The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

The number of overdose deaths in adolescents nearly doubled in 2020 from the year before and increased substantially again in 2021 after nearly a decade of fairly stable rates, according to data published in a JAMA research letter.

Most of the deaths involved fentanyl, the researchers found.

Joseph Friedman, MPH, of the Center for Social Medicine and Humanities at the University of California, Los Angeles, led the study, which analyzed adolescent (14-18 years old) overdose deaths in the United States from 2010 to June 2021 in light of increasing contamination in the supply of illicit drugs.

The researchers found there were 518 deaths among adolescents (2.40 per 100,000 population) in 2010, and the rates remained stable through 2019 with 492 deaths (2.36 per 100,000).

In 2020, however, deaths spiked to 954 (4.57 per 100 000), increasing by 94.3%, compared with 2019. In 2021, they increased another 20%.

The rise in fentanyl-involved deaths was particularly striking. Fentanyl-involved deaths increased from 253 (1.21 per 100,000) in 2019 to 680 (3.26 per 100,000) in 2020. The numbers through June 2021 were annualized for 2021 and calculations predicted 884 deaths (4.23 per 100,000) for the year.
 

Numbers point to fentanyl potency

In 2021, more than three-fourths (77.14%) of adolescent overdose deaths involved fentanyl, compared with 13.26% for benzodiazepines, 9.77% for methamphetamine, 7.33% for cocaine, 5.76% for prescription opioids, and 2.27% for heroin.

American Indian and Alaska Native adolescents had the highest overdose rate in 2021 (n = 24; 11.79 per 100,000), followed by Latinx adolescents (n = 354; 6.98 per 100,000).

“These adolescent trends fit a wider pattern of increasing racial and ethnic inequalities in overdose that deserve further investigation and intervention efforts,” the authors wrote.
 

Pandemic’s role unclear

The spikes in adolescent overdoses overlap the COVID-19 pandemic, but Dr. Friedman said in an interview the pandemic “may or may not have been a big factor. “

The authors wrote that drug use had generally been stable among adolescents between 2010 and 2020. The number of 10th graders reporting any illicit drug use was 30.2% in 2010 and 30.4% in 2020.

“So it’s not that more teens are using drugs. It’s just that drug use is becoming more dangerous due to the spread of counterfeit pills containing fentanyls,” Dr. Friedman said.

The authors noted that “the illicit drug supply has increasingly become contaminated with illicitly manufactured fentanyls and other synthetic opioid and benzodiazepine analogues.”

Mr. Friedman said the pandemic may have accelerated the spread of more dangerous forms of drugs as supply chains were disrupted.

Benjamin Brady, DrPH, an assistant professor at the University of Arizona, Tucson, who also has an appointment in the university’s Comprehensive Pain and Addiction Center, said in an interview the numbers that Dr. Friedman and colleagues present represent “worst fears coming true.”

He said he and his colleagues in the field “were anticipating a rise in overdose deaths for the next 5-10 years because of the way the supply-and-demand environment exists in the U.S.”

Dr. Brady explained that restricting access to prescription opioids has had an unfortunate side effect in decreasing access to a safer supply of drugs.

“Without having solutions that would reduce demand at the same rate, supply of the safer form of the drug has been reduced; that has pushed people toward heroin and street drugs and from 2016 on those have been adulterated with fentanyl,” he said.

He said the United States, compared with other developed nations, has been slower to embrace longer-term harm-reduction strategies and to improve access to treatment and care.

COVID likely also has exacerbated the problem in terms of isolation and reduction in quality of life that has adolescents seeking to fill that void with drugs, Dr. Brady said. They may be completely unaware that the drugs they are seeking are commonly cut with counterfeit fentanyl.

“Fentanyl can be up to 50 times stronger than heroin,” he noted. “Even just a little bit of fentanyl dramatically changes the risk profile on an overdose.”

Increasing rates of mental health concerns among adolescents over decades also contribute to drug-seeking trends, Dr. Brady noted.
 

Overdose increases in the overall population were smaller

In the overall population, the percentage increases were not nearly as large in 2020 and 2021 as they were for adolescents.

Rates of overdose deaths in the overall population increased steadily from 2010 and reached 70,630 in 2019. In 2020, the deaths increased to 91,799 (an increase of 29.48% from 2019) and increased 11.48% in 2021.

The researchers analyzed numbers from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) database, which has records of all U.S. deaths for which drug overdose was listed as the underlying cause.

The authors and Dr. Brady report no relevant financial relationships.

Similar outcomes in patients with ventilator-associated pneumonia (VAP) suggest that antibiotics selected by Gram staining were noninferior to those based on guidelines and also significantly decreased the use of broad-spectrum antibiotics in this patient population.

The findings were published  in JAMA Network Open. The multicenter, open-label, noninferiority, randomized trial, Gram Stain-Guided Antibiotics Choice for VAP (GRACE-VAP), was conducted for 2 years in intensive care units (ICUs) of a dozen tertiary referral hospitals in Japan, from April 1, 2018, through May 31, 2020.

The authors noted in their paper that the 2016 clinical practice guidelines for VAP published by the Infectious Diseases Society of America (IDSA) and the American Thoracic Society recommend antibiotic agents active against both methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa as an empirical treatment. Adherence to these guidelines may lead to overuse of broad-spectrum antibiotic agents and could be associated with the accelerated emergence of antimicrobial-resistant organisms, the authors postulated.

The study sought to answer the question: Can Gram staining be used as an alternative to established guidelines to direct antibiotic use – thereby curbing the use of broad-spectrum antibiotics – without compromising patient safety and clinical outcomes?

A total of 206 patients, with a mean age of 69, took part in the study. The same number of patients were assigned to each arm. Patients aged 15 years or older with a VAP diagnosis and a modified Clinical Pulmonary Infection Score of 5 or higher were included.

Investigators reported that 79 patients (76.7%) responded to antibiotics in the Gram stain-guided group and 74 (71.8%) responded in the guideline-based group (risk difference, 0.05; 95% confidence interval, –0.07 to 0.17; P < .001, for noninferiority).

There was a decrease in antipseudomonal agent use comparing the Gram stain-guided group with the guideline-based group (30.1%; 95% CI, 21.5% to 39.9%; P < .001). There also was a decrease in anti-MRSA agents in the Gram stain-guided group, compared with the guideline-based group (38.8%; 95% CI, 29.4% to 48.9%; P < .001).

The 28-day cumulative incidence of mortality was 13.6% (n = 14) in the Gram stain-guided group versus 17.5% (n = 18) in the guideline-based group. Escalation of antibiotics according to culture results was performed in seven patients (6.8%) in the Gram stain-guided group and in one patient (1.0%) in the guideline-based group. No significant differences in study arms were observed on other measures, such as ICU-free days, ventilator-free days, and adverse events.

The authors concluded that their findings support the use of Gram staining as a strategy to manage infectious diseases and contain the development of multidrug resistant organisms (MDROs) in the setting of critical care.

“In the GRACE-VAP trial, we used the time-honored Gram stain technique as part of the daily management of infectious diseases. We believe that the trial results are acceptable and have the potential to change the strategy of antibiotic choice worldwide,” the authors wrote.

Benjamin D. Galvan MLS(ASCP), CIC, an infection preventionist with a professional background in clinical microbiology, noted that Gram staining is more accessible and significantly less costly than the rapid polymerase chain reaction testing certain institutions use to rapidly identify MDROs to help tailor therapy.

But one of the pitfalls with relying on Gram stain collection to guide antibiotic use is that it is operator dependent and subject to extrinsic factors, like prior antibiotic use, he pointed out.

“If it is not collected, set up, and read properly, the Gram stain is not going to necessarily be reliable” said Mr. Galvan, also a member of the national communications committee for the Association for Professionals in Infection Control and Epidemiology. He added that the sample in the study was not representative of institutions dealing with elevated rates of multidrug resistance.

“Even from their own results, they were looking at hospitals that have a low rate of multidrug resistance,” he said. “It was not clear if MRSA or just Staphylococcus aureus was identified in significant quantities upon review, and they recognized a lower-than-expected number of isolates of Pseudomonas aeruginosa.”

Establishing antibiotic treatment from the results of Gram-stain collection may not be sufficiently comprehensive, he said.

“Generally speaking, basing it (antibiotic therapy) solely off of a Gram stain is not looking at the whole picture,” said Mr. Galvan, noting that the 2016 IDSA guidelines call for an evaluation of the clinical status, including risk, of the individual patient, as well as locally available antibiotic resistance data.

Moreover, the evidence-based IDSA guidelines are in place to help address the issue of antimicrobial resistance trends, already recommending tailoring empiric antibiotic therapy based upon the levels of resistance in the local population, according to Galvan.

While the study suggests that this Gram-stain-driven tailoring of empiric antibiotic therapy may be noninferior to current guidelines in health care settings with low MDRO rates, its utility may not be suitable in hospitals that are already dealing with high rates of MDROs, such as Pseudomonas aeruginosa and Acinetobacter baumannii, or severe clinical cases of VAP, Mr. Galvan explained.

The researchers and Mr. Galvan disclosed no relevant financial relationships.

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

Similar outcomes in patients with ventilator-associated pneumonia (VAP) suggest that antibiotics selected by Gram staining were noninferior to those based on guidelines and also significantly decreased the use of broad-spectrum antibiotics in this patient population.

The findings were published  in JAMA Network Open. The multicenter, open-label, noninferiority, randomized trial, Gram Stain-Guided Antibiotics Choice for VAP (GRACE-VAP), was conducted for 2 years in intensive care units (ICUs) of a dozen tertiary referral hospitals in Japan, from April 1, 2018, through May 31, 2020.

The authors noted in their paper that the 2016 clinical practice guidelines for VAP published by the Infectious Diseases Society of America (IDSA) and the American Thoracic Society recommend antibiotic agents active against both methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa as an empirical treatment. Adherence to these guidelines may lead to overuse of broad-spectrum antibiotic agents and could be associated with the accelerated emergence of antimicrobial-resistant organisms, the authors postulated.

The study sought to answer the question: Can Gram staining be used as an alternative to established guidelines to direct antibiotic use – thereby curbing the use of broad-spectrum antibiotics – without compromising patient safety and clinical outcomes?

A total of 206 patients, with a mean age of 69, took part in the study. The same number of patients were assigned to each arm. Patients aged 15 years or older with a VAP diagnosis and a modified Clinical Pulmonary Infection Score of 5 or higher were included.

Investigators reported that 79 patients (76.7%) responded to antibiotics in the Gram stain-guided group and 74 (71.8%) responded in the guideline-based group (risk difference, 0.05; 95% confidence interval, –0.07 to 0.17; P < .001, for noninferiority).

There was a decrease in antipseudomonal agent use comparing the Gram stain-guided group with the guideline-based group (30.1%; 95% CI, 21.5% to 39.9%; P < .001). There also was a decrease in anti-MRSA agents in the Gram stain-guided group, compared with the guideline-based group (38.8%; 95% CI, 29.4% to 48.9%; P < .001).

The 28-day cumulative incidence of mortality was 13.6% (n = 14) in the Gram stain-guided group versus 17.5% (n = 18) in the guideline-based group. Escalation of antibiotics according to culture results was performed in seven patients (6.8%) in the Gram stain-guided group and in one patient (1.0%) in the guideline-based group. No significant differences in study arms were observed on other measures, such as ICU-free days, ventilator-free days, and adverse events.

The authors concluded that their findings support the use of Gram staining as a strategy to manage infectious diseases and contain the development of multidrug resistant organisms (MDROs) in the setting of critical care.

“In the GRACE-VAP trial, we used the time-honored Gram stain technique as part of the daily management of infectious diseases. We believe that the trial results are acceptable and have the potential to change the strategy of antibiotic choice worldwide,” the authors wrote.

Benjamin D. Galvan MLS(ASCP), CIC, an infection preventionist with a professional background in clinical microbiology, noted that Gram staining is more accessible and significantly less costly than the rapid polymerase chain reaction testing certain institutions use to rapidly identify MDROs to help tailor therapy.

But one of the pitfalls with relying on Gram stain collection to guide antibiotic use is that it is operator dependent and subject to extrinsic factors, like prior antibiotic use, he pointed out.

“If it is not collected, set up, and read properly, the Gram stain is not going to necessarily be reliable” said Mr. Galvan, also a member of the national communications committee for the Association for Professionals in Infection Control and Epidemiology. He added that the sample in the study was not representative of institutions dealing with elevated rates of multidrug resistance.

“Even from their own results, they were looking at hospitals that have a low rate of multidrug resistance,” he said. “It was not clear if MRSA or just Staphylococcus aureus was identified in significant quantities upon review, and they recognized a lower-than-expected number of isolates of Pseudomonas aeruginosa.”

Establishing antibiotic treatment from the results of Gram-stain collection may not be sufficiently comprehensive, he said.

“Generally speaking, basing it (antibiotic therapy) solely off of a Gram stain is not looking at the whole picture,” said Mr. Galvan, noting that the 2016 IDSA guidelines call for an evaluation of the clinical status, including risk, of the individual patient, as well as locally available antibiotic resistance data.

Moreover, the evidence-based IDSA guidelines are in place to help address the issue of antimicrobial resistance trends, already recommending tailoring empiric antibiotic therapy based upon the levels of resistance in the local population, according to Galvan.

While the study suggests that this Gram-stain-driven tailoring of empiric antibiotic therapy may be noninferior to current guidelines in health care settings with low MDRO rates, its utility may not be suitable in hospitals that are already dealing with high rates of MDROs, such as Pseudomonas aeruginosa and Acinetobacter baumannii, or severe clinical cases of VAP, Mr. Galvan explained.

The researchers and Mr. Galvan disclosed no relevant financial relationships.

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

Similar outcomes in patients with ventilator-associated pneumonia (VAP) suggest that antibiotics selected by Gram staining were noninferior to those based on guidelines and also significantly decreased the use of broad-spectrum antibiotics in this patient population.

The findings were published  in JAMA Network Open. The multicenter, open-label, noninferiority, randomized trial, Gram Stain-Guided Antibiotics Choice for VAP (GRACE-VAP), was conducted for 2 years in intensive care units (ICUs) of a dozen tertiary referral hospitals in Japan, from April 1, 2018, through May 31, 2020.

The authors noted in their paper that the 2016 clinical practice guidelines for VAP published by the Infectious Diseases Society of America (IDSA) and the American Thoracic Society recommend antibiotic agents active against both methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa as an empirical treatment. Adherence to these guidelines may lead to overuse of broad-spectrum antibiotic agents and could be associated with the accelerated emergence of antimicrobial-resistant organisms, the authors postulated.

The study sought to answer the question: Can Gram staining be used as an alternative to established guidelines to direct antibiotic use – thereby curbing the use of broad-spectrum antibiotics – without compromising patient safety and clinical outcomes?

A total of 206 patients, with a mean age of 69, took part in the study. The same number of patients were assigned to each arm. Patients aged 15 years or older with a VAP diagnosis and a modified Clinical Pulmonary Infection Score of 5 or higher were included.

Investigators reported that 79 patients (76.7%) responded to antibiotics in the Gram stain-guided group and 74 (71.8%) responded in the guideline-based group (risk difference, 0.05; 95% confidence interval, –0.07 to 0.17; P < .001, for noninferiority).

There was a decrease in antipseudomonal agent use comparing the Gram stain-guided group with the guideline-based group (30.1%; 95% CI, 21.5% to 39.9%; P < .001). There also was a decrease in anti-MRSA agents in the Gram stain-guided group, compared with the guideline-based group (38.8%; 95% CI, 29.4% to 48.9%; P < .001).

The 28-day cumulative incidence of mortality was 13.6% (n = 14) in the Gram stain-guided group versus 17.5% (n = 18) in the guideline-based group. Escalation of antibiotics according to culture results was performed in seven patients (6.8%) in the Gram stain-guided group and in one patient (1.0%) in the guideline-based group. No significant differences in study arms were observed on other measures, such as ICU-free days, ventilator-free days, and adverse events.

The authors concluded that their findings support the use of Gram staining as a strategy to manage infectious diseases and contain the development of multidrug resistant organisms (MDROs) in the setting of critical care.

“In the GRACE-VAP trial, we used the time-honored Gram stain technique as part of the daily management of infectious diseases. We believe that the trial results are acceptable and have the potential to change the strategy of antibiotic choice worldwide,” the authors wrote.

Benjamin D. Galvan MLS(ASCP), CIC, an infection preventionist with a professional background in clinical microbiology, noted that Gram staining is more accessible and significantly less costly than the rapid polymerase chain reaction testing certain institutions use to rapidly identify MDROs to help tailor therapy.

But one of the pitfalls with relying on Gram stain collection to guide antibiotic use is that it is operator dependent and subject to extrinsic factors, like prior antibiotic use, he pointed out.

“If it is not collected, set up, and read properly, the Gram stain is not going to necessarily be reliable” said Mr. Galvan, also a member of the national communications committee for the Association for Professionals in Infection Control and Epidemiology. He added that the sample in the study was not representative of institutions dealing with elevated rates of multidrug resistance.

“Even from their own results, they were looking at hospitals that have a low rate of multidrug resistance,” he said. “It was not clear if MRSA or just Staphylococcus aureus was identified in significant quantities upon review, and they recognized a lower-than-expected number of isolates of Pseudomonas aeruginosa.”

Establishing antibiotic treatment from the results of Gram-stain collection may not be sufficiently comprehensive, he said.

“Generally speaking, basing it (antibiotic therapy) solely off of a Gram stain is not looking at the whole picture,” said Mr. Galvan, noting that the 2016 IDSA guidelines call for an evaluation of the clinical status, including risk, of the individual patient, as well as locally available antibiotic resistance data.

Moreover, the evidence-based IDSA guidelines are in place to help address the issue of antimicrobial resistance trends, already recommending tailoring empiric antibiotic therapy based upon the levels of resistance in the local population, according to Galvan.

While the study suggests that this Gram-stain-driven tailoring of empiric antibiotic therapy may be noninferior to current guidelines in health care settings with low MDRO rates, its utility may not be suitable in hospitals that are already dealing with high rates of MDROs, such as Pseudomonas aeruginosa and Acinetobacter baumannii, or severe clinical cases of VAP, Mr. Galvan explained.

The researchers and Mr. Galvan disclosed no relevant financial relationships.

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

Structural aortic valve deterioration (SVD) at 5 years is lower following repair with a contemporary transcatheter implantation (TAVI) device than with surgery, according to a pooled analysis of major trials.

For healthier patients with a relatively long life expectancy, this is important information for deciding whether to undergo TAVI or surgical aortic valve repair (SAVR), Michael J. Reardon, MD, said at the annual scientific sessions of the American College of Cardiology.

“Every week I get this question about which repair is more durable,” said Dr. Reardon, whose study was not only designed to compare device deterioration but to evaluate the effect of SVD on major outcomes.

In this analysis, the rates of SVD were compared for the self-expanding supra-annular CoreValve Evolut device and SAVR. The SVD curves separated within the first year. At 5 years, the differences were highly significant favoring TAVI (2.57% vs. 4.38%; P = .0095).

As part of this analysis, the impact of SVD was also assessed independent of type of repair. At 5 years, those with SVD relative to those without had an approximately twofold increase in all-cause mortality, cardiovascular mortality, and hospitalization of aortic valve worsening. These risks were elevated regardless of type of valve repair.

The data presented by Dr. Reardon can be considered device specific. The earlier PARTNER 2A study comparing older- and newer-generation TAVI devices with SAVR produced a different result. When a second-generation balloon-expandable SAPIEN XT device and a third-generation SAPIEN 3 device were compared with surgery, neither device achieved lower SVD rates relative to SAVR.

In PARTNER 2A, the SVD rate for the older device was nearly three times greater than SAVR (1.61 vs. 0.58 per 100 patient-years). The numerically higher SVD rates for the newer device (0.68 vs. 0.58 per 100 patient-years) was not statistically different, but the TAVI device was not superior.

More than 4,000 patients evaluated at 5 years

In the analysis presented by Dr. Reardon, data were pooled from the randomized CoreValve U.S. High-Risk Pivotal Trial and the SURTAVI Intermediate Risk Trial. Together, these studies randomized 971 patients to surgery and 1,128 patients to TAVI. Data on an additional 2,663 patients treated with the Evolut valve in two registries were added to the randomized trial data, providing data on 4,762 total patients with 5-year follow-up.

SVD was defined by two criteria. The first was a mean gradient increase of at least 10 mm Hg plus a mean overall gradient of at least 20 mm Hg as measured with echocardiography and assessed, when possible, by an independent core laboratory. The second was new-onset or increased intraprosthetic aortic regurgitation of at least moderate severity.

When graphed over time, the SVD curves separated in favor of TAVI after about 6 months of follow-up. The shape of the curves also differed. Unlike the steady rise in SVD observed in the surgery group, the SVD rate in the TAVI group remained below 1% for almost 4 years before beginning to climb.

There was greater relative benefit for the TAVI device in patients with annular diameters of 23 mm or less. Unlike the rise in SVD rates that began about 6 months after SAVR, the SVD rates in the TAVI patients remained at 0% for more than 2 years. At 5 years, the differences remained significant favoring TAVI (1.39% vs. 5.86%; P = .049).

In those with larger annular diameters, there was still a consistently lower SVD rate over time for TAVI relative to SAVR, but the trend for an advantage at 5 years fell just short of significance (2.48% vs. 3.96%; P = .067).
 

SVD linked to doubling of mortality

SVD worsened outcomes. When all data surgery and TAVI data were pooled, the hazard ratios corresponded with about a doubling of risk for major adverse outcomes, including all-cause mortality (HR, 1.98; P < .001), cardiovascular mortality (HR, 1.82; P = .008), and hospitalization for aortic valve disease or worsening heart failure (HR, 2.11; P = .01). The relative risks were similar in the two treatment groups, including the risk of all-cause mortality (HR, 2.24; P < .001 for TAVI vs. HR, 2.45; P = .002 for SAVR).

The predictors for SVD on multivariate analysis included female sex, increased body surface area, prior percutaneous coronary intervention, and a prior diagnosis of atrial fibrillation.

Design improvements in TAVI devices are likely to explain these results, said Dr. Reardon, chair of cardiovascular research at Houston Methodist Hospital.

“The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the first and only transcatheter bioprosthesis to demonstrate lower rates of SVD, compared with surgery,” Dr. Reardon said.

This analysis validated the risks posed by the definition of SVD applied in this study, which appears to be a practical tool for tracking valve function and patient risk. Dr. Reardon also said that the study confirms the value of serial Doppler transthoracic echocardiography as a tool for monitoring SVD.

Several experts agreed that this is important new information.

“This is a remarkable series of findings,” said James McClurken, MD, who is a cardiovascular surgeon affiliated with Temple University, Philadelphia, and practices in Doylestown, Penn. By both demonstrating the prognostic importance of SVD and showing differences between the study device and SAVR, this trial will yield practical data to inform patients about relative risks and benefits.

Athena Poppas, MD, the new president of the ACC and a professor of medicine at Brown University, Providence, R.I., called this study “practice changing” for the same reasons. She also thinks it has valuable data for guiding choice of intervention.

Overall, the data are likely to change thinking about the role of TAVI and surgery in younger, fit patients, according to Megan Coylewright, MD, chief of cardiology at Erlanger Cardiology, Chattanooga, Tenn.

“There are patients [in need of aortic valve repair] with a long life expectancy who have been told you have to have a surgical repair because we know they last longer,” she said. Although she said that relative outcomes after longer follow-up remain unknown, “I think this does throw that comment into question.”

Dr. Reardon has financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr. Poppas and McClurken reported no potential financial conflicts of interest. Dr. Coylewright reported financial relationships with Abbott, Alleviant, Boston Scientific, Cardiosmart, Edwards Lifesciences, Medtronic, and Occlutech. The study received financial support from Medtronic.

Structural aortic valve deterioration (SVD) at 5 years is lower following repair with a contemporary transcatheter implantation (TAVI) device than with surgery, according to a pooled analysis of major trials.

For healthier patients with a relatively long life expectancy, this is important information for deciding whether to undergo TAVI or surgical aortic valve repair (SAVR), Michael J. Reardon, MD, said at the annual scientific sessions of the American College of Cardiology.

“Every week I get this question about which repair is more durable,” said Dr. Reardon, whose study was not only designed to compare device deterioration but to evaluate the effect of SVD on major outcomes.

In this analysis, the rates of SVD were compared for the self-expanding supra-annular CoreValve Evolut device and SAVR. The SVD curves separated within the first year. At 5 years, the differences were highly significant favoring TAVI (2.57% vs. 4.38%; P = .0095).

As part of this analysis, the impact of SVD was also assessed independent of type of repair. At 5 years, those with SVD relative to those without had an approximately twofold increase in all-cause mortality, cardiovascular mortality, and hospitalization of aortic valve worsening. These risks were elevated regardless of type of valve repair.

The data presented by Dr. Reardon can be considered device specific. The earlier PARTNER 2A study comparing older- and newer-generation TAVI devices with SAVR produced a different result. When a second-generation balloon-expandable SAPIEN XT device and a third-generation SAPIEN 3 device were compared with surgery, neither device achieved lower SVD rates relative to SAVR.

In PARTNER 2A, the SVD rate for the older device was nearly three times greater than SAVR (1.61 vs. 0.58 per 100 patient-years). The numerically higher SVD rates for the newer device (0.68 vs. 0.58 per 100 patient-years) was not statistically different, but the TAVI device was not superior.

More than 4,000 patients evaluated at 5 years

In the analysis presented by Dr. Reardon, data were pooled from the randomized CoreValve U.S. High-Risk Pivotal Trial and the SURTAVI Intermediate Risk Trial. Together, these studies randomized 971 patients to surgery and 1,128 patients to TAVI. Data on an additional 2,663 patients treated with the Evolut valve in two registries were added to the randomized trial data, providing data on 4,762 total patients with 5-year follow-up.

SVD was defined by two criteria. The first was a mean gradient increase of at least 10 mm Hg plus a mean overall gradient of at least 20 mm Hg as measured with echocardiography and assessed, when possible, by an independent core laboratory. The second was new-onset or increased intraprosthetic aortic regurgitation of at least moderate severity.

When graphed over time, the SVD curves separated in favor of TAVI after about 6 months of follow-up. The shape of the curves also differed. Unlike the steady rise in SVD observed in the surgery group, the SVD rate in the TAVI group remained below 1% for almost 4 years before beginning to climb.

There was greater relative benefit for the TAVI device in patients with annular diameters of 23 mm or less. Unlike the rise in SVD rates that began about 6 months after SAVR, the SVD rates in the TAVI patients remained at 0% for more than 2 years. At 5 years, the differences remained significant favoring TAVI (1.39% vs. 5.86%; P = .049).

In those with larger annular diameters, there was still a consistently lower SVD rate over time for TAVI relative to SAVR, but the trend for an advantage at 5 years fell just short of significance (2.48% vs. 3.96%; P = .067).
 

SVD linked to doubling of mortality

SVD worsened outcomes. When all data surgery and TAVI data were pooled, the hazard ratios corresponded with about a doubling of risk for major adverse outcomes, including all-cause mortality (HR, 1.98; P < .001), cardiovascular mortality (HR, 1.82; P = .008), and hospitalization for aortic valve disease or worsening heart failure (HR, 2.11; P = .01). The relative risks were similar in the two treatment groups, including the risk of all-cause mortality (HR, 2.24; P < .001 for TAVI vs. HR, 2.45; P = .002 for SAVR).

The predictors for SVD on multivariate analysis included female sex, increased body surface area, prior percutaneous coronary intervention, and a prior diagnosis of atrial fibrillation.

Design improvements in TAVI devices are likely to explain these results, said Dr. Reardon, chair of cardiovascular research at Houston Methodist Hospital.

“The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the first and only transcatheter bioprosthesis to demonstrate lower rates of SVD, compared with surgery,” Dr. Reardon said.

This analysis validated the risks posed by the definition of SVD applied in this study, which appears to be a practical tool for tracking valve function and patient risk. Dr. Reardon also said that the study confirms the value of serial Doppler transthoracic echocardiography as a tool for monitoring SVD.

Several experts agreed that this is important new information.

“This is a remarkable series of findings,” said James McClurken, MD, who is a cardiovascular surgeon affiliated with Temple University, Philadelphia, and practices in Doylestown, Penn. By both demonstrating the prognostic importance of SVD and showing differences between the study device and SAVR, this trial will yield practical data to inform patients about relative risks and benefits.

Athena Poppas, MD, the new president of the ACC and a professor of medicine at Brown University, Providence, R.I., called this study “practice changing” for the same reasons. She also thinks it has valuable data for guiding choice of intervention.

Overall, the data are likely to change thinking about the role of TAVI and surgery in younger, fit patients, according to Megan Coylewright, MD, chief of cardiology at Erlanger Cardiology, Chattanooga, Tenn.

“There are patients [in need of aortic valve repair] with a long life expectancy who have been told you have to have a surgical repair because we know they last longer,” she said. Although she said that relative outcomes after longer follow-up remain unknown, “I think this does throw that comment into question.”

Dr. Reardon has financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr. Poppas and McClurken reported no potential financial conflicts of interest. Dr. Coylewright reported financial relationships with Abbott, Alleviant, Boston Scientific, Cardiosmart, Edwards Lifesciences, Medtronic, and Occlutech. The study received financial support from Medtronic.

Structural aortic valve deterioration (SVD) at 5 years is lower following repair with a contemporary transcatheter implantation (TAVI) device than with surgery, according to a pooled analysis of major trials.

For healthier patients with a relatively long life expectancy, this is important information for deciding whether to undergo TAVI or surgical aortic valve repair (SAVR), Michael J. Reardon, MD, said at the annual scientific sessions of the American College of Cardiology.

“Every week I get this question about which repair is more durable,” said Dr. Reardon, whose study was not only designed to compare device deterioration but to evaluate the effect of SVD on major outcomes.

In this analysis, the rates of SVD were compared for the self-expanding supra-annular CoreValve Evolut device and SAVR. The SVD curves separated within the first year. At 5 years, the differences were highly significant favoring TAVI (2.57% vs. 4.38%; P = .0095).

As part of this analysis, the impact of SVD was also assessed independent of type of repair. At 5 years, those with SVD relative to those without had an approximately twofold increase in all-cause mortality, cardiovascular mortality, and hospitalization of aortic valve worsening. These risks were elevated regardless of type of valve repair.

The data presented by Dr. Reardon can be considered device specific. The earlier PARTNER 2A study comparing older- and newer-generation TAVI devices with SAVR produced a different result. When a second-generation balloon-expandable SAPIEN XT device and a third-generation SAPIEN 3 device were compared with surgery, neither device achieved lower SVD rates relative to SAVR.

In PARTNER 2A, the SVD rate for the older device was nearly three times greater than SAVR (1.61 vs. 0.58 per 100 patient-years). The numerically higher SVD rates for the newer device (0.68 vs. 0.58 per 100 patient-years) was not statistically different, but the TAVI device was not superior.

More than 4,000 patients evaluated at 5 years

In the analysis presented by Dr. Reardon, data were pooled from the randomized CoreValve U.S. High-Risk Pivotal Trial and the SURTAVI Intermediate Risk Trial. Together, these studies randomized 971 patients to surgery and 1,128 patients to TAVI. Data on an additional 2,663 patients treated with the Evolut valve in two registries were added to the randomized trial data, providing data on 4,762 total patients with 5-year follow-up.

SVD was defined by two criteria. The first was a mean gradient increase of at least 10 mm Hg plus a mean overall gradient of at least 20 mm Hg as measured with echocardiography and assessed, when possible, by an independent core laboratory. The second was new-onset or increased intraprosthetic aortic regurgitation of at least moderate severity.

When graphed over time, the SVD curves separated in favor of TAVI after about 6 months of follow-up. The shape of the curves also differed. Unlike the steady rise in SVD observed in the surgery group, the SVD rate in the TAVI group remained below 1% for almost 4 years before beginning to climb.

There was greater relative benefit for the TAVI device in patients with annular diameters of 23 mm or less. Unlike the rise in SVD rates that began about 6 months after SAVR, the SVD rates in the TAVI patients remained at 0% for more than 2 years. At 5 years, the differences remained significant favoring TAVI (1.39% vs. 5.86%; P = .049).

In those with larger annular diameters, there was still a consistently lower SVD rate over time for TAVI relative to SAVR, but the trend for an advantage at 5 years fell just short of significance (2.48% vs. 3.96%; P = .067).
 

SVD linked to doubling of mortality

SVD worsened outcomes. When all data surgery and TAVI data were pooled, the hazard ratios corresponded with about a doubling of risk for major adverse outcomes, including all-cause mortality (HR, 1.98; P < .001), cardiovascular mortality (HR, 1.82; P = .008), and hospitalization for aortic valve disease or worsening heart failure (HR, 2.11; P = .01). The relative risks were similar in the two treatment groups, including the risk of all-cause mortality (HR, 2.24; P < .001 for TAVI vs. HR, 2.45; P = .002 for SAVR).

The predictors for SVD on multivariate analysis included female sex, increased body surface area, prior percutaneous coronary intervention, and a prior diagnosis of atrial fibrillation.

Design improvements in TAVI devices are likely to explain these results, said Dr. Reardon, chair of cardiovascular research at Houston Methodist Hospital.

“The CoreValve/Evolut supra-annular, self-expanding bioprosthesis is the first and only transcatheter bioprosthesis to demonstrate lower rates of SVD, compared with surgery,” Dr. Reardon said.

This analysis validated the risks posed by the definition of SVD applied in this study, which appears to be a practical tool for tracking valve function and patient risk. Dr. Reardon also said that the study confirms the value of serial Doppler transthoracic echocardiography as a tool for monitoring SVD.

Several experts agreed that this is important new information.

“This is a remarkable series of findings,” said James McClurken, MD, who is a cardiovascular surgeon affiliated with Temple University, Philadelphia, and practices in Doylestown, Penn. By both demonstrating the prognostic importance of SVD and showing differences between the study device and SAVR, this trial will yield practical data to inform patients about relative risks and benefits.

Athena Poppas, MD, the new president of the ACC and a professor of medicine at Brown University, Providence, R.I., called this study “practice changing” for the same reasons. She also thinks it has valuable data for guiding choice of intervention.

Overall, the data are likely to change thinking about the role of TAVI and surgery in younger, fit patients, according to Megan Coylewright, MD, chief of cardiology at Erlanger Cardiology, Chattanooga, Tenn.

“There are patients [in need of aortic valve repair] with a long life expectancy who have been told you have to have a surgical repair because we know they last longer,” she said. Although she said that relative outcomes after longer follow-up remain unknown, “I think this does throw that comment into question.”

Dr. Reardon has financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical. Dr. Poppas and McClurken reported no potential financial conflicts of interest. Dr. Coylewright reported financial relationships with Abbott, Alleviant, Boston Scientific, Cardiosmart, Edwards Lifesciences, Medtronic, and Occlutech. The study received financial support from Medtronic.

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.

Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.

Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.

Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.

Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.

Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.

Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.

Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.

The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.

I am Andrew Kaunitz. Please take care of yourself and each other.

Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.

Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.

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

There is a variety of ways to support the many impactful new programs the CHEST Foundation will launch in 2022, but one of the most anticipated options is the annual Belmont Stakes Dinner and Auction on June 11 in New York City. This fun-filled evening will include a viewing of the 154th running of “The Championship Track,” a cocktail reception and plated dinner, a silent auction, a rooftop party, and much more.

This year, the dinner and auction will support the CHEST Foundation’s work in patient education and CHEST initiatives to improve patient care. Two areas of focus are disparities in care delivery and improving patients’ quality of life through partnerships designed to encourage earlier diagnosis and treatment.

With these goals in mind, new initiatives include an extension of the 2020 Foundation Listening Tour designed to help clinicians increase trust, equity, and access to health care for patients in traditionally marginalized communities.

In addition, CHEST is partnering with the Three Lakes Foundation on a program dedicated to shortening the time to diagnosis for pulmonary fibrosis (PF). This initiative will bring together pulmonologists and primary care physicians to develop a strategy for identifying PF more quickly, ensuring treatment can begin earlier in the disease trajectory. Early detection of PF is associated with better quality of life for patients, so improving clinicians’ understanding of the signs and symptoms of this rare disease and formulating better guidance for diagnosing it could result in drastic improvements for those living with PF.

To highlight the importance of these efforts, the evening also will include speeches from two patient advocates who have turned their own experiences with living with chronic lung disease into incredible action on behalf of patients.

To learn more about the CHEST Foundation’s initiatives in 2022 and how you can attend the Belmont Stakes Dinner and Auction to support these efforts, visit foundation.chestnet.org.

There is a variety of ways to support the many impactful new programs the CHEST Foundation will launch in 2022, but one of the most anticipated options is the annual Belmont Stakes Dinner and Auction on June 11 in New York City. This fun-filled evening will include a viewing of the 154th running of “The Championship Track,” a cocktail reception and plated dinner, a silent auction, a rooftop party, and much more.

This year, the dinner and auction will support the CHEST Foundation’s work in patient education and CHEST initiatives to improve patient care. Two areas of focus are disparities in care delivery and improving patients’ quality of life through partnerships designed to encourage earlier diagnosis and treatment.

With these goals in mind, new initiatives include an extension of the 2020 Foundation Listening Tour designed to help clinicians increase trust, equity, and access to health care for patients in traditionally marginalized communities.

In addition, CHEST is partnering with the Three Lakes Foundation on a program dedicated to shortening the time to diagnosis for pulmonary fibrosis (PF). This initiative will bring together pulmonologists and primary care physicians to develop a strategy for identifying PF more quickly, ensuring treatment can begin earlier in the disease trajectory. Early detection of PF is associated with better quality of life for patients, so improving clinicians’ understanding of the signs and symptoms of this rare disease and formulating better guidance for diagnosing it could result in drastic improvements for those living with PF.

To highlight the importance of these efforts, the evening also will include speeches from two patient advocates who have turned their own experiences with living with chronic lung disease into incredible action on behalf of patients.

To learn more about the CHEST Foundation’s initiatives in 2022 and how you can attend the Belmont Stakes Dinner and Auction to support these efforts, visit foundation.chestnet.org.

There is a variety of ways to support the many impactful new programs the CHEST Foundation will launch in 2022, but one of the most anticipated options is the annual Belmont Stakes Dinner and Auction on June 11 in New York City. This fun-filled evening will include a viewing of the 154th running of “The Championship Track,” a cocktail reception and plated dinner, a silent auction, a rooftop party, and much more.

This year, the dinner and auction will support the CHEST Foundation’s work in patient education and CHEST initiatives to improve patient care. Two areas of focus are disparities in care delivery and improving patients’ quality of life through partnerships designed to encourage earlier diagnosis and treatment.

With these goals in mind, new initiatives include an extension of the 2020 Foundation Listening Tour designed to help clinicians increase trust, equity, and access to health care for patients in traditionally marginalized communities.

In addition, CHEST is partnering with the Three Lakes Foundation on a program dedicated to shortening the time to diagnosis for pulmonary fibrosis (PF). This initiative will bring together pulmonologists and primary care physicians to develop a strategy for identifying PF more quickly, ensuring treatment can begin earlier in the disease trajectory. Early detection of PF is associated with better quality of life for patients, so improving clinicians’ understanding of the signs and symptoms of this rare disease and formulating better guidance for diagnosing it could result in drastic improvements for those living with PF.

To highlight the importance of these efforts, the evening also will include speeches from two patient advocates who have turned their own experiences with living with chronic lung disease into incredible action on behalf of patients.

To learn more about the CHEST Foundation’s initiatives in 2022 and how you can attend the Belmont Stakes Dinner and Auction to support these efforts, visit foundation.chestnet.org.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

In 2014, the Task Force for Mass Critical Care (TFMCC) published a CHEST consensus statement on disaster preparedness principles in caring for the critically ill during disasters and pandemics (Christian et al. CHEST. 2014;146[4_suppl]:8s-34s). This publication attempted to guide preparedness for both single-event disasters and more prolonged events, including a feared influenza pandemic.

Despite the foundation of planning and support this guidance provided, the COVID-19 pandemic response revealed substantial gaps in our understanding and preparedness for these more prolonged and widespread events.

In New York City, as the first COVID-19 wave began in March and April of 2020, area hospitals responded with surge plans that prioritized what was felt to be most important (Griffin et al. Am J Respir Crit Care Med. 2020 Jun 1;201[11]:1337-44). Tiered, creative staffing structures were rapidly created with intensivists supervising non-ICU physicians and APPs. Procedure teams were created for intubation, proning, and central line placement. ICU space was created with adaptations to ORs and PACUs, and rooms on med-surg floors and step-down units underwent emergency renovations to allow creation of new “pop-up” ICUs. Triage protocols were altered: patients on high levels of supplemental oxygen, who would under normal circumstances have been admitted to an ICU, were triaged to floors and stepdown units. Equipment was reused, modified, and substituted creatively to optimize care for the maximum number of patients.

In the face of all of these struggles, many around the country and the world felt the efforts, though heroic, resulted in less than standard of care. Two subsequent publications validated this concern (Kadri et al. Ann Int Med. 2021,174;9:1240-51; Bravata DM et al. JAMA Open Network. 2021;4[1]:e2034266), demonstrating during severe surge, COVID-19 patients’ mortality increased significantly beyond that seen in non-surging or less-severe surging times, demonstrating a mortality effect of surge itself. Though these studies observed COVID-19 patients only, there is every reason to believe the findings applied to all critically ill patients cared for during these surges.

These experiences led the TFMCC to report updated strategies for remaining in contingency care levels and avoiding crisis care (Dichter JR et al. CHEST. 2022;161[2]:429-47). Contingency is equivalent to routine care though may require adaptations and employment of otherwise non-traditional resources. The ultimate goal of mass critical care in a public health emergency is to avoid crisis-operating conditions, crisis standards of care, and their associated challenging triage decisions regarding allocation of scarce resources.

The 10 suggestions included in the most recent TFMCC publication include staffing strategies and suggestions based on COVID-19 experiences for graded staff-to-patient ratios, and support processes to preserve the existing health care work force. Strategies also include reduction of redundant documentation, limiting overtime, and most importantly, approaches for improving teamwork and supporting psychological well-being and resilience. Examples include daily unit huddles to update care and share experiences, genuine intra-team recognition and appreciation, and embedding emotional health experts within teams to provide ongoing support.

Consistent communication between incident command and frontline clinicians was also a suggested priority, perhaps with a newly proposed position of physician clinical support supervisor. This would be a formal role within hospital incident command, a liaison between the two groups.

Surge strategies should include empowerment of bedside clinicians and leaders with both planning and real-time assessment of the clinical situation, as being at the front line of care enables the situational awareness to assess ICU strain most effectively. Further, ICU clinicians must recognize when progression deeper into contingency operations occurs and they become perilously close to crisis mode. At this point, decisions are made and scarce resources are modified beyond routine standards of care to preserve life. TFMCC designates this gray area between contingency and crisis as the Critical Clinical Prioritization level (Figure).

Courtesy ACCP

At this point, more resources must be provided, or patients must be transferred to other resourced hospitals.

Critical Clinical Prioritization is an illustration of necessity being the mother of invention, as these are adaptations clinicians devised under duress. Some particularly poignant examples are the spreading of 24 hours of continuous renal replacement therapy (CRRT) resource between two and sometimes three patients to provide life sustainment to all; and when ventilators were in short supply, determining which patients required full ICU ventilator support vs those who could manage with lower functioning ventilators, and trading them between patients when demands changed.

These adaptations can only be done by experienced clinicians proactively managing bedside critical care under duress, further underscoring the importance of our suggestion that Critical Clinical Prioritization and ICU strain be managed by bedside clinicians and leaders.

The response of early transfer of patients – load-balancing - should be considered as soon as any hospital enters contingency conditions. This strategy is commonly implemented within larger health systems, ideally before reaching Critical Clinical Prioritization. Formal, organized state or regional load-balancing coordination, now referred to as medical operations command centers (MOCCs), were highly effective and proved lifesaving for those states that implemented them (including Arizona, Washington, California, Minnesota, and others). Support for establishment of MOCC’s is crucial in prolonging contingency operations and further helps support and protect disadvantaged populations (White et al. N Engl J Med. 2021;385[24]:2211-4).

Establishment of MOCCs has met resistance due to challenges that include interhospital/intersystem competition, logistics of moving critically ill patients sometimes across significant physical distance, and the costs of assuming care of uninsured or underinsured patients. Nevertheless, the benefits to the population as a whole necessitate working through these obstacles as successful MOCCs have done, usually with government and hospital association support.

In their final suggestion of the 2022 updated strategies, TFMCC suggests that hospitals use telemedicine technology both to expand specialists’ ability to provide care and facilitate families virtually visiting their critically ill loved one when safety precludes in-person visits.

These suggestions are pivotal in planning for future public health emergencies that include mass critical care, even during events that are limited in scope and duration.

Lastly, intensivists struggled with legal and ethical concerns when mired in crisis care circumstances and decisions of allocation, and potential reallocation, of scarce resources. These issues were not well addressed during the COVID-19 pandemic, further emphasizing the importance of maintaining contingency level care and requiring further involvement from legal and medical ethics professionals for future planning.

The guiding principle of disaster preparedness is that we must do all the planning we can to ensure that we never need crisis standards of care (National Academies of Sciences, Engineering, and Medicine. 2020 Mar 28. Rapid Expert Consultation on Crisis Standards of Care for the COVID-19 Pandemic. Washington, DC: The National Academies Press.).

We must be prepared. Guidelines and suggestions laid out through decades of experience gained a real-world test in the COVID-19 pandemic. Now we must all reorganize and create new plans or augment old ones with the information we have gained. The time is now. The work must continue.
 

Dr. Griffin is Assistant Professor of Medicine, New York Presbyterian Hospital – Weill Cornell Medicine. Dr. Dichter is Associate Professor of Medicine, University of Minnesota.

A quality educational meeting starts with a great slate of programs tailored to its audience, and CHEST 2022 is on-track to offer the highest tier of education for those in pulmonary, critical care, and sleep medicine.

Although planning for the meeting started after CHEST 2021 wrapped up, the real magic started to happen a few months ago when the schedule began coming together. In mid-February, members of the Scientific Planning Committee gathered both virtually and in-person at the CHEST headquarters to solidify the schedule for the upcoming CHEST 2022 meeting taking place in Nashville, TN, October 16-19.

The excitement in the room was palpable as committee members gathered for the first time in over a year to plan what will be the first in-person meeting since CHEST 2019 in New Orleans.

Chair of CHEST 2022, Subani Chandra, MD, FCCP, has high expectations for the meeting and is excited for everyone to be together in Nashville. “There is something special about an in-person meeting and my goal for CHEST 2022 is to not only meet the academic needs of the attendees, but also to serve as a chance to recharge after a long haul in managing COVID-19,” says Dr. Chandra. “Many first-time CHEST attendees are fellows and, with the last two meetings being virtual, there are a lot of fellows who have yet to attend a meeting in-person, so that is a big responsibility for us and opportunity for them. We want to make sure they have a fun and productive meeting – learn from the best, understand how to apply the latest research, get to present their work, network, participate, and have fun doing it all!”

With something for everyone in chest medicine, the CHEST 2022 meeting will feature over 200 sessions covering eight curriculum groups:

• Obstructive lung disease
• Sleep
• Chest infections
• Cardiovascular/pulmonary vascular disease
• Pulmonary procedures/lung cancer/cardiothoracic surgery
• Interstitial lung disease/radiology
• Interdisciplinary/practice operations/education
• Critical care

Covering a large breadth of information, the sessions will include the latest trends in COVID-19 care – recommended protocols, surge-planning and best practices; deeper looks into the latest CHEST guidelines – thromboprophylaxis in patients with COVID-19, antithrombotic therapy for VTE disease, and the guidelines for lung cancer screening; and sessions speaking to diversity, inclusion, and equity within medicine, including how lung disease affects populations differently.

Dr. Chandra says diversity was top of mind throughout the planning process. When submitting session ideas, it was noted that “submissions with speakers representing one gender and/or one institution will not be considered,” and that “selection priority will be given to outstanding submissions with proposed speakers who represent diversity of race, ethnicity, and professional status.”

During February’s meeting, as the committee members confirmed each of the sessions, they took the time to ensure every single one had presenters from a variety of backgrounds, including diversity of gender, race, credentialing, and years of experience in medicine.

It was important to the committee that this not be a physician-only meeting, because both CHEST and Pulmonary/Critical Care Medicine feature an array of team members including physicians, advance practice providers, respiratory therapists, nurses and other members of the care team and the sessions will reflect that.

When asked what she hopes attendees will gain from CHEST 2022, Dr. Chandra says, “I want attendees to feel the joy that comes from not only being together, but learning together.”

She continued, “I want this meeting to remind clinicians why they fell in love with medicine and to remember why it is that we do what we do, especially after two grueling years. Attendees should leave feeling reinvigorated and charged with the latest literature and clinical expertise ready to be implemented into practice. Most of all, I want all of the attendees to have fun, because we are there to learn, but CHEST is also about enjoying medicine and those around you. I just cannot wait.”

A quality educational meeting starts with a great slate of programs tailored to its audience, and CHEST 2022 is on-track to offer the highest tier of education for those in pulmonary, critical care, and sleep medicine.

Although planning for the meeting started after CHEST 2021 wrapped up, the real magic started to happen a few months ago when the schedule began coming together. In mid-February, members of the Scientific Planning Committee gathered both virtually and in-person at the CHEST headquarters to solidify the schedule for the upcoming CHEST 2022 meeting taking place in Nashville, TN, October 16-19.

The excitement in the room was palpable as committee members gathered for the first time in over a year to plan what will be the first in-person meeting since CHEST 2019 in New Orleans.

Chair of CHEST 2022, Subani Chandra, MD, FCCP, has high expectations for the meeting and is excited for everyone to be together in Nashville. “There is something special about an in-person meeting and my goal for CHEST 2022 is to not only meet the academic needs of the attendees, but also to serve as a chance to recharge after a long haul in managing COVID-19,” says Dr. Chandra. “Many first-time CHEST attendees are fellows and, with the last two meetings being virtual, there are a lot of fellows who have yet to attend a meeting in-person, so that is a big responsibility for us and opportunity for them. We want to make sure they have a fun and productive meeting – learn from the best, understand how to apply the latest research, get to present their work, network, participate, and have fun doing it all!”

With something for everyone in chest medicine, the CHEST 2022 meeting will feature over 200 sessions covering eight curriculum groups:

• Obstructive lung disease
• Sleep
• Chest infections
• Cardiovascular/pulmonary vascular disease
• Pulmonary procedures/lung cancer/cardiothoracic surgery
• Interstitial lung disease/radiology
• Interdisciplinary/practice operations/education
• Critical care

Covering a large breadth of information, the sessions will include the latest trends in COVID-19 care – recommended protocols, surge-planning and best practices; deeper looks into the latest CHEST guidelines – thromboprophylaxis in patients with COVID-19, antithrombotic therapy for VTE disease, and the guidelines for lung cancer screening; and sessions speaking to diversity, inclusion, and equity within medicine, including how lung disease affects populations differently.

Dr. Chandra says diversity was top of mind throughout the planning process. When submitting session ideas, it was noted that “submissions with speakers representing one gender and/or one institution will not be considered,” and that “selection priority will be given to outstanding submissions with proposed speakers who represent diversity of race, ethnicity, and professional status.”

During February’s meeting, as the committee members confirmed each of the sessions, they took the time to ensure every single one had presenters from a variety of backgrounds, including diversity of gender, race, credentialing, and years of experience in medicine.

It was important to the committee that this not be a physician-only meeting, because both CHEST and Pulmonary/Critical Care Medicine feature an array of team members including physicians, advance practice providers, respiratory therapists, nurses and other members of the care team and the sessions will reflect that.

When asked what she hopes attendees will gain from CHEST 2022, Dr. Chandra says, “I want attendees to feel the joy that comes from not only being together, but learning together.”

She continued, “I want this meeting to remind clinicians why they fell in love with medicine and to remember why it is that we do what we do, especially after two grueling years. Attendees should leave feeling reinvigorated and charged with the latest literature and clinical expertise ready to be implemented into practice. Most of all, I want all of the attendees to have fun, because we are there to learn, but CHEST is also about enjoying medicine and those around you. I just cannot wait.”

A quality educational meeting starts with a great slate of programs tailored to its audience, and CHEST 2022 is on-track to offer the highest tier of education for those in pulmonary, critical care, and sleep medicine.

Although planning for the meeting started after CHEST 2021 wrapped up, the real magic started to happen a few months ago when the schedule began coming together. In mid-February, members of the Scientific Planning Committee gathered both virtually and in-person at the CHEST headquarters to solidify the schedule for the upcoming CHEST 2022 meeting taking place in Nashville, TN, October 16-19.

The excitement in the room was palpable as committee members gathered for the first time in over a year to plan what will be the first in-person meeting since CHEST 2019 in New Orleans.

Chair of CHEST 2022, Subani Chandra, MD, FCCP, has high expectations for the meeting and is excited for everyone to be together in Nashville. “There is something special about an in-person meeting and my goal for CHEST 2022 is to not only meet the academic needs of the attendees, but also to serve as a chance to recharge after a long haul in managing COVID-19,” says Dr. Chandra. “Many first-time CHEST attendees are fellows and, with the last two meetings being virtual, there are a lot of fellows who have yet to attend a meeting in-person, so that is a big responsibility for us and opportunity for them. We want to make sure they have a fun and productive meeting – learn from the best, understand how to apply the latest research, get to present their work, network, participate, and have fun doing it all!”

With something for everyone in chest medicine, the CHEST 2022 meeting will feature over 200 sessions covering eight curriculum groups:

• Obstructive lung disease
• Sleep
• Chest infections
• Cardiovascular/pulmonary vascular disease
• Pulmonary procedures/lung cancer/cardiothoracic surgery
• Interstitial lung disease/radiology
• Interdisciplinary/practice operations/education
• Critical care

Covering a large breadth of information, the sessions will include the latest trends in COVID-19 care – recommended protocols, surge-planning and best practices; deeper looks into the latest CHEST guidelines – thromboprophylaxis in patients with COVID-19, antithrombotic therapy for VTE disease, and the guidelines for lung cancer screening; and sessions speaking to diversity, inclusion, and equity within medicine, including how lung disease affects populations differently.

Dr. Chandra says diversity was top of mind throughout the planning process. When submitting session ideas, it was noted that “submissions with speakers representing one gender and/or one institution will not be considered,” and that “selection priority will be given to outstanding submissions with proposed speakers who represent diversity of race, ethnicity, and professional status.”

During February’s meeting, as the committee members confirmed each of the sessions, they took the time to ensure every single one had presenters from a variety of backgrounds, including diversity of gender, race, credentialing, and years of experience in medicine.

It was important to the committee that this not be a physician-only meeting, because both CHEST and Pulmonary/Critical Care Medicine feature an array of team members including physicians, advance practice providers, respiratory therapists, nurses and other members of the care team and the sessions will reflect that.

When asked what she hopes attendees will gain from CHEST 2022, Dr. Chandra says, “I want attendees to feel the joy that comes from not only being together, but learning together.”

She continued, “I want this meeting to remind clinicians why they fell in love with medicine and to remember why it is that we do what we do, especially after two grueling years. Attendees should leave feeling reinvigorated and charged with the latest literature and clinical expertise ready to be implemented into practice. Most of all, I want all of the attendees to have fun, because we are there to learn, but CHEST is also about enjoying medicine and those around you. I just cannot wait.”

The SARS-CoV-2 pandemic required health care systems around the world to rapidly innovate and adapt to unprecedented operational and clinical strain. Many health care systems leveraged virtual care capabilities as an innovative approach to safely and efficiently manage patients while reducing staff exposure and medical resource constraints (Healthcare [Basel]. 2020 Nov;8[4]:517; JMIR Form Res. 2021 Jan; 5[1]:e23190). With Medicare insurance claims data demonstrating a 30% reduction of in-person health visits, telemedicine has become an essential means to fill the gaps in providing essential medical services (JAMA Intern Med. 2021 Mar;181[3]:388-91). A vast majority of virtual health care visits come via telephonic encounters, which have inherent limitations in the ability to monitor patients with complex or critical medical conditions (Front Public Health. 2020;8:410; N Engl J Med. 2020 Apr;382[18]:1679-81). Remote patient monitoring (RPM) has been established in multiple clinical models as an effective adjunct in telemedicine encounters in order to ensure treatment regimen adherence, make real-time treatment adjustments, and identify patients at risk for early decompensation.

Long-term RPM data has demonstrated cost reduction, reduced burden of in-office visits, expedited management of significant clinical events, and decreased all-cause mortality rates. Previously RPM was limited to the care of patients with chronic conditions, particularly cardiac patients with congestive heart failure and invasive devices, such as pacemakers or implantable cardioverter–defibrillators (JMIR Form Res. 2021 Jan;5[1]:e23190; Front Public Health. 2020; 8:410). In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) added RPM billing codes in 2019 and then included coverage of acute conditions in 2020 that permitted a more extensive role of RPM in telemedicine. This change in financial reimbursement led to a more aggressive expansion of RPM devices to assess physiologic parameters, such as weight, blood pressure, oxygen saturation, and blood glucose levels for clinicians to review.

Courtesy ACCP

Currently, RPM devices fall within a low-risk FDA category that do not require clinical trials for validation prior to being cleared for CMS billing in a fee-for-service reimbursement model (N Engl J Med. 2021 Apr;384[15]:1384-6). A shortage of evidence-based publications to guide clinicians in this new landscape creates challenges from underuse, misuse, or abuse of RPM tools. In order to maximize the clinical benefits of RPM, standardized processes and device specifications derived from up-to-date research need to be established in professional society guidelines.

Courtesy ACCP

Formalized RPM protocols should play a key role in overcoming the hesitancy of health institutions becoming early adopters of RPM technologies. Some significant challenges leading to reluctance of executing an RPM program were recently highlighted at the REPROGRAM international consortium of telemedicine. These concerns involved building a technological infrastructure, training clinical staff, ensuring remote connectivity with broadband Internet, and working with patients of various technologic literacy (Front Public Health. 2020;8:410). We attempted to address these challenges by using a COVID-19 remote patient monitoring (CRPM) strategy within our Military Health System (MHS). By using the well-established responsible, accountable, consulted, and informed (RACI) matrix process mapping tool, we created a standardized enrollment process of high-risk patients across eight military treatment facilities (MTFs). High risk patients included those with COVID-19 pneumonia and persistent hypoxemia, those recovering from acute exacerbations of congestive heart failure, those with cardiopulmonary instability associated with malignancy, and other conditions that required continuous monitoring outside of the hospital setting.

Courtesy ACCP

In our CRPM process, the hospital inpatient unit or ED refer high-risk patients to a primary designated provider at each MTF for enrollment prior to discharge. Enrolled patients are equipped with an FDA-approved home monitoring kit that contains an electronic tablet, a network hub that operates independently of and/or in conjunction with Wi-Fi, and an armband containing a coin-sized monitor. The system has the capability to pair with additional smart-enabled accessories, such as a blood pressure cuff, temperature patch, and digital spirometer. With continuous bio-physiologic and symptom-based monitoring, a team of teleworking critical-care nurses monitor patients continuously. In case of a decompensation necessitating a higher level of care, an emergency action plan (EAP) is activated to ensure patients urgently receive emergency medical services. Once released from the CRPM program, discharged patients use prepaid shipping boxes to facilitate contactless repackaging, sanitization, and pickup for redistribution of devices to the MTF.

Courtesy ACCP

Given the increased number of hospital admissions noted during the COVID-19 global pandemic, the CRPM program has allowed us to address overutilization of hospital beds. Furthermore, it has allowed us to address issues of screening and resource utilization as we consider patients for safe implementation of home monitoring. While data concerning the outcome of the CRPM program are pending, we are encouraged about the ability to provide high quality care in a remote setting. To that end, we have addressed technologic difficulties, communication between remote providers and patients in the home environment, and communication between health care providers in various settings, such as the ED, inpatient wards, and the outpatient clinic.

Courtesy ACCP

To be sure, there are many challenges in making sure that CRPM adequately addresses the needs of patients, who may have persistent perturbations in cardiopulmonary status, tremendous anxiety about the progress or deterioration in their health status, and lack of understanding about their medical condition. Furthermore, providers face the challenge of making clinical decisions sometimes without the advantage of in-person examinations. Sometimes decisions must be made with incomplete information or when the status of the patient does not follow presupposed algorithms. Nevertheless, like many issues during the COVID-19 pandemic, patients and providers have evolved, pivoted, and made necessary adjustments to address an unprecedented time in recent history.

Ultimately, we believe that a continuous remote patient monitoring program can be designed, implemented, and maintained across a multifacility health care system for safe, effective, and efficient health care delivery. Limitations in implementing such a program might include lack of adequate Internet services, lack of telephonic communication, inadequate home facilities, lack of adequate home support, and, perhaps, lack of available emergency services. However, if the conditions for home monitoring are optimized, CRPM holds the promise of reducing the burden on emergency and inpatient hospital services, particularly when those services are strained in circumstances such as the ongoing global pandemic due to COVID-19. With further study, standardization, and evolution, remote monitoring will likely become a more acceptable and necessary form of health care delivery in the future.
 

Dr. Salomon is an Internal Medicine Resident (PGY-2); Dr. Muller is an Internal Medicine Resident (PGY-2); Dr. Boster is a Pulmonary and Critical Care Fellow; Dr. Loudermilk is a Pulmonary and Critical Care Fellow; and Dr. Kemp is Pulmonary and Critical Care staff, San Antonio Military Medical Center, Fort Sam Houston, Texas.

The SARS-CoV-2 pandemic required health care systems around the world to rapidly innovate and adapt to unprecedented operational and clinical strain. Many health care systems leveraged virtual care capabilities as an innovative approach to safely and efficiently manage patients while reducing staff exposure and medical resource constraints (Healthcare [Basel]. 2020 Nov;8[4]:517; JMIR Form Res. 2021 Jan; 5[1]:e23190). With Medicare insurance claims data demonstrating a 30% reduction of in-person health visits, telemedicine has become an essential means to fill the gaps in providing essential medical services (JAMA Intern Med. 2021 Mar;181[3]:388-91). A vast majority of virtual health care visits come via telephonic encounters, which have inherent limitations in the ability to monitor patients with complex or critical medical conditions (Front Public Health. 2020;8:410; N Engl J Med. 2020 Apr;382[18]:1679-81). Remote patient monitoring (RPM) has been established in multiple clinical models as an effective adjunct in telemedicine encounters in order to ensure treatment regimen adherence, make real-time treatment adjustments, and identify patients at risk for early decompensation.

Long-term RPM data has demonstrated cost reduction, reduced burden of in-office visits, expedited management of significant clinical events, and decreased all-cause mortality rates. Previously RPM was limited to the care of patients with chronic conditions, particularly cardiac patients with congestive heart failure and invasive devices, such as pacemakers or implantable cardioverter–defibrillators (JMIR Form Res. 2021 Jan;5[1]:e23190; Front Public Health. 2020; 8:410). In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) added RPM billing codes in 2019 and then included coverage of acute conditions in 2020 that permitted a more extensive role of RPM in telemedicine. This change in financial reimbursement led to a more aggressive expansion of RPM devices to assess physiologic parameters, such as weight, blood pressure, oxygen saturation, and blood glucose levels for clinicians to review.

Courtesy ACCP

Currently, RPM devices fall within a low-risk FDA category that do not require clinical trials for validation prior to being cleared for CMS billing in a fee-for-service reimbursement model (N Engl J Med. 2021 Apr;384[15]:1384-6). A shortage of evidence-based publications to guide clinicians in this new landscape creates challenges from underuse, misuse, or abuse of RPM tools. In order to maximize the clinical benefits of RPM, standardized processes and device specifications derived from up-to-date research need to be established in professional society guidelines.

Courtesy ACCP

Formalized RPM protocols should play a key role in overcoming the hesitancy of health institutions becoming early adopters of RPM technologies. Some significant challenges leading to reluctance of executing an RPM program were recently highlighted at the REPROGRAM international consortium of telemedicine. These concerns involved building a technological infrastructure, training clinical staff, ensuring remote connectivity with broadband Internet, and working with patients of various technologic literacy (Front Public Health. 2020;8:410). We attempted to address these challenges by using a COVID-19 remote patient monitoring (CRPM) strategy within our Military Health System (MHS). By using the well-established responsible, accountable, consulted, and informed (RACI) matrix process mapping tool, we created a standardized enrollment process of high-risk patients across eight military treatment facilities (MTFs). High risk patients included those with COVID-19 pneumonia and persistent hypoxemia, those recovering from acute exacerbations of congestive heart failure, those with cardiopulmonary instability associated with malignancy, and other conditions that required continuous monitoring outside of the hospital setting.

Courtesy ACCP

In our CRPM process, the hospital inpatient unit or ED refer high-risk patients to a primary designated provider at each MTF for enrollment prior to discharge. Enrolled patients are equipped with an FDA-approved home monitoring kit that contains an electronic tablet, a network hub that operates independently of and/or in conjunction with Wi-Fi, and an armband containing a coin-sized monitor. The system has the capability to pair with additional smart-enabled accessories, such as a blood pressure cuff, temperature patch, and digital spirometer. With continuous bio-physiologic and symptom-based monitoring, a team of teleworking critical-care nurses monitor patients continuously. In case of a decompensation necessitating a higher level of care, an emergency action plan (EAP) is activated to ensure patients urgently receive emergency medical services. Once released from the CRPM program, discharged patients use prepaid shipping boxes to facilitate contactless repackaging, sanitization, and pickup for redistribution of devices to the MTF.

Courtesy ACCP

Given the increased number of hospital admissions noted during the COVID-19 global pandemic, the CRPM program has allowed us to address overutilization of hospital beds. Furthermore, it has allowed us to address issues of screening and resource utilization as we consider patients for safe implementation of home monitoring. While data concerning the outcome of the CRPM program are pending, we are encouraged about the ability to provide high quality care in a remote setting. To that end, we have addressed technologic difficulties, communication between remote providers and patients in the home environment, and communication between health care providers in various settings, such as the ED, inpatient wards, and the outpatient clinic.

Courtesy ACCP

To be sure, there are many challenges in making sure that CRPM adequately addresses the needs of patients, who may have persistent perturbations in cardiopulmonary status, tremendous anxiety about the progress or deterioration in their health status, and lack of understanding about their medical condition. Furthermore, providers face the challenge of making clinical decisions sometimes without the advantage of in-person examinations. Sometimes decisions must be made with incomplete information or when the status of the patient does not follow presupposed algorithms. Nevertheless, like many issues during the COVID-19 pandemic, patients and providers have evolved, pivoted, and made necessary adjustments to address an unprecedented time in recent history.

Ultimately, we believe that a continuous remote patient monitoring program can be designed, implemented, and maintained across a multifacility health care system for safe, effective, and efficient health care delivery. Limitations in implementing such a program might include lack of adequate Internet services, lack of telephonic communication, inadequate home facilities, lack of adequate home support, and, perhaps, lack of available emergency services. However, if the conditions for home monitoring are optimized, CRPM holds the promise of reducing the burden on emergency and inpatient hospital services, particularly when those services are strained in circumstances such as the ongoing global pandemic due to COVID-19. With further study, standardization, and evolution, remote monitoring will likely become a more acceptable and necessary form of health care delivery in the future.
 

Dr. Salomon is an Internal Medicine Resident (PGY-2); Dr. Muller is an Internal Medicine Resident (PGY-2); Dr. Boster is a Pulmonary and Critical Care Fellow; Dr. Loudermilk is a Pulmonary and Critical Care Fellow; and Dr. Kemp is Pulmonary and Critical Care staff, San Antonio Military Medical Center, Fort Sam Houston, Texas.

The SARS-CoV-2 pandemic required health care systems around the world to rapidly innovate and adapt to unprecedented operational and clinical strain. Many health care systems leveraged virtual care capabilities as an innovative approach to safely and efficiently manage patients while reducing staff exposure and medical resource constraints (Healthcare [Basel]. 2020 Nov;8[4]:517; JMIR Form Res. 2021 Jan; 5[1]:e23190). With Medicare insurance claims data demonstrating a 30% reduction of in-person health visits, telemedicine has become an essential means to fill the gaps in providing essential medical services (JAMA Intern Med. 2021 Mar;181[3]:388-91). A vast majority of virtual health care visits come via telephonic encounters, which have inherent limitations in the ability to monitor patients with complex or critical medical conditions (Front Public Health. 2020;8:410; N Engl J Med. 2020 Apr;382[18]:1679-81). Remote patient monitoring (RPM) has been established in multiple clinical models as an effective adjunct in telemedicine encounters in order to ensure treatment regimen adherence, make real-time treatment adjustments, and identify patients at risk for early decompensation.

Long-term RPM data has demonstrated cost reduction, reduced burden of in-office visits, expedited management of significant clinical events, and decreased all-cause mortality rates. Previously RPM was limited to the care of patients with chronic conditions, particularly cardiac patients with congestive heart failure and invasive devices, such as pacemakers or implantable cardioverter–defibrillators (JMIR Form Res. 2021 Jan;5[1]:e23190; Front Public Health. 2020; 8:410). In response to the pandemic, the Centers for Medicare and Medicaid Services (CMS) added RPM billing codes in 2019 and then included coverage of acute conditions in 2020 that permitted a more extensive role of RPM in telemedicine. This change in financial reimbursement led to a more aggressive expansion of RPM devices to assess physiologic parameters, such as weight, blood pressure, oxygen saturation, and blood glucose levels for clinicians to review.

Courtesy ACCP

Currently, RPM devices fall within a low-risk FDA category that do not require clinical trials for validation prior to being cleared for CMS billing in a fee-for-service reimbursement model (N Engl J Med. 2021 Apr;384[15]:1384-6). A shortage of evidence-based publications to guide clinicians in this new landscape creates challenges from underuse, misuse, or abuse of RPM tools. In order to maximize the clinical benefits of RPM, standardized processes and device specifications derived from up-to-date research need to be established in professional society guidelines.

Courtesy ACCP

Formalized RPM protocols should play a key role in overcoming the hesitancy of health institutions becoming early adopters of RPM technologies. Some significant challenges leading to reluctance of executing an RPM program were recently highlighted at the REPROGRAM international consortium of telemedicine. These concerns involved building a technological infrastructure, training clinical staff, ensuring remote connectivity with broadband Internet, and working with patients of various technologic literacy (Front Public Health. 2020;8:410). We attempted to address these challenges by using a COVID-19 remote patient monitoring (CRPM) strategy within our Military Health System (MHS). By using the well-established responsible, accountable, consulted, and informed (RACI) matrix process mapping tool, we created a standardized enrollment process of high-risk patients across eight military treatment facilities (MTFs). High risk patients included those with COVID-19 pneumonia and persistent hypoxemia, those recovering from acute exacerbations of congestive heart failure, those with cardiopulmonary instability associated with malignancy, and other conditions that required continuous monitoring outside of the hospital setting.

Courtesy ACCP

In our CRPM process, the hospital inpatient unit or ED refer high-risk patients to a primary designated provider at each MTF for enrollment prior to discharge. Enrolled patients are equipped with an FDA-approved home monitoring kit that contains an electronic tablet, a network hub that operates independently of and/or in conjunction with Wi-Fi, and an armband containing a coin-sized monitor. The system has the capability to pair with additional smart-enabled accessories, such as a blood pressure cuff, temperature patch, and digital spirometer. With continuous bio-physiologic and symptom-based monitoring, a team of teleworking critical-care nurses monitor patients continuously. In case of a decompensation necessitating a higher level of care, an emergency action plan (EAP) is activated to ensure patients urgently receive emergency medical services. Once released from the CRPM program, discharged patients use prepaid shipping boxes to facilitate contactless repackaging, sanitization, and pickup for redistribution of devices to the MTF.

Courtesy ACCP

Given the increased number of hospital admissions noted during the COVID-19 global pandemic, the CRPM program has allowed us to address overutilization of hospital beds. Furthermore, it has allowed us to address issues of screening and resource utilization as we consider patients for safe implementation of home monitoring. While data concerning the outcome of the CRPM program are pending, we are encouraged about the ability to provide high quality care in a remote setting. To that end, we have addressed technologic difficulties, communication between remote providers and patients in the home environment, and communication between health care providers in various settings, such as the ED, inpatient wards, and the outpatient clinic.

Courtesy ACCP

To be sure, there are many challenges in making sure that CRPM adequately addresses the needs of patients, who may have persistent perturbations in cardiopulmonary status, tremendous anxiety about the progress or deterioration in their health status, and lack of understanding about their medical condition. Furthermore, providers face the challenge of making clinical decisions sometimes without the advantage of in-person examinations. Sometimes decisions must be made with incomplete information or when the status of the patient does not follow presupposed algorithms. Nevertheless, like many issues during the COVID-19 pandemic, patients and providers have evolved, pivoted, and made necessary adjustments to address an unprecedented time in recent history.

Ultimately, we believe that a continuous remote patient monitoring program can be designed, implemented, and maintained across a multifacility health care system for safe, effective, and efficient health care delivery. Limitations in implementing such a program might include lack of adequate Internet services, lack of telephonic communication, inadequate home facilities, lack of adequate home support, and, perhaps, lack of available emergency services. However, if the conditions for home monitoring are optimized, CRPM holds the promise of reducing the burden on emergency and inpatient hospital services, particularly when those services are strained in circumstances such as the ongoing global pandemic due to COVID-19. With further study, standardization, and evolution, remote monitoring will likely become a more acceptable and necessary form of health care delivery in the future.
 

Dr. Salomon is an Internal Medicine Resident (PGY-2); Dr. Muller is an Internal Medicine Resident (PGY-2); Dr. Boster is a Pulmonary and Critical Care Fellow; Dr. Loudermilk is a Pulmonary and Critical Care Fellow; and Dr. Kemp is Pulmonary and Critical Care staff, San Antonio Military Medical Center, Fort Sam Houston, Texas.

Physicians from every specialty have stepped up in extraordinary ways during the pandemic; however, ABIM recognizes that pulmonary disease and critical care physicians, along with hospitalists and infectious disease specialists, have been especially burdened. ABIM has heard from many pulmonary disease and critical care medicine physicians asking for greater flexibility and choice in how they can maintain their board certifications.

For that reason, ABIM has extended deadlines for all Maintenance of Certification (MOC) requirements to 12/31/22 and to 2023 for Critical Care Medicine, Hospital Medicine, Infectious Disease, and Pulmonary Disease.
 

What assessment options does ABIM offer?

If you haven’t needed to take an MOC exam for a while, you might not be aware of ABIM’s current options and how they might work for you:

• The traditional, 10-year MOC assessment (a point-in-time exam taken at a test center)
• The new Longitudinal Knowledge Assessment (LKATM) (available in 12 specialties including Internal Medicine and Sleep Medicine now, and in Critical Care Medicine and Pulmonary Disease in 2023)

The 2-year Knowledge Check-In was retired at the end of 2021 with the introduction of the LKA.
 

How the new LKA works

As a longitudinal assessment, the LKA is designed to help you measure your medical knowledge over time and better melds assessment and learning. It consists of a 5-year cycle, during which you’ll be offered 30 questions each quarter, and need to open at least 500 out of 600 questions to meet the LKA Participation Requirement. You can choose not to open up to 100 questions over 5 years, allowing you to take breaks when you need them.

Once enrolled, you can take questions on your laptop, desktop, or smartphone. You’ll also be able to answer questions where and when it’s convenient for you, such as at your home or office – with no need to schedule an appointment or go to a test center. You can use all the same resources you use in practice – journals, apps, and your own personal notes—anything except another person. For most questions, you’ll find out immediately if your answer was correct or not, and you’ll receive a rationale explaining why, along with one or more references.

You’ll have 4 minutes to answer each question and can add extra time if needed by drawing from an annual 30-minute time bank. For each correct answer, you’ll earn 0.2 MOC points, and if you choose to participate in LKA for more than one of your certificates, you’ll have even more opportunities to earn points. In addition, beginning in your second year of participation, interim score reports will give you helpful information to let you know how you’re doing, so you can re-adjust your approach and focus your studies as needed. A pass/fail decision is made at the end of the 5-year cycle.
 

About eligibility

If you are currently certified in Critical Care Medicine or Pulmonary Disease and had an assessment due in 2020, 2021 or 2022, you don’t need to take an assessment this year and will be eligible to enroll in the LKA in 2023, or you can choose to take the traditional 10-year MOC exam.

Upon enrolling, you will continue to be reported as “Certified” as long as you are meeting the LKA Participation Requirement. If your next assessment isn’t due for a while, you will be able to enroll in the LKA in your assessment due year—not before then.

More information about eligibility can be found in a special section of ABIM’s website.
 

How much does it cost?

ABIM revised its MOC fees in 2022 to provide an option to pay less over time than previously, and the LKA will be included in your annual MOC fee at no additional cost. Here’s how it works:

In closing

Thousands of physicians have already started taking the LKA in 2022 and are reporting positive experiences with it. The ABIM is excited that physicians in additional disciplines, including Critical Care Medicine and Pulmonary Disease, will get to experience it themselves in 2023.

Physicians from every specialty have stepped up in extraordinary ways during the pandemic; however, ABIM recognizes that pulmonary disease and critical care physicians, along with hospitalists and infectious disease specialists, have been especially burdened. ABIM has heard from many pulmonary disease and critical care medicine physicians asking for greater flexibility and choice in how they can maintain their board certifications.

For that reason, ABIM has extended deadlines for all Maintenance of Certification (MOC) requirements to 12/31/22 and to 2023 for Critical Care Medicine, Hospital Medicine, Infectious Disease, and Pulmonary Disease.
 

What assessment options does ABIM offer?

If you haven’t needed to take an MOC exam for a while, you might not be aware of ABIM’s current options and how they might work for you:

• The traditional, 10-year MOC assessment (a point-in-time exam taken at a test center)
• The new Longitudinal Knowledge Assessment (LKATM) (available in 12 specialties including Internal Medicine and Sleep Medicine now, and in Critical Care Medicine and Pulmonary Disease in 2023)

The 2-year Knowledge Check-In was retired at the end of 2021 with the introduction of the LKA.
 

How the new LKA works

As a longitudinal assessment, the LKA is designed to help you measure your medical knowledge over time and better melds assessment and learning. It consists of a 5-year cycle, during which you’ll be offered 30 questions each quarter, and need to open at least 500 out of 600 questions to meet the LKA Participation Requirement. You can choose not to open up to 100 questions over 5 years, allowing you to take breaks when you need them.

Once enrolled, you can take questions on your laptop, desktop, or smartphone. You’ll also be able to answer questions where and when it’s convenient for you, such as at your home or office – with no need to schedule an appointment or go to a test center. You can use all the same resources you use in practice – journals, apps, and your own personal notes—anything except another person. For most questions, you’ll find out immediately if your answer was correct or not, and you’ll receive a rationale explaining why, along with one or more references.

You’ll have 4 minutes to answer each question and can add extra time if needed by drawing from an annual 30-minute time bank. For each correct answer, you’ll earn 0.2 MOC points, and if you choose to participate in LKA for more than one of your certificates, you’ll have even more opportunities to earn points. In addition, beginning in your second year of participation, interim score reports will give you helpful information to let you know how you’re doing, so you can re-adjust your approach and focus your studies as needed. A pass/fail decision is made at the end of the 5-year cycle.
 

About eligibility

If you are currently certified in Critical Care Medicine or Pulmonary Disease and had an assessment due in 2020, 2021 or 2022, you don’t need to take an assessment this year and will be eligible to enroll in the LKA in 2023, or you can choose to take the traditional 10-year MOC exam.

Upon enrolling, you will continue to be reported as “Certified” as long as you are meeting the LKA Participation Requirement. If your next assessment isn’t due for a while, you will be able to enroll in the LKA in your assessment due year—not before then.

More information about eligibility can be found in a special section of ABIM’s website.
 

How much does it cost?

ABIM revised its MOC fees in 2022 to provide an option to pay less over time than previously, and the LKA will be included in your annual MOC fee at no additional cost. Here’s how it works:

In closing

Thousands of physicians have already started taking the LKA in 2022 and are reporting positive experiences with it. The ABIM is excited that physicians in additional disciplines, including Critical Care Medicine and Pulmonary Disease, will get to experience it themselves in 2023.

Physicians from every specialty have stepped up in extraordinary ways during the pandemic; however, ABIM recognizes that pulmonary disease and critical care physicians, along with hospitalists and infectious disease specialists, have been especially burdened. ABIM has heard from many pulmonary disease and critical care medicine physicians asking for greater flexibility and choice in how they can maintain their board certifications.

For that reason, ABIM has extended deadlines for all Maintenance of Certification (MOC) requirements to 12/31/22 and to 2023 for Critical Care Medicine, Hospital Medicine, Infectious Disease, and Pulmonary Disease.
 

What assessment options does ABIM offer?

If you haven’t needed to take an MOC exam for a while, you might not be aware of ABIM’s current options and how they might work for you:

• The traditional, 10-year MOC assessment (a point-in-time exam taken at a test center)
• The new Longitudinal Knowledge Assessment (LKATM) (available in 12 specialties including Internal Medicine and Sleep Medicine now, and in Critical Care Medicine and Pulmonary Disease in 2023)

The 2-year Knowledge Check-In was retired at the end of 2021 with the introduction of the LKA.
 

How the new LKA works

As a longitudinal assessment, the LKA is designed to help you measure your medical knowledge over time and better melds assessment and learning. It consists of a 5-year cycle, during which you’ll be offered 30 questions each quarter, and need to open at least 500 out of 600 questions to meet the LKA Participation Requirement. You can choose not to open up to 100 questions over 5 years, allowing you to take breaks when you need them.

Once enrolled, you can take questions on your laptop, desktop, or smartphone. You’ll also be able to answer questions where and when it’s convenient for you, such as at your home or office – with no need to schedule an appointment or go to a test center. You can use all the same resources you use in practice – journals, apps, and your own personal notes—anything except another person. For most questions, you’ll find out immediately if your answer was correct or not, and you’ll receive a rationale explaining why, along with one or more references.

You’ll have 4 minutes to answer each question and can add extra time if needed by drawing from an annual 30-minute time bank. For each correct answer, you’ll earn 0.2 MOC points, and if you choose to participate in LKA for more than one of your certificates, you’ll have even more opportunities to earn points. In addition, beginning in your second year of participation, interim score reports will give you helpful information to let you know how you’re doing, so you can re-adjust your approach and focus your studies as needed. A pass/fail decision is made at the end of the 5-year cycle.
 

About eligibility

If you are currently certified in Critical Care Medicine or Pulmonary Disease and had an assessment due in 2020, 2021 or 2022, you don’t need to take an assessment this year and will be eligible to enroll in the LKA in 2023, or you can choose to take the traditional 10-year MOC exam.

Upon enrolling, you will continue to be reported as “Certified” as long as you are meeting the LKA Participation Requirement. If your next assessment isn’t due for a while, you will be able to enroll in the LKA in your assessment due year—not before then.

More information about eligibility can be found in a special section of ABIM’s website.
 

How much does it cost?

ABIM revised its MOC fees in 2022 to provide an option to pay less over time than previously, and the LKA will be included in your annual MOC fee at no additional cost. Here’s how it works:

In closing

Thousands of physicians have already started taking the LKA in 2022 and are reporting positive experiences with it. The ABIM is excited that physicians in additional disciplines, including Critical Care Medicine and Pulmonary Disease, will get to experience it themselves in 2023.

Since its inception, the CMS Sep-1 Core Quality Measure has been unpopular in some circles. It is now under official attack by the American College of Emergency Physicians (ACEP) and the Infectious Diseases Society of America (IDSA), along with a handful of smaller professional societies. These societies appealed the National Quality Forum’s (NQF) 2021 recommendation that the measure be renewed. The NQF is the multidisciplinary and broadly representative group of evaluators who evaluate proposals for CMS-sponsored quality improvement on behalf of the American people and of the Centers for Medicare & Medicaid Services (CMS). Readers of CHEST Physician are likely familiar with core measures, in general, and with Sep-1, in particular. CMS requires hospitals to publicly report their compliance with several Core Quality Measures, and the failure to do so results in across the board reductions in Medicare payments. As of now, no penalties are levied for the degree of compliance but only for failure to report the degree of compliance.

The measure asks, in the main, for hospitals to perform what most physicians can agree should be standard care for patients with sepsis. Depending on whether shock is present, the measure requires:

1. Blood cultures before antibiotics

2. Antibiotics within 3 hours of recognition of sepsis

3. Serum lactate measurement in the first 3 hours and, if increased, a repeat measurement by 6 hours

4. If the patient is hypotensive, 30 mL/kg IV crystalloid within 3 hours, or documentation of why that is not appropriate for the patient

5. If hypotension persists, vasopressors within 6 hours

6. Repeat cardiovascular assessment within 6 hours for patients with shock

If I evaluate these criteria as a patient who has been hospitalized for a serious infection, which I am, they do not seem particularly stringent. In fact, as a patient, I would want my doctors and nurses to act substantially faster than this if I had sepsis or septic shock. If my doctor did not come back in less than 6 hours to check on my shock status, I would be disappointed, to say the least. Nevertheless, some physicians and professional societies see no reason why these should be standards and state that the data underlying them are of low quality. Meanwhile, according to CMS’ own careful evaluation, national compliance with the measures is less than 50%, while being compliant with the measures reduces absolute overall mortality by approximately 4%, from 26.3% to 22.2% (Townsend SR et al. Chest. 2022;161[2]:392-406). This would translate to between 14,000 and 15,000 fewer patients dying from sepsis per year, if all patients received bundled, measure-compliant care. These are patients I don’t care to ignore.

ACEP and IDSA point specifically to the new Surviving Sepsis Campaign Guidelines (SSC) recommendations as evidence that the antibiotic measure is based on low quality evidence (Evans L et al. Crit Care Med. 2021;49[11]:1974-82). In this regard, they are technically correct; the system of evidence review that the SSC panel uses, Grading of Assessment, Recommendations, and Evaluation (GRADE), considers that retrospective analyses, which nearly all of these studies are, can be graded no higher than low quality. Clearly, retrospective studies will never achieve the level of certainty that we achieve with randomized controlled trials, but the NQF, itself, typically views that when a number of well-performed retrospective studies point in the same direction, the level of evidence is at least moderate. After all, just as it would be inappropriate to randomize participants to decades of smoking vs nonsmoking in order prove that smoking causes lung cancer, it is not appropriate to randomize patients with sepsis to receive delayed antibiotics before we accept that such delays are harmful to them.

ACEP and IDSA also assert that the association of early antibiotics with survival is “stronger” for septic shock than for sepsis. In fact, the association is quite strong for both severities of illness. Until it progresses to septic shock, the expected mortality of sepsis is lower, and the percent reduction in mortality is less than for septic shock. However, the opportunity for lives preserved is quite large, because the number of patients with sepsis at presentation is approximately 10 times higher than the number with septic shock at presentation. Antibiotic delays are also associated with progression from infection or sepsis to septic shock (Whiles BB et al. Crit Care Med. 2017;45[4]:623-29; Bisarya R et al. Chest. 2022;161[1]:112-20). Importantly, SSC gave a strong recommendation for all patients with suspected sepsis to receive antibiotics within 3 hours of suspecting sepsis and within 1 hour of suspecting septic shock, a recommendation even stronger than that of Sep-1.

Critics opine that CMS should stop looking at the process measures and focus only on the outcomes of sepsis care. There is a certain attractiveness to this proposition. One could say that it does not matter so much how a hospital achieves lower mortality as long as they do achieve it. However, the question would then become – how low should the mortality rate be? I have a notion that whatever the number, the Sep-1 critics would find it unbearable.

There is a core principle embedded in the Sep-1 process measures, in SSC guidelines, and in the concept of early goal-directed therapy that preceded them: success is not dependent only on what we do but on when we do it. All of you have experienced this. Each of you has attended a professional school, whether medical, nursing, respiratory therapy, etc. None of you showed up unannounced on opening day of the semester and was admitted to that school. All of you garnered the grades, solicited the letters of recommendation, took the entrance exams, and submitted an application. Some of you went to an interview. All of these things were done in a timely fashion; professional schools do not accept incomplete applications or late applications. Doing the right things at the wrong time would have left us all pursuing different careers.

Very early in my career as an attending physician in the ICU, I found myself exasperated by the circumstances of many patients who we received in the ICU with sepsis. I would peruse their medical records and find that they had been septic, ie, had met criteria for severe sepsis, 1 to 2 days before their deterioration to septic shock, yet they had not been diagnosed with sepsis until shock developed. In the ICU, we began resuscitative fluids, ensured appropriate antibiotics, and started vasopressors, but it was often to no avail. The treatments we gave made no difference for many patients, because they were given too late. For me, this was career altering; much of my career since that time has focused on teaching medical personnel how to recognize sepsis, how to give timely and appropriate treatments, and how to keep the data to show when they have done that and when they have not.

Before Sep-1 many, if not most, of the hospitals in the United States had no particular strategy in place to recognize and treat patients with sepsis, even though it was and is the most common cause of death and the costliest condition in American hospitals. Now, most hospitals do have such strategies. Assertions by professional societies that it is difficult to collect the data for Sep-1 reporting are likely true. However, keeping patients safe and alive is a hospital’s primary reason for existing. As long as hospitals are tracking each antibiotic and every liter of fluid so that they can bill for them, my own ears are deaf to hearing that it is too difficult to make sure that we are doing our job. Modifying or eliminating Sep-1 for any reason except data that show we can clearly further improve the outcome for all patients with sepsis is the wrong move to make. So far, other professional societies want to remove elements of Sep-1 without evidence that it would improve our care for patients with sepsis or their outcomes. Thankfully, from the time we proposed the first criteria for diagnosing sepsis, CHEST has promoted what is best for patients, whether it is difficult or not.
 

Dr. Simpson is a pulmonologist and intensivist with an extensive background in sepsis and in critical care quality improvement, including by serving as a senior adviser to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services and an author of the 2016 and 2020 updates of the Surviving Sepsis Campaign Guidelines. Dr. Simpson is the senior medical adviser for Sepsis Alliance, a nationwide patient information and advocacy organization. He is the immediate past president of CHEST.

Since its inception, the CMS Sep-1 Core Quality Measure has been unpopular in some circles. It is now under official attack by the American College of Emergency Physicians (ACEP) and the Infectious Diseases Society of America (IDSA), along with a handful of smaller professional societies. These societies appealed the National Quality Forum’s (NQF) 2021 recommendation that the measure be renewed. The NQF is the multidisciplinary and broadly representative group of evaluators who evaluate proposals for CMS-sponsored quality improvement on behalf of the American people and of the Centers for Medicare & Medicaid Services (CMS). Readers of CHEST Physician are likely familiar with core measures, in general, and with Sep-1, in particular. CMS requires hospitals to publicly report their compliance with several Core Quality Measures, and the failure to do so results in across the board reductions in Medicare payments. As of now, no penalties are levied for the degree of compliance but only for failure to report the degree of compliance.

The measure asks, in the main, for hospitals to perform what most physicians can agree should be standard care for patients with sepsis. Depending on whether shock is present, the measure requires:

1. Blood cultures before antibiotics

2. Antibiotics within 3 hours of recognition of sepsis

3. Serum lactate measurement in the first 3 hours and, if increased, a repeat measurement by 6 hours

4. If the patient is hypotensive, 30 mL/kg IV crystalloid within 3 hours, or documentation of why that is not appropriate for the patient

5. If hypotension persists, vasopressors within 6 hours

6. Repeat cardiovascular assessment within 6 hours for patients with shock

If I evaluate these criteria as a patient who has been hospitalized for a serious infection, which I am, they do not seem particularly stringent. In fact, as a patient, I would want my doctors and nurses to act substantially faster than this if I had sepsis or septic shock. If my doctor did not come back in less than 6 hours to check on my shock status, I would be disappointed, to say the least. Nevertheless, some physicians and professional societies see no reason why these should be standards and state that the data underlying them are of low quality. Meanwhile, according to CMS’ own careful evaluation, national compliance with the measures is less than 50%, while being compliant with the measures reduces absolute overall mortality by approximately 4%, from 26.3% to 22.2% (Townsend SR et al. Chest. 2022;161[2]:392-406). This would translate to between 14,000 and 15,000 fewer patients dying from sepsis per year, if all patients received bundled, measure-compliant care. These are patients I don’t care to ignore.

ACEP and IDSA point specifically to the new Surviving Sepsis Campaign Guidelines (SSC) recommendations as evidence that the antibiotic measure is based on low quality evidence (Evans L et al. Crit Care Med. 2021;49[11]:1974-82). In this regard, they are technically correct; the system of evidence review that the SSC panel uses, Grading of Assessment, Recommendations, and Evaluation (GRADE), considers that retrospective analyses, which nearly all of these studies are, can be graded no higher than low quality. Clearly, retrospective studies will never achieve the level of certainty that we achieve with randomized controlled trials, but the NQF, itself, typically views that when a number of well-performed retrospective studies point in the same direction, the level of evidence is at least moderate. After all, just as it would be inappropriate to randomize participants to decades of smoking vs nonsmoking in order prove that smoking causes lung cancer, it is not appropriate to randomize patients with sepsis to receive delayed antibiotics before we accept that such delays are harmful to them.

ACEP and IDSA also assert that the association of early antibiotics with survival is “stronger” for septic shock than for sepsis. In fact, the association is quite strong for both severities of illness. Until it progresses to septic shock, the expected mortality of sepsis is lower, and the percent reduction in mortality is less than for septic shock. However, the opportunity for lives preserved is quite large, because the number of patients with sepsis at presentation is approximately 10 times higher than the number with septic shock at presentation. Antibiotic delays are also associated with progression from infection or sepsis to septic shock (Whiles BB et al. Crit Care Med. 2017;45[4]:623-29; Bisarya R et al. Chest. 2022;161[1]:112-20). Importantly, SSC gave a strong recommendation for all patients with suspected sepsis to receive antibiotics within 3 hours of suspecting sepsis and within 1 hour of suspecting septic shock, a recommendation even stronger than that of Sep-1.

Critics opine that CMS should stop looking at the process measures and focus only on the outcomes of sepsis care. There is a certain attractiveness to this proposition. One could say that it does not matter so much how a hospital achieves lower mortality as long as they do achieve it. However, the question would then become – how low should the mortality rate be? I have a notion that whatever the number, the Sep-1 critics would find it unbearable.

There is a core principle embedded in the Sep-1 process measures, in SSC guidelines, and in the concept of early goal-directed therapy that preceded them: success is not dependent only on what we do but on when we do it. All of you have experienced this. Each of you has attended a professional school, whether medical, nursing, respiratory therapy, etc. None of you showed up unannounced on opening day of the semester and was admitted to that school. All of you garnered the grades, solicited the letters of recommendation, took the entrance exams, and submitted an application. Some of you went to an interview. All of these things were done in a timely fashion; professional schools do not accept incomplete applications or late applications. Doing the right things at the wrong time would have left us all pursuing different careers.

Very early in my career as an attending physician in the ICU, I found myself exasperated by the circumstances of many patients who we received in the ICU with sepsis. I would peruse their medical records and find that they had been septic, ie, had met criteria for severe sepsis, 1 to 2 days before their deterioration to septic shock, yet they had not been diagnosed with sepsis until shock developed. In the ICU, we began resuscitative fluids, ensured appropriate antibiotics, and started vasopressors, but it was often to no avail. The treatments we gave made no difference for many patients, because they were given too late. For me, this was career altering; much of my career since that time has focused on teaching medical personnel how to recognize sepsis, how to give timely and appropriate treatments, and how to keep the data to show when they have done that and when they have not.

Before Sep-1 many, if not most, of the hospitals in the United States had no particular strategy in place to recognize and treat patients with sepsis, even though it was and is the most common cause of death and the costliest condition in American hospitals. Now, most hospitals do have such strategies. Assertions by professional societies that it is difficult to collect the data for Sep-1 reporting are likely true. However, keeping patients safe and alive is a hospital’s primary reason for existing. As long as hospitals are tracking each antibiotic and every liter of fluid so that they can bill for them, my own ears are deaf to hearing that it is too difficult to make sure that we are doing our job. Modifying or eliminating Sep-1 for any reason except data that show we can clearly further improve the outcome for all patients with sepsis is the wrong move to make. So far, other professional societies want to remove elements of Sep-1 without evidence that it would improve our care for patients with sepsis or their outcomes. Thankfully, from the time we proposed the first criteria for diagnosing sepsis, CHEST has promoted what is best for patients, whether it is difficult or not.
 

Dr. Simpson is a pulmonologist and intensivist with an extensive background in sepsis and in critical care quality improvement, including by serving as a senior adviser to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services and an author of the 2016 and 2020 updates of the Surviving Sepsis Campaign Guidelines. Dr. Simpson is the senior medical adviser for Sepsis Alliance, a nationwide patient information and advocacy organization. He is the immediate past president of CHEST.

Since its inception, the CMS Sep-1 Core Quality Measure has been unpopular in some circles. It is now under official attack by the American College of Emergency Physicians (ACEP) and the Infectious Diseases Society of America (IDSA), along with a handful of smaller professional societies. These societies appealed the National Quality Forum’s (NQF) 2021 recommendation that the measure be renewed. The NQF is the multidisciplinary and broadly representative group of evaluators who evaluate proposals for CMS-sponsored quality improvement on behalf of the American people and of the Centers for Medicare & Medicaid Services (CMS). Readers of CHEST Physician are likely familiar with core measures, in general, and with Sep-1, in particular. CMS requires hospitals to publicly report their compliance with several Core Quality Measures, and the failure to do so results in across the board reductions in Medicare payments. As of now, no penalties are levied for the degree of compliance but only for failure to report the degree of compliance.

The measure asks, in the main, for hospitals to perform what most physicians can agree should be standard care for patients with sepsis. Depending on whether shock is present, the measure requires:

1. Blood cultures before antibiotics

2. Antibiotics within 3 hours of recognition of sepsis

3. Serum lactate measurement in the first 3 hours and, if increased, a repeat measurement by 6 hours

4. If the patient is hypotensive, 30 mL/kg IV crystalloid within 3 hours, or documentation of why that is not appropriate for the patient

5. If hypotension persists, vasopressors within 6 hours

6. Repeat cardiovascular assessment within 6 hours for patients with shock

If I evaluate these criteria as a patient who has been hospitalized for a serious infection, which I am, they do not seem particularly stringent. In fact, as a patient, I would want my doctors and nurses to act substantially faster than this if I had sepsis or septic shock. If my doctor did not come back in less than 6 hours to check on my shock status, I would be disappointed, to say the least. Nevertheless, some physicians and professional societies see no reason why these should be standards and state that the data underlying them are of low quality. Meanwhile, according to CMS’ own careful evaluation, national compliance with the measures is less than 50%, while being compliant with the measures reduces absolute overall mortality by approximately 4%, from 26.3% to 22.2% (Townsend SR et al. Chest. 2022;161[2]:392-406). This would translate to between 14,000 and 15,000 fewer patients dying from sepsis per year, if all patients received bundled, measure-compliant care. These are patients I don’t care to ignore.

ACEP and IDSA point specifically to the new Surviving Sepsis Campaign Guidelines (SSC) recommendations as evidence that the antibiotic measure is based on low quality evidence (Evans L et al. Crit Care Med. 2021;49[11]:1974-82). In this regard, they are technically correct; the system of evidence review that the SSC panel uses, Grading of Assessment, Recommendations, and Evaluation (GRADE), considers that retrospective analyses, which nearly all of these studies are, can be graded no higher than low quality. Clearly, retrospective studies will never achieve the level of certainty that we achieve with randomized controlled trials, but the NQF, itself, typically views that when a number of well-performed retrospective studies point in the same direction, the level of evidence is at least moderate. After all, just as it would be inappropriate to randomize participants to decades of smoking vs nonsmoking in order prove that smoking causes lung cancer, it is not appropriate to randomize patients with sepsis to receive delayed antibiotics before we accept that such delays are harmful to them.

ACEP and IDSA also assert that the association of early antibiotics with survival is “stronger” for septic shock than for sepsis. In fact, the association is quite strong for both severities of illness. Until it progresses to septic shock, the expected mortality of sepsis is lower, and the percent reduction in mortality is less than for septic shock. However, the opportunity for lives preserved is quite large, because the number of patients with sepsis at presentation is approximately 10 times higher than the number with septic shock at presentation. Antibiotic delays are also associated with progression from infection or sepsis to septic shock (Whiles BB et al. Crit Care Med. 2017;45[4]:623-29; Bisarya R et al. Chest. 2022;161[1]:112-20). Importantly, SSC gave a strong recommendation for all patients with suspected sepsis to receive antibiotics within 3 hours of suspecting sepsis and within 1 hour of suspecting septic shock, a recommendation even stronger than that of Sep-1.

Critics opine that CMS should stop looking at the process measures and focus only on the outcomes of sepsis care. There is a certain attractiveness to this proposition. One could say that it does not matter so much how a hospital achieves lower mortality as long as they do achieve it. However, the question would then become – how low should the mortality rate be? I have a notion that whatever the number, the Sep-1 critics would find it unbearable.

There is a core principle embedded in the Sep-1 process measures, in SSC guidelines, and in the concept of early goal-directed therapy that preceded them: success is not dependent only on what we do but on when we do it. All of you have experienced this. Each of you has attended a professional school, whether medical, nursing, respiratory therapy, etc. None of you showed up unannounced on opening day of the semester and was admitted to that school. All of you garnered the grades, solicited the letters of recommendation, took the entrance exams, and submitted an application. Some of you went to an interview. All of these things were done in a timely fashion; professional schools do not accept incomplete applications or late applications. Doing the right things at the wrong time would have left us all pursuing different careers.

Very early in my career as an attending physician in the ICU, I found myself exasperated by the circumstances of many patients who we received in the ICU with sepsis. I would peruse their medical records and find that they had been septic, ie, had met criteria for severe sepsis, 1 to 2 days before their deterioration to septic shock, yet they had not been diagnosed with sepsis until shock developed. In the ICU, we began resuscitative fluids, ensured appropriate antibiotics, and started vasopressors, but it was often to no avail. The treatments we gave made no difference for many patients, because they were given too late. For me, this was career altering; much of my career since that time has focused on teaching medical personnel how to recognize sepsis, how to give timely and appropriate treatments, and how to keep the data to show when they have done that and when they have not.

Before Sep-1 many, if not most, of the hospitals in the United States had no particular strategy in place to recognize and treat patients with sepsis, even though it was and is the most common cause of death and the costliest condition in American hospitals. Now, most hospitals do have such strategies. Assertions by professional societies that it is difficult to collect the data for Sep-1 reporting are likely true. However, keeping patients safe and alive is a hospital’s primary reason for existing. As long as hospitals are tracking each antibiotic and every liter of fluid so that they can bill for them, my own ears are deaf to hearing that it is too difficult to make sure that we are doing our job. Modifying or eliminating Sep-1 for any reason except data that show we can clearly further improve the outcome for all patients with sepsis is the wrong move to make. So far, other professional societies want to remove elements of Sep-1 without evidence that it would improve our care for patients with sepsis or their outcomes. Thankfully, from the time we proposed the first criteria for diagnosing sepsis, CHEST has promoted what is best for patients, whether it is difficult or not.
 

Dr. Simpson is a pulmonologist and intensivist with an extensive background in sepsis and in critical care quality improvement, including by serving as a senior adviser to the Solving Sepsis initiative of the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services and an author of the 2016 and 2020 updates of the Surviving Sepsis Campaign Guidelines. Dr. Simpson is the senior medical adviser for Sepsis Alliance, a nationwide patient information and advocacy organization. He is the immediate past president of CHEST.