After decades of off-label use, vinorelbine finally has a randomized clinical trial supporting its efficacy as a second-line treatment of mesothelioma, an investigator reported at the annual meeting of the American Society of Clinical Oncology.

However, the development of other treatment regimens, and notably immuno-oncology approaches, are pushing this classic chemotherapy option to later lines of therapy in patients with malignant pleural mesothelioma (MPM), a speaker said at the meeting.

Adding vinorelbine to active symptom control statistically improved progression-free survival (PFS), among patients with MPM who had prior platinum-based therapy, according to results of the randomized Vinorelbine in Mesothelioma (VIM) trial.

Median PFS reached 4.2 months in the vinorelbine arm, versus 2.8 months for active symptom control alone, study results show.

That finding , coupled with safety results, supports the off-label use of vinorelbine as a treatment option for patients with relapsed MPM, according to investigator Dean Anthony Fennell, FRCP, PhD, of the University of Leicester (England).

“Vinorelbine appears to be a safe and effective treatment and could be considered as a treatment option for patients with relapsed mesothelioma,” Prof. Fennell said in his presentation at ASCO (Abstract 8507).
 

Changing status

While that welcome pronouncement was a long time coming, there are now other promising treatment approaches that relegate vinorelbine to a “lower priority” in the treatment algorithm, said discussant Anna K. Nowak, MBBS, FRACP, PhD, of the University of Western Australia, Nedlands.

In October 2020, the U.S. Food and Drug Administration approved the combination of ipilimumab and nivolumab for the first-line treatment of unresectable malignant pleural mesothelioma, on the basis of results from CHECKMATE-743, a randomized, open-label trial.

“Certainly, we know now that first-line ipilimumab and nivolumab is of very substantial benefit to these patients, and we still have clinical trials open in this space as well,” Prof. Nowak said in her discussion at ASCO.

There is “no doubt” that many patients with mesothelioma should at some point receive an IO agent, particularly now with recently reported randomized clinical trial evidence of an overall survival benefit, she added.

“This really pushes vinorelbine out to be a third- or fourth-line treatment,” she added, “and we know that there are usually diminishing returns from using chemotherapies further down the treatment algorithm.”
 

Trial details

The VIM trial described at ASCO by Prof. Fennell was a randomized, controlled phase 2 including 154 patients with MPM that had progressed after first-line chemotherapy.

“Vinorelbine has shown useful clinical activity in single-arm phase two studies, however, the specific efficacy of vinorelbine has not been evaluated in an appropriately controlled randomized trial,” Prof. Fennell said in this presentation.

Patients in the trial were randomized 2:1 to either vinorelbine plus active supportive care or active supportive care alone. Vinorelbine was given initially at 60 mg/m² weekly every 21 days, escalated to 80 mg/m² from cycle 2.

The median age of patients in VIM was approximately 71 years, and about 80% were male.

More partial responses were seen in the vinorelbine arm, at 3.1% of patients, compared with 1.8% for active supportive care, according to Prof. Fennell. Likewise, the rate of stable disease was higher in the vinorelbine arm, at 62.2%, versus 46.4% in the control arm.

The primary outcome of the study, PFS, was significantly improved in the vinorelbine arm, according to Dr. Fennell. The median PFS was 4.2 months in the vinorelbine arm and 2.8 months in the supportive care arm (P = .002), translating into a hazard ratio of 0.60 (95% confidence interval, 0.41-0.86), Prof. Fennell reported.

The most common grade 3-4 adverse event was neutropenia, occurring in 12.5% of the vinorelbine-treated patients and no patients managed with supportive care alone, according to the report. Other grade 3-4 adverse events occurred in fewer than 10% of patients and included dyspnea, lower respiratory infection, lymphopenia, and fatigue, among others.

Overall survival (OS) was not statistically different between vinorelbine and supportive care arms, with median OS of 9.3 months and 9.1 months, respectively.

However, a number of patients in the control arm went on to receive subsequent therapy, including 15 (or about 27%) who went into CONFIRM, a randomized phase 3 trial that, as recently reported, met its coprimary endpoints of improve OS and PFS with nivolumab vs. placebo in relapsed malignant mesothelioma.

Investigators also sought to test the hypothesis that BRCA1-negative patients might be chemoresistant, based in part on preclinical models demonstrating that BRCA1 predicted sensitivity to vinorelbine. However, there was no difference in PFS by BRCA1 expression in the VIM study, according to Prof. Fennell.

Taken together, findings of the VIM trial suggest vinorelbine is a “modestly active” agent with low cost and acceptable toxicity, according to Prof. Nowak.

“It is incumbent on us to have clear discussions with our patients on the risks and benefits of trying this as a subsequent-line therapy, in the context of this evidence that was generated as a second-line therapy,” she said in her discussant remarks on the study.

“I would say that it is a lower priority in our algorithm than cisplatin and pemetrexed, or of course, immuno-oncology agents,” she added.

Dr. Fennell reported disclosures related to AstraZeneca, Astex Therapeutics, Bayer, and multiple other pharmaceutical companies. Dr. Nowak reported disclosures with AstraZeneca, Atara Biotherapeutics, Boehringer Ingelheim, and multiple other pharmaceutical companies.

After decades of off-label use, vinorelbine finally has a randomized clinical trial supporting its efficacy as a second-line treatment of mesothelioma, an investigator reported at the annual meeting of the American Society of Clinical Oncology.

However, the development of other treatment regimens, and notably immuno-oncology approaches, are pushing this classic chemotherapy option to later lines of therapy in patients with malignant pleural mesothelioma (MPM), a speaker said at the meeting.

Adding vinorelbine to active symptom control statistically improved progression-free survival (PFS), among patients with MPM who had prior platinum-based therapy, according to results of the randomized Vinorelbine in Mesothelioma (VIM) trial.

Median PFS reached 4.2 months in the vinorelbine arm, versus 2.8 months for active symptom control alone, study results show.

That finding , coupled with safety results, supports the off-label use of vinorelbine as a treatment option for patients with relapsed MPM, according to investigator Dean Anthony Fennell, FRCP, PhD, of the University of Leicester (England).

“Vinorelbine appears to be a safe and effective treatment and could be considered as a treatment option for patients with relapsed mesothelioma,” Prof. Fennell said in his presentation at ASCO (Abstract 8507).
 

Changing status

While that welcome pronouncement was a long time coming, there are now other promising treatment approaches that relegate vinorelbine to a “lower priority” in the treatment algorithm, said discussant Anna K. Nowak, MBBS, FRACP, PhD, of the University of Western Australia, Nedlands.

In October 2020, the U.S. Food and Drug Administration approved the combination of ipilimumab and nivolumab for the first-line treatment of unresectable malignant pleural mesothelioma, on the basis of results from CHECKMATE-743, a randomized, open-label trial.

“Certainly, we know now that first-line ipilimumab and nivolumab is of very substantial benefit to these patients, and we still have clinical trials open in this space as well,” Prof. Nowak said in her discussion at ASCO.

There is “no doubt” that many patients with mesothelioma should at some point receive an IO agent, particularly now with recently reported randomized clinical trial evidence of an overall survival benefit, she added.

“This really pushes vinorelbine out to be a third- or fourth-line treatment,” she added, “and we know that there are usually diminishing returns from using chemotherapies further down the treatment algorithm.”
 

Trial details

The VIM trial described at ASCO by Prof. Fennell was a randomized, controlled phase 2 including 154 patients with MPM that had progressed after first-line chemotherapy.

“Vinorelbine has shown useful clinical activity in single-arm phase two studies, however, the specific efficacy of vinorelbine has not been evaluated in an appropriately controlled randomized trial,” Prof. Fennell said in this presentation.

Patients in the trial were randomized 2:1 to either vinorelbine plus active supportive care or active supportive care alone. Vinorelbine was given initially at 60 mg/m² weekly every 21 days, escalated to 80 mg/m² from cycle 2.

The median age of patients in VIM was approximately 71 years, and about 80% were male.

More partial responses were seen in the vinorelbine arm, at 3.1% of patients, compared with 1.8% for active supportive care, according to Prof. Fennell. Likewise, the rate of stable disease was higher in the vinorelbine arm, at 62.2%, versus 46.4% in the control arm.

The primary outcome of the study, PFS, was significantly improved in the vinorelbine arm, according to Dr. Fennell. The median PFS was 4.2 months in the vinorelbine arm and 2.8 months in the supportive care arm (P = .002), translating into a hazard ratio of 0.60 (95% confidence interval, 0.41-0.86), Prof. Fennell reported.

The most common grade 3-4 adverse event was neutropenia, occurring in 12.5% of the vinorelbine-treated patients and no patients managed with supportive care alone, according to the report. Other grade 3-4 adverse events occurred in fewer than 10% of patients and included dyspnea, lower respiratory infection, lymphopenia, and fatigue, among others.

Overall survival (OS) was not statistically different between vinorelbine and supportive care arms, with median OS of 9.3 months and 9.1 months, respectively.

However, a number of patients in the control arm went on to receive subsequent therapy, including 15 (or about 27%) who went into CONFIRM, a randomized phase 3 trial that, as recently reported, met its coprimary endpoints of improve OS and PFS with nivolumab vs. placebo in relapsed malignant mesothelioma.

Investigators also sought to test the hypothesis that BRCA1-negative patients might be chemoresistant, based in part on preclinical models demonstrating that BRCA1 predicted sensitivity to vinorelbine. However, there was no difference in PFS by BRCA1 expression in the VIM study, according to Prof. Fennell.

Taken together, findings of the VIM trial suggest vinorelbine is a “modestly active” agent with low cost and acceptable toxicity, according to Prof. Nowak.

“It is incumbent on us to have clear discussions with our patients on the risks and benefits of trying this as a subsequent-line therapy, in the context of this evidence that was generated as a second-line therapy,” she said in her discussant remarks on the study.

“I would say that it is a lower priority in our algorithm than cisplatin and pemetrexed, or of course, immuno-oncology agents,” she added.

Dr. Fennell reported disclosures related to AstraZeneca, Astex Therapeutics, Bayer, and multiple other pharmaceutical companies. Dr. Nowak reported disclosures with AstraZeneca, Atara Biotherapeutics, Boehringer Ingelheim, and multiple other pharmaceutical companies.

After decades of off-label use, vinorelbine finally has a randomized clinical trial supporting its efficacy as a second-line treatment of mesothelioma, an investigator reported at the annual meeting of the American Society of Clinical Oncology.

However, the development of other treatment regimens, and notably immuno-oncology approaches, are pushing this classic chemotherapy option to later lines of therapy in patients with malignant pleural mesothelioma (MPM), a speaker said at the meeting.

Adding vinorelbine to active symptom control statistically improved progression-free survival (PFS), among patients with MPM who had prior platinum-based therapy, according to results of the randomized Vinorelbine in Mesothelioma (VIM) trial.

Median PFS reached 4.2 months in the vinorelbine arm, versus 2.8 months for active symptom control alone, study results show.

That finding , coupled with safety results, supports the off-label use of vinorelbine as a treatment option for patients with relapsed MPM, according to investigator Dean Anthony Fennell, FRCP, PhD, of the University of Leicester (England).

“Vinorelbine appears to be a safe and effective treatment and could be considered as a treatment option for patients with relapsed mesothelioma,” Prof. Fennell said in his presentation at ASCO (Abstract 8507).
 

Changing status

While that welcome pronouncement was a long time coming, there are now other promising treatment approaches that relegate vinorelbine to a “lower priority” in the treatment algorithm, said discussant Anna K. Nowak, MBBS, FRACP, PhD, of the University of Western Australia, Nedlands.

In October 2020, the U.S. Food and Drug Administration approved the combination of ipilimumab and nivolumab for the first-line treatment of unresectable malignant pleural mesothelioma, on the basis of results from CHECKMATE-743, a randomized, open-label trial.

“Certainly, we know now that first-line ipilimumab and nivolumab is of very substantial benefit to these patients, and we still have clinical trials open in this space as well,” Prof. Nowak said in her discussion at ASCO.

There is “no doubt” that many patients with mesothelioma should at some point receive an IO agent, particularly now with recently reported randomized clinical trial evidence of an overall survival benefit, she added.

“This really pushes vinorelbine out to be a third- or fourth-line treatment,” she added, “and we know that there are usually diminishing returns from using chemotherapies further down the treatment algorithm.”
 

Trial details

The VIM trial described at ASCO by Prof. Fennell was a randomized, controlled phase 2 including 154 patients with MPM that had progressed after first-line chemotherapy.

“Vinorelbine has shown useful clinical activity in single-arm phase two studies, however, the specific efficacy of vinorelbine has not been evaluated in an appropriately controlled randomized trial,” Prof. Fennell said in this presentation.

Patients in the trial were randomized 2:1 to either vinorelbine plus active supportive care or active supportive care alone. Vinorelbine was given initially at 60 mg/m² weekly every 21 days, escalated to 80 mg/m² from cycle 2.

The median age of patients in VIM was approximately 71 years, and about 80% were male.

More partial responses were seen in the vinorelbine arm, at 3.1% of patients, compared with 1.8% for active supportive care, according to Prof. Fennell. Likewise, the rate of stable disease was higher in the vinorelbine arm, at 62.2%, versus 46.4% in the control arm.

The primary outcome of the study, PFS, was significantly improved in the vinorelbine arm, according to Dr. Fennell. The median PFS was 4.2 months in the vinorelbine arm and 2.8 months in the supportive care arm (P = .002), translating into a hazard ratio of 0.60 (95% confidence interval, 0.41-0.86), Prof. Fennell reported.

The most common grade 3-4 adverse event was neutropenia, occurring in 12.5% of the vinorelbine-treated patients and no patients managed with supportive care alone, according to the report. Other grade 3-4 adverse events occurred in fewer than 10% of patients and included dyspnea, lower respiratory infection, lymphopenia, and fatigue, among others.

Overall survival (OS) was not statistically different between vinorelbine and supportive care arms, with median OS of 9.3 months and 9.1 months, respectively.

However, a number of patients in the control arm went on to receive subsequent therapy, including 15 (or about 27%) who went into CONFIRM, a randomized phase 3 trial that, as recently reported, met its coprimary endpoints of improve OS and PFS with nivolumab vs. placebo in relapsed malignant mesothelioma.

Investigators also sought to test the hypothesis that BRCA1-negative patients might be chemoresistant, based in part on preclinical models demonstrating that BRCA1 predicted sensitivity to vinorelbine. However, there was no difference in PFS by BRCA1 expression in the VIM study, according to Prof. Fennell.

Taken together, findings of the VIM trial suggest vinorelbine is a “modestly active” agent with low cost and acceptable toxicity, according to Prof. Nowak.

“It is incumbent on us to have clear discussions with our patients on the risks and benefits of trying this as a subsequent-line therapy, in the context of this evidence that was generated as a second-line therapy,” she said in her discussant remarks on the study.

“I would say that it is a lower priority in our algorithm than cisplatin and pemetrexed, or of course, immuno-oncology agents,” she added.

Dr. Fennell reported disclosures related to AstraZeneca, Astex Therapeutics, Bayer, and multiple other pharmaceutical companies. Dr. Nowak reported disclosures with AstraZeneca, Atara Biotherapeutics, Boehringer Ingelheim, and multiple other pharmaceutical companies.

Primary care practices with zero burnout are more often solo practices owned by physicians and practices not involved in transformation initiatives, such as accountable care organizations (ACOs), according to an analysis published June 7 in Health Affairs.

The findings may have particular significance in an era when more physicians are being employed by hospitals and health systems, says lead author Samuel T. Edwards, MD, an assistant professor of medicine at Oregon Health & Science University, Portland.

“Market forces and various reform efforts have driven practices to consolidate, and we certainly see some signal here that burnout might be a potential negative consequence of that,” said Dr. Edwards, who is also a staff physician in internal medicine at the Veterans Affairs Portland Health Care System.
 

30% of practices reported zero burnout

Dr. Edwards told this news organization that he was surprised that 30% of the practices surveyed for this analysis reported zero burnout – meaning no member of the practice reported burnout – because reports of burnout are so pervasive in medicine.

For comparison, in 13% of practices surveyed, more than 40% of practice members reported burnout.

Burnout was assessed with a five-point measure that correlates with the emotional exhaustion scale of the Maslach Burnout Inventory.

It was also surprising, Dr. Edwards said, that practices with some of the heaviest workloads – solo practitioners juggling large numbers of patients, insurance plans, and regulatory requirements – were much more likely than larger practices to report zero burnout.

In this study, solo practices were 5.3 times as likely as practices with 6 to 10 clinicians to report zero burnout (95% confidence interval, 1.25-22.6).

The researchers found no link between burnout and patient volume or the proportion of patients with Medicaid insurance.

“People assume that working harder is associated with more burnout, and there are lots of studies that say that’s true. But in our study, it appears that people work really hard in some settings and are not burned out,” Dr. Edwards said.

He says in small offices, there may be a stronger sense of agency, a sense that everyone is on the same team, and there may be stronger relationships with patients.

The study included survey data from 715 small- to medium-size primary care practices in the United States that participated in the Agency for Healthcare Research and Quality’s EvidenceNOW quality improvement initiative between September 2015 and June 2017.

Zero-burnout practices shared several traits. They were more likely to have “a strong practice culture – one in which teamwork, communication, psychological safety, mindfulness of others, facilitative leadership, and understanding that people make and can learn from mistakes were among the key attributes,” Dr. Edwards and colleagues write.
 

Burnout higher with ACO participation

Organizations that participated in ACOs and other external primary care transformation projects were more likely to have high burnout rates. Specifically, 29% of these practices reported zero burnout, versus 53% that reported high rates of burnout.

Dr. Edwards said the reasons for that are unclear in this cross-sectional study, but there seemed to be an indication that getting involved in too many demonstration projects might be associated with burnout. He noted that participants in this study were already involved in the EvidenceNOW initiative.

Factors regarding electronic health records (EHRs) were not tied to burnout in this study. Dr. Edwards said they surveyed for both satisfaction with EHRs and EHR features and whether they were linked to zero burnout.

He speculates that this may indicate that by now, practices have adapted to using EHRs, though they continue to be a source of frustration for individual clinicians.

Debora Goetz Goldberg, PhD, MHA, MBA, associate professor at George Mason University, McLean, Virginia, told this news organization that she has found similar results in her research of primary care practices and burnout. She found that health system–owned practices had higher levels of burnout.

“We thought that probably was related to less autonomy and decision-making authority,” she said.

She pointed out that Dr. Edwards and colleagues found that physicians who had more “adaptive reserves” were more likely to have zero burnout. Her research found a similar association.

Such organizations, she explained, have a higher level of organizational development and a culture of innovation. They are more comfortable with change and adapt well.

“They are characterized by teamwork, strong communication, and a culture of learning,” she said.

By contrast, burnout may be higher in health system–owned practices because clinicians may feel they have less control over their work environment and feel a loss of autonomy, according to Dr. Goldberg.

“Moral distress,” which can happen when an individual’s professional values don’t line up with an organization’s values, may also play a part, she said. Physicians may be required to see more patients than they feel they can serve well in a day, for instance.

Reducing burnout may take building a more collaborative leadership style, she said.
 

No link between burnout and patient volume

The current research also highlighted leadership style as a potential driver of burnout.

Dr. Edwards and colleagues found that one of the strongest associations was between facilitative leadership and low burnout. Zero burnout is associated with participatory decision-making.

“Interestingly, we saw that that kind of leadership could exist in multiple settings,” he said. Health care professionals in smaller practices might know each other better and have a shared mission, but shared decision making can also exist in larger practices, he said.

Higher burnout was associated with traditional leadership models that are hierarchical and that operate with a command-and-control structure, according to the study.

The data may have implications for strategies regarding both the smallest and largest practices.

Initiatives that help small practices remain strong are valuable, especially for communities that depend on those practices, Dr. Edwards said.

The researchers give as an example the funding of primary care practice extension networks, which provide support similar to agricultural extension programs for farmers.

At the same time, “having agency at the practice level about how things work is really important in reducing burnout. So in a large system, finding ways to promote agency at the most local level possible can really help with burnout,” he said.

Dr. Edwards said his team controlled for the fact that mathematically, it’s more likely zero burnout would be reported in a solo practice than in a larger practice.

Every practice in this study, he said, had to have at least three persons who responded to the survey, and responses had to represent three roles – a clinician, a nonclinician staff member, and a clinical staff member. The response rate also had to be 50% within the practice, he explained.

All authors are supported by the Agency for Healthcare Research and Quality. Dr. Edwards was also supported by the Department of Veterans Affairs Health Services Research and Development. Dr. Goldberg has disclosed no relevant financial relationships.

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

Primary care practices with zero burnout are more often solo practices owned by physicians and practices not involved in transformation initiatives, such as accountable care organizations (ACOs), according to an analysis published June 7 in Health Affairs.

The findings may have particular significance in an era when more physicians are being employed by hospitals and health systems, says lead author Samuel T. Edwards, MD, an assistant professor of medicine at Oregon Health & Science University, Portland.

“Market forces and various reform efforts have driven practices to consolidate, and we certainly see some signal here that burnout might be a potential negative consequence of that,” said Dr. Edwards, who is also a staff physician in internal medicine at the Veterans Affairs Portland Health Care System.
 

30% of practices reported zero burnout

Dr. Edwards told this news organization that he was surprised that 30% of the practices surveyed for this analysis reported zero burnout – meaning no member of the practice reported burnout – because reports of burnout are so pervasive in medicine.

For comparison, in 13% of practices surveyed, more than 40% of practice members reported burnout.

Burnout was assessed with a five-point measure that correlates with the emotional exhaustion scale of the Maslach Burnout Inventory.

It was also surprising, Dr. Edwards said, that practices with some of the heaviest workloads – solo practitioners juggling large numbers of patients, insurance plans, and regulatory requirements – were much more likely than larger practices to report zero burnout.

In this study, solo practices were 5.3 times as likely as practices with 6 to 10 clinicians to report zero burnout (95% confidence interval, 1.25-22.6).

The researchers found no link between burnout and patient volume or the proportion of patients with Medicaid insurance.

“People assume that working harder is associated with more burnout, and there are lots of studies that say that’s true. But in our study, it appears that people work really hard in some settings and are not burned out,” Dr. Edwards said.

He says in small offices, there may be a stronger sense of agency, a sense that everyone is on the same team, and there may be stronger relationships with patients.

The study included survey data from 715 small- to medium-size primary care practices in the United States that participated in the Agency for Healthcare Research and Quality’s EvidenceNOW quality improvement initiative between September 2015 and June 2017.

Zero-burnout practices shared several traits. They were more likely to have “a strong practice culture – one in which teamwork, communication, psychological safety, mindfulness of others, facilitative leadership, and understanding that people make and can learn from mistakes were among the key attributes,” Dr. Edwards and colleagues write.
 

Burnout higher with ACO participation

Organizations that participated in ACOs and other external primary care transformation projects were more likely to have high burnout rates. Specifically, 29% of these practices reported zero burnout, versus 53% that reported high rates of burnout.

Dr. Edwards said the reasons for that are unclear in this cross-sectional study, but there seemed to be an indication that getting involved in too many demonstration projects might be associated with burnout. He noted that participants in this study were already involved in the EvidenceNOW initiative.

Factors regarding electronic health records (EHRs) were not tied to burnout in this study. Dr. Edwards said they surveyed for both satisfaction with EHRs and EHR features and whether they were linked to zero burnout.

He speculates that this may indicate that by now, practices have adapted to using EHRs, though they continue to be a source of frustration for individual clinicians.

Debora Goetz Goldberg, PhD, MHA, MBA, associate professor at George Mason University, McLean, Virginia, told this news organization that she has found similar results in her research of primary care practices and burnout. She found that health system–owned practices had higher levels of burnout.

“We thought that probably was related to less autonomy and decision-making authority,” she said.

She pointed out that Dr. Edwards and colleagues found that physicians who had more “adaptive reserves” were more likely to have zero burnout. Her research found a similar association.

Such organizations, she explained, have a higher level of organizational development and a culture of innovation. They are more comfortable with change and adapt well.

“They are characterized by teamwork, strong communication, and a culture of learning,” she said.

By contrast, burnout may be higher in health system–owned practices because clinicians may feel they have less control over their work environment and feel a loss of autonomy, according to Dr. Goldberg.

“Moral distress,” which can happen when an individual’s professional values don’t line up with an organization’s values, may also play a part, she said. Physicians may be required to see more patients than they feel they can serve well in a day, for instance.

Reducing burnout may take building a more collaborative leadership style, she said.
 

No link between burnout and patient volume

The current research also highlighted leadership style as a potential driver of burnout.

Dr. Edwards and colleagues found that one of the strongest associations was between facilitative leadership and low burnout. Zero burnout is associated with participatory decision-making.

“Interestingly, we saw that that kind of leadership could exist in multiple settings,” he said. Health care professionals in smaller practices might know each other better and have a shared mission, but shared decision making can also exist in larger practices, he said.

Higher burnout was associated with traditional leadership models that are hierarchical and that operate with a command-and-control structure, according to the study.

The data may have implications for strategies regarding both the smallest and largest practices.

Initiatives that help small practices remain strong are valuable, especially for communities that depend on those practices, Dr. Edwards said.

The researchers give as an example the funding of primary care practice extension networks, which provide support similar to agricultural extension programs for farmers.

At the same time, “having agency at the practice level about how things work is really important in reducing burnout. So in a large system, finding ways to promote agency at the most local level possible can really help with burnout,” he said.

Dr. Edwards said his team controlled for the fact that mathematically, it’s more likely zero burnout would be reported in a solo practice than in a larger practice.

Every practice in this study, he said, had to have at least three persons who responded to the survey, and responses had to represent three roles – a clinician, a nonclinician staff member, and a clinical staff member. The response rate also had to be 50% within the practice, he explained.

All authors are supported by the Agency for Healthcare Research and Quality. Dr. Edwards was also supported by the Department of Veterans Affairs Health Services Research and Development. Dr. Goldberg has disclosed no relevant financial relationships.

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

Primary care practices with zero burnout are more often solo practices owned by physicians and practices not involved in transformation initiatives, such as accountable care organizations (ACOs), according to an analysis published June 7 in Health Affairs.

The findings may have particular significance in an era when more physicians are being employed by hospitals and health systems, says lead author Samuel T. Edwards, MD, an assistant professor of medicine at Oregon Health & Science University, Portland.

“Market forces and various reform efforts have driven practices to consolidate, and we certainly see some signal here that burnout might be a potential negative consequence of that,” said Dr. Edwards, who is also a staff physician in internal medicine at the Veterans Affairs Portland Health Care System.
 

30% of practices reported zero burnout

Dr. Edwards told this news organization that he was surprised that 30% of the practices surveyed for this analysis reported zero burnout – meaning no member of the practice reported burnout – because reports of burnout are so pervasive in medicine.

For comparison, in 13% of practices surveyed, more than 40% of practice members reported burnout.

Burnout was assessed with a five-point measure that correlates with the emotional exhaustion scale of the Maslach Burnout Inventory.

It was also surprising, Dr. Edwards said, that practices with some of the heaviest workloads – solo practitioners juggling large numbers of patients, insurance plans, and regulatory requirements – were much more likely than larger practices to report zero burnout.

In this study, solo practices were 5.3 times as likely as practices with 6 to 10 clinicians to report zero burnout (95% confidence interval, 1.25-22.6).

The researchers found no link between burnout and patient volume or the proportion of patients with Medicaid insurance.

“People assume that working harder is associated with more burnout, and there are lots of studies that say that’s true. But in our study, it appears that people work really hard in some settings and are not burned out,” Dr. Edwards said.

He says in small offices, there may be a stronger sense of agency, a sense that everyone is on the same team, and there may be stronger relationships with patients.

The study included survey data from 715 small- to medium-size primary care practices in the United States that participated in the Agency for Healthcare Research and Quality’s EvidenceNOW quality improvement initiative between September 2015 and June 2017.

Zero-burnout practices shared several traits. They were more likely to have “a strong practice culture – one in which teamwork, communication, psychological safety, mindfulness of others, facilitative leadership, and understanding that people make and can learn from mistakes were among the key attributes,” Dr. Edwards and colleagues write.
 

Burnout higher with ACO participation

Organizations that participated in ACOs and other external primary care transformation projects were more likely to have high burnout rates. Specifically, 29% of these practices reported zero burnout, versus 53% that reported high rates of burnout.

Dr. Edwards said the reasons for that are unclear in this cross-sectional study, but there seemed to be an indication that getting involved in too many demonstration projects might be associated with burnout. He noted that participants in this study were already involved in the EvidenceNOW initiative.

Factors regarding electronic health records (EHRs) were not tied to burnout in this study. Dr. Edwards said they surveyed for both satisfaction with EHRs and EHR features and whether they were linked to zero burnout.

He speculates that this may indicate that by now, practices have adapted to using EHRs, though they continue to be a source of frustration for individual clinicians.

Debora Goetz Goldberg, PhD, MHA, MBA, associate professor at George Mason University, McLean, Virginia, told this news organization that she has found similar results in her research of primary care practices and burnout. She found that health system–owned practices had higher levels of burnout.

“We thought that probably was related to less autonomy and decision-making authority,” she said.

She pointed out that Dr. Edwards and colleagues found that physicians who had more “adaptive reserves” were more likely to have zero burnout. Her research found a similar association.

Such organizations, she explained, have a higher level of organizational development and a culture of innovation. They are more comfortable with change and adapt well.

“They are characterized by teamwork, strong communication, and a culture of learning,” she said.

By contrast, burnout may be higher in health system–owned practices because clinicians may feel they have less control over their work environment and feel a loss of autonomy, according to Dr. Goldberg.

“Moral distress,” which can happen when an individual’s professional values don’t line up with an organization’s values, may also play a part, she said. Physicians may be required to see more patients than they feel they can serve well in a day, for instance.

Reducing burnout may take building a more collaborative leadership style, she said.
 

No link between burnout and patient volume

The current research also highlighted leadership style as a potential driver of burnout.

Dr. Edwards and colleagues found that one of the strongest associations was between facilitative leadership and low burnout. Zero burnout is associated with participatory decision-making.

“Interestingly, we saw that that kind of leadership could exist in multiple settings,” he said. Health care professionals in smaller practices might know each other better and have a shared mission, but shared decision making can also exist in larger practices, he said.

Higher burnout was associated with traditional leadership models that are hierarchical and that operate with a command-and-control structure, according to the study.

The data may have implications for strategies regarding both the smallest and largest practices.

Initiatives that help small practices remain strong are valuable, especially for communities that depend on those practices, Dr. Edwards said.

The researchers give as an example the funding of primary care practice extension networks, which provide support similar to agricultural extension programs for farmers.

At the same time, “having agency at the practice level about how things work is really important in reducing burnout. So in a large system, finding ways to promote agency at the most local level possible can really help with burnout,” he said.

Dr. Edwards said his team controlled for the fact that mathematically, it’s more likely zero burnout would be reported in a solo practice than in a larger practice.

Every practice in this study, he said, had to have at least three persons who responded to the survey, and responses had to represent three roles – a clinician, a nonclinician staff member, and a clinical staff member. The response rate also had to be 50% within the practice, he explained.

All authors are supported by the Agency for Healthcare Research and Quality. Dr. Edwards was also supported by the Department of Veterans Affairs Health Services Research and Development. Dr. Goldberg has disclosed no relevant financial relationships.

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

Due to the condition’s persistence and the negative KOH prep, erythrasma was the most likely diagnosis.

Erythrasma is caused by a bacterial infection with Corynebacterium minutissimum. It occurs in intertriginous areas that tend to be moist and irritated by friction. The erythema is usually a dull red, rather than the bright red that one would see with yeast infections. In addition, there is typically central pallor.

Woods lamp examination can confirm the diagnosis by showing coral pink fluorescence. In this patient, however, there was no fluorescence because the patient had recently washed the area and, thus, removed the porphyrins produced by C minutissimum. Biopsy for pathology is not usually necessary.

Erythrasma is treated with topical clindamycin, fusidic acid, or mupirocin. Oral macrolides and tetracyclines are also effective.¹ Due to the chronicity of the erythrasma and the discomfort it caused, this patient opted for oral doxycycline 100 mg twice daily for 10 days. At follow-up 2 weeks later, the erythrasma had resolved.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Due to the condition’s persistence and the negative KOH prep, erythrasma was the most likely diagnosis.

Erythrasma is caused by a bacterial infection with Corynebacterium minutissimum. It occurs in intertriginous areas that tend to be moist and irritated by friction. The erythema is usually a dull red, rather than the bright red that one would see with yeast infections. In addition, there is typically central pallor.

Woods lamp examination can confirm the diagnosis by showing coral pink fluorescence. In this patient, however, there was no fluorescence because the patient had recently washed the area and, thus, removed the porphyrins produced by C minutissimum. Biopsy for pathology is not usually necessary.

Erythrasma is treated with topical clindamycin, fusidic acid, or mupirocin. Oral macrolides and tetracyclines are also effective.¹ Due to the chronicity of the erythrasma and the discomfort it caused, this patient opted for oral doxycycline 100 mg twice daily for 10 days. At follow-up 2 weeks later, the erythrasma had resolved.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Due to the condition’s persistence and the negative KOH prep, erythrasma was the most likely diagnosis.

Erythrasma is caused by a bacterial infection with Corynebacterium minutissimum. It occurs in intertriginous areas that tend to be moist and irritated by friction. The erythema is usually a dull red, rather than the bright red that one would see with yeast infections. In addition, there is typically central pallor.

Woods lamp examination can confirm the diagnosis by showing coral pink fluorescence. In this patient, however, there was no fluorescence because the patient had recently washed the area and, thus, removed the porphyrins produced by C minutissimum. Biopsy for pathology is not usually necessary.

Erythrasma is treated with topical clindamycin, fusidic acid, or mupirocin. Oral macrolides and tetracyclines are also effective.¹ Due to the chronicity of the erythrasma and the discomfort it caused, this patient opted for oral doxycycline 100 mg twice daily for 10 days. At follow-up 2 weeks later, the erythrasma had resolved.

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque

Current guideline recommendations for fluid resuscitation in sepsis patients calls for an initial crystalloid fluid bolus of at least 30 mL/kg (Rhodes, et al. Intensive Care Med. 2017;43[3]:304-77) For fluid management beyond this initial bolus, recommendations had previously called for using early goal-directed therapy (EGDT) with central venous pressure (CVP) and central venous oxygen saturation to guide the use of IV fluids, vasopressors, transfusions, and dobutamine, based on the results of one single-center study that found an improvement in mortality using EGDT as compared with standard therapy.

The triad of sepsis studies

In the following years, multiple concerns were raised regarding the generalizability of this study. Three large multicenter trials were conducted in multiple countries to test the recommendations for EGDT.

PROMISE: ProMISe was a 1,260-patient randomized trial comparing the impact of EGDT vs usual care on 90-day all-cause mortality in patients with early septic shock at 56 hospitals in England. There was no significant difference in the primary study endpoint with 90-day mortality rates of 29.5% and 29.2% (RR: 1.01, 95% CI: 0.85-1.20, P =.90) (Mouncey, et al. N Engl J Med. 2015;372[14]:1301-11).

PROCESS: ProCESS was a 1,351-patient randomized trial comparing the impact of protocol-based EGDT, protocol-based standard of care, and usual care on 60 day in-hospital mortality in patients with early septic shock at 31 hospitals in the United States. There was no significant difference in the primary study endpoint with 60-day mortality rates of 21.0%, 18.2%, and 18.9% (P = .83) or in the secondary outcome of 90-day mortality with rates of 31.9%, 30.8%, and 33.7% (P = .66) (ProCESS Investigators, et al. N Engl J Med. 2014;370[18]:1683-93).

ARISE: ARISE was a 1,600-patient randomized trial comparing the impact of EGDT vs usual care on 90-day all-cause mortality in patients with early septic shock at 51 hospitals in New Zealand and Australia. There was no significant difference in the primary study end point with 90-day mortality rates of 18.6% and 18.8% (RR: 0.98, 95% CI: 0.80-1.21, P = .90). There were also no significant differences in 28-day or in-hospital mortality, duration of organ support, or length of hospital stay (ARISE Investigators, et al. N Engl J Med. 2014;371[16]:1496-506).

In summary, all three “triad” trials found no improvement with EGDT over usual care (Rowan, et al. N Engl J Med. 2017;376[23]:2223-34) calling into question the recommended methods of universally protocolized approaches to fluid and pressor resuscitation. Probable reasons for why structured EGDT was ineffective at improving outcomes over usual care in the “triad” trials was that (a) liberal fluid volume administration was the “usual care” in most enrolled patients and (b) that macrocirculatory hemodynamics, such as BP, and static intravascular pressures such as CVP and pulmonary arterial wedge pressure are poor correlates and predictors of effective circulatory volumes and the presence of fluid responsiveness.

Counterintuitively, in situations of central hypovolemia, peripheral sympathetic activity remains high in many patients while stroke volume decreases. This provides insight into why some patients appear not to benefit from fluid administration as peripheral arterial pressure may be maintained despite low central filling pressure (Convertino VA, et al. Auton Neurosci. 2004;111[2]:127-34). Many patients with sepsis and septic shock initially present in an undifferentiated state and empiric treatment decisions regarding fluid and pressor treatments are then misaligned to functional physiological status.

Novel methods and approaches are needed to differentiate these patients and provide appropriate, physiologically guided fluid resuscitation. Dynamic measurement of stroke volume (SV) after a passive leg raise (PLR) or a small IV fluid challenge is an emerging method for determining fluid responsiveness. Evidence suggests that the use of SV-guided resuscitation can reduce net fluid balance, ICU length of stay, risk of mechanical ventilation, time on vasopressors, and risk of renal replacement therapy.(Latham HE, et al. J Crit Care. 2017;42:42-6).

In addition to the lack of efficacy from administering fluid to nonfluid responsive patients, there remains a risk of over-resuscitation from excessive fluid administration. Excessive fluid administration causes hypervolemia and is associated with a variety of negative patient outcomes including tissue edema, organ dysfunction, increased ICU length of stay, prolonged ventilator dependence, and higher mortality rates (Tigabu BM, et al. J Crit Care. 2018;48:153-9). Further, unnecessary initial fluid administration necessitates a “de-resuscitative” phase that can prolong hospital stay and is associated with amplification of sepsis-associated organ failures. Specifically, a 2017 analysis of hospital discharge data found that large volume fluid resuscitation in sepsis patients during the first 24 hours of care was associated with higher rates of hospital mortality than was predicted for patients’ disease severity (Mansoori JN, et al. Crit Care. 2020;24[1]:25).
 

The FRESH trial

The Fluid Response Evaluation in Sepsis Hypotension and Shock (FRESH) trial was a prospective, randomized clinical trial in adults with septic shock comparing PLR-guided SV responsiveness (intervention) as a guide for fluid management with usual care. Patients presented to the ER with sepsis-associated hypotension and anticipated ICU admission. In the intervention arm, patients were assessed for fluid responsiveness (FR) before any clinically driven fluid bolus or increase in vasopressors. If a patient’s stroke volume increased by ≥10% in response to a PLR, they were considered fluid responsive and fluid was recommended as the first therapy. If a patient’s stroke volume increased by <10% then the patient was considered not to be FR and vasopressors were recommended as first-line therapy. The control arm received usual care. The primary end point was the difference in positive fluid balance at the first of either 72 hours or ICU discharge. Patients had received ~2.3 L of crystalloid fluid prior to randomization (~3.5 h from initial presentation), in keeping with 30 mL/kg recommendations. Patients treated with the PLR-guided fluid and pressor protocol had a significant lower net fluid balance (1.37 L (95% CI: 2.53-0.21, P = .021) at 72 hours or ICU discharge. In addition, the intervention group experienced significantly less frequent requirement for renal replacement therapy with a difference of 12.4% (95% CI: 27%-1%, P = .042) as well as a decreased requirement for ventilator use with a difference of 16.42% (95% CI: 33%-0%, P = .044) (Douglas IS, et al. Chest. 2020;158[4]:1431-45).

FRESH demonstrated that PLR-guided FR drove lower fluid balance in patients with septic shock who present to the ER with sepsis and creates a paradigm for future management of fluid and pressor resuscitation beyond the initial 30 mL/kg bolus. Functional evaluation for lack of FR adequately identifies a group of patients with sepsis-associated hypotension who are unlikely to benefit from additional IV fluids to establish hemodynamically stability. It facilitated physiologically informed treatment decisions for the individual patient at a specific moment in their course of treatment as opposed to relying on static measurements and goals that may ultimately not be indicative of fluid responsiveness and circulatory effectiveness. This could reduce the likelihood of fluid overload and associated organ failure and, thus, improve patient outcomes.

Microcirculatory function is significantly impacted by sepsis with a decline in capillary density and inappropriate vasodilation/constriction resulting in insufficient tissue and organ perfusion and increased oxidative stress. Such dysfunction has been found to be associated with worsened patient outcomes, including mortality. However, microcirculatory function does not correlate well with traditionally used macrohemodynamic assessments and treating to improve macrohemodynamic values does not ensure that microcirculation will improve (Charlton M, et al. J Intensive Care Soc. 2017;18(3):221-7).

Ongoing studies are exploring if dynamic fluid-guided resuscitation has the potential to improve survival in sepsis by providing insight into whether the administration of fluid will impact the microcirculation and subsequent organ perfusion of the patient.

Future directions include expanding the dynamic treatment algorithm into other settings, such as rapid response calls, or other patient populations, including those initially presenting with undifferentiated hypotension. While FRESH was not sufficiently powered to detect differences in mortality, there are currently multiple large studies being conducted aimed at determining the impact of a restricted fluid and early vasopressor strategy as compared with a large initial IV fluid bolus on mortality. The results of these studies could be used to determine if the results of FRESH will translate into patient survival outcomes.
 

Current guideline recommendations for fluid resuscitation in sepsis patients calls for an initial crystalloid fluid bolus of at least 30 mL/kg (Rhodes, et al. Intensive Care Med. 2017;43[3]:304-77) For fluid management beyond this initial bolus, recommendations had previously called for using early goal-directed therapy (EGDT) with central venous pressure (CVP) and central venous oxygen saturation to guide the use of IV fluids, vasopressors, transfusions, and dobutamine, based on the results of one single-center study that found an improvement in mortality using EGDT as compared with standard therapy.

The triad of sepsis studies

In the following years, multiple concerns were raised regarding the generalizability of this study. Three large multicenter trials were conducted in multiple countries to test the recommendations for EGDT.

PROMISE: ProMISe was a 1,260-patient randomized trial comparing the impact of EGDT vs usual care on 90-day all-cause mortality in patients with early septic shock at 56 hospitals in England. There was no significant difference in the primary study endpoint with 90-day mortality rates of 29.5% and 29.2% (RR: 1.01, 95% CI: 0.85-1.20, P =.90) (Mouncey, et al. N Engl J Med. 2015;372[14]:1301-11).

PROCESS: ProCESS was a 1,351-patient randomized trial comparing the impact of protocol-based EGDT, protocol-based standard of care, and usual care on 60 day in-hospital mortality in patients with early septic shock at 31 hospitals in the United States. There was no significant difference in the primary study endpoint with 60-day mortality rates of 21.0%, 18.2%, and 18.9% (P = .83) or in the secondary outcome of 90-day mortality with rates of 31.9%, 30.8%, and 33.7% (P = .66) (ProCESS Investigators, et al. N Engl J Med. 2014;370[18]:1683-93).

ARISE: ARISE was a 1,600-patient randomized trial comparing the impact of EGDT vs usual care on 90-day all-cause mortality in patients with early septic shock at 51 hospitals in New Zealand and Australia. There was no significant difference in the primary study end point with 90-day mortality rates of 18.6% and 18.8% (RR: 0.98, 95% CI: 0.80-1.21, P = .90). There were also no significant differences in 28-day or in-hospital mortality, duration of organ support, or length of hospital stay (ARISE Investigators, et al. N Engl J Med. 2014;371[16]:1496-506).

In summary, all three “triad” trials found no improvement with EGDT over usual care (Rowan, et al. N Engl J Med. 2017;376[23]:2223-34) calling into question the recommended methods of universally protocolized approaches to fluid and pressor resuscitation. Probable reasons for why structured EGDT was ineffective at improving outcomes over usual care in the “triad” trials was that (a) liberal fluid volume administration was the “usual care” in most enrolled patients and (b) that macrocirculatory hemodynamics, such as BP, and static intravascular pressures such as CVP and pulmonary arterial wedge pressure are poor correlates and predictors of effective circulatory volumes and the presence of fluid responsiveness.

Counterintuitively, in situations of central hypovolemia, peripheral sympathetic activity remains high in many patients while stroke volume decreases. This provides insight into why some patients appear not to benefit from fluid administration as peripheral arterial pressure may be maintained despite low central filling pressure (Convertino VA, et al. Auton Neurosci. 2004;111[2]:127-34). Many patients with sepsis and septic shock initially present in an undifferentiated state and empiric treatment decisions regarding fluid and pressor treatments are then misaligned to functional physiological status.

Novel methods and approaches are needed to differentiate these patients and provide appropriate, physiologically guided fluid resuscitation. Dynamic measurement of stroke volume (SV) after a passive leg raise (PLR) or a small IV fluid challenge is an emerging method for determining fluid responsiveness. Evidence suggests that the use of SV-guided resuscitation can reduce net fluid balance, ICU length of stay, risk of mechanical ventilation, time on vasopressors, and risk of renal replacement therapy.(Latham HE, et al. J Crit Care. 2017;42:42-6).

In addition to the lack of efficacy from administering fluid to nonfluid responsive patients, there remains a risk of over-resuscitation from excessive fluid administration. Excessive fluid administration causes hypervolemia and is associated with a variety of negative patient outcomes including tissue edema, organ dysfunction, increased ICU length of stay, prolonged ventilator dependence, and higher mortality rates (Tigabu BM, et al. J Crit Care. 2018;48:153-9). Further, unnecessary initial fluid administration necessitates a “de-resuscitative” phase that can prolong hospital stay and is associated with amplification of sepsis-associated organ failures. Specifically, a 2017 analysis of hospital discharge data found that large volume fluid resuscitation in sepsis patients during the first 24 hours of care was associated with higher rates of hospital mortality than was predicted for patients’ disease severity (Mansoori JN, et al. Crit Care. 2020;24[1]:25).
 

The FRESH trial

The Fluid Response Evaluation in Sepsis Hypotension and Shock (FRESH) trial was a prospective, randomized clinical trial in adults with septic shock comparing PLR-guided SV responsiveness (intervention) as a guide for fluid management with usual care. Patients presented to the ER with sepsis-associated hypotension and anticipated ICU admission. In the intervention arm, patients were assessed for fluid responsiveness (FR) before any clinically driven fluid bolus or increase in vasopressors. If a patient’s stroke volume increased by ≥10% in response to a PLR, they were considered fluid responsive and fluid was recommended as the first therapy. If a patient’s stroke volume increased by <10% then the patient was considered not to be FR and vasopressors were recommended as first-line therapy. The control arm received usual care. The primary end point was the difference in positive fluid balance at the first of either 72 hours or ICU discharge. Patients had received ~2.3 L of crystalloid fluid prior to randomization (~3.5 h from initial presentation), in keeping with 30 mL/kg recommendations. Patients treated with the PLR-guided fluid and pressor protocol had a significant lower net fluid balance (1.37 L (95% CI: 2.53-0.21, P = .021) at 72 hours or ICU discharge. In addition, the intervention group experienced significantly less frequent requirement for renal replacement therapy with a difference of 12.4% (95% CI: 27%-1%, P = .042) as well as a decreased requirement for ventilator use with a difference of 16.42% (95% CI: 33%-0%, P = .044) (Douglas IS, et al. Chest. 2020;158[4]:1431-45).

FRESH demonstrated that PLR-guided FR drove lower fluid balance in patients with septic shock who present to the ER with sepsis and creates a paradigm for future management of fluid and pressor resuscitation beyond the initial 30 mL/kg bolus. Functional evaluation for lack of FR adequately identifies a group of patients with sepsis-associated hypotension who are unlikely to benefit from additional IV fluids to establish hemodynamically stability. It facilitated physiologically informed treatment decisions for the individual patient at a specific moment in their course of treatment as opposed to relying on static measurements and goals that may ultimately not be indicative of fluid responsiveness and circulatory effectiveness. This could reduce the likelihood of fluid overload and associated organ failure and, thus, improve patient outcomes.

Microcirculatory function is significantly impacted by sepsis with a decline in capillary density and inappropriate vasodilation/constriction resulting in insufficient tissue and organ perfusion and increased oxidative stress. Such dysfunction has been found to be associated with worsened patient outcomes, including mortality. However, microcirculatory function does not correlate well with traditionally used macrohemodynamic assessments and treating to improve macrohemodynamic values does not ensure that microcirculation will improve (Charlton M, et al. J Intensive Care Soc. 2017;18(3):221-7).

Ongoing studies are exploring if dynamic fluid-guided resuscitation has the potential to improve survival in sepsis by providing insight into whether the administration of fluid will impact the microcirculation and subsequent organ perfusion of the patient.

Future directions include expanding the dynamic treatment algorithm into other settings, such as rapid response calls, or other patient populations, including those initially presenting with undifferentiated hypotension. While FRESH was not sufficiently powered to detect differences in mortality, there are currently multiple large studies being conducted aimed at determining the impact of a restricted fluid and early vasopressor strategy as compared with a large initial IV fluid bolus on mortality. The results of these studies could be used to determine if the results of FRESH will translate into patient survival outcomes.
 

Current guideline recommendations for fluid resuscitation in sepsis patients calls for an initial crystalloid fluid bolus of at least 30 mL/kg (Rhodes, et al. Intensive Care Med. 2017;43[3]:304-77) For fluid management beyond this initial bolus, recommendations had previously called for using early goal-directed therapy (EGDT) with central venous pressure (CVP) and central venous oxygen saturation to guide the use of IV fluids, vasopressors, transfusions, and dobutamine, based on the results of one single-center study that found an improvement in mortality using EGDT as compared with standard therapy.

The triad of sepsis studies

In the following years, multiple concerns were raised regarding the generalizability of this study. Three large multicenter trials were conducted in multiple countries to test the recommendations for EGDT.

PROMISE: ProMISe was a 1,260-patient randomized trial comparing the impact of EGDT vs usual care on 90-day all-cause mortality in patients with early septic shock at 56 hospitals in England. There was no significant difference in the primary study endpoint with 90-day mortality rates of 29.5% and 29.2% (RR: 1.01, 95% CI: 0.85-1.20, P =.90) (Mouncey, et al. N Engl J Med. 2015;372[14]:1301-11).

PROCESS: ProCESS was a 1,351-patient randomized trial comparing the impact of protocol-based EGDT, protocol-based standard of care, and usual care on 60 day in-hospital mortality in patients with early septic shock at 31 hospitals in the United States. There was no significant difference in the primary study endpoint with 60-day mortality rates of 21.0%, 18.2%, and 18.9% (P = .83) or in the secondary outcome of 90-day mortality with rates of 31.9%, 30.8%, and 33.7% (P = .66) (ProCESS Investigators, et al. N Engl J Med. 2014;370[18]:1683-93).

ARISE: ARISE was a 1,600-patient randomized trial comparing the impact of EGDT vs usual care on 90-day all-cause mortality in patients with early septic shock at 51 hospitals in New Zealand and Australia. There was no significant difference in the primary study end point with 90-day mortality rates of 18.6% and 18.8% (RR: 0.98, 95% CI: 0.80-1.21, P = .90). There were also no significant differences in 28-day or in-hospital mortality, duration of organ support, or length of hospital stay (ARISE Investigators, et al. N Engl J Med. 2014;371[16]:1496-506).

In summary, all three “triad” trials found no improvement with EGDT over usual care (Rowan, et al. N Engl J Med. 2017;376[23]:2223-34) calling into question the recommended methods of universally protocolized approaches to fluid and pressor resuscitation. Probable reasons for why structured EGDT was ineffective at improving outcomes over usual care in the “triad” trials was that (a) liberal fluid volume administration was the “usual care” in most enrolled patients and (b) that macrocirculatory hemodynamics, such as BP, and static intravascular pressures such as CVP and pulmonary arterial wedge pressure are poor correlates and predictors of effective circulatory volumes and the presence of fluid responsiveness.

Counterintuitively, in situations of central hypovolemia, peripheral sympathetic activity remains high in many patients while stroke volume decreases. This provides insight into why some patients appear not to benefit from fluid administration as peripheral arterial pressure may be maintained despite low central filling pressure (Convertino VA, et al. Auton Neurosci. 2004;111[2]:127-34). Many patients with sepsis and septic shock initially present in an undifferentiated state and empiric treatment decisions regarding fluid and pressor treatments are then misaligned to functional physiological status.

Novel methods and approaches are needed to differentiate these patients and provide appropriate, physiologically guided fluid resuscitation. Dynamic measurement of stroke volume (SV) after a passive leg raise (PLR) or a small IV fluid challenge is an emerging method for determining fluid responsiveness. Evidence suggests that the use of SV-guided resuscitation can reduce net fluid balance, ICU length of stay, risk of mechanical ventilation, time on vasopressors, and risk of renal replacement therapy.(Latham HE, et al. J Crit Care. 2017;42:42-6).

In addition to the lack of efficacy from administering fluid to nonfluid responsive patients, there remains a risk of over-resuscitation from excessive fluid administration. Excessive fluid administration causes hypervolemia and is associated with a variety of negative patient outcomes including tissue edema, organ dysfunction, increased ICU length of stay, prolonged ventilator dependence, and higher mortality rates (Tigabu BM, et al. J Crit Care. 2018;48:153-9). Further, unnecessary initial fluid administration necessitates a “de-resuscitative” phase that can prolong hospital stay and is associated with amplification of sepsis-associated organ failures. Specifically, a 2017 analysis of hospital discharge data found that large volume fluid resuscitation in sepsis patients during the first 24 hours of care was associated with higher rates of hospital mortality than was predicted for patients’ disease severity (Mansoori JN, et al. Crit Care. 2020;24[1]:25).
 

The FRESH trial

The Fluid Response Evaluation in Sepsis Hypotension and Shock (FRESH) trial was a prospective, randomized clinical trial in adults with septic shock comparing PLR-guided SV responsiveness (intervention) as a guide for fluid management with usual care. Patients presented to the ER with sepsis-associated hypotension and anticipated ICU admission. In the intervention arm, patients were assessed for fluid responsiveness (FR) before any clinically driven fluid bolus or increase in vasopressors. If a patient’s stroke volume increased by ≥10% in response to a PLR, they were considered fluid responsive and fluid was recommended as the first therapy. If a patient’s stroke volume increased by <10% then the patient was considered not to be FR and vasopressors were recommended as first-line therapy. The control arm received usual care. The primary end point was the difference in positive fluid balance at the first of either 72 hours or ICU discharge. Patients had received ~2.3 L of crystalloid fluid prior to randomization (~3.5 h from initial presentation), in keeping with 30 mL/kg recommendations. Patients treated with the PLR-guided fluid and pressor protocol had a significant lower net fluid balance (1.37 L (95% CI: 2.53-0.21, P = .021) at 72 hours or ICU discharge. In addition, the intervention group experienced significantly less frequent requirement for renal replacement therapy with a difference of 12.4% (95% CI: 27%-1%, P = .042) as well as a decreased requirement for ventilator use with a difference of 16.42% (95% CI: 33%-0%, P = .044) (Douglas IS, et al. Chest. 2020;158[4]:1431-45).

FRESH demonstrated that PLR-guided FR drove lower fluid balance in patients with septic shock who present to the ER with sepsis and creates a paradigm for future management of fluid and pressor resuscitation beyond the initial 30 mL/kg bolus. Functional evaluation for lack of FR adequately identifies a group of patients with sepsis-associated hypotension who are unlikely to benefit from additional IV fluids to establish hemodynamically stability. It facilitated physiologically informed treatment decisions for the individual patient at a specific moment in their course of treatment as opposed to relying on static measurements and goals that may ultimately not be indicative of fluid responsiveness and circulatory effectiveness. This could reduce the likelihood of fluid overload and associated organ failure and, thus, improve patient outcomes.

Microcirculatory function is significantly impacted by sepsis with a decline in capillary density and inappropriate vasodilation/constriction resulting in insufficient tissue and organ perfusion and increased oxidative stress. Such dysfunction has been found to be associated with worsened patient outcomes, including mortality. However, microcirculatory function does not correlate well with traditionally used macrohemodynamic assessments and treating to improve macrohemodynamic values does not ensure that microcirculation will improve (Charlton M, et al. J Intensive Care Soc. 2017;18(3):221-7).

Ongoing studies are exploring if dynamic fluid-guided resuscitation has the potential to improve survival in sepsis by providing insight into whether the administration of fluid will impact the microcirculation and subsequent organ perfusion of the patient.

Future directions include expanding the dynamic treatment algorithm into other settings, such as rapid response calls, or other patient populations, including those initially presenting with undifferentiated hypotension. While FRESH was not sufficiently powered to detect differences in mortality, there are currently multiple large studies being conducted aimed at determining the impact of a restricted fluid and early vasopressor strategy as compared with a large initial IV fluid bolus on mortality. The results of these studies could be used to determine if the results of FRESH will translate into patient survival outcomes.
 

Cardiovascular medicine and surgery

Evolution of ECMO as a result of COVID

A year and a half ago, the enormity of this pandemic was only beginning to be realized. Likewise, we have never before been so well-equipped to communicate, investigate, and collaborate through modern innovations. Despite our monumental progress with diagnostics and expedited vaccine production, there remain significant challenges with management of infected individuals suffering from severe sequelae after infection such as respiratory failure. Pharmacologic therapies with steroids, antivirals, and targeted immune modulators have demonstrated modest results at best thus far.

Early intubation unsurprisingly resulted in poor outcomes and a return to other established methods using high-flow nasal cannula and noninvasive positive-pressure ventilation (NIPPV) with a goal of avoiding mechanical ventilation are again the standard of care (Rola P, et al. Clin Exp Emerg Med. 2020 Jun 10. doi: 10.15441/ceem.20.043). Furthermore, limited resources encouraged utilization of established and probably previously underutilized techniques, such as proning with expected improvements in outcomes.

When conventional lung protective mechanical ventilation strategies have been unsuccessful, we have seen improved survival with the incorporation of extracorporeal membrane oxygenation (ECMO), especially when cannulated earlier (Giraud R, et al. 2021. Phys Rep). Many centers now offer ECMO support with considerable expertise and trends toward earlier ECMO cannulation, which permit ultraprotective lung ventilation (Schmidt M, et al. Am J Respir Crit Care Med. 2019 Oct 15;200[8]:1002-12). With benefits that parallel early tracheostomy, early ECMO may permit decreased sedation and earlier mobilization, which contribute to improved outcomes (Levin NM, et al. J Clin Med. 2021 Jan 12;10[2]:25). We may be approaching a paradigm shift where ECMO is performed in lieu of mechanical ventilation (Kurihara C, et al. 2018. Crit Care Med. 2018 Nov;46[11]:e1070-e1073). Future randomized clinical trials will need to be designed to answer this question.

Robert Baeten, II, DSc, PA-C, FCCP

NetWork Steering Committee Member
 

Chest infections

COVID-19-associated pulmonary aspergillosis: A cause for concern?

Since the global spread of SARS-CoV-2 more than a year ago, reports of secondary infections with Aspergillus spp. have emerged. Like influenza, there has been speculation that severe COVID-19 pneumonia is a unique risk factor for invasive pulmonary aspergillosis (IPA). This entity has been dubbed CAPA, or COVID-associated pulmonary aspergillosis. While the reported incidence of CAPA has ranged from around 5% to 35% in critically ill patients, it has been difficult to distinguish reports of colonization from true infection as histopathologic evidence of disease has been limited. Using stringent diagnostic criteria, a retrospective review of 145 mechanically ventilated patients with COVID-19 found the incidence of CAPA to be 4.8% (Fekkar A, et al. Am J Respir Crit Care Med. 2021 Feb 1;203[3]:307-17) which is similar to other non-COVID ARDS series. The authors found solid organ transplant and prolonged steroid treatment to be risk factors. Like other studies, no comparator group was utilized, limiting the conclusions regarding COVID-19 as an independent risk factor for IPA. Diagnostic criteria have been adapted to assist clinicians and allow for future research: Proven infection requires temporal relation with COVID-19 ICU admission and histopathologic evidence of Aspergillus spp. invasion or positive culture from sterile sites (Koehler P, et al. Lancet Infect Dis. 2020 Dec 14;S1473-3099[20]30847-1).

Aspergillus conidia are ubiquitous in the environment, and the respiratory epithelium and associated cilia act as the first defense against IPA. Distinct from influenza pneumonia, severe COVID-19 causes diffuse alveolar damage and does not appear to cause significant damage to the respiratory epithelium (Borczuk AC, et al. Mod Pathol. 2020;33[11]:2156-68). This coupled with the lack of histopathologic evidence of invasion in most reports of CAPA raises question regarding the extent of the association between COVID-19 and IPA. Nonetheless, immune perturbation caused by COVID-19 immunomodulating therapies, such as corticosteroids and IL-6 inhibitors, may ultimately leave patients susceptible to IPA and other opportunistic infections.

Kelly M. Pennington, MD

Charles S. Dela Cruz, MD

Sebastion Kurz, MD

NetWork Steering Committee Members
 

Clinical pulmonary medicine

New USPSTF guidelines for lung cancer screening: A step forward

Despite lung cancer being the number one cause of cancer-related death in America, screening for lung cancer remains low, with only 2-16% eligible patients being offered screening since the US Preventive Services Task Force (USPSTF) recommendation in 2013. New guidelines published in JAMA (Krist AH, et al. JAMA. 2021;325[10]:962-970; Meza R, et al. JAMA. 2021;325[10]:988-97; Jonas DE, at al. JAMA. 2021;325[10]:971-87) have suggested broadening eligibility to those 50-80 years old, who are smokers or previously quit in the past 15 years and have a minimum 20 pack-year smoking history (Grade B recommendation). The change lowers the starting age to 50 and the smoking requirement from 30 to 20 pack-years. Based on Cancer Intervention and Surveillance Modeling Network (CISNET) modeling, utilized by the UPSTF, this change can result in 503 (vs. 381 in the prior guideline) cancer deaths averted for every 100,000 adults and an estimated 13% reduction in lung cancer mortality and 6,918 life-years gained.

This recommendation will dramatically increase the number of eligible adults for screening by 6.4 million people, an increase of 86% compared with the 2013 guidelines. Most importantly, the decrease in pack-year requirement to 20 is expected to increase eligibility for women and minimize racial disparities. African American men have a higher incidence of lung cancer with less smoke exposure compared with white men. Non-Hispanic Black, Hispanics, American Indian/Alaska Native persons are hoped to have significant benefit from these new recommendations. Original recommendations in the 2013 guideline mirrored the National Lung Screening Trial, in which 91% participants were White. Regardless of these updated recommendations, serious socioeconomic barriers may continue to limit racial/ethnic minorities from accessing high-quality lung cancer screening programs. Besides changing the screening criteria, barriers to access will need to be addressed to achieve maximal benefits of the lung cancer screening program.

Munish Luthra, MD, FCCP

Samantha D’Annunzio, MD

Steering Committee Members
 

Interprofessional team

Let food be thy medicine and medicine be thy food – Hippocrates

Recently an article published in The Lancet discussed malnutrition in the patient with COVID-19 infection requiring non-invasive ventilation (NIV) (Turner P, et al. Lancet. 2021 Apr 3;397[10281]:126). It is known that COVID-19 infection causes hyperinflammation and hypercatabolism, resulting in disruption of metabolic pathways leading to muscle wasting, including cardiac muscle dysfunction, muscle weakness, and prolonged fatigue (Singer PJ, et al. 2021. Intensive Med. In press).

Lipids, specifically DHA and EPA, are known to inhibit cyclooxygenase enzyme and may suppress prostaglandin production and block platelet-activating factor. Consumption of carbohydrates with high glycemic indexes can result in free radical synthesis (increasing inflammatory cytokines C reactive protein, tumor necrosis alpha and interleukin-6). Other nutrients known to have an anti-inflammatory role include vitamins A & D, selenium, and copper. Vitamin A is known to enhance an antigen-specific immune response. Probiotics may also play a role in enhancing the immune response (Turner P, et al. 2021. Lancet. 2021 Apr 3;397[10281]:1261).

Patients requiring NIV encounter impaired tolerance to oral nutrition, and enteral nutrition (EN) is prescribed (Singer PJ, et al. 2021. Intensive Med. In press). Advantages of EN are maintenance of gut integrity and intestinal permeability as well as down regulation of the inflammatory response and insulin resistance. Furthermore, negative energy balance is associated with poor outcomes. Better focus on nutrition assessment practices is needed to overcome energy deficits during treatment of COVID-19 pneumonia. An interprofessional team approach increases use of nutritional scores and optimizes nutritional interventions.

If oral nutrition is feasible, prescribing small, frequent meals and high‐protein, calorically dense foods can ensure adequate caloric intake. (Behrens S, et al. Nutr Clin Pract. 2021 Feb;36[1]:105-9). When EN is indicated, the Intensive Care Society endorses the use of fine bore feeding tubes and NIV masks with special nasogastric tube adapters to reduce mask leak. Head-of-bed elevation and avoidance of bolus feeding improve EN tolerance (Pardo T, et al. 2021. Anaesth Crit Care Pain Med. 2020 Dec;39[6]:738-9).

*Due to the novelty of this disease information is limited and further study is warranted.

David W. Unkle, MSN, APN, FCCP

Robert Baeten, DMSc, PA-C, FCCP

Nikky Keer, DO

NetWork Steering Committee Members
 

Occupational and environmental health

Not just COVID in the air

Particulate matter (PM) is a specific type of air pollution referred to by its size in micrometers. A direct correlation has been shown between non-accidental death and PM2.5 concentration with a 1.5% increase in daily mortality (Schwartz J, et al. J Air Waste Manag Assoc. 1996 Oct;46[10]:927-39). From 2000-2019, PM2.5 concentrations have steadily decreased over 43% (Environmental Protection Agency). Significant decline in air pollution has occurred early in the COVID-19 pandemic. PM2.5 declined in counties from states instituting early non-essential business closures in the U.S. Additionally, NASA models revealed a nearly 20% drop in global nitrogen dioxide concentrations using a COVID-19-free 2020 model to compare with actual space and ground-based observations since February 2020 (NASA Model Reveals How Much COVID-related Pollution Levels Deviated from the Norm. 2020 Nov 17. The pandemic has shown that there is a significant human behavior-driven contribution to air pollution. The historic fire season of 2020 in the western states contributed to record high air pollution with attributable mortality (Liu X, et al. medRxiv 2020.09.20197921). Additionally, the COVID-19 pandemic impeded firefighting response (Burke M, et al. PNAS. 2021;11[2]:e2011048118).
 

Despite the pandemic related reduction, racial-ethnic disparities continue to exist in consumption of PM2.5. In a model looking at production of PM2.5, defined as consumption by the consumer and exposure as where the product or service originated, African American and Hispanic individuals have up to 12-21% greater pollution exposure within the United States (Tessum CW, et al. Proc Natl Acad Sci USA. 2019 Mar 26;116[13]:6001-6). PM pollution increased the risk of asthma attacks corresponding to zip codes with higher poverty levels and eligibility to Medicaid (O’Lenick CR, et al. Epidemiol Community Health. 2017 Feb;71[2]:129-36). Other studies have shown people with a lower socioeconomic position, have less education, live nearer to major sources of pollution, greater reliance on public transportation and unemployment are at higher risk from effects of PM pollution (American Lung Association. Disparities in the impact of air pollution.

Disclaimer: The views expressed in this article are those of the author(s) and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or US government.

Tyler Church, DO

Fellow-in-Training Member

Bathmapriya Balakrishnan, MD

Dixie Harris, MD

NetWork Steering Committee Members

Cardiovascular medicine and surgery

Evolution of ECMO as a result of COVID

A year and a half ago, the enormity of this pandemic was only beginning to be realized. Likewise, we have never before been so well-equipped to communicate, investigate, and collaborate through modern innovations. Despite our monumental progress with diagnostics and expedited vaccine production, there remain significant challenges with management of infected individuals suffering from severe sequelae after infection such as respiratory failure. Pharmacologic therapies with steroids, antivirals, and targeted immune modulators have demonstrated modest results at best thus far.

Early intubation unsurprisingly resulted in poor outcomes and a return to other established methods using high-flow nasal cannula and noninvasive positive-pressure ventilation (NIPPV) with a goal of avoiding mechanical ventilation are again the standard of care (Rola P, et al. Clin Exp Emerg Med. 2020 Jun 10. doi: 10.15441/ceem.20.043). Furthermore, limited resources encouraged utilization of established and probably previously underutilized techniques, such as proning with expected improvements in outcomes.

When conventional lung protective mechanical ventilation strategies have been unsuccessful, we have seen improved survival with the incorporation of extracorporeal membrane oxygenation (ECMO), especially when cannulated earlier (Giraud R, et al. 2021. Phys Rep). Many centers now offer ECMO support with considerable expertise and trends toward earlier ECMO cannulation, which permit ultraprotective lung ventilation (Schmidt M, et al. Am J Respir Crit Care Med. 2019 Oct 15;200[8]:1002-12). With benefits that parallel early tracheostomy, early ECMO may permit decreased sedation and earlier mobilization, which contribute to improved outcomes (Levin NM, et al. J Clin Med. 2021 Jan 12;10[2]:25). We may be approaching a paradigm shift where ECMO is performed in lieu of mechanical ventilation (Kurihara C, et al. 2018. Crit Care Med. 2018 Nov;46[11]:e1070-e1073). Future randomized clinical trials will need to be designed to answer this question.

Robert Baeten, II, DSc, PA-C, FCCP

NetWork Steering Committee Member
 

Chest infections

COVID-19-associated pulmonary aspergillosis: A cause for concern?

Since the global spread of SARS-CoV-2 more than a year ago, reports of secondary infections with Aspergillus spp. have emerged. Like influenza, there has been speculation that severe COVID-19 pneumonia is a unique risk factor for invasive pulmonary aspergillosis (IPA). This entity has been dubbed CAPA, or COVID-associated pulmonary aspergillosis. While the reported incidence of CAPA has ranged from around 5% to 35% in critically ill patients, it has been difficult to distinguish reports of colonization from true infection as histopathologic evidence of disease has been limited. Using stringent diagnostic criteria, a retrospective review of 145 mechanically ventilated patients with COVID-19 found the incidence of CAPA to be 4.8% (Fekkar A, et al. Am J Respir Crit Care Med. 2021 Feb 1;203[3]:307-17) which is similar to other non-COVID ARDS series. The authors found solid organ transplant and prolonged steroid treatment to be risk factors. Like other studies, no comparator group was utilized, limiting the conclusions regarding COVID-19 as an independent risk factor for IPA. Diagnostic criteria have been adapted to assist clinicians and allow for future research: Proven infection requires temporal relation with COVID-19 ICU admission and histopathologic evidence of Aspergillus spp. invasion or positive culture from sterile sites (Koehler P, et al. Lancet Infect Dis. 2020 Dec 14;S1473-3099[20]30847-1).

Aspergillus conidia are ubiquitous in the environment, and the respiratory epithelium and associated cilia act as the first defense against IPA. Distinct from influenza pneumonia, severe COVID-19 causes diffuse alveolar damage and does not appear to cause significant damage to the respiratory epithelium (Borczuk AC, et al. Mod Pathol. 2020;33[11]:2156-68). This coupled with the lack of histopathologic evidence of invasion in most reports of CAPA raises question regarding the extent of the association between COVID-19 and IPA. Nonetheless, immune perturbation caused by COVID-19 immunomodulating therapies, such as corticosteroids and IL-6 inhibitors, may ultimately leave patients susceptible to IPA and other opportunistic infections.

Kelly M. Pennington, MD

Charles S. Dela Cruz, MD

Sebastion Kurz, MD

NetWork Steering Committee Members
 

Clinical pulmonary medicine

New USPSTF guidelines for lung cancer screening: A step forward

Despite lung cancer being the number one cause of cancer-related death in America, screening for lung cancer remains low, with only 2-16% eligible patients being offered screening since the US Preventive Services Task Force (USPSTF) recommendation in 2013. New guidelines published in JAMA (Krist AH, et al. JAMA. 2021;325[10]:962-970; Meza R, et al. JAMA. 2021;325[10]:988-97; Jonas DE, at al. JAMA. 2021;325[10]:971-87) have suggested broadening eligibility to those 50-80 years old, who are smokers or previously quit in the past 15 years and have a minimum 20 pack-year smoking history (Grade B recommendation). The change lowers the starting age to 50 and the smoking requirement from 30 to 20 pack-years. Based on Cancer Intervention and Surveillance Modeling Network (CISNET) modeling, utilized by the UPSTF, this change can result in 503 (vs. 381 in the prior guideline) cancer deaths averted for every 100,000 adults and an estimated 13% reduction in lung cancer mortality and 6,918 life-years gained.

This recommendation will dramatically increase the number of eligible adults for screening by 6.4 million people, an increase of 86% compared with the 2013 guidelines. Most importantly, the decrease in pack-year requirement to 20 is expected to increase eligibility for women and minimize racial disparities. African American men have a higher incidence of lung cancer with less smoke exposure compared with white men. Non-Hispanic Black, Hispanics, American Indian/Alaska Native persons are hoped to have significant benefit from these new recommendations. Original recommendations in the 2013 guideline mirrored the National Lung Screening Trial, in which 91% participants were White. Regardless of these updated recommendations, serious socioeconomic barriers may continue to limit racial/ethnic minorities from accessing high-quality lung cancer screening programs. Besides changing the screening criteria, barriers to access will need to be addressed to achieve maximal benefits of the lung cancer screening program.

Munish Luthra, MD, FCCP

Samantha D’Annunzio, MD

Steering Committee Members
 

Interprofessional team

Let food be thy medicine and medicine be thy food – Hippocrates

Recently an article published in The Lancet discussed malnutrition in the patient with COVID-19 infection requiring non-invasive ventilation (NIV) (Turner P, et al. Lancet. 2021 Apr 3;397[10281]:126). It is known that COVID-19 infection causes hyperinflammation and hypercatabolism, resulting in disruption of metabolic pathways leading to muscle wasting, including cardiac muscle dysfunction, muscle weakness, and prolonged fatigue (Singer PJ, et al. 2021. Intensive Med. In press).

Lipids, specifically DHA and EPA, are known to inhibit cyclooxygenase enzyme and may suppress prostaglandin production and block platelet-activating factor. Consumption of carbohydrates with high glycemic indexes can result in free radical synthesis (increasing inflammatory cytokines C reactive protein, tumor necrosis alpha and interleukin-6). Other nutrients known to have an anti-inflammatory role include vitamins A & D, selenium, and copper. Vitamin A is known to enhance an antigen-specific immune response. Probiotics may also play a role in enhancing the immune response (Turner P, et al. 2021. Lancet. 2021 Apr 3;397[10281]:1261).

Patients requiring NIV encounter impaired tolerance to oral nutrition, and enteral nutrition (EN) is prescribed (Singer PJ, et al. 2021. Intensive Med. In press). Advantages of EN are maintenance of gut integrity and intestinal permeability as well as down regulation of the inflammatory response and insulin resistance. Furthermore, negative energy balance is associated with poor outcomes. Better focus on nutrition assessment practices is needed to overcome energy deficits during treatment of COVID-19 pneumonia. An interprofessional team approach increases use of nutritional scores and optimizes nutritional interventions.

If oral nutrition is feasible, prescribing small, frequent meals and high‐protein, calorically dense foods can ensure adequate caloric intake. (Behrens S, et al. Nutr Clin Pract. 2021 Feb;36[1]:105-9). When EN is indicated, the Intensive Care Society endorses the use of fine bore feeding tubes and NIV masks with special nasogastric tube adapters to reduce mask leak. Head-of-bed elevation and avoidance of bolus feeding improve EN tolerance (Pardo T, et al. 2021. Anaesth Crit Care Pain Med. 2020 Dec;39[6]:738-9).

*Due to the novelty of this disease information is limited and further study is warranted.

David W. Unkle, MSN, APN, FCCP

Robert Baeten, DMSc, PA-C, FCCP

Nikky Keer, DO

NetWork Steering Committee Members
 

Occupational and environmental health

Not just COVID in the air

Particulate matter (PM) is a specific type of air pollution referred to by its size in micrometers. A direct correlation has been shown between non-accidental death and PM2.5 concentration with a 1.5% increase in daily mortality (Schwartz J, et al. J Air Waste Manag Assoc. 1996 Oct;46[10]:927-39). From 2000-2019, PM2.5 concentrations have steadily decreased over 43% (Environmental Protection Agency). Significant decline in air pollution has occurred early in the COVID-19 pandemic. PM2.5 declined in counties from states instituting early non-essential business closures in the U.S. Additionally, NASA models revealed a nearly 20% drop in global nitrogen dioxide concentrations using a COVID-19-free 2020 model to compare with actual space and ground-based observations since February 2020 (NASA Model Reveals How Much COVID-related Pollution Levels Deviated from the Norm. 2020 Nov 17. The pandemic has shown that there is a significant human behavior-driven contribution to air pollution. The historic fire season of 2020 in the western states contributed to record high air pollution with attributable mortality (Liu X, et al. medRxiv 2020.09.20197921). Additionally, the COVID-19 pandemic impeded firefighting response (Burke M, et al. PNAS. 2021;11[2]:e2011048118).
 

Despite the pandemic related reduction, racial-ethnic disparities continue to exist in consumption of PM2.5. In a model looking at production of PM2.5, defined as consumption by the consumer and exposure as where the product or service originated, African American and Hispanic individuals have up to 12-21% greater pollution exposure within the United States (Tessum CW, et al. Proc Natl Acad Sci USA. 2019 Mar 26;116[13]:6001-6). PM pollution increased the risk of asthma attacks corresponding to zip codes with higher poverty levels and eligibility to Medicaid (O’Lenick CR, et al. Epidemiol Community Health. 2017 Feb;71[2]:129-36). Other studies have shown people with a lower socioeconomic position, have less education, live nearer to major sources of pollution, greater reliance on public transportation and unemployment are at higher risk from effects of PM pollution (American Lung Association. Disparities in the impact of air pollution.

Disclaimer: The views expressed in this article are those of the author(s) and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or US government.

Tyler Church, DO

Fellow-in-Training Member

Bathmapriya Balakrishnan, MD

Dixie Harris, MD

NetWork Steering Committee Members

Cardiovascular medicine and surgery

Evolution of ECMO as a result of COVID

A year and a half ago, the enormity of this pandemic was only beginning to be realized. Likewise, we have never before been so well-equipped to communicate, investigate, and collaborate through modern innovations. Despite our monumental progress with diagnostics and expedited vaccine production, there remain significant challenges with management of infected individuals suffering from severe sequelae after infection such as respiratory failure. Pharmacologic therapies with steroids, antivirals, and targeted immune modulators have demonstrated modest results at best thus far.

Early intubation unsurprisingly resulted in poor outcomes and a return to other established methods using high-flow nasal cannula and noninvasive positive-pressure ventilation (NIPPV) with a goal of avoiding mechanical ventilation are again the standard of care (Rola P, et al. Clin Exp Emerg Med. 2020 Jun 10. doi: 10.15441/ceem.20.043). Furthermore, limited resources encouraged utilization of established and probably previously underutilized techniques, such as proning with expected improvements in outcomes.

When conventional lung protective mechanical ventilation strategies have been unsuccessful, we have seen improved survival with the incorporation of extracorporeal membrane oxygenation (ECMO), especially when cannulated earlier (Giraud R, et al. 2021. Phys Rep). Many centers now offer ECMO support with considerable expertise and trends toward earlier ECMO cannulation, which permit ultraprotective lung ventilation (Schmidt M, et al. Am J Respir Crit Care Med. 2019 Oct 15;200[8]:1002-12). With benefits that parallel early tracheostomy, early ECMO may permit decreased sedation and earlier mobilization, which contribute to improved outcomes (Levin NM, et al. J Clin Med. 2021 Jan 12;10[2]:25). We may be approaching a paradigm shift where ECMO is performed in lieu of mechanical ventilation (Kurihara C, et al. 2018. Crit Care Med. 2018 Nov;46[11]:e1070-e1073). Future randomized clinical trials will need to be designed to answer this question.

Robert Baeten, II, DSc, PA-C, FCCP

NetWork Steering Committee Member
 

Chest infections

COVID-19-associated pulmonary aspergillosis: A cause for concern?

Since the global spread of SARS-CoV-2 more than a year ago, reports of secondary infections with Aspergillus spp. have emerged. Like influenza, there has been speculation that severe COVID-19 pneumonia is a unique risk factor for invasive pulmonary aspergillosis (IPA). This entity has been dubbed CAPA, or COVID-associated pulmonary aspergillosis. While the reported incidence of CAPA has ranged from around 5% to 35% in critically ill patients, it has been difficult to distinguish reports of colonization from true infection as histopathologic evidence of disease has been limited. Using stringent diagnostic criteria, a retrospective review of 145 mechanically ventilated patients with COVID-19 found the incidence of CAPA to be 4.8% (Fekkar A, et al. Am J Respir Crit Care Med. 2021 Feb 1;203[3]:307-17) which is similar to other non-COVID ARDS series. The authors found solid organ transplant and prolonged steroid treatment to be risk factors. Like other studies, no comparator group was utilized, limiting the conclusions regarding COVID-19 as an independent risk factor for IPA. Diagnostic criteria have been adapted to assist clinicians and allow for future research: Proven infection requires temporal relation with COVID-19 ICU admission and histopathologic evidence of Aspergillus spp. invasion or positive culture from sterile sites (Koehler P, et al. Lancet Infect Dis. 2020 Dec 14;S1473-3099[20]30847-1).

Aspergillus conidia are ubiquitous in the environment, and the respiratory epithelium and associated cilia act as the first defense against IPA. Distinct from influenza pneumonia, severe COVID-19 causes diffuse alveolar damage and does not appear to cause significant damage to the respiratory epithelium (Borczuk AC, et al. Mod Pathol. 2020;33[11]:2156-68). This coupled with the lack of histopathologic evidence of invasion in most reports of CAPA raises question regarding the extent of the association between COVID-19 and IPA. Nonetheless, immune perturbation caused by COVID-19 immunomodulating therapies, such as corticosteroids and IL-6 inhibitors, may ultimately leave patients susceptible to IPA and other opportunistic infections.

Kelly M. Pennington, MD

Charles S. Dela Cruz, MD

Sebastion Kurz, MD

NetWork Steering Committee Members
 

Clinical pulmonary medicine

New USPSTF guidelines for lung cancer screening: A step forward

Despite lung cancer being the number one cause of cancer-related death in America, screening for lung cancer remains low, with only 2-16% eligible patients being offered screening since the US Preventive Services Task Force (USPSTF) recommendation in 2013. New guidelines published in JAMA (Krist AH, et al. JAMA. 2021;325[10]:962-970; Meza R, et al. JAMA. 2021;325[10]:988-97; Jonas DE, at al. JAMA. 2021;325[10]:971-87) have suggested broadening eligibility to those 50-80 years old, who are smokers or previously quit in the past 15 years and have a minimum 20 pack-year smoking history (Grade B recommendation). The change lowers the starting age to 50 and the smoking requirement from 30 to 20 pack-years. Based on Cancer Intervention and Surveillance Modeling Network (CISNET) modeling, utilized by the UPSTF, this change can result in 503 (vs. 381 in the prior guideline) cancer deaths averted for every 100,000 adults and an estimated 13% reduction in lung cancer mortality and 6,918 life-years gained.

This recommendation will dramatically increase the number of eligible adults for screening by 6.4 million people, an increase of 86% compared with the 2013 guidelines. Most importantly, the decrease in pack-year requirement to 20 is expected to increase eligibility for women and minimize racial disparities. African American men have a higher incidence of lung cancer with less smoke exposure compared with white men. Non-Hispanic Black, Hispanics, American Indian/Alaska Native persons are hoped to have significant benefit from these new recommendations. Original recommendations in the 2013 guideline mirrored the National Lung Screening Trial, in which 91% participants were White. Regardless of these updated recommendations, serious socioeconomic barriers may continue to limit racial/ethnic minorities from accessing high-quality lung cancer screening programs. Besides changing the screening criteria, barriers to access will need to be addressed to achieve maximal benefits of the lung cancer screening program.

Munish Luthra, MD, FCCP

Samantha D’Annunzio, MD

Steering Committee Members
 

Interprofessional team

Let food be thy medicine and medicine be thy food – Hippocrates

Recently an article published in The Lancet discussed malnutrition in the patient with COVID-19 infection requiring non-invasive ventilation (NIV) (Turner P, et al. Lancet. 2021 Apr 3;397[10281]:126). It is known that COVID-19 infection causes hyperinflammation and hypercatabolism, resulting in disruption of metabolic pathways leading to muscle wasting, including cardiac muscle dysfunction, muscle weakness, and prolonged fatigue (Singer PJ, et al. 2021. Intensive Med. In press).

Lipids, specifically DHA and EPA, are known to inhibit cyclooxygenase enzyme and may suppress prostaglandin production and block platelet-activating factor. Consumption of carbohydrates with high glycemic indexes can result in free radical synthesis (increasing inflammatory cytokines C reactive protein, tumor necrosis alpha and interleukin-6). Other nutrients known to have an anti-inflammatory role include vitamins A & D, selenium, and copper. Vitamin A is known to enhance an antigen-specific immune response. Probiotics may also play a role in enhancing the immune response (Turner P, et al. 2021. Lancet. 2021 Apr 3;397[10281]:1261).

Patients requiring NIV encounter impaired tolerance to oral nutrition, and enteral nutrition (EN) is prescribed (Singer PJ, et al. 2021. Intensive Med. In press). Advantages of EN are maintenance of gut integrity and intestinal permeability as well as down regulation of the inflammatory response and insulin resistance. Furthermore, negative energy balance is associated with poor outcomes. Better focus on nutrition assessment practices is needed to overcome energy deficits during treatment of COVID-19 pneumonia. An interprofessional team approach increases use of nutritional scores and optimizes nutritional interventions.

If oral nutrition is feasible, prescribing small, frequent meals and high‐protein, calorically dense foods can ensure adequate caloric intake. (Behrens S, et al. Nutr Clin Pract. 2021 Feb;36[1]:105-9). When EN is indicated, the Intensive Care Society endorses the use of fine bore feeding tubes and NIV masks with special nasogastric tube adapters to reduce mask leak. Head-of-bed elevation and avoidance of bolus feeding improve EN tolerance (Pardo T, et al. 2021. Anaesth Crit Care Pain Med. 2020 Dec;39[6]:738-9).

*Due to the novelty of this disease information is limited and further study is warranted.

David W. Unkle, MSN, APN, FCCP

Robert Baeten, DMSc, PA-C, FCCP

Nikky Keer, DO

NetWork Steering Committee Members
 

Occupational and environmental health

Not just COVID in the air

Particulate matter (PM) is a specific type of air pollution referred to by its size in micrometers. A direct correlation has been shown between non-accidental death and PM2.5 concentration with a 1.5% increase in daily mortality (Schwartz J, et al. J Air Waste Manag Assoc. 1996 Oct;46[10]:927-39). From 2000-2019, PM2.5 concentrations have steadily decreased over 43% (Environmental Protection Agency). Significant decline in air pollution has occurred early in the COVID-19 pandemic. PM2.5 declined in counties from states instituting early non-essential business closures in the U.S. Additionally, NASA models revealed a nearly 20% drop in global nitrogen dioxide concentrations using a COVID-19-free 2020 model to compare with actual space and ground-based observations since February 2020 (NASA Model Reveals How Much COVID-related Pollution Levels Deviated from the Norm. 2020 Nov 17. The pandemic has shown that there is a significant human behavior-driven contribution to air pollution. The historic fire season of 2020 in the western states contributed to record high air pollution with attributable mortality (Liu X, et al. medRxiv 2020.09.20197921). Additionally, the COVID-19 pandemic impeded firefighting response (Burke M, et al. PNAS. 2021;11[2]:e2011048118).
 

Despite the pandemic related reduction, racial-ethnic disparities continue to exist in consumption of PM2.5. In a model looking at production of PM2.5, defined as consumption by the consumer and exposure as where the product or service originated, African American and Hispanic individuals have up to 12-21% greater pollution exposure within the United States (Tessum CW, et al. Proc Natl Acad Sci USA. 2019 Mar 26;116[13]:6001-6). PM pollution increased the risk of asthma attacks corresponding to zip codes with higher poverty levels and eligibility to Medicaid (O’Lenick CR, et al. Epidemiol Community Health. 2017 Feb;71[2]:129-36). Other studies have shown people with a lower socioeconomic position, have less education, live nearer to major sources of pollution, greater reliance on public transportation and unemployment are at higher risk from effects of PM pollution (American Lung Association. Disparities in the impact of air pollution.

Disclaimer: The views expressed in this article are those of the author(s) and do not reflect the official policy of the Department of Army/Navy/Air Force, Department of Defense, or US government.

Tyler Church, DO

Fellow-in-Training Member

Bathmapriya Balakrishnan, MD

Dixie Harris, MD

NetWork Steering Committee Members

Lung cancer is the second-most common cancer and one of the leading causes of mortality in the United States among both men and women. It accounts for almost 25% of all cancer deaths, and every year more people die of lung cancer than colon, breast, and prostate cancers combined. The American Cancer Society estimates about 235,760 new lung cancer cases and about 131,880 deaths from lung cancer in 2021.

Smoking and increasing age are the two most important risk factors for lung cancer. Lung cancer has a higher incidence among Black men than White men, and among White women compared with Black women. These differences are likely related to smoking exposure. Early diagnosis of lung cancer can improve survival, and hence screening for lung cancer in high-risk populations is desired. Among the available cancer screening tests, radiology is primarily involved in breast and lung cancer screening (LCS). In 2011, the National Lung Screening Trial (NLST) showed a benefit of annual low- dose chest CT for LCS, with about 20% reduction in lung cancer-related mortality in high-risk participants compared with chest radiographs (Aberle DR, et al. N Engl J Med. 2011 Aug 4;365[5]:395-409).

Dr. Stowell and Dr. Sonavane are with the Mayo Clinic in Jacksonville, Fla.

Lung cancer is the second-most common cancer and one of the leading causes of mortality in the United States among both men and women. It accounts for almost 25% of all cancer deaths, and every year more people die of lung cancer than colon, breast, and prostate cancers combined. The American Cancer Society estimates about 235,760 new lung cancer cases and about 131,880 deaths from lung cancer in 2021.

Smoking and increasing age are the two most important risk factors for lung cancer. Lung cancer has a higher incidence among Black men than White men, and among White women compared with Black women. These differences are likely related to smoking exposure. Early diagnosis of lung cancer can improve survival, and hence screening for lung cancer in high-risk populations is desired. Among the available cancer screening tests, radiology is primarily involved in breast and lung cancer screening (LCS). In 2011, the National Lung Screening Trial (NLST) showed a benefit of annual low- dose chest CT for LCS, with about 20% reduction in lung cancer-related mortality in high-risk participants compared with chest radiographs (Aberle DR, et al. N Engl J Med. 2011 Aug 4;365[5]:395-409).

Dr. Stowell and Dr. Sonavane are with the Mayo Clinic in Jacksonville, Fla.

Lung cancer is the second-most common cancer and one of the leading causes of mortality in the United States among both men and women. It accounts for almost 25% of all cancer deaths, and every year more people die of lung cancer than colon, breast, and prostate cancers combined. The American Cancer Society estimates about 235,760 new lung cancer cases and about 131,880 deaths from lung cancer in 2021.

Smoking and increasing age are the two most important risk factors for lung cancer. Lung cancer has a higher incidence among Black men than White men, and among White women compared with Black women. These differences are likely related to smoking exposure. Early diagnosis of lung cancer can improve survival, and hence screening for lung cancer in high-risk populations is desired. Among the available cancer screening tests, radiology is primarily involved in breast and lung cancer screening (LCS). In 2011, the National Lung Screening Trial (NLST) showed a benefit of annual low- dose chest CT for LCS, with about 20% reduction in lung cancer-related mortality in high-risk participants compared with chest radiographs (Aberle DR, et al. N Engl J Med. 2011 Aug 4;365[5]:395-409).

Dr. Stowell and Dr. Sonavane are with the Mayo Clinic in Jacksonville, Fla.

Over the past year, you’ve had to adapt to Zoom calls and socially distanced learning. It’s time to come back together, face-to-face, for our top-tier learning event in sunny Orlando, Florida.

Grab your sunscreen and book your flights – we’re ready to welcome you back to CHEST 2021 with team-focused learning sessions, immersive gaming opportunities, expert-led faculty presentations, and more. We are making the meeting as safe as possible so you can attend in person.

After careful planning, we are excited to be able at the Orange County Convention Center (OCCC) for CHEST 2021. Health and safety are our biggest concerns for the meeting, which is why we chose this location. The convention center features the extra square footage we needed to design a meeting space with ample room for social distancing.

We are committed to create a meeting experience where you can safely and effectively conduct business, network with colleagues, and experience high-quality education. With your feedback, we have implemented COVID-19 safety measures similar to what is used in your hospitals and facilities. To ensure your health and safety, there will be a few requirements asked of in-person attendees.
 

Preparing for CHEST 2021

As the pandemic continues and vaccines are more readily available, we are requiring all attendees – participants, vendors, and staff – to be vaccinated to attend in person in Orlando, Florida. Your second vaccination shot should take place at least 2 weeks prior to the conference start. When you complete your registration information, you will be asked to attest that you have or will have completed an FDA-approved vaccination for COVID-19 by October 17, 2021.

We also suggest scheduling extra time at your arrival to the conference site. Realize that registration, lunch lines, hotel check-in, etc, may take longer as we navigate a new way to meet in person. This year, registration will be contactless. Have your digital or print confirmation ready when you arrive – the more prepared you are, the faster registration will be.

While the venue will regularly sanitize all high touch points in the public space throughout the day, remember to pack any personal supplies you may need for individual use, especially masks. Attendees will be required to wear a mask covering the mouth and nose at all times during the meeting. There will be masks on-site in case you forget or misplace your own.

Before making your way to Orlando, complete one last health self-assessment. Are you symptom free? Consider what advice you would give your patient if they felt the way you do in that moment. When in doubt, stay home and join us online. That’s one of the benefits of CHEST 2021.
 

Keeping safe while experiencing CHEST 2021

Any time you are in the conference center and the Hilton Hotel, the no-contact policy is applicable. Greet your colleagues and new friends using elbow bumps, waves, and any other form of contactless gestures. We will save our handshakes and hugs for CHEST 2022!

By attending in person, you are also agreeing to perform a health status self-check every day for any onset of COVID symptoms as defined by the CDC. If you are feeling ill, immediately notify the first aid office at the meeting.

Help us deliver a high-quality experience with the lowest reasonable risk in a manner that protects us all by complying to these health and safety measures. In addition, the layout and schedule of the conference is being designed to allow time for cleaning spaces between sessions. This means more time to get to your next location, visit the exhibit hall, or spend with your colleagues.
 

Our commitment to your safety

CHEST is taking extra precautions to keep you safe too – it’s not just on you! Daily temperature screenings will be conducted upon entry to the convention center and Hilton Orlando for everyone.

During the meeting, floor graphics will be used to outline 6-ft social distancing. In the concession areas, seating will be properly distanced and transparent shields will be in place. The exhibit hall will have extra wide aisles, which are not only safe, but easier to move through.

Public space and public restrooms are monitored by OCCC Environmental Services. They conduct sanitizing tasks within the restroom banks throughout the day and a thorough cleaning overnight. They also regularly sanitize all high touch points in the public space throughout the day as well; ie, door handles, ATMs, escalator handrails, elevator buttons, etc.

Staff and security have been increased to provide the best customer service and information accessibility to all in-person attendees. Medical personnel will also be present on site and available to help individuals who are feeling unwell.

It’s been a long year apart from our CHEST community. We can’t wait to see you in Orlando, Florida, October 17-20, for the high-quality education you expect.

Over the past year, you’ve had to adapt to Zoom calls and socially distanced learning. It’s time to come back together, face-to-face, for our top-tier learning event in sunny Orlando, Florida.

Grab your sunscreen and book your flights – we’re ready to welcome you back to CHEST 2021 with team-focused learning sessions, immersive gaming opportunities, expert-led faculty presentations, and more. We are making the meeting as safe as possible so you can attend in person.

After careful planning, we are excited to be able at the Orange County Convention Center (OCCC) for CHEST 2021. Health and safety are our biggest concerns for the meeting, which is why we chose this location. The convention center features the extra square footage we needed to design a meeting space with ample room for social distancing.

We are committed to create a meeting experience where you can safely and effectively conduct business, network with colleagues, and experience high-quality education. With your feedback, we have implemented COVID-19 safety measures similar to what is used in your hospitals and facilities. To ensure your health and safety, there will be a few requirements asked of in-person attendees.
 

Preparing for CHEST 2021

As the pandemic continues and vaccines are more readily available, we are requiring all attendees – participants, vendors, and staff – to be vaccinated to attend in person in Orlando, Florida. Your second vaccination shot should take place at least 2 weeks prior to the conference start. When you complete your registration information, you will be asked to attest that you have or will have completed an FDA-approved vaccination for COVID-19 by October 17, 2021.

We also suggest scheduling extra time at your arrival to the conference site. Realize that registration, lunch lines, hotel check-in, etc, may take longer as we navigate a new way to meet in person. This year, registration will be contactless. Have your digital or print confirmation ready when you arrive – the more prepared you are, the faster registration will be.

While the venue will regularly sanitize all high touch points in the public space throughout the day, remember to pack any personal supplies you may need for individual use, especially masks. Attendees will be required to wear a mask covering the mouth and nose at all times during the meeting. There will be masks on-site in case you forget or misplace your own.

Before making your way to Orlando, complete one last health self-assessment. Are you symptom free? Consider what advice you would give your patient if they felt the way you do in that moment. When in doubt, stay home and join us online. That’s one of the benefits of CHEST 2021.
 

Keeping safe while experiencing CHEST 2021

Any time you are in the conference center and the Hilton Hotel, the no-contact policy is applicable. Greet your colleagues and new friends using elbow bumps, waves, and any other form of contactless gestures. We will save our handshakes and hugs for CHEST 2022!

By attending in person, you are also agreeing to perform a health status self-check every day for any onset of COVID symptoms as defined by the CDC. If you are feeling ill, immediately notify the first aid office at the meeting.

Help us deliver a high-quality experience with the lowest reasonable risk in a manner that protects us all by complying to these health and safety measures. In addition, the layout and schedule of the conference is being designed to allow time for cleaning spaces between sessions. This means more time to get to your next location, visit the exhibit hall, or spend with your colleagues.
 

Our commitment to your safety

CHEST is taking extra precautions to keep you safe too – it’s not just on you! Daily temperature screenings will be conducted upon entry to the convention center and Hilton Orlando for everyone.

During the meeting, floor graphics will be used to outline 6-ft social distancing. In the concession areas, seating will be properly distanced and transparent shields will be in place. The exhibit hall will have extra wide aisles, which are not only safe, but easier to move through.

Public space and public restrooms are monitored by OCCC Environmental Services. They conduct sanitizing tasks within the restroom banks throughout the day and a thorough cleaning overnight. They also regularly sanitize all high touch points in the public space throughout the day as well; ie, door handles, ATMs, escalator handrails, elevator buttons, etc.

Staff and security have been increased to provide the best customer service and information accessibility to all in-person attendees. Medical personnel will also be present on site and available to help individuals who are feeling unwell.

It’s been a long year apart from our CHEST community. We can’t wait to see you in Orlando, Florida, October 17-20, for the high-quality education you expect.

Over the past year, you’ve had to adapt to Zoom calls and socially distanced learning. It’s time to come back together, face-to-face, for our top-tier learning event in sunny Orlando, Florida.

Grab your sunscreen and book your flights – we’re ready to welcome you back to CHEST 2021 with team-focused learning sessions, immersive gaming opportunities, expert-led faculty presentations, and more. We are making the meeting as safe as possible so you can attend in person.

After careful planning, we are excited to be able at the Orange County Convention Center (OCCC) for CHEST 2021. Health and safety are our biggest concerns for the meeting, which is why we chose this location. The convention center features the extra square footage we needed to design a meeting space with ample room for social distancing.

We are committed to create a meeting experience where you can safely and effectively conduct business, network with colleagues, and experience high-quality education. With your feedback, we have implemented COVID-19 safety measures similar to what is used in your hospitals and facilities. To ensure your health and safety, there will be a few requirements asked of in-person attendees.
 

Preparing for CHEST 2021

As the pandemic continues and vaccines are more readily available, we are requiring all attendees – participants, vendors, and staff – to be vaccinated to attend in person in Orlando, Florida. Your second vaccination shot should take place at least 2 weeks prior to the conference start. When you complete your registration information, you will be asked to attest that you have or will have completed an FDA-approved vaccination for COVID-19 by October 17, 2021.

We also suggest scheduling extra time at your arrival to the conference site. Realize that registration, lunch lines, hotel check-in, etc, may take longer as we navigate a new way to meet in person. This year, registration will be contactless. Have your digital or print confirmation ready when you arrive – the more prepared you are, the faster registration will be.

While the venue will regularly sanitize all high touch points in the public space throughout the day, remember to pack any personal supplies you may need for individual use, especially masks. Attendees will be required to wear a mask covering the mouth and nose at all times during the meeting. There will be masks on-site in case you forget or misplace your own.

Before making your way to Orlando, complete one last health self-assessment. Are you symptom free? Consider what advice you would give your patient if they felt the way you do in that moment. When in doubt, stay home and join us online. That’s one of the benefits of CHEST 2021.
 

Keeping safe while experiencing CHEST 2021

Any time you are in the conference center and the Hilton Hotel, the no-contact policy is applicable. Greet your colleagues and new friends using elbow bumps, waves, and any other form of contactless gestures. We will save our handshakes and hugs for CHEST 2022!

By attending in person, you are also agreeing to perform a health status self-check every day for any onset of COVID symptoms as defined by the CDC. If you are feeling ill, immediately notify the first aid office at the meeting.

Help us deliver a high-quality experience with the lowest reasonable risk in a manner that protects us all by complying to these health and safety measures. In addition, the layout and schedule of the conference is being designed to allow time for cleaning spaces between sessions. This means more time to get to your next location, visit the exhibit hall, or spend with your colleagues.
 

Our commitment to your safety

CHEST is taking extra precautions to keep you safe too – it’s not just on you! Daily temperature screenings will be conducted upon entry to the convention center and Hilton Orlando for everyone.

During the meeting, floor graphics will be used to outline 6-ft social distancing. In the concession areas, seating will be properly distanced and transparent shields will be in place. The exhibit hall will have extra wide aisles, which are not only safe, but easier to move through.

Public space and public restrooms are monitored by OCCC Environmental Services. They conduct sanitizing tasks within the restroom banks throughout the day and a thorough cleaning overnight. They also regularly sanitize all high touch points in the public space throughout the day as well; ie, door handles, ATMs, escalator handrails, elevator buttons, etc.

Staff and security have been increased to provide the best customer service and information accessibility to all in-person attendees. Medical personnel will also be present on site and available to help individuals who are feeling unwell.

It’s been a long year apart from our CHEST community. We can’t wait to see you in Orlando, Florida, October 17-20, for the high-quality education you expect.

The recently announced ruling by the FDA to ban menthol in tobacco products is a large step forward toward abolishing tobacco-related disease and death. It is also a big step forward to abolishing the institutional racism of the tobacco industry, which has targeted Black communities with menthol cigarettes for decades, and a step toward improving health equity. Although tobacco use across the United States has decreased from 45% of adults smoking in the 1950s to only 14% smoking today, tobacco continues to be the leading cause of preventable disease and death. Critically, some populations have not seen reductions in tobacco use that benefited others, namely communities of color, low-income populations and LGBTQ+ individuals. A key to this health disparity is the preference for menthol-flavored tobacco products by these groups. Menthol within cigarettes and cigars masks the unpleasant smell of tobacco and numbs the airways to irritation caused by tobacco smoke, while amplifying the effects of nicotine. Eighteen million people smoke menthol cigarettes, with 85% of Black smokers using menthol cigarettes – tobacco ends 45,000 Black lives every year, and menthol is the primary driver of over 38,000 of these Black deaths.

The data supporting a menthol ban has been strong for years. It is well known that flavors, like menthol, increase the appeal of tobacco and increase initiation of tobacco use by women, children, young adults, people of color, low-income, and LGBTQ+ communities. Menthol in particular increases the addictive potential of tobacco and makes it harder for menthol smokers to quit. The evidence behind banning menthol across tobacco products and flavored cigars to protect our children and young adults is also strong. Half of adolescents who try tobacco choose menthol-flavored products; 74% of teenagers aged 14-17 who smoke cigars say they do so because they enjoy the flavors.

There are many reasons why we as pulmonary and critical care medicine physicians are excited about this recent FDA ruling. The most important of which is that this rule is an important step toward advancing health equity in our country. Banning menthol-flavored tobacco products will save lives, including those of thousands of Black Americans. Banning menthol will reduce tobacco addiction, diminish youth experimentation and youth initiation of tobacco use, and increase the ability of tobacco smokers to successfully quit.

While celebrating this incredible win against the racist institution that is Big Tobacco, we must acknowledge the hard work of those who made it happen: the African American Tobacco Control Leadership Council, Center for Black Health & Equity, Campaign for Tobacco-Free Kids, American Medical Association, and many others. It is extremely exciting that menthol cigarettes, which are responsible for 10,000 deaths per year and >265,000 new smokers per year since 1980 (Le TT and Mendez D, Tob Control. 2021 Feb 25. doi: 10.1136/tobaccocontrol-2020-056256).

will soon be a thing of the past. Next on the CHEST Health Policy and Advocacy Committee (HPAC) to-do list? Ensuring that the menthol ban is extended to e-cigarettes, another tobacco product that targets Americans of all kinds. Finally, we must continue the fight to end tobacco-related disease and death across the country and across the world by helping our patients with smoking cessation efforts and by working to prevent initiation of tobacco use (including e-cigarettes and other vaping devices) by children, at-risk individuals, and communities of all kinds.
 

Laura E. Crotty Alexander, MD, is with UC San Diego and the VA San Diego Healthcare System.

The recently announced ruling by the FDA to ban menthol in tobacco products is a large step forward toward abolishing tobacco-related disease and death. It is also a big step forward to abolishing the institutional racism of the tobacco industry, which has targeted Black communities with menthol cigarettes for decades, and a step toward improving health equity. Although tobacco use across the United States has decreased from 45% of adults smoking in the 1950s to only 14% smoking today, tobacco continues to be the leading cause of preventable disease and death. Critically, some populations have not seen reductions in tobacco use that benefited others, namely communities of color, low-income populations and LGBTQ+ individuals. A key to this health disparity is the preference for menthol-flavored tobacco products by these groups. Menthol within cigarettes and cigars masks the unpleasant smell of tobacco and numbs the airways to irritation caused by tobacco smoke, while amplifying the effects of nicotine. Eighteen million people smoke menthol cigarettes, with 85% of Black smokers using menthol cigarettes – tobacco ends 45,000 Black lives every year, and menthol is the primary driver of over 38,000 of these Black deaths.

The data supporting a menthol ban has been strong for years. It is well known that flavors, like menthol, increase the appeal of tobacco and increase initiation of tobacco use by women, children, young adults, people of color, low-income, and LGBTQ+ communities. Menthol in particular increases the addictive potential of tobacco and makes it harder for menthol smokers to quit. The evidence behind banning menthol across tobacco products and flavored cigars to protect our children and young adults is also strong. Half of adolescents who try tobacco choose menthol-flavored products; 74% of teenagers aged 14-17 who smoke cigars say they do so because they enjoy the flavors.

There are many reasons why we as pulmonary and critical care medicine physicians are excited about this recent FDA ruling. The most important of which is that this rule is an important step toward advancing health equity in our country. Banning menthol-flavored tobacco products will save lives, including those of thousands of Black Americans. Banning menthol will reduce tobacco addiction, diminish youth experimentation and youth initiation of tobacco use, and increase the ability of tobacco smokers to successfully quit.

While celebrating this incredible win against the racist institution that is Big Tobacco, we must acknowledge the hard work of those who made it happen: the African American Tobacco Control Leadership Council, Center for Black Health & Equity, Campaign for Tobacco-Free Kids, American Medical Association, and many others. It is extremely exciting that menthol cigarettes, which are responsible for 10,000 deaths per year and >265,000 new smokers per year since 1980 (Le TT and Mendez D, Tob Control. 2021 Feb 25. doi: 10.1136/tobaccocontrol-2020-056256).

will soon be a thing of the past. Next on the CHEST Health Policy and Advocacy Committee (HPAC) to-do list? Ensuring that the menthol ban is extended to e-cigarettes, another tobacco product that targets Americans of all kinds. Finally, we must continue the fight to end tobacco-related disease and death across the country and across the world by helping our patients with smoking cessation efforts and by working to prevent initiation of tobacco use (including e-cigarettes and other vaping devices) by children, at-risk individuals, and communities of all kinds.
 

Laura E. Crotty Alexander, MD, is with UC San Diego and the VA San Diego Healthcare System.

The recently announced ruling by the FDA to ban menthol in tobacco products is a large step forward toward abolishing tobacco-related disease and death. It is also a big step forward to abolishing the institutional racism of the tobacco industry, which has targeted Black communities with menthol cigarettes for decades, and a step toward improving health equity. Although tobacco use across the United States has decreased from 45% of adults smoking in the 1950s to only 14% smoking today, tobacco continues to be the leading cause of preventable disease and death. Critically, some populations have not seen reductions in tobacco use that benefited others, namely communities of color, low-income populations and LGBTQ+ individuals. A key to this health disparity is the preference for menthol-flavored tobacco products by these groups. Menthol within cigarettes and cigars masks the unpleasant smell of tobacco and numbs the airways to irritation caused by tobacco smoke, while amplifying the effects of nicotine. Eighteen million people smoke menthol cigarettes, with 85% of Black smokers using menthol cigarettes – tobacco ends 45,000 Black lives every year, and menthol is the primary driver of over 38,000 of these Black deaths.

The data supporting a menthol ban has been strong for years. It is well known that flavors, like menthol, increase the appeal of tobacco and increase initiation of tobacco use by women, children, young adults, people of color, low-income, and LGBTQ+ communities. Menthol in particular increases the addictive potential of tobacco and makes it harder for menthol smokers to quit. The evidence behind banning menthol across tobacco products and flavored cigars to protect our children and young adults is also strong. Half of adolescents who try tobacco choose menthol-flavored products; 74% of teenagers aged 14-17 who smoke cigars say they do so because they enjoy the flavors.

There are many reasons why we as pulmonary and critical care medicine physicians are excited about this recent FDA ruling. The most important of which is that this rule is an important step toward advancing health equity in our country. Banning menthol-flavored tobacco products will save lives, including those of thousands of Black Americans. Banning menthol will reduce tobacco addiction, diminish youth experimentation and youth initiation of tobacco use, and increase the ability of tobacco smokers to successfully quit.

While celebrating this incredible win against the racist institution that is Big Tobacco, we must acknowledge the hard work of those who made it happen: the African American Tobacco Control Leadership Council, Center for Black Health & Equity, Campaign for Tobacco-Free Kids, American Medical Association, and many others. It is extremely exciting that menthol cigarettes, which are responsible for 10,000 deaths per year and >265,000 new smokers per year since 1980 (Le TT and Mendez D, Tob Control. 2021 Feb 25. doi: 10.1136/tobaccocontrol-2020-056256).

will soon be a thing of the past. Next on the CHEST Health Policy and Advocacy Committee (HPAC) to-do list? Ensuring that the menthol ban is extended to e-cigarettes, another tobacco product that targets Americans of all kinds. Finally, we must continue the fight to end tobacco-related disease and death across the country and across the world by helping our patients with smoking cessation efforts and by working to prevent initiation of tobacco use (including e-cigarettes and other vaping devices) by children, at-risk individuals, and communities of all kinds.
 

Laura E. Crotty Alexander, MD, is with UC San Diego and the VA San Diego Healthcare System.

1. POINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments During Crisis Standards of Care? YesBy Dr. J. Bishop and Dr. J. Eberl



2. COUNTERPOINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments for Reallocation During Crisis Standards of Care? NoBy Dr. D. Sulmasy and Dr. F. Maldonado



3. National Trends and Disparities in Health-Care Access and Coverage Among Adults With Asthma and COPD: 1997-2018By Dr. A. Gaffney, et al.



4. Geographic Variation in Racial Disparities in Mortality From Influenza and Pneumonia in the United States in the Pre-Coronavirus Disease 2019 EraBy Dr. S. Donaldson, et al.



5. Palliative Care Needs and Integration of Palliative Care Support in COPD: A Qualitative StudyBy Dr. F. Yu, et al.



6. How I Do It: Building Teams in Health CareBy. Dr. J. Stoller

1. POINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments During Crisis Standards of Care? YesBy Dr. J. Bishop and Dr. J. Eberl



2. COUNTERPOINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments for Reallocation During Crisis Standards of Care? NoBy Dr. D. Sulmasy and Dr. F. Maldonado



3. National Trends and Disparities in Health-Care Access and Coverage Among Adults With Asthma and COPD: 1997-2018By Dr. A. Gaffney, et al.



4. Geographic Variation in Racial Disparities in Mortality From Influenza and Pneumonia in the United States in the Pre-Coronavirus Disease 2019 EraBy Dr. S. Donaldson, et al.



5. Palliative Care Needs and Integration of Palliative Care Support in COPD: A Qualitative StudyBy Dr. F. Yu, et al.



6. How I Do It: Building Teams in Health CareBy. Dr. J. Stoller

1. POINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments During Crisis Standards of Care? YesBy Dr. J. Bishop and Dr. J. Eberl



2. COUNTERPOINT: Is It Ethically Permissible to Unilaterally Withdraw Life-Sustaining Treatments for Reallocation During Crisis Standards of Care? NoBy Dr. D. Sulmasy and Dr. F. Maldonado



3. National Trends and Disparities in Health-Care Access and Coverage Among Adults With Asthma and COPD: 1997-2018By Dr. A. Gaffney, et al.



4. Geographic Variation in Racial Disparities in Mortality From Influenza and Pneumonia in the United States in the Pre-Coronavirus Disease 2019 EraBy Dr. S. Donaldson, et al.



5. Palliative Care Needs and Integration of Palliative Care Support in COPD: A Qualitative StudyBy Dr. F. Yu, et al.



6. How I Do It: Building Teams in Health CareBy. Dr. J. Stoller

The ambitious infrastructure bill now being debated in the US Congress might be one of the best immediate opportunities to lobby for legislative or policy changes in delivery of health care during the current Biden administration, according to an analysis delivered at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.

The infrastructure bill is likely to be pushed forward in the filibuster-proof reconciliation process, which means “that some things might get passed that otherwise would not,” explained Keith S. Studdard, Vice President, Jeffrey J. Kimbell & Associates, Washington, DC.

The ambitious infrastructure bill now being debated in the US Congress might be one of the best immediate opportunities to lobby for legislative or policy changes in delivery of health care during the current Biden administration, according to an analysis delivered at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.

The infrastructure bill is likely to be pushed forward in the filibuster-proof reconciliation process, which means “that some things might get passed that otherwise would not,” explained Keith S. Studdard, Vice President, Jeffrey J. Kimbell & Associates, Washington, DC.

The ambitious infrastructure bill now being debated in the US Congress might be one of the best immediate opportunities to lobby for legislative or policy changes in delivery of health care during the current Biden administration, according to an analysis delivered at the annual health policy and advocacy conference sponsored by the American College of Chest Physicians.

The infrastructure bill is likely to be pushed forward in the filibuster-proof reconciliation process, which means “that some things might get passed that otherwise would not,” explained Keith S. Studdard, Vice President, Jeffrey J. Kimbell & Associates, Washington, DC.