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Heart attack care not equal for women and people of color
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Radiating chest pain, shortness of breath, nausea, lightheadedness. Everyone knows the telltale signs of a myocardial infarction. Yet a new study shows that despite this widespread recognition, heart attacks aren’t attended to quickly across the board. Historically, the study says, women and people of color wait longer to access emergency care for a heart attack.
Researchers from the University of California, San Francisco published these findings in the Annals of Emergency Medicine. The study used the Office of Statewide Health Planning and Development dataset to gather information on 453,136 cases of heart attack in California between 2005 and 2015. They found that over time, differences in timely treatment between the demographics narrowed, but the gap still existed.
The study defined timely treatment as receiving care for a heart attack within 3 days of admission to a hospital. Women and people of color were found to wait 3 days or more to receive care than their White male counterparts. A disparity of this sort can cause ripples of health effects across society, ripples that doctors should be aware of, says lead author Juan Carlos Montoy, MD. Dr. Montoy was “sadly surprised by our findings that disparities for women and for Black patients only decreased slightly or not at all over time.”
In the study, the team separated the dataset between the two primary types of heart attack: ST-segment elevation myocardial infarction (STEMI), caused by blood vessel blockage, and non–ST-segment elevation myocardial infarction (NSTEMI), caused by a narrowing or temporary blockage of the artery.
Regardless of the type of heart attack, the standard first step in treatment is a coronary angiogram. After finding out where blood flow is disrupted using the angiogram, a physician can proceed with treatment.
But when looking back, the team found that it took a while for many patients to receive this first step in treatment. In 2005, 50% of men and 35.7% of women with STEMI and 45% of men and 33.1% of women with NSTEMI had a timely angiography. In the same year, 46% of White patients and 31.2% of Black patients with STEMI underwent timely angiography.
By 2015, timely treatment increased across the board, but there were still discrepancies, with 76.7% of men and 66.8% of women with STEMI undergoing timely angiography and 56.3% of men and 45.9% of women with NSTEMI undergoing timely angiography. Also in 2015, 75.2% of White patients and 69.2% of Black patients underwent timely angiography for STEMI.
Although differences in care decreased between the demographics, the gap still exists. Whereas this dataset only extends to 2015, this trend may still persist today, says Robert Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, who was not involved in the study. Therefore, physicians need to consider this bias when treating patients. “The bottom line is that we continue to have much work to do to achieve equality in managing not only medical conditions but treating people who have them equally,” Dr. Glatter said.
“Raising awareness of ongoing inequality in care related to gender and ethnic disparities is critical to drive change in our institutions,” he emphasized. “We simply cannot accept the status quo.”
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Glatter and the authors declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF EMERGENCY MEDICINE
What are the benefits of a fourth vaccination against COVID?
The fourth vaccination against COVID-19 is the subject of intense discussion. Immunity against new Omicron variants (currently BA.4 and BA.5) is getting weaker and weaker. Is another vaccination with the available vaccines worth it?
For Leif Erik Sander, MD, director of infectious diseases and pneumology at Charité University Medicine, Berlin, the latest data send a clear message. “The COVID-19 vaccination is still effective against Omicron. After three doses of the vaccine, it continues to prevent severe diseases, respiratory failures, and death,” he reported at the 62nd Congress of the German Pneumology and Respiratory Medicine Society in Leipzig.
The most recent data from the United Kingdom show that the vaccine’s effectiveness against Omicron decreases after just a few months, which speaks in favor of a fourth vaccination. “Omicron is a development that we did not anticipate occurring so early on,” said Dr. Sander.
In terms of phylogenetics, Omicron is far removed from the previous variants of concern. More than 30 mutations to the spike protein (the antigen that is vaccinated against) foster the loss of immunity.
Boosters broaden immunity
“The booster makes all the difference here,” emphasized Dr. Sander. Experiments at Charité Berlin show that after double vaccination, the vaccination sera from healthy young people no longer neutralizes Omicron.
“The third vaccination broadens the humoral immune response against the spike protein so that conserved epitopes that are unchanged, even in Omicron, are addressed, with the result that you have neutralization capacity again,” the infectious diseases specialist explained.
Continued protection
However, data from the United Kingdom on vaccine effectiveness show where the limit lies. Initially, after three doses, vaccine effectiveness against symptomatic disease after Omicron infection is very good. This effectiveness decreases significantly over the course of the next few months. “Lots of people experience an Omicron infection despite the booster,” said Mr. Sander.
Nonetheless, the high incidence of Omicron infections in the recent past has not overwhelmed the health care system. “This is because the vaccine’s effectiveness against severe diseases that require hospitalization and against respiratory failure is still good in the at-risk population over the age of 65, once they have had their three vaccinations,” said Dr. Sander. The data also show that there is good protection of over 90%, even against mortality.
Waning observed
It could be said that currently, vaccination even continues to work against Omicron, says Dr. Sander. It prevents severe disease, respiratory failure, and death. Nonetheless, after just 3 months, a slight waning of immune protection can be observed in all three endpoints.
Therefore, the question arises as to whether a fourth vaccination is worthwhile. In Israel, “Delta was successfully eradicated with the third vaccination,” and now they are trying this again for Omicron with a fourth vaccination, reported Dr. Sander.
Fourth vaccination protective
The first investigations show that protection against severe disease can be increased once more. “For the over-60s, protection is almost quadrupled through the fourth vaccination,” says Dr. Sander. “However, this is still plagued with a lot of uncertainty; it is still not known how stable it is.”
There is hope on the basis of results of an as yet non–peer-reviewed study from Sweden, which is currently available only as a preprint. That study shows that a fourth vaccination in a high-risk population of care-home residents and people older than 80 years can halve overall mortality. “If this can be confirmed and replicated, it must be recommended quite extensively for this high-risk group,” said Dr. Sander. The Standing Committee on Vaccination in Germany is currently recommending that high-risk groups be vaccinated against COVID-19 for the fourth time. To date, though, this has only been implemented halfheartedly.
Propensity for mutation
Omicron keeps developing. Following BA.1 and the more infectious subvariant BA.2, BA.4 and BA.5 are spreading in Germany. “To date, there is no evidence that vaccine protection against severe diseases has changed as a result of BA.2 emerging,” said Dr. Sander.
However, the loss of immunity against BA.4 and BA.5 is more strongly pronounced. “If you were infected with BA.1, you are not immune to BA.5,” says Dr. Sander. Lessened immunity from BA.4 and BA.5 is even more pronounced. “Anyone who was infected with BA.1 is not immune to BA.5,” says Dr. Sander. The two clades not only have spike protein mutations shared by BA.2 but also additional spike protein mutations. According to the expert, it could well be that these strains will prevail because they are best able to avoid the immunity of the population.
Adapted vaccines feasible?
“Vaccines adapted to BA.1 were developed very early on and were also part of clinical research,” said Dr. Sander. The initial data indicate that additional antibody responses are being mobilized that may neutralize the new variants.
It was deduced from trials on monkeys that the available vaccines were so good that only small improvements were to be expected, said Dr. Sander.
Moderna’s adapted vaccine
The U.S. pharmaceutical company Moderna recently submitted the first results regarding its bivalent Omicron vaccine mRNA-1273.214, which is adapted to Omicron BA.1. Data from BioNTech are expected soon.
Moderna tested a booster that contains both the spike mRNA from the original vaccine and a new mRNA adapted to the Omicron variant BA.1. The experimental vaccine mRNA-1273.214 exhibited an eightfold increase in geometric mean neutralization titer against Omicron in study participants who were seronegative at the start, compared with the already-approved vaccine.
In its latest notice, Moderna did not publish any data on how effective the updated vaccine is against the virus variants BA.4 or BA.5. Data on clinical endpoints, such as hospitalization or mortality, are also not available.
Conservative epitopes
Should it be assumed that the development of vaccines will always lag the emergence of new subvariants? In this respect, Dr. Sander appears optimistic. “The immunological mechanism is clear, that various B cells and antibodies will be formed that are directed against conservative epitopes that have various variants. This is good news, since we do not want to protect against BA.1 now, just for BA.8 to emerge when the vaccine goes to market. We want to protect ourselves as broadly as possible, and it seems like it may be possible to do so with this vaccine.”
Double vaccination?
Dr. Sander anticipates that a fourth vaccination against COVID-19 will occur with the next wave of the coronavirus in September or October. He remarked that coupling it with the influenza vaccination should be considered.
The coronavirus pandemic has led to shifts in other seasonal waves of pathogens. In the summer, pediatric departments were unexpectedly inundated with children suffering from RSV infections. And while the flu season over the past 2 years has been almost absent, the influenza wave may occur significantly earlier than usual this year.
“In Australia, the influenza wave arrived much earlier this year than usual, which may of course also be fruitful for us,” said Dr. Sander. “Perhaps we will also get influenza as early as in September or October. I would then plead for vaccine centers to be allowed to vaccinate against both influenza and COVID-19 at the same time. Maybe then we will also have a reasonable influenza vaccination rate,” he added.
This article was translated from the Medscape German edition.
A version of this article first appeared on Medscape.com.
The fourth vaccination against COVID-19 is the subject of intense discussion. Immunity against new Omicron variants (currently BA.4 and BA.5) is getting weaker and weaker. Is another vaccination with the available vaccines worth it?
For Leif Erik Sander, MD, director of infectious diseases and pneumology at Charité University Medicine, Berlin, the latest data send a clear message. “The COVID-19 vaccination is still effective against Omicron. After three doses of the vaccine, it continues to prevent severe diseases, respiratory failures, and death,” he reported at the 62nd Congress of the German Pneumology and Respiratory Medicine Society in Leipzig.
The most recent data from the United Kingdom show that the vaccine’s effectiveness against Omicron decreases after just a few months, which speaks in favor of a fourth vaccination. “Omicron is a development that we did not anticipate occurring so early on,” said Dr. Sander.
In terms of phylogenetics, Omicron is far removed from the previous variants of concern. More than 30 mutations to the spike protein (the antigen that is vaccinated against) foster the loss of immunity.
Boosters broaden immunity
“The booster makes all the difference here,” emphasized Dr. Sander. Experiments at Charité Berlin show that after double vaccination, the vaccination sera from healthy young people no longer neutralizes Omicron.
“The third vaccination broadens the humoral immune response against the spike protein so that conserved epitopes that are unchanged, even in Omicron, are addressed, with the result that you have neutralization capacity again,” the infectious diseases specialist explained.
Continued protection
However, data from the United Kingdom on vaccine effectiveness show where the limit lies. Initially, after three doses, vaccine effectiveness against symptomatic disease after Omicron infection is very good. This effectiveness decreases significantly over the course of the next few months. “Lots of people experience an Omicron infection despite the booster,” said Mr. Sander.
Nonetheless, the high incidence of Omicron infections in the recent past has not overwhelmed the health care system. “This is because the vaccine’s effectiveness against severe diseases that require hospitalization and against respiratory failure is still good in the at-risk population over the age of 65, once they have had their three vaccinations,” said Dr. Sander. The data also show that there is good protection of over 90%, even against mortality.
Waning observed
It could be said that currently, vaccination even continues to work against Omicron, says Dr. Sander. It prevents severe disease, respiratory failure, and death. Nonetheless, after just 3 months, a slight waning of immune protection can be observed in all three endpoints.
Therefore, the question arises as to whether a fourth vaccination is worthwhile. In Israel, “Delta was successfully eradicated with the third vaccination,” and now they are trying this again for Omicron with a fourth vaccination, reported Dr. Sander.
Fourth vaccination protective
The first investigations show that protection against severe disease can be increased once more. “For the over-60s, protection is almost quadrupled through the fourth vaccination,” says Dr. Sander. “However, this is still plagued with a lot of uncertainty; it is still not known how stable it is.”
There is hope on the basis of results of an as yet non–peer-reviewed study from Sweden, which is currently available only as a preprint. That study shows that a fourth vaccination in a high-risk population of care-home residents and people older than 80 years can halve overall mortality. “If this can be confirmed and replicated, it must be recommended quite extensively for this high-risk group,” said Dr. Sander. The Standing Committee on Vaccination in Germany is currently recommending that high-risk groups be vaccinated against COVID-19 for the fourth time. To date, though, this has only been implemented halfheartedly.
Propensity for mutation
Omicron keeps developing. Following BA.1 and the more infectious subvariant BA.2, BA.4 and BA.5 are spreading in Germany. “To date, there is no evidence that vaccine protection against severe diseases has changed as a result of BA.2 emerging,” said Dr. Sander.
However, the loss of immunity against BA.4 and BA.5 is more strongly pronounced. “If you were infected with BA.1, you are not immune to BA.5,” says Dr. Sander. Lessened immunity from BA.4 and BA.5 is even more pronounced. “Anyone who was infected with BA.1 is not immune to BA.5,” says Dr. Sander. The two clades not only have spike protein mutations shared by BA.2 but also additional spike protein mutations. According to the expert, it could well be that these strains will prevail because they are best able to avoid the immunity of the population.
Adapted vaccines feasible?
“Vaccines adapted to BA.1 were developed very early on and were also part of clinical research,” said Dr. Sander. The initial data indicate that additional antibody responses are being mobilized that may neutralize the new variants.
It was deduced from trials on monkeys that the available vaccines were so good that only small improvements were to be expected, said Dr. Sander.
Moderna’s adapted vaccine
The U.S. pharmaceutical company Moderna recently submitted the first results regarding its bivalent Omicron vaccine mRNA-1273.214, which is adapted to Omicron BA.1. Data from BioNTech are expected soon.
Moderna tested a booster that contains both the spike mRNA from the original vaccine and a new mRNA adapted to the Omicron variant BA.1. The experimental vaccine mRNA-1273.214 exhibited an eightfold increase in geometric mean neutralization titer against Omicron in study participants who were seronegative at the start, compared with the already-approved vaccine.
In its latest notice, Moderna did not publish any data on how effective the updated vaccine is against the virus variants BA.4 or BA.5. Data on clinical endpoints, such as hospitalization or mortality, are also not available.
Conservative epitopes
Should it be assumed that the development of vaccines will always lag the emergence of new subvariants? In this respect, Dr. Sander appears optimistic. “The immunological mechanism is clear, that various B cells and antibodies will be formed that are directed against conservative epitopes that have various variants. This is good news, since we do not want to protect against BA.1 now, just for BA.8 to emerge when the vaccine goes to market. We want to protect ourselves as broadly as possible, and it seems like it may be possible to do so with this vaccine.”
Double vaccination?
Dr. Sander anticipates that a fourth vaccination against COVID-19 will occur with the next wave of the coronavirus in September or October. He remarked that coupling it with the influenza vaccination should be considered.
The coronavirus pandemic has led to shifts in other seasonal waves of pathogens. In the summer, pediatric departments were unexpectedly inundated with children suffering from RSV infections. And while the flu season over the past 2 years has been almost absent, the influenza wave may occur significantly earlier than usual this year.
“In Australia, the influenza wave arrived much earlier this year than usual, which may of course also be fruitful for us,” said Dr. Sander. “Perhaps we will also get influenza as early as in September or October. I would then plead for vaccine centers to be allowed to vaccinate against both influenza and COVID-19 at the same time. Maybe then we will also have a reasonable influenza vaccination rate,” he added.
This article was translated from the Medscape German edition.
A version of this article first appeared on Medscape.com.
The fourth vaccination against COVID-19 is the subject of intense discussion. Immunity against new Omicron variants (currently BA.4 and BA.5) is getting weaker and weaker. Is another vaccination with the available vaccines worth it?
For Leif Erik Sander, MD, director of infectious diseases and pneumology at Charité University Medicine, Berlin, the latest data send a clear message. “The COVID-19 vaccination is still effective against Omicron. After three doses of the vaccine, it continues to prevent severe diseases, respiratory failures, and death,” he reported at the 62nd Congress of the German Pneumology and Respiratory Medicine Society in Leipzig.
The most recent data from the United Kingdom show that the vaccine’s effectiveness against Omicron decreases after just a few months, which speaks in favor of a fourth vaccination. “Omicron is a development that we did not anticipate occurring so early on,” said Dr. Sander.
In terms of phylogenetics, Omicron is far removed from the previous variants of concern. More than 30 mutations to the spike protein (the antigen that is vaccinated against) foster the loss of immunity.
Boosters broaden immunity
“The booster makes all the difference here,” emphasized Dr. Sander. Experiments at Charité Berlin show that after double vaccination, the vaccination sera from healthy young people no longer neutralizes Omicron.
“The third vaccination broadens the humoral immune response against the spike protein so that conserved epitopes that are unchanged, even in Omicron, are addressed, with the result that you have neutralization capacity again,” the infectious diseases specialist explained.
Continued protection
However, data from the United Kingdom on vaccine effectiveness show where the limit lies. Initially, after three doses, vaccine effectiveness against symptomatic disease after Omicron infection is very good. This effectiveness decreases significantly over the course of the next few months. “Lots of people experience an Omicron infection despite the booster,” said Mr. Sander.
Nonetheless, the high incidence of Omicron infections in the recent past has not overwhelmed the health care system. “This is because the vaccine’s effectiveness against severe diseases that require hospitalization and against respiratory failure is still good in the at-risk population over the age of 65, once they have had their three vaccinations,” said Dr. Sander. The data also show that there is good protection of over 90%, even against mortality.
Waning observed
It could be said that currently, vaccination even continues to work against Omicron, says Dr. Sander. It prevents severe disease, respiratory failure, and death. Nonetheless, after just 3 months, a slight waning of immune protection can be observed in all three endpoints.
Therefore, the question arises as to whether a fourth vaccination is worthwhile. In Israel, “Delta was successfully eradicated with the third vaccination,” and now they are trying this again for Omicron with a fourth vaccination, reported Dr. Sander.
Fourth vaccination protective
The first investigations show that protection against severe disease can be increased once more. “For the over-60s, protection is almost quadrupled through the fourth vaccination,” says Dr. Sander. “However, this is still plagued with a lot of uncertainty; it is still not known how stable it is.”
There is hope on the basis of results of an as yet non–peer-reviewed study from Sweden, which is currently available only as a preprint. That study shows that a fourth vaccination in a high-risk population of care-home residents and people older than 80 years can halve overall mortality. “If this can be confirmed and replicated, it must be recommended quite extensively for this high-risk group,” said Dr. Sander. The Standing Committee on Vaccination in Germany is currently recommending that high-risk groups be vaccinated against COVID-19 for the fourth time. To date, though, this has only been implemented halfheartedly.
Propensity for mutation
Omicron keeps developing. Following BA.1 and the more infectious subvariant BA.2, BA.4 and BA.5 are spreading in Germany. “To date, there is no evidence that vaccine protection against severe diseases has changed as a result of BA.2 emerging,” said Dr. Sander.
However, the loss of immunity against BA.4 and BA.5 is more strongly pronounced. “If you were infected with BA.1, you are not immune to BA.5,” says Dr. Sander. Lessened immunity from BA.4 and BA.5 is even more pronounced. “Anyone who was infected with BA.1 is not immune to BA.5,” says Dr. Sander. The two clades not only have spike protein mutations shared by BA.2 but also additional spike protein mutations. According to the expert, it could well be that these strains will prevail because they are best able to avoid the immunity of the population.
Adapted vaccines feasible?
“Vaccines adapted to BA.1 were developed very early on and were also part of clinical research,” said Dr. Sander. The initial data indicate that additional antibody responses are being mobilized that may neutralize the new variants.
It was deduced from trials on monkeys that the available vaccines were so good that only small improvements were to be expected, said Dr. Sander.
Moderna’s adapted vaccine
The U.S. pharmaceutical company Moderna recently submitted the first results regarding its bivalent Omicron vaccine mRNA-1273.214, which is adapted to Omicron BA.1. Data from BioNTech are expected soon.
Moderna tested a booster that contains both the spike mRNA from the original vaccine and a new mRNA adapted to the Omicron variant BA.1. The experimental vaccine mRNA-1273.214 exhibited an eightfold increase in geometric mean neutralization titer against Omicron in study participants who were seronegative at the start, compared with the already-approved vaccine.
In its latest notice, Moderna did not publish any data on how effective the updated vaccine is against the virus variants BA.4 or BA.5. Data on clinical endpoints, such as hospitalization or mortality, are also not available.
Conservative epitopes
Should it be assumed that the development of vaccines will always lag the emergence of new subvariants? In this respect, Dr. Sander appears optimistic. “The immunological mechanism is clear, that various B cells and antibodies will be formed that are directed against conservative epitopes that have various variants. This is good news, since we do not want to protect against BA.1 now, just for BA.8 to emerge when the vaccine goes to market. We want to protect ourselves as broadly as possible, and it seems like it may be possible to do so with this vaccine.”
Double vaccination?
Dr. Sander anticipates that a fourth vaccination against COVID-19 will occur with the next wave of the coronavirus in September or October. He remarked that coupling it with the influenza vaccination should be considered.
The coronavirus pandemic has led to shifts in other seasonal waves of pathogens. In the summer, pediatric departments were unexpectedly inundated with children suffering from RSV infections. And while the flu season over the past 2 years has been almost absent, the influenza wave may occur significantly earlier than usual this year.
“In Australia, the influenza wave arrived much earlier this year than usual, which may of course also be fruitful for us,” said Dr. Sander. “Perhaps we will also get influenza as early as in September or October. I would then plead for vaccine centers to be allowed to vaccinate against both influenza and COVID-19 at the same time. Maybe then we will also have a reasonable influenza vaccination rate,” he added.
This article was translated from the Medscape German edition.
A version of this article first appeared on Medscape.com.
Study confirms increased CVT with AstraZeneca COVID vaccine
A new Scandinavian study has confirmed previous data showing increased rates of cerebral venous thrombosis and thrombocytopenia after the AstraZeneca COVID-19 vaccine.
The study also showed higher rates of several thromboembolic and thrombocytopenic outcomes after the Pfizer and Moderna mRNA vaccines, although these increases were less than the rates observed after the AstraZeneca vaccine, and sensitivity analyses were not consistent.
The researchers conclude that confirmatory analysis on the two mRNA vaccines by other methods are warranted.
The study was published in the June issue of JAMA Network Open.
“This study confirms what we know from other studies: that the AstraZeneca vaccine is associated with the rare but serious side effect of vaccine-induced immune thrombotic thrombocytopenia,” lead author Jacob Dag Berild, MD, Norwegian Institute of Public Health, Oslo, told this news organization.
he added.
Dr. Dag Berild noted that in the current study there was an excess of 1.6 events of cerebral venous thrombosis per 100,000 AstraZeneca vaccine doses, which is similar to what has been previously reported.
Asked how he saw these results affecting continued use of these vaccines, Dr. Dag Berild pointed out that the risk-benefit ratio of the vaccine depends on the risk of contracting COVID-19 and the risk for a severe outcome from COVID-19 weighed against the risk for an adverse event after vaccination.
“The European Medicines Agency has concluded that the overall risk-benefit ratio remains positive for the AstraZeneca vaccine, but Norway, Finland, and Denmark no longer use the AstraZeneca vaccine in their vaccination programs because of adequate availability of alternative vaccines. I think this is a reasonable decision,” he said.
For the current study, the researchers linked individual-level data separately from national population, patient, and vaccination registers in Norway, Finland, and Denmark. Patient registers were used to identify hospital visits and admissions related to thromboembolic and thrombocytopenic disease in all three countries.
The main outcomes were relative rates of coronary artery disease, coagulation disorders, and cerebrovascular disease in the 28-day period after vaccination, compared with the control period prior to vaccination.
The authors note that a strength of this study is the use of registers with full population coverage in three countries with universal health care, ensuring equal access to care for all permanent residents. At the end of the study period, from Jan. 1, 2020 to May 16, 2021, more than 5.3 million people in the three countries were vaccinated with one or two doses.
Another strength is the inherent adjustment for time-invariant confounders in the self-controlled case series design and the resulting control of confounders that can affect the more traditional observational studies when complete data for confounders are not available, they add.
Of the 265,339 hospital contacts, 43% were made by female patients and 93% by patients born in or before 1971, and 44% were for coronary artery disease, 21% for coagulation disorders, and 35% for cerebrovascular disease.
In the 28-day period after vaccination, there was an elevated rate of coronary artery disease after the Moderna vaccine (relative rate, 1.13) but not after the AstraZeneca (RR, 0.92) or Pfizer (RR, 0.96) vaccines.
There was an observed increase in the rate of coagulation disorders after all three vaccines (AstraZeneca RR, 2.01; Pfizer RR, 1.12; and Moderna RR, 1.26).
There was also an increase in the rate of cerebrovascular disease after all three vaccines (AstraZeneca RR, 1.32; Pfizer RR, 1.09; and Moderna RR, 1.21).
For individual diseases in the main outcomes, two notably high rates were observed after the AstraZeneca vaccine, with relative rates of 12.04 for cerebral venous thrombosis and 4.29 for thrombocytopenia, corresponding to 1.6 and 4.9 excess events per 100,000 doses, respectively.
The elevated risk after the AstraZeneca vaccine was consistent across all three countries and robust in sensitivity analyses.
The researchers report that they also observed statistically significant increases in hospital contacts for thrombocytopenic and thromboembolic events after the Pfizer and Moderna vaccines. However, the risk was smaller than after the AstraZeneca vaccine.
“Additionally, the national estimates varied, increased risk [was] observed only in the oldest cohorts, and sensitivity analysis checking underlying assumptions of the analyses were not consistent. Therefore, the overall and combined increased relative risks following the Pfizer and Moderna vaccinations should be interpreted with caution,” they say.
They note that their results with the AstraZeneca vaccine are in line with a comparison of observed and historic rates performed on partly the same population in Norway and Denmark and also with a Scottish national case-control study.
A version of this article first appeared on Medscape.com.
A new Scandinavian study has confirmed previous data showing increased rates of cerebral venous thrombosis and thrombocytopenia after the AstraZeneca COVID-19 vaccine.
The study also showed higher rates of several thromboembolic and thrombocytopenic outcomes after the Pfizer and Moderna mRNA vaccines, although these increases were less than the rates observed after the AstraZeneca vaccine, and sensitivity analyses were not consistent.
The researchers conclude that confirmatory analysis on the two mRNA vaccines by other methods are warranted.
The study was published in the June issue of JAMA Network Open.
“This study confirms what we know from other studies: that the AstraZeneca vaccine is associated with the rare but serious side effect of vaccine-induced immune thrombotic thrombocytopenia,” lead author Jacob Dag Berild, MD, Norwegian Institute of Public Health, Oslo, told this news organization.
he added.
Dr. Dag Berild noted that in the current study there was an excess of 1.6 events of cerebral venous thrombosis per 100,000 AstraZeneca vaccine doses, which is similar to what has been previously reported.
Asked how he saw these results affecting continued use of these vaccines, Dr. Dag Berild pointed out that the risk-benefit ratio of the vaccine depends on the risk of contracting COVID-19 and the risk for a severe outcome from COVID-19 weighed against the risk for an adverse event after vaccination.
“The European Medicines Agency has concluded that the overall risk-benefit ratio remains positive for the AstraZeneca vaccine, but Norway, Finland, and Denmark no longer use the AstraZeneca vaccine in their vaccination programs because of adequate availability of alternative vaccines. I think this is a reasonable decision,” he said.
For the current study, the researchers linked individual-level data separately from national population, patient, and vaccination registers in Norway, Finland, and Denmark. Patient registers were used to identify hospital visits and admissions related to thromboembolic and thrombocytopenic disease in all three countries.
The main outcomes were relative rates of coronary artery disease, coagulation disorders, and cerebrovascular disease in the 28-day period after vaccination, compared with the control period prior to vaccination.
The authors note that a strength of this study is the use of registers with full population coverage in three countries with universal health care, ensuring equal access to care for all permanent residents. At the end of the study period, from Jan. 1, 2020 to May 16, 2021, more than 5.3 million people in the three countries were vaccinated with one or two doses.
Another strength is the inherent adjustment for time-invariant confounders in the self-controlled case series design and the resulting control of confounders that can affect the more traditional observational studies when complete data for confounders are not available, they add.
Of the 265,339 hospital contacts, 43% were made by female patients and 93% by patients born in or before 1971, and 44% were for coronary artery disease, 21% for coagulation disorders, and 35% for cerebrovascular disease.
In the 28-day period after vaccination, there was an elevated rate of coronary artery disease after the Moderna vaccine (relative rate, 1.13) but not after the AstraZeneca (RR, 0.92) or Pfizer (RR, 0.96) vaccines.
There was an observed increase in the rate of coagulation disorders after all three vaccines (AstraZeneca RR, 2.01; Pfizer RR, 1.12; and Moderna RR, 1.26).
There was also an increase in the rate of cerebrovascular disease after all three vaccines (AstraZeneca RR, 1.32; Pfizer RR, 1.09; and Moderna RR, 1.21).
For individual diseases in the main outcomes, two notably high rates were observed after the AstraZeneca vaccine, with relative rates of 12.04 for cerebral venous thrombosis and 4.29 for thrombocytopenia, corresponding to 1.6 and 4.9 excess events per 100,000 doses, respectively.
The elevated risk after the AstraZeneca vaccine was consistent across all three countries and robust in sensitivity analyses.
The researchers report that they also observed statistically significant increases in hospital contacts for thrombocytopenic and thromboembolic events after the Pfizer and Moderna vaccines. However, the risk was smaller than after the AstraZeneca vaccine.
“Additionally, the national estimates varied, increased risk [was] observed only in the oldest cohorts, and sensitivity analysis checking underlying assumptions of the analyses were not consistent. Therefore, the overall and combined increased relative risks following the Pfizer and Moderna vaccinations should be interpreted with caution,” they say.
They note that their results with the AstraZeneca vaccine are in line with a comparison of observed and historic rates performed on partly the same population in Norway and Denmark and also with a Scottish national case-control study.
A version of this article first appeared on Medscape.com.
A new Scandinavian study has confirmed previous data showing increased rates of cerebral venous thrombosis and thrombocytopenia after the AstraZeneca COVID-19 vaccine.
The study also showed higher rates of several thromboembolic and thrombocytopenic outcomes after the Pfizer and Moderna mRNA vaccines, although these increases were less than the rates observed after the AstraZeneca vaccine, and sensitivity analyses were not consistent.
The researchers conclude that confirmatory analysis on the two mRNA vaccines by other methods are warranted.
The study was published in the June issue of JAMA Network Open.
“This study confirms what we know from other studies: that the AstraZeneca vaccine is associated with the rare but serious side effect of vaccine-induced immune thrombotic thrombocytopenia,” lead author Jacob Dag Berild, MD, Norwegian Institute of Public Health, Oslo, told this news organization.
he added.
Dr. Dag Berild noted that in the current study there was an excess of 1.6 events of cerebral venous thrombosis per 100,000 AstraZeneca vaccine doses, which is similar to what has been previously reported.
Asked how he saw these results affecting continued use of these vaccines, Dr. Dag Berild pointed out that the risk-benefit ratio of the vaccine depends on the risk of contracting COVID-19 and the risk for a severe outcome from COVID-19 weighed against the risk for an adverse event after vaccination.
“The European Medicines Agency has concluded that the overall risk-benefit ratio remains positive for the AstraZeneca vaccine, but Norway, Finland, and Denmark no longer use the AstraZeneca vaccine in their vaccination programs because of adequate availability of alternative vaccines. I think this is a reasonable decision,” he said.
For the current study, the researchers linked individual-level data separately from national population, patient, and vaccination registers in Norway, Finland, and Denmark. Patient registers were used to identify hospital visits and admissions related to thromboembolic and thrombocytopenic disease in all three countries.
The main outcomes were relative rates of coronary artery disease, coagulation disorders, and cerebrovascular disease in the 28-day period after vaccination, compared with the control period prior to vaccination.
The authors note that a strength of this study is the use of registers with full population coverage in three countries with universal health care, ensuring equal access to care for all permanent residents. At the end of the study period, from Jan. 1, 2020 to May 16, 2021, more than 5.3 million people in the three countries were vaccinated with one or two doses.
Another strength is the inherent adjustment for time-invariant confounders in the self-controlled case series design and the resulting control of confounders that can affect the more traditional observational studies when complete data for confounders are not available, they add.
Of the 265,339 hospital contacts, 43% were made by female patients and 93% by patients born in or before 1971, and 44% were for coronary artery disease, 21% for coagulation disorders, and 35% for cerebrovascular disease.
In the 28-day period after vaccination, there was an elevated rate of coronary artery disease after the Moderna vaccine (relative rate, 1.13) but not after the AstraZeneca (RR, 0.92) or Pfizer (RR, 0.96) vaccines.
There was an observed increase in the rate of coagulation disorders after all three vaccines (AstraZeneca RR, 2.01; Pfizer RR, 1.12; and Moderna RR, 1.26).
There was also an increase in the rate of cerebrovascular disease after all three vaccines (AstraZeneca RR, 1.32; Pfizer RR, 1.09; and Moderna RR, 1.21).
For individual diseases in the main outcomes, two notably high rates were observed after the AstraZeneca vaccine, with relative rates of 12.04 for cerebral venous thrombosis and 4.29 for thrombocytopenia, corresponding to 1.6 and 4.9 excess events per 100,000 doses, respectively.
The elevated risk after the AstraZeneca vaccine was consistent across all three countries and robust in sensitivity analyses.
The researchers report that they also observed statistically significant increases in hospital contacts for thrombocytopenic and thromboembolic events after the Pfizer and Moderna vaccines. However, the risk was smaller than after the AstraZeneca vaccine.
“Additionally, the national estimates varied, increased risk [was] observed only in the oldest cohorts, and sensitivity analysis checking underlying assumptions of the analyses were not consistent. Therefore, the overall and combined increased relative risks following the Pfizer and Moderna vaccinations should be interpreted with caution,” they say.
They note that their results with the AstraZeneca vaccine are in line with a comparison of observed and historic rates performed on partly the same population in Norway and Denmark and also with a Scottish national case-control study.
A version of this article first appeared on Medscape.com.
Cannabis use causes spike in ED visits
Cannabis users had a 22% increased risk of an emergency department (ED) visit or hospitalization compared to nonusers, as determined from data from more than 30,000 individuals.
Although cannabis contains compounds similar to tobacco, “data published on the association between cannabis smoking and airways health have been contradictory,” and whether smoking cannabis increases a user’s risk of developing acute respiratory illness remains unclear, wrote Nicholas T. Vozoris, MD, of the University of Toronto, and colleagues.
In a study published in BMJ Open Respiratory Research, the investigators reviewed national health records data from 35,114 individuals aged 12-65 years for the period January 2009 to December 2015. Of these persons, 4,807 of the 6,425 who reported cannabis use in the past year were matched with 10,395 never-users who served as controls. The mean age of the study population at the index date was 35 years, and 42% were women; demographics were similar between users and control persons.
Overall, the odds of respiratory-related emergency department visits or hospitalizations were not significantly different between the cannabis users and the control persons (3.6% vs. 3.9%; odds ratio, 0.91). However, cannabis users had significantly greater odds of all-cause ED visits or hospitalizations (30.0% vs. 26.0%; OR, 1.22). All-cause mortality was 0.2% for both groups.
Respiratory problems were the second-highest reason for all-cause visits, the researchers noted. The lack of a difference in respiratory-related visits between cannabis users and nonusers conflicts somewhat with previous studies on this topic, which were limited, the researchers noted in their discussion.
The negative results also might stem from factors for which the researchers could not adjust, including insufficient cannabis smoke exposure among users in the study population, noninhalational cannabis use, which is less likely to have a respiratory effect, and possible secondhand exposure among control persons.
“It is also possible that our analysis might have been insufficiently powered to detect a significant signal with respect to the primary outcome,” they noted.
However, after the researchers controlled for multiple variables, the risk of an equally important morbidity outcome, all-cause ED visits or hospitalizations, was significantly greater among cannabis users than among control individuals, and respiratory reasons were the second most common cause for ED visits and hospitalizations in the all-cause outcome, they emphasized.
The study findings were limited by several factors, including the retrospective and observational design and the inability to control for all confounding variables, the researchers noted. Other limitations include the use of self-reports and potential for bias, the inability to perform dose-response analysis, and the high number of infrequent cannabis users in the study population.
However, the results suggest that cannabis use is associated with an increased risk of serious health events and should be discouraged, although more research is needed to confirm the current study findings, they concluded.
Consider range of causes for cannabis emergency visits
“With growing numbers of states legalizing recreational use of cannabis, it’s important to understand whether cannabis use is associated with increased emergency department visits,” Robert D. Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, told this news organization.
Previous studies have shown an association between increased ED visits and cannabis use in states, especially with edibles, where cannabis is legal, and “the current study reinforces the elevated risk of ED visits along with hospitalizations,” he said.
“While the researchers found no increased risk of respiratory-related complaints among users compared to the general population, there was an associated increase in ED visits and hospitalizations, which is important to understand,” said Dr. Glatter, who was not involved in the study.
“While this observational study found that the incidence of respiratory complaints was not significantly different among frequent users of cannabis, the increased odds that cannabis users would require evaluation in the emergency room or even hospitalization was still apparent even after the investigators controlled for such factors as use of alcohol, tobacco, illicit drug use, or other mental health–related disorders,” Dr. Glatter noted.
“That said, it’s a bit surprising that with the continued popularity of vaping, especially among teens, there was still not any appreciable or significant increase in respiratory complaints observed. Beyond this finding, I was not surprised by the overall conclusions of the current study, as we continue to see an elevated number of patients presenting to the ED with adverse events related to cannabis use.”
Dr. Glatter noted that “the majority of patients we see in the ED are associated with use of edibles, since it takes longer for the person to feel the effects, leading the user to consume more of the product up front, with delayed effects lasting up to 12 hours. This is what gets people into trouble and leads to toxicity of cannabis, or ‘overdoses,’ “ he explained.
When consuming edible cannabis products, “[p]eople need to begin at low dosages and not take additional gummies up front, since it can take up to 2 or even 3 hours in some cases to feel the initial effects. With the drug’s effects lasting up to 12 hours, it’s especially important to avoid operating any motor vehicles, bicycles, or scooters, since reaction time is impaired, as well as overall judgment, balance, and fine motor skills,” Dr. Glatter said.
Cannabis can land users in the ED for a range of reasons, said Dr. Glatter. “According to the study, 15% of the emergency room visits and hospitalizations were due to acute trauma, 14% due to respiratory issues, and 13% to gastrointestinal illnesses. These effects were seen in first-time users but not those with chronic use, according to the study inclusion criteria.”
Cannabis use could result in physical injuries through “impaired judgment, coordination, combined with an altered state of consciousness or generalized drowsiness, that could contribute to an increase in motor vehicle collisions, along with an increased risk for falls leading to lacerations, fractures, contusions, or bruising,” said Dr. Glatter. “Cannabis may also lead to an altered sense of perception related to interactions with others, resulting in feelings of anxiety or restlessness culminating in physical altercations and other injuries.”
The current study indicates the need for understanding the potential physical and psychological effects of cannabis use, he said.
“Additional research is needed to better understand the relative percentage cases related to edibles vs. inhalation presenting to the ED,” he noted. “There is no question that edibles continue to present significant dangers for those who don’t read labels or remain poorly informed regarding their dosing as a result of delayed onset and longer duration,” he said. To help reduce risk of toxicity, the concept of a “high lasting 12-15 hours, as with edibles, as opposed to 3-4 hours from inhalation must be clearly stated on packaging and better communicated with users, as the toxicity with edibles is more often from lack of prior knowledge about onset of effects related to dosing.”
In addition, the “potential for psychosis to develop with more chronic cannabis use, along with cannabinoid hyperemesis syndrome should be on every clinician’s radar,” Dr. Glatter emphasized.
“The bottom line is that as more states legalize the use of cannabis, it’s vital to also implement comprehensive public education efforts to provide users with the reported risks associated with not only inhalation (vaping or flower) but also edibles, which account for an increasingly greater percentage of ED visits and associated adverse effects,” he said.
The study was supported by the Lung Association–Ontario, as well as by grants from the Ontario Ministry of Health and the Ministry of Long-Term Care. The researchers and Dr. Glatter have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cannabis users had a 22% increased risk of an emergency department (ED) visit or hospitalization compared to nonusers, as determined from data from more than 30,000 individuals.
Although cannabis contains compounds similar to tobacco, “data published on the association between cannabis smoking and airways health have been contradictory,” and whether smoking cannabis increases a user’s risk of developing acute respiratory illness remains unclear, wrote Nicholas T. Vozoris, MD, of the University of Toronto, and colleagues.
In a study published in BMJ Open Respiratory Research, the investigators reviewed national health records data from 35,114 individuals aged 12-65 years for the period January 2009 to December 2015. Of these persons, 4,807 of the 6,425 who reported cannabis use in the past year were matched with 10,395 never-users who served as controls. The mean age of the study population at the index date was 35 years, and 42% were women; demographics were similar between users and control persons.
Overall, the odds of respiratory-related emergency department visits or hospitalizations were not significantly different between the cannabis users and the control persons (3.6% vs. 3.9%; odds ratio, 0.91). However, cannabis users had significantly greater odds of all-cause ED visits or hospitalizations (30.0% vs. 26.0%; OR, 1.22). All-cause mortality was 0.2% for both groups.
Respiratory problems were the second-highest reason for all-cause visits, the researchers noted. The lack of a difference in respiratory-related visits between cannabis users and nonusers conflicts somewhat with previous studies on this topic, which were limited, the researchers noted in their discussion.
The negative results also might stem from factors for which the researchers could not adjust, including insufficient cannabis smoke exposure among users in the study population, noninhalational cannabis use, which is less likely to have a respiratory effect, and possible secondhand exposure among control persons.
“It is also possible that our analysis might have been insufficiently powered to detect a significant signal with respect to the primary outcome,” they noted.
However, after the researchers controlled for multiple variables, the risk of an equally important morbidity outcome, all-cause ED visits or hospitalizations, was significantly greater among cannabis users than among control individuals, and respiratory reasons were the second most common cause for ED visits and hospitalizations in the all-cause outcome, they emphasized.
The study findings were limited by several factors, including the retrospective and observational design and the inability to control for all confounding variables, the researchers noted. Other limitations include the use of self-reports and potential for bias, the inability to perform dose-response analysis, and the high number of infrequent cannabis users in the study population.
However, the results suggest that cannabis use is associated with an increased risk of serious health events and should be discouraged, although more research is needed to confirm the current study findings, they concluded.
Consider range of causes for cannabis emergency visits
“With growing numbers of states legalizing recreational use of cannabis, it’s important to understand whether cannabis use is associated with increased emergency department visits,” Robert D. Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, told this news organization.
Previous studies have shown an association between increased ED visits and cannabis use in states, especially with edibles, where cannabis is legal, and “the current study reinforces the elevated risk of ED visits along with hospitalizations,” he said.
“While the researchers found no increased risk of respiratory-related complaints among users compared to the general population, there was an associated increase in ED visits and hospitalizations, which is important to understand,” said Dr. Glatter, who was not involved in the study.
“While this observational study found that the incidence of respiratory complaints was not significantly different among frequent users of cannabis, the increased odds that cannabis users would require evaluation in the emergency room or even hospitalization was still apparent even after the investigators controlled for such factors as use of alcohol, tobacco, illicit drug use, or other mental health–related disorders,” Dr. Glatter noted.
“That said, it’s a bit surprising that with the continued popularity of vaping, especially among teens, there was still not any appreciable or significant increase in respiratory complaints observed. Beyond this finding, I was not surprised by the overall conclusions of the current study, as we continue to see an elevated number of patients presenting to the ED with adverse events related to cannabis use.”
Dr. Glatter noted that “the majority of patients we see in the ED are associated with use of edibles, since it takes longer for the person to feel the effects, leading the user to consume more of the product up front, with delayed effects lasting up to 12 hours. This is what gets people into trouble and leads to toxicity of cannabis, or ‘overdoses,’ “ he explained.
When consuming edible cannabis products, “[p]eople need to begin at low dosages and not take additional gummies up front, since it can take up to 2 or even 3 hours in some cases to feel the initial effects. With the drug’s effects lasting up to 12 hours, it’s especially important to avoid operating any motor vehicles, bicycles, or scooters, since reaction time is impaired, as well as overall judgment, balance, and fine motor skills,” Dr. Glatter said.
Cannabis can land users in the ED for a range of reasons, said Dr. Glatter. “According to the study, 15% of the emergency room visits and hospitalizations were due to acute trauma, 14% due to respiratory issues, and 13% to gastrointestinal illnesses. These effects were seen in first-time users but not those with chronic use, according to the study inclusion criteria.”
Cannabis use could result in physical injuries through “impaired judgment, coordination, combined with an altered state of consciousness or generalized drowsiness, that could contribute to an increase in motor vehicle collisions, along with an increased risk for falls leading to lacerations, fractures, contusions, or bruising,” said Dr. Glatter. “Cannabis may also lead to an altered sense of perception related to interactions with others, resulting in feelings of anxiety or restlessness culminating in physical altercations and other injuries.”
The current study indicates the need for understanding the potential physical and psychological effects of cannabis use, he said.
“Additional research is needed to better understand the relative percentage cases related to edibles vs. inhalation presenting to the ED,” he noted. “There is no question that edibles continue to present significant dangers for those who don’t read labels or remain poorly informed regarding their dosing as a result of delayed onset and longer duration,” he said. To help reduce risk of toxicity, the concept of a “high lasting 12-15 hours, as with edibles, as opposed to 3-4 hours from inhalation must be clearly stated on packaging and better communicated with users, as the toxicity with edibles is more often from lack of prior knowledge about onset of effects related to dosing.”
In addition, the “potential for psychosis to develop with more chronic cannabis use, along with cannabinoid hyperemesis syndrome should be on every clinician’s radar,” Dr. Glatter emphasized.
“The bottom line is that as more states legalize the use of cannabis, it’s vital to also implement comprehensive public education efforts to provide users with the reported risks associated with not only inhalation (vaping or flower) but also edibles, which account for an increasingly greater percentage of ED visits and associated adverse effects,” he said.
The study was supported by the Lung Association–Ontario, as well as by grants from the Ontario Ministry of Health and the Ministry of Long-Term Care. The researchers and Dr. Glatter have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cannabis users had a 22% increased risk of an emergency department (ED) visit or hospitalization compared to nonusers, as determined from data from more than 30,000 individuals.
Although cannabis contains compounds similar to tobacco, “data published on the association between cannabis smoking and airways health have been contradictory,” and whether smoking cannabis increases a user’s risk of developing acute respiratory illness remains unclear, wrote Nicholas T. Vozoris, MD, of the University of Toronto, and colleagues.
In a study published in BMJ Open Respiratory Research, the investigators reviewed national health records data from 35,114 individuals aged 12-65 years for the period January 2009 to December 2015. Of these persons, 4,807 of the 6,425 who reported cannabis use in the past year were matched with 10,395 never-users who served as controls. The mean age of the study population at the index date was 35 years, and 42% were women; demographics were similar between users and control persons.
Overall, the odds of respiratory-related emergency department visits or hospitalizations were not significantly different between the cannabis users and the control persons (3.6% vs. 3.9%; odds ratio, 0.91). However, cannabis users had significantly greater odds of all-cause ED visits or hospitalizations (30.0% vs. 26.0%; OR, 1.22). All-cause mortality was 0.2% for both groups.
Respiratory problems were the second-highest reason for all-cause visits, the researchers noted. The lack of a difference in respiratory-related visits between cannabis users and nonusers conflicts somewhat with previous studies on this topic, which were limited, the researchers noted in their discussion.
The negative results also might stem from factors for which the researchers could not adjust, including insufficient cannabis smoke exposure among users in the study population, noninhalational cannabis use, which is less likely to have a respiratory effect, and possible secondhand exposure among control persons.
“It is also possible that our analysis might have been insufficiently powered to detect a significant signal with respect to the primary outcome,” they noted.
However, after the researchers controlled for multiple variables, the risk of an equally important morbidity outcome, all-cause ED visits or hospitalizations, was significantly greater among cannabis users than among control individuals, and respiratory reasons were the second most common cause for ED visits and hospitalizations in the all-cause outcome, they emphasized.
The study findings were limited by several factors, including the retrospective and observational design and the inability to control for all confounding variables, the researchers noted. Other limitations include the use of self-reports and potential for bias, the inability to perform dose-response analysis, and the high number of infrequent cannabis users in the study population.
However, the results suggest that cannabis use is associated with an increased risk of serious health events and should be discouraged, although more research is needed to confirm the current study findings, they concluded.
Consider range of causes for cannabis emergency visits
“With growing numbers of states legalizing recreational use of cannabis, it’s important to understand whether cannabis use is associated with increased emergency department visits,” Robert D. Glatter, MD, an emergency medicine physician at Lenox Hill Hospital, New York, told this news organization.
Previous studies have shown an association between increased ED visits and cannabis use in states, especially with edibles, where cannabis is legal, and “the current study reinforces the elevated risk of ED visits along with hospitalizations,” he said.
“While the researchers found no increased risk of respiratory-related complaints among users compared to the general population, there was an associated increase in ED visits and hospitalizations, which is important to understand,” said Dr. Glatter, who was not involved in the study.
“While this observational study found that the incidence of respiratory complaints was not significantly different among frequent users of cannabis, the increased odds that cannabis users would require evaluation in the emergency room or even hospitalization was still apparent even after the investigators controlled for such factors as use of alcohol, tobacco, illicit drug use, or other mental health–related disorders,” Dr. Glatter noted.
“That said, it’s a bit surprising that with the continued popularity of vaping, especially among teens, there was still not any appreciable or significant increase in respiratory complaints observed. Beyond this finding, I was not surprised by the overall conclusions of the current study, as we continue to see an elevated number of patients presenting to the ED with adverse events related to cannabis use.”
Dr. Glatter noted that “the majority of patients we see in the ED are associated with use of edibles, since it takes longer for the person to feel the effects, leading the user to consume more of the product up front, with delayed effects lasting up to 12 hours. This is what gets people into trouble and leads to toxicity of cannabis, or ‘overdoses,’ “ he explained.
When consuming edible cannabis products, “[p]eople need to begin at low dosages and not take additional gummies up front, since it can take up to 2 or even 3 hours in some cases to feel the initial effects. With the drug’s effects lasting up to 12 hours, it’s especially important to avoid operating any motor vehicles, bicycles, or scooters, since reaction time is impaired, as well as overall judgment, balance, and fine motor skills,” Dr. Glatter said.
Cannabis can land users in the ED for a range of reasons, said Dr. Glatter. “According to the study, 15% of the emergency room visits and hospitalizations were due to acute trauma, 14% due to respiratory issues, and 13% to gastrointestinal illnesses. These effects were seen in first-time users but not those with chronic use, according to the study inclusion criteria.”
Cannabis use could result in physical injuries through “impaired judgment, coordination, combined with an altered state of consciousness or generalized drowsiness, that could contribute to an increase in motor vehicle collisions, along with an increased risk for falls leading to lacerations, fractures, contusions, or bruising,” said Dr. Glatter. “Cannabis may also lead to an altered sense of perception related to interactions with others, resulting in feelings of anxiety or restlessness culminating in physical altercations and other injuries.”
The current study indicates the need for understanding the potential physical and psychological effects of cannabis use, he said.
“Additional research is needed to better understand the relative percentage cases related to edibles vs. inhalation presenting to the ED,” he noted. “There is no question that edibles continue to present significant dangers for those who don’t read labels or remain poorly informed regarding their dosing as a result of delayed onset and longer duration,” he said. To help reduce risk of toxicity, the concept of a “high lasting 12-15 hours, as with edibles, as opposed to 3-4 hours from inhalation must be clearly stated on packaging and better communicated with users, as the toxicity with edibles is more often from lack of prior knowledge about onset of effects related to dosing.”
In addition, the “potential for psychosis to develop with more chronic cannabis use, along with cannabinoid hyperemesis syndrome should be on every clinician’s radar,” Dr. Glatter emphasized.
“The bottom line is that as more states legalize the use of cannabis, it’s vital to also implement comprehensive public education efforts to provide users with the reported risks associated with not only inhalation (vaping or flower) but also edibles, which account for an increasingly greater percentage of ED visits and associated adverse effects,” he said.
The study was supported by the Lung Association–Ontario, as well as by grants from the Ontario Ministry of Health and the Ministry of Long-Term Care. The researchers and Dr. Glatter have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Irritable bowel syndrome therapy removed from market (again)
Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.
The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.
The drug has been through a teeter totter of regulations since its inception.
When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.
Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.
Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.
“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.
Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.
A version of this article first appeared on Medscape.com.
Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.
The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.
The drug has been through a teeter totter of regulations since its inception.
When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.
Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.
Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.
“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.
Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.
A version of this article first appeared on Medscape.com.
Zelnorm (tegaserod), an oral short-term treatment of irritable bowel syndrome and constipation (IBS-C), is being removed from the U.S. market effective June 30, according to the manufacturer, Alfasigma.
The Italian pharmaceutical company said the drug is being removed for business purposes, not because of any concern involving its safety or efficacy, nor has it been recalled.
The drug has been through a teeter totter of regulations since its inception.
When it was first introduced in 2002, Zelnorm was a first-of-its-kind drug and was intended to treat all women with IBS-C in the short term. But it was removed from the market 5 years later following concerns about cardiovascular side effects. Clinical data showed an increased incidence of stroke and angina in women taking Zelnorm.
Despite these concerns, the U.S. Food and Drug Administration voted to reintroduce the drug into the market in 2019, but only for women without a history of heart health problems.
Though Alfasigma will stop making the drug, a company news release said current users can continue use for a while.
“Patients will continue to have access to Zelnorm (tegaserod) for as long as the existing supply of product remains in the trade channel,” Alfasigma said in a news release about the drug removal. The company urged its customers to discuss alternative IBS medications with their doctor.
Zelnorm is a serotonin agonist, meaning it binds to receptors and stops the release of serotonin into the system. These sorts of drugs can decrease the pain associated with IBS and help increase gut motility in order to pass stool. Other drugs besides Zelnorm that use this mechanism include alosetron and cilansetron.
A version of this article first appeared on Medscape.com.
Persistent abdominal pain: Not always IBS
Persistent abdominal pain may be caused by a whole range of different conditions, say French experts who call for more physician awareness to achieve early diagnosis and treatment so as to improve patient outcomes.
Benoit Coffin, MD, PhD, and Henri Duboc, MD, PhD, from Hôpital Louis Mourier, Colombes, France, conducted a literature review to identify rare and less well-known causes of persistent abdominal pain, identifying almost 50 across several categories.
“Some causes of persistent abdominal pain can be effectively treated using established approaches after a definitive diagnosis has been reached,” they wrote.
“Other causes are more complex and may benefit from a multidisciplinary approach involving gastroenterologists, pain specialists, allergists, immunologists, rheumatologists, psychologists, physiotherapists, dietitians, and primary care clinicians,” they wrote.
The research was published online in Alimentary Pharmacology and Therapeutics.
Frequent and frustrating symptoms
Although there is “no commonly accepted definition” for persistent abdominal pain, the authors said it may be defined as “continuous or intermittent abdominal discomfort that persists for at least 6 months and fails to respond to conventional therapeutic approaches.”
They highlight that it is “frequently encountered” by physicians and has a prevalence of 22.9 per 1,000 person-years, regardless of age group, ethnicity, or geographical region, with many patients experiencing pain for more than 5 years.
The cause of persistent abdominal pain can be organic with a clear cause or functional, making diagnosis and management “challenging and frustrating for patients and physicians.”
“Clinicians not only need to recognize somatic abnormalities, but they must also perceive the patient’s cognitions and emotions related to the pain,” they added, suggesting that clinicians take time to “listen to the patient and perceive psychological factors.”
Dr. Coffin and Dr. Duboc write that the most common conditions associated with persistent abdominal pain are irritable bowel syndrome and functional dyspepsia, as well as inflammatory bowel disease, chronic pancreatitis, and gallstones.
To examine the diagnosis and management of its less well-known causes, the authors conducted a literature review, beginning with the diagnosis of persistent abdominal pain.
Diagnostic workup
“Given its chronicity, many patients will have already undergone extensive and redundant medical testing,” they wrote, emphasizing that clinicians should be on the lookout for any change in the description of persistent abdominal pain or new symptoms.
“Other ‘red-flag’ symptoms include fever, vomiting, diarrhea, acute change in bowel habit, obstipation, syncope, tachycardia, hypotension, concomitant chest or back pain, unintentional weight loss, night sweats, and acute gastrointestinal bleeding,” the authors said.
They stressed the need to determine whether the origin of the pain is organic or functional, as well as the importance of identifying a “triggering event, such as an adverse life event, infection, initiating a new medication, or surgical procedure.” They also recommend discussing the patient’s diet.
There are currently no specific algorithms for diagnostic workup of persistent abdominal pain, the authors said. Patients will have undergone repeated laboratory tests, “upper and lower endoscopic examinations, abdominal ultrasounds, and computed tomography scans of the abdominal/pelvic area.”
Consequently, “in the absence of alarm features, any additional tests should be ordered in a conservative and cost-effective manner,” they advised.
They suggested that, at a tertiary center, patients should be assessed in three steps:
- In-depth questioning of the symptoms and medical history
- Summary of all previous investigations and treatments and their effectiveness
- Determination of the complementary explorations to be performed
The authors went on to list 49 rare or less well-known potential causes of persistent abdominal pain, some linked to digestive disorders, such as eosinophilic gastroenteritis, mesenteric panniculitis, and chronic mesenteric ischemia, as well as endometriosis, chronic abdominal wall pain, and referred osteoarticular pain.
Systemic causes of persistent abdominal pain may include adrenal insufficiency and mast cell activation syndrome, while acute hepatic porphyrias and Ehlers-Danlos syndrome may be genetic causes.
There are also centrally mediated disorders that lead to persistent abdominal pain, the authors noted, including postural orthostatic tachycardia syndrome and narcotic bowel syndrome caused by opioid therapy, among others.
Writing support for the manuscript was funded by Alnylam Switzerland. Dr. Coffin has served as a speaker for Kyowa Kyrin and Mayoly Spindler and as an advisory board member for Sanofi and Alnylam. Dr. Duboc reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Persistent abdominal pain may be caused by a whole range of different conditions, say French experts who call for more physician awareness to achieve early diagnosis and treatment so as to improve patient outcomes.
Benoit Coffin, MD, PhD, and Henri Duboc, MD, PhD, from Hôpital Louis Mourier, Colombes, France, conducted a literature review to identify rare and less well-known causes of persistent abdominal pain, identifying almost 50 across several categories.
“Some causes of persistent abdominal pain can be effectively treated using established approaches after a definitive diagnosis has been reached,” they wrote.
“Other causes are more complex and may benefit from a multidisciplinary approach involving gastroenterologists, pain specialists, allergists, immunologists, rheumatologists, psychologists, physiotherapists, dietitians, and primary care clinicians,” they wrote.
The research was published online in Alimentary Pharmacology and Therapeutics.
Frequent and frustrating symptoms
Although there is “no commonly accepted definition” for persistent abdominal pain, the authors said it may be defined as “continuous or intermittent abdominal discomfort that persists for at least 6 months and fails to respond to conventional therapeutic approaches.”
They highlight that it is “frequently encountered” by physicians and has a prevalence of 22.9 per 1,000 person-years, regardless of age group, ethnicity, or geographical region, with many patients experiencing pain for more than 5 years.
The cause of persistent abdominal pain can be organic with a clear cause or functional, making diagnosis and management “challenging and frustrating for patients and physicians.”
“Clinicians not only need to recognize somatic abnormalities, but they must also perceive the patient’s cognitions and emotions related to the pain,” they added, suggesting that clinicians take time to “listen to the patient and perceive psychological factors.”
Dr. Coffin and Dr. Duboc write that the most common conditions associated with persistent abdominal pain are irritable bowel syndrome and functional dyspepsia, as well as inflammatory bowel disease, chronic pancreatitis, and gallstones.
To examine the diagnosis and management of its less well-known causes, the authors conducted a literature review, beginning with the diagnosis of persistent abdominal pain.
Diagnostic workup
“Given its chronicity, many patients will have already undergone extensive and redundant medical testing,” they wrote, emphasizing that clinicians should be on the lookout for any change in the description of persistent abdominal pain or new symptoms.
“Other ‘red-flag’ symptoms include fever, vomiting, diarrhea, acute change in bowel habit, obstipation, syncope, tachycardia, hypotension, concomitant chest or back pain, unintentional weight loss, night sweats, and acute gastrointestinal bleeding,” the authors said.
They stressed the need to determine whether the origin of the pain is organic or functional, as well as the importance of identifying a “triggering event, such as an adverse life event, infection, initiating a new medication, or surgical procedure.” They also recommend discussing the patient’s diet.
There are currently no specific algorithms for diagnostic workup of persistent abdominal pain, the authors said. Patients will have undergone repeated laboratory tests, “upper and lower endoscopic examinations, abdominal ultrasounds, and computed tomography scans of the abdominal/pelvic area.”
Consequently, “in the absence of alarm features, any additional tests should be ordered in a conservative and cost-effective manner,” they advised.
They suggested that, at a tertiary center, patients should be assessed in three steps:
- In-depth questioning of the symptoms and medical history
- Summary of all previous investigations and treatments and their effectiveness
- Determination of the complementary explorations to be performed
The authors went on to list 49 rare or less well-known potential causes of persistent abdominal pain, some linked to digestive disorders, such as eosinophilic gastroenteritis, mesenteric panniculitis, and chronic mesenteric ischemia, as well as endometriosis, chronic abdominal wall pain, and referred osteoarticular pain.
Systemic causes of persistent abdominal pain may include adrenal insufficiency and mast cell activation syndrome, while acute hepatic porphyrias and Ehlers-Danlos syndrome may be genetic causes.
There are also centrally mediated disorders that lead to persistent abdominal pain, the authors noted, including postural orthostatic tachycardia syndrome and narcotic bowel syndrome caused by opioid therapy, among others.
Writing support for the manuscript was funded by Alnylam Switzerland. Dr. Coffin has served as a speaker for Kyowa Kyrin and Mayoly Spindler and as an advisory board member for Sanofi and Alnylam. Dr. Duboc reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Persistent abdominal pain may be caused by a whole range of different conditions, say French experts who call for more physician awareness to achieve early diagnosis and treatment so as to improve patient outcomes.
Benoit Coffin, MD, PhD, and Henri Duboc, MD, PhD, from Hôpital Louis Mourier, Colombes, France, conducted a literature review to identify rare and less well-known causes of persistent abdominal pain, identifying almost 50 across several categories.
“Some causes of persistent abdominal pain can be effectively treated using established approaches after a definitive diagnosis has been reached,” they wrote.
“Other causes are more complex and may benefit from a multidisciplinary approach involving gastroenterologists, pain specialists, allergists, immunologists, rheumatologists, psychologists, physiotherapists, dietitians, and primary care clinicians,” they wrote.
The research was published online in Alimentary Pharmacology and Therapeutics.
Frequent and frustrating symptoms
Although there is “no commonly accepted definition” for persistent abdominal pain, the authors said it may be defined as “continuous or intermittent abdominal discomfort that persists for at least 6 months and fails to respond to conventional therapeutic approaches.”
They highlight that it is “frequently encountered” by physicians and has a prevalence of 22.9 per 1,000 person-years, regardless of age group, ethnicity, or geographical region, with many patients experiencing pain for more than 5 years.
The cause of persistent abdominal pain can be organic with a clear cause or functional, making diagnosis and management “challenging and frustrating for patients and physicians.”
“Clinicians not only need to recognize somatic abnormalities, but they must also perceive the patient’s cognitions and emotions related to the pain,” they added, suggesting that clinicians take time to “listen to the patient and perceive psychological factors.”
Dr. Coffin and Dr. Duboc write that the most common conditions associated with persistent abdominal pain are irritable bowel syndrome and functional dyspepsia, as well as inflammatory bowel disease, chronic pancreatitis, and gallstones.
To examine the diagnosis and management of its less well-known causes, the authors conducted a literature review, beginning with the diagnosis of persistent abdominal pain.
Diagnostic workup
“Given its chronicity, many patients will have already undergone extensive and redundant medical testing,” they wrote, emphasizing that clinicians should be on the lookout for any change in the description of persistent abdominal pain or new symptoms.
“Other ‘red-flag’ symptoms include fever, vomiting, diarrhea, acute change in bowel habit, obstipation, syncope, tachycardia, hypotension, concomitant chest or back pain, unintentional weight loss, night sweats, and acute gastrointestinal bleeding,” the authors said.
They stressed the need to determine whether the origin of the pain is organic or functional, as well as the importance of identifying a “triggering event, such as an adverse life event, infection, initiating a new medication, or surgical procedure.” They also recommend discussing the patient’s diet.
There are currently no specific algorithms for diagnostic workup of persistent abdominal pain, the authors said. Patients will have undergone repeated laboratory tests, “upper and lower endoscopic examinations, abdominal ultrasounds, and computed tomography scans of the abdominal/pelvic area.”
Consequently, “in the absence of alarm features, any additional tests should be ordered in a conservative and cost-effective manner,” they advised.
They suggested that, at a tertiary center, patients should be assessed in three steps:
- In-depth questioning of the symptoms and medical history
- Summary of all previous investigations and treatments and their effectiveness
- Determination of the complementary explorations to be performed
The authors went on to list 49 rare or less well-known potential causes of persistent abdominal pain, some linked to digestive disorders, such as eosinophilic gastroenteritis, mesenteric panniculitis, and chronic mesenteric ischemia, as well as endometriosis, chronic abdominal wall pain, and referred osteoarticular pain.
Systemic causes of persistent abdominal pain may include adrenal insufficiency and mast cell activation syndrome, while acute hepatic porphyrias and Ehlers-Danlos syndrome may be genetic causes.
There are also centrally mediated disorders that lead to persistent abdominal pain, the authors noted, including postural orthostatic tachycardia syndrome and narcotic bowel syndrome caused by opioid therapy, among others.
Writing support for the manuscript was funded by Alnylam Switzerland. Dr. Coffin has served as a speaker for Kyowa Kyrin and Mayoly Spindler and as an advisory board member for Sanofi and Alnylam. Dr. Duboc reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ALIMENTARY PHARMACOLOGY AND THERAPEUTICS
In the Grand Canyon, norovirus gives new meaning to ‘leave no trace’
Ain’t gastroenteritis grand?
The Grand Canyon is perhaps America’s greatest natural wonder. The mile-deep gorge of epic proportions, carved over eons by the Colorado River, elicits superlatives of the highest order from those seeing it for the first time. In the past few months, though, visitors to the Grand Canyon have been experiencing a rather more unpleasant sort of reaction: Involuntary bowel evacuation.
Since April, more than 150 river rafters and backcountry campers have fallen ill with bouts of acute gastroenteritis, likely caused by norovirus. Hey, a viral outbreak and our old friend SARS-CoV-2 isn’t involved! Hopefully it won’t get jealous. Whatever the culprit is, however, it got everywhere, as clusters of illness have popped up in unconnected parts of the park and some hikers have been restricted to a smaller portion of the park to avoid further disease spread. The majority of cases occurred in May, so it’s hoped that the outbreak is dying down, but the park remains on alert.
Now, acute gastroenteritis is certainly an unpleasant disease, but it isn’t typically a life-threatening one. There are, however, a couple of unique factors complicating this outbreak. For one, the Grand Canyon is in Arizona (duh), which can get rather hot in the summer months. Expelling waste from both ends becomes rather more dangerous when the thermometer reads over a hundred degrees, and there have been reports of multiple helicopter rescues.
That’s pretty bad, but in a way, they’re the lucky ones. How can we explain this … see, when you visit the Grand Canyon, you’re expected to follow the general rules of Leave No Trace. That means several things, but essentially, if you bring it in, you have to bring it out. Yes, that includes the various consequences of an acute gastroenteritis attack.
Forget spooky campfire stories and hungry wildlife lurking in the night, because true horror is scraping your friend’s diarrhea off the walls of the Grand Canyon into a plastic bag and stuffing it into your backpack. Probably not the sublime one-on-one Grand Canyon experience that people are expecting.
Give us a pee! ... for stem cell retrieval
Getting cells for regenerative stem cell treatment has traditionally been painful and difficult – usually they are retrieved by surgical means from bone marrow or fat tissue – but there may be an easier way.
Just pee in a cup.
Apparently, human urine contains stem cells with the potential to be used for regenerative effects. The magic ingredient? The enzyme telomerase, which “is essential for the self-renewal and potential of different types of stem cells” and is related to longevity, according to researchers at Wake Forest Institute for Regenerative Medicine.
They looked into how regenerative telomerase activity is for various capabilities beyond chromosomal stability, and whether these stem cells can become other kinds of cells for optimal tissue repair. Turns out they could, acting as a “distinct subpopulation” that has the ability not only to grow cells but also to morph into other cells, they said in a written statement.
Safety is also an issue. “Being able to use a patient’s own stem cells for therapy is considered advantageous because they do not induce immune responses or rejection,” said Anthony Atala, MD, a coauthor of the study published in Frontiers in Cell and Developmental Biology.
So less risk, easier retrieval, and great regenerative results. If this takes off, the other methods of retrieval could get flushed down the toilet.
Politicians playing the long game, literally
Before we get started with actual information, here’s a joke about politicians:
What do you call a lawyer with an IQ of 100? Your Honor.
What do you call a lawyer with an IQ of 50? Senator.
Politics is a dirty business, no doubt, so why do people do it? Is it for the prestige? Seems like everyone hates politicians, so it’s probably not that. Is it their selfless concern for the well-being of others? Probably not that either. Is it for the money? Most members of Congress have more corporate sponsors than a NASCAR driver, but we’re going to pass on that one as well.
Once again, science gives us the real answer: Longevity. Politicians live longer than the rest of us, and that longevity gap is getting wider.
Investigators looked at data from 11 industrialized countries, some of it going back to 1817, and found that politicians in the United States can expect to live about 7 years longer than the national average. The difference is around 3 years in Switzerland, 4.5 years in Germany, and 6 years in France.
“For almost all countries, politicians had similar rates of mortality to the general population in the late 19th and early 20th centuries. Throughout the 20th century, differences in mortality rates widened significantly across all countries, so that politicians had an increasing survival advantage over the general population,” they said in a written statement.
Income inequality could be a factor, but the longevity gains made by politicians, which started before the 1940s, predate the rise of their earnings relative to the rest of the population, which didn’t really get going until the 1980s, the investigators noted.
Whatever the reason, we have this closing thought regarding our long-lived lawmakers: What’s the difference between a politician and a snail? One is a slimy pest that leaves a trail everywhere. The other is a snail.
Land of the free, home of obesity
In the United States, it seems, people are becoming more comfortable with obesity. TikTok and Instagram trends often try to show the world that all sizes are beautiful. There’s also the growing popularity of the dad bod.
America, it has been said, is the land of the free. We love our freedom, and we value our individualism. If an obese man orders three meals from McDonald’s just for himself, no one is going to stop him. Many Americans also have more access to the food they want at any given time, even while they are moving around a lot less because of their sedentary lifestyles.
According to a recent study cited by the New York Post, however, America is not the only country battling obesity. Egypt and Mexico, for example, also have men with higher BMIs who cherish their individualism and the right to eat what they want, Plamen Akaliyski, PhD, of University Carlos III of Madrid, and associates, said in Social Science & Medicine.
Women are not as likely to think the same way. “Men in particular think, ‘I’m an individual, don’t tell me what to do. I’m going to eat what I want,’ ” bariatric surgeon George A. Fielding, MD, said in the Post article. Dr. Fielding also noted that women are three times more likely than men to seek bariatric surgery.
Dr. Akaliyski and associates found that Asian countries such as Japan, Singapore, and South Korea – countries that value thrift, discipline, self control, and delaying gratification – have lower rates of obesity.
So yes, we can go to the drive through of a fast food restaurant whenever we want and order whatever we want, but can doesn’t always mean should.
Ain’t gastroenteritis grand?
The Grand Canyon is perhaps America’s greatest natural wonder. The mile-deep gorge of epic proportions, carved over eons by the Colorado River, elicits superlatives of the highest order from those seeing it for the first time. In the past few months, though, visitors to the Grand Canyon have been experiencing a rather more unpleasant sort of reaction: Involuntary bowel evacuation.
Since April, more than 150 river rafters and backcountry campers have fallen ill with bouts of acute gastroenteritis, likely caused by norovirus. Hey, a viral outbreak and our old friend SARS-CoV-2 isn’t involved! Hopefully it won’t get jealous. Whatever the culprit is, however, it got everywhere, as clusters of illness have popped up in unconnected parts of the park and some hikers have been restricted to a smaller portion of the park to avoid further disease spread. The majority of cases occurred in May, so it’s hoped that the outbreak is dying down, but the park remains on alert.
Now, acute gastroenteritis is certainly an unpleasant disease, but it isn’t typically a life-threatening one. There are, however, a couple of unique factors complicating this outbreak. For one, the Grand Canyon is in Arizona (duh), which can get rather hot in the summer months. Expelling waste from both ends becomes rather more dangerous when the thermometer reads over a hundred degrees, and there have been reports of multiple helicopter rescues.
That’s pretty bad, but in a way, they’re the lucky ones. How can we explain this … see, when you visit the Grand Canyon, you’re expected to follow the general rules of Leave No Trace. That means several things, but essentially, if you bring it in, you have to bring it out. Yes, that includes the various consequences of an acute gastroenteritis attack.
Forget spooky campfire stories and hungry wildlife lurking in the night, because true horror is scraping your friend’s diarrhea off the walls of the Grand Canyon into a plastic bag and stuffing it into your backpack. Probably not the sublime one-on-one Grand Canyon experience that people are expecting.
Give us a pee! ... for stem cell retrieval
Getting cells for regenerative stem cell treatment has traditionally been painful and difficult – usually they are retrieved by surgical means from bone marrow or fat tissue – but there may be an easier way.
Just pee in a cup.
Apparently, human urine contains stem cells with the potential to be used for regenerative effects. The magic ingredient? The enzyme telomerase, which “is essential for the self-renewal and potential of different types of stem cells” and is related to longevity, according to researchers at Wake Forest Institute for Regenerative Medicine.
They looked into how regenerative telomerase activity is for various capabilities beyond chromosomal stability, and whether these stem cells can become other kinds of cells for optimal tissue repair. Turns out they could, acting as a “distinct subpopulation” that has the ability not only to grow cells but also to morph into other cells, they said in a written statement.
Safety is also an issue. “Being able to use a patient’s own stem cells for therapy is considered advantageous because they do not induce immune responses or rejection,” said Anthony Atala, MD, a coauthor of the study published in Frontiers in Cell and Developmental Biology.
So less risk, easier retrieval, and great regenerative results. If this takes off, the other methods of retrieval could get flushed down the toilet.
Politicians playing the long game, literally
Before we get started with actual information, here’s a joke about politicians:
What do you call a lawyer with an IQ of 100? Your Honor.
What do you call a lawyer with an IQ of 50? Senator.
Politics is a dirty business, no doubt, so why do people do it? Is it for the prestige? Seems like everyone hates politicians, so it’s probably not that. Is it their selfless concern for the well-being of others? Probably not that either. Is it for the money? Most members of Congress have more corporate sponsors than a NASCAR driver, but we’re going to pass on that one as well.
Once again, science gives us the real answer: Longevity. Politicians live longer than the rest of us, and that longevity gap is getting wider.
Investigators looked at data from 11 industrialized countries, some of it going back to 1817, and found that politicians in the United States can expect to live about 7 years longer than the national average. The difference is around 3 years in Switzerland, 4.5 years in Germany, and 6 years in France.
“For almost all countries, politicians had similar rates of mortality to the general population in the late 19th and early 20th centuries. Throughout the 20th century, differences in mortality rates widened significantly across all countries, so that politicians had an increasing survival advantage over the general population,” they said in a written statement.
Income inequality could be a factor, but the longevity gains made by politicians, which started before the 1940s, predate the rise of their earnings relative to the rest of the population, which didn’t really get going until the 1980s, the investigators noted.
Whatever the reason, we have this closing thought regarding our long-lived lawmakers: What’s the difference between a politician and a snail? One is a slimy pest that leaves a trail everywhere. The other is a snail.
Land of the free, home of obesity
In the United States, it seems, people are becoming more comfortable with obesity. TikTok and Instagram trends often try to show the world that all sizes are beautiful. There’s also the growing popularity of the dad bod.
America, it has been said, is the land of the free. We love our freedom, and we value our individualism. If an obese man orders three meals from McDonald’s just for himself, no one is going to stop him. Many Americans also have more access to the food they want at any given time, even while they are moving around a lot less because of their sedentary lifestyles.
According to a recent study cited by the New York Post, however, America is not the only country battling obesity. Egypt and Mexico, for example, also have men with higher BMIs who cherish their individualism and the right to eat what they want, Plamen Akaliyski, PhD, of University Carlos III of Madrid, and associates, said in Social Science & Medicine.
Women are not as likely to think the same way. “Men in particular think, ‘I’m an individual, don’t tell me what to do. I’m going to eat what I want,’ ” bariatric surgeon George A. Fielding, MD, said in the Post article. Dr. Fielding also noted that women are three times more likely than men to seek bariatric surgery.
Dr. Akaliyski and associates found that Asian countries such as Japan, Singapore, and South Korea – countries that value thrift, discipline, self control, and delaying gratification – have lower rates of obesity.
So yes, we can go to the drive through of a fast food restaurant whenever we want and order whatever we want, but can doesn’t always mean should.
Ain’t gastroenteritis grand?
The Grand Canyon is perhaps America’s greatest natural wonder. The mile-deep gorge of epic proportions, carved over eons by the Colorado River, elicits superlatives of the highest order from those seeing it for the first time. In the past few months, though, visitors to the Grand Canyon have been experiencing a rather more unpleasant sort of reaction: Involuntary bowel evacuation.
Since April, more than 150 river rafters and backcountry campers have fallen ill with bouts of acute gastroenteritis, likely caused by norovirus. Hey, a viral outbreak and our old friend SARS-CoV-2 isn’t involved! Hopefully it won’t get jealous. Whatever the culprit is, however, it got everywhere, as clusters of illness have popped up in unconnected parts of the park and some hikers have been restricted to a smaller portion of the park to avoid further disease spread. The majority of cases occurred in May, so it’s hoped that the outbreak is dying down, but the park remains on alert.
Now, acute gastroenteritis is certainly an unpleasant disease, but it isn’t typically a life-threatening one. There are, however, a couple of unique factors complicating this outbreak. For one, the Grand Canyon is in Arizona (duh), which can get rather hot in the summer months. Expelling waste from both ends becomes rather more dangerous when the thermometer reads over a hundred degrees, and there have been reports of multiple helicopter rescues.
That’s pretty bad, but in a way, they’re the lucky ones. How can we explain this … see, when you visit the Grand Canyon, you’re expected to follow the general rules of Leave No Trace. That means several things, but essentially, if you bring it in, you have to bring it out. Yes, that includes the various consequences of an acute gastroenteritis attack.
Forget spooky campfire stories and hungry wildlife lurking in the night, because true horror is scraping your friend’s diarrhea off the walls of the Grand Canyon into a plastic bag and stuffing it into your backpack. Probably not the sublime one-on-one Grand Canyon experience that people are expecting.
Give us a pee! ... for stem cell retrieval
Getting cells for regenerative stem cell treatment has traditionally been painful and difficult – usually they are retrieved by surgical means from bone marrow or fat tissue – but there may be an easier way.
Just pee in a cup.
Apparently, human urine contains stem cells with the potential to be used for regenerative effects. The magic ingredient? The enzyme telomerase, which “is essential for the self-renewal and potential of different types of stem cells” and is related to longevity, according to researchers at Wake Forest Institute for Regenerative Medicine.
They looked into how regenerative telomerase activity is for various capabilities beyond chromosomal stability, and whether these stem cells can become other kinds of cells for optimal tissue repair. Turns out they could, acting as a “distinct subpopulation” that has the ability not only to grow cells but also to morph into other cells, they said in a written statement.
Safety is also an issue. “Being able to use a patient’s own stem cells for therapy is considered advantageous because they do not induce immune responses or rejection,” said Anthony Atala, MD, a coauthor of the study published in Frontiers in Cell and Developmental Biology.
So less risk, easier retrieval, and great regenerative results. If this takes off, the other methods of retrieval could get flushed down the toilet.
Politicians playing the long game, literally
Before we get started with actual information, here’s a joke about politicians:
What do you call a lawyer with an IQ of 100? Your Honor.
What do you call a lawyer with an IQ of 50? Senator.
Politics is a dirty business, no doubt, so why do people do it? Is it for the prestige? Seems like everyone hates politicians, so it’s probably not that. Is it their selfless concern for the well-being of others? Probably not that either. Is it for the money? Most members of Congress have more corporate sponsors than a NASCAR driver, but we’re going to pass on that one as well.
Once again, science gives us the real answer: Longevity. Politicians live longer than the rest of us, and that longevity gap is getting wider.
Investigators looked at data from 11 industrialized countries, some of it going back to 1817, and found that politicians in the United States can expect to live about 7 years longer than the national average. The difference is around 3 years in Switzerland, 4.5 years in Germany, and 6 years in France.
“For almost all countries, politicians had similar rates of mortality to the general population in the late 19th and early 20th centuries. Throughout the 20th century, differences in mortality rates widened significantly across all countries, so that politicians had an increasing survival advantage over the general population,” they said in a written statement.
Income inequality could be a factor, but the longevity gains made by politicians, which started before the 1940s, predate the rise of their earnings relative to the rest of the population, which didn’t really get going until the 1980s, the investigators noted.
Whatever the reason, we have this closing thought regarding our long-lived lawmakers: What’s the difference between a politician and a snail? One is a slimy pest that leaves a trail everywhere. The other is a snail.
Land of the free, home of obesity
In the United States, it seems, people are becoming more comfortable with obesity. TikTok and Instagram trends often try to show the world that all sizes are beautiful. There’s also the growing popularity of the dad bod.
America, it has been said, is the land of the free. We love our freedom, and we value our individualism. If an obese man orders three meals from McDonald’s just for himself, no one is going to stop him. Many Americans also have more access to the food they want at any given time, even while they are moving around a lot less because of their sedentary lifestyles.
According to a recent study cited by the New York Post, however, America is not the only country battling obesity. Egypt and Mexico, for example, also have men with higher BMIs who cherish their individualism and the right to eat what they want, Plamen Akaliyski, PhD, of University Carlos III of Madrid, and associates, said in Social Science & Medicine.
Women are not as likely to think the same way. “Men in particular think, ‘I’m an individual, don’t tell me what to do. I’m going to eat what I want,’ ” bariatric surgeon George A. Fielding, MD, said in the Post article. Dr. Fielding also noted that women are three times more likely than men to seek bariatric surgery.
Dr. Akaliyski and associates found that Asian countries such as Japan, Singapore, and South Korea – countries that value thrift, discipline, self control, and delaying gratification – have lower rates of obesity.
So yes, we can go to the drive through of a fast food restaurant whenever we want and order whatever we want, but can doesn’t always mean should.
ACC/AHA issue clinical lexicon for complications of COVID-19
The American College of Cardiology and the American Heart Association have jointly issued a comprehensive set of data standards to help clarify definitions of the cardiovascular (CV) and non-CV complications of COVID-19.
It’s the work of the ACC/AHA Task Force on Clinical Data Standards and has been endorsed by the Heart Failure Society of America and Society for Cardiac Angiography and Interventions.
There is increased importance to understanding the acute and long-term impact of COVID-19 on CV health, the writing group notes. Until now, however, there has not been “clarity or consensus” on definitions of CV conditions related to COVID-19, with different diagnostic terminologies being used for overlapping conditions, such as “myocardial injury,” “myocarditis,” “type Il myocardial infarction,” “stress cardiomyopathy,” and “inflammatory cardiomyopathy,” they point out.
“We, as a research community, did some things right and some things wrong surrounding the COVID pandemic,” Sandeep Das, MD, MPH, vice chair of the writing group, noted in an interview with this news organization.
“The things that we really did right is that everybody responded with enthusiasm, kind of all hands on deck with a massive crisis response, and that was fantastic,” Dr. Das said.
“However, because of the need to hurry, we didn’t structure and organize in the way that we typically would for something that was sort of a slow burn kind of problem rather than an emergency. One of the consequences of that was fragmentation of how things are collected, reported, et cetera, and that leads to confusion,” he added.
The report was published simultaneously June 23 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.
A necessary but not glamorous project
The new data standards for COVID-19 will help standardize definitions and set the framework to capture and better understand how COVID-19 affects CV health.
“It wasn’t exactly a glamorous-type project but, at the same time, it’s super necessary to kind of get everybody on the same page and working together,” Dr. Das said.
Broad agreement on common vocabulary and definitions will help with efforts to pool or compare data from electronic health records, clinical registries, administrative datasets, and other databases, and determine whether these data apply to clinical practice and research endeavors, the writing group says.
They considered data elements relevant to the full range of care provided to COVID-19 patients in all care settings. Among the key items included in the document are:
- Case definitions for confirmed, probable, and suspected acute COVID-19, as well as postacute sequelae of COVID-19.
- Definitions for acute CV complications related to COVID-19, including acute myocardial injury, heart failure, shock, arrhythmia, thromboembolic complications, and .
- Data elements related to COVID-19 vaccination status, comorbidities, and preexisting CV conditions.
- Definitions for postacute CV sequelae of SARS-CoV-2 infection and long-term CV complications of COVID-19.
- Data elements for CV mortality during acute COVID-19.
- Data elements for non-CV complications to help document severity of illness and other competing diagnoses and complications that might affect CV outcomes.
- A list of symptoms and signs related to COVID-19 and CV complications.
- Data elements for diagnostic and therapeutic strategies for COVID-19 and CV conditions.
- A discussion of advanced therapies, including , extracorporeal membrane oxygenation, and end-of-life management strategies.
These data standards will be useful for researchers, registry developers, and clinicians, and they are proposed as a framework for ICD-10 code development of COVID-19–related CV conditions, the writing group says.
The standards are also of “great importance” to patients, clinicians, investigators, scientists, administrators, public health officials, policymakers, and payers, the group says.
Dr. Das said that, although there is no formal plan in place to update the document, he could see sections that might be refined.
“For example, there’s a nice long list of all the various variants, and unfortunately, I suspect that that is going to change and evolve over time,” Dr. Das told this news organization.
“We tried very hard not to include things like specifying specific treatments so we didn’t get proscriptive. We wanted to make it descriptive, so hopefully it will stand the test of time pretty well,” he added.
This research had no commercial funding. The writing group has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The American College of Cardiology and the American Heart Association have jointly issued a comprehensive set of data standards to help clarify definitions of the cardiovascular (CV) and non-CV complications of COVID-19.
It’s the work of the ACC/AHA Task Force on Clinical Data Standards and has been endorsed by the Heart Failure Society of America and Society for Cardiac Angiography and Interventions.
There is increased importance to understanding the acute and long-term impact of COVID-19 on CV health, the writing group notes. Until now, however, there has not been “clarity or consensus” on definitions of CV conditions related to COVID-19, with different diagnostic terminologies being used for overlapping conditions, such as “myocardial injury,” “myocarditis,” “type Il myocardial infarction,” “stress cardiomyopathy,” and “inflammatory cardiomyopathy,” they point out.
“We, as a research community, did some things right and some things wrong surrounding the COVID pandemic,” Sandeep Das, MD, MPH, vice chair of the writing group, noted in an interview with this news organization.
“The things that we really did right is that everybody responded with enthusiasm, kind of all hands on deck with a massive crisis response, and that was fantastic,” Dr. Das said.
“However, because of the need to hurry, we didn’t structure and organize in the way that we typically would for something that was sort of a slow burn kind of problem rather than an emergency. One of the consequences of that was fragmentation of how things are collected, reported, et cetera, and that leads to confusion,” he added.
The report was published simultaneously June 23 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.
A necessary but not glamorous project
The new data standards for COVID-19 will help standardize definitions and set the framework to capture and better understand how COVID-19 affects CV health.
“It wasn’t exactly a glamorous-type project but, at the same time, it’s super necessary to kind of get everybody on the same page and working together,” Dr. Das said.
Broad agreement on common vocabulary and definitions will help with efforts to pool or compare data from electronic health records, clinical registries, administrative datasets, and other databases, and determine whether these data apply to clinical practice and research endeavors, the writing group says.
They considered data elements relevant to the full range of care provided to COVID-19 patients in all care settings. Among the key items included in the document are:
- Case definitions for confirmed, probable, and suspected acute COVID-19, as well as postacute sequelae of COVID-19.
- Definitions for acute CV complications related to COVID-19, including acute myocardial injury, heart failure, shock, arrhythmia, thromboembolic complications, and .
- Data elements related to COVID-19 vaccination status, comorbidities, and preexisting CV conditions.
- Definitions for postacute CV sequelae of SARS-CoV-2 infection and long-term CV complications of COVID-19.
- Data elements for CV mortality during acute COVID-19.
- Data elements for non-CV complications to help document severity of illness and other competing diagnoses and complications that might affect CV outcomes.
- A list of symptoms and signs related to COVID-19 and CV complications.
- Data elements for diagnostic and therapeutic strategies for COVID-19 and CV conditions.
- A discussion of advanced therapies, including , extracorporeal membrane oxygenation, and end-of-life management strategies.
These data standards will be useful for researchers, registry developers, and clinicians, and they are proposed as a framework for ICD-10 code development of COVID-19–related CV conditions, the writing group says.
The standards are also of “great importance” to patients, clinicians, investigators, scientists, administrators, public health officials, policymakers, and payers, the group says.
Dr. Das said that, although there is no formal plan in place to update the document, he could see sections that might be refined.
“For example, there’s a nice long list of all the various variants, and unfortunately, I suspect that that is going to change and evolve over time,” Dr. Das told this news organization.
“We tried very hard not to include things like specifying specific treatments so we didn’t get proscriptive. We wanted to make it descriptive, so hopefully it will stand the test of time pretty well,” he added.
This research had no commercial funding. The writing group has no relevant disclosures.
A version of this article first appeared on Medscape.com.
The American College of Cardiology and the American Heart Association have jointly issued a comprehensive set of data standards to help clarify definitions of the cardiovascular (CV) and non-CV complications of COVID-19.
It’s the work of the ACC/AHA Task Force on Clinical Data Standards and has been endorsed by the Heart Failure Society of America and Society for Cardiac Angiography and Interventions.
There is increased importance to understanding the acute and long-term impact of COVID-19 on CV health, the writing group notes. Until now, however, there has not been “clarity or consensus” on definitions of CV conditions related to COVID-19, with different diagnostic terminologies being used for overlapping conditions, such as “myocardial injury,” “myocarditis,” “type Il myocardial infarction,” “stress cardiomyopathy,” and “inflammatory cardiomyopathy,” they point out.
“We, as a research community, did some things right and some things wrong surrounding the COVID pandemic,” Sandeep Das, MD, MPH, vice chair of the writing group, noted in an interview with this news organization.
“The things that we really did right is that everybody responded with enthusiasm, kind of all hands on deck with a massive crisis response, and that was fantastic,” Dr. Das said.
“However, because of the need to hurry, we didn’t structure and organize in the way that we typically would for something that was sort of a slow burn kind of problem rather than an emergency. One of the consequences of that was fragmentation of how things are collected, reported, et cetera, and that leads to confusion,” he added.
The report was published simultaneously June 23 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes.
A necessary but not glamorous project
The new data standards for COVID-19 will help standardize definitions and set the framework to capture and better understand how COVID-19 affects CV health.
“It wasn’t exactly a glamorous-type project but, at the same time, it’s super necessary to kind of get everybody on the same page and working together,” Dr. Das said.
Broad agreement on common vocabulary and definitions will help with efforts to pool or compare data from electronic health records, clinical registries, administrative datasets, and other databases, and determine whether these data apply to clinical practice and research endeavors, the writing group says.
They considered data elements relevant to the full range of care provided to COVID-19 patients in all care settings. Among the key items included in the document are:
- Case definitions for confirmed, probable, and suspected acute COVID-19, as well as postacute sequelae of COVID-19.
- Definitions for acute CV complications related to COVID-19, including acute myocardial injury, heart failure, shock, arrhythmia, thromboembolic complications, and .
- Data elements related to COVID-19 vaccination status, comorbidities, and preexisting CV conditions.
- Definitions for postacute CV sequelae of SARS-CoV-2 infection and long-term CV complications of COVID-19.
- Data elements for CV mortality during acute COVID-19.
- Data elements for non-CV complications to help document severity of illness and other competing diagnoses and complications that might affect CV outcomes.
- A list of symptoms and signs related to COVID-19 and CV complications.
- Data elements for diagnostic and therapeutic strategies for COVID-19 and CV conditions.
- A discussion of advanced therapies, including , extracorporeal membrane oxygenation, and end-of-life management strategies.
These data standards will be useful for researchers, registry developers, and clinicians, and they are proposed as a framework for ICD-10 code development of COVID-19–related CV conditions, the writing group says.
The standards are also of “great importance” to patients, clinicians, investigators, scientists, administrators, public health officials, policymakers, and payers, the group says.
Dr. Das said that, although there is no formal plan in place to update the document, he could see sections that might be refined.
“For example, there’s a nice long list of all the various variants, and unfortunately, I suspect that that is going to change and evolve over time,” Dr. Das told this news organization.
“We tried very hard not to include things like specifying specific treatments so we didn’t get proscriptive. We wanted to make it descriptive, so hopefully it will stand the test of time pretty well,” he added.
This research had no commercial funding. The writing group has no relevant disclosures.
A version of this article first appeared on Medscape.com.
School shootings rose to highest number in 20 years, data shows
School shootings from 2020 to 2021 climbed to the highest point in 2 decades, according to a new report from the National Center for Education Statistics and the Bureau of Justice Statistics.
There were 93 shootings with casualties at public and private K-12 schools across the United States from 2020 to 2021, as compared with 23 in the 2000-2001 school year. The latest number included 43 incidents with deaths.
The annual report, which examines crime and safety in schools and colleges, also found a rise in cyberbullying and verbal abuse or disrespect of teachers during the past decade.
“While the lasting impact of these crime and safety issues cannot be measured in statistics alone, these data are valuable to the efforts of our policymakers, school officials and community members to identify and implement preventive and responsive measures,” Peggy Carr, PhD, the commissioner for the National Center for Education Statistics, said in a statement.
The report used a broad definition of shootings, which included instances when guns were fired or flashed on school property, as well as when a bullet hit school grounds for any reason and shootings that happened on school property during remote instruction throughout the COVID-19 pandemic.
More than 311,000 children at 331 schools have gone through gun violence since the shooting at Columbine High School in 1999, according to The Washington Post.
“The increase in shootings in schools is likely a consequence of an overall increase in gun violence and not specific to schools,” Dewey Cornell, PhD, a professor of education at the University of Virginia, Charlottesville, told the newspaper.
“However, most schools will never have a shooting, and their main problems will be fighting and bullying,” he said.
Between 2009 and 2020, the rate of nonfatal criminal victimization, including theft and violent crimes, decreased for ages 12-18, the report found. The rate fell from 51 victimizations per 1,000 students to 11. A major portion of the decline happened during the first year of the pandemic.
Lower percentages of public schools reported certain issues from 2019 to 2020 than from 2009 to 2010, the report found. For instance, 15% of schools reported student bullying at least once a week, as compared with 23% a decade ago. Student sexual harassment of other students dropped from 3% to 2%, and student harassment of other students based on sexual orientation or gender identity dropped from 3% to 2%.
At the same time, teachers faced more hardships, the report found. Schools reporting verbal abuse of teachers at least once a week rose to 10% in the 2019-2020 school year, as compared with 5% in the 2009-2010 school year. Schools reporting acts of disrespect for teachers climbed from 9% to 15%.
The percentage of schools that reported cyberbullying at least once a week doubled during the decade, rising from 8% in 2009-2010 to 16% in 2019-2020, the report found. The prominence of social media has likely added to that increase, the Post reported.
What’s more, about 55% of public schools offered mental health assessments in 2019-2020, and 42% offered mental health treatment services, the report found. The low rates could be linked to not having enough funding or access to licensed professionals, the newspaper reported.
A version of this article first appeared on WebMD.com.
School shootings from 2020 to 2021 climbed to the highest point in 2 decades, according to a new report from the National Center for Education Statistics and the Bureau of Justice Statistics.
There were 93 shootings with casualties at public and private K-12 schools across the United States from 2020 to 2021, as compared with 23 in the 2000-2001 school year. The latest number included 43 incidents with deaths.
The annual report, which examines crime and safety in schools and colleges, also found a rise in cyberbullying and verbal abuse or disrespect of teachers during the past decade.
“While the lasting impact of these crime and safety issues cannot be measured in statistics alone, these data are valuable to the efforts of our policymakers, school officials and community members to identify and implement preventive and responsive measures,” Peggy Carr, PhD, the commissioner for the National Center for Education Statistics, said in a statement.
The report used a broad definition of shootings, which included instances when guns were fired or flashed on school property, as well as when a bullet hit school grounds for any reason and shootings that happened on school property during remote instruction throughout the COVID-19 pandemic.
More than 311,000 children at 331 schools have gone through gun violence since the shooting at Columbine High School in 1999, according to The Washington Post.
“The increase in shootings in schools is likely a consequence of an overall increase in gun violence and not specific to schools,” Dewey Cornell, PhD, a professor of education at the University of Virginia, Charlottesville, told the newspaper.
“However, most schools will never have a shooting, and their main problems will be fighting and bullying,” he said.
Between 2009 and 2020, the rate of nonfatal criminal victimization, including theft and violent crimes, decreased for ages 12-18, the report found. The rate fell from 51 victimizations per 1,000 students to 11. A major portion of the decline happened during the first year of the pandemic.
Lower percentages of public schools reported certain issues from 2019 to 2020 than from 2009 to 2010, the report found. For instance, 15% of schools reported student bullying at least once a week, as compared with 23% a decade ago. Student sexual harassment of other students dropped from 3% to 2%, and student harassment of other students based on sexual orientation or gender identity dropped from 3% to 2%.
At the same time, teachers faced more hardships, the report found. Schools reporting verbal abuse of teachers at least once a week rose to 10% in the 2019-2020 school year, as compared with 5% in the 2009-2010 school year. Schools reporting acts of disrespect for teachers climbed from 9% to 15%.
The percentage of schools that reported cyberbullying at least once a week doubled during the decade, rising from 8% in 2009-2010 to 16% in 2019-2020, the report found. The prominence of social media has likely added to that increase, the Post reported.
What’s more, about 55% of public schools offered mental health assessments in 2019-2020, and 42% offered mental health treatment services, the report found. The low rates could be linked to not having enough funding or access to licensed professionals, the newspaper reported.
A version of this article first appeared on WebMD.com.
School shootings from 2020 to 2021 climbed to the highest point in 2 decades, according to a new report from the National Center for Education Statistics and the Bureau of Justice Statistics.
There were 93 shootings with casualties at public and private K-12 schools across the United States from 2020 to 2021, as compared with 23 in the 2000-2001 school year. The latest number included 43 incidents with deaths.
The annual report, which examines crime and safety in schools and colleges, also found a rise in cyberbullying and verbal abuse or disrespect of teachers during the past decade.
“While the lasting impact of these crime and safety issues cannot be measured in statistics alone, these data are valuable to the efforts of our policymakers, school officials and community members to identify and implement preventive and responsive measures,” Peggy Carr, PhD, the commissioner for the National Center for Education Statistics, said in a statement.
The report used a broad definition of shootings, which included instances when guns were fired or flashed on school property, as well as when a bullet hit school grounds for any reason and shootings that happened on school property during remote instruction throughout the COVID-19 pandemic.
More than 311,000 children at 331 schools have gone through gun violence since the shooting at Columbine High School in 1999, according to The Washington Post.
“The increase in shootings in schools is likely a consequence of an overall increase in gun violence and not specific to schools,” Dewey Cornell, PhD, a professor of education at the University of Virginia, Charlottesville, told the newspaper.
“However, most schools will never have a shooting, and their main problems will be fighting and bullying,” he said.
Between 2009 and 2020, the rate of nonfatal criminal victimization, including theft and violent crimes, decreased for ages 12-18, the report found. The rate fell from 51 victimizations per 1,000 students to 11. A major portion of the decline happened during the first year of the pandemic.
Lower percentages of public schools reported certain issues from 2019 to 2020 than from 2009 to 2010, the report found. For instance, 15% of schools reported student bullying at least once a week, as compared with 23% a decade ago. Student sexual harassment of other students dropped from 3% to 2%, and student harassment of other students based on sexual orientation or gender identity dropped from 3% to 2%.
At the same time, teachers faced more hardships, the report found. Schools reporting verbal abuse of teachers at least once a week rose to 10% in the 2019-2020 school year, as compared with 5% in the 2009-2010 school year. Schools reporting acts of disrespect for teachers climbed from 9% to 15%.
The percentage of schools that reported cyberbullying at least once a week doubled during the decade, rising from 8% in 2009-2010 to 16% in 2019-2020, the report found. The prominence of social media has likely added to that increase, the Post reported.
What’s more, about 55% of public schools offered mental health assessments in 2019-2020, and 42% offered mental health treatment services, the report found. The low rates could be linked to not having enough funding or access to licensed professionals, the newspaper reported.
A version of this article first appeared on WebMD.com.
FDA Class I recall: Batteries for CARESCAPE 2860 Ventilator
A total of 1,533 complaints allege that the batteries are draining much faster than expected, prompting manufacturer GE Healthcare to initiate the recall. There have been no injuries, and no deaths associated with the use of this device, according to an FDA corrected announcement.
Health care personnel and those patients who receive breathing support with these ventilators should be cautious about using CARESCAPE battery products moving forward, the agency said.
This type of ventilator is primarily powered by plugging into a wall outlet, but it has the capability to operate on backup batteries. These batteries are not solely for emergency situations such as power outages, but are also for routine situations such as transporting a patient within the hospital. GE Healthcare supplies these backup batteries with the ventilator, and sells replacements when they run out.
However, if the ventilator loses power because of battery malfunction, the patient may lose access to oxygen, leading to hypoxia, which can lead to brain injury and death. Therefore, if these batteries drain quicker than anticipated, it may put the patient at risk.
To prevent this danger, GE Healthcare recommends customers perform a battery performance test after they see this notice and every 3 months following. Consumers should take extra precaution and make sure their batteries are charged following a long period of inactivity. If the device is inactive for a while, the company says users should keep it plugged in to avoid draining the battery. Batteries should be replaced at a minimum of every 3 years.
When these devices are still plugged into the wall, they’re safe to use, according to the FDA. But when using the backup power source, clinicians should make sure to have alternative routes for breathing support on hand, such as with a bag-valve mask system.
There are 4,222 of these possibly defective batteries currently on the market. They were distributed from April 2, 2019, through April 18 of this year, when GE Healthcare stopped distributing these products and began the recall process. Any issues with these products should be reported to the FDA’s MedWatch database or by sending a medical device notification acknowledgment response to GE at the email address listed at the bottom of the recall announcement.
A version of this article first appeared on Medscape.com.
This article was updated 7/6/22.
A total of 1,533 complaints allege that the batteries are draining much faster than expected, prompting manufacturer GE Healthcare to initiate the recall. There have been no injuries, and no deaths associated with the use of this device, according to an FDA corrected announcement.
Health care personnel and those patients who receive breathing support with these ventilators should be cautious about using CARESCAPE battery products moving forward, the agency said.
This type of ventilator is primarily powered by plugging into a wall outlet, but it has the capability to operate on backup batteries. These batteries are not solely for emergency situations such as power outages, but are also for routine situations such as transporting a patient within the hospital. GE Healthcare supplies these backup batteries with the ventilator, and sells replacements when they run out.
However, if the ventilator loses power because of battery malfunction, the patient may lose access to oxygen, leading to hypoxia, which can lead to brain injury and death. Therefore, if these batteries drain quicker than anticipated, it may put the patient at risk.
To prevent this danger, GE Healthcare recommends customers perform a battery performance test after they see this notice and every 3 months following. Consumers should take extra precaution and make sure their batteries are charged following a long period of inactivity. If the device is inactive for a while, the company says users should keep it plugged in to avoid draining the battery. Batteries should be replaced at a minimum of every 3 years.
When these devices are still plugged into the wall, they’re safe to use, according to the FDA. But when using the backup power source, clinicians should make sure to have alternative routes for breathing support on hand, such as with a bag-valve mask system.
There are 4,222 of these possibly defective batteries currently on the market. They were distributed from April 2, 2019, through April 18 of this year, when GE Healthcare stopped distributing these products and began the recall process. Any issues with these products should be reported to the FDA’s MedWatch database or by sending a medical device notification acknowledgment response to GE at the email address listed at the bottom of the recall announcement.
A version of this article first appeared on Medscape.com.
This article was updated 7/6/22.
A total of 1,533 complaints allege that the batteries are draining much faster than expected, prompting manufacturer GE Healthcare to initiate the recall. There have been no injuries, and no deaths associated with the use of this device, according to an FDA corrected announcement.
Health care personnel and those patients who receive breathing support with these ventilators should be cautious about using CARESCAPE battery products moving forward, the agency said.
This type of ventilator is primarily powered by plugging into a wall outlet, but it has the capability to operate on backup batteries. These batteries are not solely for emergency situations such as power outages, but are also for routine situations such as transporting a patient within the hospital. GE Healthcare supplies these backup batteries with the ventilator, and sells replacements when they run out.
However, if the ventilator loses power because of battery malfunction, the patient may lose access to oxygen, leading to hypoxia, which can lead to brain injury and death. Therefore, if these batteries drain quicker than anticipated, it may put the patient at risk.
To prevent this danger, GE Healthcare recommends customers perform a battery performance test after they see this notice and every 3 months following. Consumers should take extra precaution and make sure their batteries are charged following a long period of inactivity. If the device is inactive for a while, the company says users should keep it plugged in to avoid draining the battery. Batteries should be replaced at a minimum of every 3 years.
When these devices are still plugged into the wall, they’re safe to use, according to the FDA. But when using the backup power source, clinicians should make sure to have alternative routes for breathing support on hand, such as with a bag-valve mask system.
There are 4,222 of these possibly defective batteries currently on the market. They were distributed from April 2, 2019, through April 18 of this year, when GE Healthcare stopped distributing these products and began the recall process. Any issues with these products should be reported to the FDA’s MedWatch database or by sending a medical device notification acknowledgment response to GE at the email address listed at the bottom of the recall announcement.
A version of this article first appeared on Medscape.com.
This article was updated 7/6/22.