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Innovation requires experimentation
A call for more health care trials
Successful innovation requires experimentation, according to a recent editorial in BMJ Quality & Safety – that’s why health systems should engage in more experimenting, more systematically, to improve health care.
“Most health systems implement interventions without testing them against other designs,” said co-author Mitesh S. Patel, MD, MBA, MS, of the University of Pennsylvania, Philadelphia. “This means that good ideas are often not spread (because we don’t know how impactful they are) and bad ones persist (because we don’t realize they don’t work).”
Dr. Patel, who is director of the Penn Medicine Nudge Unit at the Perelman Center for Advanced Medicine, encourages health systems and clinicians to implement new interventions in testable ways such as through a randomized trial, so that we can learn what works and why. A more systematic approach could help to expand programs that work and improve workflow and patient care.
“First, we must embed research teams within health systems in order to create the capacity for this kind of work. Expertise is required to identify a promising intervention, design the conceptual approach, conduct the technical implementation and rigorously evaluate the trial. These teams are also able to design interventions within the context of existing workflows in order to ensure that successful projects can be quickly scaled and that ineffective initiatives can be seamlessly terminated.” the authors wrote.
“Second, we must take advantage of existing data systems. The field of health care is ripe with detailed and reliable administrative data and electronic medical record data. These data offer the potential to do high-quality, low-cost, rapid trials. Third, we must measure a wide range of meaningful outcomes. We should examine the effect of interventions on health care costs, health care utilization and health outcomes.”
Next steps could be focused on thinking about the key priority areas and how can experiments be used to generate new knowledge on what works and what does not. “Luckily, the complex world of health care provides endless opportunities for rapid-cycle, randomized trials that target health care costs and outcomes,” Dr. Patel said.
Reference
1. Oakes AH, Patel MS. A nudge towards increased experimentation to more rapidly improve healthcare. BMJ Qual Saf. 2020;29:179-181. doi: 10.1136/bmjqs-2019-009948. Accessed Dec 3, 2019.
A call for more health care trials
A call for more health care trials
Successful innovation requires experimentation, according to a recent editorial in BMJ Quality & Safety – that’s why health systems should engage in more experimenting, more systematically, to improve health care.
“Most health systems implement interventions without testing them against other designs,” said co-author Mitesh S. Patel, MD, MBA, MS, of the University of Pennsylvania, Philadelphia. “This means that good ideas are often not spread (because we don’t know how impactful they are) and bad ones persist (because we don’t realize they don’t work).”
Dr. Patel, who is director of the Penn Medicine Nudge Unit at the Perelman Center for Advanced Medicine, encourages health systems and clinicians to implement new interventions in testable ways such as through a randomized trial, so that we can learn what works and why. A more systematic approach could help to expand programs that work and improve workflow and patient care.
“First, we must embed research teams within health systems in order to create the capacity for this kind of work. Expertise is required to identify a promising intervention, design the conceptual approach, conduct the technical implementation and rigorously evaluate the trial. These teams are also able to design interventions within the context of existing workflows in order to ensure that successful projects can be quickly scaled and that ineffective initiatives can be seamlessly terminated.” the authors wrote.
“Second, we must take advantage of existing data systems. The field of health care is ripe with detailed and reliable administrative data and electronic medical record data. These data offer the potential to do high-quality, low-cost, rapid trials. Third, we must measure a wide range of meaningful outcomes. We should examine the effect of interventions on health care costs, health care utilization and health outcomes.”
Next steps could be focused on thinking about the key priority areas and how can experiments be used to generate new knowledge on what works and what does not. “Luckily, the complex world of health care provides endless opportunities for rapid-cycle, randomized trials that target health care costs and outcomes,” Dr. Patel said.
Reference
1. Oakes AH, Patel MS. A nudge towards increased experimentation to more rapidly improve healthcare. BMJ Qual Saf. 2020;29:179-181. doi: 10.1136/bmjqs-2019-009948. Accessed Dec 3, 2019.
Successful innovation requires experimentation, according to a recent editorial in BMJ Quality & Safety – that’s why health systems should engage in more experimenting, more systematically, to improve health care.
“Most health systems implement interventions without testing them against other designs,” said co-author Mitesh S. Patel, MD, MBA, MS, of the University of Pennsylvania, Philadelphia. “This means that good ideas are often not spread (because we don’t know how impactful they are) and bad ones persist (because we don’t realize they don’t work).”
Dr. Patel, who is director of the Penn Medicine Nudge Unit at the Perelman Center for Advanced Medicine, encourages health systems and clinicians to implement new interventions in testable ways such as through a randomized trial, so that we can learn what works and why. A more systematic approach could help to expand programs that work and improve workflow and patient care.
“First, we must embed research teams within health systems in order to create the capacity for this kind of work. Expertise is required to identify a promising intervention, design the conceptual approach, conduct the technical implementation and rigorously evaluate the trial. These teams are also able to design interventions within the context of existing workflows in order to ensure that successful projects can be quickly scaled and that ineffective initiatives can be seamlessly terminated.” the authors wrote.
“Second, we must take advantage of existing data systems. The field of health care is ripe with detailed and reliable administrative data and electronic medical record data. These data offer the potential to do high-quality, low-cost, rapid trials. Third, we must measure a wide range of meaningful outcomes. We should examine the effect of interventions on health care costs, health care utilization and health outcomes.”
Next steps could be focused on thinking about the key priority areas and how can experiments be used to generate new knowledge on what works and what does not. “Luckily, the complex world of health care provides endless opportunities for rapid-cycle, randomized trials that target health care costs and outcomes,” Dr. Patel said.
Reference
1. Oakes AH, Patel MS. A nudge towards increased experimentation to more rapidly improve healthcare. BMJ Qual Saf. 2020;29:179-181. doi: 10.1136/bmjqs-2019-009948. Accessed Dec 3, 2019.
Janssen/J&J COVID-19 vaccine cuts transmission, new data show
The single-dose vaccine reduces the risk of asymptomatic transmission by 74% at 71 days, compared with placebo, according to documents released today by the U.S. Food and Drug Administration.
“The decrease in asymptomatic transmission is very welcome news too in curbing the spread of the virus,” Phyllis Tien, MD, told this news organization.
“While the earlier press release reported that the vaccine was effective against preventing severe COVID-19 disease, as well as hospitalizations and death, this new data shows that the vaccine can also decrease transmission, which is very important on a public health level,” said Dr. Tien, professor of medicine in the division of infectious diseases at the University of California, San Francisco.
“It is extremely important in terms of getting to herd immunity,” Paul Goepfert, MD, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama, Birmingham, said in an interview. “It means that this vaccine is likely preventing subsequent transmission after a single dose, which could have huge implications once we get the majority of folks vaccinated.”
The FDA cautioned that the numbers of participants included in the study are relatively small and need to be verified. However, the Johnson & Johnson vaccine might not be the only product offering this advantage. Early data suggest that the Pfizer/BioNTech vaccine also decreases transmission, providing further evidence that the protection offered by immunization goes beyond the individual.
The new analyses were provided by the FDA in advance of its review of the Janssen/Johnson & Johnson vaccine. The agency plans to fully address the Ad26.COV2.S vaccine at its Vaccines and Related Biological Products Advisory Committee Meeting on Friday, including evaluating its safety and efficacy.
The agency’s decision on whether or not to grant emergency use authorization (EUA) to the Johnson & Johnson vaccine could come as early as Friday evening or Saturday.
In addition to the newly released data, officials are likely to discuss phase 3 data, released Jan. 29, that reveal an 85% efficacy for the vaccine against severe COVID-19 illness globally, including data from South America, South Africa, and the United States. When the analysis was restricted to data from U.S. participants, the trial showed a 73% efficacy against moderate to severe COVID-19.
If and when the FDA grants an EUA, it remains unclear how much of the new vaccine will be immediately available. Initially, Johnson & Johnson predicted 18 million doses would be ready by the end of February, but others stated the figure will be closer to 2-4 million. The manufacturer’s contract with the U.S. government stipulates production of 100-million doses by the end of June.
Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the SF VA HealthCare System. Dr. Goepfert has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The single-dose vaccine reduces the risk of asymptomatic transmission by 74% at 71 days, compared with placebo, according to documents released today by the U.S. Food and Drug Administration.
“The decrease in asymptomatic transmission is very welcome news too in curbing the spread of the virus,” Phyllis Tien, MD, told this news organization.
“While the earlier press release reported that the vaccine was effective against preventing severe COVID-19 disease, as well as hospitalizations and death, this new data shows that the vaccine can also decrease transmission, which is very important on a public health level,” said Dr. Tien, professor of medicine in the division of infectious diseases at the University of California, San Francisco.
“It is extremely important in terms of getting to herd immunity,” Paul Goepfert, MD, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama, Birmingham, said in an interview. “It means that this vaccine is likely preventing subsequent transmission after a single dose, which could have huge implications once we get the majority of folks vaccinated.”
The FDA cautioned that the numbers of participants included in the study are relatively small and need to be verified. However, the Johnson & Johnson vaccine might not be the only product offering this advantage. Early data suggest that the Pfizer/BioNTech vaccine also decreases transmission, providing further evidence that the protection offered by immunization goes beyond the individual.
The new analyses were provided by the FDA in advance of its review of the Janssen/Johnson & Johnson vaccine. The agency plans to fully address the Ad26.COV2.S vaccine at its Vaccines and Related Biological Products Advisory Committee Meeting on Friday, including evaluating its safety and efficacy.
The agency’s decision on whether or not to grant emergency use authorization (EUA) to the Johnson & Johnson vaccine could come as early as Friday evening or Saturday.
In addition to the newly released data, officials are likely to discuss phase 3 data, released Jan. 29, that reveal an 85% efficacy for the vaccine against severe COVID-19 illness globally, including data from South America, South Africa, and the United States. When the analysis was restricted to data from U.S. participants, the trial showed a 73% efficacy against moderate to severe COVID-19.
If and when the FDA grants an EUA, it remains unclear how much of the new vaccine will be immediately available. Initially, Johnson & Johnson predicted 18 million doses would be ready by the end of February, but others stated the figure will be closer to 2-4 million. The manufacturer’s contract with the U.S. government stipulates production of 100-million doses by the end of June.
Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the SF VA HealthCare System. Dr. Goepfert has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The single-dose vaccine reduces the risk of asymptomatic transmission by 74% at 71 days, compared with placebo, according to documents released today by the U.S. Food and Drug Administration.
“The decrease in asymptomatic transmission is very welcome news too in curbing the spread of the virus,” Phyllis Tien, MD, told this news organization.
“While the earlier press release reported that the vaccine was effective against preventing severe COVID-19 disease, as well as hospitalizations and death, this new data shows that the vaccine can also decrease transmission, which is very important on a public health level,” said Dr. Tien, professor of medicine in the division of infectious diseases at the University of California, San Francisco.
“It is extremely important in terms of getting to herd immunity,” Paul Goepfert, MD, director of the Alabama Vaccine Research Clinic and infectious disease specialist at the University of Alabama, Birmingham, said in an interview. “It means that this vaccine is likely preventing subsequent transmission after a single dose, which could have huge implications once we get the majority of folks vaccinated.”
The FDA cautioned that the numbers of participants included in the study are relatively small and need to be verified. However, the Johnson & Johnson vaccine might not be the only product offering this advantage. Early data suggest that the Pfizer/BioNTech vaccine also decreases transmission, providing further evidence that the protection offered by immunization goes beyond the individual.
The new analyses were provided by the FDA in advance of its review of the Janssen/Johnson & Johnson vaccine. The agency plans to fully address the Ad26.COV2.S vaccine at its Vaccines and Related Biological Products Advisory Committee Meeting on Friday, including evaluating its safety and efficacy.
The agency’s decision on whether or not to grant emergency use authorization (EUA) to the Johnson & Johnson vaccine could come as early as Friday evening or Saturday.
In addition to the newly released data, officials are likely to discuss phase 3 data, released Jan. 29, that reveal an 85% efficacy for the vaccine against severe COVID-19 illness globally, including data from South America, South Africa, and the United States. When the analysis was restricted to data from U.S. participants, the trial showed a 73% efficacy against moderate to severe COVID-19.
If and when the FDA grants an EUA, it remains unclear how much of the new vaccine will be immediately available. Initially, Johnson & Johnson predicted 18 million doses would be ready by the end of February, but others stated the figure will be closer to 2-4 million. The manufacturer’s contract with the U.S. government stipulates production of 100-million doses by the end of June.
Dr. Tien received support from Johnson & Johnson to conduct the J&J COVID-19 vaccine trial in the SF VA HealthCare System. Dr. Goepfert has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Loss of smell lingers post COVID-19
The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.
Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.
‘Striking’ finding
Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.
The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.
Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.
They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.
Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.
The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.
The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.
Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.
The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.
However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
Not a CNS problem?
Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.
For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.
“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.
The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.
Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.
The researchers have not yet examined whether the results differ by type of health care worker.
They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.
As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.
He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.
The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.
“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”
The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.
Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
Confirmatory findings
Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.
Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.
His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.
Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”
Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.
However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.
Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.
He also noted the difficulty of separating loss of smell from loss of taste.
“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.
Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.
‘Striking’ finding
Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.
The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.
Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.
They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.
Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.
The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.
The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.
Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.
The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.
However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
Not a CNS problem?
Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.
For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.
“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.
The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.
Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.
The researchers have not yet examined whether the results differ by type of health care worker.
They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.
As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.
He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.
The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.
“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”
The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.
Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
Confirmatory findings
Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.
Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.
His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.
Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”
Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.
However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.
Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.
He also noted the difficulty of separating loss of smell from loss of taste.
“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The findings illustrate that olfactory problems are common not only during the acute COVID-19 phase but also “in the long run” and that these problems should be “taken into consideration” when following up these patients, study investigator Johannes Frasnelli, MD, professor, department of anatomy, Université du Québec à Trois-Rivières, said in an interview.
Loss of the sense of smell can affect quality of life because it affects eating and drinking, and may even be dangerous, said Dr. Frasnelli. “If your sense of smell is impaired, you may unknowingly eat spoiled food, or you may not smell smoke or gas in your home,” he said. In addition, Dr. Frasnelli noted that an impaired sense of smell is associated with higher rates of depression. The findings will be presented at the annual meeting of the American Academy of Neurology in April.
‘Striking’ finding
Research shows that about 60% of patients with COVID-19 lose their sense of smell to some degree during the acute phase of the disease. “But we wanted to go further and look at the longer-term effects of loss of smell and taste,” said Dr. Frasnelli.
The analysis included 813 health care workers in the province of Quebec. For all the patients, SARS-CoV-2 infection was confirmed through testing with a nasopharyngeal viral swab.
Participants completed a 64-item online questionnaire that asked about three senses: olfactory; gustatory, which includes tastes such as sweet, sour, bitter, salty, savory and umami; and trigeminal, which includes sensations such as spiciness of hot peppers and “coolness” of mint.
They were asked to rate these on a scale of 0 (no perception) to 10 (very strong perception) before the infection, during the infection, and currently. They were also asked about other symptoms, including fatigue.
Most respondents had been infected in the first wave of the virus in March and April of 2020 and responded to the questionnaire an average of 5 months later.
The vast majority of respondents (84.1%) were women, which Dr. Frasnelli said was not surprising because women predominate in the health care field.
The analysis showed that average smell ratings were 8.98 before infection, 2.85 during the acute phase, and 7.41 when respondents answered the questionnaire. The sense of taste was less affected and recovered faster than did the sense of smell. Results for taste were 9.20 before infection, 3.59 during the acute phase, and 8.05 after COVID-19.
Among 580 respondents who indicated a compromised sense of smell during the acute phase, the average smell rating when answering the questionnaire was 6.89, compared to 9.03 before the infection. More than half (51.2%) reported not regaining full olfactory function.
The fact that the sense of smell had not returned to normal for half the participants so long after being infected is “novel and quite striking,” said Dr. Frasnelli.
However, he noted, this doesn’t necessarily mean all those with a compromised sense of smell “have huge problems.” In some cases, he said, the problem “is more subtle.”
Not a CNS problem?
Respondents also completed a chemosensory dysfunction home test (CD-HT). They were asked to prepare common household food items, such as peanut butter, sugar, salt, and vinegar, in a particular way – for example, to add sugar or salt to water – and provide feedback on how they smell and taste.
For this CD-HT analysis, 18.4% of respondents reported having persistent loss of smell. This, Dr. Frasnelli said, adds to evidence from self-reported responses and suggests that in some cases, the problem is more than senses not returning to normal.
“From the questionnaires, roughly 50% said their sense of smell is still not back to normal, and when we look at the CD home test, we see that almost 20% of subjects indeed have pretty strong impairment of their sense of smell,” he said.
The results showed no sex differences, although Dr. Frasnelli noted that most of the sample were women. “It’s tricky to look at the data with regard to sex because it’s a bit skewed,” he said.
Male respondents were older than female participants, but there was no difference in impairment between age groups. Dr. Frasnelli said this was “quite interesting,” inasmuch as older people usually lose some sense of smell.
The researchers have not yet examined whether the results differ by type of health care worker.
They also have not examined in detail whether infection severity affects the risk for extended olfactory impairment. Although some research suggests that the problem with smell is more common in less severe cases, Dr. Frasnelli noted this could be because loss of smell is not a huge problem for patients battling grave health problems.
As for other symptoms, many respondents reported lingering fatigue; some reported debilitating fatigue, said Dr. Frasnelli. However, he cautioned that this is difficult to interpret, because the participants were health care workers, many of whom returned to work during the pandemic and perhaps had not fully rested.
He also noted that he and his colleagues have not “made the link” between impaired smell and the degree of fatigue.
The COVID-19 virus appears to attack supporting sustentacular cells in the olfactory epithelium, not nerve cells.
“Right now, it seems that the smell problem is not a central nervous system problem but a peripheral problem,” said Dr. Frasnelli. “But we don’t know for sure; it may be that the virus somehow gets into the brain and some symptoms are caused by the effects of the infection on the brain.”
The researchers will extend their research with another questionnaire to assess senses 10-12 months after COVID-19.
Limitations of the study include the subjective nature of the smell and taste ratings and the single time point at which data were collected.
Confirmatory findings
Commenting on the research in an interview, Thomas Hummel, MD, professor, smell and taste clinic, department of otorhinolaryngology, Technische Universität Dresden (Germany), said the new results regarding loss of smell after COVID-19 are “very congruent” with what he and his colleagues have observed.
Research shows that up to one in five of those infected with SARS-CoV-2 experience olfactory loss. “While the numbers may vary a bit from study to study or lab to lab, I think 5% to 20% of post–COVID-19 patients exhibit long-term olfactory loss,” Dr. Hummel said.
His group has observed that “many more are not back to normal,” which conforms with what Dr. Frasnelli’s study reveals, said Dr. Hummel.
Also commenting on the research, Kenneth L. Tyler, MD, professor of neurology, University of Colorado at Denver, Aurora, and a fellow of the American Academy of Neurology, said the study was relatively large and the results “interesting.”
Although it “provides more evidence there’s a subset of patients with symptoms even well past the acute phase” of COVID-19, the results are “mostly confirmatory” and include “nothing super surprising,” Dr. Tyler said in an interview.
However, the investigators did attempt to make the study “a little more quantitative” and “to confirm the self-reporting with their validated CD home test,” he said.
Dr. Tyler wondered how representative the sample was and whether the study drew more participants with impaired senses. “If I had a loss of smell or taste, maybe I would be more likely to respond to such a survey,” he said.
He also noted the difficulty of separating loss of smell from loss of taste.
“If you lose your sense of smell, things don’t taste right, so it can be confounding as to how to separate out those two,” he noted.
The study was supported by the Foundation of the Université du Québec à Trois-Rivières and the Province of Quebec. Dr. Frasnelli has received royalties from Styriabooks in Austria for a book on olfaction published in 2019 and has received honoraria for speaking engagements. Dr. Hummel and Dr. Tyler have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SHM Converge: New format, fresh content
While we all long for a traditional in-person meeting “like the good old days”, there are some significant advantages to a virtual meeting like Converge.
The most significant advantage is the ability to review more content than ever before, as we offer a combination of live and recorded “on-demand” sessions. This allows for incredible flexibility in garnering “top-shelf” content from hospital medicine experts around the country, without having to choose from competing sessions. We are especially looking forward to new sessions this year focused on COVID-19; diversity, equity, and inclusion; and resilience.
The Converge conference will still be offering networking sessions throughout – even in the virtual conference environment. We consider networking a vital and endearing part of the value equation for SHM members. For example, we now can participate in several Special Interest Forums, since many of us have several niche interests and want to take advantage of more than one of these networking opportunities. We also carefully preserved the signature “Update in Hospital Medicine” session, as well as the scientific abstract poster reception and the Best of Research and Innovation sessions. These are long-term favorites at the annual conference and lend themselves well to virtual transformation. Some of the workshops and special sessions have exclusive audience engagement and are not offered on demand, so signing up early for these sessions is highly recommended.
SHM remains the professional home for hospitalists, and we rely on the annual conference to keep us all informed on current and forward-thinking clinical practice, practice management, leadership, academics, research, and other topics. This is one of many examples of how SHM has been able to pivot to meet the needs of hospitalists throughout the pandemic. Not only have we successfully converted “traditional” meetings into virtual meetings, but we have been able to curate and deliver content faster and more seamlessly than ever before.
Whether via The Hospitalist, the Journal of Hospital Medicine, the SHM website, or our other educational platforms, SHM has remained committed to being the single “source of truth” for all things hospital medicine. Within the tumultuous political landscape of the past year, the SHM advocacy team has been more active and engaged than ever, in advocating for a myriad of hospitalist-related legislative changes. These are just a few of the ways SHM continues to add value to hospitalist members every day.
Although we will certainly miss seeing each other in person, we are confident that the SHM team will meet and exceed expectations on content delivery and will take advantage of the virtual format to improve content access. We look forward to “seeing” you at SHM Converge this year and hope you take advantage of the enhanced delivery and access to an array of amazing content!
Dr. Scheurer is president of the Society of Hospital Medicine. She is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston.
While we all long for a traditional in-person meeting “like the good old days”, there are some significant advantages to a virtual meeting like Converge.
The most significant advantage is the ability to review more content than ever before, as we offer a combination of live and recorded “on-demand” sessions. This allows for incredible flexibility in garnering “top-shelf” content from hospital medicine experts around the country, without having to choose from competing sessions. We are especially looking forward to new sessions this year focused on COVID-19; diversity, equity, and inclusion; and resilience.
The Converge conference will still be offering networking sessions throughout – even in the virtual conference environment. We consider networking a vital and endearing part of the value equation for SHM members. For example, we now can participate in several Special Interest Forums, since many of us have several niche interests and want to take advantage of more than one of these networking opportunities. We also carefully preserved the signature “Update in Hospital Medicine” session, as well as the scientific abstract poster reception and the Best of Research and Innovation sessions. These are long-term favorites at the annual conference and lend themselves well to virtual transformation. Some of the workshops and special sessions have exclusive audience engagement and are not offered on demand, so signing up early for these sessions is highly recommended.
SHM remains the professional home for hospitalists, and we rely on the annual conference to keep us all informed on current and forward-thinking clinical practice, practice management, leadership, academics, research, and other topics. This is one of many examples of how SHM has been able to pivot to meet the needs of hospitalists throughout the pandemic. Not only have we successfully converted “traditional” meetings into virtual meetings, but we have been able to curate and deliver content faster and more seamlessly than ever before.
Whether via The Hospitalist, the Journal of Hospital Medicine, the SHM website, or our other educational platforms, SHM has remained committed to being the single “source of truth” for all things hospital medicine. Within the tumultuous political landscape of the past year, the SHM advocacy team has been more active and engaged than ever, in advocating for a myriad of hospitalist-related legislative changes. These are just a few of the ways SHM continues to add value to hospitalist members every day.
Although we will certainly miss seeing each other in person, we are confident that the SHM team will meet and exceed expectations on content delivery and will take advantage of the virtual format to improve content access. We look forward to “seeing” you at SHM Converge this year and hope you take advantage of the enhanced delivery and access to an array of amazing content!
Dr. Scheurer is president of the Society of Hospital Medicine. She is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston.
While we all long for a traditional in-person meeting “like the good old days”, there are some significant advantages to a virtual meeting like Converge.
The most significant advantage is the ability to review more content than ever before, as we offer a combination of live and recorded “on-demand” sessions. This allows for incredible flexibility in garnering “top-shelf” content from hospital medicine experts around the country, without having to choose from competing sessions. We are especially looking forward to new sessions this year focused on COVID-19; diversity, equity, and inclusion; and resilience.
The Converge conference will still be offering networking sessions throughout – even in the virtual conference environment. We consider networking a vital and endearing part of the value equation for SHM members. For example, we now can participate in several Special Interest Forums, since many of us have several niche interests and want to take advantage of more than one of these networking opportunities. We also carefully preserved the signature “Update in Hospital Medicine” session, as well as the scientific abstract poster reception and the Best of Research and Innovation sessions. These are long-term favorites at the annual conference and lend themselves well to virtual transformation. Some of the workshops and special sessions have exclusive audience engagement and are not offered on demand, so signing up early for these sessions is highly recommended.
SHM remains the professional home for hospitalists, and we rely on the annual conference to keep us all informed on current and forward-thinking clinical practice, practice management, leadership, academics, research, and other topics. This is one of many examples of how SHM has been able to pivot to meet the needs of hospitalists throughout the pandemic. Not only have we successfully converted “traditional” meetings into virtual meetings, but we have been able to curate and deliver content faster and more seamlessly than ever before.
Whether via The Hospitalist, the Journal of Hospital Medicine, the SHM website, or our other educational platforms, SHM has remained committed to being the single “source of truth” for all things hospital medicine. Within the tumultuous political landscape of the past year, the SHM advocacy team has been more active and engaged than ever, in advocating for a myriad of hospitalist-related legislative changes. These are just a few of the ways SHM continues to add value to hospitalist members every day.
Although we will certainly miss seeing each other in person, we are confident that the SHM team will meet and exceed expectations on content delivery and will take advantage of the virtual format to improve content access. We look forward to “seeing” you at SHM Converge this year and hope you take advantage of the enhanced delivery and access to an array of amazing content!
Dr. Scheurer is president of the Society of Hospital Medicine. She is a hospitalist and chief quality officer, MUSC Health System, Medical University of South Carolina, Charleston.
New cases of child COVID-19 drop for fifth straight week
The fifth consecutive week with a decline has the number of new COVID-19 cases in children at its lowest level since late October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
, when 61,000 cases were reported, the AAP and CHA said in their weekly COVID-19 report.
The cumulative number of COVID-19 cases in children is now just over 3.1 million, which represents 13.1% of cases among all ages in the United States, based on data gathered from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
More children in California (439,000) have been infected than in any other state, while Illinois (176,000), Florida (145,000), Tennessee (137,000), Arizona (127,000), Ohio (121,000), and Pennsylvania (111,000) are the only other states with more than 100,000 cases, the AAP/CHA report shows.
Proportionally, the children of Wyoming have been hardest hit: Pediatric cases represent 19.4% of all cases in the state. The other four states with proportions of 18% or more are Alaska, Vermont, South Carolina, and Tennessee. Cumulative rates, however, tell a somewhat different story, as North Dakota leads with just over 8,500 cases per 100,000 children, followed by Tennessee (7,700 per 100,000) and Rhode Island (7,000 per 100,000), the AAP and CHA said.
Deaths in children, which had not been following the trend of fewer new cases over the last few weeks, dropped below double digits for the first time in a month. The six deaths that occurred during the week of Feb. 12-18 bring the total to 247 since the start of the pandemic in the 43 states, along with New York City and Guam, that are reporting such data, according to the report.
The fifth consecutive week with a decline has the number of new COVID-19 cases in children at its lowest level since late October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
, when 61,000 cases were reported, the AAP and CHA said in their weekly COVID-19 report.
The cumulative number of COVID-19 cases in children is now just over 3.1 million, which represents 13.1% of cases among all ages in the United States, based on data gathered from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
More children in California (439,000) have been infected than in any other state, while Illinois (176,000), Florida (145,000), Tennessee (137,000), Arizona (127,000), Ohio (121,000), and Pennsylvania (111,000) are the only other states with more than 100,000 cases, the AAP/CHA report shows.
Proportionally, the children of Wyoming have been hardest hit: Pediatric cases represent 19.4% of all cases in the state. The other four states with proportions of 18% or more are Alaska, Vermont, South Carolina, and Tennessee. Cumulative rates, however, tell a somewhat different story, as North Dakota leads with just over 8,500 cases per 100,000 children, followed by Tennessee (7,700 per 100,000) and Rhode Island (7,000 per 100,000), the AAP and CHA said.
Deaths in children, which had not been following the trend of fewer new cases over the last few weeks, dropped below double digits for the first time in a month. The six deaths that occurred during the week of Feb. 12-18 bring the total to 247 since the start of the pandemic in the 43 states, along with New York City and Guam, that are reporting such data, according to the report.
The fifth consecutive week with a decline has the number of new COVID-19 cases in children at its lowest level since late October, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
, when 61,000 cases were reported, the AAP and CHA said in their weekly COVID-19 report.
The cumulative number of COVID-19 cases in children is now just over 3.1 million, which represents 13.1% of cases among all ages in the United States, based on data gathered from the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
More children in California (439,000) have been infected than in any other state, while Illinois (176,000), Florida (145,000), Tennessee (137,000), Arizona (127,000), Ohio (121,000), and Pennsylvania (111,000) are the only other states with more than 100,000 cases, the AAP/CHA report shows.
Proportionally, the children of Wyoming have been hardest hit: Pediatric cases represent 19.4% of all cases in the state. The other four states with proportions of 18% or more are Alaska, Vermont, South Carolina, and Tennessee. Cumulative rates, however, tell a somewhat different story, as North Dakota leads with just over 8,500 cases per 100,000 children, followed by Tennessee (7,700 per 100,000) and Rhode Island (7,000 per 100,000), the AAP and CHA said.
Deaths in children, which had not been following the trend of fewer new cases over the last few weeks, dropped below double digits for the first time in a month. The six deaths that occurred during the week of Feb. 12-18 bring the total to 247 since the start of the pandemic in the 43 states, along with New York City and Guam, that are reporting such data, according to the report.
Accessing data during EHR downtime
Reducing loss of efficiency
Electronic health record (EHR) implementations involve long downtimes, which are an under-recognized patient safety risk, as clinicians are forced to switch to completely manual, paper-based, and important unfamiliar workflows to care for their acutely ill patients, said Subha Airan-Javia, MD, FAMIA, a hospitalist at the University of Pennsylvania, Philadelphia.
“In this setting, we discovered an unanticipated benefit of our tool [Carelign, initially built to digitize the handoff process] as a clinical resource during EHR downtime, giving clinicians access to critical data as well as an electronic platform to collaborate as a team around the care of their patients,” she said.
There are two important takeaways from their study on this issue. “The first is that Carelign was able to give clinicians access to clinical data that would otherwise have been unavailable, including vitals, labs, medications, care plans and care team assignments,” Dr. Airan-Javia said. “This undoubtedly mitigated patient safety risks during the EHR downtime.”
The second: “As many clinicians know, any change in workflow, even for a few hours, can make providing a high level of patient care very difficult,” she added. “During a downtime without a tool like Carelign, clinicians have to rely on paper and bedside charts, writing notes on paper and then re-typing them into the EHR when it is back up. This adds to the already excessive amount of administrative work that is burning clinicians out.” Using a tool like Carelign means no such loss in efficiency.
“A tool like Carelign, particularly because it is something that can be used without having to integrate it with the EHR, can put some control back into a hospitalist’s hands, to have a say in their workflow,” Dr. Airan-Javia said. “In a world where EHRs are designed to optimize billing, it can be game-changer to have a tool like Carelign that was created by a practicing clinician, for clinicians. Anyone interested in this area is welcome to reach out to me at [email protected] for collaboration or more information.”
Reference
1. Airan-Javia SL, et al. Mind the gap: Revolutionizing the EHR downtime experience with an interoperable workflow tool. Abstract published at Hospital Medicine 2019, March 24-27, National Harbor, Md. Abstract 380. https://www.shmabstracts.com/abstract/mind-the-gap-revolutionizing-the-ehr-downtime-experience-with-an-interoperable-workflow-tool/. Accessed Dec 11, 2019.
Reducing loss of efficiency
Reducing loss of efficiency
Electronic health record (EHR) implementations involve long downtimes, which are an under-recognized patient safety risk, as clinicians are forced to switch to completely manual, paper-based, and important unfamiliar workflows to care for their acutely ill patients, said Subha Airan-Javia, MD, FAMIA, a hospitalist at the University of Pennsylvania, Philadelphia.
“In this setting, we discovered an unanticipated benefit of our tool [Carelign, initially built to digitize the handoff process] as a clinical resource during EHR downtime, giving clinicians access to critical data as well as an electronic platform to collaborate as a team around the care of their patients,” she said.
There are two important takeaways from their study on this issue. “The first is that Carelign was able to give clinicians access to clinical data that would otherwise have been unavailable, including vitals, labs, medications, care plans and care team assignments,” Dr. Airan-Javia said. “This undoubtedly mitigated patient safety risks during the EHR downtime.”
The second: “As many clinicians know, any change in workflow, even for a few hours, can make providing a high level of patient care very difficult,” she added. “During a downtime without a tool like Carelign, clinicians have to rely on paper and bedside charts, writing notes on paper and then re-typing them into the EHR when it is back up. This adds to the already excessive amount of administrative work that is burning clinicians out.” Using a tool like Carelign means no such loss in efficiency.
“A tool like Carelign, particularly because it is something that can be used without having to integrate it with the EHR, can put some control back into a hospitalist’s hands, to have a say in their workflow,” Dr. Airan-Javia said. “In a world where EHRs are designed to optimize billing, it can be game-changer to have a tool like Carelign that was created by a practicing clinician, for clinicians. Anyone interested in this area is welcome to reach out to me at [email protected] for collaboration or more information.”
Reference
1. Airan-Javia SL, et al. Mind the gap: Revolutionizing the EHR downtime experience with an interoperable workflow tool. Abstract published at Hospital Medicine 2019, March 24-27, National Harbor, Md. Abstract 380. https://www.shmabstracts.com/abstract/mind-the-gap-revolutionizing-the-ehr-downtime-experience-with-an-interoperable-workflow-tool/. Accessed Dec 11, 2019.
Electronic health record (EHR) implementations involve long downtimes, which are an under-recognized patient safety risk, as clinicians are forced to switch to completely manual, paper-based, and important unfamiliar workflows to care for their acutely ill patients, said Subha Airan-Javia, MD, FAMIA, a hospitalist at the University of Pennsylvania, Philadelphia.
“In this setting, we discovered an unanticipated benefit of our tool [Carelign, initially built to digitize the handoff process] as a clinical resource during EHR downtime, giving clinicians access to critical data as well as an electronic platform to collaborate as a team around the care of their patients,” she said.
There are two important takeaways from their study on this issue. “The first is that Carelign was able to give clinicians access to clinical data that would otherwise have been unavailable, including vitals, labs, medications, care plans and care team assignments,” Dr. Airan-Javia said. “This undoubtedly mitigated patient safety risks during the EHR downtime.”
The second: “As many clinicians know, any change in workflow, even for a few hours, can make providing a high level of patient care very difficult,” she added. “During a downtime without a tool like Carelign, clinicians have to rely on paper and bedside charts, writing notes on paper and then re-typing them into the EHR when it is back up. This adds to the already excessive amount of administrative work that is burning clinicians out.” Using a tool like Carelign means no such loss in efficiency.
“A tool like Carelign, particularly because it is something that can be used without having to integrate it with the EHR, can put some control back into a hospitalist’s hands, to have a say in their workflow,” Dr. Airan-Javia said. “In a world where EHRs are designed to optimize billing, it can be game-changer to have a tool like Carelign that was created by a practicing clinician, for clinicians. Anyone interested in this area is welcome to reach out to me at [email protected] for collaboration or more information.”
Reference
1. Airan-Javia SL, et al. Mind the gap: Revolutionizing the EHR downtime experience with an interoperable workflow tool. Abstract published at Hospital Medicine 2019, March 24-27, National Harbor, Md. Abstract 380. https://www.shmabstracts.com/abstract/mind-the-gap-revolutionizing-the-ehr-downtime-experience-with-an-interoperable-workflow-tool/. Accessed Dec 11, 2019.
Variants spur new FDA guidance on COVID vaccines, tests, drugs
The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.
Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
Tailoring may be necessary
Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.
In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.
Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.
Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
Variants and testing
The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.
The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.
However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
Updated guidance for therapeutics
The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.
“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”
While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.
The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”
Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”
A version of this article first appeared on Medscape.com.
The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.
Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
Tailoring may be necessary
Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.
In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.
Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.
Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
Variants and testing
The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.
The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.
However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
Updated guidance for therapeutics
The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.
“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”
While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.
The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”
Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”
A version of this article first appeared on Medscape.com.
The United States is currently facing three main variant threats, according to the Centers for Disease Control and Prevention: B.1.1.7, which originated in the United Kingdom; B.1.351 from South Africa; and the P.1 variant, which originated in Brazil.
Acting FDA Commissioner Janet Woodcock, MD, said on a telephone press briefing call Feb. 22 that the FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products, but these guidelines are issued for the sake of transparency and to welcome scientific input.
Tailoring may be necessary
Dr. Woodcock emphasized that, “at this time, available data suggest the FDA-authorized vaccines are effective in protecting circulating strains of SARS-CoV-2.” However, in the event the strains start to show resistance, it may be necessary to tailor the vaccine to the variant.
In that case, effectiveness of a modified vaccine should be determined by data from clinical immunogenicity studies, which would compare a recipient’s immune response with virus variants induced by the modified vaccine against the immune response to the authorized vaccine, the guidance states.
Manufacturers should also study the vaccine in both nonvaccinated people and people fully vaccinated with the authorized vaccine, according to the guidance.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said on the call that the clinical immunogenicity data is needed to understand, for instance, whether a new vaccine strain is able to cover the new and old strain or whether it just covers the new strain. Information is also needed to understand whether the modified vaccine, when given to someone fully vaccinated, will still promote a positive response without introducing safety concerns.
Further discussions will be necessary to decide whether future modified vaccines may be authorized without the need for clinical studies.
Variants and testing
The FDA’s updated guidance for test developers, Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests, includes information that test performance can be influenced by the sequence of the variant, prevalence of the variant in the population, or design of the test. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to genetic variants than tests designed to detect a single genetic target.
The FDA already issued a safety alert on Jan. 8 to caution that genetic mutations to the virus in a patient sample can potentially change the performance of a diagnostic test. The FDA identified three tests that had been granted emergency-use authorization (EUA) that are known to be affected.
However, Dr. Woodcock said on the call, “at this time the impact does not appear to be significant.”
Updated guidance for therapeutics
The FDA has issued new guidance on the effect of variants on monoclonal antibody treatments.
“The FDA is aware that some of the monoclonal antibodies that have been authorized are less active against some of the SARS-CoV-2 variants that have emerged,” the FDA noted in its press release. “This guidance provides recommendations on efficient approaches to the generation of ... manufacturing and controls data that could potentially support an EUA for monoclonal antibody products that may be effective against emerging variants.”
While the FDA is monitoring the effects of variants, manufacturers bear a lot of the responsibility as well.
The FDA added: “With these guidances, the FDA is encouraging developers of drugs or biological products targeting SARS-CoV-2 to continuously monitor genomic databases for emerging SARS-CoV-2 variants and evaluate phenotypically any specific variants in the product target that are becoming prevalent or could potentially impact its activity.”
Dr.Woodcock added that “we urge all Americans to continue to get tested, get their vaccines when available, and follow important heath measures such as handwashing, masking, and social distancing.”
A version of this article first appeared on Medscape.com.
New light cast on type 2 MI aims to sharpen diagnosis, therapy
The hospital and postdischarge course of patients diagnosed with type 2 myocardial infarction, triggered when myocardial oxygen demand outstrips supply, differs in telling ways from those with the more common atherothrombotic type 1 MI, suggests a new registry analysis that aims to lift a cloud of confusion surrounding their management.
The observational study of more than 250,000 patients with either form of MI, said to be the largest of its kind, points to widespread unfamiliarity with distinctions between the two, and the diagnostic and therapeutic implications of misclassification. It suggests, in particular, that type 2 MI may be grossly underdiagnosed and undertreated.
The minority of patients with type 2 MI were more likely female and to have heart failure (HF), renal disease, valve disease, or atrial fibrillation, and less likely to have a lipid disorder, compared with those with type 1 MI. They were one-fifth as likely to be referred for coronary angiography and 20 times less likely to undergo revascularization.
Indeed, only about 2% of the type 2 cohort ultimately underwent percutaneous coronary intervention (PCI) or coronary bypass surgery (CABG). Yet the analysis suggests that cardiovascular risk climbs regardless of MI type and that in patients with type 2 MI, coronary revascularization might well cut the risk of death in half over the short term.
There were also disparities in clinical outcomes in the analysis, based on data from the final 3 months of 2017 in the Nationwide Readmissions Database, which reportedly documents almost 60% of hospitalizations in the United States.
For example, those with type 1 or type 2 MI – as characterized in the then-current third Universal Definition of Myocardial Infarction and today’s UDMI-4 – were comparably at risk for both 30-day all-cause readmission and HF readmission. But type 2 patients were less likely to die in the hospital or be readmitted within 30 days for recurrent MI.
Revascularization uncertainty
Importantly, the study’s 3-month observation period immediately followed the debut of a code specifically for type 2 MI in the ICD-10-CM system.
Type 2 accounted for about 15% of MIs during that period, the percentage climbing sharply from the first to the third month. That suggests clinicians were still getting used to the code during the early weeks, “undercoding” for type-2 MI at first but less so after some experience, Cian P. McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston, said in an interview.
“I can imagine that as people become more aware of the coding, using it more often, the proportion of type 2 MI relative to the total MI cases will probably be much higher,” said McCarthy, lead author on the study published online Feb. 15, 2021, in the Journal of the American College of Cardiology.
What had been understood about type 2 MI came largely from single-center studies, he said. This “first national study of type-2 MI in the United States” sought to determine whether such findings are hospital specific or “representative of what people are doing nationally.”
The new analysis largely confirms that patients with type 2 MI are typically burdened with multiple comorbidities, Dr. McCarthy said, but also suggests that type 2 often was, and likely still is, incorrectly classified as type 1. So, it was “surprising” that they were rarely referred for angiography. “Only 1 in 50 received revascularization.”
Those diagnosed with type-2 MI were far less likely to receive coronary angiography (10.9% vs. 57.3%), PCI (1.7% vs. 38.5%), or CABG (0.4% vs. 7.8%) (P < .001 for all three differences), the report noted.
That, Dr. McCarthy said, “clearly shows that clinicians are uncertain about whether revascularization is beneficial” in type 2 MI.
Coding not in sync with UDMI
If there is confusion in practice about differentiating type 2 from type 1 MI, it likely has multiple sources, and one may be inconsistencies in how the UDMI and relevant ICD codes are applied in practice.
For example, the coding mandate is always to classify ST-segment elevation MI and non-STEMI as type 1, yet UDMI-4 itself states that a type 2 MI may be either STEMI or non-STEMI, noted Dr. McCarthy, as well as an editorial accompanying the report.
“It also can be difficult at times to distinguish type 2 MI from the diagnosis of myocardial injury,” both of which are partly defined by elevated cardiac troponin (cTn), adds the editorial, from Kristian Thygesen, MD, DSc, Aarhus (Denmark) University Hospital, Aarhus, Denmark, and Allan S. Jaffe, MD, Mayo Clinic, Rochester, Minn.
Crucially, but potentially sometimes overlooked, a diagnosis of infarction requires evidence of ischemia along with the biomarker elevation, whereas myocardial injury is defined by raised cTn without evidence of ischemia. Yet there is no ICD-10-CM code for “nonischemic myocardial injury,” Dr. Thygesen and Dr. Jaffe observed.
“Instead, the new ICD-10-CM coding includes a proxy called ‘non-MI troponin elevation due to an underlying cause,’ ” they wrote. “Unfortunately, although some have advocated using this code for myocardial injury, it is not specific for an elevated cTn value and could represent any abnormal laboratory measurements.” The code could be “misleading” and thus worsen the potential for miscoding and “misattribution of MI diagnoses.”
In the current study, 84.6% of the cohort were classified with type 1 MI, 14.8% with type 2, and 0.6% with both types. Of those with type 1 MI, 22.1% had STEMI, 76.4% had non-STEMI with the remainder “unspecified.”
“I think the introduction of ICD codes for type-2 MI is helpful in that we can study type 2 MI more broadly, across institutions, and try and get a better sense of its outcomes and how these patients are treated,” Dr. McCarthy said. But the coding system’s deficiencies may often lead to misclassification of patients. Especially, patients with type 2 STEMI may be miscoded as having type-1 STEMI, and those with only myocardial injury may be miscoded as having type 2 MI.
Most type 2 MI is a complication
A profile of patients with type 2 MI may be helpful for making distinctions. The analysis showed that, compared with patients with type 1 MI, they were slightly but significantly older and more likely to have clinical depression, alcohol or other substance abuse disorder, and to be female. They also had more heart failure (27.9% vs. 10.9%), kidney disease (35.7% vs. 25.7%), atrial fibrillation (31% vs. 21%), and anemia (26% vs. 18.9%) (P < .001 for all differences).
Type 2 patients were less likely to have CV risk factors usually associated with plaque instability and atherothrombosis, including a history of smoking, dyslipidemia, MI, PCI, or CABG (P < .001 for all differences), the group noted.
Of the 37,765 patients with type 2 MI, 91% received the diagnosis as secondary to another condition, including sepsis in 24.5%, hypertension in 16.9%, arrhythmias in 6.1%, respiratory failure in 4.3%, and pneumonia in 2.8% of cases.
In multivariate analyses, patients with type 2 MI, compared with type 1, showed lower risks of in-hospital death and readmission for MI within 30 days. Their 30-day risks of readmission from any cause and from MI were similar.
In-hospital mortality was lower for patients with type 2 MI who underwent revascularization, compared with those who did not, “but they were a very select, small proportion of the patient group. I would say there are probably unmeasured confounders,” Dr. McCarthy said.
“There’s a real kind of equipoise, so I think we desperately need a trial to guide us on whether revascularization is beneficial.”
Dr. McCarthy has disclosed no relevant financial relationships. Dr. Thygesen disclosed no relevant financial relationships. Dr. Jaffe disclosed serving as a consultant for Abbott, Roche, Siemens, Beckman-Coulter, Radiometer, ET Healthcare, Sphingotec, Brava, Quidel, Amgen, Novartis, and Medscape for educational activities.
A version of this article first appeared on Medscape.com.
The hospital and postdischarge course of patients diagnosed with type 2 myocardial infarction, triggered when myocardial oxygen demand outstrips supply, differs in telling ways from those with the more common atherothrombotic type 1 MI, suggests a new registry analysis that aims to lift a cloud of confusion surrounding their management.
The observational study of more than 250,000 patients with either form of MI, said to be the largest of its kind, points to widespread unfamiliarity with distinctions between the two, and the diagnostic and therapeutic implications of misclassification. It suggests, in particular, that type 2 MI may be grossly underdiagnosed and undertreated.
The minority of patients with type 2 MI were more likely female and to have heart failure (HF), renal disease, valve disease, or atrial fibrillation, and less likely to have a lipid disorder, compared with those with type 1 MI. They were one-fifth as likely to be referred for coronary angiography and 20 times less likely to undergo revascularization.
Indeed, only about 2% of the type 2 cohort ultimately underwent percutaneous coronary intervention (PCI) or coronary bypass surgery (CABG). Yet the analysis suggests that cardiovascular risk climbs regardless of MI type and that in patients with type 2 MI, coronary revascularization might well cut the risk of death in half over the short term.
There were also disparities in clinical outcomes in the analysis, based on data from the final 3 months of 2017 in the Nationwide Readmissions Database, which reportedly documents almost 60% of hospitalizations in the United States.
For example, those with type 1 or type 2 MI – as characterized in the then-current third Universal Definition of Myocardial Infarction and today’s UDMI-4 – were comparably at risk for both 30-day all-cause readmission and HF readmission. But type 2 patients were less likely to die in the hospital or be readmitted within 30 days for recurrent MI.
Revascularization uncertainty
Importantly, the study’s 3-month observation period immediately followed the debut of a code specifically for type 2 MI in the ICD-10-CM system.
Type 2 accounted for about 15% of MIs during that period, the percentage climbing sharply from the first to the third month. That suggests clinicians were still getting used to the code during the early weeks, “undercoding” for type-2 MI at first but less so after some experience, Cian P. McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston, said in an interview.
“I can imagine that as people become more aware of the coding, using it more often, the proportion of type 2 MI relative to the total MI cases will probably be much higher,” said McCarthy, lead author on the study published online Feb. 15, 2021, in the Journal of the American College of Cardiology.
What had been understood about type 2 MI came largely from single-center studies, he said. This “first national study of type-2 MI in the United States” sought to determine whether such findings are hospital specific or “representative of what people are doing nationally.”
The new analysis largely confirms that patients with type 2 MI are typically burdened with multiple comorbidities, Dr. McCarthy said, but also suggests that type 2 often was, and likely still is, incorrectly classified as type 1. So, it was “surprising” that they were rarely referred for angiography. “Only 1 in 50 received revascularization.”
Those diagnosed with type-2 MI were far less likely to receive coronary angiography (10.9% vs. 57.3%), PCI (1.7% vs. 38.5%), or CABG (0.4% vs. 7.8%) (P < .001 for all three differences), the report noted.
That, Dr. McCarthy said, “clearly shows that clinicians are uncertain about whether revascularization is beneficial” in type 2 MI.
Coding not in sync with UDMI
If there is confusion in practice about differentiating type 2 from type 1 MI, it likely has multiple sources, and one may be inconsistencies in how the UDMI and relevant ICD codes are applied in practice.
For example, the coding mandate is always to classify ST-segment elevation MI and non-STEMI as type 1, yet UDMI-4 itself states that a type 2 MI may be either STEMI or non-STEMI, noted Dr. McCarthy, as well as an editorial accompanying the report.
“It also can be difficult at times to distinguish type 2 MI from the diagnosis of myocardial injury,” both of which are partly defined by elevated cardiac troponin (cTn), adds the editorial, from Kristian Thygesen, MD, DSc, Aarhus (Denmark) University Hospital, Aarhus, Denmark, and Allan S. Jaffe, MD, Mayo Clinic, Rochester, Minn.
Crucially, but potentially sometimes overlooked, a diagnosis of infarction requires evidence of ischemia along with the biomarker elevation, whereas myocardial injury is defined by raised cTn without evidence of ischemia. Yet there is no ICD-10-CM code for “nonischemic myocardial injury,” Dr. Thygesen and Dr. Jaffe observed.
“Instead, the new ICD-10-CM coding includes a proxy called ‘non-MI troponin elevation due to an underlying cause,’ ” they wrote. “Unfortunately, although some have advocated using this code for myocardial injury, it is not specific for an elevated cTn value and could represent any abnormal laboratory measurements.” The code could be “misleading” and thus worsen the potential for miscoding and “misattribution of MI diagnoses.”
In the current study, 84.6% of the cohort were classified with type 1 MI, 14.8% with type 2, and 0.6% with both types. Of those with type 1 MI, 22.1% had STEMI, 76.4% had non-STEMI with the remainder “unspecified.”
“I think the introduction of ICD codes for type-2 MI is helpful in that we can study type 2 MI more broadly, across institutions, and try and get a better sense of its outcomes and how these patients are treated,” Dr. McCarthy said. But the coding system’s deficiencies may often lead to misclassification of patients. Especially, patients with type 2 STEMI may be miscoded as having type-1 STEMI, and those with only myocardial injury may be miscoded as having type 2 MI.
Most type 2 MI is a complication
A profile of patients with type 2 MI may be helpful for making distinctions. The analysis showed that, compared with patients with type 1 MI, they were slightly but significantly older and more likely to have clinical depression, alcohol or other substance abuse disorder, and to be female. They also had more heart failure (27.9% vs. 10.9%), kidney disease (35.7% vs. 25.7%), atrial fibrillation (31% vs. 21%), and anemia (26% vs. 18.9%) (P < .001 for all differences).
Type 2 patients were less likely to have CV risk factors usually associated with plaque instability and atherothrombosis, including a history of smoking, dyslipidemia, MI, PCI, or CABG (P < .001 for all differences), the group noted.
Of the 37,765 patients with type 2 MI, 91% received the diagnosis as secondary to another condition, including sepsis in 24.5%, hypertension in 16.9%, arrhythmias in 6.1%, respiratory failure in 4.3%, and pneumonia in 2.8% of cases.
In multivariate analyses, patients with type 2 MI, compared with type 1, showed lower risks of in-hospital death and readmission for MI within 30 days. Their 30-day risks of readmission from any cause and from MI were similar.
In-hospital mortality was lower for patients with type 2 MI who underwent revascularization, compared with those who did not, “but they were a very select, small proportion of the patient group. I would say there are probably unmeasured confounders,” Dr. McCarthy said.
“There’s a real kind of equipoise, so I think we desperately need a trial to guide us on whether revascularization is beneficial.”
Dr. McCarthy has disclosed no relevant financial relationships. Dr. Thygesen disclosed no relevant financial relationships. Dr. Jaffe disclosed serving as a consultant for Abbott, Roche, Siemens, Beckman-Coulter, Radiometer, ET Healthcare, Sphingotec, Brava, Quidel, Amgen, Novartis, and Medscape for educational activities.
A version of this article first appeared on Medscape.com.
The hospital and postdischarge course of patients diagnosed with type 2 myocardial infarction, triggered when myocardial oxygen demand outstrips supply, differs in telling ways from those with the more common atherothrombotic type 1 MI, suggests a new registry analysis that aims to lift a cloud of confusion surrounding their management.
The observational study of more than 250,000 patients with either form of MI, said to be the largest of its kind, points to widespread unfamiliarity with distinctions between the two, and the diagnostic and therapeutic implications of misclassification. It suggests, in particular, that type 2 MI may be grossly underdiagnosed and undertreated.
The minority of patients with type 2 MI were more likely female and to have heart failure (HF), renal disease, valve disease, or atrial fibrillation, and less likely to have a lipid disorder, compared with those with type 1 MI. They were one-fifth as likely to be referred for coronary angiography and 20 times less likely to undergo revascularization.
Indeed, only about 2% of the type 2 cohort ultimately underwent percutaneous coronary intervention (PCI) or coronary bypass surgery (CABG). Yet the analysis suggests that cardiovascular risk climbs regardless of MI type and that in patients with type 2 MI, coronary revascularization might well cut the risk of death in half over the short term.
There were also disparities in clinical outcomes in the analysis, based on data from the final 3 months of 2017 in the Nationwide Readmissions Database, which reportedly documents almost 60% of hospitalizations in the United States.
For example, those with type 1 or type 2 MI – as characterized in the then-current third Universal Definition of Myocardial Infarction and today’s UDMI-4 – were comparably at risk for both 30-day all-cause readmission and HF readmission. But type 2 patients were less likely to die in the hospital or be readmitted within 30 days for recurrent MI.
Revascularization uncertainty
Importantly, the study’s 3-month observation period immediately followed the debut of a code specifically for type 2 MI in the ICD-10-CM system.
Type 2 accounted for about 15% of MIs during that period, the percentage climbing sharply from the first to the third month. That suggests clinicians were still getting used to the code during the early weeks, “undercoding” for type-2 MI at first but less so after some experience, Cian P. McCarthy, MB, BCh, BAO, Massachusetts General Hospital, Boston, said in an interview.
“I can imagine that as people become more aware of the coding, using it more often, the proportion of type 2 MI relative to the total MI cases will probably be much higher,” said McCarthy, lead author on the study published online Feb. 15, 2021, in the Journal of the American College of Cardiology.
What had been understood about type 2 MI came largely from single-center studies, he said. This “first national study of type-2 MI in the United States” sought to determine whether such findings are hospital specific or “representative of what people are doing nationally.”
The new analysis largely confirms that patients with type 2 MI are typically burdened with multiple comorbidities, Dr. McCarthy said, but also suggests that type 2 often was, and likely still is, incorrectly classified as type 1. So, it was “surprising” that they were rarely referred for angiography. “Only 1 in 50 received revascularization.”
Those diagnosed with type-2 MI were far less likely to receive coronary angiography (10.9% vs. 57.3%), PCI (1.7% vs. 38.5%), or CABG (0.4% vs. 7.8%) (P < .001 for all three differences), the report noted.
That, Dr. McCarthy said, “clearly shows that clinicians are uncertain about whether revascularization is beneficial” in type 2 MI.
Coding not in sync with UDMI
If there is confusion in practice about differentiating type 2 from type 1 MI, it likely has multiple sources, and one may be inconsistencies in how the UDMI and relevant ICD codes are applied in practice.
For example, the coding mandate is always to classify ST-segment elevation MI and non-STEMI as type 1, yet UDMI-4 itself states that a type 2 MI may be either STEMI or non-STEMI, noted Dr. McCarthy, as well as an editorial accompanying the report.
“It also can be difficult at times to distinguish type 2 MI from the diagnosis of myocardial injury,” both of which are partly defined by elevated cardiac troponin (cTn), adds the editorial, from Kristian Thygesen, MD, DSc, Aarhus (Denmark) University Hospital, Aarhus, Denmark, and Allan S. Jaffe, MD, Mayo Clinic, Rochester, Minn.
Crucially, but potentially sometimes overlooked, a diagnosis of infarction requires evidence of ischemia along with the biomarker elevation, whereas myocardial injury is defined by raised cTn without evidence of ischemia. Yet there is no ICD-10-CM code for “nonischemic myocardial injury,” Dr. Thygesen and Dr. Jaffe observed.
“Instead, the new ICD-10-CM coding includes a proxy called ‘non-MI troponin elevation due to an underlying cause,’ ” they wrote. “Unfortunately, although some have advocated using this code for myocardial injury, it is not specific for an elevated cTn value and could represent any abnormal laboratory measurements.” The code could be “misleading” and thus worsen the potential for miscoding and “misattribution of MI diagnoses.”
In the current study, 84.6% of the cohort were classified with type 1 MI, 14.8% with type 2, and 0.6% with both types. Of those with type 1 MI, 22.1% had STEMI, 76.4% had non-STEMI with the remainder “unspecified.”
“I think the introduction of ICD codes for type-2 MI is helpful in that we can study type 2 MI more broadly, across institutions, and try and get a better sense of its outcomes and how these patients are treated,” Dr. McCarthy said. But the coding system’s deficiencies may often lead to misclassification of patients. Especially, patients with type 2 STEMI may be miscoded as having type-1 STEMI, and those with only myocardial injury may be miscoded as having type 2 MI.
Most type 2 MI is a complication
A profile of patients with type 2 MI may be helpful for making distinctions. The analysis showed that, compared with patients with type 1 MI, they were slightly but significantly older and more likely to have clinical depression, alcohol or other substance abuse disorder, and to be female. They also had more heart failure (27.9% vs. 10.9%), kidney disease (35.7% vs. 25.7%), atrial fibrillation (31% vs. 21%), and anemia (26% vs. 18.9%) (P < .001 for all differences).
Type 2 patients were less likely to have CV risk factors usually associated with plaque instability and atherothrombosis, including a history of smoking, dyslipidemia, MI, PCI, or CABG (P < .001 for all differences), the group noted.
Of the 37,765 patients with type 2 MI, 91% received the diagnosis as secondary to another condition, including sepsis in 24.5%, hypertension in 16.9%, arrhythmias in 6.1%, respiratory failure in 4.3%, and pneumonia in 2.8% of cases.
In multivariate analyses, patients with type 2 MI, compared with type 1, showed lower risks of in-hospital death and readmission for MI within 30 days. Their 30-day risks of readmission from any cause and from MI were similar.
In-hospital mortality was lower for patients with type 2 MI who underwent revascularization, compared with those who did not, “but they were a very select, small proportion of the patient group. I would say there are probably unmeasured confounders,” Dr. McCarthy said.
“There’s a real kind of equipoise, so I think we desperately need a trial to guide us on whether revascularization is beneficial.”
Dr. McCarthy has disclosed no relevant financial relationships. Dr. Thygesen disclosed no relevant financial relationships. Dr. Jaffe disclosed serving as a consultant for Abbott, Roche, Siemens, Beckman-Coulter, Radiometer, ET Healthcare, Sphingotec, Brava, Quidel, Amgen, Novartis, and Medscape for educational activities.
A version of this article first appeared on Medscape.com.
Six-month follow-up shows continuing morbidity for COVID-19 survivors
In December 2019, a cluster of cases of what was first identified as a “mysterious pneumonia” was reported in the central Chinese city of Wuhan. Within a few short months, the disease had spread all over the world.
Wuhan was essentially “ground zero” for the novel coronavirus, or COVID-19, and now researchers report that many of the early survivors continue to experience a variety of lingering health issues.
At 6 months, for example, pulmonary and immune function have still not returned to normal in many of the patients who had been critically ill, said Zhiyong Peng, MD, PhD, an intensivist and medical researcher, in the department of critical care medicine, Zhonnan Hospital, Wuhan.
In addition, many are still experiencing varying degrees of psychiatric disability and physical morbidity.
The results of the report were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
In 2020, Dr. Peng and colleagues conducted a single-center case series involving 138 patients with coronavirus pneumonia in order to describe the clinical characteristics of this new disease. Within this group, 26% of patients required admission to the intensive care unit and 4.3% died. As of Feb. 3, 2020, 26% required ICU care, 34.1% were discharged, 4.3% died, and 61.6% remained hospitalized. (JAMA. 2020 Mar 17;323[11]:1061-69) Not surprisingly, those requiring critical care experienced a higher rate of severe complications, including shock, arrythmias, acute cardiac injury and acute respiratory distress syndrome, compared with non-ICU patients.
“However, the long-term outcomes of survivors were unknown,” said Dr. Peng. Thus, the goal of the current study was to analyze the outcomes based on pulmonary function, physical morbidity, immunological status, health-related quality of life, cognitive impairment, and psychiatric disability.
The cohort included patients from four hospitals in Wuhan, who had been treated in the adult ICU and required mechanical ventilation (invasive or noninvasive), or had a high FiO2 concentration, or needed an intravenous infusion of vasopressors.
In all, 171 critically ill patients were admitted to the four designated hospitals, and of this group, 110 were discharged from ICU and 106 survived. At the 3-month follow-up, 92 patients were evaluated and at 6 months, 72 were evaluated.
Pulmonary function tests were performed, and all patients received a chest CT scan, and did the “6-minute walk test.” For immune function, lymphocyte counts and function assays were performed. The SF-36 questionnaire was used to evaluate health related quality of life, and cognitive and psychological assessments were conducted with a variety of tools including the Mini-Mental State Examination and Montreal Cognitive Assessment. Depression and anxiety were measured with Zung’s Self-Rating Anxiety Scale and the Hamilton Rating Scale.
At 3 months, 5 patients (5.4%) were seropositive for IgM and 9 (9.8%) were seronegative, while at 6 months, 9 patients (12.9%) tested seropositive for IgM and 12 (16.67%) tested seronegative.
A high proportion of patients also reported tachypnea after exercising (54%), heart palpitations (51.8%), fatigue (44.6%), and joint pain (20.5%).
In terms of lung function, survivors who had been intubated scored worse on pulmonary function tests and had a significant decrease in diffusing capacity for carbon monoxide (DLCO), compared with those who had not been intubated.
At 6 months, the DLCO remained at 76% of the predicted level, but the walking test and chest CT scan improved over time. “In multivariate analysis tracheostomy was a risk factor associated with distance walked in 6 minutes,” said Dr. Peng.
Other results showed that B cells were lower in survivors who had been intubated, compared with those who weren’t, and they were still low at 3 and 6 months, compared with normal values. T-cell subsets were also persistently low.
“Hyperfunction of T lymphocytes and hypofunction of NK cells were detected, which had not improved at 6 months,” said Dr. Peng.
Cognitive dysfunction and depression were reported in some survivors. Cognitive dysfunction at 3 months affected 12.8% of survivors, but it improved by 6 months, affecting on only 2.9% of the cohort (P = .029). However, rates of depression more than doubled from 3 to 6 months (20% vs. 47.8%, P < .001), and anxiety showed a slight increase (15.6% vs. 17.6%, P = .726).
“Further follow-up will be performed to confirm these findings,” Dr. Peng concluded.
Rahul Kashyap, MBBS, MBA, a research scientist and assistant professor of anesthesiology at the Mayo Clinic, Rochester, Minn., noted that currently the research from Wuhan is showing the follow-up for 6 months, but it takes time to gather and analyze the data. “I suspect we will be seeing results from the 1-year follow-up by June,” he said.
Dr. Kashyap, who was approached for an independent comment, also pointed out that in follow-up of SARS patients, some of them recovered but went on to develop chronic fatigue syndrome which is characterized by extreme fatigue that doesn’t improve with rest. “So the scientific community is contemplating if this will be true for patients with COVID-19 infection as well,” he said. “We have already seen that some of the ‘long haulers’ continue to have symptoms such as shortness of breath, joint pain, fatigue, loss of smell and taste, and even hearing loss in extreme cases.”
Some research is also confirming what has been reported from Wuhan. “Data from Ireland, that looked at 150 survivors, showed that almost 60% said they did not feel they were back to full health, regardless of the severity of the disease,” Dr. Kashyap said. “So, aside from Wuhan, we are now getting data from other sources that is similar. But what is interesting about the data from Ireland is that not all of the patients had severe illness or were in ICU.”
He added that data continue to come in from the United States and other countries, looking at long-term effects. “More and more patients are surviving as the care is getting better,” he said. “But beyond a year, we just don’t know yet.”
There was no outside sponsor listed. Dr. Peng and Dr. Kashyap have no disclosures.
In December 2019, a cluster of cases of what was first identified as a “mysterious pneumonia” was reported in the central Chinese city of Wuhan. Within a few short months, the disease had spread all over the world.
Wuhan was essentially “ground zero” for the novel coronavirus, or COVID-19, and now researchers report that many of the early survivors continue to experience a variety of lingering health issues.
At 6 months, for example, pulmonary and immune function have still not returned to normal in many of the patients who had been critically ill, said Zhiyong Peng, MD, PhD, an intensivist and medical researcher, in the department of critical care medicine, Zhonnan Hospital, Wuhan.
In addition, many are still experiencing varying degrees of psychiatric disability and physical morbidity.
The results of the report were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
In 2020, Dr. Peng and colleagues conducted a single-center case series involving 138 patients with coronavirus pneumonia in order to describe the clinical characteristics of this new disease. Within this group, 26% of patients required admission to the intensive care unit and 4.3% died. As of Feb. 3, 2020, 26% required ICU care, 34.1% were discharged, 4.3% died, and 61.6% remained hospitalized. (JAMA. 2020 Mar 17;323[11]:1061-69) Not surprisingly, those requiring critical care experienced a higher rate of severe complications, including shock, arrythmias, acute cardiac injury and acute respiratory distress syndrome, compared with non-ICU patients.
“However, the long-term outcomes of survivors were unknown,” said Dr. Peng. Thus, the goal of the current study was to analyze the outcomes based on pulmonary function, physical morbidity, immunological status, health-related quality of life, cognitive impairment, and psychiatric disability.
The cohort included patients from four hospitals in Wuhan, who had been treated in the adult ICU and required mechanical ventilation (invasive or noninvasive), or had a high FiO2 concentration, or needed an intravenous infusion of vasopressors.
In all, 171 critically ill patients were admitted to the four designated hospitals, and of this group, 110 were discharged from ICU and 106 survived. At the 3-month follow-up, 92 patients were evaluated and at 6 months, 72 were evaluated.
Pulmonary function tests were performed, and all patients received a chest CT scan, and did the “6-minute walk test.” For immune function, lymphocyte counts and function assays were performed. The SF-36 questionnaire was used to evaluate health related quality of life, and cognitive and psychological assessments were conducted with a variety of tools including the Mini-Mental State Examination and Montreal Cognitive Assessment. Depression and anxiety were measured with Zung’s Self-Rating Anxiety Scale and the Hamilton Rating Scale.
At 3 months, 5 patients (5.4%) were seropositive for IgM and 9 (9.8%) were seronegative, while at 6 months, 9 patients (12.9%) tested seropositive for IgM and 12 (16.67%) tested seronegative.
A high proportion of patients also reported tachypnea after exercising (54%), heart palpitations (51.8%), fatigue (44.6%), and joint pain (20.5%).
In terms of lung function, survivors who had been intubated scored worse on pulmonary function tests and had a significant decrease in diffusing capacity for carbon monoxide (DLCO), compared with those who had not been intubated.
At 6 months, the DLCO remained at 76% of the predicted level, but the walking test and chest CT scan improved over time. “In multivariate analysis tracheostomy was a risk factor associated with distance walked in 6 minutes,” said Dr. Peng.
Other results showed that B cells were lower in survivors who had been intubated, compared with those who weren’t, and they were still low at 3 and 6 months, compared with normal values. T-cell subsets were also persistently low.
“Hyperfunction of T lymphocytes and hypofunction of NK cells were detected, which had not improved at 6 months,” said Dr. Peng.
Cognitive dysfunction and depression were reported in some survivors. Cognitive dysfunction at 3 months affected 12.8% of survivors, but it improved by 6 months, affecting on only 2.9% of the cohort (P = .029). However, rates of depression more than doubled from 3 to 6 months (20% vs. 47.8%, P < .001), and anxiety showed a slight increase (15.6% vs. 17.6%, P = .726).
“Further follow-up will be performed to confirm these findings,” Dr. Peng concluded.
Rahul Kashyap, MBBS, MBA, a research scientist and assistant professor of anesthesiology at the Mayo Clinic, Rochester, Minn., noted that currently the research from Wuhan is showing the follow-up for 6 months, but it takes time to gather and analyze the data. “I suspect we will be seeing results from the 1-year follow-up by June,” he said.
Dr. Kashyap, who was approached for an independent comment, also pointed out that in follow-up of SARS patients, some of them recovered but went on to develop chronic fatigue syndrome which is characterized by extreme fatigue that doesn’t improve with rest. “So the scientific community is contemplating if this will be true for patients with COVID-19 infection as well,” he said. “We have already seen that some of the ‘long haulers’ continue to have symptoms such as shortness of breath, joint pain, fatigue, loss of smell and taste, and even hearing loss in extreme cases.”
Some research is also confirming what has been reported from Wuhan. “Data from Ireland, that looked at 150 survivors, showed that almost 60% said they did not feel they were back to full health, regardless of the severity of the disease,” Dr. Kashyap said. “So, aside from Wuhan, we are now getting data from other sources that is similar. But what is interesting about the data from Ireland is that not all of the patients had severe illness or were in ICU.”
He added that data continue to come in from the United States and other countries, looking at long-term effects. “More and more patients are surviving as the care is getting better,” he said. “But beyond a year, we just don’t know yet.”
There was no outside sponsor listed. Dr. Peng and Dr. Kashyap have no disclosures.
In December 2019, a cluster of cases of what was first identified as a “mysterious pneumonia” was reported in the central Chinese city of Wuhan. Within a few short months, the disease had spread all over the world.
Wuhan was essentially “ground zero” for the novel coronavirus, or COVID-19, and now researchers report that many of the early survivors continue to experience a variety of lingering health issues.
At 6 months, for example, pulmonary and immune function have still not returned to normal in many of the patients who had been critically ill, said Zhiyong Peng, MD, PhD, an intensivist and medical researcher, in the department of critical care medicine, Zhonnan Hospital, Wuhan.
In addition, many are still experiencing varying degrees of psychiatric disability and physical morbidity.
The results of the report were presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.
In 2020, Dr. Peng and colleagues conducted a single-center case series involving 138 patients with coronavirus pneumonia in order to describe the clinical characteristics of this new disease. Within this group, 26% of patients required admission to the intensive care unit and 4.3% died. As of Feb. 3, 2020, 26% required ICU care, 34.1% were discharged, 4.3% died, and 61.6% remained hospitalized. (JAMA. 2020 Mar 17;323[11]:1061-69) Not surprisingly, those requiring critical care experienced a higher rate of severe complications, including shock, arrythmias, acute cardiac injury and acute respiratory distress syndrome, compared with non-ICU patients.
“However, the long-term outcomes of survivors were unknown,” said Dr. Peng. Thus, the goal of the current study was to analyze the outcomes based on pulmonary function, physical morbidity, immunological status, health-related quality of life, cognitive impairment, and psychiatric disability.
The cohort included patients from four hospitals in Wuhan, who had been treated in the adult ICU and required mechanical ventilation (invasive or noninvasive), or had a high FiO2 concentration, or needed an intravenous infusion of vasopressors.
In all, 171 critically ill patients were admitted to the four designated hospitals, and of this group, 110 were discharged from ICU and 106 survived. At the 3-month follow-up, 92 patients were evaluated and at 6 months, 72 were evaluated.
Pulmonary function tests were performed, and all patients received a chest CT scan, and did the “6-minute walk test.” For immune function, lymphocyte counts and function assays were performed. The SF-36 questionnaire was used to evaluate health related quality of life, and cognitive and psychological assessments were conducted with a variety of tools including the Mini-Mental State Examination and Montreal Cognitive Assessment. Depression and anxiety were measured with Zung’s Self-Rating Anxiety Scale and the Hamilton Rating Scale.
At 3 months, 5 patients (5.4%) were seropositive for IgM and 9 (9.8%) were seronegative, while at 6 months, 9 patients (12.9%) tested seropositive for IgM and 12 (16.67%) tested seronegative.
A high proportion of patients also reported tachypnea after exercising (54%), heart palpitations (51.8%), fatigue (44.6%), and joint pain (20.5%).
In terms of lung function, survivors who had been intubated scored worse on pulmonary function tests and had a significant decrease in diffusing capacity for carbon monoxide (DLCO), compared with those who had not been intubated.
At 6 months, the DLCO remained at 76% of the predicted level, but the walking test and chest CT scan improved over time. “In multivariate analysis tracheostomy was a risk factor associated with distance walked in 6 minutes,” said Dr. Peng.
Other results showed that B cells were lower in survivors who had been intubated, compared with those who weren’t, and they were still low at 3 and 6 months, compared with normal values. T-cell subsets were also persistently low.
“Hyperfunction of T lymphocytes and hypofunction of NK cells were detected, which had not improved at 6 months,” said Dr. Peng.
Cognitive dysfunction and depression were reported in some survivors. Cognitive dysfunction at 3 months affected 12.8% of survivors, but it improved by 6 months, affecting on only 2.9% of the cohort (P = .029). However, rates of depression more than doubled from 3 to 6 months (20% vs. 47.8%, P < .001), and anxiety showed a slight increase (15.6% vs. 17.6%, P = .726).
“Further follow-up will be performed to confirm these findings,” Dr. Peng concluded.
Rahul Kashyap, MBBS, MBA, a research scientist and assistant professor of anesthesiology at the Mayo Clinic, Rochester, Minn., noted that currently the research from Wuhan is showing the follow-up for 6 months, but it takes time to gather and analyze the data. “I suspect we will be seeing results from the 1-year follow-up by June,” he said.
Dr. Kashyap, who was approached for an independent comment, also pointed out that in follow-up of SARS patients, some of them recovered but went on to develop chronic fatigue syndrome which is characterized by extreme fatigue that doesn’t improve with rest. “So the scientific community is contemplating if this will be true for patients with COVID-19 infection as well,” he said. “We have already seen that some of the ‘long haulers’ continue to have symptoms such as shortness of breath, joint pain, fatigue, loss of smell and taste, and even hearing loss in extreme cases.”
Some research is also confirming what has been reported from Wuhan. “Data from Ireland, that looked at 150 survivors, showed that almost 60% said they did not feel they were back to full health, regardless of the severity of the disease,” Dr. Kashyap said. “So, aside from Wuhan, we are now getting data from other sources that is similar. But what is interesting about the data from Ireland is that not all of the patients had severe illness or were in ICU.”
He added that data continue to come in from the United States and other countries, looking at long-term effects. “More and more patients are surviving as the care is getting better,” he said. “But beyond a year, we just don’t know yet.”
There was no outside sponsor listed. Dr. Peng and Dr. Kashyap have no disclosures.
FROM CCC50
How do you run a hospital with no running water?
It’s bad enough that this month’s historic snowstorm left ordinary Texans scrambling for heat and resorting to melted snow for drinking, washing, and flushing. But what about hospitals, where sanitation is paramount and ample water is a sine qua non?
As pipes burst, pumps froze, and water pressure plummeted, patient care was affected as well as maintenance, food preparation, laundry, and heat. To counter the problems, several Texas hospitals stepped up to the plate with inventive responses.
“At the worst point, two of our hospitals, Houston Methodist West and Houston Methodist Baytown, had no city water supply, one for over 48 hours and the other for 72 hours,” said Marc L. Boom, MD, MBA, Houston Methodist’s president and CEO.
Although the main hospital had a reserve supply of potable water, a supply of water for laundry, cooking, and cleaning was another matter. “We introduced significant water restrictions and had to have 6,000-gallon tankers bring in extra water,” Dr. Boom said.
One hospital in the network got creative. When it rained the day after the ice storm, the staff rigged up a rain collection system using the huge bins that move linens around the hospital to collect nonpotable water for cleaning and flushing toilets, Dr. Boom said. Another hospital was able to provide showers for staff by bringing in bathroom trailers with self-contained water supplies of the kind used at some sporting events.
And at some facilities, patients were discharged into the lobby as they could not return home with transportation, electricity, and water systems crippled. With widespread challenges continuing, even as temperatures warmed, President Biden signed a major disaster declaration Feb. 20 that will provide emergency assistance to residents and businesses in more than a third of Texas counties, including those surrounding Houston, Dallas, and Austin.
Although conditions forced the rescheduling of some nonemergent surgeries, the water shortage had no impact on COVID-19 care, except for the unavailability of showers in the case of mobile patients. “At the worst, they just had to use bucket flushing for the toilets,” Dr. Boom said.
And in an unexpected win, when a Harris County freezer for COVID-19 vaccine storage failed and threatened to spoil 8,400 precious doses, Dr. Boom’s center was able to take delivery on 1,000 doses and administer them in 3 hours at a hastily set up ad hoc immunization center.
In all this, the lessons of the pandemic had a positive preparatory role. “2020 taught us to be agile as things change and to align our goals across different medical teams,” said Ben Saldana, MD, medical director of Houston Methodist’s emergency care centers. “And we were prepared for hurricanes, but not for snow.”
Increased pressure on emergency departments
As the outages continued and stress levels in the community rose, the network started seeing exacerbations of chronic conditions after the power shut-down incapacitated electrical devices running machines for heart assistance, oxygen delivery, and sleep apnea. “We started seeing food-borne illness and carbon monoxide poisoning, as well as more heart attacks, strokes, and sepsis,” Dr. Saldana said.
One serious strain on the network’s main hospital was the sudden need to accommodate large numbers of patients on dialysis, a procedure that uses a lot of water and is typically performed in small, vulnerable community facilities with limited infrastructure and no generators. “The hospitals are their backup and act as a safety net for them,” Boom said. Some hospital areas generally used for other types of conditions had to be marshaled for renal care.
Emergency rooms became pop-up dialysis centers, Dr. Saldana said. “And if the water pressure dropped, we had to cut dialysis time from the standard 4 hours to 2. That’s like putting a band-aid on patients.”
Fortunately, municipal water pressure in the Houston area has steadily risen and is almost back to normal. And according to Dr. Boom, the brutal storm may yet have a silver lining: a decline in county coronavirus cases as the storm and icy road conditions forced people to stay sequestered at home.
Further north in Austin, a number of hospitals lost municipal water pressure, creating a series of problems. Among them was St. David’s South Austin Medical Center, at which, according to reports in the Austin American-Statesman, staff members were at one point asked to use trash bags to remove waste from toilets, to refrain from showering, and to clean their hands only with sanitizer.
A statement issued by David Huffstutler, CEO of St. David’s HealthCare, acknowledged that the heating system is based on a water-fed boiler. When the building lost heat owing to lack of water, some patients had to be transferred elsewhere or discharged. The hospital distributed jugs and bottles of water for handwashing and drinking, and was working with city officials to obtain portable toilets.
Meanwhile, officials at Austin’s Dell Children’s Medical Center acknowledged in a memo that its toilets no longer had “flushing capabilities.” Other area hospitals in the Ascension Seton network were also suffering from compromised water supplies last week, according to local news reports.
Washroom facilities were affected elsewhere as well. A post on a medical association Facebook page referred to a memo ordering staff to use a single toilet in an outpatient area for bowel movements and warned them to limit their time there. No paper or other products were to be used in other toilets designated for urination.
‘The pandemic was the prelude to the ice storm’
Some hospitals fared better. Along the Coastal Bend, Corpus Christi Medical Center managed to maintain its electricity and water supply to ensure continuity of hospital services after the storm, according to a statement.
But back in Houston, Liz Youngblood, MBA, RN, president of Baylor St. Luke’s Medical Center, said a number of hospitals in her network experienced low water pressure after the storm.
“Fortunately, we had water conservation measures and low-water alerts in place for such emergencies,” she said. “And we rely on water tankers to help maintain enough pressure for the basics.”
Some of the challenges posed by the storm are quite similar to what St. Luke’s faced after Hurricane Harvey in 2017. “We had already made plans to address them and so we felt prepared,” Ms. Youngblood said.
And thanks to COVID-19, Texas hospitals have been operating in crisis mode for the past year. “The pandemic was the prelude to the ice storm,” said Gina Blocker, MD, a St. Luke’s ED physician, “so we had measures and teams in place. We did have some reduction in water pressure, though the pressure was still good.”
But the hospital was inundated with patients looking for shelter. “Some were just scared about what might happen to them if their heat didn’t come back on and they wanted to be where they could get care,” Dr. Blocker said. Others came in with expected storm-related injuries such as hypothermia and carbon monoxide poisoning.
According to Ms. Youngblood, little compromise in patient care was necessary except for the cancellation of some operations and vaccinations owing to the treacherous travel conditions. “But one of the biggest remaining issues is that we need plenty of blood, so we’re encouraging people to donate at their local centers.”
A version of this article first appeared on Medscape.com
It’s bad enough that this month’s historic snowstorm left ordinary Texans scrambling for heat and resorting to melted snow for drinking, washing, and flushing. But what about hospitals, where sanitation is paramount and ample water is a sine qua non?
As pipes burst, pumps froze, and water pressure plummeted, patient care was affected as well as maintenance, food preparation, laundry, and heat. To counter the problems, several Texas hospitals stepped up to the plate with inventive responses.
“At the worst point, two of our hospitals, Houston Methodist West and Houston Methodist Baytown, had no city water supply, one for over 48 hours and the other for 72 hours,” said Marc L. Boom, MD, MBA, Houston Methodist’s president and CEO.
Although the main hospital had a reserve supply of potable water, a supply of water for laundry, cooking, and cleaning was another matter. “We introduced significant water restrictions and had to have 6,000-gallon tankers bring in extra water,” Dr. Boom said.
One hospital in the network got creative. When it rained the day after the ice storm, the staff rigged up a rain collection system using the huge bins that move linens around the hospital to collect nonpotable water for cleaning and flushing toilets, Dr. Boom said. Another hospital was able to provide showers for staff by bringing in bathroom trailers with self-contained water supplies of the kind used at some sporting events.
And at some facilities, patients were discharged into the lobby as they could not return home with transportation, electricity, and water systems crippled. With widespread challenges continuing, even as temperatures warmed, President Biden signed a major disaster declaration Feb. 20 that will provide emergency assistance to residents and businesses in more than a third of Texas counties, including those surrounding Houston, Dallas, and Austin.
Although conditions forced the rescheduling of some nonemergent surgeries, the water shortage had no impact on COVID-19 care, except for the unavailability of showers in the case of mobile patients. “At the worst, they just had to use bucket flushing for the toilets,” Dr. Boom said.
And in an unexpected win, when a Harris County freezer for COVID-19 vaccine storage failed and threatened to spoil 8,400 precious doses, Dr. Boom’s center was able to take delivery on 1,000 doses and administer them in 3 hours at a hastily set up ad hoc immunization center.
In all this, the lessons of the pandemic had a positive preparatory role. “2020 taught us to be agile as things change and to align our goals across different medical teams,” said Ben Saldana, MD, medical director of Houston Methodist’s emergency care centers. “And we were prepared for hurricanes, but not for snow.”
Increased pressure on emergency departments
As the outages continued and stress levels in the community rose, the network started seeing exacerbations of chronic conditions after the power shut-down incapacitated electrical devices running machines for heart assistance, oxygen delivery, and sleep apnea. “We started seeing food-borne illness and carbon monoxide poisoning, as well as more heart attacks, strokes, and sepsis,” Dr. Saldana said.
One serious strain on the network’s main hospital was the sudden need to accommodate large numbers of patients on dialysis, a procedure that uses a lot of water and is typically performed in small, vulnerable community facilities with limited infrastructure and no generators. “The hospitals are their backup and act as a safety net for them,” Boom said. Some hospital areas generally used for other types of conditions had to be marshaled for renal care.
Emergency rooms became pop-up dialysis centers, Dr. Saldana said. “And if the water pressure dropped, we had to cut dialysis time from the standard 4 hours to 2. That’s like putting a band-aid on patients.”
Fortunately, municipal water pressure in the Houston area has steadily risen and is almost back to normal. And according to Dr. Boom, the brutal storm may yet have a silver lining: a decline in county coronavirus cases as the storm and icy road conditions forced people to stay sequestered at home.
Further north in Austin, a number of hospitals lost municipal water pressure, creating a series of problems. Among them was St. David’s South Austin Medical Center, at which, according to reports in the Austin American-Statesman, staff members were at one point asked to use trash bags to remove waste from toilets, to refrain from showering, and to clean their hands only with sanitizer.
A statement issued by David Huffstutler, CEO of St. David’s HealthCare, acknowledged that the heating system is based on a water-fed boiler. When the building lost heat owing to lack of water, some patients had to be transferred elsewhere or discharged. The hospital distributed jugs and bottles of water for handwashing and drinking, and was working with city officials to obtain portable toilets.
Meanwhile, officials at Austin’s Dell Children’s Medical Center acknowledged in a memo that its toilets no longer had “flushing capabilities.” Other area hospitals in the Ascension Seton network were also suffering from compromised water supplies last week, according to local news reports.
Washroom facilities were affected elsewhere as well. A post on a medical association Facebook page referred to a memo ordering staff to use a single toilet in an outpatient area for bowel movements and warned them to limit their time there. No paper or other products were to be used in other toilets designated for urination.
‘The pandemic was the prelude to the ice storm’
Some hospitals fared better. Along the Coastal Bend, Corpus Christi Medical Center managed to maintain its electricity and water supply to ensure continuity of hospital services after the storm, according to a statement.
But back in Houston, Liz Youngblood, MBA, RN, president of Baylor St. Luke’s Medical Center, said a number of hospitals in her network experienced low water pressure after the storm.
“Fortunately, we had water conservation measures and low-water alerts in place for such emergencies,” she said. “And we rely on water tankers to help maintain enough pressure for the basics.”
Some of the challenges posed by the storm are quite similar to what St. Luke’s faced after Hurricane Harvey in 2017. “We had already made plans to address them and so we felt prepared,” Ms. Youngblood said.
And thanks to COVID-19, Texas hospitals have been operating in crisis mode for the past year. “The pandemic was the prelude to the ice storm,” said Gina Blocker, MD, a St. Luke’s ED physician, “so we had measures and teams in place. We did have some reduction in water pressure, though the pressure was still good.”
But the hospital was inundated with patients looking for shelter. “Some were just scared about what might happen to them if their heat didn’t come back on and they wanted to be where they could get care,” Dr. Blocker said. Others came in with expected storm-related injuries such as hypothermia and carbon monoxide poisoning.
According to Ms. Youngblood, little compromise in patient care was necessary except for the cancellation of some operations and vaccinations owing to the treacherous travel conditions. “But one of the biggest remaining issues is that we need plenty of blood, so we’re encouraging people to donate at their local centers.”
A version of this article first appeared on Medscape.com
It’s bad enough that this month’s historic snowstorm left ordinary Texans scrambling for heat and resorting to melted snow for drinking, washing, and flushing. But what about hospitals, where sanitation is paramount and ample water is a sine qua non?
As pipes burst, pumps froze, and water pressure plummeted, patient care was affected as well as maintenance, food preparation, laundry, and heat. To counter the problems, several Texas hospitals stepped up to the plate with inventive responses.
“At the worst point, two of our hospitals, Houston Methodist West and Houston Methodist Baytown, had no city water supply, one for over 48 hours and the other for 72 hours,” said Marc L. Boom, MD, MBA, Houston Methodist’s president and CEO.
Although the main hospital had a reserve supply of potable water, a supply of water for laundry, cooking, and cleaning was another matter. “We introduced significant water restrictions and had to have 6,000-gallon tankers bring in extra water,” Dr. Boom said.
One hospital in the network got creative. When it rained the day after the ice storm, the staff rigged up a rain collection system using the huge bins that move linens around the hospital to collect nonpotable water for cleaning and flushing toilets, Dr. Boom said. Another hospital was able to provide showers for staff by bringing in bathroom trailers with self-contained water supplies of the kind used at some sporting events.
And at some facilities, patients were discharged into the lobby as they could not return home with transportation, electricity, and water systems crippled. With widespread challenges continuing, even as temperatures warmed, President Biden signed a major disaster declaration Feb. 20 that will provide emergency assistance to residents and businesses in more than a third of Texas counties, including those surrounding Houston, Dallas, and Austin.
Although conditions forced the rescheduling of some nonemergent surgeries, the water shortage had no impact on COVID-19 care, except for the unavailability of showers in the case of mobile patients. “At the worst, they just had to use bucket flushing for the toilets,” Dr. Boom said.
And in an unexpected win, when a Harris County freezer for COVID-19 vaccine storage failed and threatened to spoil 8,400 precious doses, Dr. Boom’s center was able to take delivery on 1,000 doses and administer them in 3 hours at a hastily set up ad hoc immunization center.
In all this, the lessons of the pandemic had a positive preparatory role. “2020 taught us to be agile as things change and to align our goals across different medical teams,” said Ben Saldana, MD, medical director of Houston Methodist’s emergency care centers. “And we were prepared for hurricanes, but not for snow.”
Increased pressure on emergency departments
As the outages continued and stress levels in the community rose, the network started seeing exacerbations of chronic conditions after the power shut-down incapacitated electrical devices running machines for heart assistance, oxygen delivery, and sleep apnea. “We started seeing food-borne illness and carbon monoxide poisoning, as well as more heart attacks, strokes, and sepsis,” Dr. Saldana said.
One serious strain on the network’s main hospital was the sudden need to accommodate large numbers of patients on dialysis, a procedure that uses a lot of water and is typically performed in small, vulnerable community facilities with limited infrastructure and no generators. “The hospitals are their backup and act as a safety net for them,” Boom said. Some hospital areas generally used for other types of conditions had to be marshaled for renal care.
Emergency rooms became pop-up dialysis centers, Dr. Saldana said. “And if the water pressure dropped, we had to cut dialysis time from the standard 4 hours to 2. That’s like putting a band-aid on patients.”
Fortunately, municipal water pressure in the Houston area has steadily risen and is almost back to normal. And according to Dr. Boom, the brutal storm may yet have a silver lining: a decline in county coronavirus cases as the storm and icy road conditions forced people to stay sequestered at home.
Further north in Austin, a number of hospitals lost municipal water pressure, creating a series of problems. Among them was St. David’s South Austin Medical Center, at which, according to reports in the Austin American-Statesman, staff members were at one point asked to use trash bags to remove waste from toilets, to refrain from showering, and to clean their hands only with sanitizer.
A statement issued by David Huffstutler, CEO of St. David’s HealthCare, acknowledged that the heating system is based on a water-fed boiler. When the building lost heat owing to lack of water, some patients had to be transferred elsewhere or discharged. The hospital distributed jugs and bottles of water for handwashing and drinking, and was working with city officials to obtain portable toilets.
Meanwhile, officials at Austin’s Dell Children’s Medical Center acknowledged in a memo that its toilets no longer had “flushing capabilities.” Other area hospitals in the Ascension Seton network were also suffering from compromised water supplies last week, according to local news reports.
Washroom facilities were affected elsewhere as well. A post on a medical association Facebook page referred to a memo ordering staff to use a single toilet in an outpatient area for bowel movements and warned them to limit their time there. No paper or other products were to be used in other toilets designated for urination.
‘The pandemic was the prelude to the ice storm’
Some hospitals fared better. Along the Coastal Bend, Corpus Christi Medical Center managed to maintain its electricity and water supply to ensure continuity of hospital services after the storm, according to a statement.
But back in Houston, Liz Youngblood, MBA, RN, president of Baylor St. Luke’s Medical Center, said a number of hospitals in her network experienced low water pressure after the storm.
“Fortunately, we had water conservation measures and low-water alerts in place for such emergencies,” she said. “And we rely on water tankers to help maintain enough pressure for the basics.”
Some of the challenges posed by the storm are quite similar to what St. Luke’s faced after Hurricane Harvey in 2017. “We had already made plans to address them and so we felt prepared,” Ms. Youngblood said.
And thanks to COVID-19, Texas hospitals have been operating in crisis mode for the past year. “The pandemic was the prelude to the ice storm,” said Gina Blocker, MD, a St. Luke’s ED physician, “so we had measures and teams in place. We did have some reduction in water pressure, though the pressure was still good.”
But the hospital was inundated with patients looking for shelter. “Some were just scared about what might happen to them if their heat didn’t come back on and they wanted to be where they could get care,” Dr. Blocker said. Others came in with expected storm-related injuries such as hypothermia and carbon monoxide poisoning.
According to Ms. Youngblood, little compromise in patient care was necessary except for the cancellation of some operations and vaccinations owing to the treacherous travel conditions. “But one of the biggest remaining issues is that we need plenty of blood, so we’re encouraging people to donate at their local centers.”
A version of this article first appeared on Medscape.com