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Evidence or anecdote: Clinical judgment in COVID care
As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.
In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.
Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
Referendum on remdesivir
The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).
“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.
The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.
Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.
In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”
Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.
Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.
Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
Taking on tocilizumab
Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.
Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.
Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.
By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.
Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).
He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.
Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.
Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.
Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.
Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.
As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.
In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.
Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
Referendum on remdesivir
The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).
“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.
The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.
Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.
In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”
Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.
Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.
Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
Taking on tocilizumab
Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.
Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.
Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.
By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.
Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).
He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.
Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.
Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.
Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.
Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.
As the COVID-19 pandemic continues and evidence evolves, clinical judgment is the bottom line for clinical care, according to Adarsh Bhimraj, MD, of the Cleveland Clinic, and James Walter, MD, of Northwestern Medicine, Chicago.
In a debate/discussion presented at SHM Converge, the annual conference of the Society of Hospital Medicine, Dr. Bhimraj and Dr. Walter took sides in a friendly debate on the value of remdesivir and tocilizumab for hospitalized COVID-19 patients.
Dr. Bhimraj argued for the use of remdesivir or tocilizumab in patients hospitalized with COVID-19 pneumonia, and Dr. Walter presented the case against their use.
Referendum on remdesivir
The main sources referenced by the presenters regarding remdesivir were the WHO Solidarity Trial (N Engl J Med. 2021 Feb 11. doi: 10.1056/NEJMoa2023184) and the Adaptive Covid-19 Treatment Trial (ACCT) final report (N Engl J Med. 2020 Nov 5. doi: 10.1056/NEJMoa2007764).
“The ‘debate’ is partly artificial,” and meant to illustrate how clinicians can use their own clinical faculties and reasoning to make an informed decision when treating COVID-19 patients, Dr. Bhimraj said.
The ACCT trial compared remdesivir with placebo in patients with severe enough COVID-19 to require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation. The primary outcome in the study was time to recovery, and “the devil is in the details,” Dr. Bhimraj said. The outcomes clinicians should look for in studies are those that matter to patients, such as death, disability, and discomfort, he noted. Disease-oriented endpoints are easier to measure, but not always meaningful for patients, he said. The study showed an average 5-day decrease in illness, “but the fact is that it did not show a mortality benefit,” he noted.
Another large, open-label study of remdesivir across 30 countries showed no survival benefit associated with the drug, compared with standard of care, said Dr. Bhimraj. Patients treated with remdesivir remained in the hospital longer, but Dr. Bhimraj said he believed that was a bias. “I think the physicians kept the patients in the hospital longer to give the treatment rather than the treatments themselves prolonging the treatment duration,” he said.
In conclusion for remdesivir, “the solid data show that there is an early recovery,” he said. “At least for severe disease, even if there is no mortality benefit, there is a role. I argue that, if someone asks if you want to use remdesivir in severe COVID-19 patients, say yes, especially if you value people getting out of the hospital sooner. In a crisis situation, there is a role for remdesivir.”
Dr. Walter discussed the “con” side of using remdesivir. “We can start with a predata hypothesis, but integrate new data about the efficacy into a postdata hypothesis,” he said.
Dr. Walter made several points against the use of remdesivir in hospitalized COVID-19 patients. First, it has not shown any improvement in mortality and may increase the length of hospital stay, he noted.
Data from the ACCT-1 trial and the WHO solidarity trial, showed “no signal of mortality benefit at all,” he said. In addition, the World Health Organization, American College of Physicians, and National Institutes of Health all recommend against remdesivir for patients who require mechanical ventilation or extracorporeal membrane oxygenation, he said. The efficacy when used with steroids remains unclear, and long-term safety data are lacking, he added.
Taking on tocilizumab
Tocilizumab, an anti-inflammatory agent, has demonstrated an impact on several surrogate markers, notably C-reactive protein, temperature, and oxygenation. Dr. Bhimraj said. He reviewed data from eight published studies on the use of tocilizumab in COVID-19 patients.
Arguably, some trials may not have been powered adequately, and in combination, some trials show an effect on clinical deterioration, if not a mortality benefit, he said.
Consequently, in the context of COVID-19, tocilizumab “should be used early in the disease process, especially if steroids are not working,” said Dr. Bhimraj. Despite the limited evidence, “there is a niche population where this might be beneficial,” he said.
By contrast, Dr. Walter took the position of skepticism about the value of tocilizumab for COVID-19 patients.
Notably, decades of research show that tocilizumab has shown no benefit in patients with sepsis or septic shock, or those with acute respiratory distress syndrome, which have similarities to COVID-19 (JAMA. 2020 Sep 3. doi: 10.1001/jama.2020.17052).
He cited a research letter published in JAMA in September 2020, which showed that cytokine levels were in fact lower in critically ill patients with COVID-19, compared with those who had conditions including sepsis with and without ARDS.
Dr. Walter also cited data on the questionable benefit of tocilizumab when used with steroids and the negligible impact on mortality in hospitalized COVID-19 patients seen in the RECOVERY trial.
Limited data mean that therapeutic decisions related to COVID-19 are more nuanced, but they can be made, the presenters agreed.
Ultimately, when trying to decide whether a drug is efficacious, futile, or harmful, “What we have to do is consider the grand totality of the evidence,” Dr. Bhimraj emphasized.
Dr. Bhimraj and Dr. Walter had no relevant financial conflicts to disclose.
FROM SHM CONVERGE 2021
Weight-related COVID-19 severity starts in normal BMI range, especially in young
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
The risk of severe outcomes with COVID-19 increases with excess weight in a linear manner beginning in normal body mass index ranges, with the effect apparently independent of obesity-related diseases such as diabetes, and stronger among younger people and Black persons, new research shows.
“Even a small increase in body mass index above 23 kg/m² is a risk factor for adverse outcomes after infection with SARS-CoV-2,” the authors reported.
“Excess weight is a modifiable risk factor and investment in the treatment of overweight and obesity, and long-term preventive strategies could help reduce the severity of COVID-19 disease,” they wrote.
The findings shed important new light in the ongoing efforts to understand COVID-19 effects, Krishnan Bhaskaran, PhD, said in an interview.
“These results confirm and add detail to the established links between overweight and obesity and COVID-19, and also add new information on risks among people with low BMI levels,” said Dr. Bhaskaran, an epidemiologist at the London School of Hygiene & Tropical Medicine, who authored an accompanying editorial.
Obesity has been well established as a major risk factor for poor outcomes among people with COVID-19; however, less is known about the risk of severe outcomes over the broader spectrum of excess weight, and its relationship with other factors.
For the prospective, community-based study, Carmen Piernas, PhD, of the University of Oxford (England) and colleagues evaluated data on nearly 7 million individuals registered in the U.K. QResearch database during Jan. 24–April 30, 2020.
Overall, patients had a mean BMI of 27 kg/m². Among them, 13,503 (.20%) were admitted to the hospital during the study period, 1,601 (.02%) were admitted to an ICU and 5,479 (.08%) died after testing positive for SARS-CoV-2.
Risk rises from BMI of 23 kg/m²
In looking at the risk of hospital admission with COVID-19, the authors found a J-shaped relationship with BMI, with the risk increased with a BMI of 20 kg/m² or lower, as well as an increased risk beginning with a BMI of 23 kg/m² – considered normal weight – or higher (hazard ratio, 1.05).
The risk of death from COVID-19 was also J-shaped, however the association with increases in BMI started higher – at 28 kg/m² (adjusted HR 1.04).
In terms of the risk of ICU admission with COVID-19, the curve was not J-shaped, with just a linear association of admission with increasing BMI beginning at 23 kg/m2 (adjusted HR 1.10).
“It was surprising to see that the lowest risk of severe COVID-19 was found at a BMI of 23, and each extra BMI unit was associated with significantly higher risk, but we don’t really know yet what the reason is for this,” Dr. Piernas said in an interview.
The association between increasing BMI and risk of hospital admission for COVID-19 beginning at a BMI of 23 kg/m² was more significant among younger people aged 20-39 years than in those aged 80-100 years, with an adjusted HR for hospital admission per BMI unit above 23 kg/m² of 1.09 versus 1.01 (P < .0001).
In addition, the risk associated with BMI and hospital admission was stronger in people who were Black, compared with those who were White (1.07 vs. 1.04), as was the risk of death due to COVID-19 (1.08 vs. 1.04; P < .0001 for both).
“For the risk of death, Blacks have an 8% higher risk with each extra BMI unit, whereas Whites have a 4% increase, which is half the risk,” Dr. Piernas said.
Notably, the increased risks of hospital admission and ICU due to COVID-19 seen with increases in BMI were slightly lower among people with type 2 diabetes, hypertension, and cardiovascular disease compared with patients who did not have those comorbidities, suggesting the association with BMI is not explained by those risk factors.
Dr. Piernas speculated that the effect could reflect that people with diabetes or cardiovascular disease already have a preexisting condition which makes them more susceptible to SARS-CoV-2.
Hence, “the association with BMI in this group may not be as strong as the association found among those without those conditions, in which BMI explains a higher proportion of this increased risk, given the absence of these preexisting conditions.”
Similarly, the effect of BMI on COVID-19 outcomes in younger patients may appear stronger because their rates of other comorbidities are much lower than in older patients.
“Among older people, preexisting conditions and perhaps a weaker immune system may explain their much higher rates of severe COVID outcomes,” Dr. Piernas noted.
Furthermore, older patients may have frailty and high comorbidities that could explain their lower rates of ICU admission with COVID-19, Dr. Bhaskaran added in further comments.
The findings overall underscore that excess weight can represent a risk in COVID-19 outcomes that is, importantly, modifiable, and “suggest that supporting people to reach and maintain a healthy weight is likely to help people reduce their risk of experiencing severe outcomes from this disease, now or in any future waves,” he concluded.
Dr. Piernas and Dr. Bhaskaran had no disclosures to report. Coauthors’ disclosures are detailed in the published study.
FROM LANCET DIABETES & ENDOCRINOLOGY
New child COVID-19 cases drop for second consecutive week
New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Despite that drop, however, based on data in the weekly AAP/CHA report.
New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.
Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.
There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.
The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.
New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Despite that drop, however, based on data in the weekly AAP/CHA report.
New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.
Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.
There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.
The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.
New cases of COVID-19 in children are trending downward again after dropping for a second consecutive week, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Despite that drop, however, based on data in the weekly AAP/CHA report.
New cases totaled 71,649 for the week of April 23-29, down by 10.3% from the week before and by 19.0% over this most recent 2-week decline, but still a ways to go before reaching the low point of the year (52,695) recorded during the second week of March, the report shows.
Since the beginning of the pandemic, just over 3.78 million children have been infected by SARS-CoV-2, which is 13.8% of all cases reported in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The overall rate of COVID-19 has reached 5,026 cases per 100,000 children, or 5% of the total pediatric population, although there is considerable variation among the states regarding age ranges used to define child cases. Most states use a range of 0-17 or 0-19 years, but Florida and Utah use a range of 0-14 years and South Carolina and Tennessee go with 0-20, the AAP and CHA noted.
There is also much variation between the states when it comes to cumulative child COVID-19 rates, with the lowest rate reported in Hawaii (1,264 per 100,000) and the highest in North Dakota (9,416 per 100,000). The lowest proportion of child cases to all cases is found in Florida (8.7%) and the highest in Vermont (22.2%), the AAP and CHA said.
The number of COVID-19–related deaths was 303 as of April 29, up by 7 from the previous week in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting mortality data by age. The proportion of child deaths to child cases remains at 0.01%, and children represent just 0.06% of all COVID-19 deaths, according to the AAP/CHA report.
FDA set to okay Pfizer vaccine in younger teens
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration could expand the use of the Pfizer COVID-19 vaccine to teens early next week, The New York Times and CNN reported, both citing unnamed officials familiar with the agency’s plans.
In late March, Pfizer submitted data to the FDA showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12 to 15. Their vaccine is already authorized for use teens and adults ages 16 and older.
The move would make about 17 million more Americans eligible for vaccination and would be a major step toward getting both adolescents and teens back into classrooms full time by next fall.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 U.K. variant,” Ugur Sahin, CEO and co-founder of Pfizer partner BioNTech, said in a March 31 press release.
Getting schools fully reopened for in-person learning has been a goal of both the Trump and Biden administrations, but it has been tricky to pull off, as some parents and teachers have been reluctant to return to classrooms with so much uncertainty about the risk and the role of children in spreading the virus.
A recent study of roughly 150,000 school-aged children in Israel found that while kids under age 10 were unlikely to catch or spread the virus as they reentered classrooms. Older children, though, were a different story. The study found that children ages 10-19 had risks of catching the virus that were as high as adults ages 20-60.
The risk for severe illness and death from COVID-19 rises with age.
Children and teens are at relatively low risk from severe outcomes after a COVID-19 infection compared to adults, but they can catch it and some will get really sick with it, especially if they have an underlying health condition, like obesity or asthma that makes them more vulnerable.
Beyond the initial infection, children can get a rare late complication called MIS-C, that while treatable, can be severe and requires hospitalization. Emerging reports also suggest there are some kids that become long haulers in much the same way adults do, dealing with lingering problems for months after they first get sick.
As new variants of the coronavirus circulate in the United States, some states have seen big increases in the number of children and teens with COVID. In Michigan, for example, which recently dealt with a spring surge of cases dominated by the B.1.1.7 variant, cases in children and teens quadrupled in April compared to February.
Beyond individual protection, vaccinating children and teens has been seen as important to achieving strong community protection, or herd immunity, against the new coronavirus.
If the FDA expands the authorization for the Pfizer vaccine, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will likely meet to review data on the safety and efficacy of the vaccine. The committee may then vote on new recommendations for use of the vaccine in the United States.
Not everyone agrees with the idea that American adolescents, who are at relatively low risk of bad outcomes, could get access to COVID vaccines ahead of vulnerable essential workers and seniors in other parts of the world that are still fighting the pandemic with little access to vaccines.
A version of this article first appeared on WebMD.com.
Moral distress in the COVID era weighs on hospitalists
Focus on effort, not just outcomes
Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.
Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.
These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.
In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”1 They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.
Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”
COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”
And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.
People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
What is moral distress?
Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.2 Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.
Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.
Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”
Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.3 “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.
“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”
COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
What to call it
Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.4 More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”5
In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.
“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”
“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.
“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
Where is the leadership?
“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.
“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”
David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.
“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”
In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.
But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.
“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
What can be done?
What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.
Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.
“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”
Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”
The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”
The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”
SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
Respect, advocacy, self-care
Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.
“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”
A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”
Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
References
1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.
2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.
3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.
4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.
5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.
Focus on effort, not just outcomes
Focus on effort, not just outcomes
Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.
Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.
These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.
In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”1 They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.
Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”
COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”
And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.
People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
What is moral distress?
Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.2 Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.
Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.
Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”
Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.3 “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.
“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”
COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
What to call it
Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.4 More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”5
In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.
“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”
“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.
“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
Where is the leadership?
“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.
“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”
David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.
“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”
In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.
But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.
“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
What can be done?
What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.
Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.
“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”
Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”
The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”
The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”
SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
Respect, advocacy, self-care
Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.
“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”
A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”
Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
References
1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.
2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.
3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.
4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.
5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.
Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.
Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.
These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.
In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”1 They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.
Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”
COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”
And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.
People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
What is moral distress?
Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.2 Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.
Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.
Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”
Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.3 “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.
“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”
COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
What to call it
Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.4 More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”5
In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.
“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”
“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.
“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
Where is the leadership?
“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.
“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”
David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.
“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”
In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.
But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.
“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
What can be done?
What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.
Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.
“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”
Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”
The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”
The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”
SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
Respect, advocacy, self-care
Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.
“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”
A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”
Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
References
1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.
2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.
3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.
4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.
5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.
Most kids with type 1 diabetes and COVID-19 in U.S. fared well
The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.
Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.
The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.
The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..
“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
Disproportionate rate of hospitalization, DKA among Black patients
Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.
Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.
However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).
Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.
The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.
The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.
“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.
One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.
The registry remains open.
The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.
A version of this article first appeared on Medscape.com.
The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.
Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.
The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.
The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..
“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
Disproportionate rate of hospitalization, DKA among Black patients
Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.
Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.
However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).
Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.
The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.
The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.
“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.
One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.
The registry remains open.
The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.
A version of this article first appeared on Medscape.com.
The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.
Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.
The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.
The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..
“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
Disproportionate rate of hospitalization, DKA among Black patients
Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.
Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.
However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).
Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.
The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.
The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.
“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.
One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.
The registry remains open.
The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.
A version of this article first appeared on Medscape.com.
Torsemide vs. furosemide in heart failure patients
Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.
Study design: Systematic review and meta-analysis.
Setting: 19 published randomized, controlled trials (RCTs) or observational studies in the English language.
Synopsis: 19 RCTs and observational studies comparing furosemide and torsemide were analyzed to identify differences in New York Heart Association functional classification, side effects, hospitalizations for heart failure, cardiac mortality, and all-cause mortality. More than 19,000 patients were included with a mean follow-up of 15 months. Torsemide was associated with a significant improvement in functional status with a number needed to treat of five. In addition, there were lower numbers of hospitalizations from heart failure and a lower risk of cardiac death in the torsemide arm though these differences disappeared when RCTs were analyzed alone. There were no differences in all-cause mortality or medication side effects between furosemide and torsemide.
Bottom line: The use of torsemide is associated with significant improvement in functional status. It is also – though less significantly – associated with lower hospitalization rates for heart failure and lower cardiac mortality.
Citation: Abraham B et al. Meta-analysis comparing torsemide versus furosemide in patients with heart failure. Am J Cardiol. 2020 Jan 1;125: 92-9.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.
Study design: Systematic review and meta-analysis.
Setting: 19 published randomized, controlled trials (RCTs) or observational studies in the English language.
Synopsis: 19 RCTs and observational studies comparing furosemide and torsemide were analyzed to identify differences in New York Heart Association functional classification, side effects, hospitalizations for heart failure, cardiac mortality, and all-cause mortality. More than 19,000 patients were included with a mean follow-up of 15 months. Torsemide was associated with a significant improvement in functional status with a number needed to treat of five. In addition, there were lower numbers of hospitalizations from heart failure and a lower risk of cardiac death in the torsemide arm though these differences disappeared when RCTs were analyzed alone. There were no differences in all-cause mortality or medication side effects between furosemide and torsemide.
Bottom line: The use of torsemide is associated with significant improvement in functional status. It is also – though less significantly – associated with lower hospitalization rates for heart failure and lower cardiac mortality.
Citation: Abraham B et al. Meta-analysis comparing torsemide versus furosemide in patients with heart failure. Am J Cardiol. 2020 Jan 1;125: 92-9.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Treatment goals of heart failure include improvement in quality of life, prevention of hospitalization, and decreases in mortality. Loop diuretics can improve these goals. Furosemide (Lasix) is the most widely used diuretic in heart failure patients. Torsemide (Demadex) has a better pharmacokinetic and pharmacodynamic profile than does furosemide, with greater bioavailability, a longer half-life, and higher potency. In addition, there is a suggestion that torsemide has a vasodilatory effect and a possible antialdosterone effect that may contribute to its efficacy. However, it is not known if that better profile leads to differences or improvements in primary treatment goals.
Study design: Systematic review and meta-analysis.
Setting: 19 published randomized, controlled trials (RCTs) or observational studies in the English language.
Synopsis: 19 RCTs and observational studies comparing furosemide and torsemide were analyzed to identify differences in New York Heart Association functional classification, side effects, hospitalizations for heart failure, cardiac mortality, and all-cause mortality. More than 19,000 patients were included with a mean follow-up of 15 months. Torsemide was associated with a significant improvement in functional status with a number needed to treat of five. In addition, there were lower numbers of hospitalizations from heart failure and a lower risk of cardiac death in the torsemide arm though these differences disappeared when RCTs were analyzed alone. There were no differences in all-cause mortality or medication side effects between furosemide and torsemide.
Bottom line: The use of torsemide is associated with significant improvement in functional status. It is also – though less significantly – associated with lower hospitalization rates for heart failure and lower cardiac mortality.
Citation: Abraham B et al. Meta-analysis comparing torsemide versus furosemide in patients with heart failure. Am J Cardiol. 2020 Jan 1;125: 92-9.
Dr. Tsien is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Ruling out PE in patients with low C-PTP and D dimer of less than 1,000 ng/mL
Background: A pulmonary embolism can be considered ruled out if patients have a low C-PTP for PE and a D-dimer level of less than 500 ng/mL. However, this occurs in approximately 30% of outpatients only. By increasing the D-dimer threshold used to define a negative test to 1,000 ng/mL in patients with a low C-PTP, we might be able to rule out a larger segment of patients and avoid chest imaging.
Study design: Prospective study.
Setting: University-based clinical centers in Canada.
Synopsis: This study enrolled 2,017 patients presenting with symptoms of PE. The Wells’ criteria was used to categorize the patient’s C-PTP as low (0-4.0), moderate (4.5-6.0), or high (6.5 or more). Patients with a low or moderate C-PTP had a D dimer drawn. Those with a low C-PTP and D dimer of less than 1,000 ng/mL or moderate C-PTP and a D dimer of less than 500 ng/mL underwent no further testing. Outcomes were assessed at 90 days. Of the 1,325 patients with a low C-PTP or moderate C-PTP and a negative D-dimer test (less than 1,000 or 500 ng/mL, respectively), none had venous thromboembolism during follow-up (95% confidence interval, 0.00-0.29). This strategy resulted in the use of chest imaging in only 34.3% of patients versus 51.9% using the prior criteria of a D-dimer level of less than 500 ng/mL (difference, –17.6 percentage points; 95% CI, −19.2 to −15.9). One limitation of the study is that almost all patients enrolled were outpatients (only one inpatient).
Bottom line: A combination of a low C-PTP and a D-dimer level of less than 1,000 ng/mL identified a group of patients at low risk for pulmonary embolism during follow-up.
Citation: Kearon C et al. Diagnosis of pulmonary embolism with D-dimer adjusted to clinical probability. N Engl J Med 2019 Nov 28;381:2125-34.
Dr. Santa is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: A pulmonary embolism can be considered ruled out if patients have a low C-PTP for PE and a D-dimer level of less than 500 ng/mL. However, this occurs in approximately 30% of outpatients only. By increasing the D-dimer threshold used to define a negative test to 1,000 ng/mL in patients with a low C-PTP, we might be able to rule out a larger segment of patients and avoid chest imaging.
Study design: Prospective study.
Setting: University-based clinical centers in Canada.
Synopsis: This study enrolled 2,017 patients presenting with symptoms of PE. The Wells’ criteria was used to categorize the patient’s C-PTP as low (0-4.0), moderate (4.5-6.0), or high (6.5 or more). Patients with a low or moderate C-PTP had a D dimer drawn. Those with a low C-PTP and D dimer of less than 1,000 ng/mL or moderate C-PTP and a D dimer of less than 500 ng/mL underwent no further testing. Outcomes were assessed at 90 days. Of the 1,325 patients with a low C-PTP or moderate C-PTP and a negative D-dimer test (less than 1,000 or 500 ng/mL, respectively), none had venous thromboembolism during follow-up (95% confidence interval, 0.00-0.29). This strategy resulted in the use of chest imaging in only 34.3% of patients versus 51.9% using the prior criteria of a D-dimer level of less than 500 ng/mL (difference, –17.6 percentage points; 95% CI, −19.2 to −15.9). One limitation of the study is that almost all patients enrolled were outpatients (only one inpatient).
Bottom line: A combination of a low C-PTP and a D-dimer level of less than 1,000 ng/mL identified a group of patients at low risk for pulmonary embolism during follow-up.
Citation: Kearon C et al. Diagnosis of pulmonary embolism with D-dimer adjusted to clinical probability. N Engl J Med 2019 Nov 28;381:2125-34.
Dr. Santa is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: A pulmonary embolism can be considered ruled out if patients have a low C-PTP for PE and a D-dimer level of less than 500 ng/mL. However, this occurs in approximately 30% of outpatients only. By increasing the D-dimer threshold used to define a negative test to 1,000 ng/mL in patients with a low C-PTP, we might be able to rule out a larger segment of patients and avoid chest imaging.
Study design: Prospective study.
Setting: University-based clinical centers in Canada.
Synopsis: This study enrolled 2,017 patients presenting with symptoms of PE. The Wells’ criteria was used to categorize the patient’s C-PTP as low (0-4.0), moderate (4.5-6.0), or high (6.5 or more). Patients with a low or moderate C-PTP had a D dimer drawn. Those with a low C-PTP and D dimer of less than 1,000 ng/mL or moderate C-PTP and a D dimer of less than 500 ng/mL underwent no further testing. Outcomes were assessed at 90 days. Of the 1,325 patients with a low C-PTP or moderate C-PTP and a negative D-dimer test (less than 1,000 or 500 ng/mL, respectively), none had venous thromboembolism during follow-up (95% confidence interval, 0.00-0.29). This strategy resulted in the use of chest imaging in only 34.3% of patients versus 51.9% using the prior criteria of a D-dimer level of less than 500 ng/mL (difference, –17.6 percentage points; 95% CI, −19.2 to −15.9). One limitation of the study is that almost all patients enrolled were outpatients (only one inpatient).
Bottom line: A combination of a low C-PTP and a D-dimer level of less than 1,000 ng/mL identified a group of patients at low risk for pulmonary embolism during follow-up.
Citation: Kearon C et al. Diagnosis of pulmonary embolism with D-dimer adjusted to clinical probability. N Engl J Med 2019 Nov 28;381:2125-34.
Dr. Santa is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
AHA guidance on blood clots linked to COVID-19 vaccine
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.
The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.
That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.
However, the new report noted that these conditions are very rare.
“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.
“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”
The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
Assessing 81 million patients
In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.
Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.
Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.
Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.
For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.
“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected.
Rare events
The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.
An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.
An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.
A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.
“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”
A version of this article first appeared on Medscape.com.
Higher MI shock survival with NCSI protocol: Final results
What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.
Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.
Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.
Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.
“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”
The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.
Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.
The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.
Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.
One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.
Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.
Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.
That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.
“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO2 to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.
Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.
“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.
Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.
Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.
During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.
“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”
Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”
NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.
A version of this article first appeared on Medscape.com.
What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.
Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.
Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.
Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.
“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”
The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.
Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.
The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.
Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.
One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.
Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.
Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.
That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.
“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO2 to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.
Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.
“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.
Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.
Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.
During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.
“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”
Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”
NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.
A version of this article first appeared on Medscape.com.
What started as an attempt to standardize care for acute myocardial infarction with cardiogenic shock at a handful of Detroit-area hospitals has led to markedly better survival rates than the traditional flip of a coin, in a nationwide analysis.
Final results from the National Cardiogenic Shock Initiative (NCSI) show 71% of patients survived to discharge and 68% were alive at 30 days.
Patients presenting in stage C or D shock, who comprised the bulk of patients in previous trials, had survival rates of 79% and 77%, respectively.
Among stage E patients, who are in extremis and have typical survival rates of less than 20%, survival was 54% at discharge and 49% at 30 days, co–principal investigator Babar Basir, DO, Henry Ford Hospital, Detroit, reported at the Society for Cardiovascular Angiography and Interventions (SCAI) annual scientific sessions, held virtually.
“This is the first push to really be able to consistently get survival rates over 50%, particularly in those patients who presented in stage C and D shock,” he said. “Really, it’s important to emphasize here the hard work it’s taken to get to this point and all the research that’s been done.”
The NCSI protocol emphasizes rapid identification and support of cardiogenic shock (door to support time <90 minutes), early placement of the Impella (Abiomed) ventricular assist device prior to percutaneous coronary intervention (PCI), and right heart monitoring to reduce the use of inotropes and vasopressors.
Co–principal investigator William O’Neill, MD, also from Henry Ford, previously reported results from the pilot study showing 84% of 30 patients survived to discharge.
The present analysis was based on outcomes of 406 consecutive acute MI patients (mean age, 63.7 years; 24% female) who presented with cardiogenic shock at 32 academic and 48 community hospitals in 29 states and the District of Columbia.
Dr. Basir emphasized that this is the largest prospective North American acute MI cardiogenic shock study in 20 years and recruited “one of the sickest cohorts ever studied.” The average blood pressure among the patients was 77/50 mm Hg; 77% had a lactate of at least 2 mmol/L (mean, 4.8 mmol/L), and 25% were in stage E shock.
One-quarter of patients were transferred from other institutions, 82% presented with ST-segment elevation MI, two-thirds had multivessel disease, and 13% had a left main culprit lesion.
Right heart catheterization was used in 90% of patients, an Impella CP device in 92%, an Impella 2.5 device in 5%, femoral access PCI in 78%, and aspiration thrombectomy in a full 27%.
Despite this sick cohort, survival at 30 days was better than in any previous study of cardiogenic shock, Dr. Basir said. In comparison, 30-day survival rates were 53%, 60%, and 49% in the SHOCK, IABP SHOCK, and CULPRIT SHOCK trials, respectively.
That said, survival over the course of the first year fell to 53% in the entire cohort, 62% in patients with stage C or D shock, and 31% in those in stage E shock.
“One-year mortality continues to be a problem for these patients and emphasizes the need for goal-directed medical therapy, early advanced heart failure follow-up, and novel therapies such as what we are planning with the evaluation of [supersaturated oxygen] SSO2 to reduce infarct sizes in the ISO-SHOCK trial,” set to begin later this year, Dr. Basir said.
Given the promising results in the NCSI, the randomized controlled RECOVER IV trial is planned to begin in 2022, he noted. It will assess whether Impella pre-PCI is superior to PCI without Impella in patients with inclusion criteria similar to that of the NCSI. The DanGer Shock randomized trial is ongoing in Denmark and Germany and assessing all-cause mortality at 6 months with the Impella CP device compared with standard of care.
“We hypothesize that greater utilization of this protocol, and refinement of the escalation strategies will consistently lead to a survival rate greater than 80%,” Dr. Basir concluded.
Past SCAI president Kirk Garratt, MD, Christiana Care, Newark, Del., who moderated a press conference where the data were highlighted, noted that late complications led to a roughly 20% absolute mortality increase from discharge to 1 year, and questioned what percentage could be attributed to the mechanical support offered.
Dr. Basir said that information was not specifically tracked but that many patients presented with multiorgan failure and, irrespective of that, the majority died from ongoing heart failure.
During the formal presentation, panelist Ron Waksman, MD, MedStar Heart Institute, Washington, questioned whether results were different between academic and community centers, but also pointed to the lack of a comparator in the single-arm study.
“It’s very hard to do any comparison historically; we do need to have a control group,” he said. “If you would have opened it to any treatment at the time of the initiative, which is great, but not just limit it to use of the Impella devices, we would have better understanding if there is really a differentiation between one device versus the other devices.”
Dr. Basir replied, “I think that is a very reasonable comment and, in regard to your question, it is always difficult to differentiate between academic and community centers, but these were large community programs that have all of the technologies available in an academic center.”
NCIS is funded in part by unrestricted grants from Abiomed and Chiesi. Dr. Basir reported consulting for Abbott Vascular, Abiomed, Cardiovascular Systems, Chiesi, Procyrion, and Zoll.
A version of this article first appeared on Medscape.com.