The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

mlesney@mdedge.com

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

mlesney@mdedge.com

The Food and Drug Administration announced that it has approved cefiderocol (Fetroja), an IV antibacterial drug to treat complicated urinary tract infections (cUTIs), including kidney infections, caused by multidrug-resistant gram-negative microorganisms in patients 18 years of age or older.

The safety and effectiveness of cefiderocol was demonstrated in a pivotal study of 448 patients with cUTIs. Published results indicated that 73% of patients had resolution of symptoms and eradication of the bacteria approximately 7 days after completing treatment, compared with 55% in patients who received an alternative antibiotic.

The approval is for patients who have limited or no alternative treatment options and includes a label warning regarding cefiderocol’s higher all-cause mortality observed in comparison to patients treated with other antibiotics in a trial of critically ill patients having multidrug-resistant gram-negative bacterial infections (clinical trials. gov NCT02714595).

The cause of the increase in mortality has not been determined, according to the FDA. Some of the deaths in the study were attributable to worsening or complications of infection, or underlying comorbidities, in patients treated for hospital-acquired/ventilator-associated pneumonia (i.e., nosocomial pneumonia), bloodstream infections, or sepsis. Thus, safety and efficacy of cefiderocol has not been established for the treating these types of infections, according to the announcement.

Adverse reactions observed in patients treated with cefiderocol included diarrhea, constipation, nausea, vomiting, elevations in liver tests, rash, infusion-site reactions, and candidiasis. The FDA added that cefiderocol should not be used in persons known to have a severe hypersensitivity to beta-lactam antibacterial drugs.

“A key global challenge the FDA faces as a public health agency is addressing the threat of antimicrobial-resistant infections, like cUTIs. This approval represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research said in the FDA press statement.

Fetroja is a product of Shionogi.

mlesney@mdedge.com

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

As wildfires increase the likelihood of respiratory illnesses for residents in California and Queensland, Australia, a new report from the Lancet warns that such health risks will become increasingly common without action to address climate change. But, the authors stressed, it’s still possible to prevent some health effects and mitigate others.

Given the magnitude of the issue, lead author Nick Watts, MBBS, MA, framed the issue in terms of what an individual child born today will face in his or her future. If the world continues on its current trajectory, such a child will eventually live in a world at least 4º C above average preindustrial temperatures.

“We roughly know what that looks like from a climate perspective,” said Dr. Watts, executive director of The Lancet Countdown: Tracking Progress on Health and Climate Change, during a telebriefing on the report.

“We have no idea of what that looks like from a public health perspective, but we know it is catastrophic,” he continued. “We know that it has the potential to undermine the last 50 years of gains in public health and overwhelm the health systems that we rely on.”

Health sector a significant, growing contributor

The report described the changes to which climate change has already contributed and addresses both the health threats and the way institutions and states are currently responding to those threats. It also included policy briefs specific to individual countries and an extensive appendix with projections data.

The authors noted that progress in mitigating fossil fuel combustion – the biggest driver of rising temperatures – is “intermittent at best,” with carbon dioxide emissions continuing to rise in 2018. The past decade has included 8 of the 10 hottest years on record. “Many of the indicators contained in this report suggest the world is following this ‘business as usual’ pathway,” the authors wrote.

In fact, the trend of coal-produced energy that had been declining actually increased 1.7% between 2016 and 2018. Perhaps ironically, given the focus of the report, “the health­care sector is responsible for about 4.6% of global emissions, a value which is steadily rising across most major economies,” Dr. Watts and colleagues reported.

The potential health risks from climate change range from increased chronic illness, such as asthma and cardiovascular disease, to the increased spread of infectious diseases, especially vector-borne diseases, including dengue fever, malaria, and chikungunya. Increases in the frequency and intensity of severe weather events can lead to increased acute and longer-term morbidity and mortality.

Though children will suffer the brunt of negative health impact from climate change, the effects will touch people at every stage of life, from in utero development through old age, the authors emphasized.

“Downward trends in global yield potential for all major crops tracked since 1960 threaten food production and food security, with infants often the worst affected by the potentially permanent effects of undernutrition,” the authors reported. Children are also most susceptible to diarrheal disease and infectious diseases, particularly dengue.

Mitigating actions available

But the report focused as much on solutions and mitigation strategies as it did on the worst-case scenario without action. Speakers during the telebriefing emphasized the responsibility of all people, including physicians and other health care providers, to play a role in countering the public health disaster that could result from inaction on climate.

“Thankfully, here we have the treatment for climate change, solutions to shift away from the carbon pollution and towards clean energy and working to find the best way to protect ourselves and each other from climate change,” Renee N. Salas, MD, MPH, lead author of the 2019 Lancet Countdown U.S. Policy Brief and a Harvard C-CHANGE Fellow, said during the press briefing. “All we need is political will.”

Salas compared the present moment to that period when a physician still has the ability to save a critically ill patient’s life with fast action.

“If I don’t act quickly, the patient may still die even though that treatment would have saved their life earlier,” she said. “We are in that narrow window.”

Physicians have a responsibility to speak to patients and families frankly about not only specific conditions, such as asthma, but also the climate-related causes of those conditions, such as increasing air pollution, said Gina McCarthy, director of the Harvard Center for Climate, Health and the Global Environment and the 13th administrator U.S. Environmental Policy Administration. Physicians are trusted advisers and therefore need to speak up because climate change is “about the health and well-being and the future of children,” she said.

Political polarization is one of the biggest challenges to addressing climate change and stymies efforts to take action, according to Richard Carmona, MD, who served as the 17th U.S. Surgeon General.

“The thing that frustrated me as a surgeon general and continues to frustrate me today is that these very scientifically vetted issues are reduced to political currency that creates divisiveness, and things don’t get done,” he said during the briefing.

“We have to move beyond that and elevate this discussion to one of the survival of our civilization and the health and safety and security of all nations in the world,” continued Dr. Carmona, who is also a professor of public health at the University of Arizona in Tucson.

The report notes that the warming is already “occurring faster than governments are able, or willing, to respond,” likely contributing to the increased outcry across the world from youth about the need to act.

And anyone can take some kind of action, Ms. McCarthy said. Her aim is to make the reality of climate change effects personal so that people understand its impact on them as well as what they can do.

“The report provides a list of actions that policy makers can take today to reduce the threat of climate change” as well as information on “how we can adapt and be more resilient as communities” while facing climate change’s challenges, she said.

Ms. McCarthy encouraged people to pay particular attention to the report’s mitigation and adaptation recommendations, “because I want them to know that climate change isn’t a lost cause,” she said. The actions people can demand of policymakers will not only avoid the worst-case health scenario but can also improve health today, she added.

“We can do better than to dwell on the problem,” Ms. McCarthy said. “We need people now to be hopeful about climate change, to do as others have suggested and demand action and take action in their own lives. We can use that to really drive solutions.”

Annual report assesses numerous indicators

The Lancet Countdown is an annual report supported by the Wellcome Trust that pulls together research from 35 academic institutions and United Nations agencies across the world to provide an update on what the authors described as “41 health indicators across five key domains: climate change impacts, exposures and vulnerability; adaptation, planning, and resilience for health; mitigation action and health cobenefits; economics and finance; [and] public and political engagement.”

Given the complexity of the issue of climate change and the wide range of possible effects and preventive measures, contributing researchers included not just climate scientists but also ecologists, mathematicians, engineers, hydrologists, social and political scientists, physicians and other public health professionals, and experts in energy, food, and transportation.

The research was supported by the Wellcome Trust. Multiple authors also received support from a range of government institutions and public and private foundations and fellowships. No relevant financial relationships were noted.
 

SOURCE: Watts N et al. Lancet. 2019 Nov 13. doi: 10.1016/S0140-6736(19)32596-6.

This story first appeared in Medscape.com.

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

msullivan@mdedge.com

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

msullivan@mdedge.com

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

Adults worried about dementia are far more likely to do crossword puzzles and take fish oil than they are to talk to their doctor about risk, Donovan T. Maust, MD, and colleagues reported in a research letter published in JAMA Neurology.

More than half of study participants used crossword puzzles as a memory exercise, but only 5% said they spoke to their physician about how to reduce risk. Ironically, this lack of communication was also associated with buying unproven over-the-counter memory supplements, while still remaining ignorant of proven ways to head off dementia and other contributing chronic conditions, wrote Dr. Maust of the University of Michigan, Ann Arbor, and coauthors.

Their analysis of the Michigan National Poll on Healthy Aging found that close to half of respondents (48.5%) reported that they were at least somewhat likely to develop dementia. Another 4.2% thought dementia was “very likely” in their future.

The study comprised survey responses from 1,019 adults aged 50-64 years. Most rated their physical health either excellent (445 respondents) or good (413 respondents). Most also reported excellent or very good mental health (721 respondents); 234 reported good mental health. Many (678) were affluent, with annual incomes of $60,000 or higher. They tended to be well educated; only 337 were without at least some college education. More than half were white (753); there were 101 Hispanic respondents and 93 black respondents. Other groups made up the remainder.

A multivariate analysis found that black respondents were about half as likely to believe they would develop dementia, compared with whites – an assumption contrary to epidemiologic findings that blacks are more likely than whites to develop dementia.

People who reported fair or poor mental health were more than twice as likely to feel dementia was in their future (odds ratio, 2.3). But fair or poor physical health was not significantly associated with that concern.

“Those with fair to poor physical health did not accurately perceive that their likelihood of developing dementia was potentially higher than respondents with very good or excellent physical health,” the authors wrote. “In contrast, fair to poor mental health had the largest association with perceived likelihood of dementia, even though less evidence suggests that poor mental health is causally linked with dementia.”

Despite the concerns, just 5% of respondents said that they had spoken to their physician. Those who believed they had a high likelihood of dementia were more likely to talk with their clinician (7.1%) than those who believed they had a low risk (3.6%).

Many more, however, were using non–evidence-based compounds touted as memory supporting. These included fish oil or omega-3 fatty acids (31.6%) and vitamins or supplements (32.9%). Crossword puzzles were a very popular prevention strategy, employed by about 55% in both belief groups.

“While managing chronic medical conditions, such as diabetes or cardiovascular disease, could reduce dementia risk, few respondents appear to have discussed this with their physician. Given repeated failures of disease-preventing or disease-modifying treatments for dementia, interest in treatment and prevention has shifted earlier in the disease process. Adults in middle age may not accurately estimate their risk of developing dementia, which could lead to both overuse and underuse if preclinical dementia treatments become available. Policy and physicians should emphasize current evidence-based strategies of managing lifestyle and chronic medical conditions to reduce the risk of dementia,” the investigators wrote.

Dr. Maust had no financial disclosures.

msullivan@mdedge.com

SOURCE: Maust D et al. JAMA Neurol. 2019 Nov 15. doi: 10.1001/jamaneurol.2019.3946

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

COPENHAGEN – Paying patients with schizophrenia a modest sum to take their long-acting injectable antipsychotic agents is a proven, evidence-based strategy for achieving improved adherence. Now it’s time to find out whether the same approach will work in patients on oral antipsychotics, Daniel Guinart, MD, said at the annual congress of the European College of Neuropsychopharmacology.

He presented a systematic literature review that turned up four studies, including two randomized clinical trials, of economic incentives aimed at improving adherence to long-acting injectable antipsychotics. The studies, all positive, showed that small financial incentives improved adherence by 12%-15%. However, once the intervention ended, adherence drifted back downward, so the financial reinforcement needs to be ongoing.

This approach has not previously been tested in outpatients with severe mental illness who are on oral antipsychotics because of the intrinsic limitations of reliance upon patient self-reported adherence. But Dr. Guinart and his coinvestigator, John M. Kane, MD, professor and chair of the department of psychiatry at Hofstra University in Hempstead, N.Y., have launched a 25-patient proof-of-concept study using technology to measure outpatient adherence. Provided that the pilot study shows this approach is feasible, the plan is to conduct a larger, longer-term, randomized controlled trial, said Dr. Guinart, also at Hofstra University.

If the modest financial expenditures involved in payment for pill taking do indeed prove to improve outpatient adherence to oral antipsychotics, it could reap major dividends in terms of fewer relapses, emergency department visits, hospitalizations, suicide attempts, and legal problems for patients, he noted.

The financial incentive to take oral antipsychotics needs to be big enough to promote behavioral change, but not so large that it poses ethical issues or encourages patients to game the system by lowering their adherence in order to gain entrance into the program. Fortunately, prior studies of successful behavioral incentives to take antihypertensive medications and other oral nonpsychotrophic drugs provide guidance on this score.

“One to two dollars per day is considered a reasonable incentive because it generates behavioral change, yet $30 per month doesn’t really serve as a financial aid,” the psychiatrist explained in an interview.

In the pilot study, adherence to oral antipsychotics is being assessed by having patients snap a cell phone photo of their daily medications being held in hand. Proprietary software analyzes whether those are the correct pills as prescribed. If so, the patient gets rewarded.

“It’s possible that after taking the photo some patients may throw the pills away. In adherence studies, we’re not the police, so at some point we have to trust that the patient is taking the medication,” he said.

Dr. Guinart reported having no financial conflicts of interest regarding his presentation.

bjancin@mdedge.com

Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?

Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.

Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.

Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.

The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.

Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.

The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”

Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?

Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.

Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.

Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.

The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.

Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.

The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”

Veterans have some of the highest rates of overweight and obesity in the country: 78%, compared with 35% of American adults overall. So bariatric surgery can be a boon to many veterans. But while it improves health for those with severe obesity, does it also translate into lower health care costs?

Researchers from the Durham VA Medical Center (VAMC) say no. In a study funded by VA Health Services Research and Development and the National Institute on Drug Abuse, they analyzed data on 2,498 veterans who underwent bariatric surgery between January 2000 and September 2011, and 7,456 patients (also severely obese) who did not have surgery. The researchers compared the 2 groups’ outpatient, inpatient, and pharmacy expenditures from 3 years before surgery to 10 years after surgery.

Mean total expenditures for the surgery cohort were $5,093 at 7 to 12 months before surgery, $1,400 higher than costs for the nonsurgery group. The numbers rose to $7,448 at 6 months after surgery—$3,000 higher than in the nonsurgery group. Postsurgical expenditures dropped to $6,692 at 5 years, then gradually increased to $8,495 at 10 years. Outpatient pharmacy expenditures were significantly lower among the surgery cohort throughout the follow-up, but the cost reductions were offset by higher inpatient and outpatient expenditures.

Total expenditures were higher in the surgery cohort than the nonsurgery cohort during the 3 years before and the first 2 years after surgery, but the numbers of the 2 groups converged 5 to 10 years after surgery.

The researchers offer some possible reasons that the surgery did not lower health care costs. For instance, despite better overall health, patients may still need to be treated for short-term complications of bariatric surgery, such as nausea, anemia, and vitamin deficiencies. The surgery patients also may have needed additional procedures, such as removal of excess skin. They might have become eligible for knee or hip replacement after having lost weight.

Finally, the researchers point out, many conditions linked to obesity, such as diabetes, do not necessarily go away when the patient loses weight.

The study authors noted that “few health care treatments are required to be cost saving or even cost-effective to be widely available, so requiring cost savings of bariatric surgery imposes an unfair standard.”

The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

Olivier Le Moal/Getty Images

The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.

The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.

Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.

The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.

“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.

lfranki@mdedge.com

The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

Olivier Le Moal/Getty Images

The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.

The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.

Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.

The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.

“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.

lfranki@mdedge.com

The Food and Drug Administration has approved zanubrutinib (Brukinsa) for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.

Olivier Le Moal/Getty Images

The approval is based on results from two separate studies; in a global phase 1/2 trial, patients with relapsed or refractory MCL who received zanubrutinib had an overall response rate of 84%, with 22% experiencing a complete response and 62% experiencing partial response. Median duration of response was 18.5 months. The ORR in the second study – a multicenter phase 2 trial – was also 84%, but with 59% experiencing a complete response and 24% experiencing partial response; duration of response was 19.5 months.

The most common adverse events reported during the trials were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, cough, musculoskeletal pain, pneumonia, urinary tract infection, hematuria, fatigue, constipation, and hemorrhage. The most common serious adverse events were pneumonia and hemorrhage.

Of the 118 patients with MCL treated with zanubrutinib over the two trials, 8 had to be discontinued because of adverse events.

The recommended dose of zanubrutinib is 320 mg, taken orally 160 mg twice daily or 320 mg once daily, with or without food.

“BTK [Bruton kinase] inhibition is an established mode of treatment for patients with MCL, but many patients treated with previously approved BTK inhibitors do not fully respond to BTK therapy or are forced to discontinue treatment early due to side effects. Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL,” Luhua (Michael) Wang, MD, clinical trial investigator and professor in the department of lymphoma and myeloma at the University of Texas MD Anderson Cancer Center, Houston, said in a statement.

lfranki@mdedge.com

ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.

Jeff Craven/MDedge News

For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.

“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.

Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.

The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.

At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).

Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).

Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and ­–1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).

Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.

There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.

Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”

When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.

“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.

The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.

SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.

ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.

Jeff Craven/MDedge News

For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.

“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.

Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.

The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.

At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).

Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).

Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and ­–1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).

Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.

There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.

Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”

When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.

“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.

The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.

SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.

ATLANTA – Patients with nonradiographic axial spondyloarthritis who received secukinumab with or without loading doses showed improvements in physical function, quality of life, inflammation, and other disease signs and symptoms, according to results from a phase 3 study presented at the annual meeting of the American College of Rheumatology.

Jeff Craven/MDedge News

For patients with nonradiographic axial spondyloarthritis in the double-blind, randomized, placebo-controlled PREVENT trial, these benefits persisted up to 52 weeks, Atul A. Deodhar, MD, professor of medicine in the division of arthritis and rheumatic diseases at Oregon Health & Science University, Portland, said in his presentation.

“This is the largest study done for a biologic agent in nonradiographic axial spondyloarthritis,” Dr. Deodhar said. The trial enrolled 185 patients who received subcutaneous secukinumab (Cosentyx) at a dose of 150 mg, 184 patients who received the medication without a loading dose, and 186 patients who received placebo.

Patients were included if they were aged at least 18 years with 6 months or more of inflammatory back pain, had objective signs of inflammation (sacroiliitis on MRI and/or C-reactive protein [CRP] at 5.0 mg/dL or higher), had active disease and spinal pain according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), had total back pain with a visual analog scale of 40 mm or greater, and had not received a tumor necrosis factor inhibitor (TNFi) or had an inadequate response to no more than one TNFi. Patients were also stratified by inflammation measured on MRI and CRP. A little more than half of the patients in each group were women, and at baseline their mean age was 39 years, with a mean symptom duration of more than 8 years and mean Ankylosing Spondylitis Disease Activity Score of 3.5-3.7.

The primary endpoint was at least 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks to meet European Union regulatory requirements and at 52 weeks for the Food and Drug Administration. Escape to open-label secukinumab or standard of care was permitted any time after week 20 for patients deemed to have inadequate response based on clinical judgment of disease activity by the investigator and patient; at 52 weeks, the trial became open label and patients in the placebo group could begin secukinumab or standard of care. The U.S. and European Union analyses were performed independently, with the European analysis including only secukinumab with loading doses and the U.S. analysis including secukinumab without loading.

At 16 weeks, an analysis of the overall population showed that 40.8% of patients in the secukinumab nonloading group had an ASAS40 response, compared with 40.0% in those who got a loading dose and 28.0% with placebo (P less than .05 for both). Among the 90% of patients who were TNFi naive, ASAS40 responses occurred in 42.2% of patients in the nonloading group, 41.5% who received a loading dose, and 29.2% with placebo (P less than .05 for both). ASAS40 response rates persisted at 52 weeks for patients in the nonloading (39.8%), loading (35.4%), and placebo (19.9%) groups (P less than .05).

Over the same time period, the least-square mean changes in total BASDAI score improved from baseline by 2.43 in the nonloading group, 2.35 in the loading group, and 1.46 in the placebo group (P less than .05). The percentage of patients who had 50% or greater improvement in BASDAI was 37% in both treatment groups, compared with 21% with placebo (P less than .05).

Function score as measured by the Bath Ankylosing Spondylitis Functional Index also showed significantly greater improvements at 16 weeks for both loading and nonloading patients versus placebo (–1.75 and ­–1.64 vs. –1.01; P less than .05). Treatment with or without a loading dose led to significant reductions in sacroiliac joint edema on MRI and high-sensitivity CRP. The percentage patients who met ASAS partial remission criteria were significantly higher in the loading (21.6%) and nonloading (21.2%) groups, compared with placebo (7.0%; P less than .05).

Physical function and quality of life assessments at 16 weeks using the 36-item Short Form Health Survey physical component score and the Ankylosing Spondylitis Quality of Life questionnaire showed significant improvements both with and without a loading dose.

There were no new safety concerns with secukinumab that arose in the trial, Dr. Deodhar said.

Dr. Deodhar admitted the placebo effect was high in the PREVENT study, but noted that this was a reoccurring problem in other areas of rheumatology. “The rates are going up in several studies, including in RA, so [in terms of] axial spondyloarthritis and why that happens, we really don’t know.”

When asked about the effect of the loading dose, Dr. Deodhar said that “the load is not really going to take over or have different response by 52 weeks; the load would have a response by 8 weeks or maybe 12 weeks, but then beyond that, I don’t think the load would have any response at all.

“In my clinical experience, speaking outside this trial, load obviously helps the patient quickly to feel better, and so that’s the way I practice my medicine,” he added.

The PREVENT study was sponsored by Novartis, which markets secukinumab. Some of the authors reported relationships with Novartis and many other pharmaceutical companies. Four authors were employees of Novartis.

SOURCE: Deodhar AA et al. Arthritis Rheumatol. 2019;71(suppl 10), Abstract L21.

PHM19 session

Mitigating the harm we cause learners in medical education

Presenters

Benjamin Kinnear, MD, MEd

Andrew Olson, MD

Matthew Kelleher, MD, MEd

Session summary

Dr. Kinnear, Dr. Olson, and Dr. Kelleher expertly led this TED-Talk style session at Pediatric Hospital Medicine 2019, convincing the audience that medical educators persistently harm the learners under their supervision.

Dr. Kinnear, of Cincinnati Children’s Hospital, opened the session noting that the path through medical school presently has a perverse focus on grades as a necessary achievement. As an expert in competency-based assessment, he asserted that the current learner assessment strategy is neither valid nor robust enough to indicate actual competence. Summary assessments presented throughout medical school are lacking continuous constructive feedback, leaving early residents in a state of shock when receiving corrective or negative assessments. He also noted that structurally many rotations create both team and patient discontinuity, leaving the learner with a feeling of detachment and limited ownership of the human patient under his/her/their care.

Dr. Olson of the University of Minnesota next described the need for the USMLE STEP 1 exam to be transitioned to a pass/fail endeavor. He cited the error of measurement of 24 points (i.e., the same test taker could have a 220 one day and a 244 the next) and the potential loss of valuable rotation experiences during the several-month period of intense study. He challenged audience members to complete an esoteric exam question to prove his point and asserted that many learners are lacking in humility, communication skills, and professionalism, and seek only the honors designation on rotations. He likened the experience of medical students on rotation and residents on service weeks to a series of first dates and affirmed the value of longitudinal learner-educator relationships.

Further, he outlined the detachment of learners from patient outcomes, demonstrated by frequent hand-offs and rotation transitions. Dr Olson also cited medical pedagogy as failing to meet the known needs of adult learners to engage in deliberate progressive practice, reflective practice, or to use concepts such as spacing or interleaving to reinforce knowledge.

Dr. Kelleher, also of Cincinnati Children’s Hospital, ended the session by taking those in attendance on an imagined “what-if” journey where each of the wrongs currently done to early learners in medical education were corrected. This included engagement in daily reflection (5 minutes at a time), reporting system issues on rounds that had failed the patient, presenting learners with a CV of attending failures to reinforce the imperfection that is a reality in medicine, praising learners when they admit “they don’t know the answer” to a question posed on rounds, completing assessments in real time in the learner’s presence, rounding until specific feedback can be identified for each learner on the team, having a kiosk on each floor where ANY team member could provide feedback to learners, using cognitive science on rounds for teaching (i.e., Socratic) rather than pimping, modeling interprofessional teamwork daily using a culture of vulnerability rather than infallibility (i.e., airline culture), and by encouraging the attending to care for patients or complete tasks independently, showing the value of education over service and model ideal family-centered communication with the team.

One might wonder, if all of the above were accomplished at the request of our talented presenters, would a pass/fail USMLE world where medical education was learner centered and filled with longitudinal relationships with teams and patients, and outcomes were connected to education produce more engaged, knowledgeable, and holistic physicians? According to this team of presenters, yes.
 

Key takeaways

• Current processes in medical education are harming today’s adult learner.

• Harms include reliance on numerical rather than competency-based assessment, fragmented learning environments, focus on perfection rather than improvement, ignorance of updates in cognitive science for instructional methodology, and individualist rather than team-based learning.

• Reforms are needed to remedy harms in health professional education, including making USMLE pass/fail, creating a learning-centered rather than service-centered residency environment, encouraging longitudinal relationships between teacher and learner, and connecting education to clinical outcomes.

Dr. King is associate program director, University of Minnesota Pediatric Residency Program, Minneapolis.

PHM19 session

Mitigating the harm we cause learners in medical education

Presenters

Benjamin Kinnear, MD, MEd

Andrew Olson, MD

Matthew Kelleher, MD, MEd

Session summary

Dr. Kinnear, Dr. Olson, and Dr. Kelleher expertly led this TED-Talk style session at Pediatric Hospital Medicine 2019, convincing the audience that medical educators persistently harm the learners under their supervision.

Dr. Kinnear, of Cincinnati Children’s Hospital, opened the session noting that the path through medical school presently has a perverse focus on grades as a necessary achievement. As an expert in competency-based assessment, he asserted that the current learner assessment strategy is neither valid nor robust enough to indicate actual competence. Summary assessments presented throughout medical school are lacking continuous constructive feedback, leaving early residents in a state of shock when receiving corrective or negative assessments. He also noted that structurally many rotations create both team and patient discontinuity, leaving the learner with a feeling of detachment and limited ownership of the human patient under his/her/their care.

Dr. Olson of the University of Minnesota next described the need for the USMLE STEP 1 exam to be transitioned to a pass/fail endeavor. He cited the error of measurement of 24 points (i.e., the same test taker could have a 220 one day and a 244 the next) and the potential loss of valuable rotation experiences during the several-month period of intense study. He challenged audience members to complete an esoteric exam question to prove his point and asserted that many learners are lacking in humility, communication skills, and professionalism, and seek only the honors designation on rotations. He likened the experience of medical students on rotation and residents on service weeks to a series of first dates and affirmed the value of longitudinal learner-educator relationships.

Further, he outlined the detachment of learners from patient outcomes, demonstrated by frequent hand-offs and rotation transitions. Dr Olson also cited medical pedagogy as failing to meet the known needs of adult learners to engage in deliberate progressive practice, reflective practice, or to use concepts such as spacing or interleaving to reinforce knowledge.

Dr. Kelleher, also of Cincinnati Children’s Hospital, ended the session by taking those in attendance on an imagined “what-if” journey where each of the wrongs currently done to early learners in medical education were corrected. This included engagement in daily reflection (5 minutes at a time), reporting system issues on rounds that had failed the patient, presenting learners with a CV of attending failures to reinforce the imperfection that is a reality in medicine, praising learners when they admit “they don’t know the answer” to a question posed on rounds, completing assessments in real time in the learner’s presence, rounding until specific feedback can be identified for each learner on the team, having a kiosk on each floor where ANY team member could provide feedback to learners, using cognitive science on rounds for teaching (i.e., Socratic) rather than pimping, modeling interprofessional teamwork daily using a culture of vulnerability rather than infallibility (i.e., airline culture), and by encouraging the attending to care for patients or complete tasks independently, showing the value of education over service and model ideal family-centered communication with the team.

One might wonder, if all of the above were accomplished at the request of our talented presenters, would a pass/fail USMLE world where medical education was learner centered and filled with longitudinal relationships with teams and patients, and outcomes were connected to education produce more engaged, knowledgeable, and holistic physicians? According to this team of presenters, yes.
 

Key takeaways

• Current processes in medical education are harming today’s adult learner.

• Harms include reliance on numerical rather than competency-based assessment, fragmented learning environments, focus on perfection rather than improvement, ignorance of updates in cognitive science for instructional methodology, and individualist rather than team-based learning.

• Reforms are needed to remedy harms in health professional education, including making USMLE pass/fail, creating a learning-centered rather than service-centered residency environment, encouraging longitudinal relationships between teacher and learner, and connecting education to clinical outcomes.

Dr. King is associate program director, University of Minnesota Pediatric Residency Program, Minneapolis.

PHM19 session

Mitigating the harm we cause learners in medical education

Presenters

Benjamin Kinnear, MD, MEd

Andrew Olson, MD

Matthew Kelleher, MD, MEd

Session summary

Dr. Kinnear, Dr. Olson, and Dr. Kelleher expertly led this TED-Talk style session at Pediatric Hospital Medicine 2019, convincing the audience that medical educators persistently harm the learners under their supervision.

Dr. Kinnear, of Cincinnati Children’s Hospital, opened the session noting that the path through medical school presently has a perverse focus on grades as a necessary achievement. As an expert in competency-based assessment, he asserted that the current learner assessment strategy is neither valid nor robust enough to indicate actual competence. Summary assessments presented throughout medical school are lacking continuous constructive feedback, leaving early residents in a state of shock when receiving corrective or negative assessments. He also noted that structurally many rotations create both team and patient discontinuity, leaving the learner with a feeling of detachment and limited ownership of the human patient under his/her/their care.

Dr. Olson of the University of Minnesota next described the need for the USMLE STEP 1 exam to be transitioned to a pass/fail endeavor. He cited the error of measurement of 24 points (i.e., the same test taker could have a 220 one day and a 244 the next) and the potential loss of valuable rotation experiences during the several-month period of intense study. He challenged audience members to complete an esoteric exam question to prove his point and asserted that many learners are lacking in humility, communication skills, and professionalism, and seek only the honors designation on rotations. He likened the experience of medical students on rotation and residents on service weeks to a series of first dates and affirmed the value of longitudinal learner-educator relationships.

Further, he outlined the detachment of learners from patient outcomes, demonstrated by frequent hand-offs and rotation transitions. Dr Olson also cited medical pedagogy as failing to meet the known needs of adult learners to engage in deliberate progressive practice, reflective practice, or to use concepts such as spacing or interleaving to reinforce knowledge.

Dr. Kelleher, also of Cincinnati Children’s Hospital, ended the session by taking those in attendance on an imagined “what-if” journey where each of the wrongs currently done to early learners in medical education were corrected. This included engagement in daily reflection (5 minutes at a time), reporting system issues on rounds that had failed the patient, presenting learners with a CV of attending failures to reinforce the imperfection that is a reality in medicine, praising learners when they admit “they don’t know the answer” to a question posed on rounds, completing assessments in real time in the learner’s presence, rounding until specific feedback can be identified for each learner on the team, having a kiosk on each floor where ANY team member could provide feedback to learners, using cognitive science on rounds for teaching (i.e., Socratic) rather than pimping, modeling interprofessional teamwork daily using a culture of vulnerability rather than infallibility (i.e., airline culture), and by encouraging the attending to care for patients or complete tasks independently, showing the value of education over service and model ideal family-centered communication with the team.

One might wonder, if all of the above were accomplished at the request of our talented presenters, would a pass/fail USMLE world where medical education was learner centered and filled with longitudinal relationships with teams and patients, and outcomes were connected to education produce more engaged, knowledgeable, and holistic physicians? According to this team of presenters, yes.
 

Key takeaways

• Current processes in medical education are harming today’s adult learner.

• Harms include reliance on numerical rather than competency-based assessment, fragmented learning environments, focus on perfection rather than improvement, ignorance of updates in cognitive science for instructional methodology, and individualist rather than team-based learning.

• Reforms are needed to remedy harms in health professional education, including making USMLE pass/fail, creating a learning-centered rather than service-centered residency environment, encouraging longitudinal relationships between teacher and learner, and connecting education to clinical outcomes.

Dr. King is associate program director, University of Minnesota Pediatric Residency Program, Minneapolis.

There is not much common ground between Republicans and Democrats these days, but both sides strongly supported the use of medical marijuana in a recent survey by the American Society of Clinical Oncology.

Overall support of medical marijuana among all 4,001 respondents was higher (84%) for use among cancer patients, but 76% also supported its use for any medical reason, according to data from the survey conducted for ASCO by the Harris Poll.

The differences in support between Republicans and Democrats were significant, but both parties were over 80% for marijuana use by cancer patients and over 70% for use for any medical reason. In both cases, the independents in between mirrored the overall population, with support at 84% and 76%, respectively, ASCO said.

Support for medical marijuana also was consistent based on the respondents’ cancer experience. For use by cancer patients, those who were current or previous patients were at 84%, caregivers (those providing unpaid care to an immediate family member or loved one with cancer) and other family members/loved ones were both at 87%, and those with no cancer experiences were at 82%, the survey results showed.

Use of marijuana for any medical reason was supported by 72% of current/previous patients, 79% of family members and loved ones, 80% of caregivers, and 74% of those with no cancer experience, ASCO reported.

In a question asked only of current or previous patients, 62% said that they are/were open to use of marijuana to alleviate cancer-related pain, nausea, or other symptoms, and 60% said that they wished they had more information about the benefits of medical marijuana use, according to the results of the survey, which was conducted online from July 9 to Aug. 10, 2019.

rfranki@mdedge.com

There is not much common ground between Republicans and Democrats these days, but both sides strongly supported the use of medical marijuana in a recent survey by the American Society of Clinical Oncology.

Overall support of medical marijuana among all 4,001 respondents was higher (84%) for use among cancer patients, but 76% also supported its use for any medical reason, according to data from the survey conducted for ASCO by the Harris Poll.

The differences in support between Republicans and Democrats were significant, but both parties were over 80% for marijuana use by cancer patients and over 70% for use for any medical reason. In both cases, the independents in between mirrored the overall population, with support at 84% and 76%, respectively, ASCO said.

Support for medical marijuana also was consistent based on the respondents’ cancer experience. For use by cancer patients, those who were current or previous patients were at 84%, caregivers (those providing unpaid care to an immediate family member or loved one with cancer) and other family members/loved ones were both at 87%, and those with no cancer experiences were at 82%, the survey results showed.

Use of marijuana for any medical reason was supported by 72% of current/previous patients, 79% of family members and loved ones, 80% of caregivers, and 74% of those with no cancer experience, ASCO reported.

In a question asked only of current or previous patients, 62% said that they are/were open to use of marijuana to alleviate cancer-related pain, nausea, or other symptoms, and 60% said that they wished they had more information about the benefits of medical marijuana use, according to the results of the survey, which was conducted online from July 9 to Aug. 10, 2019.

rfranki@mdedge.com

There is not much common ground between Republicans and Democrats these days, but both sides strongly supported the use of medical marijuana in a recent survey by the American Society of Clinical Oncology.

Overall support of medical marijuana among all 4,001 respondents was higher (84%) for use among cancer patients, but 76% also supported its use for any medical reason, according to data from the survey conducted for ASCO by the Harris Poll.

The differences in support between Republicans and Democrats were significant, but both parties were over 80% for marijuana use by cancer patients and over 70% for use for any medical reason. In both cases, the independents in between mirrored the overall population, with support at 84% and 76%, respectively, ASCO said.

Support for medical marijuana also was consistent based on the respondents’ cancer experience. For use by cancer patients, those who were current or previous patients were at 84%, caregivers (those providing unpaid care to an immediate family member or loved one with cancer) and other family members/loved ones were both at 87%, and those with no cancer experiences were at 82%, the survey results showed.

Use of marijuana for any medical reason was supported by 72% of current/previous patients, 79% of family members and loved ones, 80% of caregivers, and 74% of those with no cancer experience, ASCO reported.

In a question asked only of current or previous patients, 62% said that they are/were open to use of marijuana to alleviate cancer-related pain, nausea, or other symptoms, and 60% said that they wished they had more information about the benefits of medical marijuana use, according to the results of the survey, which was conducted online from July 9 to Aug. 10, 2019.

rfranki@mdedge.com

Researchers are attempting to determine, early in the treatment process, which children with acute lymphoblastic leukemia (ALL) have an increased risk of neurocognitive deficits after chemotherapy.

Rutgers Cancer Institute of New Jersey

The goal of the researchers’ project (5R01CA220568-02) is to determine if gene variants and biomarkers associated with oxidative stress, neuroinflammation, and folate physiology correlate with cognitive decline during and after chemotherapy. Ideally, certain variants and biomarkers will reveal patients who might benefit from interventions to prevent or even reverse cognitive deficits.

Peter D. Cole, MD, of Rutgers Cancer Institute, New Brunswick, N.J., and colleagues are conducting this research in patients from the DFCI-16-001 trial (NCT03020030). This multicenter, phase 3 study is enrolling patients (aged 1-21 years) with B- or T-cell ALL who then receive a multidrug chemotherapy regimen.

Dr. Cole and colleagues are analyzing a subset of patients from the trial, looking for relationships between chemotherapy-induced neurocognitive changes, gene variants, and changes in biomarkers detected in cerebrospinal fluid (CSF).

“We’re looking at a broad panel of target gene variants that are associated with either drug metabolism, defenses against oxidative stress, neuroinflammation, or folate physiology,” Dr. Cole said in an interview.

This includes variants Dr. Cole and colleagues identified in a previous, retrospective study of ALL survivors. The researchers found that survivors who were homozygous for NOS3 894T, had a variant SLCO2A1 G allele, or had at least one GSTP1 T allele were more likely to exhibit cognitive deficits (J Clin Oncol. 2015 Jul 1;33[19]:2205-11).

The researchers are also analyzing CSF samples, looking for changes in tau protein, homocysteine, homocysteic acid, the adenosylmethionine to adenosylhomocysteine ratio, and other biomarkers of oxidative stress, neuroinflammation, and folate physiology. The CSF is collected at five time points: the start of chemotherapy, day 18, the start of first consolidation, the end of first consolidation, and 7 weeks later in second consolidation.

Cognitive testing

While Dr. Cole is leading the genetic and biomarker analyses, Stephen A. Sands, PsyD, of Memorial Sloan Kettering Cancer Center in New York, is leading the cognitive testing.

The researchers are evaluating patients for cognitive decline using computerized tests from a company called Cogstate. The tests are designed to assess functions such as processing speed, attention, visual learning, and working memory. The tests are administered on an iPad and involve tasks like identifying features of playing cards and finding the correct way through a maze.

The patients – aged 3 years and older – undergo cognitive testing at six time points: baseline, which is any time between days 8 and 32 of induction (except within 72 hours after sedation or anesthesia); at first consolidation; the end of central nervous system therapy; 1 year into chemotherapy; the end of chemotherapy; and 1 year after chemotherapy ends.

In a prior study, Cogstate testing proved reliable for detecting neurocognitive changes in patients undergoing treatment for ALL (Support Care Cancer. 2017;25[2]:449-57). In the current study, the researchers are supplementing Cogstate test results with Wechsler IQ tests administered 1 year after patients complete chemotherapy.

Dr. Sands noted that Cogstate tests provide benefits over the Wechsler “paper-and-pencil” tests. One benefit is that Cogstate tests can be given more often without inducing practice effects (J Clin Exp Neuropsychol. 2006 Oct;28[7]:1095-112). Another is that Cogstate tests can be administered by anyone with a bachelor’s degree who has undergone the appropriate training, while Wechsler IQ tests must be given by psychologists.

Preliminary results

This research is ongoing, so it’s too early to announce any discoveries, but the study is moving along as planned.

Gio_tto/Thinkstock

“The preliminary data we have so far are demonstrating the validity of the study,” Dr. Cole said. “Things are going well. We’re able to do the cognitive testing and collect the samples that we need and ship them without losing the integrity of the samples.”

Dr. Sands noted that enrollment has been encouraging. As this is a substudy of DFCI-16-001, the researchers must obtain consent separately from the main study. Dr. Sands said about 89% of parents involved in the main study have agreed to enroll their children in the substudy.

Dr. Sands also said that early results from Cogstate testing have revealed patients who are experiencing cognitive decline during treatment. The researchers still have to determine if these results correlate with any biomarkers or gene variants.

Potential interventions

If the researchers can pinpoint patients at risk for cognitive deficits, the next step will be to investigate pharmacologic and behavioral interventions.

Dr. Cole said he is particularly interested in treatments that reduce oxidative stress, such as dextromethorphan and memantine. Dextromethorphan has been shown to resolve symptoms of methotrexate-induced neurotoxicity in patients (Pediatr Hematol Oncol. 2002 Jul-Aug;19[5]:319-27), and memantine reduced memory deficits in animals treated with methotrexate (Clin Cancer Res. 2013 Aug 15;19[16]:4446-54).

“Memantine hasn’t been used in kids with leukemia yet, but it’s something that I’d like to see brought to a clinical trial,” Dr. Cole said.

Dr. Sands pointed to other potential pharmacologic interventions, including the stimulants methylphenidate and modafinil. Both drugs have been shown to improve cognitive deficits in cancer survivors (J Clin Oncol. 2001 Mar 15;19[6]:1802-8; Cancer. 2009 Jun 15; 115[12]: 2605-16).

Computer-based cognitive training tools may be another option. One such tool, Lumosity, improved executive functions in a study of breast cancer survivors (Clin Breast Cancer. 2013 Aug;13[4]:299-306). Another tool, CogMed, improved working memory in survivors of brain tumors and ALL (Psychooncology. 2013 Aug; 22[8]: 1856-65).

Other behavioral interventions might include sleep hygiene and exercise. Sleep hygiene has been shown to improve cognitive function in childhood cancer survivors (Cancer. 2011 Jun 1;117[11]:2559-68), and a recent study revealed an association between exercise intolerance and negative neurocognitive outcomes in ALL survivors (Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510).

“What we need to figure out is which children will respond to which interventions,” Dr. Sands said, adding that interventions will likely need to be combined.

“It’s not going to be one thing that will work for everybody,” he said. “It’s going to be: What packages of things will work for different people?”

Dr. Sands and Dr. Cole reported having no relevant financial disclosures.

jensmith@mdedge.com

Researchers are attempting to determine, early in the treatment process, which children with acute lymphoblastic leukemia (ALL) have an increased risk of neurocognitive deficits after chemotherapy.

Rutgers Cancer Institute of New Jersey

The goal of the researchers’ project (5R01CA220568-02) is to determine if gene variants and biomarkers associated with oxidative stress, neuroinflammation, and folate physiology correlate with cognitive decline during and after chemotherapy. Ideally, certain variants and biomarkers will reveal patients who might benefit from interventions to prevent or even reverse cognitive deficits.

Peter D. Cole, MD, of Rutgers Cancer Institute, New Brunswick, N.J., and colleagues are conducting this research in patients from the DFCI-16-001 trial (NCT03020030). This multicenter, phase 3 study is enrolling patients (aged 1-21 years) with B- or T-cell ALL who then receive a multidrug chemotherapy regimen.

Dr. Cole and colleagues are analyzing a subset of patients from the trial, looking for relationships between chemotherapy-induced neurocognitive changes, gene variants, and changes in biomarkers detected in cerebrospinal fluid (CSF).

“We’re looking at a broad panel of target gene variants that are associated with either drug metabolism, defenses against oxidative stress, neuroinflammation, or folate physiology,” Dr. Cole said in an interview.

This includes variants Dr. Cole and colleagues identified in a previous, retrospective study of ALL survivors. The researchers found that survivors who were homozygous for NOS3 894T, had a variant SLCO2A1 G allele, or had at least one GSTP1 T allele were more likely to exhibit cognitive deficits (J Clin Oncol. 2015 Jul 1;33[19]:2205-11).

The researchers are also analyzing CSF samples, looking for changes in tau protein, homocysteine, homocysteic acid, the adenosylmethionine to adenosylhomocysteine ratio, and other biomarkers of oxidative stress, neuroinflammation, and folate physiology. The CSF is collected at five time points: the start of chemotherapy, day 18, the start of first consolidation, the end of first consolidation, and 7 weeks later in second consolidation.

Cognitive testing

While Dr. Cole is leading the genetic and biomarker analyses, Stephen A. Sands, PsyD, of Memorial Sloan Kettering Cancer Center in New York, is leading the cognitive testing.

The researchers are evaluating patients for cognitive decline using computerized tests from a company called Cogstate. The tests are designed to assess functions such as processing speed, attention, visual learning, and working memory. The tests are administered on an iPad and involve tasks like identifying features of playing cards and finding the correct way through a maze.

The patients – aged 3 years and older – undergo cognitive testing at six time points: baseline, which is any time between days 8 and 32 of induction (except within 72 hours after sedation or anesthesia); at first consolidation; the end of central nervous system therapy; 1 year into chemotherapy; the end of chemotherapy; and 1 year after chemotherapy ends.

In a prior study, Cogstate testing proved reliable for detecting neurocognitive changes in patients undergoing treatment for ALL (Support Care Cancer. 2017;25[2]:449-57). In the current study, the researchers are supplementing Cogstate test results with Wechsler IQ tests administered 1 year after patients complete chemotherapy.

Dr. Sands noted that Cogstate tests provide benefits over the Wechsler “paper-and-pencil” tests. One benefit is that Cogstate tests can be given more often without inducing practice effects (J Clin Exp Neuropsychol. 2006 Oct;28[7]:1095-112). Another is that Cogstate tests can be administered by anyone with a bachelor’s degree who has undergone the appropriate training, while Wechsler IQ tests must be given by psychologists.

Preliminary results

This research is ongoing, so it’s too early to announce any discoveries, but the study is moving along as planned.

Gio_tto/Thinkstock

“The preliminary data we have so far are demonstrating the validity of the study,” Dr. Cole said. “Things are going well. We’re able to do the cognitive testing and collect the samples that we need and ship them without losing the integrity of the samples.”

Dr. Sands noted that enrollment has been encouraging. As this is a substudy of DFCI-16-001, the researchers must obtain consent separately from the main study. Dr. Sands said about 89% of parents involved in the main study have agreed to enroll their children in the substudy.

Dr. Sands also said that early results from Cogstate testing have revealed patients who are experiencing cognitive decline during treatment. The researchers still have to determine if these results correlate with any biomarkers or gene variants.

Potential interventions

If the researchers can pinpoint patients at risk for cognitive deficits, the next step will be to investigate pharmacologic and behavioral interventions.

Dr. Cole said he is particularly interested in treatments that reduce oxidative stress, such as dextromethorphan and memantine. Dextromethorphan has been shown to resolve symptoms of methotrexate-induced neurotoxicity in patients (Pediatr Hematol Oncol. 2002 Jul-Aug;19[5]:319-27), and memantine reduced memory deficits in animals treated with methotrexate (Clin Cancer Res. 2013 Aug 15;19[16]:4446-54).

“Memantine hasn’t been used in kids with leukemia yet, but it’s something that I’d like to see brought to a clinical trial,” Dr. Cole said.

Dr. Sands pointed to other potential pharmacologic interventions, including the stimulants methylphenidate and modafinil. Both drugs have been shown to improve cognitive deficits in cancer survivors (J Clin Oncol. 2001 Mar 15;19[6]:1802-8; Cancer. 2009 Jun 15; 115[12]: 2605-16).

Computer-based cognitive training tools may be another option. One such tool, Lumosity, improved executive functions in a study of breast cancer survivors (Clin Breast Cancer. 2013 Aug;13[4]:299-306). Another tool, CogMed, improved working memory in survivors of brain tumors and ALL (Psychooncology. 2013 Aug; 22[8]: 1856-65).

Other behavioral interventions might include sleep hygiene and exercise. Sleep hygiene has been shown to improve cognitive function in childhood cancer survivors (Cancer. 2011 Jun 1;117[11]:2559-68), and a recent study revealed an association between exercise intolerance and negative neurocognitive outcomes in ALL survivors (Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510).

“What we need to figure out is which children will respond to which interventions,” Dr. Sands said, adding that interventions will likely need to be combined.

“It’s not going to be one thing that will work for everybody,” he said. “It’s going to be: What packages of things will work for different people?”

Dr. Sands and Dr. Cole reported having no relevant financial disclosures.

jensmith@mdedge.com

Researchers are attempting to determine, early in the treatment process, which children with acute lymphoblastic leukemia (ALL) have an increased risk of neurocognitive deficits after chemotherapy.

Rutgers Cancer Institute of New Jersey

The goal of the researchers’ project (5R01CA220568-02) is to determine if gene variants and biomarkers associated with oxidative stress, neuroinflammation, and folate physiology correlate with cognitive decline during and after chemotherapy. Ideally, certain variants and biomarkers will reveal patients who might benefit from interventions to prevent or even reverse cognitive deficits.

Peter D. Cole, MD, of Rutgers Cancer Institute, New Brunswick, N.J., and colleagues are conducting this research in patients from the DFCI-16-001 trial (NCT03020030). This multicenter, phase 3 study is enrolling patients (aged 1-21 years) with B- or T-cell ALL who then receive a multidrug chemotherapy regimen.

Dr. Cole and colleagues are analyzing a subset of patients from the trial, looking for relationships between chemotherapy-induced neurocognitive changes, gene variants, and changes in biomarkers detected in cerebrospinal fluid (CSF).

“We’re looking at a broad panel of target gene variants that are associated with either drug metabolism, defenses against oxidative stress, neuroinflammation, or folate physiology,” Dr. Cole said in an interview.

This includes variants Dr. Cole and colleagues identified in a previous, retrospective study of ALL survivors. The researchers found that survivors who were homozygous for NOS3 894T, had a variant SLCO2A1 G allele, or had at least one GSTP1 T allele were more likely to exhibit cognitive deficits (J Clin Oncol. 2015 Jul 1;33[19]:2205-11).

The researchers are also analyzing CSF samples, looking for changes in tau protein, homocysteine, homocysteic acid, the adenosylmethionine to adenosylhomocysteine ratio, and other biomarkers of oxidative stress, neuroinflammation, and folate physiology. The CSF is collected at five time points: the start of chemotherapy, day 18, the start of first consolidation, the end of first consolidation, and 7 weeks later in second consolidation.

Cognitive testing

While Dr. Cole is leading the genetic and biomarker analyses, Stephen A. Sands, PsyD, of Memorial Sloan Kettering Cancer Center in New York, is leading the cognitive testing.

The researchers are evaluating patients for cognitive decline using computerized tests from a company called Cogstate. The tests are designed to assess functions such as processing speed, attention, visual learning, and working memory. The tests are administered on an iPad and involve tasks like identifying features of playing cards and finding the correct way through a maze.

The patients – aged 3 years and older – undergo cognitive testing at six time points: baseline, which is any time between days 8 and 32 of induction (except within 72 hours after sedation or anesthesia); at first consolidation; the end of central nervous system therapy; 1 year into chemotherapy; the end of chemotherapy; and 1 year after chemotherapy ends.

In a prior study, Cogstate testing proved reliable for detecting neurocognitive changes in patients undergoing treatment for ALL (Support Care Cancer. 2017;25[2]:449-57). In the current study, the researchers are supplementing Cogstate test results with Wechsler IQ tests administered 1 year after patients complete chemotherapy.

Dr. Sands noted that Cogstate tests provide benefits over the Wechsler “paper-and-pencil” tests. One benefit is that Cogstate tests can be given more often without inducing practice effects (J Clin Exp Neuropsychol. 2006 Oct;28[7]:1095-112). Another is that Cogstate tests can be administered by anyone with a bachelor’s degree who has undergone the appropriate training, while Wechsler IQ tests must be given by psychologists.

Preliminary results

This research is ongoing, so it’s too early to announce any discoveries, but the study is moving along as planned.

Gio_tto/Thinkstock

“The preliminary data we have so far are demonstrating the validity of the study,” Dr. Cole said. “Things are going well. We’re able to do the cognitive testing and collect the samples that we need and ship them without losing the integrity of the samples.”

Dr. Sands noted that enrollment has been encouraging. As this is a substudy of DFCI-16-001, the researchers must obtain consent separately from the main study. Dr. Sands said about 89% of parents involved in the main study have agreed to enroll their children in the substudy.

Dr. Sands also said that early results from Cogstate testing have revealed patients who are experiencing cognitive decline during treatment. The researchers still have to determine if these results correlate with any biomarkers or gene variants.

Potential interventions

If the researchers can pinpoint patients at risk for cognitive deficits, the next step will be to investigate pharmacologic and behavioral interventions.

Dr. Cole said he is particularly interested in treatments that reduce oxidative stress, such as dextromethorphan and memantine. Dextromethorphan has been shown to resolve symptoms of methotrexate-induced neurotoxicity in patients (Pediatr Hematol Oncol. 2002 Jul-Aug;19[5]:319-27), and memantine reduced memory deficits in animals treated with methotrexate (Clin Cancer Res. 2013 Aug 15;19[16]:4446-54).

“Memantine hasn’t been used in kids with leukemia yet, but it’s something that I’d like to see brought to a clinical trial,” Dr. Cole said.

Dr. Sands pointed to other potential pharmacologic interventions, including the stimulants methylphenidate and modafinil. Both drugs have been shown to improve cognitive deficits in cancer survivors (J Clin Oncol. 2001 Mar 15;19[6]:1802-8; Cancer. 2009 Jun 15; 115[12]: 2605-16).

Computer-based cognitive training tools may be another option. One such tool, Lumosity, improved executive functions in a study of breast cancer survivors (Clin Breast Cancer. 2013 Aug;13[4]:299-306). Another tool, CogMed, improved working memory in survivors of brain tumors and ALL (Psychooncology. 2013 Aug; 22[8]: 1856-65).

Other behavioral interventions might include sleep hygiene and exercise. Sleep hygiene has been shown to improve cognitive function in childhood cancer survivors (Cancer. 2011 Jun 1;117[11]:2559-68), and a recent study revealed an association between exercise intolerance and negative neurocognitive outcomes in ALL survivors (Cancer. 2019 Oct 21. doi: 10.1002/cncr.32510).

“What we need to figure out is which children will respond to which interventions,” Dr. Sands said, adding that interventions will likely need to be combined.

“It’s not going to be one thing that will work for everybody,” he said. “It’s going to be: What packages of things will work for different people?”

Dr. Sands and Dr. Cole reported having no relevant financial disclosures.

jensmith@mdedge.com