Federal Practitioner

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

Eating sufficient amounts of vegetables might be good for overall health, but surprising results from a study suggested that their inclusion in the diet might have little or no effect on the risk of developing cardiovascular disease (CVD).

An investigation, led by the Nuffield department of population health at the University of Oxford, found that cooked vegetables did not appear to lower CVD risk, and that a small decrease associated with eating raw vegetables could be attributed to confounding factors. They said their findings, published in the journal Frontiers in Nutrition might mean that advice on vegetable intake and heart disease in high-income countries should be reappraised.

Teresa Burton/MDedge News

However, leading experts commented that the findings confirmed that higher overall vegetable consumption did lower the risk of cardiovascular disease.
 

UK Biobank data

Boosting health through a diet rich in vegetables has been backed by a large body of evidence, with guidelines consistently recommending them as a valuable source of macronutrients and micronutrients, such as dietary fiber, vitamins, and phytochemicals. However, the research team, which included the Chinese University of Hong Kong and the University of Bristol, set out to probe the independent effects of cooked and raw vegetables on health outcomes. Previous epidemiological studies had demonstrated inconsistent findings, they said.

They based their research on 399,586 people with no history of angina, stroke, and myocardial infarction, who enrolled in the UK Biobank. Of those, 55.4% were women, and 90.9% were of White ethnicity. The average body mass index was 27.3.
 

Raw and cooked vegetables

From their enrollment questionnaire, the mean intake of vegetables was found to be 2.3 heaped tablespoons per day of raw vegetables, and 2.8 of cooked vegetables. During an average follow-up of 12.1 years, 4.5% of the participants went on to develop CVD.

There was an inverse association between incident CVD and total and raw vegetable intake, but not cooked vegetable intake. Those who ate the most vegetables – both cooked and raw – had a 10% lower incidence of CVD, compared with those who ate the least. However, whereas raw vegetable intake was associated with an 11% reduction in CVD for those who ate the most, compared with the least, no reduction was seen for cooked vegetables.

Consuming two or more heaped tablespoons each day of cooked and raw vegetables was associated with a lower risk of dying from CVD, but little evidence was seen that a higher intake increased protection further. Similarly, there was evidence of an inverse association of CVD mortality with raw vegetable intake.

Researcher Qi Feng, from the Nuffield department of population health, said: “Our large study did not find evidence for a protective effect of vegetable intake on the occurrence of CVD. Instead, our analyses show that the seemingly protective effect of vegetable intake against CVD risk is very likely to be accounted for by bias from residual confounding factors, related to differences in socioeconomic situation and lifestyle.”

Expert opinions

Some clinical specialists took issue with the interpretation of the findings.

Dr. Dipender Gill, BMBCh, PhD, National Institute for Health Research clinical lecturer at St George’s, University of London, told the Science Media Centre that: “Many of the considered confounders that were adjusted for may actually represent mediating mechanisms.  For example, vegetable consumption may reduce cardiovascular risk by lowering blood pressure and bodyweight, and improving glycaemic control. 

“By adjusting for such traits, the authors may inadvertently be negating some of the mechanisms by which vegetable consumption is exerting beneficial effects.”

Tom Sanders, DSc, PhD, professor emeritus of nutrition and dietetics at King’s College London, said: “The conclusion that cooked vegetables may not be effective in reducing risk of cardiovascular disease may not be justified, especially as the group consuming the highest levels of vegetables were more likely to be receiving medication for high blood cholesterol and high blood pressure (i.e. this group was at higher risk of CVD), compared with those consuming the lowest intake.” He added: “These findings should not be taken to indicate that eating more vegetables has no benefit to health, especially cardiovascular health.”

Naveed Sattar, FMedSci, FRCPath, FRCPGlas, professor of metabolic medicine at the University of Glasgow, agreed. “In short, this paper should in no way change advice to eat at least five portions of fruit and vegetables a day,” he said. “Many living in the U.K. fall well short of this, sadly, and more needs to be done to encourage better intake of vegetables.

“In fact, I suspect we may have underestimated the importance of a healthy diet on health and disease in general.”

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

As COVID-19 cases and hospitalizations continue to decline across the United States, all states but one -- Hawaii -- have dropped their mask mandates or have announced plans to do so in coming weeks.

Retailers and cruises are following along, with Apple and Target stores lifting their own mask mandates this week. Cruise lines such as Norwegian and Royal Caribbean International have said mask requirements will be relaxed for vaccinated passengers, according to the Washington Post.

But guidance from the Centers for Disease Control and Prevention hasn’t changed even as the Omicron variant recedes across the country. Vaccinated people should wear masks when indoors in areas of “substantial or high transmission,” which still covers more than 95% of the country, according to a CDC map.

As daily cases continue to fall, the CDC is reviewing its recommendations, Rochelle Walensky, MD, the CDC director, said during a briefing last week.

“We want to give people a break from things like mask-wearing, when these metrics are better, and then have the ability to reach for them again should things worsen,” she said.

As states relax mask rules, county and city officials are now deciding what to do in their jurisdictions. Vaccinated residents in Los Angeles County may soon be able to go maskless in indoor settings that check for proof of vaccination, according to the Los Angeles Times.

Chicago will also end its mask and COVID-19 vaccine mandates for public places such as restaurants Feb. 28, according to the Chicago Tribune. Illinois will end a statewide indoor mask mandate on the same day. Masks will still be required in health care settings and public transmit.

State and local school boards are debating their mask policies as well. The Maryland State Board of Education voted Feb. 22 to allow local school districts to decide whether students must wear face coverings in school, according to the Associated Press. The update will take effect on March 1 if approved by a Maryland General Assembly committee that oversees the rule.

In New York, state officials have begun lifting mask rules. At the same time, 58% of New York voters want to see early March data before school mask mandates are ended, according to a new poll, released Feb. 22 by the Siena College Research Institute. About 45% of those polled said the state’s indoor public mask mandate should also still be in place.

The debate about wearing masks in schools will likely continue, especially as districts get caught between health authorities and parents, according to the Wall Street Journal. District officials in several states are receiving hundreds of emails daily from both sides, with parents calling for mask rules to end or saying that requirements should remain in place for now to keep kids safe.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

American health care workers have remained resilient during the pandemic but are feeling the ongoing strain, with 23% saying they are likely to leave the field in the near future, according to a new poll.

About half of the respondents to the poll from USA Today/Ipsos reported feeling “burned out,” 43% said they were “anxious,” and 21% said they were “angry” about politics and abuse from patients and families.

“We’re trying to help people here, and we are getting verbally and physically abused for it,” Sarah Fried, a nurse in California who responded to the survey, told USA Today in a follow-up interview.

“Early in this pandemic, people were clapping for us and calling us heroes,” she said. “And what happened to that? What happened to them appreciating what nurses are doing?”

The poll was done Feb. 9-16 among 1,170 adults in the U.S. health care industry, including doctors, nurses, paramedics, therapists, home health aides, dentists, and other medical professionals.

A large majority of workers still reported being satisfied with their jobs, although that optimism has declined somewhat since early 2021 when the COVID-19 vaccine rollout was underway. About 80% of those in the recent poll said they were somewhat or very satisfied with their current job, which is down from 89% in an April 2021 poll from Kaiser Family Foundation/the Washington Post.

Most health care workers reported feeling “hopeful” (59%), “motivated” (59%), or “optimistic” (56%) about going to work. But “hopeful” is down from 76% and “optimistic” is down from 67%, compared with last year.

If they could pick a career over again, about 16% disagreed with the statement, “I would still decide to go into health care,” and 18% said they didn’t know how they felt about it.

“The pandemic has actually made me realize how important this career is and how I really do make a difference. I still love it,” Christina Rosa, a mental health counselor in Massachusetts, told USA Today.

During the pandemic, about 66% of those polled said they had treated a COVID-19 patient, which increased to 84% among nurses and 86% among hospital workers. Among those, 47% reported having a patient who died from COVID-19, including 53% of nurses and 55% of hospital workers.

What’s more, 81% of those who treated COVID-19 patients have cared for unvaccinated patients. Among those, 67% said their patients continued to express skepticism toward COVID-19 vaccines, and 38% said some patients expressed regret for not getting a vaccine. Beyond that, 26% said unvaccinated patients asked for unproven treatments, and 30% said the patient or family criticized the care they received.

Regarding coronavirus-related policy, most Americans working in health care expressed skepticism or criticism of the nation’s handling of the pandemic. About 39% agreed that the American health care system is “on the verge of collapse.”

Only 21% said the pandemic is mostly or completely under control. About 61% don’t think Americans are taking enough precautions to prevent the spread of the coronavirus.

Health care workers were slightly positive when it comes to the Centers for Disease Control and Prevention (54% approve, 34% disapprove), divided on the Biden administration (41% approve, 40% disapprove), and critical of the news media (20% approve, 61% disapprove) and the American public (18% approve, 68% disapprove).

Broadly, though, health care workers support public health efforts. About 85% back measures that provide N95 masks, and 83% back measures that provide COVID-19 tests.

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

Columbia University has suspended Jeffrey Lieberman, MD, as chair of the psychiatry department at the Vagelos College of Physicians and Surgeons and has removed him as psychiatrist-in-chief at New York Presbyterian Hospital.

The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.

The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.

Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.

However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”

The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.

Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
 

Apology letter?

David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.

In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”

“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.

Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”

This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.  

Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.

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

Columbia University has suspended Jeffrey Lieberman, MD, as chair of the psychiatry department at the Vagelos College of Physicians and Surgeons and has removed him as psychiatrist-in-chief at New York Presbyterian Hospital.

The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.

The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.

Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.

However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”

The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.

Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
 

Apology letter?

David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.

In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”

“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.

Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”

This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.  

Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.

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

Columbia University has suspended Jeffrey Lieberman, MD, as chair of the psychiatry department at the Vagelos College of Physicians and Surgeons and has removed him as psychiatrist-in-chief at New York Presbyterian Hospital.

The university had not confirmed the suspension to this news organization by press time, but a letter from the school’s leadership notifying staff of the suspension was posted on Twitter the morning of Feb. 23 by addiction psychiatrist Jeremy Kidd, MD, who is a colleague of Dr. Lieberman’s at Columbia.

The suspension comes in the wake of Dr. Lieberman’s Feb. 21 tweet that drew immediate backlash by Twitter users who characterized it as racist and misogynist.

Dr. Lieberman, a former president of the American Psychiatric Association, reportedly deleted the tweet and his entire Twitter account soon after, according to NewsOne.

However, the tweet was captured by others, including Jack Turban, MD, a child psychiatry fellow at Stanford University. In Turban’s retweet, Dr. Lieberman commented on a tweet about a black model, noting, “whether a work of art or a freak of nature she’s a beautiful sight to behold.”

The response on Twitter was swift. “My ancestors would roll over in their graves if I refrained from commentary on how anti-Blackness shows up in ‘compliments,’” tweeted Jessica Isom, MD, MPH, a psychiatrist at Yale University.

Dr. Turban speculated that there will be no consequences for Dr. Lieberman, adding in his tweet, “He will continue to make the hiring decisions (including for faculty candidates who are women of color).”
 

Apology letter?

David Pagliaccio, a research scientist at the New York State Psychiatric Institute, posted what appeared to be an apology letter from Dr. Lieberman, although it could not be verified by this news organization.

In it, Dr. Lieberman was quoted as saying, “Yesterday, I tweeted from my personal account a message that was racist and sexist,” adding that prejudices he didn’t know he had held had been exposed, “and I’m deeply ashamed and very sorry.”

“I’ve hurt many, and I am beginning to understand the work ahead to make needed personal changes and over time to regain your trust,” Dr. Lieberman added.

Dr. Kidd called the suspension “absolutely the right move.” He added in his tweet that it “is only the beginning of what Columbia must do to heal & earn the trust our patients & trainees place in us every day.”

This news organization’s queries to Columbia University and to Dr. Lieberman were not returned by press time.  

Dr. Lieberman is also director of the New York State Psychiatric Institute, was an advisory board member for Medscape Psychiatry and a frequent columnist for Medscape Medical News (sister organizations of MDedge.com), and was a consultant for Clinical Psychiatry.

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

There was a remarkable reduction in bowel and urinary side effects when MRI was used instead of CT to guide stereotactic body radiotherapy (SBRT) for localized prostate cancer, shows a study from the University of California, Los Angeles.

Among the first 100 men in the phase 3 MIRAGE trial (Magnetic Resonance Imaging–Guided Versus Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer), MRI guidance more than halved the incidence of grade 2 or higher physician-reported genitourinary toxicity within 90 days of the procedure, which fell from 47.1% with CT to 22.4% with MRI.

While 13.7% of men had gastrointestinal complications with CT guidance, there wasn’t a single case in the MRI arm. The findings were presented Feb. 17 at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

The investigators thought they’d need 300 men to detect a safety difference, but the results are so strong that they’ve scaled back enrollment to 154. In the meantime, MRI-guided SBRT is now offered routinely to men with localized prostate cancer at UCLA.

“Our final results are expected later this year, but we are extremely optimistic by what we’re seeing, and hope this technology will soon begin to offer men undergoing radiotherapy for prostate cancer better outcomes,” said lead investigator Amar Upadhyaya Kishan, MD, a genitourinary oncology radiologist, in a UCLA press release.

The better outcomes are caused by the enhanced imaging capabilities of MRI, including real time tracking and automatic beam shutoff when the prostate moves too far outside of the treatment boundary, Dr. Kishan explained on Twitter.

Because of the extra precision, “we felt we could safely reduce the planning margins to only 2 mm” with MRI, down from 4 mm with CT. It translated to smaller treatment volumes and less collateral tissue damage, he said.

Across the first 100 subjects, 49 men were randomized to MRI-guided SBRT and 51 to SBRT with CT guidance. Their prostates and proximal seminal vesicles were dosed with 40 Gy of radiation in five fractions. Rectal spacing and nodal irradiation were at physician discretion.

Patients in the MRI arm also reported significantly fewer urinary symptoms, including urgency, incontinence, burning sensations, and bowel dysfunction, such as pain, diarrhea, and obstruction, among others, at 1 month with MRI guidance. The differences diminished at 3 months with adverse event management in the CT arm.

Lymph nodes were irradiated in 29% of men in the CT group versus 20% in the MRI arm, and 37% of the CT group versus 27% with MRI had rectal spacing.

Baseline gland size was a median of 39 mL in both groups. Baseline International Prostate Symptom Scores were a median of 8 points in the MRI group but 5 points in the CT arm.

The work was funded by UCLA, among others. Dr. Kishan has ownership interests in ViewRay, the company that makes the MRI-guiding technology used in the trial, and reported honoraria and research funding from the company.

There was a remarkable reduction in bowel and urinary side effects when MRI was used instead of CT to guide stereotactic body radiotherapy (SBRT) for localized prostate cancer, shows a study from the University of California, Los Angeles.

Among the first 100 men in the phase 3 MIRAGE trial (Magnetic Resonance Imaging–Guided Versus Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer), MRI guidance more than halved the incidence of grade 2 or higher physician-reported genitourinary toxicity within 90 days of the procedure, which fell from 47.1% with CT to 22.4% with MRI.

While 13.7% of men had gastrointestinal complications with CT guidance, there wasn’t a single case in the MRI arm. The findings were presented Feb. 17 at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

The investigators thought they’d need 300 men to detect a safety difference, but the results are so strong that they’ve scaled back enrollment to 154. In the meantime, MRI-guided SBRT is now offered routinely to men with localized prostate cancer at UCLA.

“Our final results are expected later this year, but we are extremely optimistic by what we’re seeing, and hope this technology will soon begin to offer men undergoing radiotherapy for prostate cancer better outcomes,” said lead investigator Amar Upadhyaya Kishan, MD, a genitourinary oncology radiologist, in a UCLA press release.

The better outcomes are caused by the enhanced imaging capabilities of MRI, including real time tracking and automatic beam shutoff when the prostate moves too far outside of the treatment boundary, Dr. Kishan explained on Twitter.

Because of the extra precision, “we felt we could safely reduce the planning margins to only 2 mm” with MRI, down from 4 mm with CT. It translated to smaller treatment volumes and less collateral tissue damage, he said.

Across the first 100 subjects, 49 men were randomized to MRI-guided SBRT and 51 to SBRT with CT guidance. Their prostates and proximal seminal vesicles were dosed with 40 Gy of radiation in five fractions. Rectal spacing and nodal irradiation were at physician discretion.

Patients in the MRI arm also reported significantly fewer urinary symptoms, including urgency, incontinence, burning sensations, and bowel dysfunction, such as pain, diarrhea, and obstruction, among others, at 1 month with MRI guidance. The differences diminished at 3 months with adverse event management in the CT arm.

Lymph nodes were irradiated in 29% of men in the CT group versus 20% in the MRI arm, and 37% of the CT group versus 27% with MRI had rectal spacing.

Baseline gland size was a median of 39 mL in both groups. Baseline International Prostate Symptom Scores were a median of 8 points in the MRI group but 5 points in the CT arm.

The work was funded by UCLA, among others. Dr. Kishan has ownership interests in ViewRay, the company that makes the MRI-guiding technology used in the trial, and reported honoraria and research funding from the company.

There was a remarkable reduction in bowel and urinary side effects when MRI was used instead of CT to guide stereotactic body radiotherapy (SBRT) for localized prostate cancer, shows a study from the University of California, Los Angeles.

Among the first 100 men in the phase 3 MIRAGE trial (Magnetic Resonance Imaging–Guided Versus Computed Tomography–Guided Stereotactic Body Radiotherapy for Prostate Cancer), MRI guidance more than halved the incidence of grade 2 or higher physician-reported genitourinary toxicity within 90 days of the procedure, which fell from 47.1% with CT to 22.4% with MRI.

While 13.7% of men had gastrointestinal complications with CT guidance, there wasn’t a single case in the MRI arm. The findings were presented Feb. 17 at the American Society of Clinical Oncology Genitourinary Cancers Symposium.

The investigators thought they’d need 300 men to detect a safety difference, but the results are so strong that they’ve scaled back enrollment to 154. In the meantime, MRI-guided SBRT is now offered routinely to men with localized prostate cancer at UCLA.

“Our final results are expected later this year, but we are extremely optimistic by what we’re seeing, and hope this technology will soon begin to offer men undergoing radiotherapy for prostate cancer better outcomes,” said lead investigator Amar Upadhyaya Kishan, MD, a genitourinary oncology radiologist, in a UCLA press release.

The better outcomes are caused by the enhanced imaging capabilities of MRI, including real time tracking and automatic beam shutoff when the prostate moves too far outside of the treatment boundary, Dr. Kishan explained on Twitter.

Because of the extra precision, “we felt we could safely reduce the planning margins to only 2 mm” with MRI, down from 4 mm with CT. It translated to smaller treatment volumes and less collateral tissue damage, he said.

Across the first 100 subjects, 49 men were randomized to MRI-guided SBRT and 51 to SBRT with CT guidance. Their prostates and proximal seminal vesicles were dosed with 40 Gy of radiation in five fractions. Rectal spacing and nodal irradiation were at physician discretion.

Patients in the MRI arm also reported significantly fewer urinary symptoms, including urgency, incontinence, burning sensations, and bowel dysfunction, such as pain, diarrhea, and obstruction, among others, at 1 month with MRI guidance. The differences diminished at 3 months with adverse event management in the CT arm.

Lymph nodes were irradiated in 29% of men in the CT group versus 20% in the MRI arm, and 37% of the CT group versus 27% with MRI had rectal spacing.

Baseline gland size was a median of 39 mL in both groups. Baseline International Prostate Symptom Scores were a median of 8 points in the MRI group but 5 points in the CT arm.

The work was funded by UCLA, among others. Dr. Kishan has ownership interests in ViewRay, the company that makes the MRI-guiding technology used in the trial, and reported honoraria and research funding from the company.

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Women with early-stage breast cancer who are poorly represented in clinical trials have worse survival than their well-represented peers, according to a real-world analysis.

The study shows that more than half of women with early breast cancer are not well represented in clinical trials because of age, comorbidities, or race, yet they receive therapies based on the results of these trials.

“The most interesting finding is that patients with comorbidities resulting in lab abnormalities that would typically exclude them from receiving medication on a trial are still frequently receiving these medications and have an almost threefold higher mortality,” Gabrielle Rocque, MD, with the division of hematology and oncology, University of Alabama at Birmingham, told this news organization.

“We need to do a deeper dive to better understand what is driving this mortality difference and test specific medications in patients with these conditions to understand the optimal treatment for this population,” Dr. Rocque added.

The study was published Feb. 1 in JCO Oncology Practice.

Many patient groups are not well represented in clinical trials, including patients of color, older patients, and those with comorbidities, and it remains unclear how treatment outcomes may differ among these patients, compared with those who are well represented in trials.

To investigate, Dr. Rocque and colleagues looked at 11,770 women diagnosed with stage I-III breast cancer between 2005 and 2015 in the American Society of Clinical Oncology CancerLinQ database.

White women between 45 and 69 years of age with no comorbid conditions were considered well represented and made up 48% of the cohort.

Non-White women and/or those younger than 45 years or older than 70 were considered under represented and made up 45% of the cohort. The unrepresented group (7%) included women with comorbidities – such as liver disease, renal insufficiency, thrombocytopenia, anemia, or uncontrolled diabetes – or concurrent cancer.

The majority of the women received a high-intensity chemotherapy regimen, including 58% of unrepresented, 66% of underrepresented, and 63% of well-represented patients.

Compared with well-represented women, unrepresented women had a higher risk of death at 5 years (adjusted hazard ratio, 2.71; 95% confidence interval, 2.08-3.52).

Overall, the team found no significant increase in the risk of death at 5 years in underrepresented vs. well-represented women (aHR, 1.19; 95% CI, 0.98-1.45). However, that risk varied with age. Among underrepresented women, those aged 70 and older had more than a twofold higher risk of 5-year mortality (aHR, 2.21), while those younger than 45 had a lower risk of 5-year mortality (aHR, 0.63), compared with those aged 45-69 years.

For three cancer subtypes, unrepresented patients had a greater than twofold higher risk of 5-year mortality, compared with well-represented patients (aHR, 2.50 for HER2-positive disease; aHR, 2.54 for HR-positive/HER2-negative disease; and aHR, 2.75 for triple-negative disease).

Underrepresented patients with HR-positive/HER2-negative disease had a 38% increased risk of 5-year mortality, compared with their well-represented peers (aHR, 1.38). However, there were no significant differences in 5-year mortality for underrepresented vs. well-represented patients with HER2-positive or triple-negative subtypes.
 

Risky business?

This analysis shows that unrepresented populations receive common treatment regimens at a similar rate as well-represented patients, the researchers note.

“By excluding patients with differing clinical conditions from trials but including them in the population to which drugs can be disseminated, one runs the risk of inadvertently causing injury,” the authors caution.

“To inform the practice of evidence-based medicine in an equitable manner, our findings support a need to both expand clinical trial inclusion criteria and report on clinical trial outcomes by clinical and demographic characteristics,” Dr. Rocque and colleagues conclude.

Charles Shapiro, MD, professor of medicine, hematology, and medical oncology, Icahn School of Medicine at Mount Sinai, New York, is not surprised by the findings of this study.

“We know that clinical trials are too restrictive and include only a selected population largely without comorbidities, but in the real world, people have comorbidities,” Dr. Shapiro, who was not involved in the research, told this news organization.

The study “starkly illustrates” the poorer survival of populations not represented in clinical trials.

“It could be that we need to change clinical trials, maybe ask fewer questions or maybe ask more important questions and loosen the eligibility up, because in the real world, there are people with comorbidities and people who are over 70,” Dr. Shapiro stated.

Are strides being made to change that? “Not really,” Dr. Shapiro said in an interview.

The study was supported by grants from the Robert Wood Johnson Foundation and the American Cancer Society. Dr. Rocque has served as a consultant or advisor for Pfizer; has received research funding from Carevive Systems, Genentech, and Pfizer; and has received travel, accommodations, and expenses from Carevive. Dr. Shapiro has financial relationships with UptoDate, 2nd MD, and Anthenum.

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

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

Introduction

Amidst an aggressive vaccination campaign for COVID-19, misinformation has spread over the Internet, affecting public perception and making some people hesitant to participate in ongoing immunization campaigns. Of chief concern are issues pertaining to fertility or viability of sperm – information circulating on social networks posits that the coronavirus vaccine may influence infertility in men, which, according to physicians, is not grounded in reality. From the perspective of evidence-based medicine, there is a dearth of information suggesting an untoward effect of the vaccine on male fertility. The risk of adverse reactions arising from approved vaccines is negligible, with mild, albeit controllable, side effects demonstrated by patients in clinical trials. Therefore, there is no plausible reason for the general public to avoid vaccinations.¹

Infertility following vaccination

The source of confusion can be traced back to a study conducted by researchers at the University of Miami Miller School of Medicine; the general public has conflated a side effect of the virus, namely, infertility and erectile dysfunction, with that of the vaccine.² According to Ranjith Ramasamy, MD, director of the urology program at Miller, “We were the first to demonstrate that the COVID virus, itself, can affect male fertility and be a potential cause for erectile dysfunction. We are now the first to examine if there is any impact of the COVID vaccine on male fertility potential, which we did not find.”³

Coronavirus can indeed cause significant damage to the testicular tissue of infected men by means of mediating ACE2 expression on Leydig and Sertoli cells of the testis. It should be noted that COVID-19 may potentially attack any type of cell in the body that expresses the enzyme ACE2. However, it is particularly harmful to cells with high levels of expression of this enzyme, such as testicular cells. The spermatogenesis process can be affected, thereby posing a risk to male fertility.⁴

Expanding on the theme of fertility during the pandemic, a number of false claims^5-7 about the vaccine and its overall effect on the placenta and fertility have also emerged as a contentious topic for debate on social media; doctors continue to explain why the theories are not reasonable or a cause for concern. The World Health Organization (WHO) provides recommendations on COVID-19 vaccinations for pregnant and/or lactating women and encourages a shared decision process involving risk/benefit assessment with the prescribing physician.⁵ Pregnant women, especially those with underlying comorbid conditions, are susceptible to developing severe symptom manifestations of COVID-19 with the disease also being associated with an increased likelihood of premature birth. As far as lactating women are concerned, the evidence thus far has indicated that the risk of side effects of the vaccine is very low, suggesting that these women could be vaccinated.⁵

The vaccine is the best option

While more studies are needed to ascertain the relationship between COVID-19 and male infertility, the vaccine is currently the best option for those who are concerned about their fertility from exposure to the coronavirus. Because of delayed wholesale acceptance of vaccines by the general population, clinicians should continue to emphasize the importance of preventive care with respect to disease exposure.⁶

In addition, those who are concerned with fertility can opt for ways to preserve their reproductive capacity, such as the removal of semen for freezing sperm, albeit with adherence to sperm-washing procedures to preclude cross-contamination from viruses.^8,9 For the preservation of sperm, the noninvasive method is often performed, preferably collected in several samples. Then, the semen is cryopreserved.⁸ In some instances, the sperm can also be removed directly from the testicles with a simple needle or by means of a minor surgical procedure.

A wait and try approach is advocated by clinicians for individuals who have already experienced COVID-19 symptoms and are therefore concerned about the prospect of childbearing.¹⁰ If the couple is unable to conceive after a year of trying, it is recommended that they consult a reproductive specialist; the clinician can carry out a comprehensive evaluation and order a series of tests to identify the source of the problem, indicating whether there are alternative methods for helping the couple to start a family (addressing the underlying factors involved in infertility, or treating via assisted reproduction procedures, such as in vitro fertilization).¹¹

Dr. Aman is faculty member at the biology department of City Colleges of Chicago, and a postdoctoral researcher at the International Maternal and Child Health Foundation (IMCHF). She disclosed no relevant financial relationships. Dr. Islam is a medical writer for the IMCHF, Montreal, is based in New York, and disclosed no relevant financial relationships. Mr. Choudhry is a research assistant at the IMCHF and he has no disclosures. Dr. Zia Choudhry is the chief scientific officer and head of the department of mental health and clinical research at the IMCHF. He has no disclosures.

References

1. Berry SD et al. J Am Geriatr Soc. 2021 May;69(5):1140-6.

2. Achua JK et al. World J Men’s Health. 2021 Jan;39(1):65-74.

3. Broderick JM. Urology Times. 2021 June.

4. Huang C et al. Andrology. 2021 Jan;9(1):80-7.

5. Sajjadi NB et al. J Osteopath Med. 2021 Apr 12;121(6):583-7.

6. Sallam M et al. Vaccines. 2021 Jan;9(1):42.

7. Islam MS et al. PloS One. 2021 May 12;16(5):e0251605.

8. Tesarik J. J Fertil Preserv. 2021;2:art246111.

9. Adiga SK et al. Reprod BioMed Online. 2020 Dec;41(6):991-7.

10. FAQs related to COVID-19. Q: If I get sick or test positive for COVID-19, when is it safe to become pregnant? American Society for Reproductive Medicine.

11. Cross C. Wellness and Prevention: Why can’t I get pregnant? John Hopkins Medicine.

            Kishan et al conducted a meta-analysis to evaluate the relative effects of the addition of androgen deprivation therapy (ADT) to radiation therapy (RT) on metastasis-free survival (MFS) in patients with localized prostate cancer in the following three settings: 1) RT alone versus RT plus adjuvant ADT, 2) extension of ADT duration in the neoadjuvant setting before RT, and 3) extension of adjuvant ADT duration. MFS was increased in the adjuvant ADT setting, and prolongation of ADT duration was associated with a higher MFS than shorter duration. However, extension of neoadjuvant ADT was not associated with a higher MFS compared to a shorter duration. The meta-analysis further supports a longer versus shorter ADT duration, but it does not support a longer neoadjuvant ADT duration.

            To determine the effects of salvage RT on outcomes in the setting of biochemical relapse, Tilki et al conducted a retrospective cohort analysis of a multi-institutional database of patients with biochemical recurrence after radical prostatectomy (RP). MFS at 15 years post-RP was 84.3% in the RT group and 76.9% in the non-RT group, while overall survival (OS), also at 15 years post-RP, was 85.3% in the RT group versus 74.4% in the non-RT group (both analyses were statistically significant). While supportive of salvage RT, there was no data on prostate-specific antigen (PSA) doubling times, nor was it possible to control for imaging modality. It is possible that newer prostate-specific membrane antigen (PSMA)-based positron emission tomography imaging may affect MFS in studies such as these.

            Prostatectomy (with or without lymph node dissection), external beam RT (EBRT) with  ADT, or EBRT with brachytherapy (BT) with or without ADT are options in unfavorable intermediate-risk prostate cancer. The optimal use of BT in localized prostate cancer is somewhat uncertain, especially across the risk spectrum. Andruska et al conducted an analysis of the National Cancer Database (NCDB) to evaluate whether EBRT plus BT with or without ADT results in an improvement in overall survival (OS) compared with BT with or without ADT. OS was higher for the EBRT plus BT groups; however, when the ADT + EBRT + BT group was compared with EBRT + BT without ADT group, the improvement in OS was not statistically significant. Overall, the analysis favored EBRT + BT over BT alone, further supporting current guidelines.

            Kishan et al conducted a meta-analysis to evaluate the relative effects of the addition of androgen deprivation therapy (ADT) to radiation therapy (RT) on metastasis-free survival (MFS) in patients with localized prostate cancer in the following three settings: 1) RT alone versus RT plus adjuvant ADT, 2) extension of ADT duration in the neoadjuvant setting before RT, and 3) extension of adjuvant ADT duration. MFS was increased in the adjuvant ADT setting, and prolongation of ADT duration was associated with a higher MFS than shorter duration. However, extension of neoadjuvant ADT was not associated with a higher MFS compared to a shorter duration. The meta-analysis further supports a longer versus shorter ADT duration, but it does not support a longer neoadjuvant ADT duration.

            To determine the effects of salvage RT on outcomes in the setting of biochemical relapse, Tilki et al conducted a retrospective cohort analysis of a multi-institutional database of patients with biochemical recurrence after radical prostatectomy (RP). MFS at 15 years post-RP was 84.3% in the RT group and 76.9% in the non-RT group, while overall survival (OS), also at 15 years post-RP, was 85.3% in the RT group versus 74.4% in the non-RT group (both analyses were statistically significant). While supportive of salvage RT, there was no data on prostate-specific antigen (PSA) doubling times, nor was it possible to control for imaging modality. It is possible that newer prostate-specific membrane antigen (PSMA)-based positron emission tomography imaging may affect MFS in studies such as these.

            Prostatectomy (with or without lymph node dissection), external beam RT (EBRT) with  ADT, or EBRT with brachytherapy (BT) with or without ADT are options in unfavorable intermediate-risk prostate cancer. The optimal use of BT in localized prostate cancer is somewhat uncertain, especially across the risk spectrum. Andruska et al conducted an analysis of the National Cancer Database (NCDB) to evaluate whether EBRT plus BT with or without ADT results in an improvement in overall survival (OS) compared with BT with or without ADT. OS was higher for the EBRT plus BT groups; however, when the ADT + EBRT + BT group was compared with EBRT + BT without ADT group, the improvement in OS was not statistically significant. Overall, the analysis favored EBRT + BT over BT alone, further supporting current guidelines.

            Kishan et al conducted a meta-analysis to evaluate the relative effects of the addition of androgen deprivation therapy (ADT) to radiation therapy (RT) on metastasis-free survival (MFS) in patients with localized prostate cancer in the following three settings: 1) RT alone versus RT plus adjuvant ADT, 2) extension of ADT duration in the neoadjuvant setting before RT, and 3) extension of adjuvant ADT duration. MFS was increased in the adjuvant ADT setting, and prolongation of ADT duration was associated with a higher MFS than shorter duration. However, extension of neoadjuvant ADT was not associated with a higher MFS compared to a shorter duration. The meta-analysis further supports a longer versus shorter ADT duration, but it does not support a longer neoadjuvant ADT duration.

            To determine the effects of salvage RT on outcomes in the setting of biochemical relapse, Tilki et al conducted a retrospective cohort analysis of a multi-institutional database of patients with biochemical recurrence after radical prostatectomy (RP). MFS at 15 years post-RP was 84.3% in the RT group and 76.9% in the non-RT group, while overall survival (OS), also at 15 years post-RP, was 85.3% in the RT group versus 74.4% in the non-RT group (both analyses were statistically significant). While supportive of salvage RT, there was no data on prostate-specific antigen (PSA) doubling times, nor was it possible to control for imaging modality. It is possible that newer prostate-specific membrane antigen (PSMA)-based positron emission tomography imaging may affect MFS in studies such as these.

            Prostatectomy (with or without lymph node dissection), external beam RT (EBRT) with  ADT, or EBRT with brachytherapy (BT) with or without ADT are options in unfavorable intermediate-risk prostate cancer. The optimal use of BT in localized prostate cancer is somewhat uncertain, especially across the risk spectrum. Andruska et al conducted an analysis of the National Cancer Database (NCDB) to evaluate whether EBRT plus BT with or without ADT results in an improvement in overall survival (OS) compared with BT with or without ADT. OS was higher for the EBRT plus BT groups; however, when the ADT + EBRT + BT group was compared with EBRT + BT without ADT group, the improvement in OS was not statistically significant. Overall, the analysis favored EBRT + BT over BT alone, further supporting current guidelines.

A Florida jury has found a Palm Beach psychiatrist guilty of one count of conspiracy to commit healthcare fraud and wire fraud and 11 counts of healthcare fraud.

Mark Agresti, MD, 59, was convicted of unlawfully billing approximately $110 million of medically unnecessary urinalysis services for patients living at Good Decisions Sober Living (GDSL), a drug rehabilitation facility in West Palm Beach, Fla. Dr. Agresti was once the director of psychiatry at the former Columbia Hospital in West Palm Beach.

According to evidence presented at the trial, Dr. Agresti, as medical director of GDSL, agreed to provide standing orders for urinalysis for GDSL patients in exchange for a monthly fee. Three to four times a week, patients were required to submit to excessive and medically unnecessary urine tests, costing $6,000 to $9,000 per test, according to federal officials. Dr. Agresti did not review the results of these tests and did not use the tests to treat patients. The evidence also showed that he had also done this at other addiction facilities in the West Palm Beach area, resulting in thousands of additional fraudulent tests. Dr. Agresti had GDSL patients visit his private practice so he could fraudulently bill for services there as well.

“This defendant used his medical license to facilitate an egregious, multimillion-dollar fraud scheme that exploited vulnerable substance abusers,” said Juan Antonio Gonzalez, U.S. Attorney for the Southern District of Florida, in a statement announcing the conviction.

Three other defendants, including GDSL’s owner, Kenneth Bailynson, were previously indicted and pleaded guilty to related charges connected with the scheme. Dr. Agresti, however, insisted on his innocence throughout the trial, arguing that he was himself the victim of Mr. Bailynson. Mr. Bailynson, as a part of his plea deal, testified against Dr. Agresti at the trial.

According to a report in the Palm Beach Post, Dr. Agresti’s lawyers, in closing statements, argued, “The government did a fantastic job of proving that Dr. Agresti was negligent, maybe even grossly negligent, but that’s not the issue in this case.” The jury disagreed.

Dr. Agresti faces a maximum penalty of 20 years in prison for the healthcare fraud and wire fraud conspiracy charges and 10 years for each count of healthcare fraud. Sentencing is scheduled for April 21.
 

Ten people, including two physicians, charged in Texas kickback scheme

Jose Maldonado, MD, 48, a family medicine physician, and Eduardo Carlos Canova, MD, 44, an internal medicine specialist, both based in Laredo, Tex., were among ten people indicted in connection with a $300 million healthcare fraud scheme

According to the federal indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs, LLC, allegedly paid kickbacks to medical practitioners in exchange for orders for medically unnecessary lab tests, which were then billed to Medicare and other federal healthcare programs. The medical professionals, including Dr. Maldonado and Dr. Canova, are alleged to have accepted bribes for ordering millions of dollars’ worth of tests.

The scheme was facilitated by marketing firms, which paid doctors hundreds of thousands of dollars for “advisory services,” according to officials. Rather than providing advice, however, the physicians provided lab test referrals. The labs are accused of paying portions of the salaries of the doctors’ staffs as well as portions of their leases. In some instances, direct payments were made to the practitioner’s spouse. In one case, the labs informed one practitioner that the payments would cease if he didn’t refer more tests. He responded to the threat by immediately increasing his lab referrals, averaging 20 to 30 referrals a day.

Jeffrey Madison, the founder of Spectrum and Unified, is accused of convincing Reliable’s founders to convert their business to a physician-owned lab to disguise the kickbacks. Reliable offered physicians ownership opportunities only if they referred enough lab tests. In some cases, says the indictment, the labs made advance payments to physicians to ensure that those physicians would not send samples to other labs.

The scheme resulted in more than $300 million in billing to federal government healthcare programs. Between 2015 and 2018, Dr. Maldonado alone received more than $400,000 in kickbacks for ordering more than $4 million worth of lab tests, and Dr. Canova received more than $300,000 for ordering more than $12 million in tests, according to the indictment.

The 26-count indictment included charges of conspiracy to commit healthcare fraud, conspiracy to pay and receive healthcare kickbacks, offering or paying illegal kickbacks, and soliciting or receiving illegal kickbacks.
 

N.J. doc charged on 34 counts of illegally prescribing controlled substances

A N.J. orthopedic surgeon has been charged with 34 counts of illegally prescribing controlled substances.

According to documents filed in the case, from November 2016 to February 2018 Evangelos Megariotis, MD, 68, of Passaic County, N.J., prescribed opiates — including oxycodone, alprazolam (Xanax), and cough syrup with codeine — as well as stimulants without a legitimate medical purpose and outside the usual course of his practice.

Before the State of New Jersey permanently banned him from practicing medicine, Dr. Megariotis owned and operated Clifton Orthopedic Associates, in Clifton, N.J.

According to The Bergin Record, the state alleges that Dr. Megariotis prescribed thousands of doses of painkillers even though he knew his patients were abusing them and in some cases were getting similar drugs from other doctors. In addition, Dr. Megariotis failed to diagnose or treat these patients’ underlying conditions, treated illnesses outside his scope of practice, and performed surgery in the absence of medical need.

If convicted, Dr. Megariotis could face a lengthy prison sentence as well as substantial fines. The counts of illegally prescribing Schedule II opioids and stimulants are punishable by a maximum of 20 years in prison and a $1 million fine. Illegally prescribing Schedule IV controlled substances brings a maximum of 5 years in prison and a $250,000 fine. The counts of illegally prescribing cough syrup with codeine, a Schedule V controlled substance, are punishable by a maximum of 1 year in prison and a $100,000 fine.
 

Michigan surgeon pleads guilty to fraud scheme

A Bay City, Mich., vascular surgeon has pleaded guilty to engaging in a scheme to defraud Medicare, Medicaid, and Blue Cross/Blue Shield of Michigan out of approximately $19.5 million

According to the plea agreement, in 2009, Vasso Godiali, MD, 59, began false and fraudulent billing to the three insurers. False claims included billing for the placement of stents in dialysis patients and for the treatment of arterial blood clots. The surgeon admitted to billing for the placement of multiple stents in the same vessel and preparing medical records to support the necessity of placing those stents. However, he never placed the stents.

In the plea document, Dr. Godiali also admitted that his medical records would describe occluded arteries that would justify arterial thrombectomies. However, in many cases, there were no occluded arteries, and no thrombectomies were performed, even though Dr. Godiali billed insurers for them.

“When Dr Godiali submitted claims for medical services that were never provided, he violated the trust of his patients and defrauded taxpayer-funded health care programs,” Mario M. Pinto, special agent in charge, said in a statement announcing the plea.

In 2014, The Bay City Times interviewed Dr. Godiali after he was featured by USA Today as one of seven physicians in the United States to receive more than $10 million for Medicare reimbursements in 2012. He told The Times he was a workaholic. “I work a lot — I work probably more than surgeons that you meet,” he told the paper.

Dr. Godiali faces up to 10 years in prison. In addition, he will be required to pay $19.5 million in restitution to the three insurers. A civil forfeiture case against approximately $39.9 million seized from accounts controlled by Dr. Godiali is pending. Sentencing is scheduled for September 15.

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

A Florida jury has found a Palm Beach psychiatrist guilty of one count of conspiracy to commit healthcare fraud and wire fraud and 11 counts of healthcare fraud.

Mark Agresti, MD, 59, was convicted of unlawfully billing approximately $110 million of medically unnecessary urinalysis services for patients living at Good Decisions Sober Living (GDSL), a drug rehabilitation facility in West Palm Beach, Fla. Dr. Agresti was once the director of psychiatry at the former Columbia Hospital in West Palm Beach.

According to evidence presented at the trial, Dr. Agresti, as medical director of GDSL, agreed to provide standing orders for urinalysis for GDSL patients in exchange for a monthly fee. Three to four times a week, patients were required to submit to excessive and medically unnecessary urine tests, costing $6,000 to $9,000 per test, according to federal officials. Dr. Agresti did not review the results of these tests and did not use the tests to treat patients. The evidence also showed that he had also done this at other addiction facilities in the West Palm Beach area, resulting in thousands of additional fraudulent tests. Dr. Agresti had GDSL patients visit his private practice so he could fraudulently bill for services there as well.

“This defendant used his medical license to facilitate an egregious, multimillion-dollar fraud scheme that exploited vulnerable substance abusers,” said Juan Antonio Gonzalez, U.S. Attorney for the Southern District of Florida, in a statement announcing the conviction.

Three other defendants, including GDSL’s owner, Kenneth Bailynson, were previously indicted and pleaded guilty to related charges connected with the scheme. Dr. Agresti, however, insisted on his innocence throughout the trial, arguing that he was himself the victim of Mr. Bailynson. Mr. Bailynson, as a part of his plea deal, testified against Dr. Agresti at the trial.

According to a report in the Palm Beach Post, Dr. Agresti’s lawyers, in closing statements, argued, “The government did a fantastic job of proving that Dr. Agresti was negligent, maybe even grossly negligent, but that’s not the issue in this case.” The jury disagreed.

Dr. Agresti faces a maximum penalty of 20 years in prison for the healthcare fraud and wire fraud conspiracy charges and 10 years for each count of healthcare fraud. Sentencing is scheduled for April 21.
 

Ten people, including two physicians, charged in Texas kickback scheme

Jose Maldonado, MD, 48, a family medicine physician, and Eduardo Carlos Canova, MD, 44, an internal medicine specialist, both based in Laredo, Tex., were among ten people indicted in connection with a $300 million healthcare fraud scheme

According to the federal indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs, LLC, allegedly paid kickbacks to medical practitioners in exchange for orders for medically unnecessary lab tests, which were then billed to Medicare and other federal healthcare programs. The medical professionals, including Dr. Maldonado and Dr. Canova, are alleged to have accepted bribes for ordering millions of dollars’ worth of tests.

The scheme was facilitated by marketing firms, which paid doctors hundreds of thousands of dollars for “advisory services,” according to officials. Rather than providing advice, however, the physicians provided lab test referrals. The labs are accused of paying portions of the salaries of the doctors’ staffs as well as portions of their leases. In some instances, direct payments were made to the practitioner’s spouse. In one case, the labs informed one practitioner that the payments would cease if he didn’t refer more tests. He responded to the threat by immediately increasing his lab referrals, averaging 20 to 30 referrals a day.

Jeffrey Madison, the founder of Spectrum and Unified, is accused of convincing Reliable’s founders to convert their business to a physician-owned lab to disguise the kickbacks. Reliable offered physicians ownership opportunities only if they referred enough lab tests. In some cases, says the indictment, the labs made advance payments to physicians to ensure that those physicians would not send samples to other labs.

The scheme resulted in more than $300 million in billing to federal government healthcare programs. Between 2015 and 2018, Dr. Maldonado alone received more than $400,000 in kickbacks for ordering more than $4 million worth of lab tests, and Dr. Canova received more than $300,000 for ordering more than $12 million in tests, according to the indictment.

The 26-count indictment included charges of conspiracy to commit healthcare fraud, conspiracy to pay and receive healthcare kickbacks, offering or paying illegal kickbacks, and soliciting or receiving illegal kickbacks.
 

N.J. doc charged on 34 counts of illegally prescribing controlled substances

A N.J. orthopedic surgeon has been charged with 34 counts of illegally prescribing controlled substances.

According to documents filed in the case, from November 2016 to February 2018 Evangelos Megariotis, MD, 68, of Passaic County, N.J., prescribed opiates — including oxycodone, alprazolam (Xanax), and cough syrup with codeine — as well as stimulants without a legitimate medical purpose and outside the usual course of his practice.

Before the State of New Jersey permanently banned him from practicing medicine, Dr. Megariotis owned and operated Clifton Orthopedic Associates, in Clifton, N.J.

According to The Bergin Record, the state alleges that Dr. Megariotis prescribed thousands of doses of painkillers even though he knew his patients were abusing them and in some cases were getting similar drugs from other doctors. In addition, Dr. Megariotis failed to diagnose or treat these patients’ underlying conditions, treated illnesses outside his scope of practice, and performed surgery in the absence of medical need.

If convicted, Dr. Megariotis could face a lengthy prison sentence as well as substantial fines. The counts of illegally prescribing Schedule II opioids and stimulants are punishable by a maximum of 20 years in prison and a $1 million fine. Illegally prescribing Schedule IV controlled substances brings a maximum of 5 years in prison and a $250,000 fine. The counts of illegally prescribing cough syrup with codeine, a Schedule V controlled substance, are punishable by a maximum of 1 year in prison and a $100,000 fine.
 

Michigan surgeon pleads guilty to fraud scheme

A Bay City, Mich., vascular surgeon has pleaded guilty to engaging in a scheme to defraud Medicare, Medicaid, and Blue Cross/Blue Shield of Michigan out of approximately $19.5 million

According to the plea agreement, in 2009, Vasso Godiali, MD, 59, began false and fraudulent billing to the three insurers. False claims included billing for the placement of stents in dialysis patients and for the treatment of arterial blood clots. The surgeon admitted to billing for the placement of multiple stents in the same vessel and preparing medical records to support the necessity of placing those stents. However, he never placed the stents.

In the plea document, Dr. Godiali also admitted that his medical records would describe occluded arteries that would justify arterial thrombectomies. However, in many cases, there were no occluded arteries, and no thrombectomies were performed, even though Dr. Godiali billed insurers for them.

“When Dr Godiali submitted claims for medical services that were never provided, he violated the trust of his patients and defrauded taxpayer-funded health care programs,” Mario M. Pinto, special agent in charge, said in a statement announcing the plea.

In 2014, The Bay City Times interviewed Dr. Godiali after he was featured by USA Today as one of seven physicians in the United States to receive more than $10 million for Medicare reimbursements in 2012. He told The Times he was a workaholic. “I work a lot — I work probably more than surgeons that you meet,” he told the paper.

Dr. Godiali faces up to 10 years in prison. In addition, he will be required to pay $19.5 million in restitution to the three insurers. A civil forfeiture case against approximately $39.9 million seized from accounts controlled by Dr. Godiali is pending. Sentencing is scheduled for September 15.

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

A Florida jury has found a Palm Beach psychiatrist guilty of one count of conspiracy to commit healthcare fraud and wire fraud and 11 counts of healthcare fraud.

Mark Agresti, MD, 59, was convicted of unlawfully billing approximately $110 million of medically unnecessary urinalysis services for patients living at Good Decisions Sober Living (GDSL), a drug rehabilitation facility in West Palm Beach, Fla. Dr. Agresti was once the director of psychiatry at the former Columbia Hospital in West Palm Beach.

According to evidence presented at the trial, Dr. Agresti, as medical director of GDSL, agreed to provide standing orders for urinalysis for GDSL patients in exchange for a monthly fee. Three to four times a week, patients were required to submit to excessive and medically unnecessary urine tests, costing $6,000 to $9,000 per test, according to federal officials. Dr. Agresti did not review the results of these tests and did not use the tests to treat patients. The evidence also showed that he had also done this at other addiction facilities in the West Palm Beach area, resulting in thousands of additional fraudulent tests. Dr. Agresti had GDSL patients visit his private practice so he could fraudulently bill for services there as well.

“This defendant used his medical license to facilitate an egregious, multimillion-dollar fraud scheme that exploited vulnerable substance abusers,” said Juan Antonio Gonzalez, U.S. Attorney for the Southern District of Florida, in a statement announcing the conviction.

Three other defendants, including GDSL’s owner, Kenneth Bailynson, were previously indicted and pleaded guilty to related charges connected with the scheme. Dr. Agresti, however, insisted on his innocence throughout the trial, arguing that he was himself the victim of Mr. Bailynson. Mr. Bailynson, as a part of his plea deal, testified against Dr. Agresti at the trial.

According to a report in the Palm Beach Post, Dr. Agresti’s lawyers, in closing statements, argued, “The government did a fantastic job of proving that Dr. Agresti was negligent, maybe even grossly negligent, but that’s not the issue in this case.” The jury disagreed.

Dr. Agresti faces a maximum penalty of 20 years in prison for the healthcare fraud and wire fraud conspiracy charges and 10 years for each count of healthcare fraud. Sentencing is scheduled for April 21.
 

Ten people, including two physicians, charged in Texas kickback scheme

Jose Maldonado, MD, 48, a family medicine physician, and Eduardo Carlos Canova, MD, 44, an internal medicine specialist, both based in Laredo, Tex., were among ten people indicted in connection with a $300 million healthcare fraud scheme

According to the federal indictment, the founders of several lab companies, including Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs, LLC, allegedly paid kickbacks to medical practitioners in exchange for orders for medically unnecessary lab tests, which were then billed to Medicare and other federal healthcare programs. The medical professionals, including Dr. Maldonado and Dr. Canova, are alleged to have accepted bribes for ordering millions of dollars’ worth of tests.

The scheme was facilitated by marketing firms, which paid doctors hundreds of thousands of dollars for “advisory services,” according to officials. Rather than providing advice, however, the physicians provided lab test referrals. The labs are accused of paying portions of the salaries of the doctors’ staffs as well as portions of their leases. In some instances, direct payments were made to the practitioner’s spouse. In one case, the labs informed one practitioner that the payments would cease if he didn’t refer more tests. He responded to the threat by immediately increasing his lab referrals, averaging 20 to 30 referrals a day.

Jeffrey Madison, the founder of Spectrum and Unified, is accused of convincing Reliable’s founders to convert their business to a physician-owned lab to disguise the kickbacks. Reliable offered physicians ownership opportunities only if they referred enough lab tests. In some cases, says the indictment, the labs made advance payments to physicians to ensure that those physicians would not send samples to other labs.

The scheme resulted in more than $300 million in billing to federal government healthcare programs. Between 2015 and 2018, Dr. Maldonado alone received more than $400,000 in kickbacks for ordering more than $4 million worth of lab tests, and Dr. Canova received more than $300,000 for ordering more than $12 million in tests, according to the indictment.

The 26-count indictment included charges of conspiracy to commit healthcare fraud, conspiracy to pay and receive healthcare kickbacks, offering or paying illegal kickbacks, and soliciting or receiving illegal kickbacks.
 

N.J. doc charged on 34 counts of illegally prescribing controlled substances

A N.J. orthopedic surgeon has been charged with 34 counts of illegally prescribing controlled substances.

According to documents filed in the case, from November 2016 to February 2018 Evangelos Megariotis, MD, 68, of Passaic County, N.J., prescribed opiates — including oxycodone, alprazolam (Xanax), and cough syrup with codeine — as well as stimulants without a legitimate medical purpose and outside the usual course of his practice.

Before the State of New Jersey permanently banned him from practicing medicine, Dr. Megariotis owned and operated Clifton Orthopedic Associates, in Clifton, N.J.

According to The Bergin Record, the state alleges that Dr. Megariotis prescribed thousands of doses of painkillers even though he knew his patients were abusing them and in some cases were getting similar drugs from other doctors. In addition, Dr. Megariotis failed to diagnose or treat these patients’ underlying conditions, treated illnesses outside his scope of practice, and performed surgery in the absence of medical need.

If convicted, Dr. Megariotis could face a lengthy prison sentence as well as substantial fines. The counts of illegally prescribing Schedule II opioids and stimulants are punishable by a maximum of 20 years in prison and a $1 million fine. Illegally prescribing Schedule IV controlled substances brings a maximum of 5 years in prison and a $250,000 fine. The counts of illegally prescribing cough syrup with codeine, a Schedule V controlled substance, are punishable by a maximum of 1 year in prison and a $100,000 fine.
 

Michigan surgeon pleads guilty to fraud scheme

A Bay City, Mich., vascular surgeon has pleaded guilty to engaging in a scheme to defraud Medicare, Medicaid, and Blue Cross/Blue Shield of Michigan out of approximately $19.5 million

According to the plea agreement, in 2009, Vasso Godiali, MD, 59, began false and fraudulent billing to the three insurers. False claims included billing for the placement of stents in dialysis patients and for the treatment of arterial blood clots. The surgeon admitted to billing for the placement of multiple stents in the same vessel and preparing medical records to support the necessity of placing those stents. However, he never placed the stents.

In the plea document, Dr. Godiali also admitted that his medical records would describe occluded arteries that would justify arterial thrombectomies. However, in many cases, there were no occluded arteries, and no thrombectomies were performed, even though Dr. Godiali billed insurers for them.

“When Dr Godiali submitted claims for medical services that were never provided, he violated the trust of his patients and defrauded taxpayer-funded health care programs,” Mario M. Pinto, special agent in charge, said in a statement announcing the plea.

In 2014, The Bay City Times interviewed Dr. Godiali after he was featured by USA Today as one of seven physicians in the United States to receive more than $10 million for Medicare reimbursements in 2012. He told The Times he was a workaholic. “I work a lot — I work probably more than surgeons that you meet,” he told the paper.

Dr. Godiali faces up to 10 years in prison. In addition, he will be required to pay $19.5 million in restitution to the three insurers. A civil forfeiture case against approximately $39.9 million seized from accounts controlled by Dr. Godiali is pending. Sentencing is scheduled for September 15.

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

The use of a robotic-assisted device to perform transcranial Doppler ultrasound greatly improved the detection of right-to-left cardiac shunts in patients with presumed embolic strokes compared with the current standard of care – transthoracic echocardiography – in a new study.

Being far easier to perform than regular transcranial Doppler ultrasound, it’s hoped that use of the robotic device will enable many more patients to undergo the more sensitive transcranial screening modality and increase the number of shunts identified.

“I believe robot-assisted transcranial Doppler ultrasound can fill the gap between the gold standard transcranial Doppler and transthoracic echocardiography, which is the current standard of care,” said lead author Mark Rubin, MD.  

Dr. Rubin, who is assistant professor of neurology at University of Tennessee Health Science Center, Memphis, presented results of the BUBL study at the International Stroke Conference (ISC) 2022, where they were greeted with applause from the floor.
 

An improvement in the current standard of care

Dr. Rubin explained that patients with suspected embolic stroke are routinely screened for shunts in the heart, such as patent foramen ovale (PFO), that allow blood to flow from the right chamber to the left chamber and can lead to clots from the venous system, accessing the arterial system, then traveling to the brain and causing a stroke.

The current standard of care in screening for such shunts is the use of transthoracic echocardiography (TTE), a widely available and easy to perform, non-invasive procedure. “But we have known for decades that TTE does not pick up these shunts very well. With a sensitivity of only around 45%, it identifies less than half of the patients affected,” Dr. Rubin noted.  

The more sensitive transesophageal echocardiography (TEE) gives much better results, but it is an invasive and unpleasant procedure with the ultrasound probe being passed down the throat, and the patient needing to be sedated, so it’s not appropriate for everyone, he noted.

“Transcranial Doppler ultrasound (TCD) also gives excellent results, with a sensitivity of about 96% for detecting PFO, but this procedure is difficult to perform and requires a great deal of skill in placing the probes in the right position and interpreting the signal,” Dr. Rubin said. “TCD has been around for decades, but it hasn’t caught on, as it is too difficult to do. It takes a lot of time to learn the technique.”

“With the robotic-assisted transcranial Doppler device, we can achieve the sensitivity of TCD without needing expert operators. This should vastly improve accessibility to this technology,” he said. “With such technology we can make significant strides into more accurate diagnoses on the cause of stroke, which should lead to better preventive treatments in those found to have right-to-left shunts.”  
 

Robotic detection of shunts

For the BUBL study, the robotic TCD technique was compared with the standard TTE in 129 patients who had a diagnosis of presumed embolic stroke or transient ischemic attack (TIA), with all patients undergoing both procedures.  

The robotic TCD device resembles a giant pair of headphones containing the ultrasound probes, which are attached to a frame. In the study, it was operated by a health care professional without TCD skills. Each ultrasound probe independently scans the temporal area autonomously – with angling and positive pressure against the scalp akin to a sonographer – to find and optimize bilateral middle cerebral artery signals, Dr. Rubin explained.

The primary endpoint was the detection of a right-to-left shunt. This occurred in 82 of the 129 patients (63.6%) with the robotic TCD device but in only 27 patients (20.9%) when TTE was used. This gives an absolute difference of 42.6% (95% confidence interval, 28.6%-56.7%; P < .001), which Dr. Rubin described as “astounding.”

However, he said he was not surprised by these results.

“In my experience with transcranial Doppler, I find shunts in patients every day that have not been seen with transthoracic echo,” he commented.

He noted that a previous meta-analysis has suggested a similar difference between TCD and transthoracic echo, but the current study provides prospectively collected data produced in a clinical trial setting and is therefore more reliable. 

“What I hope comes from this is that more patients will be able to undergo transcranial Doppler, which is a far superior screening technique for identifying right-to-left shunts. There is so much evidence to support the use of transcranial Doppler, but with this new artificial-intelligence robotic device, we don’t need an expert to use it,” Dr. Rubin said.   

He explained that finding a right-to-left shunt in stroke patients is particularly important, as it can direct treatment strategies to reduce future risk of recurrent strokes.

“If a patient has a large shunt, then they have a high risk of having another stroke, and the PFO should be closed.”

In this study, the robotic-assisted TCD detected three times as many large shunts that were considered “intervenable,” compared with transthoracic echo, identifying these shunts in 35 patients (27%) compared to just 13 (10%) with TTE.

“Of the 35 patients with intervenable shunts detected with robotic transcranial Doppler, TTE was completely negative in 18 of them and only suggested a small shunt in the others. So, the standard of care (TTE) missed half the patients with intervenable PFOs,” Dr. Rubin reported.