Nearly two-thirds of people who had persistent COVID-19 symptoms during the first 2 years of the pandemic were women, according to a new study published in JAMA.

The global study also found that about 6% of people with symptomatic infections had long COVID in 2020 and 2021. The risk for long COVID seemed to be greater among those who needed hospitalization, especially those who needed intensive care.

“Quantifying the number of individuals with long COVID may help policy makers ensure adequate access to services to guide people toward recovery, return to the workplace or school, and restore their mental health and social life,” the researchers wrote.

The study team, which included dozens of researchers across nearly every continent, analyzed data from 54 studies and two databases for more than 1 million patients in 22 countries who had symptomatic COVID infections in 2020 and 2021. They looked at three long COVID symptom types: persistent fatigue with bodily pain or mood swings, ongoing respiratory problems, and cognitive issues. The study included people aged 4-66.

Overall, 6.2% of people reported one of the long COVID symptom types, including 3.7% with ongoing respiratory problems, 3.2% with persistent fatigue and bodily pain or mood swings, and 2.2% with cognitive problems. Among those with long COVID, 38% of people reported more than one symptom cluster.

At 3 months after infection, long COVID symptoms were nearly twice as common in women who were at least 20 years old at 10.6%, compared with men who were at least 20 years old at 5.4%.

Children and teens appeared to have lower risks of long COVID. About 2.8% of patients under age 20 with symptomatic infection developed long-term issues.

The estimated average duration of long COVID symptoms was 9 months among hospitalized patients and 4 months among those who weren’t hospitalized. About 15% of people with long COVID symptoms 3 months after the initial infection continued to have symptoms at 12 months.

The study was largely based on detailed data from ongoing COVID-19 studies in the United States, Austria, the Faroe Islands, Germany, Iran, Italy, the Netherlands, Russia, Sweden, and Switzerland, according to UPI. It was supplemented by published data and research conducted as part of the Global Burden of Diseases, Injuries and Risk Factors Study. The dozens of researchers are referred to as “Global Burden of Disease Long COVID Collaborators.”

The study had limitations, the researchers said, including the assumption that long COVID follows a similar course in all countries. Additional studies may show how long COVID symptoms and severity may vary in different countries and continents.

Ultimately, ongoing studies of large numbers of people with long COVID could help scientists and public health officials understand risk factors and ways to treat the debilitating condition, the study authors wrote, noting that “postinfection fatigue syndrome” has been reported before, namely during the 1918 flu pandemic, after the SARS outbreak in 2003, and after the Ebola epidemic in West Africa in 2014.

“Similar symptoms have been reported after other viral infections, including the Epstein-Barr virus, mononucleosis, and dengue, as well as after nonviral infections such as Q fever, Lyme disease and giardiasis,” they wrote.

Several study investigators reported receiving grants and personal fees from a variety of sources.

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

Nearly two-thirds of people who had persistent COVID-19 symptoms during the first 2 years of the pandemic were women, according to a new study published in JAMA.

The global study also found that about 6% of people with symptomatic infections had long COVID in 2020 and 2021. The risk for long COVID seemed to be greater among those who needed hospitalization, especially those who needed intensive care.

“Quantifying the number of individuals with long COVID may help policy makers ensure adequate access to services to guide people toward recovery, return to the workplace or school, and restore their mental health and social life,” the researchers wrote.

The study team, which included dozens of researchers across nearly every continent, analyzed data from 54 studies and two databases for more than 1 million patients in 22 countries who had symptomatic COVID infections in 2020 and 2021. They looked at three long COVID symptom types: persistent fatigue with bodily pain or mood swings, ongoing respiratory problems, and cognitive issues. The study included people aged 4-66.

Overall, 6.2% of people reported one of the long COVID symptom types, including 3.7% with ongoing respiratory problems, 3.2% with persistent fatigue and bodily pain or mood swings, and 2.2% with cognitive problems. Among those with long COVID, 38% of people reported more than one symptom cluster.

At 3 months after infection, long COVID symptoms were nearly twice as common in women who were at least 20 years old at 10.6%, compared with men who were at least 20 years old at 5.4%.

Children and teens appeared to have lower risks of long COVID. About 2.8% of patients under age 20 with symptomatic infection developed long-term issues.

The estimated average duration of long COVID symptoms was 9 months among hospitalized patients and 4 months among those who weren’t hospitalized. About 15% of people with long COVID symptoms 3 months after the initial infection continued to have symptoms at 12 months.

The study was largely based on detailed data from ongoing COVID-19 studies in the United States, Austria, the Faroe Islands, Germany, Iran, Italy, the Netherlands, Russia, Sweden, and Switzerland, according to UPI. It was supplemented by published data and research conducted as part of the Global Burden of Diseases, Injuries and Risk Factors Study. The dozens of researchers are referred to as “Global Burden of Disease Long COVID Collaborators.”

The study had limitations, the researchers said, including the assumption that long COVID follows a similar course in all countries. Additional studies may show how long COVID symptoms and severity may vary in different countries and continents.

Ultimately, ongoing studies of large numbers of people with long COVID could help scientists and public health officials understand risk factors and ways to treat the debilitating condition, the study authors wrote, noting that “postinfection fatigue syndrome” has been reported before, namely during the 1918 flu pandemic, after the SARS outbreak in 2003, and after the Ebola epidemic in West Africa in 2014.

“Similar symptoms have been reported after other viral infections, including the Epstein-Barr virus, mononucleosis, and dengue, as well as after nonviral infections such as Q fever, Lyme disease and giardiasis,” they wrote.

Several study investigators reported receiving grants and personal fees from a variety of sources.

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

Nearly two-thirds of people who had persistent COVID-19 symptoms during the first 2 years of the pandemic were women, according to a new study published in JAMA.

The global study also found that about 6% of people with symptomatic infections had long COVID in 2020 and 2021. The risk for long COVID seemed to be greater among those who needed hospitalization, especially those who needed intensive care.

“Quantifying the number of individuals with long COVID may help policy makers ensure adequate access to services to guide people toward recovery, return to the workplace or school, and restore their mental health and social life,” the researchers wrote.

The study team, which included dozens of researchers across nearly every continent, analyzed data from 54 studies and two databases for more than 1 million patients in 22 countries who had symptomatic COVID infections in 2020 and 2021. They looked at three long COVID symptom types: persistent fatigue with bodily pain or mood swings, ongoing respiratory problems, and cognitive issues. The study included people aged 4-66.

Overall, 6.2% of people reported one of the long COVID symptom types, including 3.7% with ongoing respiratory problems, 3.2% with persistent fatigue and bodily pain or mood swings, and 2.2% with cognitive problems. Among those with long COVID, 38% of people reported more than one symptom cluster.

At 3 months after infection, long COVID symptoms were nearly twice as common in women who were at least 20 years old at 10.6%, compared with men who were at least 20 years old at 5.4%.

Children and teens appeared to have lower risks of long COVID. About 2.8% of patients under age 20 with symptomatic infection developed long-term issues.

The estimated average duration of long COVID symptoms was 9 months among hospitalized patients and 4 months among those who weren’t hospitalized. About 15% of people with long COVID symptoms 3 months after the initial infection continued to have symptoms at 12 months.

The study was largely based on detailed data from ongoing COVID-19 studies in the United States, Austria, the Faroe Islands, Germany, Iran, Italy, the Netherlands, Russia, Sweden, and Switzerland, according to UPI. It was supplemented by published data and research conducted as part of the Global Burden of Diseases, Injuries and Risk Factors Study. The dozens of researchers are referred to as “Global Burden of Disease Long COVID Collaborators.”

The study had limitations, the researchers said, including the assumption that long COVID follows a similar course in all countries. Additional studies may show how long COVID symptoms and severity may vary in different countries and continents.

Ultimately, ongoing studies of large numbers of people with long COVID could help scientists and public health officials understand risk factors and ways to treat the debilitating condition, the study authors wrote, noting that “postinfection fatigue syndrome” has been reported before, namely during the 1918 flu pandemic, after the SARS outbreak in 2003, and after the Ebola epidemic in West Africa in 2014.

“Similar symptoms have been reported after other viral infections, including the Epstein-Barr virus, mononucleosis, and dengue, as well as after nonviral infections such as Q fever, Lyme disease and giardiasis,” they wrote.

Several study investigators reported receiving grants and personal fees from a variety of sources.

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

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

Have you ever lied about COVID-19?

Before you get upset, before the “how dare you,” I want you to think carefully.

Did you have COVID-19 (or think you did) and not mention it to someone you were going to be with? Did you tell someone you were taking more COVID precautions than you really were? Did you tell someone you were vaccinated when you weren’t? Have you avoided getting a COVID test even though you knew you should have?

A new study, appearing in JAMA Network Open, suggests that nearly half of people have lied about something to do with COVID. And those are just the people who admit it.

Researchers appreciated the fact that public health interventions in COVID are important but are only as good as the percentage of people who actually abide by them. So, they designed a survey to ask the questions that many people don’t want to hear the answer to.

A total of 1,733 participants – 80% of those invited – responded to the survey. By design, approximately one-third of respondents (477) had already had COVID, one-third (499) were vaccinated and not yet infected, and one-third (509) were unvaccinated and not yet infected.

Of those surveyed, 41.6% admitted that they lied about COVID or didn’t adhere to COVID guidelines - a conservative estimate, if you ask me.

Breaking down some of the results, about 20% of people who previously were infected with COVID said they didn’t mention it when meeting with someone. A similar number said they didn’t tell anyone when they were entering a public place. A bit more concerning to me, roughly 20% reported not disclosing their COVID-positive status when going to a health care provider’s office.

About 10% of those who had not been vaccinated reported lying about their vaccination status. That’s actually less than the 15% of vaccinated people who lied and told someone they weren’t vaccinated.

About 17% of people lied about the need to quarantine, and many more broke quarantine rules.

The authors tried to see if certain personal characteristics predicted people who were more likely to lie about COVID-19–related issues. Turns out there was only one thing that predicted honesty: age.

Older people were more honest about their COVID status and COVID habits. Other factors – gender, education, race, political affiliation, COVID-19 conspiracy beliefs, and where you got your COVID information – did not seem to make much of a difference. Why are older people more honest? Because older people take COVID more seriously. And they should; COVID is more severe in older people.

The problem arises, of course, because people who are at lower risk for COVID complications interact with people at higher risk – and in those situations, honesty matters more.

On the other hand, isn’t lying about COVID stuff inevitable? If you know that a positive test means you can’t go to work, and not going to work means you won’t get paid, might you not be more likely to lie about the test? Or not get the test at all?

The authors explored the reasons for dishonesty and they are fairly broad, ranging from the desire for life to feel normal (more than half of people who lied) to not believing that COVID was real (a whopping 30%). Some of the reasons for lying included:

• Wanted life to feel normal (50%).
• Freedom (45%).
• It’s no one’s business (40%).
• COVID isn’t real (30%).

In the end, though, we need to realize that public health recommendations are not going to be universally followed, and people may tell us they are following them when, in fact, they are not.

What this adds is another data point to a trend we’ve seen across the course of the pandemic, a shift from collective to individual responsibility. If you can’t be sure what others are doing in regard to COVID, you need to focus on protecting yourself. Perhaps that shift was inevitable. Doesn’t mean we have to like it.

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

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape. He tweets @fperrywilson and hosts a repository of his communication work at www.methodsman.com.

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

Have you ever lied about COVID-19?

Before you get upset, before the “how dare you,” I want you to think carefully.

Did you have COVID-19 (or think you did) and not mention it to someone you were going to be with? Did you tell someone you were taking more COVID precautions than you really were? Did you tell someone you were vaccinated when you weren’t? Have you avoided getting a COVID test even though you knew you should have?

A new study, appearing in JAMA Network Open, suggests that nearly half of people have lied about something to do with COVID. And those are just the people who admit it.

Researchers appreciated the fact that public health interventions in COVID are important but are only as good as the percentage of people who actually abide by them. So, they designed a survey to ask the questions that many people don’t want to hear the answer to.

A total of 1,733 participants – 80% of those invited – responded to the survey. By design, approximately one-third of respondents (477) had already had COVID, one-third (499) were vaccinated and not yet infected, and one-third (509) were unvaccinated and not yet infected.

Of those surveyed, 41.6% admitted that they lied about COVID or didn’t adhere to COVID guidelines - a conservative estimate, if you ask me.

Breaking down some of the results, about 20% of people who previously were infected with COVID said they didn’t mention it when meeting with someone. A similar number said they didn’t tell anyone when they were entering a public place. A bit more concerning to me, roughly 20% reported not disclosing their COVID-positive status when going to a health care provider’s office.

About 10% of those who had not been vaccinated reported lying about their vaccination status. That’s actually less than the 15% of vaccinated people who lied and told someone they weren’t vaccinated.

About 17% of people lied about the need to quarantine, and many more broke quarantine rules.

The authors tried to see if certain personal characteristics predicted people who were more likely to lie about COVID-19–related issues. Turns out there was only one thing that predicted honesty: age.

Older people were more honest about their COVID status and COVID habits. Other factors – gender, education, race, political affiliation, COVID-19 conspiracy beliefs, and where you got your COVID information – did not seem to make much of a difference. Why are older people more honest? Because older people take COVID more seriously. And they should; COVID is more severe in older people.

The problem arises, of course, because people who are at lower risk for COVID complications interact with people at higher risk – and in those situations, honesty matters more.

On the other hand, isn’t lying about COVID stuff inevitable? If you know that a positive test means you can’t go to work, and not going to work means you won’t get paid, might you not be more likely to lie about the test? Or not get the test at all?

The authors explored the reasons for dishonesty and they are fairly broad, ranging from the desire for life to feel normal (more than half of people who lied) to not believing that COVID was real (a whopping 30%). Some of the reasons for lying included:

• Wanted life to feel normal (50%).
• Freedom (45%).
• It’s no one’s business (40%).
• COVID isn’t real (30%).

In the end, though, we need to realize that public health recommendations are not going to be universally followed, and people may tell us they are following them when, in fact, they are not.

What this adds is another data point to a trend we’ve seen across the course of the pandemic, a shift from collective to individual responsibility. If you can’t be sure what others are doing in regard to COVID, you need to focus on protecting yourself. Perhaps that shift was inevitable. Doesn’t mean we have to like it.

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

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape. He tweets @fperrywilson and hosts a repository of his communication work at www.methodsman.com.

This transcript has been edited for clarity.

Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr. F. Perry Wilson of the Yale School of Medicine.

Have you ever lied about COVID-19?

Before you get upset, before the “how dare you,” I want you to think carefully.

Did you have COVID-19 (or think you did) and not mention it to someone you were going to be with? Did you tell someone you were taking more COVID precautions than you really were? Did you tell someone you were vaccinated when you weren’t? Have you avoided getting a COVID test even though you knew you should have?

A new study, appearing in JAMA Network Open, suggests that nearly half of people have lied about something to do with COVID. And those are just the people who admit it.

Researchers appreciated the fact that public health interventions in COVID are important but are only as good as the percentage of people who actually abide by them. So, they designed a survey to ask the questions that many people don’t want to hear the answer to.

A total of 1,733 participants – 80% of those invited – responded to the survey. By design, approximately one-third of respondents (477) had already had COVID, one-third (499) were vaccinated and not yet infected, and one-third (509) were unvaccinated and not yet infected.

Of those surveyed, 41.6% admitted that they lied about COVID or didn’t adhere to COVID guidelines - a conservative estimate, if you ask me.

Breaking down some of the results, about 20% of people who previously were infected with COVID said they didn’t mention it when meeting with someone. A similar number said they didn’t tell anyone when they were entering a public place. A bit more concerning to me, roughly 20% reported not disclosing their COVID-positive status when going to a health care provider’s office.

About 10% of those who had not been vaccinated reported lying about their vaccination status. That’s actually less than the 15% of vaccinated people who lied and told someone they weren’t vaccinated.

About 17% of people lied about the need to quarantine, and many more broke quarantine rules.

The authors tried to see if certain personal characteristics predicted people who were more likely to lie about COVID-19–related issues. Turns out there was only one thing that predicted honesty: age.

Older people were more honest about their COVID status and COVID habits. Other factors – gender, education, race, political affiliation, COVID-19 conspiracy beliefs, and where you got your COVID information – did not seem to make much of a difference. Why are older people more honest? Because older people take COVID more seriously. And they should; COVID is more severe in older people.

The problem arises, of course, because people who are at lower risk for COVID complications interact with people at higher risk – and in those situations, honesty matters more.

On the other hand, isn’t lying about COVID stuff inevitable? If you know that a positive test means you can’t go to work, and not going to work means you won’t get paid, might you not be more likely to lie about the test? Or not get the test at all?

The authors explored the reasons for dishonesty and they are fairly broad, ranging from the desire for life to feel normal (more than half of people who lied) to not believing that COVID was real (a whopping 30%). Some of the reasons for lying included:

• Wanted life to feel normal (50%).
• Freedom (45%).
• It’s no one’s business (40%).
• COVID isn’t real (30%).

In the end, though, we need to realize that public health recommendations are not going to be universally followed, and people may tell us they are following them when, in fact, they are not.

What this adds is another data point to a trend we’ve seen across the course of the pandemic, a shift from collective to individual responsibility. If you can’t be sure what others are doing in regard to COVID, you need to focus on protecting yourself. Perhaps that shift was inevitable. Doesn’t mean we have to like it.

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

F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. His science communication work can be found in the Huffington Post, on NPR, and here on Medscape. He tweets @fperrywilson and hosts a repository of his communication work at www.methodsman.com.

Thiazolidinediones (TZDs), such as pioglitazone, appear to be protective against dementia whereas sulfonylureas appear to increase the risk, a new observational study in patients with type 2 diabetes suggests.

The data, obtained from nationwide electronic medical records from the Department of Veterans Affairs, yielded a 22% lower risk of dementia with TZD monotherapy and a 12% elevated risk with sulfonylurea monotherapy, compared with metformin monotherapy. The apparent protective effects of TZDs were greater among individuals with overweight or obesity.

“Our findings provide additional information to aid clinicians’ selection of [glucose-lowering medications] for patients with mild or moderate type 2 diabetes and [who] are at high risk of dementia,” Xin Tang and colleagues wrote in their article, published online in BMJ Open Diabetes Research & Care.

The results “add substantially to the literature concerning the effects of [glucose-lowering medications] on dementia where previous findings have been inconsistent. Studies with a follow-up time of less than 3 years have mainly reported null associations, while studies with longer a follow-up time typically yielded protective findings. With a mean follow-up time of 6.8 years, we had a sufficient duration to detect treatment differences,” the investigators wrote.

“Supplementing [a] sulfonylurea with either metformin or [a] TZD may partially offset its prodementia effects. These findings may help inform medication selection for elderly patients with T2D at high risk of dementia,” they added.
 

Randomized trials needed to determine cause and effect

Ivan Koychev, PhD, a senior clinical researcher in the department of psychiatry at the University of Oxford (England), told the UK Science Media Centre: “This is a large, well-conducted real-world data study that highlights the importance of checking whether already prescribed medications may be useful for preventing dementia.”

The findings regarding TZDs, also known as glitazones, are in line with existing literature suggesting dementia protection with other drugs prescribed for type 2 diabetes that weren’t examined in the current study, such as newer agents like glucagonlike peptide–1 (GLP-1) agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. Koychev said.

“The main limitations of this study is that following the initial 2-year period the authors were interested in, the participants may have been prescribed one of the other type 2 diabetes drugs [GLP-1 agonists or SGLT2 inhibitors] that have been found to reduce dementia risk, thus potentially making the direct glitazone [TZD] effect more difficult to discern,” Dr. Koychev noted.

And, he pointed out that the study design limits attribution of causality. “It is also important to note that people with type 2 diabetes do run a higher risk of both dementia and cognitive deficits and that these medications are only prescribed in these patients, so all this data is from this patient group rather than the general population.”

James Connell, PhD, head of translational science at Alzheimer’s Research UK, agreed. “While this observational study found that those with type 2 diabetes taking thiazolidinedione had a lower dementia risk than those on the most common medication for type 2 diabetes, it only shows an association between taking the drug and dementia risk and not a causal relationship.

“Double-blind and placebo-controlled clinical trials are needed to see whether the drug [TDZ] could help lower dementia risk in people with and without diabetes. Anyone with any questions about what treatments they are receiving should speak to their doctor,” he told the UK Science Media Centre.
 

Opposite effects of sulfonylureas, TZDs versus metformin

The study authors analyzed 559,106 VA patients with type 2 diabetes who initiated glucose-lowering medication during 2001-2017 and took it for at least a year. They were aged 60 years or older and did not have dementia at baseline. Most were White (76.8%) and male (96.9%), two-thirds (63.1%) had obesity, and mean hemoglobin A1c was 6.8%.

Overall, 31,125 developed all-cause dementia. The incidence rate was 8.2 cases per 1,000 person-years, ranging from 6.2 cases per 1,000 person-years among those taking metformin monotherapy to 13.4 cases per 1,000 person-years in those taking both sulfonylurea and a TZD.

Compared with metformin monotherapy, the hazard ratio for all-cause dementia for sulfonylurea monotherapy was a significant 1.12. The increased risk was also seen for vascular dementia, with an HR of 1.14.

In contrast, TZD monotherapy was associated with a significantly lower risk for all-cause dementia (HR, 0.78), as well as for Alzheimer’s disease (HR, 0.89) and vascular dementia (HR, 0.43), compared with metformin monotherapy.

The combination of metformin and TZD also lowered the risk of all-cause dementia, while regimens including sulfonylureas raised the risks for all-cause and vascular dementia.

Most of the results didn’t change significantly when the drug exposure window was extended to 2 years.
 

Effects more pronounced in those with obesity

The protective 1-year effects of TZD monotherapy and of metformin plus TZD, compared with metformin alone, were more significant among participants aged 75 or younger and with a body mass index above 25 kg/m², compared with those who were older than 75 years and with normal BMIs, respectively.

On the other hand, the greater risk for dementia incurred with sulfonylureas was further increased among those with higher BMI.

This research was partially funded by grants from the National Human Genome Research Institute, the National Science Foundation, the National Institute of Diabetes and Digestive and Kidney Disease, and the National Heart, Lung, and Blood Institute. Dr. Koychev is chief investigator for a trial, sponsored by Oxford University and funded by Novo Nordisk, testing whether the GLP-1 agonist semaglutide reduces the risk for dementia in aging adults.

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

Thiazolidinediones (TZDs), such as pioglitazone, appear to be protective against dementia whereas sulfonylureas appear to increase the risk, a new observational study in patients with type 2 diabetes suggests.

The data, obtained from nationwide electronic medical records from the Department of Veterans Affairs, yielded a 22% lower risk of dementia with TZD monotherapy and a 12% elevated risk with sulfonylurea monotherapy, compared with metformin monotherapy. The apparent protective effects of TZDs were greater among individuals with overweight or obesity.

“Our findings provide additional information to aid clinicians’ selection of [glucose-lowering medications] for patients with mild or moderate type 2 diabetes and [who] are at high risk of dementia,” Xin Tang and colleagues wrote in their article, published online in BMJ Open Diabetes Research & Care.

The results “add substantially to the literature concerning the effects of [glucose-lowering medications] on dementia where previous findings have been inconsistent. Studies with a follow-up time of less than 3 years have mainly reported null associations, while studies with longer a follow-up time typically yielded protective findings. With a mean follow-up time of 6.8 years, we had a sufficient duration to detect treatment differences,” the investigators wrote.

“Supplementing [a] sulfonylurea with either metformin or [a] TZD may partially offset its prodementia effects. These findings may help inform medication selection for elderly patients with T2D at high risk of dementia,” they added.
 

Randomized trials needed to determine cause and effect

Ivan Koychev, PhD, a senior clinical researcher in the department of psychiatry at the University of Oxford (England), told the UK Science Media Centre: “This is a large, well-conducted real-world data study that highlights the importance of checking whether already prescribed medications may be useful for preventing dementia.”

The findings regarding TZDs, also known as glitazones, are in line with existing literature suggesting dementia protection with other drugs prescribed for type 2 diabetes that weren’t examined in the current study, such as newer agents like glucagonlike peptide–1 (GLP-1) agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. Koychev said.

“The main limitations of this study is that following the initial 2-year period the authors were interested in, the participants may have been prescribed one of the other type 2 diabetes drugs [GLP-1 agonists or SGLT2 inhibitors] that have been found to reduce dementia risk, thus potentially making the direct glitazone [TZD] effect more difficult to discern,” Dr. Koychev noted.

And, he pointed out that the study design limits attribution of causality. “It is also important to note that people with type 2 diabetes do run a higher risk of both dementia and cognitive deficits and that these medications are only prescribed in these patients, so all this data is from this patient group rather than the general population.”

James Connell, PhD, head of translational science at Alzheimer’s Research UK, agreed. “While this observational study found that those with type 2 diabetes taking thiazolidinedione had a lower dementia risk than those on the most common medication for type 2 diabetes, it only shows an association between taking the drug and dementia risk and not a causal relationship.

“Double-blind and placebo-controlled clinical trials are needed to see whether the drug [TDZ] could help lower dementia risk in people with and without diabetes. Anyone with any questions about what treatments they are receiving should speak to their doctor,” he told the UK Science Media Centre.
 

Opposite effects of sulfonylureas, TZDs versus metformin

The study authors analyzed 559,106 VA patients with type 2 diabetes who initiated glucose-lowering medication during 2001-2017 and took it for at least a year. They were aged 60 years or older and did not have dementia at baseline. Most were White (76.8%) and male (96.9%), two-thirds (63.1%) had obesity, and mean hemoglobin A1c was 6.8%.

Overall, 31,125 developed all-cause dementia. The incidence rate was 8.2 cases per 1,000 person-years, ranging from 6.2 cases per 1,000 person-years among those taking metformin monotherapy to 13.4 cases per 1,000 person-years in those taking both sulfonylurea and a TZD.

Compared with metformin monotherapy, the hazard ratio for all-cause dementia for sulfonylurea monotherapy was a significant 1.12. The increased risk was also seen for vascular dementia, with an HR of 1.14.

In contrast, TZD monotherapy was associated with a significantly lower risk for all-cause dementia (HR, 0.78), as well as for Alzheimer’s disease (HR, 0.89) and vascular dementia (HR, 0.43), compared with metformin monotherapy.

The combination of metformin and TZD also lowered the risk of all-cause dementia, while regimens including sulfonylureas raised the risks for all-cause and vascular dementia.

Most of the results didn’t change significantly when the drug exposure window was extended to 2 years.
 

Effects more pronounced in those with obesity

The protective 1-year effects of TZD monotherapy and of metformin plus TZD, compared with metformin alone, were more significant among participants aged 75 or younger and with a body mass index above 25 kg/m², compared with those who were older than 75 years and with normal BMIs, respectively.

On the other hand, the greater risk for dementia incurred with sulfonylureas was further increased among those with higher BMI.

This research was partially funded by grants from the National Human Genome Research Institute, the National Science Foundation, the National Institute of Diabetes and Digestive and Kidney Disease, and the National Heart, Lung, and Blood Institute. Dr. Koychev is chief investigator for a trial, sponsored by Oxford University and funded by Novo Nordisk, testing whether the GLP-1 agonist semaglutide reduces the risk for dementia in aging adults.

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

Thiazolidinediones (TZDs), such as pioglitazone, appear to be protective against dementia whereas sulfonylureas appear to increase the risk, a new observational study in patients with type 2 diabetes suggests.

The data, obtained from nationwide electronic medical records from the Department of Veterans Affairs, yielded a 22% lower risk of dementia with TZD monotherapy and a 12% elevated risk with sulfonylurea monotherapy, compared with metformin monotherapy. The apparent protective effects of TZDs were greater among individuals with overweight or obesity.

“Our findings provide additional information to aid clinicians’ selection of [glucose-lowering medications] for patients with mild or moderate type 2 diabetes and [who] are at high risk of dementia,” Xin Tang and colleagues wrote in their article, published online in BMJ Open Diabetes Research & Care.

The results “add substantially to the literature concerning the effects of [glucose-lowering medications] on dementia where previous findings have been inconsistent. Studies with a follow-up time of less than 3 years have mainly reported null associations, while studies with longer a follow-up time typically yielded protective findings. With a mean follow-up time of 6.8 years, we had a sufficient duration to detect treatment differences,” the investigators wrote.

“Supplementing [a] sulfonylurea with either metformin or [a] TZD may partially offset its prodementia effects. These findings may help inform medication selection for elderly patients with T2D at high risk of dementia,” they added.
 

Randomized trials needed to determine cause and effect

Ivan Koychev, PhD, a senior clinical researcher in the department of psychiatry at the University of Oxford (England), told the UK Science Media Centre: “This is a large, well-conducted real-world data study that highlights the importance of checking whether already prescribed medications may be useful for preventing dementia.”

The findings regarding TZDs, also known as glitazones, are in line with existing literature suggesting dementia protection with other drugs prescribed for type 2 diabetes that weren’t examined in the current study, such as newer agents like glucagonlike peptide–1 (GLP-1) agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors, Dr. Koychev said.

“The main limitations of this study is that following the initial 2-year period the authors were interested in, the participants may have been prescribed one of the other type 2 diabetes drugs [GLP-1 agonists or SGLT2 inhibitors] that have been found to reduce dementia risk, thus potentially making the direct glitazone [TZD] effect more difficult to discern,” Dr. Koychev noted.

And, he pointed out that the study design limits attribution of causality. “It is also important to note that people with type 2 diabetes do run a higher risk of both dementia and cognitive deficits and that these medications are only prescribed in these patients, so all this data is from this patient group rather than the general population.”

James Connell, PhD, head of translational science at Alzheimer’s Research UK, agreed. “While this observational study found that those with type 2 diabetes taking thiazolidinedione had a lower dementia risk than those on the most common medication for type 2 diabetes, it only shows an association between taking the drug and dementia risk and not a causal relationship.

“Double-blind and placebo-controlled clinical trials are needed to see whether the drug [TDZ] could help lower dementia risk in people with and without diabetes. Anyone with any questions about what treatments they are receiving should speak to their doctor,” he told the UK Science Media Centre.
 

Opposite effects of sulfonylureas, TZDs versus metformin

The study authors analyzed 559,106 VA patients with type 2 diabetes who initiated glucose-lowering medication during 2001-2017 and took it for at least a year. They were aged 60 years or older and did not have dementia at baseline. Most were White (76.8%) and male (96.9%), two-thirds (63.1%) had obesity, and mean hemoglobin A1c was 6.8%.

Overall, 31,125 developed all-cause dementia. The incidence rate was 8.2 cases per 1,000 person-years, ranging from 6.2 cases per 1,000 person-years among those taking metformin monotherapy to 13.4 cases per 1,000 person-years in those taking both sulfonylurea and a TZD.

Compared with metformin monotherapy, the hazard ratio for all-cause dementia for sulfonylurea monotherapy was a significant 1.12. The increased risk was also seen for vascular dementia, with an HR of 1.14.

In contrast, TZD monotherapy was associated with a significantly lower risk for all-cause dementia (HR, 0.78), as well as for Alzheimer’s disease (HR, 0.89) and vascular dementia (HR, 0.43), compared with metformin monotherapy.

The combination of metformin and TZD also lowered the risk of all-cause dementia, while regimens including sulfonylureas raised the risks for all-cause and vascular dementia.

Most of the results didn’t change significantly when the drug exposure window was extended to 2 years.
 

Effects more pronounced in those with obesity

The protective 1-year effects of TZD monotherapy and of metformin plus TZD, compared with metformin alone, were more significant among participants aged 75 or younger and with a body mass index above 25 kg/m², compared with those who were older than 75 years and with normal BMIs, respectively.

On the other hand, the greater risk for dementia incurred with sulfonylureas was further increased among those with higher BMI.

This research was partially funded by grants from the National Human Genome Research Institute, the National Science Foundation, the National Institute of Diabetes and Digestive and Kidney Disease, and the National Heart, Lung, and Blood Institute. Dr. Koychev is chief investigator for a trial, sponsored by Oxford University and funded by Novo Nordisk, testing whether the GLP-1 agonist semaglutide reduces the risk for dementia in aging adults.

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

Weeks after Jeannie Volpe caught COVID-19 in November 2020, she could no longer do her job running sexual assault support groups in Anniston, Ala., because she kept forgetting the details that survivors had shared with her. “People were telling me they were having to revisit their traumatic memories, which isn’t fair to anybody,” the 47-year-old says.

Ms. Volpe has been diagnosed with long-COVID autonomic dysfunction, which includes severe muscle pain, depression, anxiety, and a loss of thinking skills. Some of her symptoms are more commonly known as brain fog, and they’re among the most frequent problems reported by people who have long-term issues after a bout of COVID-19.

Many experts and medical professionals say they haven’t even begun to scratch the surface of what impact this will have in years to come. 

“I’m very worried that we have an epidemic of neurologic dysfunction coming down the pike,” says Pamela Davis, MD, PhD, a research professor at Case Western Reserve University, Cleveland.

In the 2 years Ms. Volpe has been living with long COVID, her executive function – the mental processes that enable people to focus attention, retain information, and multitask – has been so diminished that she had to relearn to drive. One of the various doctors assessing her has suggested speech therapy to help Ms. Volpe relearn how to form words. “I can see the words I want to say in my mind, but I can’t make them come out of my mouth,” she says in a sluggish voice that gives away her condition. 

All of those symptoms make it difficult for her to care for herself. Without a job and health insurance, Ms. Volpe says she’s researched assisted suicide in the states that allow it but has ultimately decided she wants to live. 

“People tell you things like you should be grateful you survived it, and you should; but you shouldn’t expect somebody to not grieve after losing their autonomy, their career, their finances.”

The findings of researchers studying the brain effects of COVID-19 reinforce what people with long COVID have been dealing with from the start. Their experiences aren’t imaginary; they’re consistent with neurological disorders – including myalgic encephalomyelitis, also known as chronic fatigue syndrome, or ME/CFS – which carry much more weight in the public imagination than the term brain fog, which can often be used dismissively.

Studies have found that COVID-19 is linked to conditions such as strokes; seizures; and mood, memory, and movement disorders. 

While there are still a lot of unanswered questions about exactly how COVID-19 affects the brain and what the long-term effects are, there’s enough reason to suggest people should be trying to avoid both infection and reinfection until researchers get more answers.

Worldwide, it’s estimated that COVID-19 has contributed to more than 40 million new cases of neurological disorders, says Ziyad Al-Aly, MD, a clinical epidemiologist and long COVID researcher at Washington University in St. Louis. In his latest study of 14 million medical records of the U.S. Department of Veterans Affairs, the country’s largest integrated health care system, researchers found that regardless of age, gender, race, and lifestyle, people who have had COVID-19 are at a higher risk of getting a wide array of 44 neurological conditions after the first year of infection.

He noted that some of the conditions, such as headaches and mild decline in memory and sharpness, may improve and go away over time. But others that showed up, such as stroke, encephalitis (inflammation of the brain), and Guillain-Barré syndrome (a rare disorder in which the body’s immune system attacks the nerves), often lead to lasting damage. Dr. Al-Aly’s team found that neurological conditions were 7% more likely in those who had COVID-19 than in those who had never been infected. 

What’s more, researchers noticed that compared with control groups, the risk of post-COVID thinking problems was more pronounced in people in their 30s, 40s, and 50s – a group that usually would be very unlikely to have these problems. For those over the age of 60, the risks stood out less because at that stage of life, such thinking problems aren’t as rare.

Another study of the veterans system last year showed that COVID-19 survivors were at a 46% higher risk of considering suicide after 1 year.

“We need to be paying attention to this,” says Dr. Al-Aly.  “What we’ve seen is really the tip of the iceberg.” He worries that millions of people, including youths, will lose out on employment and education while dealing with long-term disabilities – and the economic and societal implications of such a fallout. “What we will all be left with is the aftermath of sheer devastation in some people’s lives,” he says.

Igor Koralnik, MD, chief of neuro-infectious disease and global neurology at Northwestern University, Chicago, has been running a specialized long COVID clinic. His team published a paper in March 2021 detailing what they saw in their first 100 patients. “About half the population in the study missed at least 10 days of work. This is going to have persistent impact on the workforce,” Dr. Koralnik said in a podcast posted on the Northwestern website. “We have seen that not only [do] patients have symptoms, but they have decreased quality of life.”

For older people and their caregivers, the risk of potential neurodegenerative diseases that the virus has shown to accelerate, such as dementia, is also a big concern. Alzheimer’s is already the fifth leading cause of death for people 65 and older. 

In a recent study of more than 6 million people over the age of 65, Dr. Davis and her team at Case Western found the risk of Alzheimer’s in the year after COVID-19 increased by 50%-80%. The chances were especially high for women older than 85.

To date, there are no good treatments for Alzheimer’s, yet total health care costs for long-term care and hospice services for people with dementia topped $300 billion in 2020. That doesn’t even include the related costs to families.

“The downstream effect of having someone with Alzheimer’s being taken care of by a family member can be devastating on everyone,” she says. “Sometimes the caregivers don’t weather that very well.” 

When Dr. Davis’s own father got Alzheimer’s at age 86, her mother took care of him until she had a stroke one morning while making breakfast. Dr. Davis attributes the stroke to the stress of caregiving. That left Dr. Davis no choice but to seek housing where both her parents could get care. 

Looking at the broader picture, Dr. Davis believes widespread isolation, loneliness, and grief during the pandemic, and the disease of COVID-19 itself, will continue to have a profound impact on psychiatric diagnoses. This in turn could trigger a wave of new substance abuse as a result of unchecked mental health problems.

Still, not all brain experts are jumping to worst-case scenarios, with a lot yet to be understood before sounding the alarm. Joanna Hellmuth, MD, a neurologist and researcher at the University of California, San Francisco, cautions against reading too much into early data, including any assumptions that COVID-19 causes neurodegeneration or irreversible damage in the brain. 

Even with before-and-after brain scans by University of Oxford, England, researchers that show structural changes to the brain after infection, she points out that they didn’t actually study the clinical symptoms of the people in the study, so it’s too soon to reach conclusions about associated cognitive problems.

“It’s an important piece of the puzzle, but we don’t know how that fits together with everything else,” says Dr. Hellmuth. “Some of my patients get better. … I haven’t seen a single person get worse since the pandemic started, and so I’m hopeful.”

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

Weeks after Jeannie Volpe caught COVID-19 in November 2020, she could no longer do her job running sexual assault support groups in Anniston, Ala., because she kept forgetting the details that survivors had shared with her. “People were telling me they were having to revisit their traumatic memories, which isn’t fair to anybody,” the 47-year-old says.

Ms. Volpe has been diagnosed with long-COVID autonomic dysfunction, which includes severe muscle pain, depression, anxiety, and a loss of thinking skills. Some of her symptoms are more commonly known as brain fog, and they’re among the most frequent problems reported by people who have long-term issues after a bout of COVID-19.

Many experts and medical professionals say they haven’t even begun to scratch the surface of what impact this will have in years to come. 

“I’m very worried that we have an epidemic of neurologic dysfunction coming down the pike,” says Pamela Davis, MD, PhD, a research professor at Case Western Reserve University, Cleveland.

In the 2 years Ms. Volpe has been living with long COVID, her executive function – the mental processes that enable people to focus attention, retain information, and multitask – has been so diminished that she had to relearn to drive. One of the various doctors assessing her has suggested speech therapy to help Ms. Volpe relearn how to form words. “I can see the words I want to say in my mind, but I can’t make them come out of my mouth,” she says in a sluggish voice that gives away her condition. 

All of those symptoms make it difficult for her to care for herself. Without a job and health insurance, Ms. Volpe says she’s researched assisted suicide in the states that allow it but has ultimately decided she wants to live. 

“People tell you things like you should be grateful you survived it, and you should; but you shouldn’t expect somebody to not grieve after losing their autonomy, their career, their finances.”

The findings of researchers studying the brain effects of COVID-19 reinforce what people with long COVID have been dealing with from the start. Their experiences aren’t imaginary; they’re consistent with neurological disorders – including myalgic encephalomyelitis, also known as chronic fatigue syndrome, or ME/CFS – which carry much more weight in the public imagination than the term brain fog, which can often be used dismissively.

Studies have found that COVID-19 is linked to conditions such as strokes; seizures; and mood, memory, and movement disorders. 

While there are still a lot of unanswered questions about exactly how COVID-19 affects the brain and what the long-term effects are, there’s enough reason to suggest people should be trying to avoid both infection and reinfection until researchers get more answers.

Worldwide, it’s estimated that COVID-19 has contributed to more than 40 million new cases of neurological disorders, says Ziyad Al-Aly, MD, a clinical epidemiologist and long COVID researcher at Washington University in St. Louis. In his latest study of 14 million medical records of the U.S. Department of Veterans Affairs, the country’s largest integrated health care system, researchers found that regardless of age, gender, race, and lifestyle, people who have had COVID-19 are at a higher risk of getting a wide array of 44 neurological conditions after the first year of infection.

He noted that some of the conditions, such as headaches and mild decline in memory and sharpness, may improve and go away over time. But others that showed up, such as stroke, encephalitis (inflammation of the brain), and Guillain-Barré syndrome (a rare disorder in which the body’s immune system attacks the nerves), often lead to lasting damage. Dr. Al-Aly’s team found that neurological conditions were 7% more likely in those who had COVID-19 than in those who had never been infected. 

What’s more, researchers noticed that compared with control groups, the risk of post-COVID thinking problems was more pronounced in people in their 30s, 40s, and 50s – a group that usually would be very unlikely to have these problems. For those over the age of 60, the risks stood out less because at that stage of life, such thinking problems aren’t as rare.

Another study of the veterans system last year showed that COVID-19 survivors were at a 46% higher risk of considering suicide after 1 year.

“We need to be paying attention to this,” says Dr. Al-Aly.  “What we’ve seen is really the tip of the iceberg.” He worries that millions of people, including youths, will lose out on employment and education while dealing with long-term disabilities – and the economic and societal implications of such a fallout. “What we will all be left with is the aftermath of sheer devastation in some people’s lives,” he says.

Igor Koralnik, MD, chief of neuro-infectious disease and global neurology at Northwestern University, Chicago, has been running a specialized long COVID clinic. His team published a paper in March 2021 detailing what they saw in their first 100 patients. “About half the population in the study missed at least 10 days of work. This is going to have persistent impact on the workforce,” Dr. Koralnik said in a podcast posted on the Northwestern website. “We have seen that not only [do] patients have symptoms, but they have decreased quality of life.”

For older people and their caregivers, the risk of potential neurodegenerative diseases that the virus has shown to accelerate, such as dementia, is also a big concern. Alzheimer’s is already the fifth leading cause of death for people 65 and older. 

In a recent study of more than 6 million people over the age of 65, Dr. Davis and her team at Case Western found the risk of Alzheimer’s in the year after COVID-19 increased by 50%-80%. The chances were especially high for women older than 85.

To date, there are no good treatments for Alzheimer’s, yet total health care costs for long-term care and hospice services for people with dementia topped $300 billion in 2020. That doesn’t even include the related costs to families.

“The downstream effect of having someone with Alzheimer’s being taken care of by a family member can be devastating on everyone,” she says. “Sometimes the caregivers don’t weather that very well.” 

When Dr. Davis’s own father got Alzheimer’s at age 86, her mother took care of him until she had a stroke one morning while making breakfast. Dr. Davis attributes the stroke to the stress of caregiving. That left Dr. Davis no choice but to seek housing where both her parents could get care. 

Looking at the broader picture, Dr. Davis believes widespread isolation, loneliness, and grief during the pandemic, and the disease of COVID-19 itself, will continue to have a profound impact on psychiatric diagnoses. This in turn could trigger a wave of new substance abuse as a result of unchecked mental health problems.

Still, not all brain experts are jumping to worst-case scenarios, with a lot yet to be understood before sounding the alarm. Joanna Hellmuth, MD, a neurologist and researcher at the University of California, San Francisco, cautions against reading too much into early data, including any assumptions that COVID-19 causes neurodegeneration or irreversible damage in the brain. 

Even with before-and-after brain scans by University of Oxford, England, researchers that show structural changes to the brain after infection, she points out that they didn’t actually study the clinical symptoms of the people in the study, so it’s too soon to reach conclusions about associated cognitive problems.

“It’s an important piece of the puzzle, but we don’t know how that fits together with everything else,” says Dr. Hellmuth. “Some of my patients get better. … I haven’t seen a single person get worse since the pandemic started, and so I’m hopeful.”

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

Weeks after Jeannie Volpe caught COVID-19 in November 2020, she could no longer do her job running sexual assault support groups in Anniston, Ala., because she kept forgetting the details that survivors had shared with her. “People were telling me they were having to revisit their traumatic memories, which isn’t fair to anybody,” the 47-year-old says.

Ms. Volpe has been diagnosed with long-COVID autonomic dysfunction, which includes severe muscle pain, depression, anxiety, and a loss of thinking skills. Some of her symptoms are more commonly known as brain fog, and they’re among the most frequent problems reported by people who have long-term issues after a bout of COVID-19.

Many experts and medical professionals say they haven’t even begun to scratch the surface of what impact this will have in years to come. 

“I’m very worried that we have an epidemic of neurologic dysfunction coming down the pike,” says Pamela Davis, MD, PhD, a research professor at Case Western Reserve University, Cleveland.

In the 2 years Ms. Volpe has been living with long COVID, her executive function – the mental processes that enable people to focus attention, retain information, and multitask – has been so diminished that she had to relearn to drive. One of the various doctors assessing her has suggested speech therapy to help Ms. Volpe relearn how to form words. “I can see the words I want to say in my mind, but I can’t make them come out of my mouth,” she says in a sluggish voice that gives away her condition. 

All of those symptoms make it difficult for her to care for herself. Without a job and health insurance, Ms. Volpe says she’s researched assisted suicide in the states that allow it but has ultimately decided she wants to live. 

“People tell you things like you should be grateful you survived it, and you should; but you shouldn’t expect somebody to not grieve after losing their autonomy, their career, their finances.”

The findings of researchers studying the brain effects of COVID-19 reinforce what people with long COVID have been dealing with from the start. Their experiences aren’t imaginary; they’re consistent with neurological disorders – including myalgic encephalomyelitis, also known as chronic fatigue syndrome, or ME/CFS – which carry much more weight in the public imagination than the term brain fog, which can often be used dismissively.

Studies have found that COVID-19 is linked to conditions such as strokes; seizures; and mood, memory, and movement disorders. 

While there are still a lot of unanswered questions about exactly how COVID-19 affects the brain and what the long-term effects are, there’s enough reason to suggest people should be trying to avoid both infection and reinfection until researchers get more answers.

Worldwide, it’s estimated that COVID-19 has contributed to more than 40 million new cases of neurological disorders, says Ziyad Al-Aly, MD, a clinical epidemiologist and long COVID researcher at Washington University in St. Louis. In his latest study of 14 million medical records of the U.S. Department of Veterans Affairs, the country’s largest integrated health care system, researchers found that regardless of age, gender, race, and lifestyle, people who have had COVID-19 are at a higher risk of getting a wide array of 44 neurological conditions after the first year of infection.

He noted that some of the conditions, such as headaches and mild decline in memory and sharpness, may improve and go away over time. But others that showed up, such as stroke, encephalitis (inflammation of the brain), and Guillain-Barré syndrome (a rare disorder in which the body’s immune system attacks the nerves), often lead to lasting damage. Dr. Al-Aly’s team found that neurological conditions were 7% more likely in those who had COVID-19 than in those who had never been infected. 

What’s more, researchers noticed that compared with control groups, the risk of post-COVID thinking problems was more pronounced in people in their 30s, 40s, and 50s – a group that usually would be very unlikely to have these problems. For those over the age of 60, the risks stood out less because at that stage of life, such thinking problems aren’t as rare.

Another study of the veterans system last year showed that COVID-19 survivors were at a 46% higher risk of considering suicide after 1 year.

“We need to be paying attention to this,” says Dr. Al-Aly.  “What we’ve seen is really the tip of the iceberg.” He worries that millions of people, including youths, will lose out on employment and education while dealing with long-term disabilities – and the economic and societal implications of such a fallout. “What we will all be left with is the aftermath of sheer devastation in some people’s lives,” he says.

Igor Koralnik, MD, chief of neuro-infectious disease and global neurology at Northwestern University, Chicago, has been running a specialized long COVID clinic. His team published a paper in March 2021 detailing what they saw in their first 100 patients. “About half the population in the study missed at least 10 days of work. This is going to have persistent impact on the workforce,” Dr. Koralnik said in a podcast posted on the Northwestern website. “We have seen that not only [do] patients have symptoms, but they have decreased quality of life.”

For older people and their caregivers, the risk of potential neurodegenerative diseases that the virus has shown to accelerate, such as dementia, is also a big concern. Alzheimer’s is already the fifth leading cause of death for people 65 and older. 

In a recent study of more than 6 million people over the age of 65, Dr. Davis and her team at Case Western found the risk of Alzheimer’s in the year after COVID-19 increased by 50%-80%. The chances were especially high for women older than 85.

To date, there are no good treatments for Alzheimer’s, yet total health care costs for long-term care and hospice services for people with dementia topped $300 billion in 2020. That doesn’t even include the related costs to families.

“The downstream effect of having someone with Alzheimer’s being taken care of by a family member can be devastating on everyone,” she says. “Sometimes the caregivers don’t weather that very well.” 

When Dr. Davis’s own father got Alzheimer’s at age 86, her mother took care of him until she had a stroke one morning while making breakfast. Dr. Davis attributes the stroke to the stress of caregiving. That left Dr. Davis no choice but to seek housing where both her parents could get care. 

Looking at the broader picture, Dr. Davis believes widespread isolation, loneliness, and grief during the pandemic, and the disease of COVID-19 itself, will continue to have a profound impact on psychiatric diagnoses. This in turn could trigger a wave of new substance abuse as a result of unchecked mental health problems.

Still, not all brain experts are jumping to worst-case scenarios, with a lot yet to be understood before sounding the alarm. Joanna Hellmuth, MD, a neurologist and researcher at the University of California, San Francisco, cautions against reading too much into early data, including any assumptions that COVID-19 causes neurodegeneration or irreversible damage in the brain. 

Even with before-and-after brain scans by University of Oxford, England, researchers that show structural changes to the brain after infection, she points out that they didn’t actually study the clinical symptoms of the people in the study, so it’s too soon to reach conclusions about associated cognitive problems.

“It’s an important piece of the puzzle, but we don’t know how that fits together with everything else,” says Dr. Hellmuth. “Some of my patients get better. … I haven’t seen a single person get worse since the pandemic started, and so I’m hopeful.”

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

The American College of Cardiology has released an Expert Consensus Decision Pathway on the evaluation and disposition of acute chest pain in the emergency department.

Chest pain accounts for more than 7 million ED visits annually. A major challenge is to quickly identify the small number of patients with acute coronary syndrome (ACS) among the large number of patients who have noncardiac conditions.

The new document is intended to provide guidance on how to “practically apply” recommendations from the 2021 American Heart Association/American College of Cardiology Guideline for the Evaluation and Diagnosis of Chest Pain, focusing specifically on patients who present to the ED, the writing group explains.

“A systematic approach – both at the level of the institution and the individual patient – is essential to achieve optimal outcomes for patients presenting with chest pain to the ED,” say writing group chair Michael Kontos, MD, Virginia Commonwealth University, Richmond, and colleagues.

At the institution level, this decision pathway recommends high-sensitivity cardiac troponin (hs-cTn) assays coupled with a clinical decision pathway (CDP) to reduce ED “dwell” times and increase the number of patients with chest pain who can safely be discharged without additional testing. This will decrease ED crowding and limit unnecessary testing, they point out. 

At the individual patient level, this document aims to provide structure for the ED evaluation of chest pain, accelerating the evaluation process and matching the intensity of testing and treatment to patient risk.

The 36-page document was published online in the Journal of the American College of Cardiology.

Key summary points in the document include the following:

• Electrocardiogram remains the best initial test for evaluation of chest pain in the ED and should be performed and interpreted within 10 minutes of ED arrival.
• In patients who arrive via ambulance, the prehospital ECG should be reviewed, because ischemic changes may have resolved before ED arrival.
• When the ECG shows evidence of acute infarction or ischemia, subsequent care should follow current guidelines for management of acute ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation ACS (NSTE-ACS).
• Patients with a nonischemic ECG can enter an accelerated CDP designed to provide rapid risk assessment and exclusion of ACS.
• Patients who are hemodynamically unstable, have significant arrhythmias, or evidence of significant heart failure should be evaluated and treated appropriately and are not candidates for an accelerated CDP.
• High-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) are the preferred biomarkers for evaluation of possible ACS.
• Patients classified as low risk (rule out) using the current hs-cTn-based CDPs can generally be discharged directly from the ED without additional testing, although outpatient testing may be considered in selected cases.
• Patients with substantially elevated initial hs-cTn values or those with significant dynamic changes over 1-3 hours are assigned to the abnormal/high-risk category and should be further classified according to the universal definition of myocardial infarction type 1 or 2 or acute or chronic nonischemic cardiac injury.
• High-risk patients should usually be admitted to an inpatient setting for further evaluation and treatment.
• Patients determined to be intermediate risk with the CDP should undergo additional observation with repeat hs-cTn measurements at 3-6 hours and risk assessment using either the modified HEART (history, ECG, age, risk factors, and troponin) score or the ED assessment of chest pain score (EDACS).
• Noninvasive testing should be considered for the intermediate-risk group unless low-risk features are identified using risk scores or noninvasive testing has been performed recently with normal or low-risk findings.

The writing group notes that “safe and efficient” management of chest pain in the ED requires appropriate follow-up after discharge. Timing of follow-up and referral for outpatient noninvasive testing should be influenced by patient risk and results of cardiac testing.

Disclosures for members of the writing group are available with the original article.

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

The American College of Cardiology has released an Expert Consensus Decision Pathway on the evaluation and disposition of acute chest pain in the emergency department.

Chest pain accounts for more than 7 million ED visits annually. A major challenge is to quickly identify the small number of patients with acute coronary syndrome (ACS) among the large number of patients who have noncardiac conditions.

The new document is intended to provide guidance on how to “practically apply” recommendations from the 2021 American Heart Association/American College of Cardiology Guideline for the Evaluation and Diagnosis of Chest Pain, focusing specifically on patients who present to the ED, the writing group explains.

“A systematic approach – both at the level of the institution and the individual patient – is essential to achieve optimal outcomes for patients presenting with chest pain to the ED,” say writing group chair Michael Kontos, MD, Virginia Commonwealth University, Richmond, and colleagues.

At the institution level, this decision pathway recommends high-sensitivity cardiac troponin (hs-cTn) assays coupled with a clinical decision pathway (CDP) to reduce ED “dwell” times and increase the number of patients with chest pain who can safely be discharged without additional testing. This will decrease ED crowding and limit unnecessary testing, they point out. 

At the individual patient level, this document aims to provide structure for the ED evaluation of chest pain, accelerating the evaluation process and matching the intensity of testing and treatment to patient risk.

The 36-page document was published online in the Journal of the American College of Cardiology.

Key summary points in the document include the following:

• Electrocardiogram remains the best initial test for evaluation of chest pain in the ED and should be performed and interpreted within 10 minutes of ED arrival.
• In patients who arrive via ambulance, the prehospital ECG should be reviewed, because ischemic changes may have resolved before ED arrival.
• When the ECG shows evidence of acute infarction or ischemia, subsequent care should follow current guidelines for management of acute ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation ACS (NSTE-ACS).
• Patients with a nonischemic ECG can enter an accelerated CDP designed to provide rapid risk assessment and exclusion of ACS.
• Patients who are hemodynamically unstable, have significant arrhythmias, or evidence of significant heart failure should be evaluated and treated appropriately and are not candidates for an accelerated CDP.
• High-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) are the preferred biomarkers for evaluation of possible ACS.
• Patients classified as low risk (rule out) using the current hs-cTn-based CDPs can generally be discharged directly from the ED without additional testing, although outpatient testing may be considered in selected cases.
• Patients with substantially elevated initial hs-cTn values or those with significant dynamic changes over 1-3 hours are assigned to the abnormal/high-risk category and should be further classified according to the universal definition of myocardial infarction type 1 or 2 or acute or chronic nonischemic cardiac injury.
• High-risk patients should usually be admitted to an inpatient setting for further evaluation and treatment.
• Patients determined to be intermediate risk with the CDP should undergo additional observation with repeat hs-cTn measurements at 3-6 hours and risk assessment using either the modified HEART (history, ECG, age, risk factors, and troponin) score or the ED assessment of chest pain score (EDACS).
• Noninvasive testing should be considered for the intermediate-risk group unless low-risk features are identified using risk scores or noninvasive testing has been performed recently with normal or low-risk findings.

The writing group notes that “safe and efficient” management of chest pain in the ED requires appropriate follow-up after discharge. Timing of follow-up and referral for outpatient noninvasive testing should be influenced by patient risk and results of cardiac testing.

Disclosures for members of the writing group are available with the original article.

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

The American College of Cardiology has released an Expert Consensus Decision Pathway on the evaluation and disposition of acute chest pain in the emergency department.

Chest pain accounts for more than 7 million ED visits annually. A major challenge is to quickly identify the small number of patients with acute coronary syndrome (ACS) among the large number of patients who have noncardiac conditions.

The new document is intended to provide guidance on how to “practically apply” recommendations from the 2021 American Heart Association/American College of Cardiology Guideline for the Evaluation and Diagnosis of Chest Pain, focusing specifically on patients who present to the ED, the writing group explains.

“A systematic approach – both at the level of the institution and the individual patient – is essential to achieve optimal outcomes for patients presenting with chest pain to the ED,” say writing group chair Michael Kontos, MD, Virginia Commonwealth University, Richmond, and colleagues.

At the institution level, this decision pathway recommends high-sensitivity cardiac troponin (hs-cTn) assays coupled with a clinical decision pathway (CDP) to reduce ED “dwell” times and increase the number of patients with chest pain who can safely be discharged without additional testing. This will decrease ED crowding and limit unnecessary testing, they point out. 

At the individual patient level, this document aims to provide structure for the ED evaluation of chest pain, accelerating the evaluation process and matching the intensity of testing and treatment to patient risk.

The 36-page document was published online in the Journal of the American College of Cardiology.

Key summary points in the document include the following:

• Electrocardiogram remains the best initial test for evaluation of chest pain in the ED and should be performed and interpreted within 10 minutes of ED arrival.
• In patients who arrive via ambulance, the prehospital ECG should be reviewed, because ischemic changes may have resolved before ED arrival.
• When the ECG shows evidence of acute infarction or ischemia, subsequent care should follow current guidelines for management of acute ST-segment elevation myocardial infarction (STEMI) and non–ST-segment elevation ACS (NSTE-ACS).
• Patients with a nonischemic ECG can enter an accelerated CDP designed to provide rapid risk assessment and exclusion of ACS.
• Patients who are hemodynamically unstable, have significant arrhythmias, or evidence of significant heart failure should be evaluated and treated appropriately and are not candidates for an accelerated CDP.
• High-sensitivity cardiac troponin T (hs-cTnT) and high-sensitivity cardiac troponin I (hs-cTnI) are the preferred biomarkers for evaluation of possible ACS.
• Patients classified as low risk (rule out) using the current hs-cTn-based CDPs can generally be discharged directly from the ED without additional testing, although outpatient testing may be considered in selected cases.
• Patients with substantially elevated initial hs-cTn values or those with significant dynamic changes over 1-3 hours are assigned to the abnormal/high-risk category and should be further classified according to the universal definition of myocardial infarction type 1 or 2 or acute or chronic nonischemic cardiac injury.
• High-risk patients should usually be admitted to an inpatient setting for further evaluation and treatment.
• Patients determined to be intermediate risk with the CDP should undergo additional observation with repeat hs-cTn measurements at 3-6 hours and risk assessment using either the modified HEART (history, ECG, age, risk factors, and troponin) score or the ED assessment of chest pain score (EDACS).
• Noninvasive testing should be considered for the intermediate-risk group unless low-risk features are identified using risk scores or noninvasive testing has been performed recently with normal or low-risk findings.

The writing group notes that “safe and efficient” management of chest pain in the ED requires appropriate follow-up after discharge. Timing of follow-up and referral for outpatient noninvasive testing should be influenced by patient risk and results of cardiac testing.

Disclosures for members of the writing group are available with the original article.

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

In 2019 the Defense Advanced Research Projects Agency invested $27 million in the Focused Pharma program to develop new, more efficacious, rapid-acting drugs, including hallucinogens.¹ While Focused Pharma does not include human studies, the Veterans Health Administration’s (VHA) newly launched psychedelics program research does include clinical trials.² When I read of these ambitious projects, I recalled 2 prescient memories from my youth.

The first memory was of a dinner table conversation between my father, then chief of pediatrics at a military hospital, and one of my older brothers, a burgeoning hippie. My father mentioned that the military was doing research on lysergic acid diethylamide (LSD), and my brother asked whether he could bring some home for my brother to try. My father looked up from the dinner table with incredulity and in an ironic monotone replied, “No you would not qualify for the research, you are not in the Army.”

The second was about 10 years later, when I visited the state psychiatric hospital where my father directed the adolescent ward. I saw a group of young adults watching test patterns on an old-fashioned television set. When I asked my father what was wrong with them, he shook his head and said, “Too much LSD.”

Albert Hoffman was a Sandoz chemist when in 1938 he serendipitously developed LSD while working on a fungus that grew on grain. LSD’s psychoactive properties were not discovered until 1943. About a decade later, as the Cold War chilled international relations, the Central Intelligence Agency (CIA) began conducting experiments on military personnel in the MKUltra program using LSD, electroshock, hypnosis, and other techniques to develop a mind control program before its rivals did.³

Beginning in the 1950s, the US government collaborated with pharmaceutical companies and research universities to develop LSD as part of a campaign of psychological warfare. Though planned to be used against enemies, the program instead exploited US service members to develop hallucinogens as a form of chemical warfare that could render enemy troops mentally incapacitated. That psychiatrists, who then (as now) led much of this research, raised a host of ethical concerns about dual roles, disclosure, and duty.⁴

Government investigations and academic studies have shown that even soldiers who volunteered for the research were not given adequate information about the nature of the experiments and the potential adverse effects, such as persisting flashbacks. The military’s research on LSD ended in 1963, not because of the unethical aspects of the research, but because the effects of LSD were so unpredictable that the drug could not be effectively weaponized. Like Tuskegee and other research abuses of the time, when the MKUltra program was exposed, there were congressional investigations.⁵ Later studies found that many of the active-duty research subjects experienced a plethora of lasting and serious psychiatric symptoms. VHA practitioners had to put back together many of these broken service members. This program was rife with violations of research ethics and human rights, and those abuses tainted the field of hallucinogenic research in US Department of Defense (DoD) and VHA circles for decades.⁵ These research abuses, in part, have led to hallucinogens being categorized as Schedule I controlled substances, effectively blocking federal funding for research until recently.

LSD, Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine), and 3,4-methylenedioxy-methamphetamine (MDMA), popularly known as psychedelics, are again receiving attention. However, the current investigations into psychedelics are vastly different—scientifically and ethically. The most important difference is that the context and leadership of these studies is not national security—it is health care.

The goal of this new wave of psychedelic research is not mind control or brain alteration, but liberation of the mind from cycles of rumination and trauma and empowerment to change patterns of self-destruction to affirmation of life. The impetus for this research is not international espionage but to find better treatments for chronic posttraumatic stress disorder, severe substance use disorders, and treatment-resistant depression that contribute to unquantifiable mental pain, psychosocial dysfunction, and an epidemic of suicide among military service members and veterans.⁶ Though we have some effective treatments for these often combat-inflicted maladies—primarily evidence-based psychotherapies—yet these treatments are not tolerable or safe, fast-acting, or long-lasting enough to succor each and every troubled soul. The success of ketamine, a dissociative drug, in relieving the most distressing service-connected psychiatric diagnoses has provided a proof of concept to reinvigorate the moribund hallucinogenic research idea.⁷

This dark chapter in US military research is a cautionary tale. The often quoted and more often ignored advice of the Spanish American philosopher George Santayana, “Those who cannot remember the past are condemned to repeat it,” should serve as the guiding principle of the new hallucinogenic research.⁸ Human subjects’ protections have exponentially improved since the days of the secret LSD project even for active-duty personnel. The Common Rule governs that all research participants are given adequate information that includes whatever is known about the risks and benefits of the research.¹⁰ Participants must provide full and free informed consent to enroll in these clinical trials, a consent that encompasses the right to withdraw from the research at any time without jeopardizing their careers, benefits, or ongoing health care.¹⁰

These rules, though, can be bent, broken, avoided, or worked around. Only the moral integrity of study personnel, administrators, oversight agencies, research compliance officers, and most important, principal investigators can assure that the rules are upheld and the rights they guarantee are respected.⁹ It would be a tragic shame if the promised hope for the relief of psychic pain went unrealized due to media hype, shared desperation of clinicians and patients, and conflicts of interests that today are more likely to come from profit-driven pharmaceutical companies than national security agencies. And for all of us in federal practice, remembering the sordid past forays with LSD can redeem the present research so future service members and veterans and the clinicians who care for them have better balms to heal the wounds of war.

In 2019 the Defense Advanced Research Projects Agency invested $27 million in the Focused Pharma program to develop new, more efficacious, rapid-acting drugs, including hallucinogens.¹ While Focused Pharma does not include human studies, the Veterans Health Administration’s (VHA) newly launched psychedelics program research does include clinical trials.² When I read of these ambitious projects, I recalled 2 prescient memories from my youth.

The first memory was of a dinner table conversation between my father, then chief of pediatrics at a military hospital, and one of my older brothers, a burgeoning hippie. My father mentioned that the military was doing research on lysergic acid diethylamide (LSD), and my brother asked whether he could bring some home for my brother to try. My father looked up from the dinner table with incredulity and in an ironic monotone replied, “No you would not qualify for the research, you are not in the Army.”

The second was about 10 years later, when I visited the state psychiatric hospital where my father directed the adolescent ward. I saw a group of young adults watching test patterns on an old-fashioned television set. When I asked my father what was wrong with them, he shook his head and said, “Too much LSD.”

Albert Hoffman was a Sandoz chemist when in 1938 he serendipitously developed LSD while working on a fungus that grew on grain. LSD’s psychoactive properties were not discovered until 1943. About a decade later, as the Cold War chilled international relations, the Central Intelligence Agency (CIA) began conducting experiments on military personnel in the MKUltra program using LSD, electroshock, hypnosis, and other techniques to develop a mind control program before its rivals did.³

Beginning in the 1950s, the US government collaborated with pharmaceutical companies and research universities to develop LSD as part of a campaign of psychological warfare. Though planned to be used against enemies, the program instead exploited US service members to develop hallucinogens as a form of chemical warfare that could render enemy troops mentally incapacitated. That psychiatrists, who then (as now) led much of this research, raised a host of ethical concerns about dual roles, disclosure, and duty.⁴

Government investigations and academic studies have shown that even soldiers who volunteered for the research were not given adequate information about the nature of the experiments and the potential adverse effects, such as persisting flashbacks. The military’s research on LSD ended in 1963, not because of the unethical aspects of the research, but because the effects of LSD were so unpredictable that the drug could not be effectively weaponized. Like Tuskegee and other research abuses of the time, when the MKUltra program was exposed, there were congressional investigations.⁵ Later studies found that many of the active-duty research subjects experienced a plethora of lasting and serious psychiatric symptoms. VHA practitioners had to put back together many of these broken service members. This program was rife with violations of research ethics and human rights, and those abuses tainted the field of hallucinogenic research in US Department of Defense (DoD) and VHA circles for decades.⁵ These research abuses, in part, have led to hallucinogens being categorized as Schedule I controlled substances, effectively blocking federal funding for research until recently.

LSD, Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine), and 3,4-methylenedioxy-methamphetamine (MDMA), popularly known as psychedelics, are again receiving attention. However, the current investigations into psychedelics are vastly different—scientifically and ethically. The most important difference is that the context and leadership of these studies is not national security—it is health care.

The goal of this new wave of psychedelic research is not mind control or brain alteration, but liberation of the mind from cycles of rumination and trauma and empowerment to change patterns of self-destruction to affirmation of life. The impetus for this research is not international espionage but to find better treatments for chronic posttraumatic stress disorder, severe substance use disorders, and treatment-resistant depression that contribute to unquantifiable mental pain, psychosocial dysfunction, and an epidemic of suicide among military service members and veterans.⁶ Though we have some effective treatments for these often combat-inflicted maladies—primarily evidence-based psychotherapies—yet these treatments are not tolerable or safe, fast-acting, or long-lasting enough to succor each and every troubled soul. The success of ketamine, a dissociative drug, in relieving the most distressing service-connected psychiatric diagnoses has provided a proof of concept to reinvigorate the moribund hallucinogenic research idea.⁷

This dark chapter in US military research is a cautionary tale. The often quoted and more often ignored advice of the Spanish American philosopher George Santayana, “Those who cannot remember the past are condemned to repeat it,” should serve as the guiding principle of the new hallucinogenic research.⁸ Human subjects’ protections have exponentially improved since the days of the secret LSD project even for active-duty personnel. The Common Rule governs that all research participants are given adequate information that includes whatever is known about the risks and benefits of the research.¹⁰ Participants must provide full and free informed consent to enroll in these clinical trials, a consent that encompasses the right to withdraw from the research at any time without jeopardizing their careers, benefits, or ongoing health care.¹⁰

These rules, though, can be bent, broken, avoided, or worked around. Only the moral integrity of study personnel, administrators, oversight agencies, research compliance officers, and most important, principal investigators can assure that the rules are upheld and the rights they guarantee are respected.⁹ It would be a tragic shame if the promised hope for the relief of psychic pain went unrealized due to media hype, shared desperation of clinicians and patients, and conflicts of interests that today are more likely to come from profit-driven pharmaceutical companies than national security agencies. And for all of us in federal practice, remembering the sordid past forays with LSD can redeem the present research so future service members and veterans and the clinicians who care for them have better balms to heal the wounds of war.

In 2019 the Defense Advanced Research Projects Agency invested $27 million in the Focused Pharma program to develop new, more efficacious, rapid-acting drugs, including hallucinogens.¹ While Focused Pharma does not include human studies, the Veterans Health Administration’s (VHA) newly launched psychedelics program research does include clinical trials.² When I read of these ambitious projects, I recalled 2 prescient memories from my youth.

The first memory was of a dinner table conversation between my father, then chief of pediatrics at a military hospital, and one of my older brothers, a burgeoning hippie. My father mentioned that the military was doing research on lysergic acid diethylamide (LSD), and my brother asked whether he could bring some home for my brother to try. My father looked up from the dinner table with incredulity and in an ironic monotone replied, “No you would not qualify for the research, you are not in the Army.”

The second was about 10 years later, when I visited the state psychiatric hospital where my father directed the adolescent ward. I saw a group of young adults watching test patterns on an old-fashioned television set. When I asked my father what was wrong with them, he shook his head and said, “Too much LSD.”

Albert Hoffman was a Sandoz chemist when in 1938 he serendipitously developed LSD while working on a fungus that grew on grain. LSD’s psychoactive properties were not discovered until 1943. About a decade later, as the Cold War chilled international relations, the Central Intelligence Agency (CIA) began conducting experiments on military personnel in the MKUltra program using LSD, electroshock, hypnosis, and other techniques to develop a mind control program before its rivals did.³

Beginning in the 1950s, the US government collaborated with pharmaceutical companies and research universities to develop LSD as part of a campaign of psychological warfare. Though planned to be used against enemies, the program instead exploited US service members to develop hallucinogens as a form of chemical warfare that could render enemy troops mentally incapacitated. That psychiatrists, who then (as now) led much of this research, raised a host of ethical concerns about dual roles, disclosure, and duty.⁴

Government investigations and academic studies have shown that even soldiers who volunteered for the research were not given adequate information about the nature of the experiments and the potential adverse effects, such as persisting flashbacks. The military’s research on LSD ended in 1963, not because of the unethical aspects of the research, but because the effects of LSD were so unpredictable that the drug could not be effectively weaponized. Like Tuskegee and other research abuses of the time, when the MKUltra program was exposed, there were congressional investigations.⁵ Later studies found that many of the active-duty research subjects experienced a plethora of lasting and serious psychiatric symptoms. VHA practitioners had to put back together many of these broken service members. This program was rife with violations of research ethics and human rights, and those abuses tainted the field of hallucinogenic research in US Department of Defense (DoD) and VHA circles for decades.⁵ These research abuses, in part, have led to hallucinogens being categorized as Schedule I controlled substances, effectively blocking federal funding for research until recently.

LSD, Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine), and 3,4-methylenedioxy-methamphetamine (MDMA), popularly known as psychedelics, are again receiving attention. However, the current investigations into psychedelics are vastly different—scientifically and ethically. The most important difference is that the context and leadership of these studies is not national security—it is health care.

The goal of this new wave of psychedelic research is not mind control or brain alteration, but liberation of the mind from cycles of rumination and trauma and empowerment to change patterns of self-destruction to affirmation of life. The impetus for this research is not international espionage but to find better treatments for chronic posttraumatic stress disorder, severe substance use disorders, and treatment-resistant depression that contribute to unquantifiable mental pain, psychosocial dysfunction, and an epidemic of suicide among military service members and veterans.⁶ Though we have some effective treatments for these often combat-inflicted maladies—primarily evidence-based psychotherapies—yet these treatments are not tolerable or safe, fast-acting, or long-lasting enough to succor each and every troubled soul. The success of ketamine, a dissociative drug, in relieving the most distressing service-connected psychiatric diagnoses has provided a proof of concept to reinvigorate the moribund hallucinogenic research idea.⁷

This dark chapter in US military research is a cautionary tale. The often quoted and more often ignored advice of the Spanish American philosopher George Santayana, “Those who cannot remember the past are condemned to repeat it,” should serve as the guiding principle of the new hallucinogenic research.⁸ Human subjects’ protections have exponentially improved since the days of the secret LSD project even for active-duty personnel. The Common Rule governs that all research participants are given adequate information that includes whatever is known about the risks and benefits of the research.¹⁰ Participants must provide full and free informed consent to enroll in these clinical trials, a consent that encompasses the right to withdraw from the research at any time without jeopardizing their careers, benefits, or ongoing health care.¹⁰

These rules, though, can be bent, broken, avoided, or worked around. Only the moral integrity of study personnel, administrators, oversight agencies, research compliance officers, and most important, principal investigators can assure that the rules are upheld and the rights they guarantee are respected.⁹ It would be a tragic shame if the promised hope for the relief of psychic pain went unrealized due to media hype, shared desperation of clinicians and patients, and conflicts of interests that today are more likely to come from profit-driven pharmaceutical companies than national security agencies. And for all of us in federal practice, remembering the sordid past forays with LSD can redeem the present research so future service members and veterans and the clinicians who care for them have better balms to heal the wounds of war.

The U.S. Preventive Services Task Force on Oct. 11 posted final recommendations on screening for anxiety, depression, and suicide risk in children and adolescents.

For the first time, the task force recommended screening for anxiety in children aged 8-18 years who do not have a diagnosed anxiety disorder and are not showing signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in 8- to 18-year-olds has a moderate net benefit, the task force said.

However, the task force found “insufficient” evidence to weigh the balance of benefits and harms of screening for anxiety in children aged 7 and younger and therefore issued an “I” statement.

The task force also recommended screening for children aged 12-18 years for major depressive disorder (“B” recommendation) but said there is insufficient evidence to weigh the balance of benefits and harms of screening for depression in children aged 11 and younger (“I” statement). 

These recommendations are in line with the 2016 recommendations on depression screening from the USPSTF.

“Fortunately, screening older children for anxiety and depression can identify these conditions so children and teens can receive the care that they need,” task force member Martha Kubik, PhD, RN, with George Mason University, Fairfax, Va., said in a statement.

“Unfortunately, there are key evidence gaps related to screening for anxiety and depression in younger children and screening for suicide risk in all youth,” added task force member Lori Pbert, PhD, University of Massachusetts, Worcester.

“We are calling for more research in these critical areas so we can provide health care professionals with evidence-based ways to keep their young patients healthy,” Dr. Pbert said.
 

Suicide screening

Turning to suicide, the task force says there is not enough evidence to recommend for or against screening for suicide risk in children and adolescents, and therefore issued an “I” statement – in line with the 2014 recommendation statement from the task force.

The task force acknowledged that the American Academy of Pediatrics, the American Foundation for Suicide Prevention, and experts from the National Institute of Mental Health have released a “Blueprint for Youth Suicide Prevention” that recommends universal screening for suicide risk in youth 12 years or older, while children aged 8-11 years should be screened as clinically indicated.

The task force’s final recommendation statements and corresponding evidence summaries on screening children and adolescents for anxiety, depression and suicide were published online Oct. 11, 2022, in JAMA and the USPSTF website.

The final recommendations are consistent with the 2022 draft recommendation statements on these topics.

The task force emphasized that screening is only the first step in helping children and adolescents with anxiety and depression. Youth who screen positive need further evaluation to determine if they have anxiety or depression.

After diagnosis, youth should participate in shared decision-making with their parents and healthcare professional to identify the best treatment or combination of treatments.
 

Only a first step

In an accompanying editorial, John Walkup, MD, with Ann and Robert H. Lurie Children’s Hospital, Chicago, and coauthors made the point that, for the potential of screening for pediatric anxiety disorders to be fully realized, research focused on the process of screening from evaluation to treatment needs to be a priority.

“Perhaps most critical is developing a smart and sophisticated process of screening aligned with evidence-based treatment strategies that brings added value to routine pediatric medical care and that improves physical and mental health outcomes for children and adolescents,” they wrote.

Members of the USPSTF disclosed no relevant financial relationships. Dr. Walkup reported serving as an unpaid member of the scientific council of the Anxiety and Depression Association of America, receiving royalties for anxiety-related continuing medical education activities from Wolters Kluwer and honoraria for anxiety presentations from the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics.

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

The U.S. Preventive Services Task Force on Oct. 11 posted final recommendations on screening for anxiety, depression, and suicide risk in children and adolescents.

For the first time, the task force recommended screening for anxiety in children aged 8-18 years who do not have a diagnosed anxiety disorder and are not showing signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in 8- to 18-year-olds has a moderate net benefit, the task force said.

However, the task force found “insufficient” evidence to weigh the balance of benefits and harms of screening for anxiety in children aged 7 and younger and therefore issued an “I” statement.

The task force also recommended screening for children aged 12-18 years for major depressive disorder (“B” recommendation) but said there is insufficient evidence to weigh the balance of benefits and harms of screening for depression in children aged 11 and younger (“I” statement). 

These recommendations are in line with the 2016 recommendations on depression screening from the USPSTF.

“Fortunately, screening older children for anxiety and depression can identify these conditions so children and teens can receive the care that they need,” task force member Martha Kubik, PhD, RN, with George Mason University, Fairfax, Va., said in a statement.

“Unfortunately, there are key evidence gaps related to screening for anxiety and depression in younger children and screening for suicide risk in all youth,” added task force member Lori Pbert, PhD, University of Massachusetts, Worcester.

“We are calling for more research in these critical areas so we can provide health care professionals with evidence-based ways to keep their young patients healthy,” Dr. Pbert said.
 

Suicide screening

Turning to suicide, the task force says there is not enough evidence to recommend for or against screening for suicide risk in children and adolescents, and therefore issued an “I” statement – in line with the 2014 recommendation statement from the task force.

The task force acknowledged that the American Academy of Pediatrics, the American Foundation for Suicide Prevention, and experts from the National Institute of Mental Health have released a “Blueprint for Youth Suicide Prevention” that recommends universal screening for suicide risk in youth 12 years or older, while children aged 8-11 years should be screened as clinically indicated.

The task force’s final recommendation statements and corresponding evidence summaries on screening children and adolescents for anxiety, depression and suicide were published online Oct. 11, 2022, in JAMA and the USPSTF website.

The final recommendations are consistent with the 2022 draft recommendation statements on these topics.

The task force emphasized that screening is only the first step in helping children and adolescents with anxiety and depression. Youth who screen positive need further evaluation to determine if they have anxiety or depression.

After diagnosis, youth should participate in shared decision-making with their parents and healthcare professional to identify the best treatment or combination of treatments.
 

Only a first step

In an accompanying editorial, John Walkup, MD, with Ann and Robert H. Lurie Children’s Hospital, Chicago, and coauthors made the point that, for the potential of screening for pediatric anxiety disorders to be fully realized, research focused on the process of screening from evaluation to treatment needs to be a priority.

“Perhaps most critical is developing a smart and sophisticated process of screening aligned with evidence-based treatment strategies that brings added value to routine pediatric medical care and that improves physical and mental health outcomes for children and adolescents,” they wrote.

Members of the USPSTF disclosed no relevant financial relationships. Dr. Walkup reported serving as an unpaid member of the scientific council of the Anxiety and Depression Association of America, receiving royalties for anxiety-related continuing medical education activities from Wolters Kluwer and honoraria for anxiety presentations from the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics.

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

The U.S. Preventive Services Task Force on Oct. 11 posted final recommendations on screening for anxiety, depression, and suicide risk in children and adolescents.

For the first time, the task force recommended screening for anxiety in children aged 8-18 years who do not have a diagnosed anxiety disorder and are not showing signs or symptoms of anxiety.

This “B” recommendation reflects “moderate certainty” evidence that screening for anxiety in 8- to 18-year-olds has a moderate net benefit, the task force said.

However, the task force found “insufficient” evidence to weigh the balance of benefits and harms of screening for anxiety in children aged 7 and younger and therefore issued an “I” statement.

The task force also recommended screening for children aged 12-18 years for major depressive disorder (“B” recommendation) but said there is insufficient evidence to weigh the balance of benefits and harms of screening for depression in children aged 11 and younger (“I” statement). 

These recommendations are in line with the 2016 recommendations on depression screening from the USPSTF.

“Fortunately, screening older children for anxiety and depression can identify these conditions so children and teens can receive the care that they need,” task force member Martha Kubik, PhD, RN, with George Mason University, Fairfax, Va., said in a statement.

“Unfortunately, there are key evidence gaps related to screening for anxiety and depression in younger children and screening for suicide risk in all youth,” added task force member Lori Pbert, PhD, University of Massachusetts, Worcester.

“We are calling for more research in these critical areas so we can provide health care professionals with evidence-based ways to keep their young patients healthy,” Dr. Pbert said.
 

Suicide screening

Turning to suicide, the task force says there is not enough evidence to recommend for or against screening for suicide risk in children and adolescents, and therefore issued an “I” statement – in line with the 2014 recommendation statement from the task force.

The task force acknowledged that the American Academy of Pediatrics, the American Foundation for Suicide Prevention, and experts from the National Institute of Mental Health have released a “Blueprint for Youth Suicide Prevention” that recommends universal screening for suicide risk in youth 12 years or older, while children aged 8-11 years should be screened as clinically indicated.

The task force’s final recommendation statements and corresponding evidence summaries on screening children and adolescents for anxiety, depression and suicide were published online Oct. 11, 2022, in JAMA and the USPSTF website.

The final recommendations are consistent with the 2022 draft recommendation statements on these topics.

The task force emphasized that screening is only the first step in helping children and adolescents with anxiety and depression. Youth who screen positive need further evaluation to determine if they have anxiety or depression.

After diagnosis, youth should participate in shared decision-making with their parents and healthcare professional to identify the best treatment or combination of treatments.
 

Only a first step

In an accompanying editorial, John Walkup, MD, with Ann and Robert H. Lurie Children’s Hospital, Chicago, and coauthors made the point that, for the potential of screening for pediatric anxiety disorders to be fully realized, research focused on the process of screening from evaluation to treatment needs to be a priority.

“Perhaps most critical is developing a smart and sophisticated process of screening aligned with evidence-based treatment strategies that brings added value to routine pediatric medical care and that improves physical and mental health outcomes for children and adolescents,” they wrote.

Members of the USPSTF disclosed no relevant financial relationships. Dr. Walkup reported serving as an unpaid member of the scientific council of the Anxiety and Depression Association of America, receiving royalties for anxiety-related continuing medical education activities from Wolters Kluwer and honoraria for anxiety presentations from the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics.

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

A symptom-based screening tool can identify 2-year-olds at increased risk of asthma, persistent symptoms of wheeze, and health care burden by the age of 5, according to researchers.

The validated CHILDhood Asthma Risk Tool (CHART) determines high, moderate, or low risk of asthma based on symptoms reported before the age of 3 years. It also recommends follow-up.

Potentially, CHART could be used “to identify children who need monitoring, timely symptom control, and introduction of preventive therapies,” said Padmaja Subbarao, MD, MSc, associate chief of clinical research at the Hospital for Sick Children, Toronto, and colleagues in JAMA Network Open.

“The implementation of CHART as a first-step screening tool in general practice could promote timely treatment control and, in turn, improve quality of life for patients and reduce the clinical and economic burden of asthma,” they wrote.

Dr. Subbarao and colleagues developed CHART using data from parent questionnaires and 3- and 5-year clinic visits in the CHILD study. Children were categorized as “high risk” when they experienced two or more episodes of wheeze annually at both 3 and 5 years of age, concurrent with ED visits, hospitalizations, asthma medication, or frequent dry cough. Children with only cough episodes or with cough episodes plus one episode of wheeze in the past 12 months were categorized as “low risk.”

“Our unique approach to classification of wheeze symptoms is important because it helps busy practitioners identify the smaller subset of children with more frequent or severe wheezing episodes who have a higher probability of continued symptoms and impaired lung function in adult life among most children with infrequent wheeze,” Dr. Sabbarao and coauthors said.

Their diagnostic study to evaluate CHART’s predictive capacity showed that the tool had the highest proportion of true-positive asthma at 5 years (sensitivity, 50.0%), compared with physicians’ diagnosis at 3 years (sensitivity, 43.5%), and positive standardized modified Asthma Predictive Index (mAPI) at 3 years (sensitivity, 24.4%).

CHART also outperformed physician assessments and mAPI for predicting persistent wheeze at 5 years and provided the highest predictive capacity for subsequent health care use at 5 years of age. The study showed that it identified 20% more children with emergency department visits or hospitalizations than the standardized mAPI (sensitivity 45.5% vs. 25.0%), and approximately 10% more at-risk children than physician diagnosis.

“These findings are especially important given that many hospitalizations are avoidable if appropriate treatment and management of asthma are implemented at primary care,” Dr. Subbarao and colleagues wrote.

CHART has been validated in two external cohorts: a general-population cohort of 2,185 children from the Raine Study in Australia at 5 years of age; and the other a high-risk cohort of 349 children from the Canadian Asthma Primary Prevention Study at 7 years of age.

“We want to highlight the importance of periodic monitoring of wheeze symptoms and simplify the identification of high-risk children for primary care providers and parents or caregivers,” said Dr. Subbarao, who is director of the CHILD study and professor of pediatrics at the University of Toronto.

The tool “does not identify the underlying biology, which could impact the efficacy of our current standard asthma treatment,” Dr. Subbarao emphasized. CHART has not been tested in low-prevalence settings or in countries in which the term “wheeze” is not commonly recognized, she added.

“CHART helps you focus your crystal ball a little bit, look into the future, and see what’s going to happen,” said Harold Farber, MD, a pediatric pulmonologist who was not involved in the study. “It’s useful even if it just confirms what I’m already doing clinically.”

Dr. Farber, who is professor of pediatrics at Baylor College of Medicine and the Texas Children’s Hospital, Houston, cautioned that the predictive value of CHART is based on the diagnosis of asthma, and that this can differ across health care communities. “Between the extremes and what’s considered borderline, there’s a lot of diagnostic variation in what we call asthma,” he explained in an interview. “The diagnosis is, to some extent, subjective.”

However, Dr. Farber agreed that two or more wheezing episodes in the past 12 months – enough to require treatment – puts a child at very high risk for future wheezing. “Kids with a bunch of wheezing problems at 3 years are likely to have wheezing problems at 5. We have to think about what we can do for a toddler today to keep him from wheezing later.”

CHART is simple to use, the investigators said. The information needed can be easily gathered through interviews and parent-reported questionnaires, then put into the electronic medical record to flag children at high risk for further investigation, and well as those at low or moderate risk for monitoring.

Parents and caregivers can also use CHART to document symptoms every 6 months in children older than 1 year of age, said Dr. Subbarao. This information can be brought to the attention of the doctor “to facilitate a deeper discussion,” she suggested.

This study was funded by the Canadian Institutes of Health Research, Allergy, Genes and Environment Network of Centers of Excellence; Don and Debbie Morrison; Women’s and Children Health Research Institute; and Canada Research Chairs. Dr Subbarao reported having no potential conflicts of interest. Coauthor Vanessa Breton, PhD, disclosed being employed by F. Hoffmann-La Roche Ltd., and coauthor Elinor Simons, MD, PhD, reported membership on the Sanofi-Genzyme Data Monitoring Board. No other conflicts of interest were reported by the study authors. Dr Farber disclosed having no potential conflicts of interest.

A symptom-based screening tool can identify 2-year-olds at increased risk of asthma, persistent symptoms of wheeze, and health care burden by the age of 5, according to researchers.

The validated CHILDhood Asthma Risk Tool (CHART) determines high, moderate, or low risk of asthma based on symptoms reported before the age of 3 years. It also recommends follow-up.

Potentially, CHART could be used “to identify children who need monitoring, timely symptom control, and introduction of preventive therapies,” said Padmaja Subbarao, MD, MSc, associate chief of clinical research at the Hospital for Sick Children, Toronto, and colleagues in JAMA Network Open.

“The implementation of CHART as a first-step screening tool in general practice could promote timely treatment control and, in turn, improve quality of life for patients and reduce the clinical and economic burden of asthma,” they wrote.

Dr. Subbarao and colleagues developed CHART using data from parent questionnaires and 3- and 5-year clinic visits in the CHILD study. Children were categorized as “high risk” when they experienced two or more episodes of wheeze annually at both 3 and 5 years of age, concurrent with ED visits, hospitalizations, asthma medication, or frequent dry cough. Children with only cough episodes or with cough episodes plus one episode of wheeze in the past 12 months were categorized as “low risk.”

“Our unique approach to classification of wheeze symptoms is important because it helps busy practitioners identify the smaller subset of children with more frequent or severe wheezing episodes who have a higher probability of continued symptoms and impaired lung function in adult life among most children with infrequent wheeze,” Dr. Sabbarao and coauthors said.

Their diagnostic study to evaluate CHART’s predictive capacity showed that the tool had the highest proportion of true-positive asthma at 5 years (sensitivity, 50.0%), compared with physicians’ diagnosis at 3 years (sensitivity, 43.5%), and positive standardized modified Asthma Predictive Index (mAPI) at 3 years (sensitivity, 24.4%).

CHART also outperformed physician assessments and mAPI for predicting persistent wheeze at 5 years and provided the highest predictive capacity for subsequent health care use at 5 years of age. The study showed that it identified 20% more children with emergency department visits or hospitalizations than the standardized mAPI (sensitivity 45.5% vs. 25.0%), and approximately 10% more at-risk children than physician diagnosis.

“These findings are especially important given that many hospitalizations are avoidable if appropriate treatment and management of asthma are implemented at primary care,” Dr. Subbarao and colleagues wrote.

CHART has been validated in two external cohorts: a general-population cohort of 2,185 children from the Raine Study in Australia at 5 years of age; and the other a high-risk cohort of 349 children from the Canadian Asthma Primary Prevention Study at 7 years of age.

“We want to highlight the importance of periodic monitoring of wheeze symptoms and simplify the identification of high-risk children for primary care providers and parents or caregivers,” said Dr. Subbarao, who is director of the CHILD study and professor of pediatrics at the University of Toronto.

The tool “does not identify the underlying biology, which could impact the efficacy of our current standard asthma treatment,” Dr. Subbarao emphasized. CHART has not been tested in low-prevalence settings or in countries in which the term “wheeze” is not commonly recognized, she added.

“CHART helps you focus your crystal ball a little bit, look into the future, and see what’s going to happen,” said Harold Farber, MD, a pediatric pulmonologist who was not involved in the study. “It’s useful even if it just confirms what I’m already doing clinically.”

Dr. Farber, who is professor of pediatrics at Baylor College of Medicine and the Texas Children’s Hospital, Houston, cautioned that the predictive value of CHART is based on the diagnosis of asthma, and that this can differ across health care communities. “Between the extremes and what’s considered borderline, there’s a lot of diagnostic variation in what we call asthma,” he explained in an interview. “The diagnosis is, to some extent, subjective.”

However, Dr. Farber agreed that two or more wheezing episodes in the past 12 months – enough to require treatment – puts a child at very high risk for future wheezing. “Kids with a bunch of wheezing problems at 3 years are likely to have wheezing problems at 5. We have to think about what we can do for a toddler today to keep him from wheezing later.”

CHART is simple to use, the investigators said. The information needed can be easily gathered through interviews and parent-reported questionnaires, then put into the electronic medical record to flag children at high risk for further investigation, and well as those at low or moderate risk for monitoring.

Parents and caregivers can also use CHART to document symptoms every 6 months in children older than 1 year of age, said Dr. Subbarao. This information can be brought to the attention of the doctor “to facilitate a deeper discussion,” she suggested.

This study was funded by the Canadian Institutes of Health Research, Allergy, Genes and Environment Network of Centers of Excellence; Don and Debbie Morrison; Women’s and Children Health Research Institute; and Canada Research Chairs. Dr Subbarao reported having no potential conflicts of interest. Coauthor Vanessa Breton, PhD, disclosed being employed by F. Hoffmann-La Roche Ltd., and coauthor Elinor Simons, MD, PhD, reported membership on the Sanofi-Genzyme Data Monitoring Board. No other conflicts of interest were reported by the study authors. Dr Farber disclosed having no potential conflicts of interest.

A symptom-based screening tool can identify 2-year-olds at increased risk of asthma, persistent symptoms of wheeze, and health care burden by the age of 5, according to researchers.

The validated CHILDhood Asthma Risk Tool (CHART) determines high, moderate, or low risk of asthma based on symptoms reported before the age of 3 years. It also recommends follow-up.

Potentially, CHART could be used “to identify children who need monitoring, timely symptom control, and introduction of preventive therapies,” said Padmaja Subbarao, MD, MSc, associate chief of clinical research at the Hospital for Sick Children, Toronto, and colleagues in JAMA Network Open.

“The implementation of CHART as a first-step screening tool in general practice could promote timely treatment control and, in turn, improve quality of life for patients and reduce the clinical and economic burden of asthma,” they wrote.

Dr. Subbarao and colleagues developed CHART using data from parent questionnaires and 3- and 5-year clinic visits in the CHILD study. Children were categorized as “high risk” when they experienced two or more episodes of wheeze annually at both 3 and 5 years of age, concurrent with ED visits, hospitalizations, asthma medication, or frequent dry cough. Children with only cough episodes or with cough episodes plus one episode of wheeze in the past 12 months were categorized as “low risk.”

“Our unique approach to classification of wheeze symptoms is important because it helps busy practitioners identify the smaller subset of children with more frequent or severe wheezing episodes who have a higher probability of continued symptoms and impaired lung function in adult life among most children with infrequent wheeze,” Dr. Sabbarao and coauthors said.

Their diagnostic study to evaluate CHART’s predictive capacity showed that the tool had the highest proportion of true-positive asthma at 5 years (sensitivity, 50.0%), compared with physicians’ diagnosis at 3 years (sensitivity, 43.5%), and positive standardized modified Asthma Predictive Index (mAPI) at 3 years (sensitivity, 24.4%).

CHART also outperformed physician assessments and mAPI for predicting persistent wheeze at 5 years and provided the highest predictive capacity for subsequent health care use at 5 years of age. The study showed that it identified 20% more children with emergency department visits or hospitalizations than the standardized mAPI (sensitivity 45.5% vs. 25.0%), and approximately 10% more at-risk children than physician diagnosis.

“These findings are especially important given that many hospitalizations are avoidable if appropriate treatment and management of asthma are implemented at primary care,” Dr. Subbarao and colleagues wrote.

CHART has been validated in two external cohorts: a general-population cohort of 2,185 children from the Raine Study in Australia at 5 years of age; and the other a high-risk cohort of 349 children from the Canadian Asthma Primary Prevention Study at 7 years of age.

“We want to highlight the importance of periodic monitoring of wheeze symptoms and simplify the identification of high-risk children for primary care providers and parents or caregivers,” said Dr. Subbarao, who is director of the CHILD study and professor of pediatrics at the University of Toronto.

The tool “does not identify the underlying biology, which could impact the efficacy of our current standard asthma treatment,” Dr. Subbarao emphasized. CHART has not been tested in low-prevalence settings or in countries in which the term “wheeze” is not commonly recognized, she added.

“CHART helps you focus your crystal ball a little bit, look into the future, and see what’s going to happen,” said Harold Farber, MD, a pediatric pulmonologist who was not involved in the study. “It’s useful even if it just confirms what I’m already doing clinically.”

Dr. Farber, who is professor of pediatrics at Baylor College of Medicine and the Texas Children’s Hospital, Houston, cautioned that the predictive value of CHART is based on the diagnosis of asthma, and that this can differ across health care communities. “Between the extremes and what’s considered borderline, there’s a lot of diagnostic variation in what we call asthma,” he explained in an interview. “The diagnosis is, to some extent, subjective.”

However, Dr. Farber agreed that two or more wheezing episodes in the past 12 months – enough to require treatment – puts a child at very high risk for future wheezing. “Kids with a bunch of wheezing problems at 3 years are likely to have wheezing problems at 5. We have to think about what we can do for a toddler today to keep him from wheezing later.”

CHART is simple to use, the investigators said. The information needed can be easily gathered through interviews and parent-reported questionnaires, then put into the electronic medical record to flag children at high risk for further investigation, and well as those at low or moderate risk for monitoring.

Parents and caregivers can also use CHART to document symptoms every 6 months in children older than 1 year of age, said Dr. Subbarao. This information can be brought to the attention of the doctor “to facilitate a deeper discussion,” she suggested.

This study was funded by the Canadian Institutes of Health Research, Allergy, Genes and Environment Network of Centers of Excellence; Don and Debbie Morrison; Women’s and Children Health Research Institute; and Canada Research Chairs. Dr Subbarao reported having no potential conflicts of interest. Coauthor Vanessa Breton, PhD, disclosed being employed by F. Hoffmann-La Roche Ltd., and coauthor Elinor Simons, MD, PhD, reported membership on the Sanofi-Genzyme Data Monitoring Board. No other conflicts of interest were reported by the study authors. Dr Farber disclosed having no potential conflicts of interest.

A real-world analysis in the United Kingdom found that a fully covered metal stent is safe and effective at controlling anastomotic strictures (AS) following liver transplants.

Biliary AS occurs in an estimated 5%-32% of patients following a liver transplant. Generally, these have been managed by insertion of side-by-side plastic stents to remodel the stricture, but this often required multiple procedures to resolve the problem. More recently, transpapillary fully covered self-expanding metallic stents (FCSEMSs) have been introduced and they appear to perform equivalently to their plastic counterparts while requiring fewer procedures.

The new study “is yet another large experience demonstrating that use of fully covered metal stents for treating anastomotic biliary strictures is highly effective and also cost-effective because you really decrease the number of ERCPs [endoscopic retrograde cholangiopancreatographies] that are required to treat an anastomotic stricture,” said Vladimir Kushnir, MD, who was asked to comment on the study, which was published in Therapeutic Advances in Gastroenterology.

The researchers analyzed retrospective data from 162 consecutive patients who underwent ERCP with intraductal self-expanding metal stent (IDSEMS) insertion at nine tertiary centers. The procedures employed the Kaffes (Taewoong Niti-S) biliary covered stent, which is not available in the United States. Unlike conventional FCSEMSs, the device does not have to traverse the papilla. It is also shorter and includes an antimigration waist and removal wires that may reduce the risk of silent migration. Small case series suggested efficacy in the treatment of post–liver transplant AS.

There were 176 episodes of stent insertion among the 162 included patients; 62% of patients were male, and the median age at transplant was 54 years. Etiologies included hepatocellular carcinoma (22%), alcohol-related liver disease (18%), and nonalcoholic fatty liver disease (12%). The median time to development of a stricture was 24.9 weeks. Among all patients, 35% had previously received stents; 75% of those were plastic stents.

Overall, 10% of patients experienced stricture recurrence at a median interval of 19 weeks following stent removal. Median stent emplacement was 15 weeks, and 81% of patients had a resolution of their strictures.

Dr. Kushnir, from Washington University in St. Louis, highlighted the differences between the stent used in the study and those currently available in the United States. “This type of stent is a self-expanding metal stent that’s covered, but what’s different about it is that it’s designed to go completely within the bile duct, whereas a traditional fully covered metal stent traverses the major duodenal papilla.”

Despite those differences, he believes that the study can inform current practice in the United States. “In situations where you’re faced with a question of whether or not you leave multiple plastic stents in, or you put a full metal stent in that’s going to be fully within the bile duct, I think this data does provide some reassurance. If you’re using one of the traditional stents that we have in the United States and putting it fully within the bile duct, you do need to be prepared to have a little bit of a harder time removing the stent when the time comes for the removal procedure, which could require cholangioscopy. But this does provide some evidence to back up the practice of using fully covered metal stents fully within the bile duct to remediate anastomotic strictures that may be just a little too high up to treat traditionally with a stent that remains transpapillary,” said Dr. Kushnir.

The study also suggests an avenue for further research. “What’s also interesting about this study is that they only left the stents in for 3 months. In most clinical trials, where we’ve used fully covered metal stents for treating anastomotic biliary strictures, you leave the stent in from anywhere from 6 to 12 months. So with only 3 months dwell time they were able to get pretty impressive results, at least in the short term, in a retrospective study, so it does raise the question of should we be evaluating shorter dwell times for stents in treating anastomotic strictures when we’re using a fully covered metal stent that’s a larger diameter?” said Dr. Kushnir.

The authors noted some limitations, such as the retrospective design, small sample size, and lack of control group. They also noted that the multicenter design may have introduced heterogeneity in patient management and follow-up.

“In conclusion, IDSEMS appear to be safe and highly efficacious in the management of [post–liver transplant] AS,” concluded the authors. “Long-term outcomes appear good with low rates of AS recurrence.”

The authors declare no conflicts of interest. Dr. Kushnir is a consultant for ConMed and Boston Scientific.

A real-world analysis in the United Kingdom found that a fully covered metal stent is safe and effective at controlling anastomotic strictures (AS) following liver transplants.

Biliary AS occurs in an estimated 5%-32% of patients following a liver transplant. Generally, these have been managed by insertion of side-by-side plastic stents to remodel the stricture, but this often required multiple procedures to resolve the problem. More recently, transpapillary fully covered self-expanding metallic stents (FCSEMSs) have been introduced and they appear to perform equivalently to their plastic counterparts while requiring fewer procedures.

The new study “is yet another large experience demonstrating that use of fully covered metal stents for treating anastomotic biliary strictures is highly effective and also cost-effective because you really decrease the number of ERCPs [endoscopic retrograde cholangiopancreatographies] that are required to treat an anastomotic stricture,” said Vladimir Kushnir, MD, who was asked to comment on the study, which was published in Therapeutic Advances in Gastroenterology.

The researchers analyzed retrospective data from 162 consecutive patients who underwent ERCP with intraductal self-expanding metal stent (IDSEMS) insertion at nine tertiary centers. The procedures employed the Kaffes (Taewoong Niti-S) biliary covered stent, which is not available in the United States. Unlike conventional FCSEMSs, the device does not have to traverse the papilla. It is also shorter and includes an antimigration waist and removal wires that may reduce the risk of silent migration. Small case series suggested efficacy in the treatment of post–liver transplant AS.

There were 176 episodes of stent insertion among the 162 included patients; 62% of patients were male, and the median age at transplant was 54 years. Etiologies included hepatocellular carcinoma (22%), alcohol-related liver disease (18%), and nonalcoholic fatty liver disease (12%). The median time to development of a stricture was 24.9 weeks. Among all patients, 35% had previously received stents; 75% of those were plastic stents.

Overall, 10% of patients experienced stricture recurrence at a median interval of 19 weeks following stent removal. Median stent emplacement was 15 weeks, and 81% of patients had a resolution of their strictures.

Dr. Kushnir, from Washington University in St. Louis, highlighted the differences between the stent used in the study and those currently available in the United States. “This type of stent is a self-expanding metal stent that’s covered, but what’s different about it is that it’s designed to go completely within the bile duct, whereas a traditional fully covered metal stent traverses the major duodenal papilla.”

Despite those differences, he believes that the study can inform current practice in the United States. “In situations where you’re faced with a question of whether or not you leave multiple plastic stents in, or you put a full metal stent in that’s going to be fully within the bile duct, I think this data does provide some reassurance. If you’re using one of the traditional stents that we have in the United States and putting it fully within the bile duct, you do need to be prepared to have a little bit of a harder time removing the stent when the time comes for the removal procedure, which could require cholangioscopy. But this does provide some evidence to back up the practice of using fully covered metal stents fully within the bile duct to remediate anastomotic strictures that may be just a little too high up to treat traditionally with a stent that remains transpapillary,” said Dr. Kushnir.

The study also suggests an avenue for further research. “What’s also interesting about this study is that they only left the stents in for 3 months. In most clinical trials, where we’ve used fully covered metal stents for treating anastomotic biliary strictures, you leave the stent in from anywhere from 6 to 12 months. So with only 3 months dwell time they were able to get pretty impressive results, at least in the short term, in a retrospective study, so it does raise the question of should we be evaluating shorter dwell times for stents in treating anastomotic strictures when we’re using a fully covered metal stent that’s a larger diameter?” said Dr. Kushnir.

The authors noted some limitations, such as the retrospective design, small sample size, and lack of control group. They also noted that the multicenter design may have introduced heterogeneity in patient management and follow-up.

“In conclusion, IDSEMS appear to be safe and highly efficacious in the management of [post–liver transplant] AS,” concluded the authors. “Long-term outcomes appear good with low rates of AS recurrence.”

The authors declare no conflicts of interest. Dr. Kushnir is a consultant for ConMed and Boston Scientific.

A real-world analysis in the United Kingdom found that a fully covered metal stent is safe and effective at controlling anastomotic strictures (AS) following liver transplants.

Biliary AS occurs in an estimated 5%-32% of patients following a liver transplant. Generally, these have been managed by insertion of side-by-side plastic stents to remodel the stricture, but this often required multiple procedures to resolve the problem. More recently, transpapillary fully covered self-expanding metallic stents (FCSEMSs) have been introduced and they appear to perform equivalently to their plastic counterparts while requiring fewer procedures.

The new study “is yet another large experience demonstrating that use of fully covered metal stents for treating anastomotic biliary strictures is highly effective and also cost-effective because you really decrease the number of ERCPs [endoscopic retrograde cholangiopancreatographies] that are required to treat an anastomotic stricture,” said Vladimir Kushnir, MD, who was asked to comment on the study, which was published in Therapeutic Advances in Gastroenterology.

The researchers analyzed retrospective data from 162 consecutive patients who underwent ERCP with intraductal self-expanding metal stent (IDSEMS) insertion at nine tertiary centers. The procedures employed the Kaffes (Taewoong Niti-S) biliary covered stent, which is not available in the United States. Unlike conventional FCSEMSs, the device does not have to traverse the papilla. It is also shorter and includes an antimigration waist and removal wires that may reduce the risk of silent migration. Small case series suggested efficacy in the treatment of post–liver transplant AS.

There were 176 episodes of stent insertion among the 162 included patients; 62% of patients were male, and the median age at transplant was 54 years. Etiologies included hepatocellular carcinoma (22%), alcohol-related liver disease (18%), and nonalcoholic fatty liver disease (12%). The median time to development of a stricture was 24.9 weeks. Among all patients, 35% had previously received stents; 75% of those were plastic stents.

Overall, 10% of patients experienced stricture recurrence at a median interval of 19 weeks following stent removal. Median stent emplacement was 15 weeks, and 81% of patients had a resolution of their strictures.

Dr. Kushnir, from Washington University in St. Louis, highlighted the differences between the stent used in the study and those currently available in the United States. “This type of stent is a self-expanding metal stent that’s covered, but what’s different about it is that it’s designed to go completely within the bile duct, whereas a traditional fully covered metal stent traverses the major duodenal papilla.”

Despite those differences, he believes that the study can inform current practice in the United States. “In situations where you’re faced with a question of whether or not you leave multiple plastic stents in, or you put a full metal stent in that’s going to be fully within the bile duct, I think this data does provide some reassurance. If you’re using one of the traditional stents that we have in the United States and putting it fully within the bile duct, you do need to be prepared to have a little bit of a harder time removing the stent when the time comes for the removal procedure, which could require cholangioscopy. But this does provide some evidence to back up the practice of using fully covered metal stents fully within the bile duct to remediate anastomotic strictures that may be just a little too high up to treat traditionally with a stent that remains transpapillary,” said Dr. Kushnir.

The study also suggests an avenue for further research. “What’s also interesting about this study is that they only left the stents in for 3 months. In most clinical trials, where we’ve used fully covered metal stents for treating anastomotic biliary strictures, you leave the stent in from anywhere from 6 to 12 months. So with only 3 months dwell time they were able to get pretty impressive results, at least in the short term, in a retrospective study, so it does raise the question of should we be evaluating shorter dwell times for stents in treating anastomotic strictures when we’re using a fully covered metal stent that’s a larger diameter?” said Dr. Kushnir.

The authors noted some limitations, such as the retrospective design, small sample size, and lack of control group. They also noted that the multicenter design may have introduced heterogeneity in patient management and follow-up.

“In conclusion, IDSEMS appear to be safe and highly efficacious in the management of [post–liver transplant] AS,” concluded the authors. “Long-term outcomes appear good with low rates of AS recurrence.”

The authors declare no conflicts of interest. Dr. Kushnir is a consultant for ConMed and Boston Scientific.

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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

A new consensus statement summarizes the benefits, limitations, and challenges of using automated insulin delivery (AID) systems and provides recommendations for use by people with diabetes.  

“Automated insulin delivery systems” is becoming the standard terminology – including by the U.S. Food and Drug Administration – to refer to systems that integrate data from a continuous glucose monitoring (CGM) system via a control algorithm into an insulin pump in order to automate subcutaneous insulin delivery. “Hybrid AID” or “hybrid closed-loop” refers to the current status of these systems, which still require some degree of user input to control glucose levels.

The term “artificial pancreas” was used interchangeably with AID in the past, but it doesn’t take into account exocrine pancreatic function. The term “bionic pancreas” refers to a specific system in development that would ultimately include glucagon along with insulin.

The new consensus report, titled “Automated insulin delivery: Benefits, challenges, and recommendations,” was published online in Diabetes Care and Diabetologia.  

The document is geared toward not only diabetologists and other specialists, but also diabetes nurses and specialist dietitians. Colleagues working at regulatory agencies, health care organizations, and related media might also benefit from reading it.

It is endorsed by two professional societies – the European Association for the Study of Diabetes and the American Diabetes Association – and contrasts with other statements about AID systems that are sponsored by their manufacturers, noted document co-author Mark Evans, PhD, professor of diabetic medicine, University of Cambridge, England, in a statement.

“Many clinically relevant aspects, including safety, are addressed in this report. The aim ... is to encourage ongoing improvement of this technology, its safe and effective use, and its accessibility to all who can benefit from it,” Dr. Evans said.

Lead author Jennifer Sherr, MD, PhD, pediatric endocrinology, Yale University, New Haven, Conn., commented that the report “addresses the clinical usage of AID systems from a practical point of view rather than as ... a meta-analysis or a review of all relevant clinical studies. ... As such, the benefits and limitations of systems are discussed while also considering safety, regulatory pathways, and access to this technology.”
 

AID systems do not mean diabetes is “cured”

Separate recommendations provided at the end of the document are aimed at specific stakeholders, including health care providers, patients and their caregivers, manufacturers, regulatory agencies, and the research community.  

The authors make clear in the introduction that, while representing “a significant movement toward optimizing glucose management for individuals with diabetes,” the use of AID systems doesn’t mean that diabetes is “cured.” Rather, “expectations need to be set adequately so that individuals with diabetes and providers understand what such systems can and cannot do.”

In particular, current commercially available AID systems require user input for mealtime insulin dosing and sometimes for correction doses of high blood glucose levels, although the systems at least partially automate that.

“When integrated into care, AID systems hold promise to relieve some of the daily burdens of diabetes care,” the authors write.

The statement also details problems that may arise with the physical devices, including skin irritation from adhesives, occlusion of insulin infusion sets, early CGM sensor failure, and inadequate dosing algorithms.

“Individuals with diabetes who are considering this type of advanced diabetes therapy should not only have appropriate technical understanding of the system but also be able to revert to standard diabetes treatment (that is, nonautomated subcutaneous insulin delivery by pump or injections) in case the AID system fails. They should be able to independently troubleshoot and have access to their health care provider if needed.”

To monitor the impact of the technology, the authors emphasize the importance of the time-in-range metric derived from CGM, with the goal of achieving 70% or greater time in target blood glucose range.

Separate sections of the document address the benefits and limitations of AID systems, education and expectations for both patients and providers, and patient and provider perspectives, including how to handle urgent questions.

Other sections cover special populations such as pregnant women and people with type 2 diabetes, considerations for patient selection for current AID systems, safety, improving access to the technology, liability, and do-it-yourself systems.
 

Recommendations for health care professionals

A table near the end of the document provides specific recommendations for health care professionals, including the following:

• Be knowledgeable about AID systems and nuances of different systems, including their distinguishing features as well as strengths and weaknesses.
• Inform patients with diabetes about AID systems, including review of currently available systems, and create realistic expectations for device use.
• Involve patients with diabetes in shared decision-making when considering use of AID systems.
• Share information with patients with diabetes, as well as their peers, about general standards set by national and international guidelines on AID systems.
• Provide an on-call number or method by which a person with diabetes can always access support from a health care provider at the practice, including weekends and nights.
• Implement, potentially, protocols on times when AID systems should not be used.
• Use an individual’s health data to improve quality of care and health outcomes.

Most members of the ADA/EASD Diabetes Technology Working Group work with industry, but industry had no input on the project. Dr. Sherr has reported conducting clinical trials for Eli Lilly, Insulet, and Medtronic, and has received in-kind support for research studies from Dexcom and Medtronic. She has also reported consulting for Eli Lilly, Lexicon, Medtronic, and Sanofi, and being an advisory board member for Bigfoot Biomedical, Cecelia Health, Eli Lilly, Insulet, T1D Fund, and Vertex Pharmaceuticals. Dr. Evans has reported conducting clinical trials or research collaborations for, serving on advisory boards for, or receiving speakers fees or travel support from Medtronic, Roche, Abbott Diabetes Care, Dexcom, Novo Nordisk, Eli Lilly, Sanofi, Zucara Therapeutics, Pila Pharma, and AstraZeneca. The University of Cambridge has received salary support for Dr. Evans from the National Health Service.

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