Federal Practitioner

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

Drinking more than three cups of caffeinated coffee a day is associated with less liver stiffness, according to an analysis of a nationally representative survey, which was recently published in Clinical Gastroenterology and Hepatology.

amenic181/Getty Images

The study is likely the most rigorous look to date on the benefits of coffee on liver health in the U.S. It was based on data from the National Health and Nutrition Examination Survey (NHANES), in which participants were asked about what they eat and drink. Crucially, in 2017, NHANES began to include elastography (FibroScan), of participants’ liver stiffness, not because of suspected problems with the liver but as across-the-board evaluations of all participants.

“Because it’s an unselected population for FibroScan and because of the detail, the granularity, the richness of the information from the nutritional surveys that they do, this is the closest we’re ever going to get to a linkage between what people are eating or drinking and the health of their liver, absent a longitudinal study where we set out to follow people for many, many years,” said Elliot Tapper, MD, assistant professor of gastroenterology at the University of Michigan, Ann Arbor, and the study’s senior author.

Researchers examined data from about 4,500 patients who had participated in the NHANES study in 2017-2018. The participants were aged 20 years or older, with an average age of 48; 73% were overweight, about the national average.

The researchers found no association between coffee consumption and controlled attenuation parameter (CAP), a measure of fatty liver. But they found a link between coffee and liver stiffness.

Those who drank more than three cups of coffee daily had a liver stiffness measure (LSM) that was 0.9 kilopascals (kPa) lower than others (P = .03). Drinking more than three cups a day also was found to be protective against an LSM of 9.5 kPa or higher, the threshold for advanced liver fibrosis (OR, 0.4; P = .05). Decaffeinated coffee was not found to be associated with LSM.

Caffeine is an antagonist to adenosine receptors in the liver cell that, if blocked, stops the production of scar tissue, according to the researchers. But when they looked at estimated caffeine consumption, calculated through the detailed, trained interviews performed by nutritionists, there was no association with liver stiffness. That said, Dr. Tapper noted that this could be due to the imperfection of making those estimations.

“If we had to hypothesize about a mechanism, it would most likely be caffeine, and the reason we couldn’t see that here is because these are estimated milligrams of caffeine per coffee – but the way that we brew coffee, and the beans that we’re using, are so highly variable it just can’t be captured in this kind of database,” he said.

He said the data will be reassuring to clinicians who suggest coffee-drinking to patients.

“There are hepatologists around the world who are actively recommending coffee – they’ll feel empowered by these data,” he said. “I would still like to see more robust longitudinal data before I start spending our precious time counseling patients about coffee. There are many other data-driven interventions for the management of liver disease that we should be focusing our time on.”

Moreover, he said that the data will be important for patients who are particularly interested in natural remedies.

“For patients who are very interested in a natural supplement, to feel like they’re taking an active role in the health of their liver, I will tell them to avoid carbohydrates and increase their exercise – and that it is OK to add coffee to their daily routine.”

A study based on a UK database found that coffee was associated with protection against chronic liver disease, but the association was seen for both caffeinated and decaffeinated drinks, noted Nathan Davies, PhD, professor of biochemistry at the Institute of the Liver and Digestive Health at the University College London.

Dr. Davies, a registered nutritionist who has studied coffee’s effects on the liver, said that while including elastography in the Michigan study is interesting, it “does not necessarily by itself add greatly” to the evidence base.

The outcomes from both studies do suggest a positive effect for coffee, but he said it’s important to remember that liver disease develops over years and decades.

“Looking at a snapshot moment does not necessarily reflect an individual’s behavior during the onset and development of their condition,” he said. “As such, there are a number of behavioral and nutritional factors that could be contributing to the observed effect over a period of years.”

He pointed out that while different coffee and brewing types affect the amount of caffeine in a cup, all cups of coffee in this study were treated the same way. He noted there was no apparent dose-dependent effect, which would have been expected if there is an active ingredient that affects liver stiffness.

“In general, my advice is to improve diet, take more exercise, and reduce alcohol consumption, which is likely to be more effective in preventing liver disease – and its progression – than drinking an extra cup of coffee,” Dr. Davies said. “That being said, for patients at increased risk for liver disease who currently drink three cups or more of coffee daily, it may be prudent for them to continue because this level of consumption might be actively lowering their chances of developing more serious disease.”

Dr. Tapper has done consulting for Novartis, Axcella and Allergan, has served on advisory boards for Mallinckrodt, Bausch Health, Kaleido, and Novo Nordisk, and has unrestricted research grants from Gilead and Valeant. The remaining authors disclose no conflicts. Dr. Davies reported no relevant disclosures.

The recent U.S. Preventive Services Task Force (USPSTF) draft statement on aspirin use is concerning: “The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.” I take no issue with the data and appreciate the efforts of the researchers, but at a minimum the public statement is incomplete. At most, it’s dangerously poor messaging.

As physicians, we understand how best to apply this information, but most laypeople, some at significant cardiovascular risk, closed their medicine cabinets this morning and left their aspirin bottle unopened on the shelf. Some of these patients have never spent an hour in the hospital for cardiac-related issues, but they have mitigated their risk for myocardial infarction by purposely poisoning their platelets daily with 81 mg of aspirin. And they should continue to do so.
 

Don’t forget the calcium score

Take, for instance, my patient Jack, who is typical of many patients I’ve seen throughout the years. Jack is 68 years old and has never had a cardiac event or a gastrointestinal bleed. His daily routine includes a walk, a statin, and a baby aspirin because his CT coronary artery calcium (CAC) score was 10,000 at age 58.

He first visited me 10 years ago because his father died of a myocardial infarction in his late 50s. Jack’s left ventricular ejection fraction is normal and his stress ECG shows 1-mm ST-segment depression at 8 minutes on a Bruce protocol stress test, without angina. Because Jack is well-educated and keeps up with the latest cardiology recommendations, he is precisely the type of patient who may be harmed by this new USPSTF statement by stopping his aspirin.

In October 2020, an analysis from the DALLAS Heart Study showed that persons with a CAC score greater than 100 had a higher cumulative incidence of bleeding and of atherosclerotic cardiovascular disease (ASCVD) events compared with those with no coronary calcium. After adjustment for clinical risk factors, the association between CAC and bleeding was attenuated and no longer statistically significant, whereas the relationship between CAC and ASCVD remained.

I asked one of the investigators, Amit Khera, MD, MSc, from UT Southwestern Medical Center, about the latest recommendations. He emphasized that both the American College of Cardiology/American Heart Association prevention guidelines and the USPSTF statement say that aspirin could still be considered among patients who are at higher risk for cardiovascular events. The USPSTF delineated this as a 10-year ASCVD risk greater than 10%.

Dr. Khera, who was an author of the 2019 guidelines, explained that the guideline committee purposely did not make specific recommendations as to what demarcated higher risk because the data were not clear at that time. Since then, a couple of papers, including the Dallas Heart Study analysis published in JAMA Cardiology, showed that patients at low bleeding risk with a calcium score above 100 may get a net benefit from aspirin. “Thus, in my patients who have a high calcium score and low bleeding risk, I do discuss the option to start or continue aspirin,” he said.
 

One size does not fit all

I watched ABC World News Tonight on Tuesday, October 12, and was immediately troubled about the coverage of the USPSTF statement. With viewership for the “Big Three” networks in the millions, the message to discontinue aspirin may have unintended consequences for many at-risk patients. The blood-thinning effects of a single dose of aspirin last about 10 days; it will be interesting to see if the rates of myocardial infarction increase over time. This could have been avoided with a better-worded statement – I’m concerned that the lack of nuance could spell big trouble for some.

In JAMA Cardiology, Dr. Khera and colleagues wrote that, “Aspirin use is not a one-size-fits-all therapy.” All physicians likely agree with that opinion. The USPSTF statement should have included the point that if you have a high CT coronary artery calcium score and a low bleeding risk, aspirin still fits very well even if you haven’t experienced a cardiac event. At a minimum, the USPSTF statement should have included the suggestion for patients to consult their physician for advice before discontinuing aspirin therapy.

I hope patients like Jack get the right message.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology.

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

The recent U.S. Preventive Services Task Force (USPSTF) draft statement on aspirin use is concerning: “The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.” I take no issue with the data and appreciate the efforts of the researchers, but at a minimum the public statement is incomplete. At most, it’s dangerously poor messaging.

As physicians, we understand how best to apply this information, but most laypeople, some at significant cardiovascular risk, closed their medicine cabinets this morning and left their aspirin bottle unopened on the shelf. Some of these patients have never spent an hour in the hospital for cardiac-related issues, but they have mitigated their risk for myocardial infarction by purposely poisoning their platelets daily with 81 mg of aspirin. And they should continue to do so.
 

Don’t forget the calcium score

Take, for instance, my patient Jack, who is typical of many patients I’ve seen throughout the years. Jack is 68 years old and has never had a cardiac event or a gastrointestinal bleed. His daily routine includes a walk, a statin, and a baby aspirin because his CT coronary artery calcium (CAC) score was 10,000 at age 58.

He first visited me 10 years ago because his father died of a myocardial infarction in his late 50s. Jack’s left ventricular ejection fraction is normal and his stress ECG shows 1-mm ST-segment depression at 8 minutes on a Bruce protocol stress test, without angina. Because Jack is well-educated and keeps up with the latest cardiology recommendations, he is precisely the type of patient who may be harmed by this new USPSTF statement by stopping his aspirin.

In October 2020, an analysis from the DALLAS Heart Study showed that persons with a CAC score greater than 100 had a higher cumulative incidence of bleeding and of atherosclerotic cardiovascular disease (ASCVD) events compared with those with no coronary calcium. After adjustment for clinical risk factors, the association between CAC and bleeding was attenuated and no longer statistically significant, whereas the relationship between CAC and ASCVD remained.

I asked one of the investigators, Amit Khera, MD, MSc, from UT Southwestern Medical Center, about the latest recommendations. He emphasized that both the American College of Cardiology/American Heart Association prevention guidelines and the USPSTF statement say that aspirin could still be considered among patients who are at higher risk for cardiovascular events. The USPSTF delineated this as a 10-year ASCVD risk greater than 10%.

Dr. Khera, who was an author of the 2019 guidelines, explained that the guideline committee purposely did not make specific recommendations as to what demarcated higher risk because the data were not clear at that time. Since then, a couple of papers, including the Dallas Heart Study analysis published in JAMA Cardiology, showed that patients at low bleeding risk with a calcium score above 100 may get a net benefit from aspirin. “Thus, in my patients who have a high calcium score and low bleeding risk, I do discuss the option to start or continue aspirin,” he said.
 

One size does not fit all

I watched ABC World News Tonight on Tuesday, October 12, and was immediately troubled about the coverage of the USPSTF statement. With viewership for the “Big Three” networks in the millions, the message to discontinue aspirin may have unintended consequences for many at-risk patients. The blood-thinning effects of a single dose of aspirin last about 10 days; it will be interesting to see if the rates of myocardial infarction increase over time. This could have been avoided with a better-worded statement – I’m concerned that the lack of nuance could spell big trouble for some.

In JAMA Cardiology, Dr. Khera and colleagues wrote that, “Aspirin use is not a one-size-fits-all therapy.” All physicians likely agree with that opinion. The USPSTF statement should have included the point that if you have a high CT coronary artery calcium score and a low bleeding risk, aspirin still fits very well even if you haven’t experienced a cardiac event. At a minimum, the USPSTF statement should have included the suggestion for patients to consult their physician for advice before discontinuing aspirin therapy.

I hope patients like Jack get the right message.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology.

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

The recent U.S. Preventive Services Task Force (USPSTF) draft statement on aspirin use is concerning: “The USPSTF concludes with moderate certainty that initiating aspirin use for the primary prevention of CVD events in adults age 60 years or older has no net benefit.” I take no issue with the data and appreciate the efforts of the researchers, but at a minimum the public statement is incomplete. At most, it’s dangerously poor messaging.

As physicians, we understand how best to apply this information, but most laypeople, some at significant cardiovascular risk, closed their medicine cabinets this morning and left their aspirin bottle unopened on the shelf. Some of these patients have never spent an hour in the hospital for cardiac-related issues, but they have mitigated their risk for myocardial infarction by purposely poisoning their platelets daily with 81 mg of aspirin. And they should continue to do so.
 

Don’t forget the calcium score

Take, for instance, my patient Jack, who is typical of many patients I’ve seen throughout the years. Jack is 68 years old and has never had a cardiac event or a gastrointestinal bleed. His daily routine includes a walk, a statin, and a baby aspirin because his CT coronary artery calcium (CAC) score was 10,000 at age 58.

He first visited me 10 years ago because his father died of a myocardial infarction in his late 50s. Jack’s left ventricular ejection fraction is normal and his stress ECG shows 1-mm ST-segment depression at 8 minutes on a Bruce protocol stress test, without angina. Because Jack is well-educated and keeps up with the latest cardiology recommendations, he is precisely the type of patient who may be harmed by this new USPSTF statement by stopping his aspirin.

In October 2020, an analysis from the DALLAS Heart Study showed that persons with a CAC score greater than 100 had a higher cumulative incidence of bleeding and of atherosclerotic cardiovascular disease (ASCVD) events compared with those with no coronary calcium. After adjustment for clinical risk factors, the association between CAC and bleeding was attenuated and no longer statistically significant, whereas the relationship between CAC and ASCVD remained.

I asked one of the investigators, Amit Khera, MD, MSc, from UT Southwestern Medical Center, about the latest recommendations. He emphasized that both the American College of Cardiology/American Heart Association prevention guidelines and the USPSTF statement say that aspirin could still be considered among patients who are at higher risk for cardiovascular events. The USPSTF delineated this as a 10-year ASCVD risk greater than 10%.

Dr. Khera, who was an author of the 2019 guidelines, explained that the guideline committee purposely did not make specific recommendations as to what demarcated higher risk because the data were not clear at that time. Since then, a couple of papers, including the Dallas Heart Study analysis published in JAMA Cardiology, showed that patients at low bleeding risk with a calcium score above 100 may get a net benefit from aspirin. “Thus, in my patients who have a high calcium score and low bleeding risk, I do discuss the option to start or continue aspirin,” he said.
 

One size does not fit all

I watched ABC World News Tonight on Tuesday, October 12, and was immediately troubled about the coverage of the USPSTF statement. With viewership for the “Big Three” networks in the millions, the message to discontinue aspirin may have unintended consequences for many at-risk patients. The blood-thinning effects of a single dose of aspirin last about 10 days; it will be interesting to see if the rates of myocardial infarction increase over time. This could have been avoided with a better-worded statement – I’m concerned that the lack of nuance could spell big trouble for some.

In JAMA Cardiology, Dr. Khera and colleagues wrote that, “Aspirin use is not a one-size-fits-all therapy.” All physicians likely agree with that opinion. The USPSTF statement should have included the point that if you have a high CT coronary artery calcium score and a low bleeding risk, aspirin still fits very well even if you haven’t experienced a cardiac event. At a minimum, the USPSTF statement should have included the suggestion for patients to consult their physician for advice before discontinuing aspirin therapy.

I hope patients like Jack get the right message.

Melissa Walton-Shirley, MD, is a native Kentuckian who retired from full-time invasive cardiology.

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

Editor’s note: This story was updated with the CDC director’s endorsement.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.

The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.

“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.

She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.

The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.

Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.

They are:

• Anyone over age 65.
• Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
• Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.

These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.

There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
 

Questions, concerns

Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.

“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.

She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.

“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.

The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.

But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.

On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.

Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.

The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.

Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.

The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.

These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
 

“Real world” recommendations

In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.

“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.

Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.

The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.

Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.

Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.

Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.

The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.

In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.

Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.

“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
 

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

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

The U.S. Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.

Developed by Cognetivity Neurosciences, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper–based cognitive tests, the company said in a news release.

“These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias, and absence of learning effect upon repeat testing,” the company notes.

Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.

According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer’s disease. That number is projected to increase to 12.7 million by 2050.

“We’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the U.S. and make a positive impact on the health and wellbeing of millions of Americans,” Sina Habibi, PhD, cofounder and CEO of Cognetivity, said in the news release.

The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the U.K.’s National Health Service.

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

The U.S. Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.

Developed by Cognetivity Neurosciences, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper–based cognitive tests, the company said in a news release.

“These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias, and absence of learning effect upon repeat testing,” the company notes.

Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.

According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer’s disease. That number is projected to increase to 12.7 million by 2050.

“We’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the U.S. and make a positive impact on the health and wellbeing of millions of Americans,” Sina Habibi, PhD, cofounder and CEO of Cognetivity, said in the news release.

The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the U.K.’s National Health Service.

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

The U.S. Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.

Developed by Cognetivity Neurosciences, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper–based cognitive tests, the company said in a news release.

“These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias, and absence of learning effect upon repeat testing,” the company notes.

Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.

According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer’s disease. That number is projected to increase to 12.7 million by 2050.

“We’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the U.S. and make a positive impact on the health and wellbeing of millions of Americans,” Sina Habibi, PhD, cofounder and CEO of Cognetivity, said in the news release.

The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the U.K.’s National Health Service.

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

Adenoma miss rates were significantly lower with the use of an artificial intelligence (AI)–based computer-aided detection (CADe) system than with high-definition white light (HDWL), according to a new prospective, multicenter, single-blind randomized study based on data from more than 200 colonoscopies.

Missed adenomas can be generally categorized as adenomas fully obscured from the visual field or those appearing partly or fully in the visual field but missed by an endoscopist, wrote Jeremy R. Glissen Brown, MD, of Harvard Medical School, Boston, and colleagues. While retrospective and prospective studies in China, Italy, and Japan have shown that deep-learning CADe improves adenoma identification during colonoscopy, there have been no prospective U.S. studies on CADe in a diverse population, they noted.

In the study published in Clinical Gastroenterology and Hepatology, the researchers reviewed data from 223 adults aged 22 years and older who underwent screening colonoscopies across four U.S. academic medical centers between 2019 and 2020. The procedure indication was primary colorectal cancer screening for 59.6% of the patients and postpolypectomy surveillance for 40.4%. Among this cohort, 45.3% (101) were female, 67.7% (151) were White, and 21% (133) were African American. Participants were randomized to receive either CADe colonoscopy first or HDWL colonoscopy first; the patients immediately underwent the other procedure in tandem fashion from the same endoscopist.

The primary outcome of the study was adenoma miss rate (AMR), defined as “the number of histologically confirmed adenomas detected during the second colonoscopy in either arm divided by the total number of adenomas detected during both procedures.” Sessile serrated lesion (SSL) miss rates and adenomas per colonoscopy (APC) were secondary outcomes.

Overall, the primary outcome of AMR was significantly lower in the CADe-first group, compared with the HDWL-first group (20.12% vs. 31.25%; P = .0247), with an odds ratio of 1.8048 (95% CI, 1.0780-3.0217). The CADe-first group yielded a lower SSL miss rate, compared with the HDLW-first group (7.14% vs. 42.11%; P = .0482), as well as a lower polyp miss rate (20.70% vs. 33.71%; P = .0007). The first-pass number of APC was significantly higher in the CADe-first group, compared with the HDWL-first group (1.19 [SD 2.03] vs. 0.90 [SD 1.55]; P = .0323). In addition, the first-pass adenoma detection rate (ADR) was not significantly different in the CADe-first group, compared with the HDWL-first group (50.44% vs. 43.64%; P = .3091), and the median withdrawal time was significantly shorter with CADe, compared with HDWL (9.5 minutes vs. 8.5 minutes; P = .0098).

There were no significant observable differences between the two groups regarding missed adenomas arranged by size or location. Moreover, there were no significant differences in miss rates for hyperplastic polyps or advanced adenomas. Factors significantly associated with missed adenomas included being in the HDLW-first group, age 65 years or younger, and the right colon vs. other locations. No immediate adverse events occurred in either group.

According to the researchers, while previous studies in China and Italy have shown increased ADR using CADe systems, these results are not generalizable to the U.S. population for several reasons, notably the studies’ inclusion of colonoscopy indications other than colorectal cancer screening and surveillance. Though the present study showed a significantly lower AMR with CADe, it still represents missed adenomas. The researchers note: “In the present study, in which CADe detected 285 polyps, there were only three false negatives (defined as polyps that were visualized by the endoscopist but not by the CADe system). Overall, this suggests that the ‘missed polyps’ in the CADe arm may have been obscured behind folds rather than in the visual field.” They added, “Further research is needed on combining CADe technologies with mucosal exposure devices, as the benefits of these tools for polyp detection may be additive.”

The study findings were limited by several factors, including the inability to detect a difference in overall ADR, the limited generalizability of the tandem study design to real-world practice, the inclusion of only experienced endoscopists, and the use of a second monitor that may have impacted gaze patterns, the researchers noted. However, the results represent the first examination of deep-learning CADe in a diverse U.S. population and showed a decrease in adenoma miss rates and decreased miss rates for polyps and SSLs, compared with HDWL. Based on these findings, the authors concluded CADe “has the potential to decrease inter-provider variability in colonoscopy quality by reducing adenoma miss rate even in experienced providers.”
 

Reducing miss rates matters

“Missed adenomas can be associated with the development of interval colorectal cancer, so whether novel technologies such as artificial intelligence-based computer-aided polyp detection system can decrease adenoma miss rate is of interest,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr Sakuraba said he was not surprised by the current study findings, as several pilot and randomized studies have shown the benefits of AI-based polyp detection systems. As for how the AI-assisted technology might improve practice, he said it may be a valuable addition. “Adenoma miss rate was significantly lower with an AI-based polyp detection system, so it might lead to decreased colorectal cancer,” he explained. “Various methods to improve adenoma detection should complement each other. 

Dr. Sakuraba also commented that additional research is needed outside of academic centers, noting “further studies in the community setting involving various endoscopists are required to confirm generalizability.”

Lead author Dr. Glissen Brown had no financial conflicts to disclose. This was an investigator-initiated study, with research software and study funding provided by Wision. Dr. Sakuraba disclosed collaborative research with Fuji film, which was not involved in this study.

Adenoma miss rates were significantly lower with the use of an artificial intelligence (AI)–based computer-aided detection (CADe) system than with high-definition white light (HDWL), according to a new prospective, multicenter, single-blind randomized study based on data from more than 200 colonoscopies.

Missed adenomas can be generally categorized as adenomas fully obscured from the visual field or those appearing partly or fully in the visual field but missed by an endoscopist, wrote Jeremy R. Glissen Brown, MD, of Harvard Medical School, Boston, and colleagues. While retrospective and prospective studies in China, Italy, and Japan have shown that deep-learning CADe improves adenoma identification during colonoscopy, there have been no prospective U.S. studies on CADe in a diverse population, they noted.

In the study published in Clinical Gastroenterology and Hepatology, the researchers reviewed data from 223 adults aged 22 years and older who underwent screening colonoscopies across four U.S. academic medical centers between 2019 and 2020. The procedure indication was primary colorectal cancer screening for 59.6% of the patients and postpolypectomy surveillance for 40.4%. Among this cohort, 45.3% (101) were female, 67.7% (151) were White, and 21% (133) were African American. Participants were randomized to receive either CADe colonoscopy first or HDWL colonoscopy first; the patients immediately underwent the other procedure in tandem fashion from the same endoscopist.

The primary outcome of the study was adenoma miss rate (AMR), defined as “the number of histologically confirmed adenomas detected during the second colonoscopy in either arm divided by the total number of adenomas detected during both procedures.” Sessile serrated lesion (SSL) miss rates and adenomas per colonoscopy (APC) were secondary outcomes.

Overall, the primary outcome of AMR was significantly lower in the CADe-first group, compared with the HDWL-first group (20.12% vs. 31.25%; P = .0247), with an odds ratio of 1.8048 (95% CI, 1.0780-3.0217). The CADe-first group yielded a lower SSL miss rate, compared with the HDLW-first group (7.14% vs. 42.11%; P = .0482), as well as a lower polyp miss rate (20.70% vs. 33.71%; P = .0007). The first-pass number of APC was significantly higher in the CADe-first group, compared with the HDWL-first group (1.19 [SD 2.03] vs. 0.90 [SD 1.55]; P = .0323). In addition, the first-pass adenoma detection rate (ADR) was not significantly different in the CADe-first group, compared with the HDWL-first group (50.44% vs. 43.64%; P = .3091), and the median withdrawal time was significantly shorter with CADe, compared with HDWL (9.5 minutes vs. 8.5 minutes; P = .0098).

There were no significant observable differences between the two groups regarding missed adenomas arranged by size or location. Moreover, there were no significant differences in miss rates for hyperplastic polyps or advanced adenomas. Factors significantly associated with missed adenomas included being in the HDLW-first group, age 65 years or younger, and the right colon vs. other locations. No immediate adverse events occurred in either group.

According to the researchers, while previous studies in China and Italy have shown increased ADR using CADe systems, these results are not generalizable to the U.S. population for several reasons, notably the studies’ inclusion of colonoscopy indications other than colorectal cancer screening and surveillance. Though the present study showed a significantly lower AMR with CADe, it still represents missed adenomas. The researchers note: “In the present study, in which CADe detected 285 polyps, there were only three false negatives (defined as polyps that were visualized by the endoscopist but not by the CADe system). Overall, this suggests that the ‘missed polyps’ in the CADe arm may have been obscured behind folds rather than in the visual field.” They added, “Further research is needed on combining CADe technologies with mucosal exposure devices, as the benefits of these tools for polyp detection may be additive.”

The study findings were limited by several factors, including the inability to detect a difference in overall ADR, the limited generalizability of the tandem study design to real-world practice, the inclusion of only experienced endoscopists, and the use of a second monitor that may have impacted gaze patterns, the researchers noted. However, the results represent the first examination of deep-learning CADe in a diverse U.S. population and showed a decrease in adenoma miss rates and decreased miss rates for polyps and SSLs, compared with HDWL. Based on these findings, the authors concluded CADe “has the potential to decrease inter-provider variability in colonoscopy quality by reducing adenoma miss rate even in experienced providers.”
 

Reducing miss rates matters

“Missed adenomas can be associated with the development of interval colorectal cancer, so whether novel technologies such as artificial intelligence-based computer-aided polyp detection system can decrease adenoma miss rate is of interest,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr Sakuraba said he was not surprised by the current study findings, as several pilot and randomized studies have shown the benefits of AI-based polyp detection systems. As for how the AI-assisted technology might improve practice, he said it may be a valuable addition. “Adenoma miss rate was significantly lower with an AI-based polyp detection system, so it might lead to decreased colorectal cancer,” he explained. “Various methods to improve adenoma detection should complement each other. 

Dr. Sakuraba also commented that additional research is needed outside of academic centers, noting “further studies in the community setting involving various endoscopists are required to confirm generalizability.”

Lead author Dr. Glissen Brown had no financial conflicts to disclose. This was an investigator-initiated study, with research software and study funding provided by Wision. Dr. Sakuraba disclosed collaborative research with Fuji film, which was not involved in this study.

Adenoma miss rates were significantly lower with the use of an artificial intelligence (AI)–based computer-aided detection (CADe) system than with high-definition white light (HDWL), according to a new prospective, multicenter, single-blind randomized study based on data from more than 200 colonoscopies.

Missed adenomas can be generally categorized as adenomas fully obscured from the visual field or those appearing partly or fully in the visual field but missed by an endoscopist, wrote Jeremy R. Glissen Brown, MD, of Harvard Medical School, Boston, and colleagues. While retrospective and prospective studies in China, Italy, and Japan have shown that deep-learning CADe improves adenoma identification during colonoscopy, there have been no prospective U.S. studies on CADe in a diverse population, they noted.

In the study published in Clinical Gastroenterology and Hepatology, the researchers reviewed data from 223 adults aged 22 years and older who underwent screening colonoscopies across four U.S. academic medical centers between 2019 and 2020. The procedure indication was primary colorectal cancer screening for 59.6% of the patients and postpolypectomy surveillance for 40.4%. Among this cohort, 45.3% (101) were female, 67.7% (151) were White, and 21% (133) were African American. Participants were randomized to receive either CADe colonoscopy first or HDWL colonoscopy first; the patients immediately underwent the other procedure in tandem fashion from the same endoscopist.

The primary outcome of the study was adenoma miss rate (AMR), defined as “the number of histologically confirmed adenomas detected during the second colonoscopy in either arm divided by the total number of adenomas detected during both procedures.” Sessile serrated lesion (SSL) miss rates and adenomas per colonoscopy (APC) were secondary outcomes.

Overall, the primary outcome of AMR was significantly lower in the CADe-first group, compared with the HDWL-first group (20.12% vs. 31.25%; P = .0247), with an odds ratio of 1.8048 (95% CI, 1.0780-3.0217). The CADe-first group yielded a lower SSL miss rate, compared with the HDLW-first group (7.14% vs. 42.11%; P = .0482), as well as a lower polyp miss rate (20.70% vs. 33.71%; P = .0007). The first-pass number of APC was significantly higher in the CADe-first group, compared with the HDWL-first group (1.19 [SD 2.03] vs. 0.90 [SD 1.55]; P = .0323). In addition, the first-pass adenoma detection rate (ADR) was not significantly different in the CADe-first group, compared with the HDWL-first group (50.44% vs. 43.64%; P = .3091), and the median withdrawal time was significantly shorter with CADe, compared with HDWL (9.5 minutes vs. 8.5 minutes; P = .0098).

There were no significant observable differences between the two groups regarding missed adenomas arranged by size or location. Moreover, there were no significant differences in miss rates for hyperplastic polyps or advanced adenomas. Factors significantly associated with missed adenomas included being in the HDLW-first group, age 65 years or younger, and the right colon vs. other locations. No immediate adverse events occurred in either group.

According to the researchers, while previous studies in China and Italy have shown increased ADR using CADe systems, these results are not generalizable to the U.S. population for several reasons, notably the studies’ inclusion of colonoscopy indications other than colorectal cancer screening and surveillance. Though the present study showed a significantly lower AMR with CADe, it still represents missed adenomas. The researchers note: “In the present study, in which CADe detected 285 polyps, there were only three false negatives (defined as polyps that were visualized by the endoscopist but not by the CADe system). Overall, this suggests that the ‘missed polyps’ in the CADe arm may have been obscured behind folds rather than in the visual field.” They added, “Further research is needed on combining CADe technologies with mucosal exposure devices, as the benefits of these tools for polyp detection may be additive.”

The study findings were limited by several factors, including the inability to detect a difference in overall ADR, the limited generalizability of the tandem study design to real-world practice, the inclusion of only experienced endoscopists, and the use of a second monitor that may have impacted gaze patterns, the researchers noted. However, the results represent the first examination of deep-learning CADe in a diverse U.S. population and showed a decrease in adenoma miss rates and decreased miss rates for polyps and SSLs, compared with HDWL. Based on these findings, the authors concluded CADe “has the potential to decrease inter-provider variability in colonoscopy quality by reducing adenoma miss rate even in experienced providers.”
 

Reducing miss rates matters

“Missed adenomas can be associated with the development of interval colorectal cancer, so whether novel technologies such as artificial intelligence-based computer-aided polyp detection system can decrease adenoma miss rate is of interest,” said Atsushi Sakuraba, MD, of the University of Chicago, in an interview.

Dr Sakuraba said he was not surprised by the current study findings, as several pilot and randomized studies have shown the benefits of AI-based polyp detection systems. As for how the AI-assisted technology might improve practice, he said it may be a valuable addition. “Adenoma miss rate was significantly lower with an AI-based polyp detection system, so it might lead to decreased colorectal cancer,” he explained. “Various methods to improve adenoma detection should complement each other. 

Dr. Sakuraba also commented that additional research is needed outside of academic centers, noting “further studies in the community setting involving various endoscopists are required to confirm generalizability.”

Lead author Dr. Glissen Brown had no financial conflicts to disclose. This was an investigator-initiated study, with research software and study funding provided by Wision. Dr. Sakuraba disclosed collaborative research with Fuji film, which was not involved in this study.

Dementia remains a major cause of disability in older adults. In addition, it places a strain on family members and other caregivers taking care of these patients.

It is estimated that by the year 2060, 13.9 million Americans over the age of 65 will be diagnosed with dementia. Few good treatments are currently available.

Earlier this year, the American Psychological Association (APA) Task Force issued clinical guidelines “for the Evaluation of Dementia and Age-Related Cognitive Change.” While these 16 guidelines are aimed at psychologists, primary care doctors are often the first ones to evaluate a patient who may have dementia. As a family physician, I find having these guidelines especially helpful.
 

Neuropsychiatric testing and defining severity and type

This new guidance places emphasis on neuropsychiatric testing and defining the severity and type of dementia present.

Over the past 2 decades, diagnoses of mild neurocognitive disorders have increased, and this, in part, is due to diagnosing these problems earlier and with greater precision. It is also important to know that biomarkers are being increasingly researched, and it is imperative that we stay current with this research.

Cognitive decline may also occur with the coexistence of other mental health disorders, such as depression, so it is important that we screen for these as well. This is often difficult given the behavioral changes that can arise in dementia, but, as primary care doctors, we must differentiate these to treat our patients appropriately.
 

Informed consent

Informed consent can become an issue with patients with dementia. It must be assessed whether the patient has the capacity to make an informed decision and can competently communicate that decision.

The diagnosis of dementia alone does not preclude a patient from giving informed consent. A patient’s mental capacity must be determined, and if they are not capable of making an informed decision, the person legally responsible for giving informed consent on behalf of the patient must be identified.

Patients with dementia often have other medical comorbidities and take several medications. It is imperative to keep accurate medical records and medication lists. Sometimes, patients with dementia cannot provide this information. If that is the case, every attempt should be made to obtain records from every possible source.
 

Cultural competence

The guidelines also stress that there may be cultural differences when applying neuropsychiatric tests. It is our duty to maintain cultural competence and understand these differences. We all need to work to ensure we control our biases, and it is suggested that we review relevant evidence-based literature.

While ageism is common in our society, it shouldn’t be in our practices. For these reasons, outreach in at-risk populations is very important.
 

Pertinent data

The guidelines also suggest obtaining all possible information in our evaluation, especially when the patient is unable to give it to us.

Often, as primary care physicians, we refer these patients to other providers, and we should be providing all pertinent data to those we are referring these patients to. If all information is not available at the time of evaluation, follow-up visits should be scheduled.

If possible, family members should be present at the time of visit. They often provide valuable information regarding the extent and progression of the decline. Also, they know how the patient is functioning in the home setting and how much assistance they need with activities of daily living.
 

Caretaker support

Another important factor to consider is caretaker burnout. Caretakers are often under a lot of stress and have high rates of depression. It is important to provide them with education and support, as well as resources that may be available to them. For some, accepting the diagnosis that their loved one has dementia may be a struggle.

As doctors treating dementia patients, we need to know the resources that are available to assist dementia patients and their families. There are many local organizations that can help.

Also, research into dementia is ongoing and we need to stay current. The diagnosis of dementia should be made as early as possible using appropriate screening tools. The sooner the diagnosis is made, the quicker interventions can be started and the family members, as well as the patient, can come to accept the diagnosis.

As the population ages, we can expect the demands of dementia to rise as well. Primary care doctors are in a unique position to diagnose dementia once it starts to appear.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Dementia remains a major cause of disability in older adults. In addition, it places a strain on family members and other caregivers taking care of these patients.

It is estimated that by the year 2060, 13.9 million Americans over the age of 65 will be diagnosed with dementia. Few good treatments are currently available.

Earlier this year, the American Psychological Association (APA) Task Force issued clinical guidelines “for the Evaluation of Dementia and Age-Related Cognitive Change.” While these 16 guidelines are aimed at psychologists, primary care doctors are often the first ones to evaluate a patient who may have dementia. As a family physician, I find having these guidelines especially helpful.
 

Neuropsychiatric testing and defining severity and type

This new guidance places emphasis on neuropsychiatric testing and defining the severity and type of dementia present.

Over the past 2 decades, diagnoses of mild neurocognitive disorders have increased, and this, in part, is due to diagnosing these problems earlier and with greater precision. It is also important to know that biomarkers are being increasingly researched, and it is imperative that we stay current with this research.

Cognitive decline may also occur with the coexistence of other mental health disorders, such as depression, so it is important that we screen for these as well. This is often difficult given the behavioral changes that can arise in dementia, but, as primary care doctors, we must differentiate these to treat our patients appropriately.
 

Informed consent

Informed consent can become an issue with patients with dementia. It must be assessed whether the patient has the capacity to make an informed decision and can competently communicate that decision.

The diagnosis of dementia alone does not preclude a patient from giving informed consent. A patient’s mental capacity must be determined, and if they are not capable of making an informed decision, the person legally responsible for giving informed consent on behalf of the patient must be identified.

Patients with dementia often have other medical comorbidities and take several medications. It is imperative to keep accurate medical records and medication lists. Sometimes, patients with dementia cannot provide this information. If that is the case, every attempt should be made to obtain records from every possible source.
 

Cultural competence

The guidelines also stress that there may be cultural differences when applying neuropsychiatric tests. It is our duty to maintain cultural competence and understand these differences. We all need to work to ensure we control our biases, and it is suggested that we review relevant evidence-based literature.

While ageism is common in our society, it shouldn’t be in our practices. For these reasons, outreach in at-risk populations is very important.
 

Pertinent data

The guidelines also suggest obtaining all possible information in our evaluation, especially when the patient is unable to give it to us.

Often, as primary care physicians, we refer these patients to other providers, and we should be providing all pertinent data to those we are referring these patients to. If all information is not available at the time of evaluation, follow-up visits should be scheduled.

If possible, family members should be present at the time of visit. They often provide valuable information regarding the extent and progression of the decline. Also, they know how the patient is functioning in the home setting and how much assistance they need with activities of daily living.
 

Caretaker support

Another important factor to consider is caretaker burnout. Caretakers are often under a lot of stress and have high rates of depression. It is important to provide them with education and support, as well as resources that may be available to them. For some, accepting the diagnosis that their loved one has dementia may be a struggle.

As doctors treating dementia patients, we need to know the resources that are available to assist dementia patients and their families. There are many local organizations that can help.

Also, research into dementia is ongoing and we need to stay current. The diagnosis of dementia should be made as early as possible using appropriate screening tools. The sooner the diagnosis is made, the quicker interventions can be started and the family members, as well as the patient, can come to accept the diagnosis.

As the population ages, we can expect the demands of dementia to rise as well. Primary care doctors are in a unique position to diagnose dementia once it starts to appear.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Dementia remains a major cause of disability in older adults. In addition, it places a strain on family members and other caregivers taking care of these patients.

It is estimated that by the year 2060, 13.9 million Americans over the age of 65 will be diagnosed with dementia. Few good treatments are currently available.

Earlier this year, the American Psychological Association (APA) Task Force issued clinical guidelines “for the Evaluation of Dementia and Age-Related Cognitive Change.” While these 16 guidelines are aimed at psychologists, primary care doctors are often the first ones to evaluate a patient who may have dementia. As a family physician, I find having these guidelines especially helpful.
 

Neuropsychiatric testing and defining severity and type

This new guidance places emphasis on neuropsychiatric testing and defining the severity and type of dementia present.

Over the past 2 decades, diagnoses of mild neurocognitive disorders have increased, and this, in part, is due to diagnosing these problems earlier and with greater precision. It is also important to know that biomarkers are being increasingly researched, and it is imperative that we stay current with this research.

Cognitive decline may also occur with the coexistence of other mental health disorders, such as depression, so it is important that we screen for these as well. This is often difficult given the behavioral changes that can arise in dementia, but, as primary care doctors, we must differentiate these to treat our patients appropriately.
 

Informed consent

Informed consent can become an issue with patients with dementia. It must be assessed whether the patient has the capacity to make an informed decision and can competently communicate that decision.

The diagnosis of dementia alone does not preclude a patient from giving informed consent. A patient’s mental capacity must be determined, and if they are not capable of making an informed decision, the person legally responsible for giving informed consent on behalf of the patient must be identified.

Patients with dementia often have other medical comorbidities and take several medications. It is imperative to keep accurate medical records and medication lists. Sometimes, patients with dementia cannot provide this information. If that is the case, every attempt should be made to obtain records from every possible source.
 

Cultural competence

The guidelines also stress that there may be cultural differences when applying neuropsychiatric tests. It is our duty to maintain cultural competence and understand these differences. We all need to work to ensure we control our biases, and it is suggested that we review relevant evidence-based literature.

While ageism is common in our society, it shouldn’t be in our practices. For these reasons, outreach in at-risk populations is very important.
 

Pertinent data

The guidelines also suggest obtaining all possible information in our evaluation, especially when the patient is unable to give it to us.

Often, as primary care physicians, we refer these patients to other providers, and we should be providing all pertinent data to those we are referring these patients to. If all information is not available at the time of evaluation, follow-up visits should be scheduled.

If possible, family members should be present at the time of visit. They often provide valuable information regarding the extent and progression of the decline. Also, they know how the patient is functioning in the home setting and how much assistance they need with activities of daily living.
 

Caretaker support

Another important factor to consider is caretaker burnout. Caretakers are often under a lot of stress and have high rates of depression. It is important to provide them with education and support, as well as resources that may be available to them. For some, accepting the diagnosis that their loved one has dementia may be a struggle.

As doctors treating dementia patients, we need to know the resources that are available to assist dementia patients and their families. There are many local organizations that can help.

Also, research into dementia is ongoing and we need to stay current. The diagnosis of dementia should be made as early as possible using appropriate screening tools. The sooner the diagnosis is made, the quicker interventions can be started and the family members, as well as the patient, can come to accept the diagnosis.

As the population ages, we can expect the demands of dementia to rise as well. Primary care doctors are in a unique position to diagnose dementia once it starts to appear.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Calculating the estimated glucose disposal rate (eGDR) as a proxy for the level of insulin resistance may be useful way to determine if someone with type 2 diabetes (T2D) is at risk for having a first stroke, Swedish researchers have found.

purestock/Thinkstock

In a large population-based study, the lower the eGDR score went, the higher the risk for having a first stroke became.

The eGDR score was also predictive of the chance of dying from any or a cardiovascular cause, Alexander Zabala, MD, reported at the annual meeting of the European Association for the Study of Diabetes (Abstract OP 01-4).

The link between insulin resistance and an increased risk for stroke has been known for some time, and not just in people with T2D. However, the current way of determining insulin resistance is not suitable for widespread practice.

“The goal standard technique for measuring insulin resistance is the euglycemic clamp method,” said Dr. Zabala, an internal medical resident at Södersjukhuset hospital and researcher at the Karolinska Institutet in Stockholm.

“For that reason, [the eGDR], a method based on readily available clinical factors – waist circumference, hypertension, and glycosylated hemoglobin was developed,” he explained. Body mass index can also be used in place of waist circumference, he qualified.

The eGDR has already been proven to be very precise in people with type 1 diabetes, said Dr. Zabala, and could be an “excellent tool to measure insulin resistance in a large patient population.”
 

Investigating the link between eGDR and first stroke risk

The aim of the study he presented was to see if changes in the eGDR were associated with changes in the risk of someone with T2D experiencing a first stroke, or dying from a cardiovascular or other cause.

An observational cohort was formed by first considering data on all adult patients with T2D who were logged in the Swedish National Diabetes Registry (NDR) during 2004-2016. Then anyone with a history of stroke, or with any missing data on the clinical variables needed to calculate the eGDR, were excluded.

This resulted in an overall population of 104,697 individuals, aged a mean of 63 years, who had developed T2D at around the age of 59 years. About 44% of the study population were women. The mean eGDR for the whole population was 5.6 mg/kg per min.

The study subjects were grouped according to four eGDR levels: 24,706 were in the lowest quartile of eGDR (less than 4 mg/kg per min), signifying the highest level of insulin resistance, and 18,762 were in the upper quartile of eGDR (greater than 8 mg/kg per min), signifying the lowest level of insulin resistance. The middle two groups had an eGDR between 4 and 6 mg/kg per min (40,187), and 6 and 8 mg/kg/min (21,042).

Data from the NDR were then combined with the Swedish Cause of Death register, the Swedish In-patient Care Diagnoses registry, and the Longitudinal Database for Health Insurance and Labour Market Studies (LISA) to determine the rates of stroke, ischemic stroke, hemorrhagic stroke, all-cause mortality, and cardiovascular mortality.
 

Increasing insulin resistance ups risk for stroke, death

After a median follow-up of 5.6 years, 4% (4,201) of the study population had had a stroke.

“We clearly see an increased occurrence of first-time stroke in the group with the lowest eGDR, indicating worst insulin resistance, in comparison with the group with the highest eGDR, indicating less insulin resistance,” Dr. Zabala reported.

After adjustment for potential confounding factors, including age at baseline, gender, diabetes duration, among other variables, the risk for stroke was lowest in those with a high eGDR value and highest for those with a low eGDR value.

Using individuals with the lowest eGDR (less than 4 mg/kg per min) and thus greatest risk of stroke as the reference, adjusted hazard ratios (aHR) for first-time stroke were: 0.60, 0.68, and 0.77 for those with an eGDR of greater than 8, 6-8, and 4-6 mg/kg per min, respectively.

The corresponding values for risk of ischemic stroke were 0.55, 0.68, and 0.75. Regarding hemorrhagic stroke, there was no statistically significant correlation between eGDR levels and stroke occurrence. This was due to the small number of cases recorded.

As for all-cause and cardiovascular mortality, a similar pattern was seen, with higher rates of death linked to increasing insulin resistance. Adjusted hazard ratios according to increasing insulin resistance (decreasing eGDR scores) for all-cause death were 0.68, 0.75, and 0.82 and for cardiovascular mortality were 0.65, 0.75, and 0.82.

A sensitivity analysis, using BMI instead of waist circumference to calculate the eGDR, showed a similar pattern, and “interestingly, a correlation between eGDR levels and risk of hemorrhagic stroke.” Dr. Zabala said.
 

Limitations and take-homes

Of course, this is an observational cohort study, so no conclusions on causality can be made and there are no data on the use of anti-diabetic treatments specifically. But there are strengths such as covering almost all adults with T2D in Sweden and a relatively long-follow-up time.

The findings suggest that “eGDR, which may reflect insulin resistance may be a useful risk marker for stroke and death in people with type 2 diabetes,” said Dr. Zabala.

“You had a very large cohort, and that certainly makes your results very valid,” observed Peter Novodvorsky, MUDr. (Hons), PhD, MRCP, a consultant diabetologist in Trenčín, Slovakia.

Dr. Novodvorsky, who chaired the session, picked up on the lack of information about how many people were taking newer diabetes drugs, such as the glucagon-like peptide 1 receptor antagonists and sodium glucose-lowering transport 2 inhibitors.

“As we all know, these might have protective effects which are not necessarily related to the glucose lowering or insulin resistance-lowering” effects, so could have influenced the results. In terms of how practical the eGDR is for clinical practice, Dr. Zabala observed in a press release: “eGDR could be used to help T2D patients better understand and manage their risk of stroke and death. 

“It could also be of importance in research. In this era of personalized medicine, better stratification of type 2 diabetes patients will help optimize clinical trials and further vital research into treatment, diagnosis, care and prevention.”

The research was a collaboration between the Karolinska Institutet, Gothenburg University and the Swedish National Diabetes Registry. Dr. Zabala and coauthors reported having no conflicts of interest.

Calculating the estimated glucose disposal rate (eGDR) as a proxy for the level of insulin resistance may be useful way to determine if someone with type 2 diabetes (T2D) is at risk for having a first stroke, Swedish researchers have found.

purestock/Thinkstock

In a large population-based study, the lower the eGDR score went, the higher the risk for having a first stroke became.

The eGDR score was also predictive of the chance of dying from any or a cardiovascular cause, Alexander Zabala, MD, reported at the annual meeting of the European Association for the Study of Diabetes (Abstract OP 01-4).

The link between insulin resistance and an increased risk for stroke has been known for some time, and not just in people with T2D. However, the current way of determining insulin resistance is not suitable for widespread practice.

“The goal standard technique for measuring insulin resistance is the euglycemic clamp method,” said Dr. Zabala, an internal medical resident at Södersjukhuset hospital and researcher at the Karolinska Institutet in Stockholm.

“For that reason, [the eGDR], a method based on readily available clinical factors – waist circumference, hypertension, and glycosylated hemoglobin was developed,” he explained. Body mass index can also be used in place of waist circumference, he qualified.

The eGDR has already been proven to be very precise in people with type 1 diabetes, said Dr. Zabala, and could be an “excellent tool to measure insulin resistance in a large patient population.”
 

Investigating the link between eGDR and first stroke risk

The aim of the study he presented was to see if changes in the eGDR were associated with changes in the risk of someone with T2D experiencing a first stroke, or dying from a cardiovascular or other cause.

An observational cohort was formed by first considering data on all adult patients with T2D who were logged in the Swedish National Diabetes Registry (NDR) during 2004-2016. Then anyone with a history of stroke, or with any missing data on the clinical variables needed to calculate the eGDR, were excluded.

This resulted in an overall population of 104,697 individuals, aged a mean of 63 years, who had developed T2D at around the age of 59 years. About 44% of the study population were women. The mean eGDR for the whole population was 5.6 mg/kg per min.

The study subjects were grouped according to four eGDR levels: 24,706 were in the lowest quartile of eGDR (less than 4 mg/kg per min), signifying the highest level of insulin resistance, and 18,762 were in the upper quartile of eGDR (greater than 8 mg/kg per min), signifying the lowest level of insulin resistance. The middle two groups had an eGDR between 4 and 6 mg/kg per min (40,187), and 6 and 8 mg/kg/min (21,042).

Data from the NDR were then combined with the Swedish Cause of Death register, the Swedish In-patient Care Diagnoses registry, and the Longitudinal Database for Health Insurance and Labour Market Studies (LISA) to determine the rates of stroke, ischemic stroke, hemorrhagic stroke, all-cause mortality, and cardiovascular mortality.
 

Increasing insulin resistance ups risk for stroke, death

After a median follow-up of 5.6 years, 4% (4,201) of the study population had had a stroke.

“We clearly see an increased occurrence of first-time stroke in the group with the lowest eGDR, indicating worst insulin resistance, in comparison with the group with the highest eGDR, indicating less insulin resistance,” Dr. Zabala reported.

After adjustment for potential confounding factors, including age at baseline, gender, diabetes duration, among other variables, the risk for stroke was lowest in those with a high eGDR value and highest for those with a low eGDR value.

Using individuals with the lowest eGDR (less than 4 mg/kg per min) and thus greatest risk of stroke as the reference, adjusted hazard ratios (aHR) for first-time stroke were: 0.60, 0.68, and 0.77 for those with an eGDR of greater than 8, 6-8, and 4-6 mg/kg per min, respectively.

The corresponding values for risk of ischemic stroke were 0.55, 0.68, and 0.75. Regarding hemorrhagic stroke, there was no statistically significant correlation between eGDR levels and stroke occurrence. This was due to the small number of cases recorded.

As for all-cause and cardiovascular mortality, a similar pattern was seen, with higher rates of death linked to increasing insulin resistance. Adjusted hazard ratios according to increasing insulin resistance (decreasing eGDR scores) for all-cause death were 0.68, 0.75, and 0.82 and for cardiovascular mortality were 0.65, 0.75, and 0.82.

A sensitivity analysis, using BMI instead of waist circumference to calculate the eGDR, showed a similar pattern, and “interestingly, a correlation between eGDR levels and risk of hemorrhagic stroke.” Dr. Zabala said.
 

Limitations and take-homes

Of course, this is an observational cohort study, so no conclusions on causality can be made and there are no data on the use of anti-diabetic treatments specifically. But there are strengths such as covering almost all adults with T2D in Sweden and a relatively long-follow-up time.

The findings suggest that “eGDR, which may reflect insulin resistance may be a useful risk marker for stroke and death in people with type 2 diabetes,” said Dr. Zabala.

“You had a very large cohort, and that certainly makes your results very valid,” observed Peter Novodvorsky, MUDr. (Hons), PhD, MRCP, a consultant diabetologist in Trenčín, Slovakia.

Dr. Novodvorsky, who chaired the session, picked up on the lack of information about how many people were taking newer diabetes drugs, such as the glucagon-like peptide 1 receptor antagonists and sodium glucose-lowering transport 2 inhibitors.

“As we all know, these might have protective effects which are not necessarily related to the glucose lowering or insulin resistance-lowering” effects, so could have influenced the results. In terms of how practical the eGDR is for clinical practice, Dr. Zabala observed in a press release: “eGDR could be used to help T2D patients better understand and manage their risk of stroke and death. 

“It could also be of importance in research. In this era of personalized medicine, better stratification of type 2 diabetes patients will help optimize clinical trials and further vital research into treatment, diagnosis, care and prevention.”

The research was a collaboration between the Karolinska Institutet, Gothenburg University and the Swedish National Diabetes Registry. Dr. Zabala and coauthors reported having no conflicts of interest.

Calculating the estimated glucose disposal rate (eGDR) as a proxy for the level of insulin resistance may be useful way to determine if someone with type 2 diabetes (T2D) is at risk for having a first stroke, Swedish researchers have found.

purestock/Thinkstock

In a large population-based study, the lower the eGDR score went, the higher the risk for having a first stroke became.

The eGDR score was also predictive of the chance of dying from any or a cardiovascular cause, Alexander Zabala, MD, reported at the annual meeting of the European Association for the Study of Diabetes (Abstract OP 01-4).

The link between insulin resistance and an increased risk for stroke has been known for some time, and not just in people with T2D. However, the current way of determining insulin resistance is not suitable for widespread practice.

“The goal standard technique for measuring insulin resistance is the euglycemic clamp method,” said Dr. Zabala, an internal medical resident at Södersjukhuset hospital and researcher at the Karolinska Institutet in Stockholm.

“For that reason, [the eGDR], a method based on readily available clinical factors – waist circumference, hypertension, and glycosylated hemoglobin was developed,” he explained. Body mass index can also be used in place of waist circumference, he qualified.

The eGDR has already been proven to be very precise in people with type 1 diabetes, said Dr. Zabala, and could be an “excellent tool to measure insulin resistance in a large patient population.”
 

Investigating the link between eGDR and first stroke risk

The aim of the study he presented was to see if changes in the eGDR were associated with changes in the risk of someone with T2D experiencing a first stroke, or dying from a cardiovascular or other cause.

An observational cohort was formed by first considering data on all adult patients with T2D who were logged in the Swedish National Diabetes Registry (NDR) during 2004-2016. Then anyone with a history of stroke, or with any missing data on the clinical variables needed to calculate the eGDR, were excluded.

This resulted in an overall population of 104,697 individuals, aged a mean of 63 years, who had developed T2D at around the age of 59 years. About 44% of the study population were women. The mean eGDR for the whole population was 5.6 mg/kg per min.

The study subjects were grouped according to four eGDR levels: 24,706 were in the lowest quartile of eGDR (less than 4 mg/kg per min), signifying the highest level of insulin resistance, and 18,762 were in the upper quartile of eGDR (greater than 8 mg/kg per min), signifying the lowest level of insulin resistance. The middle two groups had an eGDR between 4 and 6 mg/kg per min (40,187), and 6 and 8 mg/kg/min (21,042).

Data from the NDR were then combined with the Swedish Cause of Death register, the Swedish In-patient Care Diagnoses registry, and the Longitudinal Database for Health Insurance and Labour Market Studies (LISA) to determine the rates of stroke, ischemic stroke, hemorrhagic stroke, all-cause mortality, and cardiovascular mortality.
 

Increasing insulin resistance ups risk for stroke, death

After a median follow-up of 5.6 years, 4% (4,201) of the study population had had a stroke.

“We clearly see an increased occurrence of first-time stroke in the group with the lowest eGDR, indicating worst insulin resistance, in comparison with the group with the highest eGDR, indicating less insulin resistance,” Dr. Zabala reported.

After adjustment for potential confounding factors, including age at baseline, gender, diabetes duration, among other variables, the risk for stroke was lowest in those with a high eGDR value and highest for those with a low eGDR value.

Using individuals with the lowest eGDR (less than 4 mg/kg per min) and thus greatest risk of stroke as the reference, adjusted hazard ratios (aHR) for first-time stroke were: 0.60, 0.68, and 0.77 for those with an eGDR of greater than 8, 6-8, and 4-6 mg/kg per min, respectively.

The corresponding values for risk of ischemic stroke were 0.55, 0.68, and 0.75. Regarding hemorrhagic stroke, there was no statistically significant correlation between eGDR levels and stroke occurrence. This was due to the small number of cases recorded.

As for all-cause and cardiovascular mortality, a similar pattern was seen, with higher rates of death linked to increasing insulin resistance. Adjusted hazard ratios according to increasing insulin resistance (decreasing eGDR scores) for all-cause death were 0.68, 0.75, and 0.82 and for cardiovascular mortality were 0.65, 0.75, and 0.82.

A sensitivity analysis, using BMI instead of waist circumference to calculate the eGDR, showed a similar pattern, and “interestingly, a correlation between eGDR levels and risk of hemorrhagic stroke.” Dr. Zabala said.
 

Limitations and take-homes

Of course, this is an observational cohort study, so no conclusions on causality can be made and there are no data on the use of anti-diabetic treatments specifically. But there are strengths such as covering almost all adults with T2D in Sweden and a relatively long-follow-up time.

The findings suggest that “eGDR, which may reflect insulin resistance may be a useful risk marker for stroke and death in people with type 2 diabetes,” said Dr. Zabala.

“You had a very large cohort, and that certainly makes your results very valid,” observed Peter Novodvorsky, MUDr. (Hons), PhD, MRCP, a consultant diabetologist in Trenčín, Slovakia.

Dr. Novodvorsky, who chaired the session, picked up on the lack of information about how many people were taking newer diabetes drugs, such as the glucagon-like peptide 1 receptor antagonists and sodium glucose-lowering transport 2 inhibitors.

“As we all know, these might have protective effects which are not necessarily related to the glucose lowering or insulin resistance-lowering” effects, so could have influenced the results. In terms of how practical the eGDR is for clinical practice, Dr. Zabala observed in a press release: “eGDR could be used to help T2D patients better understand and manage their risk of stroke and death. 

“It could also be of importance in research. In this era of personalized medicine, better stratification of type 2 diabetes patients will help optimize clinical trials and further vital research into treatment, diagnosis, care and prevention.”

The research was a collaboration between the Karolinska Institutet, Gothenburg University and the Swedish National Diabetes Registry. Dr. Zabala and coauthors reported having no conflicts of interest.

Racial/ethnic disparities in COVID-19 mortality rates may be related more to comorbidities than to demographics, suggest authors of a new study.

Researchers compared the length of stay in intensive care units in two suburban hospitals for patients with severe SARS-CoV-2 infections. Their study shows that although the incidence of comorbidities and rates of use of mechanical ventilation and death were higher among Black patients than among patients of other races, length of stay in the ICU was generally similar for patients of all races. The study was conducted by Tripti Kumar, DO, from Lankenau Medical Center, Wynnewood, Pennsylvania, and colleagues.

“Racial disparities are observed in the United States concerning COVID-19, and studies have discovered that minority populations are at ongoing risk for health inequity,” Dr. Kumar said in a narrated e-poster presented during the American College of Chest Physicians (CHEST) 2021 Annual Meeting.

“Primary prevention initiatives should take precedence in mitigating the effect that comorbidities have on these vulnerable populations to help reduce necessity for mechanical ventilation, hospital length of stay, and overall mortality,” she said.
 

Higher death rates for Black patients

At the time the study was conducted, the COVID-19 death rate in the United States had topped 500,000 (as of this writing, it stands at 726,000). Of those who died, 22.4% were Black, 18.1% were Hispanic, and 3.6% were of Asian descent. The numbers of COVID-19 diagnoses and deaths were significantly higher in U.S. counties where the proportions of Black residents were higher, the authors note.

To see whether differences in COVID-19 outcomes were reflected in ICU length of stay, the researchers conducted a retrospective chart review of data on 162 patients admitted to ICUs at Paoli Hospital and Lankenau Medical Center, both in the suburban Philadelphia town of Wynnewood.

All patients were diagnosed with COVID-19 from March through June 2020.

In all, 60% of the study population were Black, 35% were White, 3% were Asian, and 2% were Hispanic. Women composed 46% of the sample.

The average length of ICU stay, which was the primary endpoint, was similar among Black patients (15.4 days), White patients (15.5 days), and Asians (16 days). The shortest average hospital stay was among Hispanic patients, at 11.3 days.

The investigators determined that among all races, the prevalence of type 2 diabetes, obesity, hypertension, and smoking was highest among Black patients.

Overall, nearly 85% of patients required mechanical ventilation. Among the patients who required it, 86% were Black, 84% were White, 66% were Hispanic, and 75% were Asian.

Overall mortality was 62%. It was higher among Black patients, at 60%, than among White patients, at 33%. The investigators did not report mortality rates for Hispanic or Asian patients.