Critical Care

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

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

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

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

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

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

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

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

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

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

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

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

The prosecution concluded its case on Oct. 13 against a nurse from Chester who is on trial for the murder of seven babies and the attempted murder of another 10 babies under her care. Lucy Letby, 32, who worked at the Countess of Chester Hospital, is accused of multiple baby murders in the hospital’s neonatal unit from June 2015 to June 2016. She denies all charges.

Manchester Crown Court heard how Ms. Letby allegedly attempted to kill the children by injecting them with air, milk, or insulin, including two brothers from a set of triplets and one premature baby girl, who was only 98 minutes old.

Prosecutor Nicholas Johnson KC said the circumstances of the girl’s death were “an extreme example even by the standards of this case.”

“There were four separate occasions on which we allege Lucy Letby tried to kill her,” he said. “But ultimately at the fourth attempt, Lucy Letby succeeded in killing her.”
 

Attempts to murder the child ‘cold-blooded’ and ‘calculated’, says prosecutor

In the first alleged attempt, Ms. Letby injected the girl, identified for legal reasons as Child I, with air, but she was “resilient,” said Mr. Johnson. After the second attempt, Ms. Letby had stood in the doorway of Child I’s darkened room and commented that she looked pale. The designated nurse then approached and turned on the light, noticing that the child wasn’t breathing. After a third attempt the child was found to have excess air in her stomach, which had affected her breathing. Child I was then transferred to Arrowe Park Hospital, where she was stabilized before she was returned to Chester.

After the fourth attempt, Child I’s medical alarm rang, leading a nurse to spot Ms. Letby by the child’s incubator. Child I died that morning, said Mr. Johnson, who described the nurse’s attacks as premeditated. “It was persistent, it was calculated, and it was cold-blooded.”

The judge, Mr. Justice Goss, and jury heard how shortly after the parents were told of their child’s death, Ms. Letby approached the mother, who testified that the nurse was “smiling and kept going on about how she was present at the baby’s first bath and how much the baby had loved it.” She also sent a sympathy card to the parents, and the prosecutor says she kept an image of the card on her phone.
 

Doctor interrupted another alleged attempt

Dr. Ravi Jayaram, a paediatric consultant, had become suspicious of Ms. Letby in a number of unexplained child deaths. He later interrupted her as she allegedly tried to kill another baby, identified as Child K. He noticed that the nurse was alone with the baby and walked into the room, seeing Ms. Letby standing over the child’s incubator. He was “uncomfortable” as he had “started to notice a coincidence between unexplained deaths, serious collapses, and the presence of Lucy Letby,” said the prosecutor.

“Dr. Jayaram could see from the monitor on the wall that Child K’s oxygen saturation level was falling dangerously low, to somewhere in the 80s,” said Mr. Johnson. “He said an alarm should have been sounding as Child K’s oxygen levels were falling.” Despite this, the nurse had not called for assistance.

“We allege she was trying to kill Child K when Dr. Jayaram walked in,” Mr. Johnson said, adding that the child’s breathing tube was found dislodged. The prosecutor said it was possible for this to happen in an active baby, but Child K was very premature and had been sedated.

Despite his concerns, Dr. Jayaram did not make a note of his suspicions. Later that morning, Ms. Letby was again at Child K’s incubator calling for help. The nurse was assisting the baby with her breathing and the breathing tube was found to have slipped too far into her throat. The child was transferred to another hospital but later died. Ms. Letby is not accused of Child K’s murder.

However, after the death of Child K, Ms. Letby was moved to day shifts “because the consultants were concerned about the correlation between her presence and unexpected deaths and life-threatening episodes on the night shifts,” said Mr. Johnson. She was removed from the neonatal ward in June 2016 and moved to clerical duties where she would not come into contact with children.
 

Post-it note: Admission or anguish?

At the end of the prosecution’s presentation, Mr. Johnson mentioned a Post-it on which Ms. Letby had written, “I AM EVIL I DID THIS.” In the defense’s opening statements, Ben Myers KC, said the note was an “anguished outpouring of a young woman in fear and despair when she realises the enormity of what’s being said about her, in a moment to herself.”

He added that the nurse was dealing with employment issues at the time it was written, including a grievance procedure with the NHS Trust where she worked. Another note was shown on screens to the jury, which read: “Not good enough. I’m an awful person. I will never have children or marry. Despair.” and “I haven’t done anything wrong.”

Mr. Myers said that Ms. Letby was the type of person who often scribbles things down and the note was “nothing more extraordinary than that.”

In presenting the defense case, Mr. Myers argued that there was no evidence of Letby hurting the children, and that the prosecution’s case was “driven by the assumption that someone was doing deliberate harm” and that this was combined with “coincidence on certain occasions of Miss Letby’s presence.”

“What it isn’t driven by is evidence of Miss Letby actually doing what is alleged against her,” he added.

“There is a real danger that people will simply accept the prosecution theory of guilt, and that’s all we have so far,” Mr. Myers said. “A theory of guilt based firmly on coincidence – if anything can be based firmly on coincidence.”

A version of this article first appeared on Medscape UK.

The prosecution concluded its case on Oct. 13 against a nurse from Chester who is on trial for the murder of seven babies and the attempted murder of another 10 babies under her care. Lucy Letby, 32, who worked at the Countess of Chester Hospital, is accused of multiple baby murders in the hospital’s neonatal unit from June 2015 to June 2016. She denies all charges.

Manchester Crown Court heard how Ms. Letby allegedly attempted to kill the children by injecting them with air, milk, or insulin, including two brothers from a set of triplets and one premature baby girl, who was only 98 minutes old.

Prosecutor Nicholas Johnson KC said the circumstances of the girl’s death were “an extreme example even by the standards of this case.”

“There were four separate occasions on which we allege Lucy Letby tried to kill her,” he said. “But ultimately at the fourth attempt, Lucy Letby succeeded in killing her.”
 

Attempts to murder the child ‘cold-blooded’ and ‘calculated’, says prosecutor

In the first alleged attempt, Ms. Letby injected the girl, identified for legal reasons as Child I, with air, but she was “resilient,” said Mr. Johnson. After the second attempt, Ms. Letby had stood in the doorway of Child I’s darkened room and commented that she looked pale. The designated nurse then approached and turned on the light, noticing that the child wasn’t breathing. After a third attempt the child was found to have excess air in her stomach, which had affected her breathing. Child I was then transferred to Arrowe Park Hospital, where she was stabilized before she was returned to Chester.

After the fourth attempt, Child I’s medical alarm rang, leading a nurse to spot Ms. Letby by the child’s incubator. Child I died that morning, said Mr. Johnson, who described the nurse’s attacks as premeditated. “It was persistent, it was calculated, and it was cold-blooded.”

The judge, Mr. Justice Goss, and jury heard how shortly after the parents were told of their child’s death, Ms. Letby approached the mother, who testified that the nurse was “smiling and kept going on about how she was present at the baby’s first bath and how much the baby had loved it.” She also sent a sympathy card to the parents, and the prosecutor says she kept an image of the card on her phone.
 

Doctor interrupted another alleged attempt

Dr. Ravi Jayaram, a paediatric consultant, had become suspicious of Ms. Letby in a number of unexplained child deaths. He later interrupted her as she allegedly tried to kill another baby, identified as Child K. He noticed that the nurse was alone with the baby and walked into the room, seeing Ms. Letby standing over the child’s incubator. He was “uncomfortable” as he had “started to notice a coincidence between unexplained deaths, serious collapses, and the presence of Lucy Letby,” said the prosecutor.

“Dr. Jayaram could see from the monitor on the wall that Child K’s oxygen saturation level was falling dangerously low, to somewhere in the 80s,” said Mr. Johnson. “He said an alarm should have been sounding as Child K’s oxygen levels were falling.” Despite this, the nurse had not called for assistance.

“We allege she was trying to kill Child K when Dr. Jayaram walked in,” Mr. Johnson said, adding that the child’s breathing tube was found dislodged. The prosecutor said it was possible for this to happen in an active baby, but Child K was very premature and had been sedated.

Despite his concerns, Dr. Jayaram did not make a note of his suspicions. Later that morning, Ms. Letby was again at Child K’s incubator calling for help. The nurse was assisting the baby with her breathing and the breathing tube was found to have slipped too far into her throat. The child was transferred to another hospital but later died. Ms. Letby is not accused of Child K’s murder.

However, after the death of Child K, Ms. Letby was moved to day shifts “because the consultants were concerned about the correlation between her presence and unexpected deaths and life-threatening episodes on the night shifts,” said Mr. Johnson. She was removed from the neonatal ward in June 2016 and moved to clerical duties where she would not come into contact with children.
 

Post-it note: Admission or anguish?

At the end of the prosecution’s presentation, Mr. Johnson mentioned a Post-it on which Ms. Letby had written, “I AM EVIL I DID THIS.” In the defense’s opening statements, Ben Myers KC, said the note was an “anguished outpouring of a young woman in fear and despair when she realises the enormity of what’s being said about her, in a moment to herself.”

He added that the nurse was dealing with employment issues at the time it was written, including a grievance procedure with the NHS Trust where she worked. Another note was shown on screens to the jury, which read: “Not good enough. I’m an awful person. I will never have children or marry. Despair.” and “I haven’t done anything wrong.”

Mr. Myers said that Ms. Letby was the type of person who often scribbles things down and the note was “nothing more extraordinary than that.”

In presenting the defense case, Mr. Myers argued that there was no evidence of Letby hurting the children, and that the prosecution’s case was “driven by the assumption that someone was doing deliberate harm” and that this was combined with “coincidence on certain occasions of Miss Letby’s presence.”

“What it isn’t driven by is evidence of Miss Letby actually doing what is alleged against her,” he added.

“There is a real danger that people will simply accept the prosecution theory of guilt, and that’s all we have so far,” Mr. Myers said. “A theory of guilt based firmly on coincidence – if anything can be based firmly on coincidence.”

A version of this article first appeared on Medscape UK.

The prosecution concluded its case on Oct. 13 against a nurse from Chester who is on trial for the murder of seven babies and the attempted murder of another 10 babies under her care. Lucy Letby, 32, who worked at the Countess of Chester Hospital, is accused of multiple baby murders in the hospital’s neonatal unit from June 2015 to June 2016. She denies all charges.

Manchester Crown Court heard how Ms. Letby allegedly attempted to kill the children by injecting them with air, milk, or insulin, including two brothers from a set of triplets and one premature baby girl, who was only 98 minutes old.

Prosecutor Nicholas Johnson KC said the circumstances of the girl’s death were “an extreme example even by the standards of this case.”

“There were four separate occasions on which we allege Lucy Letby tried to kill her,” he said. “But ultimately at the fourth attempt, Lucy Letby succeeded in killing her.”
 

Attempts to murder the child ‘cold-blooded’ and ‘calculated’, says prosecutor

In the first alleged attempt, Ms. Letby injected the girl, identified for legal reasons as Child I, with air, but she was “resilient,” said Mr. Johnson. After the second attempt, Ms. Letby had stood in the doorway of Child I’s darkened room and commented that she looked pale. The designated nurse then approached and turned on the light, noticing that the child wasn’t breathing. After a third attempt the child was found to have excess air in her stomach, which had affected her breathing. Child I was then transferred to Arrowe Park Hospital, where she was stabilized before she was returned to Chester.

After the fourth attempt, Child I’s medical alarm rang, leading a nurse to spot Ms. Letby by the child’s incubator. Child I died that morning, said Mr. Johnson, who described the nurse’s attacks as premeditated. “It was persistent, it was calculated, and it was cold-blooded.”

The judge, Mr. Justice Goss, and jury heard how shortly after the parents were told of their child’s death, Ms. Letby approached the mother, who testified that the nurse was “smiling and kept going on about how she was present at the baby’s first bath and how much the baby had loved it.” She also sent a sympathy card to the parents, and the prosecutor says she kept an image of the card on her phone.
 

Doctor interrupted another alleged attempt

Dr. Ravi Jayaram, a paediatric consultant, had become suspicious of Ms. Letby in a number of unexplained child deaths. He later interrupted her as she allegedly tried to kill another baby, identified as Child K. He noticed that the nurse was alone with the baby and walked into the room, seeing Ms. Letby standing over the child’s incubator. He was “uncomfortable” as he had “started to notice a coincidence between unexplained deaths, serious collapses, and the presence of Lucy Letby,” said the prosecutor.

“Dr. Jayaram could see from the monitor on the wall that Child K’s oxygen saturation level was falling dangerously low, to somewhere in the 80s,” said Mr. Johnson. “He said an alarm should have been sounding as Child K’s oxygen levels were falling.” Despite this, the nurse had not called for assistance.

“We allege she was trying to kill Child K when Dr. Jayaram walked in,” Mr. Johnson said, adding that the child’s breathing tube was found dislodged. The prosecutor said it was possible for this to happen in an active baby, but Child K was very premature and had been sedated.

Despite his concerns, Dr. Jayaram did not make a note of his suspicions. Later that morning, Ms. Letby was again at Child K’s incubator calling for help. The nurse was assisting the baby with her breathing and the breathing tube was found to have slipped too far into her throat. The child was transferred to another hospital but later died. Ms. Letby is not accused of Child K’s murder.

However, after the death of Child K, Ms. Letby was moved to day shifts “because the consultants were concerned about the correlation between her presence and unexpected deaths and life-threatening episodes on the night shifts,” said Mr. Johnson. She was removed from the neonatal ward in June 2016 and moved to clerical duties where she would not come into contact with children.
 

Post-it note: Admission or anguish?

At the end of the prosecution’s presentation, Mr. Johnson mentioned a Post-it on which Ms. Letby had written, “I AM EVIL I DID THIS.” In the defense’s opening statements, Ben Myers KC, said the note was an “anguished outpouring of a young woman in fear and despair when she realises the enormity of what’s being said about her, in a moment to herself.”

He added that the nurse was dealing with employment issues at the time it was written, including a grievance procedure with the NHS Trust where she worked. Another note was shown on screens to the jury, which read: “Not good enough. I’m an awful person. I will never have children or marry. Despair.” and “I haven’t done anything wrong.”

Mr. Myers said that Ms. Letby was the type of person who often scribbles things down and the note was “nothing more extraordinary than that.”

In presenting the defense case, Mr. Myers argued that there was no evidence of Letby hurting the children, and that the prosecution’s case was “driven by the assumption that someone was doing deliberate harm” and that this was combined with “coincidence on certain occasions of Miss Letby’s presence.”

“What it isn’t driven by is evidence of Miss Letby actually doing what is alleged against her,” he added.

“There is a real danger that people will simply accept the prosecution theory of guilt, and that’s all we have so far,” Mr. Myers said. “A theory of guilt based firmly on coincidence – if anything can be based firmly on coincidence.”

A version of this article first appeared on Medscape UK.

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

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

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

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

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

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

Intensive care telemedicine was first described in 1982 after implementation in a seven-bed, inner-city ICU using 19-inch television screens connected with intensivists at the University Hospitals of Cleveland (Grundy, et al. Crit Care Med. 1982;10[7]:471). After this proof-of-concept report, however, ICU telemedicine gained little traction for nearly 20 years, until Johns Hopkins Hospital established a continuously monitored ICU telemedicine service in a nonintensivist staffed surgical ICU. Their pre/post analysis suggested a 64% decrease in severity-adjusted ICU mortality and greater than 30% decrease in ICU length of stay, ICU complications, and costs (Rosenfeld, et al. Crit Care Med. 2000;28[12]:3925).

Along with better and less costly telemedicine technology, rapid adoption of electronic medical records, and a nationwide intensivist shortage, this and other evidence for the service’s clinical and cost effectiveness has spurred explosive growth in ICU telemedicine in the succeeding 2 decades, with at least 18% of hospitals and 28% of ICU beds supported by ICU telemedicine by 2018 (Ofoma, et al. Crit Care Explor. 2021;4[3]:e0468).

Importantly, what “ICU telemedicine” represents varies substantially across hospitals and even across ICUs within systems. Two-way audiovisual technology is the defining feature, and at a minimum, programs provide intensivists and/or nurses who respond to consultation requests. Commonly, telemedicine clinicians directly connect with patients; monitor labs, hemodynamics, and alarms; and proactively contact on-site clinicians with recommendations or place orders directly into the electronic health record depending on whether the clinician acts as the patients’ primary, co-managing, or consultant provider. A centralized hub and spoke model with telemedicine personnel located at a single, remote center is the most common and best studied ICU telemedicine design. Additional staffing may include respiratory therapists, pharmacists, and advanced practice clinicians in coverage models that range from 24/7 to nocturnal and can also differ in whether patients are monitored continuously or on an as needed basis, triggered by alarms or clinician/nursing concerns.

On-demand services may extend to support for teams responding to medical emergencies inside and sometimes outside the ICU. Another equally important role that ICU telemedicine can provide is helping ensure facilities adhere to ICU quality metrics, such as ventilator bundles, DVT prophylaxis, and daily SAT/SBT.

Unsurprisingly, integrating ICU telemedicine into an existing system is very costly and complex, requiring substantial and thoughtful process redesign to maximize fiscal and clinical return on investment. One vendor of proprietary telemedicine technology, Philips eICU, estimates an implementation cost of $50,000 to $100,000 per bed with annual overhead, software maintenance, and IT staffing of ~20% of implementation costs in addition to clinician staffing of $1-2 million per 100 beds. However, some (but not all) evidence suggests that ICU telemedicine programs pay for themselves over time. An influential report from Sentara Healthcare, an early adopter of ICU telemedicine, described equipment costs of more than $1 million for a total of 103 critical care beds but attributed savings of $460,000 per month to decreased length of stay (Coustasse, et al. The Permanente Journal. 2014;18[4]:76).

Cost savings are great, of course, but ICU telemedicine’s potential to improve clinical outcomes is the real priority. While Sentara’s early report included a 27% decrease in ICU mortality after telemedicine adoption, a 2011 meta-analysis of 13 studies, including 35 ICUs and over 40,000 patients, suggested decreased ICU mortality and LOS with a statistically significant effect on overall hospital mortality and LOS (Young, et al. Arch Intern Med. 2011;171[6]:498). This highlights the Achilles heel of ICU telemedicine evidence: the pretest/posttest studies that dominate this field and likely contribute substantially to the inconsistencies in the evidence base.

In the absence of risk adjustment and control groups, many studies observed postimplementation changes that may reflect trends in patient mix or the effects of unrelated practice changes rather than the causal influence of ICU telemedicine. In fact, in studies using more robust methods, ICU telemedicine’s effect size has been smaller or nonexistent. For example, in 2016, Kahn and colleagues used CMS data to evaluate 132 ICU telemedicine programs using 389 matched controlled hospitals. There was a slight reduction in 90-day mortality (OR=0.96, CI 0.94-0.98) with only 12% showing a statistically significant reduction in mortality. Interestingly, hospitals in urban areas demonstrated greater benefit than rural facilities (Kahn, et al. Medical Care. 2016;54[3]:319).

The heterogeneity of the studied programs (e.g., primary vs consultative role, on-demand vs proactive involvement) and recipient ICUs (e.g., rural vs tertiary care facility, presence of bedside intensivists) further hinders a clear answer to the key question: Would ICU telemedicine benefit my hospital? Fortunately, some recent, well-designed studies have attempted to understand which attributes of ICU telemedicine programs provide results and which ICUs will see the most benefit. In a cohort of 118,990 patients across 56 ICUs, four interventions were associated with lower mortality and reduced LOS: (1) evaluation of patients within 1 hour of ICU admission, (2) frequent leadership review of performance data, (3) ICU best practice compliance, and (4) prompt response to alerts (Lilly, et al. Chest. 2014;145[3]:500). Kahn and colleagues have also investigated this issue, conducting an in-depth ethnographic evaluation of 10 hospitals identified in their 2016 study to have positive, neutral, or negative outcomes after ICU telemedicine implementation (Kahn, et al. Am J Respir Crit Care Med. 2019;199[8]:970). They found that successful programs:

(1) provided consistent services matched to recipient needs;

(2) provided services both proactively and reactively without being obtrusive;

(3) embedded routine engagements unobtrusively into usual routines;

(4) had engaged leadership who set clear expectations and mediated conflicts; and

(5) had bedside clinicians who valued and sought out telemedicine participation in care.

The authors concluded that, “the true value of ICU telemedicine lies not in whether the technology exists but in how it is applied.” However, another recent analysis also suggested that, rather than telemedicine or recipient ICU design, targeting underperforming recipient ICU performance may be the key determinant of whether ICU telemedicine implementation improves outcomes (Fusaro, et al. Crit Care Med. 2019; 47[4]:501). While the finding may reflect regression to the mean, the idea that ICUs with above-expected mortality derive greater benefit from ICU telemedicine support than already well-performing ICUs is certainly logical.

As COVID-19 strained health care systems across the country, we and others found ways to use ICU telemedicine to preserve optimal care delivery for critically ill patients. Our program at Intermountain Healthcare – already supporting 17 ICUs within our 24-hospital health system, as well as 10 external ICUs with experienced critical care physicians, nurses, respiratory therapists, and pharmacists – took on increased responsibility for ICU load balancing and interhospital transfers.

Leveraging telemedicine services also helped community ICUs care for sicker, more complex patients than usual and aided nonintensivist physicians called upon to manage critically ill patients in ad hoc ICUs at referral hospitals. While the pandemic certainly stressed ICU staff, we suspect that telemedicine’s ability to balance caseloads and distribute clinical tasks helped mitigate these stresses. At age 40, ICU telemedicine is both mature and still growing, with continued expansion of bed coverage and the range of services available. Looking ahead, as we confront a national shortage of intensivists, ICU telemedicine likely represents a cost effective and efficient strategy to maintain critical care capacity with the potential to ensure low-cost, high-quality care for all, regardless of location.
 

Dr. Graham and Dr. Peltan are with the Division of Pulmonary & Critical Care Medicine, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah; and Dr. Peltan is also with the Division of Pulmonary & Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Murray, Utah.

Intensive care telemedicine was first described in 1982 after implementation in a seven-bed, inner-city ICU using 19-inch television screens connected with intensivists at the University Hospitals of Cleveland (Grundy, et al. Crit Care Med. 1982;10[7]:471). After this proof-of-concept report, however, ICU telemedicine gained little traction for nearly 20 years, until Johns Hopkins Hospital established a continuously monitored ICU telemedicine service in a nonintensivist staffed surgical ICU. Their pre/post analysis suggested a 64% decrease in severity-adjusted ICU mortality and greater than 30% decrease in ICU length of stay, ICU complications, and costs (Rosenfeld, et al. Crit Care Med. 2000;28[12]:3925).

Along with better and less costly telemedicine technology, rapid adoption of electronic medical records, and a nationwide intensivist shortage, this and other evidence for the service’s clinical and cost effectiveness has spurred explosive growth in ICU telemedicine in the succeeding 2 decades, with at least 18% of hospitals and 28% of ICU beds supported by ICU telemedicine by 2018 (Ofoma, et al. Crit Care Explor. 2021;4[3]:e0468).

Importantly, what “ICU telemedicine” represents varies substantially across hospitals and even across ICUs within systems. Two-way audiovisual technology is the defining feature, and at a minimum, programs provide intensivists and/or nurses who respond to consultation requests. Commonly, telemedicine clinicians directly connect with patients; monitor labs, hemodynamics, and alarms; and proactively contact on-site clinicians with recommendations or place orders directly into the electronic health record depending on whether the clinician acts as the patients’ primary, co-managing, or consultant provider. A centralized hub and spoke model with telemedicine personnel located at a single, remote center is the most common and best studied ICU telemedicine design. Additional staffing may include respiratory therapists, pharmacists, and advanced practice clinicians in coverage models that range from 24/7 to nocturnal and can also differ in whether patients are monitored continuously or on an as needed basis, triggered by alarms or clinician/nursing concerns.

On-demand services may extend to support for teams responding to medical emergencies inside and sometimes outside the ICU. Another equally important role that ICU telemedicine can provide is helping ensure facilities adhere to ICU quality metrics, such as ventilator bundles, DVT prophylaxis, and daily SAT/SBT.

Unsurprisingly, integrating ICU telemedicine into an existing system is very costly and complex, requiring substantial and thoughtful process redesign to maximize fiscal and clinical return on investment. One vendor of proprietary telemedicine technology, Philips eICU, estimates an implementation cost of $50,000 to $100,000 per bed with annual overhead, software maintenance, and IT staffing of ~20% of implementation costs in addition to clinician staffing of $1-2 million per 100 beds. However, some (but not all) evidence suggests that ICU telemedicine programs pay for themselves over time. An influential report from Sentara Healthcare, an early adopter of ICU telemedicine, described equipment costs of more than $1 million for a total of 103 critical care beds but attributed savings of $460,000 per month to decreased length of stay (Coustasse, et al. The Permanente Journal. 2014;18[4]:76).

Cost savings are great, of course, but ICU telemedicine’s potential to improve clinical outcomes is the real priority. While Sentara’s early report included a 27% decrease in ICU mortality after telemedicine adoption, a 2011 meta-analysis of 13 studies, including 35 ICUs and over 40,000 patients, suggested decreased ICU mortality and LOS with a statistically significant effect on overall hospital mortality and LOS (Young, et al. Arch Intern Med. 2011;171[6]:498). This highlights the Achilles heel of ICU telemedicine evidence: the pretest/posttest studies that dominate this field and likely contribute substantially to the inconsistencies in the evidence base.

In the absence of risk adjustment and control groups, many studies observed postimplementation changes that may reflect trends in patient mix or the effects of unrelated practice changes rather than the causal influence of ICU telemedicine. In fact, in studies using more robust methods, ICU telemedicine’s effect size has been smaller or nonexistent. For example, in 2016, Kahn and colleagues used CMS data to evaluate 132 ICU telemedicine programs using 389 matched controlled hospitals. There was a slight reduction in 90-day mortality (OR=0.96, CI 0.94-0.98) with only 12% showing a statistically significant reduction in mortality. Interestingly, hospitals in urban areas demonstrated greater benefit than rural facilities (Kahn, et al. Medical Care. 2016;54[3]:319).

The heterogeneity of the studied programs (e.g., primary vs consultative role, on-demand vs proactive involvement) and recipient ICUs (e.g., rural vs tertiary care facility, presence of bedside intensivists) further hinders a clear answer to the key question: Would ICU telemedicine benefit my hospital? Fortunately, some recent, well-designed studies have attempted to understand which attributes of ICU telemedicine programs provide results and which ICUs will see the most benefit. In a cohort of 118,990 patients across 56 ICUs, four interventions were associated with lower mortality and reduced LOS: (1) evaluation of patients within 1 hour of ICU admission, (2) frequent leadership review of performance data, (3) ICU best practice compliance, and (4) prompt response to alerts (Lilly, et al. Chest. 2014;145[3]:500). Kahn and colleagues have also investigated this issue, conducting an in-depth ethnographic evaluation of 10 hospitals identified in their 2016 study to have positive, neutral, or negative outcomes after ICU telemedicine implementation (Kahn, et al. Am J Respir Crit Care Med. 2019;199[8]:970). They found that successful programs:

(1) provided consistent services matched to recipient needs;

(2) provided services both proactively and reactively without being obtrusive;

(3) embedded routine engagements unobtrusively into usual routines;

(4) had engaged leadership who set clear expectations and mediated conflicts; and

(5) had bedside clinicians who valued and sought out telemedicine participation in care.

The authors concluded that, “the true value of ICU telemedicine lies not in whether the technology exists but in how it is applied.” However, another recent analysis also suggested that, rather than telemedicine or recipient ICU design, targeting underperforming recipient ICU performance may be the key determinant of whether ICU telemedicine implementation improves outcomes (Fusaro, et al. Crit Care Med. 2019; 47[4]:501). While the finding may reflect regression to the mean, the idea that ICUs with above-expected mortality derive greater benefit from ICU telemedicine support than already well-performing ICUs is certainly logical.

As COVID-19 strained health care systems across the country, we and others found ways to use ICU telemedicine to preserve optimal care delivery for critically ill patients. Our program at Intermountain Healthcare – already supporting 17 ICUs within our 24-hospital health system, as well as 10 external ICUs with experienced critical care physicians, nurses, respiratory therapists, and pharmacists – took on increased responsibility for ICU load balancing and interhospital transfers.

Leveraging telemedicine services also helped community ICUs care for sicker, more complex patients than usual and aided nonintensivist physicians called upon to manage critically ill patients in ad hoc ICUs at referral hospitals. While the pandemic certainly stressed ICU staff, we suspect that telemedicine’s ability to balance caseloads and distribute clinical tasks helped mitigate these stresses. At age 40, ICU telemedicine is both mature and still growing, with continued expansion of bed coverage and the range of services available. Looking ahead, as we confront a national shortage of intensivists, ICU telemedicine likely represents a cost effective and efficient strategy to maintain critical care capacity with the potential to ensure low-cost, high-quality care for all, regardless of location.
 

Dr. Graham and Dr. Peltan are with the Division of Pulmonary & Critical Care Medicine, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah; and Dr. Peltan is also with the Division of Pulmonary & Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Murray, Utah.

Intensive care telemedicine was first described in 1982 after implementation in a seven-bed, inner-city ICU using 19-inch television screens connected with intensivists at the University Hospitals of Cleveland (Grundy, et al. Crit Care Med. 1982;10[7]:471). After this proof-of-concept report, however, ICU telemedicine gained little traction for nearly 20 years, until Johns Hopkins Hospital established a continuously monitored ICU telemedicine service in a nonintensivist staffed surgical ICU. Their pre/post analysis suggested a 64% decrease in severity-adjusted ICU mortality and greater than 30% decrease in ICU length of stay, ICU complications, and costs (Rosenfeld, et al. Crit Care Med. 2000;28[12]:3925).

Along with better and less costly telemedicine technology, rapid adoption of electronic medical records, and a nationwide intensivist shortage, this and other evidence for the service’s clinical and cost effectiveness has spurred explosive growth in ICU telemedicine in the succeeding 2 decades, with at least 18% of hospitals and 28% of ICU beds supported by ICU telemedicine by 2018 (Ofoma, et al. Crit Care Explor. 2021;4[3]:e0468).

Importantly, what “ICU telemedicine” represents varies substantially across hospitals and even across ICUs within systems. Two-way audiovisual technology is the defining feature, and at a minimum, programs provide intensivists and/or nurses who respond to consultation requests. Commonly, telemedicine clinicians directly connect with patients; monitor labs, hemodynamics, and alarms; and proactively contact on-site clinicians with recommendations or place orders directly into the electronic health record depending on whether the clinician acts as the patients’ primary, co-managing, or consultant provider. A centralized hub and spoke model with telemedicine personnel located at a single, remote center is the most common and best studied ICU telemedicine design. Additional staffing may include respiratory therapists, pharmacists, and advanced practice clinicians in coverage models that range from 24/7 to nocturnal and can also differ in whether patients are monitored continuously or on an as needed basis, triggered by alarms or clinician/nursing concerns.

On-demand services may extend to support for teams responding to medical emergencies inside and sometimes outside the ICU. Another equally important role that ICU telemedicine can provide is helping ensure facilities adhere to ICU quality metrics, such as ventilator bundles, DVT prophylaxis, and daily SAT/SBT.

Unsurprisingly, integrating ICU telemedicine into an existing system is very costly and complex, requiring substantial and thoughtful process redesign to maximize fiscal and clinical return on investment. One vendor of proprietary telemedicine technology, Philips eICU, estimates an implementation cost of $50,000 to $100,000 per bed with annual overhead, software maintenance, and IT staffing of ~20% of implementation costs in addition to clinician staffing of $1-2 million per 100 beds. However, some (but not all) evidence suggests that ICU telemedicine programs pay for themselves over time. An influential report from Sentara Healthcare, an early adopter of ICU telemedicine, described equipment costs of more than $1 million for a total of 103 critical care beds but attributed savings of $460,000 per month to decreased length of stay (Coustasse, et al. The Permanente Journal. 2014;18[4]:76).

Cost savings are great, of course, but ICU telemedicine’s potential to improve clinical outcomes is the real priority. While Sentara’s early report included a 27% decrease in ICU mortality after telemedicine adoption, a 2011 meta-analysis of 13 studies, including 35 ICUs and over 40,000 patients, suggested decreased ICU mortality and LOS with a statistically significant effect on overall hospital mortality and LOS (Young, et al. Arch Intern Med. 2011;171[6]:498). This highlights the Achilles heel of ICU telemedicine evidence: the pretest/posttest studies that dominate this field and likely contribute substantially to the inconsistencies in the evidence base.

In the absence of risk adjustment and control groups, many studies observed postimplementation changes that may reflect trends in patient mix or the effects of unrelated practice changes rather than the causal influence of ICU telemedicine. In fact, in studies using more robust methods, ICU telemedicine’s effect size has been smaller or nonexistent. For example, in 2016, Kahn and colleagues used CMS data to evaluate 132 ICU telemedicine programs using 389 matched controlled hospitals. There was a slight reduction in 90-day mortality (OR=0.96, CI 0.94-0.98) with only 12% showing a statistically significant reduction in mortality. Interestingly, hospitals in urban areas demonstrated greater benefit than rural facilities (Kahn, et al. Medical Care. 2016;54[3]:319).

The heterogeneity of the studied programs (e.g., primary vs consultative role, on-demand vs proactive involvement) and recipient ICUs (e.g., rural vs tertiary care facility, presence of bedside intensivists) further hinders a clear answer to the key question: Would ICU telemedicine benefit my hospital? Fortunately, some recent, well-designed studies have attempted to understand which attributes of ICU telemedicine programs provide results and which ICUs will see the most benefit. In a cohort of 118,990 patients across 56 ICUs, four interventions were associated with lower mortality and reduced LOS: (1) evaluation of patients within 1 hour of ICU admission, (2) frequent leadership review of performance data, (3) ICU best practice compliance, and (4) prompt response to alerts (Lilly, et al. Chest. 2014;145[3]:500). Kahn and colleagues have also investigated this issue, conducting an in-depth ethnographic evaluation of 10 hospitals identified in their 2016 study to have positive, neutral, or negative outcomes after ICU telemedicine implementation (Kahn, et al. Am J Respir Crit Care Med. 2019;199[8]:970). They found that successful programs:

(1) provided consistent services matched to recipient needs;

(2) provided services both proactively and reactively without being obtrusive;

(3) embedded routine engagements unobtrusively into usual routines;

(4) had engaged leadership who set clear expectations and mediated conflicts; and

(5) had bedside clinicians who valued and sought out telemedicine participation in care.

The authors concluded that, “the true value of ICU telemedicine lies not in whether the technology exists but in how it is applied.” However, another recent analysis also suggested that, rather than telemedicine or recipient ICU design, targeting underperforming recipient ICU performance may be the key determinant of whether ICU telemedicine implementation improves outcomes (Fusaro, et al. Crit Care Med. 2019; 47[4]:501). While the finding may reflect regression to the mean, the idea that ICUs with above-expected mortality derive greater benefit from ICU telemedicine support than already well-performing ICUs is certainly logical.

As COVID-19 strained health care systems across the country, we and others found ways to use ICU telemedicine to preserve optimal care delivery for critically ill patients. Our program at Intermountain Healthcare – already supporting 17 ICUs within our 24-hospital health system, as well as 10 external ICUs with experienced critical care physicians, nurses, respiratory therapists, and pharmacists – took on increased responsibility for ICU load balancing and interhospital transfers.

Leveraging telemedicine services also helped community ICUs care for sicker, more complex patients than usual and aided nonintensivist physicians called upon to manage critically ill patients in ad hoc ICUs at referral hospitals. While the pandemic certainly stressed ICU staff, we suspect that telemedicine’s ability to balance caseloads and distribute clinical tasks helped mitigate these stresses. At age 40, ICU telemedicine is both mature and still growing, with continued expansion of bed coverage and the range of services available. Looking ahead, as we confront a national shortage of intensivists, ICU telemedicine likely represents a cost effective and efficient strategy to maintain critical care capacity with the potential to ensure low-cost, high-quality care for all, regardless of location.
 

Dr. Graham and Dr. Peltan are with the Division of Pulmonary & Critical Care Medicine, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah; and Dr. Peltan is also with the Division of Pulmonary & Critical Care Medicine, Department of Medicine, Intermountain Medical Center, Murray, Utah.

In 2002, two landmark trials found that targeted temperature management (TTM) after out-of-hospital cardiac arrest led to improvements in neurologic outcomes. The larger of the two trials found a reduction in mortality. Such treatment benefits are hard to come by in critical care in general and in out-of-hospital cardiac arrest in particular. With the therapeutic overconfidence typical of our profession, my institution embraced TTM quickly and completely soon after these trials were published. Remember, this was “back in the day” when sepsis management included drotrecogin alfa, Cortrosyn stim tests, tight glucose control (90-120 mg/dL), and horrible over-resuscitation via the early goal-directed therapy paradigm.

If you’ve been practicing critical care medicine for more than a few years, you already know where I’m going. Most of the interventions in the preceding paragraph were adopted but discarded before 2010. Though TTM has managed to stand the test of time, our confidence in its benefit has waned since 2002. Hypothermia – temperature management with a goal of 32-36° C – has been struggling to stay relevant ever since the publication of the TTM randomized controlled trial (RCT) in 2013. Then came the HYPERION trial, which brought the 32-36° C target back from the dead (pun definitely intended) in 2019. This is critical care medicine: Today’s life-saving intervention proves harmful tomorrow, but withholding it may constitute malpractice a few months down the road.

So where are we now? Good question. I’ve had seasoned neurointensivists insist that 33° C remains the standard of care and others who’ve endorsed normothermia. So much for finding an answer via my more specialized colleagues.

Let’s go to the guidelines then. Prompted largely by HYPERION, a temperature target of 32-36° C was endorsed in 2020 and 2021. Then came publication of the TTM2 trial, the largest temperature management RCT to date, which found no benefit to targeting 33° C. A network meta-analysis published in 2021 reached a similar conclusion. A recently released update by the same international guideline group now recommends targeting normothermia (< 37.7° C) and avoiding fever, and it specifically says that there is insufficient evidence to support a 32-36° C target. Okay, everyone tracking all that?

Lest I sound overly catty and nihilistic, I see all this in a positive light. Huge credit goes to the critical care medicine academic community for putting together so many RCTs. The scientific reality is that it takes “a lotta” sample size to clarify the effects of an intervention. Throw in the inevitable bevy of confounders (in- vs. out-of-hospital cardiac arrest, resuscitation time, initial rhythm, and so on), and you get a feel for the work required to understand a treatment’s true effects.

Advances in guideline science and the hard, often unpaid work of panels are also important. The guideline panel I’ve been citing came out for aggressive temperature control (32-36° C) a few months before the TTM2 RCT was published. In the past, they updated their recommendations every 5 years, but this time, they were out with a new manuscript that incorporated TTM2 in less than a year. If you’ve been involved at any level with producing guidelines, you can appreciate this achievement. Assuming that aggressive hypothermia is truly harmful, waiting 5 years to incorporate TTM2 could have led to significant morbidity.

I do take issue with you early adopters, though. Given the litany of failed therapies that have shown initial promise, and the well-documented human tendency to underestimate the impact of sample size, your rapid implementation of major interventions is puzzling. One might think you’d learned your lessons after seeing drotrecogin alfa, Cortrosyn stim tests, tight glucose control, early goal-directed therapy, and aggressive TTM come and go. Your recent enthusiasm for vitamin C after publication of a single before-after study suggests that you haven’t.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center, Bethesda, Md. He has received a research grant from Fisher-Paykel.

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

In 2002, two landmark trials found that targeted temperature management (TTM) after out-of-hospital cardiac arrest led to improvements in neurologic outcomes. The larger of the two trials found a reduction in mortality. Such treatment benefits are hard to come by in critical care in general and in out-of-hospital cardiac arrest in particular. With the therapeutic overconfidence typical of our profession, my institution embraced TTM quickly and completely soon after these trials were published. Remember, this was “back in the day” when sepsis management included drotrecogin alfa, Cortrosyn stim tests, tight glucose control (90-120 mg/dL), and horrible over-resuscitation via the early goal-directed therapy paradigm.

If you’ve been practicing critical care medicine for more than a few years, you already know where I’m going. Most of the interventions in the preceding paragraph were adopted but discarded before 2010. Though TTM has managed to stand the test of time, our confidence in its benefit has waned since 2002. Hypothermia – temperature management with a goal of 32-36° C – has been struggling to stay relevant ever since the publication of the TTM randomized controlled trial (RCT) in 2013. Then came the HYPERION trial, which brought the 32-36° C target back from the dead (pun definitely intended) in 2019. This is critical care medicine: Today’s life-saving intervention proves harmful tomorrow, but withholding it may constitute malpractice a few months down the road.

So where are we now? Good question. I’ve had seasoned neurointensivists insist that 33° C remains the standard of care and others who’ve endorsed normothermia. So much for finding an answer via my more specialized colleagues.

Let’s go to the guidelines then. Prompted largely by HYPERION, a temperature target of 32-36° C was endorsed in 2020 and 2021. Then came publication of the TTM2 trial, the largest temperature management RCT to date, which found no benefit to targeting 33° C. A network meta-analysis published in 2021 reached a similar conclusion. A recently released update by the same international guideline group now recommends targeting normothermia (< 37.7° C) and avoiding fever, and it specifically says that there is insufficient evidence to support a 32-36° C target. Okay, everyone tracking all that?

Lest I sound overly catty and nihilistic, I see all this in a positive light. Huge credit goes to the critical care medicine academic community for putting together so many RCTs. The scientific reality is that it takes “a lotta” sample size to clarify the effects of an intervention. Throw in the inevitable bevy of confounders (in- vs. out-of-hospital cardiac arrest, resuscitation time, initial rhythm, and so on), and you get a feel for the work required to understand a treatment’s true effects.

Advances in guideline science and the hard, often unpaid work of panels are also important. The guideline panel I’ve been citing came out for aggressive temperature control (32-36° C) a few months before the TTM2 RCT was published. In the past, they updated their recommendations every 5 years, but this time, they were out with a new manuscript that incorporated TTM2 in less than a year. If you’ve been involved at any level with producing guidelines, you can appreciate this achievement. Assuming that aggressive hypothermia is truly harmful, waiting 5 years to incorporate TTM2 could have led to significant morbidity.

I do take issue with you early adopters, though. Given the litany of failed therapies that have shown initial promise, and the well-documented human tendency to underestimate the impact of sample size, your rapid implementation of major interventions is puzzling. One might think you’d learned your lessons after seeing drotrecogin alfa, Cortrosyn stim tests, tight glucose control, early goal-directed therapy, and aggressive TTM come and go. Your recent enthusiasm for vitamin C after publication of a single before-after study suggests that you haven’t.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center, Bethesda, Md. He has received a research grant from Fisher-Paykel.

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

In 2002, two landmark trials found that targeted temperature management (TTM) after out-of-hospital cardiac arrest led to improvements in neurologic outcomes. The larger of the two trials found a reduction in mortality. Such treatment benefits are hard to come by in critical care in general and in out-of-hospital cardiac arrest in particular. With the therapeutic overconfidence typical of our profession, my institution embraced TTM quickly and completely soon after these trials were published. Remember, this was “back in the day” when sepsis management included drotrecogin alfa, Cortrosyn stim tests, tight glucose control (90-120 mg/dL), and horrible over-resuscitation via the early goal-directed therapy paradigm.

If you’ve been practicing critical care medicine for more than a few years, you already know where I’m going. Most of the interventions in the preceding paragraph were adopted but discarded before 2010. Though TTM has managed to stand the test of time, our confidence in its benefit has waned since 2002. Hypothermia – temperature management with a goal of 32-36° C – has been struggling to stay relevant ever since the publication of the TTM randomized controlled trial (RCT) in 2013. Then came the HYPERION trial, which brought the 32-36° C target back from the dead (pun definitely intended) in 2019. This is critical care medicine: Today’s life-saving intervention proves harmful tomorrow, but withholding it may constitute malpractice a few months down the road.

So where are we now? Good question. I’ve had seasoned neurointensivists insist that 33° C remains the standard of care and others who’ve endorsed normothermia. So much for finding an answer via my more specialized colleagues.

Let’s go to the guidelines then. Prompted largely by HYPERION, a temperature target of 32-36° C was endorsed in 2020 and 2021. Then came publication of the TTM2 trial, the largest temperature management RCT to date, which found no benefit to targeting 33° C. A network meta-analysis published in 2021 reached a similar conclusion. A recently released update by the same international guideline group now recommends targeting normothermia (< 37.7° C) and avoiding fever, and it specifically says that there is insufficient evidence to support a 32-36° C target. Okay, everyone tracking all that?

Lest I sound overly catty and nihilistic, I see all this in a positive light. Huge credit goes to the critical care medicine academic community for putting together so many RCTs. The scientific reality is that it takes “a lotta” sample size to clarify the effects of an intervention. Throw in the inevitable bevy of confounders (in- vs. out-of-hospital cardiac arrest, resuscitation time, initial rhythm, and so on), and you get a feel for the work required to understand a treatment’s true effects.

Advances in guideline science and the hard, often unpaid work of panels are also important. The guideline panel I’ve been citing came out for aggressive temperature control (32-36° C) a few months before the TTM2 RCT was published. In the past, they updated their recommendations every 5 years, but this time, they were out with a new manuscript that incorporated TTM2 in less than a year. If you’ve been involved at any level with producing guidelines, you can appreciate this achievement. Assuming that aggressive hypothermia is truly harmful, waiting 5 years to incorporate TTM2 could have led to significant morbidity.

I do take issue with you early adopters, though. Given the litany of failed therapies that have shown initial promise, and the well-documented human tendency to underestimate the impact of sample size, your rapid implementation of major interventions is puzzling. One might think you’d learned your lessons after seeing drotrecogin alfa, Cortrosyn stim tests, tight glucose control, early goal-directed therapy, and aggressive TTM come and go. Your recent enthusiasm for vitamin C after publication of a single before-after study suggests that you haven’t.

Aaron B. Holley, MD, is an associate professor of medicine at Uniformed Services University and program director of pulmonary and critical care medicine at Walter Reed National Military Medical Center, Bethesda, Md. He has received a research grant from Fisher-Paykel.

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

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Study 1 Overview (Oberhaus et al)

Objective: To compare the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to the long-form Confusion Assessment Method (CAM) in detecting postoperative delirium.

Design: Prospective concurrent comparison of 3D-CAM and CAM evaluations in a cohort of postoperative geriatric patients.

Setting and participants: Eligible participants were patients aged 60 years or older undergoing major elective surgery at Barnes Jewish Hospital (St. Louis, Missouri) who were enrolled in ongoing clinical trials (PODCAST, ENGAGES, SATISFY-SOS) between 2015 and 2018. Surgeries were at least 2 hours in length and required general anesthesia, planned extubation, and a minimum 2-day hospital stay. Investigators were extensively trained in administering 3D-CAM and CAM instruments. Participants were evaluated 2 hours after the end of anesthesia care on the day of surgery, then daily until follow-up was completed per clinical trial protocol or until the participant was determined by CAM to be nondelirious for 3 consecutive days. For each evaluation, both 3D-CAM and CAM assessors approached the participant together, but the evaluation was conducted such that the 3D-CAM assessor was masked to the additional questions ascertained by the long-form CAM assessment. The 3D-CAM or CAM assessor independently scored their respective assessments blinded to the results of the other assessor.

Main outcome measures: Participants were concurrently evaluated for postoperative delirium by both 3D-CAM and long-form CAM assessments. Comparisons between 3D-CAM and CAM scores were made using Cohen κ with repeated measures, generalized linear mixed-effects model, and Bland-Altman analysis.

Main results: Sixteen raters performed 471 concurrent 3D-CAM and CAM assessments in 299 participants (mean [SD] age, 69 [6.5] years). Of these participants, 152 (50.8%) were men, 263 (88.0%) were White, and 211 (70.6%) underwent noncardiac surgery. Both instruments showed good intraclass correlation (0.98 for 3D-CAM, 0.84 for CAM) with good overall agreement (Cohen κ = 0.71; 95% CI, 0.58-0.83). The mixed-effects model indicated a significant disagreement between the 3D-CAM and CAM assessments (estimated difference in fixed effect, –0.68; 95% CI, –1.32 to –0.05; P = .04). The Bland-Altman analysis showed that the probability of a delirium diagnosis with the 3D-CAM was more than twice that with the CAM (probability ratio, 2.78; 95% CI, 2.44-3.23).

Conclusion: The high degree of agreement between 3D-CAM and long-form CAM assessments suggests that the former may be a pragmatic and easy-to-administer clinical tool to screen for postoperative delirium in vulnerable older surgical patients.

Study 2 Overview (Shenkin et al)

Objective: To assess the accuracy of the 4 ‘A’s Test (4AT) for delirium detection in the medical inpatient setting and to compare the 4AT to the CAM.

Design: Prospective randomized diagnostic test accuracy study.

Setting and participants: This study was conducted in emergency departments and acute medical wards at 3 UK sites (Edinburgh, Bradford, and Sheffield) and enrolled acute medical patients aged 70 years or older without acute life-threatening illnesses and/or coma. Assessors administering the delirium evaluation were nurses or graduate clinical research associates who underwent systematic training in delirium and delirium assessment. Additional training was provided to those administering the CAM but not to those administering the 4AT as the latter is designed to be administered without special training. First, all participants underwent a reference standard delirium assessment using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) criteria to derive a final definitive diagnosis of delirium via expert consensus (1 psychiatrist and 2 geriatricians). Then, the participants were randomized to either the 4AT or the comparator CAM group using computer-generated pseudo-random numbers, stratified by study site, with block allocation. All assessments were performed by pairs of independent assessors blinded to the results of the other assessment.

Main outcome measures: All participants were evaluated by the reference standard (DSM-IV criteria for delirium) and by either 4AT or CAM instruments for delirium. The accuracy of the 4AT instrument was evaluated by comparing its positive and negative predictive values, sensitivity, and specificity to the reference standard and analyzed via the area under the receiver operating characteristic curve. The diagnostic accuracy of 4AT, compared to the CAM, was evaluated by comparing positive and negative predictive values, sensitivity, and specificity using Fisher’s exact test. The overall performance of 4AT and CAM was summarized using Youden’s Index and the diagnostic odds ratio of sensitivity to specificity.

Results: All 843 individuals enrolled in the study were randomized and 785 were included in the analysis (23 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome). Of the participants analyzed, the mean age was 81.4 [6.4] years, and 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT group had an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.84-0.96), a sensitivity of 76% (95% CI, 61%-87%), and a specificity of 94% (95% CI, 92%-97%). In comparison, the CAM group had a sensitivity of 40% (95% CI, 26%-57%) and a specificity of 100% (95% CI, 98%-100%).

Conclusions: The 4AT is a pragmatic screening test for delirium in a medical space that does not require special training to administer. The use of this instrument may help to improve delirium detection as a part of routine clinical care in hospitalized older adults.

Delirium is an acute confusional state marked by fluctuating mental status, inattention, disorganized thinking, and altered level of consciousness. It is exceedingly common in older patients in both surgical and medical settings and is associated with increased morbidity, mortality, hospital length of stay, institutionalization, and health care costs. Delirium is frequently underdiagnosed in the hospitalized setting, perhaps due to a combination of its waxing and waning nature and a lack of pragmatic and easily implementable screening tools that can be readily administered by clinicians and nonclinicians alike.¹ While the CAM is a well-validated instrument to diagnose delirium, it requires specific training in the rating of each of the cardinal features ascertained through a brief cognitive assessment and takes 5 to 10 minutes to complete. Taken together, given the high patient load for clinicians in the hospital setting, the validation and application of brief delirium screening instruments that can be reliably administered by nonphysicians and nonclinicians may enhance delirium detection in vulnerable patients and consequently improve their outcomes.

In Study 1, Oberhaus et al approach the challenge of underdiagnosing delirium in the postoperative setting by investigating whether the widely accepted long-form CAM and an abbreviated 3-minute version, the 3D-CAM, provide similar delirium detection in older surgical patients. The authors found that both instruments were reliable tests individually (high interrater reliability) and had good overall agreement. However, the 3D-CAM was more likely to yield a positive diagnosis of delirium compared to the long-form CAM, consistent with its purpose as a screening tool with a high sensitivity. It is important to emphasize that the 3D-CAM takes less time to administer, but also requires less extensive training and clinical knowledge than the long-form CAM. Therefore, this instrument meets the prerequisite of a brief screening test that can be rapidly administered by nonclinicians, and if affirmative, followed by a more extensive confirmatory test performed by a clinician. Limitations of this study include a lack of a reference standard structured interview conducted by a physician-rater to better determine the true diagnostic accuracy of both 3D-CAM and CAM assessments, and the use of convenience sampling at a single center, which reduces the generalizability of its findings.

In a similar vein, Shenkin et al in Study 2 attempt to evaluate the utility of the 4AT instrument in diagnosing delirium in older medical inpatients by testing the diagnostic accuracy of the 4AT against a reference standard (ie, DSM-IV–based evaluation by physicians) as well as comparing it to CAM. The 4AT takes less time (~2 minutes) and requires less knowledge and training to administer as compared to the CAM. The study showed that the abbreviated 4AT, compared to CAM, had a higher sensitivity (76% vs 40%) and lower specificity (94% vs 100%) in delirium detection. Thus, akin to the application of 3D-CAM in the postoperative setting, 4AT possesses key characteristics of a brief delirium screening test for older patients in the acute medical setting. In contrast to the Oberhaus et al study, a major strength of this study was the utilization of a reference standard that was validated by expert consensus. This allowed the 4AT and CAM assessments to be compared to a more objective standard, thereby directly testing their diagnostic performance in detecting delirium.

Application for Clinical Practice and System Implementation

The findings from both Study 1 and 2 suggest that using an abbreviated delirium instrument in both surgical and acute medical settings may provide a pragmatic and sensitive method to detect delirium in older patients. The brevity of administration of 3D-CAM (~3 minutes) and 4AT (~2 minutes), combined with their higher sensitivity for detecting delirium compared to CAM, make these instruments potentially effective rapid screening tests for delirium in hospitalized older patients. Importantly, the utilization of such instruments might be a feasible way to mitigate the issue of underdiagnosing delirium in the hospital.

Several additional aspects of these abbreviated delirium instruments increase their suitability for clinical application. Specifically, the 3D-CAM and 4AT require less extensive training and clinical knowledge to both administer and interpret the results than the CAM.² For instance, a multistage, multiday training for CAM is a key factor in maintaining its diagnostic accuracy.^3,4 In contrast, the 3D-CAM requires only a 1- to 2-hour training session, and the 4AT can be administered by a nonclinician without the need for instrument-specific training. Thus, implementation of these instruments can be particularly pragmatic in clinical settings in which the staff involved in delirium screening cannot undergo the substantial training required to administer CAM. Moreover, these abbreviated tests enable nonphysician care team members to assume the role of delirium screener in the hospital. Taken together, the adoption of these abbreviated instruments may facilitate brief screenings of delirium in older patients by caregivers who see them most often—nurses and certified nursing assistants—thereby improving early detection and prevention of delirium-related complications in the hospital.

The feasibility of using abbreviated delirium screening instruments in the hospital setting raises a system implementation question—if these instruments are designed to be administered by those with limited to no training, could nonclinicians, such as hospital volunteers, effectively take on delirium screening roles in the hospital? If volunteers are able to take on this role, the integration of hospital volunteers into the clinical team can greatly expand the capacity for delirium screening in the hospital setting. Further research is warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Practice Points

• Abbreviated delirium screening tools such as 3D-CAM and 4AT may be pragmatic instruments to improve delirium detection in surgical and hospitalized older patients, respectively.
• Further studies are warranted to validate the diagnostic accuracy of 3D-CAM and 4AT by nonclinician administrators in order to more broadly adopt this approach to delirium screening.

Jared Doan, BS, and Fred Ko, MD
Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai

Inhaled vasodilators with nitric oxide and epoprostenol yielded similar patient outcomes, based on data from more than 11,000 patients.

Mechanically ventilated patients with severe acute respiratory failure may be treated with inhaled vasodilators using nitric oxide or epoprostenol to improve oxygenation, but data on practice patterns and head-to-head comparisons of effectiveness for the two options are limited, wrote Nicholas A. Bosch, MD, of Boston University, and colleagues.

In a study published in the journal Chest, the researchers used the Premier Healthcare Database to emulate a cluster randomized trial. The study population included 11,200 patients aged 18 years and older who were hospitalized at one of 303 hospitals with acute respiratory failure or acute respiratory distress between 2016 and 2020.

The patients received either nitric oxide (iNO) or epoprostenol (iEpo) during a hospital stay. A total of 6,366 patients received iNO first, 4,720 received iEpo first, and 114 received both on the same day. The median age of the patients was 58 years, and 64.6% of patients received neuromuscular blockades on the day they began vasodilator therapy. The primary outcome for effectiveness was successful extubation within 28 days of receiving a vasodilator. The outcomes for evaluating practice patterns included the choice of first inhaled vasodilator, days of invasive mechanical ventilation before starting a vasodilator, duration of use, proportion of patients who switched between iNO and iEpo, and the proportion who received each type of vasodilator.

A total of 104 hospitals (34.3%) used iNO exclusively, and 118 hospitals (38.9%) used iEpo exclusively. No differences in successful extubation rates appeared between these iNO and iEpo groups (37.0% vs. 34.7%; hazard ratio, 0.97). In addition, no differences were observed between the iNO and iEpo hospitals in total hospital costs or patient deaths or discharge to hospice, and the results persisted in a multivariate analysis.

Overall, the results were similar in a subgroup analysis, although patients receiving iNO were more likely to have successful extubation after controlling for organ dysfunction, the researchers noted.

“Our study provides stronger and more robust evidence that there are no differences in patient outcomes based on inhaled vasodilator type,” and suggest that either type may be used for patients whom clinicians think would benefit, the researchers wrote in their discussion. However, neither vasodilator type has been shown to significantly improve mortality, they noted.

The findings were limited by several factors including the observational design, lack of data on medication dose, and the use of nonrandom samples of hospitalizations and patients with laboratory and vital signs data, the researchers noted. The study also did not identify the specific indication for inhaled vasodilator therapy, and did not adjust for other therapies such as prone positioning or adherence to lung protective ventilation, they said.

However, the results were strengthened by the large sample size and more precise estimates of effectiveness than previous smaller studies, and suggest similar outcomes for patients and costs for hospitals, they concluded.

The study was funded by the National Institutes of Health National Center for Advancing Translational Sciences. Lead author Dr. Bosch also was supported by NIH/NCATS, the National Heart, Lung, and Blood Institute, and the Department of Defense. The researchers had no financial conflicts to disclose.

Inhaled vasodilators with nitric oxide and epoprostenol yielded similar patient outcomes, based on data from more than 11,000 patients.

Mechanically ventilated patients with severe acute respiratory failure may be treated with inhaled vasodilators using nitric oxide or epoprostenol to improve oxygenation, but data on practice patterns and head-to-head comparisons of effectiveness for the two options are limited, wrote Nicholas A. Bosch, MD, of Boston University, and colleagues.

In a study published in the journal Chest, the researchers used the Premier Healthcare Database to emulate a cluster randomized trial. The study population included 11,200 patients aged 18 years and older who were hospitalized at one of 303 hospitals with acute respiratory failure or acute respiratory distress between 2016 and 2020.

The patients received either nitric oxide (iNO) or epoprostenol (iEpo) during a hospital stay. A total of 6,366 patients received iNO first, 4,720 received iEpo first, and 114 received both on the same day. The median age of the patients was 58 years, and 64.6% of patients received neuromuscular blockades on the day they began vasodilator therapy. The primary outcome for effectiveness was successful extubation within 28 days of receiving a vasodilator. The outcomes for evaluating practice patterns included the choice of first inhaled vasodilator, days of invasive mechanical ventilation before starting a vasodilator, duration of use, proportion of patients who switched between iNO and iEpo, and the proportion who received each type of vasodilator.

A total of 104 hospitals (34.3%) used iNO exclusively, and 118 hospitals (38.9%) used iEpo exclusively. No differences in successful extubation rates appeared between these iNO and iEpo groups (37.0% vs. 34.7%; hazard ratio, 0.97). In addition, no differences were observed between the iNO and iEpo hospitals in total hospital costs or patient deaths or discharge to hospice, and the results persisted in a multivariate analysis.

Overall, the results were similar in a subgroup analysis, although patients receiving iNO were more likely to have successful extubation after controlling for organ dysfunction, the researchers noted.

“Our study provides stronger and more robust evidence that there are no differences in patient outcomes based on inhaled vasodilator type,” and suggest that either type may be used for patients whom clinicians think would benefit, the researchers wrote in their discussion. However, neither vasodilator type has been shown to significantly improve mortality, they noted.

The findings were limited by several factors including the observational design, lack of data on medication dose, and the use of nonrandom samples of hospitalizations and patients with laboratory and vital signs data, the researchers noted. The study also did not identify the specific indication for inhaled vasodilator therapy, and did not adjust for other therapies such as prone positioning or adherence to lung protective ventilation, they said.

However, the results were strengthened by the large sample size and more precise estimates of effectiveness than previous smaller studies, and suggest similar outcomes for patients and costs for hospitals, they concluded.

The study was funded by the National Institutes of Health National Center for Advancing Translational Sciences. Lead author Dr. Bosch also was supported by NIH/NCATS, the National Heart, Lung, and Blood Institute, and the Department of Defense. The researchers had no financial conflicts to disclose.

Inhaled vasodilators with nitric oxide and epoprostenol yielded similar patient outcomes, based on data from more than 11,000 patients.

Mechanically ventilated patients with severe acute respiratory failure may be treated with inhaled vasodilators using nitric oxide or epoprostenol to improve oxygenation, but data on practice patterns and head-to-head comparisons of effectiveness for the two options are limited, wrote Nicholas A. Bosch, MD, of Boston University, and colleagues.

In a study published in the journal Chest, the researchers used the Premier Healthcare Database to emulate a cluster randomized trial. The study population included 11,200 patients aged 18 years and older who were hospitalized at one of 303 hospitals with acute respiratory failure or acute respiratory distress between 2016 and 2020.

The patients received either nitric oxide (iNO) or epoprostenol (iEpo) during a hospital stay. A total of 6,366 patients received iNO first, 4,720 received iEpo first, and 114 received both on the same day. The median age of the patients was 58 years, and 64.6% of patients received neuromuscular blockades on the day they began vasodilator therapy. The primary outcome for effectiveness was successful extubation within 28 days of receiving a vasodilator. The outcomes for evaluating practice patterns included the choice of first inhaled vasodilator, days of invasive mechanical ventilation before starting a vasodilator, duration of use, proportion of patients who switched between iNO and iEpo, and the proportion who received each type of vasodilator.

A total of 104 hospitals (34.3%) used iNO exclusively, and 118 hospitals (38.9%) used iEpo exclusively. No differences in successful extubation rates appeared between these iNO and iEpo groups (37.0% vs. 34.7%; hazard ratio, 0.97). In addition, no differences were observed between the iNO and iEpo hospitals in total hospital costs or patient deaths or discharge to hospice, and the results persisted in a multivariate analysis.

Overall, the results were similar in a subgroup analysis, although patients receiving iNO were more likely to have successful extubation after controlling for organ dysfunction, the researchers noted.

“Our study provides stronger and more robust evidence that there are no differences in patient outcomes based on inhaled vasodilator type,” and suggest that either type may be used for patients whom clinicians think would benefit, the researchers wrote in their discussion. However, neither vasodilator type has been shown to significantly improve mortality, they noted.

The findings were limited by several factors including the observational design, lack of data on medication dose, and the use of nonrandom samples of hospitalizations and patients with laboratory and vital signs data, the researchers noted. The study also did not identify the specific indication for inhaled vasodilator therapy, and did not adjust for other therapies such as prone positioning or adherence to lung protective ventilation, they said.

However, the results were strengthened by the large sample size and more precise estimates of effectiveness than previous smaller studies, and suggest similar outcomes for patients and costs for hospitals, they concluded.

The study was funded by the National Institutes of Health National Center for Advancing Translational Sciences. Lead author Dr. Bosch also was supported by NIH/NCATS, the National Heart, Lung, and Blood Institute, and the Department of Defense. The researchers had no financial conflicts to disclose.