Critical Care

A new statistical analysis of an existing meta-analysis reaffirms a finding that hospitalized patients with COVID-19 who are on simple oxygen or noninvasive ventilation can benefit from treatment with the arthritis drug tocilizumab (Actemra) in conjunction with corticosteroids. But the report also casts doubt on the effectiveness of tocilizumab in patients who are on ventilators.

“Clinicians should prescribe steroids and tocilizumab for hospitalized patients needing simple oxygen or noninvasive ventilation,” epidemiologist and study coauthor James (Jay) Brophy, MD, PhD, of McGill University, Montreal, said in an interview. “Further research is required to answer the question of whether tocilizumab is beneficial in patients requiring invasive ventilation, and consideration of participation in further tocilizumab studies seems reasonable.”

The new analysis was published Feb. 28, 2022, in JAMA Network Open.

The initial meta-analysis, published in 2021 in JAMA, was conducted by the WHO Rapid Evidence Appraisal for COVID-19 Therapies Working Group. It analyzed the results of 27 randomized trials that explored the use of interleukin-6 antagonists, including tocilizumab, and found that “28-day all-cause mortality was lower among patients who received IL-6 antagonists, compared with those who received usual care or placebo (summary odds ratio, 0.86). The summary ORs for the association of IL-6 antagonist treatment with 28-day all-cause mortality were 0.78 with concomitant administration of corticosteroids versus 1.09 without administration of corticosteroids.”

For the new report, researchers conducted a Bayesian statistical analysis of 15 studies within the meta-analysis that specifically examined the use of the rheumatoid arthritis drug tocilizumab. “Bayesian analysis allows one to make direct probability statements regarding the exact magnitude and the certainty of any benefit,” Dr. Brophy said. “This provides clinicians with the information they require to make well-informed decisions.”

The analysis estimated that the probability of a “clinically meaningful association” (absolute mortality risk difference, >1%) because of use of tocilizumab was higher than 95% in patients receiving simple oxygen and higher than 90% in those receiving noninvasive ventilation. But the probability was only about 67% higher in those receiving invasive mechanical ventilation.

Also, the researchers estimated that about 72% of future tocilizumab studies in patients on invasive mechanical ventilation would show a benefit.

The new analysis findings don’t add much to existing knowledge, said nephrologist David E. Leaf, MD, MMSc, of Harvard Medical School, Boston, who’s studied tocilizumab in COVID-19.

“The signal seems to be consistent that there is a greater benefit of tocilizumab in less ill patients than those who are more ill – e.g., those who are receiving invasive mechanical ventilation,” Dr. Leaf said in an interview. “This is interesting because in clinical practice the opposite approach is often undertaken, with tocilizumab use only being used in the sickest patients, even though the patients most likely to benefit seem to be those who are less ill.”

Clinically, he said, “hospitalized patients with COVID-19 should receive tocilizumab unless they have a clear contraindication and assuming it can be administered relatively early in their disease course. Earlier administration, before the onset of irreversible organ injury, is likely to have greater benefit.”

Dr. Leaf also noted it’s unknown whether the drug is helpful in several groups – patients presenting later in the course of COVID-19 illness, patients with additional infections, and immunocompromised patients.

It’s also not clear if tocilizumab benefits patients with lower levels of C-reactive protein, Shruti Gupta, MD, MPH, a nephrologist at Brigham and Women’s Hospital in Boston, said in an interview. The RECOVERY trial, for example, limited subjects to those with C-reactive protein of at least 75 mg/L.

Dr. Leaf and Dr. Gupta coauthored a 2021 cohort study analyzing mortality rates in patients with COVID-19 who were treated with tocilizumab versus those who were not.

No study funding was reported. Dr. Brophy, Dr. Leaf, and Dr. Gupta disclosed no relevant financial relationships. One study author reported participating in one of the randomized clinical trials included in the analysis.

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

A new statistical analysis of an existing meta-analysis reaffirms a finding that hospitalized patients with COVID-19 who are on simple oxygen or noninvasive ventilation can benefit from treatment with the arthritis drug tocilizumab (Actemra) in conjunction with corticosteroids. But the report also casts doubt on the effectiveness of tocilizumab in patients who are on ventilators.

“Clinicians should prescribe steroids and tocilizumab for hospitalized patients needing simple oxygen or noninvasive ventilation,” epidemiologist and study coauthor James (Jay) Brophy, MD, PhD, of McGill University, Montreal, said in an interview. “Further research is required to answer the question of whether tocilizumab is beneficial in patients requiring invasive ventilation, and consideration of participation in further tocilizumab studies seems reasonable.”

The new analysis was published Feb. 28, 2022, in JAMA Network Open.

The initial meta-analysis, published in 2021 in JAMA, was conducted by the WHO Rapid Evidence Appraisal for COVID-19 Therapies Working Group. It analyzed the results of 27 randomized trials that explored the use of interleukin-6 antagonists, including tocilizumab, and found that “28-day all-cause mortality was lower among patients who received IL-6 antagonists, compared with those who received usual care or placebo (summary odds ratio, 0.86). The summary ORs for the association of IL-6 antagonist treatment with 28-day all-cause mortality were 0.78 with concomitant administration of corticosteroids versus 1.09 without administration of corticosteroids.”

For the new report, researchers conducted a Bayesian statistical analysis of 15 studies within the meta-analysis that specifically examined the use of the rheumatoid arthritis drug tocilizumab. “Bayesian analysis allows one to make direct probability statements regarding the exact magnitude and the certainty of any benefit,” Dr. Brophy said. “This provides clinicians with the information they require to make well-informed decisions.”

The analysis estimated that the probability of a “clinically meaningful association” (absolute mortality risk difference, >1%) because of use of tocilizumab was higher than 95% in patients receiving simple oxygen and higher than 90% in those receiving noninvasive ventilation. But the probability was only about 67% higher in those receiving invasive mechanical ventilation.

Also, the researchers estimated that about 72% of future tocilizumab studies in patients on invasive mechanical ventilation would show a benefit.

The new analysis findings don’t add much to existing knowledge, said nephrologist David E. Leaf, MD, MMSc, of Harvard Medical School, Boston, who’s studied tocilizumab in COVID-19.

“The signal seems to be consistent that there is a greater benefit of tocilizumab in less ill patients than those who are more ill – e.g., those who are receiving invasive mechanical ventilation,” Dr. Leaf said in an interview. “This is interesting because in clinical practice the opposite approach is often undertaken, with tocilizumab use only being used in the sickest patients, even though the patients most likely to benefit seem to be those who are less ill.”

Clinically, he said, “hospitalized patients with COVID-19 should receive tocilizumab unless they have a clear contraindication and assuming it can be administered relatively early in their disease course. Earlier administration, before the onset of irreversible organ injury, is likely to have greater benefit.”

Dr. Leaf also noted it’s unknown whether the drug is helpful in several groups – patients presenting later in the course of COVID-19 illness, patients with additional infections, and immunocompromised patients.

It’s also not clear if tocilizumab benefits patients with lower levels of C-reactive protein, Shruti Gupta, MD, MPH, a nephrologist at Brigham and Women’s Hospital in Boston, said in an interview. The RECOVERY trial, for example, limited subjects to those with C-reactive protein of at least 75 mg/L.

Dr. Leaf and Dr. Gupta coauthored a 2021 cohort study analyzing mortality rates in patients with COVID-19 who were treated with tocilizumab versus those who were not.

No study funding was reported. Dr. Brophy, Dr. Leaf, and Dr. Gupta disclosed no relevant financial relationships. One study author reported participating in one of the randomized clinical trials included in the analysis.

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

A new statistical analysis of an existing meta-analysis reaffirms a finding that hospitalized patients with COVID-19 who are on simple oxygen or noninvasive ventilation can benefit from treatment with the arthritis drug tocilizumab (Actemra) in conjunction with corticosteroids. But the report also casts doubt on the effectiveness of tocilizumab in patients who are on ventilators.

“Clinicians should prescribe steroids and tocilizumab for hospitalized patients needing simple oxygen or noninvasive ventilation,” epidemiologist and study coauthor James (Jay) Brophy, MD, PhD, of McGill University, Montreal, said in an interview. “Further research is required to answer the question of whether tocilizumab is beneficial in patients requiring invasive ventilation, and consideration of participation in further tocilizumab studies seems reasonable.”

The new analysis was published Feb. 28, 2022, in JAMA Network Open.

The initial meta-analysis, published in 2021 in JAMA, was conducted by the WHO Rapid Evidence Appraisal for COVID-19 Therapies Working Group. It analyzed the results of 27 randomized trials that explored the use of interleukin-6 antagonists, including tocilizumab, and found that “28-day all-cause mortality was lower among patients who received IL-6 antagonists, compared with those who received usual care or placebo (summary odds ratio, 0.86). The summary ORs for the association of IL-6 antagonist treatment with 28-day all-cause mortality were 0.78 with concomitant administration of corticosteroids versus 1.09 without administration of corticosteroids.”

For the new report, researchers conducted a Bayesian statistical analysis of 15 studies within the meta-analysis that specifically examined the use of the rheumatoid arthritis drug tocilizumab. “Bayesian analysis allows one to make direct probability statements regarding the exact magnitude and the certainty of any benefit,” Dr. Brophy said. “This provides clinicians with the information they require to make well-informed decisions.”

The analysis estimated that the probability of a “clinically meaningful association” (absolute mortality risk difference, >1%) because of use of tocilizumab was higher than 95% in patients receiving simple oxygen and higher than 90% in those receiving noninvasive ventilation. But the probability was only about 67% higher in those receiving invasive mechanical ventilation.

Also, the researchers estimated that about 72% of future tocilizumab studies in patients on invasive mechanical ventilation would show a benefit.

The new analysis findings don’t add much to existing knowledge, said nephrologist David E. Leaf, MD, MMSc, of Harvard Medical School, Boston, who’s studied tocilizumab in COVID-19.

“The signal seems to be consistent that there is a greater benefit of tocilizumab in less ill patients than those who are more ill – e.g., those who are receiving invasive mechanical ventilation,” Dr. Leaf said in an interview. “This is interesting because in clinical practice the opposite approach is often undertaken, with tocilizumab use only being used in the sickest patients, even though the patients most likely to benefit seem to be those who are less ill.”

Clinically, he said, “hospitalized patients with COVID-19 should receive tocilizumab unless they have a clear contraindication and assuming it can be administered relatively early in their disease course. Earlier administration, before the onset of irreversible organ injury, is likely to have greater benefit.”

Dr. Leaf also noted it’s unknown whether the drug is helpful in several groups – patients presenting later in the course of COVID-19 illness, patients with additional infections, and immunocompromised patients.

It’s also not clear if tocilizumab benefits patients with lower levels of C-reactive protein, Shruti Gupta, MD, MPH, a nephrologist at Brigham and Women’s Hospital in Boston, said in an interview. The RECOVERY trial, for example, limited subjects to those with C-reactive protein of at least 75 mg/L.

Dr. Leaf and Dr. Gupta coauthored a 2021 cohort study analyzing mortality rates in patients with COVID-19 who were treated with tocilizumab versus those who were not.

No study funding was reported. Dr. Brophy, Dr. Leaf, and Dr. Gupta disclosed no relevant financial relationships. One study author reported participating in one of the randomized clinical trials included in the analysis.

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

Hemodynamic instability is rewarded with a sojourn in the intensive care unit (ICU). When the intensivists see it, they’re going to throw fluids at it. Most likely a crystalloid of some type. This has been true for decades, centuries even. When I was a medical student, which was decades but not centuries ago, I used crystalloids every day on the surgical wards, in the operating room, in the emergency department, or on the medicine wards. Medicine docs preferred normal saline (NS) and surgeons used lactated Ringer’s solution (LR). I never gave this a second thought.

During medical school, I was drawn to internal medicine by the heavy emphasis on evidence-based medicine in the field. Prior to 2015 though, there wasn’t much data to support using one crystalloid formulation over another. Pre-2010, we had an American Thoracic Society (ATS) consensus statement on using crystalloid vs. colloid, making recommendations largely drawn from the SAFE trial. The ATS statement also suggested starches may be harmful, a view that was confirmed in a series of articles published in 2012 and 2013. There was less discussion about what type of crystalloid was best.

In 2014, I finally read a paper that compared crystalloid formulations. It was a network meta-analysis, which is “statistician speak” for combining disparate trials to make indirect comparisons. In the absence of large, randomized trials, this approach was a welcome addition to the data we had at the time. The authors concluded that “balanced” (typically LR or Plasma-Lyte) are superior to “unbalanced” (another term for NS) crystalloids. Balanced fluids typically have acetate or lactate and have a higher pH and lower chloride than NS. I found the signal for balanced fluids interesting at the time but promptly forgot about it.

Since 2015, the critical care community has rallied to produce a bevy of large trials comparing balanced vs. unbalanced crystalloids. The first was the SPLIT trial, which showed equivalence. Then came the SMART trial in 2018, which showed balanced fluids were better. Of note, another trial with an identical design (SALT-ED) was published in the same issue of The New England Journal of Medicine as SMART. SALT-ED enrolled patients in the emergency department, not the ICU, but also found benefit to using balanced fluids, albeit not for their primary outcome. I admit, after SMART and SALT-ED were published, I made the switch to LR. A secondary analysis of patients with sepsis pushed me further toward LR, while others withheld judgment.

Then we saw publication of the BaSICs trial, another large, randomized study evaluating crystalloid composition. I was hoping this one might put the issue to rest. That nephrologist who perseverated on every patient’s chloride during morning report would be vindicated. NS would prove to be too unbalanced and would finally be retired. No such luck. This is critical care medicine, where the initial signal is rarely confirmed in the follow-up trials. BaSICs found no difference between crystalloids for most important outcomes. The study did find balanced fluids may worsen outcomes for patients with head injuries.

Finally, there’s the PLUS trial, a large, multicenter randomized controlled trial comparing Plasma-Lyte vs. NS in the ICU. I could make the argument that this trial was the best of the bunch, and it was negative. The researchers did an excellent job of showing that serum pH and chloride levels did vary by fluid composition, but despite this, mortality and renal outcomes did not differ. Case closed? Crystalloid composition doesn’t matter, right?

An editorial that accompanies the BaSICs trial does an outstanding job of reviewing SPLIT, SMART, and BaSICs. The authors discuss design and population differences that may have led to differing results, and there are many. They conclude for most patients in the ICU, there’s no compelling reason to choose one crystalloid over another. Perhaps they’re right.

An updated meta-analysis that included all the studies I’ve mentioned concluded there was an 89% probability that balanced fluid reduces mortality for ICU patients. How could the meta-analysis authors reach this conclusion given all the negative trials? It has to do with their statistical methods – they performed both standard, frequentist (if statistical significance isn’t reached the study, is considered negative) and Bayesian analyses (posterior probability of benefit is calculated, regardless of P value). The frequentist approach was negative, but the posterior probability for benefit remained high.

Personally, I see no reason not to favor LR when resuscitating ICU patients without head injuries. In particular, it seems that medical patients (who made up almost 80% of those in the SMART trial) and those with sepsis may benefit. The critical care community has again outdone itself by performing large, well-designed trials to address important questions. Despite not having a definitive answer on crystalloid resuscitation, we know a lot more than we did when I was a medical student.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He reported receiving research grant from: Fisher-Paykel and receiving income from the American College of Chest Physicians. A version of this article first appeared on Medscape.com.

Hemodynamic instability is rewarded with a sojourn in the intensive care unit (ICU). When the intensivists see it, they’re going to throw fluids at it. Most likely a crystalloid of some type. This has been true for decades, centuries even. When I was a medical student, which was decades but not centuries ago, I used crystalloids every day on the surgical wards, in the operating room, in the emergency department, or on the medicine wards. Medicine docs preferred normal saline (NS) and surgeons used lactated Ringer’s solution (LR). I never gave this a second thought.

During medical school, I was drawn to internal medicine by the heavy emphasis on evidence-based medicine in the field. Prior to 2015 though, there wasn’t much data to support using one crystalloid formulation over another. Pre-2010, we had an American Thoracic Society (ATS) consensus statement on using crystalloid vs. colloid, making recommendations largely drawn from the SAFE trial. The ATS statement also suggested starches may be harmful, a view that was confirmed in a series of articles published in 2012 and 2013. There was less discussion about what type of crystalloid was best.

In 2014, I finally read a paper that compared crystalloid formulations. It was a network meta-analysis, which is “statistician speak” for combining disparate trials to make indirect comparisons. In the absence of large, randomized trials, this approach was a welcome addition to the data we had at the time. The authors concluded that “balanced” (typically LR or Plasma-Lyte) are superior to “unbalanced” (another term for NS) crystalloids. Balanced fluids typically have acetate or lactate and have a higher pH and lower chloride than NS. I found the signal for balanced fluids interesting at the time but promptly forgot about it.

Since 2015, the critical care community has rallied to produce a bevy of large trials comparing balanced vs. unbalanced crystalloids. The first was the SPLIT trial, which showed equivalence. Then came the SMART trial in 2018, which showed balanced fluids were better. Of note, another trial with an identical design (SALT-ED) was published in the same issue of The New England Journal of Medicine as SMART. SALT-ED enrolled patients in the emergency department, not the ICU, but also found benefit to using balanced fluids, albeit not for their primary outcome. I admit, after SMART and SALT-ED were published, I made the switch to LR. A secondary analysis of patients with sepsis pushed me further toward LR, while others withheld judgment.

Then we saw publication of the BaSICs trial, another large, randomized study evaluating crystalloid composition. I was hoping this one might put the issue to rest. That nephrologist who perseverated on every patient’s chloride during morning report would be vindicated. NS would prove to be too unbalanced and would finally be retired. No such luck. This is critical care medicine, where the initial signal is rarely confirmed in the follow-up trials. BaSICs found no difference between crystalloids for most important outcomes. The study did find balanced fluids may worsen outcomes for patients with head injuries.

Finally, there’s the PLUS trial, a large, multicenter randomized controlled trial comparing Plasma-Lyte vs. NS in the ICU. I could make the argument that this trial was the best of the bunch, and it was negative. The researchers did an excellent job of showing that serum pH and chloride levels did vary by fluid composition, but despite this, mortality and renal outcomes did not differ. Case closed? Crystalloid composition doesn’t matter, right?

An editorial that accompanies the BaSICs trial does an outstanding job of reviewing SPLIT, SMART, and BaSICs. The authors discuss design and population differences that may have led to differing results, and there are many. They conclude for most patients in the ICU, there’s no compelling reason to choose one crystalloid over another. Perhaps they’re right.

An updated meta-analysis that included all the studies I’ve mentioned concluded there was an 89% probability that balanced fluid reduces mortality for ICU patients. How could the meta-analysis authors reach this conclusion given all the negative trials? It has to do with their statistical methods – they performed both standard, frequentist (if statistical significance isn’t reached the study, is considered negative) and Bayesian analyses (posterior probability of benefit is calculated, regardless of P value). The frequentist approach was negative, but the posterior probability for benefit remained high.

Personally, I see no reason not to favor LR when resuscitating ICU patients without head injuries. In particular, it seems that medical patients (who made up almost 80% of those in the SMART trial) and those with sepsis may benefit. The critical care community has again outdone itself by performing large, well-designed trials to address important questions. Despite not having a definitive answer on crystalloid resuscitation, we know a lot more than we did when I was a medical student.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He reported receiving research grant from: Fisher-Paykel and receiving income from the American College of Chest Physicians. A version of this article first appeared on Medscape.com.

Hemodynamic instability is rewarded with a sojourn in the intensive care unit (ICU). When the intensivists see it, they’re going to throw fluids at it. Most likely a crystalloid of some type. This has been true for decades, centuries even. When I was a medical student, which was decades but not centuries ago, I used crystalloids every day on the surgical wards, in the operating room, in the emergency department, or on the medicine wards. Medicine docs preferred normal saline (NS) and surgeons used lactated Ringer’s solution (LR). I never gave this a second thought.

During medical school, I was drawn to internal medicine by the heavy emphasis on evidence-based medicine in the field. Prior to 2015 though, there wasn’t much data to support using one crystalloid formulation over another. Pre-2010, we had an American Thoracic Society (ATS) consensus statement on using crystalloid vs. colloid, making recommendations largely drawn from the SAFE trial. The ATS statement also suggested starches may be harmful, a view that was confirmed in a series of articles published in 2012 and 2013. There was less discussion about what type of crystalloid was best.

In 2014, I finally read a paper that compared crystalloid formulations. It was a network meta-analysis, which is “statistician speak” for combining disparate trials to make indirect comparisons. In the absence of large, randomized trials, this approach was a welcome addition to the data we had at the time. The authors concluded that “balanced” (typically LR or Plasma-Lyte) are superior to “unbalanced” (another term for NS) crystalloids. Balanced fluids typically have acetate or lactate and have a higher pH and lower chloride than NS. I found the signal for balanced fluids interesting at the time but promptly forgot about it.

Since 2015, the critical care community has rallied to produce a bevy of large trials comparing balanced vs. unbalanced crystalloids. The first was the SPLIT trial, which showed equivalence. Then came the SMART trial in 2018, which showed balanced fluids were better. Of note, another trial with an identical design (SALT-ED) was published in the same issue of The New England Journal of Medicine as SMART. SALT-ED enrolled patients in the emergency department, not the ICU, but also found benefit to using balanced fluids, albeit not for their primary outcome. I admit, after SMART and SALT-ED were published, I made the switch to LR. A secondary analysis of patients with sepsis pushed me further toward LR, while others withheld judgment.

Then we saw publication of the BaSICs trial, another large, randomized study evaluating crystalloid composition. I was hoping this one might put the issue to rest. That nephrologist who perseverated on every patient’s chloride during morning report would be vindicated. NS would prove to be too unbalanced and would finally be retired. No such luck. This is critical care medicine, where the initial signal is rarely confirmed in the follow-up trials. BaSICs found no difference between crystalloids for most important outcomes. The study did find balanced fluids may worsen outcomes for patients with head injuries.

Finally, there’s the PLUS trial, a large, multicenter randomized controlled trial comparing Plasma-Lyte vs. NS in the ICU. I could make the argument that this trial was the best of the bunch, and it was negative. The researchers did an excellent job of showing that serum pH and chloride levels did vary by fluid composition, but despite this, mortality and renal outcomes did not differ. Case closed? Crystalloid composition doesn’t matter, right?

An editorial that accompanies the BaSICs trial does an outstanding job of reviewing SPLIT, SMART, and BaSICs. The authors discuss design and population differences that may have led to differing results, and there are many. They conclude for most patients in the ICU, there’s no compelling reason to choose one crystalloid over another. Perhaps they’re right.

An updated meta-analysis that included all the studies I’ve mentioned concluded there was an 89% probability that balanced fluid reduces mortality for ICU patients. How could the meta-analysis authors reach this conclusion given all the negative trials? It has to do with their statistical methods – they performed both standard, frequentist (if statistical significance isn’t reached the study, is considered negative) and Bayesian analyses (posterior probability of benefit is calculated, regardless of P value). The frequentist approach was negative, but the posterior probability for benefit remained high.

Personally, I see no reason not to favor LR when resuscitating ICU patients without head injuries. In particular, it seems that medical patients (who made up almost 80% of those in the SMART trial) and those with sepsis may benefit. The critical care community has again outdone itself by performing large, well-designed trials to address important questions. Despite not having a definitive answer on crystalloid resuscitation, we know a lot more than we did when I was a medical student.

Dr. Holley is associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center. He reported receiving research grant from: Fisher-Paykel and receiving income from the American College of Chest Physicians. A version of this article first appeared on Medscape.com.

Early initiation of the antiviral oseltamivir (Tamiflu) reduces the risk for death in patients hospitalized with community-acquired pneumonia (CAP) but patients have to be tested for influenza first and that is not happening often enough, a large observational cohort of adult patients indicates.

“Early testing allows for early treatment, and we found that early treatment was associated with reduced mortality so testing patients during the flu season is crucial,” senior author Michael Rothberg, MD, MPH, of the Cleveland Clinic said in an interview.

“Even during the flu season, most patients with CAP in our study went untested for influenza [even though] those who received early oseltamivir exhibited lower 14-day in-hospital case fatality ... suggesting more widespread testing might improve patient outcomes,” the authors added.

The study was published online Feb. 5, 2022, in the journal CHEST.
 

Premier database

Data from the Premier Database – a hospital discharge database with information from over 600 hospitals in the United States – were analyzed between July 2010 and June 2015. Microbiological laboratory data was provided by 179 hospitals. “For each year, we evaluated the total percentage of patients tested for influenza A/B within 3 days of hospitalization,” lead author Abhishek Deshpande, MD, PhD, Cleveland Clinic, and colleagues explained.

A total of 166,268 patients with CAP were included in the study, among which only about one-quarter were tested for influenza. Some 11.5% tested positive for the flu, the authors noted. Testing did increase from 15.4% in 2010 to 35.6% in 2015 and it was higher at close to 29% during the influenza season, compared with only about 8% during the summer months.

Patients who were tested for influenza were younger at age 66.6 years, compared with untested patients, who were 70 years of age (P < .001). Tested patients were also less likely to have been admitted from a nursing facility (P < .001), were less likely to have been hospitalized in the preceding 6 months (P < .001) and have fewer comorbidities than those who were not tested (P < .001).

“Both groups had similar illness severities on admission,” the authors observed, “but patients who were tested were less likely to die in the hospital within 14 days,” the authors reported – at 6.7% versus 10.9% for untested patients (P < .001).

More than 80% of patients who tested positive for influenza received an antibacterial on day 1 of their admission, compared with virtually all those who were either not tested or who tested negative, the investigators added (P < .001). The mean duration of antibacterial therapy among patients with a bacterial coinfection was not influenced by influenza test results.

However, among those who tested positive for influenza, almost 60% received oseltamivir on day 1 whereas roughly 30% received treatment on day 2 or later. In fact, almost all patients who received early oseltamivir were tested for influenza on day 1, the investigators pointed out. Patients who received early oseltamivir had a 25% lower risk of death within the first 14 days in hospital at an adjusted odds ratio of 0.75 (95% confidence interval, 0.59-0.96).

Early initiation of the antiviral also reduced the risk of requiring subsequent ICU care by 36% at an aOR of 0.64; invasive mechanical ventilation by 46% at an aOR of 0.54, and the need for vasopressor therapy by 47% at an aOR of 0.53. All results were within the 95% confidence levels.

Early use of antiviral therapy also reduced both the length of hospital stay and the cost of that stay by 12%.
 

ATS-IDSA guidelines

As Dr. Deshpande noted, the American Thoracic Society and the Infectious Diseases Society of America guidelines recommend testing and empiric treatment of influenza in patients hospitalized with CAP. “Testing more inpatients especially during the flu season can reduce other diagnostic testing and improve antimicrobial stewardship,” Deshpande noted.

Thus, while the rate of testing for influenza did increase over the 5-year study interval, “there is substantial room for improvement,” he added, as a positive test clearly does trigger the need for intervention. As Dr. Deshpande also noted, the past two influenza seasons have been mild, but influenza activity has again picked up lately again in many parts of the United States.

With the COVID-19 pandemic overwhelming influenza over the past few years, “differentiating between the two based on symptoms alone can be challenging,” he acknowledged, “and clinicians will need to test and treat accordingly.” This is particularly important given that this study clearly indicates that early treatment with an antiviral can lower the risk of short-term mortality in hospitalized CAP patients.

One limitation of the study was the lack of data on time of symptom onset, which may be an important confounder of the effect of oseltamivir on outcomes, the authors point out. Asked to comment on the findings, Barbara Jones, MD, University of Utah Health, Salt Lake City, noted that timely antivirals for patients with influenza are highly effective at mitigating severe disease and are thus strongly recommended by practice guidelines.

“However, it is hard for clinicians to keep influenza on the radar and change testing and treatment approaches according to the season and prevalence [of influenza infections],” she said in an interview. “This is an important study that highlights this challenge.

“We need a better understanding of the solutions that have been effective at improving influenza recognition and treatment, possibly by studying facilities that perform well at this process,” she said.

Dr. Deshpande reported receiving research funding to his institution from the Clorox Company and consultant fees from Merck.

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

Early initiation of the antiviral oseltamivir (Tamiflu) reduces the risk for death in patients hospitalized with community-acquired pneumonia (CAP) but patients have to be tested for influenza first and that is not happening often enough, a large observational cohort of adult patients indicates.

“Early testing allows for early treatment, and we found that early treatment was associated with reduced mortality so testing patients during the flu season is crucial,” senior author Michael Rothberg, MD, MPH, of the Cleveland Clinic said in an interview.

“Even during the flu season, most patients with CAP in our study went untested for influenza [even though] those who received early oseltamivir exhibited lower 14-day in-hospital case fatality ... suggesting more widespread testing might improve patient outcomes,” the authors added.

The study was published online Feb. 5, 2022, in the journal CHEST.
 

Premier database

Data from the Premier Database – a hospital discharge database with information from over 600 hospitals in the United States – were analyzed between July 2010 and June 2015. Microbiological laboratory data was provided by 179 hospitals. “For each year, we evaluated the total percentage of patients tested for influenza A/B within 3 days of hospitalization,” lead author Abhishek Deshpande, MD, PhD, Cleveland Clinic, and colleagues explained.

A total of 166,268 patients with CAP were included in the study, among which only about one-quarter were tested for influenza. Some 11.5% tested positive for the flu, the authors noted. Testing did increase from 15.4% in 2010 to 35.6% in 2015 and it was higher at close to 29% during the influenza season, compared with only about 8% during the summer months.

Patients who were tested for influenza were younger at age 66.6 years, compared with untested patients, who were 70 years of age (P < .001). Tested patients were also less likely to have been admitted from a nursing facility (P < .001), were less likely to have been hospitalized in the preceding 6 months (P < .001) and have fewer comorbidities than those who were not tested (P < .001).

“Both groups had similar illness severities on admission,” the authors observed, “but patients who were tested were less likely to die in the hospital within 14 days,” the authors reported – at 6.7% versus 10.9% for untested patients (P < .001).

More than 80% of patients who tested positive for influenza received an antibacterial on day 1 of their admission, compared with virtually all those who were either not tested or who tested negative, the investigators added (P < .001). The mean duration of antibacterial therapy among patients with a bacterial coinfection was not influenced by influenza test results.

However, among those who tested positive for influenza, almost 60% received oseltamivir on day 1 whereas roughly 30% received treatment on day 2 or later. In fact, almost all patients who received early oseltamivir were tested for influenza on day 1, the investigators pointed out. Patients who received early oseltamivir had a 25% lower risk of death within the first 14 days in hospital at an adjusted odds ratio of 0.75 (95% confidence interval, 0.59-0.96).

Early initiation of the antiviral also reduced the risk of requiring subsequent ICU care by 36% at an aOR of 0.64; invasive mechanical ventilation by 46% at an aOR of 0.54, and the need for vasopressor therapy by 47% at an aOR of 0.53. All results were within the 95% confidence levels.

Early use of antiviral therapy also reduced both the length of hospital stay and the cost of that stay by 12%.
 

ATS-IDSA guidelines

As Dr. Deshpande noted, the American Thoracic Society and the Infectious Diseases Society of America guidelines recommend testing and empiric treatment of influenza in patients hospitalized with CAP. “Testing more inpatients especially during the flu season can reduce other diagnostic testing and improve antimicrobial stewardship,” Deshpande noted.

Thus, while the rate of testing for influenza did increase over the 5-year study interval, “there is substantial room for improvement,” he added, as a positive test clearly does trigger the need for intervention. As Dr. Deshpande also noted, the past two influenza seasons have been mild, but influenza activity has again picked up lately again in many parts of the United States.

With the COVID-19 pandemic overwhelming influenza over the past few years, “differentiating between the two based on symptoms alone can be challenging,” he acknowledged, “and clinicians will need to test and treat accordingly.” This is particularly important given that this study clearly indicates that early treatment with an antiviral can lower the risk of short-term mortality in hospitalized CAP patients.

One limitation of the study was the lack of data on time of symptom onset, which may be an important confounder of the effect of oseltamivir on outcomes, the authors point out. Asked to comment on the findings, Barbara Jones, MD, University of Utah Health, Salt Lake City, noted that timely antivirals for patients with influenza are highly effective at mitigating severe disease and are thus strongly recommended by practice guidelines.

“However, it is hard for clinicians to keep influenza on the radar and change testing and treatment approaches according to the season and prevalence [of influenza infections],” she said in an interview. “This is an important study that highlights this challenge.

“We need a better understanding of the solutions that have been effective at improving influenza recognition and treatment, possibly by studying facilities that perform well at this process,” she said.

Dr. Deshpande reported receiving research funding to his institution from the Clorox Company and consultant fees from Merck.

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

Early initiation of the antiviral oseltamivir (Tamiflu) reduces the risk for death in patients hospitalized with community-acquired pneumonia (CAP) but patients have to be tested for influenza first and that is not happening often enough, a large observational cohort of adult patients indicates.

“Early testing allows for early treatment, and we found that early treatment was associated with reduced mortality so testing patients during the flu season is crucial,” senior author Michael Rothberg, MD, MPH, of the Cleveland Clinic said in an interview.

“Even during the flu season, most patients with CAP in our study went untested for influenza [even though] those who received early oseltamivir exhibited lower 14-day in-hospital case fatality ... suggesting more widespread testing might improve patient outcomes,” the authors added.

The study was published online Feb. 5, 2022, in the journal CHEST.
 

Premier database

Data from the Premier Database – a hospital discharge database with information from over 600 hospitals in the United States – were analyzed between July 2010 and June 2015. Microbiological laboratory data was provided by 179 hospitals. “For each year, we evaluated the total percentage of patients tested for influenza A/B within 3 days of hospitalization,” lead author Abhishek Deshpande, MD, PhD, Cleveland Clinic, and colleagues explained.

A total of 166,268 patients with CAP were included in the study, among which only about one-quarter were tested for influenza. Some 11.5% tested positive for the flu, the authors noted. Testing did increase from 15.4% in 2010 to 35.6% in 2015 and it was higher at close to 29% during the influenza season, compared with only about 8% during the summer months.

Patients who were tested for influenza were younger at age 66.6 years, compared with untested patients, who were 70 years of age (P < .001). Tested patients were also less likely to have been admitted from a nursing facility (P < .001), were less likely to have been hospitalized in the preceding 6 months (P < .001) and have fewer comorbidities than those who were not tested (P < .001).

“Both groups had similar illness severities on admission,” the authors observed, “but patients who were tested were less likely to die in the hospital within 14 days,” the authors reported – at 6.7% versus 10.9% for untested patients (P < .001).

More than 80% of patients who tested positive for influenza received an antibacterial on day 1 of their admission, compared with virtually all those who were either not tested or who tested negative, the investigators added (P < .001). The mean duration of antibacterial therapy among patients with a bacterial coinfection was not influenced by influenza test results.

However, among those who tested positive for influenza, almost 60% received oseltamivir on day 1 whereas roughly 30% received treatment on day 2 or later. In fact, almost all patients who received early oseltamivir were tested for influenza on day 1, the investigators pointed out. Patients who received early oseltamivir had a 25% lower risk of death within the first 14 days in hospital at an adjusted odds ratio of 0.75 (95% confidence interval, 0.59-0.96).

Early initiation of the antiviral also reduced the risk of requiring subsequent ICU care by 36% at an aOR of 0.64; invasive mechanical ventilation by 46% at an aOR of 0.54, and the need for vasopressor therapy by 47% at an aOR of 0.53. All results were within the 95% confidence levels.

Early use of antiviral therapy also reduced both the length of hospital stay and the cost of that stay by 12%.
 

ATS-IDSA guidelines

As Dr. Deshpande noted, the American Thoracic Society and the Infectious Diseases Society of America guidelines recommend testing and empiric treatment of influenza in patients hospitalized with CAP. “Testing more inpatients especially during the flu season can reduce other diagnostic testing and improve antimicrobial stewardship,” Deshpande noted.

Thus, while the rate of testing for influenza did increase over the 5-year study interval, “there is substantial room for improvement,” he added, as a positive test clearly does trigger the need for intervention. As Dr. Deshpande also noted, the past two influenza seasons have been mild, but influenza activity has again picked up lately again in many parts of the United States.

With the COVID-19 pandemic overwhelming influenza over the past few years, “differentiating between the two based on symptoms alone can be challenging,” he acknowledged, “and clinicians will need to test and treat accordingly.” This is particularly important given that this study clearly indicates that early treatment with an antiviral can lower the risk of short-term mortality in hospitalized CAP patients.

One limitation of the study was the lack of data on time of symptom onset, which may be an important confounder of the effect of oseltamivir on outcomes, the authors point out. Asked to comment on the findings, Barbara Jones, MD, University of Utah Health, Salt Lake City, noted that timely antivirals for patients with influenza are highly effective at mitigating severe disease and are thus strongly recommended by practice guidelines.

“However, it is hard for clinicians to keep influenza on the radar and change testing and treatment approaches according to the season and prevalence [of influenza infections],” she said in an interview. “This is an important study that highlights this challenge.

“We need a better understanding of the solutions that have been effective at improving influenza recognition and treatment, possibly by studying facilities that perform well at this process,” she said.

Dr. Deshpande reported receiving research funding to his institution from the Clorox Company and consultant fees from Merck.

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

Sepsis is an alarmingly common cause behind ICU admissions in patients with multiple sclerosis (MS), a retrospective, population-based cohort study indicates.

Furthermore, it contributes to a disproportionately high percentage of the short-term mortality risk among patients with MS admitted to the ICU, findings also show. Short-term mortality risk was defined in the study as a combination of in-hospital death or discharge to hospice.

“We found that the risk of short-term mortality in critically ill patients with MS is four times higher among those with sepsis ... so sepsis appears to be comparatively more lethal among patients with MS than in the general population,” Lavi Oud, MD, professor of medicine, Texas Tech University HSC at the Permian Basin, Odessa, said in an email.

“[Although] the specific mechanisms underlying the markedly higher risk of sepsis among patients with MS compared to the general population remain to be fully elucidated ... it’s thought that the risk may stem from the dysfunction of the immune system in these patients related to MS itself and to the potentially adverse effect of the immunomodulating therapy we use in these patients,” he added.

The study was published online Jan. 11 in the Journal of Critical Care.
 

Sepsis rates

The Texas Inpatient Public Use Data File was used to identify adults with a diagnosis of MS admitted to the hospital between 2010 and 2017. Among the 19,837 patients with MS admitted to the ICU during the study interval, almost one-third (31.5%) had sepsis, investigators report. “The rate of sepsis among ICU admissions increased with age, ranging from 20.8% among those aged 18-44 to 39.4% among those aged 65 years or older,” investigators note.

The most common site of infection among MS patients admitted to the ICU were urinary in nature (65.2%), followed by respiratory (36.1%). A smaller proportion of infections (7.6%) involved the skin and soft tissues, researchers note. A full one-quarter of patients developed septic shock in response to their infection while the length of stay among patients with sepsis (mean of 10.9 days) was substantially longer than it was for those without sepsis (mean of 5.6 days), they observe.

At a mean total hospital cost of $121,797 for each ICU patient with sepsis, the cost of caring for each patient was nearly twofold higher than the mean total cost of taking care of ICU patients without sepsis (mean total cost, $65,179). On adjusted analysis, sepsis was associated with a 42.7% (95% confidence interval, 38.9-46.5; P < .0001) longer length of hospital stay and a 26.2% (95% CI, 23.1-29.1; P < .0001) higher total hospital cost compared with patients without sepsis, the authors point out.

Indeed, ICU admissions with sepsis accounted for 47.3% of all hospital days and for 46.1% of the aggregate hospital charges among all MS patients admitted to the ICU.

“The adjusted probability of short-term mortality was 13.4% (95% CI, 13.0-13.7) among ICU admissions with sepsis and 3.3% (95% CI, 3.2-3.4) among ICU admissions without sepsis,” the authors report.

This translated into a 44% higher risk of short-term mortality at an adjusted odds ratio of 1.44 (95% CI, 1.23-1.69; P < .0001) for those with sepsis, compared with those without, they add. Among all ICU admissions, sepsis was reported in over two-thirds of documented short-term mortality events. The risk of short-term mortality was also almost threefold higher among patients with sepsis who were age 65 years and older compared with patients aged 18-44. 

As Dr. Oud noted, there is no specific test for sepsis, and it can initially present in an atypical manner, especially in older, frailer, chronically ill patients as well as in patients with immune dysfunction. “Thus, considering sepsis as a possible cause of new deterioration in a patient’s condition is essential, along with the timely start of sepsis-related care,” Dr. Oud observed.

A limitation of the study was that the dataset did not include information on the type of MS a patient had, the duration of their illness, the treatment received, the level of disease activity, or the level of disability.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

Sepsis is an alarmingly common cause behind ICU admissions in patients with multiple sclerosis (MS), a retrospective, population-based cohort study indicates.

Furthermore, it contributes to a disproportionately high percentage of the short-term mortality risk among patients with MS admitted to the ICU, findings also show. Short-term mortality risk was defined in the study as a combination of in-hospital death or discharge to hospice.

“We found that the risk of short-term mortality in critically ill patients with MS is four times higher among those with sepsis ... so sepsis appears to be comparatively more lethal among patients with MS than in the general population,” Lavi Oud, MD, professor of medicine, Texas Tech University HSC at the Permian Basin, Odessa, said in an email.

“[Although] the specific mechanisms underlying the markedly higher risk of sepsis among patients with MS compared to the general population remain to be fully elucidated ... it’s thought that the risk may stem from the dysfunction of the immune system in these patients related to MS itself and to the potentially adverse effect of the immunomodulating therapy we use in these patients,” he added.

The study was published online Jan. 11 in the Journal of Critical Care.
 

Sepsis rates

The Texas Inpatient Public Use Data File was used to identify adults with a diagnosis of MS admitted to the hospital between 2010 and 2017. Among the 19,837 patients with MS admitted to the ICU during the study interval, almost one-third (31.5%) had sepsis, investigators report. “The rate of sepsis among ICU admissions increased with age, ranging from 20.8% among those aged 18-44 to 39.4% among those aged 65 years or older,” investigators note.

The most common site of infection among MS patients admitted to the ICU were urinary in nature (65.2%), followed by respiratory (36.1%). A smaller proportion of infections (7.6%) involved the skin and soft tissues, researchers note. A full one-quarter of patients developed septic shock in response to their infection while the length of stay among patients with sepsis (mean of 10.9 days) was substantially longer than it was for those without sepsis (mean of 5.6 days), they observe.

At a mean total hospital cost of $121,797 for each ICU patient with sepsis, the cost of caring for each patient was nearly twofold higher than the mean total cost of taking care of ICU patients without sepsis (mean total cost, $65,179). On adjusted analysis, sepsis was associated with a 42.7% (95% confidence interval, 38.9-46.5; P < .0001) longer length of hospital stay and a 26.2% (95% CI, 23.1-29.1; P < .0001) higher total hospital cost compared with patients without sepsis, the authors point out.

Indeed, ICU admissions with sepsis accounted for 47.3% of all hospital days and for 46.1% of the aggregate hospital charges among all MS patients admitted to the ICU.

“The adjusted probability of short-term mortality was 13.4% (95% CI, 13.0-13.7) among ICU admissions with sepsis and 3.3% (95% CI, 3.2-3.4) among ICU admissions without sepsis,” the authors report.

This translated into a 44% higher risk of short-term mortality at an adjusted odds ratio of 1.44 (95% CI, 1.23-1.69; P < .0001) for those with sepsis, compared with those without, they add. Among all ICU admissions, sepsis was reported in over two-thirds of documented short-term mortality events. The risk of short-term mortality was also almost threefold higher among patients with sepsis who were age 65 years and older compared with patients aged 18-44. 

As Dr. Oud noted, there is no specific test for sepsis, and it can initially present in an atypical manner, especially in older, frailer, chronically ill patients as well as in patients with immune dysfunction. “Thus, considering sepsis as a possible cause of new deterioration in a patient’s condition is essential, along with the timely start of sepsis-related care,” Dr. Oud observed.

A limitation of the study was that the dataset did not include information on the type of MS a patient had, the duration of their illness, the treatment received, the level of disease activity, or the level of disability.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

Sepsis is an alarmingly common cause behind ICU admissions in patients with multiple sclerosis (MS), a retrospective, population-based cohort study indicates.

Furthermore, it contributes to a disproportionately high percentage of the short-term mortality risk among patients with MS admitted to the ICU, findings also show. Short-term mortality risk was defined in the study as a combination of in-hospital death or discharge to hospice.

“We found that the risk of short-term mortality in critically ill patients with MS is four times higher among those with sepsis ... so sepsis appears to be comparatively more lethal among patients with MS than in the general population,” Lavi Oud, MD, professor of medicine, Texas Tech University HSC at the Permian Basin, Odessa, said in an email.

“[Although] the specific mechanisms underlying the markedly higher risk of sepsis among patients with MS compared to the general population remain to be fully elucidated ... it’s thought that the risk may stem from the dysfunction of the immune system in these patients related to MS itself and to the potentially adverse effect of the immunomodulating therapy we use in these patients,” he added.

The study was published online Jan. 11 in the Journal of Critical Care.
 

Sepsis rates

The Texas Inpatient Public Use Data File was used to identify adults with a diagnosis of MS admitted to the hospital between 2010 and 2017. Among the 19,837 patients with MS admitted to the ICU during the study interval, almost one-third (31.5%) had sepsis, investigators report. “The rate of sepsis among ICU admissions increased with age, ranging from 20.8% among those aged 18-44 to 39.4% among those aged 65 years or older,” investigators note.

The most common site of infection among MS patients admitted to the ICU were urinary in nature (65.2%), followed by respiratory (36.1%). A smaller proportion of infections (7.6%) involved the skin and soft tissues, researchers note. A full one-quarter of patients developed septic shock in response to their infection while the length of stay among patients with sepsis (mean of 10.9 days) was substantially longer than it was for those without sepsis (mean of 5.6 days), they observe.

At a mean total hospital cost of $121,797 for each ICU patient with sepsis, the cost of caring for each patient was nearly twofold higher than the mean total cost of taking care of ICU patients without sepsis (mean total cost, $65,179). On adjusted analysis, sepsis was associated with a 42.7% (95% confidence interval, 38.9-46.5; P < .0001) longer length of hospital stay and a 26.2% (95% CI, 23.1-29.1; P < .0001) higher total hospital cost compared with patients without sepsis, the authors point out.

Indeed, ICU admissions with sepsis accounted for 47.3% of all hospital days and for 46.1% of the aggregate hospital charges among all MS patients admitted to the ICU.

“The adjusted probability of short-term mortality was 13.4% (95% CI, 13.0-13.7) among ICU admissions with sepsis and 3.3% (95% CI, 3.2-3.4) among ICU admissions without sepsis,” the authors report.

This translated into a 44% higher risk of short-term mortality at an adjusted odds ratio of 1.44 (95% CI, 1.23-1.69; P < .0001) for those with sepsis, compared with those without, they add. Among all ICU admissions, sepsis was reported in over two-thirds of documented short-term mortality events. The risk of short-term mortality was also almost threefold higher among patients with sepsis who were age 65 years and older compared with patients aged 18-44. 

As Dr. Oud noted, there is no specific test for sepsis, and it can initially present in an atypical manner, especially in older, frailer, chronically ill patients as well as in patients with immune dysfunction. “Thus, considering sepsis as a possible cause of new deterioration in a patient’s condition is essential, along with the timely start of sepsis-related care,” Dr. Oud observed.

A limitation of the study was that the dataset did not include information on the type of MS a patient had, the duration of their illness, the treatment received, the level of disease activity, or the level of disability.

The study had no specific funding. The authors have disclosed no relevant financial relationships.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has refined its cardiogenic shock (CS) classification system based on the literature and clinician feedback from real-world experience.

Mitchel L. Zoler/MDedge News

“In the 2 years since publication in 2019, the initial definition has been broadly accepted and eagerly appreciated, allowing a very intuitive way to stage these patients for better communication, triage, and treatment,” Srihari S. Naidu, MD, professor of medicine, New York Medical College, Valhalla, said in an interview.

“But the initial definition was based on consensus opinion, with a lack of real fundamental data on segregating patients into different stages. Now we have a lot more data utilizing the definition, and it became very clear that there were a couple of limitations in the initial definition,” Dr. Naidu explained.

The refined CS classification system – authored by Dr. Naidu and a multidisciplinary panel of experts from specialties that included cardiac critical care, interventional cardiology, surgery, nursing, emergency medicine, and heart failure – was published online Jan. 31 in the Journal of the Society for Cardiovascular Angiography and Interventions, with simultaneous publication in the Journal of the American College of Cardiology.  

It maintains the five-stage pyramid of CS, starting with “at risk” and moving through “beginning,” “classic,” “deteriorating,” and “extremis” but now includes gradations of severity within each stage and pathways by which patients progress or recover.

“Progression across the SCAI shock stage continuum is a dynamic process, incorporating new information as available, and patient trajectories are important both for communication among clinicians and for decisionmaking regarding the next level of care and therapeutics,” the panel writes.

The second iteration adds a streamlined table incorporating commonly seen variables, based on lessons learned from validation studies and clinician experience.

“While keeping the same initial framework of looking at the three components of staging – the physical exam, the biochemical markers, and hemodynamics – we’ve made it very clear that there are some factors in each of these that are most typically seen. And then there are other factors that are consistent with that stage but don’t necessarily have to be seen, ... are not typically seen in that stage, or [are] not always present at that stage,” Dr. Naidu told this news organization.

The refined CS classification system provides more granularity on cardiac arrest as a risk modifier, which now excludes very brief episodes with rapid response to defibrillation and comprises only those patients who have impaired mental status with unknown neurologic recovery status after cardiopulmonary resuscitation.

Lactate level and thresholds have been highlighted to detect hypoperfusion but may be dissociated from hemodynamics in cases such as chronic heart failure.

In addition, patients may have other manifestations of end-organ hypoperfusion with a normal lactate level, and there are also important causes of an elevated lactate level other than shock.

The revision proposes a three-axis model of CS evaluation and prognostication that integrates shock severity, clinical phenotype, and risk modifiers as distinct elements that should be applied to individualize patient management.

The revision also places more emphasis on the trajectory of the patient with CS through hospitalization, including a “hub and spoke” model for transfer of higher-risk patients, including those with a deteriorating SCAI shock stage.

“It is our desire and belief that the revised SCAI SHOCK stage classification system will enhance both clinical care and CS research trial design,” the panel writes.

This statement has been endorsed by the American College of Cardiology, American College of Emergency Physicians, American Heart Association, European Society of Cardiology Association for Acute Cardiovascular Care, International Society for Heart and Lung Transplantation, Society of Critical Care Medicine, and Society of Thoracic Surgeons.

This research had no commercial funding. Dr. Naidu has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has refined its cardiogenic shock (CS) classification system based on the literature and clinician feedback from real-world experience.

Mitchel L. Zoler/MDedge News

“In the 2 years since publication in 2019, the initial definition has been broadly accepted and eagerly appreciated, allowing a very intuitive way to stage these patients for better communication, triage, and treatment,” Srihari S. Naidu, MD, professor of medicine, New York Medical College, Valhalla, said in an interview.

“But the initial definition was based on consensus opinion, with a lack of real fundamental data on segregating patients into different stages. Now we have a lot more data utilizing the definition, and it became very clear that there were a couple of limitations in the initial definition,” Dr. Naidu explained.

The refined CS classification system – authored by Dr. Naidu and a multidisciplinary panel of experts from specialties that included cardiac critical care, interventional cardiology, surgery, nursing, emergency medicine, and heart failure – was published online Jan. 31 in the Journal of the Society for Cardiovascular Angiography and Interventions, with simultaneous publication in the Journal of the American College of Cardiology.  

It maintains the five-stage pyramid of CS, starting with “at risk” and moving through “beginning,” “classic,” “deteriorating,” and “extremis” but now includes gradations of severity within each stage and pathways by which patients progress or recover.

“Progression across the SCAI shock stage continuum is a dynamic process, incorporating new information as available, and patient trajectories are important both for communication among clinicians and for decisionmaking regarding the next level of care and therapeutics,” the panel writes.

The second iteration adds a streamlined table incorporating commonly seen variables, based on lessons learned from validation studies and clinician experience.

“While keeping the same initial framework of looking at the three components of staging – the physical exam, the biochemical markers, and hemodynamics – we’ve made it very clear that there are some factors in each of these that are most typically seen. And then there are other factors that are consistent with that stage but don’t necessarily have to be seen, ... are not typically seen in that stage, or [are] not always present at that stage,” Dr. Naidu told this news organization.

The refined CS classification system provides more granularity on cardiac arrest as a risk modifier, which now excludes very brief episodes with rapid response to defibrillation and comprises only those patients who have impaired mental status with unknown neurologic recovery status after cardiopulmonary resuscitation.

Lactate level and thresholds have been highlighted to detect hypoperfusion but may be dissociated from hemodynamics in cases such as chronic heart failure.

In addition, patients may have other manifestations of end-organ hypoperfusion with a normal lactate level, and there are also important causes of an elevated lactate level other than shock.

The revision proposes a three-axis model of CS evaluation and prognostication that integrates shock severity, clinical phenotype, and risk modifiers as distinct elements that should be applied to individualize patient management.

The revision also places more emphasis on the trajectory of the patient with CS through hospitalization, including a “hub and spoke” model for transfer of higher-risk patients, including those with a deteriorating SCAI shock stage.

“It is our desire and belief that the revised SCAI SHOCK stage classification system will enhance both clinical care and CS research trial design,” the panel writes.

This statement has been endorsed by the American College of Cardiology, American College of Emergency Physicians, American Heart Association, European Society of Cardiology Association for Acute Cardiovascular Care, International Society for Heart and Lung Transplantation, Society of Critical Care Medicine, and Society of Thoracic Surgeons.

This research had no commercial funding. Dr. Naidu has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

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

The Society for Cardiovascular Angiography and Interventions (SCAI) has refined its cardiogenic shock (CS) classification system based on the literature and clinician feedback from real-world experience.

Mitchel L. Zoler/MDedge News

“In the 2 years since publication in 2019, the initial definition has been broadly accepted and eagerly appreciated, allowing a very intuitive way to stage these patients for better communication, triage, and treatment,” Srihari S. Naidu, MD, professor of medicine, New York Medical College, Valhalla, said in an interview.

“But the initial definition was based on consensus opinion, with a lack of real fundamental data on segregating patients into different stages. Now we have a lot more data utilizing the definition, and it became very clear that there were a couple of limitations in the initial definition,” Dr. Naidu explained.

The refined CS classification system – authored by Dr. Naidu and a multidisciplinary panel of experts from specialties that included cardiac critical care, interventional cardiology, surgery, nursing, emergency medicine, and heart failure – was published online Jan. 31 in the Journal of the Society for Cardiovascular Angiography and Interventions, with simultaneous publication in the Journal of the American College of Cardiology.  

It maintains the five-stage pyramid of CS, starting with “at risk” and moving through “beginning,” “classic,” “deteriorating,” and “extremis” but now includes gradations of severity within each stage and pathways by which patients progress or recover.

“Progression across the SCAI shock stage continuum is a dynamic process, incorporating new information as available, and patient trajectories are important both for communication among clinicians and for decisionmaking regarding the next level of care and therapeutics,” the panel writes.

The second iteration adds a streamlined table incorporating commonly seen variables, based on lessons learned from validation studies and clinician experience.

“While keeping the same initial framework of looking at the three components of staging – the physical exam, the biochemical markers, and hemodynamics – we’ve made it very clear that there are some factors in each of these that are most typically seen. And then there are other factors that are consistent with that stage but don’t necessarily have to be seen, ... are not typically seen in that stage, or [are] not always present at that stage,” Dr. Naidu told this news organization.

The refined CS classification system provides more granularity on cardiac arrest as a risk modifier, which now excludes very brief episodes with rapid response to defibrillation and comprises only those patients who have impaired mental status with unknown neurologic recovery status after cardiopulmonary resuscitation.

Lactate level and thresholds have been highlighted to detect hypoperfusion but may be dissociated from hemodynamics in cases such as chronic heart failure.

In addition, patients may have other manifestations of end-organ hypoperfusion with a normal lactate level, and there are also important causes of an elevated lactate level other than shock.

The revision proposes a three-axis model of CS evaluation and prognostication that integrates shock severity, clinical phenotype, and risk modifiers as distinct elements that should be applied to individualize patient management.

The revision also places more emphasis on the trajectory of the patient with CS through hospitalization, including a “hub and spoke” model for transfer of higher-risk patients, including those with a deteriorating SCAI shock stage.

“It is our desire and belief that the revised SCAI SHOCK stage classification system will enhance both clinical care and CS research trial design,” the panel writes.

This statement has been endorsed by the American College of Cardiology, American College of Emergency Physicians, American Heart Association, European Society of Cardiology Association for Acute Cardiovascular Care, International Society for Heart and Lung Transplantation, Society of Critical Care Medicine, and Society of Thoracic Surgeons.

This research had no commercial funding. Dr. Naidu has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article.

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

Nearly one-third of adults over age 65 developed one or more new medical conditions in the weeks following a COVID-19 infection, according to new research.

The findings of the observational study, which were published in the BMJ, show the risk of a new condition being triggered by COVID is more than twice as high in seniors, compared with younger patients. Plus, the researchers observed an even higher risk among those who were hospitalized, with nearly half (46%) of patients having developed new conditions after the acute COVID-19 infection period.

Respiratory failure with shortness of breath was the most common postacute sequela, but a wide range of heart, kidney, lung, liver, cognitive, mental health, and other conditions were diagnosed at least 3 weeks after initial infection and persisted beyond 30 days.

This is one of the first studies to specifically describe the incidence and severity of new conditions triggered by COVID-19 infection in a general sample of older adults, said study author Ken Cohen MD, FACP, executive director of translational research at Optum Labs and national senior medical director at Optum Care.

“Much of what has been published on the postacute sequelae of COVID-19 has been predominantly from a younger population, and many of the patients had been hospitalized,” Dr. Cohen noted. “This was the first study to focus on a large population of seniors, most of whom did not require hospitalization.”

Dr. Cohen and colleagues reviewed the health insurance records of more than 133,000 Medicare beneficiaries aged 65 or older who were diagnosed with COVID-19 before April 2020. They also matched individuals by age, race, sex, hospitalization status, and other factors to comparison groups without COVID-19 (one from 2020 and one from 2019), and to a group diagnosed with other lower respiratory tract viral infections before the pandemic.
 

Risk of developing new conditions was higher in hospitalized

After acute COVID-19 infection, 32% of seniors sought medical care for at least one new medical condition in 2020, compared with 21% of uninfected people in the same year.

The most commonly observed conditions included:

• Respiratory failure (7.55% higher risk).
• Fatigue (5.66% higher risk).
• High blood pressure (4.43% higher risk).
• Memory problems (2.63% higher risk).
• Kidney injury (2.59% higher risk).
• Mental health diagnoses (2.5% higher risk).
• Blood-clotting disorders (1.47 % higher risk).
• Heart rhythm disorders (2.9% higher risk).

The risk of developing new conditions was even higher among those 23,486 who were hospitalized in 2020. Those individuals showed a 23.6% higher risk for developing at least one new condition, compared with uninfected seniors in the same year. Also, patients older than 75 had a higher risk for neurological disorders, including dementia, encephalopathy, and memory problems. The researchers also found that respiratory failure and kidney injury were significantly more likely to affect men and Black patients.

When those who had COVID were compared with the group with other lower respiratory viral infections before the pandemic, only the risks of respiratory failure (2.39% higher), dementia (0.71% higher), and fatigue (0.18% higher) were higher.

Primary care providers can learn from these data to better evaluate and manage their geriatric patients with COVID-19 infection, said Amit Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, in an interview.

“We must assess older patients who have had COVID-19 for more than just improvement from the respiratory symptoms of COVID-19 in post-COVID follow-up visits,” he said. “Older individuals with frailty have vulnerability to subsequent complications from severe illnesses and it is common to see post-illness diagnoses, such as new diagnosis of delirium; dementia; or renal, respiratory, or cardiac issues that is precipitated by the original illness. This study confirms that this is likely the case with COVID-19 as well.

“Primary care physicians should be vigilant for these complications, including attention to the rehabilitation needs of older patients with longer-term postviral fatigue from COVID-19,” Dr. Shah added.
 

Data predates ‘Omicron wave’

It remains uncertain whether sequelae will differ with the Omicron variant, but the findings remain applicable, Dr. Cohen said.

“We know that illness from the Omicron variant is on average less severe in those that have been vaccinated. However, throughout the Omicron wave, individuals who have not been vaccinated continue to have significant rates of serious illness and hospitalization,” he said.

“Our findings showed that serious illness with hospitalization was associated with a higher rate of sequelae. It can therefore be inferred that the rates of sequelae seen in our study would continue to occur in unvaccinated individuals who contract Omicron, but might occur less frequently in vaccinated individuals who contract Omicron and have less severe illness.”

Dr. Cohen serves as a consultant for Pfizer. Dr. Shah has disclosed no relevant financial relationships.

Nearly one-third of adults over age 65 developed one or more new medical conditions in the weeks following a COVID-19 infection, according to new research.

The findings of the observational study, which were published in the BMJ, show the risk of a new condition being triggered by COVID is more than twice as high in seniors, compared with younger patients. Plus, the researchers observed an even higher risk among those who were hospitalized, with nearly half (46%) of patients having developed new conditions after the acute COVID-19 infection period.

Respiratory failure with shortness of breath was the most common postacute sequela, but a wide range of heart, kidney, lung, liver, cognitive, mental health, and other conditions were diagnosed at least 3 weeks after initial infection and persisted beyond 30 days.

This is one of the first studies to specifically describe the incidence and severity of new conditions triggered by COVID-19 infection in a general sample of older adults, said study author Ken Cohen MD, FACP, executive director of translational research at Optum Labs and national senior medical director at Optum Care.

“Much of what has been published on the postacute sequelae of COVID-19 has been predominantly from a younger population, and many of the patients had been hospitalized,” Dr. Cohen noted. “This was the first study to focus on a large population of seniors, most of whom did not require hospitalization.”

Dr. Cohen and colleagues reviewed the health insurance records of more than 133,000 Medicare beneficiaries aged 65 or older who were diagnosed with COVID-19 before April 2020. They also matched individuals by age, race, sex, hospitalization status, and other factors to comparison groups without COVID-19 (one from 2020 and one from 2019), and to a group diagnosed with other lower respiratory tract viral infections before the pandemic.
 

Risk of developing new conditions was higher in hospitalized

After acute COVID-19 infection, 32% of seniors sought medical care for at least one new medical condition in 2020, compared with 21% of uninfected people in the same year.

The most commonly observed conditions included:

• Respiratory failure (7.55% higher risk).
• Fatigue (5.66% higher risk).
• High blood pressure (4.43% higher risk).
• Memory problems (2.63% higher risk).
• Kidney injury (2.59% higher risk).
• Mental health diagnoses (2.5% higher risk).
• Blood-clotting disorders (1.47 % higher risk).
• Heart rhythm disorders (2.9% higher risk).

The risk of developing new conditions was even higher among those 23,486 who were hospitalized in 2020. Those individuals showed a 23.6% higher risk for developing at least one new condition, compared with uninfected seniors in the same year. Also, patients older than 75 had a higher risk for neurological disorders, including dementia, encephalopathy, and memory problems. The researchers also found that respiratory failure and kidney injury were significantly more likely to affect men and Black patients.

When those who had COVID were compared with the group with other lower respiratory viral infections before the pandemic, only the risks of respiratory failure (2.39% higher), dementia (0.71% higher), and fatigue (0.18% higher) were higher.

Primary care providers can learn from these data to better evaluate and manage their geriatric patients with COVID-19 infection, said Amit Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, in an interview.

“We must assess older patients who have had COVID-19 for more than just improvement from the respiratory symptoms of COVID-19 in post-COVID follow-up visits,” he said. “Older individuals with frailty have vulnerability to subsequent complications from severe illnesses and it is common to see post-illness diagnoses, such as new diagnosis of delirium; dementia; or renal, respiratory, or cardiac issues that is precipitated by the original illness. This study confirms that this is likely the case with COVID-19 as well.

“Primary care physicians should be vigilant for these complications, including attention to the rehabilitation needs of older patients with longer-term postviral fatigue from COVID-19,” Dr. Shah added.
 

Data predates ‘Omicron wave’

It remains uncertain whether sequelae will differ with the Omicron variant, but the findings remain applicable, Dr. Cohen said.

“We know that illness from the Omicron variant is on average less severe in those that have been vaccinated. However, throughout the Omicron wave, individuals who have not been vaccinated continue to have significant rates of serious illness and hospitalization,” he said.

“Our findings showed that serious illness with hospitalization was associated with a higher rate of sequelae. It can therefore be inferred that the rates of sequelae seen in our study would continue to occur in unvaccinated individuals who contract Omicron, but might occur less frequently in vaccinated individuals who contract Omicron and have less severe illness.”

Dr. Cohen serves as a consultant for Pfizer. Dr. Shah has disclosed no relevant financial relationships.

Nearly one-third of adults over age 65 developed one or more new medical conditions in the weeks following a COVID-19 infection, according to new research.

The findings of the observational study, which were published in the BMJ, show the risk of a new condition being triggered by COVID is more than twice as high in seniors, compared with younger patients. Plus, the researchers observed an even higher risk among those who were hospitalized, with nearly half (46%) of patients having developed new conditions after the acute COVID-19 infection period.

Respiratory failure with shortness of breath was the most common postacute sequela, but a wide range of heart, kidney, lung, liver, cognitive, mental health, and other conditions were diagnosed at least 3 weeks after initial infection and persisted beyond 30 days.

This is one of the first studies to specifically describe the incidence and severity of new conditions triggered by COVID-19 infection in a general sample of older adults, said study author Ken Cohen MD, FACP, executive director of translational research at Optum Labs and national senior medical director at Optum Care.

“Much of what has been published on the postacute sequelae of COVID-19 has been predominantly from a younger population, and many of the patients had been hospitalized,” Dr. Cohen noted. “This was the first study to focus on a large population of seniors, most of whom did not require hospitalization.”

Dr. Cohen and colleagues reviewed the health insurance records of more than 133,000 Medicare beneficiaries aged 65 or older who were diagnosed with COVID-19 before April 2020. They also matched individuals by age, race, sex, hospitalization status, and other factors to comparison groups without COVID-19 (one from 2020 and one from 2019), and to a group diagnosed with other lower respiratory tract viral infections before the pandemic.
 

Risk of developing new conditions was higher in hospitalized

After acute COVID-19 infection, 32% of seniors sought medical care for at least one new medical condition in 2020, compared with 21% of uninfected people in the same year.

The most commonly observed conditions included:

• Respiratory failure (7.55% higher risk).
• Fatigue (5.66% higher risk).
• High blood pressure (4.43% higher risk).
• Memory problems (2.63% higher risk).
• Kidney injury (2.59% higher risk).
• Mental health diagnoses (2.5% higher risk).
• Blood-clotting disorders (1.47 % higher risk).
• Heart rhythm disorders (2.9% higher risk).

The risk of developing new conditions was even higher among those 23,486 who were hospitalized in 2020. Those individuals showed a 23.6% higher risk for developing at least one new condition, compared with uninfected seniors in the same year. Also, patients older than 75 had a higher risk for neurological disorders, including dementia, encephalopathy, and memory problems. The researchers also found that respiratory failure and kidney injury were significantly more likely to affect men and Black patients.

When those who had COVID were compared with the group with other lower respiratory viral infections before the pandemic, only the risks of respiratory failure (2.39% higher), dementia (0.71% higher), and fatigue (0.18% higher) were higher.

Primary care providers can learn from these data to better evaluate and manage their geriatric patients with COVID-19 infection, said Amit Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, in an interview.

“We must assess older patients who have had COVID-19 for more than just improvement from the respiratory symptoms of COVID-19 in post-COVID follow-up visits,” he said. “Older individuals with frailty have vulnerability to subsequent complications from severe illnesses and it is common to see post-illness diagnoses, such as new diagnosis of delirium; dementia; or renal, respiratory, or cardiac issues that is precipitated by the original illness. This study confirms that this is likely the case with COVID-19 as well.

“Primary care physicians should be vigilant for these complications, including attention to the rehabilitation needs of older patients with longer-term postviral fatigue from COVID-19,” Dr. Shah added.
 

Data predates ‘Omicron wave’

It remains uncertain whether sequelae will differ with the Omicron variant, but the findings remain applicable, Dr. Cohen said.

“We know that illness from the Omicron variant is on average less severe in those that have been vaccinated. However, throughout the Omicron wave, individuals who have not been vaccinated continue to have significant rates of serious illness and hospitalization,” he said.

“Our findings showed that serious illness with hospitalization was associated with a higher rate of sequelae. It can therefore be inferred that the rates of sequelae seen in our study would continue to occur in unvaccinated individuals who contract Omicron, but might occur less frequently in vaccinated individuals who contract Omicron and have less severe illness.”

Dr. Cohen serves as a consultant for Pfizer. Dr. Shah has disclosed no relevant financial relationships.

From the Department of Emergency Medicine, Santa Croce e Carle Hospital, Cuneo, Italy (Drs. Abram, Tosello, Emanuele Bernardi, Allione, Cavalot, Dutto, Corsini, Martini, Sciolla, Sara Bernardi, and Lauria). From the School of Emergency Medicine, University of Turin, Turin, Italy (Drs. Paglietta and Giamello).

Objective: This retrospective and prospective cohort study was designed to describe the characteristics, treatments, and outcomes of patients with SARS-CoV-2 infection (COVID-19) admitted to subintensive care units (SICU) and to identify the variables associated with outcomes. SICUs have been extremely stressed during the pandemic, but most data regarding critically ill COVID-19 patients come from intensive care units (ICUs). Studies about COVID-19 patients in SICUs are lacking.

Setting and participants: The study included 88 COVID-19 patients admitted to our SICU in Cuneo, Italy, between March and May 2020.

Measurements: Clinical and ventilatory data were collected, and patients were divided by outcome. Multivariable logistic regression analysis examined the variables associated with negative outcomes (transfer to the ICU, palliation, or death in a SICU).

Results: A total of 60 patients (68%) had a positive outcome, and 28 patients (32%) had a negative outcome; 69 patients (78%) underwent continuous positive airway pressure (CPAP). Pronation (n = 37 [42%]) had been more frequently adopted in patients who had a positive outcome vs a negative outcome (n = 30 [50%] vs n = 7 [25%]; P = .048), and the median (interquartile range) Pao₂/Fio₂ ratio after 6 hours of prone positioning was lower in patients who had a negative outcome vs a positive outcome (144 [140-168] vs 249 [195-268], P = .006). Independent predictors of a negative outcome were diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P = .015), higher D-dimer (OR, 1.28; 95% CI, 1.04-1.57; P = .019), higher lactate dehydrogenase level (OR, 1.003; 95% CI, 1.000-1.006; P = .039), and lower lymphocytes count (OR, 0.996; 95% CI, 0.993-0.999; P = .004).

Conclusion: SICUs have a fundamental role in the treatment of critically ill patients with COVID-19, who require long-term CPAP and pronation cycles. Diabetes, lymphopenia, and high D-dimer and LDH levels are associated with negative outcomes.

Keywords: emergency medicine, noninvasive ventilation, prone position, continuous positive airway pressure.

The COVID-19 pandemic has led to large increases in hospital admissions. Subintensive care units (SICUs) are among the wards most under pressure worldwide,¹ dealing with the increased number of critically ill patients who need noninvasive ventilation, as well as serving as the best alternative to overfilled intensive care units (ICUs). In Italy, SICUs are playing a fundamental role in the management of COVID-19 patients, providing early treatment of respiratory failure by continuous noninvasive ventilation in order to reduce the need for intubation.^2-5 Nevertheless, the great majority of available data about critically ill COVID-19 patients comes from ICUs. Full studies about outcomes of patients in SICUs are lacking and need to be conducted.

We sought to evaluate the characteristics and outcomes of patients admitted to our SICU for COVID-19 to describe the treatments they needed and their impact on prognosis, and to identify the variables associated with patient outcomes.

Methods

Study Design

This cohort study used data from patients who were admitted in the very first weeks of the pandemic. Data were collected retrospectively as well as prospectively, since the ethical committee approved our project. The quality and quantity of data in the 2 groups were comparable.

Data were collected from electronic and written medical records gathered during the patient’s entire stay in our SICU. Data were entered in a database with limited and controlled access. This study complied with the Declaration of Helsinki and was approved by the local ethics committees (ID: MEDURG10).

Study Population

We studied 88 consecutive patients admitted to the SICU of the Santa Croce e Carle Teaching Hospital, Cuneo, Italy, for COVID-19, from March 8 to May 1, 2020. The diagnosis was based on acute respiratory failure associated with SARS-CoV-2 RNA detection on nasopharyngeal swab or tracheal aspirate and/or typical COVID-19 features on a pulmonary computed tomography (CT) scan.⁶ Exclusion criteria were age younger than 18 years and patient denial of permission to use their data for research purposes (the great majority of patients could actively give consent; for patients who were too sick to do so, family members were asked whether they were aware of any reason why the patient would deny consent).

The past medical history and recent symptoms description were obtained by manually reviewing medical records. Epidemiological exposure was defined as contact with SARS-CoV-2–positive people or staying in an epidemic outbreak area. Initial vital parameters, venous blood tests, arterial blood gas analysis, chest x-ray, as well as the result of the nasopharyngeal swab were gathered from the emergency department (ED) examination. (Additional swabs could be requested when the first one was negative but clinical suspicion for COVID-19 was high.) Upon admission to the SICU, a standardized panel of blood tests was performed, which was repeated the next day and then every 48 hours. Arterial blood gas analysis was performed when clinically indicated, at least twice a day, or following a scheduled time in patients undergoing pronation. Charlson Comorbidity Index⁷ and MuLBSTA score⁸ were calculated based on the collected data.

Imaging

Chest ultrasonography was performed in the ED at the time of hospitalization and once a day in the SICU. Pulmonary high-resolution computed tomography (HRCT) was performed when clinically indicated or when the results of nasopharyngeal swabs and/or x-ray results were discordant with COVID-19 clinical suspicion. Contrast CT was performed when pulmonary embolism was suspected.

Medical Therapy

Hydroxychloroquine, antiviral agents, tocilizumab, and ruxolitinib were used in the early phase of the pandemic, then were dismissed after evidence of no efficacy.^9-11 Steroids and low-molecular-weight heparin were used afterward. Enoxaparin was used at the standard prophylactic dosage, and 70% of the anticoagulant dosage was also adopted in patients with moderate-to-severe COVID-19 and D-dimer values >3 times the normal value.^12-14 Antibiotics were given when a bacterial superinfection was suspected.

Oxygen and Ventilatory Therapy

Oxygen support or noninvasive ventilation were started based on patients’ respiratory efficacy, estimated by respiratory rate and the ratio of partial pressure of arterial oxygen and fraction of inspired oxygen (P/F ratio).^15,16 Oxygen support was delivered through nasal cannula, Venturi mask, or reservoir mask. Noninvasive ventilation was performed by continuous positive airway pressure (CPAP) when the P/F ratio was <250 or the respiratory rate was >25 breaths per minute, using the helmet interface.^5,17 Prone positioning during CPAP^18-20 was adopted in patients meeting the acute respiratory distress syndrome (ARDS) criteria²¹ and having persistence of respiratory distress and P/F <300 after a 1-hour trial of CPAP.

The prone position was maintained based on patient tolerance. P/F ratio was measured before pronation (T0), after 1 hour of prone position (T1), before resupination (T2), and 6 hours after resupination (T3). With the same timing, the patient was asked to rate their comfort in each position, from 0 (lack of comfort) to 10 (optimal comfort). Delta P/F was defined as the difference between P/F at T3 and basal P/F at T0.

Outcomes

Positive outcomes were defined as patient discharge from the SICU or transfer to a lower-intensity care ward for treatment continuation. Negative outcomes were defined as need for transfer to the ICU, transfer to another ward for palliation, or death in the SICU.

Statistical Analysis

Continuous data are reported as median and interquartile range (IQR); normal distribution of variables was tested using the Shapiro-Wilk test. Categorical variables were reported as absolute number and percentage. The Mann-Whitney test was used to compare continuous variables between groups, and chi-square test with continuity correction was used for categorical variables. The variables that were most significantly associated with a negative outcome on the univariate analysis were included in a stepwise logistic regression analysis, in order to identify independent predictors of patient outcome. Statistical analysis was performed using JASP (JASP Team) software.

Study Population

Of the 88 patients included in the study, 70% were male; the median age was 66 years (IQR, 60-77). In most patients, the diagnosis of COVID-19 was derived from a positive SARS-CoV-2 nasopharyngeal swab. Six patients, however, maintained a negative swab at all determinations but had clinical and imaging features strongly suggesting COVID-19. No patients met the exclusion criteria. Most patients came from the ED (n = 58 [66%]) or general wards (n = 22 [25%]), while few were transferred from the ICU (n = 8 [9%]). The median length of stay in the SICU was 4 days (IQR, 2-7). An epidemiological link to affected persons or a known virus exposure was identifiable in 37 patients (42%).

Clinical, Laboratory, and Imaging Data

The clinical and anthropometric characteristics of patients are shown in Table 1. Hypertension and smoking habits were prevalent in our population, and the median Charlson Comorbidity Index was 3. Most patients experienced fever, dyspnea, and cough during the days before hospitalization.

Laboratory data showed a marked inflammatory milieu in all studied patients, both at baseline and after 24 and 72 hours. Lymphopenia was observed, along with a significant increase of lactate dehydrogenase (LDH), C-reactive protein (CPR), and D-dimer, and a mild increase of procalcitonin. N-terminal pro-brain natriuretic peptide (NT-proBNP) values were also increased, with normal troponin I values (Table 2).

Medical Therapy

Most patients (89%) received hydroxychloroquine, whereas steroids were used in one-third of the population (36%). Immunomodulators (tocilizumab and ruxolitinib) were restricted to 12 patients (14%). Empirical antiviral therapy was introduced in the first 41 patients (47%). Enoxaparin was the default agent for thromboembolism prophylaxis, and 6 patients (7%) received 70% of the anticoagulating dose.

Oxygen and Ventilatory Therapy

Basal median P/F ratio was 253 (IQR, 218-291), and respiratory rate at triage was 20 breaths/min (IQR, 16-28), underlining a moderate-to-severe respiratory insufficiency at presentation. A total of 69 patients (78%) underwent CPAP, with a median positive end-expiratory pressure (PEEP) of 10.0 cm H₂O (IQR, 7.5-10.0) and fraction of inspired oxygen (Fio₂) of 0.40 (IQR, 0.40-0.50). In 37 patients (42%) who received ongoing CPAP, prone positioning was adopted. In this subgroup, respiratory rate was not significantly different from baseline to resupination (24 vs 25 breaths/min). The median P/F improved from 197 (IQR, 154-236) at baseline to 217 (IQR, 180-262) after pronation (the duration of the prone position was variable, depending on patients’ tolerance: 1 to 6 hours or every pronation cycle). The median delta P/F ratio was 39.4 (IQR, –17.0 to 78.0).

Outcomes

A total of 28 patients (32%) had a negative outcome in the SICU: 8 patients (9%) died, having no clinical indication for higher-intensity care; 6 patients (7%) were transferred to general wards for palliation; and 14 patients (16%) needed an upgrade of cure intensity and were transferred to the ICU. Of these 14 patients, 9 died in the ICU. The total in-hospital mortality of COVID-19 patients, including patients transferred from the SICU to general wards in fair condition, was 27% (n = 24). Clinical, laboratory, and therapeutic characteristics between the 2 groups are shown in Table 4.

Patients who had a negative outcome were significantly older and had more comorbidities, as suggested by a significantly higher prevalence of diabetes and higher Charlson Comorbidity scores (reflecting the mortality risk based on age and comorbidities). The median MuLBSTA score, which estimates the 90-day mortality risk from viral pneumonia, was also higher in patients who had a negative outcome (9.33%). Symptom occurrence was not different in patients with a negative outcome (apart from cough, which was less frequent), but these patients underwent hospitalization earlier—since the appearance of their first COVID-19 symptoms—compared to patients who had a positive outcome. No difference was found in antihypertensive therapy with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among outcome groups.

More pronounced laboratory abnormalities were found in patients who had a negative outcome, compared to patients who had a positive outcome: lower lymphocytes and higher C-reactive protein (CRP), procalcitonin, D-dimer, LDH, and NT-proBNP. We found no differences in the radiological distribution of pulmonary involvement in patients who had negative or positive outcomes, nor in the adopted medical treatment.

Data showed no difference in CPAP implementation in the 2 groups. However, prone positioning had been more frequently adopted in the group of patients who had a positive outcome, compared with patients who had a negative outcome. No differences of basal P/F were found in patients who had a negative or positive outcome, but the median P/F after 6 hours of prone position was significantly lower in patients who had a negative outcome. The delta P/F ratio did not differ in the 2 groups of patients.

Multivariate Analysis

A logistic regression model was created, including the variables significantly associated with outcomes in the univariate analysis (age, sex, history of diabetes, lymphocytes, CRP, procalcitonin, LDH, NT-proBNP, and D-dimer). In the multivariate analysis, independent predictors of a negative outcome were history of diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P =.015), high D-dimer values (OR, 1.28; CI, 1.04-1.57; P = .019), high LDH values (OR, 1.003; CI, 1.000-1.006; P = .039), and low lymphocytes count (OR, 0.996; CI, 0.993-0.999; P = .004).

Discussion

Role of Subintensive Units and Mortality

The novelty of our report is its attempt to investigate the specific group of COVID-19 patients admitted to a SICU. In Italy, SICUs receive acutely ill, spontaneously breathing patients who need (invasive) hemodynamic monitoring, vasoactive medication, renal replacement therapy, chest- tube placement, thrombolysis, and respiratory noninvasive support. The nurse-to-patient ratio is higher than for general wards (usually 1 nurse to every 4 or 5 patients), though lower than for ICUs. In northern Italy, a great number of COVID-19 patients have required this kind of high-intensity care during the pandemic: Noninvasive ventilation support had to be maintained for several days, pronation maneuvers required a high number of people 2 or 3 times a day, and strict monitoring had to be assured. The SICU setting allows patients to buy time as a bridge to progressive reduction of pulmonary involvement, sometimes preventing the need for intubation.

The high prevalence of negative outcomes in the SICU underlines the complexity of COVID-19 patients in this setting. In fact, published data about mortality for patients with severe COVID-19 pneumonia are similar to ours.^22,23

Clinical, Laboratory, and Imaging Data

Our analysis confirmed a high rate of comorbidities in COVID-19 patients²⁴ and their prognostic role with age.^25,26 A marked inflammatory milieu was a negative prognostic indicator, and associated concomitant bacterial superinfection could have led to a worse prognosis (procalcitonin was associated with negative outcomes).²⁷ The cardiovascular system was nevertheless stressed, as suggested by higher values of NT-proBNP in patients with negative outcomes, which could reflect sepsis-related systemic involvement.²⁸

It is known that the pulmonary damage caused by SARS-CoV-2 has a dynamic radiological and clinical course, with early areas of subsegmental consolidation, and bilateral ground-glass opacities predominating later in the course of the disease.²⁹ This could explain why in our population we found no specific radiological pattern leading to a worse outcome.

Medical Therapy

No specific pharmacological therapy was found to be associated with a positive outcome in our study, just like antiviral and immunomodulator therapies failed to demonstrate effectiveness in subsequent pandemic surges. The low statistical power of our study did not allow us to give insight into the effectiveness of steroids and heparin at any dosage.

PEEP Support and Prone Positioning

Continuous positive airway pressure was initiated in the majority of patients and maintained for several days. This was an absolute novelty, because we rarely had to keep patients in helmets for long. This was feasible thanks to the SICU’s high nurse-to-patient ratio and the possibility of providing monitored sedation. Patients who could no longer tolerate CPAP helmets or did not improve with CPAP support were evaluated with anesthetists for programming further management. No initial data on respiratory rate, level of hypoxemia, or oxygen support need (level of PEEP and Fio₂) could discriminate between outcomes.

Prone positioning during CPAP was implemented in 42% of our study population: P/F ratio amelioration after prone positioning was highly variable, ranging from very good P/F ratio improvements to few responses or no response. No significantly greater delta P/F ratio was seen after the first prone positioning cycle in patients who had a positive outcome, probably due to the small size of our population, but we observed a clear positive trend. Interestingly, patients showing a negative outcome had a lower percentage of long-term responses to prone positioning: 6 hours after resupination, they lost the benefit of prone positioning in terms of P/F ratio amelioration. Similarly, a greater number of patients tolerating prone positioning had a positive outcome. These data give insight on the possible benefits of prone positioning in a noninvasively supported cohort of patients, which has been mentioned in previous studies.^30,31

Outcomes and Variables Associated With Negative Outcomes

After correction for age and sex, we found in multiple regression analysis that higher D-dimer and LDH values, lymphopenia, and history of diabetes were independently associated with a worse outcome. Although our results had low statistical significance, we consider the trend of the obtained odds ratios important from a clinical point of view. These results could lead to greater attention being placed on COVID-19 patients who present with these characteristics upon their arrival to the ED because they have increased risk of death or intensive care need. Clinicians should consider SICU admission for these patients in order to guarantee closer monitoring and possibly more aggressive ventilatory treatments, earlier pronation, or earlier transfer to the ICU.

Limitations

The major limitation to our study is undoubtedly its statistical power, due to its relatively low patient population. Particularly, the small number of patients who underwent pronation did not allow speculation about the efficacy of this technique, although preliminary data seem promising. However, ours is among the first studies regarding patients with COVID-19 admitted to a SICU, and these preliminary data truthfully describe the Italian, and perhaps international, experience with the first surge of the pandemic.

Conclusions

Our data highlight the primary role of the SICU in COVID-19 in adequately treating critically ill patients who have high care needs different from intubation, and who require noninvasive ventilation for prolonged times as well as frequent pronation cycles. This setting of care may represent a valid, reliable, and effective option for critically ill respiratory patients. History of diabetes, lymphopenia, and high D-dimer and LDH values are independently associated with negative outcomes, and patients presenting with these characteristics should be strictly monitored.

Acknowledgments: The authors thank the Informatica System S.R.L., as well as Allessando Mendolia for the pro bono creation of the ISCovidCollect data collecting app.

Corresponding author: Sara Abram, MD, via Coppino, 12100 Cuneo, Italy; [email protected].

Disclosures: None.

From the Department of Emergency Medicine, Santa Croce e Carle Hospital, Cuneo, Italy (Drs. Abram, Tosello, Emanuele Bernardi, Allione, Cavalot, Dutto, Corsini, Martini, Sciolla, Sara Bernardi, and Lauria). From the School of Emergency Medicine, University of Turin, Turin, Italy (Drs. Paglietta and Giamello).

Objective: This retrospective and prospective cohort study was designed to describe the characteristics, treatments, and outcomes of patients with SARS-CoV-2 infection (COVID-19) admitted to subintensive care units (SICU) and to identify the variables associated with outcomes. SICUs have been extremely stressed during the pandemic, but most data regarding critically ill COVID-19 patients come from intensive care units (ICUs). Studies about COVID-19 patients in SICUs are lacking.

Setting and participants: The study included 88 COVID-19 patients admitted to our SICU in Cuneo, Italy, between March and May 2020.

Measurements: Clinical and ventilatory data were collected, and patients were divided by outcome. Multivariable logistic regression analysis examined the variables associated with negative outcomes (transfer to the ICU, palliation, or death in a SICU).

Results: A total of 60 patients (68%) had a positive outcome, and 28 patients (32%) had a negative outcome; 69 patients (78%) underwent continuous positive airway pressure (CPAP). Pronation (n = 37 [42%]) had been more frequently adopted in patients who had a positive outcome vs a negative outcome (n = 30 [50%] vs n = 7 [25%]; P = .048), and the median (interquartile range) Pao₂/Fio₂ ratio after 6 hours of prone positioning was lower in patients who had a negative outcome vs a positive outcome (144 [140-168] vs 249 [195-268], P = .006). Independent predictors of a negative outcome were diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P = .015), higher D-dimer (OR, 1.28; 95% CI, 1.04-1.57; P = .019), higher lactate dehydrogenase level (OR, 1.003; 95% CI, 1.000-1.006; P = .039), and lower lymphocytes count (OR, 0.996; 95% CI, 0.993-0.999; P = .004).

Conclusion: SICUs have a fundamental role in the treatment of critically ill patients with COVID-19, who require long-term CPAP and pronation cycles. Diabetes, lymphopenia, and high D-dimer and LDH levels are associated with negative outcomes.

Keywords: emergency medicine, noninvasive ventilation, prone position, continuous positive airway pressure.

The COVID-19 pandemic has led to large increases in hospital admissions. Subintensive care units (SICUs) are among the wards most under pressure worldwide,¹ dealing with the increased number of critically ill patients who need noninvasive ventilation, as well as serving as the best alternative to overfilled intensive care units (ICUs). In Italy, SICUs are playing a fundamental role in the management of COVID-19 patients, providing early treatment of respiratory failure by continuous noninvasive ventilation in order to reduce the need for intubation.^2-5 Nevertheless, the great majority of available data about critically ill COVID-19 patients comes from ICUs. Full studies about outcomes of patients in SICUs are lacking and need to be conducted.

We sought to evaluate the characteristics and outcomes of patients admitted to our SICU for COVID-19 to describe the treatments they needed and their impact on prognosis, and to identify the variables associated with patient outcomes.

Methods

Study Design

This cohort study used data from patients who were admitted in the very first weeks of the pandemic. Data were collected retrospectively as well as prospectively, since the ethical committee approved our project. The quality and quantity of data in the 2 groups were comparable.

Data were collected from electronic and written medical records gathered during the patient’s entire stay in our SICU. Data were entered in a database with limited and controlled access. This study complied with the Declaration of Helsinki and was approved by the local ethics committees (ID: MEDURG10).

Study Population

We studied 88 consecutive patients admitted to the SICU of the Santa Croce e Carle Teaching Hospital, Cuneo, Italy, for COVID-19, from March 8 to May 1, 2020. The diagnosis was based on acute respiratory failure associated with SARS-CoV-2 RNA detection on nasopharyngeal swab or tracheal aspirate and/or typical COVID-19 features on a pulmonary computed tomography (CT) scan.⁶ Exclusion criteria were age younger than 18 years and patient denial of permission to use their data for research purposes (the great majority of patients could actively give consent; for patients who were too sick to do so, family members were asked whether they were aware of any reason why the patient would deny consent).

The past medical history and recent symptoms description were obtained by manually reviewing medical records. Epidemiological exposure was defined as contact with SARS-CoV-2–positive people or staying in an epidemic outbreak area. Initial vital parameters, venous blood tests, arterial blood gas analysis, chest x-ray, as well as the result of the nasopharyngeal swab were gathered from the emergency department (ED) examination. (Additional swabs could be requested when the first one was negative but clinical suspicion for COVID-19 was high.) Upon admission to the SICU, a standardized panel of blood tests was performed, which was repeated the next day and then every 48 hours. Arterial blood gas analysis was performed when clinically indicated, at least twice a day, or following a scheduled time in patients undergoing pronation. Charlson Comorbidity Index⁷ and MuLBSTA score⁸ were calculated based on the collected data.

Imaging

Chest ultrasonography was performed in the ED at the time of hospitalization and once a day in the SICU. Pulmonary high-resolution computed tomography (HRCT) was performed when clinically indicated or when the results of nasopharyngeal swabs and/or x-ray results were discordant with COVID-19 clinical suspicion. Contrast CT was performed when pulmonary embolism was suspected.

Medical Therapy

Hydroxychloroquine, antiviral agents, tocilizumab, and ruxolitinib were used in the early phase of the pandemic, then were dismissed after evidence of no efficacy.^9-11 Steroids and low-molecular-weight heparin were used afterward. Enoxaparin was used at the standard prophylactic dosage, and 70% of the anticoagulant dosage was also adopted in patients with moderate-to-severe COVID-19 and D-dimer values >3 times the normal value.^12-14 Antibiotics were given when a bacterial superinfection was suspected.

Oxygen and Ventilatory Therapy

Oxygen support or noninvasive ventilation were started based on patients’ respiratory efficacy, estimated by respiratory rate and the ratio of partial pressure of arterial oxygen and fraction of inspired oxygen (P/F ratio).^15,16 Oxygen support was delivered through nasal cannula, Venturi mask, or reservoir mask. Noninvasive ventilation was performed by continuous positive airway pressure (CPAP) when the P/F ratio was <250 or the respiratory rate was >25 breaths per minute, using the helmet interface.^5,17 Prone positioning during CPAP^18-20 was adopted in patients meeting the acute respiratory distress syndrome (ARDS) criteria²¹ and having persistence of respiratory distress and P/F <300 after a 1-hour trial of CPAP.

The prone position was maintained based on patient tolerance. P/F ratio was measured before pronation (T0), after 1 hour of prone position (T1), before resupination (T2), and 6 hours after resupination (T3). With the same timing, the patient was asked to rate their comfort in each position, from 0 (lack of comfort) to 10 (optimal comfort). Delta P/F was defined as the difference between P/F at T3 and basal P/F at T0.

Outcomes

Positive outcomes were defined as patient discharge from the SICU or transfer to a lower-intensity care ward for treatment continuation. Negative outcomes were defined as need for transfer to the ICU, transfer to another ward for palliation, or death in the SICU.

Statistical Analysis

Continuous data are reported as median and interquartile range (IQR); normal distribution of variables was tested using the Shapiro-Wilk test. Categorical variables were reported as absolute number and percentage. The Mann-Whitney test was used to compare continuous variables between groups, and chi-square test with continuity correction was used for categorical variables. The variables that were most significantly associated with a negative outcome on the univariate analysis were included in a stepwise logistic regression analysis, in order to identify independent predictors of patient outcome. Statistical analysis was performed using JASP (JASP Team) software.

Study Population

Of the 88 patients included in the study, 70% were male; the median age was 66 years (IQR, 60-77). In most patients, the diagnosis of COVID-19 was derived from a positive SARS-CoV-2 nasopharyngeal swab. Six patients, however, maintained a negative swab at all determinations but had clinical and imaging features strongly suggesting COVID-19. No patients met the exclusion criteria. Most patients came from the ED (n = 58 [66%]) or general wards (n = 22 [25%]), while few were transferred from the ICU (n = 8 [9%]). The median length of stay in the SICU was 4 days (IQR, 2-7). An epidemiological link to affected persons or a known virus exposure was identifiable in 37 patients (42%).

Clinical, Laboratory, and Imaging Data

The clinical and anthropometric characteristics of patients are shown in Table 1. Hypertension and smoking habits were prevalent in our population, and the median Charlson Comorbidity Index was 3. Most patients experienced fever, dyspnea, and cough during the days before hospitalization.

Laboratory data showed a marked inflammatory milieu in all studied patients, both at baseline and after 24 and 72 hours. Lymphopenia was observed, along with a significant increase of lactate dehydrogenase (LDH), C-reactive protein (CPR), and D-dimer, and a mild increase of procalcitonin. N-terminal pro-brain natriuretic peptide (NT-proBNP) values were also increased, with normal troponin I values (Table 2).

Medical Therapy

Most patients (89%) received hydroxychloroquine, whereas steroids were used in one-third of the population (36%). Immunomodulators (tocilizumab and ruxolitinib) were restricted to 12 patients (14%). Empirical antiviral therapy was introduced in the first 41 patients (47%). Enoxaparin was the default agent for thromboembolism prophylaxis, and 6 patients (7%) received 70% of the anticoagulating dose.

Oxygen and Ventilatory Therapy

Basal median P/F ratio was 253 (IQR, 218-291), and respiratory rate at triage was 20 breaths/min (IQR, 16-28), underlining a moderate-to-severe respiratory insufficiency at presentation. A total of 69 patients (78%) underwent CPAP, with a median positive end-expiratory pressure (PEEP) of 10.0 cm H₂O (IQR, 7.5-10.0) and fraction of inspired oxygen (Fio₂) of 0.40 (IQR, 0.40-0.50). In 37 patients (42%) who received ongoing CPAP, prone positioning was adopted. In this subgroup, respiratory rate was not significantly different from baseline to resupination (24 vs 25 breaths/min). The median P/F improved from 197 (IQR, 154-236) at baseline to 217 (IQR, 180-262) after pronation (the duration of the prone position was variable, depending on patients’ tolerance: 1 to 6 hours or every pronation cycle). The median delta P/F ratio was 39.4 (IQR, –17.0 to 78.0).

Outcomes

A total of 28 patients (32%) had a negative outcome in the SICU: 8 patients (9%) died, having no clinical indication for higher-intensity care; 6 patients (7%) were transferred to general wards for palliation; and 14 patients (16%) needed an upgrade of cure intensity and were transferred to the ICU. Of these 14 patients, 9 died in the ICU. The total in-hospital mortality of COVID-19 patients, including patients transferred from the SICU to general wards in fair condition, was 27% (n = 24). Clinical, laboratory, and therapeutic characteristics between the 2 groups are shown in Table 4.

Patients who had a negative outcome were significantly older and had more comorbidities, as suggested by a significantly higher prevalence of diabetes and higher Charlson Comorbidity scores (reflecting the mortality risk based on age and comorbidities). The median MuLBSTA score, which estimates the 90-day mortality risk from viral pneumonia, was also higher in patients who had a negative outcome (9.33%). Symptom occurrence was not different in patients with a negative outcome (apart from cough, which was less frequent), but these patients underwent hospitalization earlier—since the appearance of their first COVID-19 symptoms—compared to patients who had a positive outcome. No difference was found in antihypertensive therapy with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among outcome groups.

More pronounced laboratory abnormalities were found in patients who had a negative outcome, compared to patients who had a positive outcome: lower lymphocytes and higher C-reactive protein (CRP), procalcitonin, D-dimer, LDH, and NT-proBNP. We found no differences in the radiological distribution of pulmonary involvement in patients who had negative or positive outcomes, nor in the adopted medical treatment.

Data showed no difference in CPAP implementation in the 2 groups. However, prone positioning had been more frequently adopted in the group of patients who had a positive outcome, compared with patients who had a negative outcome. No differences of basal P/F were found in patients who had a negative or positive outcome, but the median P/F after 6 hours of prone position was significantly lower in patients who had a negative outcome. The delta P/F ratio did not differ in the 2 groups of patients.

Multivariate Analysis

A logistic regression model was created, including the variables significantly associated with outcomes in the univariate analysis (age, sex, history of diabetes, lymphocytes, CRP, procalcitonin, LDH, NT-proBNP, and D-dimer). In the multivariate analysis, independent predictors of a negative outcome were history of diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P =.015), high D-dimer values (OR, 1.28; CI, 1.04-1.57; P = .019), high LDH values (OR, 1.003; CI, 1.000-1.006; P = .039), and low lymphocytes count (OR, 0.996; CI, 0.993-0.999; P = .004).

Discussion

Role of Subintensive Units and Mortality

The novelty of our report is its attempt to investigate the specific group of COVID-19 patients admitted to a SICU. In Italy, SICUs receive acutely ill, spontaneously breathing patients who need (invasive) hemodynamic monitoring, vasoactive medication, renal replacement therapy, chest- tube placement, thrombolysis, and respiratory noninvasive support. The nurse-to-patient ratio is higher than for general wards (usually 1 nurse to every 4 or 5 patients), though lower than for ICUs. In northern Italy, a great number of COVID-19 patients have required this kind of high-intensity care during the pandemic: Noninvasive ventilation support had to be maintained for several days, pronation maneuvers required a high number of people 2 or 3 times a day, and strict monitoring had to be assured. The SICU setting allows patients to buy time as a bridge to progressive reduction of pulmonary involvement, sometimes preventing the need for intubation.

The high prevalence of negative outcomes in the SICU underlines the complexity of COVID-19 patients in this setting. In fact, published data about mortality for patients with severe COVID-19 pneumonia are similar to ours.^22,23

Clinical, Laboratory, and Imaging Data

Our analysis confirmed a high rate of comorbidities in COVID-19 patients²⁴ and their prognostic role with age.^25,26 A marked inflammatory milieu was a negative prognostic indicator, and associated concomitant bacterial superinfection could have led to a worse prognosis (procalcitonin was associated with negative outcomes).²⁷ The cardiovascular system was nevertheless stressed, as suggested by higher values of NT-proBNP in patients with negative outcomes, which could reflect sepsis-related systemic involvement.²⁸

It is known that the pulmonary damage caused by SARS-CoV-2 has a dynamic radiological and clinical course, with early areas of subsegmental consolidation, and bilateral ground-glass opacities predominating later in the course of the disease.²⁹ This could explain why in our population we found no specific radiological pattern leading to a worse outcome.

Medical Therapy

No specific pharmacological therapy was found to be associated with a positive outcome in our study, just like antiviral and immunomodulator therapies failed to demonstrate effectiveness in subsequent pandemic surges. The low statistical power of our study did not allow us to give insight into the effectiveness of steroids and heparin at any dosage.

PEEP Support and Prone Positioning

Continuous positive airway pressure was initiated in the majority of patients and maintained for several days. This was an absolute novelty, because we rarely had to keep patients in helmets for long. This was feasible thanks to the SICU’s high nurse-to-patient ratio and the possibility of providing monitored sedation. Patients who could no longer tolerate CPAP helmets or did not improve with CPAP support were evaluated with anesthetists for programming further management. No initial data on respiratory rate, level of hypoxemia, or oxygen support need (level of PEEP and Fio₂) could discriminate between outcomes.

Prone positioning during CPAP was implemented in 42% of our study population: P/F ratio amelioration after prone positioning was highly variable, ranging from very good P/F ratio improvements to few responses or no response. No significantly greater delta P/F ratio was seen after the first prone positioning cycle in patients who had a positive outcome, probably due to the small size of our population, but we observed a clear positive trend. Interestingly, patients showing a negative outcome had a lower percentage of long-term responses to prone positioning: 6 hours after resupination, they lost the benefit of prone positioning in terms of P/F ratio amelioration. Similarly, a greater number of patients tolerating prone positioning had a positive outcome. These data give insight on the possible benefits of prone positioning in a noninvasively supported cohort of patients, which has been mentioned in previous studies.^30,31

Outcomes and Variables Associated With Negative Outcomes

After correction for age and sex, we found in multiple regression analysis that higher D-dimer and LDH values, lymphopenia, and history of diabetes were independently associated with a worse outcome. Although our results had low statistical significance, we consider the trend of the obtained odds ratios important from a clinical point of view. These results could lead to greater attention being placed on COVID-19 patients who present with these characteristics upon their arrival to the ED because they have increased risk of death or intensive care need. Clinicians should consider SICU admission for these patients in order to guarantee closer monitoring and possibly more aggressive ventilatory treatments, earlier pronation, or earlier transfer to the ICU.

Limitations

The major limitation to our study is undoubtedly its statistical power, due to its relatively low patient population. Particularly, the small number of patients who underwent pronation did not allow speculation about the efficacy of this technique, although preliminary data seem promising. However, ours is among the first studies regarding patients with COVID-19 admitted to a SICU, and these preliminary data truthfully describe the Italian, and perhaps international, experience with the first surge of the pandemic.

Conclusions

Our data highlight the primary role of the SICU in COVID-19 in adequately treating critically ill patients who have high care needs different from intubation, and who require noninvasive ventilation for prolonged times as well as frequent pronation cycles. This setting of care may represent a valid, reliable, and effective option for critically ill respiratory patients. History of diabetes, lymphopenia, and high D-dimer and LDH values are independently associated with negative outcomes, and patients presenting with these characteristics should be strictly monitored.

Acknowledgments: The authors thank the Informatica System S.R.L., as well as Allessando Mendolia for the pro bono creation of the ISCovidCollect data collecting app.

Corresponding author: Sara Abram, MD, via Coppino, 12100 Cuneo, Italy; [email protected].

Disclosures: None.

From the Department of Emergency Medicine, Santa Croce e Carle Hospital, Cuneo, Italy (Drs. Abram, Tosello, Emanuele Bernardi, Allione, Cavalot, Dutto, Corsini, Martini, Sciolla, Sara Bernardi, and Lauria). From the School of Emergency Medicine, University of Turin, Turin, Italy (Drs. Paglietta and Giamello).

Objective: This retrospective and prospective cohort study was designed to describe the characteristics, treatments, and outcomes of patients with SARS-CoV-2 infection (COVID-19) admitted to subintensive care units (SICU) and to identify the variables associated with outcomes. SICUs have been extremely stressed during the pandemic, but most data regarding critically ill COVID-19 patients come from intensive care units (ICUs). Studies about COVID-19 patients in SICUs are lacking.

Setting and participants: The study included 88 COVID-19 patients admitted to our SICU in Cuneo, Italy, between March and May 2020.

Measurements: Clinical and ventilatory data were collected, and patients were divided by outcome. Multivariable logistic regression analysis examined the variables associated with negative outcomes (transfer to the ICU, palliation, or death in a SICU).

Results: A total of 60 patients (68%) had a positive outcome, and 28 patients (32%) had a negative outcome; 69 patients (78%) underwent continuous positive airway pressure (CPAP). Pronation (n = 37 [42%]) had been more frequently adopted in patients who had a positive outcome vs a negative outcome (n = 30 [50%] vs n = 7 [25%]; P = .048), and the median (interquartile range) Pao₂/Fio₂ ratio after 6 hours of prone positioning was lower in patients who had a negative outcome vs a positive outcome (144 [140-168] vs 249 [195-268], P = .006). Independent predictors of a negative outcome were diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P = .015), higher D-dimer (OR, 1.28; 95% CI, 1.04-1.57; P = .019), higher lactate dehydrogenase level (OR, 1.003; 95% CI, 1.000-1.006; P = .039), and lower lymphocytes count (OR, 0.996; 95% CI, 0.993-0.999; P = .004).

Conclusion: SICUs have a fundamental role in the treatment of critically ill patients with COVID-19, who require long-term CPAP and pronation cycles. Diabetes, lymphopenia, and high D-dimer and LDH levels are associated with negative outcomes.

Keywords: emergency medicine, noninvasive ventilation, prone position, continuous positive airway pressure.

The COVID-19 pandemic has led to large increases in hospital admissions. Subintensive care units (SICUs) are among the wards most under pressure worldwide,¹ dealing with the increased number of critically ill patients who need noninvasive ventilation, as well as serving as the best alternative to overfilled intensive care units (ICUs). In Italy, SICUs are playing a fundamental role in the management of COVID-19 patients, providing early treatment of respiratory failure by continuous noninvasive ventilation in order to reduce the need for intubation.^2-5 Nevertheless, the great majority of available data about critically ill COVID-19 patients comes from ICUs. Full studies about outcomes of patients in SICUs are lacking and need to be conducted.

We sought to evaluate the characteristics and outcomes of patients admitted to our SICU for COVID-19 to describe the treatments they needed and their impact on prognosis, and to identify the variables associated with patient outcomes.

Methods

Study Design

This cohort study used data from patients who were admitted in the very first weeks of the pandemic. Data were collected retrospectively as well as prospectively, since the ethical committee approved our project. The quality and quantity of data in the 2 groups were comparable.

Data were collected from electronic and written medical records gathered during the patient’s entire stay in our SICU. Data were entered in a database with limited and controlled access. This study complied with the Declaration of Helsinki and was approved by the local ethics committees (ID: MEDURG10).

Study Population

We studied 88 consecutive patients admitted to the SICU of the Santa Croce e Carle Teaching Hospital, Cuneo, Italy, for COVID-19, from March 8 to May 1, 2020. The diagnosis was based on acute respiratory failure associated with SARS-CoV-2 RNA detection on nasopharyngeal swab or tracheal aspirate and/or typical COVID-19 features on a pulmonary computed tomography (CT) scan.⁶ Exclusion criteria were age younger than 18 years and patient denial of permission to use their data for research purposes (the great majority of patients could actively give consent; for patients who were too sick to do so, family members were asked whether they were aware of any reason why the patient would deny consent).

The past medical history and recent symptoms description were obtained by manually reviewing medical records. Epidemiological exposure was defined as contact with SARS-CoV-2–positive people or staying in an epidemic outbreak area. Initial vital parameters, venous blood tests, arterial blood gas analysis, chest x-ray, as well as the result of the nasopharyngeal swab were gathered from the emergency department (ED) examination. (Additional swabs could be requested when the first one was negative but clinical suspicion for COVID-19 was high.) Upon admission to the SICU, a standardized panel of blood tests was performed, which was repeated the next day and then every 48 hours. Arterial blood gas analysis was performed when clinically indicated, at least twice a day, or following a scheduled time in patients undergoing pronation. Charlson Comorbidity Index⁷ and MuLBSTA score⁸ were calculated based on the collected data.

Imaging

Chest ultrasonography was performed in the ED at the time of hospitalization and once a day in the SICU. Pulmonary high-resolution computed tomography (HRCT) was performed when clinically indicated or when the results of nasopharyngeal swabs and/or x-ray results were discordant with COVID-19 clinical suspicion. Contrast CT was performed when pulmonary embolism was suspected.

Medical Therapy

Hydroxychloroquine, antiviral agents, tocilizumab, and ruxolitinib were used in the early phase of the pandemic, then were dismissed after evidence of no efficacy.^9-11 Steroids and low-molecular-weight heparin were used afterward. Enoxaparin was used at the standard prophylactic dosage, and 70% of the anticoagulant dosage was also adopted in patients with moderate-to-severe COVID-19 and D-dimer values >3 times the normal value.^12-14 Antibiotics were given when a bacterial superinfection was suspected.

Oxygen and Ventilatory Therapy

Oxygen support or noninvasive ventilation were started based on patients’ respiratory efficacy, estimated by respiratory rate and the ratio of partial pressure of arterial oxygen and fraction of inspired oxygen (P/F ratio).^15,16 Oxygen support was delivered through nasal cannula, Venturi mask, or reservoir mask. Noninvasive ventilation was performed by continuous positive airway pressure (CPAP) when the P/F ratio was <250 or the respiratory rate was >25 breaths per minute, using the helmet interface.^5,17 Prone positioning during CPAP^18-20 was adopted in patients meeting the acute respiratory distress syndrome (ARDS) criteria²¹ and having persistence of respiratory distress and P/F <300 after a 1-hour trial of CPAP.

The prone position was maintained based on patient tolerance. P/F ratio was measured before pronation (T0), after 1 hour of prone position (T1), before resupination (T2), and 6 hours after resupination (T3). With the same timing, the patient was asked to rate their comfort in each position, from 0 (lack of comfort) to 10 (optimal comfort). Delta P/F was defined as the difference between P/F at T3 and basal P/F at T0.

Outcomes

Positive outcomes were defined as patient discharge from the SICU or transfer to a lower-intensity care ward for treatment continuation. Negative outcomes were defined as need for transfer to the ICU, transfer to another ward for palliation, or death in the SICU.

Statistical Analysis

Continuous data are reported as median and interquartile range (IQR); normal distribution of variables was tested using the Shapiro-Wilk test. Categorical variables were reported as absolute number and percentage. The Mann-Whitney test was used to compare continuous variables between groups, and chi-square test with continuity correction was used for categorical variables. The variables that were most significantly associated with a negative outcome on the univariate analysis were included in a stepwise logistic regression analysis, in order to identify independent predictors of patient outcome. Statistical analysis was performed using JASP (JASP Team) software.

Study Population

Of the 88 patients included in the study, 70% were male; the median age was 66 years (IQR, 60-77). In most patients, the diagnosis of COVID-19 was derived from a positive SARS-CoV-2 nasopharyngeal swab. Six patients, however, maintained a negative swab at all determinations but had clinical and imaging features strongly suggesting COVID-19. No patients met the exclusion criteria. Most patients came from the ED (n = 58 [66%]) or general wards (n = 22 [25%]), while few were transferred from the ICU (n = 8 [9%]). The median length of stay in the SICU was 4 days (IQR, 2-7). An epidemiological link to affected persons or a known virus exposure was identifiable in 37 patients (42%).

Clinical, Laboratory, and Imaging Data

The clinical and anthropometric characteristics of patients are shown in Table 1. Hypertension and smoking habits were prevalent in our population, and the median Charlson Comorbidity Index was 3. Most patients experienced fever, dyspnea, and cough during the days before hospitalization.

Laboratory data showed a marked inflammatory milieu in all studied patients, both at baseline and after 24 and 72 hours. Lymphopenia was observed, along with a significant increase of lactate dehydrogenase (LDH), C-reactive protein (CPR), and D-dimer, and a mild increase of procalcitonin. N-terminal pro-brain natriuretic peptide (NT-proBNP) values were also increased, with normal troponin I values (Table 2).

Medical Therapy

Most patients (89%) received hydroxychloroquine, whereas steroids were used in one-third of the population (36%). Immunomodulators (tocilizumab and ruxolitinib) were restricted to 12 patients (14%). Empirical antiviral therapy was introduced in the first 41 patients (47%). Enoxaparin was the default agent for thromboembolism prophylaxis, and 6 patients (7%) received 70% of the anticoagulating dose.

Oxygen and Ventilatory Therapy

Basal median P/F ratio was 253 (IQR, 218-291), and respiratory rate at triage was 20 breaths/min (IQR, 16-28), underlining a moderate-to-severe respiratory insufficiency at presentation. A total of 69 patients (78%) underwent CPAP, with a median positive end-expiratory pressure (PEEP) of 10.0 cm H₂O (IQR, 7.5-10.0) and fraction of inspired oxygen (Fio₂) of 0.40 (IQR, 0.40-0.50). In 37 patients (42%) who received ongoing CPAP, prone positioning was adopted. In this subgroup, respiratory rate was not significantly different from baseline to resupination (24 vs 25 breaths/min). The median P/F improved from 197 (IQR, 154-236) at baseline to 217 (IQR, 180-262) after pronation (the duration of the prone position was variable, depending on patients’ tolerance: 1 to 6 hours or every pronation cycle). The median delta P/F ratio was 39.4 (IQR, –17.0 to 78.0).

Outcomes

A total of 28 patients (32%) had a negative outcome in the SICU: 8 patients (9%) died, having no clinical indication for higher-intensity care; 6 patients (7%) were transferred to general wards for palliation; and 14 patients (16%) needed an upgrade of cure intensity and were transferred to the ICU. Of these 14 patients, 9 died in the ICU. The total in-hospital mortality of COVID-19 patients, including patients transferred from the SICU to general wards in fair condition, was 27% (n = 24). Clinical, laboratory, and therapeutic characteristics between the 2 groups are shown in Table 4.

Patients who had a negative outcome were significantly older and had more comorbidities, as suggested by a significantly higher prevalence of diabetes and higher Charlson Comorbidity scores (reflecting the mortality risk based on age and comorbidities). The median MuLBSTA score, which estimates the 90-day mortality risk from viral pneumonia, was also higher in patients who had a negative outcome (9.33%). Symptom occurrence was not different in patients with a negative outcome (apart from cough, which was less frequent), but these patients underwent hospitalization earlier—since the appearance of their first COVID-19 symptoms—compared to patients who had a positive outcome. No difference was found in antihypertensive therapy with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers among outcome groups.

More pronounced laboratory abnormalities were found in patients who had a negative outcome, compared to patients who had a positive outcome: lower lymphocytes and higher C-reactive protein (CRP), procalcitonin, D-dimer, LDH, and NT-proBNP. We found no differences in the radiological distribution of pulmonary involvement in patients who had negative or positive outcomes, nor in the adopted medical treatment.

Data showed no difference in CPAP implementation in the 2 groups. However, prone positioning had been more frequently adopted in the group of patients who had a positive outcome, compared with patients who had a negative outcome. No differences of basal P/F were found in patients who had a negative or positive outcome, but the median P/F after 6 hours of prone position was significantly lower in patients who had a negative outcome. The delta P/F ratio did not differ in the 2 groups of patients.

Multivariate Analysis

A logistic regression model was created, including the variables significantly associated with outcomes in the univariate analysis (age, sex, history of diabetes, lymphocytes, CRP, procalcitonin, LDH, NT-proBNP, and D-dimer). In the multivariate analysis, independent predictors of a negative outcome were history of diabetes (odds ratio [OR], 8.22; 95% CI, 1.50-44.70; P =.015), high D-dimer values (OR, 1.28; CI, 1.04-1.57; P = .019), high LDH values (OR, 1.003; CI, 1.000-1.006; P = .039), and low lymphocytes count (OR, 0.996; CI, 0.993-0.999; P = .004).

Discussion

Role of Subintensive Units and Mortality

The novelty of our report is its attempt to investigate the specific group of COVID-19 patients admitted to a SICU. In Italy, SICUs receive acutely ill, spontaneously breathing patients who need (invasive) hemodynamic monitoring, vasoactive medication, renal replacement therapy, chest- tube placement, thrombolysis, and respiratory noninvasive support. The nurse-to-patient ratio is higher than for general wards (usually 1 nurse to every 4 or 5 patients), though lower than for ICUs. In northern Italy, a great number of COVID-19 patients have required this kind of high-intensity care during the pandemic: Noninvasive ventilation support had to be maintained for several days, pronation maneuvers required a high number of people 2 or 3 times a day, and strict monitoring had to be assured. The SICU setting allows patients to buy time as a bridge to progressive reduction of pulmonary involvement, sometimes preventing the need for intubation.

The high prevalence of negative outcomes in the SICU underlines the complexity of COVID-19 patients in this setting. In fact, published data about mortality for patients with severe COVID-19 pneumonia are similar to ours.^22,23

Clinical, Laboratory, and Imaging Data

Our analysis confirmed a high rate of comorbidities in COVID-19 patients²⁴ and their prognostic role with age.^25,26 A marked inflammatory milieu was a negative prognostic indicator, and associated concomitant bacterial superinfection could have led to a worse prognosis (procalcitonin was associated with negative outcomes).²⁷ The cardiovascular system was nevertheless stressed, as suggested by higher values of NT-proBNP in patients with negative outcomes, which could reflect sepsis-related systemic involvement.²⁸

It is known that the pulmonary damage caused by SARS-CoV-2 has a dynamic radiological and clinical course, with early areas of subsegmental consolidation, and bilateral ground-glass opacities predominating later in the course of the disease.²⁹ This could explain why in our population we found no specific radiological pattern leading to a worse outcome.

Medical Therapy

No specific pharmacological therapy was found to be associated with a positive outcome in our study, just like antiviral and immunomodulator therapies failed to demonstrate effectiveness in subsequent pandemic surges. The low statistical power of our study did not allow us to give insight into the effectiveness of steroids and heparin at any dosage.

PEEP Support and Prone Positioning

Continuous positive airway pressure was initiated in the majority of patients and maintained for several days. This was an absolute novelty, because we rarely had to keep patients in helmets for long. This was feasible thanks to the SICU’s high nurse-to-patient ratio and the possibility of providing monitored sedation. Patients who could no longer tolerate CPAP helmets or did not improve with CPAP support were evaluated with anesthetists for programming further management. No initial data on respiratory rate, level of hypoxemia, or oxygen support need (level of PEEP and Fio₂) could discriminate between outcomes.

Prone positioning during CPAP was implemented in 42% of our study population: P/F ratio amelioration after prone positioning was highly variable, ranging from very good P/F ratio improvements to few responses or no response. No significantly greater delta P/F ratio was seen after the first prone positioning cycle in patients who had a positive outcome, probably due to the small size of our population, but we observed a clear positive trend. Interestingly, patients showing a negative outcome had a lower percentage of long-term responses to prone positioning: 6 hours after resupination, they lost the benefit of prone positioning in terms of P/F ratio amelioration. Similarly, a greater number of patients tolerating prone positioning had a positive outcome. These data give insight on the possible benefits of prone positioning in a noninvasively supported cohort of patients, which has been mentioned in previous studies.^30,31

Outcomes and Variables Associated With Negative Outcomes

After correction for age and sex, we found in multiple regression analysis that higher D-dimer and LDH values, lymphopenia, and history of diabetes were independently associated with a worse outcome. Although our results had low statistical significance, we consider the trend of the obtained odds ratios important from a clinical point of view. These results could lead to greater attention being placed on COVID-19 patients who present with these characteristics upon their arrival to the ED because they have increased risk of death or intensive care need. Clinicians should consider SICU admission for these patients in order to guarantee closer monitoring and possibly more aggressive ventilatory treatments, earlier pronation, or earlier transfer to the ICU.

Limitations

The major limitation to our study is undoubtedly its statistical power, due to its relatively low patient population. Particularly, the small number of patients who underwent pronation did not allow speculation about the efficacy of this technique, although preliminary data seem promising. However, ours is among the first studies regarding patients with COVID-19 admitted to a SICU, and these preliminary data truthfully describe the Italian, and perhaps international, experience with the first surge of the pandemic.

Conclusions

Our data highlight the primary role of the SICU in COVID-19 in adequately treating critically ill patients who have high care needs different from intubation, and who require noninvasive ventilation for prolonged times as well as frequent pronation cycles. This setting of care may represent a valid, reliable, and effective option for critically ill respiratory patients. History of diabetes, lymphopenia, and high D-dimer and LDH values are independently associated with negative outcomes, and patients presenting with these characteristics should be strictly monitored.

Acknowledgments: The authors thank the Informatica System S.R.L., as well as Allessando Mendolia for the pro bono creation of the ISCovidCollect data collecting app.

Corresponding author: Sara Abram, MD, via Coppino, 12100 Cuneo, Italy; [email protected].

Disclosures: None.

Equitable Standards for All Patients in a Crisis

Health care delivered during a pandemic instantiates medicine’s perspectives on the value of human life in clinical scenarios where resource allocation is limited. The COVID-19 pandemic has fostered dialogue and debate around the ethical principles that underly such resource allocation, which generally balance (1) utilitarian optimization of resources, (2) equality or equity in health access, (3) the instrumental value of individuals as agents in society, and (4) prioritizing the “worst off” in their natural history of disease.^1,2 State legislatures and health systems have responded to the challeges posed by COVID-19 by considering both the scarcity of intensive care resources, such as mechanical ventilation and hemodialysis, and the clinical criteria to be used for determining which patients should receive said resources. These crisis guidelines have yielded several concerning themes vis-à-vis equitable distribution of health care resources, particularly when the disability status of patients is considered alongside life-expectancy or quality of life.³

Crisis standards of care (CSC) prioritize population-level health under a utilitarian paradigm, explicitly maximizing “life-years” within a population of patients rather than the life of any individual patient.⁴ Debated during initial COVID surges, these CSC guidelines have recently been enacted at the state level in several settings, including Alaska and Idaho.⁵ In a setting with scarce intensive care resources, balancing health equity in access to these resources against population-based survival metrics has been a challenge for commissions considering CSC.^6,7 This need for balance has further promoted systemic views of “disability,” raising concern for structural “ableism” and highlighting the need for greater “ability awareness” in clinicians’ continued professional learning.

Structural Ableism: Defining Perspectives to Address Health Equity

Ableism has been defined as “a system that places value on people’s bodies and minds, based on societally constructed ideas of normalcy, intelligence, excellence, and productivity…[and] leads to people and society determining who is valuable and worthy based on their appearance and/or their ability to satisfactorily [re]produce, excel, and ‘behave.’”⁸ Regarding CSC, concerns about systemic bias in guideline design were raised early by disability advocacy groups during comment periods.^9,10 More broadly, concerns about ableism sit alongside many deeply rooted societal perspectives of disabled individuals as pitiable or, conversely, heroic for having “overcome” their disability in some way. As a physician who sits in a manual wheelchair with paraplegia and mobility impairment, I have equally been subject to inappropriate bias and inappropriate praise for living in a wheelchair. I have also wondered, alongside my patients living with different levels of mobility or ability, why others often view us as “worse off.” Addressing directly whether disabled individuals are “worse off,” disability rights attorney and advocate Harriet McBryde Johnson has articulated a predominant sentiment among persons living with unique or different abilities:

Are we “worse off”? I don’t think so. Not in any meaningful way. There are too many variables. For those of us with congenital conditions, disability shapes all we are. Those disabled later in life adapt. We take constraints that no one would choose and build rich and satisfying lives within them. We enjoy pleasures other people enjoy and pleasures peculiarly our own. We have something the world needs.¹¹

Many physician colleagues have common, invisible diseases such as diabetes and heart disease; fewer colleagues share conditions that are as visible as my spinal cord injury, as readily apparent to patients upon my entry to their hospital rooms. This simultaneous and inescapable identity as both patient and provider has afforded me wonderful doctor-patient interactions, particularly with those patients who appreciate how my patient experience impacts my ability to partially understand theirs. However, this simultaneous identity as doctor and patient also informed my personal and professional concerns regarding structural ableism as I considered scoring my own acutely ill hospital medicine patients with CSC triage scores in April 2020.

As a practicing hospital medicine physician, I have been emboldened by the efforts of my fellow clinicians amid COVID-19; their efforts have reaffirmed all the reasons I pursued a career in medicine. However, when I heard my clinical colleagues’ first explanation of the Massachusetts CSC guidelines in April 2020, I raised my hand to ask whether the “life-years” to which the guidelines referred were quality-adjusted. My concern regarding the implicit use of quality-adjusted life years (QALY) or disability-adjusted life years in clinical decision-making and implementation of these guidelines was validated when no clinical leaders could address this question directly. Sitting on the CSC committee for my hospital during this time was an honor. However, it was disconcerting to hear many clinicians’ unease when estimating mean survival for common chronic diseases, ranging from end-stage renal disease to advanced heart failure. If my expert colleagues, clinical specialists in kidney and heart disease, could not confidently apply mean survival estimates to multimorbid hospital patients, then idiosyncratic clinical judgment was sure to have a heavy hand in any calculation of “life-years.” Thus, my primary concern was that clinicians using triage heuristics would be subject to bias, regardless of their intention, and negatively adjust for the quality of a disabled life in their CSC triage scoring. My secondary concern was that the CSC guidelines themselves included systemic bias against disabled individuals.

According to CSC schema, triage scores index heavily on Sequential Organ Failure Assessment (SOFA) scores to define short-term survival; SOFA scores are partially driven by the Glasgow Coma Scale (GCS). Following professional and public comment periods, CSC guidelines in Massachusetts were revised to, among other critical points of revision, change prognostic estimation via “life years” in favor of generic estimation of short-term survival (Table). I wondered, if I presented to an emergency department with severe COVID-19 and was scored with the GCS for the purpose of making a CSC ventilator triage decision, how would my complete paraplegia and lower-extremity motor impairment be accounted for by a clinician assessing “best motor response” in the GCS? The purpose of these scores is to act algorithmically, to guide clinicians whose cognitive load and time limitations may not allow for adjustment of these algorithms based on the individual patient in front of them. Individualization of clinical decisions is part of medicine’s art, but is difficult in the best of times and no easier during a crisis in care delivery. As CSC triage scores were amended and addended throughout 2020, I returned to the COVID wards, time and again wondering, “What have we learned about systemic bias and health inequity in the CSC process and the pandemic broadly, with specific regard to disability?”

Ability Awareness: Room for Our Improvement

Unfortunately, there is reason to believe that clinical judgment is impaired by structural ableism. In seminal work on this topic, Gerhart et al¹² demonstrated that clinicians considered spinal cord injury (SCI) survivors to have low self-perceptions of worthiness, overall negative attitudes, and low self-esteem as compared to able-bodied individuals. However, surveyed SCI survivors generally had similar self-perceptions of worth and positivity as compared to ”able-bodied” clinicians.¹² For providers who care for persons with disabilities, the majority (82.4%) have rated their disabled patients’ quality of life as worse.¹³ It is no wonder that patients with disabilities are more likely to feel that their doctor-patient relationship is impacted by lack of understanding, negative sentiment, or simple lack of listening.¹⁴ Generally, this poor doctor-patient relationship with disabled patients is exacerbated by poor exposure of medical trainees to disability education; only 34.2% of internal medicine residents recall any form of disability education in medical school, while only 52% of medical school deans report having disability educational content in their curricula.^15,16 There is a similar lack of disability representation in the population of medical trainees themselves. While approximately 20% of the American population lives with a disability, less than 2% of American medical students have a disability.^17-19

While representation of disabled populations in medical practice remains poor, disabled patients are generally less likely to receive age-appropriate prevention, appropriate access to care, and equal access to treatment.^20-22 “Diagnostic overshadowing” refers to clinicians’ attribution of nonspecific signs or symptoms to a patient’s chronic disability as opposed to acute illness.²³ This phenomenon has led to higher rates of preventable malignancy in disabled patients and misattribution of common somatic symptoms to intellectual disability.^24,25 With this disparity in place as status quo for health care delivery to disabled populations, it is no surprise that certain portions of the disabled population have accounted for disproportionate mortality due to COVID-19.^26,27Disability advocates have called for “nothing about us without us,” a phrase associated with the United Nations Convention on the Rights of Persons with Disabilities. Understanding the profound neurodiversity among several forms of sensory and cognitive disabilities, as well as the functional difference between cognitive disabilities, mobility impairment, and inability to meet one’s instrumental activities of daily living independently, others have proposed a unique approach to certain disabled populations in COVID care.²⁸ My own perspective is that definite progress may require a more general understanding of the prevalence of disability by clinicians, both via medical training and by directly addressing health equity for disabled populations in such calculations as the CSC. Systemic ableism is apparent in our most common clinical scoring systems, ranging from the GCS and Functional Assessment Staging Table to the Eastern Cooperative Oncology Group and Karnofsky Performance Status scales. I have reexamined these scoring systems in my own understanding given their general equation of ambulation with ability or normalcy. As a doctor in a manual wheelchair who values greatly my personal quality of life and professional contribution to patient care, I worry that these scoring systems inherently discount my own equitable access to care. Individualization of patients’ particular abilities in the context of these scales must occur alongside evidence-based, guideline-directed management via these scoring systems.

Conclusion: Future Orientation

Updated CSC guidelines have accounted for the unique considerations of disabled patients by effectively caveating their scoring algorithms, directing clinicians via disclaimers to uniquely consider their disabled patients in clinical judgement. This is a first step, but it is also one that erodes the value of algorithms, which generally obviate more deliberative thinking and individualization. For our patients who lack certain abilities, as CSC continue to be activated in several states, we have an opportunity to pursue more inherently equitable solutions before further suffering accrues.²⁹ By way of example, adaptations to scoring systems that leverage QALYs for value-based drug pricing indices have been proposed by organizations like the Institute for Clinical and Economic Review, which proposed the Equal-Value-of Life-Years-Gained framework to inform QALY-based arbitration of drug pricing.³⁰ This is not a perfect rubric but instead represents an attempt to balance consideration of drugs, as has been done with ventilators during the pandemic, as a scare and expensive resource while addressing the just concerns of advocacy groups in structural ableism.

Resource stewardship during a crisis should not discount those states of human life that are perceived to be less desirable, particularly if they are not experienced as less desirable but are experienced uniquely. Instead, we should consider equitably measuring our intervention to match a patient’s needs, as we would dose-adjust a medication for renal function or consider minimally invasive procedures for multimorbid patients. COVID-19 has reflected our profession’s ethical adaptation during crisis as resources have become scarce; there is no better time to define solutions for health equity. We should now be concerned equally by the influence our personal biases have on our clinical practice and by the way in which these crisis standards will influence patients’ perception of and trust in their care providers during periods of perceived plentiful resources in the future. Health care resources are always limited, allocated according to societal values; if we value health equity for people of all abilities, then we will consider these abilities equitably as we pursue new standards for health care delivery.

Corresponding author: Gregory D. Snyder, MD, MBA, 2014 Washington Street, Newton, MA 02462; [email protected].

Disclosures: None.
 

Equitable Standards for All Patients in a Crisis

Health care delivered during a pandemic instantiates medicine’s perspectives on the value of human life in clinical scenarios where resource allocation is limited. The COVID-19 pandemic has fostered dialogue and debate around the ethical principles that underly such resource allocation, which generally balance (1) utilitarian optimization of resources, (2) equality or equity in health access, (3) the instrumental value of individuals as agents in society, and (4) prioritizing the “worst off” in their natural history of disease.^1,2 State legislatures and health systems have responded to the challeges posed by COVID-19 by considering both the scarcity of intensive care resources, such as mechanical ventilation and hemodialysis, and the clinical criteria to be used for determining which patients should receive said resources. These crisis guidelines have yielded several concerning themes vis-à-vis equitable distribution of health care resources, particularly when the disability status of patients is considered alongside life-expectancy or quality of life.³

Crisis standards of care (CSC) prioritize population-level health under a utilitarian paradigm, explicitly maximizing “life-years” within a population of patients rather than the life of any individual patient.⁴ Debated during initial COVID surges, these CSC guidelines have recently been enacted at the state level in several settings, including Alaska and Idaho.⁵ In a setting with scarce intensive care resources, balancing health equity in access to these resources against population-based survival metrics has been a challenge for commissions considering CSC.^6,7 This need for balance has further promoted systemic views of “disability,” raising concern for structural “ableism” and highlighting the need for greater “ability awareness” in clinicians’ continued professional learning.

Structural Ableism: Defining Perspectives to Address Health Equity

Ableism has been defined as “a system that places value on people’s bodies and minds, based on societally constructed ideas of normalcy, intelligence, excellence, and productivity…[and] leads to people and society determining who is valuable and worthy based on their appearance and/or their ability to satisfactorily [re]produce, excel, and ‘behave.’”⁸ Regarding CSC, concerns about systemic bias in guideline design were raised early by disability advocacy groups during comment periods.^9,10 More broadly, concerns about ableism sit alongside many deeply rooted societal perspectives of disabled individuals as pitiable or, conversely, heroic for having “overcome” their disability in some way. As a physician who sits in a manual wheelchair with paraplegia and mobility impairment, I have equally been subject to inappropriate bias and inappropriate praise for living in a wheelchair. I have also wondered, alongside my patients living with different levels of mobility or ability, why others often view us as “worse off.” Addressing directly whether disabled individuals are “worse off,” disability rights attorney and advocate Harriet McBryde Johnson has articulated a predominant sentiment among persons living with unique or different abilities:

Are we “worse off”? I don’t think so. Not in any meaningful way. There are too many variables. For those of us with congenital conditions, disability shapes all we are. Those disabled later in life adapt. We take constraints that no one would choose and build rich and satisfying lives within them. We enjoy pleasures other people enjoy and pleasures peculiarly our own. We have something the world needs.¹¹

Many physician colleagues have common, invisible diseases such as diabetes and heart disease; fewer colleagues share conditions that are as visible as my spinal cord injury, as readily apparent to patients upon my entry to their hospital rooms. This simultaneous and inescapable identity as both patient and provider has afforded me wonderful doctor-patient interactions, particularly with those patients who appreciate how my patient experience impacts my ability to partially understand theirs. However, this simultaneous identity as doctor and patient also informed my personal and professional concerns regarding structural ableism as I considered scoring my own acutely ill hospital medicine patients with CSC triage scores in April 2020.

As a practicing hospital medicine physician, I have been emboldened by the efforts of my fellow clinicians amid COVID-19; their efforts have reaffirmed all the reasons I pursued a career in medicine. However, when I heard my clinical colleagues’ first explanation of the Massachusetts CSC guidelines in April 2020, I raised my hand to ask whether the “life-years” to which the guidelines referred were quality-adjusted. My concern regarding the implicit use of quality-adjusted life years (QALY) or disability-adjusted life years in clinical decision-making and implementation of these guidelines was validated when no clinical leaders could address this question directly. Sitting on the CSC committee for my hospital during this time was an honor. However, it was disconcerting to hear many clinicians’ unease when estimating mean survival for common chronic diseases, ranging from end-stage renal disease to advanced heart failure. If my expert colleagues, clinical specialists in kidney and heart disease, could not confidently apply mean survival estimates to multimorbid hospital patients, then idiosyncratic clinical judgment was sure to have a heavy hand in any calculation of “life-years.” Thus, my primary concern was that clinicians using triage heuristics would be subject to bias, regardless of their intention, and negatively adjust for the quality of a disabled life in their CSC triage scoring. My secondary concern was that the CSC guidelines themselves included systemic bias against disabled individuals.

According to CSC schema, triage scores index heavily on Sequential Organ Failure Assessment (SOFA) scores to define short-term survival; SOFA scores are partially driven by the Glasgow Coma Scale (GCS). Following professional and public comment periods, CSC guidelines in Massachusetts were revised to, among other critical points of revision, change prognostic estimation via “life years” in favor of generic estimation of short-term survival (Table). I wondered, if I presented to an emergency department with severe COVID-19 and was scored with the GCS for the purpose of making a CSC ventilator triage decision, how would my complete paraplegia and lower-extremity motor impairment be accounted for by a clinician assessing “best motor response” in the GCS? The purpose of these scores is to act algorithmically, to guide clinicians whose cognitive load and time limitations may not allow for adjustment of these algorithms based on the individual patient in front of them. Individualization of clinical decisions is part of medicine’s art, but is difficult in the best of times and no easier during a crisis in care delivery. As CSC triage scores were amended and addended throughout 2020, I returned to the COVID wards, time and again wondering, “What have we learned about systemic bias and health inequity in the CSC process and the pandemic broadly, with specific regard to disability?”

Ability Awareness: Room for Our Improvement

Unfortunately, there is reason to believe that clinical judgment is impaired by structural ableism. In seminal work on this topic, Gerhart et al¹² demonstrated that clinicians considered spinal cord injury (SCI) survivors to have low self-perceptions of worthiness, overall negative attitudes, and low self-esteem as compared to able-bodied individuals. However, surveyed SCI survivors generally had similar self-perceptions of worth and positivity as compared to ”able-bodied” clinicians.¹² For providers who care for persons with disabilities, the majority (82.4%) have rated their disabled patients’ quality of life as worse.¹³ It is no wonder that patients with disabilities are more likely to feel that their doctor-patient relationship is impacted by lack of understanding, negative sentiment, or simple lack of listening.¹⁴ Generally, this poor doctor-patient relationship with disabled patients is exacerbated by poor exposure of medical trainees to disability education; only 34.2% of internal medicine residents recall any form of disability education in medical school, while only 52% of medical school deans report having disability educational content in their curricula.^15,16 There is a similar lack of disability representation in the population of medical trainees themselves. While approximately 20% of the American population lives with a disability, less than 2% of American medical students have a disability.^17-19

While representation of disabled populations in medical practice remains poor, disabled patients are generally less likely to receive age-appropriate prevention, appropriate access to care, and equal access to treatment.^20-22 “Diagnostic overshadowing” refers to clinicians’ attribution of nonspecific signs or symptoms to a patient’s chronic disability as opposed to acute illness.²³ This phenomenon has led to higher rates of preventable malignancy in disabled patients and misattribution of common somatic symptoms to intellectual disability.^24,25 With this disparity in place as status quo for health care delivery to disabled populations, it is no surprise that certain portions of the disabled population have accounted for disproportionate mortality due to COVID-19.^26,27Disability advocates have called for “nothing about us without us,” a phrase associated with the United Nations Convention on the Rights of Persons with Disabilities. Understanding the profound neurodiversity among several forms of sensory and cognitive disabilities, as well as the functional difference between cognitive disabilities, mobility impairment, and inability to meet one’s instrumental activities of daily living independently, others have proposed a unique approach to certain disabled populations in COVID care.²⁸ My own perspective is that definite progress may require a more general understanding of the prevalence of disability by clinicians, both via medical training and by directly addressing health equity for disabled populations in such calculations as the CSC. Systemic ableism is apparent in our most common clinical scoring systems, ranging from the GCS and Functional Assessment Staging Table to the Eastern Cooperative Oncology Group and Karnofsky Performance Status scales. I have reexamined these scoring systems in my own understanding given their general equation of ambulation with ability or normalcy. As a doctor in a manual wheelchair who values greatly my personal quality of life and professional contribution to patient care, I worry that these scoring systems inherently discount my own equitable access to care. Individualization of patients’ particular abilities in the context of these scales must occur alongside evidence-based, guideline-directed management via these scoring systems.

Conclusion: Future Orientation

Updated CSC guidelines have accounted for the unique considerations of disabled patients by effectively caveating their scoring algorithms, directing clinicians via disclaimers to uniquely consider their disabled patients in clinical judgement. This is a first step, but it is also one that erodes the value of algorithms, which generally obviate more deliberative thinking and individualization. For our patients who lack certain abilities, as CSC continue to be activated in several states, we have an opportunity to pursue more inherently equitable solutions before further suffering accrues.²⁹ By way of example, adaptations to scoring systems that leverage QALYs for value-based drug pricing indices have been proposed by organizations like the Institute for Clinical and Economic Review, which proposed the Equal-Value-of Life-Years-Gained framework to inform QALY-based arbitration of drug pricing.³⁰ This is not a perfect rubric but instead represents an attempt to balance consideration of drugs, as has been done with ventilators during the pandemic, as a scare and expensive resource while addressing the just concerns of advocacy groups in structural ableism.

Resource stewardship during a crisis should not discount those states of human life that are perceived to be less desirable, particularly if they are not experienced as less desirable but are experienced uniquely. Instead, we should consider equitably measuring our intervention to match a patient’s needs, as we would dose-adjust a medication for renal function or consider minimally invasive procedures for multimorbid patients. COVID-19 has reflected our profession’s ethical adaptation during crisis as resources have become scarce; there is no better time to define solutions for health equity. We should now be concerned equally by the influence our personal biases have on our clinical practice and by the way in which these crisis standards will influence patients’ perception of and trust in their care providers during periods of perceived plentiful resources in the future. Health care resources are always limited, allocated according to societal values; if we value health equity for people of all abilities, then we will consider these abilities equitably as we pursue new standards for health care delivery.

Corresponding author: Gregory D. Snyder, MD, MBA, 2014 Washington Street, Newton, MA 02462; [email protected].

Disclosures: None.
 

Equitable Standards for All Patients in a Crisis

Health care delivered during a pandemic instantiates medicine’s perspectives on the value of human life in clinical scenarios where resource allocation is limited. The COVID-19 pandemic has fostered dialogue and debate around the ethical principles that underly such resource allocation, which generally balance (1) utilitarian optimization of resources, (2) equality or equity in health access, (3) the instrumental value of individuals as agents in society, and (4) prioritizing the “worst off” in their natural history of disease.^1,2 State legislatures and health systems have responded to the challeges posed by COVID-19 by considering both the scarcity of intensive care resources, such as mechanical ventilation and hemodialysis, and the clinical criteria to be used for determining which patients should receive said resources. These crisis guidelines have yielded several concerning themes vis-à-vis equitable distribution of health care resources, particularly when the disability status of patients is considered alongside life-expectancy or quality of life.³

Crisis standards of care (CSC) prioritize population-level health under a utilitarian paradigm, explicitly maximizing “life-years” within a population of patients rather than the life of any individual patient.⁴ Debated during initial COVID surges, these CSC guidelines have recently been enacted at the state level in several settings, including Alaska and Idaho.⁵ In a setting with scarce intensive care resources, balancing health equity in access to these resources against population-based survival metrics has been a challenge for commissions considering CSC.^6,7 This need for balance has further promoted systemic views of “disability,” raising concern for structural “ableism” and highlighting the need for greater “ability awareness” in clinicians’ continued professional learning.

Structural Ableism: Defining Perspectives to Address Health Equity

Ableism has been defined as “a system that places value on people’s bodies and minds, based on societally constructed ideas of normalcy, intelligence, excellence, and productivity…[and] leads to people and society determining who is valuable and worthy based on their appearance and/or their ability to satisfactorily [re]produce, excel, and ‘behave.’”⁸ Regarding CSC, concerns about systemic bias in guideline design were raised early by disability advocacy groups during comment periods.^9,10 More broadly, concerns about ableism sit alongside many deeply rooted societal perspectives of disabled individuals as pitiable or, conversely, heroic for having “overcome” their disability in some way. As a physician who sits in a manual wheelchair with paraplegia and mobility impairment, I have equally been subject to inappropriate bias and inappropriate praise for living in a wheelchair. I have also wondered, alongside my patients living with different levels of mobility or ability, why others often view us as “worse off.” Addressing directly whether disabled individuals are “worse off,” disability rights attorney and advocate Harriet McBryde Johnson has articulated a predominant sentiment among persons living with unique or different abilities:

Are we “worse off”? I don’t think so. Not in any meaningful way. There are too many variables. For those of us with congenital conditions, disability shapes all we are. Those disabled later in life adapt. We take constraints that no one would choose and build rich and satisfying lives within them. We enjoy pleasures other people enjoy and pleasures peculiarly our own. We have something the world needs.¹¹

Many physician colleagues have common, invisible diseases such as diabetes and heart disease; fewer colleagues share conditions that are as visible as my spinal cord injury, as readily apparent to patients upon my entry to their hospital rooms. This simultaneous and inescapable identity as both patient and provider has afforded me wonderful doctor-patient interactions, particularly with those patients who appreciate how my patient experience impacts my ability to partially understand theirs. However, this simultaneous identity as doctor and patient also informed my personal and professional concerns regarding structural ableism as I considered scoring my own acutely ill hospital medicine patients with CSC triage scores in April 2020.

As a practicing hospital medicine physician, I have been emboldened by the efforts of my fellow clinicians amid COVID-19; their efforts have reaffirmed all the reasons I pursued a career in medicine. However, when I heard my clinical colleagues’ first explanation of the Massachusetts CSC guidelines in April 2020, I raised my hand to ask whether the “life-years” to which the guidelines referred were quality-adjusted. My concern regarding the implicit use of quality-adjusted life years (QALY) or disability-adjusted life years in clinical decision-making and implementation of these guidelines was validated when no clinical leaders could address this question directly. Sitting on the CSC committee for my hospital during this time was an honor. However, it was disconcerting to hear many clinicians’ unease when estimating mean survival for common chronic diseases, ranging from end-stage renal disease to advanced heart failure. If my expert colleagues, clinical specialists in kidney and heart disease, could not confidently apply mean survival estimates to multimorbid hospital patients, then idiosyncratic clinical judgment was sure to have a heavy hand in any calculation of “life-years.” Thus, my primary concern was that clinicians using triage heuristics would be subject to bias, regardless of their intention, and negatively adjust for the quality of a disabled life in their CSC triage scoring. My secondary concern was that the CSC guidelines themselves included systemic bias against disabled individuals.

According to CSC schema, triage scores index heavily on Sequential Organ Failure Assessment (SOFA) scores to define short-term survival; SOFA scores are partially driven by the Glasgow Coma Scale (GCS). Following professional and public comment periods, CSC guidelines in Massachusetts were revised to, among other critical points of revision, change prognostic estimation via “life years” in favor of generic estimation of short-term survival (Table). I wondered, if I presented to an emergency department with severe COVID-19 and was scored with the GCS for the purpose of making a CSC ventilator triage decision, how would my complete paraplegia and lower-extremity motor impairment be accounted for by a clinician assessing “best motor response” in the GCS? The purpose of these scores is to act algorithmically, to guide clinicians whose cognitive load and time limitations may not allow for adjustment of these algorithms based on the individual patient in front of them. Individualization of clinical decisions is part of medicine’s art, but is difficult in the best of times and no easier during a crisis in care delivery. As CSC triage scores were amended and addended throughout 2020, I returned to the COVID wards, time and again wondering, “What have we learned about systemic bias and health inequity in the CSC process and the pandemic broadly, with specific regard to disability?”

Ability Awareness: Room for Our Improvement

Unfortunately, there is reason to believe that clinical judgment is impaired by structural ableism. In seminal work on this topic, Gerhart et al¹² demonstrated that clinicians considered spinal cord injury (SCI) survivors to have low self-perceptions of worthiness, overall negative attitudes, and low self-esteem as compared to able-bodied individuals. However, surveyed SCI survivors generally had similar self-perceptions of worth and positivity as compared to ”able-bodied” clinicians.¹² For providers who care for persons with disabilities, the majority (82.4%) have rated their disabled patients’ quality of life as worse.¹³ It is no wonder that patients with disabilities are more likely to feel that their doctor-patient relationship is impacted by lack of understanding, negative sentiment, or simple lack of listening.¹⁴ Generally, this poor doctor-patient relationship with disabled patients is exacerbated by poor exposure of medical trainees to disability education; only 34.2% of internal medicine residents recall any form of disability education in medical school, while only 52% of medical school deans report having disability educational content in their curricula.^15,16 There is a similar lack of disability representation in the population of medical trainees themselves. While approximately 20% of the American population lives with a disability, less than 2% of American medical students have a disability.^17-19

While representation of disabled populations in medical practice remains poor, disabled patients are generally less likely to receive age-appropriate prevention, appropriate access to care, and equal access to treatment.^20-22 “Diagnostic overshadowing” refers to clinicians’ attribution of nonspecific signs or symptoms to a patient’s chronic disability as opposed to acute illness.²³ This phenomenon has led to higher rates of preventable malignancy in disabled patients and misattribution of common somatic symptoms to intellectual disability.^24,25 With this disparity in place as status quo for health care delivery to disabled populations, it is no surprise that certain portions of the disabled population have accounted for disproportionate mortality due to COVID-19.^26,27Disability advocates have called for “nothing about us without us,” a phrase associated with the United Nations Convention on the Rights of Persons with Disabilities. Understanding the profound neurodiversity among several forms of sensory and cognitive disabilities, as well as the functional difference between cognitive disabilities, mobility impairment, and inability to meet one’s instrumental activities of daily living independently, others have proposed a unique approach to certain disabled populations in COVID care.²⁸ My own perspective is that definite progress may require a more general understanding of the prevalence of disability by clinicians, both via medical training and by directly addressing health equity for disabled populations in such calculations as the CSC. Systemic ableism is apparent in our most common clinical scoring systems, ranging from the GCS and Functional Assessment Staging Table to the Eastern Cooperative Oncology Group and Karnofsky Performance Status scales. I have reexamined these scoring systems in my own understanding given their general equation of ambulation with ability or normalcy. As a doctor in a manual wheelchair who values greatly my personal quality of life and professional contribution to patient care, I worry that these scoring systems inherently discount my own equitable access to care. Individualization of patients’ particular abilities in the context of these scales must occur alongside evidence-based, guideline-directed management via these scoring systems.

Conclusion: Future Orientation

Updated CSC guidelines have accounted for the unique considerations of disabled patients by effectively caveating their scoring algorithms, directing clinicians via disclaimers to uniquely consider their disabled patients in clinical judgement. This is a first step, but it is also one that erodes the value of algorithms, which generally obviate more deliberative thinking and individualization. For our patients who lack certain abilities, as CSC continue to be activated in several states, we have an opportunity to pursue more inherently equitable solutions before further suffering accrues.²⁹ By way of example, adaptations to scoring systems that leverage QALYs for value-based drug pricing indices have been proposed by organizations like the Institute for Clinical and Economic Review, which proposed the Equal-Value-of Life-Years-Gained framework to inform QALY-based arbitration of drug pricing.³⁰ This is not a perfect rubric but instead represents an attempt to balance consideration of drugs, as has been done with ventilators during the pandemic, as a scare and expensive resource while addressing the just concerns of advocacy groups in structural ableism.

Resource stewardship during a crisis should not discount those states of human life that are perceived to be less desirable, particularly if they are not experienced as less desirable but are experienced uniquely. Instead, we should consider equitably measuring our intervention to match a patient’s needs, as we would dose-adjust a medication for renal function or consider minimally invasive procedures for multimorbid patients. COVID-19 has reflected our profession’s ethical adaptation during crisis as resources have become scarce; there is no better time to define solutions for health equity. We should now be concerned equally by the influence our personal biases have on our clinical practice and by the way in which these crisis standards will influence patients’ perception of and trust in their care providers during periods of perceived plentiful resources in the future. Health care resources are always limited, allocated according to societal values; if we value health equity for people of all abilities, then we will consider these abilities equitably as we pursue new standards for health care delivery.

Corresponding author: Gregory D. Snyder, MD, MBA, 2014 Washington Street, Newton, MA 02462; [email protected].

Disclosures: None.
 

On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.

Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.

Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”

In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.

Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.

Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*

Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.  

“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”

The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.

Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.

There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.

Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.

A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.

“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”

Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.

Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.

“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”

In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.

Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.

Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.

“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**

Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.

In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.

“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.

Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.

“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”

Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.

Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”

Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.

“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”

Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.

“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”

The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.

First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.

After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”

Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.

Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”

Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.

Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.

“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”

Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.

Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.

After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.

Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.

“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”

Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.

But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel. Under the Zero Harm patient safety program Mount Carmel West launched in 2017, medical staffers were supposed to report safety concerns up the chain of command. That apparently did not happen.

Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.

“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”

While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.

“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”

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

Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice. 

This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.

On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.

Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.

Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”

In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.

Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.

Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*

Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.  

“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”

The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.

Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.

There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.

Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.

A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.

“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”

Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.

Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.

“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”

In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.

Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.

Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.

“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**

Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.

In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.

“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.

Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.

“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”

Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.

Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”

Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.

“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”

Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.

“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”

The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.

First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.

After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”

Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.

Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”

Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.

Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.

“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”

Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.

Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.

After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.

Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.

“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”

Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.

But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel. Under the Zero Harm patient safety program Mount Carmel West launched in 2017, medical staffers were supposed to report safety concerns up the chain of command. That apparently did not happen.

Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.

“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”

While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.

“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”

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

Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice. 

This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.

On Dec. 5, 2017, Danny Mollette, age 74, was brought to the emergency department of Mount Carmel West Medical Center in Columbus, Ohio, in critical condition. Staff inserted a breathing tube and sent him to the intensive care unit.

Mr. Mollette, who had diabetes, previously had been hospitalized for treatment of a gangrenous foot. When he arrived in the ICU, he was suffering from acute renal failure and low blood pressure, and had had two heart stoppages, according to a 2020 Ohio Board of Pharmacy report. He was placed under the care of William Husel, DO, the sole physician on duty in the ICU during the overnight shift.

Around 9:00 p.m., Dr. Husel discussed Mr. Mollette’s “grim prognosis” with family members at the patient’s bedside. He advised them that Mr. Mollette had “minutes to live” and asked, “How would you want him to take his last breath: on the ventilator or without these machines?”

In less than an hour, Mr. Mollette was dead. Some said that what happened in his case was similar to what happened with 34 other ICU patients at Mount Carmel West and Mount Carmel St. Ann’s in Westerville, Ohio, from 2014 through 2018 – all under Dr. Husel’s care.

Like Mr. Mollette, most of these gravely ill patients died minutes after receiving a single, unusually large intravenous dose of the powerful opioid fentanyl – often combined with a dose of one or more other painkillers or sedatives like hydromorphone – and being withdrawn from the ventilator. These deaths all occurred following a procedure called palliative extubation, the removal of the endotracheal tube in patients who are expected to die.

Mount Carmel fired Dr. Husel in December 2018 following an investigation that concluded that the opioid dosages he used were “significantly excessive and potentially fatal,” and “went beyond providing comfort.” His Ohio medical license was suspended. In February 2022, he is scheduled to go on trial in Columbus on 14 counts of murder.*

Hanging over the murder case against Dr. Husel is the question of how Mount Carmel, a 136-year-old Catholic hospital owned by the giant Trinity Health system, allowed this pattern of care to continue for so many patients over 4 years, and why numerous registered nurses and hospital pharmacists went along with Dr. Husel’s actions. Nearly two dozen RNs and two pharmacists involved in these cases have faced disciplinary action, mostly license suspension.  

“The first time a patient died on a very high dose, someone should have flagged this,” said Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School, Newark. “As soon as I see it the second time or 27th time, it doesn’t seem okay. There was a breakdown in oversight to allow this to continue. The hospital didn’t have guardrails in place.”

The Franklin County (Ohio) Prosecuting Attorney’s Office faces two big challenges in trying Dr. Husel for murder. The prosecutors must prove that the drugs Dr. Husel ordered are what directly caused these critically ill patients to die, and that he intended to kill them.

Federal and state agencies have cited the hospital system for faults in its patient safety systems and culture that were exposed by the Husel cases. An outside medical expert, Robert Powers, MD, a professor of emergency medicine at the University of Virginia, Charlottesville, testified in one of the dozens of wrongful death lawsuits against Mount Carmel and Dr. Husel that there was no record of anyone supervising Dr. Husel or monitoring his care.

There also are questions about why Mount Carmel administrators and physician leaders did not find out about Dr. Husel’s criminal record as a young man before hiring and credentialing him, even though the Ohio Medical Board had obtained that record. As a college freshman in West Virginia in 1994, Dr. Husel and a friend allegedly stole car stereos, and after a classmate reported their behavior, they built a pipe bomb they planned to plant under the classmate’s car, according to court records.

Dr. Husel pleaded guilty in 1996 to a federal misdemeanor for improperly storing explosive materials, and he received a 6-month sentence followed by supervision. He did not disclose that criminal conviction on his application for medical liability insurance as part of his Mount Carmel employment application, attorneys representing the families of his deceased patients say.

A Mount Carmel spokeswoman said the hospital only checks a physician applicant’s background record for the previous 10 years.

“I think [the credentialing process] should have been more careful and more comprehensive than it was,” Robert Powers testified in a September 2020 deposition. “This guy was a bomber and a thief. You don’t hire bombers and thieves to take care of patients.”

Mount Carmel and Trinity leaders say they knew nothing about Dr. Husel’s palliative extubation practices until a staffer reported Dr. Husel’s high-dose fentanyl orders in October 2018. However, three more Husel patients died under similar circumstances before he was removed from patient care in November 2018.

Mount Carmel and Trinity already have settled a number of wrongful death lawsuits filed by the families of Dr. Husel’s patients for nearly $20 million, with many more suits pending. The Mount Carmel CEO, the chief clinical officer, other physician, nursing, and pharmacy leaders, as well as dozens of nurses and pharmacists have been terminated or entered into retirement.

“What happened is tragic and unacceptable,” the Mount Carmel spokeswoman said in a written statement. “We have made a number of changes designed to prevent this from ever happening again. … Our new hospital leadership team is committed to patient safety and will take immediate action whenever patient safety is at issue.”

In January 2019, Mount Carmel’s then-CEO Ed Lamb acknowledged that “processes in place were not sufficient to prevent these actions from happening.” Mr. Lamb later said Mount Carmel was investigating whether five of the ICU patients who died under Dr. Husel’s care could have been treated and survived. Mr. Lamb stepped down in June 2019.

Before performing a palliative extubation, physicians commonly administer opioids and/or sedatives to ease pain and discomfort, and spare family members from witnessing their loved one gasping for breath. But most medical experts say the fentanyl doses Dr. Husel ordered – 500-2,000 mcg – were five to 20 times larger than doses normally used in palliative extubation. Such doses, they say, would quickly kill most patients – except those with high opioid tolerance – by stopping their breathing.

Physicians say they typically give much smaller doses of fentanyl or morphine, then administer more as needed if they observe the patient experiencing pain or distress. Mount Carmel’s 2016 guidelines for IV administration of fentanyl specified a dosage range of 50-100 mcg for relieving pain, and its 2018 guidelines reduced that to 25-50 mcg.

“If I perform a painful procedure, I might give 100 or 150 micrograms of fentanyl, or 500 or 600 for open heart surgery,” said Dr. Nelson of Rutgers, who also practices medical toxicology and addiction medicine. “But you’ll be intubated and monitored carefully. Without having a tube in your airway to help you breathe, those doses will kill you.”**

Mount Carmel West hired Dr. Husel in 2013 to work the late-night shift in its ICU. It was his first job as a full-fledged physician, after completing a residency and fellowship in critical care medicine at Cleveland Clinic. A good-looking and charismatic former high school basketball star, he was a hard worker and was popular with the ICU nurses and staff, who looked to him as a teacher and mentor, according to depositions of nurses and Ohio Board of Nursing reports.

In 2014, Dr. Husel was chosen by his hospital colleagues as physician of the year. He was again nominated in 2018. Before October 2018, there were no complaints about his care, according to the deposition of Larry Swanner, MD, Mount Carmel’s former vice president of medical affairs, who was fired in 2019.

“Dr. Husel is so knowledgeable that we would try to soak up as much knowledge as we could,” said Jason Schulze, RN, in a July 2020 deposition. Mr. Schulze’s license was suspended, however, that suspension was stayed for a minimum period of two years. This was in connection with his care of one of Dr. Husel’s ICU patients, 44-year-old Troy Allison, who died 3 minutes after Mr. Schulze administered a 1,000-microgram dose of fentanyl ordered by Dr. Husel in July 2018.

Dr. Husel’s winning personality and seeming expertise in the use of pain drugs, combined with his training at the prestigious Cleveland Clinic, may have lulled other hospital staff into going along with his decisions.

“They’re thinking, the guy’s likable and he must know what he’s doing,” said Michael Cohen, RPh, founder and president emeritus of the Institute for Safe Medication Practices. “But you can’t get fooled by that. You need a policy in place for what to do if pharmacists or nurses disagree with an order, and you need to have practice simulations so people know how to handle these situations.”

Dr. Husel’s criminal defense attorney, Jose Baez, said Dr. Husel’s treatment of all these palliative extubation patients, including his prescribed dosages of fentanyl and other drugs, was completely appropriate. “Dr. Husel practiced medicine with compassion, and never wanted to see any of his patients suffer, nor their family,” Mr. Baez said.

Most medical and pharmacy experts sharply disagree. “I’m a pharmacist, and I’ve never seen anything like those kinds of doses,” Mr. Cohen said. “Something strange was going on there.”

Complicating these issues, eight nurses and a pharmacist have sued Mount Carmel and Trinity for wrongful termination and defamation in connection with the Husel allegations. They strongly defend Dr. Husel’s and their care as compassionate and appropriate. Beyond that, they argue that the changes Mount Carmel and Trinity made to ICU procedures to prevent such situations from happening again are potentially harmful to patient care.

“None of the nurses ever thought that Dr. Husel did anything to harm his patients or do anything other than provide comfort care during a very difficult time,” said Robert Landy, a New York attorney who’s representing the plaintiffs in the federal wrongful termination suit. “The real harm came in January 2019, when there were substantial policy changes that were detrimental to patient care and safety.”

Many of these patient deaths occurred during a period when the Mount Carmel system and Trinity were in the process of closing the old Mount Carmel West hospital, located in the low-income, inner-city neighborhood of Columbus, and opening a new hospital in the affluent suburb of Grove City, Ohio.

“They were done with this old, worn-out, inner-city hospital and its patient base and wanted a brand-new sparkling object in the suburbs,” said Gerry Leeseberg, a Columbus attorney who is representing 17 families of patients who died under Dr. Husel’s care. “They may have directed less energy, attention, and resources to the inner-city hospital.”

The case of Danny Mollette illustrates the multiple issues with Mount Carmel’s patient safety system.

First, there was no evidence in the record that Mr. Mollette was in pain or lacked the ability to breathe on his own prior to Dr. Husel’s palliative extubation. He had received no pain medications in the hospital that day, according to the report of an Ohio Board of Nursing examiner in a licensure discipline action brought against nurse Jacob Deemer for his care of Mr. Mollette and two other ICU patients who died. Mr. Deemer said Dr. Husel told him that the patient had to be in pain given his condition.

After consulting with Mr. Mollette’s family at the bedside, Dr. Husel ordered Mr. Deemer to administer 1,000 mcg of fentanyl, followed by 2 mg of hydromorphone, and 4 mg of midzolam, a sedative. Mr. Deemer withdrew the drugs from the Pyxis dispensing cabinet, overriding the pharmacist preapproval system. He said Dr. Husel told him the pharmacist had said, “It is okay.”

Actually, according to the pharmacy board report, the pharmacist, Gregory White, wrote in the medical record system that he did not agree to the fentanyl order. But his dissent came as the drugs were being administered, the breathing tube was being removed, and the patient was about to die. Mr. White was later disciplined by the Ohio Board of Pharmacy for failing to inform his supervisors about the incident and preventing the use of those high drug dosages in the cases of Mr. Mollette and two subsequent Husel patients.

Then there are questions about whether the families of Mr. Mollette and other Husel patients were fully and accurately informed about their loved ones’ conditions before agreeing to the palliative extubation. Mr. Mollette’s son, Brian, told reporters in July 2019 that Dr. Husel “said my father’s organs were shutting down and he was brain damaged. In hindsight, we felt kind of rushed to make that decision.”

Plaintiff attorneys bringing civil wrongful death cases against Mount Carmel and Dr. Husel must overcome hurdles similar to those faced by prosecutors in the murder case against Dr. Husel. Even if the patients were likely to die from their underlying conditions, did the drugs hasten their deaths, and by how much? In the civil cases, there’s the additional question of how much a few more hours or days or weeks of life are worth in terms of monetary damages.

Another challenge in bringing both the criminal and civil cases is that physicians and other medical providers have certain legal protections for administering drugs to patients for the purpose of relieving pain and suffering, even if the drugs hasten the patients’ deaths – as long the intent was not to cause death and the drugs were properly used. This is known as the double-effect principle. In contrast, intentional killing to relieve pain and suffering is called euthanasia, and that’s illegal in the United States.

“There is no evidence that medication played any part in the death of any of these patients,” said Mr. Landy, who’s representing the nurses and pharmacists in the wrongful termination suit. “The only evidence we have is that higher dosages of opioids following extubation extend life, not shorten it.”

Dr. Husel, as well as the nurses and pharmacists who have faced licensure actions, claim their actions were legally shielded by the double-effect principle. But the Centers for Medicare & Medicaid Services, the Ohio Board of Nursing, and Ohio Board of Pharmacy haven’t accepted that defense. Instead, they have cited Mount Carmel, Dr. Husel, and the nurses and pharmacists for numerous patient safety violations, including administering excessive dosages of fentanyl and other drugs.

Among those violations is that many of Dr. Husel’s drug orders were given verbally instead of through the standard process of entering the orders into the electronic health record. He and the nurses on duty skipped the standard nonemergency process of getting preapproval from the pharmacist on duty. Instead, they used the override function on Mount Carmel’s automated Pyxis system to withdraw the drugs from the cabinet and avoid pharmacist review. In many cases, there was no retrospective review of the appropriateness of the orders by a pharmacist after the drugs were administered, which is required.

After threatening to cut off Medicare and Medicaid payments to Mount Carmel, CMS in June 2019 accepted the hospital’s correction plan, which restricted use of verbal drug orders and prohibited Pyxis system overrides for opioids except in life-threatening emergencies. The Ohio Board of Pharmacy hit Mount Carmel with $477,000 in fines and costs for pharmacy rules violations.

Under the agreement with CMS, Mount Carmel physicians must receive permission from a physician executive to order painkilling drugs that exceed hospital-set dosage parameters for palliative ventilator withdrawal. In addition, pharmacists must immediately report concerns about drug-prescribing safety up the hospital pharmacy chain of command.

“We have trained staff to ensure they feel empowered to speak up when appropriate,” the Mount Carmel spokeswoman said. “Staff members have multiple avenues for elevating a complaint or concern.”

Dr. Husel’s high dosages of fentanyl and other painkillers were well-known among the ICU nurses and pharmacists, who rarely – if ever – questioned those dosages, and went along with his standard use of verbal orders and overrides of the Pyxis system, according to depositions of nurses and pharmacists in the wrongful death lawsuits.

But the Mount Carmel nurses and pharmacists had a professional responsibility to question such dosages and demand evidence from the medical literature to support their use, according to hearing examiners at the nursing and pharmacy boards, who meted out licensure actions to providers working with Dr. Husel. Under the Zero Harm patient safety program Mount Carmel West launched in 2017, medical staffers were supposed to report safety concerns up the chain of command. That apparently did not happen.

Nursing board hearing examiner Jack Decker emphasized those responsibilities in his November 30, 2020, report on nurse Deemer’s actions regarding three patients who died under Dr. Husel’s care in 2017 and 2018. Mr. Deemer’s license was suspended, however, that suspension was stayed for a minimum period of three years. Mr. Decker wrote that the ICU nurses had a professional responsibility to question Dr. Husel and, if necessary, refuse to carry out the doctor’s order and report their concerns to managers.

“Challenging a physician’s order is a difficult step even under ideal circumstances,” wrote Mr. Decker, who called Mount Carmel West’s ICU a “dysfunctional” environment. “But,” he noted, “when Mr. Deemer signed on to become a nurse, he enlisted to use his own critical thinking skills to serve as a patient protector and advocate. … Clearly, Mr. Deemer trusted Dr. Husel. But Dr. Husel was not to be trusted.”

While patient safety experts say these cases reveal that Mount Carmel had a flawed system and culture that did not train and empower staff to report safety concerns up the chain of command, they acknowledged that this could have happened at many U.S. hospitals.

“Sadly, I’m not sure it’s all that uncommon,” said Dr. Nelson of Rutgers. “Nurses and pharmacists have historically been afraid to raise concerns about physicians. We’ve been trying to break down barriers, but it’s a natural human instinct to play your role in the hierarchy.”

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

Corrections 2/1/22: An earlier version of this article misstated (*) the number of murder counts and (**) Dr. Nelson's area of practice. 

This article was updated 2/2/22 to reflect the fact that the license suspensions of Mr. Deemer and Mr. Schulze were stayed.

Some details have been changed to protect the patient’s identity.

The first thing I noticed about Mr. Barry as I entered the intensive care unit was his left foot: Half of it was black, shriveled, and gangrenous, jutting out from under the white blanket. The soft rays of the morning sun illuminated his gaunt, unshaven, hollow cheeks. Sedated on propofol, with a green endotracheal tube sticking out of his chapped lips, he looked frail. His nurse, Becky, had just cleaned him after he passed tarry, maroon-colored stool. As she turned him over, I saw that the skin over his tailbone was broken. He had a large decubitus ulcer, the edges of which were now dried and black. The Foley bag, hanging next to his bed, was empty; there had been no urine for several hours now.

No one knew much about Mr. Barry. I don’t mean his current medical status – I mean what he did in life, who he loved, whether he had kids, what he valued. All we knew was that he was 83 years old and lived alone. No prior records in our system. No advanced directives. No information on any family. One of his neighbors called 911 after he was not seen for at least 10 days. Emergency medical services found Mr. Barry in bed, nearly lifeless. In the emergency room, he was noted to be in shock, with a dangerously low blood pressure. He was dry as a bone with markedly elevated sodium levels. His laboratory makers for kidney and liver function were deranged. He was admitted to the medical ICU with a diagnosis of hypovolemic shock and/or septic shock with multiorgan dysfunction. With 48 hours of supportive management with intravenous fluids and antibiotics, he did not improve. Blood cultures were positive for gram-positive cocci. The doses for medications used to maintain the blood pressure increased steadily. He also developed gastrointestinal bleeding.
 

Futile vs. potentially inappropriate

I was called for a cardiology consult because he had transient ST elevation in inferolateral leads on the monitor. Given his clinical scenario, the likelihood of type 1 myocardial infarction from plaque rupture was low; the ST elevations were probably related to vasospasm from increasing pressor requirement. Diagnostic cardiac catheterization showed clean coronary arteries. Continuous renal replacement therapy was soon started. Given Mr Barry’s multiorgan dysfunction and extremely poor prognosis, I recommended making all efforts to find his family or surrogate decision-maker to discuss goals of care or having a two-physician sign-off to place a DNR order.

Despite all efforts, we could not trace the family. We physicians vary individually on how we define value as related to life. We also vary on the degree of uncertainty about prognostication that we are comfortable with. This is one of the reasons the term “futility” is controversial and there is a push to use “potentially inappropriate” instead. The primary team had a different threshold for placing a DNR order and did not do it. That night, after I left the hospital, Mr Barry had a PEA (pulseless electrical activity) arrest and was resuscitated after 10 minutes of CPR. The next day, I noticed his bruised chest. He was on multiple medications to support his blood pressure.
 

My patient and a Hemingway protagonist

Whether by coincidence or irony, I started reading Ernest Hemingway’s short story “The Snows of Kilimanjaro” the same day that I met Mr. Barry. He reminded me of the story’s protagonist, Harry, lying on the cot with a gangrenous leg, waiting to die. Harry could sense death approaching. He reminisced about his past. All he wanted was to drink his “whiskey-soda.” “Darling, don’t drink that. We have to do everything we can,” his wife said. “You do it. I am tired,” Harry said, and continued to drink his whiskey-soda.

Mr. Barry looked tired. Tired of life? I can’t say with certainty. However, if I had to guess, the medical team’s heroics meant nothing to him. Unfortunately, he was not awake like Harry and could not do what he wished. I wondered what snippets of his life flashed before him as he lay on his bed at home for days. Did he want to have a whiskey-soda before dying? But we are not letting him die. Not easily anyway. We have to do everything we can: medications, coronary angiogram, dialysis, multiple rounds of CPR. Why?

In this country, we need permission to forgo CPR. If there are no advanced directives or next of kin available to discuss end-of-life care, performing CPR is the default status for all hospitalized patients, irrespective of the underlying severity of the illness. A unilateral DNR order written by a physician in good conscience (in a medically futile situation), but to which the patient has not consented, is generally invalid in most U.S. states. If health directives are not available, CPR will be administered on the presumption that the patient would want us to “do everything we can.” The medicolegal consequences and fear of not administering CPR is more profound than being found wrong and defying a patient’s wishes against CPR.

In patients with outside-hospital cardiac arrest, especially if related to ventricular fibrillation, early bystander CPR improves the survival rate. Hence, it makes sense for first responders and paramedics to administer CPR as the default option, focusing on the technique, rather than thinking about its utility based on the patient’s underlying comorbidities.

In the inpatient setting, however, physicians have enough information to comprehensively evaluate the patient. In a cohort of 5,690 critically ill ICU patients, obtained from a U.S. registry, the rate of survival to discharge after inpatient cardiac arrest is very low at 12.5%. Chronic health conditions, malignancy, end-stage renal disease, multiorgan dysfunction, need for vasopressor support, prior CPR, initial rhythm of asystole, or PEA advanced age were all associated with a less than 10% survival rate after CPR.

Dying is a process. Administering CPR to a dying patient is of little to no value. For Mr. Barry, it resulted in a bruised chest and broken ribs. James R. Jude, MD, one of the pioneers of closed chest compression, or modern-day CPR, wrote in 1965 that “resuscitation of the dying patient with irreparable damage to lungs, heart, kidneys, brain or any other vital system of the body has no medical, ethical, or moral justification. The techniques described in this monograph were designed to resuscitate the victim of acute insult, whether be it from drowning, electrical shock, untoward effect of drugs, anesthetic accident, heart block, acute myocardial infarction, or surgery.”

Yet, doctors continue to provide futile treatments at end of life for a variety of reasons: concerns about medico-legal risks, discomfort or inexperience with death and dying, uncertainty in prognostication, family requests, and organizational barriers such as lack of palliative services that can help lead end-of-life care discussions. Despite knowing that CPR has little benefit in critically ill patients with terminal illness and multiorgan dysfunction, we often ask the patient and their surrogate decision-makers: “If your heart stops, do you want us to restore your heart by pressing on the chest and giving electric shocks?” The very act of asking the question implies that CPR may be beneficial. We often do not go over the risks or offer an opinion on whether CPR should be performed. We take a neutral stance.

Anoxic brain injury, pain from broken ribs, and low likelihood of survival to discharge with acceptable neurologic recovery are rarely discussed in detail. Laypeople may overestimate the chances of survival after CPR and they may not comprehend that it does not reverse the dying process in patients with a terminal illness. When you ask about CPR, most families hear: “Do you want your loved one to live?” and the answer is nearly always “Yes.” We then administer CPR, thinking that we are respecting the patient’s autonomy in the medical decision-making process. However, in end-of-life care, elderly patients or surrogates may not fully understand the complexities involved or the outcomes of CPR. So, are we truly respecting their autonomy?
 

When to offer CPR?

In 2011, Billings and Krakauer, palliative care specialists from Massachusetts General Hospital, Boston, suggested that we focus on understanding our patient’s values and goals of care, and then decide whether to offer CPR, rather than taking a neutral stance. With this approach, we continue to respect the patient’s autonomy and also affirm our responsibility in providing care consistent with medical reality. We need to have the humility to accept that death is inevitable. Taking care of the dying to ensure a peaceful and dignified death is as much our moral and ethical responsibility as respecting a patient’s autonomy.

It has been 10 years since a group of physicians from Columbia University Medical Center, Harvard Medical School, MGH, and Boston Children’s Hospital proposed changes to how we determine resuscitation status. Instead of assuming that CPR is always wanted, they suggested three distinct approaches: consider CPR when the benefits versus risks are uncertain, and the patient is not end stage; recommend against CPR when there is a low likelihood of benefit and high likelihood of harm (e.g., patients with anoxic brain injury, advanced incurable cancer, or end-stage multiorgan dysfunction); and do not offer CPR to patients who will die imminently and have no chance of surviving CPR (e.g., patients with multiorgan dysfunction, increasing pressor requirements, and those who are actively dying without a single immediately reversible cause). I agree with their proposal.

Mr. Barry was actively dying. Unfortunately, we had neither his advanced directives nor access to family members or surrogates to discuss values and goals of care. Given the futility of administering CPR again, and based on our humanitarian principles, a moral and ethical responsibility to ensure a peaceful dying process, I and another ICU attending placed the DNR order. He passed away, peacefully, within a few hours.

That evening, as I was sitting on my porch reading the last page of “The Snows of Kilimanjaro,” my phone pinged. It was an email asking me to complete the final attestation for the death certificate. I imagined that Mr. Barry knew where he was going. He probably had his own special place – something beautiful and majestic, great and tall, dazzlingly white in the hot sun, like the snow-capped mountain of Kilimanjaro that Harry saw at the time of his death.

Dr. Mallidi is a general cardiologist at Zuckerberg San Francisco General Hospital, UCSF. He disclosed no relevant financial relationships.

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

Some details have been changed to protect the patient’s identity.

The first thing I noticed about Mr. Barry as I entered the intensive care unit was his left foot: Half of it was black, shriveled, and gangrenous, jutting out from under the white blanket. The soft rays of the morning sun illuminated his gaunt, unshaven, hollow cheeks. Sedated on propofol, with a green endotracheal tube sticking out of his chapped lips, he looked frail. His nurse, Becky, had just cleaned him after he passed tarry, maroon-colored stool. As she turned him over, I saw that the skin over his tailbone was broken. He had a large decubitus ulcer, the edges of which were now dried and black. The Foley bag, hanging next to his bed, was empty; there had been no urine for several hours now.

No one knew much about Mr. Barry. I don’t mean his current medical status – I mean what he did in life, who he loved, whether he had kids, what he valued. All we knew was that he was 83 years old and lived alone. No prior records in our system. No advanced directives. No information on any family. One of his neighbors called 911 after he was not seen for at least 10 days. Emergency medical services found Mr. Barry in bed, nearly lifeless. In the emergency room, he was noted to be in shock, with a dangerously low blood pressure. He was dry as a bone with markedly elevated sodium levels. His laboratory makers for kidney and liver function were deranged. He was admitted to the medical ICU with a diagnosis of hypovolemic shock and/or septic shock with multiorgan dysfunction. With 48 hours of supportive management with intravenous fluids and antibiotics, he did not improve. Blood cultures were positive for gram-positive cocci. The doses for medications used to maintain the blood pressure increased steadily. He also developed gastrointestinal bleeding.
 

Futile vs. potentially inappropriate

I was called for a cardiology consult because he had transient ST elevation in inferolateral leads on the monitor. Given his clinical scenario, the likelihood of type 1 myocardial infarction from plaque rupture was low; the ST elevations were probably related to vasospasm from increasing pressor requirement. Diagnostic cardiac catheterization showed clean coronary arteries. Continuous renal replacement therapy was soon started. Given Mr Barry’s multiorgan dysfunction and extremely poor prognosis, I recommended making all efforts to find his family or surrogate decision-maker to discuss goals of care or having a two-physician sign-off to place a DNR order.

Despite all efforts, we could not trace the family. We physicians vary individually on how we define value as related to life. We also vary on the degree of uncertainty about prognostication that we are comfortable with. This is one of the reasons the term “futility” is controversial and there is a push to use “potentially inappropriate” instead. The primary team had a different threshold for placing a DNR order and did not do it. That night, after I left the hospital, Mr Barry had a PEA (pulseless electrical activity) arrest and was resuscitated after 10 minutes of CPR. The next day, I noticed his bruised chest. He was on multiple medications to support his blood pressure.
 

My patient and a Hemingway protagonist

Whether by coincidence or irony, I started reading Ernest Hemingway’s short story “The Snows of Kilimanjaro” the same day that I met Mr. Barry. He reminded me of the story’s protagonist, Harry, lying on the cot with a gangrenous leg, waiting to die. Harry could sense death approaching. He reminisced about his past. All he wanted was to drink his “whiskey-soda.” “Darling, don’t drink that. We have to do everything we can,” his wife said. “You do it. I am tired,” Harry said, and continued to drink his whiskey-soda.

Mr. Barry looked tired. Tired of life? I can’t say with certainty. However, if I had to guess, the medical team’s heroics meant nothing to him. Unfortunately, he was not awake like Harry and could not do what he wished. I wondered what snippets of his life flashed before him as he lay on his bed at home for days. Did he want to have a whiskey-soda before dying? But we are not letting him die. Not easily anyway. We have to do everything we can: medications, coronary angiogram, dialysis, multiple rounds of CPR. Why?

In this country, we need permission to forgo CPR. If there are no advanced directives or next of kin available to discuss end-of-life care, performing CPR is the default status for all hospitalized patients, irrespective of the underlying severity of the illness. A unilateral DNR order written by a physician in good conscience (in a medically futile situation), but to which the patient has not consented, is generally invalid in most U.S. states. If health directives are not available, CPR will be administered on the presumption that the patient would want us to “do everything we can.” The medicolegal consequences and fear of not administering CPR is more profound than being found wrong and defying a patient’s wishes against CPR.

In patients with outside-hospital cardiac arrest, especially if related to ventricular fibrillation, early bystander CPR improves the survival rate. Hence, it makes sense for first responders and paramedics to administer CPR as the default option, focusing on the technique, rather than thinking about its utility based on the patient’s underlying comorbidities.

In the inpatient setting, however, physicians have enough information to comprehensively evaluate the patient. In a cohort of 5,690 critically ill ICU patients, obtained from a U.S. registry, the rate of survival to discharge after inpatient cardiac arrest is very low at 12.5%. Chronic health conditions, malignancy, end-stage renal disease, multiorgan dysfunction, need for vasopressor support, prior CPR, initial rhythm of asystole, or PEA advanced age were all associated with a less than 10% survival rate after CPR.

Dying is a process. Administering CPR to a dying patient is of little to no value. For Mr. Barry, it resulted in a bruised chest and broken ribs. James R. Jude, MD, one of the pioneers of closed chest compression, or modern-day CPR, wrote in 1965 that “resuscitation of the dying patient with irreparable damage to lungs, heart, kidneys, brain or any other vital system of the body has no medical, ethical, or moral justification. The techniques described in this monograph were designed to resuscitate the victim of acute insult, whether be it from drowning, electrical shock, untoward effect of drugs, anesthetic accident, heart block, acute myocardial infarction, or surgery.”

Yet, doctors continue to provide futile treatments at end of life for a variety of reasons: concerns about medico-legal risks, discomfort or inexperience with death and dying, uncertainty in prognostication, family requests, and organizational barriers such as lack of palliative services that can help lead end-of-life care discussions. Despite knowing that CPR has little benefit in critically ill patients with terminal illness and multiorgan dysfunction, we often ask the patient and their surrogate decision-makers: “If your heart stops, do you want us to restore your heart by pressing on the chest and giving electric shocks?” The very act of asking the question implies that CPR may be beneficial. We often do not go over the risks or offer an opinion on whether CPR should be performed. We take a neutral stance.

Anoxic brain injury, pain from broken ribs, and low likelihood of survival to discharge with acceptable neurologic recovery are rarely discussed in detail. Laypeople may overestimate the chances of survival after CPR and they may not comprehend that it does not reverse the dying process in patients with a terminal illness. When you ask about CPR, most families hear: “Do you want your loved one to live?” and the answer is nearly always “Yes.” We then administer CPR, thinking that we are respecting the patient’s autonomy in the medical decision-making process. However, in end-of-life care, elderly patients or surrogates may not fully understand the complexities involved or the outcomes of CPR. So, are we truly respecting their autonomy?
 

When to offer CPR?

In 2011, Billings and Krakauer, palliative care specialists from Massachusetts General Hospital, Boston, suggested that we focus on understanding our patient’s values and goals of care, and then decide whether to offer CPR, rather than taking a neutral stance. With this approach, we continue to respect the patient’s autonomy and also affirm our responsibility in providing care consistent with medical reality. We need to have the humility to accept that death is inevitable. Taking care of the dying to ensure a peaceful and dignified death is as much our moral and ethical responsibility as respecting a patient’s autonomy.

It has been 10 years since a group of physicians from Columbia University Medical Center, Harvard Medical School, MGH, and Boston Children’s Hospital proposed changes to how we determine resuscitation status. Instead of assuming that CPR is always wanted, they suggested three distinct approaches: consider CPR when the benefits versus risks are uncertain, and the patient is not end stage; recommend against CPR when there is a low likelihood of benefit and high likelihood of harm (e.g., patients with anoxic brain injury, advanced incurable cancer, or end-stage multiorgan dysfunction); and do not offer CPR to patients who will die imminently and have no chance of surviving CPR (e.g., patients with multiorgan dysfunction, increasing pressor requirements, and those who are actively dying without a single immediately reversible cause). I agree with their proposal.

Mr. Barry was actively dying. Unfortunately, we had neither his advanced directives nor access to family members or surrogates to discuss values and goals of care. Given the futility of administering CPR again, and based on our humanitarian principles, a moral and ethical responsibility to ensure a peaceful dying process, I and another ICU attending placed the DNR order. He passed away, peacefully, within a few hours.

That evening, as I was sitting on my porch reading the last page of “The Snows of Kilimanjaro,” my phone pinged. It was an email asking me to complete the final attestation for the death certificate. I imagined that Mr. Barry knew where he was going. He probably had his own special place – something beautiful and majestic, great and tall, dazzlingly white in the hot sun, like the snow-capped mountain of Kilimanjaro that Harry saw at the time of his death.

Dr. Mallidi is a general cardiologist at Zuckerberg San Francisco General Hospital, UCSF. He disclosed no relevant financial relationships.

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

Some details have been changed to protect the patient’s identity.

The first thing I noticed about Mr. Barry as I entered the intensive care unit was his left foot: Half of it was black, shriveled, and gangrenous, jutting out from under the white blanket. The soft rays of the morning sun illuminated his gaunt, unshaven, hollow cheeks. Sedated on propofol, with a green endotracheal tube sticking out of his chapped lips, he looked frail. His nurse, Becky, had just cleaned him after he passed tarry, maroon-colored stool. As she turned him over, I saw that the skin over his tailbone was broken. He had a large decubitus ulcer, the edges of which were now dried and black. The Foley bag, hanging next to his bed, was empty; there had been no urine for several hours now.

No one knew much about Mr. Barry. I don’t mean his current medical status – I mean what he did in life, who he loved, whether he had kids, what he valued. All we knew was that he was 83 years old and lived alone. No prior records in our system. No advanced directives. No information on any family. One of his neighbors called 911 after he was not seen for at least 10 days. Emergency medical services found Mr. Barry in bed, nearly lifeless. In the emergency room, he was noted to be in shock, with a dangerously low blood pressure. He was dry as a bone with markedly elevated sodium levels. His laboratory makers for kidney and liver function were deranged. He was admitted to the medical ICU with a diagnosis of hypovolemic shock and/or septic shock with multiorgan dysfunction. With 48 hours of supportive management with intravenous fluids and antibiotics, he did not improve. Blood cultures were positive for gram-positive cocci. The doses for medications used to maintain the blood pressure increased steadily. He also developed gastrointestinal bleeding.
 

Futile vs. potentially inappropriate

I was called for a cardiology consult because he had transient ST elevation in inferolateral leads on the monitor. Given his clinical scenario, the likelihood of type 1 myocardial infarction from plaque rupture was low; the ST elevations were probably related to vasospasm from increasing pressor requirement. Diagnostic cardiac catheterization showed clean coronary arteries. Continuous renal replacement therapy was soon started. Given Mr Barry’s multiorgan dysfunction and extremely poor prognosis, I recommended making all efforts to find his family or surrogate decision-maker to discuss goals of care or having a two-physician sign-off to place a DNR order.

Despite all efforts, we could not trace the family. We physicians vary individually on how we define value as related to life. We also vary on the degree of uncertainty about prognostication that we are comfortable with. This is one of the reasons the term “futility” is controversial and there is a push to use “potentially inappropriate” instead. The primary team had a different threshold for placing a DNR order and did not do it. That night, after I left the hospital, Mr Barry had a PEA (pulseless electrical activity) arrest and was resuscitated after 10 minutes of CPR. The next day, I noticed his bruised chest. He was on multiple medications to support his blood pressure.
 

My patient and a Hemingway protagonist

Whether by coincidence or irony, I started reading Ernest Hemingway’s short story “The Snows of Kilimanjaro” the same day that I met Mr. Barry. He reminded me of the story’s protagonist, Harry, lying on the cot with a gangrenous leg, waiting to die. Harry could sense death approaching. He reminisced about his past. All he wanted was to drink his “whiskey-soda.” “Darling, don’t drink that. We have to do everything we can,” his wife said. “You do it. I am tired,” Harry said, and continued to drink his whiskey-soda.

Mr. Barry looked tired. Tired of life? I can’t say with certainty. However, if I had to guess, the medical team’s heroics meant nothing to him. Unfortunately, he was not awake like Harry and could not do what he wished. I wondered what snippets of his life flashed before him as he lay on his bed at home for days. Did he want to have a whiskey-soda before dying? But we are not letting him die. Not easily anyway. We have to do everything we can: medications, coronary angiogram, dialysis, multiple rounds of CPR. Why?

In this country, we need permission to forgo CPR. If there are no advanced directives or next of kin available to discuss end-of-life care, performing CPR is the default status for all hospitalized patients, irrespective of the underlying severity of the illness. A unilateral DNR order written by a physician in good conscience (in a medically futile situation), but to which the patient has not consented, is generally invalid in most U.S. states. If health directives are not available, CPR will be administered on the presumption that the patient would want us to “do everything we can.” The medicolegal consequences and fear of not administering CPR is more profound than being found wrong and defying a patient’s wishes against CPR.

In patients with outside-hospital cardiac arrest, especially if related to ventricular fibrillation, early bystander CPR improves the survival rate. Hence, it makes sense for first responders and paramedics to administer CPR as the default option, focusing on the technique, rather than thinking about its utility based on the patient’s underlying comorbidities.

In the inpatient setting, however, physicians have enough information to comprehensively evaluate the patient. In a cohort of 5,690 critically ill ICU patients, obtained from a U.S. registry, the rate of survival to discharge after inpatient cardiac arrest is very low at 12.5%. Chronic health conditions, malignancy, end-stage renal disease, multiorgan dysfunction, need for vasopressor support, prior CPR, initial rhythm of asystole, or PEA advanced age were all associated with a less than 10% survival rate after CPR.

Dying is a process. Administering CPR to a dying patient is of little to no value. For Mr. Barry, it resulted in a bruised chest and broken ribs. James R. Jude, MD, one of the pioneers of closed chest compression, or modern-day CPR, wrote in 1965 that “resuscitation of the dying patient with irreparable damage to lungs, heart, kidneys, brain or any other vital system of the body has no medical, ethical, or moral justification. The techniques described in this monograph were designed to resuscitate the victim of acute insult, whether be it from drowning, electrical shock, untoward effect of drugs, anesthetic accident, heart block, acute myocardial infarction, or surgery.”

Yet, doctors continue to provide futile treatments at end of life for a variety of reasons: concerns about medico-legal risks, discomfort or inexperience with death and dying, uncertainty in prognostication, family requests, and organizational barriers such as lack of palliative services that can help lead end-of-life care discussions. Despite knowing that CPR has little benefit in critically ill patients with terminal illness and multiorgan dysfunction, we often ask the patient and their surrogate decision-makers: “If your heart stops, do you want us to restore your heart by pressing on the chest and giving electric shocks?” The very act of asking the question implies that CPR may be beneficial. We often do not go over the risks or offer an opinion on whether CPR should be performed. We take a neutral stance.

Anoxic brain injury, pain from broken ribs, and low likelihood of survival to discharge with acceptable neurologic recovery are rarely discussed in detail. Laypeople may overestimate the chances of survival after CPR and they may not comprehend that it does not reverse the dying process in patients with a terminal illness. When you ask about CPR, most families hear: “Do you want your loved one to live?” and the answer is nearly always “Yes.” We then administer CPR, thinking that we are respecting the patient’s autonomy in the medical decision-making process. However, in end-of-life care, elderly patients or surrogates may not fully understand the complexities involved or the outcomes of CPR. So, are we truly respecting their autonomy?
 

When to offer CPR?

In 2011, Billings and Krakauer, palliative care specialists from Massachusetts General Hospital, Boston, suggested that we focus on understanding our patient’s values and goals of care, and then decide whether to offer CPR, rather than taking a neutral stance. With this approach, we continue to respect the patient’s autonomy and also affirm our responsibility in providing care consistent with medical reality. We need to have the humility to accept that death is inevitable. Taking care of the dying to ensure a peaceful and dignified death is as much our moral and ethical responsibility as respecting a patient’s autonomy.

It has been 10 years since a group of physicians from Columbia University Medical Center, Harvard Medical School, MGH, and Boston Children’s Hospital proposed changes to how we determine resuscitation status. Instead of assuming that CPR is always wanted, they suggested three distinct approaches: consider CPR when the benefits versus risks are uncertain, and the patient is not end stage; recommend against CPR when there is a low likelihood of benefit and high likelihood of harm (e.g., patients with anoxic brain injury, advanced incurable cancer, or end-stage multiorgan dysfunction); and do not offer CPR to patients who will die imminently and have no chance of surviving CPR (e.g., patients with multiorgan dysfunction, increasing pressor requirements, and those who are actively dying without a single immediately reversible cause). I agree with their proposal.

Mr. Barry was actively dying. Unfortunately, we had neither his advanced directives nor access to family members or surrogates to discuss values and goals of care. Given the futility of administering CPR again, and based on our humanitarian principles, a moral and ethical responsibility to ensure a peaceful dying process, I and another ICU attending placed the DNR order. He passed away, peacefully, within a few hours.

That evening, as I was sitting on my porch reading the last page of “The Snows of Kilimanjaro,” my phone pinged. It was an email asking me to complete the final attestation for the death certificate. I imagined that Mr. Barry knew where he was going. He probably had his own special place – something beautiful and majestic, great and tall, dazzlingly white in the hot sun, like the snow-capped mountain of Kilimanjaro that Harry saw at the time of his death.

Dr. Mallidi is a general cardiologist at Zuckerberg San Francisco General Hospital, UCSF. He disclosed no relevant financial relationships.

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