to below the baseline rate – marking the end of the season – might take 5 or 6 weeks and would make 2019-2020 even longer than 2018-2019.
The activity situation on the state level reflects the small national decline. For the week ending Feb. 29, there were 33 states at level 10 on the CDC’s 1-10 activity scale, compared with 37 the week before, and a total of 40 in the “high” range of 8-10, compared with 43 the week before, the CDC’s influenza division reported.
The other main measure of influenza activity, percentage of respiratory specimens testing positive, also declined for the third week in a row and is now at 24.3% after reaching a high of 30.3% during the week of Feb. 2-8, the influenza division said.
The overall cumulative hospitalization rate continues to remain at a fairly typical 57.9 per 100,000 population, but rates for school-aged children (84.9 per 100,000) and young adults (31.2 per 100,000) are among the highest ever recorded at this point in the season. Mortality among children – now at 136 for 2019-2020 – is higher than for any season since reporting began in 2004, with the exception of the 2009 pandemic, the CDC said.
Outpatient visits to health care providers for influenza-like illness dropped from 5.5% the previous week to 5.3% of all visits for the week ending Feb. 29, the Centers for Disease Control and Prevention said on March 6.
The national baseline rate of 2.4% was first reached during the week of Nov. 9, 2019 – marking the start of flu season – and has remained at or above that level for 17 consecutive weeks. Last year’s season, which also was the longest in a decade, lasted 21 consecutive weeks but started 2 weeks later than the current season and had a lower outpatient-visit rate (4.5%) for the last week of February, CDC data show.
This season’s earlier start could mean that even a somewhat steep decline in visits to below the baseline rate – marking the end of the season – might take 5 or 6 weeks and would make 2019-2020 even longer than 2018-2019.
The activity situation on the state level reflects the small national decline. For the week ending Feb. 29, there were 33 states at level 10 on the CDC’s 1-10 activity scale, compared with 37 the week before, and a total of 40 in the “high” range of 8-10, compared with 43 the week before, the CDC’s influenza division reported.
The other main measure of influenza activity, percentage of respiratory specimens testing positive, also declined for the third week in a row and is now at 24.3% after reaching a high of 30.3% during the week of Feb. 2-8, the influenza division said.
The overall cumulative hospitalization rate continues to remain at a fairly typical 57.9 per 100,000 population, but rates for school-aged children (84.9 per 100,000) and young adults (31.2 per 100,000) are among the highest ever recorded at this point in the season. Mortality among children – now at 136 for 2019-2020 – is higher than for any season since reporting began in 2004, with the exception of the 2009 pandemic, the CDC said.
Novel coronavirus may cause environmental contamination through fecal shedding
The toilet bowl, sink, and bathroom door handle of an isolation room housing a patient with the novel coronavirus tested positive for the virus, raising the possibility that viral shedding in the stool could represent another route of transmission, investigators reported.
Air outlet fans and other room sites also tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), though an anteroom, a corridor, and most personal protective equipment (PPE) worn by health care providers tested negative, according to the researchers, led by Sean Wei Xiang Ong, MBBS, of the National Centre for Infectious Diseases, Singapore.
Taken together, these findings suggest a “need for strict adherence to environmental and hand hygiene” to combat significant environmental contamination through respiratory droplets and fecal shedding, Dr. Ong and colleagues wrote in JAMA.
Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau in New York, said these results demonstrate that SARS-CoV-2 is “clearly capable” of contaminating bathroom sinks and toilets.
“That wouldn’t have been the first place I would have thought of, before this study,” he said in an interview. “You need to pay attention to cleaning the bathrooms, which we obviously do, but that’s an important reminder.”
The report by Dr. Ong and coauthors included a total of three patients housed in airborne infection isolation rooms in a dedicated SARS-CoV-2 outbreak center in Singapore. For each patient, surface samples were taken from 26 sites in the isolation room, an anteroom, and a bathroom. Samples were also taken from PPE on physicians as they left the patient rooms.
Samples for the first patient, taken right after routine cleaning, were all negative, according to researchers. That room was sampled twice, on days 4 and 10 of the illness, while the patient was still symptomatic. Likewise, for the second patient, postcleaning samples were negative; those samples were taken 2 days after cleaning.
However, for the third patient, samples were taken before routine cleaning. In this case, Dr. Ong and colleagues said 13 of 15 room sites (87%) were positive, including air outlet fans, while 3 of 5 toilet sites (60%) were positive as well, though no contamination was found in the anteroom, corridor, or in air samples.
That patient had two stool samples that were positive for SARS-CoV-2, but no diarrhea, authors said, and had upper respiratory tract involvement without pneumonia.
The fact that swabs of the air exhaust outlets tested positive suggests that virus-laden droplets could be “displaced by airflows” and end up on vents or other equipment, Dr. Ong and coauthors reported.
All PPE samples tested negative, except for the front of one shoe.
“The risk of transmission from contaminated footwear is likely low, as evidenced by negative results in the anteroom and corridor,” they wrote.
While this study included only a small number of patients, Dr. Glatt said the findings represent an important and useful contribution to the literature on coronavirus disease 2019 (COVID-19).
“Every day we’re getting more information, and each little piece of the puzzle helps us in the overall management of individuals with COVID-19,” he said in the interview. “They’re adding to our ability to manage, control, and mitigate further spread of the disease.”
Funding for the study came from the National Medical Research Council in Singapore and DSO National Laboratories. Dr. Ong and colleagues reported no conflicts of interest.
SOURCE: Ong SWX et al. JAMA. 2020 Mar 4. doi: 10.1001/jama.2020.3227.
The toilet bowl, sink, and bathroom door handle of an isolation room housing a patient with the novel coronavirus tested positive for the virus, raising the possibility that viral shedding in the stool could represent another route of transmission, investigators reported.
Air outlet fans and other room sites also tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), though an anteroom, a corridor, and most personal protective equipment (PPE) worn by health care providers tested negative, according to the researchers, led by Sean Wei Xiang Ong, MBBS, of the National Centre for Infectious Diseases, Singapore.
Taken together, these findings suggest a “need for strict adherence to environmental and hand hygiene” to combat significant environmental contamination through respiratory droplets and fecal shedding, Dr. Ong and colleagues wrote in JAMA.
Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau in New York, said these results demonstrate that SARS-CoV-2 is “clearly capable” of contaminating bathroom sinks and toilets.
“That wouldn’t have been the first place I would have thought of, before this study,” he said in an interview. “You need to pay attention to cleaning the bathrooms, which we obviously do, but that’s an important reminder.”
The report by Dr. Ong and coauthors included a total of three patients housed in airborne infection isolation rooms in a dedicated SARS-CoV-2 outbreak center in Singapore. For each patient, surface samples were taken from 26 sites in the isolation room, an anteroom, and a bathroom. Samples were also taken from PPE on physicians as they left the patient rooms.
Samples for the first patient, taken right after routine cleaning, were all negative, according to researchers. That room was sampled twice, on days 4 and 10 of the illness, while the patient was still symptomatic. Likewise, for the second patient, postcleaning samples were negative; those samples were taken 2 days after cleaning.
However, for the third patient, samples were taken before routine cleaning. In this case, Dr. Ong and colleagues said 13 of 15 room sites (87%) were positive, including air outlet fans, while 3 of 5 toilet sites (60%) were positive as well, though no contamination was found in the anteroom, corridor, or in air samples.
That patient had two stool samples that were positive for SARS-CoV-2, but no diarrhea, authors said, and had upper respiratory tract involvement without pneumonia.
The fact that swabs of the air exhaust outlets tested positive suggests that virus-laden droplets could be “displaced by airflows” and end up on vents or other equipment, Dr. Ong and coauthors reported.
All PPE samples tested negative, except for the front of one shoe.
“The risk of transmission from contaminated footwear is likely low, as evidenced by negative results in the anteroom and corridor,” they wrote.
While this study included only a small number of patients, Dr. Glatt said the findings represent an important and useful contribution to the literature on coronavirus disease 2019 (COVID-19).
“Every day we’re getting more information, and each little piece of the puzzle helps us in the overall management of individuals with COVID-19,” he said in the interview. “They’re adding to our ability to manage, control, and mitigate further spread of the disease.”
Funding for the study came from the National Medical Research Council in Singapore and DSO National Laboratories. Dr. Ong and colleagues reported no conflicts of interest.
SOURCE: Ong SWX et al. JAMA. 2020 Mar 4. doi: 10.1001/jama.2020.3227.
The toilet bowl, sink, and bathroom door handle of an isolation room housing a patient with the novel coronavirus tested positive for the virus, raising the possibility that viral shedding in the stool could represent another route of transmission, investigators reported.
Air outlet fans and other room sites also tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), though an anteroom, a corridor, and most personal protective equipment (PPE) worn by health care providers tested negative, according to the researchers, led by Sean Wei Xiang Ong, MBBS, of the National Centre for Infectious Diseases, Singapore.
Taken together, these findings suggest a “need for strict adherence to environmental and hand hygiene” to combat significant environmental contamination through respiratory droplets and fecal shedding, Dr. Ong and colleagues wrote in JAMA.
Aaron Eli Glatt, MD, chair of medicine at Mount Sinai South Nassau in New York, said these results demonstrate that SARS-CoV-2 is “clearly capable” of contaminating bathroom sinks and toilets.
“That wouldn’t have been the first place I would have thought of, before this study,” he said in an interview. “You need to pay attention to cleaning the bathrooms, which we obviously do, but that’s an important reminder.”
The report by Dr. Ong and coauthors included a total of three patients housed in airborne infection isolation rooms in a dedicated SARS-CoV-2 outbreak center in Singapore. For each patient, surface samples were taken from 26 sites in the isolation room, an anteroom, and a bathroom. Samples were also taken from PPE on physicians as they left the patient rooms.
Samples for the first patient, taken right after routine cleaning, were all negative, according to researchers. That room was sampled twice, on days 4 and 10 of the illness, while the patient was still symptomatic. Likewise, for the second patient, postcleaning samples were negative; those samples were taken 2 days after cleaning.
However, for the third patient, samples were taken before routine cleaning. In this case, Dr. Ong and colleagues said 13 of 15 room sites (87%) were positive, including air outlet fans, while 3 of 5 toilet sites (60%) were positive as well, though no contamination was found in the anteroom, corridor, or in air samples.
That patient had two stool samples that were positive for SARS-CoV-2, but no diarrhea, authors said, and had upper respiratory tract involvement without pneumonia.
The fact that swabs of the air exhaust outlets tested positive suggests that virus-laden droplets could be “displaced by airflows” and end up on vents or other equipment, Dr. Ong and coauthors reported.
All PPE samples tested negative, except for the front of one shoe.
“The risk of transmission from contaminated footwear is likely low, as evidenced by negative results in the anteroom and corridor,” they wrote.
While this study included only a small number of patients, Dr. Glatt said the findings represent an important and useful contribution to the literature on coronavirus disease 2019 (COVID-19).
“Every day we’re getting more information, and each little piece of the puzzle helps us in the overall management of individuals with COVID-19,” he said in the interview. “They’re adding to our ability to manage, control, and mitigate further spread of the disease.”
Funding for the study came from the National Medical Research Council in Singapore and DSO National Laboratories. Dr. Ong and colleagues reported no conflicts of interest.
SOURCE: Ong SWX et al. JAMA. 2020 Mar 4. doi: 10.1001/jama.2020.3227.
FROM JAMA
COVID-19 and public health preparedness in the United States
Background
On Dec. 31, 2019, the Chinese city of Wuhan reported an outbreak of pneumonia from an unknown cause. The outbreak was found to be linked to the Hunan seafood market because of a shared history of exposure by many patients. After a full-scale investigation, China’s Center for Disease Control activated a level 2 emergency response on Jan. 4, 2020. A novel coronavirus was officially identified as a causative pathogen for the outbreak.1
Coronavirus, first discovered in the 1960s, is a respiratory RNA virus, most commonly associated with the “common cold.” However, we have had two highly pathogenic forms of coronavirus that originated from animal reservoirs, leading to global epidemics. This includes SARS-CoV in 2002-2004 and MERS-CoV in 2012 with more than 10,000 combined cases. The primary host has been bats, but mammals like camels, cattle, cats, and palm civets have been intermediate hosts in previous epidemics.2
The International Committee on Taxonomy of Viruses named the 2019-nCoV officially as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the coronavirus disease, COVID-19, on Feb. 11, 2020.3 Currently, the presentation includes fever, cough, trouble breathing, fatigue, and, rarely, watery diarrhea. More severe presentations include respiratory failure and death. Based on the incubation period of illness for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) coronaviruses, as well as observational data from reports of travel-related COVID-19, CDC estimates that symptoms of COVID-19 occur within 2-14 days after exposure. Asymptomatic transmission is also documented in some cases.4
On Jan. 13, the first case of COVID-19 outside of China was identified in Thailand. On Jan. 21, the first case of COVID-19 was identified in the United States. On Jan. 23, Chinese authorities suspended travel in and out of Wuhan, followed by other cities in the Hubei Province, leading to a quarantine of 50 million people. By Jan. 30, the World Health Organization had identified COVID-19 as the highest level of an epidemic alert referred to as a PHEIC: Public Health Emergency of International Concern. On Feb. 2, the first death outside China from coronavirus was reported in the Philippines. As of March 4 there have been 95,000 confirmed cases and 3,246 deaths globally. Within China, there have been 80,200 cases with 2,981 deaths.5
Cases have now been diagnosed in increasing numbers in Italy, Japan, South Korea, Iran, and 76 countries. Of note, the fatalities were of patients already in critical condition, who were typically older (more than 60 years old, especially more than 80) and immunocompromised with comorbid conditions (cardiovascular disease, diabetes, chronic respiratory disease, cancer).6 To put this in perspective, since 2010, CDC reports 140,000-810,000 hospitalizations and 12,000-61,000 deaths from the influenza virus annually in the US.7
The current situation in the United States
In the United States, as of March 4, 2020, there are currently 152 confirmed cases in 16 states. The first U.S. case of coronavirus without any of the travel-related and exposure risk factors was identified on Feb. 27 in California, indicating the first instance of community spread.8 The first death was reported in Washington state on Feb. 28, after which the state’s governor declared a state of emergency.9 On March 1, Washington state health officials investigated an outbreak of coronavirus at a long-term nursing facility in which two people tested positive for the disease, heralding the probable first nosocomial transmission of the virus in the United States. Since then, there have been 10 deaths in Washington state related to the coronavirus.
Current interventions in the United States
The U.S. Centers for Disease Control and Prevention is leading a multiagency effort to combat the COVID-19 potential pandemic. A Feb. 24 report in Morbidity and Mortality Weekly Report revealed that 1,336 CDC staff members have been involved in the COVID-19 response.10 CDC staff members have been deployed to 39 locations in the United States and internationally. CDC staff members are working with state and local health departments and other public health authorities to assist with case identification, contact tracing, evaluation of persons under investigation (PUI) for COVID-19, and medical management of cases, as well as with research and academic institutions to understand the virulence, risk for transmission, and other characteristics of this novel virus. The CDC is also working with other agencies of the U.S. government including the U.S. Department of Defense, Department of Health & Human Services and the U.S. Department of State to safely evacuate U.S. citizens, residents, and their families from international locations with high incidence and transmission of COVID-19.
Specific real-time updated guidance has been developed and posted online for health care settings for patient management, infection control and prevention, laboratory testing, environmental cleaning, worker safety, and international travel. The CDC has developed communications materials in English and Spanish for communities and guidance for health care settings, public health, laboratories, schools, and businesses to prepare for a potential pandemic. Travel advisories to countries affected by the epidemic are regularly updated to inform travelers and clinicians about current health issues that need to be considered before travel.11 A level 3 travel notice (avoid all nonessential travel) for China has been in effect since Jan. 27, and on Feb. 29 this was upgraded to a level 4 travel notice.12 Airport screening has been implemented in the 11 U.S. international airports to which flights from China have been diverted, and a total of 46,016 air travelers had been screened by Feb. 23. Incoming passengers are screened for fever, cough, and shortness of breath.
Currently, the CDC has a comprehensive algorithm for further investigation of a PUI – fever, cough, shortness of breath, and a history of travel to areas with increased coronavirus circulation within 14 days of onset of symptoms, OR a close household contact of a confirmed case. When there is a PUI, the current protocol indicates health care providers should alert a local or state health department official. After the health department completes a case investigation, the CDC will help transport specimens (upper respiratory and lower respiratory specimens, and sometimes stool or urine) as soon as possible to the centralized lab for polymerase chain reaction (PCR) testing.13 CDC laboratories are currently using real-time reverse transcription–PCR (RT-PCR). The CDC is also developing a serologic test to assist with surveillance for SARS-CoV-2 circulation in the U.S. population. There is also a safe repository of viral isolates set up to help with sharing of isolates with academic institutions for research purposes.14
At hospitals and outpatient offices in the United States, we are preparing for potential cases by reminding frontline health care workers to routinely ask about travel history in addition to relevant symptoms. By eliciting the history early, they should be able to identify and isolate PUIs, appropriately minimizing exposure. Some facilities are displaying signage in waiting rooms to alert patients to provide relevant history, helping to improve triage. COVID-19 symptoms are like those of influenza (e.g., fever, cough, and shortness of breath), and the current outbreak is occurring during a time of year when respiratory illnesses from influenza and other viruses are highly prevalent. To prevent influenza and possible unnecessary evaluation for COVID-19, all persons aged 6 months and older are strongly encouraged to receive an annual influenza vaccine.
To decrease the risk for respiratory disease, persons can practice recommended preventive measures. Persons ill with symptoms of COVID-19 who have had contact with a person with COVID-19, or recent travel to countries with apparent community spread, should proactively communicate with their health care provider before showing up at the health care facility to help make arrangements to prevent possible transmission in the health care setting. In a medical emergency, they should inform emergency medical personnel about possible COVID-19 exposure. If found positive, the current recommendation is to place patients on airborne isolation. N95 masks are being recommended for health care professionals. Hospitals are reinforcing effective infection control procedures, updating pandemic preparedness protocols, and ensuring adequate supplies in the case of an enormous influx of patients.15
Challenges and opportunities
Many challenges present in the process of getting prepared for a potential outbreak. Personal protective equipment such as N-95 masks are in short supply, as they are in high demand in the general public.16 The CDC currently does not recommend that members of the general public use face masks, given low levels of circulation of SARS-CoV-2 currently in the United States. The CDC has developed several documents regarding infection control, hospital preparedness assessments, personal protective equipment (PPE) supply planning, clinical evaluation and management, and respirator conservation strategies.
The RT-PCR test developed by the CDC has had some setbacks, with recent testing kits showing “inconclusive results.” The testing was initially available only through the CDC lab in Atlanta, with a 48-hour turnaround. This led to potential delays in diagnosis and the timely isolation and treatment of infected patients. On March 3, the CDC broadened the guidelines for coronavirus testing, allowing clinicians to order a test for any patients who have symptoms of COVID-19 infection. The greatest need is for decentralized testing in local and state labs, as well as validated testing in local hospitals and commercial labs. The ability to develop and scale-up diagnostic abilities is critically important.
There is also concern about overwhelming hospitals with a strain on the availability of beds, ventilators, and airborne isolation rooms. The CDC is recommending leveraging telehealth tools to direct people to the right level of health care for their medical needs. Hospitalization should only be for the sickest patients.17
Funding for a pandemic response is of paramount importance. Proposed 2021 federal budget cuts include $2.9 billion in cuts to the National Institutes of Health, and $708 million in cuts to the CDC, which makes the situation look especially worrisome as we face a potentially severe pandemic. The Infectious Diseases Society of America identifies antimicrobial resistance, NIH research, global health security, global HIV epidemic, and CDC vaccine programs as five “deeply underfunded” areas in the federal budget.18
The NIH has recently begun the first randomized clinical trial, treating patients at the University of Nebraska with laboratory-confirmed SARS-CoV-2 with a broad-spectrum antiviral drug called remdesivir. Patients from the Diamond Princess Cruise ship are also participating in this clinical trial. This study will hopefully shed light on potential treatments for coronavirus to stop or alleviate the consequences in real time. Similar clinical trials are also occurring in China.19
Vaccine development is underway in many public and private research facilities, but it will take approximately 6-18 months before they will be available for use. In the absence of a vaccine or therapeutic, community mitigation measures are the primary method to respond to the widespread transmission, and supportive care is the current medical treatment. In the case of a pandemic, the mitigation measures might include school dismissals and social distancing in other settings, like suspension of mass gatherings, telework and remote-meeting options in workplaces.
Many respected medical journals in the United States have made access to SARS-CoV-2 articles and literature readily and freely available, which is a remarkable step. Multiple societies and journals have made information available in real time and have used media effectively (e.g., podcasts, e-learning) to disseminate information to the general public. Articles have been made available in other languages, including Chinese.
Conclusions
In summary, there have been 3,280 total deaths attributable to SARS-CoV-2 to date globally, mostly among geriatric patients with comorbidities. To provide some perspective on the statistics, influenza has killed almost 14,000 patients this season alone (much more than coronavirus). COVID-19 is undoubtedly a global public health threat. We in the U.S. health care system are taking swift public health actions, including isolation of patients and contacts to prevent secondary spread, but it is unclear if this is enough to stop an outbreak from becoming a pandemic.
The CDC is warning of significant social and economic disruption in the coming weeks, with more expected community spread and confirmed cases. It is challenging to prepare for a pandemic when the transmission dynamics are not clearly known, the duration of infectiousness is not well defined, and asymptomatic transmission is a possibility. It is time for the public to be informed from trusted sources and avoid unverified information, especially on social media which can lead to confusion and panic. The spread of COVID-19 infection in the United States is inevitable, and there must be sufficient, well-coordinated planning that can curtail the spread and reduce the impact.
Dr. Tirupathi is the medical director of Keystone Infectious Diseases/HIV in Chambersburg, Pa., and currently chair of infection prevention at Wellspan Chambersburg and Waynesboro (Pa.) Hospitals. He also is the lead physician for antibiotic stewardship at these hospitals. Dr. Palabindala is hospital medicine division chief at the University of Mississippi Medical Center, Jackson. Ms. Sathya Areti is a 3rd-year medical student at the Virginia Commonwealth University School of Medicine (class of 2021), planning to apply into Internal Medicine-Pediatrics. Dr. Swetha Areti is currently working as a hospitalist at Wellspan Chambersburg Hospital and is also a member of the Wellspan Pharmacy and Therapeutics committee.
References
1. Phelan AL et al. The novel coronavirus originating in Wuhan, China: Challenges for global health governance. JAMA. 2020;323(8):709-10. doi: 10.1001/jama.2020.1097.
2. del Rio C, Malani PN. 2019 Novel coronavirus – Important information for clinicians. JAMA. Published online Feb. 5, 2020. doi: 10.1001/jama.2020.1490.
3. Gorbalenya AE et al. Severe acute respiratory syndrome-related coronavirus: The species and its viruses – a statement of the Coronavirus Study Group. bioRxiv. Published Jan. 1, 2020. doi: 10.1101/2020.02.07.937862.
4. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020;69:216-19. doi: 10.15585/mmwr.mm6908e1.
5. Coronavirus disease 2019 (COVID-19). Situation Report – 40. Published Feb. 29, 2020.
6. Kaiyuan Sun, et al. Early epidemiological analysis of the coronavirus disease 2019 outbreak based on crowdsourced data: a population level observational study, Feb. 20, 2020. Lancet Digital Health 2020. doi: 10.1016/S2589-7500(20)30026-1.
7. Rolfes MA et al. Annual estimates of the burden of seasonal influenza in the United States: A tool for strengthening influenza surveillance and preparedness. Influenza Other Respir Viruses. 2018;12(1):132-7. doi: 10.1111/irv.12486.
8. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020;69:216-19. doi: 10.15585/mmwr.mm6908e1.
9. Jablon R, Baumann L. Washington governor declares state of emergency over virus. AP News. Published Feb. 29, 2020.
10. Jernigan DB, CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020; 69:216-219. doi: 10.15585/mmwr.mm6908e1.
11. Information for health departments on reporting a person under investigation (PUI) or laboratory-confirmed case for COVID-19. Centers for Disease Control and Prevention. Published Feb 24, 2020.
12. Hines M. Coronavirus: Travel advisory for Italy, South Korea raised to level 4, ‘Do Not Travel’. USA Today. Published Feb. 29, 2020.
13. Information for health departments on reporting a person under investigation (PUI) or laboratory-confirmed case for COVID-19. Centers for Disease Control and Prevention. Published Feb. 24, 2020.
14. CDC Tests for COVID-19. Centers for Disease Control and Prevention. Published Feb. 25, 2020.
15. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020; 69:216-19. doi: 10.15585/mmwr.mm6908e1.
16. Gunia A. The global shortage of medical masks won’t be easing soon. Time. Published Feb. 27, 2020.
17. CDC in action: Preparing communities for potential spread of COVID-19. Centers for Disease Control and Prevention. Published Feb. 23, 2020.
18. Kadets L. White House budget cuts vital domestic and global public health programs. IDSA Home. Published 2020.
19. NIH clinical trial of remdesivir to treat COVID-19 begins. National Institutes of Health. Feb. 25, 2020.
Background
On Dec. 31, 2019, the Chinese city of Wuhan reported an outbreak of pneumonia from an unknown cause. The outbreak was found to be linked to the Hunan seafood market because of a shared history of exposure by many patients. After a full-scale investigation, China’s Center for Disease Control activated a level 2 emergency response on Jan. 4, 2020. A novel coronavirus was officially identified as a causative pathogen for the outbreak.1
Coronavirus, first discovered in the 1960s, is a respiratory RNA virus, most commonly associated with the “common cold.” However, we have had two highly pathogenic forms of coronavirus that originated from animal reservoirs, leading to global epidemics. This includes SARS-CoV in 2002-2004 and MERS-CoV in 2012 with more than 10,000 combined cases. The primary host has been bats, but mammals like camels, cattle, cats, and palm civets have been intermediate hosts in previous epidemics.2
The International Committee on Taxonomy of Viruses named the 2019-nCoV officially as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the coronavirus disease, COVID-19, on Feb. 11, 2020.3 Currently, the presentation includes fever, cough, trouble breathing, fatigue, and, rarely, watery diarrhea. More severe presentations include respiratory failure and death. Based on the incubation period of illness for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) coronaviruses, as well as observational data from reports of travel-related COVID-19, CDC estimates that symptoms of COVID-19 occur within 2-14 days after exposure. Asymptomatic transmission is also documented in some cases.4
On Jan. 13, the first case of COVID-19 outside of China was identified in Thailand. On Jan. 21, the first case of COVID-19 was identified in the United States. On Jan. 23, Chinese authorities suspended travel in and out of Wuhan, followed by other cities in the Hubei Province, leading to a quarantine of 50 million people. By Jan. 30, the World Health Organization had identified COVID-19 as the highest level of an epidemic alert referred to as a PHEIC: Public Health Emergency of International Concern. On Feb. 2, the first death outside China from coronavirus was reported in the Philippines. As of March 4 there have been 95,000 confirmed cases and 3,246 deaths globally. Within China, there have been 80,200 cases with 2,981 deaths.5
Cases have now been diagnosed in increasing numbers in Italy, Japan, South Korea, Iran, and 76 countries. Of note, the fatalities were of patients already in critical condition, who were typically older (more than 60 years old, especially more than 80) and immunocompromised with comorbid conditions (cardiovascular disease, diabetes, chronic respiratory disease, cancer).6 To put this in perspective, since 2010, CDC reports 140,000-810,000 hospitalizations and 12,000-61,000 deaths from the influenza virus annually in the US.7
The current situation in the United States
In the United States, as of March 4, 2020, there are currently 152 confirmed cases in 16 states. The first U.S. case of coronavirus without any of the travel-related and exposure risk factors was identified on Feb. 27 in California, indicating the first instance of community spread.8 The first death was reported in Washington state on Feb. 28, after which the state’s governor declared a state of emergency.9 On March 1, Washington state health officials investigated an outbreak of coronavirus at a long-term nursing facility in which two people tested positive for the disease, heralding the probable first nosocomial transmission of the virus in the United States. Since then, there have been 10 deaths in Washington state related to the coronavirus.
Current interventions in the United States
The U.S. Centers for Disease Control and Prevention is leading a multiagency effort to combat the COVID-19 potential pandemic. A Feb. 24 report in Morbidity and Mortality Weekly Report revealed that 1,336 CDC staff members have been involved in the COVID-19 response.10 CDC staff members have been deployed to 39 locations in the United States and internationally. CDC staff members are working with state and local health departments and other public health authorities to assist with case identification, contact tracing, evaluation of persons under investigation (PUI) for COVID-19, and medical management of cases, as well as with research and academic institutions to understand the virulence, risk for transmission, and other characteristics of this novel virus. The CDC is also working with other agencies of the U.S. government including the U.S. Department of Defense, Department of Health & Human Services and the U.S. Department of State to safely evacuate U.S. citizens, residents, and their families from international locations with high incidence and transmission of COVID-19.
Specific real-time updated guidance has been developed and posted online for health care settings for patient management, infection control and prevention, laboratory testing, environmental cleaning, worker safety, and international travel. The CDC has developed communications materials in English and Spanish for communities and guidance for health care settings, public health, laboratories, schools, and businesses to prepare for a potential pandemic. Travel advisories to countries affected by the epidemic are regularly updated to inform travelers and clinicians about current health issues that need to be considered before travel.11 A level 3 travel notice (avoid all nonessential travel) for China has been in effect since Jan. 27, and on Feb. 29 this was upgraded to a level 4 travel notice.12 Airport screening has been implemented in the 11 U.S. international airports to which flights from China have been diverted, and a total of 46,016 air travelers had been screened by Feb. 23. Incoming passengers are screened for fever, cough, and shortness of breath.
Currently, the CDC has a comprehensive algorithm for further investigation of a PUI – fever, cough, shortness of breath, and a history of travel to areas with increased coronavirus circulation within 14 days of onset of symptoms, OR a close household contact of a confirmed case. When there is a PUI, the current protocol indicates health care providers should alert a local or state health department official. After the health department completes a case investigation, the CDC will help transport specimens (upper respiratory and lower respiratory specimens, and sometimes stool or urine) as soon as possible to the centralized lab for polymerase chain reaction (PCR) testing.13 CDC laboratories are currently using real-time reverse transcription–PCR (RT-PCR). The CDC is also developing a serologic test to assist with surveillance for SARS-CoV-2 circulation in the U.S. population. There is also a safe repository of viral isolates set up to help with sharing of isolates with academic institutions for research purposes.14
At hospitals and outpatient offices in the United States, we are preparing for potential cases by reminding frontline health care workers to routinely ask about travel history in addition to relevant symptoms. By eliciting the history early, they should be able to identify and isolate PUIs, appropriately minimizing exposure. Some facilities are displaying signage in waiting rooms to alert patients to provide relevant history, helping to improve triage. COVID-19 symptoms are like those of influenza (e.g., fever, cough, and shortness of breath), and the current outbreak is occurring during a time of year when respiratory illnesses from influenza and other viruses are highly prevalent. To prevent influenza and possible unnecessary evaluation for COVID-19, all persons aged 6 months and older are strongly encouraged to receive an annual influenza vaccine.
To decrease the risk for respiratory disease, persons can practice recommended preventive measures. Persons ill with symptoms of COVID-19 who have had contact with a person with COVID-19, or recent travel to countries with apparent community spread, should proactively communicate with their health care provider before showing up at the health care facility to help make arrangements to prevent possible transmission in the health care setting. In a medical emergency, they should inform emergency medical personnel about possible COVID-19 exposure. If found positive, the current recommendation is to place patients on airborne isolation. N95 masks are being recommended for health care professionals. Hospitals are reinforcing effective infection control procedures, updating pandemic preparedness protocols, and ensuring adequate supplies in the case of an enormous influx of patients.15
Challenges and opportunities
Many challenges present in the process of getting prepared for a potential outbreak. Personal protective equipment such as N-95 masks are in short supply, as they are in high demand in the general public.16 The CDC currently does not recommend that members of the general public use face masks, given low levels of circulation of SARS-CoV-2 currently in the United States. The CDC has developed several documents regarding infection control, hospital preparedness assessments, personal protective equipment (PPE) supply planning, clinical evaluation and management, and respirator conservation strategies.
The RT-PCR test developed by the CDC has had some setbacks, with recent testing kits showing “inconclusive results.” The testing was initially available only through the CDC lab in Atlanta, with a 48-hour turnaround. This led to potential delays in diagnosis and the timely isolation and treatment of infected patients. On March 3, the CDC broadened the guidelines for coronavirus testing, allowing clinicians to order a test for any patients who have symptoms of COVID-19 infection. The greatest need is for decentralized testing in local and state labs, as well as validated testing in local hospitals and commercial labs. The ability to develop and scale-up diagnostic abilities is critically important.
There is also concern about overwhelming hospitals with a strain on the availability of beds, ventilators, and airborne isolation rooms. The CDC is recommending leveraging telehealth tools to direct people to the right level of health care for their medical needs. Hospitalization should only be for the sickest patients.17
Funding for a pandemic response is of paramount importance. Proposed 2021 federal budget cuts include $2.9 billion in cuts to the National Institutes of Health, and $708 million in cuts to the CDC, which makes the situation look especially worrisome as we face a potentially severe pandemic. The Infectious Diseases Society of America identifies antimicrobial resistance, NIH research, global health security, global HIV epidemic, and CDC vaccine programs as five “deeply underfunded” areas in the federal budget.18
The NIH has recently begun the first randomized clinical trial, treating patients at the University of Nebraska with laboratory-confirmed SARS-CoV-2 with a broad-spectrum antiviral drug called remdesivir. Patients from the Diamond Princess Cruise ship are also participating in this clinical trial. This study will hopefully shed light on potential treatments for coronavirus to stop or alleviate the consequences in real time. Similar clinical trials are also occurring in China.19
Vaccine development is underway in many public and private research facilities, but it will take approximately 6-18 months before they will be available for use. In the absence of a vaccine or therapeutic, community mitigation measures are the primary method to respond to the widespread transmission, and supportive care is the current medical treatment. In the case of a pandemic, the mitigation measures might include school dismissals and social distancing in other settings, like suspension of mass gatherings, telework and remote-meeting options in workplaces.
Many respected medical journals in the United States have made access to SARS-CoV-2 articles and literature readily and freely available, which is a remarkable step. Multiple societies and journals have made information available in real time and have used media effectively (e.g., podcasts, e-learning) to disseminate information to the general public. Articles have been made available in other languages, including Chinese.
Conclusions
In summary, there have been 3,280 total deaths attributable to SARS-CoV-2 to date globally, mostly among geriatric patients with comorbidities. To provide some perspective on the statistics, influenza has killed almost 14,000 patients this season alone (much more than coronavirus). COVID-19 is undoubtedly a global public health threat. We in the U.S. health care system are taking swift public health actions, including isolation of patients and contacts to prevent secondary spread, but it is unclear if this is enough to stop an outbreak from becoming a pandemic.
The CDC is warning of significant social and economic disruption in the coming weeks, with more expected community spread and confirmed cases. It is challenging to prepare for a pandemic when the transmission dynamics are not clearly known, the duration of infectiousness is not well defined, and asymptomatic transmission is a possibility. It is time for the public to be informed from trusted sources and avoid unverified information, especially on social media which can lead to confusion and panic. The spread of COVID-19 infection in the United States is inevitable, and there must be sufficient, well-coordinated planning that can curtail the spread and reduce the impact.
Dr. Tirupathi is the medical director of Keystone Infectious Diseases/HIV in Chambersburg, Pa., and currently chair of infection prevention at Wellspan Chambersburg and Waynesboro (Pa.) Hospitals. He also is the lead physician for antibiotic stewardship at these hospitals. Dr. Palabindala is hospital medicine division chief at the University of Mississippi Medical Center, Jackson. Ms. Sathya Areti is a 3rd-year medical student at the Virginia Commonwealth University School of Medicine (class of 2021), planning to apply into Internal Medicine-Pediatrics. Dr. Swetha Areti is currently working as a hospitalist at Wellspan Chambersburg Hospital and is also a member of the Wellspan Pharmacy and Therapeutics committee.
References
1. Phelan AL et al. The novel coronavirus originating in Wuhan, China: Challenges for global health governance. JAMA. 2020;323(8):709-10. doi: 10.1001/jama.2020.1097.
2. del Rio C, Malani PN. 2019 Novel coronavirus – Important information for clinicians. JAMA. Published online Feb. 5, 2020. doi: 10.1001/jama.2020.1490.
3. Gorbalenya AE et al. Severe acute respiratory syndrome-related coronavirus: The species and its viruses – a statement of the Coronavirus Study Group. bioRxiv. Published Jan. 1, 2020. doi: 10.1101/2020.02.07.937862.
4. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020;69:216-19. doi: 10.15585/mmwr.mm6908e1.
5. Coronavirus disease 2019 (COVID-19). Situation Report – 40. Published Feb. 29, 2020.
6. Kaiyuan Sun, et al. Early epidemiological analysis of the coronavirus disease 2019 outbreak based on crowdsourced data: a population level observational study, Feb. 20, 2020. Lancet Digital Health 2020. doi: 10.1016/S2589-7500(20)30026-1.
7. Rolfes MA et al. Annual estimates of the burden of seasonal influenza in the United States: A tool for strengthening influenza surveillance and preparedness. Influenza Other Respir Viruses. 2018;12(1):132-7. doi: 10.1111/irv.12486.
8. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020;69:216-19. doi: 10.15585/mmwr.mm6908e1.
9. Jablon R, Baumann L. Washington governor declares state of emergency over virus. AP News. Published Feb. 29, 2020.
10. Jernigan DB, CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020; 69:216-219. doi: 10.15585/mmwr.mm6908e1.
11. Information for health departments on reporting a person under investigation (PUI) or laboratory-confirmed case for COVID-19. Centers for Disease Control and Prevention. Published Feb 24, 2020.
12. Hines M. Coronavirus: Travel advisory for Italy, South Korea raised to level 4, ‘Do Not Travel’. USA Today. Published Feb. 29, 2020.
13. Information for health departments on reporting a person under investigation (PUI) or laboratory-confirmed case for COVID-19. Centers for Disease Control and Prevention. Published Feb. 24, 2020.
14. CDC Tests for COVID-19. Centers for Disease Control and Prevention. Published Feb. 25, 2020.
15. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020; 69:216-19. doi: 10.15585/mmwr.mm6908e1.
16. Gunia A. The global shortage of medical masks won’t be easing soon. Time. Published Feb. 27, 2020.
17. CDC in action: Preparing communities for potential spread of COVID-19. Centers for Disease Control and Prevention. Published Feb. 23, 2020.
18. Kadets L. White House budget cuts vital domestic and global public health programs. IDSA Home. Published 2020.
19. NIH clinical trial of remdesivir to treat COVID-19 begins. National Institutes of Health. Feb. 25, 2020.
Background
On Dec. 31, 2019, the Chinese city of Wuhan reported an outbreak of pneumonia from an unknown cause. The outbreak was found to be linked to the Hunan seafood market because of a shared history of exposure by many patients. After a full-scale investigation, China’s Center for Disease Control activated a level 2 emergency response on Jan. 4, 2020. A novel coronavirus was officially identified as a causative pathogen for the outbreak.1
Coronavirus, first discovered in the 1960s, is a respiratory RNA virus, most commonly associated with the “common cold.” However, we have had two highly pathogenic forms of coronavirus that originated from animal reservoirs, leading to global epidemics. This includes SARS-CoV in 2002-2004 and MERS-CoV in 2012 with more than 10,000 combined cases. The primary host has been bats, but mammals like camels, cattle, cats, and palm civets have been intermediate hosts in previous epidemics.2
The International Committee on Taxonomy of Viruses named the 2019-nCoV officially as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes the coronavirus disease, COVID-19, on Feb. 11, 2020.3 Currently, the presentation includes fever, cough, trouble breathing, fatigue, and, rarely, watery diarrhea. More severe presentations include respiratory failure and death. Based on the incubation period of illness for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS) coronaviruses, as well as observational data from reports of travel-related COVID-19, CDC estimates that symptoms of COVID-19 occur within 2-14 days after exposure. Asymptomatic transmission is also documented in some cases.4
On Jan. 13, the first case of COVID-19 outside of China was identified in Thailand. On Jan. 21, the first case of COVID-19 was identified in the United States. On Jan. 23, Chinese authorities suspended travel in and out of Wuhan, followed by other cities in the Hubei Province, leading to a quarantine of 50 million people. By Jan. 30, the World Health Organization had identified COVID-19 as the highest level of an epidemic alert referred to as a PHEIC: Public Health Emergency of International Concern. On Feb. 2, the first death outside China from coronavirus was reported in the Philippines. As of March 4 there have been 95,000 confirmed cases and 3,246 deaths globally. Within China, there have been 80,200 cases with 2,981 deaths.5
Cases have now been diagnosed in increasing numbers in Italy, Japan, South Korea, Iran, and 76 countries. Of note, the fatalities were of patients already in critical condition, who were typically older (more than 60 years old, especially more than 80) and immunocompromised with comorbid conditions (cardiovascular disease, diabetes, chronic respiratory disease, cancer).6 To put this in perspective, since 2010, CDC reports 140,000-810,000 hospitalizations and 12,000-61,000 deaths from the influenza virus annually in the US.7
The current situation in the United States
In the United States, as of March 4, 2020, there are currently 152 confirmed cases in 16 states. The first U.S. case of coronavirus without any of the travel-related and exposure risk factors was identified on Feb. 27 in California, indicating the first instance of community spread.8 The first death was reported in Washington state on Feb. 28, after which the state’s governor declared a state of emergency.9 On March 1, Washington state health officials investigated an outbreak of coronavirus at a long-term nursing facility in which two people tested positive for the disease, heralding the probable first nosocomial transmission of the virus in the United States. Since then, there have been 10 deaths in Washington state related to the coronavirus.
Current interventions in the United States
The U.S. Centers for Disease Control and Prevention is leading a multiagency effort to combat the COVID-19 potential pandemic. A Feb. 24 report in Morbidity and Mortality Weekly Report revealed that 1,336 CDC staff members have been involved in the COVID-19 response.10 CDC staff members have been deployed to 39 locations in the United States and internationally. CDC staff members are working with state and local health departments and other public health authorities to assist with case identification, contact tracing, evaluation of persons under investigation (PUI) for COVID-19, and medical management of cases, as well as with research and academic institutions to understand the virulence, risk for transmission, and other characteristics of this novel virus. The CDC is also working with other agencies of the U.S. government including the U.S. Department of Defense, Department of Health & Human Services and the U.S. Department of State to safely evacuate U.S. citizens, residents, and their families from international locations with high incidence and transmission of COVID-19.
Specific real-time updated guidance has been developed and posted online for health care settings for patient management, infection control and prevention, laboratory testing, environmental cleaning, worker safety, and international travel. The CDC has developed communications materials in English and Spanish for communities and guidance for health care settings, public health, laboratories, schools, and businesses to prepare for a potential pandemic. Travel advisories to countries affected by the epidemic are regularly updated to inform travelers and clinicians about current health issues that need to be considered before travel.11 A level 3 travel notice (avoid all nonessential travel) for China has been in effect since Jan. 27, and on Feb. 29 this was upgraded to a level 4 travel notice.12 Airport screening has been implemented in the 11 U.S. international airports to which flights from China have been diverted, and a total of 46,016 air travelers had been screened by Feb. 23. Incoming passengers are screened for fever, cough, and shortness of breath.
Currently, the CDC has a comprehensive algorithm for further investigation of a PUI – fever, cough, shortness of breath, and a history of travel to areas with increased coronavirus circulation within 14 days of onset of symptoms, OR a close household contact of a confirmed case. When there is a PUI, the current protocol indicates health care providers should alert a local or state health department official. After the health department completes a case investigation, the CDC will help transport specimens (upper respiratory and lower respiratory specimens, and sometimes stool or urine) as soon as possible to the centralized lab for polymerase chain reaction (PCR) testing.13 CDC laboratories are currently using real-time reverse transcription–PCR (RT-PCR). The CDC is also developing a serologic test to assist with surveillance for SARS-CoV-2 circulation in the U.S. population. There is also a safe repository of viral isolates set up to help with sharing of isolates with academic institutions for research purposes.14
At hospitals and outpatient offices in the United States, we are preparing for potential cases by reminding frontline health care workers to routinely ask about travel history in addition to relevant symptoms. By eliciting the history early, they should be able to identify and isolate PUIs, appropriately minimizing exposure. Some facilities are displaying signage in waiting rooms to alert patients to provide relevant history, helping to improve triage. COVID-19 symptoms are like those of influenza (e.g., fever, cough, and shortness of breath), and the current outbreak is occurring during a time of year when respiratory illnesses from influenza and other viruses are highly prevalent. To prevent influenza and possible unnecessary evaluation for COVID-19, all persons aged 6 months and older are strongly encouraged to receive an annual influenza vaccine.
To decrease the risk for respiratory disease, persons can practice recommended preventive measures. Persons ill with symptoms of COVID-19 who have had contact with a person with COVID-19, or recent travel to countries with apparent community spread, should proactively communicate with their health care provider before showing up at the health care facility to help make arrangements to prevent possible transmission in the health care setting. In a medical emergency, they should inform emergency medical personnel about possible COVID-19 exposure. If found positive, the current recommendation is to place patients on airborne isolation. N95 masks are being recommended for health care professionals. Hospitals are reinforcing effective infection control procedures, updating pandemic preparedness protocols, and ensuring adequate supplies in the case of an enormous influx of patients.15
Challenges and opportunities
Many challenges present in the process of getting prepared for a potential outbreak. Personal protective equipment such as N-95 masks are in short supply, as they are in high demand in the general public.16 The CDC currently does not recommend that members of the general public use face masks, given low levels of circulation of SARS-CoV-2 currently in the United States. The CDC has developed several documents regarding infection control, hospital preparedness assessments, personal protective equipment (PPE) supply planning, clinical evaluation and management, and respirator conservation strategies.
The RT-PCR test developed by the CDC has had some setbacks, with recent testing kits showing “inconclusive results.” The testing was initially available only through the CDC lab in Atlanta, with a 48-hour turnaround. This led to potential delays in diagnosis and the timely isolation and treatment of infected patients. On March 3, the CDC broadened the guidelines for coronavirus testing, allowing clinicians to order a test for any patients who have symptoms of COVID-19 infection. The greatest need is for decentralized testing in local and state labs, as well as validated testing in local hospitals and commercial labs. The ability to develop and scale-up diagnostic abilities is critically important.
There is also concern about overwhelming hospitals with a strain on the availability of beds, ventilators, and airborne isolation rooms. The CDC is recommending leveraging telehealth tools to direct people to the right level of health care for their medical needs. Hospitalization should only be for the sickest patients.17
Funding for a pandemic response is of paramount importance. Proposed 2021 federal budget cuts include $2.9 billion in cuts to the National Institutes of Health, and $708 million in cuts to the CDC, which makes the situation look especially worrisome as we face a potentially severe pandemic. The Infectious Diseases Society of America identifies antimicrobial resistance, NIH research, global health security, global HIV epidemic, and CDC vaccine programs as five “deeply underfunded” areas in the federal budget.18
The NIH has recently begun the first randomized clinical trial, treating patients at the University of Nebraska with laboratory-confirmed SARS-CoV-2 with a broad-spectrum antiviral drug called remdesivir. Patients from the Diamond Princess Cruise ship are also participating in this clinical trial. This study will hopefully shed light on potential treatments for coronavirus to stop or alleviate the consequences in real time. Similar clinical trials are also occurring in China.19
Vaccine development is underway in many public and private research facilities, but it will take approximately 6-18 months before they will be available for use. In the absence of a vaccine or therapeutic, community mitigation measures are the primary method to respond to the widespread transmission, and supportive care is the current medical treatment. In the case of a pandemic, the mitigation measures might include school dismissals and social distancing in other settings, like suspension of mass gatherings, telework and remote-meeting options in workplaces.
Many respected medical journals in the United States have made access to SARS-CoV-2 articles and literature readily and freely available, which is a remarkable step. Multiple societies and journals have made information available in real time and have used media effectively (e.g., podcasts, e-learning) to disseminate information to the general public. Articles have been made available in other languages, including Chinese.
Conclusions
In summary, there have been 3,280 total deaths attributable to SARS-CoV-2 to date globally, mostly among geriatric patients with comorbidities. To provide some perspective on the statistics, influenza has killed almost 14,000 patients this season alone (much more than coronavirus). COVID-19 is undoubtedly a global public health threat. We in the U.S. health care system are taking swift public health actions, including isolation of patients and contacts to prevent secondary spread, but it is unclear if this is enough to stop an outbreak from becoming a pandemic.
The CDC is warning of significant social and economic disruption in the coming weeks, with more expected community spread and confirmed cases. It is challenging to prepare for a pandemic when the transmission dynamics are not clearly known, the duration of infectiousness is not well defined, and asymptomatic transmission is a possibility. It is time for the public to be informed from trusted sources and avoid unverified information, especially on social media which can lead to confusion and panic. The spread of COVID-19 infection in the United States is inevitable, and there must be sufficient, well-coordinated planning that can curtail the spread and reduce the impact.
Dr. Tirupathi is the medical director of Keystone Infectious Diseases/HIV in Chambersburg, Pa., and currently chair of infection prevention at Wellspan Chambersburg and Waynesboro (Pa.) Hospitals. He also is the lead physician for antibiotic stewardship at these hospitals. Dr. Palabindala is hospital medicine division chief at the University of Mississippi Medical Center, Jackson. Ms. Sathya Areti is a 3rd-year medical student at the Virginia Commonwealth University School of Medicine (class of 2021), planning to apply into Internal Medicine-Pediatrics. Dr. Swetha Areti is currently working as a hospitalist at Wellspan Chambersburg Hospital and is also a member of the Wellspan Pharmacy and Therapeutics committee.
References
1. Phelan AL et al. The novel coronavirus originating in Wuhan, China: Challenges for global health governance. JAMA. 2020;323(8):709-10. doi: 10.1001/jama.2020.1097.
2. del Rio C, Malani PN. 2019 Novel coronavirus – Important information for clinicians. JAMA. Published online Feb. 5, 2020. doi: 10.1001/jama.2020.1490.
3. Gorbalenya AE et al. Severe acute respiratory syndrome-related coronavirus: The species and its viruses – a statement of the Coronavirus Study Group. bioRxiv. Published Jan. 1, 2020. doi: 10.1101/2020.02.07.937862.
4. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020;69:216-19. doi: 10.15585/mmwr.mm6908e1.
5. Coronavirus disease 2019 (COVID-19). Situation Report – 40. Published Feb. 29, 2020.
6. Kaiyuan Sun, et al. Early epidemiological analysis of the coronavirus disease 2019 outbreak based on crowdsourced data: a population level observational study, Feb. 20, 2020. Lancet Digital Health 2020. doi: 10.1016/S2589-7500(20)30026-1.
7. Rolfes MA et al. Annual estimates of the burden of seasonal influenza in the United States: A tool for strengthening influenza surveillance and preparedness. Influenza Other Respir Viruses. 2018;12(1):132-7. doi: 10.1111/irv.12486.
8. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020;69:216-19. doi: 10.15585/mmwr.mm6908e1.
9. Jablon R, Baumann L. Washington governor declares state of emergency over virus. AP News. Published Feb. 29, 2020.
10. Jernigan DB, CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020; 69:216-219. doi: 10.15585/mmwr.mm6908e1.
11. Information for health departments on reporting a person under investigation (PUI) or laboratory-confirmed case for COVID-19. Centers for Disease Control and Prevention. Published Feb 24, 2020.
12. Hines M. Coronavirus: Travel advisory for Italy, South Korea raised to level 4, ‘Do Not Travel’. USA Today. Published Feb. 29, 2020.
13. Information for health departments on reporting a person under investigation (PUI) or laboratory-confirmed case for COVID-19. Centers for Disease Control and Prevention. Published Feb. 24, 2020.
14. CDC Tests for COVID-19. Centers for Disease Control and Prevention. Published Feb. 25, 2020.
15. Jernigan DB. CDC COVID-19 response team. Update: Public health response to the coronavirus disease 2019 outbreak – United States, Feb. 24, 2020. MMWR Morbidity and Mortality Weekly Report 2020; 69:216-19. doi: 10.15585/mmwr.mm6908e1.
16. Gunia A. The global shortage of medical masks won’t be easing soon. Time. Published Feb. 27, 2020.
17. CDC in action: Preparing communities for potential spread of COVID-19. Centers for Disease Control and Prevention. Published Feb. 23, 2020.
18. Kadets L. White House budget cuts vital domestic and global public health programs. IDSA Home. Published 2020.
19. NIH clinical trial of remdesivir to treat COVID-19 begins. National Institutes of Health. Feb. 25, 2020.
Infection control protects hospital staff from COVID-19, study shows
Hospital-related infections have been widely reported during the ongoing coronavirus outbreak, with healthcare professionals bearing a disproportionate risk. However, a proactive response in Hong Kong’s public hospital system appears to have bucked this trend and successfully protected both patients and staff from SARS-CoV-2, according to a study published online today in Infection Control & Hospital Epidemiology.
During the first 42 days of the outbreak, the 43 hospitals in the network tested 1275 suspected cases and treated 42 patients with confirmed COVID-19, the disease caused by SARS-CoV-2 infection. Yet, there were no nosocomial infections or infections among healthcare personnel, report Vincent C.C. Cheng, MD, FRCPath, the hospital’s infection control officer, and colleagues.
Cheng and colleagues note that 11 out of 413 healthcare workers who treat patients with confirmed infections had unprotected exposure and were in quarantine for 14 days, but none became ill.
In comparison, they note, the 2003 SARS outbreak saw almost 60% of nosocomial cases occurring in healthcare workers.
Proactive bundle
The Hong Kong success story may be due to a stepped-up proactive bundle of measures that included enhanced laboratory surveillance, early airborne infection isolation, and rapid-turnaround molecular diagnostics. Other strategies included staff forums and one-on-one discussions about infection control, employee training in protective equipment use, hand-hygiene compliance enforcement, and contact tracing for workers with unprotected exposure.
In addition, surgical masks were provided for all healthcare workers, patients, and visitors to clinical areas, a practice previously associated with reduced in-hospital transmission during influenza outbreaks, the authors note.
Hospitals also mandated use of personal protective equipment (PPE) for aerosol-generating procedures (AGPs), such as endotracheal intubation, open suctioning, and high-flow oxygen use, as AGPs had been linked to nosocomial transmission to healthcare workers during the 2003 SARS outbreak.
The infection control measures, which were part of a preparedness plan developed after the SARS outbreak, were initiated on December 31, when the first reports of a cluster of infections came from Wuhan, China.
As the outbreak evolved, the Hong Kong hospitals quickly widened the epidemiologic criteria for screening, from initially including only those who had been to a wet market in Wuhan within 14 days of symptom onset, to eventually including anyone who had been to Hubei province, been in a medical facility in mainland China, or in contact with a known case.
All suspected cases were sent to an airborne-infection isolation room (AIIR) or a ward with at least a meter of space between patients.
“Appropriate hospital infection control measures could prevent nosocomial transmission of SARS-CoV-2,” the authors write. “Vigilance in hand hygiene practice, wearing of surgical mask in the hospital, and appropriate use of PPE in patient care, especially [when] performing AGPs, are the key infection control measures to prevent nosocomial transmission of SARS-CoV-2 even before the availability of effective antiviral agents and vaccine.”
Asked for his perspective on the report, Aaron E. Glatt, MD, chairman of the department of medicine and chief of infectious diseases at Mount Sinai South Nassau in Oceanside, New York, said that apart from the widespread issuing of surgical masks to workers, patients, and visitors, the measures taken in Hong Kong are not different from standard infection-control practices in American hospitals. Glatt, who is also a hospital epidemiologist, said it was unclear how much impact the masks would have.
“Although the infection control was impressive, I don’t see any evidence of a difference in care,” he told Medscape Medical News.
Could zero infection transmission be achieved in the more far-flung and variable settings of hospitals across the United States? “The ability to get zero transmission is only possible if people adhere to the strictest infection-control guidelines,” Glatt said. “That is clearly the goal, and it will take time to see if our existing strict guidelines are sufficient to maintain zero or close to zero contamination and transmission rates in our hospitals.”
Rather than looking to change US practices, he stressed adherence to widely established tenets of care. “It’s critically important to keep paying close attention to the basics, to the simple blocking and tackling, and to identify which patients are at risk, and therefore, when workers need protective equipment,” he said.
“Follow the recommended standards,” continued Glatt, who is also a spokesperson for the Infectious Diseases Society of America and did not participate in this study.
In a finding from an ancillary pilot experiment, the Hong Kong researchers found exhaled air from a patient with a moderate coronavirus load showed no evidence of the virus, whether the patient was breathing normally or heavily, speaking, or coughing. And spot tests around the room detected the virus in just one location.
“We may not be able to make a definite conclusion based on the analysis of a single patient,” the authors write. “However, it may help to reassure our staff that the exhaled air may be rapidly diluted inside the AIIR with 12 air changes per hour, or probably the SARS-CoV-2 may not be predominantly transmitted by [the] airborne route.”
However, a recent Singapore study showed widespread environmental contamination by SARS-CoV-2 through respiratory droplets and fecal shedding, underlining the need for strict adherence to environmental and hand hygiene. Post-cleaning samples tested negative, suggesting that standard decontamination practices are effective.
This work was partly supported by the Consultancy Service for Enhancing Laboratory Surveillance of Emerging Infectious Diseases of the Department of Health, Hong Kong Special Administrative Region; and the Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Ministry of Education of China. The authors and Glatt have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Hospital-related infections have been widely reported during the ongoing coronavirus outbreak, with healthcare professionals bearing a disproportionate risk. However, a proactive response in Hong Kong’s public hospital system appears to have bucked this trend and successfully protected both patients and staff from SARS-CoV-2, according to a study published online today in Infection Control & Hospital Epidemiology.
During the first 42 days of the outbreak, the 43 hospitals in the network tested 1275 suspected cases and treated 42 patients with confirmed COVID-19, the disease caused by SARS-CoV-2 infection. Yet, there were no nosocomial infections or infections among healthcare personnel, report Vincent C.C. Cheng, MD, FRCPath, the hospital’s infection control officer, and colleagues.
Cheng and colleagues note that 11 out of 413 healthcare workers who treat patients with confirmed infections had unprotected exposure and were in quarantine for 14 days, but none became ill.
In comparison, they note, the 2003 SARS outbreak saw almost 60% of nosocomial cases occurring in healthcare workers.
Proactive bundle
The Hong Kong success story may be due to a stepped-up proactive bundle of measures that included enhanced laboratory surveillance, early airborne infection isolation, and rapid-turnaround molecular diagnostics. Other strategies included staff forums and one-on-one discussions about infection control, employee training in protective equipment use, hand-hygiene compliance enforcement, and contact tracing for workers with unprotected exposure.
In addition, surgical masks were provided for all healthcare workers, patients, and visitors to clinical areas, a practice previously associated with reduced in-hospital transmission during influenza outbreaks, the authors note.
Hospitals also mandated use of personal protective equipment (PPE) for aerosol-generating procedures (AGPs), such as endotracheal intubation, open suctioning, and high-flow oxygen use, as AGPs had been linked to nosocomial transmission to healthcare workers during the 2003 SARS outbreak.
The infection control measures, which were part of a preparedness plan developed after the SARS outbreak, were initiated on December 31, when the first reports of a cluster of infections came from Wuhan, China.
As the outbreak evolved, the Hong Kong hospitals quickly widened the epidemiologic criteria for screening, from initially including only those who had been to a wet market in Wuhan within 14 days of symptom onset, to eventually including anyone who had been to Hubei province, been in a medical facility in mainland China, or in contact with a known case.
All suspected cases were sent to an airborne-infection isolation room (AIIR) or a ward with at least a meter of space between patients.
“Appropriate hospital infection control measures could prevent nosocomial transmission of SARS-CoV-2,” the authors write. “Vigilance in hand hygiene practice, wearing of surgical mask in the hospital, and appropriate use of PPE in patient care, especially [when] performing AGPs, are the key infection control measures to prevent nosocomial transmission of SARS-CoV-2 even before the availability of effective antiviral agents and vaccine.”
Asked for his perspective on the report, Aaron E. Glatt, MD, chairman of the department of medicine and chief of infectious diseases at Mount Sinai South Nassau in Oceanside, New York, said that apart from the widespread issuing of surgical masks to workers, patients, and visitors, the measures taken in Hong Kong are not different from standard infection-control practices in American hospitals. Glatt, who is also a hospital epidemiologist, said it was unclear how much impact the masks would have.
“Although the infection control was impressive, I don’t see any evidence of a difference in care,” he told Medscape Medical News.
Could zero infection transmission be achieved in the more far-flung and variable settings of hospitals across the United States? “The ability to get zero transmission is only possible if people adhere to the strictest infection-control guidelines,” Glatt said. “That is clearly the goal, and it will take time to see if our existing strict guidelines are sufficient to maintain zero or close to zero contamination and transmission rates in our hospitals.”
Rather than looking to change US practices, he stressed adherence to widely established tenets of care. “It’s critically important to keep paying close attention to the basics, to the simple blocking and tackling, and to identify which patients are at risk, and therefore, when workers need protective equipment,” he said.
“Follow the recommended standards,” continued Glatt, who is also a spokesperson for the Infectious Diseases Society of America and did not participate in this study.
In a finding from an ancillary pilot experiment, the Hong Kong researchers found exhaled air from a patient with a moderate coronavirus load showed no evidence of the virus, whether the patient was breathing normally or heavily, speaking, or coughing. And spot tests around the room detected the virus in just one location.
“We may not be able to make a definite conclusion based on the analysis of a single patient,” the authors write. “However, it may help to reassure our staff that the exhaled air may be rapidly diluted inside the AIIR with 12 air changes per hour, or probably the SARS-CoV-2 may not be predominantly transmitted by [the] airborne route.”
However, a recent Singapore study showed widespread environmental contamination by SARS-CoV-2 through respiratory droplets and fecal shedding, underlining the need for strict adherence to environmental and hand hygiene. Post-cleaning samples tested negative, suggesting that standard decontamination practices are effective.
This work was partly supported by the Consultancy Service for Enhancing Laboratory Surveillance of Emerging Infectious Diseases of the Department of Health, Hong Kong Special Administrative Region; and the Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Ministry of Education of China. The authors and Glatt have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Hospital-related infections have been widely reported during the ongoing coronavirus outbreak, with healthcare professionals bearing a disproportionate risk. However, a proactive response in Hong Kong’s public hospital system appears to have bucked this trend and successfully protected both patients and staff from SARS-CoV-2, according to a study published online today in Infection Control & Hospital Epidemiology.
During the first 42 days of the outbreak, the 43 hospitals in the network tested 1275 suspected cases and treated 42 patients with confirmed COVID-19, the disease caused by SARS-CoV-2 infection. Yet, there were no nosocomial infections or infections among healthcare personnel, report Vincent C.C. Cheng, MD, FRCPath, the hospital’s infection control officer, and colleagues.
Cheng and colleagues note that 11 out of 413 healthcare workers who treat patients with confirmed infections had unprotected exposure and were in quarantine for 14 days, but none became ill.
In comparison, they note, the 2003 SARS outbreak saw almost 60% of nosocomial cases occurring in healthcare workers.
Proactive bundle
The Hong Kong success story may be due to a stepped-up proactive bundle of measures that included enhanced laboratory surveillance, early airborne infection isolation, and rapid-turnaround molecular diagnostics. Other strategies included staff forums and one-on-one discussions about infection control, employee training in protective equipment use, hand-hygiene compliance enforcement, and contact tracing for workers with unprotected exposure.
In addition, surgical masks were provided for all healthcare workers, patients, and visitors to clinical areas, a practice previously associated with reduced in-hospital transmission during influenza outbreaks, the authors note.
Hospitals also mandated use of personal protective equipment (PPE) for aerosol-generating procedures (AGPs), such as endotracheal intubation, open suctioning, and high-flow oxygen use, as AGPs had been linked to nosocomial transmission to healthcare workers during the 2003 SARS outbreak.
The infection control measures, which were part of a preparedness plan developed after the SARS outbreak, were initiated on December 31, when the first reports of a cluster of infections came from Wuhan, China.
As the outbreak evolved, the Hong Kong hospitals quickly widened the epidemiologic criteria for screening, from initially including only those who had been to a wet market in Wuhan within 14 days of symptom onset, to eventually including anyone who had been to Hubei province, been in a medical facility in mainland China, or in contact with a known case.
All suspected cases were sent to an airborne-infection isolation room (AIIR) or a ward with at least a meter of space between patients.
“Appropriate hospital infection control measures could prevent nosocomial transmission of SARS-CoV-2,” the authors write. “Vigilance in hand hygiene practice, wearing of surgical mask in the hospital, and appropriate use of PPE in patient care, especially [when] performing AGPs, are the key infection control measures to prevent nosocomial transmission of SARS-CoV-2 even before the availability of effective antiviral agents and vaccine.”
Asked for his perspective on the report, Aaron E. Glatt, MD, chairman of the department of medicine and chief of infectious diseases at Mount Sinai South Nassau in Oceanside, New York, said that apart from the widespread issuing of surgical masks to workers, patients, and visitors, the measures taken in Hong Kong are not different from standard infection-control practices in American hospitals. Glatt, who is also a hospital epidemiologist, said it was unclear how much impact the masks would have.
“Although the infection control was impressive, I don’t see any evidence of a difference in care,” he told Medscape Medical News.
Could zero infection transmission be achieved in the more far-flung and variable settings of hospitals across the United States? “The ability to get zero transmission is only possible if people adhere to the strictest infection-control guidelines,” Glatt said. “That is clearly the goal, and it will take time to see if our existing strict guidelines are sufficient to maintain zero or close to zero contamination and transmission rates in our hospitals.”
Rather than looking to change US practices, he stressed adherence to widely established tenets of care. “It’s critically important to keep paying close attention to the basics, to the simple blocking and tackling, and to identify which patients are at risk, and therefore, when workers need protective equipment,” he said.
“Follow the recommended standards,” continued Glatt, who is also a spokesperson for the Infectious Diseases Society of America and did not participate in this study.
In a finding from an ancillary pilot experiment, the Hong Kong researchers found exhaled air from a patient with a moderate coronavirus load showed no evidence of the virus, whether the patient was breathing normally or heavily, speaking, or coughing. And spot tests around the room detected the virus in just one location.
“We may not be able to make a definite conclusion based on the analysis of a single patient,” the authors write. “However, it may help to reassure our staff that the exhaled air may be rapidly diluted inside the AIIR with 12 air changes per hour, or probably the SARS-CoV-2 may not be predominantly transmitted by [the] airborne route.”
However, a recent Singapore study showed widespread environmental contamination by SARS-CoV-2 through respiratory droplets and fecal shedding, underlining the need for strict adherence to environmental and hand hygiene. Post-cleaning samples tested negative, suggesting that standard decontamination practices are effective.
This work was partly supported by the Consultancy Service for Enhancing Laboratory Surveillance of Emerging Infectious Diseases of the Department of Health, Hong Kong Special Administrative Region; and the Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Ministry of Education of China. The authors and Glatt have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
CMS issues guidance on containing spread of coronavirus
The first guidance document, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” issued March 4, provides some basic guidance, including identifying which patients are at risk, how facilities should screen for COVID-19, how facilities should monitor or restrict health care facility staff, and other recommendations for infection prevention and control.
“Hospitals should identify visitors and patients at risk for having COVID-19 infection before or immediately upon arrival to the healthcare facility,” the guidance document notes. “For patients, implement respiratory hygiene and cough etiquette (i.e., placing a face mask over the patient’s nose and mouth if that has not already been done) and isolate the patient in an examination room with the door closed. If the patient cannot be immediately moved to an examination room, ensure they are not allowed to wait among other patients seeking care.”
The document offers further information regarding the care of patients and provides numerous links to existing guidance from the Centers for Disease Control and Prevention.
The second document, “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes,” issued the same day, provides information on how to limit and monitor visitors as well as monitor and restrict health staff. It details when to transfer residents with suspected or confirmed coronavirus infection, and when a nursing home should accept a resident diagnosed with COVID-19.
Facilities “should contact their local health department if they have questions or suspect a resident of a nursing home has COVID-19,” the document states. “Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposure among patients, healthcare personnel, and visitors at the facility.”
The CMS also announced that it is suspending all nonemergency survey activity.
“CMS is suspending nonemergency inspections across the country, allowing inspectors to turn their focus on the most serious health and safety threats like infectious diseases and abuse,” the agency stated in a March 4 memo. “This shift in approach will also allow inspectors to focus on addressing the spread of ... COVID-19. CMS is issuing this memorandum to State Survey Agencies to provide important guidelines for the inspection process in situations in which a COVID-19 is suspected.”
In a statement, CMS Administrator Seema Verma said these actions “represent a call to action across the health care system. All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention.”
The first guidance document, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” issued March 4, provides some basic guidance, including identifying which patients are at risk, how facilities should screen for COVID-19, how facilities should monitor or restrict health care facility staff, and other recommendations for infection prevention and control.
“Hospitals should identify visitors and patients at risk for having COVID-19 infection before or immediately upon arrival to the healthcare facility,” the guidance document notes. “For patients, implement respiratory hygiene and cough etiquette (i.e., placing a face mask over the patient’s nose and mouth if that has not already been done) and isolate the patient in an examination room with the door closed. If the patient cannot be immediately moved to an examination room, ensure they are not allowed to wait among other patients seeking care.”
The document offers further information regarding the care of patients and provides numerous links to existing guidance from the Centers for Disease Control and Prevention.
The second document, “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes,” issued the same day, provides information on how to limit and monitor visitors as well as monitor and restrict health staff. It details when to transfer residents with suspected or confirmed coronavirus infection, and when a nursing home should accept a resident diagnosed with COVID-19.
Facilities “should contact their local health department if they have questions or suspect a resident of a nursing home has COVID-19,” the document states. “Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposure among patients, healthcare personnel, and visitors at the facility.”
The CMS also announced that it is suspending all nonemergency survey activity.
“CMS is suspending nonemergency inspections across the country, allowing inspectors to turn their focus on the most serious health and safety threats like infectious diseases and abuse,” the agency stated in a March 4 memo. “This shift in approach will also allow inspectors to focus on addressing the spread of ... COVID-19. CMS is issuing this memorandum to State Survey Agencies to provide important guidelines for the inspection process in situations in which a COVID-19 is suspected.”
In a statement, CMS Administrator Seema Verma said these actions “represent a call to action across the health care system. All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention.”
The first guidance document, “Guidance for Infection Control and Prevention Concerning Coronavirus Disease (COVID-19): FAQs and Considerations for Patient Triage, Placement and Hospital Discharge,” issued March 4, provides some basic guidance, including identifying which patients are at risk, how facilities should screen for COVID-19, how facilities should monitor or restrict health care facility staff, and other recommendations for infection prevention and control.
“Hospitals should identify visitors and patients at risk for having COVID-19 infection before or immediately upon arrival to the healthcare facility,” the guidance document notes. “For patients, implement respiratory hygiene and cough etiquette (i.e., placing a face mask over the patient’s nose and mouth if that has not already been done) and isolate the patient in an examination room with the door closed. If the patient cannot be immediately moved to an examination room, ensure they are not allowed to wait among other patients seeking care.”
The document offers further information regarding the care of patients and provides numerous links to existing guidance from the Centers for Disease Control and Prevention.
The second document, “Guidance for Infection Control and Prevention of Coronavirus Disease 2019 (COVID-19) in Nursing Homes,” issued the same day, provides information on how to limit and monitor visitors as well as monitor and restrict health staff. It details when to transfer residents with suspected or confirmed coronavirus infection, and when a nursing home should accept a resident diagnosed with COVID-19.
Facilities “should contact their local health department if they have questions or suspect a resident of a nursing home has COVID-19,” the document states. “Per CDC, prompt detection, triage and isolation of potentially infectious patients are essential to prevent unnecessary exposure among patients, healthcare personnel, and visitors at the facility.”
The CMS also announced that it is suspending all nonemergency survey activity.
“CMS is suspending nonemergency inspections across the country, allowing inspectors to turn their focus on the most serious health and safety threats like infectious diseases and abuse,” the agency stated in a March 4 memo. “This shift in approach will also allow inspectors to focus on addressing the spread of ... COVID-19. CMS is issuing this memorandum to State Survey Agencies to provide important guidelines for the inspection process in situations in which a COVID-19 is suspected.”
In a statement, CMS Administrator Seema Verma said these actions “represent a call to action across the health care system. All health care providers must immediately review their procedures to ensure compliance with CMS’ infection control requirements, as well as the guidelines from the Centers for Disease Control and Prevention.”
FDA issues stronger warning on neuropsychiatric event risk linked to montelukast
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
The Food and Drug Administration has issued , a prescription drug for asthma and allergy.
The new boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, the FDA said in a press release. The drug was first approved in 1998, and the product labeling was updated in 2008 to include information about neuropsychiatric adverse events reported with usage of montelukast.
While the Sentinel study, along with other observational studies, did not find an increased risk of mental health side effects with montelukast treatment, compared with inhaled corticosteroids, those studies had limitations that may have affected results, the FDA said in the Drug Safety Communication. However, the FDA has continued to receive reports of neuropsychiatric events – including agitation, depression, sleeping problems, and suicidal thoughts and actions – in patients receiving the medication.
“The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks,” Sally Seymour, MD, director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “There are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”
In addition to the boxed warning, the FDA now requires a new medication guide to be given to patients with each montelukast prescription, the FDA said.
FDA moves to expand coronavirus testing capacity; CDC clarifies testing criteria
The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.
At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a the virus that is causing the current outbreak of COVID-19.
Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.
“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.
On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.
“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.
The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.
“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.
“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*
Updated criteria
The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.
Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.
In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.
Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.
The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.
“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.
*An earlier version of this article misattributed this quote.
The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.
At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a the virus that is causing the current outbreak of COVID-19.
Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.
“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.
On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.
“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.
The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.
“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.
“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*
Updated criteria
The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.
Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.
In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.
Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.
The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.
“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.
*An earlier version of this article misattributed this quote.
The White House Coronavirus Task Force appeared at a press briefing March 2 to provide updates about testing strategies and public health coordination to address the current outbreak of the coronavirus COVID-19. Speaking at the briefing, led by Vice President Mike Pence, Centers for Disease Control and Prevention (CDC) director Robert Redfield, MD, said, “Working with our public health partners we continue to be able to identify new community cases and use our public health efforts to aggressively confirm, isolate, and do contact tracking.” Calling state, local, tribal, and territorial public health departments “the backbone of the public health system in our country,” Dr. Redfield noted that he expected many more confirmed COVID-19 cases to emerge.
At least some of the expected increase in confirmed cases of COVID-19 will occur because of expanded testing capacity, noted several of the task force members. On Feb. 29, the Food and Drug Administration issued a the virus that is causing the current outbreak of COVID-19.
Highly qualified laboratories, including both those run by public agencies and private labs, are now authorized to begin using their own validated test for the virus as long as they submit an Emergency Use Authorization (EUA) to the Food and Drug Administration within 15 days of notifying the agency of validation.
“To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with wide availability of testing capabilities in health care settings, reference and commercial laboratories, and at the point of care,” the agency wrote in a press announcement of the expedited test expansion.
On Feb. 4, the Secretary of the Department of Health & Human Services declared a coronavirus public health emergency. The FDA was then authorized to allow individual laboratories with validated coronavirus tests to begin testing samples immediately. The goal is a more rapid and expanded testing capacity in the United States.
“The global emergence of COVID-19 is concerning, and we appreciate the efforts of the FDA to help bring more testing capability to the U.S.,” Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), said in the press release.
The new guidance that permits the immediate use of clinical tests after individual development and validation, said the FDA, only applies to labs already certified to perform high complexity testing under Clinical Laboratory Improvement Amendments. Many governmental, academic, and private laboratories fall into this category, however.
“Under this policy, we expect certain laboratories who develop validated tests for coronavirus would begin using them right away prior to FDA review,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We believe this action will support laboratories across the country working on this urgent public health situation,” he added in the press release.
“By the end of this week, close to a million tests will be available,” FDA Commissioner Stephen M. Hahn, MD, said during the March 2 briefing.*
Updated criteria
The CDC is maintaining updated criteria for the virus testing on its website. Testing criteria are based both on clinical features and epidemiologic risk.
Individuals with less severe clinical features – those who have either fever or signs and symptoms of lower respiratory disease such as cough or shortness of breath, but who don’t require hospitalization – should be tested if they have high epidemiologic risk. “High risk” is defined by the CDC as any individual, including health care workers, who has had close contact with a person with confirmed COVID-19 within the past 2 weeks. For health care workers, testing can be considered even if they have relatively mild respiratory symptoms or have had contact with a person who is suspected, but not yet confirmed, to have coronavirus.
In its testing guidance, the CDC recognizes that defining close contact is difficult. General guidelines are that individuals are considered to have been in close contact with a person who has COVID-19 if they were within about six feet of the person for a prolonged period, or cared for or have spent a prolonged amount of time in the same room or house as a person with confirmed COVID-19.
Individuals who have both fever and signs or symptoms of lower respiratory illness who require hospitalization should be tested if they have a history of travel from any affected geographic area within 14 days of the onset of their symptoms. The CDC now defines “affected geographic area” as any country or region that has at least a CDC Level 2 Travel Health Notice for COVID-19, so that the testing criteria themselves don’t need to be updated when new geographic areas are included in these alerts. As of March 3, China, Iran, Italy, Japan, and South Korea all have Level 2 or 3 travel alerts.
The CDC now recommends that any patient who has severe acute lower respiratory illness that requires hospitalization and doesn’t have an alternative diagnosis should be tested, even without any identified source of exposure.
“Despite seeing these new cases, the risk to the American people is low,” said the CDC’s Dr. Redfield. In response to a question from the press about how fast the coronavirus will spread across the United States, Dr. Redfield said, “From the beginning we’ve anticipated seeing community cases pop up.” He added that as these cases arise, testing and public health strategies will focus on unearthing linkages and contacts to learn how the virus is spreading. “We’ll use the public health strategies that we can to limit that transmission,” he said.
*An earlier version of this article misattributed this quote.
FROM A PRESS BRIEFING BY THE WHITE HOUSE CORONAVIRUS TASK FORCE