MDedge Neurology

Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.

Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.

That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.

However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.

Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.

“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.

Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.

The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.

“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.

Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.

“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”

The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.

The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).

Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.

Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.

Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.

“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.

Dr. Shapiro said she had no conflicts of interest to disclose.

SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.

Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.

Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.

That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.

However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.

Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.

“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.

Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.

The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.

“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.

Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.

“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”

The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.

The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).

Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.

Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.

Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.

“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.

Dr. Shapiro said she had no conflicts of interest to disclose.

SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.

Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.

Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.

That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.

However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.

Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.

“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.

Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.

The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.

“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.

Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.

“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”

The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.

The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).

Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.

Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.

Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.

“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.

Dr. Shapiro said she had no conflicts of interest to disclose.

SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.

Here are the stories our MDedge editors across specialties think you need to know about today:

Many physicians live within their means and save

Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.

Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.

Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.

The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
 

Phase 3 COVID-19 vaccine trials launching in July

There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.

FDA approves in-home breast cancer treatment

The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.

The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.

Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.

Could a visual tool aid migraine management?

A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.

The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.

Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.

Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Many physicians live within their means and save

Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.

Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.

Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.

The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
 

Phase 3 COVID-19 vaccine trials launching in July

There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.

FDA approves in-home breast cancer treatment

The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.

The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.

Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.

Could a visual tool aid migraine management?

A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.

The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.

Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.

Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Many physicians live within their means and save

Although about two of five physicians report a net worth of between $1 million and $5 million, about half report that they are living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.

Net worth figures varied greatly by specialty. Among specialists, orthopedists were most likely (at 19%) to top the $5 million level, followed by plastic surgeons and gastroenterologists (both at 16%). Conversely, 46% of family physicians and 44% of pediatricians reported that their net worth was under $500,000. Gender gaps were also apparent in the data, especially at the highest levels. Twice as many male physicians (10%) as their female counterparts (5%) had a net worth of more than $5 million.

Asked about saving habits, 43% of physicians reported they live below their means. Just 7% said they live above their means. How do they save money? Survey respondents reported putting bonus money into an investment account, putting extra money toward paying down the mortgage, and bringing lunch to work everyday.

The survey responses on salary, debt, and net worth from more than 17,000 physicians spanning 30 specialties were collected prior to Feb. 11, before COVID-19 was declared a pandemic. Read more.
 

Phase 3 COVID-19 vaccine trials launching in July

There are now 120 Investigational New Drug applications to the Food and Drug Administration for a SARS-CoV-2 vaccine, and researchers at more than 70 companies across the globe are interested in making a vaccine, according to Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

“The good news is that the new coronavirus is relatively stable,” Dr. Offit said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.” Read more.

FDA approves in-home breast cancer treatment

The Food and Drug Administration has approved a combination of subcutaneous breast cancer treatments that could be administered at home, following completion of chemotherapy.

The agency gave the green light to pertuzumab (Perjeta, Genentech/Roche), trastuzumab (Herceptin, Genentech/Roche) and hyaluronidase (Phesgo, Genentech/Roche), administered subcutaneously rather than intravenously, for the treatment of early and metastatic HER2-positive breast cancers.

Phesgo is initially used in combination with chemotherapy at an infusion center but could continue to be administered in a patient’s home by a qualified health care professional once chemotherapy is complete. Read more.

Could a visual tool aid migraine management?

A new visual tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines.

The tool is still just a prototype, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors from depression to insomnia.

Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” lead researcher Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, said in an interview.

Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.

According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.

“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”

Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”

Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”

Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”

Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”

According to Dr. Offit, the phase 3 COVID-19 vaccine trials supported by BARDA will launch in July 2020 and will enroll 20,000 people in the vaccine treatment arm and 10,000 in the placebo arm. “Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”

The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”

A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”

Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”

Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”

Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”

[email protected]

The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.

According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.

“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”

Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”

Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”

Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”

Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”

According to Dr. Offit, the phase 3 COVID-19 vaccine trials supported by BARDA will launch in July 2020 and will enroll 20,000 people in the vaccine treatment arm and 10,000 in the placebo arm. “Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”

The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”

A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”

Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”

Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”

Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”

[email protected]

The race to develop a SARS-CoV-2 vaccine is unlike any other global research and development effort in modern medicine.

According to Paul A. Offit, MD, there are now 120 Investigational New Drug applications to the Food and Drug Administration for these vaccines, and researchers at more than 70 companies across the globe are interested in making a vaccine. The Biomedical Advanced Research and Development Authority (BARDA) has awarded $2.5 billion to five different pharmaceutical companies to make a vaccine.

“The good news is that the new coronavirus is relatively stable,” Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said during the virtual Pediatric Dermatology 2020: Best Practices and Innovations Conference. “Although it is a single-stranded RNA virus, it does mutate to some extent, but it doesn’t look like it’s going to mutate away from the vaccine. So, this is not going to be like influenza virus, where you must give a vaccine every year. I think we can make a vaccine that will last for several years. And we know the protein we’re interested in. We’re interested in antibodies directed against the spike glycoprotein, which is abundantly present on the surface of the virus. We know that if we make an antibody response to that protein, we can therefore prevent infection.”

Some research groups are interested in developing a whole, killed virus like those used in the inactivated polio vaccine, and vaccines for hepatitis A virus and rabies, said Dr. Offit, who is a member of Accelerating COVID-19 Technical Innovations And Vaccines, a public-private partnership formed by the National Institutes of Health. Other groups are interested in making a live-attenuated vaccine like those for measles, mumps, and rubella. “Some are interested in using a vectored vaccine, where you take a virus that is relatively weak and doesn’t cause disease in people, like vesicular stomatitis virus, and then clone into that the gene that codes for this coronavirus spike protein, which is the way that we made the Ebola virus vaccine,” Dr. Offit said. “Those approaches have all been used before, with success.”

Novel approaches are also being employed to make this vaccine, including using a replication-defective adenovirus. “That means that the virus can’t reproduce itself, but it can make proteins,” he explained. “There are some proteins that are made, but most aren’t. Therefore, the virus can’t reproduce itself. We’ll see whether or not that [approach] works, but it’s never been used before.”

Another approach is to inject messenger RNA that codes for the coronavirus spike protein, where that genetic material is translated into the spike protein. The other platform being evaluated is a DNA vaccine, in which “you give DNA which is coded for that spike protein, which is transcribed to messenger RNA and then is translated to other proteins.”

Typical vaccine development involves animal models to prove the concept, dose-ranging studies in humans, and progressively larger safety and immunogenicity studies in hundreds of thousands of people. Next come phase 3 studies, “where the proof is in the pudding,” he said. “These are large, prospective placebo-controlled trials to prove that the vaccine is safe. This is the only way whether you can prove or not a vaccine is effective.”

According to Dr. Offit, the phase 3 COVID-19 vaccine trials supported by BARDA will launch in July 2020 and will enroll 20,000 people in the vaccine treatment arm and 10,000 in the placebo arm. “Some companies may branch out on their own and do smaller studies than that,” he said. “We’ll see how this plays out. Keep your eyes open for that, because you really want to make sure you have a fairly large phase 3 trial. That’s the best way to show whether something works and whether it’s safe.”

The tried and true vaccines that emerge from the effort will not be FDA-licensed products. Rather, they will be approved products under the Emergency Use Authorization program. “Ever since the 1950s, every vaccine that has been used in the U.S. has been under the auspices of FDA licensure,” said Dr. Offit, who is also professor of pediatrics and the Maurice R. Hilleman professor of vaccinology at the University of Pennsylvania, Philadelphia. “That’s not going to be true here. The FDA is involved every step of the way but here they have a somewhat lighter touch.”

A few candidate vaccines are being mass-produced at risk, “meaning they’re being produced not knowing whether these vaccines are safe and effective yet or not,” he said. “But when they’re shown in a phase 3 trial to be safe and effective, you will have already produced it, and then it’s much easier to roll it out to the general public the minute you’ve shown that it works. This is what we did for the polio vaccine back in the 1950s. We mass-produced that vaccine at risk.”

Dr. Offit emphasized the importance of managing expectations once a COVID-19 vaccine gets approved for use. “Regarding safety, these vaccines will be tested in tens of thousands of people, not tens of millions of people, so although you can disprove a relatively uncommon side effect preapproval, you’re not going to disprove a rare side effect preapproval. You’re only going to know that post approval. I think we need to make people aware of that and to let them know that through groups like the Vaccine Safety Datalink, we’re going to be monitoring these vaccines once they’re approved.”

Regarding efficacy, he continued, “we’re not going know about the rates of immunity initially; we’re only going to know about that after the vaccine [has been administered]. My guess is the protection is going to be short lived and incomplete. By short lived, I mean that protection would last for years but not decades. By incomplete, I mean that protection will be against moderate to severe disease, which is fine. You don’t need protection against all of the disease; it’s hard to do that with respiratory viruses. That means you can keep people out of the hospital, and you can keep them from dying. That’s the main goal.”

Dr. Offit closed his remarks by noting that much is at stake in this effort to develop a vaccine so quickly and that it “could go one of two ways. We could find that the vaccine is a lifesaver, and [that] we can finally end this awful pandemic. Or, if we cut corners and don’t prove that the vaccines are safe and effective as we should before they’re released, we could shake what is a fragile vaccine confidence in this country. Hopefully, it doesn’t play out that way.”

[email protected]

Although about two of five physicians report a net worth of between $1 million and $5 million, half are under the million dollars and about half believe in living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.

43% live below their means

Asked about habits regarding saving, 43% of physicians reported they live below their means. Half said they live at their means, and 7% said they live above their means.

Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minn., recommends in the report trying to save 20% of annual gross salary.

More than a third of physicians who responded (39%) said they put more than $2,000/month into tax-deferred retirement or college savings, but Dr. Greenwald acknowledged that this may become more challenging.

“Many have seen the employer match in their retirement plans reduced or eliminated through the end of 2020, with what comes in 2021 as yet undefined,” he said.

A smaller percentage (26%) answered that they put more than $2,000 a month into a taxable retirement or college savings account each month.

Home size by specialty

Mortgages on a primary residence were the top reasons for debt (63%), followed by car loans (37%), personal education loans (26%), and credit card balances (25%).

Half of specialists and 61% of primary care physicians live in homes with up to 3,000 square feet. Only 7% of PCPs and 12% of specialists live in homes with 5000 square feet or more.

At 22%, plastic surgeons and orthopedists were the most likely groups to have houses with the largest square footage, according to the survey.

About one in four physicians in five specialties (urology, cardiology, plastic surgery, otolaryngology, and critical care) reported that they had mortgages of more than $500,000.

Standard financial advice, the report authors note, is that a mortgage should take up no more than 28% of monthly gross income.

Another large source of debt came from student loans. Close to 80% of graduating medical students have educational debt. The average balance for graduating students in 2018 was $196,520, the report authors state.

Those in physical medicine/rehabilitation and family medicine were most likely to still be paying off student debt (34% said they were). Conversely, half as many nephrologists and rheumatologists (15%) and gastroenterologists (14%) reported that they were paying off educational debt.

Only 11% of physicians said they were currently free of any debt.

Most physicians in the survey (72%) reported that they had not experienced a significant financial loss in the past year.

For those who did experience such a loss, the top reason given was related to a bad investment or the stock market (9%).
 

Cost-cutting strategies

Revenue reduction will likely lead to spending less this year as the pandemic challenges continue.

Survey respondents offered their most effective cost-cutting strategies.

A hospitalist said, “Half of every bonus goes into the investment account, no matter how much.”

“We add an extra amount to the principal of our monthly mortgage payment,” an internist said.

A pediatrician offered, “I bring my lunch to work every day and don’t eat in restaurants often.”
 

This article first appeared on Medscape.com.

Although about two of five physicians report a net worth of between $1 million and $5 million, half are under the million dollars and about half believe in living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.

43% live below their means

Asked about habits regarding saving, 43% of physicians reported they live below their means. Half said they live at their means, and 7% said they live above their means.

Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minn., recommends in the report trying to save 20% of annual gross salary.

More than a third of physicians who responded (39%) said they put more than $2,000/month into tax-deferred retirement or college savings, but Dr. Greenwald acknowledged that this may become more challenging.

“Many have seen the employer match in their retirement plans reduced or eliminated through the end of 2020, with what comes in 2021 as yet undefined,” he said.

A smaller percentage (26%) answered that they put more than $2,000 a month into a taxable retirement or college savings account each month.

Home size by specialty

Mortgages on a primary residence were the top reasons for debt (63%), followed by car loans (37%), personal education loans (26%), and credit card balances (25%).

Half of specialists and 61% of primary care physicians live in homes with up to 3,000 square feet. Only 7% of PCPs and 12% of specialists live in homes with 5000 square feet or more.

At 22%, plastic surgeons and orthopedists were the most likely groups to have houses with the largest square footage, according to the survey.

About one in four physicians in five specialties (urology, cardiology, plastic surgery, otolaryngology, and critical care) reported that they had mortgages of more than $500,000.

Standard financial advice, the report authors note, is that a mortgage should take up no more than 28% of monthly gross income.

Another large source of debt came from student loans. Close to 80% of graduating medical students have educational debt. The average balance for graduating students in 2018 was $196,520, the report authors state.

Those in physical medicine/rehabilitation and family medicine were most likely to still be paying off student debt (34% said they were). Conversely, half as many nephrologists and rheumatologists (15%) and gastroenterologists (14%) reported that they were paying off educational debt.

Only 11% of physicians said they were currently free of any debt.

Most physicians in the survey (72%) reported that they had not experienced a significant financial loss in the past year.

For those who did experience such a loss, the top reason given was related to a bad investment or the stock market (9%).
 

Cost-cutting strategies

Revenue reduction will likely lead to spending less this year as the pandemic challenges continue.

Survey respondents offered their most effective cost-cutting strategies.

A hospitalist said, “Half of every bonus goes into the investment account, no matter how much.”

“We add an extra amount to the principal of our monthly mortgage payment,” an internist said.

A pediatrician offered, “I bring my lunch to work every day and don’t eat in restaurants often.”
 

This article first appeared on Medscape.com.

Although about two of five physicians report a net worth of between $1 million and $5 million, half are under the million dollars and about half believe in living at or below their means, according to the latest Medscape Physician Debt and Net Worth Report 2020.

43% live below their means

Asked about habits regarding saving, 43% of physicians reported they live below their means. Half said they live at their means, and 7% said they live above their means.

Joel Greenwald, MD, CEO of Greenwald Wealth Management in St. Louis Park, Minn., recommends in the report trying to save 20% of annual gross salary.

More than a third of physicians who responded (39%) said they put more than $2,000/month into tax-deferred retirement or college savings, but Dr. Greenwald acknowledged that this may become more challenging.

“Many have seen the employer match in their retirement plans reduced or eliminated through the end of 2020, with what comes in 2021 as yet undefined,” he said.

A smaller percentage (26%) answered that they put more than $2,000 a month into a taxable retirement or college savings account each month.

Home size by specialty

Mortgages on a primary residence were the top reasons for debt (63%), followed by car loans (37%), personal education loans (26%), and credit card balances (25%).

Half of specialists and 61% of primary care physicians live in homes with up to 3,000 square feet. Only 7% of PCPs and 12% of specialists live in homes with 5000 square feet or more.

At 22%, plastic surgeons and orthopedists were the most likely groups to have houses with the largest square footage, according to the survey.

About one in four physicians in five specialties (urology, cardiology, plastic surgery, otolaryngology, and critical care) reported that they had mortgages of more than $500,000.

Standard financial advice, the report authors note, is that a mortgage should take up no more than 28% of monthly gross income.

Another large source of debt came from student loans. Close to 80% of graduating medical students have educational debt. The average balance for graduating students in 2018 was $196,520, the report authors state.

Those in physical medicine/rehabilitation and family medicine were most likely to still be paying off student debt (34% said they were). Conversely, half as many nephrologists and rheumatologists (15%) and gastroenterologists (14%) reported that they were paying off educational debt.

Only 11% of physicians said they were currently free of any debt.

Most physicians in the survey (72%) reported that they had not experienced a significant financial loss in the past year.

For those who did experience such a loss, the top reason given was related to a bad investment or the stock market (9%).
 

Cost-cutting strategies

Revenue reduction will likely lead to spending less this year as the pandemic challenges continue.

Survey respondents offered their most effective cost-cutting strategies.

A hospitalist said, “Half of every bonus goes into the investment account, no matter how much.”

“We add an extra amount to the principal of our monthly mortgage payment,” an internist said.

A pediatrician offered, “I bring my lunch to work every day and don’t eat in restaurants often.”
 

This article first appeared on Medscape.com.

A new visualization tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines. The tool is still in the prototype stage, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors, including depression, medication overuse, insomnia, and body mass index, among others.

A few such tools exist for other conditions, such as stroke and risk of developing chronic diseases. Existing migraine visualization models focus only on individual risk factors, but they are capable of much more. “Visualization tools can effectively communicate a huge amount of clinical information,” said lead author Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, in an interview. Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society.
 

A picture is worth a thousand words

Dr. Cuneo’s background is well suited to the effort: Before entering medicine, she was a documentary producer. “I have a lot of interest in the patient story and history,” she added. She also believes that the tool could improve patient-provider relationships. In rushed sessions, patients may not feel heard. Patients gain a therapeutic benefit from the belief that their provider is listening to them and listening to their story. Visualization tools could promote that if the provider can quickly identify key elements of the patient’s condition. “A lot of headache patients can have a complex picture,” said Dr. Cuneo.

Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” said Dr. Cuneo.

The prototype visualization tool uses a color-coded wheel divided into pie slices, each representing a clinical characteristic or modifiable risk factor. In the proposed tool presented in the poster, these included depression, anxiety, functional disability, insomnia, nausea, headache frequency, medication overuse, optimization of abortive medication use, nontherapeutic diet, limited exercise, and body mass index range. The circle also contains colored concentric circles, ranging from red to green, and a small filled circle represents the patient’s status in each category as ranked using the integrated questionnaire. A line connects the circles in each pie, revealing the patient’s overall status.

The visual cue allows both the physician and patient to quickly assess these factors and see them in relationship to one another. Verbally communicating each factor is time consuming and harder for the patient to take in, according to Dr. Cuneo. “The provider can just look at it and see the areas to focus questions on to try to improve care. So it’s a way I’m hopeful that we can help target visits and improve patient-provider communication without extending visit time.”

A key challenge for the project will be choosing and consolidating scales so that the patient isn’t burdened with too many questions in advance of the appointment. The team will draw from existing scales and then create their own and validate it. “The questions will have to be vetted with patients through focus groups, and then the software platform [will have to be developed] so that patients can complete the survey online. Then we have to test it to see if providers and patients feel this is something that’s helpful in the clinical practice,” said Dr. Cuneo.
 

Will it change behavior?

If successful, the tool would be a welcome addition, according to Andrew Charles, MD, who was asked to comment on the work. “Epidemiological studies have identified these risk factors, but we haven’t had a way of operationalizing a strategy to reduce them systematically, so having some sort of tool that visualizes not just one but multiple risk factors is something I think could be helpful to address those factors more aggressively. The real question would be, if you put it in the hands of practitioners and patients, will they really be able to easily implement it and will it change behavior,” said Dr. Charles, who is a professor of neurology and director of the Goldberg Migraine Program at the University of California, Los Angeles.

The study received no funding. Dr. Cuneo and Dr. Charles have no relevant financial disclosures.

SOURCE; Cuneo A et al. AHS 2020, Abstract 273715.

A new visualization tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines. The tool is still in the prototype stage, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors, including depression, medication overuse, insomnia, and body mass index, among others.

A few such tools exist for other conditions, such as stroke and risk of developing chronic diseases. Existing migraine visualization models focus only on individual risk factors, but they are capable of much more. “Visualization tools can effectively communicate a huge amount of clinical information,” said lead author Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, in an interview. Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society.
 

A picture is worth a thousand words

Dr. Cuneo’s background is well suited to the effort: Before entering medicine, she was a documentary producer. “I have a lot of interest in the patient story and history,” she added. She also believes that the tool could improve patient-provider relationships. In rushed sessions, patients may not feel heard. Patients gain a therapeutic benefit from the belief that their provider is listening to them and listening to their story. Visualization tools could promote that if the provider can quickly identify key elements of the patient’s condition. “A lot of headache patients can have a complex picture,” said Dr. Cuneo.

Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” said Dr. Cuneo.

The prototype visualization tool uses a color-coded wheel divided into pie slices, each representing a clinical characteristic or modifiable risk factor. In the proposed tool presented in the poster, these included depression, anxiety, functional disability, insomnia, nausea, headache frequency, medication overuse, optimization of abortive medication use, nontherapeutic diet, limited exercise, and body mass index range. The circle also contains colored concentric circles, ranging from red to green, and a small filled circle represents the patient’s status in each category as ranked using the integrated questionnaire. A line connects the circles in each pie, revealing the patient’s overall status.

The visual cue allows both the physician and patient to quickly assess these factors and see them in relationship to one another. Verbally communicating each factor is time consuming and harder for the patient to take in, according to Dr. Cuneo. “The provider can just look at it and see the areas to focus questions on to try to improve care. So it’s a way I’m hopeful that we can help target visits and improve patient-provider communication without extending visit time.”

A key challenge for the project will be choosing and consolidating scales so that the patient isn’t burdened with too many questions in advance of the appointment. The team will draw from existing scales and then create their own and validate it. “The questions will have to be vetted with patients through focus groups, and then the software platform [will have to be developed] so that patients can complete the survey online. Then we have to test it to see if providers and patients feel this is something that’s helpful in the clinical practice,” said Dr. Cuneo.
 

Will it change behavior?

If successful, the tool would be a welcome addition, according to Andrew Charles, MD, who was asked to comment on the work. “Epidemiological studies have identified these risk factors, but we haven’t had a way of operationalizing a strategy to reduce them systematically, so having some sort of tool that visualizes not just one but multiple risk factors is something I think could be helpful to address those factors more aggressively. The real question would be, if you put it in the hands of practitioners and patients, will they really be able to easily implement it and will it change behavior,” said Dr. Charles, who is a professor of neurology and director of the Goldberg Migraine Program at the University of California, Los Angeles.

The study received no funding. Dr. Cuneo and Dr. Charles have no relevant financial disclosures.

SOURCE; Cuneo A et al. AHS 2020, Abstract 273715.

A new visualization tool aims to streamline patient-clinician communication about risk factors for progression from episodic to chronic migraines. The tool is still in the prototype stage, but it could eventually synthesize patient responses to an integrated questionnaire and produce a chart illustrating where the patient stands with respect to a range of modifiable risk factors, including depression, medication overuse, insomnia, and body mass index, among others.

A few such tools exist for other conditions, such as stroke and risk of developing chronic diseases. Existing migraine visualization models focus only on individual risk factors, but they are capable of much more. “Visualization tools can effectively communicate a huge amount of clinical information,” said lead author Ami Cuneo, MD, who is a headache fellow at the University of Washington, Seattle, in an interview. Dr. Cuneo presented a poster describing the concept at the virtual annual meeting of the American Headache Society.
 

A picture is worth a thousand words

Dr. Cuneo’s background is well suited to the effort: Before entering medicine, she was a documentary producer. “I have a lot of interest in the patient story and history,” she added. She also believes that the tool could improve patient-provider relationships. In rushed sessions, patients may not feel heard. Patients gain a therapeutic benefit from the belief that their provider is listening to them and listening to their story. Visualization tools could promote that if the provider can quickly identify key elements of the patient’s condition. “A lot of headache patients can have a complex picture,” said Dr. Cuneo.

Physicians must see patients in short appointment periods, making it difficult to communicate all of the risk factors and behavioral characteristics that can contribute to risk of progression. “If you have a patient and you’re able to look at a visualization tool quickly and say: ‘Okay, my patient really is having insomnia and sleep issues,’ you can focus the session talking about sleep, cognitive-behavioral therapy for insomnia, and all the things we can help patients with,” said Dr. Cuneo.

The prototype visualization tool uses a color-coded wheel divided into pie slices, each representing a clinical characteristic or modifiable risk factor. In the proposed tool presented in the poster, these included depression, anxiety, functional disability, insomnia, nausea, headache frequency, medication overuse, optimization of abortive medication use, nontherapeutic diet, limited exercise, and body mass index range. The circle also contains colored concentric circles, ranging from red to green, and a small filled circle represents the patient’s status in each category as ranked using the integrated questionnaire. A line connects the circles in each pie, revealing the patient’s overall status.

The visual cue allows both the physician and patient to quickly assess these factors and see them in relationship to one another. Verbally communicating each factor is time consuming and harder for the patient to take in, according to Dr. Cuneo. “The provider can just look at it and see the areas to focus questions on to try to improve care. So it’s a way I’m hopeful that we can help target visits and improve patient-provider communication without extending visit time.”

A key challenge for the project will be choosing and consolidating scales so that the patient isn’t burdened with too many questions in advance of the appointment. The team will draw from existing scales and then create their own and validate it. “The questions will have to be vetted with patients through focus groups, and then the software platform [will have to be developed] so that patients can complete the survey online. Then we have to test it to see if providers and patients feel this is something that’s helpful in the clinical practice,” said Dr. Cuneo.
 

Will it change behavior?

If successful, the tool would be a welcome addition, according to Andrew Charles, MD, who was asked to comment on the work. “Epidemiological studies have identified these risk factors, but we haven’t had a way of operationalizing a strategy to reduce them systematically, so having some sort of tool that visualizes not just one but multiple risk factors is something I think could be helpful to address those factors more aggressively. The real question would be, if you put it in the hands of practitioners and patients, will they really be able to easily implement it and will it change behavior,” said Dr. Charles, who is a professor of neurology and director of the Goldberg Migraine Program at the University of California, Los Angeles.

The study received no funding. Dr. Cuneo and Dr. Charles have no relevant financial disclosures.

SOURCE; Cuneo A et al. AHS 2020, Abstract 273715.

Longer-term follow-up from the ARUBA study confirms earlier results showing that intervention for patients with an unruptured brain arteriovenous malformation (AVM) does more harm than good.

Enrollment into the trial, which compared medical management alone with medical management with interventional therapy (neurosurgery, embolization, or stereotactic radiotherapy, alone or in combination), was stopped prematurely in 2013 after 33 months of follow-up because of a much higher rate of death and stroke in the intervention group.
 

Reaffirming the benefit of no intervention

Now the investigators are reporting extended follow-up to 50 months. The results were very similar to those at 33 months.

The current 50-month follow-up results show that 15 of 110 patients in the medical group had died or had a stroke (3.39 per 100 patient-years) versus 41 of 116 (12.32 per 100 patient-years) in the intervention group. The results reaffirm the strong benefit of not undergoing intervention (hazard ratio, 0.31; 95% confidence interval, 0.17-0.56).

These latest results were published in the July issue of the Lancet Neurology.

“With an AVM, the natural reflex is to try and fix it, but our trial shows that the tools we have to do that seem to be more damaging than just living with the AVM. If we try to take it out, the stroke risk is three to five times higher than just leaving it alone,” coauthor Christian Stapf, MD, a professor at the University of Montreal, said in an interview.

Dr. Stapf explained that an AVM is a congenital abnormality in the linking of the arteries to the veins. “There are an excess number of arteries and veins. They usually sit there silently, but they can trigger seizures, as they can tickle the neurons in the vicinity.”

It is estimated that one to two AVMs are found spontaneously in every 100,000 persons every year, but this is dependent on the availability of MRI, and many go undetected, he noted. In MRI studies in healthy volunteers, the rate was about one AVM in every 2,000 individuals.
 

Challenging standard practice

With AVMs, rupture and intracerebral hemorrhage occur at a rate of about 1%-2% per year. Until the ARUBA results were published, the standard practice was to intervene to embolize or excise the malformation, Dr. Stapf said.

“The standard treatment was intervention. The experiment was not to do it. We were challenging standard practice, and the trial was not popular with interventionalists,” he said.

The initial study, which was published in 2014, received much criticism from the interventionalist community. Among the criticisms were that the selection criteria for enrollment limited its generalizability, fewer patients than expected in the intervention arm were referred for microvascular surgery, and the follow-up was too short to allow a meaningful comparison.

“The study received criticism, but this was mainly from interventionalists, who were having their income threatened,” Dr. Stapf said. “This was very unhappy news for them, especially in the U.S., with the fee-for-service system.”

But he says these longer-term results, together with additional analyses and data from other cohorts, reinforce their initial conclusions.

The current report also shows a benefit in functional outcome in the medical group. “After 5 years, patients are twice as likely to have a neurological handicap, defined as a score of 2 or higher on the modified Rankin scale in the intervention group,” he noted. “We also found that more patients in the intervention group had deficits not related to stroke, such as an increase in seizures.”

Results of subgroup analysis were consistent in all patient groups.

The “study was designed for 400 patients, but we only recruited about half that number. But even so, the effect of intervention on stroke is so strong there is no subgroup where it looks favorable,” Dr. Stapf said. “This result was not heterogeneous. The same effect is seen regardless of age, gender, presence of symptoms, size of AVM, location, anatomy, drainage. No matter how you look, there is no benefit for intervention.”

He also referred to a Scottish population-based cohort study that showed a similar risk reduction from not intervening. “This was an unselected population of every unruptured AVM patient in Scotland, which found a 65% relative reduction in death/stroke over 12 years. We found a 69% reduction. The Scottish study did not select any particular types of patients but showed the same result as us,” he noted. “It is hard to argue against these findings.”

Regarding the claim of selection bias, Dr. Stapf acknowledged that the study excluded patients who were judged to be in need of intervention and those judged to be at very low risk and who would not be considered for an intervention.

“But when we compared our cohort to two other unselected cohorts, they look very similar, apart from the fact that very large AVMs were not entered in our study, as they were considered too difficult to treat,” he said. “If there is a selection bias at all, it actually trends towards the intervention group, as we excluded those at the highest treatment risk, but we still showed more benefit of not intervening.”

He also says the microvascular surgery rates were consistent with real-world practice, with about 25% of patients undergoing such surgery. “This is similar to the Scottish population study. Our trial also showed a similar result in patients treated with the various different interventions – they all showed a much higher risk than not intervening,” he added.

He says practice has changed since the trial was first reported. “There are far fewer interventions now for unruptured AVMs. Most interventionalists have accepted the results now, although there are some who continue to find reasons to criticize the trial and carry on with the procedures.”

He says his advice to patients who have an unruptured AVM is to forget about it. “There doesn’t seem to be a trigger for rupture,” he said. “It doesn’t seem to be dependent on blood pressure or physical activity, and we can’t tell if it’s just about to go by looking at it. They are very different from an aneurysm in that regard.

“When I explain to patients that they are at an increased stroke risk and tell them about the results of the ARUBA study, they say they would prefer to get that stroke later in life than earlier. These patents can live for 30 or 40 years without a stroke.

“But, yes, there remains a major unmet need. We need to find a way to protect these patients. In future, we might find a better way of intervening, but at this point in time, the treatment we have is more dangerous than doing nothing,” he said.
 

Longer follow-up needed

In an editorial that accompanies the current study, Peter M. Rothwell, MD, of the University of Oxford, England, also dismisses much of the criticism of the ARUBA study. On the issue of external validity, he said: “I do not think that this is really any greater an issue for ARUBA than for most other similar trials.”

But Dr. Rothwell does believe that follow-up for longer than 5 years is needed. “To really understand the benefit/risk balance, we would need a 20- or 30-year follow-up. These patients are often in their 20s, 30s, or 40s, so we really need to know their cumulative risk over decades,” he said in an interview.

Noting that the study was funded by the National Institute of Neurological Disorders and Stroke (NINDS), Dr. Rothwell said funding should have been provided for much longer follow-up. “Patients who generously agreed to be randomly assigned in ARUBA and future similar patients have been let down by NINDS.

“We probably now won’t ever know the very–long-term impact, although the Scottish population study is following patients longer term,” he added.

“After this trial was first published, the guidelines recommended not to intervene. These latest results will not change that,” he said.

The ARUBA trial was funded internationally by the National Institutes of Health/NINDS. Dr. Stapf and Dr. Rothwell have disclosed no relevant financial relationships.

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

Longer-term follow-up from the ARUBA study confirms earlier results showing that intervention for patients with an unruptured brain arteriovenous malformation (AVM) does more harm than good.

Enrollment into the trial, which compared medical management alone with medical management with interventional therapy (neurosurgery, embolization, or stereotactic radiotherapy, alone or in combination), was stopped prematurely in 2013 after 33 months of follow-up because of a much higher rate of death and stroke in the intervention group.
 

Reaffirming the benefit of no intervention

Now the investigators are reporting extended follow-up to 50 months. The results were very similar to those at 33 months.

The current 50-month follow-up results show that 15 of 110 patients in the medical group had died or had a stroke (3.39 per 100 patient-years) versus 41 of 116 (12.32 per 100 patient-years) in the intervention group. The results reaffirm the strong benefit of not undergoing intervention (hazard ratio, 0.31; 95% confidence interval, 0.17-0.56).

These latest results were published in the July issue of the Lancet Neurology.

“With an AVM, the natural reflex is to try and fix it, but our trial shows that the tools we have to do that seem to be more damaging than just living with the AVM. If we try to take it out, the stroke risk is three to five times higher than just leaving it alone,” coauthor Christian Stapf, MD, a professor at the University of Montreal, said in an interview.

Dr. Stapf explained that an AVM is a congenital abnormality in the linking of the arteries to the veins. “There are an excess number of arteries and veins. They usually sit there silently, but they can trigger seizures, as they can tickle the neurons in the vicinity.”

It is estimated that one to two AVMs are found spontaneously in every 100,000 persons every year, but this is dependent on the availability of MRI, and many go undetected, he noted. In MRI studies in healthy volunteers, the rate was about one AVM in every 2,000 individuals.
 

Challenging standard practice

With AVMs, rupture and intracerebral hemorrhage occur at a rate of about 1%-2% per year. Until the ARUBA results were published, the standard practice was to intervene to embolize or excise the malformation, Dr. Stapf said.

“The standard treatment was intervention. The experiment was not to do it. We were challenging standard practice, and the trial was not popular with interventionalists,” he said.

The initial study, which was published in 2014, received much criticism from the interventionalist community. Among the criticisms were that the selection criteria for enrollment limited its generalizability, fewer patients than expected in the intervention arm were referred for microvascular surgery, and the follow-up was too short to allow a meaningful comparison.

“The study received criticism, but this was mainly from interventionalists, who were having their income threatened,” Dr. Stapf said. “This was very unhappy news for them, especially in the U.S., with the fee-for-service system.”

But he says these longer-term results, together with additional analyses and data from other cohorts, reinforce their initial conclusions.

The current report also shows a benefit in functional outcome in the medical group. “After 5 years, patients are twice as likely to have a neurological handicap, defined as a score of 2 or higher on the modified Rankin scale in the intervention group,” he noted. “We also found that more patients in the intervention group had deficits not related to stroke, such as an increase in seizures.”

Results of subgroup analysis were consistent in all patient groups.

The “study was designed for 400 patients, but we only recruited about half that number. But even so, the effect of intervention on stroke is so strong there is no subgroup where it looks favorable,” Dr. Stapf said. “This result was not heterogeneous. The same effect is seen regardless of age, gender, presence of symptoms, size of AVM, location, anatomy, drainage. No matter how you look, there is no benefit for intervention.”

He also referred to a Scottish population-based cohort study that showed a similar risk reduction from not intervening. “This was an unselected population of every unruptured AVM patient in Scotland, which found a 65% relative reduction in death/stroke over 12 years. We found a 69% reduction. The Scottish study did not select any particular types of patients but showed the same result as us,” he noted. “It is hard to argue against these findings.”

Regarding the claim of selection bias, Dr. Stapf acknowledged that the study excluded patients who were judged to be in need of intervention and those judged to be at very low risk and who would not be considered for an intervention.

“But when we compared our cohort to two other unselected cohorts, they look very similar, apart from the fact that very large AVMs were not entered in our study, as they were considered too difficult to treat,” he said. “If there is a selection bias at all, it actually trends towards the intervention group, as we excluded those at the highest treatment risk, but we still showed more benefit of not intervening.”

He also says the microvascular surgery rates were consistent with real-world practice, with about 25% of patients undergoing such surgery. “This is similar to the Scottish population study. Our trial also showed a similar result in patients treated with the various different interventions – they all showed a much higher risk than not intervening,” he added.

He says practice has changed since the trial was first reported. “There are far fewer interventions now for unruptured AVMs. Most interventionalists have accepted the results now, although there are some who continue to find reasons to criticize the trial and carry on with the procedures.”

He says his advice to patients who have an unruptured AVM is to forget about it. “There doesn’t seem to be a trigger for rupture,” he said. “It doesn’t seem to be dependent on blood pressure or physical activity, and we can’t tell if it’s just about to go by looking at it. They are very different from an aneurysm in that regard.

“When I explain to patients that they are at an increased stroke risk and tell them about the results of the ARUBA study, they say they would prefer to get that stroke later in life than earlier. These patents can live for 30 or 40 years without a stroke.

“But, yes, there remains a major unmet need. We need to find a way to protect these patients. In future, we might find a better way of intervening, but at this point in time, the treatment we have is more dangerous than doing nothing,” he said.
 

Longer follow-up needed

In an editorial that accompanies the current study, Peter M. Rothwell, MD, of the University of Oxford, England, also dismisses much of the criticism of the ARUBA study. On the issue of external validity, he said: “I do not think that this is really any greater an issue for ARUBA than for most other similar trials.”

But Dr. Rothwell does believe that follow-up for longer than 5 years is needed. “To really understand the benefit/risk balance, we would need a 20- or 30-year follow-up. These patients are often in their 20s, 30s, or 40s, so we really need to know their cumulative risk over decades,” he said in an interview.

Noting that the study was funded by the National Institute of Neurological Disorders and Stroke (NINDS), Dr. Rothwell said funding should have been provided for much longer follow-up. “Patients who generously agreed to be randomly assigned in ARUBA and future similar patients have been let down by NINDS.

“We probably now won’t ever know the very–long-term impact, although the Scottish population study is following patients longer term,” he added.

“After this trial was first published, the guidelines recommended not to intervene. These latest results will not change that,” he said.

The ARUBA trial was funded internationally by the National Institutes of Health/NINDS. Dr. Stapf and Dr. Rothwell have disclosed no relevant financial relationships.

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

Longer-term follow-up from the ARUBA study confirms earlier results showing that intervention for patients with an unruptured brain arteriovenous malformation (AVM) does more harm than good.

Enrollment into the trial, which compared medical management alone with medical management with interventional therapy (neurosurgery, embolization, or stereotactic radiotherapy, alone or in combination), was stopped prematurely in 2013 after 33 months of follow-up because of a much higher rate of death and stroke in the intervention group.
 

Reaffirming the benefit of no intervention

Now the investigators are reporting extended follow-up to 50 months. The results were very similar to those at 33 months.

The current 50-month follow-up results show that 15 of 110 patients in the medical group had died or had a stroke (3.39 per 100 patient-years) versus 41 of 116 (12.32 per 100 patient-years) in the intervention group. The results reaffirm the strong benefit of not undergoing intervention (hazard ratio, 0.31; 95% confidence interval, 0.17-0.56).

These latest results were published in the July issue of the Lancet Neurology.

“With an AVM, the natural reflex is to try and fix it, but our trial shows that the tools we have to do that seem to be more damaging than just living with the AVM. If we try to take it out, the stroke risk is three to five times higher than just leaving it alone,” coauthor Christian Stapf, MD, a professor at the University of Montreal, said in an interview.

Dr. Stapf explained that an AVM is a congenital abnormality in the linking of the arteries to the veins. “There are an excess number of arteries and veins. They usually sit there silently, but they can trigger seizures, as they can tickle the neurons in the vicinity.”

It is estimated that one to two AVMs are found spontaneously in every 100,000 persons every year, but this is dependent on the availability of MRI, and many go undetected, he noted. In MRI studies in healthy volunteers, the rate was about one AVM in every 2,000 individuals.
 

Challenging standard practice

With AVMs, rupture and intracerebral hemorrhage occur at a rate of about 1%-2% per year. Until the ARUBA results were published, the standard practice was to intervene to embolize or excise the malformation, Dr. Stapf said.

“The standard treatment was intervention. The experiment was not to do it. We were challenging standard practice, and the trial was not popular with interventionalists,” he said.

The initial study, which was published in 2014, received much criticism from the interventionalist community. Among the criticisms were that the selection criteria for enrollment limited its generalizability, fewer patients than expected in the intervention arm were referred for microvascular surgery, and the follow-up was too short to allow a meaningful comparison.

“The study received criticism, but this was mainly from interventionalists, who were having their income threatened,” Dr. Stapf said. “This was very unhappy news for them, especially in the U.S., with the fee-for-service system.”

But he says these longer-term results, together with additional analyses and data from other cohorts, reinforce their initial conclusions.

The current report also shows a benefit in functional outcome in the medical group. “After 5 years, patients are twice as likely to have a neurological handicap, defined as a score of 2 or higher on the modified Rankin scale in the intervention group,” he noted. “We also found that more patients in the intervention group had deficits not related to stroke, such as an increase in seizures.”

Results of subgroup analysis were consistent in all patient groups.

The “study was designed for 400 patients, but we only recruited about half that number. But even so, the effect of intervention on stroke is so strong there is no subgroup where it looks favorable,” Dr. Stapf said. “This result was not heterogeneous. The same effect is seen regardless of age, gender, presence of symptoms, size of AVM, location, anatomy, drainage. No matter how you look, there is no benefit for intervention.”

He also referred to a Scottish population-based cohort study that showed a similar risk reduction from not intervening. “This was an unselected population of every unruptured AVM patient in Scotland, which found a 65% relative reduction in death/stroke over 12 years. We found a 69% reduction. The Scottish study did not select any particular types of patients but showed the same result as us,” he noted. “It is hard to argue against these findings.”

Regarding the claim of selection bias, Dr. Stapf acknowledged that the study excluded patients who were judged to be in need of intervention and those judged to be at very low risk and who would not be considered for an intervention.

“But when we compared our cohort to two other unselected cohorts, they look very similar, apart from the fact that very large AVMs were not entered in our study, as they were considered too difficult to treat,” he said. “If there is a selection bias at all, it actually trends towards the intervention group, as we excluded those at the highest treatment risk, but we still showed more benefit of not intervening.”

He also says the microvascular surgery rates were consistent with real-world practice, with about 25% of patients undergoing such surgery. “This is similar to the Scottish population study. Our trial also showed a similar result in patients treated with the various different interventions – they all showed a much higher risk than not intervening,” he added.

He says practice has changed since the trial was first reported. “There are far fewer interventions now for unruptured AVMs. Most interventionalists have accepted the results now, although there are some who continue to find reasons to criticize the trial and carry on with the procedures.”

He says his advice to patients who have an unruptured AVM is to forget about it. “There doesn’t seem to be a trigger for rupture,” he said. “It doesn’t seem to be dependent on blood pressure or physical activity, and we can’t tell if it’s just about to go by looking at it. They are very different from an aneurysm in that regard.

“When I explain to patients that they are at an increased stroke risk and tell them about the results of the ARUBA study, they say they would prefer to get that stroke later in life than earlier. These patents can live for 30 or 40 years without a stroke.

“But, yes, there remains a major unmet need. We need to find a way to protect these patients. In future, we might find a better way of intervening, but at this point in time, the treatment we have is more dangerous than doing nothing,” he said.
 

Longer follow-up needed

In an editorial that accompanies the current study, Peter M. Rothwell, MD, of the University of Oxford, England, also dismisses much of the criticism of the ARUBA study. On the issue of external validity, he said: “I do not think that this is really any greater an issue for ARUBA than for most other similar trials.”

But Dr. Rothwell does believe that follow-up for longer than 5 years is needed. “To really understand the benefit/risk balance, we would need a 20- or 30-year follow-up. These patients are often in their 20s, 30s, or 40s, so we really need to know their cumulative risk over decades,” he said in an interview.

Noting that the study was funded by the National Institute of Neurological Disorders and Stroke (NINDS), Dr. Rothwell said funding should have been provided for much longer follow-up. “Patients who generously agreed to be randomly assigned in ARUBA and future similar patients have been let down by NINDS.

“We probably now won’t ever know the very–long-term impact, although the Scottish population study is following patients longer term,” he added.

“After this trial was first published, the guidelines recommended not to intervene. These latest results will not change that,” he said.

The ARUBA trial was funded internationally by the National Institutes of Health/NINDS. Dr. Stapf and Dr. Rothwell have disclosed no relevant financial relationships.

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

Click here to read the content.

USA-334-84065

Click here to read the content.

USA-334-84065

Click here to read the content.

USA-334-84065

There are at least five dermatologic patterns in patients who are suspected or confirmed of having COVID-19, and the knowledge base continues to evolve, according to Christine Ko, MD.

“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”

Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.

On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”

Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.

A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).

“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).

“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.

[email protected]

There are at least five dermatologic patterns in patients who are suspected or confirmed of having COVID-19, and the knowledge base continues to evolve, according to Christine Ko, MD.

“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”

Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.

On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”

Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.

A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).

“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).

“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.

[email protected]

There are at least five dermatologic patterns in patients who are suspected or confirmed of having COVID-19, and the knowledge base continues to evolve, according to Christine Ko, MD.

“Things are very fluid,” Dr. Ko, professor of dermatology and pathology at Yale University, New Haven, Conn., said during the virtual annual meeting of the American Academy of Dermatology. “New studies are coming out daily. Due to the need for rapid dissemination, a lot of the studies are case reports, but there are some nice case series. Another caveat for the literature is that a lot of these cases were not necessarily confirmed with testing for SARS-CoV-2, but some were.”

Dr. Ko framed her remarks largely on a case collection survey of images and clinical data from 375 patients in Spain with suspected or confirmed COVID-19 that was published online April 29, 2020, in the British Journal of Dermatology (doi: 10.1111/bjd.19163). Cutaneous manifestations included early vesicular eruptions mainly on the trunk or limbs (9%), maculopapular (47%) to urticarial lesions (19%) mainly on the trunk, and acral areas of erythema sometimes with vesicles or erosion (perniosis-like) (19%) that seemed to be a later manifestation of COVID-19. Retiform purpura or necrosis (6%) was most concerning in terms of skin disease, with an associated with a mortality of 10%.

On histology, the early vesicular eruptions are typically marked by dyskeratotic keratinocytes, Dr. Ko said, while urticarial lesions are characterized by a mixed dermal infiltrate; maculopapular lesions were a broad category. “There are some case reports that show spongiotic dermatitis or parakeratosis with a lymphocytic infiltrate,” she said. “A caveat to keep in mind is that, although these patients may definitely have COVID-19 and be confirmed to have it by testing, hypersensitivity reactions may be due to the multiple medications they’re on.”

Patients can develop a spectrum of lesions that are suggestive of vascular damage or occlusion, Dr. Ko continued. Livedoid lesions may remain static and not eventuate into necrosis or purpura but will self-resolve. Purpuric lesions and acral gangrene have been described, and these lesions correspond to vascular occlusion on biopsy.

A later manifestation are the so-called “COVID toes” with a superficial and deep lymphocytic infiltrate, as published June 1, 2020, in JAAD Case Reports: (doi: 10.1016/j.jdcr.2020.04.011).

“There are patients in the literature that have slightly different pathology, with lymphocytic inflammation as well as occlusion of vessels,” Dr. Ko said. A paper published June 20, 2020, in the British Journal of Dermatology used immunohistochemical staining against the SARS-CoV-2 spike protein, and biopsies of “COVID toes” had positive staining of endothelial cells, supporting the notion that “COVID toes” are a direct manifestation of viral infection (doi: 10.1111/bjd.19327).

“There’s a lot that we still don’t know, and some patterns are going to be outliers,” Dr. Ko concluded. “[As for] determining which skin manifestations are directly from coronavirus infection within the skin, more study is needed and likely time will tell.” She reported having no financial disclosures relevant to her talk.

[email protected]

Here are the stories our MDedge editors across specialties think you need to know about today:

Ignored by doctors, transgender patients turn to DIY treatments

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

ACIP plans priority groups in advance of COVID-19 vaccine

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.

‘Nietzsche was wrong’: Past stressors do not create psychological resilience.

The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.

Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.

The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.

“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.

High-impact training can build bone in older women

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report. 

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

Here are the stories our MDedge editors across specialties think you need to know about today:

Ignored by doctors, transgender patients turn to DIY treatments

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

ACIP plans priority groups in advance of COVID-19 vaccine

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.

‘Nietzsche was wrong’: Past stressors do not create psychological resilience.

The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.

Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.

The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.

“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.

High-impact training can build bone in older women

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report. 

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

Here are the stories our MDedge editors across specialties think you need to know about today:

Ignored by doctors, transgender patients turn to DIY treatments

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

ACIP plans priority groups in advance of COVID-19 vaccine

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said. Read more.

‘Nietzsche was wrong’: Past stressors do not create psychological resilience.

The famous quote from the German philosopher Friedrich Nietzsche, “That which does not kill us makes us stronger,” may not be true after all – at least when it comes to mental health.

Results of a new study show that individuals who have a history of a stressful life events are more likely to develop PTSD and/or major depressive disorder (MDD) following a major natural disaster than their counterparts who do not have such a history.

The investigation of more than a thousand Chilean residents – all of whom experienced one of the most powerful earthquakes in the country’s history – showed that the odds of developing postdisaster PTSD or MDD increased according to the number of predisaster stressors participants had experienced.

“At the clinical level, these findings help the clinician know which patients are more likely to need more intensive services,” said Stephen L. Buka, PhD. “And the more trauma and hardship they’ve experienced, the more attention they need and the less likely they’re going to be able to cope and manage on their own.” Read more.

High-impact training can build bone in older women

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report. 

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia. But new findings show that high-intensity resistance and impact training was a safe and effective way to improve bone mass.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” said Vanessa Yingling, PhD. Read more.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.






 

Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.

Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.

If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.

But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.

The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.

A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.

Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.

People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.

In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?

Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.

You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.

Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.

If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.

But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.

The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.

A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.

Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.

People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.

In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?

Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.

You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.

Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.

If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.

But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.

The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.

A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.

Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.

People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.

In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?

Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.

You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.