A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A novel program that strengthens bonds, boosts morale, and encourages supportive networks among US Air Force personnel cuts suicidal ideation and depressive symptoms after 1 month, new research shows.

The so-called Wingman-Connect initiative also had a beneficial impact on work performance, and the benefits were apparent at 6-month follow-up.

“This study suggests that group training can teach skills that help with occupational functioning and reduce the likelihood of experiencing elevated depression and suicidal ideation, at least in the short term,” lead author Peter A. Wyman, PhD, professor, department of psychiatry, University of Rochester, New York, told Medscape Medical News.

The study was published online Oct. 21 in JAMA Network Open.
 

Significant rise in suicide rates

Suicide rates among active duty military populations have increased “significantly” in the past 15 years and have exceeded rates for the general population when comparing groups of the same age and gender, said Wyman.

The study included new personnel who were taking classes at a single training center between October 2017 and October 2019.

Participants were randomly assigned to the Wingman-Connect program or to a stress management program.

The Wingman-Connect intervention involved three 2-hour blocks of group classes that focused on building skills in areas such as healthy relationships and maintaining balance. Group exercises emphasized cohesion, shared purpose, and the value of a healthy unit.

Participants in the stress management group received an overview of the stress response system, information on the effect of stress on health, and cognitive and behavioral strategies to reduce stress.

Primary outcomes included the scores on the suicide scale and the depression inventory of the Computerized Adaptive Test for Mental Health.

The study included 1,485 participants (82.3% men; mean age, 20.9 years). At the 1-month follow-up, participants in Wingman-Connect classes reported less severe suicidal ideation (effect size, −0.23; 95% confidence interval, −39 to −0.09; P = .001) and depressive symptoms (ES, −0.24; 95% CI, −0.41 to −0.08; P = .002).

Unlike most suicide prevention programs, the Wingman intervention didn’t target only high-risk participants. “You’d expect smaller effect sizes” because many people were already doing well, said Wyman.

He noted that the effects at 1 month were similar to other state-of-the-art prevention programs.

Another primary endpoint was self-reported occupational impairment. A poor outcome here, said Wyman, could mean having to repeat a class or falling short of expectations behaviorally or academically.

Investigators found a 50% reduction – from approximately 10% to 5% – among the participants in the Wingman-Connect group who had occupational problems or performance concerns, said Wyman.

About 84% of participants in both study arms participated in the 6-month follow-up. At this time point, Wingman-Connect participants reported significantly lower depressive symptoms (ES, −0.16; 95% CI, −0.34 to −0.02; P = .03), but suicidal ideation severity scores were not significantly lower (ES, −0.13; 95% CI, −0.29 to 0.01; P = .06).
 

Universally beneficial

A beneficial effect on occupational problems was not evident after 6 months. This suggests that this type of training should be continued in later stages of military careers, said Wyman.

“This is not a one-time inoculation that will likely prevent all future problems,” he said.

Study participants experienced improvements in protective factors such as cohesion, morale, and bonds to classmates. The program was also associated with reduced anxiety and anger.

Overall, the Wingman-Connect group was about 20% less likely than the stress management group to report elevated depression at either follow-up period. In addition, on average, participants in the active intervention group were 19% less likely to have elevated suicidal ideation scores, although the difference was not significant.

The “logical interpretation” of this lack of statistical significance is that because depression was more common than suicidal ideation, “the intervention could have a slightly larger and more lasting effect on depression,” said Wyman.

There was no indication that men or women or those who started out at higher risk experienced greater benefit.

“Overall, the effects seemed to be distributed across airmen, independent of how they started,” said Wyman.

Wyman emphasized the unique nature of the Wingman-Connect program. “It’s universal prevention for all airmen – for those thriving and those struggling,” he said.

“We don’t know who necessarily will become at risk later on, or 6 months later, so it’s important to provide this kind of training for everyone.”

The “key mechanism” by which the program may prevent mental health problems is use of “units of military people working together day to day,” said Wyman.

The study did not reveal whether the intervention reduced suicidal behavior. This, say the authors, will need to be determined in future studies, as will determining which personnel are most likely to benefit.
 

A ‘particular challenge’

In an accompanying editorial, Roy H. Perlis, MD, department of psychiatry, Massachusetts General Hospital and Harvard Medical School, both in Boston, and Stephan D. Fihn, MD, department of medicine, University of Washington, Seattle, noted that suicide represents a “particular challenge” in the military.

This is “because soldiers are placed in extremely stressful situations, often without adequate physical or emotional support.”

The new study “adds to a literature that group-based interventions are effective in reducing depressive symptoms and may have advantages in resource-constrained environments,” they write.

Perlis and Finn note that it remains to be seen whether targeted strategies to reduce suicide “are worthwhile, rather than simply developing better treatments for depression.”

Commenting on the study for Medscape Medical News, Elspeth Cameron Ritchie, MD, former military psychiatrist and chair of the department of psychiatry, Medstar Washington Hospital Center, Washington, D.C., said the study “is based on quite a sound premise.”

Ritchie referred to the “long history” of research “repeatedly showing that units with good cohesion and morale have fewer difficulties of all kinds.”

However, the current study didn’t investigate the “converse of that,” said Ritchie. “There’s a high likelihood for suicidal ideation among those who are expelled” from the unit for various reasons.

Ritchie noted that a variety of different prevention initiatives have been launched in all military services over the years.

“Often, they have worked for a little while when there’s a champion behind them and there’s a lot of enthusiasm, and then they kind of fade out,” she said.

Ritchie agreed that such initiatives should continue throughout a person’s military career. She noted that suicide risk is elevated during periods of transition, for example, “leaving training base and going to your first duty station,” as well as when approaching retirement.

She appreciated the universal nature of the approach used in the study.

“Often, suicides are in those who have not been identified as high risk,” she said. However, she questioned whether the study’s follow-up period was long enough.

The study was supported by the Office of the Assistant Secretary of Defense for Health Affairs. Wyman, Perlis, and Cameron have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A novel program that strengthens bonds, boosts morale, and encourages supportive networks among US Air Force personnel cuts suicidal ideation and depressive symptoms after 1 month, new research shows.

The so-called Wingman-Connect initiative also had a beneficial impact on work performance, and the benefits were apparent at 6-month follow-up.

“This study suggests that group training can teach skills that help with occupational functioning and reduce the likelihood of experiencing elevated depression and suicidal ideation, at least in the short term,” lead author Peter A. Wyman, PhD, professor, department of psychiatry, University of Rochester, New York, told Medscape Medical News.

The study was published online Oct. 21 in JAMA Network Open.
 

Significant rise in suicide rates

Suicide rates among active duty military populations have increased “significantly” in the past 15 years and have exceeded rates for the general population when comparing groups of the same age and gender, said Wyman.

The study included new personnel who were taking classes at a single training center between October 2017 and October 2019.

Participants were randomly assigned to the Wingman-Connect program or to a stress management program.

The Wingman-Connect intervention involved three 2-hour blocks of group classes that focused on building skills in areas such as healthy relationships and maintaining balance. Group exercises emphasized cohesion, shared purpose, and the value of a healthy unit.

Participants in the stress management group received an overview of the stress response system, information on the effect of stress on health, and cognitive and behavioral strategies to reduce stress.

Primary outcomes included the scores on the suicide scale and the depression inventory of the Computerized Adaptive Test for Mental Health.

The study included 1,485 participants (82.3% men; mean age, 20.9 years). At the 1-month follow-up, participants in Wingman-Connect classes reported less severe suicidal ideation (effect size, −0.23; 95% confidence interval, −39 to −0.09; P = .001) and depressive symptoms (ES, −0.24; 95% CI, −0.41 to −0.08; P = .002).

Unlike most suicide prevention programs, the Wingman intervention didn’t target only high-risk participants. “You’d expect smaller effect sizes” because many people were already doing well, said Wyman.

He noted that the effects at 1 month were similar to other state-of-the-art prevention programs.

Another primary endpoint was self-reported occupational impairment. A poor outcome here, said Wyman, could mean having to repeat a class or falling short of expectations behaviorally or academically.

Investigators found a 50% reduction – from approximately 10% to 5% – among the participants in the Wingman-Connect group who had occupational problems or performance concerns, said Wyman.

About 84% of participants in both study arms participated in the 6-month follow-up. At this time point, Wingman-Connect participants reported significantly lower depressive symptoms (ES, −0.16; 95% CI, −0.34 to −0.02; P = .03), but suicidal ideation severity scores were not significantly lower (ES, −0.13; 95% CI, −0.29 to 0.01; P = .06).
 

Universally beneficial

A beneficial effect on occupational problems was not evident after 6 months. This suggests that this type of training should be continued in later stages of military careers, said Wyman.

“This is not a one-time inoculation that will likely prevent all future problems,” he said.

Study participants experienced improvements in protective factors such as cohesion, morale, and bonds to classmates. The program was also associated with reduced anxiety and anger.

Overall, the Wingman-Connect group was about 20% less likely than the stress management group to report elevated depression at either follow-up period. In addition, on average, participants in the active intervention group were 19% less likely to have elevated suicidal ideation scores, although the difference was not significant.

The “logical interpretation” of this lack of statistical significance is that because depression was more common than suicidal ideation, “the intervention could have a slightly larger and more lasting effect on depression,” said Wyman.

There was no indication that men or women or those who started out at higher risk experienced greater benefit.

“Overall, the effects seemed to be distributed across airmen, independent of how they started,” said Wyman.

Wyman emphasized the unique nature of the Wingman-Connect program. “It’s universal prevention for all airmen – for those thriving and those struggling,” he said.

“We don’t know who necessarily will become at risk later on, or 6 months later, so it’s important to provide this kind of training for everyone.”

The “key mechanism” by which the program may prevent mental health problems is use of “units of military people working together day to day,” said Wyman.

The study did not reveal whether the intervention reduced suicidal behavior. This, say the authors, will need to be determined in future studies, as will determining which personnel are most likely to benefit.
 

A ‘particular challenge’

In an accompanying editorial, Roy H. Perlis, MD, department of psychiatry, Massachusetts General Hospital and Harvard Medical School, both in Boston, and Stephan D. Fihn, MD, department of medicine, University of Washington, Seattle, noted that suicide represents a “particular challenge” in the military.

This is “because soldiers are placed in extremely stressful situations, often without adequate physical or emotional support.”

The new study “adds to a literature that group-based interventions are effective in reducing depressive symptoms and may have advantages in resource-constrained environments,” they write.

Perlis and Finn note that it remains to be seen whether targeted strategies to reduce suicide “are worthwhile, rather than simply developing better treatments for depression.”

Commenting on the study for Medscape Medical News, Elspeth Cameron Ritchie, MD, former military psychiatrist and chair of the department of psychiatry, Medstar Washington Hospital Center, Washington, D.C., said the study “is based on quite a sound premise.”

Ritchie referred to the “long history” of research “repeatedly showing that units with good cohesion and morale have fewer difficulties of all kinds.”

However, the current study didn’t investigate the “converse of that,” said Ritchie. “There’s a high likelihood for suicidal ideation among those who are expelled” from the unit for various reasons.

Ritchie noted that a variety of different prevention initiatives have been launched in all military services over the years.

“Often, they have worked for a little while when there’s a champion behind them and there’s a lot of enthusiasm, and then they kind of fade out,” she said.

Ritchie agreed that such initiatives should continue throughout a person’s military career. She noted that suicide risk is elevated during periods of transition, for example, “leaving training base and going to your first duty station,” as well as when approaching retirement.

She appreciated the universal nature of the approach used in the study.

“Often, suicides are in those who have not been identified as high risk,” she said. However, she questioned whether the study’s follow-up period was long enough.

The study was supported by the Office of the Assistant Secretary of Defense for Health Affairs. Wyman, Perlis, and Cameron have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A novel program that strengthens bonds, boosts morale, and encourages supportive networks among US Air Force personnel cuts suicidal ideation and depressive symptoms after 1 month, new research shows.

The so-called Wingman-Connect initiative also had a beneficial impact on work performance, and the benefits were apparent at 6-month follow-up.

“This study suggests that group training can teach skills that help with occupational functioning and reduce the likelihood of experiencing elevated depression and suicidal ideation, at least in the short term,” lead author Peter A. Wyman, PhD, professor, department of psychiatry, University of Rochester, New York, told Medscape Medical News.

The study was published online Oct. 21 in JAMA Network Open.
 

Significant rise in suicide rates

Suicide rates among active duty military populations have increased “significantly” in the past 15 years and have exceeded rates for the general population when comparing groups of the same age and gender, said Wyman.

The study included new personnel who were taking classes at a single training center between October 2017 and October 2019.

Participants were randomly assigned to the Wingman-Connect program or to a stress management program.

The Wingman-Connect intervention involved three 2-hour blocks of group classes that focused on building skills in areas such as healthy relationships and maintaining balance. Group exercises emphasized cohesion, shared purpose, and the value of a healthy unit.

Participants in the stress management group received an overview of the stress response system, information on the effect of stress on health, and cognitive and behavioral strategies to reduce stress.

Primary outcomes included the scores on the suicide scale and the depression inventory of the Computerized Adaptive Test for Mental Health.

The study included 1,485 participants (82.3% men; mean age, 20.9 years). At the 1-month follow-up, participants in Wingman-Connect classes reported less severe suicidal ideation (effect size, −0.23; 95% confidence interval, −39 to −0.09; P = .001) and depressive symptoms (ES, −0.24; 95% CI, −0.41 to −0.08; P = .002).

Unlike most suicide prevention programs, the Wingman intervention didn’t target only high-risk participants. “You’d expect smaller effect sizes” because many people were already doing well, said Wyman.

He noted that the effects at 1 month were similar to other state-of-the-art prevention programs.

Another primary endpoint was self-reported occupational impairment. A poor outcome here, said Wyman, could mean having to repeat a class or falling short of expectations behaviorally or academically.

Investigators found a 50% reduction – from approximately 10% to 5% – among the participants in the Wingman-Connect group who had occupational problems or performance concerns, said Wyman.

About 84% of participants in both study arms participated in the 6-month follow-up. At this time point, Wingman-Connect participants reported significantly lower depressive symptoms (ES, −0.16; 95% CI, −0.34 to −0.02; P = .03), but suicidal ideation severity scores were not significantly lower (ES, −0.13; 95% CI, −0.29 to 0.01; P = .06).
 

Universally beneficial

A beneficial effect on occupational problems was not evident after 6 months. This suggests that this type of training should be continued in later stages of military careers, said Wyman.

“This is not a one-time inoculation that will likely prevent all future problems,” he said.

Study participants experienced improvements in protective factors such as cohesion, morale, and bonds to classmates. The program was also associated with reduced anxiety and anger.

Overall, the Wingman-Connect group was about 20% less likely than the stress management group to report elevated depression at either follow-up period. In addition, on average, participants in the active intervention group were 19% less likely to have elevated suicidal ideation scores, although the difference was not significant.

The “logical interpretation” of this lack of statistical significance is that because depression was more common than suicidal ideation, “the intervention could have a slightly larger and more lasting effect on depression,” said Wyman.

There was no indication that men or women or those who started out at higher risk experienced greater benefit.

“Overall, the effects seemed to be distributed across airmen, independent of how they started,” said Wyman.

Wyman emphasized the unique nature of the Wingman-Connect program. “It’s universal prevention for all airmen – for those thriving and those struggling,” he said.

“We don’t know who necessarily will become at risk later on, or 6 months later, so it’s important to provide this kind of training for everyone.”

The “key mechanism” by which the program may prevent mental health problems is use of “units of military people working together day to day,” said Wyman.

The study did not reveal whether the intervention reduced suicidal behavior. This, say the authors, will need to be determined in future studies, as will determining which personnel are most likely to benefit.
 

A ‘particular challenge’

In an accompanying editorial, Roy H. Perlis, MD, department of psychiatry, Massachusetts General Hospital and Harvard Medical School, both in Boston, and Stephan D. Fihn, MD, department of medicine, University of Washington, Seattle, noted that suicide represents a “particular challenge” in the military.

This is “because soldiers are placed in extremely stressful situations, often without adequate physical or emotional support.”

The new study “adds to a literature that group-based interventions are effective in reducing depressive symptoms and may have advantages in resource-constrained environments,” they write.

Perlis and Finn note that it remains to be seen whether targeted strategies to reduce suicide “are worthwhile, rather than simply developing better treatments for depression.”

Commenting on the study for Medscape Medical News, Elspeth Cameron Ritchie, MD, former military psychiatrist and chair of the department of psychiatry, Medstar Washington Hospital Center, Washington, D.C., said the study “is based on quite a sound premise.”

Ritchie referred to the “long history” of research “repeatedly showing that units with good cohesion and morale have fewer difficulties of all kinds.”

However, the current study didn’t investigate the “converse of that,” said Ritchie. “There’s a high likelihood for suicidal ideation among those who are expelled” from the unit for various reasons.

Ritchie noted that a variety of different prevention initiatives have been launched in all military services over the years.

“Often, they have worked for a little while when there’s a champion behind them and there’s a lot of enthusiasm, and then they kind of fade out,” she said.

Ritchie agreed that such initiatives should continue throughout a person’s military career. She noted that suicide risk is elevated during periods of transition, for example, “leaving training base and going to your first duty station,” as well as when approaching retirement.

She appreciated the universal nature of the approach used in the study.

“Often, suicides are in those who have not been identified as high risk,” she said. However, she questioned whether the study’s follow-up period was long enough.

The study was supported by the Office of the Assistant Secretary of Defense for Health Affairs. Wyman, Perlis, and Cameron have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Integrating PET imaging into postprostatectomy radiation therapy (RT) decisions and planning can improve prostate cancer outcomes, first results of the EMPIRE-1 trial suggest.

The findings were reported in a plenary session at the American Society for Radiation Oncology Annual Meeting 2020.

“Quite frankly, this is an area where we are shooting in the dark with conventional imaging, and that’s where we think molecular imaging has a potential role,” noted coprincipal investigator Ashesh B. Jani, MD, of the Winship Cancer Institute of Emory University, Atlanta.

“We hypothesized that radiotherapy outcomes can be improved upon by PET by excluding patients with extrapelvic disease and also by improving treatment field decisions and target definition,” Dr. Jani added.

Patients with prostate cancer were eligible for EMPIRE-1 if they had undergone prostatectomy and had a detectable prostate-specific antigen (PSA) level but negative findings on conventional imaging (a bone scan plus abdominopelvic CT and/or MRI).

A total of 165 patients were randomized to RT guided by the conventional imaging alone or combined with PET imaging using the radiotracer fluciclovine (18F). Treatment decisions in the latter group were strictly based on where uptake was seen.
 

Study results

The trial’s primary endpoint was treatment failure, defined as a PSA level exceeding 0.2 ng/mL from nadir followed by another rise, a continued PSA rise despite RT, progression on imaging or digital rectal exam, or initiation of systemic therapy.

“Most imaging studies tend to focus on diagnostic accuracy, pathologic correlation, and decision changes. It’s a very high bar for an imaging study to influence failure rates,” Dr. Jani pointed out.

Adding 18F-PET to conventional imaging altered the treatment decision for 35.4% of patients in that group (P < .001). It also significantly altered a range of volumetric and dosimetric parameters.

At a median follow-up of 2.48 years, the 3-year rate of failure-free survival was 63.0% with conventional imaging alone and 75.5% with the addition of 18F-PET (P = .003). The corresponding 4-year rate was 51.2% and 75.5%, respectively (P < .001).

In multivariate analysis, the conventional imaging group had double the risk of failure events relative to the PET group (hazard ratio, 2.04; P = .033).

Provider-reported data showed no significant difference between imaging groups in maximum acute or late genitourinary toxicity and gastrointestinal toxicity. An analysis of patient-reported toxicity data is pending.

“Randomized trials of imaging tests with a primary cancer control endpoint are important but uncommonly done,” Dr. Jani commented. “This is the first such trial of PET over conventional imaging in the postprostatectomy radiotherapy setting.”

“Inclusion of fluciclovine resulted in a significant improvement in failure rate at 3 years. This warrants further investigation,” he maintained.

To that end, the investigators have launched the EMPIRE-2 trial, which is comparing RT guided by 18F-PET with PET using another radiotracer that is not yet approved by the Food and Drug Administration, gallium-68 prostate-specific membrane antigen.
 

Findings in context

“There are several remarkable aspects of the EMPIRE-1 trial worth noting,” said invited discussant Neha Vapiwala, MD, of the University of Pennsylvania, Philadelphia.

She commended the trial’s randomization, given a bias that more imaging is better, and the diversity of its participants that better reflects the general population of prostate cancer patients.

“The study procedures appear to be well tolerated despite a net overall increase in the radiation volume treated in the patients who underwent PET, although we do still await patient-reported toxicity,” Dr. Vapiwala noted. “Finally, a high bar was set, with a clinically meaningful primary endpoint for an imaging study.

“This study ultimately demonstrated that, in the PET arm, better selection with PET was able to result in better patient outcomes,” she maintained.

At the same time, Dr. Vapiwala recommended caution when reducing or withholding definitive local therapy based on PET results, as occurred in 14 patients.

“We must always be able to see the forest from the trees, and when evaluating our patients with PET scans, what we see and what we don’t see is just one piece of the puzzle. Existing level 1 evidence and oncologic principles must still apply,” she said. “While PET can help paint a more complete picture, it should not define the picture itself.”

The study was supported by the National Institutes of Health. Dr. Jani disclosed advisory board service for Blue Earth Diagnostics. Dr. Vapiwala disclosed no relevant conflicts of interest.

SOURCE: Jani A et al. ASTRO 2020, Abstract LBA1.

Integrating PET imaging into postprostatectomy radiation therapy (RT) decisions and planning can improve prostate cancer outcomes, first results of the EMPIRE-1 trial suggest.

The findings were reported in a plenary session at the American Society for Radiation Oncology Annual Meeting 2020.

“Quite frankly, this is an area where we are shooting in the dark with conventional imaging, and that’s where we think molecular imaging has a potential role,” noted coprincipal investigator Ashesh B. Jani, MD, of the Winship Cancer Institute of Emory University, Atlanta.

“We hypothesized that radiotherapy outcomes can be improved upon by PET by excluding patients with extrapelvic disease and also by improving treatment field decisions and target definition,” Dr. Jani added.

Patients with prostate cancer were eligible for EMPIRE-1 if they had undergone prostatectomy and had a detectable prostate-specific antigen (PSA) level but negative findings on conventional imaging (a bone scan plus abdominopelvic CT and/or MRI).

A total of 165 patients were randomized to RT guided by the conventional imaging alone or combined with PET imaging using the radiotracer fluciclovine (18F). Treatment decisions in the latter group were strictly based on where uptake was seen.
 

Study results

The trial’s primary endpoint was treatment failure, defined as a PSA level exceeding 0.2 ng/mL from nadir followed by another rise, a continued PSA rise despite RT, progression on imaging or digital rectal exam, or initiation of systemic therapy.

“Most imaging studies tend to focus on diagnostic accuracy, pathologic correlation, and decision changes. It’s a very high bar for an imaging study to influence failure rates,” Dr. Jani pointed out.

Adding 18F-PET to conventional imaging altered the treatment decision for 35.4% of patients in that group (P < .001). It also significantly altered a range of volumetric and dosimetric parameters.

At a median follow-up of 2.48 years, the 3-year rate of failure-free survival was 63.0% with conventional imaging alone and 75.5% with the addition of 18F-PET (P = .003). The corresponding 4-year rate was 51.2% and 75.5%, respectively (P < .001).

In multivariate analysis, the conventional imaging group had double the risk of failure events relative to the PET group (hazard ratio, 2.04; P = .033).

Provider-reported data showed no significant difference between imaging groups in maximum acute or late genitourinary toxicity and gastrointestinal toxicity. An analysis of patient-reported toxicity data is pending.

“Randomized trials of imaging tests with a primary cancer control endpoint are important but uncommonly done,” Dr. Jani commented. “This is the first such trial of PET over conventional imaging in the postprostatectomy radiotherapy setting.”

“Inclusion of fluciclovine resulted in a significant improvement in failure rate at 3 years. This warrants further investigation,” he maintained.

To that end, the investigators have launched the EMPIRE-2 trial, which is comparing RT guided by 18F-PET with PET using another radiotracer that is not yet approved by the Food and Drug Administration, gallium-68 prostate-specific membrane antigen.
 

Findings in context

“There are several remarkable aspects of the EMPIRE-1 trial worth noting,” said invited discussant Neha Vapiwala, MD, of the University of Pennsylvania, Philadelphia.

She commended the trial’s randomization, given a bias that more imaging is better, and the diversity of its participants that better reflects the general population of prostate cancer patients.

“The study procedures appear to be well tolerated despite a net overall increase in the radiation volume treated in the patients who underwent PET, although we do still await patient-reported toxicity,” Dr. Vapiwala noted. “Finally, a high bar was set, with a clinically meaningful primary endpoint for an imaging study.

“This study ultimately demonstrated that, in the PET arm, better selection with PET was able to result in better patient outcomes,” she maintained.

At the same time, Dr. Vapiwala recommended caution when reducing or withholding definitive local therapy based on PET results, as occurred in 14 patients.

“We must always be able to see the forest from the trees, and when evaluating our patients with PET scans, what we see and what we don’t see is just one piece of the puzzle. Existing level 1 evidence and oncologic principles must still apply,” she said. “While PET can help paint a more complete picture, it should not define the picture itself.”

The study was supported by the National Institutes of Health. Dr. Jani disclosed advisory board service for Blue Earth Diagnostics. Dr. Vapiwala disclosed no relevant conflicts of interest.

SOURCE: Jani A et al. ASTRO 2020, Abstract LBA1.

Integrating PET imaging into postprostatectomy radiation therapy (RT) decisions and planning can improve prostate cancer outcomes, first results of the EMPIRE-1 trial suggest.

The findings were reported in a plenary session at the American Society for Radiation Oncology Annual Meeting 2020.

“Quite frankly, this is an area where we are shooting in the dark with conventional imaging, and that’s where we think molecular imaging has a potential role,” noted coprincipal investigator Ashesh B. Jani, MD, of the Winship Cancer Institute of Emory University, Atlanta.

“We hypothesized that radiotherapy outcomes can be improved upon by PET by excluding patients with extrapelvic disease and also by improving treatment field decisions and target definition,” Dr. Jani added.

Patients with prostate cancer were eligible for EMPIRE-1 if they had undergone prostatectomy and had a detectable prostate-specific antigen (PSA) level but negative findings on conventional imaging (a bone scan plus abdominopelvic CT and/or MRI).

A total of 165 patients were randomized to RT guided by the conventional imaging alone or combined with PET imaging using the radiotracer fluciclovine (18F). Treatment decisions in the latter group were strictly based on where uptake was seen.
 

Study results

The trial’s primary endpoint was treatment failure, defined as a PSA level exceeding 0.2 ng/mL from nadir followed by another rise, a continued PSA rise despite RT, progression on imaging or digital rectal exam, or initiation of systemic therapy.

“Most imaging studies tend to focus on diagnostic accuracy, pathologic correlation, and decision changes. It’s a very high bar for an imaging study to influence failure rates,” Dr. Jani pointed out.

Adding 18F-PET to conventional imaging altered the treatment decision for 35.4% of patients in that group (P < .001). It also significantly altered a range of volumetric and dosimetric parameters.

At a median follow-up of 2.48 years, the 3-year rate of failure-free survival was 63.0% with conventional imaging alone and 75.5% with the addition of 18F-PET (P = .003). The corresponding 4-year rate was 51.2% and 75.5%, respectively (P < .001).

In multivariate analysis, the conventional imaging group had double the risk of failure events relative to the PET group (hazard ratio, 2.04; P = .033).

Provider-reported data showed no significant difference between imaging groups in maximum acute or late genitourinary toxicity and gastrointestinal toxicity. An analysis of patient-reported toxicity data is pending.

“Randomized trials of imaging tests with a primary cancer control endpoint are important but uncommonly done,” Dr. Jani commented. “This is the first such trial of PET over conventional imaging in the postprostatectomy radiotherapy setting.”

“Inclusion of fluciclovine resulted in a significant improvement in failure rate at 3 years. This warrants further investigation,” he maintained.

To that end, the investigators have launched the EMPIRE-2 trial, which is comparing RT guided by 18F-PET with PET using another radiotracer that is not yet approved by the Food and Drug Administration, gallium-68 prostate-specific membrane antigen.
 

Findings in context

“There are several remarkable aspects of the EMPIRE-1 trial worth noting,” said invited discussant Neha Vapiwala, MD, of the University of Pennsylvania, Philadelphia.

She commended the trial’s randomization, given a bias that more imaging is better, and the diversity of its participants that better reflects the general population of prostate cancer patients.

“The study procedures appear to be well tolerated despite a net overall increase in the radiation volume treated in the patients who underwent PET, although we do still await patient-reported toxicity,” Dr. Vapiwala noted. “Finally, a high bar was set, with a clinically meaningful primary endpoint for an imaging study.

“This study ultimately demonstrated that, in the PET arm, better selection with PET was able to result in better patient outcomes,” she maintained.

At the same time, Dr. Vapiwala recommended caution when reducing or withholding definitive local therapy based on PET results, as occurred in 14 patients.

“We must always be able to see the forest from the trees, and when evaluating our patients with PET scans, what we see and what we don’t see is just one piece of the puzzle. Existing level 1 evidence and oncologic principles must still apply,” she said. “While PET can help paint a more complete picture, it should not define the picture itself.”

The study was supported by the National Institutes of Health. Dr. Jani disclosed advisory board service for Blue Earth Diagnostics. Dr. Vapiwala disclosed no relevant conflicts of interest.

SOURCE: Jani A et al. ASTRO 2020, Abstract LBA1.

Video capsule endoscopy (VCE) offers an alternative triage tool for acute GI bleeding that may reduce personnel exposure to SARS-CoV-2, based on a cohort study with historical controls.

Yuuji/iStock/Getty Images

VCE should be considered even when rapid coronavirus testing is available, as active bleeding is more likely to be detected when evaluated sooner, potentially sparing patients from invasive procedures, reported lead author Shahrad Hakimian, MD, of the University of Massachusetts Medical Center, Worchester, and colleagues.

“Endoscopists and staff are at high risk of exposure to coronavirus through aerosols, as well as unintended, unrecognized splashes that are well known to occur frequently during routine endoscopy,” Dr. Hakimian said during a virtual presentation at the annual meeting of the American College of Gastroenterology.

Although pretesting and delaying procedures as needed may mitigate risks of viral exposure, “many urgent procedures, such as endoscopic evaluation of gastrointestinal bleeding, can’t really wait,” Dr. Hakimian said.

Current guidelines recommend early upper endoscopy and/or colonoscopy for evaluation of GI bleeding, but Dr. Hakimian noted that two out of three initial tests are nondiagnostic, so multiple procedures are often needed to find an answer.

In 2018, a randomized, controlled trial coauthored by Dr. Hakimian’s colleagues demonstrated how VCE may be a better approach, as it more frequently detected active bleeding than standard of care (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64).

The present study built on these findings in the context of the COVID-19 pandemic.

Dr. Hakimian and colleagues analyzed data from 50 consecutive, hemodynamically stable patients with severe anemia or suspected GI bleeding who underwent VCE as a first-line diagnostic modality from mid-March to mid-May 2020 (COVID arm). These patients were compared with 57 consecutive patients who were evaluated for acute GI bleeding or severe anemia with standard of care prior to the COVID-19 pandemic (pre-COVID arm).

Characteristics of the two cohorts were generally similar, although the COVID arm included a slightly older population, with a median age of 68 years, compared with a median age of 61.8 years for the pre-COVID arm (P = .03). Among presenting symptoms, hematochezia was less common in the COVID group (4% vs. 18%; P = .03). Comorbidities were not significantly different between cohorts.

Per the study design, 100% of patients in the COVID arm underwent VCE as their first diagnostic modality. In the pre-COVID arm, 82% of patients first underwent upper endoscopy, followed by colonoscopy (12%) and VCE (5%).

The main outcome, bleeding localization, did not differ between groups, whether this was confined to the first test, or in terms of final localization. But VCE was significantly better at detecting active bleeding or stigmata of bleeding, at a rate of 66%, compared with 28% in the pre-COVID group (P < .001). Patients in the COVID arm were also significantly less likely to need any invasive procedures (44% vs. 96%; P < .001).

No intergroup differences were observed in rates of blood transfusion, in-hospital or GI-bleed mortality, rebleeding, or readmission for bleeding.

“VCE appears to be a safe alternative to traditional diagnostic evaluation of GI bleeding in the era of COVID,” Dr. Hakimian concluded, noting that “the VCE-first strategy reduces the risk of staff exposure to endoscopic aerosols, conserves personal protective equipment, and reduces staff utilization.”

According to Neil Sengupta, MD, of the University of Chicago, “a VCE-first strategy in GI bleeding may be a useful triage tool in the COVID-19 era to determine which patients truly benefit from invasive endoscopy,” although he also noted that “further data are needed to determine the efficacy and safety of this approach.”

Lawrence Hookey, MD, of Queen’s University, Kingston, Ont., had a similar opinion.

“VCE appears to be a reasonable alternative in this patient group, at least as a first step,” Dr. Hookey said. “However, whether it truly makes a difference in the decision making process would have to be assessed prospectively via a randomized controlled trial or a decision analysis done in real time at various steps of the patient’s care path.”

Erik A. Holzwanger, MD, a gastroenterology fellow at Tufts Medical Center in Boston, suggested that these findings may “serve as a foundation” for similar studies, “as it appears COVID-19 will be an ongoing obstacle in endoscopy for the foreseeable future.”

“It would be interesting to have further discussion of timing of VCE, any COVID-19 transmission to staff during the VCE placement, and discussion of what constituted proceeding with endoscopic intervention [high-risk lesion, active bleeding] in both groups,” he added.

David Cave, MD, PhD, coauthor of the present study and the 2015 ACG clinical guideline for small bowel bleeding, said that VCE is gaining ground as the diagnostic of choice for GI bleeding, and patients prefer it, since it does not require anesthesia.

“This abstract is another clear pointer to the way in which, we should in the future, investigate gastrointestinal bleeding, both acute and chronic,” Dr. Cave said. “We are at an inflection point of transition to a new technology.”

Dr. Cave disclosed relationships with Medtronic and Olympus. The other investigators and interviewees reported no conflicts of interest.

Video capsule endoscopy (VCE) offers an alternative triage tool for acute GI bleeding that may reduce personnel exposure to SARS-CoV-2, based on a cohort study with historical controls.

Yuuji/iStock/Getty Images

VCE should be considered even when rapid coronavirus testing is available, as active bleeding is more likely to be detected when evaluated sooner, potentially sparing patients from invasive procedures, reported lead author Shahrad Hakimian, MD, of the University of Massachusetts Medical Center, Worchester, and colleagues.

“Endoscopists and staff are at high risk of exposure to coronavirus through aerosols, as well as unintended, unrecognized splashes that are well known to occur frequently during routine endoscopy,” Dr. Hakimian said during a virtual presentation at the annual meeting of the American College of Gastroenterology.

Although pretesting and delaying procedures as needed may mitigate risks of viral exposure, “many urgent procedures, such as endoscopic evaluation of gastrointestinal bleeding, can’t really wait,” Dr. Hakimian said.

Current guidelines recommend early upper endoscopy and/or colonoscopy for evaluation of GI bleeding, but Dr. Hakimian noted that two out of three initial tests are nondiagnostic, so multiple procedures are often needed to find an answer.

In 2018, a randomized, controlled trial coauthored by Dr. Hakimian’s colleagues demonstrated how VCE may be a better approach, as it more frequently detected active bleeding than standard of care (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64).

The present study built on these findings in the context of the COVID-19 pandemic.

Dr. Hakimian and colleagues analyzed data from 50 consecutive, hemodynamically stable patients with severe anemia or suspected GI bleeding who underwent VCE as a first-line diagnostic modality from mid-March to mid-May 2020 (COVID arm). These patients were compared with 57 consecutive patients who were evaluated for acute GI bleeding or severe anemia with standard of care prior to the COVID-19 pandemic (pre-COVID arm).

Characteristics of the two cohorts were generally similar, although the COVID arm included a slightly older population, with a median age of 68 years, compared with a median age of 61.8 years for the pre-COVID arm (P = .03). Among presenting symptoms, hematochezia was less common in the COVID group (4% vs. 18%; P = .03). Comorbidities were not significantly different between cohorts.

Per the study design, 100% of patients in the COVID arm underwent VCE as their first diagnostic modality. In the pre-COVID arm, 82% of patients first underwent upper endoscopy, followed by colonoscopy (12%) and VCE (5%).

The main outcome, bleeding localization, did not differ between groups, whether this was confined to the first test, or in terms of final localization. But VCE was significantly better at detecting active bleeding or stigmata of bleeding, at a rate of 66%, compared with 28% in the pre-COVID group (P < .001). Patients in the COVID arm were also significantly less likely to need any invasive procedures (44% vs. 96%; P < .001).

No intergroup differences were observed in rates of blood transfusion, in-hospital or GI-bleed mortality, rebleeding, or readmission for bleeding.

“VCE appears to be a safe alternative to traditional diagnostic evaluation of GI bleeding in the era of COVID,” Dr. Hakimian concluded, noting that “the VCE-first strategy reduces the risk of staff exposure to endoscopic aerosols, conserves personal protective equipment, and reduces staff utilization.”

According to Neil Sengupta, MD, of the University of Chicago, “a VCE-first strategy in GI bleeding may be a useful triage tool in the COVID-19 era to determine which patients truly benefit from invasive endoscopy,” although he also noted that “further data are needed to determine the efficacy and safety of this approach.”

Lawrence Hookey, MD, of Queen’s University, Kingston, Ont., had a similar opinion.

“VCE appears to be a reasonable alternative in this patient group, at least as a first step,” Dr. Hookey said. “However, whether it truly makes a difference in the decision making process would have to be assessed prospectively via a randomized controlled trial or a decision analysis done in real time at various steps of the patient’s care path.”

Erik A. Holzwanger, MD, a gastroenterology fellow at Tufts Medical Center in Boston, suggested that these findings may “serve as a foundation” for similar studies, “as it appears COVID-19 will be an ongoing obstacle in endoscopy for the foreseeable future.”

“It would be interesting to have further discussion of timing of VCE, any COVID-19 transmission to staff during the VCE placement, and discussion of what constituted proceeding with endoscopic intervention [high-risk lesion, active bleeding] in both groups,” he added.

David Cave, MD, PhD, coauthor of the present study and the 2015 ACG clinical guideline for small bowel bleeding, said that VCE is gaining ground as the diagnostic of choice for GI bleeding, and patients prefer it, since it does not require anesthesia.

“This abstract is another clear pointer to the way in which, we should in the future, investigate gastrointestinal bleeding, both acute and chronic,” Dr. Cave said. “We are at an inflection point of transition to a new technology.”

Dr. Cave disclosed relationships with Medtronic and Olympus. The other investigators and interviewees reported no conflicts of interest.

Video capsule endoscopy (VCE) offers an alternative triage tool for acute GI bleeding that may reduce personnel exposure to SARS-CoV-2, based on a cohort study with historical controls.

Yuuji/iStock/Getty Images

VCE should be considered even when rapid coronavirus testing is available, as active bleeding is more likely to be detected when evaluated sooner, potentially sparing patients from invasive procedures, reported lead author Shahrad Hakimian, MD, of the University of Massachusetts Medical Center, Worchester, and colleagues.

“Endoscopists and staff are at high risk of exposure to coronavirus through aerosols, as well as unintended, unrecognized splashes that are well known to occur frequently during routine endoscopy,” Dr. Hakimian said during a virtual presentation at the annual meeting of the American College of Gastroenterology.

Although pretesting and delaying procedures as needed may mitigate risks of viral exposure, “many urgent procedures, such as endoscopic evaluation of gastrointestinal bleeding, can’t really wait,” Dr. Hakimian said.

Current guidelines recommend early upper endoscopy and/or colonoscopy for evaluation of GI bleeding, but Dr. Hakimian noted that two out of three initial tests are nondiagnostic, so multiple procedures are often needed to find an answer.

In 2018, a randomized, controlled trial coauthored by Dr. Hakimian’s colleagues demonstrated how VCE may be a better approach, as it more frequently detected active bleeding than standard of care (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64).

The present study built on these findings in the context of the COVID-19 pandemic.

Dr. Hakimian and colleagues analyzed data from 50 consecutive, hemodynamically stable patients with severe anemia or suspected GI bleeding who underwent VCE as a first-line diagnostic modality from mid-March to mid-May 2020 (COVID arm). These patients were compared with 57 consecutive patients who were evaluated for acute GI bleeding or severe anemia with standard of care prior to the COVID-19 pandemic (pre-COVID arm).

Characteristics of the two cohorts were generally similar, although the COVID arm included a slightly older population, with a median age of 68 years, compared with a median age of 61.8 years for the pre-COVID arm (P = .03). Among presenting symptoms, hematochezia was less common in the COVID group (4% vs. 18%; P = .03). Comorbidities were not significantly different between cohorts.

Per the study design, 100% of patients in the COVID arm underwent VCE as their first diagnostic modality. In the pre-COVID arm, 82% of patients first underwent upper endoscopy, followed by colonoscopy (12%) and VCE (5%).

The main outcome, bleeding localization, did not differ between groups, whether this was confined to the first test, or in terms of final localization. But VCE was significantly better at detecting active bleeding or stigmata of bleeding, at a rate of 66%, compared with 28% in the pre-COVID group (P < .001). Patients in the COVID arm were also significantly less likely to need any invasive procedures (44% vs. 96%; P < .001).

No intergroup differences were observed in rates of blood transfusion, in-hospital or GI-bleed mortality, rebleeding, or readmission for bleeding.

“VCE appears to be a safe alternative to traditional diagnostic evaluation of GI bleeding in the era of COVID,” Dr. Hakimian concluded, noting that “the VCE-first strategy reduces the risk of staff exposure to endoscopic aerosols, conserves personal protective equipment, and reduces staff utilization.”

According to Neil Sengupta, MD, of the University of Chicago, “a VCE-first strategy in GI bleeding may be a useful triage tool in the COVID-19 era to determine which patients truly benefit from invasive endoscopy,” although he also noted that “further data are needed to determine the efficacy and safety of this approach.”

Lawrence Hookey, MD, of Queen’s University, Kingston, Ont., had a similar opinion.

“VCE appears to be a reasonable alternative in this patient group, at least as a first step,” Dr. Hookey said. “However, whether it truly makes a difference in the decision making process would have to be assessed prospectively via a randomized controlled trial or a decision analysis done in real time at various steps of the patient’s care path.”

Erik A. Holzwanger, MD, a gastroenterology fellow at Tufts Medical Center in Boston, suggested that these findings may “serve as a foundation” for similar studies, “as it appears COVID-19 will be an ongoing obstacle in endoscopy for the foreseeable future.”

“It would be interesting to have further discussion of timing of VCE, any COVID-19 transmission to staff during the VCE placement, and discussion of what constituted proceeding with endoscopic intervention [high-risk lesion, active bleeding] in both groups,” he added.

David Cave, MD, PhD, coauthor of the present study and the 2015 ACG clinical guideline for small bowel bleeding, said that VCE is gaining ground as the diagnostic of choice for GI bleeding, and patients prefer it, since it does not require anesthesia.

“This abstract is another clear pointer to the way in which, we should in the future, investigate gastrointestinal bleeding, both acute and chronic,” Dr. Cave said. “We are at an inflection point of transition to a new technology.”

Dr. Cave disclosed relationships with Medtronic and Olympus. The other investigators and interviewees reported no conflicts of interest.

Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases

“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.

She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.

“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.

SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.

However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.

This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.

Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
 

Reduces cognitive decline

The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.

Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.

All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.

The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.

In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).

Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).

A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).

In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted

Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.

Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).

The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”

Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.

This article first appeared on Medscape.com.

Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases

“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.

She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.

“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.

SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.

However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.

This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.

Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
 

Reduces cognitive decline

The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.

Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.

All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.

The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.

In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).

Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).

A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).

In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted

Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.

Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).

The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”

Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.

This article first appeared on Medscape.com.

Stereotactic radiosurgery (SRS) should replace whole-brain radiotherapy (WBRT) as the new standard of care for patients with four or more brain metastases, say researchers who report results from a randomized trial conducted in patients with four to 15 brain metastases

“SRS was associated with reduced risk of neurocognitive deterioration compared to WBRT, as demonstrated by a constellation of neurocognitive tests, individually or by composite scores,” said lead author Jing Li, MD, PhD, associate professor of radiation oncology and codirector of the Brain Metastasis Clinic at the University of Texas MD Anderson Cancer Center, Houston.

She was speaking at the American Society for Radiation Oncology (ASTRO) 2020 Annual Meeting, which was held online this year because of the COVID pandemic.

“The results from this phase 3 randomized trial strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival,” said Li.

SRS is already the standard of care for patients with one to three brain metastases. Two previous phase 3 randomized trials showed that SRS was better at preserving cognitive function without compromising overall survival in comparison to WBRT.

However, there has been some controversy over the use of SRS for patients with multiple brain metastases, commented study discussant Sue S. Yom, MD, PhD, a professor in the Departments of Radiation Oncology and Otolaryngology–Head and Neck Surgery, University of California, San Francisco.

This study has shown, “in a practice-changing manner, that giving SRS can improve the quality of life of patients with metastatic disease,” she said.

Up to 30% of cancer patients develop brain metastases. Historically, these have been associated with poor overall survival, in the range of 1 to 4 months.
 

Reduces cognitive decline

The new trial involved 72 patients with four to 15 untreated, nonmelanoma brain metastases (up to 20 lesions were allowed at the time of treatment); the median number of brain metastases was eight. Most (83%) of the trial participants were White, nearly half were aged 60 years or older, and 58% were women.

Patients were randomly assigned to receive either SRS (15–24 Gy per Radiation Therapy Oncology Group protocol 9005) or WBRT (30 Gy in 10 fractions). On the basis of previous research, 62% of patients in the WBRT arm were also given memantine, a dementia drug that can help preserve cognitive function.

All participants completed neurocognitive testing, including testing of learning, memory, attention span, executive function, verbal fluency, processing speed, and motor dexterity, at enrollment and longitudinally.

The primary endpoints were Hopkins Verbal Learning Test – Revised Total Recall (HVLT-R TR) score and local control at 4 months. Secondary endpoints included overall survival, distant brain failure, toxicity, and time to initiation of systemic therapy.

In the primary endpoint analysis, at 4 months, the HVLT-R TR standardized z-score increased by +0.21 (standard error [SE], 0.27) for patients who received SRS, but it declined by –0.74 (SE, 0.36) for WBRT-treated patients (P = .041). On the basis of Clinical Trial Battery Composite score, neurocognitive function of patients in the SRS arm improved on average +0.23 (SE, 0.14) but declined an average –0.73 (SE, 0.35) in the WBRT arm (P = .008).

Li pointed out that there was also a “clinically meaningful and statistically significant benefit” with SRS at 1 month (P = .033) and 6 months (P = .012).

A total of 69 patients (35 for SRS and 34 for WBRT) were evaluable for overall survival, which was similar between the groups (SRS median, 7.8 months; WBRT median, 8.9 months; P = .59). Treatment with SRS resulted in better local control rates (95% at 4 months with SRS and 86.7% with WBRT; P = .09), but the median time to distant brain failure was shorter (10.5 months for WBRT and 6.3 months for SRS; P = .37).

In her discussion of the study, Yom noted that overall survival time was similar in the two arms and that, numerically, it may have even been a little longer in the SRS group. “While it is true that they had more relapses in untreated portions of the brain, they lived as long or longer than those who received WBRT and had better cognitive function,” she noted

Yom also noted that of particular importance was the finding that SRS was associated with shorter interruptions of systemic therapy (time to systemic therapy: SRS, 1.7 weeks; WBRT, 4.1 weeks; P = .001). Patients with metastatic disease usually have cancer in locations other than the brain. They may be receiving some type of systemic therapy, which is interrupted with WBRT, Li commented.

Toxicities of grade 3 or higher were observed in four patients in the WBRT arm and two in the SRS arm. Radiographic evidence of radiation necrosis, a side effect associated with SRS, was observed in 17% patients in the SRS arm of the trial (4% of all treated lesions).

The trial was halted early owing to the publication of another phase 3 trial (NRG Oncology CC 001), which provided level 1 evidence for replacing standard WBRT with hippocampal-avoidance WBRT. Despite the early trial termination, Li concluded that these results “strongly support the use of SRS in patients with four to 15 brain metastases to better preserve cognitive function and to minimize interruption of systemic therapy, without compromising overall survival.”

Li has received research funding from BMS and Medtronic and honorarium from Novocure and Monteris.

This article first appeared on Medscape.com.

Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.

However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.

“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.

“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.

Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.

“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”

Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
 

Not discussed, not warned

Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.

A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).

“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”

Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.

Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.

“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.

Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.

Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”

The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
 

Importance of being holistic

The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.

“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.

“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”

The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.

However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.

“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.

“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.

Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.

“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”

Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
 

Not discussed, not warned

Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.

A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).

“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”

Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.

Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.

“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.

Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.

Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”

The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
 

Importance of being holistic

The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.

“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.

“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”

The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Sexual dysfunction is a common treatment-related problem observed across numerous cancer diagnoses, and a new survey finds that 87% of cancer survivors have had such problems.

However, most of them also reported that their oncologist had not formally discussed the topic, and female patients were particularly unlikely to be asked about sexual dysfunction.

“The main takeaway from our study is that sexual side effects following treatment are very common,” said lead author James Taylor, MD, MPH, chief resident in radiation oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University in Philadelphia, Pennsylvania.

“Nearly 9 in 10 patients reported some change after cancer treatment that negatively affected their sexual health,” he said.

Taylor was speaking at the American Society for Radiation Oncology (ASTRO) Annual Meeting, held virtually this year because of the pandemic.

“Negative effects on sexual health after cancer treatment are unfortunately very common,” he said. “This is not just patients treated with radiation but this includes chemotherapy, hormonal therapy, surgery, and other treatment modalities.”

Potential issues include physical complications such as erectile dysfunction with prostate cancer treatment or vaginal dryness with gynecological cancer treatment. One recent study found that one-third of men who had undergone treatment for prostate cancer reported that a subsequent lack of sexual function has had the greatest impact on their quality of life. Another study reported that nearly all patients with breast cancer taking endocrine therapy experience a high degree of sexual dysfunction, including vulvovaginal dryness and severe dyspareunia.
 

Not discussed, not warned

Taylor and colleagues developed a questionnaire with input from radiation oncologists, medical oncologists, and surgeons, which consisted of more than 25 questions and was specifically targeted at cancer survivors.

A total of 405 adults completed the electronic survey about their experiences with sexual side effects after cancer treatment (391 responses were eligible for analysis). Most of the respondents were women (81%), and the most common cancer types were breast (67%), prostate (16%), and endometrial (6%). Treatments included chemotherapy (78%), radiation therapy (54%), and hormone therapy (47%).

“The questionnaires were distributed at Thomas Jefferson and throughout social media,” said Taylor. “The responses from social media are important because it shows a broad representation of patients who are treated in multiple clinics across the United States.”

Most of the survivors who responded (n = 337, 87%) stated cancer treatment had impacted sexual function or desire, with 53.8% reporting body image distortion, 73.4% with dyspareunia, and 42.3% unable to achieve orgasm.

Only about one-quarter (27.9%) said they had been formally asked about their sexual health by their clinician.

“Only about 40% said that they have been preemptively warned that their sexual health may be affected by treatment,” said Taylor.

Women were far less likely to be asked about their sexual health by their provider. The survey showed that male respondents were twice as likely to say they had been asked about sexual health and counseled about the potential toxicity (53% vs 22%; P < .001), and a substantially higher percentage of men reported receiving a formal assessment tool such as a survey (32% vs 5%; P = .001) compared with female respondents.

Taylor noted that the survey demonstrated several things. “One is that sexual toxicity is exceedingly common, and number two, it identified a gender disparity,” he said. “But number 3, and I think that this is an important aspect of our study, is that the majority of respondents felt that they would like a standard questionnaire to initiate and guide a discussion on sexual health with their provider.”

The reason that aspect is very important, he emphasized, is that “we know metrics and questionnaires already exist, so this gives us an actionable intervention that we can distribute and help mitigate some of these disparities.”
 

Importance of being holistic

The results of the survey “highlight the importance of being holistic in our approach to patient survivorship,” commented Karen Winkfield, MD, PhD, associate professor of radiation oncology at Wake Forest University, Winston-Salem, North Carolina, and executive director of the Meharry-Vanderbilt Alliance, Nashville, Tennessee.

“We need to ask patients about all parts of their well-being, including sexual health,” Winkfield said. “Body dysmorphism can impact anyone, but especially patients who have had surgery or radiation,” she said, while chemotherapy can impact energy and libido and have other toxicities that impact sexual health.

“I encourage all oncologists to ask patients about their sexual health, and a standardized form that can be used across all sites will make this much easier,” Winkfield commented. “We owe it to our patients to treat them holistically.”

The authors have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

A new poll of emergency physicians on the front lines of the COVID-19 pandemic shows many are fearful of seeking mental health care for fear of stigma and the potential career impact.

wutwhanfoto/Getty Images

The results of the nationally representative poll, conducted Oct. 7-13 by the American College of Emergency Physicians, showed almost half (45%) of 862 emergency physician respondents reported being uncomfortable seeking available psychiatric care. The poll had a margin of error of plus or minus 3 percentage points.

The findings provide new insight into both the challenges of serving in emergency medicine during the pandemic and the persistent barriers to mental health care in terms of stigma and concerns about potential career setbacks.

In the poll, 42% of respondents said they have been feeling much more stress since the start of COVID-19, with another 45% report they were feeling somewhat more stressed.

When asked about causes of stress related directly to COVID-19, 83% cited concerns about family and friends contracting COVID-19. Also factoring into emergency physicians’ stress and burnout were concerns about their own safety (80%) and lack of personal protective equipment or other needed resources (60%).

In the poll, 29% of respondents reported having excellent access to mental health treatment and 42% reported having good access. Despite this, 30% of respondents still reported feeling there was a lot of stigma in their workplace about seeking mental health treatment, with another 43% reporting they felt there was some stigma.

Poll results also showed that 24% of respondents were very concerned about what might happen with their employment if they were to seek mental health treatment, with another 33% saying they were somewhat concerned.

In recent years there have been efforts to break down cultural roadblocks in medicine that deter many physicians from seeking mental health treatment, but more needs to be done, said Mark Rosenberg, DO, MBA, who was elected president of ACEP at last weekend’s annual meeting, ACEP20.

“The pandemic emphatically underscores our need to change the status quo when it comes to physicians’ mental health,” Dr. Rosenberg said.

As previously reported by Medscape Medical News, current efforts to remove such barriers include initiatives to limit inquiries into clinicians’ past or present mental health treatment.

In May, the influential Joint Commission issued a statement urging organizations to refrain from asking about any history of mental health conditions or treatment. The Joint Commission said it supports recommendations already made by the Federation of State Medical Boards and the American Medical Association to limit inquiries on licensing applications to conditions that currently impair a clinician’s ability to perform their job.

Also supporting these efforts is the Dr. Lorna Breen Heroes’ Foundation, created in honor of an emergency physician who died by suicide in April amid the pandemic.

Lorna Breen, MD, had been working intensely in the response to the pandemic. During one shift, she covered two EDs in Manhattan at locations 5 miles apart, according to a backgrounder on the foundation’s web site.

At an ACEP press conference this week, Dr. Breen’s brother-in-law, J. Corey Feist, JD, MBA, cofounder of the foundation, noted that some states’ licensing applications for physicians include questions that fall outside of the boundaries of the Americans With Disabilities Act. He cited an analysis of state medical boards’ initial licensing questions published in 2018 in the Journal of the American Academy of Psychiatry and the Law.

In many cases, states have posed questions that extend beyond an assessment of a physician’s current ability to care for patients, creating a needless hurdle to seeking care, wrote the paper’s lead author, Carol North, MD, of the University of Texas Southwestern Medical Center, Dallas.

“Over the years, many medical licensure boards have asked applicants intrusive questions about whether they have any psychiatric history. This has created a major problem for applicants, and unfortunately this has discouraged many of those who need psychiatric treatment from seeking it because of fear of the questions,” Dr. North and colleagues noted. They cited Ohio as an example of a state that had overhauled its approach to questioning to bring it in compliance with the ADA.

Ohio previously required applicants to answer lengthy questions about their mental health, including:

• Within the last 10 years, have you been diagnosed with or have you been treated for bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Have you, since attaining the age of eighteen or within the last 10 years, whichever period is shorter, been admitted to a hospital or other facility for the treatment of bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Do you have, or have you been diagnosed as having, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?

In the new version, the single question reads: “In the past 5 years, have you been diagnosed as having, or been hospitalized for, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?”

Other states such as New York pose no mental health questions on applications for licensure.

Still, even when states have nondiscriminatory laws, physicians may not be aware of them, said Mr. Feist at an ACEP press conference. In addition to his work with the foundation, Mr. Feist is the CEO of the University of Virginia Physicians Group.

He said his sister-in-law Dr. Breen may have worried without cause about potential consequences of seeking psychiatric treatment during the pandemic. In addition, physicians in need of psychiatric care may worry about encountering hitches with medical organizations and insurers.

“This stigma and this fear of professional action on your license or your credentialing or privileging is pervasive throughout the industry,” he said.

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

A new poll of emergency physicians on the front lines of the COVID-19 pandemic shows many are fearful of seeking mental health care for fear of stigma and the potential career impact.

wutwhanfoto/Getty Images

The results of the nationally representative poll, conducted Oct. 7-13 by the American College of Emergency Physicians, showed almost half (45%) of 862 emergency physician respondents reported being uncomfortable seeking available psychiatric care. The poll had a margin of error of plus or minus 3 percentage points.

The findings provide new insight into both the challenges of serving in emergency medicine during the pandemic and the persistent barriers to mental health care in terms of stigma and concerns about potential career setbacks.

In the poll, 42% of respondents said they have been feeling much more stress since the start of COVID-19, with another 45% report they were feeling somewhat more stressed.

When asked about causes of stress related directly to COVID-19, 83% cited concerns about family and friends contracting COVID-19. Also factoring into emergency physicians’ stress and burnout were concerns about their own safety (80%) and lack of personal protective equipment or other needed resources (60%).

In the poll, 29% of respondents reported having excellent access to mental health treatment and 42% reported having good access. Despite this, 30% of respondents still reported feeling there was a lot of stigma in their workplace about seeking mental health treatment, with another 43% reporting they felt there was some stigma.

Poll results also showed that 24% of respondents were very concerned about what might happen with their employment if they were to seek mental health treatment, with another 33% saying they were somewhat concerned.

In recent years there have been efforts to break down cultural roadblocks in medicine that deter many physicians from seeking mental health treatment, but more needs to be done, said Mark Rosenberg, DO, MBA, who was elected president of ACEP at last weekend’s annual meeting, ACEP20.

“The pandemic emphatically underscores our need to change the status quo when it comes to physicians’ mental health,” Dr. Rosenberg said.

As previously reported by Medscape Medical News, current efforts to remove such barriers include initiatives to limit inquiries into clinicians’ past or present mental health treatment.

In May, the influential Joint Commission issued a statement urging organizations to refrain from asking about any history of mental health conditions or treatment. The Joint Commission said it supports recommendations already made by the Federation of State Medical Boards and the American Medical Association to limit inquiries on licensing applications to conditions that currently impair a clinician’s ability to perform their job.

Also supporting these efforts is the Dr. Lorna Breen Heroes’ Foundation, created in honor of an emergency physician who died by suicide in April amid the pandemic.

Lorna Breen, MD, had been working intensely in the response to the pandemic. During one shift, she covered two EDs in Manhattan at locations 5 miles apart, according to a backgrounder on the foundation’s web site.

At an ACEP press conference this week, Dr. Breen’s brother-in-law, J. Corey Feist, JD, MBA, cofounder of the foundation, noted that some states’ licensing applications for physicians include questions that fall outside of the boundaries of the Americans With Disabilities Act. He cited an analysis of state medical boards’ initial licensing questions published in 2018 in the Journal of the American Academy of Psychiatry and the Law.

In many cases, states have posed questions that extend beyond an assessment of a physician’s current ability to care for patients, creating a needless hurdle to seeking care, wrote the paper’s lead author, Carol North, MD, of the University of Texas Southwestern Medical Center, Dallas.

“Over the years, many medical licensure boards have asked applicants intrusive questions about whether they have any psychiatric history. This has created a major problem for applicants, and unfortunately this has discouraged many of those who need psychiatric treatment from seeking it because of fear of the questions,” Dr. North and colleagues noted. They cited Ohio as an example of a state that had overhauled its approach to questioning to bring it in compliance with the ADA.

Ohio previously required applicants to answer lengthy questions about their mental health, including:

• Within the last 10 years, have you been diagnosed with or have you been treated for bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Have you, since attaining the age of eighteen or within the last 10 years, whichever period is shorter, been admitted to a hospital or other facility for the treatment of bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Do you have, or have you been diagnosed as having, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?

In the new version, the single question reads: “In the past 5 years, have you been diagnosed as having, or been hospitalized for, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?”

Other states such as New York pose no mental health questions on applications for licensure.

Still, even when states have nondiscriminatory laws, physicians may not be aware of them, said Mr. Feist at an ACEP press conference. In addition to his work with the foundation, Mr. Feist is the CEO of the University of Virginia Physicians Group.

He said his sister-in-law Dr. Breen may have worried without cause about potential consequences of seeking psychiatric treatment during the pandemic. In addition, physicians in need of psychiatric care may worry about encountering hitches with medical organizations and insurers.

“This stigma and this fear of professional action on your license or your credentialing or privileging is pervasive throughout the industry,” he said.

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

A new poll of emergency physicians on the front lines of the COVID-19 pandemic shows many are fearful of seeking mental health care for fear of stigma and the potential career impact.

wutwhanfoto/Getty Images

The results of the nationally representative poll, conducted Oct. 7-13 by the American College of Emergency Physicians, showed almost half (45%) of 862 emergency physician respondents reported being uncomfortable seeking available psychiatric care. The poll had a margin of error of plus or minus 3 percentage points.

The findings provide new insight into both the challenges of serving in emergency medicine during the pandemic and the persistent barriers to mental health care in terms of stigma and concerns about potential career setbacks.

In the poll, 42% of respondents said they have been feeling much more stress since the start of COVID-19, with another 45% report they were feeling somewhat more stressed.

When asked about causes of stress related directly to COVID-19, 83% cited concerns about family and friends contracting COVID-19. Also factoring into emergency physicians’ stress and burnout were concerns about their own safety (80%) and lack of personal protective equipment or other needed resources (60%).

In the poll, 29% of respondents reported having excellent access to mental health treatment and 42% reported having good access. Despite this, 30% of respondents still reported feeling there was a lot of stigma in their workplace about seeking mental health treatment, with another 43% reporting they felt there was some stigma.

Poll results also showed that 24% of respondents were very concerned about what might happen with their employment if they were to seek mental health treatment, with another 33% saying they were somewhat concerned.

In recent years there have been efforts to break down cultural roadblocks in medicine that deter many physicians from seeking mental health treatment, but more needs to be done, said Mark Rosenberg, DO, MBA, who was elected president of ACEP at last weekend’s annual meeting, ACEP20.

“The pandemic emphatically underscores our need to change the status quo when it comes to physicians’ mental health,” Dr. Rosenberg said.

As previously reported by Medscape Medical News, current efforts to remove such barriers include initiatives to limit inquiries into clinicians’ past or present mental health treatment.

In May, the influential Joint Commission issued a statement urging organizations to refrain from asking about any history of mental health conditions or treatment. The Joint Commission said it supports recommendations already made by the Federation of State Medical Boards and the American Medical Association to limit inquiries on licensing applications to conditions that currently impair a clinician’s ability to perform their job.

Also supporting these efforts is the Dr. Lorna Breen Heroes’ Foundation, created in honor of an emergency physician who died by suicide in April amid the pandemic.

Lorna Breen, MD, had been working intensely in the response to the pandemic. During one shift, she covered two EDs in Manhattan at locations 5 miles apart, according to a backgrounder on the foundation’s web site.

At an ACEP press conference this week, Dr. Breen’s brother-in-law, J. Corey Feist, JD, MBA, cofounder of the foundation, noted that some states’ licensing applications for physicians include questions that fall outside of the boundaries of the Americans With Disabilities Act. He cited an analysis of state medical boards’ initial licensing questions published in 2018 in the Journal of the American Academy of Psychiatry and the Law.

In many cases, states have posed questions that extend beyond an assessment of a physician’s current ability to care for patients, creating a needless hurdle to seeking care, wrote the paper’s lead author, Carol North, MD, of the University of Texas Southwestern Medical Center, Dallas.

“Over the years, many medical licensure boards have asked applicants intrusive questions about whether they have any psychiatric history. This has created a major problem for applicants, and unfortunately this has discouraged many of those who need psychiatric treatment from seeking it because of fear of the questions,” Dr. North and colleagues noted. They cited Ohio as an example of a state that had overhauled its approach to questioning to bring it in compliance with the ADA.

Ohio previously required applicants to answer lengthy questions about their mental health, including:

• Within the last 10 years, have you been diagnosed with or have you been treated for bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Have you, since attaining the age of eighteen or within the last 10 years, whichever period is shorter, been admitted to a hospital or other facility for the treatment of bipolar disorder, schizophrenia, paranoia, or any other psychotic disorder?
• Do you have, or have you been diagnosed as having, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?

In the new version, the single question reads: “In the past 5 years, have you been diagnosed as having, or been hospitalized for, a medical condition which in any way impairs or limits your ability to practice medicine with reasonable skill and safety?”

Other states such as New York pose no mental health questions on applications for licensure.

Still, even when states have nondiscriminatory laws, physicians may not be aware of them, said Mr. Feist at an ACEP press conference. In addition to his work with the foundation, Mr. Feist is the CEO of the University of Virginia Physicians Group.

He said his sister-in-law Dr. Breen may have worried without cause about potential consequences of seeking psychiatric treatment during the pandemic. In addition, physicians in need of psychiatric care may worry about encountering hitches with medical organizations and insurers.

“This stigma and this fear of professional action on your license or your credentialing or privileging is pervasive throughout the industry,” he said.

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

Two experts at IDWeek 2020 debated the best treatment for patients with the most severe type of Clostridioides difficile infection – fulminant C. diff. The discussion pitted fecal microbiota transplants (FMT) from the stool of healthy donors against traditional antibiotics.

Fulminant C. diff infection (CDI) represents about 8% of all CDI cases and is often fatal. Patients frequently don’t respond to maximum antibiotic therapy.

Should these patients be treated with FMT before surgery is considered?

“Unequivocally, yes,” said Jessica R. Allegretti, MD, MPH, associate director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital in Boston.
 

Patients face full colectomy

Fulminant infection, she says, typically requires a total abdominal colectomy with end ileostomy.

“Patients have a quite high perioperative and intraoperative mortality because this is typically an older population with significant comorbidities,” she said.

Often the patients are poor candidates for surgery, she added.

She pointed to the efficacy of FMT in studies such as one published in Gut Microbes in 2017. The study, by Monika Fischer, MD, of Indiana University, Indianapolis, and colleagues showed a 91% cure rate at 1 month in severe patients with an average of 1.5 fecal transplants, noting that was “quite remarkable” in this very sick population.

Though FMT is not approved by the US Food and Drug Administration for fulminant CDI, Dr. Allegretti said, the FDA does allow treatment under “enforcement discretion,” which means no investigational new drug license is needed specifically if treating CDI patients who haven’t responded to standard therapy, as long as proper consent has been obtained.

“This is a patient population that is likely going to die,” she said. “If you were the one in the ICU with fulminant C. diff and you’ve been on maximum therapy for 3-5 days and you’re not getting better, wouldn’t you want somebody to offer you a fecal transplant and give you the chance to recover and leave the hospital with your colon intact? The data suggest that is possible, with a high likelihood and a good safety profile.”

She said the most recent guidelines have supported FMT, and emerging guidelines coming within months “will support this as well.”
 

Unknowns with FMT

Taking the other side of the debate, Kevin Garey, PharmD, chair of the department of pharmacy practice and translational research at University of Houston College of Pharmacy, warned against trading traditional antibiotics, such as vancomycin and fidaxomicin, for the novelty of FMT.

“With the science of the microbiome and the novelty of fecal microbiota transplantation in expanding use, I think people have somewhat forgotten pharmacotherapy,” he said.

He pointed out safety concerns with FMT reported in June 2019, after which the FDA issued an alert. Two immunocompromised patients who received FMT, both from the same donor, developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli. One died.

The FDA explained that the donated FMT samples the patients received were not tested for ESBL-producing gram-negative organisms before use.

Dr. Allegretti agreed antibiotics play a role in treatment with FMT, but she argued that the safety profile of FMT remains strong and that the safety issues came from isolated incidents at a single center.

Dr. Garey countered that there are just too many unknowns with FMT.

“We will never know what the next superbug that’s going to land in an FMT is until we’ve identified that superbug in somebody – the next Candida auris, the next CRE [carbapenem-resistant Enterobacteriaceae], the next thing that’s going to show up in FMT – until we get rid of the ‘F,’ “ Dr. Garey said.

“[Until] we get microbial therapy that’s generated without the need for healthy donors, I think we’re always going to be in this problem.”

He said although FMT “has an amazing ability to alter a microbiome” it “pales in comparison” to vancomycin’s ability to do so.

Disruption of the microbiome is, without a doubt, a hallmark of C. diff, but we don’t have to run to FMT,” Dr. Garey said. “We can think about prophylaxis strategies, we can think about new drug development that spares the microbiota. The need for FMT might be a consequence of poor pharmacotherapy management, not a part of pharmacotherapy management.”

Moderator Sam Aitken, PharmD, MPH, a clinical pharmacy specialist in infectious disease at MD Anderson Cancer Center in Houston, said in an interview the speakers found some common ground.

“I think there was a general consensus between both Dr. Allegretti and Dr. Garey that both traditional therapeutics and fecal microbiota transplantation have a role to play in these patients, although there is still quite a bit of discussion around where those might be best positioned,” Dr. Aitken said.

He added, “There’s also a general consensus that there is not likely to be one right answer for all patients with multiple recurrent CDI.”

Dr. Allegretti, Dr. Garey, and Dr. Aitken have disclosed no relevant financial relationships.
 

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

Two experts at IDWeek 2020 debated the best treatment for patients with the most severe type of Clostridioides difficile infection – fulminant C. diff. The discussion pitted fecal microbiota transplants (FMT) from the stool of healthy donors against traditional antibiotics.

Fulminant C. diff infection (CDI) represents about 8% of all CDI cases and is often fatal. Patients frequently don’t respond to maximum antibiotic therapy.

Should these patients be treated with FMT before surgery is considered?

“Unequivocally, yes,” said Jessica R. Allegretti, MD, MPH, associate director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital in Boston.
 

Patients face full colectomy

Fulminant infection, she says, typically requires a total abdominal colectomy with end ileostomy.

“Patients have a quite high perioperative and intraoperative mortality because this is typically an older population with significant comorbidities,” she said.

Often the patients are poor candidates for surgery, she added.

She pointed to the efficacy of FMT in studies such as one published in Gut Microbes in 2017. The study, by Monika Fischer, MD, of Indiana University, Indianapolis, and colleagues showed a 91% cure rate at 1 month in severe patients with an average of 1.5 fecal transplants, noting that was “quite remarkable” in this very sick population.

Though FMT is not approved by the US Food and Drug Administration for fulminant CDI, Dr. Allegretti said, the FDA does allow treatment under “enforcement discretion,” which means no investigational new drug license is needed specifically if treating CDI patients who haven’t responded to standard therapy, as long as proper consent has been obtained.

“This is a patient population that is likely going to die,” she said. “If you were the one in the ICU with fulminant C. diff and you’ve been on maximum therapy for 3-5 days and you’re not getting better, wouldn’t you want somebody to offer you a fecal transplant and give you the chance to recover and leave the hospital with your colon intact? The data suggest that is possible, with a high likelihood and a good safety profile.”

She said the most recent guidelines have supported FMT, and emerging guidelines coming within months “will support this as well.”
 

Unknowns with FMT

Taking the other side of the debate, Kevin Garey, PharmD, chair of the department of pharmacy practice and translational research at University of Houston College of Pharmacy, warned against trading traditional antibiotics, such as vancomycin and fidaxomicin, for the novelty of FMT.

“With the science of the microbiome and the novelty of fecal microbiota transplantation in expanding use, I think people have somewhat forgotten pharmacotherapy,” he said.

He pointed out safety concerns with FMT reported in June 2019, after which the FDA issued an alert. Two immunocompromised patients who received FMT, both from the same donor, developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli. One died.

The FDA explained that the donated FMT samples the patients received were not tested for ESBL-producing gram-negative organisms before use.

Dr. Allegretti agreed antibiotics play a role in treatment with FMT, but she argued that the safety profile of FMT remains strong and that the safety issues came from isolated incidents at a single center.

Dr. Garey countered that there are just too many unknowns with FMT.

“We will never know what the next superbug that’s going to land in an FMT is until we’ve identified that superbug in somebody – the next Candida auris, the next CRE [carbapenem-resistant Enterobacteriaceae], the next thing that’s going to show up in FMT – until we get rid of the ‘F,’ “ Dr. Garey said.

“[Until] we get microbial therapy that’s generated without the need for healthy donors, I think we’re always going to be in this problem.”

He said although FMT “has an amazing ability to alter a microbiome” it “pales in comparison” to vancomycin’s ability to do so.

Disruption of the microbiome is, without a doubt, a hallmark of C. diff, but we don’t have to run to FMT,” Dr. Garey said. “We can think about prophylaxis strategies, we can think about new drug development that spares the microbiota. The need for FMT might be a consequence of poor pharmacotherapy management, not a part of pharmacotherapy management.”

Moderator Sam Aitken, PharmD, MPH, a clinical pharmacy specialist in infectious disease at MD Anderson Cancer Center in Houston, said in an interview the speakers found some common ground.

“I think there was a general consensus between both Dr. Allegretti and Dr. Garey that both traditional therapeutics and fecal microbiota transplantation have a role to play in these patients, although there is still quite a bit of discussion around where those might be best positioned,” Dr. Aitken said.

He added, “There’s also a general consensus that there is not likely to be one right answer for all patients with multiple recurrent CDI.”

Dr. Allegretti, Dr. Garey, and Dr. Aitken have disclosed no relevant financial relationships.
 

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

Two experts at IDWeek 2020 debated the best treatment for patients with the most severe type of Clostridioides difficile infection – fulminant C. diff. The discussion pitted fecal microbiota transplants (FMT) from the stool of healthy donors against traditional antibiotics.

Fulminant C. diff infection (CDI) represents about 8% of all CDI cases and is often fatal. Patients frequently don’t respond to maximum antibiotic therapy.

Should these patients be treated with FMT before surgery is considered?

“Unequivocally, yes,” said Jessica R. Allegretti, MD, MPH, associate director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital in Boston.
 

Patients face full colectomy

Fulminant infection, she says, typically requires a total abdominal colectomy with end ileostomy.

“Patients have a quite high perioperative and intraoperative mortality because this is typically an older population with significant comorbidities,” she said.

Often the patients are poor candidates for surgery, she added.

She pointed to the efficacy of FMT in studies such as one published in Gut Microbes in 2017. The study, by Monika Fischer, MD, of Indiana University, Indianapolis, and colleagues showed a 91% cure rate at 1 month in severe patients with an average of 1.5 fecal transplants, noting that was “quite remarkable” in this very sick population.

Though FMT is not approved by the US Food and Drug Administration for fulminant CDI, Dr. Allegretti said, the FDA does allow treatment under “enforcement discretion,” which means no investigational new drug license is needed specifically if treating CDI patients who haven’t responded to standard therapy, as long as proper consent has been obtained.

“This is a patient population that is likely going to die,” she said. “If you were the one in the ICU with fulminant C. diff and you’ve been on maximum therapy for 3-5 days and you’re not getting better, wouldn’t you want somebody to offer you a fecal transplant and give you the chance to recover and leave the hospital with your colon intact? The data suggest that is possible, with a high likelihood and a good safety profile.”

She said the most recent guidelines have supported FMT, and emerging guidelines coming within months “will support this as well.”
 

Unknowns with FMT

Taking the other side of the debate, Kevin Garey, PharmD, chair of the department of pharmacy practice and translational research at University of Houston College of Pharmacy, warned against trading traditional antibiotics, such as vancomycin and fidaxomicin, for the novelty of FMT.

“With the science of the microbiome and the novelty of fecal microbiota transplantation in expanding use, I think people have somewhat forgotten pharmacotherapy,” he said.

He pointed out safety concerns with FMT reported in June 2019, after which the FDA issued an alert. Two immunocompromised patients who received FMT, both from the same donor, developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli. One died.

The FDA explained that the donated FMT samples the patients received were not tested for ESBL-producing gram-negative organisms before use.

Dr. Allegretti agreed antibiotics play a role in treatment with FMT, but she argued that the safety profile of FMT remains strong and that the safety issues came from isolated incidents at a single center.

Dr. Garey countered that there are just too many unknowns with FMT.

“We will never know what the next superbug that’s going to land in an FMT is until we’ve identified that superbug in somebody – the next Candida auris, the next CRE [carbapenem-resistant Enterobacteriaceae], the next thing that’s going to show up in FMT – until we get rid of the ‘F,’ “ Dr. Garey said.

“[Until] we get microbial therapy that’s generated without the need for healthy donors, I think we’re always going to be in this problem.”

He said although FMT “has an amazing ability to alter a microbiome” it “pales in comparison” to vancomycin’s ability to do so.

Disruption of the microbiome is, without a doubt, a hallmark of C. diff, but we don’t have to run to FMT,” Dr. Garey said. “We can think about prophylaxis strategies, we can think about new drug development that spares the microbiota. The need for FMT might be a consequence of poor pharmacotherapy management, not a part of pharmacotherapy management.”

Moderator Sam Aitken, PharmD, MPH, a clinical pharmacy specialist in infectious disease at MD Anderson Cancer Center in Houston, said in an interview the speakers found some common ground.

“I think there was a general consensus between both Dr. Allegretti and Dr. Garey that both traditional therapeutics and fecal microbiota transplantation have a role to play in these patients, although there is still quite a bit of discussion around where those might be best positioned,” Dr. Aitken said.

He added, “There’s also a general consensus that there is not likely to be one right answer for all patients with multiple recurrent CDI.”

Dr. Allegretti, Dr. Garey, and Dr. Aitken have disclosed no relevant financial relationships.
 

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

A new consensus statement offers detailed guidelines for inpatient use of continuous glucose monitors (CGM) and automated insulin delivery (AID) systems.

Aimed at clinicians, researchers, and hospital administrators, the open-access document was recently published by a multidisciplinary international panel of 24 experts in the Journal of Diabetes Science and Technology.

The statement includes 77 separate recommendations under five headings: 1) continued use of CGM by patients already using them at home, 2) initiation of CGM in hospital, 3) continuation of AID systems in hospital by patients already using them at home, 4) logistics and hands-on care of hospitalized patients using CGM and AID systems, and 5) data management of CGM and AID systems in hospital.

“This is the most comprehensive and up-to-date guideline on the use of diabetes technology in the hospital now,” lead author Rodolfo J. Galindo, MD, told Medscape Medical News in an interview.

“Overall, most experts believe that CGM and AID have the potential to overcome the current limitations of glycemic monitoring in the hospital to improve patient outcomes, but we need research – first to get the approval and second to get widespread use,” said Galindo, medical chair of the hospital diabetes taskforce at Emory Healthcare System, Atlanta.
 

“COVID-19 changed everything”

The guideline is an update of a 2017 statement on hospital use of CGM. The new guideline adds AID systems (sometimes referred to as an artificial pancreas), which combines a CGM and insulin pump and uses an algorithm to guide insulin delivery, and is the first to be developed during the COVID-19 era.

The update had been planned prior to the pandemic, but the actual panel meeting took place in April 2020, after the US Food and Drug Administration allowed inpatient use of CGM despite lack of official approval.

“COVID-19 changed everything. ... We had to be more specific about how to implement CGM in these patients. The standard of care is hourly point-of-care glucose monitoring in the [ICU], and at least every 4 hours outside the ICU. With limited [personal protective equipment] and the burden on nursing it was unachievable,” Galindo explained.

In June 2020, Galindo and other guideline authors developed a COVID-19–specific document (also open-access), which goes more into detail about CGM and how to implement in-hospital use during the pandemic.

The current consensus guideline “provides a high-level review of the evidence by experts,” Galindo added.
 

Recommendations cover different technologies and hospital settings

The panel “strongly” advises that hospital providers consult with an inpatient diabetes team, if available, to help manage patients already using CGM prior to admission. Among other recommendations, they list several situations in which CGM data should not be relied upon for management decisions, including severe hyper- or hypoglycemia, diabetic ketoacidosis, or in patients with skin infections near the sensor site.

The panel also call for more research into outcomes for CGM continuation in the hospital and optimal implementation of both CGM and point-of-care glucose testing. For hospitals, strong recommendations include developing standard CGM data reports and workflows, as well as policies for CGM use.

Galindo pointed out: “A lot of hospitals have policies on that, but there aren’t many studies. It’s just that patients like it and it’s very hard to take it away from patients when they’re doing well.”

The section on CGM inpatient initiation is where COVID-19 plays the greatest role, which includes just one strong clinical practice recommendation: “Healthcare providers should consider prescribing CGM to reduce the need for frequent nurse contact for point-of-care glucose testing and the use of personal protective equipment for patients on isolation with highly contagious infectious diseases (eg, COVID-19).”

Strong recommendations also include a call for outcomes research and for hospitals to develop CGM protocols and educational tools for staff.

“We can do a study for approval but if administration and hospital policies aren’t there we’re not going to be able to use them,” Galindo noted.

For patients who already use AID systems – either the Medtronic 670G or Tandem Control IQ in the United States – the panel advises assessment to ensure the AID system is the most appropriate inpatient treatment, and the development of an alternative plan for diabetes management, if necessary. They also strongly recommend research in this area, and for hospitals to develop protocols for use of AID systems in various clinical situations.
 

Most detailed guidance addresses logistics and data management

Most of the strong recommendations regarding logistics are aimed at nursing staff, including receiving training in use of CGM and AID systems, confirming patient capacity, inspection of devices, and understanding when to administer a point-of-care glucose test.

Again, the panel calls for more data and for hospitals to develop policies and protocols for ensuring safe CGM and AID systems use, and when to avoid use.

Finally, they make one strong clinical recommendation regarding data management: “Healthcare providers should develop a set of core data elements and definitions for CGM data for inclusion in common data models and the electronic health record.”

That’s followed by a long list of relevant recommendations for research in the area, and for hospitals to integrate CGM and AID system data into their EHR systems.

This last area has proven particularly challenging, Galindo said. “Right now we do four point-of-care glucoses a day, and that goes right into the EHR, but with CGM it’s much more than that. How do we get all those data into the EHR and interpret it? Many steps need to be taken into consideration.”

Studies are being conducted in order to fulfill requirements for FDA approval of inpatient CGM use, he said, with data on implementation and inpatient AID system use to follow.

“More data will be available, triggered by the COVID-19 pandemic. However, the use of technology in the hospital goes beyond COVID-19,” he said

Galindo has reported receiving unrestricted research support to Emory for investigator-initiated studies from Novo Nordisk and Dexcom, and consulting fees from Abbott Diabetes Care, Sanofi, Novo Nordisk, Eli Lilly, and Valeritas. He is partially supported by research grants from the NIH/NIDDK.
 

This article first appeared on Medscape.com.

A new consensus statement offers detailed guidelines for inpatient use of continuous glucose monitors (CGM) and automated insulin delivery (AID) systems.

Aimed at clinicians, researchers, and hospital administrators, the open-access document was recently published by a multidisciplinary international panel of 24 experts in the Journal of Diabetes Science and Technology.

The statement includes 77 separate recommendations under five headings: 1) continued use of CGM by patients already using them at home, 2) initiation of CGM in hospital, 3) continuation of AID systems in hospital by patients already using them at home, 4) logistics and hands-on care of hospitalized patients using CGM and AID systems, and 5) data management of CGM and AID systems in hospital.

“This is the most comprehensive and up-to-date guideline on the use of diabetes technology in the hospital now,” lead author Rodolfo J. Galindo, MD, told Medscape Medical News in an interview.

“Overall, most experts believe that CGM and AID have the potential to overcome the current limitations of glycemic monitoring in the hospital to improve patient outcomes, but we need research – first to get the approval and second to get widespread use,” said Galindo, medical chair of the hospital diabetes taskforce at Emory Healthcare System, Atlanta.
 

“COVID-19 changed everything”

The guideline is an update of a 2017 statement on hospital use of CGM. The new guideline adds AID systems (sometimes referred to as an artificial pancreas), which combines a CGM and insulin pump and uses an algorithm to guide insulin delivery, and is the first to be developed during the COVID-19 era.

The update had been planned prior to the pandemic, but the actual panel meeting took place in April 2020, after the US Food and Drug Administration allowed inpatient use of CGM despite lack of official approval.

“COVID-19 changed everything. ... We had to be more specific about how to implement CGM in these patients. The standard of care is hourly point-of-care glucose monitoring in the [ICU], and at least every 4 hours outside the ICU. With limited [personal protective equipment] and the burden on nursing it was unachievable,” Galindo explained.

In June 2020, Galindo and other guideline authors developed a COVID-19–specific document (also open-access), which goes more into detail about CGM and how to implement in-hospital use during the pandemic.

The current consensus guideline “provides a high-level review of the evidence by experts,” Galindo added.
 

Recommendations cover different technologies and hospital settings

The panel “strongly” advises that hospital providers consult with an inpatient diabetes team, if available, to help manage patients already using CGM prior to admission. Among other recommendations, they list several situations in which CGM data should not be relied upon for management decisions, including severe hyper- or hypoglycemia, diabetic ketoacidosis, or in patients with skin infections near the sensor site.

The panel also call for more research into outcomes for CGM continuation in the hospital and optimal implementation of both CGM and point-of-care glucose testing. For hospitals, strong recommendations include developing standard CGM data reports and workflows, as well as policies for CGM use.

Galindo pointed out: “A lot of hospitals have policies on that, but there aren’t many studies. It’s just that patients like it and it’s very hard to take it away from patients when they’re doing well.”

The section on CGM inpatient initiation is where COVID-19 plays the greatest role, which includes just one strong clinical practice recommendation: “Healthcare providers should consider prescribing CGM to reduce the need for frequent nurse contact for point-of-care glucose testing and the use of personal protective equipment for patients on isolation with highly contagious infectious diseases (eg, COVID-19).”

Strong recommendations also include a call for outcomes research and for hospitals to develop CGM protocols and educational tools for staff.

“We can do a study for approval but if administration and hospital policies aren’t there we’re not going to be able to use them,” Galindo noted.

For patients who already use AID systems – either the Medtronic 670G or Tandem Control IQ in the United States – the panel advises assessment to ensure the AID system is the most appropriate inpatient treatment, and the development of an alternative plan for diabetes management, if necessary. They also strongly recommend research in this area, and for hospitals to develop protocols for use of AID systems in various clinical situations.
 

Most detailed guidance addresses logistics and data management

Most of the strong recommendations regarding logistics are aimed at nursing staff, including receiving training in use of CGM and AID systems, confirming patient capacity, inspection of devices, and understanding when to administer a point-of-care glucose test.

Again, the panel calls for more data and for hospitals to develop policies and protocols for ensuring safe CGM and AID systems use, and when to avoid use.

Finally, they make one strong clinical recommendation regarding data management: “Healthcare providers should develop a set of core data elements and definitions for CGM data for inclusion in common data models and the electronic health record.”

That’s followed by a long list of relevant recommendations for research in the area, and for hospitals to integrate CGM and AID system data into their EHR systems.

This last area has proven particularly challenging, Galindo said. “Right now we do four point-of-care glucoses a day, and that goes right into the EHR, but with CGM it’s much more than that. How do we get all those data into the EHR and interpret it? Many steps need to be taken into consideration.”

Studies are being conducted in order to fulfill requirements for FDA approval of inpatient CGM use, he said, with data on implementation and inpatient AID system use to follow.

“More data will be available, triggered by the COVID-19 pandemic. However, the use of technology in the hospital goes beyond COVID-19,” he said

Galindo has reported receiving unrestricted research support to Emory for investigator-initiated studies from Novo Nordisk and Dexcom, and consulting fees from Abbott Diabetes Care, Sanofi, Novo Nordisk, Eli Lilly, and Valeritas. He is partially supported by research grants from the NIH/NIDDK.
 

This article first appeared on Medscape.com.

A new consensus statement offers detailed guidelines for inpatient use of continuous glucose monitors (CGM) and automated insulin delivery (AID) systems.

Aimed at clinicians, researchers, and hospital administrators, the open-access document was recently published by a multidisciplinary international panel of 24 experts in the Journal of Diabetes Science and Technology.

The statement includes 77 separate recommendations under five headings: 1) continued use of CGM by patients already using them at home, 2) initiation of CGM in hospital, 3) continuation of AID systems in hospital by patients already using them at home, 4) logistics and hands-on care of hospitalized patients using CGM and AID systems, and 5) data management of CGM and AID systems in hospital.

“This is the most comprehensive and up-to-date guideline on the use of diabetes technology in the hospital now,” lead author Rodolfo J. Galindo, MD, told Medscape Medical News in an interview.

“Overall, most experts believe that CGM and AID have the potential to overcome the current limitations of glycemic monitoring in the hospital to improve patient outcomes, but we need research – first to get the approval and second to get widespread use,” said Galindo, medical chair of the hospital diabetes taskforce at Emory Healthcare System, Atlanta.
 

“COVID-19 changed everything”

The guideline is an update of a 2017 statement on hospital use of CGM. The new guideline adds AID systems (sometimes referred to as an artificial pancreas), which combines a CGM and insulin pump and uses an algorithm to guide insulin delivery, and is the first to be developed during the COVID-19 era.

The update had been planned prior to the pandemic, but the actual panel meeting took place in April 2020, after the US Food and Drug Administration allowed inpatient use of CGM despite lack of official approval.

“COVID-19 changed everything. ... We had to be more specific about how to implement CGM in these patients. The standard of care is hourly point-of-care glucose monitoring in the [ICU], and at least every 4 hours outside the ICU. With limited [personal protective equipment] and the burden on nursing it was unachievable,” Galindo explained.

In June 2020, Galindo and other guideline authors developed a COVID-19–specific document (also open-access), which goes more into detail about CGM and how to implement in-hospital use during the pandemic.

The current consensus guideline “provides a high-level review of the evidence by experts,” Galindo added.
 

Recommendations cover different technologies and hospital settings

The panel “strongly” advises that hospital providers consult with an inpatient diabetes team, if available, to help manage patients already using CGM prior to admission. Among other recommendations, they list several situations in which CGM data should not be relied upon for management decisions, including severe hyper- or hypoglycemia, diabetic ketoacidosis, or in patients with skin infections near the sensor site.

The panel also call for more research into outcomes for CGM continuation in the hospital and optimal implementation of both CGM and point-of-care glucose testing. For hospitals, strong recommendations include developing standard CGM data reports and workflows, as well as policies for CGM use.

Galindo pointed out: “A lot of hospitals have policies on that, but there aren’t many studies. It’s just that patients like it and it’s very hard to take it away from patients when they’re doing well.”

The section on CGM inpatient initiation is where COVID-19 plays the greatest role, which includes just one strong clinical practice recommendation: “Healthcare providers should consider prescribing CGM to reduce the need for frequent nurse contact for point-of-care glucose testing and the use of personal protective equipment for patients on isolation with highly contagious infectious diseases (eg, COVID-19).”

Strong recommendations also include a call for outcomes research and for hospitals to develop CGM protocols and educational tools for staff.

“We can do a study for approval but if administration and hospital policies aren’t there we’re not going to be able to use them,” Galindo noted.

For patients who already use AID systems – either the Medtronic 670G or Tandem Control IQ in the United States – the panel advises assessment to ensure the AID system is the most appropriate inpatient treatment, and the development of an alternative plan for diabetes management, if necessary. They also strongly recommend research in this area, and for hospitals to develop protocols for use of AID systems in various clinical situations.
 

Most detailed guidance addresses logistics and data management

Most of the strong recommendations regarding logistics are aimed at nursing staff, including receiving training in use of CGM and AID systems, confirming patient capacity, inspection of devices, and understanding when to administer a point-of-care glucose test.

Again, the panel calls for more data and for hospitals to develop policies and protocols for ensuring safe CGM and AID systems use, and when to avoid use.

Finally, they make one strong clinical recommendation regarding data management: “Healthcare providers should develop a set of core data elements and definitions for CGM data for inclusion in common data models and the electronic health record.”

That’s followed by a long list of relevant recommendations for research in the area, and for hospitals to integrate CGM and AID system data into their EHR systems.

This last area has proven particularly challenging, Galindo said. “Right now we do four point-of-care glucoses a day, and that goes right into the EHR, but with CGM it’s much more than that. How do we get all those data into the EHR and interpret it? Many steps need to be taken into consideration.”

Studies are being conducted in order to fulfill requirements for FDA approval of inpatient CGM use, he said, with data on implementation and inpatient AID system use to follow.

“More data will be available, triggered by the COVID-19 pandemic. However, the use of technology in the hospital goes beyond COVID-19,” he said

Galindo has reported receiving unrestricted research support to Emory for investigator-initiated studies from Novo Nordisk and Dexcom, and consulting fees from Abbott Diabetes Care, Sanofi, Novo Nordisk, Eli Lilly, and Valeritas. He is partially supported by research grants from the NIH/NIDDK.
 

This article first appeared on Medscape.com.