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Fed Pract
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gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
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Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
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pedophilia
poker
porn
pornography
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recreational drug
sex slave rings
slot machine
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Texas hold 'em
UFC
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bunges
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butt
butt fuck
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buttfucked
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cock sucker
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.

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‘Profound human toll’ in excess deaths from COVID-19 calculated in two studies

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Thu, 08/26/2021 - 15:59

 

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

 

 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

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More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

 

 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

 

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

 

 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

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Intensive surveillance after CRC resection does not improve survival

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Intensive surveillance with carcinoembryonic antigen (CEA) testing and CT scans after colorectal cancer resection did not improve recurrence-free or overall survival when compared with standard abdominal ultrasound and chest x-ray monitoring in a phase 3 trial of almost 2,000 patients.

However, among patients with colon cancer recurrence, those randomized to intensive surveillance more often had a second surgery with curative intent. Even so, there was no overall survival benefit versus standard surveillance in this group.

In short, “none of the follow-up modalities resulted in a difference,” said investigator Come Lepage, MD, PhD, of Centre Hospitalier Universitaire de Dijon (France).

Dr. Lepage presented these findings at the European Society for Medical Oncology Virtual Congress 2020.

Dr. Lepage said the study’s results suggest guidelines that include CT and CEA monitoring should be amended, and the standard surveillance methods should be ultrasound and chest x-ray. Dr. LePage called CEA surveillance “useless” and said CT scans should be performed only in cases of suspected recurrence.

However, study discussant Tim Price, MBBS, DHSc, of the University of Adelaide, noted that both the intensive and standard arms in this study had abdominal imaging every 3 months, be it ultrasound or CT, so even in the standard arms, surveillance “was still fairly aggressive.”

Because of that, the study does not “suggest we should decrease our intensity,” Dr. Price said.

He added that the study’s major finding was that more intensive surveillance led to higher rates of secondary surgery with curative intent, probably because recurrences were caught earlier than they would have been with standard surveillance, when curative surgery was still possible.

Patients in the study were treated during 2009-2015, and that might have also made a difference. “We need to remember that, in 2020, care is very different,” Dr. Price said. This includes increased surgical interventions and options for oligometastatic disease, plus systemic therapies such as pembrolizumab. With modern treatments, detecting recurrences earlier “may well have an impact on survival.”

Perhaps patients would live longer with “earlier diagnosis in today’s setting with more active agents and more aggressive surgery and radiotherapy [e.g., stereotactic ablative radiation therapy],” Dr. Price said in an interview.
 

Study details

The trial, dubbed PRODIGE 13, was done to bring clarity to the surveillance issue. Intensive follow-up after curative surgery for colorectal cancer, including CT and CEA monitoring, is recommended by various scientific societies, but it’s based mainly on expert opinion. Results of the few clinical trials on the issue have been controversial, Dr. Lepage explained.

PRODIGE 13 included 1,995 subjects with colorectal cancer. About half of patients had stage II disease, and the other half had stage III. Most patients were 75 years or younger at baseline, and there were more men in the study than women. All patients underwent resection with curative intent and had no evidence of residual disease 3 months after surgery. Some patients received adjuvant chemotherapy.

Patients were first randomized to no CEA monitoring or CEA monitoring every 3 months for the first 2 years, then every 6 months for an additional 3 years. Members in both groups were then randomized a second time to either intensive or standard radiologic surveillance.

Surveillance in the standard arm consisted of an abdominal ultrasound every 3 months for the first 3 years, then biannually for an additional 2 years, plus chest x-rays every 6 months for 5 years. Intensive surveillance consisted of CT imaging, including thoracic imaging, alternating with abdominal ultrasound, every 3 months, then biannually for another 2 years.

At baseline, the surveillance groups were well balanced with regard to demographics, primary tumor location, and other factors, but stage III disease was more prevalent among patients randomized to standard radiologic monitoring without CEA.
 

 

 

Results

The median follow up was 6.5 years. There were no significant differences between the surveillance groups with regard to 5-year overall survival (P = .340) or recurrence-free survival (P = .473).

There were no significant differences in recurrence-free or overall survival when patients were stratified by age, sex, stage, CEA at a cut point of 5 mcg/L, and primary tumor characteristics including location, perineural invasion, and occlusion/perforation.

There were 356 recurrences in patients initially treated for colon cancer. CEA surveillance with or without CT scan was associated with an increased incidence of secondary resection with curative intent. The rate of secondary resection was 66.3% in the standard imaging with CEA arm, 59.5% in the CT plus CEA arm, 50.7% with CT imaging but no CEA, and 40.9% with standard imaging and no CEA (P = .0035).

The rates were similar among the 83 patients with recurrence after initial treatment for rectal cancer, but the between-arm differences were not significant. The rate of secondary resection with curative intent was 57.9% in the standard imaging with CEA arm, 47.8% in the CT plus CEA arm, 55% with CT imaging but no CEA, and 42.9% with standard imaging and no CEA.

The research is ongoing, and the team expects to report on secondary outcomes and ancillary studies of circulating tumor DNA, among other things, in 2021.

The study is being funded by the Federation Francophone de Cancerologie Digestive. Dr. Lepage disclosed ties with Novartis, Amgen, Bayer, Servier, and AAA. Dr. Price disclosed institutional research funding from Amgen and being an uncompensated adviser to Pierre-Fabre and Merck.

SOURCE: Lepage C et al. ESMO 2020, Abstract 398O.

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Intensive surveillance with carcinoembryonic antigen (CEA) testing and CT scans after colorectal cancer resection did not improve recurrence-free or overall survival when compared with standard abdominal ultrasound and chest x-ray monitoring in a phase 3 trial of almost 2,000 patients.

However, among patients with colon cancer recurrence, those randomized to intensive surveillance more often had a second surgery with curative intent. Even so, there was no overall survival benefit versus standard surveillance in this group.

In short, “none of the follow-up modalities resulted in a difference,” said investigator Come Lepage, MD, PhD, of Centre Hospitalier Universitaire de Dijon (France).

Dr. Lepage presented these findings at the European Society for Medical Oncology Virtual Congress 2020.

Dr. Lepage said the study’s results suggest guidelines that include CT and CEA monitoring should be amended, and the standard surveillance methods should be ultrasound and chest x-ray. Dr. LePage called CEA surveillance “useless” and said CT scans should be performed only in cases of suspected recurrence.

However, study discussant Tim Price, MBBS, DHSc, of the University of Adelaide, noted that both the intensive and standard arms in this study had abdominal imaging every 3 months, be it ultrasound or CT, so even in the standard arms, surveillance “was still fairly aggressive.”

Because of that, the study does not “suggest we should decrease our intensity,” Dr. Price said.

He added that the study’s major finding was that more intensive surveillance led to higher rates of secondary surgery with curative intent, probably because recurrences were caught earlier than they would have been with standard surveillance, when curative surgery was still possible.

Patients in the study were treated during 2009-2015, and that might have also made a difference. “We need to remember that, in 2020, care is very different,” Dr. Price said. This includes increased surgical interventions and options for oligometastatic disease, plus systemic therapies such as pembrolizumab. With modern treatments, detecting recurrences earlier “may well have an impact on survival.”

Perhaps patients would live longer with “earlier diagnosis in today’s setting with more active agents and more aggressive surgery and radiotherapy [e.g., stereotactic ablative radiation therapy],” Dr. Price said in an interview.
 

Study details

The trial, dubbed PRODIGE 13, was done to bring clarity to the surveillance issue. Intensive follow-up after curative surgery for colorectal cancer, including CT and CEA monitoring, is recommended by various scientific societies, but it’s based mainly on expert opinion. Results of the few clinical trials on the issue have been controversial, Dr. Lepage explained.

PRODIGE 13 included 1,995 subjects with colorectal cancer. About half of patients had stage II disease, and the other half had stage III. Most patients were 75 years or younger at baseline, and there were more men in the study than women. All patients underwent resection with curative intent and had no evidence of residual disease 3 months after surgery. Some patients received adjuvant chemotherapy.

Patients were first randomized to no CEA monitoring or CEA monitoring every 3 months for the first 2 years, then every 6 months for an additional 3 years. Members in both groups were then randomized a second time to either intensive or standard radiologic surveillance.

Surveillance in the standard arm consisted of an abdominal ultrasound every 3 months for the first 3 years, then biannually for an additional 2 years, plus chest x-rays every 6 months for 5 years. Intensive surveillance consisted of CT imaging, including thoracic imaging, alternating with abdominal ultrasound, every 3 months, then biannually for another 2 years.

At baseline, the surveillance groups were well balanced with regard to demographics, primary tumor location, and other factors, but stage III disease was more prevalent among patients randomized to standard radiologic monitoring without CEA.
 

 

 

Results

The median follow up was 6.5 years. There were no significant differences between the surveillance groups with regard to 5-year overall survival (P = .340) or recurrence-free survival (P = .473).

There were no significant differences in recurrence-free or overall survival when patients were stratified by age, sex, stage, CEA at a cut point of 5 mcg/L, and primary tumor characteristics including location, perineural invasion, and occlusion/perforation.

There were 356 recurrences in patients initially treated for colon cancer. CEA surveillance with or without CT scan was associated with an increased incidence of secondary resection with curative intent. The rate of secondary resection was 66.3% in the standard imaging with CEA arm, 59.5% in the CT plus CEA arm, 50.7% with CT imaging but no CEA, and 40.9% with standard imaging and no CEA (P = .0035).

The rates were similar among the 83 patients with recurrence after initial treatment for rectal cancer, but the between-arm differences were not significant. The rate of secondary resection with curative intent was 57.9% in the standard imaging with CEA arm, 47.8% in the CT plus CEA arm, 55% with CT imaging but no CEA, and 42.9% with standard imaging and no CEA.

The research is ongoing, and the team expects to report on secondary outcomes and ancillary studies of circulating tumor DNA, among other things, in 2021.

The study is being funded by the Federation Francophone de Cancerologie Digestive. Dr. Lepage disclosed ties with Novartis, Amgen, Bayer, Servier, and AAA. Dr. Price disclosed institutional research funding from Amgen and being an uncompensated adviser to Pierre-Fabre and Merck.

SOURCE: Lepage C et al. ESMO 2020, Abstract 398O.

Intensive surveillance with carcinoembryonic antigen (CEA) testing and CT scans after colorectal cancer resection did not improve recurrence-free or overall survival when compared with standard abdominal ultrasound and chest x-ray monitoring in a phase 3 trial of almost 2,000 patients.

However, among patients with colon cancer recurrence, those randomized to intensive surveillance more often had a second surgery with curative intent. Even so, there was no overall survival benefit versus standard surveillance in this group.

In short, “none of the follow-up modalities resulted in a difference,” said investigator Come Lepage, MD, PhD, of Centre Hospitalier Universitaire de Dijon (France).

Dr. Lepage presented these findings at the European Society for Medical Oncology Virtual Congress 2020.

Dr. Lepage said the study’s results suggest guidelines that include CT and CEA monitoring should be amended, and the standard surveillance methods should be ultrasound and chest x-ray. Dr. LePage called CEA surveillance “useless” and said CT scans should be performed only in cases of suspected recurrence.

However, study discussant Tim Price, MBBS, DHSc, of the University of Adelaide, noted that both the intensive and standard arms in this study had abdominal imaging every 3 months, be it ultrasound or CT, so even in the standard arms, surveillance “was still fairly aggressive.”

Because of that, the study does not “suggest we should decrease our intensity,” Dr. Price said.

He added that the study’s major finding was that more intensive surveillance led to higher rates of secondary surgery with curative intent, probably because recurrences were caught earlier than they would have been with standard surveillance, when curative surgery was still possible.

Patients in the study were treated during 2009-2015, and that might have also made a difference. “We need to remember that, in 2020, care is very different,” Dr. Price said. This includes increased surgical interventions and options for oligometastatic disease, plus systemic therapies such as pembrolizumab. With modern treatments, detecting recurrences earlier “may well have an impact on survival.”

Perhaps patients would live longer with “earlier diagnosis in today’s setting with more active agents and more aggressive surgery and radiotherapy [e.g., stereotactic ablative radiation therapy],” Dr. Price said in an interview.
 

Study details

The trial, dubbed PRODIGE 13, was done to bring clarity to the surveillance issue. Intensive follow-up after curative surgery for colorectal cancer, including CT and CEA monitoring, is recommended by various scientific societies, but it’s based mainly on expert opinion. Results of the few clinical trials on the issue have been controversial, Dr. Lepage explained.

PRODIGE 13 included 1,995 subjects with colorectal cancer. About half of patients had stage II disease, and the other half had stage III. Most patients were 75 years or younger at baseline, and there were more men in the study than women. All patients underwent resection with curative intent and had no evidence of residual disease 3 months after surgery. Some patients received adjuvant chemotherapy.

Patients were first randomized to no CEA monitoring or CEA monitoring every 3 months for the first 2 years, then every 6 months for an additional 3 years. Members in both groups were then randomized a second time to either intensive or standard radiologic surveillance.

Surveillance in the standard arm consisted of an abdominal ultrasound every 3 months for the first 3 years, then biannually for an additional 2 years, plus chest x-rays every 6 months for 5 years. Intensive surveillance consisted of CT imaging, including thoracic imaging, alternating with abdominal ultrasound, every 3 months, then biannually for another 2 years.

At baseline, the surveillance groups were well balanced with regard to demographics, primary tumor location, and other factors, but stage III disease was more prevalent among patients randomized to standard radiologic monitoring without CEA.
 

 

 

Results

The median follow up was 6.5 years. There were no significant differences between the surveillance groups with regard to 5-year overall survival (P = .340) or recurrence-free survival (P = .473).

There were no significant differences in recurrence-free or overall survival when patients were stratified by age, sex, stage, CEA at a cut point of 5 mcg/L, and primary tumor characteristics including location, perineural invasion, and occlusion/perforation.

There were 356 recurrences in patients initially treated for colon cancer. CEA surveillance with or without CT scan was associated with an increased incidence of secondary resection with curative intent. The rate of secondary resection was 66.3% in the standard imaging with CEA arm, 59.5% in the CT plus CEA arm, 50.7% with CT imaging but no CEA, and 40.9% with standard imaging and no CEA (P = .0035).

The rates were similar among the 83 patients with recurrence after initial treatment for rectal cancer, but the between-arm differences were not significant. The rate of secondary resection with curative intent was 57.9% in the standard imaging with CEA arm, 47.8% in the CT plus CEA arm, 55% with CT imaging but no CEA, and 42.9% with standard imaging and no CEA.

The research is ongoing, and the team expects to report on secondary outcomes and ancillary studies of circulating tumor DNA, among other things, in 2021.

The study is being funded by the Federation Francophone de Cancerologie Digestive. Dr. Lepage disclosed ties with Novartis, Amgen, Bayer, Servier, and AAA. Dr. Price disclosed institutional research funding from Amgen and being an uncompensated adviser to Pierre-Fabre and Merck.

SOURCE: Lepage C et al. ESMO 2020, Abstract 398O.

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An Interdisciplinary Approach to Educating Medical Students About Dementia Assessment and Treatment Planning

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Fri, 10/23/2020 - 08:29

The global burden of dementia is increasing at an alarming pace and is estimated to soon affect 81 million individuals worldwide.1 The World Health Organization and the Institute of Medicine have recommended greater dementia awareness and education.2,3 Despite this emphasis on dementia education, many general practitioners consider dementia care beyond their clinical domain and feel that specialists, such as geriatricians, geriatric psychiatrists, or neurologists should address dementia assessment and treatment. 4 Unfortunately, the geriatric health care workforce has been shrinking. The American Geriatrics Society estimates the need for 30,000 geriatricians by 2030, although there are only 7,300 board-certified geriatricians currently in the US.5 There is an urgent need for educating all medical trainees in dementia care regardless of their specialization interest. As the largest underwriter of graduate medical education in the US, the US Department of Veterans Affairs (VA) is well placed for rolling out focused dementia education. Training needs to be practical, brief, and responsive to knowledge gaps to reach the most trainees.

Despite growing emphasis on geriatric training, many medical students have limited experience with patients with dementia or their caregivers, lack exposure to interdisciplinary teams, have a poor attitude toward geriatric patients, and display specific knowledge gaps in dementia assessment and management. 6-9 Other knowledge gaps noted in medical students included assessing behavioral problems, function, safety, and caregiver burden. Medical students also had limited exposure to interdisciplinary team dementia assessment and management.

Our goal was to develop a multicomponent, experiential, brief curriculum using team-based learning to expose senior medical students to interdisciplinary assessment of dementia. The curriculum was developed with input from the interdisciplinary team to address dementia knowledge gaps while providing an opportunity to interact with caregivers. The curriculum targeted all medical students regardless of their interest in geriatrics. Particular emphasis was placed on systems-based learning and the importance of teamwork in managing complex conditions such as dementia. Students were taught that incorporating interdisciplinary input would be more effective during dementia care planning rather than developing specialized knowledge.

Methods

Our team developed a curriculum for fourthyear medical students who rotated through the VA Memory Disorders Clinic as a part of their geriatric medicine clerkship at the University of Arkansas for Medical Sciences in Little Rock. The Memory Disorders Clinic is a consultation practice at the Central Arkansas Veterans Healthcare System (CAVHS) where patients with memory problems are evaluated by a team consisting of a geriatric psychiatrist, a geriatrician, a social worker, and a neuropsychologist. Each specialist addresses specific areas of dementia assessment and management. The curriculum included didactics, clinical experience, and team-based learning.

Didactics

An hour-long didactic session lead by the team geriatrician provided a general overview of interdisciplinary assessment of dementia to groups of 2 to 3 students at a time. The geriatrician presented an overview of dementia types, comorbidities, medications that affect memory, details of the physical examination, and laboratory, cognitive, and behavioral assessments along with treatment plan development. Students also learned about the roles of the social worker, geriatrician, neuropsychologist, and geriatric psychiatrist in the clinic. Pictographs and pie charts highlighted the role of disciplines in assessing and managing aspects of dementia.

The social work evaluation included advance care planning, functional assessment, safety assessment (driving, guns, wandering behaviors, etc), home safety evaluation, support system, and financial evaluation. Each medical student received a binder with local resources to become familiar with the depth and breadth of agencies involved in dementia care. Each medical student learned how to administer the Zarit Burden Scale to assess caregiver burden.10 The details of the geriatrician assessment included reviewing medical comorbidities and medications contributing to dementia, a physical examination, including a focused neurologic examination, laboratory assessment, and judicious use of neuroimaging.

The neuropsychology assessment education included a battery of tests and assessments. The global screening instruments included the Modified Mini-Mental State examination (3MS), Montreal Cognitive Assessment (MoCA), and Saint Louis University Mental Status examination (SLUMS).11-13 Executive function is evaluated using the Trails Making Test A and Trails Making Test B, Controlled Oral Word Association Test, Semantic Fluency Test, and Repeatable Battery for the Assessment of Neuropsychological Status test. Cognitive tests were compared and age- , education-, and race-adjusted norms for rating scales were listed if available. Each student was expected to show proficiency in ≥ 2 cognitive screening instruments (3MS, MoCA, or SLUMS). The geriatric psychiatry assessment included clinical history, onset, and course of memory problems from patient and caregiver perspectives, the Neuropsychiatric Inventory for assessing behavioral problems, employing the clinical dementia rating scale, integrating the team data, summarizing assessment, and formulating a treatment plan.14

Clinical

Students had a single clinical exposure. Students followed 1 patient and his or her caregiver through the team assessment and observed each provider’s assessment to learn interview techniques to adapt to the patient’s sensory or cognitive impairment and become familiar with different tools and devices used in the dementia clinic, such as hearing amplifiers. Each specialist provided hands-on experience. This encounter helped the students connect with caregivers and appreciate their role in patient care.

 

 

Systems learning was an important component integrated throughout the clinical experience. Examples include using video teleconferences to communicate findings among team members and electronic health records to seamlessly obtain and integrate data. Students learned how to create worksheets to graph laboratory data such as B12, thyroid-stimulating hormone, and rapid plasma regain levels. Student gained experience in using applications to retrieve neuroimaging data, results of sleep studies, and other data. Many patients had not received the results of their sleep study, and students had the responsibility to share these reports, including the number of apneic episodes. Students used the VA Computerized Patient Record System for reviewing patient records. One particularly useful tool was Joint Legacy Viewer, a remote access tool used to retrieve data on veterans from anywhere within the US. Students were also trained on medication and consult order menus in the system.

Team-Based

Learning The objectives of the team-based learning section were to teach students basic concepts of integrating the interdisciplinary assessment and formulating a treatment plan, to provide an opportunity to present their case in a group format, to discuss the differential diagnosis, management and treatment plan with a geriatrician in the team-based learning format, and to answer questions from other students. The instructors developed a set of prepared take-home points (Table 1). The team-based learning sessions were structured so that all take-home points were covered.

Evaluations

Evaluations were performed before and immediately after the clinical experience. In preevaluation, students reported the frequency of their participation in an interdisciplinary team assessment of any condition and specifically for dementia. In pre- and postevaluation, students rated their perception of the role of interdisciplinary team members in assessing and managing dementia, their personal abilities to assess cognition, behavioral problems, caregiver burden, and their perception of the impact of behavioral problems on dementia care. A Likert scale (poor = 1; fair = 2; good = 3; very good = 4; and excellent = 5) was employed (eApendices 1 and 2 can be found at doi:10.12788/fp.0052). The only demographic information collected was the student’s gender. Semistructured interviews were conducted to assess students’ current knowledge, experience, and needs. These interviews lasted about 20 minutes and collected information regarding the students’ knowledge about cognitive and behavioral problems in general and those occurring in dementia, their experience with screening, and any problems they encountered.

Statistical Analysis

Student baseline characteristics were assessed. Pre- and postassessments were analyzed with the McNemar test for paired data, and associations with experience were evaluated using χ2 tests. Ratings were dichotomized as very good/excellent vs poor/fair/ good because our educational goal was “very good” to “excellent” experience in dementia care and to avoid expected small cell counts. Two-sided P < .05 indicated statistical significance. Data were analyzed using SAS Enterprise Guide v5.1.

Results

One hundred fourth-year medical students participated, including 54 women. Thirtysix percent reported they had not previously attended an interdisciplinary team assessment for dementia, while 18% stated that they had attended only 1 interdisciplinary team assessment for dementia.

Before the education, students rated their dementia ability as poor. Only 2% (1 of 54), of those with 0 to 1 assessment experience rated their ability for assessing dementia with an interdisciplinary team format as very good/excellent compared with 20% (9/46) of those previously attending ≥ 2 assessments (P = .03); other ratings of ability were not associated with prior experience.

There was a significant change in the students’ self-efficacy ratings pre- to postassessment (P < .05) (Table 2). Only 10% rated their ability to assess for dementia as very good/excellent in before the intervention compared with 96% in postassessment (P < .01). Students’ perception of the impact of behavioral problems on dementia care improved significantly (45% to 98%, P < .01). Similarly, student’s perception of their ability to assess behavioral problems, caregiver burden, and cognition improved significantly from 7 to 88%; 7 to 78%, and 18 to 92%, respectively (P < .01). Students perception of the role of social worker, neuropsychologist, geriatrician, and geriatric psychiatrist also improved significantly for most measures from 81 to 98% (P = .02), 87 to 98% (P = .05), 94 to 99% (P = .06), and 88 to 100% (P = .01), respectively.

The semistructured interviews revealed that awareness of behavioral problems associated with dementia varied for different behavioral problems. Although many students showed familiarity with depression, agitation, and psychosis, they were not comfortable assessing them in a patient with dementia. These students were less aware of other behavioral problems such as disinhibition, apathy, and movement disorders. Deficits were noted in the skill of administering commonly used global cognitive screens, such as the Mini-Mental State Examination (MMSE).15

 

 

In semistructured interviews, only 7% of senior medical students were comfortable assessing behavioral problems associated with dementia. Most were not aware of any validated rating scale to assess neuropsychiatric symptoms. Similarly, only 7% of students were comfortable assessing caregiver burden, and most were not aware of any validated rating scale to assess caregiver burden. Only 1 in 5 students were comfortable using 2 cognitive screens to assess cognitive deficits. Many students stated that they were not routinely expected to perform common cognitive screens, such as the MMSE during their medical training except students who had expressed an interest in psychiatry and were expected to be proficient in the MMSE. Most students were making common mistakes, such as converting the 3-command task to 3 individual single commands, helping too much with serial 7s, and giving too much positive feedback throughout the test.

Discussion

Significant knowledge gaps regarding dementia were found in our study, which is in keeping with other studies in the area. Dementia knowledge deficits among medical trainees have been identified in the United Kingdom, Australia, and the US.6-9

In our study, a brief multicomponent experiential curriculum improved senior medical students’ perception and self-efficacy in diagnosing dementia. This is in keeping with other studies, such as the PAIRS Program.7 Findings from another study indicated that education for geriatric- oriented physicians should focus on experiential learning components through observation and interaction with older adults.16

A background of direct experience with older adults is associated with more positive attitudes toward older adults and increased interest in geriatric medicine.16 In our study, the exposure was brief; therefore, the results could not be compared with other long-term exposure studies. However, even with this brief intervention most students reported being comfortable with assessing caregiver burden (78%), behavioral problems of dementia (88%), and using ≥ 2 cognitive screens (92%). Comfortable in dementia assessment increased after the intervention from 10% to 96%. This finding is encouraging because brief multicomponent dementia education can be devised easily. This finding needs to be taken with caution because we did not conduct a formal skills evaluation.

A unique component of our experience was to learn medical students’ perception about the impact of neuropsychiatric symptoms on the trajectory, outcomes, and management of dementia. These symptoms included delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, nighttime behaviors, and appetite and eating. Less than half the students thought that neuropsychiatric symptoms had a significant impact on dementia before the experience. Through didactics, systematic assessment of neuropsychiatric symptoms and interaction with caregivers, > 98% of students learned that these symptoms have a significant impact on dementia management.

This experience also emphasized the role of several disciplines in dementia assessment and management. Students’ experience positively influenced appreciation of the role of the memory clinic team. Our hope is that students will seek input from social workers, neuropsychologists, and other team members when working with patients with dementia or their caregivers. The common reason why primary care physicians focus on an exclusive medical model is the time commitment for communicating with an interdisciplinary team. Students experienced the feasibility of the interdisciplinary team involvement and how technology could be used for synchronous and asynchronous communication among team members. Medical students also were introduced to complex billing codes used when ≥ 3 disciplines assess/manage a geriatric patient.

Limitations

This study is limited by the lack of long-term follow-up evaluations, no metrics for practice changes clinical outcomes, and implementation in a single medical school. The postexperience evaluation in this study was performed immediately after the intervention. Long-term follow-up would inform whether the changes noted are durable. Because of the brief nature of our intervention, we do not believe that it would change practice in clinical care. It will be informative to follow this cohort of students to study whether their clinical approach to dementia care changes. The intervention needs to be replicated in other medical schools and in more heterogeneous groups to generalize the results of the study.

Conclusions

Senior medical students are not routinely exposed to interdisciplinary team assessments. Dementia knowledge gaps were prevalent in this cohort of senior medical students. Providing interdisciplinary geriatric educational experience improved their perception of their ability to assess for dementia and their recognition of the roles of interdisciplinary team members. Plans are in place to continue and expand the program to other complex geriatric syndromes.

Acknowledgments
Poster presented at the 2019 annual meeting of the American Geriatrics Society. Oral presentation at the same meeting as part of the select Geriatric Education Methods and Materials Swap workshop.

References

1. Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005;366(9503):2112-2117. doi:10.1016/S0140-6736(05)67889-0

2. Janca A, Aarli JA, Prilipko L, Dua T, Saxena S, Saraceno B. WHO/WFN survey of neurological services: a worldwide perspective. J Neurol Sci. 2006;247(1):29-34. doi:10.1016/j.jns.2006.03.003

3. Wilkins KM, Blazek MC, Brooks WB, Lehmann SW, Popeo D, Wagenaar D. Six things all medical students need to know about geriatric psychiatry (and how to teach them). Acad Psychiatry. 2017;41(5):693-700. doi:10.1007/s40596-017-0691-7

4. Turner S, Iliffe S, Downs M, et al. General practitioners’ knowledge, confidence and attitudes in the diagnosis and management of dementia. Age Ageing. 2004;33(5):461- 467. doi:10.1093/ageing/afh140

5. Lester PE, Dharmarajan TS, Weinstein E. The looming geriatrician shortage: ramifications and solutions. J Aging Health. 2019:898264319879325. doi:10.1177/0898264319879325

6. Struck BD, Bernard MA, Teasdale TA; Oklahoma University Geriatric Education G. Effect of a mandatory geriatric medicine clerkship on third-year students. J Am Geriatr Soc. 2005;53(11):2007-2011. doi:10.1111/j.1532-5415.2005.00473.x

7. Jefferson AL, Cantwell NG, Byerly LK, Morhardt D. Medical student education program in Alzheimer’s disease: the PAIRS Program. BMC Med Educ. 2012;12:80. doi:10.1186/1472-6920-12-80

8. Nagle BJ, Usita PM, Edland SD. United States medical students’ knowledge of Alzheimer disease. J Educ Eval Health Prof. 2013;10:4. doi:10.3352/jeehp.2013.10.4

9. Scott TL, Kugelman M, Tulloch K. How medical professional students view older people with dementia: Implications for education and practice. PLoS One. 2019;14(11):e0225329. doi:10.1371/journal.pone.0225329.

10. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649-655. doi:10.1093/geront/20.6.649

11. McDowell I, Kristjansson B, Hill GB, Hebert R. Community screening for dementia: the Mini Mental State Exam (MMSE) and Modified Mini-Mental State Exam (3MS) compared. J Clin Epidemiol. 1997;50(4):377-383. doi:10.1016/s0895-4356(97)00060-7

12. Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Ger iatr Soc. 2005;53(4):695-699. doi:10.1111/j.1532-5415.2005.53221.x

13. Tariq SH, Tumosa N, Chibnall JT, Perry MH, 3rd, Morley JE. Comparison of the Saint Louis University mental status examination and the Mini-Mental State Examination for detecting dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 2006;14(11):900-910. doi:10.1097/01.JGP.0000221510.33817.86

14. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994;44(12):2308-2314. doi:10.1212/wnl.44.12.2308

15. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state.” A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189-198. doi:10.1016/0022-3956(75)90026-6

16. Fitzgerald JT, Wray LA, Halter JB, Williams BC, Supiano MA. Relating medical students’ knowledge, attitudes, and experience to an interest in geriatric medicine. Gerontologist. 2003;43(6):849-855. doi:10.1093/geront/43.6.849

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The global burden of dementia is increasing at an alarming pace and is estimated to soon affect 81 million individuals worldwide.1 The World Health Organization and the Institute of Medicine have recommended greater dementia awareness and education.2,3 Despite this emphasis on dementia education, many general practitioners consider dementia care beyond their clinical domain and feel that specialists, such as geriatricians, geriatric psychiatrists, or neurologists should address dementia assessment and treatment. 4 Unfortunately, the geriatric health care workforce has been shrinking. The American Geriatrics Society estimates the need for 30,000 geriatricians by 2030, although there are only 7,300 board-certified geriatricians currently in the US.5 There is an urgent need for educating all medical trainees in dementia care regardless of their specialization interest. As the largest underwriter of graduate medical education in the US, the US Department of Veterans Affairs (VA) is well placed for rolling out focused dementia education. Training needs to be practical, brief, and responsive to knowledge gaps to reach the most trainees.

Despite growing emphasis on geriatric training, many medical students have limited experience with patients with dementia or their caregivers, lack exposure to interdisciplinary teams, have a poor attitude toward geriatric patients, and display specific knowledge gaps in dementia assessment and management. 6-9 Other knowledge gaps noted in medical students included assessing behavioral problems, function, safety, and caregiver burden. Medical students also had limited exposure to interdisciplinary team dementia assessment and management.

Our goal was to develop a multicomponent, experiential, brief curriculum using team-based learning to expose senior medical students to interdisciplinary assessment of dementia. The curriculum was developed with input from the interdisciplinary team to address dementia knowledge gaps while providing an opportunity to interact with caregivers. The curriculum targeted all medical students regardless of their interest in geriatrics. Particular emphasis was placed on systems-based learning and the importance of teamwork in managing complex conditions such as dementia. Students were taught that incorporating interdisciplinary input would be more effective during dementia care planning rather than developing specialized knowledge.

Methods

Our team developed a curriculum for fourthyear medical students who rotated through the VA Memory Disorders Clinic as a part of their geriatric medicine clerkship at the University of Arkansas for Medical Sciences in Little Rock. The Memory Disorders Clinic is a consultation practice at the Central Arkansas Veterans Healthcare System (CAVHS) where patients with memory problems are evaluated by a team consisting of a geriatric psychiatrist, a geriatrician, a social worker, and a neuropsychologist. Each specialist addresses specific areas of dementia assessment and management. The curriculum included didactics, clinical experience, and team-based learning.

Didactics

An hour-long didactic session lead by the team geriatrician provided a general overview of interdisciplinary assessment of dementia to groups of 2 to 3 students at a time. The geriatrician presented an overview of dementia types, comorbidities, medications that affect memory, details of the physical examination, and laboratory, cognitive, and behavioral assessments along with treatment plan development. Students also learned about the roles of the social worker, geriatrician, neuropsychologist, and geriatric psychiatrist in the clinic. Pictographs and pie charts highlighted the role of disciplines in assessing and managing aspects of dementia.

The social work evaluation included advance care planning, functional assessment, safety assessment (driving, guns, wandering behaviors, etc), home safety evaluation, support system, and financial evaluation. Each medical student received a binder with local resources to become familiar with the depth and breadth of agencies involved in dementia care. Each medical student learned how to administer the Zarit Burden Scale to assess caregiver burden.10 The details of the geriatrician assessment included reviewing medical comorbidities and medications contributing to dementia, a physical examination, including a focused neurologic examination, laboratory assessment, and judicious use of neuroimaging.

The neuropsychology assessment education included a battery of tests and assessments. The global screening instruments included the Modified Mini-Mental State examination (3MS), Montreal Cognitive Assessment (MoCA), and Saint Louis University Mental Status examination (SLUMS).11-13 Executive function is evaluated using the Trails Making Test A and Trails Making Test B, Controlled Oral Word Association Test, Semantic Fluency Test, and Repeatable Battery for the Assessment of Neuropsychological Status test. Cognitive tests were compared and age- , education-, and race-adjusted norms for rating scales were listed if available. Each student was expected to show proficiency in ≥ 2 cognitive screening instruments (3MS, MoCA, or SLUMS). The geriatric psychiatry assessment included clinical history, onset, and course of memory problems from patient and caregiver perspectives, the Neuropsychiatric Inventory for assessing behavioral problems, employing the clinical dementia rating scale, integrating the team data, summarizing assessment, and formulating a treatment plan.14

Clinical

Students had a single clinical exposure. Students followed 1 patient and his or her caregiver through the team assessment and observed each provider’s assessment to learn interview techniques to adapt to the patient’s sensory or cognitive impairment and become familiar with different tools and devices used in the dementia clinic, such as hearing amplifiers. Each specialist provided hands-on experience. This encounter helped the students connect with caregivers and appreciate their role in patient care.

 

 

Systems learning was an important component integrated throughout the clinical experience. Examples include using video teleconferences to communicate findings among team members and electronic health records to seamlessly obtain and integrate data. Students learned how to create worksheets to graph laboratory data such as B12, thyroid-stimulating hormone, and rapid plasma regain levels. Student gained experience in using applications to retrieve neuroimaging data, results of sleep studies, and other data. Many patients had not received the results of their sleep study, and students had the responsibility to share these reports, including the number of apneic episodes. Students used the VA Computerized Patient Record System for reviewing patient records. One particularly useful tool was Joint Legacy Viewer, a remote access tool used to retrieve data on veterans from anywhere within the US. Students were also trained on medication and consult order menus in the system.

Team-Based

Learning The objectives of the team-based learning section were to teach students basic concepts of integrating the interdisciplinary assessment and formulating a treatment plan, to provide an opportunity to present their case in a group format, to discuss the differential diagnosis, management and treatment plan with a geriatrician in the team-based learning format, and to answer questions from other students. The instructors developed a set of prepared take-home points (Table 1). The team-based learning sessions were structured so that all take-home points were covered.

Evaluations

Evaluations were performed before and immediately after the clinical experience. In preevaluation, students reported the frequency of their participation in an interdisciplinary team assessment of any condition and specifically for dementia. In pre- and postevaluation, students rated their perception of the role of interdisciplinary team members in assessing and managing dementia, their personal abilities to assess cognition, behavioral problems, caregiver burden, and their perception of the impact of behavioral problems on dementia care. A Likert scale (poor = 1; fair = 2; good = 3; very good = 4; and excellent = 5) was employed (eApendices 1 and 2 can be found at doi:10.12788/fp.0052). The only demographic information collected was the student’s gender. Semistructured interviews were conducted to assess students’ current knowledge, experience, and needs. These interviews lasted about 20 minutes and collected information regarding the students’ knowledge about cognitive and behavioral problems in general and those occurring in dementia, their experience with screening, and any problems they encountered.

Statistical Analysis

Student baseline characteristics were assessed. Pre- and postassessments were analyzed with the McNemar test for paired data, and associations with experience were evaluated using χ2 tests. Ratings were dichotomized as very good/excellent vs poor/fair/ good because our educational goal was “very good” to “excellent” experience in dementia care and to avoid expected small cell counts. Two-sided P < .05 indicated statistical significance. Data were analyzed using SAS Enterprise Guide v5.1.

Results

One hundred fourth-year medical students participated, including 54 women. Thirtysix percent reported they had not previously attended an interdisciplinary team assessment for dementia, while 18% stated that they had attended only 1 interdisciplinary team assessment for dementia.

Before the education, students rated their dementia ability as poor. Only 2% (1 of 54), of those with 0 to 1 assessment experience rated their ability for assessing dementia with an interdisciplinary team format as very good/excellent compared with 20% (9/46) of those previously attending ≥ 2 assessments (P = .03); other ratings of ability were not associated with prior experience.

There was a significant change in the students’ self-efficacy ratings pre- to postassessment (P < .05) (Table 2). Only 10% rated their ability to assess for dementia as very good/excellent in before the intervention compared with 96% in postassessment (P < .01). Students’ perception of the impact of behavioral problems on dementia care improved significantly (45% to 98%, P < .01). Similarly, student’s perception of their ability to assess behavioral problems, caregiver burden, and cognition improved significantly from 7 to 88%; 7 to 78%, and 18 to 92%, respectively (P < .01). Students perception of the role of social worker, neuropsychologist, geriatrician, and geriatric psychiatrist also improved significantly for most measures from 81 to 98% (P = .02), 87 to 98% (P = .05), 94 to 99% (P = .06), and 88 to 100% (P = .01), respectively.

The semistructured interviews revealed that awareness of behavioral problems associated with dementia varied for different behavioral problems. Although many students showed familiarity with depression, agitation, and psychosis, they were not comfortable assessing them in a patient with dementia. These students were less aware of other behavioral problems such as disinhibition, apathy, and movement disorders. Deficits were noted in the skill of administering commonly used global cognitive screens, such as the Mini-Mental State Examination (MMSE).15

 

 

In semistructured interviews, only 7% of senior medical students were comfortable assessing behavioral problems associated with dementia. Most were not aware of any validated rating scale to assess neuropsychiatric symptoms. Similarly, only 7% of students were comfortable assessing caregiver burden, and most were not aware of any validated rating scale to assess caregiver burden. Only 1 in 5 students were comfortable using 2 cognitive screens to assess cognitive deficits. Many students stated that they were not routinely expected to perform common cognitive screens, such as the MMSE during their medical training except students who had expressed an interest in psychiatry and were expected to be proficient in the MMSE. Most students were making common mistakes, such as converting the 3-command task to 3 individual single commands, helping too much with serial 7s, and giving too much positive feedback throughout the test.

Discussion

Significant knowledge gaps regarding dementia were found in our study, which is in keeping with other studies in the area. Dementia knowledge deficits among medical trainees have been identified in the United Kingdom, Australia, and the US.6-9

In our study, a brief multicomponent experiential curriculum improved senior medical students’ perception and self-efficacy in diagnosing dementia. This is in keeping with other studies, such as the PAIRS Program.7 Findings from another study indicated that education for geriatric- oriented physicians should focus on experiential learning components through observation and interaction with older adults.16

A background of direct experience with older adults is associated with more positive attitudes toward older adults and increased interest in geriatric medicine.16 In our study, the exposure was brief; therefore, the results could not be compared with other long-term exposure studies. However, even with this brief intervention most students reported being comfortable with assessing caregiver burden (78%), behavioral problems of dementia (88%), and using ≥ 2 cognitive screens (92%). Comfortable in dementia assessment increased after the intervention from 10% to 96%. This finding is encouraging because brief multicomponent dementia education can be devised easily. This finding needs to be taken with caution because we did not conduct a formal skills evaluation.

A unique component of our experience was to learn medical students’ perception about the impact of neuropsychiatric symptoms on the trajectory, outcomes, and management of dementia. These symptoms included delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, nighttime behaviors, and appetite and eating. Less than half the students thought that neuropsychiatric symptoms had a significant impact on dementia before the experience. Through didactics, systematic assessment of neuropsychiatric symptoms and interaction with caregivers, > 98% of students learned that these symptoms have a significant impact on dementia management.

This experience also emphasized the role of several disciplines in dementia assessment and management. Students’ experience positively influenced appreciation of the role of the memory clinic team. Our hope is that students will seek input from social workers, neuropsychologists, and other team members when working with patients with dementia or their caregivers. The common reason why primary care physicians focus on an exclusive medical model is the time commitment for communicating with an interdisciplinary team. Students experienced the feasibility of the interdisciplinary team involvement and how technology could be used for synchronous and asynchronous communication among team members. Medical students also were introduced to complex billing codes used when ≥ 3 disciplines assess/manage a geriatric patient.

Limitations

This study is limited by the lack of long-term follow-up evaluations, no metrics for practice changes clinical outcomes, and implementation in a single medical school. The postexperience evaluation in this study was performed immediately after the intervention. Long-term follow-up would inform whether the changes noted are durable. Because of the brief nature of our intervention, we do not believe that it would change practice in clinical care. It will be informative to follow this cohort of students to study whether their clinical approach to dementia care changes. The intervention needs to be replicated in other medical schools and in more heterogeneous groups to generalize the results of the study.

Conclusions

Senior medical students are not routinely exposed to interdisciplinary team assessments. Dementia knowledge gaps were prevalent in this cohort of senior medical students. Providing interdisciplinary geriatric educational experience improved their perception of their ability to assess for dementia and their recognition of the roles of interdisciplinary team members. Plans are in place to continue and expand the program to other complex geriatric syndromes.

Acknowledgments
Poster presented at the 2019 annual meeting of the American Geriatrics Society. Oral presentation at the same meeting as part of the select Geriatric Education Methods and Materials Swap workshop.

The global burden of dementia is increasing at an alarming pace and is estimated to soon affect 81 million individuals worldwide.1 The World Health Organization and the Institute of Medicine have recommended greater dementia awareness and education.2,3 Despite this emphasis on dementia education, many general practitioners consider dementia care beyond their clinical domain and feel that specialists, such as geriatricians, geriatric psychiatrists, or neurologists should address dementia assessment and treatment. 4 Unfortunately, the geriatric health care workforce has been shrinking. The American Geriatrics Society estimates the need for 30,000 geriatricians by 2030, although there are only 7,300 board-certified geriatricians currently in the US.5 There is an urgent need for educating all medical trainees in dementia care regardless of their specialization interest. As the largest underwriter of graduate medical education in the US, the US Department of Veterans Affairs (VA) is well placed for rolling out focused dementia education. Training needs to be practical, brief, and responsive to knowledge gaps to reach the most trainees.

Despite growing emphasis on geriatric training, many medical students have limited experience with patients with dementia or their caregivers, lack exposure to interdisciplinary teams, have a poor attitude toward geriatric patients, and display specific knowledge gaps in dementia assessment and management. 6-9 Other knowledge gaps noted in medical students included assessing behavioral problems, function, safety, and caregiver burden. Medical students also had limited exposure to interdisciplinary team dementia assessment and management.

Our goal was to develop a multicomponent, experiential, brief curriculum using team-based learning to expose senior medical students to interdisciplinary assessment of dementia. The curriculum was developed with input from the interdisciplinary team to address dementia knowledge gaps while providing an opportunity to interact with caregivers. The curriculum targeted all medical students regardless of their interest in geriatrics. Particular emphasis was placed on systems-based learning and the importance of teamwork in managing complex conditions such as dementia. Students were taught that incorporating interdisciplinary input would be more effective during dementia care planning rather than developing specialized knowledge.

Methods

Our team developed a curriculum for fourthyear medical students who rotated through the VA Memory Disorders Clinic as a part of their geriatric medicine clerkship at the University of Arkansas for Medical Sciences in Little Rock. The Memory Disorders Clinic is a consultation practice at the Central Arkansas Veterans Healthcare System (CAVHS) where patients with memory problems are evaluated by a team consisting of a geriatric psychiatrist, a geriatrician, a social worker, and a neuropsychologist. Each specialist addresses specific areas of dementia assessment and management. The curriculum included didactics, clinical experience, and team-based learning.

Didactics

An hour-long didactic session lead by the team geriatrician provided a general overview of interdisciplinary assessment of dementia to groups of 2 to 3 students at a time. The geriatrician presented an overview of dementia types, comorbidities, medications that affect memory, details of the physical examination, and laboratory, cognitive, and behavioral assessments along with treatment plan development. Students also learned about the roles of the social worker, geriatrician, neuropsychologist, and geriatric psychiatrist in the clinic. Pictographs and pie charts highlighted the role of disciplines in assessing and managing aspects of dementia.

The social work evaluation included advance care planning, functional assessment, safety assessment (driving, guns, wandering behaviors, etc), home safety evaluation, support system, and financial evaluation. Each medical student received a binder with local resources to become familiar with the depth and breadth of agencies involved in dementia care. Each medical student learned how to administer the Zarit Burden Scale to assess caregiver burden.10 The details of the geriatrician assessment included reviewing medical comorbidities and medications contributing to dementia, a physical examination, including a focused neurologic examination, laboratory assessment, and judicious use of neuroimaging.

The neuropsychology assessment education included a battery of tests and assessments. The global screening instruments included the Modified Mini-Mental State examination (3MS), Montreal Cognitive Assessment (MoCA), and Saint Louis University Mental Status examination (SLUMS).11-13 Executive function is evaluated using the Trails Making Test A and Trails Making Test B, Controlled Oral Word Association Test, Semantic Fluency Test, and Repeatable Battery for the Assessment of Neuropsychological Status test. Cognitive tests were compared and age- , education-, and race-adjusted norms for rating scales were listed if available. Each student was expected to show proficiency in ≥ 2 cognitive screening instruments (3MS, MoCA, or SLUMS). The geriatric psychiatry assessment included clinical history, onset, and course of memory problems from patient and caregiver perspectives, the Neuropsychiatric Inventory for assessing behavioral problems, employing the clinical dementia rating scale, integrating the team data, summarizing assessment, and formulating a treatment plan.14

Clinical

Students had a single clinical exposure. Students followed 1 patient and his or her caregiver through the team assessment and observed each provider’s assessment to learn interview techniques to adapt to the patient’s sensory or cognitive impairment and become familiar with different tools and devices used in the dementia clinic, such as hearing amplifiers. Each specialist provided hands-on experience. This encounter helped the students connect with caregivers and appreciate their role in patient care.

 

 

Systems learning was an important component integrated throughout the clinical experience. Examples include using video teleconferences to communicate findings among team members and electronic health records to seamlessly obtain and integrate data. Students learned how to create worksheets to graph laboratory data such as B12, thyroid-stimulating hormone, and rapid plasma regain levels. Student gained experience in using applications to retrieve neuroimaging data, results of sleep studies, and other data. Many patients had not received the results of their sleep study, and students had the responsibility to share these reports, including the number of apneic episodes. Students used the VA Computerized Patient Record System for reviewing patient records. One particularly useful tool was Joint Legacy Viewer, a remote access tool used to retrieve data on veterans from anywhere within the US. Students were also trained on medication and consult order menus in the system.

Team-Based

Learning The objectives of the team-based learning section were to teach students basic concepts of integrating the interdisciplinary assessment and formulating a treatment plan, to provide an opportunity to present their case in a group format, to discuss the differential diagnosis, management and treatment plan with a geriatrician in the team-based learning format, and to answer questions from other students. The instructors developed a set of prepared take-home points (Table 1). The team-based learning sessions were structured so that all take-home points were covered.

Evaluations

Evaluations were performed before and immediately after the clinical experience. In preevaluation, students reported the frequency of their participation in an interdisciplinary team assessment of any condition and specifically for dementia. In pre- and postevaluation, students rated their perception of the role of interdisciplinary team members in assessing and managing dementia, their personal abilities to assess cognition, behavioral problems, caregiver burden, and their perception of the impact of behavioral problems on dementia care. A Likert scale (poor = 1; fair = 2; good = 3; very good = 4; and excellent = 5) was employed (eApendices 1 and 2 can be found at doi:10.12788/fp.0052). The only demographic information collected was the student’s gender. Semistructured interviews were conducted to assess students’ current knowledge, experience, and needs. These interviews lasted about 20 minutes and collected information regarding the students’ knowledge about cognitive and behavioral problems in general and those occurring in dementia, their experience with screening, and any problems they encountered.

Statistical Analysis

Student baseline characteristics were assessed. Pre- and postassessments were analyzed with the McNemar test for paired data, and associations with experience were evaluated using χ2 tests. Ratings were dichotomized as very good/excellent vs poor/fair/ good because our educational goal was “very good” to “excellent” experience in dementia care and to avoid expected small cell counts. Two-sided P < .05 indicated statistical significance. Data were analyzed using SAS Enterprise Guide v5.1.

Results

One hundred fourth-year medical students participated, including 54 women. Thirtysix percent reported they had not previously attended an interdisciplinary team assessment for dementia, while 18% stated that they had attended only 1 interdisciplinary team assessment for dementia.

Before the education, students rated their dementia ability as poor. Only 2% (1 of 54), of those with 0 to 1 assessment experience rated their ability for assessing dementia with an interdisciplinary team format as very good/excellent compared with 20% (9/46) of those previously attending ≥ 2 assessments (P = .03); other ratings of ability were not associated with prior experience.

There was a significant change in the students’ self-efficacy ratings pre- to postassessment (P < .05) (Table 2). Only 10% rated their ability to assess for dementia as very good/excellent in before the intervention compared with 96% in postassessment (P < .01). Students’ perception of the impact of behavioral problems on dementia care improved significantly (45% to 98%, P < .01). Similarly, student’s perception of their ability to assess behavioral problems, caregiver burden, and cognition improved significantly from 7 to 88%; 7 to 78%, and 18 to 92%, respectively (P < .01). Students perception of the role of social worker, neuropsychologist, geriatrician, and geriatric psychiatrist also improved significantly for most measures from 81 to 98% (P = .02), 87 to 98% (P = .05), 94 to 99% (P = .06), and 88 to 100% (P = .01), respectively.

The semistructured interviews revealed that awareness of behavioral problems associated with dementia varied for different behavioral problems. Although many students showed familiarity with depression, agitation, and psychosis, they were not comfortable assessing them in a patient with dementia. These students were less aware of other behavioral problems such as disinhibition, apathy, and movement disorders. Deficits were noted in the skill of administering commonly used global cognitive screens, such as the Mini-Mental State Examination (MMSE).15

 

 

In semistructured interviews, only 7% of senior medical students were comfortable assessing behavioral problems associated with dementia. Most were not aware of any validated rating scale to assess neuropsychiatric symptoms. Similarly, only 7% of students were comfortable assessing caregiver burden, and most were not aware of any validated rating scale to assess caregiver burden. Only 1 in 5 students were comfortable using 2 cognitive screens to assess cognitive deficits. Many students stated that they were not routinely expected to perform common cognitive screens, such as the MMSE during their medical training except students who had expressed an interest in psychiatry and were expected to be proficient in the MMSE. Most students were making common mistakes, such as converting the 3-command task to 3 individual single commands, helping too much with serial 7s, and giving too much positive feedback throughout the test.

Discussion

Significant knowledge gaps regarding dementia were found in our study, which is in keeping with other studies in the area. Dementia knowledge deficits among medical trainees have been identified in the United Kingdom, Australia, and the US.6-9

In our study, a brief multicomponent experiential curriculum improved senior medical students’ perception and self-efficacy in diagnosing dementia. This is in keeping with other studies, such as the PAIRS Program.7 Findings from another study indicated that education for geriatric- oriented physicians should focus on experiential learning components through observation and interaction with older adults.16

A background of direct experience with older adults is associated with more positive attitudes toward older adults and increased interest in geriatric medicine.16 In our study, the exposure was brief; therefore, the results could not be compared with other long-term exposure studies. However, even with this brief intervention most students reported being comfortable with assessing caregiver burden (78%), behavioral problems of dementia (88%), and using ≥ 2 cognitive screens (92%). Comfortable in dementia assessment increased after the intervention from 10% to 96%. This finding is encouraging because brief multicomponent dementia education can be devised easily. This finding needs to be taken with caution because we did not conduct a formal skills evaluation.

A unique component of our experience was to learn medical students’ perception about the impact of neuropsychiatric symptoms on the trajectory, outcomes, and management of dementia. These symptoms included delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, nighttime behaviors, and appetite and eating. Less than half the students thought that neuropsychiatric symptoms had a significant impact on dementia before the experience. Through didactics, systematic assessment of neuropsychiatric symptoms and interaction with caregivers, > 98% of students learned that these symptoms have a significant impact on dementia management.

This experience also emphasized the role of several disciplines in dementia assessment and management. Students’ experience positively influenced appreciation of the role of the memory clinic team. Our hope is that students will seek input from social workers, neuropsychologists, and other team members when working with patients with dementia or their caregivers. The common reason why primary care physicians focus on an exclusive medical model is the time commitment for communicating with an interdisciplinary team. Students experienced the feasibility of the interdisciplinary team involvement and how technology could be used for synchronous and asynchronous communication among team members. Medical students also were introduced to complex billing codes used when ≥ 3 disciplines assess/manage a geriatric patient.

Limitations

This study is limited by the lack of long-term follow-up evaluations, no metrics for practice changes clinical outcomes, and implementation in a single medical school. The postexperience evaluation in this study was performed immediately after the intervention. Long-term follow-up would inform whether the changes noted are durable. Because of the brief nature of our intervention, we do not believe that it would change practice in clinical care. It will be informative to follow this cohort of students to study whether their clinical approach to dementia care changes. The intervention needs to be replicated in other medical schools and in more heterogeneous groups to generalize the results of the study.

Conclusions

Senior medical students are not routinely exposed to interdisciplinary team assessments. Dementia knowledge gaps were prevalent in this cohort of senior medical students. Providing interdisciplinary geriatric educational experience improved their perception of their ability to assess for dementia and their recognition of the roles of interdisciplinary team members. Plans are in place to continue and expand the program to other complex geriatric syndromes.

Acknowledgments
Poster presented at the 2019 annual meeting of the American Geriatrics Society. Oral presentation at the same meeting as part of the select Geriatric Education Methods and Materials Swap workshop.

References

1. Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005;366(9503):2112-2117. doi:10.1016/S0140-6736(05)67889-0

2. Janca A, Aarli JA, Prilipko L, Dua T, Saxena S, Saraceno B. WHO/WFN survey of neurological services: a worldwide perspective. J Neurol Sci. 2006;247(1):29-34. doi:10.1016/j.jns.2006.03.003

3. Wilkins KM, Blazek MC, Brooks WB, Lehmann SW, Popeo D, Wagenaar D. Six things all medical students need to know about geriatric psychiatry (and how to teach them). Acad Psychiatry. 2017;41(5):693-700. doi:10.1007/s40596-017-0691-7

4. Turner S, Iliffe S, Downs M, et al. General practitioners’ knowledge, confidence and attitudes in the diagnosis and management of dementia. Age Ageing. 2004;33(5):461- 467. doi:10.1093/ageing/afh140

5. Lester PE, Dharmarajan TS, Weinstein E. The looming geriatrician shortage: ramifications and solutions. J Aging Health. 2019:898264319879325. doi:10.1177/0898264319879325

6. Struck BD, Bernard MA, Teasdale TA; Oklahoma University Geriatric Education G. Effect of a mandatory geriatric medicine clerkship on third-year students. J Am Geriatr Soc. 2005;53(11):2007-2011. doi:10.1111/j.1532-5415.2005.00473.x

7. Jefferson AL, Cantwell NG, Byerly LK, Morhardt D. Medical student education program in Alzheimer’s disease: the PAIRS Program. BMC Med Educ. 2012;12:80. doi:10.1186/1472-6920-12-80

8. Nagle BJ, Usita PM, Edland SD. United States medical students’ knowledge of Alzheimer disease. J Educ Eval Health Prof. 2013;10:4. doi:10.3352/jeehp.2013.10.4

9. Scott TL, Kugelman M, Tulloch K. How medical professional students view older people with dementia: Implications for education and practice. PLoS One. 2019;14(11):e0225329. doi:10.1371/journal.pone.0225329.

10. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649-655. doi:10.1093/geront/20.6.649

11. McDowell I, Kristjansson B, Hill GB, Hebert R. Community screening for dementia: the Mini Mental State Exam (MMSE) and Modified Mini-Mental State Exam (3MS) compared. J Clin Epidemiol. 1997;50(4):377-383. doi:10.1016/s0895-4356(97)00060-7

12. Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Ger iatr Soc. 2005;53(4):695-699. doi:10.1111/j.1532-5415.2005.53221.x

13. Tariq SH, Tumosa N, Chibnall JT, Perry MH, 3rd, Morley JE. Comparison of the Saint Louis University mental status examination and the Mini-Mental State Examination for detecting dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 2006;14(11):900-910. doi:10.1097/01.JGP.0000221510.33817.86

14. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994;44(12):2308-2314. doi:10.1212/wnl.44.12.2308

15. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state.” A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189-198. doi:10.1016/0022-3956(75)90026-6

16. Fitzgerald JT, Wray LA, Halter JB, Williams BC, Supiano MA. Relating medical students’ knowledge, attitudes, and experience to an interest in geriatric medicine. Gerontologist. 2003;43(6):849-855. doi:10.1093/geront/43.6.849

References

1. Ferri CP, Prince M, Brayne C, et al. Global prevalence of dementia: a Delphi consensus study. Lancet. 2005;366(9503):2112-2117. doi:10.1016/S0140-6736(05)67889-0

2. Janca A, Aarli JA, Prilipko L, Dua T, Saxena S, Saraceno B. WHO/WFN survey of neurological services: a worldwide perspective. J Neurol Sci. 2006;247(1):29-34. doi:10.1016/j.jns.2006.03.003

3. Wilkins KM, Blazek MC, Brooks WB, Lehmann SW, Popeo D, Wagenaar D. Six things all medical students need to know about geriatric psychiatry (and how to teach them). Acad Psychiatry. 2017;41(5):693-700. doi:10.1007/s40596-017-0691-7

4. Turner S, Iliffe S, Downs M, et al. General practitioners’ knowledge, confidence and attitudes in the diagnosis and management of dementia. Age Ageing. 2004;33(5):461- 467. doi:10.1093/ageing/afh140

5. Lester PE, Dharmarajan TS, Weinstein E. The looming geriatrician shortage: ramifications and solutions. J Aging Health. 2019:898264319879325. doi:10.1177/0898264319879325

6. Struck BD, Bernard MA, Teasdale TA; Oklahoma University Geriatric Education G. Effect of a mandatory geriatric medicine clerkship on third-year students. J Am Geriatr Soc. 2005;53(11):2007-2011. doi:10.1111/j.1532-5415.2005.00473.x

7. Jefferson AL, Cantwell NG, Byerly LK, Morhardt D. Medical student education program in Alzheimer’s disease: the PAIRS Program. BMC Med Educ. 2012;12:80. doi:10.1186/1472-6920-12-80

8. Nagle BJ, Usita PM, Edland SD. United States medical students’ knowledge of Alzheimer disease. J Educ Eval Health Prof. 2013;10:4. doi:10.3352/jeehp.2013.10.4

9. Scott TL, Kugelman M, Tulloch K. How medical professional students view older people with dementia: Implications for education and practice. PLoS One. 2019;14(11):e0225329. doi:10.1371/journal.pone.0225329.

10. Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649-655. doi:10.1093/geront/20.6.649

11. McDowell I, Kristjansson B, Hill GB, Hebert R. Community screening for dementia: the Mini Mental State Exam (MMSE) and Modified Mini-Mental State Exam (3MS) compared. J Clin Epidemiol. 1997;50(4):377-383. doi:10.1016/s0895-4356(97)00060-7

12. Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Ger iatr Soc. 2005;53(4):695-699. doi:10.1111/j.1532-5415.2005.53221.x

13. Tariq SH, Tumosa N, Chibnall JT, Perry MH, 3rd, Morley JE. Comparison of the Saint Louis University mental status examination and the Mini-Mental State Examination for detecting dementia and mild neurocognitive disorder--a pilot study. Am J Geriatr Psychiatry. 2006;14(11):900-910. doi:10.1097/01.JGP.0000221510.33817.86

14. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994;44(12):2308-2314. doi:10.1212/wnl.44.12.2308

15. Folstein MF, Folstein SE, McHugh PR. “Mini-mental state.” A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189-198. doi:10.1016/0022-3956(75)90026-6

16. Fitzgerald JT, Wray LA, Halter JB, Williams BC, Supiano MA. Relating medical students’ knowledge, attitudes, and experience to an interest in geriatric medicine. Gerontologist. 2003;43(6):849-855. doi:10.1093/geront/43.6.849

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Survey explores mental health, services use in police officers

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New research shows that about a quarter of police officers in one large force report past or present mental health problems.

Responding to a survey, 26% of police officers on the Dallas police department screened positive for depression, anxiety, PTSD, or symptoms of suicide ideation or self-harm.

Mental illness rates were particularly high among female officers, those who were divorced, widowed, or separated, and those with military experience.

The study also showed that concerns over confidentiality and stigma may prevent officers with mental illness from seeking treatment.

The results underscored the need to identify police officers with psychiatric problems and to connect them to the most appropriate individualized care, author Katelyn K. Jetelina, PhD, assistant professor in the department of epidemiology, human genetics, and environmental sciences, University of Texas Health Science Center, Dallas, said in an interview.

“This is a very hard-to-reach population, and because of that, we need to be innovative in reaching them for services,” she said.

The study was published online Oct. 7 in JAMA Network Open.

Dr. Jetelina and colleagues are investigating various aspects of police officers’ well-being, including their nutritional needs and their occupational, physical, and mental health.

The current study included 434 members of the Dallas police department, the ninth largest in the United States. The mean age of the participants was 37 years, 82% were men, and about half were White. The 434 officers represented 97% of those invited to participate (n = 446) and 31% of the total patrol population of the Dallas police department (n = 1,413).

These officers completed a short survey on their smartphone that asked about lifetime diagnoses of depression, anxiety, and PTSD. They were also asked whether they experienced suicidal ideation or self-harm during the previous 2 weeks.

Overall, 12% of survey respondents reported having been diagnosed with a mental illness. This, said Jetelina, is slightly lower than the rate reported in the general population.

Study participants who had not currently been diagnosed with a mental illness completed the Patient Health Questionnaire–2 (PHQ-2), the Generalized Anxiety Disorder–2 (GAD-2), and the Primary Care–Posttraumatic Stress Disorder (PC-PTSD).

Officers were considered to have a positive result if they had a score of 3 or more (PHQ-2, sensitivity of 83% and specificity of 92%; PC-PTSD-5, sensitivity of 93% and specificity of 85%; GAD-2, sensitivity of 86% and specificity of 83%).

About 26% of respondents had a positive screening for mental illness symptoms, mainly PTSD and depression, which Dr. Jetelina noted is a higher percentage than in the general population.

This rate of mental health symptoms is “high and concerning,” but not surprising because of the work of police officers, which could include attending to sometimes violent car crashes, domestic abuse situations, and armed conflicts, said Dr. Jetelina.

“They’re constantly exposed to traumatic calls for service; they see people on their worst day, 8 hours a day, 5 days a week. That stress and exposure will have a detrimental effect on mental health, and we have to pay more attention to that,” she said.

Dr. Jetelina pointed out that the surveys were completed in January and February 2020, before COVID-19 had become a cause of stress for everyone and before the increase in calls for defunding police amid a resurgence of Black Lives Matter demonstrations.

However, she stressed that racial biases and occupational stress among police officers are “nothing new for them.” For example, in 2016, five Dallas police officers were killed during Black Lives Matter protests because of their race/ethnicity.
 

 

 

More at risk

The study showed that certain subgroups of officers were more at risk for mental illness. After adjustment for confounders, including demographic characteristics, marital status, and educational level, the odds of being diagnosed with a mental illness during the course of one’s life were significantly higher among female officers than male officers (adjusted odds ratio, 3.20; 95% confidence interval, 1.18-8.68).

Officers who were divorced, widowed, or separated and those who had more experience and held a higher rank were also at greater risk for mental illness.

As well, military veterans had greater odds of being diagnosed with a mental health disorder, compared with nonveterans (aOR, 3.25; 95% CI, 1.38-7.67).

The study also asked participants about use of mental health care services over the past 12 months. About 35% of those who had a current mental health diagnosis and 17% of those who screened positive for mental health symptoms reported using such services.

The study also asked those who screened positive about their interest in seeking such services. After adjustments, officers with suicidal ideation or self-harm were significantly more likely to be interested in getting help, compared with officers who did not report suicidal ideation or self-harm (aOR, 7.66; 95% CI, 1.70-34.48).

Dr. Jetelina was impressed that so many officers were keen to seek help, which “is a big positive,” she said. “It’s just a matter of better detecting who needs the help and better connecting them to medical services that meet their needs.”
 

Mindfulness exercise

Dr. Jetelina and colleagues are conducting a pilot test of the use by police officers of smartwatches that monitor heart rate and oxygen levels. If measurements with these devices reach a predetermined threshold, the officers are “pinged” and are instructed to perform a mindfulness exercise in the field, she said.

Results so far “are really exciting,” said Dr. Jetelina. “Officers have found this extremely helpful and feasible, and so the next step is to test if this truly impacts mental illness over time.”

Routine mental health screening of officers might be beneficial, but only if it’s conducted in a manner “respectful of the officers’ needs and wants,” said Dr. Jetelina.

She pointed out that although psychological assessments are routinely carried out following an extreme traumatic call, such as one involving an officer-involved shooting, the “in-between” calls could have a more severe cumulative impact on mental health.

It’s important to provide officers with easy-to-access services tailored for their individual needs, said Dr. Jetelina.
 

‘Numb to it’

Eighteen patrol officers also participated in a focus group, during which several themes regarding the use of mental health care services emerged. One theme was the inability of officers to identify when they’re personally experiencing a mental health problem.

Participants said they had become “numb” to the traumatic events on the job, which is “concerning,” Dr. Jetelina said. “They think that having nightmares every week is completely normal, but it’s not, and this needs to be addressed.”

Other themes that emerged from focus groups included the belief that psychologists can’t relate to police stressors; concerns about confidentiality (one sentiment that was expressed was “you’re an idiot” if you “trust this department”); and stigma for officers who seek mental health care (participants talked about “reprisal” from seeing “a shrink,” including being labeled as “a nutter” and losing their job).

Dr. Jetelina noted that some “champion” officers revealed their mental health journey during focus groups, which tended to “open a Pandora’s box” for others to discuss their experience. She said these champions could be leveraged throughout the police department to help reduce stigma.

The study included participants from only one police department, although rigorous data collection allows for generalizability to the entire patrol department, say the authors. Although the study included only brief screens of mental illness symptoms, these short versions of screening tests have high sensitivity and specificity for mental illness in primary care, they noted.

The next step for the researchers is to study how mental illness and symptoms affect job performance, said Dr. Jetelina. “Does this impact excessive use of force? Does this impact workers’ compensation? Does this impact dispatch times, the time it takes for a police officer to respond to [a] 911 call?”
 

 

 

Possible underrepresentation

Anthony T. Ng, MD, regional medical director, East Region Hartford HealthCare Behavioral Health Network in Mansfield, Conn., and member of the American Psychiatric Association’s Council on Communications, found the study “helpful.”

However, the 26% who tested positive for mental illness may be an “underrepresentation” of the true picture, inasmuch as police officers might minimize or be less than truthful about their mental health status, said Dr. Ng.

Law enforcement has “never been easy,” but stressors may have escalated recently as police forces deal with shortages of staff and jails, said Dr. Ng.

He also noted that officers might face stressors at home. “Evidence shows that domestic violence is quite high – or higher than average – among law enforcement,” he said. “All these things add up.”

Psychiatrists and other mental health professionals should be “aware of the unique challenges” that police officers face and be “proactively involved” in providing guidance and education on mitigating stress, said Dr. Ng.

“You have police officers wearing body armor, so why can’t you give them some training to learn how to have psychiatric or psychological body armor?” he said. But it’s a two-way street; police forces should be open to outreach from mental health professionals. “We have to meet halfway.”
 

Compassion fatigue

In an accompanying commentary, John M. Violanti, PhD, of the department of epidemiology and environmental health at the State University of New York at Buffalo, said the article helps bring “to the forefront” the issue of the psychological dangers of police work.

There is conjecture as to why police experience mental distress, said Dr. Violanti, who pointed to a study of New York City police suicides during the 1930s that suggested that police have a “social license” for aggressive behavior but are restrained as part of public trust, placing them in a position of “psychological strain.”

“This situation may be reflective of the same situation police find themselves today,” said Dr. Violanti.

“Compassion fatigue,” a feeling of mental exhaustion caused by the inability to care for all persons in trouble, may also be a factor, as could the constant stress that leaves police officers feeling “cynical and isolated from others,” he wrote.

“The socialization process of becoming a police officer is associated with constrictive reasoning, viewing the world as either right or wrong, which leaves no middle ground for alternatives to deal with mental distress,” Dr. Violanti said.

He noted that police officers may abuse alcohol because of stress, peer pressure, isolation, and a culture that approves of alcohol use. “Officers tend to drink together and reinforce their own values.”.

Although no prospective studies have linked police mental health problems with childhood abuse or neglect, some mental health professionals estimate that about 25% of their police clients have a history of childhood abuse or neglect, said Dr. Violanti.

He agreed that mindfulness may help manage stress and increase cognitive flexibility in dealing with trauma and crises.

A possible way to ensure confidentiality is a peer support program that allows distressed officers to first talk privately with a trained and trusted peer officer and to then seek professional help if necessary, said Dr. Violanti.

The study was funded by a grant from the National Institute of Occupational Health and Safety. Dr. Jetelina, Dr. Ng, and Dr. Violanti disclosed no relevant financial relationships.

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

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New research shows that about a quarter of police officers in one large force report past or present mental health problems.

Responding to a survey, 26% of police officers on the Dallas police department screened positive for depression, anxiety, PTSD, or symptoms of suicide ideation or self-harm.

Mental illness rates were particularly high among female officers, those who were divorced, widowed, or separated, and those with military experience.

The study also showed that concerns over confidentiality and stigma may prevent officers with mental illness from seeking treatment.

The results underscored the need to identify police officers with psychiatric problems and to connect them to the most appropriate individualized care, author Katelyn K. Jetelina, PhD, assistant professor in the department of epidemiology, human genetics, and environmental sciences, University of Texas Health Science Center, Dallas, said in an interview.

“This is a very hard-to-reach population, and because of that, we need to be innovative in reaching them for services,” she said.

The study was published online Oct. 7 in JAMA Network Open.

Dr. Jetelina and colleagues are investigating various aspects of police officers’ well-being, including their nutritional needs and their occupational, physical, and mental health.

The current study included 434 members of the Dallas police department, the ninth largest in the United States. The mean age of the participants was 37 years, 82% were men, and about half were White. The 434 officers represented 97% of those invited to participate (n = 446) and 31% of the total patrol population of the Dallas police department (n = 1,413).

These officers completed a short survey on their smartphone that asked about lifetime diagnoses of depression, anxiety, and PTSD. They were also asked whether they experienced suicidal ideation or self-harm during the previous 2 weeks.

Overall, 12% of survey respondents reported having been diagnosed with a mental illness. This, said Jetelina, is slightly lower than the rate reported in the general population.

Study participants who had not currently been diagnosed with a mental illness completed the Patient Health Questionnaire–2 (PHQ-2), the Generalized Anxiety Disorder–2 (GAD-2), and the Primary Care–Posttraumatic Stress Disorder (PC-PTSD).

Officers were considered to have a positive result if they had a score of 3 or more (PHQ-2, sensitivity of 83% and specificity of 92%; PC-PTSD-5, sensitivity of 93% and specificity of 85%; GAD-2, sensitivity of 86% and specificity of 83%).

About 26% of respondents had a positive screening for mental illness symptoms, mainly PTSD and depression, which Dr. Jetelina noted is a higher percentage than in the general population.

This rate of mental health symptoms is “high and concerning,” but not surprising because of the work of police officers, which could include attending to sometimes violent car crashes, domestic abuse situations, and armed conflicts, said Dr. Jetelina.

“They’re constantly exposed to traumatic calls for service; they see people on their worst day, 8 hours a day, 5 days a week. That stress and exposure will have a detrimental effect on mental health, and we have to pay more attention to that,” she said.

Dr. Jetelina pointed out that the surveys were completed in January and February 2020, before COVID-19 had become a cause of stress for everyone and before the increase in calls for defunding police amid a resurgence of Black Lives Matter demonstrations.

However, she stressed that racial biases and occupational stress among police officers are “nothing new for them.” For example, in 2016, five Dallas police officers were killed during Black Lives Matter protests because of their race/ethnicity.
 

 

 

More at risk

The study showed that certain subgroups of officers were more at risk for mental illness. After adjustment for confounders, including demographic characteristics, marital status, and educational level, the odds of being diagnosed with a mental illness during the course of one’s life were significantly higher among female officers than male officers (adjusted odds ratio, 3.20; 95% confidence interval, 1.18-8.68).

Officers who were divorced, widowed, or separated and those who had more experience and held a higher rank were also at greater risk for mental illness.

As well, military veterans had greater odds of being diagnosed with a mental health disorder, compared with nonveterans (aOR, 3.25; 95% CI, 1.38-7.67).

The study also asked participants about use of mental health care services over the past 12 months. About 35% of those who had a current mental health diagnosis and 17% of those who screened positive for mental health symptoms reported using such services.

The study also asked those who screened positive about their interest in seeking such services. After adjustments, officers with suicidal ideation or self-harm were significantly more likely to be interested in getting help, compared with officers who did not report suicidal ideation or self-harm (aOR, 7.66; 95% CI, 1.70-34.48).

Dr. Jetelina was impressed that so many officers were keen to seek help, which “is a big positive,” she said. “It’s just a matter of better detecting who needs the help and better connecting them to medical services that meet their needs.”
 

Mindfulness exercise

Dr. Jetelina and colleagues are conducting a pilot test of the use by police officers of smartwatches that monitor heart rate and oxygen levels. If measurements with these devices reach a predetermined threshold, the officers are “pinged” and are instructed to perform a mindfulness exercise in the field, she said.

Results so far “are really exciting,” said Dr. Jetelina. “Officers have found this extremely helpful and feasible, and so the next step is to test if this truly impacts mental illness over time.”

Routine mental health screening of officers might be beneficial, but only if it’s conducted in a manner “respectful of the officers’ needs and wants,” said Dr. Jetelina.

She pointed out that although psychological assessments are routinely carried out following an extreme traumatic call, such as one involving an officer-involved shooting, the “in-between” calls could have a more severe cumulative impact on mental health.

It’s important to provide officers with easy-to-access services tailored for their individual needs, said Dr. Jetelina.
 

‘Numb to it’

Eighteen patrol officers also participated in a focus group, during which several themes regarding the use of mental health care services emerged. One theme was the inability of officers to identify when they’re personally experiencing a mental health problem.

Participants said they had become “numb” to the traumatic events on the job, which is “concerning,” Dr. Jetelina said. “They think that having nightmares every week is completely normal, but it’s not, and this needs to be addressed.”

Other themes that emerged from focus groups included the belief that psychologists can’t relate to police stressors; concerns about confidentiality (one sentiment that was expressed was “you’re an idiot” if you “trust this department”); and stigma for officers who seek mental health care (participants talked about “reprisal” from seeing “a shrink,” including being labeled as “a nutter” and losing their job).

Dr. Jetelina noted that some “champion” officers revealed their mental health journey during focus groups, which tended to “open a Pandora’s box” for others to discuss their experience. She said these champions could be leveraged throughout the police department to help reduce stigma.

The study included participants from only one police department, although rigorous data collection allows for generalizability to the entire patrol department, say the authors. Although the study included only brief screens of mental illness symptoms, these short versions of screening tests have high sensitivity and specificity for mental illness in primary care, they noted.

The next step for the researchers is to study how mental illness and symptoms affect job performance, said Dr. Jetelina. “Does this impact excessive use of force? Does this impact workers’ compensation? Does this impact dispatch times, the time it takes for a police officer to respond to [a] 911 call?”
 

 

 

Possible underrepresentation

Anthony T. Ng, MD, regional medical director, East Region Hartford HealthCare Behavioral Health Network in Mansfield, Conn., and member of the American Psychiatric Association’s Council on Communications, found the study “helpful.”

However, the 26% who tested positive for mental illness may be an “underrepresentation” of the true picture, inasmuch as police officers might minimize or be less than truthful about their mental health status, said Dr. Ng.

Law enforcement has “never been easy,” but stressors may have escalated recently as police forces deal with shortages of staff and jails, said Dr. Ng.

He also noted that officers might face stressors at home. “Evidence shows that domestic violence is quite high – or higher than average – among law enforcement,” he said. “All these things add up.”

Psychiatrists and other mental health professionals should be “aware of the unique challenges” that police officers face and be “proactively involved” in providing guidance and education on mitigating stress, said Dr. Ng.

“You have police officers wearing body armor, so why can’t you give them some training to learn how to have psychiatric or psychological body armor?” he said. But it’s a two-way street; police forces should be open to outreach from mental health professionals. “We have to meet halfway.”
 

Compassion fatigue

In an accompanying commentary, John M. Violanti, PhD, of the department of epidemiology and environmental health at the State University of New York at Buffalo, said the article helps bring “to the forefront” the issue of the psychological dangers of police work.

There is conjecture as to why police experience mental distress, said Dr. Violanti, who pointed to a study of New York City police suicides during the 1930s that suggested that police have a “social license” for aggressive behavior but are restrained as part of public trust, placing them in a position of “psychological strain.”

“This situation may be reflective of the same situation police find themselves today,” said Dr. Violanti.

“Compassion fatigue,” a feeling of mental exhaustion caused by the inability to care for all persons in trouble, may also be a factor, as could the constant stress that leaves police officers feeling “cynical and isolated from others,” he wrote.

“The socialization process of becoming a police officer is associated with constrictive reasoning, viewing the world as either right or wrong, which leaves no middle ground for alternatives to deal with mental distress,” Dr. Violanti said.

He noted that police officers may abuse alcohol because of stress, peer pressure, isolation, and a culture that approves of alcohol use. “Officers tend to drink together and reinforce their own values.”.

Although no prospective studies have linked police mental health problems with childhood abuse or neglect, some mental health professionals estimate that about 25% of their police clients have a history of childhood abuse or neglect, said Dr. Violanti.

He agreed that mindfulness may help manage stress and increase cognitive flexibility in dealing with trauma and crises.

A possible way to ensure confidentiality is a peer support program that allows distressed officers to first talk privately with a trained and trusted peer officer and to then seek professional help if necessary, said Dr. Violanti.

The study was funded by a grant from the National Institute of Occupational Health and Safety. Dr. Jetelina, Dr. Ng, and Dr. Violanti disclosed no relevant financial relationships.

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

 

New research shows that about a quarter of police officers in one large force report past or present mental health problems.

Responding to a survey, 26% of police officers on the Dallas police department screened positive for depression, anxiety, PTSD, or symptoms of suicide ideation or self-harm.

Mental illness rates were particularly high among female officers, those who were divorced, widowed, or separated, and those with military experience.

The study also showed that concerns over confidentiality and stigma may prevent officers with mental illness from seeking treatment.

The results underscored the need to identify police officers with psychiatric problems and to connect them to the most appropriate individualized care, author Katelyn K. Jetelina, PhD, assistant professor in the department of epidemiology, human genetics, and environmental sciences, University of Texas Health Science Center, Dallas, said in an interview.

“This is a very hard-to-reach population, and because of that, we need to be innovative in reaching them for services,” she said.

The study was published online Oct. 7 in JAMA Network Open.

Dr. Jetelina and colleagues are investigating various aspects of police officers’ well-being, including their nutritional needs and their occupational, physical, and mental health.

The current study included 434 members of the Dallas police department, the ninth largest in the United States. The mean age of the participants was 37 years, 82% were men, and about half were White. The 434 officers represented 97% of those invited to participate (n = 446) and 31% of the total patrol population of the Dallas police department (n = 1,413).

These officers completed a short survey on their smartphone that asked about lifetime diagnoses of depression, anxiety, and PTSD. They were also asked whether they experienced suicidal ideation or self-harm during the previous 2 weeks.

Overall, 12% of survey respondents reported having been diagnosed with a mental illness. This, said Jetelina, is slightly lower than the rate reported in the general population.

Study participants who had not currently been diagnosed with a mental illness completed the Patient Health Questionnaire–2 (PHQ-2), the Generalized Anxiety Disorder–2 (GAD-2), and the Primary Care–Posttraumatic Stress Disorder (PC-PTSD).

Officers were considered to have a positive result if they had a score of 3 or more (PHQ-2, sensitivity of 83% and specificity of 92%; PC-PTSD-5, sensitivity of 93% and specificity of 85%; GAD-2, sensitivity of 86% and specificity of 83%).

About 26% of respondents had a positive screening for mental illness symptoms, mainly PTSD and depression, which Dr. Jetelina noted is a higher percentage than in the general population.

This rate of mental health symptoms is “high and concerning,” but not surprising because of the work of police officers, which could include attending to sometimes violent car crashes, domestic abuse situations, and armed conflicts, said Dr. Jetelina.

“They’re constantly exposed to traumatic calls for service; they see people on their worst day, 8 hours a day, 5 days a week. That stress and exposure will have a detrimental effect on mental health, and we have to pay more attention to that,” she said.

Dr. Jetelina pointed out that the surveys were completed in January and February 2020, before COVID-19 had become a cause of stress for everyone and before the increase in calls for defunding police amid a resurgence of Black Lives Matter demonstrations.

However, she stressed that racial biases and occupational stress among police officers are “nothing new for them.” For example, in 2016, five Dallas police officers were killed during Black Lives Matter protests because of their race/ethnicity.
 

 

 

More at risk

The study showed that certain subgroups of officers were more at risk for mental illness. After adjustment for confounders, including demographic characteristics, marital status, and educational level, the odds of being diagnosed with a mental illness during the course of one’s life were significantly higher among female officers than male officers (adjusted odds ratio, 3.20; 95% confidence interval, 1.18-8.68).

Officers who were divorced, widowed, or separated and those who had more experience and held a higher rank were also at greater risk for mental illness.

As well, military veterans had greater odds of being diagnosed with a mental health disorder, compared with nonveterans (aOR, 3.25; 95% CI, 1.38-7.67).

The study also asked participants about use of mental health care services over the past 12 months. About 35% of those who had a current mental health diagnosis and 17% of those who screened positive for mental health symptoms reported using such services.

The study also asked those who screened positive about their interest in seeking such services. After adjustments, officers with suicidal ideation or self-harm were significantly more likely to be interested in getting help, compared with officers who did not report suicidal ideation or self-harm (aOR, 7.66; 95% CI, 1.70-34.48).

Dr. Jetelina was impressed that so many officers were keen to seek help, which “is a big positive,” she said. “It’s just a matter of better detecting who needs the help and better connecting them to medical services that meet their needs.”
 

Mindfulness exercise

Dr. Jetelina and colleagues are conducting a pilot test of the use by police officers of smartwatches that monitor heart rate and oxygen levels. If measurements with these devices reach a predetermined threshold, the officers are “pinged” and are instructed to perform a mindfulness exercise in the field, she said.

Results so far “are really exciting,” said Dr. Jetelina. “Officers have found this extremely helpful and feasible, and so the next step is to test if this truly impacts mental illness over time.”

Routine mental health screening of officers might be beneficial, but only if it’s conducted in a manner “respectful of the officers’ needs and wants,” said Dr. Jetelina.

She pointed out that although psychological assessments are routinely carried out following an extreme traumatic call, such as one involving an officer-involved shooting, the “in-between” calls could have a more severe cumulative impact on mental health.

It’s important to provide officers with easy-to-access services tailored for their individual needs, said Dr. Jetelina.
 

‘Numb to it’

Eighteen patrol officers also participated in a focus group, during which several themes regarding the use of mental health care services emerged. One theme was the inability of officers to identify when they’re personally experiencing a mental health problem.

Participants said they had become “numb” to the traumatic events on the job, which is “concerning,” Dr. Jetelina said. “They think that having nightmares every week is completely normal, but it’s not, and this needs to be addressed.”

Other themes that emerged from focus groups included the belief that psychologists can’t relate to police stressors; concerns about confidentiality (one sentiment that was expressed was “you’re an idiot” if you “trust this department”); and stigma for officers who seek mental health care (participants talked about “reprisal” from seeing “a shrink,” including being labeled as “a nutter” and losing their job).

Dr. Jetelina noted that some “champion” officers revealed their mental health journey during focus groups, which tended to “open a Pandora’s box” for others to discuss their experience. She said these champions could be leveraged throughout the police department to help reduce stigma.

The study included participants from only one police department, although rigorous data collection allows for generalizability to the entire patrol department, say the authors. Although the study included only brief screens of mental illness symptoms, these short versions of screening tests have high sensitivity and specificity for mental illness in primary care, they noted.

The next step for the researchers is to study how mental illness and symptoms affect job performance, said Dr. Jetelina. “Does this impact excessive use of force? Does this impact workers’ compensation? Does this impact dispatch times, the time it takes for a police officer to respond to [a] 911 call?”
 

 

 

Possible underrepresentation

Anthony T. Ng, MD, regional medical director, East Region Hartford HealthCare Behavioral Health Network in Mansfield, Conn., and member of the American Psychiatric Association’s Council on Communications, found the study “helpful.”

However, the 26% who tested positive for mental illness may be an “underrepresentation” of the true picture, inasmuch as police officers might minimize or be less than truthful about their mental health status, said Dr. Ng.

Law enforcement has “never been easy,” but stressors may have escalated recently as police forces deal with shortages of staff and jails, said Dr. Ng.

He also noted that officers might face stressors at home. “Evidence shows that domestic violence is quite high – or higher than average – among law enforcement,” he said. “All these things add up.”

Psychiatrists and other mental health professionals should be “aware of the unique challenges” that police officers face and be “proactively involved” in providing guidance and education on mitigating stress, said Dr. Ng.

“You have police officers wearing body armor, so why can’t you give them some training to learn how to have psychiatric or psychological body armor?” he said. But it’s a two-way street; police forces should be open to outreach from mental health professionals. “We have to meet halfway.”
 

Compassion fatigue

In an accompanying commentary, John M. Violanti, PhD, of the department of epidemiology and environmental health at the State University of New York at Buffalo, said the article helps bring “to the forefront” the issue of the psychological dangers of police work.

There is conjecture as to why police experience mental distress, said Dr. Violanti, who pointed to a study of New York City police suicides during the 1930s that suggested that police have a “social license” for aggressive behavior but are restrained as part of public trust, placing them in a position of “psychological strain.”

“This situation may be reflective of the same situation police find themselves today,” said Dr. Violanti.

“Compassion fatigue,” a feeling of mental exhaustion caused by the inability to care for all persons in trouble, may also be a factor, as could the constant stress that leaves police officers feeling “cynical and isolated from others,” he wrote.

“The socialization process of becoming a police officer is associated with constrictive reasoning, viewing the world as either right or wrong, which leaves no middle ground for alternatives to deal with mental distress,” Dr. Violanti said.

He noted that police officers may abuse alcohol because of stress, peer pressure, isolation, and a culture that approves of alcohol use. “Officers tend to drink together and reinforce their own values.”.

Although no prospective studies have linked police mental health problems with childhood abuse or neglect, some mental health professionals estimate that about 25% of their police clients have a history of childhood abuse or neglect, said Dr. Violanti.

He agreed that mindfulness may help manage stress and increase cognitive flexibility in dealing with trauma and crises.

A possible way to ensure confidentiality is a peer support program that allows distressed officers to first talk privately with a trained and trusted peer officer and to then seek professional help if necessary, said Dr. Violanti.

The study was funded by a grant from the National Institute of Occupational Health and Safety. Dr. Jetelina, Dr. Ng, and Dr. Violanti disclosed no relevant financial relationships.

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

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Female cardiac advantage essentially lost after MI

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Wed, 11/04/2020 - 08:51

Women are known to lag 5-10 years behind men in experiencing coronary heart disease (CHD), but new research suggests the gap narrows substantially following a myocardial infarction.

Dr. Nanette K. Wenger

“Women lose a considerable portion, but not all, of their coronary and survival advantage – i.e., the lower event rates – after suffering a MI,” study author Sanne Peters, PhD, George Institute for Global Health, Imperial College London, said in an interview.

Previous studies of sex differences in event rates after a coronary event have produced mixed results and were primarily focused on mortality following MI. Importantly, the studies also lacked a control group without a history of CHD and, thus, were unable to provide a reference point for the disparity in event rates, she explained.

Using the MarketScan and Medicare databases, however, Dr. Peters and colleagues matched 339,890 U.S. adults hospitalized for an MI between January 2015 and December 2016 with 1,359,560 U.S. adults without a history of CHD.

Over a median 1.3 years follow-up, there were 12,518 MIs in the non-CHD group and 27,115 recurrent MIs in the MI group.

The age-standardized rate of MI per 1,000 person-years was 4.0 in women and 6.1 in men without a history of CHD, compared with 57.6 in women and 62.7 in men with a prior MI.

After multivariate adjustment, the women-to-men hazard ratio for MI was 0.64 (95% confidence interval, 0.62-0.67) in the non-CHD group and 0.94 (95% CI, 0.92-0.96) in the prior MI group, the authors reported Oct. 5 in the Journal of the American College of Cardiology

Additional results show the multivariate adjusted women-to-men hazard ratios for three other cardiovascular outcomes follow a similar pattern in the non-CHD and prior MI groups:

  • CHD events: 0.53 (95% CI, 0.51-0.54) and 0.87 (95% CI, 0.85-0.89).
  • Heart failure hospitalization: 0.93 (95% CI, 0.90-0.96) and 1.02 (95% CI, 1.00-1.04).
  • All-cause mortality: 0.72 (95% CI, 0.71-0.73) and 0.90 (95% CI, 0.89-0.92).

“By including a control group of individuals without CHD, we demonstrated that the magnitude of the sex difference in cardiac event rates and survival is considerably smaller among those with prior MI than among those without a history of CHD,” Dr. Peters said.

Of note, the sex differences were consistent across age and race/ethnicity groups for all events, except for heart failure hospitalizations, where the adjusted hazard ratio for women vs. men age 80 years or older was 0.95 for those without a history of CHD (95% CI, 0.91-0.98) and 0.99 (95% CI, 0.96-1.02) for participants with a previous MI.

Dr. Peters said it’s not clear why the female advantage is attenuated post-MI but that one explanation is that women are less likely than men to receive guideline-recommended treatments and dosages or to adhere to prescribed therapies after MI hospitalization, which could put them at a higher risk of subsequent events and worse outcomes than men.

“Sex differences in pathophysiology of CHD and its complications may also explain, to some extent, why the rates of recurrent events are considerably more similar between the sexes than incident event rates,” she said. Compared with men, women have a higher incidence of MI with nonobstructive coronary artery disease and of heart failure with preserved ejection fraction, and evidence-based treatment options are more limited for both conditions.

“After people read this, I think the important thing to recognize is we need to push– as much as we can, with what meds we have, and what data we have – secondary prevention in these women,” Laxmi Mehta, MD, director of preventive cardiology and women’s cardiovascular health at Ohio State University, Columbus, said in an interview.

The lack of a female advantage post-MI should also elicit a “really meaningful conversation with our patients on shared decision-making of why they need to be on medications, remembering on our part to prescribe the medications, remembering to prescribe cardiac rehab, and also reminding our community we do need more data and need to investigate this further,” she said.

In an accompanying editorial, Nanette Wenger, MD, of Emory University, Atlanta, also points out that nonobstructive coronary disease is more common in women and, “yet, guideline-based therapies are those validated for obstructive coronary disease in a predominantly male population but, nonetheless, are applied for nonobstructive coronary disease.”

She advocates for aggressive evaluation and treatment for women with chest pain symptoms as well as early identification of women at risk for CHD, specifically those with metabolic syndromepreeclampsia, hypertensive disorders of pregnancy, chronic inflammatory conditions, and high-risk race/ethnicity.

“Next, when coronary angiography is undertaken, particularly in younger women, an assiduous search for spontaneous coronary artery dissection and its appropriate management, as well as prompt and evidence-based interventions and medical therapies for an acute coronary event [are indicated],” Dr. Wenger wrote. “However, basic to improving outcomes for women is the elucidation of the optimal noninvasive techniques to identify microvascular disease, which could then enable delineation of appropriate preventive and therapeutic approaches.”

Dr. Peters is supported by a U.K. Medical Research Council Skills Development Fellowship. Dr. Mehta and Dr. Wenger disclosed no relevant financial relationships.

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

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Women are known to lag 5-10 years behind men in experiencing coronary heart disease (CHD), but new research suggests the gap narrows substantially following a myocardial infarction.

Dr. Nanette K. Wenger

“Women lose a considerable portion, but not all, of their coronary and survival advantage – i.e., the lower event rates – after suffering a MI,” study author Sanne Peters, PhD, George Institute for Global Health, Imperial College London, said in an interview.

Previous studies of sex differences in event rates after a coronary event have produced mixed results and were primarily focused on mortality following MI. Importantly, the studies also lacked a control group without a history of CHD and, thus, were unable to provide a reference point for the disparity in event rates, she explained.

Using the MarketScan and Medicare databases, however, Dr. Peters and colleagues matched 339,890 U.S. adults hospitalized for an MI between January 2015 and December 2016 with 1,359,560 U.S. adults without a history of CHD.

Over a median 1.3 years follow-up, there were 12,518 MIs in the non-CHD group and 27,115 recurrent MIs in the MI group.

The age-standardized rate of MI per 1,000 person-years was 4.0 in women and 6.1 in men without a history of CHD, compared with 57.6 in women and 62.7 in men with a prior MI.

After multivariate adjustment, the women-to-men hazard ratio for MI was 0.64 (95% confidence interval, 0.62-0.67) in the non-CHD group and 0.94 (95% CI, 0.92-0.96) in the prior MI group, the authors reported Oct. 5 in the Journal of the American College of Cardiology

Additional results show the multivariate adjusted women-to-men hazard ratios for three other cardiovascular outcomes follow a similar pattern in the non-CHD and prior MI groups:

  • CHD events: 0.53 (95% CI, 0.51-0.54) and 0.87 (95% CI, 0.85-0.89).
  • Heart failure hospitalization: 0.93 (95% CI, 0.90-0.96) and 1.02 (95% CI, 1.00-1.04).
  • All-cause mortality: 0.72 (95% CI, 0.71-0.73) and 0.90 (95% CI, 0.89-0.92).

“By including a control group of individuals without CHD, we demonstrated that the magnitude of the sex difference in cardiac event rates and survival is considerably smaller among those with prior MI than among those without a history of CHD,” Dr. Peters said.

Of note, the sex differences were consistent across age and race/ethnicity groups for all events, except for heart failure hospitalizations, where the adjusted hazard ratio for women vs. men age 80 years or older was 0.95 for those without a history of CHD (95% CI, 0.91-0.98) and 0.99 (95% CI, 0.96-1.02) for participants with a previous MI.

Dr. Peters said it’s not clear why the female advantage is attenuated post-MI but that one explanation is that women are less likely than men to receive guideline-recommended treatments and dosages or to adhere to prescribed therapies after MI hospitalization, which could put them at a higher risk of subsequent events and worse outcomes than men.

“Sex differences in pathophysiology of CHD and its complications may also explain, to some extent, why the rates of recurrent events are considerably more similar between the sexes than incident event rates,” she said. Compared with men, women have a higher incidence of MI with nonobstructive coronary artery disease and of heart failure with preserved ejection fraction, and evidence-based treatment options are more limited for both conditions.

“After people read this, I think the important thing to recognize is we need to push– as much as we can, with what meds we have, and what data we have – secondary prevention in these women,” Laxmi Mehta, MD, director of preventive cardiology and women’s cardiovascular health at Ohio State University, Columbus, said in an interview.

The lack of a female advantage post-MI should also elicit a “really meaningful conversation with our patients on shared decision-making of why they need to be on medications, remembering on our part to prescribe the medications, remembering to prescribe cardiac rehab, and also reminding our community we do need more data and need to investigate this further,” she said.

In an accompanying editorial, Nanette Wenger, MD, of Emory University, Atlanta, also points out that nonobstructive coronary disease is more common in women and, “yet, guideline-based therapies are those validated for obstructive coronary disease in a predominantly male population but, nonetheless, are applied for nonobstructive coronary disease.”

She advocates for aggressive evaluation and treatment for women with chest pain symptoms as well as early identification of women at risk for CHD, specifically those with metabolic syndromepreeclampsia, hypertensive disorders of pregnancy, chronic inflammatory conditions, and high-risk race/ethnicity.

“Next, when coronary angiography is undertaken, particularly in younger women, an assiduous search for spontaneous coronary artery dissection and its appropriate management, as well as prompt and evidence-based interventions and medical therapies for an acute coronary event [are indicated],” Dr. Wenger wrote. “However, basic to improving outcomes for women is the elucidation of the optimal noninvasive techniques to identify microvascular disease, which could then enable delineation of appropriate preventive and therapeutic approaches.”

Dr. Peters is supported by a U.K. Medical Research Council Skills Development Fellowship. Dr. Mehta and Dr. Wenger disclosed no relevant financial relationships.

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

Women are known to lag 5-10 years behind men in experiencing coronary heart disease (CHD), but new research suggests the gap narrows substantially following a myocardial infarction.

Dr. Nanette K. Wenger

“Women lose a considerable portion, but not all, of their coronary and survival advantage – i.e., the lower event rates – after suffering a MI,” study author Sanne Peters, PhD, George Institute for Global Health, Imperial College London, said in an interview.

Previous studies of sex differences in event rates after a coronary event have produced mixed results and were primarily focused on mortality following MI. Importantly, the studies also lacked a control group without a history of CHD and, thus, were unable to provide a reference point for the disparity in event rates, she explained.

Using the MarketScan and Medicare databases, however, Dr. Peters and colleagues matched 339,890 U.S. adults hospitalized for an MI between January 2015 and December 2016 with 1,359,560 U.S. adults without a history of CHD.

Over a median 1.3 years follow-up, there were 12,518 MIs in the non-CHD group and 27,115 recurrent MIs in the MI group.

The age-standardized rate of MI per 1,000 person-years was 4.0 in women and 6.1 in men without a history of CHD, compared with 57.6 in women and 62.7 in men with a prior MI.

After multivariate adjustment, the women-to-men hazard ratio for MI was 0.64 (95% confidence interval, 0.62-0.67) in the non-CHD group and 0.94 (95% CI, 0.92-0.96) in the prior MI group, the authors reported Oct. 5 in the Journal of the American College of Cardiology

Additional results show the multivariate adjusted women-to-men hazard ratios for three other cardiovascular outcomes follow a similar pattern in the non-CHD and prior MI groups:

  • CHD events: 0.53 (95% CI, 0.51-0.54) and 0.87 (95% CI, 0.85-0.89).
  • Heart failure hospitalization: 0.93 (95% CI, 0.90-0.96) and 1.02 (95% CI, 1.00-1.04).
  • All-cause mortality: 0.72 (95% CI, 0.71-0.73) and 0.90 (95% CI, 0.89-0.92).

“By including a control group of individuals without CHD, we demonstrated that the magnitude of the sex difference in cardiac event rates and survival is considerably smaller among those with prior MI than among those without a history of CHD,” Dr. Peters said.

Of note, the sex differences were consistent across age and race/ethnicity groups for all events, except for heart failure hospitalizations, where the adjusted hazard ratio for women vs. men age 80 years or older was 0.95 for those without a history of CHD (95% CI, 0.91-0.98) and 0.99 (95% CI, 0.96-1.02) for participants with a previous MI.

Dr. Peters said it’s not clear why the female advantage is attenuated post-MI but that one explanation is that women are less likely than men to receive guideline-recommended treatments and dosages or to adhere to prescribed therapies after MI hospitalization, which could put them at a higher risk of subsequent events and worse outcomes than men.

“Sex differences in pathophysiology of CHD and its complications may also explain, to some extent, why the rates of recurrent events are considerably more similar between the sexes than incident event rates,” she said. Compared with men, women have a higher incidence of MI with nonobstructive coronary artery disease and of heart failure with preserved ejection fraction, and evidence-based treatment options are more limited for both conditions.

“After people read this, I think the important thing to recognize is we need to push– as much as we can, with what meds we have, and what data we have – secondary prevention in these women,” Laxmi Mehta, MD, director of preventive cardiology and women’s cardiovascular health at Ohio State University, Columbus, said in an interview.

The lack of a female advantage post-MI should also elicit a “really meaningful conversation with our patients on shared decision-making of why they need to be on medications, remembering on our part to prescribe the medications, remembering to prescribe cardiac rehab, and also reminding our community we do need more data and need to investigate this further,” she said.

In an accompanying editorial, Nanette Wenger, MD, of Emory University, Atlanta, also points out that nonobstructive coronary disease is more common in women and, “yet, guideline-based therapies are those validated for obstructive coronary disease in a predominantly male population but, nonetheless, are applied for nonobstructive coronary disease.”

She advocates for aggressive evaluation and treatment for women with chest pain symptoms as well as early identification of women at risk for CHD, specifically those with metabolic syndromepreeclampsia, hypertensive disorders of pregnancy, chronic inflammatory conditions, and high-risk race/ethnicity.

“Next, when coronary angiography is undertaken, particularly in younger women, an assiduous search for spontaneous coronary artery dissection and its appropriate management, as well as prompt and evidence-based interventions and medical therapies for an acute coronary event [are indicated],” Dr. Wenger wrote. “However, basic to improving outcomes for women is the elucidation of the optimal noninvasive techniques to identify microvascular disease, which could then enable delineation of appropriate preventive and therapeutic approaches.”

Dr. Peters is supported by a U.K. Medical Research Council Skills Development Fellowship. Dr. Mehta and Dr. Wenger disclosed no relevant financial relationships.

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

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Access to care: A nurse practitioner’s plea

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Tue, 02/14/2023 - 13:00

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Candice Baxendale

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

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Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Candice Baxendale

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

Having been a reader of Pediatric News for years, I want to bring to light access-to-care issues involving COVID-19 medical facility restrictions for pediatric patients and their parents.

On March 27, 2020, I received a phone call from the Department of Human Services pleading with me to take a medically fragile child who was entering the foster care system that day. He had very specific needs, and they had no one available who could medically meet those needs. The week prior was my kids’ scheduled spring break; the week I got the call was the week that I was voluntarily furloughed from my job as a pediatric nurse practitioner so that I could stay home with my kids as their school would not be reopening for the year, and someone had to be with them. I was already home with my 3-year-old and 6-year-old, so why not add another?

Leo (name changed for privacy) came to me with a multitude of diagnoses, to say the least. Not only did he require physical, speech, and occupational therapy twice weekly, but he often had appointments with 10 different specialists at the local children’s hospital. The first few weeks he was in my care, we had almost daily visits to either therapists or specialists. Keeping up with these types of appointments in a normal world is difficult ... I was getting the crash course on how to navigate all of it in the COVID-19 world.

So now, I am the primary caregiver during the day for my two children and our medically fragile foster child who has multiple medical appointments a week. Our local children’s hospital allowed only the caregiver to accompany him to his visits. In theory this sounds great, right? Fewer people in a facility equals less exposure, less risk, and fewer COVID-19 infections.

But what about the negative consequences of these hospital policies? I have two other children I was caring for. I couldn’t take them to their grandparents’ house because people over age 65 years are at risk of having COVID-19 complications. I had been furloughed, so our income was half what it typically was. Regardless, I had to hire a babysitter each time I took our foster child to the hospital for his appointments because they would not allow my children to accompany me.

Candice Baxendale

Now imagine if I were a single mom who had three kids and a lesser paying job. Schools are closed and she’s forced to work from home and homeschool her children. Or worse, she’s been laid off and living on unemployment. Do you think she is going to have the time or finances available to hire a babysitter so that she can take her medically fragile child in for his cardiology follow-up? Because not only does she have to pay the copays and whatever insurance doesn’t cover, but now she has to fork over $50 for child care. If you don’t know the answer already, it’s no, she does not have the time or the finances. So her child misses a cardiology appointment, which means that his meds weren’t increased according to his growth, which means his pulmonary hypertension is not controlled, which worsens his heart failure ... you get my drift.

Fast forward to Sept. 22, 2020. I had a cardiology appointment at our local heart hospital for myself. It’s 2020, people, I’ve been having some palpitations that I needed checked out and was going in to have a heart monitor patch placed. I had my 4-year-old son with me because he is on a hybrid schedule where we homeschool 2 days a week. We entered the building wearing masks, and I was immediately stopped by security and informed that, according to the COVID-19 policy for their hospital, children under 16 are not allowed to enter the building. After some discussion, I was ultimately refused care because my son was with me that day. Refused care because I had a masked 4-year-old with a normal temperature at my side.

These policies are not working. We are in health care. It should not matter what pandemic is on the table, we should not be refusing patients access to care based on who is by their side that day. We knew the risks when we entered our profession, and we know the proper measures to protect ourselves. Our patients also know the risks and can protect themselves accordingly.

So this is my plea to all medical facilities out there: Stop. Stop telling people their loved ones can’t accompany them to appointments. Stop telling caregivers to wait in their cars while their elderly, demented mothers have their annual physicals. Stop telling moms they need to leave their other children at home. This is now a huge access-to-care issue nationwide and it needs to stop. Excess deaths in our nation are soaring, and it’s not just because people don’t want to seek medical attention; it’s because medical facilities are making it almost impossible to seek help for many. People are dying, and it’s not only from COVID-19. This is on us as health care providers, and we need to step up to the plate and do what is right.
 

Ms. Baxendale is a nurse practitioner in Mustang, Okla. Email her at [email protected].

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Medscape Article

T2D treatments create tension between glycemic and cardiovascular goals

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Tue, 05/03/2022 - 15:08

It was no surprise that updated guidelines recently published by the European Society of Cardiology for managing cardiovascular disease in patients with diabetes highlighted optimized treatment from a cardiovascular disease perspective, while a nearly concurrent update from two major diabetes societies saw the same issue from a more glycemic point of view.

This difference led to divergent approaches to managing hyperglycemia in patients with type 2 diabetes (T2D). The two diabetes societies that wrote one set of recommendations, the American Diabetes Association and the European Association for the Study of Diabetes, put metformin at the pinnacle of their drug hierarchy. Patients with T2D and established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure should all receive metformin first unless contraindicated or not tolerated, their updated consensus report said.

Once metformin is on board, a clinician can then add a second diabetes agent from among the two drug classes recently proven to also reduce cardiovascular and renal events, either the SGLT2 (sodium-glucose transporter 2) inhibitors, or GLP-1 (glucagonlike peptide–1) receptor agonists, they advised.
 

Cardiovascular disease focus represents a ‘major paradigm shift’

In contrast, the ESC guidelines called for upfront, systematic assessment of CVD risk in patients with T2D before treatment starts, and for patients in high- or very high–risk strata, the guidelines recommended starting the patient first on an SGLT2 inhibitor or a GLP-1 receptor agonist, and only adding metformin in patients who need additional glycemic control.

The guidelines also recommended starting treatment-naive patients with moderate CVD risk on metformin. For patients already on metformin, the new ESC guidelines called for adding an agent from at least one of these two drug classes with proven CVD benefits for those at high or very high CVD risk. The guidelines also note that the CVD benefits of the two newer drug classes differ and hence require further individualization depending on the risks faced by each patient, such as the risk for heart failure hospitalizations.



It’s an approach “driven by data from the cardiovascular outcome trials,” that showed several drugs from both the SGLT2 inhibitor and GLP-1 receptor agonist classes have substantial benefit for preventing cardiovascular events, renal events, hospitalizations for heart failure, and in some studies all-cause mortality, said Francesco Cosentino, MD, during a discussion of the guideline differences at the virtual annual meeting of the European Association for the Study of Diabetes.

The ESC approach also represents “a major paradigm shift,” a “change from a glucose-centric approach to an approach driven by cardiovascular disease events,” summed up Dr. Cosentino, professor of cardiology at the Karolinska Institute in Stockholm and chair of the task force that wrote the ESC’s 2019 updated guidelines. The ESC approach advocates initiating drugs for treating patients with T2D “based on cardiovascular disease risk classification,” he highlighted. Results from some SGLT2 inhibitor cardiovascular outcome trials showed that the CVD benefit was similar regardless of whether or not patients also received metformin.

ADA, EASD call for ‘a different emphasis’

“There is a different emphasis” in the statement issued by the diabetologists of the ADA and EASD, admitted Peter J. Grant, MD, a professor of diabetes and endocrinology at the University of Leeds (England) and cochair of the ESC guidelines task force. Dr. Grant represented the EASD on the task force, and the Association collaborated with the ESC in producing its guidelines.

Dr. Peter J. Grant

“The ADA and EASD recommendations “look primarily at glucose control, with cardiovascular disease management as secondary.” In contrast, the ESC guidelines “are primarily cardiovascular disease risk guidelines, with a glucose interest,” Dr. Grant declared.

Despite his involvement in writing the ESC guidelines, Dr. Grant tilted toward the ADA/EASD statement as more globally relevant.

“There is much more to vasculopathy in diabetes than just macrovascular disease. Many patients with type 2 diabetes without macrovascular complications have microvascular disease,” including the potential for retinopathy, nephropathy, and neuropathy, he said. These complications can also have a strong impact on psychological well being and treatment satisfaction.

“It’s important that we’re not glucocentric any more, but it’s equally important that we treat glucose because it has such a benefit for microvascular disease.” Dr. Grant also cited metformin’s long history of safety and good tolerance, clinician comfort prescribing it, and its low price. Heavier reliance on SGLT2 inhibitors and GLP-1 receptor agonists will be expensive for the short term while the cost of these drugs remains high, which places a higher burden on “knowing we’re doing it right,” said Dr. Grant.

Dr. Cosentino pointed out that the higher cost of the drugs in the two classes shown to exert important cardiovascular and renal effects needs to be considered in a cost-effectiveness context, not just by cost alone.
 

‘Clinical inertia’ could be a danger

Dr. Cosentino played down a major disagreement between the two guidelines, suggesting that “focusing on the differences leads to clinical inertia” by the practicing community when they are unsure how to reconcile the two positions.

Dr. Grant agreed that adding a second drug to metformin right away made sense in at least selected patients. “Look at each patient and decide whether they need glycemic control. If so, and if they also have cardiovascular disease, use both drugs,” metformin, plus one agent from one of the two newer classes.

Something both experts agreed on is that it’s time to generally steer clear of sulfonylurea drugs. “We have evidence for harmful effects from sulfonylureas,” Dr. Cosentino said.

“I’d dump sulfonylureas,” was Dr. Grant’s assessment, but he added that they still have a role for patients who need additional glycemic control but can’t afford the newer drugs.

Dr. Cosentino has had financial relationships with Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Mundipharma, Novo Nordisk, and Pfizer, Dr. Grant has lectured on behalf of AstraZeneca, GlaxoSmithKline, Merck, Novo Nordisk, the Medicines Company, and Takeda, and he has been an adviser to Amgen, AstraZeneca, Novartis, Novo Nordisk, and Synexus.

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It was no surprise that updated guidelines recently published by the European Society of Cardiology for managing cardiovascular disease in patients with diabetes highlighted optimized treatment from a cardiovascular disease perspective, while a nearly concurrent update from two major diabetes societies saw the same issue from a more glycemic point of view.

This difference led to divergent approaches to managing hyperglycemia in patients with type 2 diabetes (T2D). The two diabetes societies that wrote one set of recommendations, the American Diabetes Association and the European Association for the Study of Diabetes, put metformin at the pinnacle of their drug hierarchy. Patients with T2D and established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure should all receive metformin first unless contraindicated or not tolerated, their updated consensus report said.

Once metformin is on board, a clinician can then add a second diabetes agent from among the two drug classes recently proven to also reduce cardiovascular and renal events, either the SGLT2 (sodium-glucose transporter 2) inhibitors, or GLP-1 (glucagonlike peptide–1) receptor agonists, they advised.
 

Cardiovascular disease focus represents a ‘major paradigm shift’

In contrast, the ESC guidelines called for upfront, systematic assessment of CVD risk in patients with T2D before treatment starts, and for patients in high- or very high–risk strata, the guidelines recommended starting the patient first on an SGLT2 inhibitor or a GLP-1 receptor agonist, and only adding metformin in patients who need additional glycemic control.

The guidelines also recommended starting treatment-naive patients with moderate CVD risk on metformin. For patients already on metformin, the new ESC guidelines called for adding an agent from at least one of these two drug classes with proven CVD benefits for those at high or very high CVD risk. The guidelines also note that the CVD benefits of the two newer drug classes differ and hence require further individualization depending on the risks faced by each patient, such as the risk for heart failure hospitalizations.



It’s an approach “driven by data from the cardiovascular outcome trials,” that showed several drugs from both the SGLT2 inhibitor and GLP-1 receptor agonist classes have substantial benefit for preventing cardiovascular events, renal events, hospitalizations for heart failure, and in some studies all-cause mortality, said Francesco Cosentino, MD, during a discussion of the guideline differences at the virtual annual meeting of the European Association for the Study of Diabetes.

The ESC approach also represents “a major paradigm shift,” a “change from a glucose-centric approach to an approach driven by cardiovascular disease events,” summed up Dr. Cosentino, professor of cardiology at the Karolinska Institute in Stockholm and chair of the task force that wrote the ESC’s 2019 updated guidelines. The ESC approach advocates initiating drugs for treating patients with T2D “based on cardiovascular disease risk classification,” he highlighted. Results from some SGLT2 inhibitor cardiovascular outcome trials showed that the CVD benefit was similar regardless of whether or not patients also received metformin.

ADA, EASD call for ‘a different emphasis’

“There is a different emphasis” in the statement issued by the diabetologists of the ADA and EASD, admitted Peter J. Grant, MD, a professor of diabetes and endocrinology at the University of Leeds (England) and cochair of the ESC guidelines task force. Dr. Grant represented the EASD on the task force, and the Association collaborated with the ESC in producing its guidelines.

Dr. Peter J. Grant

“The ADA and EASD recommendations “look primarily at glucose control, with cardiovascular disease management as secondary.” In contrast, the ESC guidelines “are primarily cardiovascular disease risk guidelines, with a glucose interest,” Dr. Grant declared.

Despite his involvement in writing the ESC guidelines, Dr. Grant tilted toward the ADA/EASD statement as more globally relevant.

“There is much more to vasculopathy in diabetes than just macrovascular disease. Many patients with type 2 diabetes without macrovascular complications have microvascular disease,” including the potential for retinopathy, nephropathy, and neuropathy, he said. These complications can also have a strong impact on psychological well being and treatment satisfaction.

“It’s important that we’re not glucocentric any more, but it’s equally important that we treat glucose because it has such a benefit for microvascular disease.” Dr. Grant also cited metformin’s long history of safety and good tolerance, clinician comfort prescribing it, and its low price. Heavier reliance on SGLT2 inhibitors and GLP-1 receptor agonists will be expensive for the short term while the cost of these drugs remains high, which places a higher burden on “knowing we’re doing it right,” said Dr. Grant.

Dr. Cosentino pointed out that the higher cost of the drugs in the two classes shown to exert important cardiovascular and renal effects needs to be considered in a cost-effectiveness context, not just by cost alone.
 

‘Clinical inertia’ could be a danger

Dr. Cosentino played down a major disagreement between the two guidelines, suggesting that “focusing on the differences leads to clinical inertia” by the practicing community when they are unsure how to reconcile the two positions.

Dr. Grant agreed that adding a second drug to metformin right away made sense in at least selected patients. “Look at each patient and decide whether they need glycemic control. If so, and if they also have cardiovascular disease, use both drugs,” metformin, plus one agent from one of the two newer classes.

Something both experts agreed on is that it’s time to generally steer clear of sulfonylurea drugs. “We have evidence for harmful effects from sulfonylureas,” Dr. Cosentino said.

“I’d dump sulfonylureas,” was Dr. Grant’s assessment, but he added that they still have a role for patients who need additional glycemic control but can’t afford the newer drugs.

Dr. Cosentino has had financial relationships with Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Mundipharma, Novo Nordisk, and Pfizer, Dr. Grant has lectured on behalf of AstraZeneca, GlaxoSmithKline, Merck, Novo Nordisk, the Medicines Company, and Takeda, and he has been an adviser to Amgen, AstraZeneca, Novartis, Novo Nordisk, and Synexus.

It was no surprise that updated guidelines recently published by the European Society of Cardiology for managing cardiovascular disease in patients with diabetes highlighted optimized treatment from a cardiovascular disease perspective, while a nearly concurrent update from two major diabetes societies saw the same issue from a more glycemic point of view.

This difference led to divergent approaches to managing hyperglycemia in patients with type 2 diabetes (T2D). The two diabetes societies that wrote one set of recommendations, the American Diabetes Association and the European Association for the Study of Diabetes, put metformin at the pinnacle of their drug hierarchy. Patients with T2D and established atherosclerotic cardiovascular disease (CVD), chronic kidney disease, or heart failure should all receive metformin first unless contraindicated or not tolerated, their updated consensus report said.

Once metformin is on board, a clinician can then add a second diabetes agent from among the two drug classes recently proven to also reduce cardiovascular and renal events, either the SGLT2 (sodium-glucose transporter 2) inhibitors, or GLP-1 (glucagonlike peptide–1) receptor agonists, they advised.
 

Cardiovascular disease focus represents a ‘major paradigm shift’

In contrast, the ESC guidelines called for upfront, systematic assessment of CVD risk in patients with T2D before treatment starts, and for patients in high- or very high–risk strata, the guidelines recommended starting the patient first on an SGLT2 inhibitor or a GLP-1 receptor agonist, and only adding metformin in patients who need additional glycemic control.

The guidelines also recommended starting treatment-naive patients with moderate CVD risk on metformin. For patients already on metformin, the new ESC guidelines called for adding an agent from at least one of these two drug classes with proven CVD benefits for those at high or very high CVD risk. The guidelines also note that the CVD benefits of the two newer drug classes differ and hence require further individualization depending on the risks faced by each patient, such as the risk for heart failure hospitalizations.



It’s an approach “driven by data from the cardiovascular outcome trials,” that showed several drugs from both the SGLT2 inhibitor and GLP-1 receptor agonist classes have substantial benefit for preventing cardiovascular events, renal events, hospitalizations for heart failure, and in some studies all-cause mortality, said Francesco Cosentino, MD, during a discussion of the guideline differences at the virtual annual meeting of the European Association for the Study of Diabetes.

The ESC approach also represents “a major paradigm shift,” a “change from a glucose-centric approach to an approach driven by cardiovascular disease events,” summed up Dr. Cosentino, professor of cardiology at the Karolinska Institute in Stockholm and chair of the task force that wrote the ESC’s 2019 updated guidelines. The ESC approach advocates initiating drugs for treating patients with T2D “based on cardiovascular disease risk classification,” he highlighted. Results from some SGLT2 inhibitor cardiovascular outcome trials showed that the CVD benefit was similar regardless of whether or not patients also received metformin.

ADA, EASD call for ‘a different emphasis’

“There is a different emphasis” in the statement issued by the diabetologists of the ADA and EASD, admitted Peter J. Grant, MD, a professor of diabetes and endocrinology at the University of Leeds (England) and cochair of the ESC guidelines task force. Dr. Grant represented the EASD on the task force, and the Association collaborated with the ESC in producing its guidelines.

Dr. Peter J. Grant

“The ADA and EASD recommendations “look primarily at glucose control, with cardiovascular disease management as secondary.” In contrast, the ESC guidelines “are primarily cardiovascular disease risk guidelines, with a glucose interest,” Dr. Grant declared.

Despite his involvement in writing the ESC guidelines, Dr. Grant tilted toward the ADA/EASD statement as more globally relevant.

“There is much more to vasculopathy in diabetes than just macrovascular disease. Many patients with type 2 diabetes without macrovascular complications have microvascular disease,” including the potential for retinopathy, nephropathy, and neuropathy, he said. These complications can also have a strong impact on psychological well being and treatment satisfaction.

“It’s important that we’re not glucocentric any more, but it’s equally important that we treat glucose because it has such a benefit for microvascular disease.” Dr. Grant also cited metformin’s long history of safety and good tolerance, clinician comfort prescribing it, and its low price. Heavier reliance on SGLT2 inhibitors and GLP-1 receptor agonists will be expensive for the short term while the cost of these drugs remains high, which places a higher burden on “knowing we’re doing it right,” said Dr. Grant.

Dr. Cosentino pointed out that the higher cost of the drugs in the two classes shown to exert important cardiovascular and renal effects needs to be considered in a cost-effectiveness context, not just by cost alone.
 

‘Clinical inertia’ could be a danger

Dr. Cosentino played down a major disagreement between the two guidelines, suggesting that “focusing on the differences leads to clinical inertia” by the practicing community when they are unsure how to reconcile the two positions.

Dr. Grant agreed that adding a second drug to metformin right away made sense in at least selected patients. “Look at each patient and decide whether they need glycemic control. If so, and if they also have cardiovascular disease, use both drugs,” metformin, plus one agent from one of the two newer classes.

Something both experts agreed on is that it’s time to generally steer clear of sulfonylurea drugs. “We have evidence for harmful effects from sulfonylureas,” Dr. Cosentino said.

“I’d dump sulfonylureas,” was Dr. Grant’s assessment, but he added that they still have a role for patients who need additional glycemic control but can’t afford the newer drugs.

Dr. Cosentino has had financial relationships with Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Mundipharma, Novo Nordisk, and Pfizer, Dr. Grant has lectured on behalf of AstraZeneca, GlaxoSmithKline, Merck, Novo Nordisk, the Medicines Company, and Takeda, and he has been an adviser to Amgen, AstraZeneca, Novartis, Novo Nordisk, and Synexus.

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AHA issues new scientific statement on heart health for LGBTQ adults

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Tue, 10/13/2020 - 11:55

 

Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.

“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.

“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.

The statement was published online Oct. 8 in Circulation.
 

‘Invisible’ population

There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.

There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.

While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:

  • LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
  • Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
  • Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
  • Transgender women and nonbinary persons are more likely to binge drink.
  • Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.

“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.

He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.

“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
 

Discrimination in health care

Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.

The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.

“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.

“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.

The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”

Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.

But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.

The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

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Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.

“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.

“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.

The statement was published online Oct. 8 in Circulation.
 

‘Invisible’ population

There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.

There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.

While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:

  • LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
  • Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
  • Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
  • Transgender women and nonbinary persons are more likely to binge drink.
  • Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.

“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.

He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.

“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
 

Discrimination in health care

Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.

The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.

“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.

“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.

The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”

Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.

But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.

The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

 

Cardiovascular health should be routinely assessed and addressed in LGBTQ adults, the American Heart Association concluded in a new scientific statement.

“Among the most important takeaways from this scientific statement is the need for health care providers in clinical settings to routinely assess sexual orientation and gender identity,” Billy A. Caceres, PhD, RN, chair of the statement writing group, said in an interview.

“This will help health care providers engage LGBTQ patients in discussions about their heart health that account for the unique experiences of this population,” said Dr. Caceres, assistant professor at Columbia University, New York.

The statement was published online Oct. 8 in Circulation.
 

‘Invisible’ population

There are roughly 11 million LGBTQ adults in the United States, yet they are often “invisible in health care settings and cardiovascular research,” Dr. Caceres noted. The AHA scientific statement is the first from a national organization in the United States to comprehensively summarize the evidence on cardiovascular (CV) research in LGBTQ adults.

There is mounting evidence that LGBTQ adults experience worse CV health relative to their cisgender heterosexual peers. Disparities in CV health may be driven by unique psychosocial stressors in the LGBTQ individuals such as family rejection and anxiety of concealment of their sexual orientation or gender identity.

While there is limited information on the CV health of LGBTQ people, the writing group said providers should be aware of the following:

  • LGBTQ adults are more likely to use tobacco than their cisgender heterosexual peers.
  • Transgender adults may be less physically active than their cisgender counterparts. Gender-affirming care might play a role in promoting physical activity among transgender people.
  • Transgender women may be at increased risk for heart disease because of behavioral and clinical factors (such as the use of gender-affirming hormones like estrogen).
  • Transgender women and nonbinary persons are more likely to binge drink.
  • Lesbian and bisexual women have a higher prevalence of obesity than heterosexual women do.

“We need to better understand how to support LGBTQ adults in optimizing their CV health. To do this, we will need rigorous research that examines potential explanations for the CV health disparities that have been observed in LGBTQ adults,” Dr. Caceres said.

He noted that research is also needed within the LGBTQ population among groups that might be at greater risk for heart disease, including racial- and ethnic-minority and low-income LGBTQ adults.

“Researchers should also design and test evidence-based interventions to promote the heart health of LGBTQ adults. This is an area that is greatly lacking within CV health research,” said Dr. Caceres.
 

Discrimination in health care

Discrimination against LGBTQ adults in health care settings also remains a problem, the authors noted.

The writing group cites data showing that nearly 56% of sexual-minority and 70% of gender-minority adults report having experienced some form of discrimination from clinicians, including the use of harsh/abusive language.

“Perhaps most alarming,” roughly 8% of sexual-minority and 25% of transgender individuals have been denied health care by clinicians, they noted.

“LGBTQ individuals are delaying primary care and preventative visits because there is a great fear of being treated differently. Being treated differently often means receiving inadequate or inferior care because of sexual orientation or gender identity,” Dr. Caceres said in a news release.

The writing group calls for greater emphasis on LGBTQ health issues in the education of all health care providers. Dr. Caceres said it’s “paramount to include content about LGBTQ health in clinical training and licensure requirements in order to address these cardiovascular health disparities.”

Traditionally, there has been very little LGBTQ-related content in health care professional education training. A 2018 online survey of students at 10 medical schools found that approximately 80% of students did not feel competent to provide care for transgender patients.

But that may soon change. In September 2020, the Accreditation Review Commission on Education for the Physician Assistant began requiring LGBTQ curricular content, the writing group notes.

The AHA scientific statement on LGBTQ was developed by the writing group on behalf of the AHA Council on Cardiovascular and Stroke Nursing, the Council on Hypertension, the Council on Lifestyle and Cardiometabolic Health, the Council on Peripheral Vascular Disease, and the Stroke Council.

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

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Benefit of rivaroxaban after limb revascularization greatest in those with comorbid CAD

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Tue, 10/13/2020 - 11:55

The absolute benefit of adding low-dose rivaroxaban to low-dose aspirin following revascularization for symptomatic lower-extremity peripheral artery disease (PAD) is significantly greater in patients with comorbid coronary artery disease (CAD), according to a new secondary analysis of the VOYAGER PAD trial.

Dr. William R. Hiatt

“These findings suggest heterogeneity of prognostic risk for ischemic events in lower-extremity PAD patients, and may support shared decision-making with these patients,” William R. Hiatt, MD, observed in presenting the study results at the virtual annual congress of the European Society of Cardiology.

VOYAGER PAD was a 3-year, 34-country clinical trial in which 6,564 patients with symptomatic PAD who had recently undergone lower-limb revascularization were randomized in double-blind fashion to rivaroxaban (Xarelto) at 2.5 mg twice daily or placebo on top of background standard therapy with low-dose aspirin.

Among the 2,067 participants with baseline comorbid CAD, the primary outcome – a composite comprised of cardiovascular death, acute MI, ischemic stroke, acute limb ischemia, and major amputation – occurred in 18.9% of the rivaroxaban group at 3 years and 24.3% on placebo, for a highly significant 22% relative risk reduction.

In contrast, in the 4,497 patients with PAD only, the primary outcome occurred in 16.1% of those on rivaroxaban and 17.9% of controls, an 11% relative risk reduction which failed to reach statistical significance. The absolute risk reduction achieved with rivaroxaban was 5.4% in patients with PAD plus CAD versus 1.8% in those with PAD alone. Thus, the significant clinical benefit with rivaroxaban plus aspirin previously reported in the overall study population, with a number needed to treat for 3 years of 39 in order to prevent one primary outcome event, was largely driven by the superior outcomes in the dual-diagnosis subgroup, reported Dr. Hiatt, professor of medicine at the University of Colorado at Denver, Aurora.

“A strategy of rivaroxaban at 2.5 mg twice daily plus low-dose aspirin versus low-dose aspirin alone reduces ischemic events of the limb, brain, and heart, but also increases bleeding, with an overall net benefit,” the cardiologist said. “In particular, the benefits of this strategy for MI and ischemic stroke are robust, especially in patients with PAD and CAD.”

Indeed, the MI rate at 3 years in the dual diagnosis subgroup was 7.3% with rivaroxaban and 8.8% with placebo, for a 23% relative risk reduction, compared with rates of 3.3% and 3.7%, respectively, in patients with PAD only. Similarly, ischemic stroke occurred in 2.9% of patients with PAD and CAD in the rivaroxaban group, compared with 3.9% with placebo, whereas the rate in the PAD only group was identical at 2.6% regardless of whether patients were on rivaroxaban or placebo.

In patients without CAD, the clinical benefit of rivaroxaban was driven by reductions in severe limb events. Their rate of acute limb ischemia was 5.2% with rivaroxaban, compared with 8.3% with placebo, for a 37% relative risk reduction. In contrast, the reduction in acute limb ischemia with rivaroxaban in patients with PAD and CAD wasn’t significantly different from placebo.

Thrombolysis in Myocardial Infarction major bleeding occurred in 2.4% of patients with PAD and CAD on rivaroxaban, compared with 1.1% on placebo, and in 1.7% and 1.5% of patients with PAD alone. Of note, rates of ischemic stroke or fatal hemorrhage were low and similar at less than 1% in all four groups, Dr. Hiatt noted.

VOYAGER PAD was sponsored by Bayer and Janssen. Dr. Hiatt reported receiving research grant support from those two companies as well as Amgen.

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The absolute benefit of adding low-dose rivaroxaban to low-dose aspirin following revascularization for symptomatic lower-extremity peripheral artery disease (PAD) is significantly greater in patients with comorbid coronary artery disease (CAD), according to a new secondary analysis of the VOYAGER PAD trial.

Dr. William R. Hiatt

“These findings suggest heterogeneity of prognostic risk for ischemic events in lower-extremity PAD patients, and may support shared decision-making with these patients,” William R. Hiatt, MD, observed in presenting the study results at the virtual annual congress of the European Society of Cardiology.

VOYAGER PAD was a 3-year, 34-country clinical trial in which 6,564 patients with symptomatic PAD who had recently undergone lower-limb revascularization were randomized in double-blind fashion to rivaroxaban (Xarelto) at 2.5 mg twice daily or placebo on top of background standard therapy with low-dose aspirin.

Among the 2,067 participants with baseline comorbid CAD, the primary outcome – a composite comprised of cardiovascular death, acute MI, ischemic stroke, acute limb ischemia, and major amputation – occurred in 18.9% of the rivaroxaban group at 3 years and 24.3% on placebo, for a highly significant 22% relative risk reduction.

In contrast, in the 4,497 patients with PAD only, the primary outcome occurred in 16.1% of those on rivaroxaban and 17.9% of controls, an 11% relative risk reduction which failed to reach statistical significance. The absolute risk reduction achieved with rivaroxaban was 5.4% in patients with PAD plus CAD versus 1.8% in those with PAD alone. Thus, the significant clinical benefit with rivaroxaban plus aspirin previously reported in the overall study population, with a number needed to treat for 3 years of 39 in order to prevent one primary outcome event, was largely driven by the superior outcomes in the dual-diagnosis subgroup, reported Dr. Hiatt, professor of medicine at the University of Colorado at Denver, Aurora.

“A strategy of rivaroxaban at 2.5 mg twice daily plus low-dose aspirin versus low-dose aspirin alone reduces ischemic events of the limb, brain, and heart, but also increases bleeding, with an overall net benefit,” the cardiologist said. “In particular, the benefits of this strategy for MI and ischemic stroke are robust, especially in patients with PAD and CAD.”

Indeed, the MI rate at 3 years in the dual diagnosis subgroup was 7.3% with rivaroxaban and 8.8% with placebo, for a 23% relative risk reduction, compared with rates of 3.3% and 3.7%, respectively, in patients with PAD only. Similarly, ischemic stroke occurred in 2.9% of patients with PAD and CAD in the rivaroxaban group, compared with 3.9% with placebo, whereas the rate in the PAD only group was identical at 2.6% regardless of whether patients were on rivaroxaban or placebo.

In patients without CAD, the clinical benefit of rivaroxaban was driven by reductions in severe limb events. Their rate of acute limb ischemia was 5.2% with rivaroxaban, compared with 8.3% with placebo, for a 37% relative risk reduction. In contrast, the reduction in acute limb ischemia with rivaroxaban in patients with PAD and CAD wasn’t significantly different from placebo.

Thrombolysis in Myocardial Infarction major bleeding occurred in 2.4% of patients with PAD and CAD on rivaroxaban, compared with 1.1% on placebo, and in 1.7% and 1.5% of patients with PAD alone. Of note, rates of ischemic stroke or fatal hemorrhage were low and similar at less than 1% in all four groups, Dr. Hiatt noted.

VOYAGER PAD was sponsored by Bayer and Janssen. Dr. Hiatt reported receiving research grant support from those two companies as well as Amgen.

The absolute benefit of adding low-dose rivaroxaban to low-dose aspirin following revascularization for symptomatic lower-extremity peripheral artery disease (PAD) is significantly greater in patients with comorbid coronary artery disease (CAD), according to a new secondary analysis of the VOYAGER PAD trial.

Dr. William R. Hiatt

“These findings suggest heterogeneity of prognostic risk for ischemic events in lower-extremity PAD patients, and may support shared decision-making with these patients,” William R. Hiatt, MD, observed in presenting the study results at the virtual annual congress of the European Society of Cardiology.

VOYAGER PAD was a 3-year, 34-country clinical trial in which 6,564 patients with symptomatic PAD who had recently undergone lower-limb revascularization were randomized in double-blind fashion to rivaroxaban (Xarelto) at 2.5 mg twice daily or placebo on top of background standard therapy with low-dose aspirin.

Among the 2,067 participants with baseline comorbid CAD, the primary outcome – a composite comprised of cardiovascular death, acute MI, ischemic stroke, acute limb ischemia, and major amputation – occurred in 18.9% of the rivaroxaban group at 3 years and 24.3% on placebo, for a highly significant 22% relative risk reduction.

In contrast, in the 4,497 patients with PAD only, the primary outcome occurred in 16.1% of those on rivaroxaban and 17.9% of controls, an 11% relative risk reduction which failed to reach statistical significance. The absolute risk reduction achieved with rivaroxaban was 5.4% in patients with PAD plus CAD versus 1.8% in those with PAD alone. Thus, the significant clinical benefit with rivaroxaban plus aspirin previously reported in the overall study population, with a number needed to treat for 3 years of 39 in order to prevent one primary outcome event, was largely driven by the superior outcomes in the dual-diagnosis subgroup, reported Dr. Hiatt, professor of medicine at the University of Colorado at Denver, Aurora.

“A strategy of rivaroxaban at 2.5 mg twice daily plus low-dose aspirin versus low-dose aspirin alone reduces ischemic events of the limb, brain, and heart, but also increases bleeding, with an overall net benefit,” the cardiologist said. “In particular, the benefits of this strategy for MI and ischemic stroke are robust, especially in patients with PAD and CAD.”

Indeed, the MI rate at 3 years in the dual diagnosis subgroup was 7.3% with rivaroxaban and 8.8% with placebo, for a 23% relative risk reduction, compared with rates of 3.3% and 3.7%, respectively, in patients with PAD only. Similarly, ischemic stroke occurred in 2.9% of patients with PAD and CAD in the rivaroxaban group, compared with 3.9% with placebo, whereas the rate in the PAD only group was identical at 2.6% regardless of whether patients were on rivaroxaban or placebo.

In patients without CAD, the clinical benefit of rivaroxaban was driven by reductions in severe limb events. Their rate of acute limb ischemia was 5.2% with rivaroxaban, compared with 8.3% with placebo, for a 37% relative risk reduction. In contrast, the reduction in acute limb ischemia with rivaroxaban in patients with PAD and CAD wasn’t significantly different from placebo.

Thrombolysis in Myocardial Infarction major bleeding occurred in 2.4% of patients with PAD and CAD on rivaroxaban, compared with 1.1% on placebo, and in 1.7% and 1.5% of patients with PAD alone. Of note, rates of ischemic stroke or fatal hemorrhage were low and similar at less than 1% in all four groups, Dr. Hiatt noted.

VOYAGER PAD was sponsored by Bayer and Janssen. Dr. Hiatt reported receiving research grant support from those two companies as well as Amgen.

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Remdesivir effective, well-tolerated in final trial report

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Drug beats placebo across multiple endpoints in COVID-19 patients

 

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

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Drug beats placebo across multiple endpoints in COVID-19 patients

Drug beats placebo across multiple endpoints in COVID-19 patients

 

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

 

A final report from the multinational placebo-controlled ACTT-1 trial confirms that remdesivir is effective and well tolerated for shortening the time to recovery from COVID-19 infection.

In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.

“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.

The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.

In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.

In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.

This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.

Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”

According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”

In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.

The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.

“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.

This point of view is shared.

“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.

“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.

An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.

The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.

According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”

This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.

Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.

SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.

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